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MS210500 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE To perform a r and omized trial comparing 70 and 80 Gy radiotherapy for prostate cancer . PATIENTS AND METHODS A total of 306 patients with localized prostate cancer were r and omized . No and rogen deprivation was allowed . The primary endpoint was biochemical relapse according to the modified 1997-American Society for Therapeutic Radiology and Oncology and Phoenix definitions . Toxicity was grade d using the Radiation Therapy Oncology Group 1991 criteria and the late effects on normal tissues-subjective , objective , management , analytic scales ( LENT-SOMA ) scales . The patients ' quality of life was scored using the European Organization for Research and Treatment of Cancer Quality of Life Question naire 30-item cancer-specific and 25-item prostate-specific modules . RESULTS The median follow-up was 61 months . According to the 1997-American Society for Therapeutic Radiology and Oncology definition , the 5-year biochemical relapse rate was 39 % and 28 % in the 70- and 80-Gy arms , respectively ( p = .036 ) . Using the Phoenix definition , the 5-year biochemical relapse rate was 32 % and 23.5 % , respectively ( p = .09 ) . The subgroup analysis showed a better biochemical outcome for the higher dose group with an initial prostate-specific antigen level > 15 ng/mL. At the last follow-up date , 26 patients had died , 10 of their disease and none of toxicity , with no differences between the two arms . According to the Radiation Therapy Oncology Group scale , the Grade 2 or greater rectal toxicity rate was 14 % and 19.5 % for the 70- and 80-Gy arms ( p = .22 ) , respectively . The Grade 2 or greater urinary toxicity was 10 % at 70 Gy and 17.5 % at 80 Gy ( p = .046 ) . Similar results were observed using the LENT-SOMA scale . Bladder toxicity was more frequent at 80 Gy than at 70 Gy ( p = .039 ) . The quality -of-life question naire results before and 5 years after treatment were available for 103 patients with no differences found between the 70- and 80-Gy arms . CONCLUSION High-dose radiotherapy provided a better 5-year biochemical outcome with slightly greater toxicity Summary Background Patient-reported outcomes ( PROs ) might detect more toxic effects of radiotherapy than do clinician-reported outcomes . We did a quality of life ( QoL ) sub study to assess PROs up to 24 months after conventionally fractionated or hypofractionated radiotherapy in the Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy in Prostate Cancer ( CHHiP ) trial . Methods The CHHiP trial is a r and omised , non-inferiority phase 3 trial done in 71 centres , of which 57 UK hospitals took part in the QoL sub study . Men with localised prostate cancer who were undergoing radiotherapy were eligible for trial entry if they had histologically confirmed T1b – T3aN0M0 prostate cancer , an estimated risk of seminal vesicle involvement less than 30 % , prostate-specific antigen concentration less than 30 ng/mL , and a WHO performance status of 0 or 1 . Participants were r and omly assigned ( 1:1:1 ) to receive a st and ard fractionation schedule of 74 Gy in 37 fractions or one of two hypofractionated schedules : 60 Gy in 20 fractions or 57 Gy in 19 fractions . R and omisation was done with computer-generated permuted block sizes of six and nine , stratified by centre and National Comprehensive Cancer Network ( NCCN ) risk group . Treatment allocation was not masked . UCLA Prostate Cancer Index ( UCLA-PCI ) , including Short Form (SF)-36 and Functional Assessment of Cancer Therapy-Prostate ( FACT-P ) , or Exp and ed Prostate Cancer Index Composite ( EPIC ) and SF-12 quality -of-life question naires were completed at baseline , pre-radiotherapy , 10 weeks post-radiotherapy , and 6 , 12 , 18 , and 24 months post-radiotherapy . The CHHiP trial completed accrual on June 16 , 2011 , and the QoL sub study was closed to further recruitment on Nov 1 , 2009 . Analysis was on an intention-to-treat basis . The primary endpoint of the QoL sub study was overall bowel bother and comparisons between fractionation groups were done at 24 months post-radiotherapy . The CHHiP trial is registered with IS RCT N registry , number IS RCT N97182923 . Findings 2100 participants in the CHHiP trial consented to be included in the QoL sub study : 696 assigned to the 74 Gy schedule , 698 assigned to the 60 Gy schedule , and 706 assigned to the 57 Gy schedule . Of these individuals , 1659 ( 79 % ) provided data pre-radiotherapy and 1444 ( 69 % ) provided data at 24 months after radiotherapy . Median follow-up was 50·0 months ( IQR 38·4–64·2 ) on April 9 , 2014 , which was the most recent follow-up measurement of all data collected before the QoL data were analysed in September , 2014 . Comparison of 74 Gy in 37 fractions , 60 Gy in 20 fractions , and 57 Gy in 19 fractions groups at 2 years showed no overall bowel bother in 269 ( 66 % ) , 266 ( 65 % ) , and 282 ( 65 % ) men ; very small bother in 92 ( 22 % ) , 91 ( 22 % ) , and 93 ( 21 % ) men ; small bother in 26 ( 6 % ) , 28 ( 7 % ) , and 38 ( 9 % ) men ; moderate bother in 19 ( 5 % ) , 23 ( 6 % ) , and 21 ( 5 % ) men , and severe bother in four ( < 1 % ) , three ( < 1 % ) and three ( < 1 % ) men respectively ( 74 Gy vs 60 Gy , ptrend=0.64 , 74 Gy vs 57 Gy , ptrend=0·59 ) . We saw no differences between treatment groups in change of bowel bother score from baseline or pre-radiotherapy to 24 months . Interpretation The incidence of patient-reported bowel symptoms was low and similar between patients in the 74 Gy control group and the hypofractionated groups up to 24 months after radiotherapy . If efficacy outcomes from CHHiP show non-inferiority for hypofractionated treatments , these findings will add to the growing evidence for moderately hypofractionated radiotherapy schedules becoming the st and ard treatment for localised prostate cancer . Funding Cancer Research UK , Department of Health , and the National Institute for Health Research Cancer Research Network BACKGROUND Tissue preservation by means of focal therapy offers some men with clinical ly significant prostate cancer an alternative to st and ard care that appears to confer favourable genito-urinary outcomes . The precise estimates of these outcomes have so far been based on small series . OBJECTIVE This analysis pools the sexual domain related patient reported outcomes from three prospect i ve , registered studies that represent a range of inclusion criteria . DESIGN , SETTING , AND PARTICIPANTS One-hundred and eighteen men with localised prostate cancer ( prostate specific antigen ≤ 15ng/ml , Gleason ≤ 4 + 3 , stage ≤ T3aN0M0 ) treated in a tissue-preserving manner using high intensity focused ultrasound from three registered studies were included . Data on International Index of Erectile Function ( IIEF-5 ) scores and use of phosphodiesterase-5-inhibitors were collected at baseline , and 1 mo , 3 mo , 6 mo , 9 mo , and 12 mo postoperatively . The IIEF-15 total and individual domain scores were used to assess overall sexual function . Urinary function was assessed with the International Prostate Symptom Score ( IPSS ) , IPSS quality -of-life , and UCLA-Exp and ed Prostate Cancer Index Composite continence question naires . General health status was derived by means of the Charlson score . Multiple linear regression was used to assess whether age , grade , stage , qualitative scores ( IIEF , IPSS , Exp and ed Prostate Cancer Index Composite , Charlson ) , or focal therapy type duration were associated with IIEF-5 and IIEF-15 scores at 12 mo . RESULTS AND LIMITATIONS Median age was 63 yr ( interquartile range [ IQR ] 52 - 70 yr ) . Median IIEF-erectile score at baseline was 23 ( IQR 11 - 28 ) . This declined significantly to 9 ( IQR 3 - 22 , p<0.01 ) at 1 mo , but improved to 20 ( IQR 9 - 29 , p=0.30 ) at 1 yr posttreatment . Changes in total IIEF and other IIEF domains were only significantly different from preoperative values at 1 mo and 3 mo postoperatively . In the same period , the proportion of men using phosphodiesterase-5-inhibitors was 10 % preoperatively , reaching 43 % and 42 % at 6 mo and 9 months before declining to 37 % at 1 yr . The only baseline determinants of postoperative erectile function were total IIEF and IIEF-erectile function scores ( p=0.002 ) . The primary limitation of our study is the relatively short follow-up of 1 yr . CONCLUSION Men who received a range of tissue preserving therapies from the three pertinent studies experienced small decreases in total IIEF , erectile , and individual sexual domain scores that are not significantly different to those recorded at baseline . The only determinant of erectile dysfunction after tissue preserving therapy was preoperative erectile dysfunction status . Tissue preservation confers a high probability of maintaining erectile function that appears independent of all perioperative factors with the exception of baseline status . PATIENT SUMMARY In this report , the largest prospect ively collected and published set of patients with erectile dysfunction outcomes post-focal therapy for prostate cancer , we have found a return to baseline International Index of Erectile Function-erectile and total International Index of Erectile Function scores by 6 mo post-focal therapy which was maintained at 1 yr , with the majority of patients not on any form of medical treatment for their erectile dysfunction at that point . Focal therapy may represent a suitable alternative for men of any age or comorbidity wishing to maintain erectile function This study prospect ively evaluated quality of life ( QOL ) in localized prostate cancer patients undergoing radiotherapy , and it examined the relationships between QOL , depression , fatigue , and sleep disturbance . Instruments that were used are Functional Assessment of Cancer Therapy for Prostate ( FACT-P ) , Beck Depression Inventory ( BDI ) , Piper Fatigue Scale ( PFS ) , and Epworth Sleepiness Scale ( ESS ) . We evaluated patients at preradiotherapy ( PRT ) , midway radiotherapy ( MRT ) , completion of radiotherapy ( CRT ) , follow-up radiotherapy ( 4 to 8 wk ) ( FRT ) , and long-term follow-up radiotherapy ( FRT2 ) ( 12 mo or more ) . Forty participants with a mean age of 67.8 yr were studied . Duration of radiotherapy was 7 - 8 wk . Mean long-term follow-up period post-CRT was 16.2 mo ( range 12- 24 mo ) . All patients had clinical T1c to T2b prostate cancer . Prostate Cancer Specific ( PCS ) and Physical Well-Being ( PWB ) subscales of FACT-P , scores at MRT and CRT were significantly lower than at PRT . At FRT2 , PWB scores declined further , while PCS scores increased . PFS median scores were significantly higher at CRT and at FRT2 as compared with PRT . Patients scoring higher on PFS were more likely to report a poorer QOL and PWB as measured with FACT-P question naire . No significant changes were noted in the BDI and ESS scores during the study periods . The PWB declined during and at CRT and worsened at FRT2 . Decline in PCS subscale scores during and at CRT reflects worsening of urinary symptoms and appearance of bowel problems . The scores improved at long-term follow-up . A relationship was found to exist between physical well-being and fatigue BACKGROUND The proportion of younger men ( < 65 years ) diagnosed with prostate cancer ( PCa ) has increased significantly . We sought to analyze the association between race/ethnicity , biochemical recurrence risk and outcomes in younger men with PCa . METHODS In this prospect i ve cohort study , we recruited 318 younger men with newly diagnosed PCa . Participants completed generic and prostate-specific Health Related Quality of Life ( HRQoL ) , out-of-pocket cost and satisfaction with care surveys at baseline and at 3 , 6 , 12 , and 24 months of follow-up . Health re source utilization and cost data were obtained from the hospital based administrative data bases . We compared time to return to baseline ( RTB ) of HRQoL scores across groups . Survival curves were used to compare mean time to RTB across groups . Linear mixed effects ( LMEs ) and generalized linear ( GLM ) models were used to analyze the association of race/ethnicity and biochemical recurrence groups with outcomes . RESULTS African Americans reported lower generic and prostate
Output:
| These patterns persisted up to the 5th year .
High-intensity focused ultrasound and active surveillance only have results at 1st year , showing no statistically significant worsening .
No remarkable differences in PRO appeared between modalities within each treatment . |
MS210501 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Spatial analyses of the effect of insecticide (permethrin)-treated bed nets ( ITNs ) on nearby households both with and without ITNs was performed in the context of a large-scale , group-r and omized , controlled mortality trial in Asembo , western Kenya . Results illustrate a protective effect of ITNs on compounds lacking ITNs located within 300 meters of compounds with ITNs for child mortality , moderate anemia , high-density parasitemia , and hemoglobin levels . This community effect on nearby compounds without nets is approximately as strong as the effect observed within villages with ITNs . This implies that in areas with intense malaria transmission with high ITN coverage , the primary effect of insecticide-treated nets is via area-wide effects on the mosquito population and not , as commonly supposed , by simple imposition of a physical barrier protecting individuals from biting . The strength of the community effect depended upon the proportion of nearby compounds with treated nets . To maximize their public health impact , high coverage with treated nets is essential The effectiveness of insecticide-treated bednets ( ITBN ) in preventing malaria and anaemia among primigravidae living in Kilifi District , Kenya , was assessed by a r and omized controlled trial between September 1994 and November 1995 . All residents within 28 community clusters received ITBN in July 1993 , whilst residents of another 28 clusters served as contemporaneous controls . All resident primigravid women with singleton pregnancies attending antenatal care at Kilifi District Hospital were eligible for recruitment . 503 primigravidae were recruited . 91.4 % were anaemic antenatally ( Hb < 11 g/dl ) : 91.0 % from the intervention arm and 92.0 % from the control arm . Severe anaemia ( Hb < 7 g/dl ) was found among 15.1 % of intervention women and 20.1 % of control women ( P = 0.28 ) . No significant differences were observed in reports of febrile illness or the presence of chloroquine in the serum or peripheral parasitaemia during the third trimester between the two groups . In the women delivering in hospital ( n = 130 ) , there was no association between placental malaria infection and the intervention : 77.4 % of placentas from control women had evidence of past or active infection , compared with 72.0 % of placentas from intervention women ( P = 0.76 ) . Similarly , in the women delivering in hospital , ITBN did not improve birth weight , and there were no differences in perinatal mortality between the two study groups . Despite ITBN having a great impact on paediatric severe malaria and mortality in this transmission setting , there was very little impact of ITBN on the morbidity associated with malaria infection in primigravidae . Alternative strategies are required to tackle this continued public health problem for pregnant women living in endemic areas similar to the Kenyan Coast The impact of insecticide (permethrin)-treated bed nets ( ITNs ) on malaria in pregnancy was studied in a rural area in western Kenya with intense perennial malaria transmission . All households in 40 of 79 villages were r and omized to receive ITNs by January 1997 . The ITNs were distributed in control villages two years later . Complete data on birth outcome were available on 2,754 ( 89.6 % ) of 3,072 deliveries . Women ( n = 780 ) were followed monthly throughout pregnancy in 19 of 79 villages . Among gravidae 1 - 4 , ITNs were associated with reductions of 38 % ( 95 % confidence interval [ CI ] = 17 - 54 % ) in the incidence of malaria parasitemia and 47 % ( 95 % CI = 6 - 71 % ) in the incidence of severe malarial anemia ( hemoglobin level < 8 g/dL with parasitemia ) during pregnancy . At the time of delivery , mean hemoglobin levels were 0.6 g/dL ( 95 % CI = 0.01 - 1.2 g/dL ) higher , the prevalence of placental or maternal malaria was reduced by 35 % ( 95 % CI = 20 - 47 % ) , and the prevalence of low birth weight was reduced by 28 % ( 95 % CI = 2 - 47 % ) in gravidae 1 - 4 from ITN villages . No beneficial impact was observed in gravidae five or higher . In areas of intense perennial malaria transmission , permethrin-treated bed nets reduce the adverse effect of malaria during the first four pregnancies As part of a community-based , group-r and omized , controlled trial of insecticide-treated bed nets ( ITNs ) in an area with intense malaria transmission in western Kenya , a birth cohort ( n = 833 ) was followed monthly until the age of 24 months to determine the potential beneficial and adverse effects of reduced malaria exposure during pregnancy and infancy . Malaria transmission and morbidity were comparable pre-intervention . The ITNs reduced malaria attack rates ( force of infection ) in infancy by 74 % , and delayed the median time-to-first parasitemia ( 4.5 to 10.7 months ; P < 0.0001 ) . The incidence of both clinical malaria and moderate-severe anemia ( hemoglobin level < 7 g/dL ) were reduced by 60 % ( P < 0.001 for both ) . Protective efficacy was greatest in infants less than three months old and similar in older infants and one-year-old children . Efficacy was lowest in the dry season . Infants from ITN villages experienced better height and weight gain . In areas of intense perennial malaria transmission , ITNs substantially reduce exposure to malaria and subsequent malaria-associated morbidity in children less than 24 months old . Reduced malaria exposure during infancy did not result , with continued ITN use , in increased malaria morbidity in one-year-old children A prospect i ve comparison of the antimalarial efficacy of bed nets was conducted with 341 pregnant women living in a mesoendemic malarious area of the Thai-Burmese border . Women in 3 adjacent study sites were allocated at r and om to receive either a single size permethrin-impregnated bed net ( PIB ) , a non-impregnated bed net ( NIB ) , or to a control group who used either their own family size non-impregnated bed net ( FNIB ) or no net . In one study site , but not the other 2 , PIB significantly reduced parasite densities and , together with FNIB , reduced the incidence of malaria in pregnancy from 56 % to 33 % ( relative risk = 1.67 , confidence interval = 1.07 - 2.61 , P = 0.03 , allowing for parity ) . Anaemia proved a more sensitive marker of bed net antimalarial efficacy than parasite rates . The incidence of anaemia ( haematocrit < 30 % ) at all study sites was significantly lower at delivery in the PIB ( 27 % ) and FNIB groups ( 21 % ) than in the NIB group ( 41 % ) or those using no net ( 56 % ) . This suggests that a significant proportion of the malaria in pregnancy in this mesoendemic area was sub-patent . Both patent Plasmodium falciparum parasitaemia and anaemia were associated with a reduction in birth weight . Infant mortality was high ( 16 % ) and strongly associated with prematurity , low birth weight and maternal anaemia . PIB were well tolerated and had no apparent adverse effect on the pregnancy or infant development . Although the overall effect of bed nets on patent parasitaemia was marginal , they were associated with a significant reduction in maternal malaria-associated anaemia . ( ABSTRACT TRUNCATED AT 250 WORDS To compare the effects of intermittent treatment with sulfadoxine-pyrimethamine ( SP ) given during the second and third trimester of pregnancy , the use of insecticide-treated nets ( ITN ) , or the combination of both on haemoglobin ( Hb ) levels during pregnancy , a r and omized , placebo-controlled intervention trial was conducted in a malaria-endemic area of western Kenya from July 1997 to September 1999 . Primigravidae and secundigravidae were enrolled into the study and r and omized into 4 intervention groups : ( i ) ITNs and SP , ( ii ) ITNs and placebo SP , ( iii ) SP alone , and ( iv ) placebo SP . All groups were offered case management and iron and folic acid supplementation . Seven hundred and fifty-two women were followed until delivery ( 53.2 % were primigravidae and 46.8 % secundigravidae ) . Among primigravidae in all the groups there was a significant improvement in Hb levels at delivery ( 107.6 g/L ) compared with recruitment ( 101.9 g/L ) ( P < 0.006 ) with the greatest improvement in the combination ITNs + SP group . The protective efficacy of ITNs + SP on anaemia was 55.8 % ( 95 % CI 30.6 - 71.8 ) , of SP alone 50.9 % ( 95 % CI 22.2 - 69.0 ) , and of ITNs 41.6 % ( 95 % CI 9.8 - 62.3 ) . Among secundigravidae , Hb levels were slightly lower at delivery compared with recruitment ( P = 0.03 ) . It was concluded that malaria is a major cause of anaemia in primigravidae but that other causes play a more significant role in secundigravidae , and that intermittent treatment with SP or use of ITNs benefits primigravidae more than secundigravidae Effects of the distribution in space of permethrin (insecticide)-impregnated bed nets ( IIBNS ) on child mortality were studied in a r and omized controlled trial of IIBNs in a an area highly endemic for Plasmodium falciparum malaria in rural northern Ghana . Eight hundred sixty-two deaths occurred among children 6 - 59 months of age during 16,841 child-years-at-risk . Mortality increased with the distance from health facilities but not with proximity to identifiable anopheline breeding sites ( reservoirs ) . The efficacy of IIBNs was independent of these distances . Mortality in users of IIBNs was independent of the proximity of nonusers , and mortality rates of nonusers and users living close to each other were similar . Poisson regression estimated a 6.7 % increase in mortality among nonusers with each 100-m shift away from the nearest compound with IIBNS , indicating that the insecticide protects nearby nonusers . High coverage of IIBNs achieves maximum impact , but users of IIBNs offer some protection to less fortunate neighbors if coverage is incomplete The impact of insecticide-treated bednet use on malaria and anaemia in pregnancy was assessed , as a supplementary study , in a major WHO/TDR-supported bednet trial in northern Ghana between July 1994 and April 1995 . The study area was divided into 96 clusters of compounds , with 48 clusters being r and omly allocated to intervention . All pregnant women were included in the study but the focus was on primigravidae and secundigravidae . 1961 pregnant women were recruited into the study --1033 ( 52.7 % ) in the treated bednet group and 928 ( 47.3 % ) in the no net group . 1806 ( 92.1 % ) had blood taken for malaria microscopy and haemoglobin determination in the third trimester . Pregnancy outcomes were reported for 847 women . The characteristics of women in intervention and control groups were comparable . The odds ratios , with 95 % confidence interval ( CI ) , for different study endpoints were , for Plasmodium falciparum parasitaemia--0.89 ( 0.73 , 1.08 ) , for anaemia--0.88 ( 0.70 , 1.09 ) , for low birthweight (LBW)--0.87 ( 0.63 , 1.19 ) , indicating no benefit for treated bednet use . Effective net use by parity varied from 42 % in primigravidae to 63 % in multigravidae , in spite of free nets and insecticide impregnation . The main reasons for not using a net were warm weather and perceived absence of mosquito biting . Chloroquine use in pregnancy was low and comparable in both groups . Implication s of findings for malaria control in pregnancy and further research are discussed
Output:
| The trial in Thail and , which r and omised individuals to ITNs or untreated nets , showed reductions in anaemia and fetal loss in all gravidae , but not reductions in clinical malaria or low birth weight .
CONCLUSIONS ITNs used throughout pregnancy or from mid-pregnancy onwards have a beneficial impact on pregnancy outcome in malaria-endemic Africa in the first few pregnancies . |
MS210502 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Trastuzumab plus chemotherapy has become the st and ard of care for women with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer . Trastuzumab-based pre-operative systemic ( neo-adjuvant ) therapy ( PST ) also appears promising , warranting further investigation . PATIENTS AND METHODS Patients with HER2-positive , stage II/III non-inflammatory , operable breast cancer requiring a mastectomy ( but who wished to conserve the breast ) received weekly trastuzumab and 3-weekly docetaxel for six cycles before surgery . The primary end point was pathological complete response ( pCR ) rate , determined from surgical specimens . RESULTS Thirty-three patients were enrolled . The majority ( 79 % ) had T2 tumors , with 42 % being N1/2 . Twenty-nine patients completed six cycles of therapy and one patient withdrew prematurely due to progressive disease . A complete or partial objective clinical response was seen in 96 % ( 73 % and 23 % , respectively ) of patients . Surgery was performed in 30 patients , breast conserving in 23 ( 77 % ) . In an intention-to-treat analysis , tumor and nodal pCR was seen in 14 ( 47 % ) patients . Treatment was generally well tolerated . Grade 3/4 neutropenia occurred in 85 % of patients while febrile neutropenia was encountered in 18 % . Only three patients withdrew prematurely due to toxicity . No symptomatic cardiac dysfunction was reported . CONCLUSIONS PST with trastuzumab plus docetaxel achieved promising efficacy , with a high pCR rate and good tolerability , in women with stage II or III HER2-positive breast cancer BACKGROUND Studies with pertuzumab , a novel anti-HER2 antibody , show improved efficacy when combined with the established HER2-directed antibody trastuzumab in breast cancer therapy . We investigated the combination of pertuzumab or trastuzumab , or both , with docetaxel and the combination of pertuzumab and trastuzumab without chemotherapy in the neoadjuvant setting . METHODS In this multicentre , open-label , phase 2 study , treatment-naive women with HER2-positive breast cancer were r and omly assigned ( 1:1:1:1 ) central ly and stratified by operable , locally advanced , and inflammatory breast cancer , and by hormone receptor expression to receive four neoadjuvant cycles of : trastuzumab ( 8 mg/kg loading dose , followed by 6 mg/kg every 3 weeks ) plus docetaxel ( 75 mg/m(2 ) , escalating , if tolerated , to 100 mg/m(2 ) every 3 weeks ; group A ) or pertuzumab ( loading dose 840 mg , followed by 420 mg every 3 weeks ) and trastuzumab plus docetaxel ( group B ) or pertuzumab and trastuzumab ( group C ) or pertuzumab plus docetaxel ( group D ) . The primary endpoint , examined in the intention-to-treat population , was pathological complete response in the breast . Neither patients nor investigators were masked to treatment . This study is registered with Clinical Trials.gov , number NCT00545688 . FINDINGS Of 417 eligible patients , 107 were r and omly assigned to group A , 107 to group B , 107 to group C , and 96 to group D. Patients given pertuzumab and trastuzumab plus docetaxel ( group B ) had a significantly improved pathological complete response rate ( 49 of 107 patients ; 45·8 % [ 95 % CI 36·1 - 55·7 ] ) compared with those given trastuzumab plus docetaxel ( group A ; 31 of 107 ; 29·0 % [ 20·6 - 38·5 ] ; p=0·0141 ) . 23 of 96 ( 24·0 % [ 15·8 - 33·7 ] ) women given pertuzumab plus docetaxel ( group D ) had a pathological complete response , as did 18 of 107 ( 16·8 % [ 10·3 - 25·3 ] ) given pertuzumab and trastuzumab ( group C ) . The most common adverse events of grade 3 or higher were neutropenia ( 61 of 107 women in group A , 48 of 107 in group B , one of 108 in group C , and 52 of 94 in group D ) , febrile neutropenia ( eight , nine , none , and seven , respectively ) , and leucopenia ( 13 , five , none , and seven , respectively ) . The number of serious adverse events was similar in groups A , B , and D ( 15 - 20 serious adverse events per group in 10 - 17 % of patients ) but lower in group C ( four serious adverse events in 4 % of patients ) . INTERPRETATION Patients given pertuzumab and trastuzumab plus docetaxel ( group B ) had a significantly improved pathological complete response rate compared with those given trastuzumab plus docetaxel , without substantial differences in tolerability . Pertuzumab and trastuzumab without chemotherapy eradicated tumours in a proportion of women and showed a favourable safety profile . These findings justify further exploration in adjuvant trials and support the neoadjuvant approach for accelerating drug assessment in early breast cancer . FUNDING F Hoffmann-La Roche BACKGROUND We compared the efficacy and safety of the addition of lapatinib versus trastuzumab to anthracycline-taxane-based neoadjuvant chemotherapy . METHODS In the GeparQuinto r and omised phase 3 trial , patients with untreated HER2-positive operable or locally advanced breast cancer were enrolled between Nov 7 , 2007 , and July 9 , 2010 . Patients were eligible if their tumours were classified as cT3/4a-d , or hormone receptor (HR)-negative , HR-positive with clinical ly node-positive and cT2 disease ( cT2 cN+ ) , or HR-positive and pathologically node-positive in the sentinel lymph node for those with cT1 disease ( cT1 pN(SLN+ ) ) . Patients were r and omly assigned in a 1:1 ratio to receive neoadjuvant treatment with four cycles of EC ( epirubicin [ 90 mg/m(2 ) intravenously ] plus cyclophosphamide [ 600 mg/m(2 ) intravenously ] , every 3 weeks ) , and four cycles of docetaxel ( 100 mg/m(2 ) intravenously every 3 weeks ) with either trastuzumab ( 6 mg/kg intravenously , with a starting loading dose of 8 mg/kg , for eight cycles , every 3 weeks ) or lapatinib ( 1000 - 1250 mg per day orally ) throughout all cycles before surgery . R and omisation was done by dynamic allocation with the minimisation method of Pocock and patients were stratified by participating site , HR status , and extent of disease ( cT1 - 3 cN0 - 2 vs T4 or N3 ) . The primary endpoint was pathological complete response ( defined as ypT0 and ypN0 ) and was analysed in all patients who received at least one cycle of EC . Participants and investigators were not masked to treatment assignment . Pathologists in centres assessing surgery outcomes were masked to group assignment . This trial is registered with Clinical Trials.gov , number NCT00567554 . FINDINGS Of 620 eligible patients , 309 were r and omly assigned to chemotherapy with trastuzumab ( ECH-TH group ) and 311 to chemotherapy with lapatinib ( ECL-TL group ) . Two patients in the ECH-TH group and three patients in the ECL-TL group did not start treatment because of withdrawal of consent or immediate surgery . 93 ( 30·3 % ) of 307 patients in the ECH-TH group and 70 ( 22·7 % ) of 308 patients in the ECL-TL group had a pathological complete response ( odds ratio [ OR ] 0·68 [ 95%CI 0·47 - 0·97 ] ; p=0·04 ) . Chemotherapy with trastuzumab was associated with more oedema ( 119 [ 39·1 % ] vs 88 [ 28·7 % ] ) and dyspnoea ( 90 [ 29·6 % ] vs 66 [ 21·4 % ] ) , and ECL-TL with more diarrhoea ( 231 [ 75·0 % ] vs 144 [ 47·4 % ] ) and skin rash ( 169 [ 54·9 % ] vs 97 [ 31·9 % ] ) . 43 ( 14·0 % ) patients discontinued in the ECH-TH group and 102 ( 33·1 % ) in the ECL-TL group . 70 serious adverse events were reported in the ECH-TH group and 87 in the ECL-TL group . INTERPRETATION This direct comparison of trastuzumab and lapatinib showed that pathological complete response rate with chemotherapy and lapatinib was significantly lower than that with chemotherapy and trastuzumab . Unless long-term outcome data show different results , lapatinib should not be used outside of clinical trials as single anti-HER2-treatment in combination with neoadjuvant chemotherapy . FUNDING GlaxoSmithKline , Roche , and Sanofi-Aventis The objective of this study is to evaluate the efficacy and safety profile of the doxorubicin followed by cisplatin/docetaxel as primary chemotherapy for patients with locally advanced breast cancer ( LABC ) . For this evaluation , 59 patients with LABC ( T2–T4 , N0–N2 , M0 ) received three cycles of doxorubicin , followed by three cycles of cisplatin/docetaxel and followed by definitive surgery and locoregional radiotherapy with or without tamoxifen . The primary end point was pathologic complete response ( pCR ) in breast and axilla . Fifty-nine patients were evaluable for analysis : median age : 41 years , premenopausal : 68 % , median tumor size : 6.0 cm ( 4–10 ) , Stage IIB : 32 % and IIIA/IIIB : 68 % , both ER/PR positive : 53 % , Her2/neu ( 3 + ) by IHC staining : 29 % . Clinical complete response was seen in 44 % , and clinical partial response was seen in 56 % . Breast conserving surgery was performed in 44 % , and MRM in 56 % . pCR in the breast was 30.5 % , in axilla was 37 % , and pCR in both breast and axilla was 24 % . Overall at follow-up of 60 months , the disease-free ( DFS ) and overall survival ( OS ) were 70 and 82 % , respectively . The DFS and OS of patients who achieved complete pathologic response in breast and axilla were 78 and 100 % , respectively , while 14 patients relapsed of which 46 % were Her2 positive . Sequential combination of doxorubicin followed by docetaxel/cisplatin is a safe , feasible , and active combination , which offers the possibility of conservative surgery and is associated with high clinical and pathologic response rates , with promising and encouraging survival outcomes BACKGROUND To evaluate capecitabine-docetaxel ( XT ) , with trastuzumab ( H ) in human epidermal growth factor receptor 2 (HER2)-positive disease , in inoperable locally advanced breast cancer ( LABC ) . PATIENTS AND METHODS Patients received up to six neoadjuvant 21-day cycles of capecitabine 900 mg/m(2 ) twice daily , days 1 - 14 , plus docetaxel 36 mg/m(2 ) , days 1 and 8 . Patients with HER2-positive disease also received trastuzumab 6 mg/kg every 3 weeks . The primary end point was pathologic complete response ( pCR ) rate , evaluated separately in HER2-negative and HER2-positive cohorts . Secondary end points included clinical response rates and tolerability . RESULTS The pCR rate was 15 % [ 95 % confidence interval ( CI ) 7 - 28 ] in 53 patients receiving XT and 40 % ( 95 % CI 26 - 55 ) in 50 patients receiving HXT . After neoadjuvant therapy , 50 patients receiving XT and 45 receiving HXT underwent surgery . No unexpected toxicity was observed : the most common grade ≥3 adverse events were diarrhea/mucositis ( 30 % and 20 % , respectively ) and grade 3 h and -foot syndrome ( 11 % and 6 % , respectively ) . Disease-free survival and overall survival were similar with XT and HXT after median follow-up of 22 months in the XT cohort and 21 months in the HXT cohort . CONCLUSION Neoadjuvant XT ( HXT in HER2-positive disease ) is highly effective in inoperable LABC , demonstrating pCR rates of 15 % and 40 % , respectively . This non-anthracycline-containing regimen offers obvious benefits in early disease , where avoidance of long-term cardiotoxicity is particularly important Background
Output:
| Significant advances have been made in HER2 targeting , result ing in a marked increase in the number of breast cancer patients experiencing tumour pCR . |
MS210503 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVES To compare the efficacy of 3-day vs 10-day treatment with a combination of amoxicillin and clavulanate potassium for children with uncomplicated urinary tract infections and to determine the role of host factors , including vesicoureteral reflux , and of bacterial virulence factors , including adhesins , in treatment outcome . DESIGN R and omized , double-blind , controlled trial . SETTING A pediatric infectious diseases clinic at an urban medical center . PATIENTS Thirty-seven children with uncomplicated urinary tract infections . INTERVENTIONS Treatment with 3 days or 10 days of antibiotics at a dosage of 20 mg/kg per day of amoxicillin and 5 mg/kg per day of clavulanate potassium in three divided doses . MEASUREMENTS AND MAIN RESULTS The success rate for 10-day treatment was 82 % ( 14/17 ) compared with 55 % ( 11/20 ) for 3-day treatment ( P = .09 ) . Among the 35 patients infected with Escherichia coli , all 10 patients infected with adhesin-negative isolates were treated successfully regardless of the duration of treatment , whereas only 14 ( 56 % ) of the 25 infections involving adhesin-positive isolates were clinical ly cured ( P = .015 ) . Two of the three failures in the 10-day treatment group were in patients with reflux . CONCLUSIONS We conclude that 3-day treatment with amoxicillin and clavulanate is insufficient for afebrile childhood urinary tract infections and that both bacterial and host factors affect treatment outcome This study was design ed to determine whether serum C-reactive protein ( CRP ) concentrations could be used to identify children with uncomplicated lower urinary tract infection who would respond favorably to short-term antibiotic therapy . A one-day or ten-day regimen of cefadroxil ( 30 mg/kg/day in two divided doses ) was assigned r and omly to 80 children who had acute urinary tract infection and CRP concentrations less than 28 microgram/ml ( CRP-negative group ) . Ten days of cefadroxil therapy was used to treat 44 children with urinary tract infection and CRP values greater than or equal to 28 microgram/ml ( CRP-positive group ) . The clinical and laboratory characteristics of the children in the two CRP-negative therapy groups were similar to , but different from those of children with CRP-positive infections . Recurrent infections occurred significantly more often at four to five days after completion of therapy in CRP-negative children who received one day ( 44.4 % ) compared to ten days ( 20 % ) of cefadroxil therapy ( P less than .05 ) . When data from this study were combined with those from our previously published investigation of short-term antibiotic therapy in CRP-negative children , a significantly larger percentage of recurrences was documented immediately after one or four days of antibiotics ( 79 % ) compared to recurrences after the st and ard ten-day regimen ( 41 % ) . Additionally , the total rate of recurrent infections for all children in both studies was significantly larger in those who received short-term therapy ( 48 % ) as opposed to conventional therapy ( 34 % ) . These data indicate that short-term antibiotic therapy is less effective than the conventional ten-day regimen in children with CRP-negative urinary tract infection The efficacy of 3-day therapy with nalidixic acid in 16 children , and trimethoprim/sulphamethoxazole in 19 children , was studied prospect ively in children with an acute infection of the lower urinary tract and compared with that of a conventional 10-day course with the same drugs . The immediate cure rate was 97 % in the 3-day group and 90 % in the 10-day group . During 3 months of follow-up there were altogether six re-infections in children given short-term treatment and six in the conventionally treated group . The results give further support for the suggestion that 3-day therapy is equivalent to 10-day treatment in uncomplicated urinary infections in children and that both nalidixic acid and trimethoprim/sulphamethoxazole are good alternatives in such an approach The patients were 117 children ( aged 4 months to 14 years ) with uncomplicated urinary tract infections caused by co-trimoxazole-sensitive Escherichia coli . The patients were r and omly assigned to receive treatment with co-trimoxazole for 3 days ( n = 58 ) or 7 days ( n = 59 ) . Urine was analyzed for bacteria before and immediately after treatment and again at 1 and 2 months . After 3 days ' treatment , infection persisted in 14 of 31 patients with P-fimbriated strains of E coli and in 1 of 27 patients with non-P-fimbriated strains . After 7 days ' treatment , infection persisted in 2 of 40 patients with fimbriated strains and in none of the 19 patients with nonfimbriated strains . One or 2 months after treatment , 3 days ' treatment was rated successful in 26 of 27 patients with nonfimbriated strains and in none of the patients with fimbriated strains . Seven days ' treatment was rated successful in all patients with nonfimbriated strains and in 32 of 40 patients with fimbriated strains . The results indicate that the length of treatment of urinary tract infections in children should be adjusted according to the presence of bacterial P-fimbriae in addition to the patients ' clinical condition We conducted a prospect i ve r and omized study to evaluate the efficacy of a single daily dose of 4 mg/kg of trimethoprim coupled with 17.5 mg/kg of sulphadiazine for three ( group 1 ) or 10 days ( group 2 ) in the treatment of uncomplicated urinary tract infections in children . Forty patients ( nine boys and 31 girls ) aged 2.5‐18 years , presenting with a urinary tract infection were allocated to one of the two groups . Patients were seen three , 10 , and 38 days after the initiation of treatment . Control urine cultures were negative in all patients at days 3 and 10 . Two patients in group 1 and one patient in group 2 suffered a relapse within a month . Single doses of trimethoprim/sulphadiazine for three or 10 days are effective in the treatment of uncomplicated urinary tract infections in children One hundred thirty-two children with acute urinary tract infection were r and omly assigned to receive trimethoprim-sulfamethoxazole in one dose , two doses daily for 3 days or two doses daily for 7 days . The patient characteristics , etiologic agents and frequency of roentgenologic abnormalities were similar for the three treatment groups . There was no significant difference in bacteriologic cure rates for the single dose regimen ( 93 % ) and multidose regimens ( 96 % ) . The difference in rates of recurrent urinary tract infection between the single dose ( 20.5 % ) and 3-day ( 5.6 % ) and 7-day ( 8 % ) regimens was statistically significant ( P = 0.033 ) . A single dose of trimethoprim-sulfamethoxazole is inadequate treatment for infants and children with acute urinary tract infection Short-course therapy for pediatric urinary tract infection ( UTI ) remains controversial . The present study was undertaken to compare the effectiveness of cefuroxime axetil ( Ceftin ) as short-course ( 2-day ) versus conventional ( 10-day ) therapy for uncomplicated pediatric UTIs . In a r and omized , controlled , prospect i ve study , we enrolled 50 children , 2 - 11 years of age , to receive oral cefuroxime axetil , 125 mg twice a day , for either 2 or 10 days . UTI was defined as at least 10(5 ) colonies/ml of a single pathogen isolated on clean catch , or at least 10(4 ) colonies/ml on a catheterized specimen . A 10-fold or greater reduction in colony count of the initially isolated organism ( 3 - 5 ) days after stopping therapy was considered a bacteriologic success , as long as the absolute colony count was below the threshold for UTI described above . Patients were followed for 15 months with multiple repeat urine cultures and radiologic studies . Twenty-five of the 50 patients enrolled were withdrawn , including 12 for initially inadequate colony counts . Eight of 12 patients in the short-course group ( 67 % ) , versus 12 of 14 in the conventional-therapy group ( 86 % ) , were initial bacteriological successes , a nonsignificant difference . All 37 initially isolated uropathogens were sensitive to cefuroxime axetil in vitro . Cefuroxime axetil is an effective antimicrobial for uncomplicated pediatric UTIs . Two-day therapy with cefuroxime axetil appears to be as effective as 10-day therapy , although sample size was limited in this study
Output:
| A 2 - 4 day course of oral antibiotics is as effective as 7 - 14 days in eradicating lower tract UTI in children |
MS210504 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Preliminary studies suggest that physical exercise interventions can improve physical fitness , fatigue and quality of life in cancer patients after completion of chemotherapy . Additional research is needed to rigorously test the effects of exercise programmes among cancer patients and to determine optimal training intensity accordingly . The present paper presents the design of a r and omized controlled trial evaluating the effectiveness and cost-effectiveness of a high intensity exercise programme compared to a low-to-moderate intensity exercise programme and a waiting list control group on physical fitness and fatigue as primary outcomes . Methods After baseline measurements , cancer patients who completed chemotherapy are r and omly assigned to either a 12-week high intensity exercise programme or a low-to-moderate intensity exercise programme . Next , patients from both groups are r and omly assigned to immediate training or a waiting list ( i.e. waiting list control group ) . After 12 weeks , patients of the waiting list control group start with the exercise programme they have been allocated to . Both interventions consist of equal bouts of resistance and endurance interval exercises with the same frequency and duration , but differ in training intensity . Additionally , patients of both exercise programmes are counselled to improve compliance and achieve and maintain an active lifestyle , tailored to their individual preferences and capabilities . Measurements will be performed at baseline ( t = 0 ) , 12 weeks after r and omization ( t = 1 ) , and 64 weeks after r and omization ( t = 2 ) . The primary outcome measures are cardiorespiratory fitness and muscle strength assessed by means of objective performance indicators , and self-reported fatigue . Secondary outcome measures include health-related quality of life , self-reported physical activity , daily functioning , body composition , mood and sleep disturbances , and return to work . In addition , compliance and satisfaction with the interventions will be evaluated . Potential moderation by pre- and post-illness lifestyle , health and exercise-related attitudes , beliefs and motivation will also be assessed . Finally , the cost-effectiveness of both exercise interventions will be evaluated . Discussion This r and omized controlled trial will be a rigorous test of effects of exercise programmes for cancer patients after chemotherapy , aim ing to contribute to evidence -based practice in cancer rehabilitation programmes . Trial registration This study is registered at the Netherl and s Trial Register ( NTR2153 Background : Substantial numbers of cancer patients use complementary medicine therapies , even without a supportive evidence base . This study aim ed to evaluate in a r and omized controlled trial , the use of Medical Qigong ( MQ ) compared with usual care to improve the quality of life ( QOL ) of cancer patients . Patients and methods : One hundred and sixty-two patients with a range of cancers were recruited . QOL and fatigue were measured by Functional Assessment of Cancer Therapy — General and Functional Assessment of Cancer Therapy — Fatigue , respectively , and mood status by Profile of Mood State . The inflammatory marker serum C-reactive protein ( CRP ) was monitored serially . Results : Regression analysis indicated that the MQ group significantly improved overall QOL ( t144 = −5.761 , P < 0.001 ) , fatigue ( t153 = −5.621 , P < 0.001 ) , mood disturbance ( t122 = 2.346 , P = 0.021 ) and inflammation ( CRP ) ( t99 = 2.042 , P < 0.044 ) compared with usual care after controlling for baseline variables . Conclusions : This study indicates that MQ can improve cancer patients ’ overall QOL and mood status and reduce specific side-effects of treatment . It may also produce physical benefits in the long term through reduced inflammation PURPOSE The aims of this pilot study were the following : 1 ) to examine patterns of adherence to a brisk walking program in women receiving adjuvant chemotherapy or radiation therapy for newly diagnosed breast cancer using a prospect i ve , r and omized , controlled experimental design ; 2 ) to examine the influence of disease symptoms and treatment side effects on exercise levels ; and 3 ) to suggest methods that may improve future clinical trials of moderate-intensity exercise in similar population s. DESCRIPTION OF STUDY Fifty-two patients with newly diagnosed breast cancer were r and omly assigned to one of two treatment arms : usual care or usual care plus exercise . Those assigned to the exercise group received a st and ardized , self-administered , home-based brisk walking intervention in addition to usual care . Each day subjects completed self-report diary forms that elicited information about activity levels , and the occurrence of symptoms and side effects during cancer treatment . RESULTS Analyses of self-reported daily activity levels revealed a diffusion of treatment effect . Fifty percent of the usual-care group reported maintaining or increasing their physical activity to a moderate-intensity level , while 33 % of the exercise group did not exercise at the prescribed levels . Analyses of self-reported disease symptoms and treatment side effects did not reveal clinical ly meaningful differences between the two groups . CLINICAL IMPLICATION S The results of this study suggest that women who exercised regularly before receiving a breast cancer diagnosis attempted to maintain their exercise programs . Women who lead sedentary lifestyles may benefit from a structured exercise program that includes information and support related to exercise adherence strategies BACKGROUND Anemia in patients with solid tumors is a common problem that is associated with impaired exercise capacity , increased fatigue , and lower quality of life ( QoL ) . Erythropoiesis-stimulating agents ( ESAs ) have been shown to improve these outcomes ; however , it is unknown if additional benefits can be achieved with aerobic exercise training . METHODS We conducted a single-center , prospect i ve , r and omized , controlled trial in 55 mild-to-moderately anemic patients with solid tumors . Patients were r and omized to either darbepoetin alfa alone ( DAL , n = 29 ) or darbepoetin alfa plus aerobic exercise training ( DEX ; n = 26 ) . The DEX group performed aerobic exercise training three times per week at 60%-100 % of baseline exercise capacity for 12 weeks . The primary endpoint was QoL assessed by the Functional Assessment of Cancer Therapy-Anemia scale . Secondary endpoints were fatigue , cardiorespiratory fitness ( VO(2peak ) ) , hemoglobin ( Hb ) response , and darbepoetin alfa dosing . RESULTS Intention-to-treat analyses indicated significant improvements in QoL and fatigue in both groups over time but there were no between-group differences . The DEX group had a significantly greater VO(2peak ) than the DAL group ( mean group difference , + 3.0 ml/kg per minute ; 95 % confidence interval , 1.2 - 4.7 ; p = .001 ) and there were borderline significant differences in favor of the DEX group for Hb response and darbepoetin alfa dosing . CONCLUSIONS Aerobic exercise training did not improve QoL or fatigue beyond the established benefits of DAL but it did result in favorable improvements in exercise capacity and a more rapid Hb response with lower dosing requirements . Our results may be useful to clinicians despite the more recent restrictions on the indications for ESAs Background Exercise interventions during adjuvant cancer therapy have been shown to increase functional capacity , relieve fatigue and distress and may assist rates of chemotherapy completion . These studies have been limited to breast , gastric and mixed cancer groups and it is not yet known if a similar intervention is even feasible among women with ovarian cancer . We aim ed to assess safety , feasibility and potential effect of a walking intervention in women undergoing chemotherapy for ovarian cancer . Methods Women newly diagnosed with ovarian cancer were recruited to participate in an individualised walking intervention throughout chemotherapy and were assessed pre- and post-intervention . Feasibility measures included session adherence , compliance with exercise physiologist prescribed walking targets and self-reported program acceptability . Changes in objective physical functioning ( 6-minute walk test ) , self-reported distress ( Hospital Anxiety and Depression Scale ) , symptoms ( Memorial Symptom Assessment Scale - Physical ) and quality of life ( Functional Assessment of Cancer Therapy - Ovarian ) were calculated , and chemotherapy completion and adverse intervention effects recorded . Results Seventeen women were enrolled ( 63 % recruitment rate ) . Mean age was 60 years ( SD = 8 years ) , 88 % were diagnosed with FIGO stage III or IV disease , 14 women underwent adjuvant and three neo-adjuvant chemotherapy . On average , women adhered to > 80 % of their intervention sessions and complied with 76 % of their walking targets , with the majority walking four days a week at moderate intensity for 30 minutes per session . Meaningful improvements were found in physical functioning , physical symptoms , physical well-being and ovarian cancer-specific quality of life . Most women ( 76 % ) completed ≥85 % of their planned chemotherapy dose . There were no withdrawals or serious adverse events and all women reported the program as being helpful . Conclusions These positive preliminary results suggest that this walking intervention for women receiving chemotherapy for ovarian cancer is safe , feasible and acceptable and could be used in development of future work . Trial registration Research suggests that stress‐reduction programs tailored to the cancer setting help patients cope with the effects of treatment and improve their quality of life . Yoga , an ancient Eastern science , incorporates stress‐reduction techniques that include regulated breathing , visual imagery , and meditation as well as various postures . The authors examined the effects of the Tibetan yoga ( TY ) practice s of Tsa lung and Trul khor , which incorporate controlled breathing and visualization , mindfulness techniques , and low‐impact postures in patients with lymphoma BACKGROUND AND OBJECTIVES This pilot project assessed the acceptability of a mixed-type , moderate-intensity exercise programme following breast cancer treatment , and the impact on presence of lymphoedema , fitness , body composition , fatigue , mood and quality of life . METHODS Ten women completed the programme and measures of fitness ( sub-maximal ergometer test ) , body composition ( bio-electrical impedance ) , lympoedema ( bio-electrical impedance and arm circumferences ) , fatigue ( revised Piper Fatigue Scale ) , mood ( Hospital Anxiety and Depression Scale ) , quality of life ( FACT-B ) and general well-being , at baseline , completion of the programme , and 6-week and 3-month follow-up . RESULTS Participation in the programme caused no adverse effect on the presence of lymphoedema . There was a trend towards reduction in fatigue and improved quality of life across the testing phases . Women rated the programme extremely favourably , citing benefits of the support of other women , trained guidance , and the opportunity to experience different types of exercise . CONCLUSIONS A mixed-type , moderate-intensity exercise program in a group format is acceptable to women following breast cancer treatment , with the potential to reduce fatigue and improve quality of life , without exacerbating or precipitating lymphoedema . This pilot work needs to be confirmed in larger r and omised studies Background To examine the effects of a 6 month lifestyle intervention on quality of life , depression , self-efficacy and eating behavior changes in overweight and obese endometrial cancer survivors . Methods Early stage endometrial cancer survivors were r and omized to intervention ( n = 23 ) or usual care ( n = 22 ) groups . Chi-square , Student 's t-test and repeated measures analysis of variance were used in intent-to-treat analyses . Outcomes were also examined according to weight loss . Results Morbidly obese patients had significantly lower self-efficacy , specifically when feeling physical discomfort . There was a significant improvement for self-efficacy related to social pressure ( p = .03 ) and restraint ( p = .02 ) in the LI group . There was a significant difference for emotional well-being quality of life ( p = .02 ) , self-efficacy related to negative emotions ( p < .01 ) , food availability ( p = .03 ) , and physical discomfort ( p = .01 ) in women who lost weight as compared to women who gained weight . Improvement in restraint was also reported in women who lost weight ( p < .01 ) . Conclusion This pilot lifestyle intervention had no effect on quality of life or depression but did improve self-efficacy and some eating behaviors . Trial Registration http://www . clinical trials.gov ; Goals of workProstate cancer patients receiving and rogen deprivation therapy ( ADT ) are vulnerable to a number of potentially debilitating side effects , which can significantly impact quality of life . The role of alternate therapies , such as physical activity ( PA ) , in attenuating these side effects is largely understudied for such a large population . Thus , the purpose of this study was to investigate the effects of PA intervention for men receiving ADT on PA behavior , quality of life , and fitness measures . Patients and methods One hundred participants were r and omized into an intervention ( n = 53 ) or a wait-list control group ( n = 47 ) , with 11 dropping out of the intervention group and 23 dropping out of the wait-list control group prior to post-testing . The intervention consisted of both an individually tailored home-based aerobic and light resistant training program and weekly group sessions . PA , quality of life , fitness , and physiological outcomes were assessed pre and post the 16-week intervention . Results Significant increases in PA , supported by changes in girth measures and blood pressure , support the beneficial impact of the intervention . Positive trends were also evident for depression and fatigue . However , due to the high dropout rate , these results must be interpreted with caution . Conclusions PA effectively attenuates many of the side effects of ADT and should be recommended to prostate survivors as an alternate therapy . Determining the maintenance of this behavior change will be important for underst and ing how the long-term benefits of increased activity levels may alleviate the late effects of ADT Recovering from cancer treatment can be a difficult experience , both physically and psychologically . This paper describes a r and omized controlled trial that evaluates the effects of exercise therapy upon quality of life in 120 women who
Output:
| HRQoL and its domains were assessed using a wide range of measures .The results suggest that exercise interventions compared with control interventions have a positive impact on overall HRQoL and certain HRQoL domains .
Since there is consistency of findings on both types of measures ( change scores and difference in follow-up scores ) there is greater confidence in the robustness of these findings .When examining exercise effects by subgroups , exercise interventions had significantly greater reduction in anxiety for survivors with breast cancer than those with other types of cancer .
Further , there was greater reduction in depression , fatigue , and sleep disturbances , and improvement in HRQoL , emotional wellbeing ( EWB ) , physical functioning , and role function for cancer survivors diagnosed with cancers other than breast cancer but not for breast cancer .
There were also greater improvements in HRQoL and physical functioning , and reduction in anxiety , fatigue , and sleep disturbances when prescribed a moderate or vigorous versus a mild exercise program .
This systematic review indicates that exercise may have beneficial effects at varying follow-up periods on HRQoL and certain HRQoL domains including physical functioning , role function , social functioning , and fatigue .
Positive effects of exercise interventions are more pronounced with moderate- or vigorous-intensity versus mild-intensity exercise programs . |
MS210505 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Purpose To evaluate changes in nucleus pulposus volume as a potential parameter for the effects of disc decompression . Methods Fifty-two discs ( T8 to L1 ) were extracted from 26 pigs and separated into thoracic ( T8 to T11 ) and thoracolumbar discs ( T12 to L1 ) . The discs were imaged using 7.1 Tesla ultrahigh-field magnetic resonance imaging ( MRI ) with acquisition of axial T2-weighted turbo spin-echo sequences for determination of baseline and postinterventional nucleus pulposus volumes . Volumes were calculated using OsiriX ® ( http://www.osirix-viewer.com ) . After r and omization , one group was treated with nucleoplasty , while the placebo group was treated with an identical procedure but without coblation current . The readers analyzing the MR images were blinded to the kind of procedure performed . Baseline and postinterventional volumes were compared between the nucleoplasty and placebo group . Results Average preinterventional nucleus volume was 0.799 ( SD : 0.212 ) ml . Postinterventional volume reduction in the nucleoplasty group was significant at 0.052 ( SD : 0.035 ) ml or 6.30 % ( p<0.0001 ) ( thoracic discs ) and 0.082 ( SD : 0.042 ) ml or 7.25 % ( p = 0.0078 ) ( thoracolumbar discs ) . Nucleoplasty achieved volume reductions of 0.114 ( SD : 0.054 ) ml or 14.72 % ( thoracic ) and 0.093 ( SD : 0.081 ) ml or 11.61 % ( thoracolumbar ) compared with the placebo group . Conclusions Nucleoplasty significantly reduces thoracic and thoracolumbar nucleus pulposus volumes in porcine discs In this study two strategies in the treatment of Mechanical Spinal Discogenic Pain have been compared : Disc Coablation and Epidural Injection of Steroids . In 2003 50 patients treated with one or two epidural injections have been selected " ad r and om " and 50 patients treated with disc coablation . Comparison of the data indicated an improvement of average VAS when relaxed for both groups ( p < 0.01 ) , while after slight-moderate strain , this value was significant only after coablation ( p < 0.001 ) . Finally , average VAS was clearly lower ( p < 0.01 ) after coablation as compared to epidural injections Background Cervical disc nucleoplasty is a significant and clinical ly demonstrated innovation in percutaneous disc decompression in case of non-herniated disc protrusions or prolpase . It allows a percutaneous decompression via a 19-gauge needle under utilization of the Coblation ® technique and under C-arm control . Until now the patients suffering of a cervicobrachialgia in cause of a disc prolapse had only the therapeutical solution between conservative treatment and monosegmental spondylodesis or disc prosthesis of the mentioned motion segment . Methods We wanted to demonstrate a new and practicable anatomical pathway for reaching the cervical disc prolapse comparable to the technique for discography of the cervical spine . The introducer needle is advanced into the disc under fluoroscopic guidance using a st and ard anterior – lateral approach . The controller delivers radiofrequency energy to quickly ablate tissue at temperatures between 50 ° and 60 ° C . The decompression will be done in ablation mode by rotating the device through 180 ° for 5 s in the posterior , medial and ventral third of the cervical disc . After failed conservative treatment over an average time period of 3 months we treated 26 patients with a contained herniated prolapse or protrusion with radicular arm pain by percutaneous decompression under utilization of the Coblation ® technique with a controlled energy plasma-mediated field . A r and omized control group of 30 patients was treated alone conservatively with medical and physical therapy in the same period . Results The average preoperative VAS was 8.8 . With a follow-up time of 2-years we found an average pain reduction with the visual pain score ( VAS ) of 2.3 who had a further check-up . The VAS was checked 24 h , 1 week , 3 , 6 , 12 and 24 months postoperatively . No complications with this method were seen . Comparable to the surgically treated group the conservative patients have had a VAS of 8.4 . Under using conservative treatment with physical therapy , physiotherapy , analgetics and perineural injections we have had a diminution of the VAS to 5.1 after 2 years . Conclusion The percutaneous decompression of the cervical disc protrusion with the Perc DC ® —Spine W and by using the Coblation mode is a quick and safe procedure . Furthermore , one may state a persistent pain relief in the follow-up time up to 2 years after the percutaneous decompression of the disc Prospect i ve case series studies have shown that plasma disc decompression ( PDD ) using the COBLATION SpineW and device ( ArthroCare Corporation , Austin , TX ) is effective for decompressing the disc nucleus in symptomatic contained cervical disc herniations . This prospect i ve , r and omized controlled clinical trial was conducted to evaluate the clinical outcomes of percutaneous PDD as compared to conservative care ( CC ) through 1 year . Patients ( n = 115 ) had neck/arm pain > 50 on the visual analog scale ( VAS ) pain scale and had failed at least 30 days of failed CC . Patients were r and omly assigned to receive either PDD ( n = 62 ) or CC ( n = 58 ) . Clinical outcome was determined by VAS pain score , neck disability index ( NDI ) score , and SF-36 health survey , collected at 6 weeks , 3 months , 6 months , and 1 year . The PDD group had significantly lower VAS pain scores at all follow-up time points ( PDD vs. CC : 6 weeks , −46.87 ± 2.71 vs. −15.26 ± 1.97 ; 3 months , −53.16 ± 2.74 vs. −30.45 ± 2.59 ; 6 months , −56.22 ± 2.63 vs. −40.26 ± 2.56 ; 1 year , −65.73 ± 2.24 vs. −36.45 ± 2.86 ; GEE , P < 0.0001 ) . PDD patients also had significant NDI score improvement over baseline when compared to CC patients at the 6 weeks ( PDD vs. CC : −9.15 ± 1.06 vs. −4.61 ± 0.53 , P < 0.0001 ) and 1 year ( PDD vs. CC : −16.70 ± 0.29 vs. −12.40 ± 1.26 , P = 0.005 ) follow-ups . PDD patients showed statistically significant improvement over baseline in SF-36 physical component summary scores when compared to CC patients at 6 weeks and 1 year ( PDD vs. CC : 8.86 + 8.04 vs. 4.24 ± 3.79 , P = 0.0004 ; 17.64 ± 10.37 vs. 10.50 ± 10.6 , P = 0.0003 , respectively ) . In patients who had neck/arm pain due to a contained cervical disc herniation , PDD was associated with significantly better clinical outcomes than a CC regimen . At 1 year , CC patients appeared to suffer a “ relapse , showing signs of decline in most measurements , whereas PDD patients showed continued stable improvement Conventional open cervical discectomy , with or without bony fusion , in common neurosurgical knowledge is considered the st and ard treatment for cervical disc herniation . Percutaneous procedures are minimally invasive and offer decreased morbidity , require no bone graft and promise shorter recuperation time . Nevertheless , c and i date s for a percutaneous procedure as inclusion criteria must complain of symptoms related to contained herniated disc or focal protrusion . It does not substitute conventional open procedures required for extruded discs . We used the coblation technology for nucleoplasty of the cervical intervertebral discs . Early and long-term effects and /or complications observed with this procedure have not been reported yet . Fifty consecutive patients presenting with contained herniated cervical disc or focal protrusion causing compression of the cervical roots or cervical pain underwent a nucleoplasty procedure on the pathological disc . A r and omized control group of twenty patients was treated conservatively with medical and physical therapy in the same period and completed the identical follow-up form . In the nucleoplasty group results were complete resolution of symptoms in 80 % of cases , only 10 % referred some residual cervical or radicular pain and are still under follow-up with a wait- and -see prospect i ve . Patients who did not have a clinical resolution were treated with alternative traditional methods ( 10 % ) . Despite the relative low cases number and the limited follow-up the encouraging results induce us to utilize this technique in well-selected cases OBJECT Patients with radiculopathy , with or without back pain , often do not respond to conservative care and may be considered for epidural steroid injection therapy or a disc decompression procedure . Plasma disc decompression ( PDD ) using the Coblation SpineW and device is a percutaneous , minimally invasive interventional procedure . The purpose of this study was to evaluate clinical outcomes with PDD as compared with st and ard care using fluoroscopy-guided transforaminal epidural steroid injection ( TFESI ) over the course of 2 years . METHODS This was a multicenter r and omized controlled clinical study . Ninety patients ( 18 - 66 years old ) who had sciatica ( visual analog scale score > or = 50 ) associated with a single-level lumbar contained disc herniation were enrolled . In all cases , their condition was refractory to initial conservative care and 1 epidural steroid injection had failed . Participants were r and omly assigned to receive either PDD ( 46 patients ) or TFESI ( 44 patients , up to 2 injections ) . RESULTS The patients in the PDD Group had significantly greater reduction in leg pain scores and significantly improved Oswestry Disability Index and 36-Item Short Form Health Survey ( [ SF-36 ] , physical function , bodily pain , social function , and physical components summary ) scores than those in the TFESI Group . During the 2-year follow-up , 25 ( 56 % ) of the patients in the PDD Group and 11 ( 28 % ) of those in the TFESI Group remained free from having a secondary procedure following the study procedure ( log-rank p = 0.02 ) . A significantly higher percentage of patients in the PDD Group showed minimum clinical ly important change in scores for leg and back pain and SF-36 scores that exceeded literature -based minimum clinical ly important changes . Procedure-related adverse events , including injection site pain , increased leg or back pain , weakness , and lightheadedness , were observed in 5 patients in the PDD Group ( 7 events ) and 7 in the TFESI Group ( 14 events ) . CONCLUSIONS In study patients who had radicular pain associated with a contained lumbar disc herniation , those patients treated with PDD had significantly reduced pain and better quality of life scores than those treated using repeated TFESI . In addition , significantly more PDD patients than TFESI patients avoided having to undergo a secondary procedure during the 2-year study follow-up
Output:
| This investigation showed that nucleoplasty constitutes an effective , minimally invasive treatment option for patients with symptomatic contained disc herniations . |
MS210506 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Preventive pharmacotherapy for migraine is not satisfactory because of the low efficacy/tolerability ratio of many available drugs . Novel and more efficient preventive strategies are therefore warranted . Abnormal excitability of cortical areas appears to play a pivotal role in migraine pathophysiology . Transcranial direct current stimulation ( tDCS ) is a non-invasive and safe technique that is able to durably modulate the activity of the underlying cerebral cortex , and is being tested in various medical indications . The results of small open studies using tDCS in migraine prophylaxis are conflicting , possibly because the optimal stimulation setting s and the brain targets were not well chosen . We have previously shown that the cerebral cortex , especially the visual cortex , is hyperresponsive in migraine patients between attacks and provided evidence from evoked potential studies that this is due to a decreased cortical preactivation level . If one accepts this concept , anodal tDCS over the visual cortex may have therapeutic potentials in migraine prevention , as it is able to increase neuronal firing . Objective To study the effects of anodal tDCS on visual cortex activity in healthy volunteers ( HV ) and episodic migraine without aura patients ( MoA ) , and its potentials for migraine prevention . Methods We recorded pattern-reversal visual evoked potentials ( VEP ) before and after a 15-min session of anodal tDCS over the visual cortex in 11 HV and 13 MoA interictally . Then 10 MoA patients reporting at least 4 attacks/month subsequently participated in a therapeutic study , and received 2 similar sessions of tDCS per week for 8 weeks as migraine preventive therapy . Results In HV as well as in MoA , anodal tDCS transiently increased habituation of the VEP N1P1 component . VEP amplitudes were not modified by tDCS . Preventive treatment with anodal tDCS turned out to be beneficial in MoA : migraine attack frequency , migraine days , attack duration and acute medication intake significantly decreased during the treatment period compared to pre-treatment baseline ( all p < 0.05 ) , and this benefit persisted on average 4.8 weeks after the end of tDCS . Conclusions Anodal tDCS over the visual cortex is thus able to increase habituation to repetitive visual stimuli in healthy volunteers and in episodic migraineurs , who on average lack habituation interictally . Moreover , 2 weekly sessions of anodal tDCS had a significant preventive anti- migraine effect , proofing the concept that the low preactivation level of the visual cortex in migraine patients can be corrected by an activating neurostimulation . The therapeutic results indicate that a larger sham-controlled trial using the same tDCS protocol is worthwhile A recent fMRI study showed that dorsolateral prefrontal cortex ( DLPFC ) exerts an inhibitory control on pain pathways in humans . We investigated whether high-frequency rTMS over left DLPFC could ameliorate chronic migraine . Treatment consisted of 12 rTMS sessions , delivered in alternate days over left DLPFC . Sham rTMS was used as placebo . Eleven patients were r and omly assigned to the rTMS ( n=6 ) or to the placebo ( n=5 ) treatment . Measures of attack frequency , headache index , number of abortive medications ( outcome measures ) were recorded in the month before , during and in the month after treatment . Subjects treated by rTMS showed a significant reduction of the outcome measures during and in the month after the treatment as compared to the month before treatment . No significant differences in the outcome measures were observed in the placebo group . High-frequency rTMS over left DLPFC was able to ameliorate chronic migraine . This is in agreement with the suggested role of DLPFC in pain control We report the efficacy of three versus single session of 10 Hz repetitive transcranial magnetic stimulation ( rTMS ) in chronic migraine ( CM ) and chronic tension-type headache ( CTTH ) . Ninety-eight patients with CM or CTTH were included and their headache frequency , severity , functional disability and number of abortive medications were noted . Fifty-two patients were r and omly assigned to group I ( three true sessions ) and 46 to group II ( one true and two sham rTMS sessions ) treatment . 10 Hz rTMS comprising 600 pulses was delivered in 412.4 s on the left frontal cortex . Outcomes were noted at 1 , 2 and 3 months . The primary outcome was 50 % reduction in headache frequency , and secondary outcomes were improvement in severity , functional disability , abortive drugs and side effects . The baseline headache characteristics were similar between the two groups . Follow up at different time points revealed significant improvement in headache frequency , severity , functional disability and number of abortive drugs compared to baseline in both group I and group II patients , although these parameters were not different between the two groups . In group I , 31 ( 79.4 % ) had reduction of headache frequency and 29 ( 74.4 % ) converted to episodic headache . In group II , these were 24 ( 64.8 % ) and 22 ( 59.2 % ) , respectively . In chronic migraine , the severity of headache at 2 months reduced in group I compared to group II ( 62.5 vs 35.3 % ; P = 0.01 ) . Both single and three sessions of 10 Hz rTMS were found to be equally effective in CM and CTTH , and result ed in conversion of chronic to episodic headache in 67.1 % patients Objective To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation ( sTMS ) for the preventive treatment of migraine . Background sTMS was originally developed for the acute treatment of migraine with aura . Open label experience has suggested a preventive benefit . The objective of this trial was to evaluate the efficacy and tolerability of sTMS for migraine prevention . Methods The e Neura S pringTMS P ost-Market O bservational U .S. S tudy of Migrain e ( ESPOUSE ) Study was a multicenter , prospect i ve , open label , observational study . From December 2014 to March 2016 , patients with migraine ( n = 263 ) were consented to complete a 1-month baseline headache diary followed by 3 months of treatment . The treatment protocol consisted of preventive ( four pulses twice daily ) and acute ( three pulses repeated up to three times for each attack ) treatment . Patients reported daily headache status , medication use , and device use with a monthly headache diary . The primary endpoint , mean reduction of headache days compared to baseline , was measured over the 28-day period during weeks 9 to 12 . The primary endpoint was compared to a statistically-derived placebo estimate ( performance goal ) . Secondary endpoints included : 50 % responder rate , acute headache medication consumption , HIT-6 , and mean reduction in total headache days from baseline of any intensity . Results Of a total of 263 consented subjects , 229 completed a baseline diary , and 220 were found to be eligible based on the number of headache days . The device was assigned to 217 subjects ( Safety Data Set ) and 132 were included in the intention to treat Full Analysis Set . For the primary endpoint , there was a −2.75 ± 0.40 mean reduction of headache days from baseline ( 9.06 days ) compared to the performance goal ( −0.63 days ) ( p < 0.0001 ) . The 50 % responder rate of 46 % ( 95 % CI 37 % , 56 % ) was also significantly higher ( p < 0.0001 ) than the performance goal ( 20 % ) . There was a reduction of −2.93 ( 5.24 ) days of acute medication use , headache impact measured by HIT-6 , −3.1 ( 6.4 ) ( p < 0.0001 ) , and total headache days of any intensity −3.16 days ( 5.21 ) compared to the performance goal ( −0.63 days ) ( p < 0.0001 ) . The most common adverse events were lightheadedness ( 3.7 % ) , tingling ( 3.2 % ) , and tinnitus ( 3.2 % ) . There were no serious adverse events . Conclusions This open label study suggests that sTMS may be an effective , well-tolerated treatment option for migraine prevention . Trial registration number Repetitive transcranial magnetic stimulation ( rTMS ) is an emerging treatment for pain but there is no class 1 study on its role in migraine prophylaxis . In this study we report the efficacy and safety of high-rate rTMS in migraine prophylaxis . Adult migraine patients having > 4 attacks/month were r and omized to high-rate rTMS or sham stimulation . Stimulation in the form of 10 Hz rTMS , 600 pulses in 10 trains were delivered to the hot spot of the right abductor digiti minimi in 412 s. Three sessions were delivered on alternate days . The outcome was defined at 1 month . The primary outcome measures were reduction in headache frequency and severity > 50 % as assessed by the Visual Analogue Scale ( VAS ) . The secondary outcome measures were functional disability , rescue medication and adverse events . Fifty patients each were r and omized to rTMS or sham stimulation . The baseline characteristics of rTMS and sham stimulation groups were similar . At 1 month , headache frequency ( 78.7 vs. 33.3 % ; P = 0.0001 ) and VAS score ( 76.6 vs. 27.1 % ; P = 0.0001 ) improved significantly in the patients receiving rTMS compared to those in the sham stimulation group . Functional disability also improved significantly in rTMS group ( P = 0.0001 ) . Only one patient following rTMS developed transient drowsiness and was withdrawn from the study . This study provides evidence of the efficacy and safety of 10 Hz rTMS in migraine prophylaxis Background Single pulse transcranial magnetic stimulation ( sTMS ) is a novel treatment for acute migraine . Previous r and omised controlled data demonstrated that sTMS is effective and well tolerated in the treatment of migraine with aura . The aim of the programme reported here was to evaluate patient responses in the setting of routine clinical practice . Methods Migraine patients with and without aura treating with sTMS had an initial review ( n = 426 ) and training call , and then participated in telephone surveys at week six ( n = 331 ) and week 12 during a 3-month treatment period ( n = 190 ) . Results Of patients surveyed with 3 month data ( n = 190 ; episodic , n = 59 ; chronic , n = 131 ) , 62 % reported pain relief , finding the device effective at reducing or alleviating migraine pain ; in addition there was relief reported of associated features : nausea- 52 % ; photophobia- 55 % ; and phonophobia- 53 % . At 3 months there was a reduction in monthly headache days for episodic migraine , from 12 ( median , 8–13 IQ range ) to 9 ( 4–12 ) and for chronic migraine , a reduction from 24 ( median , 16–30 IQ range ) to 16 ( 10–30 ) . There were no serious or unanticipated adverse events . Conclusions TMS may be a valuable addition to options for the treatment of both episodic and chronic migraine Background Chronic migraine is a prevalent disabling disease , with major health-related burden and poor quality of life . Long-term use of preventive medications carries risk of side effects . Objectives The aim of this study was to compare repetitive transcranial magnetic stimulation ( rTMS ) to botulinum toxin-A ( BTX-A ) injection as preventive therapies for chronic migraine . Methods A pilot , r and omized study was conducted on a small-scale sample of 29 Egyptian patients with chronic migraine , recruited from Kasr Al-Aini teaching hospital outpatient clinic and diagnosed according to ICHD-III ( beta version ) . Patients were r and omly assigned into two groups ; 15 patients received BTX-A injection following the Phase III Research Evaluating Migraine Prophylaxis Therapy injection paradigm and 14 patients were subjected to 12 rTMS sessions delivered at high frequency ( 10 Hz ) over the left motor cortex ( MC , M1 ) . All the patients were requested to have their 1-month headache calendar , and they were subjected to a baseline 25-item ( beta version ) Henry Ford Hospital Headache Disability Inventory ( HDI ) , Headache Impact Test ( HIT-6 ) , and visual analogue scale assessment of headache intensity . The primary efficacy measures were headache frequency and severity ; secondary measures were 25-item HDI , HIT-6 , and number of acute medications . Follow-up visits were scheduled at weeks 4 , 6 , 8 , 10 , and 12 after baseline visit . Results A reduction in all outcome measures was achieved in both the groups . However , this improvement was more sustained in the BTX-A group , and both the therapies were well tolerated . Conclusion BTX-A injection and rTMS have favorable efficacy and safety profiles in chronic migraineurs . rTMS is of comparable efficacy to BTX-A injection in chronic migraine therapy , but with less sustained effect The objective was to assess the impact of transcranial magnetic stimulation ( TMS ) on pain and the autonomic nervous system ( ANS ) in migraine . Fortytwo people [ mean age 41.43±11.69 ( SD ) years , 36 females ] were r and omised into high vs. low TMS stimulation groups and received 2 brief pulses of TMS . Thirty-three ( 33/42 ) individuals had heart-rate variability assessed , before and after stimulation
Output:
| Of all TMS and tDCS modalities , rTMS is most promising with moderate evidence that it contributes to reductions in headache frequency , duration , intensity , abortive medication use , depression , and functional impairment .
However , only few studies reported changes greater than sham treatment . |
MS210507 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE To present the results after simultaneous photorefractive keratectomy ( PRK ) followed by corneal collagen cross-linking ( CXL ) for progressive keratoconus . METHODS Twelve patients ( 14 eyes ) with progressive keratoconus were prospect ively treated with customized topography-guided PRK with the Pulzar Z1 ( wavelength 213 nm , CustomVis ) immediately followed by corneal collagen CXL with the use of riboflavin and ultraviolet A irradiation . RESULTS Mean follow-up was 10.69+/-5.95 months ( range : 3 to 16 months ) . Mean preoperative spherical equivalent refraction ( SE ) was -3.03+/-3.23 diopters ( D ) and defocus was 4.67+/-3.29 D ; at last follow-up SE and defocus were statistically significantly reduced to -1.29+/-2.05 D and 3.04+/-2.53 D , respectively ( P<.01 ) . Preoperative mean ( logMAR ) uncorrected visual acuity was 0.99+/-0.81 and best spectacle-corrected visual acuity was 0.21+/-0.19 , which improved postoperatively to 0.16+/-0.15 and 0.11+/-0.15 , respectively . The mean steepest keratometry was reduced from 48.20+/-3.40 D preoperatively to 45.13+/-1.80 D at last follow-up . CONCLUSIONS Simultaneous PRK followed by CXL seems to be a promising treatment capable of offering functional vision in patients with keratoconus Purpose To determine the variability in Scheimpflug image – derived posterior elevation measurements in eyes with keratoconus or corneal collagen crosslinking ( CXL ) . Setting Eye Institute of Thrace , Alex and roupolis , Greece . Design Prospect i ve observational study . Methods Two operators in 2 sessions obtained posterior elevation measurements using the Pentacam Scheimpflug system . Variability in measurements was assessed using Bl and ‐Altman analysis and intraclass correlation coefficients ( ICCs ) . Measurements were associated with a series of Scheimpflug‐derived keratoconus indices using the Pearson correlation and multivariate linear‐regression analysis . Results Mean interobserver differences for the central elevation point ( e1 ) and the highest elevation point ( HEP ) in the keratoconus group were −0.9 μm ( 95 % limits of agreement [ LoA ] , 5.7 to −7.5 μm ) and 1.7 μm ( 95 % LoA , 26 to −22.6 μm ) , respectively . In the CXL group , the mean differences were 0.2 μm ( 95 % LoA , 6.0 to −5.5 μm ) and −6.1 μm ( 95 % LoA , 16.8 to −29 μm ) , respectively . The ICC values in the keratoconus group were satisfactory for most elevation points ; the ICC values were unsatisfactory for a series of points in the lower corneal hemisphere . The ICC values for points in both hemispheres were unsatisfactory in the CXL group ; HEP had adequate reproducibility . The e1 and HEP parameters correlated significantly with most Scheimpflug‐derived indices ( P<.05 ) in the keratoconus group but not in the CXL group . Regression analysis indicated that the central keratoconus index was the primary determinant of the variability in keratoconus eyes . Conclusions Scheimpflug‐derived posterior elevation measurements had acceptable reproducibility in keratoconus eyes and post‐CXL eyes . Less consistent measurements were obtained in the lower hemisphere . Financial Disclosure No author has a financial or proprietary interest in any material or method mentioned Purpose : To evaluate the clinical and topographic effects after accelerated corneal collagen cross-linking ( CXL ) in keratoconus . Methods : This was a prospect i ve interventional study in 25 eyes of 24 Asian patients with keratoconus , where 10 eyes in group 1 had mild to moderate keratoconus with the steepest keratometry reading ( Kmax ) < 58 diopters ( D ) , and 15 eyes in group 2 had advanced keratoconus with Kmax ≥ 58.0 D. The patients underwent accelerated CXL with 18 W/cm2 UV-A light for 5 minutes . Clinical and topographic parameters were obtained before and 1 year after treatment . Results : Overall , spectacle-corrected distance visual acuity , refraction , average keratometry readings , Kmax , anterior elevation at the apex , and corneal endothelial cell density remained stable ( P < 0.102 ) . Posterior elevation at the apex increased at 1 year ( P = 0.002 ) . The thinnest pachymetry readings also showed significant reduction ( P < 0.001 ) . Kmax in group 1 increased by 1.00 ± 1.63 D ( range , −2.2 to 5.4 D ; P = 0.012 ) , whereas Kmax in group 2 reduced by 1.69 ± 2.61 D ( range , −8.4 to 3.2 D ; P = 0.013 ) at 1 year after accelerated CXL . The change in Kmax between the 2 groups was significantly different ( P < 0.001 ) . There was no intergroup difference for the change in other parameters . A significant correlation was found between the preoperative Kmax and postoperative change in Kmax at 1 year ( r = −0.648 ; P < 0.001 ) . Conclusions : Accelerated CXL seems to be effective in preventing progression and causing topographic flattening in advanced cases of keratoconus but not as effective in the less progressed counterparts PURPOSE To compare the long-term outcomes of accelerated and st and ard corneal cross-linking protocol s in the treatment of progressive keratoconus . DESIGN Prospect i ve r and omized clinical trial . METHODS Thirty-one eyes with keratoconus were treated with an accelerated protocol ( 18 mW/cm(2 ) , 5 min ) and all contralateral eyes were treated with the st and ard method ( 3 mW/cm(2 ) , 30 min ) using the same overall fluence of 5.4 J/cm(2 ) . RESULTS At 18 months after the procedure , the st and ard group showed significant improvement in spherical equivalent ( P < .05 ) , K-readings ( P < .05 ) , Q value ( P < .05 ) , index of surface variance ( P < .05 ) , and keratoconus index ( P = .008 ) and decline in central corneal thickness ( P < .05 ) , but no significant change in visual acuity , corneal hysteresis , corneal resistance factor , P2 area , or endothelial cell density . In the accelerated group , central corneal thickness was the only parameter with statistically significant change . However , neither of these parameters showed significant differences between the st and ard and the 18 mW/cm(2 ) accelerated protocol , except K-reading ( P = .059 ) and index surface variance ( P = .034 ) . CONCLUSION An accelerated cross-linking protocol , using 18 mW/cm(2 ) for 5 minutes , shows a comparable outcome and safety profile when compared to the st and ard protocol , but better corneal flattening is achieved with the st and ard method than the accelerated method . Overall , both methods stop the disease progression similarly . This study will continue to examine more long-term results PURPOSE In animal eyes , a significant increase in corneal biomechanical stiffness has been found after collagen crosslinking by combined riboflavin/ultraviolet-A ( UVA ) treatment . The aim of the present study was to evaluate the clinical usefulness of riboflavin/UVA-induced collagen crosslinking for bringing the progression of keratoconus to a halt . DESIGN Prospect i ve , nonr and omized clinical pilot study . METHODS Twenty-three eyes of 22 patients with moderate or advanced progressive keratoconus ( maximum K value , 48 - 72 diopters ) were included . After central corneal abrasion , photosensitizing riboflavin drops were applied and the eyes exposed to UVA ( 370 nm , 3 mW/cm(2 ) ) in a 1-cm distance for 30 minutes . Postoperative examinations were performed in 6-month intervals , including visual acuity testing , corneal topography , slit-lamp examination , measurement of endothelial cell density , and photographic documentation . The follow-up time was between 3 months and 4 years . RESULTS In all treated eyes , the progression of keratoconus was at least stopped . In 16 eyes ( 70 % ) regression with a reduction of the maximal keratometry readings by 2.01 diopters and of the refractive error by 1.14 diopters was found . Corneal and lens transparency , endothelial cell density , and intraocular pressure remained unchanged . Visual acuity improved slightly in 15 eyes ( 65 % ) . CONCLUSIONS Collagen crosslinking may be a new way for stopping the progression of keratectasia in patients with keratoconus . The need for penetrating keratoplasty might then be significantly reduced in keratoconus . Given the simplicity and minimal costs of the treatment , it might also be well-suited for developing countries . Long-term results are necessary to evaluate the duration of the stiffening effect and to exclude long term side-effects PURPOSE To assess the repeatability and agreement of three rotating Scheimpflug cameras , Pentacam , Galilei , and Sirius , in measuring the mean keratometry ( Km ) , thinnest corneal thickness ( TCT ) , anterior chamber depth ( ACD ) , and mean posterior keratometry ( pKm ) in keratoconus patients in a prospect i ve study . METHODS Fifty-five eyes of 55 patients with keratoconus underwent three consecutive scans on each machine , performed by a single operator . Within-subject st and ard deviation ( Sw ) , test-retest repeatability ( TRT ) , and coefficient of variation ( COV ) for assessing repeatability and Bl and -Altman plots for the agreement between the mean measurements of each machine were examined . RESULTS The Sw of Km and pKm measurements with Pentacam ( 0.23 and 0.10 diopters [ D ] , respectively ) were significantly lower ( better ) than those of Galilei ( 0.60 and 0.17 ) and Sirius ( 0.23 and 0.36 ) . The Sw of TCT measurements with Sirius ( 8.88 μm ) was significantly lower than that of Galilei ( 11.64 μm ) . The COV ranged between 0.5 for the Km measurements of Pentacam and 2.8 for the TCT measurements of Galilei . Significant proportional bias in agreement was detected for the pKm measurements with all the three device pairs and for the ACD measurements between Pentacam and Galilei and between Galilei and Sirius . CONCLUSIONS Though Pentacam , Galilei , and Sirius showed repeatable measurements for Km , TCT , ACD , and pKm , repeatabilities with Pentacam and Sirius were better than those with Galilei . There were significant differences in the measurements between the three devices ; hence they can not be used interchangeably for anterior segment measurements in keratoconus patients PURPOSE To evaluate the long-term results of corneal collagen cross-linking ( CXL ) in patients with progressive keratoconus . DESIGN Prospect i ve case series . PARTICIPANTS This study was conducted on 40 eyes of 32 patients with progressive keratoconus between 2006 and 2012 . METHODS Patients underwent CXL no later than 1 month after baseline examinations . For CXL , ultraviolet irradiation was applied for 30 minutes , during which riboflavin instillation was repeated every 3 minutes . MAIN OUTCOME MEASURES Patients were tested for best-corrected visual acuity ( BCVA ) , uncorrected visual acuity ( UCVA ) , manifest refraction spherical equivalent ( MRSE ) , and Scheimpflug imaging from which we extracted maximum keratometry reading ( max-K ) , average of minimum and maximum keratometry readings ( mean-K ) , central corneal thickness ( CCT ) , and anterior and posterior elevation at the apex at baseline , at 1 , 3 , 6 months after CXL , and 1 , 2 , 4 , and 5 years later . We studied results at 5 years after CXL as well as the trend of changes over the 5-year period . RESULTS Mean UCVA was 0.67 ± 0.52 logarithm of the minimum angle of resolution ( logMAR ) at baseline and 0.65 ± 0.51 logMAR at 5 years after the procedure . For mean BCVA , these values were 0.31 ± 0.28 and 0.19 ± 0.20 logMAR , respectively ( P = 0.016 ) . The mean MRSE changed from -3.18±2.23 diopters ( D ) to -2.77 ± 2.18 D , and mean refractive cylinder error changed from -3.14 ± 2.22 to -2.49 ± 1.71 D ( P = 0.089 ) . Mean max-K and mean-K decreased by 0.16 ± 2.20 and 0.10 ± 1.69 D , respectively . The CCT increased from 483.87 ± 29.07 to 485.95 ± 28.43 μm . Mean anterior elevation at the
Output:
| Pentacam repeatability of different indices is not affected by CXL .
However , the change of indices showed high variance , which should be taken into consideration , especially in systematic review s because inter- study differences can be due to low repeatability of the measures of change |
MS210508 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Study Design . A r and omized trial . Objective . To evaluate the effectiveness of a semi-intensive multidisciplinary rehabilitation for patients with chronic low back pain in an outpatient setting . Summary and Background Data . Systematic review s have shown that there is strong evidence that intensive multidisciplinary treatment ( > 100 hours ) , which includes functional restoration , improves function among chronic patients with low back pain , and moderate evidence that it reduces pain but contradictory evidence regarding improvement of working ability . However , there is paucity of data whether semi-intensive outpatient multidisciplinary rehabilitation in groups is more effective than individual physiotherapy . Material s and Methods . A total of 120 women employed as healthcare and social care professionals with nonspecific chronic low back pain were recruited from two occupational healthcare centers . The patients were r and omized into two intervention programs . Multidisciplinary rehabilitation ( n = 59 ) was conducted in groups and comprised of physical training , workplace interventions , back school , relaxation training , and cognitive-behavioral stress management methods for 70 hours . The individual physiotherapy ( n = 61 ) included physical exercise and passive treatment methods administered for 10 hours . Main outcome measures were : back pain and sciatic pain intensity , disability , sick leaves , healthcare consumption , symptoms of depression , and beliefs of working ability after 2 years . Results . There were no statistically significant differences between the two treatment groups in main outcome measures just after rehabilitation , at 6- , at 12- , or 24-month follow-up . In both intervention arms , however , the before- and -after comparison showed favorable effects , and the effects were still maintained at 2 years follow-up . Conclusions . The results of this study indicate that semilight outpatient multidisciplinary rehabilitation program for female chronic low back pain patients does not offer incremental benefits when compared with rehabilitation carried out by a physiotherapist having a cognitive-behavioral way of administering the treatment The aim of the study was to evaluate the effect of cognitive intervention ( information and physical exercise ) , on patients with long-lasting back pain referred for surgical evaluation at an orthopaedic hospital , but evaluated as unfit for surgery . One hundred and fifty-two patients were r and omized to a five days intervention or control . The intervention had no significant effects on pain . At three-month follow-up , the patients in the intervention group used significantly more active strategies to cope with the back pain compared to the control group . This effect seemed to increase over time , being more pronounced at one-year follow-up evaluation Objectives The aim of this r and omized controlled study was to investigate whether additional psychologic interventions in the context of multidisciplinary inpatient pain treatment increases treatment efficacy compared with normal orthopedic rehabilitation . In addition , we aim ed to demonstrate the additional benefit of a subsequent maintenance program in further stabilizing treatment successes . Methods We r and omly assigned 363 chronic back pain patients to 1 of 3 treatment conditions : traditional orthopedic rehabilitation , multidisciplinary ( behavioral-medical ) rehabilitation alone , and multidisciplinary rehabilitation with subsequent booster sessions . Pain disability , depression , self-efficacy , health status , life satisfaction , and coping strategies were assessed at admission , discharge , and 12 months follow-up . The completion rate was 94 % . Results All 3 treatment conditions were effective in improving core outcome measures in chronic back pain patients in the short term . The results were almost maintained at follow-up ( small-to-medium within-group effect sizes ) . Significant advantages in favor of behavioral-medical interventions were found on almost all pain coping strategies and depression compared with traditional orthopedic rehabilitation . We found only slight advantages for the behavioral-medical treatment with subsequent booster sessions compared with the condition without a further maintenance program . Discussion The results concerning the efficacy of the multidisciplinary treatment are in accordance with former meta-analyses . Surprisingly , the findings suggest that the presented traditional orthopedic treatment was inherently very effective . The implication s of these findings are discussed with respect to the benefit of additional psychologic interventions and the benefit of aftercare approaches for chronic pain patients This study examined the supplemental value of a cognitive coping skills training when added to an operant-behavioral treatment for chronic low-back pain patients . The complete treatment package ( OPCO ) was compared with an operant program + group discussion ( OPDI ) and a waiting-list control ( WLC ) . After the WL period , the WLC patients received a less protocol ized operant program usually provided in Dutch rehabilitation centers ( OPUS ) . Regression analyses showed that , compared with WLC , both OPCO and OPDI led to less negative affect , higher activity tolerance , less pain behavior , and higher pain coping and pain control . At posttreatment , OPCO led to better pain coping and pain control than OPDI . Calculation of improvement rates revealed that OPCO and OPDI had significantly more improved patients than OPUS on all the dependent variables . The discussion includes findings regarding treatment credibility , compliance , and contamination bias Study Design . Single blind r and omized study . Objectives . To compare the effectiveness of lumbar instrumented fusion with cognitive intervention and exercises in patients with chronic low back pain and disc degeneration . Summary of Background Data . To the authors ’ best knowledge , only one r and omized study has evaluated the effectiveness of lumbar fusion . The Swedish Lumbar Spine Study reported that lumbar fusion was better than continuing physiotherapy and care by the family physician . Patients and Methods . Sixty-four patients aged 25–60 years with low back pain lasting longer than 1 year and evidence of disc degeneration at L4–L5 and /or L5–S1 at radiographic examination were r and omized to either lumbar fusion with posterior transpedicular screws and postoperative physiotherapy , or cognitive intervention and exercises . The cognitive intervention consisted of a lecture to give the patient an underst and ing that ordinary physical activity would not harm the disc and a recommendation to use the back and bend it . This was reinforced by three daily physical exercise sessions for 3 weeks . The main outcome measure was the Oswestry Disability Index . Results . At the 1-year follow-up visit , 97 % of the patients , including 6 patients who had either not attended treatment or changed groups , were examined . The Oswestry Disability Index was significantly reduced from 41 to 26 after surgery , compared with 42 to 30 after cognitive intervention and exercises . The mean difference between groups was 2.3 ( −6.7 to 11.4 ) ( P = 0.33 ) . Improvements inback pain , use of analgesics , emotional distress , life satisfaction , and return to work were not different . Fear-avoidance beliefs and fingertip-floor distance were reduced more after nonoperative treatment , and lower limb pain was reduced more after surgery . The success rateaccording to an independent observer was 70 % after surgery and 76 % after cognitive intervention and exercises . The early complication rate in the surgical group was 18 % . Conclusion . The main outcome measure showed equal improvement in patients with chronic low back pain and disc degeneration r and omized to cognitive intervention and exercises , or lumbar fusion Study Design . A r and omized controlled design superimposed on treatment as usual was used to compare the effects of a cognitive-behavior intervention aim ed at preventing chronicity with two different forms of information . Objective . To develop a coping-oriented preventive intervention applicable in primary care , and to compare its impact with educational information . Summary of Background Data . Preventing long-term disability result ing from spinal pain has proved difficult . The information provided by health care professions and early interventions aim ed at preventing long-term disability may be important , but little scientific evidence exists concerning their use . Methods . A protocol for a six-session cognitive-behavior group intervention was developed on the basis of earlier research . The main focus was to prevent long-term disability by changing patients ’ behaviors and beliefs so they can cope better with their problems . Comparison groups received either a pamphlet shown earlier to have an effect , or a more extensive information package consisting of six installments . All the groups continued to receive treatment as usual in primary care . There were 243 patients with acute or subacute spinal pain who perceived that they were at risk for developing a chronic problem . These patients were r and omized to the cognitive-behavioral intervention or one of the two information groups . Because the aim was to prevent long-term disability , the key outcome variables at the 1-year follow-up assessment were sick absenteeism and health care use . Other variables were pain , function , fear-avoidance beliefs , and cognitions . Results . The comparison groups reported benefits . However , the risk for a long-term sick absence developing was lowered ninefold for the cognitive-behavior intervention group as compared with the risk for the information groups ( relative risk , 9.3 ) . Participants in the cognitive-behavior group also reported a significant decrease in perceived risk . In addition , the cognitive-behavior group demonstrated a significant decrease in physician and physical therapy use as compared with two groups receiving information , in which such use increased . All three groups tended to improve on the variables of pain , fear-avoidance , and cognitions . Conclusions . This study demonstrates that a cognitive-behavior group intervention can lower the risk of a long-term disability developing . These findings underscore the significance of early interventions that specifically aim to prevent chronic problems . This approach might be applied to primary care setting & NA ; Several treatment principles for the reduction of chronic low back pain associated disability have been postulated . To examine whether a combination of a physical training and an operant‐behavioral grade d activity with problem solving training is more effective than either alone in the long‐term , a cluster r and omized controlled trial was conducted . In total 172 patients , 18–65 years of age , with chronic disabling non‐specific low back pain referred for rehabilitation treatment , were r and omized in clusters of four consecutive patients to 10 weeks of aerobic training and muscle strengthening of back extensors ( active physical treatment ; APT ) , 10 weeks of gradual assumption of patient relevant activities based on operant‐behavioral principles and problem solving training ( grade d activity plus problem solving training ; GAP ) , or APT combined with GAP ( combination treatment ; CT ) . The primary outcome was the Rol and Disability Question naire adjusted for centre of treatment , cluster , and baseline scores . Secondary outcomes were patients ’ main complaints , pain intensity , self‐perceived improvement , depression and six physical performance tasks . During the one‐year follow‐up , there were no significant differences between each single treatment and the combination treatment on the primary outcome , the Rol and Disability Question naire . Among multiple other comparisons , only one significant difference emerged , with GAP and APT showing higher self‐perceived improvement than CT . We conclude that the combination treatment integrating physical , grade d activity with problem solving training is not a better treatment option for patients with chronic low back pain & NA ; Many psychological factors have been suggested to be important obstacles to recovery from low back pain , yet most studies focus on a limited number of factors . We compared a more comprehensive range of 20 factors in predicting outcome in primary care . Consecutive patients consulting 8 general practice s were eligible to take part in a prospect i ve cohort study ; 1591 provided data at baseline and 810 at 6 months . Clinical outcome was defined using the Rol and and Morris Disability Question naire ( RMDQ ) . The relative strength of the baseline psychological measures to predict outcome was investigated using adjusted multiple linear regression techniques . The sample was similar to other primary care cohorts ( mean age 44 years , 59 % women , mean baseline RMDQ 8.6 ) . The 20 factors each accounted for between 0.04 % and 33.3 % of the variance in baseline RMDQ score . A multivariate model including all 11 scales that were associated with outcome in the univariate analysis accounted for 47.7 % of the variance in 6 months RMDQ score ; rising to 55.8 % following adjustment . Four scales remained significantly associated with outcome in the multivariate model explaining 56.6 % of the variance : perceptions of personal control , acute/chronic timeline , illness identify and pain self‐efficacy . When all independent factors were included , depression , catastrophising and fear avoidance were no longer significant . Thus , a small number of psychological factors are strongly predictive of outcome in primary care low back pain patients . There is clear redundancy in the measurement of psychological factors . These findings should help to focus targeted interventions for back pain in the future & NA ; The effects of outpatient group cognitive therapy , relaxation training , and cognitive therapy in combination with relaxation training on chronic low back pain and associated physical and psychosocial disability were evaluated and compared . One‐hundred and two mildly disabled chronic low back pain patients were assigned r and omly to a waiting‐list ( WL ) control condition and the 3 treatments . Patient self‐report and observational measures were obtained pretreatment and post‐treatment for all conditions , and at 6‐ and 12‐month follow‐ups for the treatment conditions . Pain intensity decreased significantly pre‐ to post‐treatment for patients in all 3 treatment conditions , but not the WL condition . Depressive symptoms and disability improved significantly in all conditions ( including the waiting list ) from pretreatment to post‐treatment , with no statistically significant differences among treatments . At both follow‐ups , all 3 treatment groups remained significantly improved from pretreatment , with no statistically significant differences between treatments Background The treatment of non-specific chronic low back pain is often based on three different models regarding the development and maintenance of pain and especially functional limitations : the deconditioning model , the cognitive behavioral model and the biopsychosocial model . There is evidence that rehabilitation of patients with chronic low back pain is more effective than no treatment , but information is lacking about the differential effectiveness of different kinds of rehabilitation . A direct comparison of a physical , a cognitive-behavioral treatment and a combination of both has never been carried out so far . Methods The effectiveness of active physical , cognitive-behavioral and combined treatment for chronic non-specific low back pain compared with a waiting list control group was determined by performing a r and omized controlled trial in three rehabilitation centers . Two hundred and twenty three patients were r and
Output:
| There was moderate quality evidence that : i ) operant therapy was more effective than waiting list ( SMD -0.43 ; 95%CI -0.75 to -0.11 ) for short-term pain relief;ii ) little or no difference exists between operant , cognitive , or combined behavioural therapy for short- to intermediate-term pain relief;iii ) behavioural treatment was more effective than usual care for short-term pain relief ( MD -5.18 ; 95%CI -9.79 to -0.57 ) , but there were no differences in the intermediate- to long-term , or on functional status;iv ) there was little or no difference between behavioural treatment and group exercise for pain relief or depressive symptoms over the intermediate- to long-term;v ) adding behavioural therapy to inpatient rehabilitation was no more effective than inpatient rehabilitation alone .
For patients with CLBP , there is moderate quality evidence that in the short-term , operant therapy is more effective than waiting list and behavioural therapy is more effective than usual care for pain relief , but no specific type of behavioural therapy is more effective than another .
In the intermediate- to long-term , there is little or no difference between behavioural therapy and group exercises for pain or depressive symptoms . |
MS210509 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: This study describes a prospect i ve r and omized controlled trial to evaluate whether suture of the peritoneal layer is necessary as a separate step in the closure of midline abdominal surgical wounds . Consecutive patients undergoing abdominal operation — elective and emergency surgery — through a midline abdominal wound were r and omized to have the peritoneal layer closed with continuous catgut , or to have this step omitted . The linea alba was closed with interrupted stainless steel sutures , and the skin approximated with staples . Patients were evaluated for wound sepsis , wound dehiscence , and subsequent incisional hernia development . Postoperative pain was assessed by a self-administered visual analogue score , and by measuring narcotic requirements . There was no significant difference in narcotic requirements , pain scores , or wound complications between the 2 groups . Single-layer closure of the abdominal wall is quicker , less costly , and theoretically safer than layered closure , and it is recommended that separate suture of the peritoneum be ab and oned . ResuméDans cette étude prospect i ve , r and omisée , et contrôlée , nous avons cherché à savoir si la fermeture individualisée du péritoine était nécessaire dans la fermeture d'une laparotomie médiane . Deux cents patients consécutifs — opérés à froid ou en urgence — par laparotomie médiane , ont été r and omisés : dans un groupe , le péritoine a été fermé en un plan individualisé par un surjet au catgut , dans l'autre , le péritoine n'a pas été suturé . La ligne blanche a été fermée en un plan par des points séparés de fils d'acier ; la peau a été fermée par des agrafes . On a étudié le nombre des abcès de paroi , des éviscérations , et , à distance , des éventrations . La douleur postopératoire a été évaluée par un score analogue visuel , établi par le patient lui-même , ainsi que par la nécessité d'utiliser des antalgiques . Il n'y avait pas de différence significative entre les 2 groupes en ce qui concerne le taux de complications pariétales ou l'existence de douleur . Comme la fermeture pariétale en un seul plan est plus rapide , coûte moins cher , et , est théoriquement plus sûre ( on peut surveiller le contenu intrapéritonéal pendant la fermeture ) que la fermeture plan par plan , nous recomm and ons d'ab and oner la fermeture individualisée du péritoine . ResumenEl presente articulo describe un ensayo clínico prospect ivo destinado a investigar si es necesaria la sutura de la capa peritoneal como un paso independiente en el cierre de incisiones abdominales de línea media . Una serie de pacientes consecutivos sometidos a operaciones abdominales fueron r and omizados a cierre peritoneal con sutura continua de catgut o a omisión de este paso . La línea alba fue cerrada con suturas interrumpidas de acero inoxidable y la piel con agrafes . Se estudió la incidencia de infección de herida , de dehiscencia , y de desarrollo de hernia incisional subsiguientes . La valoración del dolor postoperatorio fue realizada mediante autoevaluación con una escala linear análoga y la determinación de los requerimientos de narcóticos . No se encontraron diferencias significativas en el requerimiento de narcóticos para analgesia , en el nivel de la escala de dolor , o en la tasa de complicaciones entre los 2 grupos . El cierre de la pared abdominal en una capa única es más rápido , menos costoso , y teóricamente más seguro ; por lo tanto , se recomienda ab and onar la sutura del peritoneo Purpose Different suture techniques and various suture material s are in use to close midline incisions after primary laparotomy . The ISSAAC study aim ed to assess the safety and efficacy of the new ultra-long-term absorbable , elastic monofilament suture material MonoMax ® for abdominal wall closure . Methods This is a single-arm , multicentre prospect i ve study that included 150 patients undergoing a primary elective midline incision . The control group consists of 141 patients from the INSECT study who received MonoPlus ® or PDS ® for abdominal wall closure . The incidences of burst abdomen and wound infection until the day of discharge were defined as the primary composite endpoints . The rate of incisional hernias 1 year after surgery , the length of postoperative hospital stay and safety parameters served as secondary endpoints . The study has been registered under www . clinical trials.gov [ NCT005725079 ] . Results Eleven patients in the ISSAAC study [ 7.3 % ; 95 % CI = ( 3.9 ; 13.1 % ) ] experienced wound infection or burst abdomen until the day of discharge as compared to 16 [ 11.3 % ; 95 % CI = ( 6.6 ; 17.8 % ) ] patients in the INSECT control group ( p = 0.31 ) . The length of postoperative hospital stay was comparable in both study groups . One year after surgery , incisional hernias were observed in 21 ISSAAC patients ( 14.0 % ) in contrast to 30 hernias ( 21.3 % ) in the INSECT control group . Conclusions The ultra-long-term absorbable , elastic monofilament suture material MonoMax ® is safe and efficient for abdominal wall closure The lateral paramedian incision has been advocated as the strongest incision for abdominal surgery . We have evaluated this incision and tested the necessity for closing the deep peritoneal layer by a prospect i ve r and omized trial . All 206 patients undergoing laparotomy in the Surgical Unit in 1984 , both elective and emergency cases , were included . In patients undergoing laparotomy through unscarred tissue , a lateral paramedian incision was performed and they were r and omized to have either the peritoneum closed ( n = 77 ) or left open ( n = 75 ) . Patients in whom the laparotomy was performed through a previous incision ( n = 51 ) and those in whom the abdomen had to be opened urgently ( n =3 ) were excluded from the trial but studied separately ( n = 54 ) . The rectus sheath was closed with monofilament nylon in all cases . Patients were assessed for wound integrity during the immediate postoperative period and at 1 , 3 , 6 and 12 months after operation . So far the patients have been followed up for between 1 and 2 years and follow‐up is continuing as in some cases incisional hernia may not be detected until several years after operation . There have been no cases of burst abdomen . No incisional hernias have developed in patients in whom a lateral paramedian incision was performed and the peritoneum was closed , and one incisional hernia has occurred in the patients in whom the peritoneum was left open . Seven incisional hernias have occurred in patients excluded from the trial of the lateral paramedian incision ( 13 per cent ) . We conclude that the lateral paramedian incision successfully abolishes the burst abdomen and that incisional hernia is rare . It is not necessary to close the peritoneum with this incision Objective : To determine the volume of pelvic fluid and febrile morbidity after hysterectomy in which the peritoneum was or was not closed . Design : Prospect i ve single-center study . Participants : Fifty-four women undergoing abdominal hysterectomy were enrolled in the study . Patients were r and omized into two groups according to peritoneal closure : group I ( n = 28 ) in which the peritoneum was closed , and group II ( n = 26 ) in which the peritoneum was left open . All participants had early postoperative transvaginal ultrasound . Outcome Measures : Volume of pelvic fluid accumulated after hysterectomy , total leukocytic count before and after hysterectomy , body temperature over the first 24 h , and wound healing . Results : There was a statistically significant difference between both groups regarding the volume of pelvic fluid collection , the duration of the operation and number of ampoules needed ( p < 0.05 ) . There was no statistically significant difference regarding body temperature , TLC , and wound complications . Conclusion : Peritoneal non-closure does not increase short-term morbidity , however it does cause an increase in peritoneal pelvic fluid . The impact of this on long-term sequelae as adhesions should be investigated Abstract . Background : A transverse skin crease incision for right hemicolectomy may result in more rapid recovery than traditional vertical midline incision . This hypothesis was tested with a prospect i ve r and omised trial . Methods : Patients from 2 centres undergoing right hemicolectomy were r and omised to received a midline or transverse incision . Incision lengths were sufficient to enable unrestricted resection of the right colon . Patients and carers were blinded to the incisions using strategically placed dressings . Analgesia and oral intake were controlled by the patient . Operative details and recovery parameters were compared . Results : A total of 28 patients were r and omised . Demographic data and tumour characteristics of the two treatment groups were similar . The transverse incision group had a slightly shorter median wound ( 10 cm vs. 11 cm , p<0.05 ) . Operative time , analgesia requirements , recovery parameters ( time to discharge , 6.5 vs. 6.5 days ) and frequency of complications were otherwise comparable . Conclusions : A transverse skin crease incision for right hemicolectomy results in a slightly smaller wound but no other advantages were demonstrated compared with a traditional vertical midline incision The effects of pelvic and periaortic peritoneal closure or ( non-closure ) on morbidity and adhesion formation were prospect ively compared in 102 patients with ovarian cancer who had undergone a pelvic and periaortic lymphadenectomy . Hysterectomy with bilateral salpingoophorectomy , bilateral pelvic and periaortic lymphadenectomy , omentectomy , appendectomy and lysis of pelvic adhesions for the st and ardization of initial adhesion scores was performed on all patients . The pelvic and periaortic peritoneum were re-approximated in group I ( n = 50 ) patients , and left open in group II ( n = 52 ) patients . The groups were similar for mean age , previous surgery , tumour histology and disease stage . Morbidity characteristics such as blood loss , transfusion rate , post-operative infectious and non-infectious complications , and total hospital stay were also similar . After six courses of PAC ( cisplatin 50 mg/m(2 ) , Adriamycin 50 mg/m(2 ) , cyclophosphamide 500 Mg/M(2 ) ) chemotherapy , all patients underwent a second-look laparotomy . Persistent cancer was detected in 49 of 102 ( 48.03 % ) patients . Adhesion scores were detected at the time of second-look laparotomy . Adhesion scores for group I ( 8.9 + /- 2.9 ) were significantly higher than the group II ( peritoneum non-closure ) ( 5.8 + /- 2.3 ) ( P<0.01 ) . Closing the pelvic and periaortic peritoneum did not effect morbidity , but leaving the pelvic and periaortic peritoneum open significantly decreased the adhesion formation Methods for combining data from several studies exist and appear to be quite useful . None satisfactorily addresses the question of what studies should be combined . This issue is the most serious method ological limitation . Even studies with statistically significant interaction might still be combined if the effect were in the same direction . Thus , substantial scientific input is required as to what criteria must be met by each potential study . Much can be learned from combining or pooling data but it must be done cautiously . Pooling exercises do not replace well design ed prospect i ve clinical trials . Efforts for establishing basic design criteria to allow for multicentre and multicountry trials to be more easily combined might be useful . Objective To compare closure and nonclosure of the peritoneum at radical abdominal hysterectonmy and pelvic node dissection with respect to postoperative morbidity . Methods Women with uterine cancer who underwent radical abdominal hysterectomy and node dissection type II or III of Piver-Rutledge were assigned r and omly to have a st and ard closure of pelvic and parietal peritoneum and placement of a T-shaped suction drain or to have the peritoneum left open but the vagina closed and two abdominal drains placed . Adjuvant radiotherapy was given to patients with risk factors . The postoperative incidence of lymphocysts ( within 8 weeks from the operation and after 1 year ) and infection-related and non-infection-related complications were analyzed . Results One hundred twenty subjects were enrolled , of whom 59 had peritoneal closure and 61 did not . Both groups were similar with regard to age , weight , nodes removed , nodal metastases , operative time , type of surgery , need for transfusion , and incidence of postoperative radiotherapy . The median follow-up was 36 months ( range 11–72 ) . Eleven patients died , four because of treatment-related complication . The amount of drainage was significantly higher in the closed group than in the unclosed group ( median 740 mL , range 50–5980 versus median 340 mL , range 40–4000 ; P < .005 ) . The incidence of asymptomatic lymphocysts was similar in the closed and open groups at 2 weeks ( 17 of 59 versus 15 of 6 , respectively ) , at 8 weeks ( eight of
Output:
| There is no evidence for any short-term or long-term advantage in peritoneal closure for non-obstetric operations . |
MS210510 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: This paper describes an investigation of the types of problems that may be experienced by Virtual Reality ( VR ) users . Initial concerns have been voiced about various issues concerning the design of VR equipment , particularly the physical ergonomics of head-mounted displays ( HMDs ) and h and -held input devices , and the problems associated with display resolution and lags . This study investigated a number of VR users ' perceptions of the types of physical ergonomics issues that they were aware of when participating in a number of different virtual environments ( VEs ) , using different VR systems . Several different methods were employed , including question naires , body mapping , user observation and interviews . Issues highlighted as either causing participants discomfort or interfering with their experience of the VE were : discomfort from static posture requirements , general discomfort from wearing the HMD , difficulty becoming accustomed to 3D h and held input devices , dissatisfaction with deficits in the visual display and fear of getting ' tangled ' in connecting cables . The implication s of these findings for developers , implementers and users of VR are discussed Although head-mounted displays ( HMDs ) are ideal devices for personal viewing of immersive stereoscopic content , exposure to VR applications on them results in significant discomfort for the majority of people , with symptoms including eye fatigue , headaches , nausea , and sweating . A conflict between accommodation and vergence depth cues on stereoscopic displays is a significant cause of visual discomfort . This article describes the results of an evaluation used to judge the effectiveness of dynamic depth-of-field ( DoF ) blur in an effort to reduce discomfort caused by exposure to stereoscopic content on HMDs . Using a commercial game engine implementation , study participants report a reduction of visual discomfort on a simulator sickness question naire when DoF blurring is enabled . The study participants reported a decrease in symptom severity caused by HMD exposure , indicating that dynamic DoF can effectively reduce visual discomfort Background Virtual reality ( VR ) has recently been explored as a tool for neurorehabilitation to enable individuals with Parkinson ’s disease ( PD ) to practice challenging skills in a safe environment . Current technological advances have enabled the use of affordable , fully immersive head-mounted displays ( HMDs ) for potential therapeutic applications . However , while previous studies have used HMDs in individuals with PD , these were only used for short bouts of walking . Clinical applications of VR for gait training would likely involve an extended exposure to the virtual environment , which has the potential to cause individuals with PD to experience simulator-related adverse effects due to their age or pathology . Thus , our objective was to evaluate the safety of using an HMD for longer bouts of walking in fully immersive VR for older adults and individuals with PD . Methods Thirty-three participants ( 11 healthy young , 11 healthy older adults , and 11 individuals with PD ) were recruited for this study . Participants walked for 20 min while viewing a virtual city scene through an HMD ( Oculus Rift DK2 ) . Safety was evaluated using the mini-BESTest , measures of center of pressure ( CoP ) excursion , and question naires addressing symptoms of simulator sickness ( SSQ ) and measures of stress and arousal . Results Most participants successfully completed all trials without any discomfort . There were no significant changes for any of our groups in symptoms of simulator sickness or measures of static and dynamic balance after exposure to the virtual environment . Surprisingly , measures of stress decreased in all groups while the PD group also increased the level of arousal after exposure . Conclusions Older adults and individuals with PD were able to successfully use immersive VR during walking without adverse effects . This provides systematic evidence supporting the safety of immersive VR for gait training in these population It has been reported that females are more susceptible to motion sickness than males . Supporting evidence is primarily based on retrospective survey question naires and self-reporting . We investigated if there is a gender difference in motion sickness susceptibility using objective and subjective measurements under controlled laboratory conditions . Thirty healthy subjects ( 14 males and 16 females ) between the ages of 18 - 46 years were exposed to Coriolis cross-coupling stimulation , induced by 120 degrees /s yaw rotation and a simultaneous 45 degrees pitch forward head movement in the sagittal plane every 12 seconds . Cutaneous forearm and calf blood flow , blood pressure , and heart rate were monitored . Graybiel 's diagnostic criteria were used to assess sickness susceptibility before and after motion exposure . Golding and Kerguelen 's scale was used to assess the severity of symptoms during motion exposure . A significant ( p<0.01 ) increase of forearm and calf blood flow during cross-coupling stimulation was observed in both sexes . However , the subjective symptoms rating and blood flow measurements indicate that there was no significant difference between male and female subjects . Our data also suggests that females may be more inclined to admit discomfort as indicated by their responses to a survey of motion sickness history prior to the experiment Stroke and traumatic brain injury affect an increasing number of people , many of whom retain permanent damage in cognitive functions . Conventionally , cognitive function has been assessed by a paper-based neuropsychological evaluation . However these test environments differ substantially from everyday life . This problem can be overcome by using virtual reality ( VR ) to objective ly evaluate behaviors and cognitive function in simulated daily activities . With our virtual shopping simulation , we compared people who had undergone a stroke with control participants in an immersive VR program that used a head-mounted display ( HMD ) . We evaluated user satisfaction with the tests , complications , and the user interface . Significant differences were consistently found between the stroke group and the control group for the following tasks : stage 1 performance index , interaction error ; stage 2 delayed recognition memory score , attention index ; and stage 3 executive index ( p < 0.001 ) . Perceptive dysfunction , visuospatial dysfunction , level of computer experience , and level of education affected the performance of the stroke group . The frequency of complications in the stroke group , calculated using the cut-off score for the Simulator Sickness Question naire , was 9.6 % for nausea , 41.9 % for oculomotor complications , and 25.8 % for disorientation . The frequency of complications between the stroke and control groups was not significantly different . Thirty-five percent of participants in the stroke group and 13 % in the control group reported difficulties with using the joystick . This computer-generated VR-based cognitive test shows promise in assessing cognitive function in patients with stroke . More refinements are needed in the user interface and the projection methods BACKGROUND Interactions between frequency and amplitude of latency in head-mounted displays ( HMDs ) are thought to affect simulator sickness . Many studies have linked system latency to subjective sickness , but recent research has found that at least with the case of inertia-based head tracking technology , latency is not a constant ; rather it varies systematic ally over time due to sensor errors and clock asynchronization . The purpose of this experiment was to further explore the relationship between frequency and amplitude of latency as they relate to subjective sickness experienced in an HMD . METHODS In a 2 ( frequency ) × 2 ( amplitude ) design , 120 subjects were r and omly assigned to 4 latency conditions . Frequency of latency was either 0.2 Hz or 1.0 Hz . Amplitude of latency was either 100 ms fixed or 20 - 100 ms varying . RESULTS A main effect of frequency of latency was found . Subjects reported greater sickness in the 0.2-Hz frequency conditions ( 39.0 ± 27.8 ) compared to the 1-Hz conditions ( 30.3 ± 17.0 ) . Additionally , 18 subjects withdrew their participation early in the 0.2-Hz conditions compared to 7 in the 1.0-Hz conditions . DISCUSSION In conclusion , frequency of latency appears to play a role in the experience of sickness in HMDs in both subjective reporting of symptoms and subject performance . The current study confirms results of earlier studies , finding that real motion around a frequency of 0.2 Hz is more sickening than other frequencies . Future work should continue to parse the effects of frequency and amplitude of latency in head-tracked HMDs . Kinsella A , Mattfeld R , Muth E , Hoover A. Frequency , not amplitude , of latency affects subjective sickness in a head-mounted display . Aerosp Med Hum Perform . 2016 ; 87(7):604 - 609 Virtual simulation sickness ( VSS ) is a form of visually induced motion sickness that can result fromimmersion in a virtual environment ( VE ) . As in their susceptibility to the sickness induced by real motion , womenhave been reported to be more susceptible than men to VSS , yet the reason for this difference is not known . The aim of the current study was to investigate the influence of themenstrual cycle on susceptibility to VSS in 16 naturally cycling women and to compare the responses of this group with control groups consisting of 1 ) 16 premenopausal women taking a combined monophasic oral contraceptive and 2 ) 16 men . All female participants were immersed in a nauseogenic VE on days 5 , 12 , 19 , and 26 of their menstrual/pill cycle . These days were chosen because they fall in line with peaks and troughs of ovarian hormone levels . Menstrual cycle phase was confirmed by salivary estradiol and progesterone levels . A 4-week “ pseudo-cycle ” was assigned to the male participants . Hormone analysis revealed that 9 participants in the experimental group had been tested at the desired phases of their cycle . These participants exhibited a significant increase in susceptibility to VSS on day 12 of their cycle . The hormone analysis also showed that the cycles of the 7 remaining members of the experimental group had not precisely followed the expected pattern , and so these people had been tested on days that did not coincide with peaks and troughs of ovarian hormone levels . No consistent variation in susceptibility was observed over the cycle in these volunteers . In addition , no change in susceptibility was observed over the pill cycle of the oral contraceptive group nor over the pseudo-cycle applied to the male control group . The authors conclude that susceptibility to VSS varies over the menstrual cycle as a consequence of hormonal variation For those interested in using head-coupled PC-based immersive virtual environment ( VE ) technology to train , entertain , or inform , it is essential to underst and the effects this technology has on its users . This study investigated potential adverse effects , including the sickness associated with exposure and extreme responses ( emesis , flashbacks ) . Participants were exposed to a VE for 15 to 60 min , with either complete or streamlined navigational control and simple or complex scenes , after which time measures of sickness were obtained . More than 80 % of participants experienced nausea , oculomotor disturbances , and /or disorientation , with disorientation potentially lasting > 24 hr . Of the participants , 12.9 % prematurely ended their exposure because of adverse effects ; of these , 9.2 % experienced an emetic response , whereas only 1.2 % of all participants experienced emesis . The results indicate that design ers may be able to reduce these rates by limiting exposure duration and reducing the degrees of freedom of the user 's navigational control . Results from gender , body mass , and past experience comparisons indicated it may be possible to identify those who will experience adverse effects attributable to exposure and warn such individuals . Applications for this research include military , entertainment , and any other interactive systems for which design ers seek to avoid adverse effects associated with exposure Background . Memory decline is a prevalent aspect of aging but may also be the first sign of cognitive pathology . Virtual reality ( VR ) using immersion and interaction may provide new approaches to the treatment of memory deficits in elderly individuals . Objective . The authors implemented a VR training intervention to try to lessen cognitive decline and improve memory functions . Methods . The authors r and omly assigned 36 elderly residents of a rest care facility ( median age 80 years ) who were impaired on the Verbal Story Recall Test either to the experimental group ( EG ) or the control group ( CG ) . The EG underwent 6 months of VR memory training ( VRMT ) that involved auditory stimulation and VR experiences in path finding . The initial training phase lasted 3 months ( 3 auditory and 3 VR sessions every 2 weeks ) , and there was a booster training phase during the following 3 months ( 1 auditory and 1 VR session per week ) . The CG underwent equivalent face-to-face training sessions using music therapy . Both groups participated in social and creative and assisted-mobility activities . Neuropsychological and functional evaluations were performed at baseline , after the initial training phase , and after the booster training phase . Results .The EG showed significant improvements in memory tests , especially in long-term recall with an effect size of 0.7 and in several other aspects of cognition . In contrast , the CG showed progressive decline . Conclusions . The authors suggest that VRMT may improve memory function in elderly adults by enhancing focused attention
Output:
| VR sickness profiles were also influenced by visual stimulation , locomotion and exposure times . |
MS210511 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Background The objective of this study was to develop and psychometrically evaluate a general measure of patients ' satisfaction with medication , the Treatment Satisfaction Question naire for Medication ( TSQM ) . Methods The content and format of 55 initial questions were based on a formal conceptual framework , an extensive literature review , and the input from three patient focus groups . Patient interviews were used to select the most relevant questions for further evaluation ( n = 31 ) . The psychometric performance of items and result ing TSQM scales were examined using eight diverse patient groups ( arthritis , asthma , major depression , type I diabetes , high cholesterol , hypertension , migraine , and psoriasis ) recruited from a national longitudinal panel study of chronic illness ( n = 567 ) . Participants were then r and omized to complete the test items using one of two alternate scaling methods ( Visual Analogue vs. Likert-type ) . Results A factor analysis ( principal component extraction with varimax rotation ) of specific items revealed three factors ( Eigenvalues > 1.7 ) explaining 75.6 % of the total variance ; namely Side effects ( 4 items , 28.4 % , Cronbach 's Alpha = .87 ) , Effectiveness ( 3 items , 24.1 % , Cronbach 's Alpha = .85 ) , and Convenience ( 3 items , 23.1 % , Cronbach 's Alpha = .87 ) . A second factor analysis of more generally worded items yielded a Global Satisfaction scale ( 3 items , Eigenvalue = 2.3 , 79.1 % , Cronbach 's Alpha = .85 ) . The final four scales possessed good psychometric properties , with the Likert-type scaling method performing better than the VAS approach . Significant differences were found on the TSQM by the route of medication administration ( oral , injectable , topical , inhalable ) , level of illness severity , and length of time on medication . Regression analyses using the TSQM scales accounted for 40–60 % of variation in patients ' ratings of their likelihood to persist with their current medication . Conclusion The TSQM is a psychometrically sound and valid measure of the major dimensions of patients ' satisfaction with medication . Preliminary evidence suggests that the TSQM may also be a good predictor of patients ' medication adherence across different types of medication and patient population BACKGROUND Medication therapy management ( MTM ) services position pharmacists to prevent , detect , and resolve medication-related problems ( MRPs . ) However , selecting patients for MTM who are most at risk for MRPs is a challenge . Using self-administered scales that are practical for use in clinical practice are one approach . OBJECTIVE The objective of this study was to estimate the psychometric properties of a brief self-administered scale as a screening tool for MRPs . METHODS This was a non-r and omized study utilizing question naires administered cross-sectionally . In Phase 1 , patients ( n = 394 ) at community pharmacies and outpatient clinics completed 78 items , provided to the study team by item authors , assessing perceived MRPs . These data were used to select items for further investigation as a brief , self-administered scale , and estimate the reliability and construct validity of the result ing instrument . In Phase 2 , a convenience sample of patients ( n = 200 ) at community pharmacies completed a nine-item , self-administered scale . After completion , they were engaged in a comprehensive medication review by their pharmacist who was blinded to question naire responses . The main outcome measure for estimating the criterion-related validity of the scale was the number of pharmacist-identified medication-related problems ( MRPs . ) Item statistics were computed as well as bivariate associations between scale scores and other variables with MRPs . A multivariate model was constructed to examine the influence of scale scores on MRPs after controlling for other significant variables . RESULTS Higher scores on the question naire were positively correlated with more pharmacist-identified MRPs ( r = 0.24 ; P = 0.001 ) and scores remained as a significant predictor ( P = 0.031 ) when controlling for other relevant variables in a multivariate regression model ( R(2 ) = 0.21 ; P < 0.001 ) . CONCLUSIONS Patient responses on the scale may have a modest role in predicting MRPs . The use of self-administered question naires such as this may supplement other available patient data in developing patient eligibility criteria for MTM , however , additional research is warranted BACKGROUND Treatment of diabetes mellitus ( DM ) is complex , requiring multifaceted lifestyle change or regulation and , for many , self-regulation of insulin levels in the blood . Historically , daily insulin treatment has been viewed as burdensome to patients , prompting newer formulations and improved delivery methods . OBJECTIVE This multicenter , clinical study was design ed to develop a conceptually sound , clinical ly meaningful , and psychometrically valid measure of insulin treatment satisfaction , applicable to a wide range of insulin therapies . METHODS A 3-phase iterative process was employed to develop and vali date the Insulin Treatment Satisfaction Question naire ( ITSQ ) : ( 1 ) conceptual development of items , ( 2 ) preliminary validation among patients with DM , and ( 3 ) confirmatory validation among patients with DM . RESULTS The ITSQ was vali date d with 170 patients in phase 2 and 402 patients in phase 3 . Confirmatory factor analysis produced a 5-factor , 22-item instrument assessing regimen inconvenience , lifestyle flexibility , glycemic control , hypoglycemic control , and satisfaction with the insulin delivery device . Results for reliability and construct validity of the final version were consistent in both sample s of patients treated with insulin , with different data collection methods . Internal consistency ( using Cronbach alpha coefficient ) of the subscales ranged from 0.79 to 0.91 . Test-retest reliability ( using Spearman rank correlation coefficients ) ranged from 0.63 to 0.94 . ITSQ scores showed moderate to high correlation with related measures of treatment burden . The ITSQ differentiated among insulin delivery methods , glycosylated hemoglobin values , the number of times the patient required assistance administering insulin , and insulin adherence . CONCLUSION In our study sample s , the ITSQ appeared to be conceptually and psychometrically sound and applicable to a wide range of insulin therapies Objective : To review literature on instruments available for assessing the physical and cognitive ability to take medications as prescribed , which serve as a way to rule out reasons for nonadherence . Data Sources : A PubMed search ( 1950–February 2008 ) was conducted to identity relevant articles . Additional references were obtained from cross-referencing the bibliographies of selected articles . Only journals containing English- language articles were selected for review . Study Selection and Data Extraction : Articles that described a simulated assessment of medication management were obtained , irrespective of whether the assessment also contained data about medication adherence or was focused on older adults . Data Synthesis : Fifteen instruments were identified . Six instruments required 5 minutes or less to administer . 5 required 6–30 minutes , and 4 had no administration time data reported . A possible advantage of 3 of the instruments is that they use a subject 's own medications and may therefore provide a more authentic assessment . Only 2 instruments have been tested by subjects other than the drug developers and only one has been used in 2 different population s , thereby affording soma insight into generalizability . These studies have used a variety of other vali date d surveys/ assessment s to provide an indication of construct validity , including neuropsychological batteries , caregiver reports , prospect i ve outcomes , instrumental activities of daily living , and levels of care . One instrument determined whether Individuals could tell if refills existed , whom to contact , and re sources to obtain medications . Three assessed numeracy literacy . Conclusions : Five instruments that measure medication management capacity should be compared for potential further use , including Beckman 's tasks , due to their brevity and assessment of numeracy literacy ; the Medication Management Ability Assessment , Drug Regimen Unassisted Grading Scale , and Hopkins Medication Schedule because of the evidence supporting their use ; and the Medication Management Instrument for Deficiencies In the Elderly because it includes an assessment of the patient 's knowledge of how to obtain more medications . No brief tool is available for the primary care setting to identify individuals with medication management problems or to guide the type and amount of support required to manage medications BACKGROUND Attention needs to be paid to comparing and st and ardizing methods for measuring patient satisfaction with consultations in primary care . OBJECTIVES To compare the Medical Interview Satisfaction Scale ( MISS ) and the Consultation Satisfaction Question naire ( CSQ ) in terms of acceptability , distribution of responses , reliability and gather evidence of validity . In addition , to compare the scores of patients completing the question naires immediately after the consultation in the general practitioners ' surgeries with those completing the question naires later at home . METHODS The two question naires were bound as a single instrument with order determined at r and om . This was given to patients immediately after their consultations in eight practice s in South Glamorgan . RESULTS One hundred and ninety-eight of 316 ( 63 % ) patients completed and returned question naires . The distributions of patient satisfaction scores for the two question naires were very similar . For the MISS : mean 76.6 % ( SD 11.4 ) ; for the CSQ mean 7.2 % ( SD 12.6 ) . Correlations between sub-scales ranged from 0.58 - 0.84 for the MISS and from 0.40 - 0.79 for the CSQ . The correlation between the overall scales was 0.82 . Levels of reliability for the scales and sub-scales were fair to good ranging from 0.78 - 0.96 for the MISS and from 0.73 - 0.94 for the CSQ . CONCLUSIONS The study does not identify one scale as being superior in psychometric terms , however by demonstrating consistency of responses it provides support for the scales as measures of patient satisfaction for use in primary care . The level of inter-correlation suggests that the sub-scales may not be clearly independent of each other and suggests that total scores may be preferred . Lower levels of satisfaction are expressed if patients complete question naires at home rather than in general practitioners ' surgeries
Output:
| There is a scarcity of psychometrically sound , comprehensive , and generic measures of experiences of using prescription medicines among adult patients living with chronic illnesses . |
MS210512 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Arbekacin ( ABK ) was approved and widely used in Japan for treatment of patients infected with MRSA , and TDM was introduced in clinical practice . The Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring decided to develop a clinical practice guidelines for TDM of ABK for the following reasons . First , although the daily dose of 150e200 mg was approved in Japan , recent PK- PD studies revealed that higher serum concentration is required to achieve better clinical efficacy and several findings concerning the usefulness of higher dosage regimen have obtained recently . Second , although maximal concentrations that obtained immediately after the end of administration ( Cmax ) w as generally adopted , the serum concentration at 1 h after initiation of administration ( peak serum con- centration ( Cpeak ) ) proved to be more suitable as an efficacy indicator of aminoglycosides . Lastly , as ABK is approved only in Japan , no international practice guideline for TDM has not been available in ABK to date . This guideline evaluated the scientific data associated with serum ABK monitoring and provided rec- ommendations based on the available evidence . Potential limitations of this guideline , however , include the findings that few prospect i ve clinical trials of TDM of ABK are available in the treatment of MRSA infections and that most of the published literature describes observational studies BACKGROUND Voriconazole is a triazole agent with excellent antifungal activity against Aspergillus species . However , despite its potential advantages , the occurrence of unpredictable toxicities might be critical in immunocompromised patients . The aim of this study was to analyze risk factors for voriconazole-related severe adverse events ( SAEs ) . METHODS This prospect i ve observational study was conducted in Korean patients with hematological malignancies and invasive aspergillosis on intravenous voriconazole therapy between June 2008 and April 2009 . RESULTS Of the 25 patients enrolled , eight ( 32 % ) showed voriconazole-related SAEs , which included hepatotoxicities ( n=5 ) , cardiac tachyarrhythmias ( n=2 ) , and neurotoxicity ( n=1 ) . Sex , age , underlying hematological malignancies , voriconazole dose , the co-administration of a proton pump inhibitor , and CYP2C19 genotype were not found to be related to the occurrence of SAEs . However , trough plasma concentrations of voriconazole were found to be significantly higher in the patients with an SAE : median 6.32 mg/l ( interquartile range ( IQR ) 2.86 - 9.71 mg/l ) vs. median 2.15 mg/l ( IQR 0.92 - 4.00 mg/l ) ; p=0.011 . Receiver operating characteristic curve analysis identified a cut-off trough concentration for SAEs of 5.83 mg/l ( sensitivity 62.5 % and specificity 94.1 % ) . Furthermore , multivariate analysis showed that a trough concentration of ≥ 5.83mg/l was the only significant independent risk factor of an SAE . CONCLUSIONS This study shows that therapeutic drug monitoring is indicated in patients with a voriconazole-related SAE and that dose adjustment is required if the trough concentration of voriconazole exceeds 5.83 mg/l Seventy-one allograft recipients receiving voriconazole , in whom complete clinical , microbiologic and pharmacokinetic data were available , were studied to determine the efficacy of voriconazole in preventing fungal infections . The length of voriconazole therapy was 6–956 days ( median 133 ) . The total number of patient-days on voriconazole was 13 805 ( ∼38 years ) . A total of 10 fungal infections were seen in patients on voriconazole ( 18 % actuarial probability at 1 year ) : C and ida glabrata ( n=5 ) , C and ida krusei ( n=1 ) , Cunninghamella ( n=1 ) , Rhizopus ( n=2 ) and Mucor ( n=1 ) . Two of the four zygomycosis cases were preceded by short duration s of voriconazole therapy , but prolonged itraconazole prophylaxis . The plasma steady-state trough voriconazole levels around the time the infection occurred were < 0.2 , < 0.2 , 0.33 , 0.55 , 0.63 and 1.78 μg/ml in the six c and idiasis cases . Excluding the four zygomycosis cases , all the six c and idiasis cases were seen among the 43 patients with voriconazole levels of ⩽2 μg/ml and none among the 24 with levels of > 2 μg/ml ( P=0.061 ) . We conclude that voriconazole is effective at preventing aspergillosis . However , breakthrough zygomycosis is seen in a small proportion of patients . The role of therapeutic voriconazole monitoring with dose adjustment to avoid breakthrough infections with fungi that are otherwise susceptible to the drug needs to be explored prospect ively BACKGROUND Blood levels of voriconazole , a first line therapy for invasive aspergillosis , may correlate with adverse events and treatment response . However , no r and omized controlled studies have been conducted to evaluate the clinical utility of routine therapeutic drug monitoring ( TDM ) of voriconazole . This study aim ed to determine whether routine TDM of voriconazole reduces drug adverse events or improves treatment response in invasive fungal infections . METHODS This was a r and omized , assessor-blinded , controlled , single center trial . One hundred ten adult patients were r and omly assigned to TDM or non-TDM groups . In the TDM group , voriconazole dosage was adjusted ( target range , 1.0 - 5.5 mg/L ) according to the serum trough level measured on the fourth day after initiation of voriconazole . The non-TDM group received a fixed , st and ard dosage . Voriconazole-related adverse events were monitored , and treatment response was assessed three months after the initiation of therapy . RESULTS Baseline characteristics including the CYP2C19 genotype were comparable between the two groups . While the incidence of adverse events was not different between the TDM group and the non-TDM group ( both 42 % ; P = .97 ) , the proportion of voriconazole discontinuation due to adverse events was significantly lower in the TDM group than in the non-TDM group ( 4 % vs 17 % ; P = .02 ) . A complete or partial response was observed in 81 % ( 30 of 37 ) of patients in the TDM group compared to 57 % ( 20 of 34 ) in the non-TDM group ( P = .04 ) . CONCLUSIONS Routine TDM of voriconazole may reduce drug discontinuation due to adverse events and improve the treatment response in invasive fungal infections . CLINICAL TRIAL REGISTRATION NCT00890708 ABSTRACT Voriconazole prophylaxis is common following lung transplantation , but the value of therapeutic drug monitoring is unknown . A prospect i ve , observational study of lung transplant recipients ( n = 93 ) receiving voriconazole prophylaxis was performed . Serum voriconazole troughs ( n = 331 ) were measured by high-pressure liquid chromatography . The median initial and subsequent troughs were 1.91 and 1.46 μg/ml , respectively . The age of the patient directly correlated with initial troughs ( P = 0.005 ) . Patients that were ≥60 years old and cystic fibrosis patients were significantly more likely to have higher and lower initial troughs , respectively . In 95 % ( 88/93 ) of patients , ≥2 troughs were measured . In 28 % ( 25/88 ) and 32 % ( 28/88 ) of these patients , all troughs were ≤1.5 μg/ml or > 1.5 μg/ml , respectively . Ten percent ( 10/93 ) and 27 % ( 25/93 ) of the patients developed invasive fungal infection ( tracheobronchitis ) and fungal colonization , respectively . The median troughs at the times of positive and negative fungal cultures were 0.92 and 1.72 μg/ml ( P = 0.07 ) . Invasive fungal infections or colonization were more likely with troughs of ≤1.5 μg/ml ( P = 0.01 ) and among patients with no trough of > 1.5 μg/ml ( P = 0.007 ) . Other cutoff troughs correlated less strongly with microbiologic outcomes . Troughs correlated directly with aspartate transferase levels ( P = 0.003 ) , but not with other liver enzymes . Voriconazole was discontinued due to suspected toxicity in 27 % ( 25/93 ) of the patients . The troughs did not differ at the times of suspected drug-induced hepatotoxicity , central nervous system ( CNS ) toxicity , or nausea/vomiting and in the absence of toxicity . Voriconazole prophylaxis was most effective at troughs of > 1.5 μg/ml . A cutoff for toxicity was not identified , but troughs of > 4 μg/ml were rare . The data support a target range of > 1.5 to 4 μg/ml There are limited data on the relationship between voriconazole levels and clinical outcomes relative to invasive aspergillosis ( IA ) . We therefore analyzed the association between initial voriconazole trough blood levels and clinical responses of IA in patients with hematologic malignancies . All adult patients treated with voriconazole in a tertiary care hospital in Seoul , South Korea , between August 2009 and April 2011 were identified from pharmacy records . Initial voriconazole trough levels were routinely measured 1 week after therapy and patient responses were classified as success ( complete or partial response ) or failure ( stable response , progression of disease , or death ) at 2 weeks post-therapy . Fifty-two patients , involving 2 ( 4 % ) proven , 29 ( 56 % ) probable , and 21 ( 40 % ) possible IA infections , were included . Of these , 11 ( 21 % ) had initial voriconazole levels of ≤ 2 mg/l and the remaining 41 ( 79 % ) had > 2 mg/l . There were slightly fewer successful responses ( 45 % , 5/11 ) in the patients with initial voriconazole levels ≤ 2 mg/l than in those with voriconazole levels > 2 mg/l ( 51 % , 21/41 ) , but the difference was not statistically significant ( P= 0.73 ) . Neutropenia ( OR 0.1 , P= 0.008 ) and immunosuppression ( OR 0.1 , P= 0.004 ) were independently associated with 2-week successful response after voriconazole therapy . In conclusion , initial voriconazole trough levels may not significantly affect clinical outcomes of IA at 2 weeks after voriconazole therapy in patients with hematologic malignancies . Further studies of prospect i ve design are needed to establish the optimal procedure for voriconazole drug monitoring Background Genetic polymorphisms of cytochrome P450 enzymes , especially CYP2C19 influence voriconazole pharmacokinetics . However , the impact of CYP2C19 genetic polymorphisms on the therapeutic efficacy and toxicity of voriconazole therapy are not well established . Material s and Methods In this prospect i ve observational study , we analyzed all consecutive adult patients with hematologic diseases who were treated for invasive aspergillosis ( IA ) with voriconazole between January 2011 and June 2012 . CYP2C19 genotype and routine therapeutic drug monitoring of voriconazole were performed . The target range for voriconazole trough levels was 1 - 5.5 mg/L. Results A total of 104 consecutive patients were enrolled , including 39 homozygous extensive metabolizers ( EMs , 38 % ) , 50 heterozygous extensive metabolizers ( HEMs , 48 % ) , and 15 poor metabolizers ( PMs , 14 % ) . The initial voriconazole trough levels were 1.8 , 2.7 , and 3.2 mg/L in EMs , HEMs , and PMs , respectively ( P = 0.068 ) . Out-of-range initial trough levels were most frequently observed in EMs ( 46 % ) followed by HEMs ( 26 % ) and PMs ( 0 % ) ( P = 0.001 ) . The frequency of initial trough levels < 1 mg/L but not > 5.5 mg/L differed significantly among the 3 groups ( P = 0.005 ) . However , treatment response , all-cause and IA-attributable mortality , and the occurrence of voriconazole-related adverse events did not differ significantly among the 3 groups ( P = 0.399 , P = 0.412 , P = 0.317 , and P = 0.518 , respectively ) . Conclusions While none of the initial voriconazole trough levels in PMs was outside the target range , subtherapeutic initial trough levels were frequent in EMs . Although there was no significant relationship between CYP2C19 genotype and either the clinical outcomes of IA or toxicity of voriconazole , further large-scale multicenter studies using clinical data from homogeneous
Output:
| A trough concentration > 3.0 mg/L is associated with increased hepatotoxicity , particularly for the Asian population , and > 4.0 mg/L is associated with increased neurotoxicity |
MS210513 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: AIMS To compare the pharmacokinetics of mycophenolic acid ( MPA ) and its metabolite ( MPAG ) when mycophenolate mofetil ( MMF ) is administered in combination with sirolimus or ciclosporin ( CsA ) in renal allograft recipients . Safety and efficacy ( biopsy-proven acute rejection ( BPAR ) ) were also assessed . METHODS Patients ( n = 45 ) were r and omized 2 : 1 to receive treatment with sirolimus ( n = 30 ; dosed to maintain trough concentrations of 10 - 25 ng ml(-1 ) until week 8 , and then 8 - 15 ng ml(-1 ) thereafter ) or CsA ( n = 15 ; administered as per centre practice ) both in combination with daclizumab , oral MMF and corticosteroids . Pharmacokinetic assessment s were performed at day 7 , week 4 , and months 3 and 6 post-transplant . The primary endpoint was the AUC(0,12 h ) for MPA and MPAG . The pharmacokinetics of sirolimus were also assessed . RESULTS MPA exposure was 39 - 50 % lower ( month 6 mean AUC(0,12 h ) ( 95%CI ) : 40.4 ( 33.8 , 47.0 ) vs. 68.5 ( 54.9 , 82.0 ) microg ml(-1 ) h ) and MPAG exposure was 25 - 52 % higher ( 722 ( 607 , 838 ) vs. 485 ( 402 , 569 ) microg ml(-1 ) h at month 6 ) in the presence of CsA compared with sirolimus across visits . BPAR was 40.0 % with sirolimus and 13.3 % with CsA. The incidence of hypertension , tremors and hirsutism was higher with CsA than with sirolimus , while the incidence of diarrhoea , hyperlipidaemia and impaired wound closure was higher with sirolimus . No deaths , malignancies or graft losses were reported . CONCLUSIONS Co-administration of sirolimus with MMF led to greater MPA exposure , but lower MPAG exposure , than co-administration with CsA. As rejection rates were higher in the absence of CsA , further study of calcineurin inhibitor-free regimens is required before general recommendations can be made BACKGROUND Acute rejection episodes after renal transplantation are an important clinical challenge , despite use of multidrug immunosuppressive regimens . We did a prospect i ve , multicentre , r and omised , double-blind trial to investigate the impact of the addition of sirolimus , compared with azathioprine , to a cyclosporin and prednisone regimen . METHODS 719 recipients of primary HLA-mismatched cadaveric or living-donor renal allografts who displayed initial graft function were r and omly assigned , after transplantation , sirolimus 2 mg daily ( n=284 ) or 5 mg daily ( n=274 ) , or azathioprine ( n=161 ) . We assessed the primary composite endpoint of efficacy failure , occurrence of biopsy-confirmed acute rejection episodes , graft loss , or death , and various secondary endpoints that characterise these episodes at 6 months and 12 months . Analyses were done by intention to treat . FINDINGS The rate of efficacy failure at 6 months was lower in the two sirolimus groups ( 2 mg 18.7 % , p=0.002 ; 5 mg 16.8 % , p<0.001 ) than in the azathioprine group ( 32.3 % ) . The frequency of biopsy-confirmed acute rejection episodes was also lower ( 2 mg 16.9 % , p=0.002 ; 5 mg 12.0 % , p<0.001 ; azathioprine 29.8 % ) . At 12 months , survival was similar in all groups for grafts ( 97.2 % , 96.0 % , and 98.1 % ) and patients ( 94.7 % , 92.7 % , and 93.8 % ) . Patients on sirolimus showed a delay in the time to first acute rejection episode and decreased frequency of moderate and severe histological grade s of rejection episodes and related antibody treatment , compared with the azathioprine group . Rates of infection and malignant disorders were similar in all groups . INTERPRETATION Use of sirolimus reduced occurrence and severity of biopsy-confirmed acute rejection episodes with no increase in complications . Further studies are needed to establish the optimum doses for the combined regimen We performed a prospect i ve r and omized trial comparing sirolimus/mycophenolate mofetil (MMF)/prednisone to cyclosporine/MMF/prednisone and selected induction therapy with basiliximab . Twenty patients received sirolimus ( 10 mg loading dose followed by 3 mg/m body surface area/day , keeping 24-hr trough levels at 10 - 15 ng/mL for six months and 5 - 10 ng/mL thereafter . Twenty-one patients began cyclosporine ( 4 to 8 mg/kg/day , keeping 12-hour trough levels at 150 - 300 ng/mL for 6 months and 100 - 200 ng/mL afterwards ) . Mean follow up was 15.8 months . One-year patient and graft survival was similar in both groups ( > 90 % ) . Acute rejection rate was 16.6 % in the sirolimus group and 5.2 % in the cyclosporine group ( P = NS ) . There were no differences in mean serum creatinine between groups . No patients who received basiliximab and had sirolimus target levels suffered acute rejection at one year . The sirolimus group had significantly higher cholesterol and triglycerides . A calcineurin inhibitor-free regimen using sirolimus produces comparable one-year transplant outcomes in living related kidney transplants compared to a calcineurin inhibitor regimen Calcineurin inhibitors have decreased acute rejection and improved early renal allograft survival , but their use has been implicated in the development of chronic nephrotoxicity . We performed a prospect i ve , r and omized trial in kidney transplantation comparing sirolimus‐MMF‐prednisone to tacrolimus‐MMF‐prednisone . Eighty‐one patients in the sirolimus group and 84 patients in the tacrolimus group were enrolled ( mean follow‐up = 33 months ; range 13–47 months ) . At 1 year , patient survival was similar in the groups ( 98 % with sirolimus , 96 % with tacrolimus ; p = 0.42 ) as was graft survival ( 94 % sirolimus vs. 92 % tacrolimus , p = 0.95 ) . The incidence of clinical acute rejection was 10 % in the tacrolimus group and 13 % in the sirolimus group ( p = 0.58 ) . There was no difference in mean GFR measured by iothalamate clearance between the tacrolimus and sirolimus groups at 1 year ( 61 ± 19 mL/min vs. 63 ± 18 mL/min , p = 0.57 ) or 2 years ( 61 ± 17 mL/min vs. 61 ± 19 mL/min , p = 0.84 ) . At 1 year , chronicity using the Banff schema showed no difference in interstitial , tubular or glomerular changes , but fewer chronic vascular changes in the sirolimus group . This study shows that a CNI‐free regimen using sirolimus‐MMF‐prednisone produces similar acute rejection rates , graft survival and renal function 1–2 years after transplantation compared to tacrolimus‐MMF‐prednisone Current immunosuppressive regimens in renal transplantation typically include calcineurin inhibitors ( CNIs ) and corticosteroids , both of which have toxicities that can impair recipient and allograft health . This 1‐year , r and omized , controlled , open‐label , exploratory study assessed two belatacept‐based regimens compared to a tacrolimus (TAC)‐based , steroid‐avoiding regimen . Recipients of living and deceased donor renal allografts were r and omized 1:1:1 to receive belatacept‐mycophenolate mofetil ( MMF ) , belatacept‐sirolimus ( SRL ) , or TAC‐MMF . All patients received induction with 4 doses of Thymoglobulin ( 6 mg/kg maximum ) and an associated short course of corticosteroids . Eighty‐nine patients were r and omized and transplanted . Acute rejection occurred in 4 , 1 and 1 patient in the belatacept‐MMF , belatacept‐SRL and TAC‐MMF groups , respectively , by Month 6 ; most acute rejection occurred in the first 3 months . More than two‐thirds of patients in the belatacept groups remained on CNI‐ and steroid‐free regimens at 12 months and the calculated glomerular filtration rate was 8–10 mL/min higher with either belatacept regimen than with TAC‐MMF . Overall safety was comparable between groups . In conclusion , primary immunosuppression with belatacept may enable the simultaneous avoidance of both CNIs and corticosteroids in recipients of living and deceased st and ard criteria donor kidneys , with acceptable rates of acute rejection and improved renal function relative to a TAC‐based regimen BACKGROUND Immunosuppressive regimens with the fewest possible toxic effects are desirable for transplant recipients . This study evaluated the efficacy and relative toxic effects of four immunosuppressive regimens . METHODS We r and omly assigned 1645 renal-transplant recipients to receive st and ard-dose cyclosporine , mycophenolate mofetil , and corticosteroids , or daclizumab induction , mycophenolate mofetil , and corticosteroids in combination with low-dose cyclosporine , low-dose tacrolimus , or low-dose sirolimus . The primary end point was the estimated glomerular filtration rate ( GFR ) , as calculated by the Cockcroft-Gault formula , 12 months after transplantation . Secondary end points included acute rejection and allograft survival . RESULTS The mean calculated GFR was higher in patients receiving low-dose tacrolimus ( 65.4 ml per minute ) than in the other three groups ( range , 56.7 to 59.4 ml per minute ) . The rate of biopsy-proven acute rejection was lower in patients receiving low-dose tacrolimus ( 12.3 % ) than in those receiving st and ard-dose cyclosporine ( 25.8 % ) , low-dose cyclosporine ( 24.0 % ) , or low-dose sirolimus ( 37.2 % ) . Allograft survival differed significantly among the four groups ( P=0.02 ) and was highest in the low-dose tacrolimus group ( 94.2 % ) , followed by the low-dose cyclosporine group ( 93.1 % ) , the st and ard-dose cyclosporine group ( 89.3 % ) , and the low-dose sirolimus group ( 89.3 % ) . Serious adverse events were more common in the low-dose sirolimus group than in the other groups ( 53.2 % vs. a range of 43.4 to 44.3 % ) , although a similar proportion of patients in each group had at least one adverse event during treatment ( 86.3 to 90.5 % ) . CONCLUSIONS A regimen of daclizumab , mycophenolate mofetil , and corticosteroids in combination with low-dose tacrolimus may be advantageous for renal function , allograft survival , and acute rejection rates , as compared with regimens containing daclizumab induction plus either low-dose cyclosporine or low-dose sirolimus or with st and ard-dose cyclosporine without induction . ( Clinical Trials.gov number , NCT00231764 [ Clinical Trials.gov ] . ) The preliminary observation of marked erythrocyte microcytosis in patients treated with sirolimus ( SRL ) and mycophenolate mofetil ( MMF ) has been evaluated as part of a prospect i ve study comparing SRL and cyclosporin A ( CsA ) as a primary immunosuppressant . Normal risk de novo kidney recipients were r and omized either to SRL or to CsA. Additional immunosuppressants consisted of MMF and prednisone . In patients with erythrocyte microcytosis , iron deficiency was excluded by measuring serum ferritin and transferrin saturation rate . Fifty-nine patients ( 30 in SRL and 29 in CsA ) were included . Mean corpuscular volume ( MCV ) ( fl ) on day 7 was 91.7 + /- 4.8 in SRL group versus 91.4 + /- 4.2 in CsA group ( P = 0.77 ) , whereas mean MCV on day 183 post-transplant was 78.5 + /- 3.8 in
Output:
| Sirolimus was associated with a reduction in the risk of malignancy and non-melanoma skin cancer in transplant recipients .
The benefit was most pronounced in patients who converted from an established immunosuppressive regimen to sirolimus .
Given the risk of mortality , however , the use of this drug does not seem warranted for most patients with kidney transplant . |
MS210514 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Evaluation of complex interventions , including st and ardisation of the intervention , types of outcomes selected and measures of change , is a fairly novel concept in the field of intellectual disabilities . Our aim was to explore these issues in a feasibility study of Manualised Individual Cognitive Behaviour Treatment ( M-iCBT ) compared to the treatment as usual alone ( TAU ) . METHODS Service users with mild to moderate intellectual disability experiencing a mood disorder or symptoms of depression and /or anxiety ( mini PAS-ADD total score > 10 or 7 respectively ) were r and omly assigned to either . RESULTS In total , 32 participants were r and omly assigned to 16 sessions of M-iCBT ( n=16 ) in addition to TAU or TAU alone ( n=16 ) . We explored recruitment and accrual rates , willingness to participate , acceptability of the intervention and suitability of assessment tools . Mean change ( 95 % CI ) in the Beck Depression Inventory-Youth ( BDI-Y ) score from baseline to the 16 week endpoint ( primary variable ) was 0.10 ( 95 % CI : -8.56 , 8.76 ) and in the Beck Anxiety Inventory-Youth ( BAI-Y ) 2.42 ( 95 % CI : -5.27 , 10.12 ) in favour of TAU . However , there was a clear trend in favour of CBT in depressed participants with or without anxiety . LIMITATIONS The intervention targeted both depression and anxiety following a transdiagnostic model . This may have impacted the anticipated size of change in the primary outcome . The precise impact of cognitive limitations on ability to use therapy effectively is not fully understood . CONCLUSIONS This study demonstrates that it is feasible to carry out a pragmatic r and omised controlled trial of M-iCBT for people with mild to moderate intellectual disability . However , uncertainties about its clinical and cost effectiveness can only be fully answered by further examination of its superiority against other treatments BACKGROUND Many people with intellectual disabilities find it hard to control their anger and this often leads to aggression which can have serious consequences , such as exclusion from mainstream services and the need for potentially more expensive emergency placements . AIMS To evaluate the effectiveness of a cognitive-behavioural therapy ( CBT ) intervention for anger management in people with intellectual disabilities . METHOD A cluster-r and omised trial of group-based 12-week CBT , which took place in day services for people with intellectual disabilities and was delivered by care staff using a treatment manual . Participants were 179 service users identified as having problems with anger control r and omly assigned to either anger management or treatment as usual . Assessment s were conducted before the intervention , and at 16 weeks and 10 months after r and omisation ( trial registration : IS RCT N37509773 ) . RESULTS The intervention had only a small , and non-significant , effect on participants ' reports of anger on the Provocation Index , the primary outcome measure ( mean difference 2.8 , 95 % CI -1.7 to 7.4 at 10 months ) . However , keyworker Provocation Index ratings were significantly lower in both follow-up assessment s , as were service-user ratings on another self-report anger measure based on personally salient triggers . Both service users and their keyworkers reported greater usage of anger coping skills at both follow-up assessment s and keyworkers and home carers reported lower levels of challenging behaviour . CONCLUSIONS The intervention was effective in improving anger control by people with intellectual disabilities . It provides evidence of the effectiveness of a CBT intervention for this client group and demonstrates that the staff who work with them can be trained and supervised to deliver such an intervention with reasonable fidelity OBJECTIVE To determine if cues help young children discriminate among thoughts , feelings and behaviours . PARTICIPANTS Ninety-six children aged 4 - 7 years from three schools in Norwich , UK . DESIGN Within each age b and ( 4 , 5 , 6 , 7 ) , children were r and omised to the cue or the no cue condition on a stratified basis ensuring that equal numbers of boys and girls from each school were in each of the eight cells ( cue condition x age ) . Cues were glove puppets and post boxes . The effect of IQ was controlled . MEASURES A discrimination task , in which children were asked to identify a thought , a feeling and a behaviour from each of six brief stories , and a brief IQ assessment were administered to children individually . RESULTS There was a significant effect of age and cue condition on performance ; older children and those who were presented with the cue performed better . There were no gender differences and no interaction between cue condition and age . CONCLUSION Many young children discriminated among thoughts , feelings and behaviours suggesting that they may be able to engage in this aspect of cognitive behaviour therapy . Simple cues ( puppets and posting boxes ) improved children 's performance and these may be useful therapeutic tools with young children AIMS Training has been shown to improve the ability of people with intellectual disabilities ( IDs ) to perform some cognitive behavioural therapy ( CBT ) tasks . This study used a computerised training paradigm with the aim of improving the ability of people with IDs to : a ) discriminate between behaviours , thoughts and feelings , and b ) link situations , thoughts and feelings . METHODS Fifty-five people with mild-to-moderate IDs were r and omly assigned to a training or attention-control condition in a single-blind mixed experimental design . Computerised tasks assessed the participants ' skills in : ( a ) discriminating between behaviours , thoughts and feelings ( separately and pooled together ) , and ( b ) cognitive mediation by selecting appropriate emotions as consequences to given thoughts , and appropriate thoughts as mediators of given emotions . RESULTS Training significantly improved ability to discriminate between behaviours , thoughts and feelings pooled together , compared to the attention-control condition , even when controlling for baseline scores and IQ . Large within-group improvements in the ability to identify behaviours and feelings were observed for the training condition , but not the attention-control group . There were no significant between-group differences in ability to identify thoughts , or on cognitive mediation skills . CONCLUSIONS A single session of computerised training can improve the ability of people with IDs to underst and and practise CBT tasks relating to behaviours and feelings . There is potential for computerised training to be used as a " primer " for CBT with people with IDs to improve engagement and outcomes , but further development on a specific computerised cognitive mediation task is needed BACKGROUND People with intellectual disabilities ( ID ) experience similar or even higher rates of mental health problems than the general population and there is a need to develop appropriate treatments . Cognitive behaviour therapy ( CBT ) is effective for a wide range of disorders in the general population . However , there is some evidence that people with ID may lack the cognitive skills needed to take part in CBT . AIMS To test if people with ID can learn skills required for CBT , specifically the ability to distinguish between thoughts , feelings , and behaviours and to link thoughts and feelings ( cognitive mediation ) . METHOD A r and omized independent groups design was used to examine the effect of training in CBT on two tasks measuring CBT skills . Thirty-four adults with ID were r and omly allocated to the experimental condition ( N=18 ) or to the control condition ( N=16 ) . CBT skills were assessed blind at baseline and after the intervention . RESULTS The training led to significant improvements in participants ' ability to link thoughts and feelings , and this skill was generalized to new material . There was no effect of training on participants ' ability to distinguish amongst thoughts , feelings , and behaviours . People with ID can , therefore , learn some skills required for CBT . This implies that preparatory training for CBT might be useful for people with ID . The results might be applicable to other groups who find aspects of CBT difficult AIMS The aim was to examine whether specific skills required for cognitive behavioural therapy ( CBT ) could be taught using a computerised training paradigm with people who have intellectual disabilities ( IDs ) . Training aim ed to improve : a ) ability to link pairs of situations and mediating beliefs to emotions , and b ) ability to link pairs of situations and emotions to mediating beliefs . METHOD Using a single-blind mixed experimental design , sixty-five participants with IDs were r and omised to receive either computerised training or an attention-control condition . Cognitive mediation skills were assessed before and after training . RESULTS Participants who received training were significantly better at selecting appropriate emotions within situation-beliefs pairs , controlling for baseline scores and IQ . Despite significant improvements in the ability of those who received training to correctly select intermediating beliefs for situation-feelings pairings , no between-group differences were observed at post-test . CONCLUSIONS The findings indicated that computerised training led to a significant improvement in some aspects of cognitive mediation for people with IDs , but whether this has a positive effect upon outcome from therapy is yet to be established
Output:
| The authors suggest eleven findings from research areas of emotion recognition , cognitive mediation , discriminating between thoughts , feelings and behaviours , linking events and emotions that have implication s for the design of CBT programmes and future research for this population |
MS210515 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Delayed diagnosis and treatment of tuberculosis ( TB ) results in severe disease and a higher mortality . It also leads to an increased period of infectivity in the community . The objective of this study was to determine the length of delays , and analyze the factors affecting the delay from onset of symptoms of pulmonary tuberculosis ( PTB ) until the commencement of treatment . Methods In r and omly selected TB management units ( TBMUs ) , i.e. government health institutions which have diagnosing and treatment facilities for TB in Amhara Region , we conducted a cross sectional study from September 1-December 31/2003 . Delay was analyzed from two perspectives , 1 . Period between onset of TB symptoms to first visit to any health provider ( health seeking period ) , and from the first health provider visit to initiation of treatment ( health providers ' delay ) , and 2 . Period between onset of TB symptoms to first visit to a medical provider ( patients ' delay ) , and from this visit to commencement of anti-TB treatment ( health systems ' delay ) . Patients were interviewed on the same date of diagnosis using a semi-structured question naire . Logistics regression analysis was applied to analyze the risk factors of delays . Results A total of 384 new smear positive PTB patients participated in the study . The median total delay was 80 days . The median health-seeking period and health providers ' delays were 15 and 61 days , respectively . Conversely , the median patients ' and health systems ' delays were 30 and 21 days , respectively . Taking medical providers as a reference point , we found that forty eight percent of the subjects delayed for more than one month . Patients ' delays were strongly associated with first visit to non-formal health providers and self treatment ( P < 0.0001 ) . Prior attendance to a health post/clinic was associated with increased health systems ' delay ( p < 0.0001 ) . Conclusion Delay in the diagnosis and treatment of PTB is unacceptably high in Amhara region . Health providers ' and health systems ' delays represent the major portion of the total delay . Accessing a simple and rapid diagnostic test for TB at the lowest level of health care facility and encouraging a dialogue among all health providers are imperative interventions Background One of the main strategies to control tuberculosis ( TB ) is to find and treat people with active disease . Unfortunately , the case detection rates remain low in many countries . Thus , we need interventions to find and treat sufficient number of patients to control TB . We investigated whether involving health extension workers ( HEWs : trained community health workers ) in TB control improved smear-positive case detection and treatment success rates in southern Ethiopia . Methodology /Principal Finding We carried out a community-r and omized trial in southern Ethiopia from September 2006 to April 2008 . Fifty-one kebeles ( with a total population of 296 , 811 ) were r and omly allocated to intervention and control groups . We trained HEWs in the intervention kebeles on how to identify suspects , collect sputum , and provide directly observed treatment . The HEWs in the intervention kebeles advised people with productive cough of 2 weeks or more duration to attend the health posts . Two hundred and thirty smear-positive patients were identified from the intervention and 88 patients from the control kebeles . The mean case detection rate was higher in the intervention than in the control kebeles ( 122.2 % vs 69.4 % , p<0.001 ) . In addition , more females patients were identified in the intervention kebeles ( 149.0 vs 91.6 , p<0.001 ) . The mean treatment success rate was higher in the intervention than in the control kebeles ( 89.3 % vs 83.1 % , p = 0.012 ) and more for females patients ( 89.8 % vs 81.3 % , p = 0.05 ) . Conclusions / Significance The involvement of HEWs in sputum collection and treatment improved smear-positive case detection and treatment success rate , possibly because of an improved service access . This could be applied in setting s with low health service coverage and a shortage of health workers . Trial Registration Clinical Trials.gov Reports of cluster r and omised trials require additional information to allow readers to interpret them accurately The effective reporting of r and omised controlled trials has received useful attention in recent years . Many journals now require that reports conform to the guidelines in the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement , first published in 1996 and revised in 2001 . The statement includes a checklist of items that should be included in the trial report . These items are evidence based whenever possible and are regularly review ed . The statement also recommends including a flow diagram to show the flow of participants from group assignment through to the final analysis . The CONSORT statement focused on reporting parallel group r and omised trials in which individual participants are r and omly assigned to study groups . However , in some situations it is preferable to r and omly assign groups of individuals ( such as families or medical practice s ) rather than individuals . Reasons include the threat of contamination of some interventions ( such as dietary interventions ) if individual r and omisation is used . 5 Also , in certain setting s r and omisation by group may be the only feasible method of conducting a trial . Trials with this design are variously known as field trials , community based trials , place based trials , or ( as in this paper ) cluster r and omised trials . In an earlier discussion paper we considered the implication s of the CONSORT statement for the reporting of cluster r and omised trials . Here we present up date d guidance , based on the 2001 revision of the CONSORT statement A cross-sectional study was made of 500 patients and 500 health care workers r and omly selected from 250 primary health care centres throughout Iraq to evaluate knowledge , attitudes and practice s towards tuberculosis ( TB ) . Using structured question naire interviews , the study showed 64.4 % of patients had good knowledge , while 54.8 % had negative attitudes and practice s towards TB . The 2 most important sources of patient information about TB were physicians and television . Of health care workers , 95.5 % had good knowledge about TB and this was significantly associated with age and job duration . By contrast , health care workers ' practice was poor : only 38.2 % h and led suspected TB cases correctly . The national TB programme in Iraq has had a good impact on knowledge of TB patients and health care workers OBJECTIVE To assess an active case-finding strategy for the identification of smear-positive pulmonary tuberculosis ( TB ) in a rural district of Amhara Region , Ethiopia . METHODS Study kebeles ( smallest administrative units ) were r and omly selected in a cross-sectional study . House-to-house visits involving individuals aged > or=15 years in all households of the kebeles were conducted . The heads of households were asked to identify subjects with TB symptoms . Identified suspects were asked to provide three sputum sample s for smear microscopy . RESULTS Among the 47,478 individuals living in households that were screened , 1006 TB suspects and 38 cases were detected . This result ed in 38 cases of smear-positive TB , i.e. , 80 per 100,000 population , using cluster sampling . The ratio of active vs. passive case detection was 2.5:1 , indicating 2.5 undetected TB cases in the community for every smear-positive TB case receiving treatment during the survey period . A higher proportion of female patients was detected by the survey . CONCLUSION The study revealed a very high proportion of undiagnosed TB . This indicates that the potential for a large infectious pool and significant transmission of TB in the community is high . The expansion of diagnostic facilities and the active involvement of health extension workers is necessary to expedite early detection , timely referral and treatment of TB Background Optimally , exp and ed HIV testing programs should reduce barriers to testing while attracting new and high-risk testers . We assessed barriers to testing and HIV risk among clients participating in mobile voluntary counseling and testing ( MVCT ) campaigns in four rural villages in the Kilimanjaro Region of Tanzania . Methods Between December 2007 and April 2008 , 878 MVCT participants and 506 r and omly selected community residents who did not access MVCT were surveyed . Gender-specific logistic regression models were used to describe differences in socioeconomic characteristics , HIV exposure risk , testing histories , HIV related stigma , and attitudes toward testing between MVCT participants and community residents who did not access MVCT . Gender-specific logistic regression models were used to describe differences in socioeconomic characteristics , HIV exposure risk , testing histories , HIV related stigma , and attitudes toward testing , between the two groups . Results MVCT clients reported greater HIV exposure risk ( OR 1.20 [ 1.04 to 1.38 ] for males ; OR 1.11 [ 1.03 to 1.19 ] for females ) . Female MVCT clients were more likely to report low household expenditures ( OR 1.47 [ 1.04 to 2.05 ] ) , male clients reported higher rates of unstable income sources ( OR 1.99 [ 1.22 to 3.24 ] ) . First-time testers were more likely than non-testers to cite distance to testing sites as a reason for not having previously tested ( OR 2.17 [ 1.05 to 4.48 ] for males ; OR 5.95 [ 2.85 to 12.45 ] for females ) . HIV-related stigma , fears of testing or test disclosure , and not being able to leave work were strongly associated with non-participation in MVCT ( ORs from 0.11 to 0.84 ) . Conclusions MVCT attracted clients with increased exposure risk and fewer economic re sources ; HIV related stigma and testing-related fears remained barriers to testing . MVCT did not disproportionately attract either first-time or frequent repeat testers . Educational campaigns to reduce stigma and fears of testing could improve the effectiveness of MVCT in attracting new and high-risk population Background The CONSORT statement is intended to improve reporting of r and omised controlled trials and focuses on minimising the risk of bias ( internal validity ) . The applicability of a trial ’s results ( generalisability or external validity ) is also important , particularly for pragmatic trials . A pragmatic trial ( a term first used in 1967 by Schwartz and Lellouch ) can be broadly defined as a r and omised controlled trial whose purpose is to inform decisions about practice . This extension of the CONSORT statement is intended to improve the reporting of such trials and focuses on applicability . Methods At two , two-day meetings held in Toronto in 2005 and 2008 , we review ed the CONSORT statement and its extensions , the literature on pragmatic trials and applicability , and our experiences in conducting pragmatic trials . Recommendations We recommend extending eight CONSORT checklist items for reporting of pragmatic trials : the background , participants , interventions , outcomes , sample size , blinding , participant flow , and generalisability of the findings . These extensions are presented , along with illustrative examples of reporting , and an explanation of each extension . Adherence to these reporting criteria will make it easier for decision makers to judge how applicable the results of r and omised controlled trials are to their own conditions . Empirical studies are needed to ascertain the usefulness and comprehensiveness of these CONSORT checklist item extensions . In the meantime we recommend that those who support , conduct , and report pragmatic trials should use this extension of the CONSORT statement to facilitate the use of trial results in decisions about health care . Pragmatic trials are design ed to inform decisions about practice , but poor reporting can reduce their usefulness . The CONSORT and Practihc groups describe modifications to the CONSORT guidelines to help readers assess the applicability of the SETTING Bangladesh national tuberculosis control programme districts supported by the Damien Foundation ( population 18 million ) . OBJECTIVE To determine whether the observed gender difference is epidemiologically true or whether it is due to accessibility barriers for women . DESIGN Two-stage r and om sampling population survey . People were interviewed by teams composed of one male and one female volunteer about the presence of symptoms suggestive of tuberculosis . One early morning sputum specimen of all thus identified tuberculosis suspects was examined by Ziehl-Neelsen technique . RESULTS A total of 266189 people were surveyed , among whom 223 936 ( 84.1 % ) could be interviewed . This led to the identification of 7001 tuberculosis suspects ( 2406 females and 4595 males ) and 64 confirmed TB cases ( 16 females and 48 males ) . The female/male ratio ( 0.33:1 ) of cases found during the survey was not higher than that observed through routine diagnosis ( 0.42:1 ) . The routine case-notification rate of sputum-positive cases during 2000 was about twice the rate observed during the survey ( 44.3 vs. 24.0 per 100 000 population ) . CONCLUSIONS The gender difference observed in routine tuberculosis diagnosis is real , and is not due to lesser accessibility of women to the health services . The routine notification rate compares favourably with the detection of previously unknown cases found during the survey Background Tuberculosis ( TB ) is a global health concern . Inadequate case finding and case holding has been cited as major barrier to the control of TB . The TB literature is written almost entirely from a biomedical perspective , while recent studies show that it is imperative to underst and lay perception to determine why people seek treatment and may stop taking treatment . The Eastern Cape is known as a province with high TB incidence , prevalence and with one of the worst cure rates of South Africa . Its inhabitants can be considered lay experts when it comes to TB . Therefore , we investigated knowledge , perceptions of ( access to ) TB treatment and adherence to treatment among an Eastern Cape population . Methods
Output:
| Many studies found no quantitative gender-related differences in barriers and delays limiting access to TB services .
When differences were identified , women experienced greater barriers and longer delays than men |
MS210516 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Objective . To study the effect of an educationally oriented intervention programme , with the recommendations from the National Board of Health and Welfare as a base . Design . A prospect i ve intervention study . Setting . Six day-care centres in Växjö , Sweden . Three centres comprised the intervention group and three constituted the control group . Subjects and main outcome measures . The parents and personnel completed a question naire on their views concerning information about infectious diseases . During a nine-month period , parents of all children reported every episode of absence , the number of days absent , the cause of absence , and any contact with doctors or prescription of antibiotics . Results . The guidelines were implementable in routine child day-care . Parents found regular information valuable and felt better informed about infectious diseases . Multilevel analyses showed no statistically significant results of the intervention . “ Infection-prone ” children had more sickness absence , doctor 's consultations , and antibiotic prescriptions than those not “ infection-prone ” . Conclusion . It is possible to implement an educationally oriented intervention programme directed against infectious diseases in child day-care . No significant effect of the intervention was found , which is why a larger intervention study is needed The objective of this study was to assess the effectiveness of a hygiene program in reducing the incidence of respiratory and diarrheal diseases in toddlers attending day care centers . A r and omized field trial was conducted in 52 day care centers in Quebec , Canada , between September 1 , 1996 and November 30 , 1997 . Absences for any reasons and the daily occurrence of colds and /or diarrhea in toddlers were recorded on calendars by the educators . The number of fecal coliforms on children 's h and s and on educators ' h and s was measured during three unannounced visits . Overall , 1,729 children were followed in 47 day care centers for a total of 153,643 child-days . The incidence rate of diarrhea was considerably reduced by the effect of monitoring ( IRR = 0.73 , 95 % CI = 0.54,0.97 ) , and the intervention reduced the incidence rate of upper respiratory tract infections ( IRR = 0.80 , 95 % CI = 0.68,0.93 ) . Monitoring alone also had an important effect in reducing the level of bacterial contamination on children 's and educators ' h and s. The results indicate that both an intervention program and monitoring alone play a role in reducing infections in children attending day care centers OBJECTIVE To evaluate the effectiveness of alcohol-based h and rubs ( ABH ) in reducing acute diarrheal diseases ( ADD ) and acute respiratory infections ( ARI ) among children 1 - 5 years of age in childcare centers with limited tap water . METHODS This was the first cluster-r and omized controlled trial in a developing country . The study took place at 42 childcare centers with sporadic and limited water availability in six towns in Colombia . Participants were r and omly assigned to use ABH as a complement to h and washing ( intervention arm : 21 centers/794 children ) ; or to continue existing h and washing practice s ( control arm : 21 centers/933 children ) . ADD and ARI cases were identified through teacher-reported signs and symptoms of illness . Adverse events were monitored . Hazard ratios ( HR ) were obtained using Cox proportional hazards multivariate regression shared frailty models . RESULTS Child-days of surveillance totaled 336 038 . Loss to follow up was 14.5 % . For both ADD and ARI , there were no differences in hazard ratios during the first trimester of the study . In the second and third trimesters , significant reductions in the risk of ADD were found in the intervention compared to control arm ( HR = 0.55 , P < 0.001 and HR = 0.44 , P < 0.001 , respectively ) . There were also significant risk reductions for ARI in the second trimester ( HR = 0.80 , P < 0.05 ) and in the third trimester ( HR = 0.69 , P < 0.001 ) . No adverse events occurred . CONCLUSIONS ABH effectively prevent ADD and ARI , and are safe . Colombia 's national public health policies for prevention of these diseases should include use of ABH , especially in setting s where h and washing with soap and water is limited by water availability OBJECTIVE Child care outside the home increases children 's infections substantially . We have to evaluate the possibilities for reducing the transmission of infections by an infection prevention program . DESIGN AND METHODS A 15-month r and omized controlled trial involving 20 day-care centers was conducted to evaluate the efficacy of an infection prevention program . The program was introduced in 10 centers and the other matched 10 centers served as controls . Records were made of the occurrence of infections and absences from care or work because of infections among the children , their parents and the personnel of the day-care centers . RESULTS Both the children and the personnel in the program centers had significantly fewer infections than those in the control centers , the reduction being 9 % [ 95 % confidence interval ( 95 % CI ) , 4 to 16 % , P < 0.002 ] among 3-year-old children and 8 % ( 95 % CI 0 to 14 % , P = 0.049 ) among the older children . The children at the program centers received 24 % fewer prescriptions of antimicrobials ( 95 % CI 22 to 27 % , P < 0.001 ) . Likewise there were 2.5 man-year fewer absences from work on the part of parents because of a child 's illness during 1 year in the program centers , a 24 % difference ( 95 % CI 18 to 29 % , P < 0.001 ) . CONCLUSIONS Effective prevention of infections is possible in child day-care centers , and this can benefit both the families and the personnel . Such a program is cost-effective even if a specialist nurse implements it Background . Acute upper respiratory infections are common in children who attend child care , and preventing transmission of disease in this setting depends on actions by child care staff . We set out to discover whether transmission of respiratory infections in child care could be reduced by improved infection control procedures . Methods . We performed a cluster , r and omized , controlled trial of an infection control intervention conducted in child care centers in 1 city in Australia . The intervention was training of child care staff about transmission of infection , h and washing , and aseptic nosewiping technique . Implementation of the intervention was recorded by an observer . Illness was measured by parent report in telephone interviews every 2 weeks . Results . There were 311 child-years of surveillance for respiratory symptoms . By multivariable analysis , there was no significant reduction in colds in intervention center children across the full age range . However , a significant reduction in respiratory illness was present in children 24 months of age and younger . When compliance with infection control practice s was high , colds in these children were reduced by 17 % . Conclusions . This trial supports the role of direct transmission of colds in young children in child care . The ability of infection control techniques to reduce episodes of colds in children in child care was limited to children 24 months of age and under Abstract . Background : The occurrence of contagious diseases among children attending day care centers ( DCCs ) is high . The possibility of reducing absences due to infections with an infection prevention program was investigated . Material s and Methods : The intervention study was conducted as an open , controlled cluster study . It included 60 municipal DCCs in one of the seven districts of the City of Helsinki ; 228 DCCs in the other six districts served as controls . The main indicator was the occurrence of absences due to upper respiratory tract infections , otitis media , eye infection and diarrhea per child-month . Results : The intervention reduced the absences due to infections by 26 % among under 3-year olds , but not among older children . The same phenomenon was observed when similar paired r and om control DCCs were compared with the intervention DCCs . Conclusion : Effective prevention of absences due to infections is possible among under 3-year olds by implementing a simple and inexpensive infection control program
Output:
| A timely and adequate h and hygiene and an appropriate cleaning of the environment have been uniformly recommended by different guidelines as non-specific prevention measures against respiratory infections . |
MS210517 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND The objective of this study was to assess the cost-effectiveness of pravastatin therapy in survivors of myocardial infa rct ion with average cholesterol levels . METHODS We performed a cost-effectiveness analysis based on actual clinical , cost , and health-related quality -of-life data from the Cholesterol and Recurrent Events ( CARE ) trial . Survival and recurrent coronary heart disease events were modeled from trial data in Markov models , with the use of different assumptions regarding the long-term benefit of therapy . RESULTS Pravastatin therapy increased quality -adjusted life expectancy at an incremental cost of $ 16,000 to $ 32,000 per quality -adjusted life-year gained . In subgroup analyses , the cost-effectiveness of pravastatin therapy was more favorable for patients > 60 years of age and for patients with pretreatment low-density lipoprotein cholesterol levels > 125 mg/dL. Results were sensitive to the cost of pravastatin and to assumptions about long-term survival benefits from pravastatin therapy . CONCLUSIONS The cost-effectiveness of pravastatin therapy in survivors of myocardial infa rct ion with average cholesterol levels compares favorably with other interventions The Beaver Dam Health Outcomes Study ( BDHOS ) is an ongoing longitudinal cohort study of health status and health-related quality of life for a r and om sample of adults ( age range at interview was 45 to 89 years ; mean = 64.1 , SD = 10.8 ) in a community population . In a face-to-face interview lasting approximately an hour , each participant responds to several batteries of questions . Included are a history of chronic medical conditions , current medi cations , and past surgeries ; the SF-36 ( a general health-status question naire ) ; the Quality of Well-being index ; self-rated health status on a five-point scale from " excellent " to " poor " ; and evaluation of current health using the method of time tradeoffs . The authors present results from 1,356 interviews on these four principal measures , reporting mean scores by sex , by age , and for persons reporting being affected by various medical conditions . They believe data from the BDHOS will provide research ers and policy makers a reference col lection of vital statistics for health-related quality of life . Additionally , the data provide a way to compare results from studies that utilize different indices from among the four principal measures of the BDHOS . Key words : health status ; quality of life ( health-related ) ; population study ; cohort study . ( Med Decis Making 1993;13:89 - 102 PURPOSE To evaluate the incremental effectiveness and cost-effectiveness of a staged-based , computerized smoking cessation intervention relative to st and ard care in an urban managed care network of primary care physicians . DESIGN Decision-analytic model based on results of a r and omized clinical trial . METHODOLOGY Patient outcomes and cost estimates were derived from clinical trial data . Effectiveness was measured in terms of 7-day point-prevalence abstinence at 6 months post-intervention . Quality -adjusted life years ( QALYs ) and cost-effectiveness ( CE ) were calculated , with CE measured as cost per patient per life year saved and per quality -adjusted life years saved . CE estimates were adjusted to account for partial behavior change as measured in terms of progression in stage of readiness to quit . Sensitivity analyses were conducted to evaluate the robustness of key model assumptions . PRINCIPAL FINDINGS Intervention patients were 1.77 times more likely to be smoke-free at 6 months follow-up than those in st and ard care ( p=.078 ) . The intervention generated an additional 3.24 quitters per year . Annualized incremental costs were $ 5,570 per primary care practice , and $ 40.83 per smoker . The mean incremental cost-effectiveness ratio was $ 1,174 per life year saved ( $ 869 per QALY ) . When the intervention impact on progression in stage of readiness to quit was also considered , the mean incremental cost-effectiveness ratio declined to $ 999 per life year saved ( $ 739 per QALY ) . CONCLUSIONS From a physician 's practice perspective , the stage-based computer tailored intervention was cost-effective relative to st and ard care . Incorporation of partial behavior change into the model further enhanced favorability of the cost-effectiveness ratio BACKGROUND As many as 70 % of smokers with acute myocardial infa rct ion ( AMI ) continue to smoke after hospital discharge despite high rates of inpatient smoking cessation counseling . Supportive contact after discharge improves quit rates but is rarely used . METHODS Using data from a meta- analysis of r and omized trials of smoking cessation interventions and other published sources , we developed a Monte Carlo model to project health and economic outcomes for a hypothetical US cohort of 327,600 smokers hospitalized with AMI . We compared routine care , consisting of advice to quit smoking , with counseling with supportive follow-up , consisting of routine care and follow-up telephone calls from a nurse after discharge . Primary outcomes were number of smokers , AMIs , and deaths averted ; health care and productivity costs ; cost per quitter ; and cost per quality -adjusted life-year . RESULTS Implementation of smoking cessation counseling with follow-up contact for the 2010 cohort of hospitalized smokers would create 50,230 new quitters , cost $ 27.3 million in nurse wages and material s , and prevent 1380 nonfatal AMIs and 7860 deaths . During a 10-year period , it would save $ 22.1 million in reduced hospitalizations but increase health care costs by $ 166.4 million , primarily through increased longevity . Productivity costs from premature death would fall by $ 1.99 billion and nonmedical expenditures would increase by $ 928 million , for a net positive value to society of $ 894 million . The program would cost $ 540 per quitter considering only intervention costs . Cost-effectiveness would be $ 5050 per quality -adjusted life-year . Results were sensitive to the utility and incidence of nonfatal AMI and the potential effect of pharmacotherapies . CONCLUSION Smoking cessation counseling with supportive contact after discharge is potentially cost-effective and may reduce the incidence of smoking and its associated adverse health events and social costs Introduction : A r and omized trial has demonstrated that lung cancer screening reduces mortality . Identifying participant and program characteristics that influence the cost-effectiveness of screening will help translate trial results into benefits at the population level . Methods : Six U.S. cohorts ( men and women aged 50 , 60 , or 70 years ) were simulated in an existing patient-level lung cancer model . Smoking histories reflected observed U.S. patterns . We simulated lifetime histories of 500,000 identical individuals per cohort in each scenario . Costs per quality -adjusted life-year gained ( $ /QALY ) were estimated for each program : computed tomography screening ; st and -alone smoking cessation therapies ( 4–30 % 1-year abstinence ) ; and combined programs . Results : Annual screening of current and former smokers aged 50 to 74 years costs between $ 126,000 and $ 169,000/QALY ( minimum 20 pack-years of smoking ) or $ 110,000 and $ 166,000/QALY ( 40 pack-year minimum ) , when compared with no screening and assuming background quit rates . Screening was beneficial but had a higher cost per QALY when the model included radiation-induced lung cancers . If screen participation doubled background quit rates , the cost of annual screening ( at age 50 years , 20 pack-year minimum ) was below $ 75,000/QALY . If screen participation halved background quit rates , benefits from screening were nearly erased . If screening had no effect on quit rates , annual screening costs more but provided fewer QALYs than annual cessation therapies . Annual combined screening/cessation therapy programs at age 50 years costs $ 130,500 to $ 159,700/QALY , when compared with annual st and -alone cessation . Conclusions : The cost-effectiveness of computed tomography screening will likely be strongly linked to achievable smoking cessation rates . Trials and further modeling should explore the consequences of relationships between smoking behaviors and screen participation There is a lack of evidence of the relative cost-effectiveness of proactive telephone counseling ( PTC ) and Web-based delivery of smoking cessation services in conjunction with pharmacotherapy . We calculated the differential cost-effectiveness of three behavioral smoking cessation modalities with varenicline treatment in a r and omized trial of current smokers from a large health system . Eligible participants were r and omized to one of three smoking cessation interventions : Web-based counseling ( n = 401 ) , PTC ( n = 402 ) , or combined PTC-Web counseling ( n = 399 ) . All participants received a st and ard 12-week course of varenicline . The primary outcome was a 7-day point prevalent nonsmoking at the 6 month follow-up . The Web intervention was the least expensive followed by the PTC and PTC-Web groups . Costs per additional 6-month nonsmoker and per additional lifetime quitter were $ 1,278 and $ 2,601 for Web , $ 1,472 and $ 2,995 for PTC , and $ 1,617 and $ 3,291 for PTC-Web . Cost per life-year ( LY ) and quality -adjusted life-year ( QALY ) saved were $ 1,148 and $ 1,136 for Web , $ 1,320 and $ 1,308 for PTC , and $ 1,450 and $ 1,437 for PTC-Web . Based on the cost per LY and QALY saved , these interventions are among the most cost-effective life-saving medical treatments . Web , PTC , and combined PTC-Web treatments were all highly cost-effective , with the Web treatment being marginally more cost-effective than the PTC or combined PTC-Web treatments OBJECTIVES To determine the differential cost effectiveness of 2 dosing regimens of bupropion sustained release ( SR ) in combination with behavioral interventions of minimal intensity ( tailored mailings [ TM ] ) or moderate intensity ( proactive telephone calls [ PTC ] ) for smoking cessation in an actual practice setting . STUDY DESIGN Open-label , r and omized trial , with 1-year follow-up , conducted in a large health system based in Seattle , Washington . METHODS A total of 1524 adult smokers interested in quitting smoking were r and omly assigned to receive 150 mg bupropion SR daily and PTC ( n = 382 ) , 150 mg bupropion SR daily and TM ( n = 381 ) , 300 mg bupropion SR daily and PTC ( n = 383 ) , or 300 mg bupropion SR daily and TM ( n = 378 ) . Sufficient medication for 8 weeks of dosing was provided to patients . The primary outcome measure was self-reported point-prevalence 7-day nonsmoking status at 12 months after the target quit date . RESULTS Although the 300-mg dose was associated with a higher 12-month nonsmoking rate relative to the 150-mg dose with both PTC and TM , the additional cost result ed in lower cost effectiveness . The PTC behavioral intervention was more expensive than TM , but the additional effectiveness result ed in almost equivalent cost effectiveness at the 150-mg dose . Costs per additional 12-month nonsmoker ( above that expected for placebo ) for the 150-mg dose groups averaged 950 dollars and per additional lifetime quitter averaged 1508 dollars ; for the 300-mg groups these costs were 1342 dollars and 2129 dollars , respectively . Cost per life-year and quality -adjusted life-years ( QALYs ) saved varied substantially by age and treatment , but were no greater than 1100 dollars for all treatment groups when averaged across the age and sex distribution for the study population . CONCLUSIONS Although the cost per life-year and QALYs saved were sufficiently low for all doses to rate these smoking cessation interventions as among the most cost effective of life-saving medical treatments , within the regimens tested 150 mg bupropion combined with either PTC or TM was the most cost effective OBJECTIVES We assess the cost-effectiveness of smoking relapse prevention interventions design ed to keep quitters from resuming the use of cigarettes . Because relapse prevention is complementary to smoking cessation efforts , the appropriate test of its cost-effectiveness is whether it reduces the incremental cost-effectiveness ratio ( ICER ) of smoking cessation . The major goal of the study is to carry out such a test . METHODS Data from a r and omized trial that ascertained the effectiveness of alternative modes of smoking relapse prevention are combined with ICER estimates of smoking cessation to assess whether relapse prevention is cost-effective . RESULTS The trial produced convincing evidence that relapse prevention yields statistically significant reductions in the proportion of quitters who are smoking at 24 months postquit . The intervention effects are substantial enough to raise the denominator terms of the smoking cessation ICER and , thereby , offset the amount relapse prevention adds to cost numerator terms . In this sense , smoking relapse prevention tends to pay for itself . CONCLUSIONS Smoking relapse prevention is a highly cost-effective addition to current efforts to curb cigarette consumption . Complementary
Output:
| Conclusions Current estimates of the lifetime medical care costs and the QALYs associated with smoking are date d and do not reflect the latest evidence on the health effects of smoking , nor the current costs and benefits of smoking cessation and prevention . |
MS210518 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Surgeons have the highest risk of contact with patients ' blood and body fluids , and breaches in gloving material may expose operating room staff to risk of infections . This prospect i ve r and omised study was done to assess the effectiveness of the practice of double gloving compared with single gloving in decreasing finger contamination during surgery . In 66 consecutive surgical procedures studied , preoperative skin abrasions were detected on the h and s of 17.4 % of the surgeons . In the double gloving pattern , 32 glove perforations were observed , of which 22 were in the outer glove and 10 in the inner glove . Only four outer glove perforations had matching inner glove perforations , thus indicating that in 82 % of cases when the outer glove is perforated the inner glove will protect the surgeon 's h and from contamination . The presence of visible skin contamination was also higher in perforation with the single gloving pattern ( 42.1 % ) than with the double gloving pattern ( 22.7 % ) . An overwhelming majority of glove perforations ( 83.3 % ) went unnoticed . Double gloving was accepted by the majority of surgeons , especially with repeated use . It is recommended that double gloves are used routinely in all surgical procedures in view of the significantly higher protection it provides OBJECTIVE : To compare the rate of glove perforation as a proxy for needlestick injuries between blunt and sharp needles used during cesarean-delivery closure and to survey physician satisfaction with blunt needles . METHODS : Patients requiring cesarean delivery were assigned r and omly to receive closure with either blunt ( study group ) or sharp needles ( control group ) . Patient demographics , operator experience , and other clinical variables were collected . Physicians reported any percutaneous injuries and were surveyed regarding satisfaction with the assigned needles . Glove perforation was determined using a vali date d water-test method . Differences between patient groups were tested using & khgr;2 and Fisher exact test for categorical variables and Student t-test or Wilcoxon rank-sum test for continuous variables . RESULTS : There were 194 patients enrolled in the trial : 97 in the control group and 97 in the study group . There were no statistical differences between groups in patient demographics . There were no differences between groups in clinical variables , type of cesarean delivery , or experience level of the surgeon . There was a significant reduction in total glove perforation rate for the primary surgeon with blunt needles ( 7.2 % ) compared with sharp needles ( 17.5 % ) ( relative risk [ RR ] 0.66 , 95 % confidence interval [ CI ] 0.49–0.89 ) as well as for the assistant surgeon ( RR 0.54 , 95 % CI 0.41–0.71 ) . There was poor correlation between reported perforations and those detected by water test ( R2=0.3 ) . Physicians reported that they were not as satisfied with blunt needles compared with sharp needles ( P=.001 ) . CONCLUSION : There was a significant decrease in the rate of glove perforation for surgeons and assistants performing cesarean-delivery closure with blunt needles . Assistant surgeons had the greatest reduction in glove perforations . However , physicians reported decreased satisfaction performing the surgery with blunt needles . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00844636 LEVEL OF EVIDENCE : The double gloving indicator underglove system ( IUS ) is based on a colored detection of the outer glove perforation . Our objective was to determine the IUS efficiency to detect outer glove perforations and to reduce the risks of blood and body fluids exposure , warning the surgeon before the breach of the surgeon – patient barrier ( SPB ) . A series of 100 visceral surgical procedures were r and omly assigned to either double ( IUS ) or single gloving . The noticed glove perforations ( using the water test method ) and the IUS efficiency were analyzed in 99 procedures . In 49 single-gloving procedures , 19 perforations were noticed : one was immediately perceived ( perceived accidental exposure , PAE ) ; 3 were discovered as the gloves were being removed , and 15 were undetected before the water test ( unperceived prolonged contact , UPC ) . In 50 double-gloving procedures ( IUS ) , 16 perforations were noticed , all of them involving only the outer glove : the IUS allowed immediate detection of 3 perforations without any blood exposure ; 13 other perforations went undetected but without any UPC . In conjunction with the protective quality of double gloving , the IUS allows detection of significant breaches of the outer glove before the breach of the SPB Glove perforation frequently occurs during the course of surgical procedures , introducing risks for both surgeons and patients . The aim of this study was to compare the use of blunt tapered and “ sharp ” needles during abdominal wall closure with respect to the incidence of glove perforation and the convenience of needle h and ling . A series of 200 patients undergoing laparotomy in a 6-month period for general surgical disorders were r and omized to two groups ; in one , the abdominal fascia was closed with a blunt tapered needle ; in the other , a sharp needle was used . The main outcome measures were glove perforation and convenience of h and ling the needle . Univariate and multivariate analyses were performed . In all , 56 glove perforations occurred during 40 ( 20 % ) surgical procedures .Perforation rates differed significantly : 12 % for the blunt ( n = 100 ) tapered needle and 28 % ( n = 100 ) for the sharp needle ( p = 0.003 ) . Only in 12 cases ( 21 % ) was the glove perforation detected at surgery . The type of needle ( odds ratio 0.35 , p = 0.006 ) and time taken to close the fascia ( odds ratio 1.001 , p = 0.05 ) significantly affected the risk of glove perforation . At multivariate logistic regression analysis the type of needle ( odds ratio 0.23 , p = 0.004 ) and the visual analog linear scale ( VAS ) for ease of needle h and ling ( odds ratio 1.18 , p = 0.019 ) were important predictive factors for glove perforation . With the blunt tapered needle , the VAS was significantly ( p = 0.0003 ) higher at primary laparotomy than at relaparotomy . Use of the blunt tapered needle reduces the incidence of glove perforation . Laborious closure predicts glove perforation . Blunt tapered needles are less convenient in closing a scarred abdominal fascia To assess the value of double‐gloving in gynaecological surgery OBJECTIVE To investigate the incidence of glove perforations during various types of gastrointestinal surgery , to record the incidence of blood contamination of the h and s , and to evaluate the protective effect of double gloving . DESIGN R and omised prospect i ve trial . SETTING University hospital , Denmark . MATERIAL 566 pairs of gloves tested on surgeons , assistants , and scrub nurses . INTERVENTIONS The participants were allocated to wear either single gloves or Indicator double gloves . MAIN OUTCOME MEASURES The number of glove perforations and the incidence of blood contamination of the h and s. RESULTS The perforation rate in single gloves was 53/306 ( 17 % ) , and that of both outer and inner Indicator gloves at corresponding sites was 6/260 ( 2 % ) ( p < 0.0001 ) . Double gloving reduced the rate of blood contamination of the h and s among surgeons from 15/115 ( 13 % ) to 2/98 ( 2 % ) ( p < 0.005 ) . CONCLUSION The use of Indicator double gloves is recommended in gastrointestinal surgery because of the appreciable protection against blood contamination that they offer BACKGROUND There is increased tendency towards double-gloving by general surgeons in our practice , due probably to awareness of the risk of contamination with blood or other body fluids during surgery . The aim of the study was to compare the relative frequency of glove puncture in single-glove versus double glove sets in general surgical procedures , and to determine if duration of surgery affects perforation rate . METHOD Surgeons at r and om do single or double gloves at their discretion , for general surgical procedures . All the gloves used by the surgeons were assessed immediately after surgery for perforation . RESULTS A total of 1120 gloves were tested , of which 880 were double-glove sets and 240 single-glove sets . There was no significant difference in the overall perforation rate between single and double glove sets ( 18.3 % versus 20 % ) . However , only 2.3 % had perforations in both the outer and inner gloves in the double glove group . Therefore , there was significantly greater risk for blood-skin exposure in the single glove sets ( p < 0.01 ) . The perforation rate was also significantly greater during procedures lasting an hour or more compared to those lasting less than an hour ( p < 0.01 ) . CONCLUSION Double-gloving reduces the risk of blood-skin contamination in all general surgical procedures , and especially so in procedures lasting an hour or more OBJECTIVE The purpose of this study was to compare the relative frequency of glove perforations in double-glove versus single-glove sets . STUDY DESIGN In this prospect i ve cohort study , surgeons single or double-gloved for pelvic surgery procedures at their own discretion . Gloves were collected at the end of each procedure and evaluated for perforations . RESULTS We tested 1000 sets of gloves : 675 double-glove sets and 325 single-glove sets . The highest rate of perforation ( 19 % ) occurred during major gynecologic procedures . Surgical nurses were the most likely member of the surgical team to sustain a glove injury . There was no significant difference in the total perforation rate between double and single glove sets ( 10 % vs 11 % ) . However , there was a significantly greater potential for blood-skin exposure in the single glove sets . Eleven percent of single glove sets contained a perforation , whereas only 2 % of double glove sets contained a corresponding defect in the inner and outer gloves ( P < .01 ) . CONCLUSION Surgeons should double-glove for all pelvic surgery procedures PURPOSE This study was conducted to comparatively evaluate , in a prospect i ve and r and omized manner , 2 techniques for providing double-gloving protection during arch bar placement for intermaxillary fixation . MATERIAL S AND METHODS A total of 42 consecutive patients in whom application of an Erich bar was indicated for intermaxillary fixation were equally divided into 2 groups . In group 1 , 2 sterile surgical gloves were used ; in group 2 , a nonsterile disposable inner glove was used under a sterile surgical glove . Wilcoxon , Mann-Whitney , Kruskal-Wallis , and binomial statistical tests were used to analyze the findings . RESULTS A total of 103 perforations were found in the outer gloves ( 47 in group 1 and 56 in group 2 ) , along with 5 perforations in inner gloves in both groups ( alpha = .01 ) . No significant statistical difference was found between groups in terms of inner glove perforations ( alpha = .05 ) . The nondominant h and presented with 70.9 % of the perforations , statistically significant to 1 % . CONCLUSIONS Both double-gloving techniques were found to provide effective clinician protection . The use of a nonsterile disposable glove under the surgical glove is possible for less-invasive procedures , offering the same safety as using 2 sterile surgical gloves while decreasing operational costs . This method does not eliminate the need to change gloves when a perforation is suspected or noted during the surgery , however BACKGROUND In surgery , intact gloves protect the surgeon from bloodborne pathogens and the surgical wound from microorganisms on the skin of the surgeon . However , glove perforation is very common , and puncture rates as high as 61 % are published in the literature . One objective of this study was to compare puncture rates between a unique double-gloving puncture indication system and single-use gloves , and another was to determine the extent to which glove perforations remain undetected during surgery . METHODS The study material comprised all gloves used in surgical operations at our hospital for a period of 2 months . The analysis was made by the glove type in a prospect i ve and r and omized manner . Gloves were tested immediately after the surgical procedure using the approved st and ardized water-leak method for 2 minutes to detect any holes . The gloves used in this study were either a double-gloving puncture indication system or the st and ard glove used at our hospital . RESULTS In 885 operations altogether , 2,462 gloves were tested ; 1,020 single gloves , 1,148 double-glove systems , and 294 combination gloves were studied . The overall perforation rate was 192 out of 2,462 gloves ( 7.80 % ) , and 162 out of 885 operations ( 18.3 % ) . The detection of perforation during surgery was 28 out of 76 ( 36.84 % ) with single gloves , 77 out of 89 with the double-gloving system ( 86.52 % ) , and 9 out of 27 with combination gloves ( 33.33 % ; P < 0.
Output:
| In conclusion , this review suggests that both safeguard interventions and educational training programs are effective in reducing the risk of having needlestick injuries . |
MS210519 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE The authors investigated the efficacy of a single exposure to 14 min of cold-water immersion ( COLD ) and contrast water therapy ( CWT ) on posttraining recovery in Australian football ( AF ) . METHOD Fourteen AF players participated in 3 wk of st and ardized training . After week 1 training , all players completed a passive recovery ( PAS ) . During week 2 , COLD or CWT was r and omly assigned . Players undertook the opposing intervention in week 3 . Repeat-sprint ability ( 6 × 20 m ) , countermovement and squat jumps , perceived muscle soreness , and fatigue were measured pretraining and over 48 h posttraining . RESULTS Immediately posttraining , groups exhibited similar performance and psychometric declines . At 24 h , repeat-sprint time had deteriorated by 4.1 % for PAS and 1.0 % for CWT but was fully restored by COLD ( 0.0 % ) . At 24 and 48 h , both COLD and CWT attenuated changes in mean muscle soreness , with COLD ( 0.6 ± 0.6 and 0.0 ± 0.4 ) more effective than CWT ( 1.9 ± 0.7 and 1.0 ± 0.7 ) and PAS having minimal effect ( 5.5 ± 0.6 and 4.0 ± 0.5 ) . Similarly , after 24 and 48 h , COLD and CWT both effectively reduced changes in perceived fatigue , with COLD ( 0.6 ± 0.6 and 0.0 ± 0.6 ) being more successful than CWT ( 0.8 ± 0.6 and 0.7 ± 0.6 ) and PAS having the smallest effect ( 2.2 ± 0.8 and 2.4 ± 0.6 ) . CONCLUSIONS AF training can result in prolonged physical and psychometric deficits persisting for up to 48 h. For restoring physical-performance and psychometric measures , COLD was more effective than CWT , with PAS being the least effective . Based on these results the authors recommend that 14 min of COLD be used after AF training In the last years , phototherapy has becoming a promising tool to improve skeletal muscle recovery after exercise , however , it was not compared with other modalities commonly used with this aim . In the present study we compared the short-term effects of cold water immersion therapy ( CWIT ) and light emitting diode therapy ( LEDT ) with placebo LEDT on biochemical markers related to skeletal muscle recovery after high-intensity exercise . A r and omized double-blind placebo-controlled crossover trial was performed with six male young futsal athletes . They were treated with CWIT ( 5 ° C of temperature [ SD ±1 ° ] ) , active LEDT ( 69 LEDs with wavelengths 660/850 nm , 10/30 mW of output power , 30 s of irradiation time per point , and 41.7 J of total energy irradiated per point , total of ten points irradiated ) or an identical placebo LEDT 5 min after each of three Wingate cycle tests . Pre-exercise , post-exercise , and post-treatment measurements were taken of blood lactate levels , creatine kinase ( CK ) activity , and C-reactive protein ( CRP ) levels . There were no significant differences in the work performed during the three Wingate tests ( p > 0.05 ) . All biochemical parameters increased from baseline values ( p < 0.05 ) after the three exercise tests , but only active LEDT decreased blood lactate levels ( p = 0.0065 ) and CK activity ( p = 0.0044 ) significantly after treatment . There were no significant differences in CRP values after treatments . We concluded that treating the leg muscles with LEDT 5 min after the Wingate cycle test seemed to inhibit the expected post-exercise increase in blood lactate levels and CK activity . This suggests that LEDT has better potential than 5 min of CWIT for improving short-term post-exercise recovery Abstract This study investigated the effects of two different hydrostatic pressures ( seated or st and ing ) during cold water immersion at attenuating the deleterious effects of strenuous exercise on indices of damage and recovery . Twenty four male well-trained games players ( age 23 ± 3 years ; body mass 81.4 ± 8.7 kg : O2max 57.5 ± 4.9 ml∙kg−1∙min−1 ) completed the Loughborough Intermittent Shuttle Test ( LIST ) and were r and omly assigned to either a control , seated cold water immersion or a st and ing cold water immersion ( 14 min at 14 ° C ) . Maximal isometric voluntary contraction , counter-movement jump , creatine kinase , C-reactive protein , interleukin-6 and delayed onset muscle soreness ( DOMS ) were measured before and up to 72 h following the LIST . All dependent variables showed main effects for time ( P < 0.05 ) following the LIST , indicating physiological stress and muscle damage following the exercise . There were no significant group differences between control and either of the cold water immersion interventions . Seated cold water immersion was associated with lower DOMS than st and ing cold water immersion ( effect size = 1.86 ; P = 0.001 ) . These data suggest that increasing hydrostatic pressure by st and ing in cold water does not provide an additional recovery benefit over seated cold water immersion , and that both seated and st and ing immersions have no benefit in promoting recovery following intermittent sprint exercise The aim of this investigation was to eluci date the reductions in muscle , skin and core temperature following exposure to −110 ° C whole body cryotherapy ( WBC ) , and compare these to 8 ° C cold water immersion ( CWI ) . Twenty active male subjects were r and omly assigned to a 4-min exposure of WBC or CWI . A minimum of 7 days later subjects were exposed to the other treatment . Muscle temperature in the right vastus lateralis ( n = 10 ) ; thigh skin ( average , maximum and minimum ) and rectal temperature ( n = 10 ) were recorded before and 60 min after treatment . The greatest reduction ( P<0.05 ) in muscle ( mean ± SD ; 1 cm : WBC , 1.6±1.2 ° C ; CWI , 2.0±1.0 ° C ; 2 cm : WBC , 1.2±0.7 ° C ; CWI , 1.7±0.9 ° C ; 3 cm : WBC , 1.6±0.6 ° C ; CWI , 1.7±0.5 ° C ) and rectal temperature ( WBC , 0.3±0.2 ° C ; CWI , 0.4±0.2 ° C ) were observed 60 min after treatment . The largest reductions in average ( WBC , 12.1±1.0 ° C ; CWI , 8.4±0.7 ° C ) , minimum ( WBC , 13.2±1.4 ° C ; CWI , 8.7±0.7 ° C ) and maximum ( WBC , 8.8±2.0 ° C ; CWI , 7.2±1.9 ° C ) skin temperature occurred immediately after both CWI and WBC ( P<0.05 ) . Skin temperature was significantly lower ( P<0.05 ) immediately after WBC compared to CWI . The present study demonstrates that a single WBC exposure decreases muscle and core temperature to a similar level of those experienced after CWI . Although both treatments significantly reduced skin temperature , WBC elicited a greater decrease compared to CWI . These data may provide information to clinicians and research ers attempting to optimise WBC and CWI protocol s in a clinical or sporting setting The purpose of this study was to determine the effect of cryotherapy on the inflammatory response to muscle-damaging exercise using a r and omized trial . Twenty recreationally active males completed a 40-min run at a −10 % grade to induce muscle damage . Ten of the subjects were immersed in a 5 ° C ice bath for 20 min and the other ten served as controls . Knee extensor peak torque , soreness rating , and thigh circumference were obtained pre- and post-run , and 1 , 6 , 24 , 48 , and 72 h post-run . Blood sample s were obtained pre- and post-run , and 1 , 6 and 24 h post-run for assay of plasma chemokine lig and 2 ( CCL2 ) . Peak torque decreased from 270 ± 57 Nm at baseline to 253 ± 65 Nm post-run and increased to 295 ± 68 Nm by 72 h post-run with no differences between groups ( p = 0.491 ) . Soreness rating increased from 3.6 ± 6.0 mm out of 100 mm at baseline to 47.4 ± 28.2 mm post-run and remained elevated at all time points with no differences between groups ( p = 0.696 ) . CCL2 concentrations increased from 116 ± 31 pg mL−1 at baseline to 293 ± 109 pg mL−1 at 6 h post-run ( control ) and from 100 ± 27 pg mL−1 at baseline to 208 ± 71 pg mL−1 at 6 h post-run ( cryotherapy ) . The difference between groups was not significant ( p = 0.116 ) , but there was a trend for lower CCL2 in the cryotherapy group at 6 h ( p = 0.102 ) , though this measure was highly variable . In conclusion , 20 min of cryotherapy was ineffective in attenuating the strength decrement and soreness seen after muscle-damaging exercise , but may have mitigated the rise in plasma CCL2 concentration . These results do not support the use of cryotherapy during recovery OBJECTIVES To compare the localized skin-cooling effects of 2 cryotherapy modalities and to review the clinical relevance of the results . DESIGN R and omized controlled trial with repeated measures . SETTING Laboratory experiment . PARTICIPANTS Convenience sample of 20 volunteers ( 13 women , 7 men ) , ages 21.3 to 44 years ( mean , 31.3 + /- 6.8 y ) . INTERVENTIONS A flexible frozen gel pack , a 454 g packet of frozen peas , or a control applied to the anterior thigh . No blinding was undertaken . MAIN OUTCOME MEASURE Surface skin temperature under the modality at baseline and 10 and 20 minutes after application . RESULTS Significant effects were recorded for modality ( F(2 ) = 290.56 , P < .0001 ) , time ( F(1.27 ) = 1868.07 , P < .0001 ) , and their interaction ( F(2.09 ) = 305.47 , P < .0001 ) . After 20 minutes , frozen peas produced the lowest mean skin temperature + /- st and ard deviation of 10.8 degrees C + /- 2.28 degrees C compared with 14.4 degrees C + /- 2.53 degrees C from the gel pack and 26.1 degrees C + /- 1.75 degrees C from the control . Skin temperature fell between both time periods with the application of frozen peas but stabilized after 10 minutes of gel pack and control application . CONCLUSIONS Application of frozen peas produced mean skin temperatures adequate to induce localized skin analgesia , to reduce nerve conduction velocity , and to reduce metabolic enzyme activity to clinical ly relevant levels . Flexible frozen gel packs did not cool skin sufficiently to achieve these levels Abstract The aim of this study was to assess the effects of a single session of cold or thermoneutral water immersion after a one-off match on muscular dysfunction and damage in soccer players . Twenty-male soccer players completed one match and were r and omly divided into cryotherapy ( 10 min cold water immersion , 10 ° C , n = 10 ) and thermoneutral ( 10 min thermoneutral water immersion , 35 ° C , n = 10 ) groups . Muscle damage ( creatine kinase , myoglobin ) , inflammation ( C-reactive protein ) , neuromuscular function ( jump and sprint abilities and maximal isometric quadriceps strength ) , and delayed-onset muscle soreness were evaluated before , within 30 min of the end , and 24 and 48 h after the match . After the match , the players in both groups showed increased plasma creatine kinase activity ( 30 min , 24 h , 48 h ) , myoglobin ( 30 min ) and C-reactive protein ( 30 min , 24 h ) concentrations . Peak jump ability and maximal strength were decreased and delayed-onset muscle soreness increased in both groups . However , differential alterations were observed between thermoneutral water and cold water immersion groups in creatine kinase ( 30 min , 24 h , 48 h ) , myoglobin ( 30 min ) , C-reactive protein ( 30 min , 24 h , 48 h ) , quadriceps strength ( 24 h ) , and quadriceps ( 24 h ) , calf ( 24 h ) and adductor ( 30 min ) delayed-onset muscle soreness . The results suggest that cold water immersion immediately after a one-off soccer match reduces muscle damage and discomfort , possibly contributing to a faster recovery of neuromuscular function BACKGROUND Cold Water Immersion ( CWI ) is commonly used to manage delayed onset muscle soreness ( DOMS ) result ing from exercise . Scientific evidence for an optimal dose of CWI is lacking and athletes continue to use a range of a treatment protocol s and water temperatures . OBJECTIVES To compare the effectiveness of four different water immersion protocol s and a pass
Output:
| Conclusions The available evidence suggests that CWI can be slightly better than passive recovery in the management of muscle soreness .
The results also demonstrated the presence of a dose – response relationship , indicating that CWI with a water temperature of between 11 and 15 ° C and an immersion time of 11–15 min can provide the best results |
MS210520 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND The comparative effectiveness of treatments for prostate cancer that is detected by prostate-specific antigen ( PSA ) testing remains uncertain . METHODS We compared active monitoring , radical prostatectomy , and external-beam radiotherapy for the treatment of clinical ly localized prostate cancer . Between 1999 and 2009 , a total of 82,429 men 50 to 69 years of age received a PSA test ; 2664 received a diagnosis of localized prostate cancer , and 1643 agreed to undergo r and omization to active monitoring ( 545 men ) , surgery ( 553 ) , or radiotherapy ( 545 ) . The primary outcome was prostate-cancer mortality at a median of 10 years of follow-up . Secondary outcomes included the rates of disease progression , metastases , and all-cause deaths . RESULTS There were 17 prostate-cancer-specific deaths overall : 8 in the active-monitoring group ( 1.5 deaths per 1000 person-years ; 95 % confidence interval [ CI ] , 0.7 to 3.0 ) , 5 in the surgery group ( 0.9 per 1000 person-years ; 95 % CI , 0.4 to 2.2 ) , and 4 in the radiotherapy group ( 0.7 per 1000 person-years ; 95 % CI , 0.3 to 2.0 ) ; the difference among the groups was not significant ( P=0.48 for the overall comparison ) . In addition , no significant difference was seen among the groups in the number of deaths from any cause ( 169 deaths overall ; P=0.87 for the comparison among the three groups ) . Metastases developed in more men in the active-monitoring group ( 33 men ; 6.3 events per 1000 person-years ; 95 % CI , 4.5 to 8.8 ) than in the surgery group ( 13 men ; 2.4 per 1000 person-years ; 95 % CI , 1.4 to 4.2 ) or the radiotherapy group ( 16 men ; 3.0 per 1000 person-years ; 95 % CI , 1.9 to 4.9 ) ( P=0.004 for the overall comparison ) . Higher rates of disease progression were seen in the active-monitoring group ( 112 men ; 22.9 events per 1000 person-years ; 95 % CI , 19.0 to 27.5 ) than in the surgery group ( 46 men ; 8.9 events per 1000 person-years ; 95 % CI , 6.7 to 11.9 ) or the radiotherapy group ( 46 men ; 9.0 events per 1000 person-years ; 95 % CI , 6.7 to 12.0 ) ( P<0.001 for the overall comparison ) . CONCLUSIONS At a median of 10 years , prostate-cancer-specific mortality was low irrespective of the treatment assigned , with no significant difference among treatments . Surgery and radiotherapy were associated with lower incidences of disease progression and metastases than was active monitoring . ( Funded by the National Institute for Health Research ; ProtecT Current Controlled Trials number , IS RCT N20141297 ; Clinical Trials.gov number , NCT02044172 . ) Background : Contemporary screening for prostate cancer frequently identifies small volume , low- grade lesions . Some clinicians have advocated focal prostatic ablation as an alternative to more aggressive interventions to manage these lesions . To identify which patients might benefit from focal ablative techniques , we analysed the surgical specimens of a large sample of population -detected men undergoing radical prostatectomy as part of a r and omised clinical trial . Methods : Surgical specimens from 525 men who underwent prostatectomy within the ProtecT study were analysed to determine tumour volume , location and grade . These findings were compared with information available in the biopsy specimen to examine whether focal therapy could be provided appropriately . Results : Solitary cancers were found in prostatectomy specimens from 19 % ( 100 out of 525 ) of men . In addition , 73 out of 425 ( 17 % ) men had multiple cancers with a solitary significant tumour focus . Thus , 173 out of 525 ( 33 % ) men had tumours potentially suitable for focal therapy . The majority of these were small , well-differentiated lesions that appeared to be pathologically insignificant ( 38–66 % ) . Criteria used to select patients for focal prostatic ablation underestimated the cancer 's significance in 26 % ( 34 out of 130 ) of men and result ed in overtreatment in more than half . Only 18 % ( 24 out of 130 ) of men presumed eligible for focal therapy , actually had significant solitary lesions . Conclusion : Focal therapy appears inappropriate for the majority of men presenting with prostate-specific antigen-detected localised prostate cancer . Unifocal prostate cancers suitable for focal ablation are difficult to identify pre-operatively using biopsy alone . Most lesions meeting criteria for focal ablation were either more aggressive than expected or posed little threat of progression INTRODUCTION Focal therapy for localized prostate cancer has the potential for oncological control without the side effects of radical therapies . However , there is currently no vali date d method for monitoring treatment success . We assessed the diagnostic performance of prostate-specific antigen ( PSA ) parameters and MRI compared to histological outcomes following focal therapy . PATIENTS AND METHODS Patients from 3 Ethics Review Board approved prospect i ve studies of focal high intensity-focused ultrasound ( HIFU ) ( Sonablate 500 ) for localized prostate cancer ( T1c-T3a , Gleason grade ≤4 + 3 , and PSA≤20 ) . Post-HIFU PSA nadir , 6-month PSA , PSA density , and early ( < 3wk ) and late ( 6mo ) MRI ( T2-weighted , dynamic contrast-enhanced±diffusion-weighted ) was assessed for predictive accuracy of cancer on postoperative biopsy , using receiver operating characteristic ( ROC ) analysis and sensitivity , specificity , and positive and negative predictive estimates . ROC areas for MRI and PSA were compared . Calculations for statistical significance ( P≤0.05 ) were obtained in a subset of patients comparing area under ROC for 6-month MRI and PSA criteria , across 4 different histological definitions of disease significance . RESULTS Of 118 men , 111 underwent at least 1 postoperative biopsy ( median 6 cores ) , with an overall positive biopsy rate of 37 % ( 41/118 ) , over a mean follow-up period of 716 days post-HIFU . Areas under ROC for early and late MRI were ( depending on definition of significant disease ) 0.65 to 0.76 and 0.77 to 0.85 , respectively , with sensitivity , specificity , and negative predictive values of 68 % to 91 % , 52 % to 55 % , and 85 % to 98 % ( early MRI ) , and 63 % to 80 % , 67 % to 73 % , and 86 % to 97 % ( late MRI ) . The area under the ROC curve was statistically significantly higher for late MRI than 6 months and nadir PSA for residual disease > 3 mm or any Gleason 4 tumor . CONCLUSIONS Early and late MRI performed better than PSA measurements in the detection of residual tumor after focal therapy Purpose The design , conduct and completion of r and omized trials for curative prostate cancer ( PCa ) treatments are challenging . To evaluate the effect of robot-assisted radical prostatectomy ( RARP ) versus focal irreversible electroporation ( IRE ) on patient-reported quality of life ( QoL ) and early oncological control using propensity-scored matching . Methods Patients with T1c – cT2b significant PCa ( high-volume ISUP 1 or any 2/3 ) who received unifocal IRE were pair-matched to patients who received nerve-sparing RARP . Patient-reported outcomes were prospect ively assessed using the Exp and ed Prostate Cancer Index Composite ( EPIC ) , AUA symptom score and Short Form of Health Survey ( SF-12 ) physical and mental components . Oncological failure was defined as biochemical recurrence ( RARP ) or positive follow-up biopsies ( IRE ) . Generalized mixed-effect models were used to compare IRE and RARP . Results 50 IRE patients were matched to 50 RARP patients by propensity score . IRE was significantly superior to RARP in preserving pad-free continence ( UC ) and erections sufficient for intercourse ( ESI ) . The absolute differences were 44 , 21 , 13 , 14 % for UC and 32 , 46 , 27 , 22 % for ESI at 1.5 , 3 , 6 , and 12 months , respectively . The EPIC summary scores showed no statistically significant differences . Urinary symptoms were reduced for IRE and RARP patients at 12 months , although IRE patient initially had more complaints . IRE patients experienced more early oncological failure than RARP patients . Conclusions These data demonstrated the superior preservation of UC and ESI with IRE compared to RARP up to 12 months after treatment . Long-term oncological data are warranted to provide ultimate proof for or against focal therapy Purpose : We evaluated focal therapy with high intensity focused ultrasound hemiablation in a prospect i ve trial . Material s and Methods : We performed a prospect i ve , multicenter , single arm study in patients with unilateral low/intermediate risk prostate cancer who were treated from April 2013 through March 2016 in Germany in AUO ( Arbeitsgemeinschaft Urologische Onkologie ) Study Protocol AP 68/11 . Unilateral prostate cancer was assessed by transrectal ultrasound guided biopsy and multiparametric magnetic resonance imaging . Hemiablation was done using the Ablatherm ® or the Focal One ® device . The oncologic outcome was assessed by the salvage treatment rate , multiparametric magnetic resonance imaging and rebiopsy at 12 months . Functional outcome , quality of life , anxiety and depression were measured by vali date d question naires at baseline and every 3 months . Results : Of the 54 recruited patients 51 completed 12‐month or greater visits . Mean ± SD followup was 17.4 ± 4.5 months . Mean prostate specific antigen decreased from 6.2 ± 2.0 to 2.9 ± 1.9 ng/ml at 12 months ( p < 0.001 ) . Biopsy at 12 months was positive for any prostate cancer and for clinical ly significant prostate cancer in 13 ( 26.5 % ) and 4 ( 8.2 % ) of the 49 patients , respectively . Posttreatment multiparametric magnetic resonance imaging had limited 25 % sensitivity for clinical ly significant prostate cancer . Ten patients ( 19.6 % ) underwent salvage treatment . Potency was maintained in 21 of the 30 men who were potent preoperatively . There was no increase in incontinence . Quality of life , anxiety and depression did not change postoperatively . The study was limited by a short followup and the lack of a control arm . Conclusions : Focal therapy hemiablation is safe with little alteration of functional outcome . The oncologic outcome is acceptable on short‐term followup . Followup multiparametric magnetic resonance imaging performed poorly and should not replace repeat biopsy . Focal therapy has no impact on posttreatment anxiety and depression Purpose To report the safety profile and 2-year functional outcomes of in-bore magnetic resonance (MR)-guided focused ultrasound on single cancer foci in men with prostate cancer . Material s and Methods Ethics approval was obtained from the central ized institutional review board for this prospect i ve single-arm study , and patients provided informed consent . Patients with untreated low-volume low- grade prostate cancer ( clinical stage T2a or lower ; Gleason score , 3 + 3 ; index tumor ≤10 mm3 ) underwent MR-guided focused ultrasound between July 2011 and February 2013 . All patients underwent robotic transperineal mapping biopsy and multiparametric MR imaging . Only those with a maximum of two lesions smaller than 10 mm at mapping biopsy were included . Target areas were sonicated with real-time MR thermometry monitoring , excluding critical areas from the beam path . Serum prostate-specific antigen ( PSA ) and Exp and ed Prostate Index Composite ( EPIC ) scores were obtained at baseline and at 1 , 3 , 6 , 12 , 18 , and 24 months and were plotted to observe their trend . Mean EPIC subdomain score changes at each serial time point were compared with the baseline score by using paired t tests ( level of significance , P < .007 ) . Repeat transperineal biopsy was performed at 6 and 24 months . Results Fourteen men ( mean age , 62.8 years ; median PSA level , 8.3 ng/mL ) underwent treatment , with 12 men completing 2-year follow-up . A median reduction of PSA level by 2.9 ng/mL was observed at 6 months . Seven men had Clavien-Dindo grade 1 - 2 complications . There was a slight insignificant deterioration of EPIC urinary symptom score ( mean increase of 7.8 points compared with baseline , P =
Output:
| Recent findings Focal therapy reduces the rate of cancer progression and conversion to radical therapy in men on active surveillance for prostate cancer .
Although long-term oncological outcomes remain lacking , focal therapy has a low complication rate , minimal impact on urinary continence and a moderate impact on erectile function .
Summary With the appropriate expertise in imaging , targeted biopsy and targeted ablation , focal therapy is a good option in men with low – intermediate risk cancer who are willing to maximize their urinary and sexual function . |
MS210521 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: The reproducibility of a variety of Doppler indexes of diastolic function in an epidemiologic setting and in atrial fibrillation have not been reported . This study examined the reproducibility of left ventricular inflow in subjects in sinus rhythm ( n = 80 ) and atrial fibrillation ( n = 12 ) , r and omly selected from the original cohort of the Framingham Heart Study . The following Doppler indexes were assessed for all subjects : peak and integral of early ( E ) diastolic inflow velocity , acceleration slope and time , deceleration slope and time , and pressure half-time . For subjects in sinus rhythm , the following parameters also were measured : the peak and integral of late ( A ) diastolic inflow velocity , ratios of peak velocities and integrals E/A , and atrial filling fraction . Intraobserver and interobserver variability were evaluated by statistical methods including Student 's t test of the systematic differences ( bias ) , percent bias , correlation coefficients , measurement precision , and percent precision . In subjects in sinus rhythm , although the interobserver bias was statistically significant for most of the parameters , it was < 10 % for all but 1 parameter ( acceleration time ) . For the peak and integral measures , the intra- and interobserver correlations were > or = 0.89 , with intra- and interobserver percent precision measures within 2.2 to 13.0 % of the corresponding mean values . The acceleration , deceleration and pressure half-time measures had somewhat lower correlations ( interobserver correlations ranging from 0.59 to 0.96 ) , with percent precision measures further from the corresponding means ( interobserver percent precision ranging from 10.1 to 19.5 % ) . ( ABSTRACT TRUNCATED AT 250 WORDS Background — There is a paucity of international data on the various types of atrial fibrillation ( AF ) outside the highly selected population s from r and omized trials . This study aim ed to describe patient characteristics , risk factors , comorbidities , symptoms , management strategy , and control of different types of AF in real-life practice . Methods and Results — Real-life global survey evaluating patients with atrial fibrillation ( RealiseAF ) was a contemporary , large-scale , cross-sectional international survey of patients with AF who had ≥1 episode in the past 12 months . Investigators were r and omly selected to avoid bias . Among 9816 eligible patients from 831 sites in 26 countries , 2606 ( 26.5 % ) had paroxysmal , 2341 ( 23.8 % ) had persistent , and 4869 ( 49.6 % ) had permanent AF . As AF progressed from paroxysmal to persistent and permanent forms , the prevalence of comorbidities , such as heart failure ( 32.9 % , 44.3 % , and 55.6 % ) , coronary artery disease ( 30.0 % , 32.9 % , and 34.3 % ) , cerebrovascular disease ( 11.7 % , 10.8 % , and 17.6 % ) , and valvular disease ( 16.7 % , 21.2 % , and 35.8 % ) , increased , and the prevalence of lone AF decreased . Similarly , there was an increase in mean CHADS2 [ cardiac failure , hypertension , age , diabetes , stroke ( doubled ) ] score ( 1.7 , 1.8 , and 2.2 ) , and more than half of patients ( 51.0 % , 56.7 % , and 67.3 % ) qualified for oral anticoagulants . Almost 90 % of patients received ≥1 antiarrhythmic drug , but > 60 % had European Heart Rhythm Association symptom scores from II to IV . Furthermore , 40.7 % of persistent and 49.8 % of permanent AF patients were still in AF with a heart rate > 80 beats per minute . Conclusions — This survey disclosed high cardiovascular risks and an unmet need in daily practice for patients with any type of AF , especially those with the permanent form BACKGROUND Doppler echocardiography is frequently used to predict filling pressures in normal sinus rhythm , but it is unknown whether it can be applied in sinus tachycardia , with merging of E and A velocities . Tissue Doppler imaging ( TDI ) can record the mitral annular velocity . The early diastolic velocity ( Ea ) behaves as a relative load-independent index of left ventricular relaxation , which corrects the influence of relaxation on the transmitral E velocity . METHODS AND RESULTS We evaluated 100 patients 64+/-12 years old with simultaneous Doppler and invasive hemodynamics . Mitral inflow was classified into 3 patterns : complete merging of E and A velocities ( pattern A ) , discernible velocities with A dominance ( B ) , or E dominance ( C ) . The Doppler data were analyzed at the mitral valve tips for E , acceleration and deceleration times of E , and isovolumic relaxation time . In patterns B and C , the A velocity , E/A ratio , and atrial filling fraction were derived . Pulmonary venous flow velocities were also measured , and TDI was used to acquire Ea and Aa . Weak significant relations were observed between pulmonary capillary wedge pressure ( PCWP ) and sole parameters of mitral flow , pulmonary venous flow , and annular measurements . These were better for patterns A and C. E/Ea ratio had the strongest relation to PCWP [ r=0.86 , PCWP=1.55 + 1.47(E/Ea ) ] , irrespective of the pattern and ejection fraction . This equation was tested prospect ively in 20 patients with sinus tachycardia . A strong relation was observed between catheter and Doppler PCWP ( r=0.91 ) , with a mean difference of 0.4+/-2.8 mm Hg . CONCLUSIONS The ratio of transmitral E velocity to Ea can be used to estimate PCWP with reasonable accuracy in sinus tachycardia , even with complete merging of E and A velocities Background —Conventional Doppler measurements have limitations in the prediction of left atrial pressure ( LAP ) in patients with mitral valve disease ( MVD ) , given the confounding effect of valve area , left ventricular ( LV ) relaxation , and stiffness . However , the time interval between the onset of early diastolic mitral inflow velocity ( E ) and annular early diastolic velocity ( Ea ) by tissue Doppler imaging ( TDI ) , TE−Ea , which is well related to the time constant of LV relaxation ( & tgr ; ) in canine and clinical studies , is not subject to these variables . We therefore undertook this study to test its usefulness in a patient population . Methods and Results —Two-dimensional Doppler and TDI echocardiography were performed simultaneously with right-heart catheterization in 51 consecutive patients ( mean±SD age , 64±11 years ) with MVD : 35 with moderately severe to severe mitral regurgitation ( MR ) and 16 with moderate to severe mitral stenosis ( MS ) . Among several Doppler measurements , only the mitral E/A ratio , isovolumetric relaxation time ( IVRT ) , and pulmonary venous Ar duration had significant relations with mean pulmonary capillary wedge pressure ( PCWP ) . The ratio of IVRT to TE−Ea ( for MR , r=−0.92 ; for MS , r=−0.88 ; both P<0.001 ) and the ratio of IVRT to & tgr ; ( for MR , r=−0.74 ; for MS , r=−0.85 ; both P<0.001 ) had the best correlations with PCWP . In 54 repeat studies , including those performed after MV repair or replacement , these ratios tracked well the changes in PCWP and readily identified changes in mean PCWP by ≥5 mm Hg . A similar correlation was noted in 13 patients with atrial fibrillation ( r=−0.92 , P<0.01 ) and in a prospect i ve group of 14 patients with MR ( r=−0.93 , P<0.001 ) . Conclusions —The ratio of IVRT to TE−Ea or to & tgr ; can be readily applied for estimating mean PCWP in patients with MVD and can track changes in PCWP after valve surgery BACKGROUND It is traditionally difficult to estimate left ventricular ( LV ) systolic function in atrial fibrillation ( AF ) . The aim of this study was to vali date the use of an index beat , the beat after the nearly equal preceding ( RR1 ) and pre-preceding ( RR2 ) intervals , for the measurement of LV peak longitudinal systolic strain ( PLSS ) . The difference between RR1 and RR2 intervals of the index beat must be < 60 msec . LV PLSS measured from the index beat ( PLSSindex ) was compared with LV PLSS measured from the conventional but time-consuming method of averaging multiple cardiac cycles ( PLSSavg ) . METHODS Ninety-eight patients with persistent or permanent AF and resting ventricular rates ≤ 105 beats/min were prospect ively included . LV PLSSindex and LV PLSSavg were obtained from two-dimensional speckle-tracking echocardiography . RESULTS LV PLSSindex had a highly significant correlation with LV PLSSavg ( r = 0.970 , P < .001 ) . Bl and -Altman analysis showed only small bias of 0.01 % , and the 95 % limits of agreement were + 1.64 % to -1.62 % . Compared with those with lower risk scores of stroke indicated by CHADS(2 ) scores < 2 or CHA(2)DS(2)-VASc scores < 2 , patients with higher risk scores of stroke indicated by CHADS(2 ) scores ≥ 2 or CHA(2)DS(2)-VASc scores ≥ 2 had lower PLSSavg and PLSSindex ( P ≤ .012 ) . CONCLUSIONS LV PLSSindex was a good alternative to LV PLSSavg in patients with AF . Use of the index beat to measure LV longitudinal systolic strain in patients with AF was as accurate as the time-consuming method of averaging multiple cardiac cycles Single-beat determination of left ventricular systolic function at a beat with equal subsequent cardiac cycles has been proposed as an accurate method in atrial fibrillation . However , there has still been substantial variability between the values calculated from beats with equal subsequent cycles . Therefore , some refinement on the single-beat method is needed . In 100 patients with atrial fibrillation , Doppler aortic flow time-velocity integral was determined for at least 20 consecutive cardiac cycles . The values at beats with equal subsequent cardiac cycles were chosen and compared with the average values over all cardiac cycles . The values at beats with cycle lengths shorter than 500 milliseconds were usually far below the average values over all cardiac cycles . Bl and -Altman agreement analysis revealed improved accuracy by gradually narrowing the range of the limits of agreement when 2 or 3 beats with equal subsequent cycles and cycle lengths longer than 500 milliseconds were used for evaluation OBJECTIVES We sought to obtain a noninvasive estimation of mean pulmonary wedge pressure ( MPWP ) in patients with chronic atrial fibrillation ( AF ) . BACKGROUND It has previously been demonstrated that MPWP can be reliably estimated from Doppler indexes of mitral and pulmonary venous flow ( PVF ) in patients with sinus rhythm . Doppler estimation of MPWP has not been vali date d in patients with AF . METHODS MPWP was correlated with variables of mitral and pulmonary venous flow velocity as assessed by Doppler transthoracic echocardiography in 35 consecutive patients . The derived algorithm was prospect ively tested in 23 additional patients . RESULTS In all patients the mitral flow pattern showed only a diastolic forward component . A significant but relatively weak correlation ( r = -0.50 ) was observed between MPWP and mitral deceleration time . In 12 ( 34 % ) of 35 patients , the pulmonary vein flow tracing demonstrated only a diastolic forward component ; a diastolic and late systolic forward flow was noted in the remaining 23 patients ( 66 % ) . A strong negative correlation was observed between MPWP and the normalized duration of the diastolic flow ( r = -0.80 ) and its initial deceleration slope time ( r = -0.91 ) . Deceleration time > 220 ms predicted MPWP < or = 12 mm Hg with 100 % sensitivity and 100 % specificity . When estimating MPWP by using the equation MPWP = -94.261 PVF deceleration time -9.831 Interval QRS to onset of diastolic PVF -16.337 Duration of PVF + 44.261 , the measured and predicted MPWP closely agreed with a mean difference of -0.85 mm Hg . The 95 % confidence limits were 4.8 and -6.1 mm Hg . CONCLUSIONS In patients with chronic AF , MPWP can be estimated from transthoracic Doppler study of PVF velocity signals Although exercise intolerance is a major symptom of patients with atrial fibrillation ( AF ) , the factors limiting these patients ' exercise capacity remains uncertain . This study evaluated the correlation of clinical and echocardiographic parameters with exercise capacity of patients with AF . In all , 73 patients ( 61 men and 12 women ; mean age 61 years ) with chronic AF were included in this study . Those patients with primary valvular diseases were excluded . St and ard 2-dimensional and Doppler echocardiography was performed , and we averaged 10 consecutive measurements of each variable . Patients then underwent a symptom-limited treadmill exercise testing . We also measured patients ' plasma levels of B-type natriuretic peptide before exercise testing . Of all clinical and echocardiographic parameters we assessed , age ( r = -0.45 , P = .006 ) , ratio of early mitral inflow
Output:
| Cardiac cycle length and equivalence were more important than the number of beats averaged .
Conclusion With careful selection of appropriate cardiac cycles , echocardiography is a valid tool to identify diastolic dysfunction in AF , and E/e ' is an independent marker of clinical status and adverse prognosis . |
MS210522 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND The treatment of unstable angina targets the specific pathophysiological thrombotic process at the site of the active culprit lesion . In unstable angina due to a restenotic lesion , smooth muscle cell proliferation and increased vasoreactivity may play a more important role than thrombus formation . Therefore , the relative benefits of nitroglycerin and heparin might differ in unstable angina associated with restenosis compared with classic unstable angina . METHODS AND RESULTS We r and omized 200 patients hospitalized for unstable angina within 6 months after angioplasty ( excluding those with intracoronary stents ) to double-blind administration of intravenous nitroglycerin , heparin , their combination , or placebo for 63+/-30 hours . Recurrent angina occurred in 75 % of patients in the placebo and heparin-alone groups , compared with 42.6 % of patients in the nitroglycerin-alone group and 41.7 % of patients in the nitroglycerin-plus-heparin group ( P<0.003 ) . Refractory angina requiring angiography occurred in 22.9 % , 29.2 % , 4 . 3 % , and 4.2 % of patients , respectively ( P<0.002 ) . The odds ratios for being event free were 0.24 ( 95 % CI , -0.13 to 0.45 , P=0.0001 ) for nitroglycerin versus no nitroglycerin and 0.98 ( 95 % CI , -0.55 to 1 . 73 , P = NS ) for heparin versus no heparin . No patient died or suffered myocardial infa rct ion . CONCLUSIONS Intravenous nitroglycerin is highly effective in preventing adverse ischemic events ( recurrent or refractory angina ) in patients with unstable angina secondary to restenosis , whereas heparin has no effect CONTEXT Despite many therapeutic advances , mortality in patients with acute ST-segment elevation myocardial infa rct ion ( STEMI ) remains high . The role of additional antithrombotic agents is unclear , especially among patients not receiving reperfusion therapy . OBJECTIVE To evaluate the effect of fondaparinux , a factor Xa inhibitor , when initiated early and given for up to 8 days vs usual care ( placebo in those in whom unfractionated heparin [ UFH ] is not indicated [ stratum 1 ] or unfractionated heparin for up to 48 hours followed by placebo for up to 8 days [ stratum 2 ] ) in patients with STEMI . DESIGN , SETTING , AND PARTICIPANTS R and omized double-blind comparison of fondaparinux 2.5 mg once daily or control for up to 8 days in 12,092 patients with STEMI from 447 hospitals in 41 countries ( September 2003-January 2006 ) . From day 3 through day 9 , all patients received either fondaparinux or placebo according to the original r and omized assignment . MAIN OUTCOME MEASURES Composite of death or reinfa rct ion at 30 days ( primary ) with secondary assessment s at 9 days and at final follow-up ( 3 or 6 months ) . RESULTS Death or reinfa rct ion at 30 days was significantly reduced from 677 ( 11.2 % ) of 6056 patients in the control group to 585 ( 9.7 % ) of 6036 patients in the fondaparinux group ( hazard ratio [ HR ] , 0.86 ; 95 % confidence interval [ CI ] , 0.77 - 0.96 ; P = .008 ) ; absolute risk reduction , 1.5 % ; 95 % CI , 0.4%-2.6 % ) . These benefits were observed at 9 days ( 537 [ 8.9 % ] placebo vs 444 [ 7.4 % ] fondaparinux ; HR , 0.83 ; 95 % CI , 0.73 - 0.94 ; P = .003 , and at study end ( 857 [ 14.8 % ] placebo vs 756 [ 13.4 % ] fondaparinux ; HR , 0.88 ; 95 % CI , 0.79 - 0.97 ; P = .008 ) . Mortality was significantly reduced throughout the study . There was no heterogeneity of the effects of fondaparinux in the 2 strata by planned heparin use . However , there was no benefit in those undergoing primary percutaneous coronary intervention . In other patients in stratum 2 , fondaparinux was superior to unfractionated heparin in preventing death or reinfa rct ion at 30 days ( HR , 0.82 ; 95 % CI , 0.66 - 1.02 ; P = .08 ) and at study end ( HR , 0.77 ; 95 % CI , 0.64 - 0.93 ; P = .008 ) . Significant benefits were observed in those receiving thrombolytic therapy ( HR , 0.79 ; P = .003 ) and those not receiving any reperfusion therapy ( HR , 0.80 ; P = .03 ) . There was a tendency to fewer severe bleeds ( 79 for placebo vs 61 for fondaparinux ; P = .13 ) , with significantly fewer cardiac tamponade ( 48 vs 28 ; P = .02 ) with fondaparinux at 9 days . CONCLUSION In patients with STEMI , particularly those not undergoing primary percutaneous coronary intervention , fondaparinux significantly reduces mortality and reinfa rct ion without increasing bleeding and strokes . TRIAL REGISTRATION Clinical Trials.gov Identifier NCT00064428 Background Antiplatelet therapy with aspirin and antithrombotic therapy with heparin both prevent the complications of unstable angina ; however , no definitive data exist on the relative clinical efficacy of the two drugs . Methods and Results Aspirin ( 325 mg bid ) or heparin ( 5000-U intravenous bolus followed by a perfusion titrated to the APTT ) were compared in a double-blind r and omized trial of 484 patients in two cohorts enrolled sequentially . The study was initiated at admission to hospital at a mean of 8.3±7.8 hours after the last episode of pain . End points were assessed 5.7±3.3 days later , when the decision for long-term management was made . Myocardial infa rct ion occurred in 2 ( 0.8 % ) of the 240 patients r and omized to heparin and in 9 ( 3.7 % ) of the 244 r and omized to aspirin ( P=.035 ) , an odds ratio of 0.22 and a risk difference of 2.9%o ( 95 % confidence limits , 0.3 % to 5.6 % ) with heparin . The only death result ed from a myocardial infa rct ion in an aspirin patient . Survival curves with Cox logistic regression analysis showed that the improvement in survival without myocardial infa rct ion with heparin ( P=.035 ) was independent of other baseline characteristics . Conclusions This study documents that heparin prevents myocardial infa rct ion better than aspirin during the acute phase of unstable angina Platelet glycoprotein IIb/IIIa inhibitors have been extensively studied in the treatment of patients with ischemic heart disease . Data regarding the use of these agents in the absence of concomitant intravenous heparin have been conflicting . We sought to determine , using propensity analysis , whether the benefit of eptifibatide , a IIb/IIIa inhibitor , in the treatment of acute coronary syndromes is affected by the concurrent administration of heparin . By trial design , patients were r and omized to either eptifibatide or placebo , whereas use of intravenous heparin was left to the discretion of treating physicians . The effect of eptifibatide on the 30-day composite end point of death or myocardial infa rct ion was studied in patients who received heparin and those who did not . Propensity analysis methods were used to control for confounding and presumed selection biases . Among 5,576 patients who were receiving heparin when the bolus dose of the study drug was administered , eptifibatide was associated with a reduced composite end point rate ( 13 % ) compared with that of placebo ( 14.5 % vs 16.6 % , p = 0.03 ) . In contrast , among 1,441 patients who were not receiving heparin , there was no difference in 30-day event rates with eptifibatide compared with placebo ( 13.7 % vs 13.1 % , p > 0.7 ) . After a propensity score for use of heparin was developed , however , use of heparin did not affect the reduced risk associated with eptifibatide ( adjusted relative risk [ RR ] for heparin-eptifibatide interaction term 0.90 , 95 % confidence interval [ CI ] 0.61 to 1.32 , p > 0.5 ) , but the propensity for heparin use was a strong predictor of events ( adjusted RR 1.76 , 95 % CI 1.42 to 2.17 , p < 0.001 ) . The use of eptifibatide independently predicted a lower risk of events ( adjusted RR 0.31 , 95 % CI 0.10 to 0.93 , p = 0.04 ) . Thus , the apparent positive impact of heparin on the benefits of eptifibatide therapy was largely due to confounding and bias Heparin , aspirin with dipyridamole or placebo were given to 266 patients with pre-infa rct ion angina treated with isosorbide dinitrate , beta blockers and nifedipidine . The number of patients who developed acute myocardial infa rct ion ( MI ) in the next 72 hours was comparable in all 3 groups . However , patients on heparin developed only 3.2 % ( 2 out of 61 ) Q MI compared with 20 % ( 20 out of 100 , p = 0.005 ) taking dipyridamole with aspirin and 19 % ( 20 out of 105 on placebo , p = 0.006 ) . Infa rct ions of patients treated with heparin as assessed by peak of serum creatine kinase ( CK ) were also smaller ( 810 + /- 538 IU/1 ) than in groups taking antiplatelets ( 1229 + /- 829 IU/1 , p = 10.048 ) or placebo ( 1417 + /- 919 IU/1 , p = 0.009 ) . We defined a subgroup at high risk patients who had prolonged chest pain longer than 45 min and ECG changes with ST segment depression more than 1 mm within 6 hours of admission : 55 % of these patients developed acute infa rct ion in the following 72 hours . Aggressive management including coronary angiography and fibrinolysis should be considered in well equipped centers for patients with evolving coronary thrombus in a general hospital , heparin infusion should be part of routine treatment as patients on heparin developed smaller infa rct ions OBJECTIVES The aims of the Safety and Efficacy of Subcutaneous Enoxaparin Versus Intravenous Unfractionated Heparin and Tirofiban Versus Placebo in the Treatment of Acute ST-Segment Elevation Myocardial Infa rct ion Patients Ineligible for Reperfusion ( TETAMI ) study were to demonstrate that enoxaparin was superior to unfractionated heparin ( UFH ) and that tirofiban was better than placebo in patients with acute ST-segment elevation myocardial infa rct ion ( STEMI ) who do not receive timely reperfusion . BACKGROUND An optimal treatment strategy has not been identified for the many STEMI patients ineligible for acute reperfusion . METHODS A total of 1224 patients were enrolled in 91 centers in 14 countries between July 1999 and July 2002 . Patients with STEMI ineligible for reperfusion were r and omized to enoxaparin , enoxaparin plus tirofiban , UFH , or UFH plus tirofiban . All patients received oral aspirin . The primary efficacy end point was the 30-day combined incidence of death , reinfa rct ion , or recurrent angina ; the primary analysis was the comparison of the pooled enoxaparin and UFH groups . RESULTS The incidence of the primary efficacy end point was 15.7 % enoxaparin versus 17.3 % for UFH ( odds ratio 0.89 [ 95 % confidence interval CI = 0.66 to 1.21 ] ) and 16.6 % for tirofiban versus 16.4 % for placebo ( odds ratio 1.02 [ 95 % CI 0.75 to 1.38 ] ) . The Thrombolysis In Myocardial Infa rct ion ( TIMI ) major hemorrhage rate was 1.5 % for enoxaparin versus 1.3 % for UFH ( odds ratio 1.16 [ 95 % CI 0.44 to 3.02 ] ) and 1.8 % versus 1 % for tirofiban versus placebo ( odds ratio 1.82 [ 95 % CI 0.6
Output:
| Compared with placebo , patients treated with heparins had a similar risk of mortality , revascularization , recurrent angina , and thrombocytopenia .
However , those treated with heparins had a decreased risk of myocardial infa rct ion and a higher incidence of minor bleeding . |
MS210523 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Trimodality therapy seems to be the best treatment for malignant pleural mesothelioma ( MPM ) . A large experience served to evaluate the efficacy of surgery followed by adjuvant chemo-radiotherapy . Trimodality therapy results have led us to test induction chemotherapy followed by EPP and adjuvant radiotherapy in stages I-III of MPM . The aim of our study was to evaluate the feasibility of this protocol and to estimate survival . METHODS From 2000 to 2003 , 21 patients with MPM ( 14 males and 7 females , median age 59 years ) were enrolled in the prospect i ve study . Induction chemotherapy consisted of Carboplatin ( AUC 5mg/mL/min on Day 1 ) and Gemcitabine ( 1000mg/m(2 ) on Days 1 , 8 , 15 ) for three to four cycles . EPP was performed 3 - 5 weeks after induction therapy , while post-operative RT was given 4 - 6 weeks after operation . RESULTS Ten patients received three cycles of chemotherapy , 10 patients received four cycles and 1 patient had two cycles . Grade s 3 - 4 haematological toxicity occurred in eight ( 38.1 % ) patients . Chemotherapy response rate was : complete 0 % , partial 33.3 % and stable disease 66.7 % . Seventeen ( 80.9 % ) out of 21 patients underwent EPP with no intra or post-operative mortality with an overall major and minor morbidity rate at 52.4 % . Median survival was 25.5 months , with an overall 1 , 3 and 5-year survival rate of 71 , 33 and 19 % , respectively . CONCLUSIONS In MPM , the combined modality approach using the Carboplatin/Gemcitabine combination as induction chemotherapy is feasible , with good results in terms of survival and morbidity . Our results are similar to those of other studies using a heavier modality treatment The first report of the Mesothelioma and Radical Surgery ( MARS ) trial appeared in the Journal of Thoracic Oncology [ 1 ] . The objective of MARS was to establish the possibility of allocating patients , at r and om , to have either extrapleural pneumonectomy ( EPP ) or no surgical resection . The target — 50 r and omised patients — was reached in late 2008 . Outcomes are not yet available ; however , the trial was not powered to prove effectiveness but to address the question of feasibility . In the MARS trial protocol ( Fig. 1 ) , patients were allocated to either trimodality therapy ( chemotherapy , EPP and radical hemithoracic radiotherapy ) or identical chemotherapy followed by any non-surgical treatment thought appropriate . The trial employed a two-stage consent process . Patients consented to participate in the study for completion of staging , chemotherapy and other work-up ( N = 112 ) . The 2—3 months required for chemotherapy between the first and second consent allowed patients and teams to come to terms with r and omisation as a means of unbiased allocation . Of the 112 patients , 50 ( 45 % ) were eventually r and omised . MARS has shown that unbiased allocation to surgery versus no surgery is not impossible — but it is far from easy . The story of MARS goes back 5 years . Cl aims were being made that EPP had the potential to prolong life [ 2 ] . The data were derived from follow-up studies of multimodality therapy ; one could not discern the effect attributable to surgery . There were no data concerning the denominator from which the cases were drawn , and it is likely that the EPP series include fitter patients with slower progressing cancer . Then , if only patients completing treatment are reported , it follows that these patients must be sufficiently well to receive the second and thirdmodalities of treatment , further biasing the interpretation of outcome . These are some of the pitfalls in the reporting of follow-up studies [ 3 ] . It was against that background that the cancer epidemiologist Julian Peto urged European surgeons to put the question of radical surgery for mesothelioma to the test in the form of a r and omised trial [ 4 ] . While MARS has been recruiting , cl aims for the benefit of EPP have moderated . The Boston group have raised a caution ary note in reporting the high burden of complications occurring in over 60 % of patients [ 5 ] . This was echoed in the Mayo clinic follow-up study in which the authors report The European Organisation for Research and Treatment of Cancer ( EORTC ; protocol 08031 ) phase II trial investigated the feasibility of trimodality therapy consisting of induction chemotherapy followed by extrapleural pneumonectomy and post-operative radiotherapy in patients with malignant pleural mesothelioma ( with a severity of cT3N1M0 or less ) . Induction chemotherapy consisted of three courses of cisplatin 75 mg·m−2 and pemetrexed 500 mg·m−2 . Nonprogressing patients underwent extrapleural pneumonectomy followed by post-operative radiotherapy ( 54 Gy , 30 fractions ) . Our primary end-point was “ success of treatment ” and our secondary end-points were toxicity , and overall and progression-free survival . 59 patients were registered , one of whom was ineligible . Subjects ’ median age was 57 yrs . The subjects ’ TNM scores were as follows : cT1 , T2 and T3 , 36 , 16 and six patients , respectively ; cN0 and N1 , 57 and one patient , respectively . 55 ( 93 % ) patients received three cycles of chemotherapy with only mild toxicity . 46 ( 79 % ) patients received surgery and 42 ( 74 % ) had extrapleural pneumonectomy with a 90-day mortality of 6.5 % . Post-operative radiotherapy was completed in 37 ( 65 % ) patients . Grade 3–4 toxicity persisted after 90 days in three ( 5.3 % ) patients . Median overall survival time was 18.4 months ( 95 % CI 15.6–32.9 ) and median progression-free survival was 13.9 months ( 95 % CI 10.9–17.2 ) . Only 24 ( 42 % ) patients met the definition of success ( one-sided 90 % CI 0.36–1.00 ) . Although feasible , trimodality therapy in patients with mesothelioma was not completed within the strictly defined timelines of this protocol and adjustments are necessary BACKGROUND The aim of this multicenter trial was to prospect ively evaluate neo-adjuvant chemotherapy followed by extrapleural pneumonectomy ( EPP ) and radiotherapy , including quality of life as outcome . PATIENTS AND METHODS Eligible patients had malignant pleural mesothelioma of all histological types , World Health Organization performance status of zero to two and clinical stage T1-T3 , N0 - 2 , M0 disease considered completely resectable . Neo-adjuvant chemotherapy consisted of three cycles of cisplatin and gemcitabine followed by EPP . Postoperative radiotherapy was considered for all patients . RESULTS In all , 58 of 61 patients completed three cycles of neo-adjuvant chemotherapy . Forty-five patients ( 74 % ) underwent EPP and in 37 patients ( 61 % ) the resection was complete . Postoperative radiotherapy was initiated in 36 patients . The median survival of all patients was 19.8 months [ 95 % confidence interval ( CI ) 14.6 - 24.5 ] . For the 45 patients undergoing EPP , the median survival was 23 months ( 95 % CI 16.6 - 32.9 ) . Psychological distress showed minor variations over time with distress above the cut-off score indicating no morbidity with 82 % ( N = 36 ) at baseline and 76 % ( N = 26 ) at 3 months after surgery ( P = 0.5 ) . CONCLUSIONS The observed rate of operability is promising . A median survival of 23 months for patients undergoing EPP compares favourably with the survival reported from single center studies of upfront surgery . This approach was not associated with an increase in psychological distress BACKGROUND Malignant pleural mesothelioma ( MPM ) is an aggressive form of cancer arising from the pleural mesothelium . Trimodality therapy ( TMT ) involving extrapleural pneumonectomy with neoadjuvant or adjuvant chemotherapy and adjuvant radiotherapy is a recognized treatment option with a curative intent . Despite encouraging results from institutional studies , TMT in the treatment of MPM remains controversial . The present systematic review aims to assess the safety and efficacy of TMT in the current literature . METHODS A systematic review was performed using five electronic data bases from 1 January 1985 to 1 October 2012 . Studies were selected independently by two review ers according to predefined selection criteria . The primary endpoint was overall survival . Secondary endpoints included disease-free survival , disease recurrence , perioperative morbidity and length of stay . RESULTS Sixteen studies were included for quantitative assessment , including one r and omized controlled trial and five prospect i ve series . Median overall survival ranged from 12.8 - 46.9 months . Disease-free survival ranged from 10 - 16.3 months . Perioperative mortality ranged from 0 - 12.5 % . Overall perioperative morbidity ranged from 50 - 82.6 % and the average length of stay was 9 - 14 days . CONCLUSIONS Outcomes of patients who underwent TMT in the current literature appeared to be inconsistent . Four prospect i ve series involving a st and ardised treatment regimen with neoadjuvant chemotherapy indicated encouraging results based on intention-to-treat analysis . However , a small study assessing the feasibility of conducting a r and omized controlled trial for TMT versus conservative treatment reported poor short- and long-term outcomes for patients who underwent pneumonectomy . Overall , results of the present systematic review suggest TMT may offer acceptable perioperative outcomes and long-term survival in selected patients treated in specialized centers Hypothesis : The effectiveness of extrapleural pneumonectomy ( EPP ) to extend quality -adjusted survival in malignant pleural mesothelioma within multimodality treatment should be proven in a r and omized controlled trial if this radical surgery is to be regarded as the st and ard of care . The question was whether r and omization to surgery versus no surgery would be possible . Methods : The Mesothelioma and Radical Surgery trial was planned to r and omize 50 patients to test feasibility . There was a two-stage consent process . At first consent , the patients who were possible c and i date s for radical surgery were registered into the trial for completion of assessment and staging . All received platinum-based chemotherapy . If still eligible , they completed a second consent to be r and omized to have either EPP followed by radical hemithorax radiotherapy or to have continued best care . Results : Patients were recruited through 11 collaborating centers in the United Kingdom . One hundred twelve potentially eligible patients gave informed consent to enter the registration phase and undergo chemotherapy . One died , 27 progressed , five were inoperable , four were treated off trial , and 18 withdrew either during or after chemotherapy but before final review . Additionally six were deemed inoperable at review after completing chemotherapy and one more patient withdrew . The remaining 50 were r and omized ; 24 to EPP and 26 to continued best care . Conclusions : In this study , 50/112 ( 45 % ) of patients entering the evaluation and induction phase of the trial went on to be r and omized . We have shown that this r and omization between surgery and no surgery is feasible . This was the primary aim of the Mesothelioma and Radical Surgery trial Introduction : To compare the outcomes of two different multimodality regimens involving neoadjuvant chemotherapy , extrapleural pneumonectomy ( EPP ) and adjuvant radiotherapy versus pleurectomy/decortication ( P/D ) , hyperthermic pleural lavage with povidone-iodine , and adjuvant chemotherapy in patients with malignant pleural mesothelioma . Methods : Nonr and omized prospect i ve study of patients treated by multimodality therapy and operated on between January 2004 and June 2011 . Second-line treatments were administered when appropriate . Survival and prognostic factors were analyzed by the Kaplan Meier method , log rank test , and Cox regression analysis . Results : Twenty-five consecutive patients received neoadjuvant chemotherapy , 22 underwent EPP , and 17 received adjuvant radiotherapy . Over the same period , 54 consecutive patients underwent P/D and hyperthermic pleural lavage and received prophylactic radiotherapy and adjuvant chemotherapy . The 30-day mortality rate was 4.5%in the EPP group and nil in the P/D group . Fifteen patients ( 68 % ) in the EPP group and 15 ( 27.7 % ) in the P/D group experienced complications . There were no differences between the EPP and P/D groups for age , sex , histology , pathologic stage , and nodal status . Trimodality therapy was completed by 68%of the patients in the EPP group and 100%in the P/D group . Survival was significantly better in the P/D group : median survival was 23 months versus 12.8 months , 2-year survival was 49%versus 18.2 % , and 5-year survival was 30.1%versus 9 % , respectively ( p = 0.004 ) . At multivariate analysis , epithelioid histology , P/D ,
Output:
| The present study indicated that selected patients who underwent extended P/D had lower perioperative morbidity and mortality with similar , if not superior , long-term survival compared to EPP , in the context of multi-modality therapy .
This may represent an important paradigm shift in the surgical management of MPM |
MS210524 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Impulsivity has been repeatedly identified as a key construct in BPD ; however , its precise definition seems to vary especially regarding the overlap with aggression . The term impulsive-aggression , also generally seen as central to an underst and ing of BPD , seems to address itself to the interface between the two , but has itself been used inconsistently in the literature , sometimes having reference to a unitary phenotypic dimension , and at other times suggesting some combination of distinct traits . This study examined the relationship between multiple measures of impulsivity , aggression , and impulsive-aggression in a BPD sample ( N = 92 ) in order to clarify the relationship between these measured constructs in this clinical population . Results show little relationship between measures of aggression and impulsivity in BPD , with measures of impulsive-aggression correlating strongly with measures of aggression only . Implication s of the present results for future research and clinical work with BPD are discussed OBJECTIVE A community-based , longitudinal prospect i ve study was conducted to investigate whether personality disorders during adolescence are associated with elevated risk for violent behavior during adolescence and early adulthood . METHOD A community-based sample of 717 youths from upstate New York and their mothers were interviewed in 1983 , 1985 - 1986 , and 1991 - 1993 . Axis I and II disorders were assessed in 1983 and 1985 - 1986 . Antisocial personality disorder was not assessed because most participants were less than 18 years of age in 1983 and 1985 - 1986 . Violent behavior was assessed in 1985 - 1986 and 1991 - 1993 . RESULTS Adolescents with a greater number of DSM-IV cluster A or cluster B personality disorder symptoms were more likely than other adolescents in the community to commit violent acts during adolescence and early adulthood , including arson , assault , breaking and entering , initiating physical fights , robbery , and threats to injure others . These associations remained significant after controlling for the youths ' age and sex , for parental psychopathology and socioeconomic status , and for co-occurring psychiatric disorders during adolescence . Paranoid , narcissistic , and passive-aggressive personality disorder symptoms during adolescence were independently associated with risk for violent acts and criminal behavior during adolescence and early adulthood after the covariates were controlled . CONCLUSIONS Cluster A and cluster B personality disorders and paranoid , narcissistic , and passive-aggressive personality disorder symptoms during adolescence may increase risk for violent behavior that persists into early adulthood OBJECTIVE The purpose of the study was to identify risk factors and correlates of violence committed by patients in an acute adult psychiatric inpatient unit in a district general hospital of the United Kingdom 's National Health Service . METHODS Incidents of violence committed by in patients over a one-year period in 1997 - 1998 were retrospectively analyzed . The clinical characteristics of 49 violent patients were compared with those of all patients admitted to the unit during the study period ( N=474 ) and with a r and om sample of nonviolent patients ( N=140 ) . Logistic regression analysis was used to identify clinical variables that predicted violent behavior . RESULTS Violence was not positively associated with schizophrenia or negatively associated with depression . Frequent medication change , high use of sedative drugs , past violent behavior , an ICD-10 diagnosis of dissocial personality disorder or emotionally unstable personality disorder ( DSM-IV antisocial personality disorder or borderline personality disorder ) , and long hospitalization were the most powerful predictors of violence . Together these variables had a sensitivity of 76 percent , a specificity of 97 percent , and a positive predictive value of 90 percent in predicting which patients became violent . Compulsory ( involuntary ) admission , comorbid diagnoses , past self-harm , and nonalcohol drug abuse were also associated with violent behavior . CONCLUSIONS Clinicians ' judgment about an inpatient 's potential for violence may be augmented by knowledge of the risk factors identified in this study . Medication variables could be especially useful predictors , particularly when information about other risk factors is not available . Factors other than mental illness per se may be crucial determinants of violence in acute inpatient setting OBJECTIVE The study of personality pathology in adolescence is in its infancy . This article examined the applicability and limits of DSM-IV axis II personality disorder diagnoses in adolescents , assessed the validity of a method for assessing adolescent personality pathology , and began to develop an empirically grounded classification . METHOD A total of 296 r and omly selected clinicians described a patient age 14 - 18 in treatment for maladaptive personality patterns using axis II ratings scales and the Shedler-Westen Assessment Procedure-200 for Adolescents ( SWAP-200-A ) , a Q-sort instrument for assessing adolescent personality pathology . After examining the nature and frequency of axis II disorders in the sample , the authors used Q-factor analysis to identify naturally occurring groupings of patients on the basis of shared personality features . RESULTS Axis II diagnoses in adolescents resembled those in adults , although application of DSM-IV criteria appeared to overdiagnose antisocial and avoidant personality disorder in adolescents . Q analysis with the SWAP-200-A isolated five personality disorders ( antisocial-psychopathic , emotionally dysregulated , avoidant-constricted , narcissistic , and histrionic ) and one personality style . Patients ' dimensional scores on each diagnostic prototype showed predictable associations with ratings of current axis II disorders , measures of adaptive functioning , and symptoms assessed with the Child Behavior Checklist . CONCLUSIONS With some exceptions , personality pathology in adolescence resembles that in adults and is diagnosable in adolescents ages 14 - 18 . Categories and criteria developed for adults may not be the optimal way of diagnosing adolescents . Data from sample s of adolescents may prove useful in developing an empirically and clinical ly grounded classification of personality pathology in adolescents Violence associated with personality disorders is usually best viewed separately from psychiatric diagnosis , as a syndrome of violence rather than a syndrome of diagnosis . The authors describe eight categories of violence associated with personality disorders that may help clinicians choose treatment or management techniques : purpose ful , instrumental violence ; purpose ful , non-instrumental violence ; purpose ful , targeted , defensive violence ; targeted , impulsive violence ; nontargeted , impulsive violence incidental to emotional escape ; r and om but purpose ful violence ; violence related to perceived or feared loss or ab and onment ; and violence related to chronic paranoia or related misconceptions . The categories are not completely mutually exclusive , nor do they represent a " decision tree . " We also point out three important principles about the relationship between personality disorders and violence : 1 ) Personality disorders are rarely ego dystonic ; 2 ) Most patients and violent situations that come to clinical attention involve comorbid conditions . 3 ) Violence and violence risk are often associated with intoxication The Life History of Aggression ( LHA ) assessment was administered to up to 252 subjects . In addition to a total LHA score , subscale scores for Aggression , Social Consequences and Antisocial Behavior , and Self-directed Aggression were calculated . Test-retest stability , interrater agreement , and internal consistency reliability were excellent both for the LHA Total score and the LHA Aggression subscore . There were moderately strong correlations between these scores and both self-reports of aggressive tendency ( Buss-Durkee Hostility Inventory : n = 214 ) and recent overt aggression ( Overt Aggression Scale-Modified for Out- patients : n = 61 ) . LHA Total scores were highest among subjects with Antisocial or Borderline Personality Disorder . These results support the use of the LHA assessment , and especially the LHA Aggression subscore , as a measure of life history of aggressive behavior Theorists and clinicians have long believed that personality psychopathology is a risk factor for aggressive behavior . Previous investigations in this area , however , have provided mixed results . In this study , the relationship between personality psychopathology and aggressive behavior was examined in 137 research volunteers . The influences of gender and coexisting major mental disorders were statistically controlled . Aggressive behavior was associated with criteria for 7 of the 11 personality disorders listed in the Diagnostic and Statistical Manual of Mental Disorders ( 3rd ed . , rev . ) . Except for schizoid criteria , all relationships with aggressive behavior were in the positive direction . When all personality disorders were considered simultaneously , paranoid and passive-aggressive criteria were significant predictors of aggressive behavior
Output:
| Results indicate that BPD does not appear to be independently associated with increased risk of violence in the general population .
History of childhood maltreatment , history of violence or criminality , and comorbid psychopathy or antisocial personality disorder appear to be predictors of violence in patients with BPD .
This review concludes that the current evidence suggests that patients with BPD are not more violent than individuals in the general population . |
MS210525 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Non-steroid anti-inflammatory drugs ( NSAIDs ) have been proposed as part of a multimodal postoperative analgesia in patients operated for colorectal cancer . However , whether these drugs are prescribed and taken by the patients have not been evaluated . The aim of this study was to quantify the postoperative use of NSAIDs in these patients . Methods Data from patients operated for colorectal cancer between January 1 , 2006 and December 31 , 2009 were collected from the Danish Colorectal Cancer Group ’s ( DCCG ) prospect i ve data base . From the electronically registered medical records , data for the use of the two NSAIDs diclofenac and ibuprofen were recorded . The data from six colorectal departments in eastern Denmark were compared . Results Of the 2,754 patients analyzed overall , 40.6 % received NSAIDs as part of their analgesic treatment . The percentage of the patients receiving NSAIDs , receiving a pre-defined dosage as a minimum and receiving NSAIDs as p.r.n . medication , and the type of NSAID were significantly different both between department and within departments . The median dose of ibuprofen and diclofenac were 1200 mg ( 400–2,400 mg ) and 100 mg ( 50–200 mg ) , respectively . Conclusions The large variation between and within the departments points to an inconsistency in the use of multimodal post-operative pain treatments . This may be a result of insufficient evidence on procedure specific pain treatments and possibly a lack of compliance to existing guidelines . High- quality large-scale studies are warranted to form the basis for guidelines for postoperative analgesic treatment Cancer cells treated with the cyclooxygenase-2 inhibitor celecoxib show growth inhibition and induced apoptosis . This study was conducted to determine if the same processes are relevant to celecoxib 's effects on human colorectal adenocarcinomas treated in vivo . A cohort of 23 patients with primary colorectal adenocarcinomas was r and omised to receive a 7-d course of celecoxib ( 400 mg b.i.d . ) or no drug prior to surgical resection . Gene expression profiling was performed on resected adenocarcinomas from the cohort of patients . Using fold change ( > 1.5 ) and p-value ( < 0.05 ) cut-offs , 190 genes were differentially expressed between adenocarcinomas from patients receiving celecoxib and those that did not . The celecoxib pre-treated sample s showed decreased expression levels in multiple genes involved in cellular lipid and glutathione metabolism ; changes associated with diminished cellular proliferation . Celecoxib pre-treatment for 7 d in vivo is associated with alterations in colorectal adenocarcinoma gene expression which are suggestive of diminished cellular proliferation OBJECTIVE To evaluate the impact of preemptive local analgesia at the incision site in reducing pain in women undergoing abdominal hysterectomy for a benign myomatous uterus . STUDY DESIGN In this prospect i ve , r and omized , double-blinded , placebo-controlled study , 20 mL of 1 % lidocaine or 0.9 % saline was injected at the abdominal incision site prior to the performance of the hysterectomy . Thirty-two women were enrolled in the study , 16 received preemptive analgesia while 14 were treated by placebo ; 2 were excluded . All operations were performed under general anesthesia . The st and ard postoperative pain treatment consisted of oral analgesia with ibuprofen ( 400 mg ) in liquid-filled capsules . Morphine ( 10 mg ) was used for rescue analgesia . Pain intensity was self-evaluated with the use of a 100 mm visual analog scale . RESULTS Compared to the placebo group , women who received preemptive analgesia with lidocaine 1 % perceived a significant reduction in postoperative pain in the first hours after surgery ( 2 h : 50.1+/-27.9 versus 70.6+/-22.6 , p=0.043 ; 5 h : 42.5+/-25.2 versus 64.6+/-28.3 , p=0.043 ; 8 h : 31.2+/-22.4 versus 53.3+/-30.3 , p=0.031 ) . CONCLUSION Preemptive analgesia with lidocaine 1 % is a simple , cheap and efficient mode to reduce pain in the first hours after hysterectomy Purpose During cancer surgery , prostagl and in-mediated inflammation may promote and activate micrometastatic disease with a consequent increase in long-term cancer recurrence . Cyclooxygenase-2 inhibitors , known to have anti-proliferative properties , may offset such perioperative perturbation . We investigated the effectiveness of these agents to minimize inflammatory changes during cancer surgery . Methods Following ethics approval , 32 patients who were to undergo major intracavity cancer surgery were enrolled in this prospect i ve , r and omized , clinical trial . The treatment group received 400 mg celecoxib preoperatively followed by five 200 mg 12-hourly doses . The control group received no anti-inflammatory agents . Inflammatory and immunomodulatory end points were measured serially . The primary end points were the measured plasma and urinary prostagl and in E metabolite ( PGEM ) levels 48 hours following surgery . Secondary endpoints included interleukin levels , leucocyte profile , and clinical end points . Results No differences in the 48-hr plasma or urinary PGEM levels were observed between the celecoxib and control groups . Linear mixed modeling , used to accommo date differences in baseline PGEM levels , showed that celecoxib ( cf . control ) administration lowered plasma PGEM over the entire 48-hr period following surgery ( β-coefficient = −0.38 pg.ml−1 ; 95 % confidence interval : −0.69 to −0.06 ; P = 0.021 ) . Celecoxib administration also lowered postoperative pain scores . Discussion St and ard dosing of the cyclooxygenase-2 inhibitor celecoxib slightly reduced perioperative cyclooxygenase activity during cancer surgery . Given cyclooxygenase ’s role in cancer pathways , we recommend dose-finding studies be undertaken before prospect i ve clinical trials are conducted testing the currently unsubstantiated hypothesis that perioperative anti-inflammatory administration improves long-term cancer outcomes . This trial was registered at : Australian New Zeal and Clinical Trial Registry : ACTRN12615000041550 ; www.anzctr.org.auRésuméObjectifPendant les chirurgies du cancer , l’inflammation médiée par les prostagl and ines pourrait favoriser et activer une maladie micrométastatique avec une augmentation conséquente de la récurrence du cancer à long terme . Les inhibiteurs de la cyclo-oxygénase-2 , do nt on connaît les propriétés antiprolifératives , pourraient compenser une telle perturbation périopératoire . Nous avons étudié l’efficacité de ces agents pour minimiser les changements inflammatoires pendant les chirurgies du cancer . MéthodeAprès avoir obtenu le consentement du Comité d’éthique , 32 patients devant subir une chirurgie ouverte majeure pour un cancer ont été enrôlés dans cette étude clinique prospect i ve et r and omisée . Le groupe traitement a reçu 400 mg de célécoxib avant l’opération , puis cinq doses de 200 mg aux 12 heures . Le groupe témoin n’a reçu aucun agent anti-inflammatoire . Les critères d’évaluation d’inflammation et d’immunomodulation ont été mesurés en série . Les critères d’évaluation principaux étaient les taux de métabolites des prostagl and ines E ( PGEM ) mesurés dans le plasma et dans l’urine 48 h après la chirurgie . Les critères d’évaluation secondaires comprenaient les taux d’interleukine , le profil leucocytaire ainsi que des critères d’évaluation cliniques . RésultatsAucune différence n’a été observée dans les taux de PGEM dans le plasma ou l’urine à 48 h entre le groupe célécoxib et le groupe témoin . Un modèle linéaire mixte , utilisé pour tenir compte des différences dans les taux de base de PGEM , a démontré que l’administration de célécoxib réduisait les PGEM dans le plasma tout au long de la période de 48 h suivant la chirurgie ( coefficient β = −0,38 ; intervalle de confiance 95 % : −0,69 à −0,06 ; P = 0,021 ) . L’administration de célécoxib a également réduit les scores de douleur postopératoires . Discussion Une posologie st and ard de l’inhibiteur de cyclo-oxygénase 2 qu’est le célécoxib a légèrement réduit l’activité périopératoire de la cyclo-oxygénase pendant une chirurgie du cancer . Étant donné le rôle de la cyclo-oxygénase dans les voies de développement du cancer , nous recomm and ons de tester l’hypothèse , actuellement non vérifiée , selon laquelle l’administration périopératoire d’anti-inflammatoires améliorerait les pronostics oncologiques à long terme , avant de réaliser des études cliniques prospect ives . Cette étude est enregistrée au : Registre australien et néozél and ais des études cliniques : ACTRN12615000041550 ; OBJECTIVE To determine pre-/intraoperative risk factors for anastomotic leak after colon resection for cancer and to create a practical instrument for predicting anastomotic leak risk . BACKGROUND Anastomotic leak is still the most dreaded complication in colorectal surgery . Many risk factors have been identified to date , but multicentric prospect i ve studies on anastomotic leak after colon resection are lacking . METHODS Fifty-two hospitals participated in this prospect i ve , observational study . Data of 3193 patients , operated for colon cancer with primary anastomosis without stoma , were included in a prospect i ve online data base ( September 2011-September 2012 ) . Forty-two pre-/intraoperative variables , related to patient , tumor , surgical procedure , and hospital , were analyzed as potential independent risk factors for anastomotic leak ( 60-day follow-up ) . A nomogram was created to easily predict the risk of anastomotic leak for a given patient . RESULTS The anastomotic leak rate was 8.7 % , and widely varied between hospitals ( variance of 0.24 on the logit scale ) . Anastomotic leak significantly increased mortality ( 15.2 % vs 1.9 % in patients without anastomotic leak , P < 0.0001 ) and length of hospitalization ( median 23 vs 7 days in uncomplicated patients , P < 0.0001 ) . In the multivariate analysis , the following variables were independent risk factors for anastomotic leak : obesity [ P = 0.003 , odds ratio ( OR ) = 2.7 ] , preoperative serum total proteins ( P = 0.03 , OR = 0.7 per g/dL ) , male sex ( P = 0.03 , OR = 1.6 ) , ongoing anticoagulant treatment ( P = 0.05 , OR = 1.8 ) , intraoperative complication ( P = 0.03 , OR = 2.2 ) , and number of hospital beds ( P = 0.04 , OR = 0.95 per 100 beds ) . CONCLUSIONS Anastomotic leak after colon resection for cancer is a frequent , relevant complication . Patients , surgical technique , and hospital are all important determining factors of anastomotic leak risk BACKGROUND : Nonsteroidal anti-inflammatory drugs have become an important component of narcotic-sparing postoperative pain management protocol s. However , conflicting evidence exists regarding the adverse association of nonsteroidal anti-inflammatory drug use with intestinal anastomotic healing in colorectal surgery . OBJECTIVE : This study compares patients receiving nonsteroidal anti-inflammatory drugs on postoperative day 1 with patients who did not receive nonsteroidal anti-inflammatory drugs with regard to the occurrence of anastomotic leaks . DESIGN : This is a retrospective study from a protocol -driven prospect ively collected statewide data base . A propensity score model was used to adjust for differences between the groups in patient demographics , characteristics , comorbidities , and laboratory values . SETTING S : The multicenter data set used in this analysis represents a variety of academic and community hospitals within the state of Michigan from July 2012 through February 2014 . PATIENTS : Nonpregnant patients over the age of 18 who underwent colon and rectal surgery with bowel anastomosis were selected . MAIN OUTCOME MEASURES : Occurrence of anastomotic leak , composite surgical site infection , sepsis , and death within 30 days of surgery were the primary outcomes measured . RESULTS : A total of 4360 patients met inclusion criteria , of which 1297 ( 29.7 % ) received nonsteroidal anti-inflammatory drugs and 3063 ( 7
Output:
| Conclusions The literature is not conclusive on whether the use of NSAIDs is associated with anastomotic leaks after gastrointestinal cancer surgery .
Also , the current evidence is equivocal regarding the effects of short-term NSAIDs on cancer recurrence after major cancer surgery .
There are no registered RCTs that are testing the hypothesis of whether the perioperative use of NSAIDs increases the rate of anastomotic leaks |
MS210526 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: GLP-1 stimulates insulin secretion , suppresses glucagon secretion , delays gastric emptying , and inhibits small bowel motility , all actions contributing to the anti-diabetogenic peptide effect . Endothelial dysfunction is strongly associated with insulin resistance and type 2 diabetes mellitus and may cause the angiopathy typifying this debilitating disease . Therefore , interventions affecting both endothelial dysfunction and insulin resistance may prove useful in improving survival in type 2 diabetes patients . We investigated GLP-1 's effect on endothelial function and insulin sensitivity ( S(I ) ) in two groups : 1 ) 12 type 2 diabetes patients with stable coronary artery disease and 2 ) 10 healthy subjects with normal endothelial function and S(I ) . Subjects underwent infusion of recombinant GLP-1 or saline in a r and om crossover study . Endothelial function was measured by postischemic FMD of brachial artery , using ultrasonography . S(I ) [ in ( 10(-4 ) dl.kg(-1).min(-1))/(muU/ml ) ] was measured by hyperinsulinemic isoglycemic clamp technique . In type 2 diabetic subjects , GLP-1 infusion significantly increased relative changes in brachial artery diameter from baseline FMD(% ) ( 3.1 + /- 0.6 vs. 6.6 + /- 1.0 % , P < 0.05 ) , with no significant effects on S(I ) ( 4.5 + /- 0.8 vs. 5.2 + /- 0.9 , P = NS ) . In healthy subjects , GLP-1 infusion affected neither FMD(% ) ( 11.9 + /- 0.9 vs. 10.3 + /- 1.0 % , P = NS ) nor S(I ) ( 14.8 + /- 1.8 vs. 11.6 + /- 2.0 , P = NS ) . We conclude that GLP-1 improves endothelial dysfunction but not insulin resistance in type 2 diabetic patients with coronary heart disease . This beneficial vascular effect of GLP-1 adds yet another salutary property of the peptide useful in diabetes treatment BACKGROUND Exenatide , an incretin mimetic for adjunctive treatment of type 2 diabetes ( T2DM ) , reduced hemoglobin A(1c ) ( A1C ) and weight in clinical trials . The objective of this study was to evaluate the effects of > or = 3 years exenatide therapy on glycemic control , body weight , cardiometabolic markers , and safety . METHODS Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended , open-label clinical trial . Patients were r and omized to twice daily ( BID ) placebo , 5 mug exenatide , or 10 mug exenatide for 30 weeks , followed by 5 mug exenatide BID for 4 weeks , then 10 mug exenatide BID for > or = 3 years of exenatide exposure . Patients continued metformin and /or sulfonylureas . RESULTS 217 patients ( 64 % male , age 58 + /- 10 years , weight 99 + /- 18 kg , BMI 34 + /- 5 kg/m(2 ) , A1C 8.2 + /- 1.0 % [ mean + /- SD ] ) completed 3 years of exenatide exposure . Reductions in A1C from baseline to week 12 ( -1.1 + /- 0.1 % [ mean + /- SEM ] ) were sustained to 3 years ( -1.0 + /- 0.1 % ; p < 0.0001 ) , with 46 % achieving A1C < or = 7 % . Exenatide progressively reduced body weight from baseline ( -5.3 + /- 0.4 kg at 3 years ; p < 0.0001 ) . Patients with elevated serum alanine aminotransferase ( ALT ) at baseline ( n = 116 ) had reduced ALT ( -10.4 + /- 1.5 IU/L ; p < 0.0001 ) and 41 % achieved normal ALT . Patients with elevated ALT at baseline tended to lose more weight than patients with normal ALT at baseline ( -6.1 + /- 0.6 kg vs. -4.4 + /- 0.5 kg ; p = 0.03 ) , however weight change was minimally correlated with baseline ALT ( r = -0.01 ) or ALT change ( r = 0.31 ) . Homeostasis Model Assessment B ( HOMA-B ) , blood pressure , and aspartate aminotransferase ( AST ) all improved . A subset achieved 3.5 years of exenatide exposure and had serum lipids available for analysis ( n = 151 ) . Triglycerides decreased 12 % ( p = 0.0003 ) , total cholesterol decreased 5 % ( p = 0.0007 ) , LDL-C decreased 6 % ( p < 0.0001 ) , and HDL-C increased 24 % ( p < 0.0001 ) . Exenatide was generally well tolerated . The most frequent adverse event was mild-to-moderate nausea . The main limitation of this study is the open-label , uncontrolled nature of the study design which does not provide a placebo group for comparison . CONCLUSION Adjunctive exenatide treatment for > or = 3 years in T2DM patients result ed in sustained improvements in glycemic control , cardiovascular risk factors , and hepatic biomarkers , coupled with progressive weight reduction Background — The incretin hormone glucagon-like peptide-1 ( GLP-1 ) has been shown to have cardioprotective properties in animal models of ischemia and infa rct ion due to promotion of myocardial glucose uptake and suppression of apoptosis . We investigated whether GLP-1 protected the heart from dysfunction caused by supply ischemia during percutaneous coronary intervention ( PCI ) . Methods and Results — Twenty patients with normal left ventricular ( LV ) function and single-vessel coronary disease within the left anterior descending artery undergoing elective PCI were studied . A conductance catheter was placed into the LV through the femoral artery , and pressure-volume loops were recorded at baseline and during a 1-minute low-pressure balloon occlusion at the site of the stenosis . The patients were r and omized to receive an infusion of either GLP-1(7–36 ) amide at 1.2 pmol/kg per minute or saline immediately after the first balloon occlusion . Coronary balloon occlusion caused LV stunning in the control group with cumulative LV dysfunction on subsequent occlusion that was not seen in the GLP-1 group . GLP-1 improved recovery of LV systolic and diastolic function at 30 minutes after balloon occlusion compared with control ( delta dP/dtmax from baseline , −1.6 % versus −12.2 % ; P=0.02 ) and reduced the LV dysfunction after the second balloon occlusion ( delta dP/dtmax , −13.1 % versus −25.3 % ; P=0.01 ) . Conclusions — In this pilot study , infusion of GLP-1 has been demonstrated to reduce ischemic LV dysfunction after supply ischemia during coronary balloon occlusion in humans and mitigates stunning . The findings require confirmation in a larger scale clinical trial . Clinical Trial Registration — URL : http://www.is rct n.org . Unique identifier : IS RCT N 77442023 BACKGROUND The cardiovascular safety and efficacy of many current antihyperglycemic agents , including saxagliptin , a dipeptidyl peptidase 4 ( DPP-4 ) inhibitor , are unclear . METHODS We r and omly assigned 16,492 patients with type 2 diabetes who had a history of , or were at risk for , cardiovascular events to receive saxagliptin or placebo and followed them for a median of 2.1 years . Physicians were permitted to adjust other medications , including antihyperglycemic agents . The primary end point was a composite of cardiovascular death , myocardial infa rct ion , or ischemic stroke . RESULTS A primary end-point event occurred in 613 patients in the saxagliptin group and in 609 patients in the placebo group ( 7.3 % and 7.2 % , respectively , according to 2-year Kaplan-Meier estimates ; hazard ratio with saxagliptin , 1.00 ; 95 % confidence interval [ CI ] , 0.89 to 1.12 ; P=0.99 for superiority ; P<0.001 for noninferiority ) ; the results were similar in the " on-treatment " analysis ( hazard ratio , 1.03 ; 95 % CI , 0.91 to 1.17 ) . The major secondary end point of a composite of cardiovascular death , myocardial infa rct ion , stroke , hospitalization for unstable angina , coronary revascularization , or heart failure occurred in 1059 patients in the saxagliptin group and in 1034 patients in the placebo group ( 12.8 % and 12.4 % , respectively , according to 2-year Kaplan-Meier estimates ; hazard ratio , 1.02 ; 95 % CI , 0.94 to 1.11 ; P=0.66 ) . More patients in the saxagliptin group than in the placebo group were hospitalized for heart failure ( 3.5 % vs. 2.8 % ; hazard ratio , 1.27 ; 95 % CI , 1.07 to 1.51 ; P=0.007 ) . Rates of adjudicated cases of acute and chronic pancreatitis were similar in the two groups ( acute pancreatitis , 0.3 % in the saxagliptin group and 0.2 % in the placebo group ; chronic pancreatitis , < 0.1 % and 0.1 % in the two groups , respectively ) . CONCLUSIONS DPP-4 inhibition with saxagliptin did not increase or decrease the rate of ischemic events , though the rate of hospitalization for heart failure was increased . Although saxagliptin improves glycemic control , other approaches are necessary to reduce cardiovascular risk in patients with diabetes . ( Funded by AstraZeneca and Bristol-Myers Squibb ; SAVOR-TIMI 53 Clinical Trials.gov number , NCT01107886 . ) OBJECTIVE The gut hormone glucagon-like peptide 1 ( GLP-1 ) has insulinotropic and anorectic effects during intravenous infusion and has been proposed as a new treatment for type 2 diabetes and obesity . The effect of a single subcutaneous injection is brief because of rapid degradation . We therefore sought to evaluate the effect of infusion of GLP-1 for 48 h in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS We infused GLP-1 ( 2.4 pmol.kg-1.min-1 ) or saline subcutaneously for 48 h in r and omized order in six patients with type 2 diabetes to evaluate the effect on appetite during fixed energy intake and on plasma glucose , insulin , glucagon , postpr and ial lipidemia , blood pressure , heart rate , and basal metabolic rate . RESULTS The infusion result ed in elevations of the plasma concentrations of intact GLP-1 similar to those observed after intravenous infusion of 1.2 pmol.kg-1.min-1 , previously shown to lower blood glucose effectively in type 2 diabetic patients . Fasting plasma glucose ( day 2 ) decreased from 14.1 + /- 0.9 ( saline ) to 12.2 + /- 0.7 mmol/l ( GLP-1 ) , P = 0.009 , and 24-h mean plasma glucose decreased from 15.4 + /- 1.0 to 13.0 + /- 1.0 mmol/l , P = 0.0009 . Fasting and total area under the curve for insulin and C-peptide levels were significantly higher during the GLP-1 administration , whereas glucagon levels were unchanged . Neither triglycerides nor free fatty acids were affected . GLP-1 administration decreased hunger and prospect i ve food intake and increased satiety , whereas fullness was unaffected . No side effects during GLP-1 infusion were recorded except for a brief cutaneous reaction . Basal metabolic rate and heart rate did not change significantly during GLP-1 administration . Both systolic and diastolic blood pressure tended to be lower during the GLP-1 infusion . CONCLUSIONS We conclude that 48-h continuous subcutaneous infusion of GLP-1 in type 2 diabetic patients 1 ) lowers fasting as well as meal-related plasma glucose , 2 ) reduces appetite , 3 ) has no gastrointestinal side effects , and 4 ) has no negative effect on blood pressure CONTEXT Glucagon-like peptide-1 ( GLP-1 ) and GLP-1 receptor agonists provide beneficial cardiovascular effects by protecting against ischemia and reperfusion injury . Type 2 diabetes mellitus patients have reduced glycolysis in the heart . OBJECTIVE We hypothesized
Output:
| RESULTS The results showed that GLP-1 agent treatment in patients with T2DM and /or CVD led to significantly improved regional left ventricular contractile parameters ( including peak left systolic tissue velocity and strain ) and global left ventricular performance ( including stroke volume , ejection fraction , and left ventricular chambers ) compared with patients receiving placebo .
GLP-1 agent treatment in T2DM and /or CVD patients is associated with a modest but significant increase in the odds of left ventricular contractile parameters and left ventricular performance compared with patients having received placebo , which may be indicative of additional cardiovascular benefits for these patients |
MS210527 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE To identify single nucleotide polymorphisms ( SNPs ) associated with development of erectile dysfunction ( ED ) among prostate cancer patients treated with radiation therapy . METHODS AND MATERIAL S A 2-stage genome-wide association study was performed . Patients were split r and omly into a stage I discovery cohort ( 132 cases , 103 controls ) and a stage II replication cohort ( 128 cases , 102 controls ) . The discovery cohort was genotyped using Affymetrix 6.0 genome-wide arrays . The 940 top ranking SNPs selected from the discovery cohort were genotyped in the replication cohort using Illumina iSelect custom SNP arrays . RESULTS Twelve SNPs identified in the discovery cohort and vali date d in the replication cohort were associated with development of ED following radiation therapy ( Fisher combined P values 2.1 × 10(-5 ) to 6.2 × 10(-4 ) ) . Notably , these 12 SNPs lie in or near genes involved in erectile function or other normal cellular functions ( adhesion and signaling ) rather than DNA damage repair . In a multivariable model including nongenetic risk factors , the odds ratios for these SNPs ranged from 1.6 to 5.6 in the pooled cohort . There was a striking relationship between the cumulative number of SNP risk alleles an individual possessed and ED status ( Sommers ' D P value=1.7 × 10(-29 ) ) . A 1-allele increase in cumulative SNP score increased the odds for developing ED by a factor of 2.2 ( P value=2.1 × 10(-19 ) ) . The cumulative SNP score model had a sensitivity of 84 % and specificity of 75 % for prediction of developing ED at the radiation therapy planning stage . CONCLUSIONS This genome-wide association study identified a set of SNPs that are associated with development of ED following radiation therapy . These c and i date genetic predictors warrant more definitive validation in an independent cohort There is increasing evidence supporting the role of genetic variants in the development of radiation-induced toxicity . However , previous c and i date gene association studies failed to eluci date the common genetic variation underlying this phenotype , which could emerge years after the completion of treatment . We performed a genome-wide association study on a Spanish cohort of 741 individuals with prostate cancer treated with external beam radiotherapy ( EBRT ) . The replication cohorts consisted of 633 cases from the UK and 368 cases from North America . One locus comprising TANC1 ( lowest unadjusted P value for overall late toxicity = 6.85 × 10−9 , odds ratio ( OR ) = 6.61 , 95 % confidence interval ( CI ) = 2.23–19.63 ) was replicated in the second stage ( lowest unadjusted P value for overall late toxicity = 2.08 × 10−4 , OR = 6.17 , 95 % CI = 2.25–16.95 ; Pcombined = 4.16 × 10−10 ) . The inclusion of the third cohort gave unadjusted Pcombined = 4.64 × 10−11 . These results , together with the role of TANC1 in regenerating damaged muscle , suggest that the TANC1 locus influences the development of late radiation-induced damage Purpose Germline genetic variations may partly explain the clinical observation that normal tissue tolerance to radiochemotherapy varies by individual . Our objective was to evaluate the association between single-nucleotide polymorphisms ( SNPs ) in radiation/platinum pathways and serious treatment-related toxicity in subjects with esophageal adenocarcinoma who received cisplatin-based preoperative radiochemotherapy . Methods In a multicenter clinical trial ( E1201 ) , 81 eligible treatment-naïve subjects with resectable esophageal adenocarcinoma received cisplatin-based chemotherapy concurrent with radiotherapy , with planned subsequent surgical resection . Toxicity endpoints were defined as grade ≥3 radiation-related or myelosuppressive events probably or definitely related to therapy , occurring during or up to 6 weeks following the completion of radiochemotherapy . SNPs were analyzed in 60 subjects in pathways related to nucleotide/base excision- or double str and ed break repair , or platinum influx , efflux , or detoxification . Results Grade ≥3 radiation-related toxicity ( mostly dysphagia ) and myelosuppression occurred in 18 and 33 % of subjects , respectively . The variant alleles of the XRCC2 5′ flanking SNP ( detected in 28 % of subjects ) and of GST-Pi Ile-105-Val ( detected in 65 % of subjects ) were each associated with higher odds of serious radiation-related toxicity compared to the major allele homozygote ( 47 % vs. 9 % , and 31 % vs. 0 % , respectively ; P = 0.005 ) . No SNP was associated with myelosuppression . Conclusions This novel finding in a well-characterized cohort with robust endpoint data supports further investigation of XRCC2 and GST-Pi as potential predictors of radiation toxicity PURPOSE Clinical radiosensitivity varies considerably among patients , and radiation-induced side effects developing in normal tissue can be therapy limiting . Some single nucleotide polymorphisms ( SNPs ) have been shown to correlate with hypersensitivity to radiotherapy . We conducted a prospect i ve study of 87 female patients with breast cancer who received radiotherapy after breast surgery . We evaluated the association between acute skin reaction following radiotherapy and 11 genetic polymorphisms in DNA repair genes : XRCC1 ( Arg399Gln and Arg194Trp ) , XRCC3 ( Thr241Met ) , XPD ( Asp312Asn and Lys751Gln ) , MSH2 ( gIVS12 - 6T > C ) , MLH1 ( Ile219Val ) , MSH3 ( Ala1045Thr ) , MGMT ( Leu84Phe ) , and in damage-detoxification GSTM1 and GSTT1 genes ( allele deletion ) . METHODS AND MATERIAL S Individual genetic polymorphisms were determined by polymerase chain reaction and single nucleotide primer extension for single nucleotide polymorphisms or by a multiplex polymerase chain reaction assay for deletion polymorphisms . The development of severe acute skin reaction ( moist desquamation or interruption of radiotherapy due to toxicity ) associated with genetic polymorphisms was modeled using Cox proportional hazards , accounting for cumulative biologically effective radiation dose . RESULTS Radiosensitivity developed in eight patients and was increased in carriers of variants XRCC3 - 241Met allele ( hazard ratio [ HR ] unquantifiably high ) , MSH2 gIVS12 - 6nt-C allele ( HR=53.36 ; 95 % confidence intervals [ 95 % CI ] , 3.56 - 798.98 ) , and MSH3 - 1045Ala allele ( HR unquantifiably high ) . Carriers of XRCC1-Arg194Trp variant allele in combination with XRCC1-Arg399Gln wild-type allele had a significant risk of radiosensitivity ( HR=38.26 ; 95 % CI , 1.19 - 1232.52 ) . CONCLUSIONS To our knowledge , this is the first report to find an association between MSH2 and MSH3 genetic variants and the development of radiosensitivity in breast cancer patients . Our findings suggest the hypothesis that mismatch repair mechanisms may be involved in cellular response to radiotherapy . Genetic polymorphisms may be promising c and i date s for predicting acute radiosensitivity , but further studies are necessary to confirm our findings Purpose : Several DNA repair gene polymorphisms have been described , which affect DNA repair capacity and modulate cancer susceptibility . We evaluated the association of six polymorphisms in the DNA repair genes : XRCC1 ( Arg194Trp , Arg280His , and Arg399Gln ) , APE1 ( Asp148Glu ) , and XPD ( Lys751Gln and Asp312Asn ) , with the risk of acute skin reactions following radiotherapy . Design : We conducted a prospect i ve study of 446 female patients with breast cancer who received radiotherapy after breast-conserving surgery . Individual genetic polymorphisms were determined using melting point analysis of sequence-specific hybridization probes . The development of acute skin reactions ( moist desquamation ) associated with DNA repair gene polymorphisms was modeled using Cox proportional hazards , accounting for cumulative biologically effective radiation dose . Results : Overall , the development of acute toxicity , which presented in 77 patients , was not associated with the genetic variants studied , although the hazard ratios ( HR ) were generally below 1 . Risks were however differential by body mass index . Among normal-weight patients only , both carriers of the APE1 148Glu and the XRCC1 399Gln alleles had decreased risk of acute skin reactions after radiotherapy ( HR , 0.49 and 0.51 , respectively ) . The results for XRCC1 were confirmed by haplotype analysis . When considering joint effects , we observed that compared with homozygote carriers of the wild-type allele in both genes , the risk was most strongly reduced in carriers of both APE1 148Glu and XRCC1 399Gln alleles with normal weight [ HR , 0.19 ; 95 % confidence interval ( 95 % CI ) , 0.06 - 0.56 ] but not in those with overweight ( HR , 1.39 ; 95 % CI , 0.56 - 3.45 ; Pinteraction = 0.009 ) . Conclusion : The XRCC1 399Gln or APE1 148Glu alleles may be protective against the development of acute side effects after radiotherapy in patients with normal weight Radiotherapy is associated with a board spectrum of early and late normal tissue injury . It is a basic clinical observation that even within a group of identically treated patients large variability exists in the incidence and severity of radiation sequelae . Although this is partly a result of the r and om nature of radiation-induced cell killing , there are at least two additional phenomena involved . One is that certain cofactors influence the expression of radiation damage . These include for example , age of the patient , hemoglobin level , and smoking habits . Another type of predisposing factors are related to coexisting morbidity , like collagen vascular disease , diabetes mellitus , hypertension , and infections . The influence of these factors on the expression of normal tissue injury is critically review ed and some of the method ological problems involved in this field are discussed . The other phenomenon , that probably contributes to the patient-to-patient variability in the expression of normal tissue reactions , is the variability in intrinsic cellular radiosensitivity that has been shown among individuals . Clinical studies have shown that patients who express a given type of normal tissue injury in one treated area are more likely also to express this injury in another treated area . On the other h and , different normal tissue reactions seem to have a very limited , if any , intrapatient correlation . A number of genetic syndromes are associated with hypersensitivity to radiation , both clinical ly and in vitro . Also , studies have shown that highly selected patients who express an unusually strong response to radiotherapy , are likely to have in vitro radiosensitivities in the lower normal range . Recently , two studies on otherwise unselected patients support the hypothesis that in vitro radiosensitivity of normal human skin fibroblasts correlated with clinical normal tissue reactions BACKGROUND Several studies have reported associations between radiation toxicity and single nucleotide polymorphisms ( SNPs ) in c and i date genes . Few associations have been tested in independent validation studies . This prospect i ve study aim ed to vali date reported associations between genotype and radiation toxicity in a large independent data set . METHODS 92 ( of 98 attempted ) SNPs in 46 genes were successfully genotyped in 1613 patients : 976 received adjuvant breast radiotherapy in the Cambridge breast IMRT trial ( IS RCT N21474421 , n=942 ) or in a prospect i ve study of breast toxicity at the Christie Hospital , Manchester , UK ( n=34 ) . A further 637 received radical prostate radiotherapy in the MRC RT01 multicentre trial ( IS RCT N47772397 , n=224 ) or in the Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer ( CHHiP ) trial ( IS RCT N97182923 , n=413 ) . Late toxicity was assessed 2 years after radiotherapy with a vali date d photographic technique ( patients with breast cancer only ) , clinical assessment , and patient question naires . Association tests of genotype with overall radiation toxicity score and individual endpoints were undertaken in univariate and multivariable analyses . At a type I error rate adjusted for multiple testing , this study had 99 % power to detect a SNP , with minor allele frequency of 0·35 , associated with a per allele odds ratio of 2·2 . FINDINGS None of the previously reported associations were confirmed by this study , after adjustment for multiple comparisons . The p value distribution of the SNPs tested against overall toxicity score was not different from that expected by chance . INTERPRETATION We did not replicate previously reported late toxicity associations , suggesting that we can essentially exclude the hypothesis that published SNPs individually exert a clinical ly relevant effect . Continued recruitment of patients into studies within the Radiogenomics Consortium is essential so that sufficiently powered studies can be done
Output:
| Conclusions The minor allele of rs13181 polymorphism may confer a protect effect against radiotoxicity . |
MS210528 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Gynoid lipodystrophy , also known as cellulite , is a common multifactorial entity that affects millions of women around the world . There have been few scientific articles dealing with its physiology and treatment in the past few years , and vascular changes seem to play an important role in its pathophysiology . Skin microvascular alterations can be observed noninvasively with a new method called orthogonal polarization spectral imaging , which was used to evaluate the effectiveness of an anticellulite drug composed mainly of a 7 % caffeine solution . Microcirculatory parameters evaluated were functional capillary density ( FCD ; number of flowing capillaries per unit area ) , diameter of the dermic papilla ( DPD ) , and capillary diameter ( CD ) . The clinical parameters analyzed were centimetrical measurements of thighs and hips and the influence of tobacco , alcohol , and physical activities on the efficacy of the treatment . After 1 month of treatment , statistical application of chi-squared and Z approximation tests showed , in treated patients , statistically significant reduction of thigh circumferences in more than 80 % of the cases and reduction of hip circumference in 67.7 % . FCD , DPD , and CD did not change significantly after treatment . Smoking as well as alcohol consumption and regular physical activity were not significantly related to the centimetrical reduction observed in treated thighs and hips The aim of this study was to determine how worthwhile it would be to combine a newly developed topical slimming product with customized dietary habits not based on calorie restriction , so as to improve the cellulite appearance of the skin . At the beginning of the study , a nutritionist recorded the dietary habits of each participant and gave recommendations to each of them according to their food consumption . The chosen methodology was a right/left comparison , one thigh and hip being treated with the new topical slimming product and the other one left untreated to serve as a r and om control . Objective evaluations were performed by blind assessors . Control of food intake improved the cellulite score after 4 weeks when compared with the base value , but this reduction was significantly greater and earlier on the treated side than on the untreated side , indicating an objective additional benefit derived from the new slimming cream . This result corroborated the slimming effect assessed by measurement in centimetres of the circumference of the upper thighs and the reconstructed volume of the thigh between two fixed horizontal slices . Furthermore , skin tonicity , a major component of cellulite visibility , was also significantly improved on the treated side after only 2 weeks CONTEXT The Consoli date d St and ards for Reporting of Trials ( CONSORT ) statement was developed to help improve the quality of reports of r and omized controlled trials ( RCTs ) . To date , a paucity of data exists regarding whether it has achieved this goal . OBJECTIVE To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs . DESIGN AND SETTING Comparative before- and -after evaluation in which reports of RCTs published in 1994 ( pre-CONSORT ) were compared with RCT reports from the same journals published in 1998 ( post-CONSORT ) . We included 211 reports from BMJ , JAMA , and The Lancet ( journals that adopted CONSORT ) as well as The New Engl and Journal of Medicine ( a journal that did not adopt CONSORT and was used as a comparator ) . MAIN OUTCOME MEASURES Number of CONSORT items included in a report , frequency of unclear reporting of allocation concealment , and overall trial quality score based on the Jadad scale , a 5-point quality assessment instrument . RESULTS Compared with 1994 , the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998 , and this increase was statistically significant for the 3 adopter journals ( pre-CONSORT , 23.4 ; mean change , 3.7 ; 95 % confidence interval [ CI ] , 2.1 - 5.3 ) . The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals , and this change was statistically significant for adopters ( pre-CONSORT , 61 % ; mean change , -22 % ; 95 % CI , -38 % to -6 % ) . Similarly , 3 of the 4 journals showed an improvement in the quality score for reports of RCTs , and this increase was statistically significant for adopter journals overall ( pre-CONSORT , 2.7 ; mean change , 0.4 ; 95 % CI , 0.1 - 0.8 ) . CONCLUSION Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs Background CONSORT ( Consoli date d St and ards for Reporting Trials ) guidelines were constructed to ensure optimal reporting quality of r and omized controlled trials ( RCTs ) . Three studies were performed to investigate the mechanism of action and evaluate the efficacy of a topical cosmetic slimming product combining tetrahydroxypropyl ethylenediamine , caffeine , carnitine , forskolin and retinol . The Ex vivo study on skin explants showed that caffeine and forskolin both stimulated glycerol release and demonstrates for the first time that retinol and carnitine in combination synergistically stimulated keratinocyte proliferation , which leads to an increase epidermal thickness . The double-blind , r and omized , placebo-controlled clinical study associating circumference measurements on five selected parts of the body , cutaneous hydration measurements as well as blinded expert grading of skin aspect was conducted on 78 women who applied the product or placebo twice daily for 12 consecutive weeks . After 4 weeks of twice-daily application of the product , significant reductions in circumference of abdomen , hips-buttocks and waist were already observed . Improvements concerned all the measured body parts after 12 weeks . Orange peel and stubborn cellulite decreased significantly from 4 weeks of treatment and tonicity improved from 8 weeks , demonstrating that the product improved skin aspect . At the end of the study , eight parameters of the thirteen evaluated were significantly improved in the active group and compared with placebo INTRODUCTION Cellulite is the unsightly dimpling and nodularity found on the thighs and buttocks of many postadolescent women . Unfortunately , poor underst and ing of its pathophysiology coupled with very few scientifically based studies have left us with limited treatment options that are tolerable and effective . PURPOSE To review current concepts of the etiology and nature of cellulite and summarize available treatment options . To evaluate a novel , pathophysiologically based , topical agent for treatment . MATERIAL S AND METHODS A total of 40 women with a moderate degree of cellulite ( 20 from each of the two research centers ) entered a double-blinded , r and omized trial where an anticellulite cream was applied on a nightly basis to the affected sites for four continuous weeks . Each subject was r and omized to receive active cream on either the right or left leg , with the contralateral side serving as placebo control . Bioceramic-coated neoprene shorts were worn overnight to enhance penetration of the topical agents by occlusion . High- quality digital photography was taken before treatment and after 4 weeks , with tangential full-spectrum lighting . Five blinded , independent physician review ers assessed the photographs for improvement . Subject question naires were completed to assess tolerability and efficacy . RESULTS Of the 34 subjects who completed the study , 62 % ( 21/34 ) noticed an overall improvement in their cellulite , with 62 % ( 13/21 ) reporting greater improvement in the thigh that received active product . All 34 subjects found the shorts and creams easy and pleasant to use . Overall , the average measured decrease in thigh circumference was 1.9 cm ( range : 0.1 - 4.5 ) with active product , and 1.3 cm ( range : 0.1 - 3.0 ) with placebo . Upon review of the pre- and post study photographs , dermatologist evaluators found thighs treated with active product showed greater improvement than thighs treated with placebo in 68 % of subjects . CONCLUSIONS The active topical agent used in this study was found to be effective in reducing the appearance of cellulite . All subjects tolerated the formulation well with no adverse effects . The success of this research vali date s the pathophysiologic concepts used to formulate the topical compound . This study both increases our underst and ing of the nature of cellulite and establishes a tolerable , effective product to treat it Numerous manufacturers are marketing topical creams , cl aim ing that they improve or eliminate unwanted fat or cellulite in a short period of time . The active ingredient in most of these creams is theophylline , and cl aims have been made that it initiates lipolysis by binding to adipocyte beta-adrenergic receptors . The creams are applied with vigorous massage to facilitate absorption and apply mechanical stress to the fat cells . The efficacy of these creams is largely untested . This prospect i ve r and omized study was conducted to determine whether there is scientific evidence that application of these creams alone can eliminate unwanted fat or cellulite . Eleven women with normal body weight as defined by insurance tables applied either Skinny Dip(TM ) or a placebo to one thigh and one half of the abdomen for 8 weeks . Each subject was examined , photographed , weighed , and measured by a study monitor on a weekly basis . There were no statistically significant differences in appearance , abdominal circumference , thigh circumference , or skin fold measurements among subjects using the active agent ( Skinny Dip(TM ) ) or the placebo . This study failed to support the efficacy of topically applied lipolytic creams in eliminating unwanted fat manifesting as a localized bulge or cellulite presenting as a dimpling of the skin A double-blind , r and omized , placebo-controlled study was conducted with 46 healthy female volunteers in order to test an anti-cellulite product containing retinol , caffeine and ruscogenine . An evaluation of different parameters related to cellulite appearance , i.e. , the skin macrorelief , the dermal and hypodermal structures , the skin mechanical characteristics , and the cutaneous flowmetry was assessed using several non-invasive methods . This combination of different evaluation methods result ed in the demonstration of significant activity of the anti-cellulite product versus baseline and showed its superiority versus the placebo in skin macrorelief ( decrease of the " orange peel " effect ) and an increase in cutaneous microcirculation . By using a combination of methods , it was possible to detail the activity of an anti-cellulite product and to show superiority of the product in comparison with the placebo Cellulite is a common phenomenon that particularly affects the thighs and buttocks of women . Little scientific evidence exists to support any of the many advertised treatments for it . A total of 52 of 69 women , who were divided into three groups , completed a 12-week , r and omized , controlled trial in which the effectiveness of two different treatments for cellulite was assessed . The patients acted as their own controls . The treatments investigated were twice-daily application of aminophylline cream and twice-weekly treatment with Endermologie ES1 . Group 1 ( double blind ) received aminophylline to one thigh/buttock and a placebo cream to the other . Group 2 ( singly blind ) received Endermologie to one thigh/buttock . Group 3 received Endermologie to both sides and used the same cream regimen as group 1 . Results were assessed subjectively by the patient and by clinical examination and photographic assessment by the surgeon ( before and after the trial ) . Morphologic assessment included body mass index , thigh girth at two points , and thigh fat depth measurement by ultrasound . No statistical difference existed in measurements between legs for any of the treatment groups ( paired t test , p > 0.4 ) . The best subjective assessment , by the patients themselves , revealed that only 3 of 35 aminophylline-treated legs and 10 of 35 Endermologie-treated legs had their cellulite appearance improved . The authors do not believe that either of these two treatments is effective in improving the appearance of cellulite BACKGROUND The development of ultrasonography allowed for skin imaging used in dermatology and esthetic medicine . By means of classic and high-frequency ultrasonographies , changes within the dermis and subcutaneous tissue can be presented . OBJECTIVE The aim of this study was to show the possibilities of applying classic and high-frequency ultrasonographies in esthetic dermatology based on monitoring various types of anti-cellulite therapies . METHODS Sixty-one women with cellulite were assigned to two smaller groups . One group was using anti-cellulite cream and the second group was a placebo group . The ultrasound examination was carried out before the initiation and after the completion of the treatment and evaluated epidermal echoes , the thickness of the subcutaneous tissue and the dermis , dermis echogenicity , the length and surface area of the subcutaneous tissue fascicles growing into the dermis , and the presence or absence of edemas . RESULTS After the completion of the treatment , a statistically significant difference was observed . The most useful parameters were as follows : the thickness of the subcutaneous tissue , echogenicity , the surface area and length of the subcutaneous tissue , as well as the presence of edemas . The discussed changes were not observed in the placebo group . CONCLUSION Classic and high-frequency ultrasonographies are useful methods for monitoring anti-cellulite therapies BACKGROUND Excessive subcutaneous adipose tissue is typically treated by physically removing the fat through liposuction , but cost and accessibility have popularized alternative treatments for reducing adipose tissue thickness . OBJECTIVE The purpose of this study was to test the absolute and relative effectiveness of a liposome-encapsulated caffeine-based cream in modifying subcutaneous adipose tissue . METHODS Forty-one patients consented and completed the double-blind , single-center , placebo-controlled study . Caliper measurements , tape measurements , and photographs were taken over a 2-month period . RESULTS Both concentrations of the cream were found to significantly reduce the thickness of the adipose tissue in all areas of the body . In addition ,
Output:
| This article provides a systematic evaluation of the scientific evidence of the efficacy of cosmetic products in cellulite reduction and supports a moderate efficacy in thigh circumference reduction |
MS210529 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Polymorphisms of glutathione S-transferase ( GST ) enzymes have been correlated with altered risk of several cancers , as well as altered response and toxicity from cancer chemotherapy . We report a low cost , highly reproducible and specific PCR-based high-throughput assay for genotyping different GSTs design ed for use in large clinical trials . In comparison to an alternative genotyping method ( single nucleotide extension ) , the sensitivity and specificity of the high throughput assay was shown to be 92 and 97 % , respectively , depending on the source of genomic DNA . Using the high-throughput assay , we demonstrate by multivariate analysis an increased risk of acute lymphoblastic leukemia , glial brain tumors , and osteosarcoma for patients carrying nonnull alleles of GSTM1 and /or GSTT1 Abstract — A model for childhood leukemia proposes that characteristic chromosomal translocations can arise in utero and that for most cases a second hit occurring postnatally will be necessary . Possible causal mechanisms for leukemias are environmental factors such as ionizing radiation from x rays and inherited susceptibility from polymorphisms in DNA repair genes . We performed a case-control study of childhood acute lymphoblastic leukemia measuring reported postnatal x rays in 701 cases aged 0–14 y and in as many population -based controls matched on age and sex . In addition we performed a case-only study in 207 cases to evaluate the interaction between x ray exposure and polymorphisms in DNA repair genes . There was an increase in risk of leukemia with number of x rays : the adjusted odds ratio for two or more x rays vs. none was 1.48 ( 95 % confidence interval : 1.11–1.97 ) . That risk was slightly higher among girls ( odds ratio = 1.67 ) . A polymorphism in the APE gene ( ex 5 ) involved in the base excision repair system was suggestive of an increased risk among boys and a reduced risk among girls . HMLH1 ( ex 8) , a mismatch repair gene , was associated with reduction of risk among girls . Results from the genetic data are still preliminary and must be interpreted with caution especially because of the relatively small number of genotyped cases . However , ionizing radiation from x rays as well as polymorphisms in DNA repair genes are plausible risk factors for childhood leukemia and should be studied more The aldo-keto reductase 1C3 ( AKR1C3 ) gene located on chromosome 10p15-p14 , a regulator of myeloid cell proliferation and differentiation , represents an important c and i date gene for study ing human carcinogenesis . In a prospect ively enrolled population -based case-control study of Han Chinese conducted in Kaohsiung in southern Taiwan , a total of 114 leukemia cases and 221 controls < 20 years old were recruited between November 1997 and December 2005 . The present study set out to evaluate the association between childhood leukemia and both maternal and offspring 's genotypes . To do so , we conducted a systematic assessment of common single-nucleotide polymorphisms ( SNPs ) at the 5 ' flanking 10 kb to 3 ' UTR of AKR1C3 gene . Gln5His and three tagSNPs ( rs2245191 , rs10508293 and rs3209896 ) and one multimarker ( rs2245191 , rs10508293 and rs3209896 ) were selected with average 90 % coverage of untagged SNPs by using the HapMap II data set . Odds ratios and 95 % confidence intervals were adjusted for age and gender . After correcting for multiple comparisons , we observed that risk of developing childhood leukemia is significantly associated with rs10508293 polymorphism on intron 4 of the AKR1C3 gene in both offspring alone and in the combined maternal and offspring genotypes ( nominal P < 0.0001 , permutation P < 0.005 ) . The maternal methylenetetrahydrofolate reductase A1298C polymorphism was found to be an effect modifier of the maternal intron 4 polymorphism of the AKR1C3 gene ( rs10508293 ) and the childhood leukemia risk . In conclusion , this study suggests that AKR1C3 polymorphisms may be important predictive markers for childhood leukemia susceptibility
Output:
| The collected evidence suggests that genetic polymorphisms in CYP2E1 , GSTM1 , NQO1 , NAT2 , MDR1 , and XRCC1 are capable of modulating leukaemia risk , mainly when associated with environmental exposures , such as domestic pesticides and insecticides , smoking , trihalomethanes , alcohol consumption , and x-rays .
More recently , genome wide association studies identified significant associations between genetic polymorphisms in ARID5B e IKZF1 and acute lymphoblastic leukaemia , but only a few studies have replicated these results until now .
In conclusion , genetic susceptibility contributes to the risk of childhood leukaemia through the effects of gene-gene and gene-environment interactions |
MS210530 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Inflammation and gonadotropins are hypothesized to influence ovarian carcinogenesis . In a prospect i ve study , we evaluated ovarian cancer risk associated with self-reported use of medications that influence inflammation or gonadotropin levels . The Breast Cancer Detection Demonstration Project Follow-Up Study enrolled 61,431 women in 1979 and used telephone interviews and 3 mailed question naires through 1998 to up date risk factor information and identify incident ovarian cancers . The 1992 - 95 question naire ascertained medication use , including duration and frequency of use for aspirin , acetaminophen , other nonsteroidal anti-inflammatory drugs ( NSAIDs ) , tranquilizers and histamine-receptor antagonists . A Poisson regression analysis generated rate ratios ( RRs ) and 95 % confidence intervals ( CIs ) for the 31,364 women who were at risk of ovarian cancer and responded to the question naire that queried regular medication use . One hundred sixteen women developed ovarian cancer during follow-up . None of the anti-inflammatory medications was associated with ovarian cancer , but the RR for more than 1 aspirin per day for 1 year or longer was 0.56 ( 95 % CI 0.20 - 1.5 ) and the RR for more than 5 years of regular " other NSAID " use was 2.0 ( 95 % CI 0.95 - 4.2 ) . Regular tranquilizer use was not associated with ovarian cancer , but histamine-receptor antagonists used regularly for more than 5 years ( RR = 3.6 , 95 % CI 1.4 - 9.1 ) or more than once daily ( RR = 3.1 , 95 % CI 1.5 - 6.5 ) appeared to increase risk . In our study , neither anti-inflammatory medications nor anti-psychotic medications were associated with ovarian cancer . Potential associations with histamine-receptor antagonists may warrant further study Objective : We sought to evaluate the association between ovarian cancer risk and use of aspirin and nonsteroidal anti-inflammatories . Methods : We prospect ively assessed use of aspirin , nonsteroidal anti-inflammatories ( NSAIDs ) , and acetaminophen use in relation to ovarian cancer risk among 76,821 participants in the Nurses ' Health Study who had no history of cancer other than non-melanoma skin cancer . Women reported known and suspected ovarian cancer risk factors in biennial mailed question naires from 1976 to 1996 , along with new diagnoses of ovarian cancer . Aspirin use was assessed in 1980 , 1982 , 1984 , and 1988–1994 . We assessed NSAID use in 1980 , and both NSAID and acetaminophen use in 1990 , 1992 , and 1994 . During 16 years of follow-up and 1,222,412 person-years , 333 cases of invasive epithelial ovarian cancer were confirmed . We used pooled logistic regression to control for age , body mass index , oral contraceptive use , smoking history , parity , postmenopausal hormone use , tubal ligation , and other potential ovarian cancer risk factors . Results : Aspirin use was not associated with ovarian cancer risk overall ( RR for users compared with nonusers , 1.00 , 95 % confidence interval ( CI 0.80–1.25 ) . We found no association between aspirin dose ( in number of weekly tablets ) and ovarian cancer risk ( RR for those taking 15 or more tablets weekly compared with nonusers , 0.98 , 95 % CI 0.63–1.52 ) . Similarly , duration of aspirin use was not associated with risk ( RR for aspirin use of 20 or more years , 0.99 , 95 % CI 0.69–1.43 ) . In separate models assessing the relation between NSAID use and ovarian cancer risk we found a 40 % reduction in risk among NSAID users versus nonusers ( RR 0.60 , 95 % CI 0.38–0.95 ) . However , when we examined this relationship in terms of days of NSAID use per month , we did not observe a dose – response with increasing NSAID use . Conclusions : We observed no association between aspirin use , dose , or duration and epithelial ovarian cancer risk . Although we found a modest reduction in risk associated with NSAID use , there was no dose – effect Background : Several epidemiologic studies have shown inverse associations between use of nonsteroidal anti-inflammatory drugs ( NSAID ) and incident ovarian cancer , but the results are inconsistent . There have been only a few studies examining possible links between NSAIDs and endometrial cancer risk . We investigated associations between use of NSAIDs and incident ovarian and endometrial cancers in a prospect i ve cohort of about 20,000 women with ages from 58 to 76 years in 1992 . Participants were asked how often they used aspirin and nonaspirin NSAIDs . Over 15 years , 311 endometrial and 167 ovarian incident malignancies were identified . Multivariate-adjusted hazard ratios were estimated using Cox proportional regression . Results : Compared with women who reported no use of aspirin , the relative risks for ovarian cancer for those who used aspirin < 2 , 2 to 5 times , and ≥6 times per week were 0.83 , 0.77 , and 0.61 , respectively ( P trend = 0.04 ) . We did not observe any association between nonaspirin NSAIDs use and ovarian cancer risk . Neither did we find associations between aspirin or nonaspirin NSAIDs use and risk for endometrial cancer . Conclusions : Our results suggest a possible inverse association between frequency of aspirin use and risk for ovarian cancer . Cancer Epidemiol Biomarkers Prev ; 19(2 ) ; Background : Previous studies have suggested that use of aspirin or other nonsteroidal anti-inflammatory drugs ( NSAIDs ) may be associated with reduced risk of lung cancer , but the data are inconsistent and are limited particularly with respect to the effects of aspirin , separate from other NSAIDs . Methods : The Iowa Women 's Health Study is a prospect i ve cohort of 41,836 Iowa women ages 55 to 69 years old at baseline in 1986 . NSAID use was assessed in 1992 . Over 10 years of follow-up , 403 incident cases of lung cancer were identified . The association of incident lung cancer with current use of aspirin or non-aspirin NSAIDs was analyzed after adjustment for lung cancer risk factors . Hazard ratios ( HR ) were estimated using multivariate COX proportional hazards regression . Results : There were 27,162 women in the analytic cohort . After controlling for age , education , alcohol intake , pack-years , smoking status , body mass index , and total fruit intake , the RR of women taking six or more aspirin weekly was 1.21 ( 95 % confidence interval , 0.92 - 1.59 ) . The HR was 1.23 for women taking six or more non-aspirin NSAIDs weekly ( 95 % confidence interval , 0.92 - 1.65 ) . There was no statistically significant trend by frequency of use for either aspirin ( Ptrend = 0.22 ) or non-aspirin NSAIDs ( Ptrend = 0.53 ) . Analyses by histologic type and smoking status yielded similar null results . Information on dosage and duration of use were not available for this analysis . Conclusion : These findings do not suggest that aspirin or other NSAIDs reduce risk of lung cancer in this cohort of postmenopausal women . ( Cancer Epidemiol Biomarkers Prev 2006;15(11):2226–31 Inflammation is postulated to play an important role in ovarian carcinogenesis . Prostagl and in endoperoxide synthase 2 ( PTGS2 ) is responsible for the conversion of arachidonic acid to prostagl and ins in response to inflammation . In a pooled analysis of two population -based studies , the Hawaii Ovarian Cancer Case – Control Study and the New Engl and Case – Control Study , including 1,025 women with invasive ovarian carcinoma and 1,687 cancer-free controls , the association of ovarian cancer risk with the PTGS2 rs5275 polymorphism and the use of nonsteroidal antiinflammatory drugs ( NSAIDs ) were examined . Odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) were estimated using unconditional logistic regression . In the pooled analysis , the CC genotype was associated with a reduced risk of nonserous ovarian carcinoma ( OR = 0.66 ; CI : 0.44–0.98 ) . In addition , the lowest risk was observed among carriers of the CC genotype who were users of only nonaspirin NSAIDs ( OR = 0.43 ; CI:0.20–0.93 ) in all women combined . The association of PTGS2 rs5275 with nonserous ovarian carcinoma and possible effect modification by NSAID use needs further validation , preferably in prospect i ve studies BACKGROUND Epidemiological evidence suggests that chronic inflammation may influence ovarian carcinogenesis . The study objective was to examine the association between the commonly used anti-inflammatory drug aspirin and epithelial ovarian cancer . METHODS The authors conducted a case-control study based in the New York University Women 's Health Study cohort enrolled between 1985 and 1991 in New York City . After a median follow-up period of 12 years , 68 incident cases of epithelial ovarian cancer were identified . Data about regular aspirin use were collected during the 1994 - 1996 follow-up question naire . Using a case-control study design , 10 controls per case were r and omly selected among study participants who matched the case by age and menopausal status . Conditional logistic regression analysis was used to study the relationships between aspirin and epithelial ovarian cancer by generating odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) . RESULTS Relative to no aspirin use , the OR for epithelial ovarian cancer among women who reported aspirin use three or more times per week for a period of at least 6 months was 0.60 ( 95 % CI 0.26 , 1.38 ) , after adjustment for age at menarche , parity , oral contraceptive use , and first-degree family history of breast cancer before age 50 . Among recent , within the previous 5 years , users of aspirin , the adjusted OR was 0.36 ( 95 % CI 0.11 , 1.18 ) . CONCLUSION Although confidence intervals included unity , the observed risk estimates seem to be compatible with previous studies suggesting that regular aspirin use could be inversely associated with risk of epithelial ovarian cancer Chronic inflammation may play an etiologic role in endometrial cancer . Nonsteroidal anti-inflammatory drugs ( NSAIDs ) reduce inflammatory activity by inhibiting the proinflammatory cyclooxygenase enzymes and , therefore , may decrease cancer risk . However , few studies have examined the association between NSAID use and endometrial cancer . We conducted a prospect i ve study among 72,524 women in the NIH-AARP Diet and Health Study . Women completed a question naire in 1996–1997 on lifestyle and health-related factors , including type and frequency of NSAID use within the past year , and were followed through 2003 by linkages to cancer registries and vital status data bases . During 488,261 person-years of follow-up , there were 732 incident endometrial cancers . NSAID use , compared with nonuse of NSAIDs , was not significantly associated with endometrial cancer risk [ relative risk ( RR ) , 0.90 ; 95 % confidence interval ( 95 % CI ) , 0.74–1.09 ] . Null associations were also observed by type of NSAID use [ aspirin only : RR , 0.88 ; 95 % CI , 0.70–1.11 ; nonaspirin NSAID ( NA-NSAID ) only : RR , 1.01 ; 95 % CI , 0.79–1.29 ; both aspirin and NA-NSAIDs : RR , 0.85 ; 95 % CI , 0.68–1.06 ] . Generally , results were not statistically significant by frequency of use for aspirin or NA-NSAIDs . Results did not change when women with a history of heart disease , hypertension , or diabetes were excluded to minimize the potential for confounding by indication . Overall , our data do not support an association between aspirin or NA-NSAID use and endometrial cancer risk To date , no prospect i ve studies have explored the relationship between the use of aspirin , other nonsteroidal anti-inflammatory medications ( NSAID ) , and acetaminophen and endometrial adenocarcinoma . Of the 82,971 women enrolled in a prospect i ve cohort study , 747 developed medical record-confirmed invasive endometrial cancer over a 24-year period . Use of aspirin was ascertained from 1980 to
Output:
| The studies reported conflicting results or no statistically significant associations between the use of non-aspirin NSAIDs and risk of lung , ovary , bladder , prostate , skin , and head and neck cancers .
We did not find sufficient evidence to support the use of the non-aspirin NSAIDs for the primary chemoprevention of a wide variety of non-gastrointestinal cancers . |
MS210531 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The microcirculation appears to be impaired in cold chronic complex regional pain syndrome ( CRPS ) . This double-blind , placebo-controlled , r and omized trial investigated the effect of the nitric oxide ( NO ) donor isosorbide dinitrate ( ISDN ) on the peripheral blood flow in patients with chronic CRPS . Twenty-four patients received 1 % ISDN in Vaseline or a placebo ointment applied to the dorsum of the affected h and four times daily for 10 weeks . The patients participated in a physical therapy program to improve activity . The primary outcome measure was blood distribution in the affected extremity , which was determined by measuring the skin temperature using videothermography . We also measured NO and endothelin-1 concentrations in blister fluid , pain using the visual analog scale , and activity limitations using an upper limb activity monitor and the Disabilities of Arm Shoulder and H and Question naire . ISDN failed to produce a significant improvement in temperature asymmetry in chronic cold CRPS patients , and it did not result in the expected reduction in pain and increase in activity compared with placebo either . There may be other central or peripheral factors contributing to the disturbed vasodynamics in cold chronic CRPS that are not influenced by NO substitution . This study does not show an improvement of the regional blood distribution by ISDN in the involved extremity of patients with cold-type CRPS Background Placebo treatment can significantly influence subjective symptoms . However , it is widely believed that response to placebo requires concealment or deception . We tested whether open-label placebo ( non-deceptive and non-concealed administration ) is superior to a no-treatment control with matched patient-provider interactions in the treatment of irritable bowel syndrome ( IBS ) . Methods Two-group , r and omized , controlled three week trial ( August 2009-April 2010 ) conducted at a single academic center , involving 80 primarily female ( 70 % ) patients , mean age 47±18 with IBS diagnosed by Rome III criteria and with a score ≥150 on the IBS Symptom Severity Scale ( IBS-SSS ) . Patients were r and omized to either open-label placebo pills presented as “ placebo pills made of an inert substance , like sugar pills , that have been shown in clinical studies to produce significant improvement in IBS symptoms through mind-body self-healing processes ” or no-treatment controls with the same quality of interaction with providers . The primary outcome was IBS Global Improvement Scale ( IBS-GIS ) . Secondary measures were IBS Symptom Severity Scale ( IBS-SSS ) , IBS Adequate Relief ( IBS-AR ) and IBS Quality of Life ( IBS-QoL ) . Findings Open-label placebo produced significantly higher mean ( ±SD ) global improvement scores ( IBS-GIS ) at both 11-day midpoint ( 5.2±1.0 vs. 4.0±1.1 , p<.001 ) and at 21-day endpoint ( 5.0±1.5 vs. 3.9±1.3 , p = .002 ) . Significant results were also observed at both time points for reduced symptom severity ( IBS-SSS , p = .008 and p = .03 ) and adequate relief ( IBS-AR , p = .02 and p = .03 ) ; and a trend favoring open-label placebo was observed for quality of life ( IBS-QoL ) at the 21-day endpoint ( p = .08 ) . Conclusion Placebos administered without deception may be an effective treatment for IBS . Further research is warranted in IBS , and perhaps other conditions , to eluci date whether physicians can benefit patients using placebos consistent with informed consent . Trial Registration Clinical Trials.gov OBJECTIVES Complex regional pain syndrome ( CRPS ) , formerly known as reflex sympathetic dystrophy ( RSD ) , is a painful , disabling disorder for which treatment is difficult . The aim of this study was to determine the efficacy of pamidronate in a double-blind r and omized placebo-controlled trial . METHODS Patients referred to our regional multidisciplinary pain management center who fulfilled the International Association for the Study of Pain criteria for CRPS Type I were enrolled in the study over a 2-year period . Patients were administered , intravenously , either pamidronate , 60 mg as a single dose , or normal saline . Patients ' pain scores , global assessment of disease severity scores , and functional assessment ( SF-36 ) scores were documented at baseline and at 1 and 3 months . RESULTS Twenty-seven patients ( 18 female , 9 male ; average age 45 years ) were recruited , of whom 14 received pamidronate and 13 received placebo . Overall improvements in pain score , patient 's global assessment of disease severity score , and physical function ( SF-36 ) score were noted in the pamidronate group at 3 months , and improvements in role physical ( SF-36 ) score were noted at 1 and 3 months . There was variability in pamidronate response among individuals . CONCLUSIONS Pamidronate may be a useful treatment option in the management of patients with CRPS Type I. Although treatment response was variable , the majority of patients improved . Early administration in t and em with other treatment measures is recommended Background . Complex regional pain syndrome type 1 ( CRPSt1 ) of the upper limb is a painful and debilitating condition , frequent after stroke , and interferes with the rehabilitative process and outcome . However , treatments used for CRPSt1 of the upper limb are limited . Objective . This r and omized controlled study was conducted to compare the effectiveness on pain and upper limb function of mirror therapy on CRPSt1 of upper limb in patients with acute stroke . Methods . Of 208 patients with first episode of unilateral stroke admitted to the authors ’ rehabilitation center , 48 patients with CRPSt1 of the affected upper limb were enrolled in a r and omized controlled study , with a 6-month follow-up , and assigned to either a mirror therapy group or placebo control group . The primary end points were a reduction in the visual analogue scale score of pain at rest , on movement , and brush-induced tactile allodynia . The secondary end points were improvement in motor function as assessed by the Wolf Motor Function Test and Motor Activity Log . Results . The mean scores of both the primary and secondary end points significantly improved in the mirror group ( P < .001 ) . No statistically significant improvement was observed in any of the control group values ( P > .001 ) . Moreover , statistically significant differences after treatment ( P < .001 ) and at the 6-month follow-up were found between the 2 groups . Conclusions . The results indicate that mirror therapy effectively reduces pain and enhances upper limb motor function in stroke patients with upper limb CRPSt1 OBJECTIVE Complex regional pain syndrome type I ( CRPS-I ) is a severely disabling pain syndrome for which no definite treatment has been established . The aim of this multi-centre , r and omized , double-blind placebo-controlled trial was to test the efficacy of the amino-bisphosphonate neridronate in patients with CRP-I. METHODS Eighty-two patients with CRP-I at either h and or foot were r and omly assigned to i.v . infusion of 100 mg neridronate given four times over 10 days or placebo . After 50 days the former placebo patients were given open label the same regimen of neridronate . RESULTS Within the first 20 days , visual analogue scale ( VAS ) score decreased significantly more in the neridronate group . In the following 20 days , VAS remained unchanged in the placebo group and further decreased in the active group by 46.5 mm ( 95 % CI -52.5 , -40.5 ) vs 22.6 mm ( 95 % CI -28.8 , -16.3 ) for placebo group ( P < 0.0001 ) . Significant improvements vs placebo were observed also for a number of other indices of pain and quality of life . During the open-extension phase in the formerly placebo group the results of treatment were superimposable on those seen during the blind phase in the active group . A year later none of the patients was referring symptoms linked to CRPS-I. CONCLUSION In patients with acute CRPS-I , four i.v . infusions of neridronate 100 mg are associated with clinical ly relevant and persistent benefits . These results provide conclusive evidence that the use of bisphosphonates , at appropriate doses , is the treatment of choice for CRPS-I. TRIAL REGISTRATION EU Clinical Trials Register , https://www . clinical trialsregister.eu/ , 2007 - 003372 - 18 Background Complex Regional Pain Syndrome type one ( CRPS I ) or formerly Reflex Sympathetic Dystrophy ( RSD ) is a disabling syndrome , in which a painful limb is accompanied by varying symptoms . Neuropathic pain is a prominent feature of CRPS I , and is often refractory to treatment . Since gabapentin is an anticonvulsant with a proven analgesic effect in various neuropathic pain syndromes , we sought to study the efficacy of the anticonvulsant gabapentin as treatment for pain in patients with CRPS I. Methods We did a r and omized double blind placebo controlled crossover study with two three-weeks treatment periods with gabapentin and placebo separated by a two-weeks washout period . Patients started at r and om with gabapentin or placebo , which was administered in identical capsules three times daily . We included 58 patients with CRPS type 1 . Results Patients reported significant pain relief in favor of gabapentin in the first period . Therapy effect in the second period was less ; finally result ing in no significant effect combining results of both periods . The CRPS patients had sensory deficits at baseline . We found that this sensory deficit was significantly reversed in gabapentin users in comparison to placebo users . Conclusions Gabapentin had a mild effect on pain in CRPS I. It significantly reduced the sensory deficit in the affected limb . A sub population of CRPS patients may benefit from gabapentin UNLABELLED To assess the effects of intravenous administration of the free radical scavenger mannitol 10 % on complaints associated with complex regional pain syndrome Type I ( CRPS I ) , a r and omized , placebo-controlled , double-blinded trial was performed . Forty-one CRPS I patients according to the Bruehl et al diagnostic criteria , were included in 2 outpatient pain clinics of 2 university medical centers and r and omly assigned to receive either 10 % mannitol iv in 1 L 0.9 % NaCL in 4 hours for 5 consecutive days or equal volumes of 0.9 % NaCL ( placebo ) . Patients in both groups received physical therapy according to protocol and rescue pain medication if required . Complaints on impairment and disability level and quality of life were assessed up to 9 weeks after baseline , with primary measurement points at 2 , 6 , and 9 weeks . Monitoring of pain using the visual analogue scale took place continuously during the course of the trial . Except for a significant improvement on a subscale of the Jebsen-Taylor h and function test , no significant differences were found between mannitol and placebo treatment . Changes in both groups in the course of the trial were small and clinical ly irrelevant on all measurement indices . We conclude that intravenous administration of 10 % mannitol is not more effective than placebo in reducing complaints for CRPS I patients and provides no addition to already-established interventions for CRPS I. Whether 10 % mannitol can provide beneficial effects for subgroups of CRPS I patients with a pathophysiological profile more closely fitting the presumed mode of action for this intervention remains to be established . PERSPECTIVE This article addresses the efficacy of the intravenous administration of the free radical scavenger mannitol for treatment of CRPS type 1 . This intervention is not more effective than placebo in reducing complaints for CRPS I patients and provides no addition to already-established interventions for CRPS Background This double-blind , r and omized , controlled trial investigated the effect of the phosphodiesterase-5 inhibitor tadalafil on the microcirculation in patients with cold Complex Regional Pain Syndrome ( CRPS ) in one lower extremity . Methods Twenty-four patients received 20 mg tadalafil or placebo daily for 12 weeks . The patients also participated in a physical therapy program . The primary outcome measure was temperature difference between the CRPS side and the contralateral side , determined by measuring the skin temperature with videothermography . Secondary outcomes were : pain measured on a Visual Analogue Scale , muscle force measured with a MicroFet 2 dynamometer , and level of activity measured with an Activity Monitor ( AM ) and walking tests . Results At the end of the study period , the temperature asymmetry was not significantly reduced in the tadalafil group compared with the placebo group , but there was a significant and clinical ly relevant reduction of pain in the tadalafil group . Muscle force improved in both treatment groups and the AM revealed small , non-significant improvements in time spent st and ing , walking , and the number of short walking periods . Conclusion Tadalafil may be a promising new treatment for patients that have chronic cold CRPS due to endothelial dysfunction , and deserves further investigation . Trial Registration The registration number in the Dutch Trial Register is IS RCT N60226869 ABSTRACT Complex Regional Pain Syndrome Type 1 ( CRPS‐1 ) responds poorly to st and ard pain treatment . We evaluated if the N‐methyl‐d‐aspartate receptor antagonist S(+)‐ketamine improves pain in CRPS‐1 patients . Sixty CRPS‐1 patients ( 48 females ) with severe pain participated in a double‐blind r and omized placebo‐controlled parallel‐group trial . Patients were given a 4.2‐day intravenous infusion of low‐dose ketamine ( n = 30 ) or placebo ( n = 30 ) using an individualized stepwise tailoring of dosage based on effect ( pain relief ) and side effects ( nausea/vomiting/psychomimetic effects ) . The primary
Output:
| Placebo response was significant at the earliest time period ( 15 - 30 minutes ) .
There was no significant evidence of placebo response at any of the other time periods .
PERSPECTIVE In this meta- analysis of placebo responses in r and omized controlled trials in long-st and ing CRPS , published during 1966 to 2013 , we found no evidence for placebo analgesia , except at very early time points . |
MS210532 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND The aim of this study was to compare the outcome and cost-effectiveness of laparoscopic ( LA ) and open appendectomy ( OA ) . METHODS Forty consecutive patients were r and omized to either the LA ( n = 19 ) or OA ( n = 21 ) group . RESULTS The medians of operative times in the LA and OA groups were 31.5 and 41 min , respectively . The total operation room times were 91 and 82 min , respectively . There was no significant difference in postoperative pain or fatigue , but return to normal life was faster in the LA group ( 14 versus 26 . 5 days ) . The median hospital costs per patient were 8,538 and 6,788 FIM ( $ 1 US = 4.6 FIM ) in the LA and OA groups , respectively ; but the total costs among working patients were lower in the LA group ( 20 , 963 versus 27,778 FIM ) due to faster return to work . CONCLUSIONS Laparoscopic appendectomy is as safe as open appendectomy . The hospital costs are higher , but LA offers significant cost savings to the payer for working patients Background A prospect i ve study including 272 patients with suspected appendicitis was performed . The aims were to evaluate the representativity of the study group and to compare diagnostic and therapeutic laparoscopy with conventional appendicectomy Aim : To see whether laparoscopy improves the accuracy of a clinical diagnosis of acute appendicitis in women of reproductive age , and to determine what the long-term sequelae are of not removing an appendix deemed at laparoscopy to be normal . Method : The initial part of the study was undertaken during 1991–1992 . Female patients between 16 and 45 years were eligible for inclusion once a clinical decision had been made to perform an appendicectomy for suspected acute appendicitis . Following consent , patients were r and omized into two groups . One group had open appendicectomy , as planned . The other group had laparoscopy , followed by open appendicectomy only if the appendix was seen to be inflamed or was not visualized . The end points for the study were the clinical outcomes of all patients , and the results of histology , where appropriate . An attempt was made to contact all patients at 10 years to determine whether they had had a subsequent appendicectomy , or had been diagnosed with another abdominal condition that might be relevant to the initial presentation in 1991–1992 . Results : Laparoscopic assessment was correct in all cases in which the appendix was visualized . Diagnostic accuracy was improved from 75 % to 97 % . Laparoscopy was associated with no added complications , no increase in hospital stay in patients who went on to appendicectomy , and a reduction in hospital stay for those who underwent laparoscopy alone . No patients developed a problem over the 10-year follow-up period from having a normal-looking appendix not removed at laparoscopy . Conclusion : Laparoscopic assessment of the appendix is reliable , and to leave a normal-looking appendix at laparoscopy does not appear to cause any long-term problems AIM The aim of this study was to determine whether it is safe and cost-effective to discharge nonspecific abdominal pain ( NSAP ) patients from the Emergency Department ( ED ) and re-evaluate diagnosis later . METHODS Patients aged between 18 and 65 years were enrolled into the study . They had been admitted to the ED for acute abdominal pain with an indefinitive diagnosis after clinical examination and base-line investigations . The patients were r and omly assigned into two groups : 1 ) active clinical observation ( ACO ) , comprising those admitted to the ED observation room ; 2 ) outpatient group ( OG ) , comprising those discharged and asked to return for re-evaluation at 8 - 12 hours intervals over the following three days . Each patient was examined by an ED physician and a consultant general surgeon . Demographics , blood tests , morbidity and mortality , number of operations , together with 6-month follow-up results were noted . Finally , a patient satisfaction question naire was administered . RESULTS A total of 105 patients were enrolled into the study ; 50 were r and omized to the ACO group and 55 to the OG . There were no statistically significant differences in demographics and blood parameters between the two groups . Overall agreement of ED diagnosis with final diagnosis was 91.4 % . Total morbidity was 10 % in the ACO group and 7.2 % in the OG . There were no statistically differences in morbidities and usage of diagnostic imaging modalities between the two groups ( P>0.05 ) . No deaths occurred in either group during the study period . The patients in the ACO group were more keen on returning for re-evaluation and willing to recommend our hospital services to other people ( P < or = 0.05 ) . CONCLUSION Outpatient evaluation of patients with an ED diagnosis of NSAP may be an option , seems to be safe , is not accompanied by an increased incidence of complications and is efficient if patients are selected properly INTRODUCTION The aim of the study is to analyse the own data and try to discuss if laparoscopic appendectomy offers any advantages in treating young women suffering from pain in right lower abfdominal quadrant . MATERIAL S AND METHODS The study was conducted on 148 patients admitted from October 1993 to December 1998 with diagnosis of of pain in right iliac fossa and operated on with a laparoscopic ( LA group : 75 cases ) or open approach ( OA group : 73 cases ) . Patients were prospect ively r and omized on the surgical approach adopted , following a r and omized list . RESULTS The operative time in LA group was significantly ( p < 0.001 ) longer ( 87.2 minutes ) than for OA group ( 65.2 minutes ) . In 2 patients ( 2.7 % ) the operation had to be converted . Diagnosis had remained unknown in 16 patients ( 21.9 % ) of OA group , in spite of only one case ( 1.4 % ) with laparoscopic technique . We did n't observed intraoperative complications . Pain in the first and second postoperative days , evaluated on the use of pain medication , was significantly less in patients in group LA ( p < 0.01 ) . There were no deaths . Postoperative complications occurred in 4 patients ( 5.5 % ) of group LA , and in 8 patients ( 10.9 % ) of group OA . Hospital stay was significantly shorter for those having laparoscopic appendectomy ( p < 0.001 ) . DISCUSSION The main advantages of laparoscopic appendectomy consist more in diagnostic accuracy , than in less postoperative pain , less hospital stay and less postoperative complications . CONCLUSION Laparoscopic appendectomy is a safe and accurate approach BACKGROUND Clinical diagnosis of acute appendicitis is most difficult in fertile-age women . In this patient group up to 50 % of open appendectomies are negative for appendicitis . We conducted a r and omized study to compare laparoscopic and open appendectomy in young female patients with suspected acute appendicitis . METHODS Fifty female patients between the ages of 16 and 40 years presenting with acute right lower abdominal pain were r and omized , 25 to laparoscopy and 25 to an open appendectomy . Diagnostic accuracy , rate of negative appendectomies , safety , and final outcome were compared in the two groups . RESULTS Diagnosis was established in 96 % of patients in the laparoscopic group and in 72 % in the open group . There were 11 ( 44 % ) unnecessary appendectomies in the open group , but only one ( 4 % ) in the laparoscopic group ( p < 0.0005 ) . CONCLUSIONS In young women with right lower abdominal pain , laparoscopy can give precise diagnosis and reduce the rate of negative appendectomies The benefits of laparoscopic appendectomy appear to be controversial . Since 1994 , several abdominal procedures have been completed by using the needlescopic technique , but there appear to be no prospect i ve studies to demonstrate the perceived benefits of needlescopic appendectomy . The authors compared open , laparoscopic , and needlescopic appendectomy in a r and omized fashion with regard to duration of surgery , length of hospitalization , analgesic dosage , and surgery-associated complications . From March to July 1998 , 75 patients admitted at the emergency station of the authors ' hospital with a final diagnosis of acute appendicitis without tumor formation were r and omized to receive one of the three treatment categories : open ( OA ) , laparoscopic ( LA ) , and needlescopic ( nLA ) appendectomy . Laparoscopic and needlescopic appendectomy were performed by using a three-port technique , although the size of the trocar used varied . There were 26 patients in the OA group , 23 in the LA group , and 26 in the nLA group . The mean operation duration s for the OA , LA , and nLA groups were 55.4 ± 28.0 minutes , 69.1 ± 48.8 minutes , and 62.3 ± 26.3 minutes , respectively , and these were not significantly different from one another . The mean number of the analgesic doses ( Pethidine 1 mg/kg ) required was 1.3 ± 1.2 mg/kg , 0.5 ± 0.8 mg/kg , and 0.2 ± 0.6 mg/kg , respectively . Significant differences were noted when comparing the OA with the LA or nLA groups ( OA vs. LA , P = 0.02 ; OA vs. nLA , P = 0.0002 ; LA vs. nLA , P = 0.06 ) . The mean oral intake duration s were 32.2 ± 16.9 hours , 21.0 ± 14.6 hours , and 20.8 ± 16.4 hours , respectively , after surgery for the OA , LA , and nLA groups , and the between-group differences were statistically significant for the OA versus LA group ( P = 0.004 ) and for the OA versus nLA group ( P = 0.003 ) . The mean duration s of hospitalization for the OA , LA , and nLA groups were 3.6 ±1.8 days , 2.8 ± 1.4 days , and 2.4 ± 0.9 days , and difference was detected between the OA and the nLA groups ( P = 0.02 ) . The OA group rendered a greater wound-complication rate and ileus than did the other two groups , but the differences were not detected between the three categories ( P = 0.065 , 0.6935 ) . The result of the current study confirmed that the nLA procedure is a feasible and safe one . The nLA procedure provided substantial advantages over the OA procedure in the context s of diminished postoperative pain and shorter hospital stay without significant increases in postoperative complication rate or surgical time BACKGROUND Laparoscopic appendectomy is feasible , but whether it confers any advantage to patients with acute appendicitis is not known . We performed a r and omized controlled trial to compare results of laparoscopic and open appendectomy in patients with signs and symptoms suggesting acute appendicitis who were seen by one surgical team . METHODS Sixty-two consecutive patients were r and omized , 30 to laparoscopy and 32 to a classical open appendectomy . Postoperative recovery , complications , and return to normal activities were compared in the two groups . RESULTS The laparoscopy group were discharged earlier ( 2.5 vs 3.8 days , p less than 0.01 ) . Postoperative complications were more frequent after open appendectomy . Follow-up showed less pain , shorter bed stay at home , and faster return to work and sport after laparoscopic appendectomy . CONCLUSIONS This prospect i ve r and omized study shows that laparoscopic appendectomy is superior to open appendectomy in terms of hospital stay , postoperative complications , and return to normal activities and is recommended as the approach of choice in the management of acute appendicitis Background The aim of this study was to study the value of diagnostic laparoscopy prospect ively in fertile women scheduled for acute appendectomy . Methods For this study , 110 women , with acute abdominal pain ages 15 to 47 years , in whom the surgeon had decided to perform an appendectomy , were r and omized to either open appendectomy or diagnostic laparoscopy , then open appendectomy if necessary . Results Appendicitis was diagnosed in 66 % of the women after open surgery , and in 73 % after laparoscopy . During laparoscopy , was appendicitis misdiagnosed in only 7 % of the women , from whom the appendix unnecessarily removed , whereas 34 % in the open surgery group had a healthy appendix removed . No appendicitis was missed in the laparoscopic group . The relative risk of removing a healthy appendix in open surgery was 6.6 relative risk ( range , 2–21 C.I. ) as compared with laparoscopy . Among the women with a healthy appendix , a gynecologic diagnosis was found in 73 % after laparoscopy , as compared with 17 % after open surgery . Conclusions Laparoscopy reduces unnecessary appendectomies and improves diagnosis in fertile women Laparoscopy in patients with a clinical suspicion of acute appendicitis has not gained wide acceptance , and its use remains controversial Background The role of laparoscopy in the management of patients with suspected acute appendicitis remains controversial . It has been suggested that laparoscopy is useful mainly in young women of reproductive age because of the high incidence of wrong diagnosis in these patients . Methods Different management protocol s for patients with suspected acute appendicitis were prospect ively used in
Output:
| Data suggest that EL performs better in establishing a final diagnosis after admission , but the lack of uniform information does not allow for the recommendation of EL as a routine strategy in clinical practice . |
MS210533 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: The priority of the National Health System in South Africa is primary health care ( PHC ) . The approach involves a health system led by PHC services and includes personal and curative services for acute minor ailments delivered by PHC nurses . The nurses are also responsible for the treatment of these ailments with essential drugs according to protocol s as proposed in the Essential Drugs List . A before-after experimental research design was used to evaluate the effect of a competency-based primary care drug therapy ( PCDT ) training programme for PHC nurses in the treatment of acute minor ailments . An experimental group ( n = 35 ) and control group ( n = 31 ) consisting of registered nurses undergoing training in PHC at Gold Fields Nursing College were r and omly selected . The results showed a significant increase in prescribing outcomes and medicine utilisation OBJECTIVE The study was carried out to evaluate short term effects of one to one educational intervention approach , conducted with 40 drug sellers in order to improve the private sector 's practice s , compliance and performance in using the national treatment guidelines for malaria and other common childhood ( diarrhoea , acute respiratory tract infection-ARI ) illnesses in Kibaha district-Tanzania . METHODS The training took place one month after baseline data collection . Data collection was undertaken eight months after training and the effects of training was evaluated . The 40 drug stores were divided into 20 intervention and 20 control facilities . Trained nurses were used as clients who posed as caretakers of sick under-five children needing medication . The drug dispensers/sellers knowledge of anti-malarials and other drugs and their dispensing practice s was assessed . RESULTS The intervention seemed to have had a significant impact on knowledge pattern for prescribing and dispensing practice s of drug stores for some common childhood illnesses but not in other control drug stores/shops . About 90 % ( n=18 ) of shops prescribed to clients , the approved first-line anti-malarial drug for uncomplicated malaria ( sulfadoxine-pyrimethamine ) , as compared to only 55 % ( n=11 ) of the control shops . CONCLUSION Changing the private sectors ' knowledge , behaviour and practice s/performance may be a slow and difficult process . The intervention approach applied in this study seems to be feasible at district-level . This strategy can be applied in all districts of Tanzania with the aim of achieving significant improvements in knowledge , behaviour , compliance , improving performance and practice s of drug sellers in drug stores/shops . However , other alternative strategies are needed to influence drug sellers'/dispensers ' compliance and performance . Thus , the overall impact on performance and practice s in these facilities will remain at moderate level for quite sometime unless national policies , other programs and stakeholders are involved actively WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT Medication errors , and particularly prescribing errors , are common in UK hospitals . Junior doctors make the majority of prescribing errors . Deficiencies in prescribing education and training have been closely linked to the high frequency of medication errors . WHAT THIS STUDY ADDS Focussed prescribing teaching can lead to an improvement in prescribing ability . Prescribing confidence can be significantly improved through education . Education is insufficient alone in eradicating prescribing errors . AIM To assess the impact of prescribing teaching on final year medical students . METHODS Students r and omly allocated to two hospitals completed a prescribing assessment . Prescribing teaching was delivered to the intervention group while no additional teaching was provided for the control group . All students then completed a second prescribing assessment . RESULTS Teaching improved the assessment score : mean assessment 2 vs. 1 , 70 % vs. 62 % , P= 0.007 ; allergy documentation : 98 % vs. 74 % , P= 0.0001 ; and confidence . However , 30 % of prescriptions continued to include prescribing errors . CONCLUSION Medical students make significant errors in prescribing . Teaching improves ability and confidence but is insufficient alone in eradicating errors OBJECTIVE To identify and analyse factors underlying intern prescribing errors to inform development of specific medication-safety interventions . DESIGN A prospect i ve qualitative study that involved face-to-face interviews and human-factor analysis . SETTING A tertiary referral teaching hospital , Brisbane , Queensl and , February-June , 2004 . PARTICIPANTS Fourteen intern prescribers involved in 21 errors . METHOD A structured question naire was used to identify factors causing the errors . Transcripts were analysed on the basis of human-error theory to identify underlying themes . MAIN OUTCOME MEASURES Factors underlying prescribing errors . RESULTS Errors were multifactorial , with a median of 4 ( range , 2 - 5 ) different types of performance-influencing factors per error . Lack of drug knowledge was not the single causative factor in any incident . The factors in new-prescribing errors included team , individual , patient and task factors . Factors associated with errors in represcribing were environment , task and number of weeks into the term . Defences against error , such as other clinicians and guidelines , were porous , and supervision was inadequate or not tailored to the patient , task , intern or environment . Factors were underpinned by an underlying culture in which prescribing is seen as a repetitive low-risk chore . CONCLUSION To reduce the risk of prescribing errors , a range of strategies addressing patient , task , individual , team and environment factors must be introduced OBJECTIVE To evaluate the effect of an educational intervention on rational drug use amongst Primary Health Care workers in two Local Government Areas ( LGAs ) , Mushin and Ikeja , in Lagos State . METHODS Mushin was r and omly selected as the intervention LGA while Ikeja was selected as the control L.G.A. A structured educational intervention design ed to improve prescribing practice s was carried in Mushin LGA for four weeks . Drug use indicators were measured before , at two weeks and three months post intervention . RESULTS At baseline , most of the drug-use indicators in the intervention LGA were significantly worse ( p < 0.05 ) than the control LGA . However , at the two-week evaluation , the educational programme achieved a significant reduction in the average number of drugs in the intervention LGA from 7.3 + 2.8 to 6.3 + 2.3 ( p=0.000 ) compared to the control LGA where there was no significant change ( from 4.9 + to 4.8 + 2.2 , p=0.647 ) . There was also a significant increase in the percentage of patients rationally managed from 18 % to 30 % ( p=0.0005 ) in the intervention LGA unlike the control LGA ( from 33 % to 31%,p=0.693 . ) . The rate of change in the average number of drugs prescribed was significantly higher in the intervention LGA ( + 14 % ) compared to the control LGA ( + 2%,p=0.0000 ) . The improvements were not sustained at the three-month evaluation , as most of the indicators were similar to values obtained at the baseline . CONCLUSION The intervention programme significantly improved rational drug use in the short-term period only . Other cost effective and sustainable intervention models for improving prescribing practice s should be developed OBJECTIVE : To study the effectiveness of an intensive small group education and peer review programme aim ed at implementing national guidelines on asthma/chronic obstructive pulmonary disease ( COPD ) on care provision by general practitioners ( GPs ) and on patient outcomes . DESIGN : A r and omised experimental study with pre-measurement and post-measurement ( after one year ) in an experimental group and a control group in Dutch general practice . SUBJECTS AND INTERVENTION : Two groups of GPs were formed and r and omised . The education and peer review group ( 17 GPs with 210 patients ) had an intervention consisting of an interactive group education and peer review programme ( four sessions each lasting two hours ) . The control group consisted of 17 GPs with 223 patients ( no intervention ) . MAIN OUTCOME MEASURES : Knowledge , skills , opinion about asthma and COPD care , presence of equipment in practice ; actual performance about peakflow measurement , non-pharmacological and pharmacological treatment ; asthma symptoms ( Dutch Medical Research Council ) , smoking habits , exacerbation ratio , and disease specific quality of life ( QOL-RIQ ) . Data were collected by a written question naire for GPs , by self recording of consultations by GPs , and by a written self administered question naire for adult patients with asthma/ COPD . RESULTS : Data from 34 GP question naires , 433 patient question naires , and recordings from 934 consultations/visits and 350 repeat prescriptions were available . Compared with the control group there were only significant changes for self estimated skills ( + 16 % , 95 % confidence interval 4 % to 26 % ) and presence of peakflow meters in practice ( + 18 % , p < 0.05 ) . No significant changes were found for provided care and patient outcomes compared with the control group . In the subgroup of more severe patients , the group of older patients , and in the group of patients not using anti-inflammatory medication at baseline , no significant changes compared with the control group were seen in patient outcomes . CONCLUSION : Except for two aspects , intensive small group education and peer review in asthma and COPD care do not seem to be effective in changing relevant aspects of the provided care by GPs in accordance with guidelines , nor in changing patients ' health status Objective Medication errors are common , with junior doctors accounting for the majority in acute healthcare . Paediatrics is uniquely challenging , but the evidence base to guide prescribing education is limited . The authors set out to develop a short , educationally sound , low cost e-learning re source for paediatric prescribing to improve junior doctors ' prescribing skills and to evaluate its effectiveness . Design A non-blinded r and omised controlled trial . Setting North Western Deanery Foundation School , UK . Participants 162 volunteer foundation ( junior ) doctors r and omised into control ( 86 ) and intervention ( 76 ) groups . Interventions On study entry , participants were assessed on prescribing skill , prescribing habits and confidence . The intervention group completed the e-learning course design ed for the study , which took 1–2 h. At 1 and 3 months after the intervention , both groups were assessed on similar prescribing assessment s , habits and confidence . Main outcome measures Total score ( expressed as a percentage ) on prescribing assessment s , confidence and satisfaction scores . Results There were no preintervention differences in prescribing assessment s ( 67 % vs 67 % , p=0.56 ) . Postintervention , the e-learning group scored significantly higher than the control group ( 63 % vs 79 % , p<0.0001 ) . At 3 months , the e-learning group still scored significantly higher ( 69 % vs 79 % , p<0.0001 ) , with improved confidence scores ( p<0.0001 ) . Conclusions This short e-learning re source significantly improved the paediatric prescribing skills of junior doctors . Outcomes were maintained at 3 months , suggesting the utility of low cost , low fidelity , educationally sound e-learning interventions . However , the direct impact on patient outcomes following this intervention has yet to be determined BACKGROUND Antibiotics are a medication class for which inappropriate prescribing is frequently described . We sought to assess the effectiveness of a mailed intervention combining confidential prescribing feedback with targeted educational bulletins in increasing the use of less expensive , first-line antibiotics by practising physicians . METHODS The participants were 251 r and omly selected primary care physicians from southern Ontario who consented to participate ( 135 in the feedback group and 116 in the control group ) . Prescribing data were obtained from the cl aims data base of the Ontario Drug Benefit program , which covers all Ontarians over age 65 years for drugs selected from a minimally restrictive formulary . Confidentially prepared profiles of antibiotic prescriptions coupled with guidelines -based educational bulletins were mailed to the intervention group every 2 months for 6 months . The control group received no intervention until after completion of the study . The main outcome measures were change from baseline in physician 's median antibiotic cost and proportion of episodes of care in which a prespecified first-line antibiotic was used first . RESULTS The median prescription cost of about $ 11 remained constant in the feedback group but rose in the control group ( change of $ 0.05 v. $ 3.37 , p < 0.002 ) . First-line drug use increased in the feedback group but decreased in the control group ( change of 2.6 % v. -1.7 % , p < 0.01 ) . In a mailed survey of 100 feedback recipients ( response rate 76 % ) , 82 % indicated that they would participate readily in another , similar program . INTERPRETATION A simple program of confidential feedback and educational material s blunted cost increases , increased the use of first-line antibiotics and was highly acceptable to Ontario primary care physicians BACKGROUND Different methods have previously been tested to affect GPs ' prescribing habits . Attention has been drawn to benzodiazepines and antipsychotic drugs that are associated with several adverse effects in the elderly . OBJECTIVE To evaluate if educational outreach visits to GP practice s can affect the prescribing of benzodiazepines and antipsychotic drugs to the elderly and to evaluate the opinions of the participating GPs on such education . METHODS In the county of Skåne , Sweden , 41 GP practice s were invited to participate in educational outreach visits . Fifteen GP practice s accepted the invitation . Practice s were r and omised to active ( 8 practice s , 23 physicians ) and control group ( 7 practice s , 31 physicians ) . After the educational outreach visits prescribing of benzodiazepines and antipsychotic drugs to patients 65
Output:
| A broad range of educational interventions have been conducted to improve prescribing competency .
The WHO Guide to Good Prescribing has the largest body of evidence to support its use and is a promising model for the design of targeted prescribing courses . |
MS210534 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: The objective of our study was to investigate the relationship between sonographic findings and the occurrence of abortion in pregnancies complicated by first-trimester bleeding in which fetal cardiac activity was documented upon admission . A prospect i ve study of transvaginal sonography was performed in 270 pregnant patients with bleeding between 5 and 12 weeks ' gestation . The study group included 149 cases in which a singleton fetus with cardiac activity was initially documented . The outcome variable was pregnancy loss prior to 20 weeks . The influence of sonographic findings on admission was studied by univariate analysis and logistic regression . The prevalence of abortion was 23/149 ( 15 % ) . A significant relationship ( p < 0.05 ) was found between the occurrence of abortion and the following : fetal bradycardia ( heart rate less than -1.2 SD from the mean ) , a discrepancy between the diameter of the gestational sac and crown-rump length less than -0.5 SD from the mean , and a discrepancy between menstrual and sonographic age of more than 1 week . According to the logistic regression equation that was obtained , the probability of abortion in first-trimester bleeding with documented fetal cardiac activity upon admission varied between a minimum of 6 % when none of the above risk factors were present and a maximum of 84 % when all were present . The presence of any of the above factors identified 84 % of all subsequent abortions Between 1983 and 1984 a double-blind r and omized study with progesterone substitution in threatened abortion was carried out . Fifty-six patients with vaginal bleeding during the first trimester of pregnancy , the internal cervical os being closed , were referred to the hospital . Twenty-five women ( 5th and 6th week of gestation ) with positive serum concentrations of beta-hCG were admitted to the study without regard to sonogram results . In other 25 women ( 7th-10th week of pregnancy ) and 6 women ( greater than or equal to 11th week of pregnancy ) fetal heart action and movement could be demonstrated by ultrasound . The patients were prescribed bed rest and vaginal suppositories twice daily , containing either 25 mg progesterone or only polyethylene glycol . The code was not broken until after completion of the study . Serial serum determinations of beta-hCG , estradiol-17 beta ( E2 ) , progesterone , and ultrasound were performed . Four patients had to be omitted from final analysis ( two tubal pregnancies , one intrauterine infection , one sectio parva ) . Three of 26 patients progesterone ( 11 % ) and five of 26 patients with placebo ( 19 % ) had an abortion , which represented no significant difference . Frequency of abortion was increased in women more than 30 years old , in women with previous abortions and after ovulation induction . Progesterone treatment result ed in a significant elevation of serum progesterone concentrations ( p less than 0.01 ) , while beta-hCG and E2 were unchanged . The results of this study confirm that pregnancy outcome is favorable in women with bleeding and normal hormone concentrations without hormonal treatment and unfavorable in women with reduced beta-hCG and E2-concentrations . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVE To assess the clinical value of a single serum CA-125 level in women presenting with symptoms of imminent abortion from 5 to 12 weeks ' gestation . STUDY DESIGN Two hundred women with symptoms of imminent abortion from 5 to 12 weeks ' gestation were allocated to 3 subgroups : group I ( n = 50 ) , abdominal pain only ; group II ( n = 80 ) , abdominal pain and vaginal bleeding of less than 3 days ' duration ; and group III ( n = 70 ) , abdominal pain and vaginal bleeding of > or = 3 days ' duration . The control group ( n = 55 ) was women undergoing a normal pregnancy of comparable gestational age . In all patients , CA-125 and beta-human chorionic gonadotropin ( beta-hCG ) levels were determined with commercially available enzymatic immunoassay tests . RESULTS A significant increase in serum CA-125 levels was observed in patients with vaginal bleeding ( groups II and III ) in comparison with the control group . In contrast to CA-125 , serum beta-hCG levels were significantly lower in patients who went on to miscarry . Receiver operating characteristic curve analysis revealed that all women with symptoms of imminent abortion who have a CA-125 level of > or = 43.1 U/mL should be considered as having a greater risk of miscarriage . Patients with bleeding of > or = 3 days should have a threshold value of 66.5 U/mL applied as a risk determinant . CONCLUSION A single serum CA-125 level determination is valuable in women with imminent abortion presenting with abdominal pain , vaginal bleeding or both OBJECTIVE To assess the diagnostic value of maternal CA 125 in patients with symptomatic first trimester pregnancy and to evaluate the prognostic significance of CA 125 versus beta-hCG in early pregnancies with intact fetal heartbeat , complicated by vaginal bleeding . STUDY DESIGN Two prospect i ve open-label studies with longitudinal follow-up in the second trial . SETTING Academic Department of Obstetrics and Gynecology , University of Cologne . PATIENTS Study 1 : 168 patients presenting between gestational weeks 6 and 12 with : extrauterine pregnancy , 29 ; missed abortion , 50 ; incomplete spontaneous abortion , 38 ; imminent abortion , 33 ; and normal pregnancy ( no history of endometriosis or ovarian mass ) , 18 . Study 2 : Fifty consecutive patients with vaginal bleeding during gestational weeks 6 - 12 all of whom having demostrable fetal heartbeat . Eighteen patients finally aborted whereas the remainder had normally continuing pregnancy until term . MAIN OUTCOME MEASURE Study 1 : Single serum determinations of CA 125 and beta-hCG were correlated with the different disorders observed . Study 2 : Two sequential measurements of serum CA 125 and beta-hCG performed within a 5 - 7 days interval were related to the outcome of pregnancy as indicated by changes of the ultrasound presentation , miscarriage , future hospitalization , or delivery . RESULTS Study 1 : Patients with vaginal bleeding generally had higher median CA 125 values ( 38 IU/ml ; range 1.3 - 540 ) compared to non-bleeding patients ( 17.8 IU/ml ; range 1.0 - 157 ) . No statistically significant differences in regard to median serum CA 125 levels between symptomatic and normal pregnancies occurred : normal pregnancy , 25.5 IU/ml ( range 3.2 - 97 ) ; ectopic pregnancy , 26 IU/ml ( range 1.3 - 157 ) ; missed abortion , 19.1IU/ml ( range 1 - 242 ) ; threatened abortion , 48 IU/ml ( range 5.2 - 540 ) ; spontaneous abortion , 40 IU/ml ( range 5.4 - 442 ) . Study 2 : Initial CA 125 levels did not differ significantly between both groups of patients with 27/32 non-aborters and 13/18 aborters showing concentrations below 65 IU/ml . After 5 - 7 days , CA 125 in all patients who eventually aborted remained high or increased whereas non-aborters all had constantly low or steeply declining CA 125 measures . beta-hCG increased in all non-aborters but also in 13/18 aborters during the 5 - 7 day interval . CONCLUSION Single serum measurements of CA 125 in symptomatic first trimester pregnant patients failed to discriminate spontaneous abortion , ectopic or normal pregnancies . However , sequential determinations of maternal CA 125 measurements appear to be a highly sensitive prognostic marker in patients with viable pregnancy at risk for abortion OBJECTIVE The purpose of this study was to determine whether patients with first-trimester threatened abortion are at increased risk for poor pregnancy outcome . STUDY DESIGN A large prospect i ve multicenter data base was studied . Subjects were divided into three groups : ( 1 ) no bleeding , ( 2 ) light bleeding , and ( 3 ) heavy bleeding . Univariate and multivariable logistic regression analyses were used . RESULTS The study comprised 16,506 patients : 14,160 patients without bleeding , 2094 patients with light bleeding , and 252 patients with heavy bleeding . Patients with vaginal bleeding , light or heavy , were more likely to experience a spontaneous loss before 24 weeks of gestation ( odds ratio , 2.5 and 4.2 , respectively ) and cesarean delivery ( odds ratio , 1.1 and 1.4 , respectively ) . Light bleeding subjects were more likely to have preeclampsia ( odds ratio , 1.5 ) , preterm delivery ( odds ratio , 1.3 ) , and placental abruption ( odds ratio , 1.6 ) . Heavy vaginal bleeding subjects were more likely to have intrauterine growth restriction ( odds ratio , 2.6 ) , preterm delivery ( odds ratio , 3.0 ) , preterm premature rupture of membranes ( odds ratio , 3.2 ) , and placental abruption ( odds ratio , 3.6 ) . CONCLUSION First-trimester vaginal bleeding is an independent risk factor for adverse obstetric outcome that is directly proportional to the amount of bleeding Problem The role of increased Th1 cytokine expression in pregnancy failure has been question ed recently . The therapeutic value of progestogens in threatened abortion ( TA ) is still debated . The aim of this prospect i ve study was to compare serum cytokine [ tumor necrosis factor (TNF)‐α , interleukin (IL)‐12 and IL‐10 ] concentrations in women with TA to those in women with normal pregnancy and to evaluate the impact of dydrogesterone supplementation in the former group on cytokine concentration OBJECTIVE To compare the influence of vaginal micronized progesterone and oral dydrogesterone supplementation on uteroplacental circulation in early pregnancy that is complicated by threatened abortion . DESIGN R and omized , parallel group , double-blind , double dummy-controlled study . SETTING Tertiary care university hospital . PATIENT(S ) Fifty-three patients with threatened abortion and a living embryo . INTERVENTION(S ) Three hundred milligrams of micronized vaginal progesterone or 30 mg of oral dydrogesterone daily supplementation for 6 weeks , serial transvaginal Doppler ultrasound measurement of pulsatility index , resistance index , and systolic/diastolic ratio of the spiral arteries , the uterine arteries , and the intrachorionic area . MAIN OUTCOME MEASURE(S ) Uteroplacental blood flow . RESULT ( S ) The study demonstrated that vaginal progesterone administration , but not oral dydrogesterone treatment , results in the decrease in the spiral artery pulsatility and resistance index and systolic/diastolic ratio . Insignificant decrease in pulsatility index and resistance index of the uterine artery was observed at > 9 weeks and was not associated with treatment regimen . Dydrogesterone treatment was only accompanied by the decrease in the uterine artery systolic/diastolic ratio . CONCLUSION ( S ) Vaginal progesterone and oral dydrogesterone supplementation have a different influence on the uteroplacental circulation in early pregnancy that is complicated by threatened abortion Abstract Objective : To estimate the miscarriage rate in a cohort of pregnant women and the final outcome of pregnancy . Design : Two year prospect i ve community study . Setting : Women registered with four semirural practice s at one health centre . Subjects : 626 pregnant women from a population 21 448 , 5140 of whom were women aged 15 - 44 years . Main outcome measures : Vaginal bleeding and outcome of pregnancy . Results : 76 of the 89 women with an unwanted pregnancy requested a termination . In the 550 ongoing pregnancies bleeding occurred before the 20th week in 117 ( 21 % ) , and 67 ( 12 % ) ended in miscarriage . The risk of miscarriage was not significantly increased after a miscarriage in the previous pregnancy ( 11 ( 15 % ) women had miscarriage v 55 ( 12 % ) women who had not had miscarriage ) who had previously had a live birth ) . Of the 117 women with bleeding , 64 were not admitted to hospital by the general practitioner ; 42 of these women had an ultrasound examination at the health centre and 19 subsequently miscarried at home . In hospital 41 of 46 women who miscarried had evacuation of the uterus . Conclusions : Bleeding occurred in one fifth of recognised pregnancies before the 20th week and over half of these miscarried . Treatment of women with miscarriage at home means current statistics on miscarriage in Britain are missing many cases . Key messages No national statistics for Britain are published on miscarriages Extrapolations from this survey indicate that in 1993 there may have been 70 000 - 90 000 miscarriages in Engl and and Wales Bleeding in early pregnancy is followed by a live birth in about half the affected pregnancies At least a quarter of all miscarriages were treated at home by general practitioners and would therefore not be recorded in any published statistics Women who
Output:
| Although all the predictive and confounding factors could not be controlled for , the results of this systematic review show a significant reduction of 47 % in the odds for miscarriage when dydrogesterone is compared to st and ard care indicating a real treatment effect |
MS210535 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND VEGFR-2 has a role in gastric cancer pathogenesis and progression . We assessed whether ramucirumab , a monoclonal antibody VEGFR-2 antagonist , in combination with paclitaxel would increase overall survival in patients previously treated for advanced gastric cancer compared with placebo plus paclitaxel . METHODS This r and omised , placebo-controlled , double-blind , phase 3 trial was done at 170 centres in 27 countries in North and South America , Europe , Asia , and Australia . Patients aged 18 years or older with advanced gastric or gastro-oesophageal junction adenocarcinoma and disease progression on or within 4 months after first-line chemotherapy ( platinum plus fluoropyrimidine with or without an anthracycline ) were r and omly assigned with a central ised interactive voice or web-response system in a 1:1 ratio to receive ramucirumab 8 mg/kg or placebo intravenously on days 1 and 15 , plus paclitaxel 80 mg/m(2 ) intravenously on days 1 , 8 , and 15 of a 28-day cycle . A permuted block r and omisation , stratified by geographic region , time to progression on first-line therapy , and disease measurability , was used . The primary endpoint was overall survival . Efficacy analysis was by intention to treat , and safety analysis included all patients who received at least one treatment with study drug . This trial is registered with Clinical Trials.gov , number NCT01170663 , and has been completed ; patients who are still receiving treatment are in the extension phase . FINDINGS Between Dec 23 , 2010 , and Sept 23 , 2012 , 665 patients were r and omly assigned to treatment-330 to ramucirumab plus paclitaxel and 335 to placebo plus paclitaxel . Overall survival was significantly longer in the ramucirumab plus paclitaxel group than in the placebo plus paclitaxel group ( median 9·6 months [ 95 % CI 8·5 - 10·8 ] vs 7·4 months [ 95 % CI 6·3 - 8·4 ] , hazard ratio 0·807 [ 95 % CI 0·678 - 0·962 ] ; p=0·017 ) . Grade 3 or higher adverse events that occurred in more than 5 % of patients in the ramucirumab plus paclitaxel group versus placebo plus paclitaxel included neutropenia ( 133 [ 41 % ] of 327 vs 62 [ 19 % ] of 329 ) , leucopenia ( 57 [ 17 % ] vs 22 [ 7 % ] ) , hypertension ( 46 [ 14 % ] vs eight [ 2 % ] ) , fatigue ( 39 [ 12 % ] vs 18 [ 5 % ] ) , anaemia ( 30 [ 9 % ] vs 34 [ 10 % ] ) , and abdominal pain ( 20 [ 6 % ] vs 11 [ 3 % ] ) . The incidence of grade 3 or higher febrile neutropenia was low in both groups ( ten [ 3 % ] vs eight [ 2 % ] ) . INTERPRETATION The combination of ramucirumab with paclitaxel significantly increases overall survival compared with placebo plus paclitaxel , and could be regarded as a new st and ard second-line treatment for patients with advanced gastric cancer . FUNDING Eli Lilly and Company Background : This study aim ed to determine whether combination S-1 plus cisplatin ( CDDP ) therapy , the most widely used therapy for Japanese patients with advanced gastric cancer , and the novel oral antiangiogenic agent TSU-68 could contribute to gastric cancer treatment . Methods : Ninety-three patients with chemotherapy-naïve unresectable or recurrent advanced gastric cancers were r and omised into two groups : TSU-68 plus S-1/CDDP ( group A ) and S-1/CDDP ( group B ) groups . Both patient groups received identical S-1 and CDDP dosages . TSU-68 was orally administered for 35 consecutive days . Group B patients received S-1 orally twice daily for three consecutive weeks , followed by intravenous CDDP on day 8 . The primary endpoint was progression-free survival ( PFS ) . Results : Median PFS periods were 208 and 213 days in groups A and B , respectively ( P=0.427 ) . Median survival periods for groups A and B were 497.0 and 463.5 days , respectively ( P=0.219 ) . No statistically significant differences were noted for PFS , survival or the adverse event ( AE ) incidence rate . All AEs were expected according to previous reports for TSU-68 , TS-1 , and CDDP . Conclusion : Combination therapy involving TSU-68 , S-1 , and CDDP was safe and well tolerated in patients with chemotherapy-naïve unresectable or recurrent advanced gastric cancers . However , factors related to therapeutic efficacy should be investigated further PURPOSE We evaluated the activity of regorafenib , an oral multikinase inhibitor , in advanced gastric adenocarcinoma . PATIENTS AND METHODS We conducted an international ( Australia and New Zeal and , South Korea , and Canada ) r and omized phase II trial in which patients were r and omly assigned at a two-to-one ratio and stratified by lines of prior chemotherapy for advanced disease ( one v two ) and region . Eligible patients received best supportive care plus regorafenib 160 mg or matching placebo orally on days 1 to 21 of each 28-day cycle until disease progression or prohibitive adverse events occurred . The primary end point was progression-free survival ( PFS ) . Final analysis included data to December 31 , 2014 . RESULTS A total of 152 patients were r and omly assigned from November 7 , 2012 , to February 25 , 2014 , yielding 147 evaluable patients ( regorafenib , n = 97 ; placebo , n = 50 ) . Baseline characteristics were balanced . Median PFS significantly differed between groups ( regorafenib , 2.6 months ; 95 % CI , 1.8 to 3.1 and placebo , 0.9 months ; 95 % CI , 0.9 to 0.9 ; hazard ratio [ HR ] , 0.40 ; 95 % CI , 0.28 to 0.59 ; P < .001 ) . The effect was greater in South Korea than in Australia , New Zeal and , and Canada combined ( HR , 0.12 v 0.61 ; interaction P < .001 ) but consistent across age , neutrophil-to-lymphocyte ratio , primary site , lines of chemotherapy , peritoneal metastasis presence , number of metastatic sites , and plasma vascular endothelial growth factor A. A survival trend in favor of regorafenib was seen ( median , 5.8 months ; 95 % CI , 4.4 to 6.8 v 4.5 months ; 95 % CI , 3.4 to 5.2 ; HR , 0.74 ; P = .147 ) . Twenty-nine patients assigned to placebo received open-label regorafenib after disease progression . Regorafenib toxicity was similar to that previously reported . CONCLUSION In this phase II trial , regorafenib was effective in prolonging PFS in refractory advanced gastric adenocarcinoma . Regional differences were found , but regorafenib was effective in both regional groups . A phase III trial is planned BACKGROUND Trastuzumab , a monoclonal antibody against human epidermal growth factor receptor 2 ( HER2 ; also known as ERBB2 ) , was investigated in combination with chemotherapy for first-line treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer . METHODS ToGA ( Trastuzumab for Gastric Cancer ) was an open-label , international , phase 3 , r and omised controlled trial undertaken in 122 centres in 24 countries . Patients with gastric or gastro-oesophageal junction cancer were eligible for inclusion if their tumours showed overexpression of HER2 protein by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation . Participants were r and omly assigned in a 1:1 ratio to receive a chemotherapy regimen consisting of capecitabine plus cisplatin or fluorouracil plus cisplatin given every 3 weeks for six cycles or chemotherapy in combination with intravenous trastuzumab . Allocation was by block r and omisation stratified by Eastern Cooperative Oncology Group performance status , chemotherapy regimen , extent of disease , primary cancer site , and measurability of disease , implemented with a central interactive voice recognition system . The primary endpoint was overall survival in all r and omised patients who received study medication at least once . This trial is registered with Clinical Trials.gov , number NCT01041404 . FINDINGS 594 patients were r and omly assigned to study treatment ( trastuzumab plus chemotherapy , n=298 ; chemotherapy alone , n=296 ) , of whom 584 were included in the primary analysis ( n=294 ; n=290 ) . Median follow-up was 18.6 months ( IQR 11 - 25 ) in the trastuzumab plus chemotherapy group and 17.1 months ( 9 - 25 ) in the chemotherapy alone group . Median overall survival was 13.8 months ( 95 % CI 12 - 16 ) in those assigned to trastuzumab plus chemotherapy compared with 11.1 months ( 10 - 13 ) in those assigned to chemotherapy alone ( hazard ratio 0.74 ; 95 % CI 0.60 - 0.91 ; p=0.0046 ) . The most common adverse events in both groups were nausea ( trastuzumab plus chemotherapy , 197 [ 67 % ] vs chemotherapy alone , 184 [ 63 % ] ) , vomiting ( 147 [ 50 % ] vs 134 [ 46 % ] ) , and neutropenia ( 157 [ 53 % ] vs 165 [ 57 % ] ) . Rates of overall grade 3 or 4 adverse events ( 201 [ 68 % ] vs 198 [ 68 % ] ) and cardiac adverse events ( 17 [ 6 % ] vs 18 [ 6 % ] ) did not differ between groups . INTERPRETATION Trastuzumab in combination with chemotherapy can be considered as a new st and ard option for patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer . FUNDING F Hoffmann-La Roche Background As a multi-targeted anti-angiogenic receptor tyrosine kinase ( RTK ) inhibitor sunitinib ( SUN ) has been established for renal cancer and gastrointestinal stromal tumors . In advanced refractory esophagogastric cancer patients , monotherapy with SUN was associated with good tolerability but limited tumor response . Methods This double-blind , placebo-controlled , multicenter , phase II clinical trial was conducted to evaluate the efficacy , safety and tolerability of SUN as an adjunct to second and third-line FOLFIRI ( NCT01020630 ) . Patients were r and omized to receive 6-week cycles including FOLFIRI plus sodium folinate ( Na-FOLFIRI ) once every two weeks and SUN or placebo ( PL ) continuously for four weeks followed by a 2-week rest period . The primary study endpoint was progression-free survival ( PFS ) . Preplanned serum analyses of VEGF-A , VEGF-D , VEGFR2 and SDF-1α were performed retrospectively . Results Overall , 91 patients were r and omized , 45 in each group ( one patient withdrew ) . The main grade ≥3 AEs were neutropenia and leucopenia , observed in 56 % /20 % and 27 % /16 % for FOLFIRI + SUN/FOLFIRI + PL , respectively . Median PFS was similar , 3.5 vs. 3.3 months ( hazard ratio ( HR ) 1.11 , 95 % CI 0.70–1.74 , P = 0.66 ) for FOLFIRI + SUN vs. FOLFIRI + PL , respectively . For FOLFIRI + SUN , a trend towards longer median overall survival ( OS ) compared with placebo was observed ( 10.4 vs. 8.9 months , HR 0.82 , 95 % CI 0.50–1.34 , one-sided P = 0.21 ) . In subgroup serum analyses , significant changes in VEGF-A ( P = 0.017 ) , VEGFR2 ( P = 0.012 ) and VEGF-D ( P < 0.001 ) serum levels were observed . Conclusions Although sunitinib combined with FOLFIRI did not improve PFS and response in chemotherapy-resistant gastric cancer , a trend towards better OS was observed . Further biomarker-driven studies with other anti-angiogenic RTK inhibitors are warranted . Trial registration This study was registered prospect ively in the NCT Clinical Trials Registry ( Clinical Trials.gov ) under NCT01020630 on November 23 , 2009 after approval by the leading ethics committee of the Medical Association of Rhinel and -Palatinate , Main
Output:
| Conclusions The addition of AAs to st and ard therapy in mOGC improves OS .
Improved efficacy was only observed in 2nd- or 3rd-line setting and not in 1st-line setting .
Consistent OS benefit was present across all geographical regions .
This benefit is at the expense of increased overall toxicity |
MS210536 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To assess the impact of digital problem-based learning ( PBL ) cases on student learning in ophthalmology courses . METHODS Ninety students were r and omly divided into 3 classes ( 30 students per class ) . The first class studied under a didactic model . The other 2 classes were divided into 6 groups ( 10 students per group ) and received PBL teaching ; 3 groups studied via cases presented in digital form and the others studied via paper-form cases . The results of theoretical and case analysis examinations were analyzed using the chi(2 ) test . Student performance on the interval practice was analyzed using the Kruskal-Wallis test . Question naires were used to evaluate student and facilitator perceptions . RESULTS Students in the digital groups exhibited better performance in the practice procedures according to tutorial evaluations compared with the other groups ( P < .05 ) . The 2 PBL classes had significantly higher mean results of theoretical and case analysis examinations ( P < .001 ) , but there was no significant difference between the 2 PBL classes . Ninety-three percent of students in the digital groups ( vs 73 % in the paper groups ) noted that the cases greatly stimulated their interest . CONCLUSIONS Introducing PBL into ophthalmology could improve educational quality and effectiveness . Digital PBL cases stimulate interest and motivate students to further improve diagnosis and problem-h and ling skills Background / aim : Owing to the complex topographical aspects of ophthalmic surgery , teaching with conventional surgical videos has led to a poor underst and ing among medical students . A novel multimedia three dimensional ( 3D ) computer animated program , called “ Ophthalmic Operation Vienna ” has been developed , where surgical videos are accompanied by 3D animated sequences of all surgical steps for five operations . The aim of the study was to assess the effect of 3D animations on the underst and ing of cataract and glaucoma surgery among medical students . Method : Set in the Medical University of Vienna , Department of Ophthalmology , 172 students were r and omised into two groups : a 3D group ( n = 90 ) , that saw the 3D animations and video sequences , and a control group ( n = 82 ) , that saw only the surgical videos . The narrated text was identical for both groups . After the presentation , students were question ed and tested using multiple choice questions . Results : Students in the 3D group found the interactive multimedia teaching methods to be a valuable supplement to the conventional surgical videos . The 3D group outperformed the control group not only in topographical underst and ing by 16 % ( p<0.0001 ) , but also in theoretical underst and ing by 7 % ( p<0.003 ) . Women in the 3D group gained most by 19 % over the control group ( p<0.0001 ) . Conclusions : The use of 3D animations lead to a better underst and ing of difficult surgical topics among medical students , especially for female users . Gender related benefits of using multimedia should be further explored OBJECTIVE Nurses need to be competent and confident in performing drug calculations to ensure patient safety . The purpose of this study is to compare an interactive e-drug calculations package , developed using Cognitive Load Theory as its theoretical framework , with traditional h and out learning support on nursing students ' drug calculation ability , self-efficacy and support material satisfaction . DESIGN A cluster r and omised controlled trial comparing the e-package with traditional h and out learning support was conducted with a September cohort ( n=137 ) and a February cohort ( n=92 ) of second year diploma nursing students . Students from each cohort were geographically dispersed over 3 or 4 independent sites . MEASUREMENTS Students from each cohort were invited to participate , halfway through their second year , before and after a 12 week clinical practice placement . During their placement the intervention group received the e-drug calculations package while the control group received traditional ' h and out ' support material . Drug calculation ability and self-efficacy tests were given to the participants pre- and post-intervention . Participants were given the support material satisfaction scale post-intervention . RESULTS Students in both cohorts r and omised to e-learning were more able to perform drug calculations than those receiving the h and out ( September : mean 48.4 % versus 34.7 % , p=0.027 ; February : mean 47.6 % versus 38.3 % , p=0.024 ) . February cohort students using the e-package were more confident in performing drug calculations than those students using h and outs ( self-efficacy mean 56.7 % versus 45.8 % , p=0.022 ) . There was no difference in improved self-efficacy between intervention and control for students in the September cohort . Students who used the package were more satisfied with its use than the students who used the h and out ( mean 29.6 versus 26.5 , p=0.001 ) , particularly with regard to the package enhancing their learning ( p=0.023 ) , being an effective way to learn ( p=0.005 ) , providing practice and feedback ( p<0.001 ) , being accessible ( p=0.027 ) , user friendly ( p=0.02 ) and providing learning enjoyment ( p=0.022 ) . CONCLUSION It is essential that nurses are educated and supported to become , and remain , confident and competent in performing drug calculations . This study found the e-drug calculations package , based on Cognitive Load Theory , to be significantly more effective than a h and out in improving students ' drug calculation ability and self-efficacy , with students who used the package being significantly more satisfied with its use than students who used the h and out . This package could particularly be useful for the continuing professional development of any healthcare professional involved in drug calculations Purpose To compare , using a prospect i ve , r and omized controlled study , three methods of teaching a medical school parasitology course : computer-based instruction , traditional lecture-based instruction , and a combination of computer-based and lecture-based instruction . Method A single class of the University of Utah School of Medicine was r and omized into three study groups for the second-year parasitology course . The computer group ( n = 29 ) used a locally developed interactive parasitology computer program ; the lecture group ( n = 32 ) had traditional lectures , and the combined group ( n = 33 ) used both the computer program and lectures . Students ' knowledge was assessed using a pretest , a final examination , and a posttest administered four months after the course . Students also used logs to track the amounts of time they spent study ing . Their impressions and course evaluations were collected using a st and ardized course-evaluation form . Results The groups ' scores on the pretest , final examination , and posttest were not statistically significantly different . Students in the computer group averaged 26.8 hours of study ing over the two-week course compared with 32.1 hours in the lecture group and 32.7 hours in the combined group . The difference in study times between the computer and combined groups yielded a significant p value of 0.036 . Students were generally positive about the course and the computer program . Conclusion Students can learn parasitology from computer-based instruction as effectively as from traditional lecture-based instruction , and they can do so in less time BACKGROUND Curricular medical training on dementia at the Department of Psychiatry and Psychotherapy at the University of Erlangen comprises of a traditional lecture . This setting was compared with two different E-Learning formats using a r and omized study design . METHODS 104 students ( average age 26.3 + /- 3.6 years ) were r and omized into 3 groups : Interactive e-Learning ; virtual lecture ( slides and audio ) and st and ard lecture ( control group ; 90 minutes ) . RESULTS Overall , the response rate was 40.4 % . Assessment of formal knowledge using a multiple-choice test yielded no differences between the three groups . In the students ' evaluation , the interactive e-learning showed the best results ( 1.86 + /- 0.69 ) , followed by the st and ard lecture ( 2.0 + /- 0.71 ) and the virtual lecture ( 2.6 + /- 0.8 ) . Nevertheless , the students would not prefer e-learning to the st and ard lecture when both methods are directly compared . CONCLUSION Our findings suggest that e-learning is equivalent to a st and ard lecture when formal knowledge is assessed . Evaluation results are best for interactive e-learning formats . The detailed reasons for the preference of different learning styles should be further investigated OBJECTIVES To determine the long-term retention of a 3-dimentional ( 3-D ) educational computer model of the larynx to teach laryngeal anatomy and to compare it with st and ard written instruction ( SWI ) . DESIGN Prospect i ve r and omized controlled trial . SETTING University education program . PARTICIPANTS One hundred health care students . INTERVENTIONS For short-term assessment , 50 students were r and omized to the 3-D model and 50 to SWI and were tested using a 20- question laryngeal test . Six months later , the same students were invited to retake the laryngeal anatomy test to examine long-term retention . MAIN OUTCOME MEASURE The score on a 20-item Web-based test that assessed the students ' level of knowledge of laryngeal anatomy approximately 6 months after their initial exposure to the laryngeal anatomy teaching intervention . RESULTS Sixty-two students retook the test : 3-D ( n = 30 ) and SWI ( n = 32 ) . No significant difference was noted in mean scores ( P = .54 ) and change in scores ( P = .59 ) between short- and long-term retention on the laryngeal anatomy test . There was a trend toward an increase in 3-D scores in both groups ( P = .07 ) and a significant increase in 3-D scores in the 3-D group only ( P = .049 ) . CONCLUSIONS A low-fidelity model ( SWI ) is just as effective as a high-fidelity model ( 3-D ) in teaching laryngeal anatomy . The acquired knowledge from either educational intervention may last up to 6 months for long-term retention . This study is one of the few in medical education to examine long-term retention OBJECTIVES To explore medical students ' use of computer tutorials embedded in a busy clinical setting ; to demonstrate that such tutorials can increase knowledge gain over and above that attributable to the clinical rotation itself . METHODS Six tutorials were installed on a computer placed in a central area in an emergency department . Each tutorial was made up of between 33 and 85 screens of information that include text , graphics , animations , and questions . They were design ed to be brief ( 10 minutes ) , focused , interactive , and immediately relevant . The authors evaluated the intervention using quantitative research methods , including usage tracking , surveys of faculty and students , and a r and omized pretest-posttest study . RESULTS Over 46 weeks , 95 medical students used the tutorials 544 times , for an overall average of 1.7 times a day . The median time spent on completed tutorials was 11 minutes ( average [ SD ] , 14 [ + /-12 ] minutes ) . Seventy-four students completed the r and omized study . They completed 65 % of the assigned tutorials , result ing in improved examination scores compared with the control ( effect size , 0.39 ; 95 % confidence interval = 0.15 to 0.62 ) . Students were positively disposed to the tutorials , ranking them as " valuable . " Fifty-four percent preferred the tutorials to small group teaching sessions with a preceptor . The faculty was also positive about the tutorials , although they did not appear to integrate the tutorials directly into their teaching . CONCLUSIONS Medical students on rotation in a busy clinical setting can and will use appropriately presented computer tutorials . The tutorials are effective in raising examination scores BACKGROUND Computer-based video training ( CBVT ) provides flexible opportunities for surgical trainees to learn fundamental technical skills , but may be ineffective in self-directed practice setting s because of poor trainee self- assessment . This study examined whether CBVT is effective in a self-directed learning environment among novice trainees . METHODS Thirty novice trainees used CBVT to learn the 1-h and ed square knot while self-assessing their proficiency every 3 minutes . On reaching self-assessed skill proficiency , trainees were r and omized to either cease practice or to complete additional practice . Performance was evaluated with computer and expert-based measures during practice and on pretests , posttests , and 1-week retention tests . RESULTS Analyses revealed performance improvements for both groups ( all P < .05 ) , but no differences between the 2 groups ( all P > .05 ) on all tests . CONCLUSIONS CBVT for the 1-h and ed square knot is effective in a self-directed learning environment among novices . This lends support to the implementation of self-directed digital media-based learning within surgical curricula BACKGROUND We carried out a prospect i ve , r and omized , 4-arm study including control arm , blinding of examiners to determine effectiveness of computer-based video instruction ( CBVI ) and different types of expert feedback ( concurrent and summary ) on learning of a basic technical skill . METHODS Using bench models , participants were pre-tested on a suturing and instrument knot-tying skill after viewing an instructional video . The students were subsequently assigned r and omly to 4 practice conditions : no additional intervention ( control ) , self study with CBVI , expert feedback during practice trials ( concurrent feedback ) , and expert feedback after practice trials ( summary feedback ) . All participants underwent 19 trials of practice , over 1 hour , in their assigned training condition . The effectiveness of training was assessed both at an immediate post-test and 1 month later at a retention test . Performance was evaluated using both expert-based ( Global Rating Scores ) and computer-based assessment ( H and Motion Analysis ) . Data were analyzed using repeated- measures ANOVA . RESULTS There were no differences in GRS between groups at pre-test . The CBVI , concurrent feedback and summary feedback methods were equally effective initially for the instruction of this basic technical skill to naive medical students and displayed better performance than control ( control , 12.7
Output:
| Generally no differences in attitudes or preference of eLearning over traditional learning were observed .
No clear trends were found in the comparison of different modes of eLearning .
Conclusions Our results suggest that offline eLearning is equivalent and possibly superior to traditional learning regarding knowledge , skills , attitudes and satisfaction . |
MS210537 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE The goals of this study were to examine agreement and estimate differences in sensitivity between pain assessment scales . DESIGN Multiple simultaneous pain assessment s by patients in acute pain after oral surgery were used to compare a four-category verbal rating scale ( VRS-4 ) and an 11-point numeric rating scale ( NRS-11 ) with a 100-mm visual analog scale ( VAS ) . The sensitivity of the scales ( i.e. , their ability [ power ] to detect differences between treatments ) was compared in a simulation model by sampling from true pairs of observations using varying treatment differences of predetermined size . RESULTS There was considerable variability in VAS scores within each VRS-4 or NRS-11 category both between patients and for repeated measures from the same patient . Simulation experiments showed that the VAS was systematic ally more powerful than the VRS-4 in all simulations performed . The sensitivity of the VAS and NRS-11 was approximately equal . CONCLUSIONS In this acute pain model , the VRS-4 was less sensitive than the VAS . The simulation results demonstrated similar sensitivity of the NRS-11 and VAS when comparing acute postoperative pain intensity . The choice between the VAS and NRS-11 can thus be based on subjective preferences & NA ; Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies Introduction This open-label , phase 3b study evaluated the effectiveness and tolerability of oral tapentadol prolonged release ( PR ; 50–250 mg twice daily [ b.i.d . ] ) for managing severe , chronic low back pain in patients responding to World Health Organization ( WHO ) step III opioids but tolerating treatment poorly . Equianalgesic ratios for tapentadol to prior strong opioids were calculated . Methods Patients rotated directly from prior WHO step III opioids to tapentadol . Patients received tapentadol PR ( 50–250 mg b.i.d . ) during 5-week titration and 7-week maintenance periods . Tapentadol immediate release ( IR ) 50 mg ( ≤twice/day , ≥4 h apart ) was allowed ( total daily dose of tapentadol PR and IR ≤500 mg/day ) . The primary endpoint was responder rate 1 at week 6 ( percentage of patients with the same or less pain intensity [ 11-point numerical rating scale ( NRS ; 3-day average ) ] vs week −1 ) . Results Responder rate 1 at week 6 ( last observation carried forward [ LOCF ] ) was 80.9 % ( 76/94 ; P < 0.0001 vs. the null responder hypothesis rate [ < 60 % ] ) , result ing in a positive trial despite premature termination ( 136 recruited of 180 planned ) . Significant improvements from baseline in pain intensity and neuropathic pain symptoms were observed at weeks 6 and 12 with tapentadol PR ( P < 0.05 ) . Equianalgesic ratios were calculated for PR formulations alone and for PR and IR formulations combined for tapentadol to oxycodone , buprenorphine , fentanyl , morphine , and hydromorphone . The prevalences of adverse events reported as the reason for switching to tapentadol ( most commonly constipation and nausea ) decreased over time . Conclusions Tapentadol PR ( 50–250 mg b.i.d . ) provided at least comparable pain relief and improved tolerability versus prior strong opioids in patients with severe , chronic low back pain responding to WHO step III therapy . Conversion from strong opioids to tapentadol PR , with its two mechanisms of action , went smoothly considering overall effectiveness and tolerability outcomes . Equianalgesic ratios of tapentadol to oxycodone and other strong opioids were in line with other phase 3/3b studies Objective : To evaluate the efficacy and safety of tapentadol extended release ( ER ) for the management of moderate to severe chronic low back pain . Research design : Patients ( N = 981 ) were r and omized 1:1:1 to receive tapentadol ER 100 – 250 mg b.i.d . , oxycodone HCl controlled release ( CR ) 20 – 50 mg b.i.d . , or placebo over 15 weeks ( 3-week titration period , 12-week maintenance period ) . Main outcome measures : Efficacy was assessed as change from baseline in average pain intensity ( 11-point NRS ) at week 12 of the maintenance period and throughout the maintenance period ; last observation carried forward was used to impute missing pain scores . Adverse events ( AEs ) were monitored throughout the study . Results : Tapentadol ER significantly reduced average pain intensity versus placebo at week 12 ( least squares mean difference vs placebo [ 95 % confidence interval ] , −0.8 [ −1.22 , −0.47 ] ; p < 0.001 ) and throughout the maintenance period ( −0.7 [ −1.06,−0.35 ] ; p < 0.001 ) . Oxycodone CR significantly reduced average pain intensity versus placebo at week 12 ( −0.9 [ −1.24,−0.49 ] ; p < 0.001 ) and throughout the maintenance period ( −0.8 [ −1.16,−0.46 ] ; p < 0.001 ) . Tapentadol ER was associated with a lower incidence of treatment-emergent AEs ( TEAEs ) than oxycodone CR . Gastrointestinal TEAEs , including constipation , nausea , and vomiting , were among the most commonly reported TEAEs ( placebo , 26.3 % ; tapentadol ER , 43.7 % ; oxycodone CR , 61.9 % ) . The odds of experiencing constipation or the composite of nausea and /or vomiting were significantly lower with tapentadol ER than with oxycodone CR ( both p < 0.001 ) . Conclusions : Tapentadol ER ( 100 – 250 mg b.i.d . ) effectively relieved moderate to severe chronic low back pain over 15 weeks and had better gastrointestinal tolerability than oxycodone HCl CR ( 20 – 50 mg b.i.d . ) OBJECTIVE To establish basic epidemiological data on chronic pain ( duration > 3 months ) in a defined population . Relationships between age , gender , and social class were tested . DESIGN A survey of pain symptoms , including location , intensity , duration , and functional capacity , was conducted by means of a mail question naire . SETTING General population s in two Swedish primary health care districts . Medical care was provided in a state health system . SUBJECTS A r and om sample ( from the population register ) of 15 % of the population aged 25 - 74 ( n = 1,806 ) . The response rate was 90 % . OUTCOME MEASURES Descriptive epidemiologic data in relation to objectives of the study . RESULTS Without sex differences , 55 % ( 95 % confidence interval , 53 - 58 % ) of the population had perceived persistent pain for 3 months and 49 % for 6 months . Among individuals with chronic pain , 90 % localized their pain to the musculoskeletal system to a variable extent . Women experienced more multiple localizations of pain and had pain in the neck , shoulder , arm , and thigh to a greater extent than men . Prevalence of pain increased by age up to 50 - 59 years for both genders and then slowly decreased . The neck-shoulder area was the most common site of pain ( 30.2 % ) , followed by the lower back ( 23.2 % ) . Even in the youngest age groups more than one of four reported chronic pain . Blue-collar workers and employers ( including farmers ) reported chronic pain to a greater extent than other groups . In 13 % of the population , manifest pain problems were associated with reduced functional capacity . CONCLUSION Chronic pain symptoms are common but unevenly distributed in a general population . The results may influence planning and consultation in primary health care as well as warranting selective prevention activities BACKGROUND Tapentadol is a novel , central ly acting analgesic with 2 mechanisms of action : µ-opioid receptor agonism and norepinephrine reuptake inhibition . This r and omized , open-label phase 3 study ( Clinical Trials.gov Identifier : NCT00361504 ) assessed the long-term safety and tolerability of tapentadol extended release ( ER ) in patients with chronic knee or hip osteoarthritis pain or low back pain . METHODS Patients were r and omized 4:1 to receive controlled , adjustable , oral , twice-daily doses of tapentadol ER ( 100 to 250 mg ) or oxycodone HCl controlled release ( CR ; 20 to 50 mg ) for up to 1 year . Efficacy evaluations included assessment s at each study visit of average pain intensity ( 11-point numerical rating scale ) over the preceding 24 hours . Treatment-emergent adverse events ( TEAEs ) and discontinuations were monitored throughout the study . RESULTS A total of 1,117 patients received at least 1 dose of study drug . Mean ( st and ard error ) pain intensity scores in the tapentadol ER and oxycodone CR groups , respectively , were 7.6 ( 0.05 ) and 7.6 ( 0.11 ) at baseline and decreased to 4.4 ( 0.09 ) and 4.5 ( 0.17 ) at endpoint . The overall incidence of TEAEs was 85.7 % in the tapentadol ER group and 90.6 % in the oxycodone CR group . In the tapentadol ER and oxycodone CR groups , respectively , TEAEs led to discontinuation in 22.1 % and 36.8 % of patients ; gastrointestinal TEAEs led to discontinuation in 8.6 % and 21.5 % of patients . CONCLUSION Tapentadol ER ( 100 to 250 mg bid ) was associated with better gastrointestinal tolerability than oxycodone HCl CR ( 20 to 50 mg bid ) and provided sustainable relief of moderate to severe chronic knee or hip osteoarthritis or low back pain for up to 1 year OBJECTIVE To evaluate via retrospective analysis the efficacy and tolerability of tapentadol extended release ( ER ; 100 - 250 mg bid ) based on patient-specific factors , including baseline pain intensity , prior opioid experience , gender , and body mass index ( BMI ) . DESIGN Data were pooled from three r and omized , double-blind phase III studies of similar design that evaluated the efficacy and tolerability of tapentadol ER for the management of moderate to severe , chronic osteoarthritis knee pain ( NCT00421928 , NCT00486811 ) or low back pain ( NCT00449176 ) . SETTING In the original trials , patients were recruited at primary , secondary , and tertiary care centers , institutional setting s , and private practice s in North America , Europe , Australia , and New Zeal and . PATIENTS Data were analyzed separately for groups of patients divided by baseline pain intensity , prior opioid experience , gender , and BMI . INTERVENTIONS Patients received twice-daily placebo , tapentadol ER ( 100 - 250 mg ) , or oxycodone HCl controlled release ( CR ; 20 - 50 mg ) for a 3-week titration and 12-week maintenance period . MAIN OUTCOME MEASURES Changes from baseline in average pain intensity ( 11-point numerical rating scale ) at week 12 of the maintenance period and for the overall maintenance period . RESULTS Efficacy and tolerability were evaluated in 2,968 and 2,974 patients , respectively . The efficacy of tapentadol ER was shown in sub population s divided by baseline
Output:
| Tapentadol extended release is associated with a reduction in pain intensity in comparison to placebo and oxycodone .
Tapentadol is associated with a more favourable safety profile and tolerability than oxycodone |
MS210538 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The effect of prostagl and in E2 ( PGE2 ) in ' ripening ' the cervix was studied in 33 patients who required surgical induction of labour . Patients included primigravidas and parous subjects between 36 and 42 weeks of gestation . Sixteen patients received a total oral dose of 5 mg PGE2 and 17 received 4 - 6 mg PGE2 intravaginally in the form of a gel . There was significant improvement in ' ripeness ' of the cervix in all groups , the intravaginal route giving slightly better results than the oral route . Ten patients remained unsuitable for induction because of inadequate dilatation of the cervix or a high fetal head . Four patients on oral therapy developed late decelerations of the fetal heart and 3 of these were delivered by immediate caesarean section . The implication s of this and the reasons for the inability to perform inductions after ' ripening ' are discussed OBJECTIVE To clarify the safety of elective induction of labor at 39 weeks of gestation . STUDY DESIGN Prospect i ve r and omized study . SUBJECTS AND METHODS Uncomplicated nulliparas ( N = 194 ) were r and omly assigned at 36 weeks of gestation . Labor was electively induced in 63 women at 39 weeks of gestation in the active management group ( I group , N = 98 ) . Spontaneous labor onset was expected with semi-weekly nonstress test ( NST ) and amniotic fluid index ( AFI ) by 42 weeks of gestation in the expectant group ( E group , N = 96 ) . Perinatal events were compared between the 2 groups . RESULTS A significantly higher incidence of meconium-stained amnios ( 19.4 % vs 3.2 % ) and fetal resuscitation ( 16.7 % vs 4.8 % ) was found in the E group than in the I group . Also , although a significantly higher incidence of epidural analgesia was noted in the I group ( 89 % ) than in the E group ( 54 % ) ( labor onset > or = 39 weeks , N = 72 ) , the duration of the 1st stage was shorter in I group and the duration of the 2nd stage was not significantly different . No other significant difference was noted between the 2 groups in terms of the rate of C-section , blood loss , incidence of pathological FHR , birth weight , Apgar score , umbilical arterial pH , or admission to NICU . CONCLUSION Active management of labor at 39 weeks could be made as safely as expectant management with modified biophysical profile monitoring Abstract . The efficacy of oral PGE2 tablets and buccal demoxytocin ( resoriblets ) for the induction of labor in cases of premature rupture of the membranes ( PROM ) after the 37th week of gestation has been evaluated in a prospect i ve , r and omized investigation of 193 women . PGE2 tablets ( Pro‐stinR ) were given to 109 parturients and demoxytocin resoriblets ( S and opartR ) to 84 . The former were given in increasing doses from an initial 0.5 mg to a maximum of 1.5 mg every hour . The demoxytocin was administered at a constant dosage of 50 I.U. every 30 min The use of prostagl and in E2 for the induction of labor with intact membranes is described and its effectiveness is compared to intravenous syntocinon . 40 primigravida and 60 multigravid patients with previous medical and obstetrical histories were studied . The patients were numbered as they entered the trial , with the odd numbers in each group being given oral prostagl and in and the even numbers intravenous syntocinon . In no case was the pregnancy less than 38 weeks maturity . No patient was in labor prior to being given either drug . Prostagl and in E2 ( PGE2 ) was supplied in ampoules containing 5 milligrams in 0.5 milliliter of ethanol . This was added to 49.5 milliliters of sterile water to produce a concentration of the drug of 0.1 milligrams per ml . The syntocinon infusion was prepared by putting 20 units of syntocinon into 1 liter of 5 % dextrose in water to produce a solution concentration of 20 mu/ml . The accepted criteria for diagnosing established labor for both groups of patients was the presence of uterine contractions occurring once every 3 minutes , associated with progressive dilatation of the cervix . For both groups of patients it was decided that cervical dilatation should be at least 6 cm within 18 hours of the infusion starting . Using this criterion there was only 1 failure , occurring in the 1st primigravid patient given PGE2 , the labor in this instance being completed with intravenous syntocinon . A further 8 patients failed to complete the trial as they had to be delivered by cesarian section . Syntocin was considerably more efficient than PGE2 in inducing labor in the remaining 91 patients particularly in primigravida . This was the case whether judged by the length of labor or by the induction delivery interval . Toco-dynamometric studies showed that the contractions produced by prostagl and in more closely resembled those of normal labor and were less painful Labor was induced for medical reasons at or near term in altogether 200 patients . The women were r and omly assigned to low amniotomy and either oral PGE2 or intravenous infusion of oxytocin . The initial PGE2 dose was 0.5 mg , followed by 1.0 mg every hour for up to 24 hours . Oxytocin was given as an intravenous pump infusion , starting with 5 mIU/min and rising stepwise to 20 mIU/min . Uterine contractility and fetal heart rate ( FHR ) were recorded by cardiotocography in 61 women receiving oxytocin and in 63 given prostagl and in E2 . A detailed analysis of the contractility pattern was performed in 16 women , eight from each group In a prospect i ve study of neonatal jaundice 739 infants , delivered vaginally , in the vertex presentation , and without major complications , were examined . Labour was induced or stimulated after r and om allocation of the mothers to one of three oxytocics ( prostagl and in E2 orally , oxytocin intravenously , or demoxytocin buccally ) . Oxytocics were unnecessary after primary amniotomy in 91 women . A linear logistic statistical analysis showed that gestational age has a highly significant influence on the risk of jaundice ( defined by maximum serum level of bilirubin greater than or equal to 205 mumol/l ) . An apparent influence of birthweight could be explained by the correlation between birthweight and gestational age . The influence of the three oxytocic agents was not significant , although they may have had a slight effect ; however , any such effect could be a consequence of the infants of mothers given oxytocics being less mature than those whom mothers did not receive oxytocics . The duration of labour and the mother 's age also had no effect on risk of jaundice . Thus , neonatal jaundice after induced and stimulated labour seems to be primarily associated with fetal maturity ; the pharmacological side-effect , if any , of oxytocics is of no importance The induction of labour with prostagl and in E2 ( PGE2 ) tablets in two dosage regimens , and with desamino-oxy-tocin , has been studied in association with amniotomy . In multiparas at or near term and with a high Bishop score . PGE2 appears superior with regard to the induction-to-delivery interval and the duration of labour , but both preparations are highly effective in this respect . In nulliparas with a low Bishop score , however , intravenous oxytocin after amniotomy is the method of choice A double blind study was undertaken to determine the effectiveness or oral prostagl and in E2 as a means of improving the pelvic score prior to induction of labour . 48 patients who were greater than 37 weeks gestation and who had Bishop scores of less than 6 entered the study . Ten tablets were given on an hourly regime . Of 25 patients in the prostagl and in group , 17 were considered successes ( 68.0 % ) , whereas of 23 patients who received a placebo , 9 were successes ( 39.1 % ) . No adverse effects were recorded . Prostagl and in E2 is therefore considered a safe and effective method for priming the unfavourable cervix prior to induction of labour We report the results of a pilot study conducted to compare the efficacy of oral prostagl and in E2 versus intravenous oxytocin in inducing labour after lower amniotomy in 20 primigravid patients at term . The results suggest no significant differences in the performance of each group for the induction to delivery interval , the mode of delivery , the Apgar score at five minutes or for third stage abnormalities . However , the use of oral PGE2 allows the patient unrestricted mobility and avoids the discomfort of i.v . infusions Sixty‐nine patients ( 48 primigravidae and 21 multigravidae ) with 12 hours of spontaneous premature rupture of membranes ( PROM ) after 36 weeks gestation were r and omly allocated to receive either prostagl and in E2 ( PGE2 ) oral tablets or intravenous oxytocin to stimulate labor Prostagl and in E2-tablets were compared to intravenous oxytocin for the stimulation of labor in 201 patients at or near term , with premature spontaneous rupture of the membranes without labor activity for 6 hours after the escape of fluid . The patients were r and omly allocated ; 99 were treated with PGE2-tablets ( 0.5 - 1.5 mg/hr ) and 102 with intravenous oxytocin ( 7.5 - 45 mIU/min ) . The treatment was ineffective in the PGE2 group in 3 cases ; these were treated successfully with intravenous oxytocin . In the oxytocin group , 3 patients were delivered by cesarean section for reasons not associated with the drug . A significant difference was found in the stimulation-delivery time , in favor of intravenous oxytocin . Although PGE2 tablets are a safe and convenient alternative to intravenous oxytocin , the investigation showed that intravenous oxytocin is preferable in cases of premature rupture of the membranes with more than 6 hours without labor activity Abstract . Oral prostagl and in in hourly doses of 0.5 mg PGE2 was given to 58 patients with an initial Bishop score of five or less , for two 12‐hour periods in order to prime the cervix . After priming , the patients were induced with oral PGE2 ; 90 % of these patients were delivered . In a control group comprising 59 patients induced with oxytocin , the delivery rate was only 51 % Summary A prospect i ve survey was carried out on 187 parous patients , in whom labour was induced by amniotomy and either intravenous oxytocin or oral prostagl and in E2 , (PGE2).The results show no significant difference in the performance of each group for the induction to delivery interval , the mode of delivery , the Apgar score at 5 minutes or for third stage anomalies . The use of oral PGE2offers advantages to the patient who is spared the discomfort , restriction and minor risks associated with an intravenous infusion ; and to the midwife who does not have to make frequent checks on the flow rate if an infusion pump is not available . The method also permits the ancillary equipment , which may well be in limited supply , to be reserved for more ‘ at risk ’ cases Fifty pregnant women at term , with a cervix unfavorable for induction , were electively induced with intravenous oxytocin after priming with either oral prostagl and in E2 or a placebo . Oral PGE2 was effective in increasing the Bishop score and in inducing labor prior to the induction , but did not increase the incidence of successful inductions A clinical trial involving 60 patients was conducted to assess the relative efficacy of intravenous oxytocin and oral prostagl and in E2 in ripening the unfavourable cervix , when given as a priming dose on the day before induction of labour . There was significant improvement in the Bishop score , and the subsequent induction‐delivery interval following priming with prostagl and in . This improvement appeared to be dose‐related Objective : The appropriate date of delivery in twin pregnancies is supposed to be earlier than that in singleton pregnancy . The aim of this study was to compare two strategies for managing twin pregnancies ( i.e. , immediate induction and expectant management ) . Methods : Seventeen patients underwent immediately induced labor by administration of oral prostagl and in E2 at 37 weeks , while 19 patients underwent expectant management . Results : The average gestational age at delivery in the induction group was 37.5 ± 0.4 weeks , significantly earlier than that in the expectant management group ( 39.0 ± 1.1 weeks ) . However , there were no significant differences in the average birth weight between the two groups ( 2,700 ± 330 g in the induction group vs. 2,672 ± 392 g in the expectant management group ) . The cesarean delivery rate in the induction group was 18 % , not significantly different from that in the expectant management group ( 32 % ) . The most common indication for cesarean section in the expectant management group was maternal infection , while there was no maternal infection in the induction group ( p = 0.08 ) . Conclusion : It may be acceptable do intervene in twin pregnancies earlier than in singleton pregnancies during term In 100 clinical ly-normal women , labor was induced at term by low amniotomy and PGE2 . The drug was administered by either the oral or the oromucosal route , the same incremental dose scheme ( initial dose of 0.5 mg ; hourly increment of 0.5 m
Output:
| Otherwise , there were no significant differences between groups for this outcome .
Oral prostagl and in was associated with vomiting across all comparison groups .
REVIEW ER 'S CONCLUSIONS Oral prostagl and in consistently result ed in more frequent gastrointestinal side effects , in particular vomiting , compared with the other treatments included in this review .
There were no clear advantages to oral prostagl and in over other methods of induction of labour |
MS210539 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND AND STUDY AIM While colonoscopy screening is widely used in several European countries and the United States , there are no r and omized trials to quantify its benefits . The Nordic-European Initiative on Colorectal Cancer ( NordICC ) is a multinational , r and omized controlled trial aim ing at investigating the effect of colonoscopy screening on colorectal cancer ( CRC ) incidence and mortality . This paper describes the rationale and design of the NordICC trial . STUDY DESIGN Men and women aged 55 to 64 years are drawn from the population registries in the participating countries and r and omly assigned to either once-only colonoscopy screening with removal of all detected lesions , or no screening ( st and ard of care in the trial regions ) . All individuals are followed for 15 years after inclusion using dedicated national registries . The primary end points of the trial are cumulative CRC-specific death and CRC incidence during 15 years of follow-up . POWER ANALYSIS : We hypothesize a 50 % CRC mortality-reducing efficacy of the colonoscopy intervention and predict 50 % compliance , yielding a 25 % mortality reduction among those invited to screening . For 90 % power and a two-sided alpha level of 0.05 , using a 2:1 r and omization , 45 600 individuals will be r and omized to control , and 22 800 individuals to the colonoscopy group . Interim analyses of the effect of colonoscopy on CRC incidence and mortality will be performed at 10-year follow-up . CONCLUSIONS The aim of the NordICC trial is to quantify the effectiveness of population -based colonoscopy screening . This will allow development of evidence -based guidelines for CRC screening in the general population Because interleukin-6 ( IL-6 ) is considered important in the proliferation of early multiple myeloma ( MM ) , we hypothesized that the addition of the anti-IL-6 monoclonal antibody siltuximab to the bortezomib-melphalan-prednisone ( VMP ) regimen would improve outcomes in transplant-ineligible patients with newly diagnosed MM . One hundred and six patients were r and omized to receive 9 cycles of VMP or VMP plus siltuximab ( 11 mg/kg every 3 weeks ) followed by siltuximab maintenance . Baseline characteristics were well balanced except for immunoglobulin A subtype and 17p deletions . With a complete response ( CR ) rate of 27 % on siltuximab plus VMP ( S+VMP ) and 22 % on VMP , the study did not confirm its hypothesis that the addition of siltuximab would increase the CR rate by at least 10 % . Overall response rate was 88 % on S+VMP and 80 % on VMP , and at least very good partial response rates were 71 % and 51 % ( P = .0382 ) , respectively . Median progression-free survival ( 17 months ) and 1-year overall survival ( 88 % ) were identical in the 2 arms . Grade ≥3 adverse-event incidence was 92 % on S+VMP and 81 % on VMP ( P = .09 ) , with trends toward more hematologic events and infections on S+VMP . Maintenance therapy with siltuximab was well tolerated . In conclusion , the addition of siltuximab to VMP did not improve the CR rate or long-term outcomes . This study was registered at http:// clinical trials.gov as # NCT00911859 Despite years of research and hundreds of reports on tumour markers in oncology , the number of markers that have emerged as clinical ly useful is pitifully small . Often initially reported studies of a marker show great promise , but subsequent studies on the same or related markers yield inconsistent conclusions or st and in direct contradiction to the promising results . It is imperative that we attempt to underst and the reasons that multiple studies of the same marker lead to differing conclusions . A variety of method ological problems have been cited to explain these discrepancies . Unfortunately , many tumour marker studies have not been reported in a rigorous fashion , and published articles often lack sufficient information to allow adequate assessment of the quality of the study or the generalisability of the study results . The development of guidelines for the reporting of tumour marker studies was a major recommendation of the US National Cancer Institute and the European Organisation for Research and Treatment of Cancer ( NCI-EORTC ) First International Meeting on Cancer Diagnostics in 2000 . Similar to the successful CONSORT initiative for r and omised trials and the STARD statement for diagnostic studies , we suggest guidelines to provide relevant information about the study design , preplanned hypotheses , patient and specimen characteristics , assay methods , and statistical analysis methods . In addition , the guidelines suggest helpful presentations of data and important elements to include in discussion s. The goal of these guidelines is to encourage transparent and complete reporting so that the relevant information will be available to others to help them to judge the usefulness of the data and underst and the context in which the conclusions apply Cytokines have been found to be elevated in cancer patients and have been associated with worse prognosis in single tumour entities . We investigated the association of eight different cytokines with venous thromboembolism ( VTE ) and prognosis in cancer patients . The Vienna Cancer and Thrombosis Study ( CATS ) , a prospect i ve study , includes patients with newly diagnosed tumour or disease progression . Patients with an overt infection are excluded . Study end‐points are VTE , death , loss to follow‐up or study completion . Interleukin ( IL ) serum levels were measured using the xMAP technology developed by Luminex . Among 726 included patients , no associations between IL levels and VTE were found , with the exception of a trend for IL‐1β and IL‐6 in pancreatic cancer . Elevated levels of IL‐6 [ as continuous variable per double increase hazard ratio ( HR ) = 1·07 , 95 % confidence interval ( CI ) = 1·027–1·114 , P = 0·001 , IL‐8 ( HR = 1·12 , 95 % CI = 1·062–1·170 , P < 0·001 ) and IL‐11 ( HR = 1·37 , 95 % CI = 1·103–1·709 , P = 0·005 ] were associated with worse survival . In subgroup analyses based on tumour type , colon carcinoma patients , who had higher IL‐6 levels , showed a shorter survival ( HR = 2·405 , 95 % CI = 1·252–4·618 , P = 0·008 ) . A significant association of elevated IL‐10 levels with a decrease in survival ( HR = 1·824 , 95 % CI = 1·098–3·031 , P = 0·020 ) was seen among patients with lung cancer . No correlation between VTE and IL levels was found , but higher IL‐6 , IL‐8 and IL‐11 levels were associated with worse survival in cancer patients . Further , elevated IL‐6 levels might be a prognostic marker in colorectal cancer and elevated IL‐10 levels in lung cancer patients Considering that the prognosis of patients with advanced biliary tract cancer ( BTC ) remains very poor , with a median survival of less than 1 year , new therapeutic approaches need to be developed . In the present study , a phase II clinical trial of personalized peptide vaccination ( PPV ) was conducted in advanced BTC patients to evaluate the feasibility of this treatment and to identify potential biomarkers . A maximum of 4 human leukocyte antigen-matched peptides , which were selected based on the pre-existing host immunity prior to vaccination , were subcutaneously administered ( weekly for 6 consecutive weeks and bi-weekly thereafter ) to 25 advanced BTC patients without severe adverse events . Humoral and /or T cell responses specific to the vaccine antigens were substantially induced in a subset of the vaccinated patients . As shown by multivariate Cox regression analysis , lower interleukin-6 ( IL-6 ) and higher albumin levels prior to vaccination and greater numbers of selected vaccine peptides were significantly favorable factors for overall survival [ hazard ratio (HR)=1.123 , 95 % confidence interval ( CI ) 1.008 - 1.252 , P=0.035 ; HR=0.158 , 95 % CI 0.029 - 0.860 , P=0.033 ; HR=0.258 , 95 % CI 0.098 - 0.682 , P=0.006 ; respectively ] . Based on the safety profile and substantial immune responses to vaccine antigens , PPV could be a promising approach for refractory BTC , although its clinical efficacy remains to be investigated in larger-scale prospect i ve studies . The identified biomarkers are potentially useful for selecting BTC patients who would benefit from PPV Background : Inflammation contributes to the pathogenesis of colorectal cancer ( CRC ) , and cytokine levels are altered during colorectal carcinogenesis . Methods : The serum levels of 13 cytokines and their relation to clinical and pathological parameters , and systemic inflammatory response ( mGPS , CRP and neutrophil – lymphocyte ratio ) , were analysed from a prospect i ve series of 148 CRC patients and 86 healthy age- and sex-matched controls . Results : CRC patients had higher serum platelet-derived growth factor , interleukin (IL)-6 , IL-7 , and IL-8 levels and lower monocyte chemotactic protein-1 ( MCP-1 ) levels than the controls . A logistic regression model for discriminating the patients from the controls – including the five most predictive cytokines ( high IL-8 , high IL-6 , low MCP-1 , low IL-1ra , and low IP-10 ) – yielded an area under curve value of 0.890 in receiver operating characteristics analysis . Serum cytokines showed distinct correlation with other markers of systemic inflammatory response , and advanced CRCs were associated with higher levels of IL-8 , IL-1ra , and IL-6 . A metastasised disease was accompanied by an orientation towards Th2 cytokine milieu . Conclusion : CRC is associated with extensive alterations in serum cytokine environment , highlighting the importance of study ing relative cytokine level alterations . Serum cytokine profile shows promise in separating CRC patients from healthy controls but its clinical value is yet to be confirmed Purpose We tested the hypothesis that high plasma YKL-40 and IL-6 associate with pancreatic cancer and short overall survival . Patients and Methods In all , 559 patients with pancreatic cancer from prospect i ve biomarker studies from Denmark ( n = 448 ) and Germany ( n = 111 ) were studied . Plasma YKL-40 and IL-6 were determined by ELISAs and serum CA 19.9 by chemiluminescent immunometric assay . Results Odds ratios ( ORs ) for prediction of pancreatic cancer were significant for all biomarkers , with CA 19.9 having the highest AUC ( CA 19.9 : OR = 2.28 , 95 % CI 1.97 to 2.68 , p<0.0001 , AUC = 0.94 ; YKL-40 : OR = 4.50 , 3.99 to 5.08 , p<0.0001 , AUC = 0.87 ; IL-6 : OR = 3.68 , 3.08 to 4.44 , p<0.0001 , AUC = 0.87 ) . Multivariate Cox analysis ( YKL-40 , IL-6 , CA 19.9 , age , stage , gender ) in patients operated on showed that high preoperative IL-6 and CA 19.9 ( dichotomized according to normal values ) were independently associated with short overall survival ( CA 19.9 : HR = 2.51 , 1.22–5.15 , p = 0.013 ; IL-6 : HR = 2.03 , 1.11 to 3.70 , p = 0.021 ) . Multivariate Cox analysis of non-operable patients ( Stage IIB-IV ) showed that high pre-treatment levels of each biomarker were independently associated with short overall survival ( YKL-40 : HR = 1.30 , 1.03 to 1.64 , p = 0.029 ; IL-6 : HR = 1.71 , 1.33 to 2.20 , p<0.0001 ; CA 19.9 : HR = 1.54 , 1.06 to 2.24 , p = 0.022 ) . Patients with preoperative elevation of both IL-6 and CA 19.9 had shorter overall survival ( p<0.005 ) compared to patients with normal levels of both biomarkers ( 45 % vs. 92 % alive after 12 months ) . Conclusions Plasma YKL-40 and IL-6 had less diagnostic impact than CA 19.9 . Combination of pretreatment YKL-40 , IL-6 , and CA 19.9 may have clinical value to identify pancreatic cancer patients with the poorest prognosis OBJECTIVES : Difficult diagnoses and a lack of effective therapy complicate biliary tract malignancies . Interleukin-6 ( IL-6 ) is a human bile duct epithelium growth factor correlated with tumor burden . We evaluated the usefulness of serum IL-6 in the diagnosis of primary BDC and measured changes in serum IL-6 levels following photodynamic therapy ( PDT ) . METHODS : We prospect ively measured serum IL
Output:
| Circulating IL-6 levels appear to be an independent prognostic biomarker in patients with GI cancer , with high IL-6 levels associated with short overall survival ( OS ) .
The results for colorectal cancer were too ambiguous to give conclusive results .
IL-6 seemed to be a marker for some of the clinical characteristics of GI cancer , and may have a role in the diagnostic workup in general practice .
In conclusion , high circulating IL-6 was associated with short OS in most studies in GI cancer patients .
Whether inhibition of IL-6 would decrease GI cancer symptoms and increase quality of life is unknown |
MS210540 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: BACKGROUND The mineralocorticoid receptor antagonist eplerenone improved clinical outcomes among patients with heart failure with reduced ejection faction ( HFrEF ) in the EMPHASIS-HF ( Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure ) study . However , similar efficacy and safety have not been established in Japanese patients . We evaluated the efficacy and safety of eplerenone in patients with HFrEF in a multicenter , r and omized , double-blind placebo-controlled outcome study ( Clinical Trials.gov Identifier : NCT01115855 ) . The aim of the study was to evaluate efficacy predefined as consistency of the primary endpoint with that of EMPHASIS-HF at a point estimate of < 1 for the hazard ratio . Methods and Results : HFrEF patients with NYHA functional class II-IV and an EF ≤35 % received eplerenone ( n=111 ) or placebo ( n=110 ) on top of st and ard therapy for at least 12 months . The primary endpoint was a composite of death from cardiovascular causes or hospitalization for HF . The primary endpoint occurred in 29.7 % of patients in the eplerenone group vs. 32.7 % in the placebo group [ hazard ratio=0.85 ( 95 % CI : 0.53 - 1.36 ) ] . Hospitalization for any cause and changes in plasma BNP and LVEF were favorable with eplerenone . A total of 17 patients ( 15.3 % ) in the eplerenone group and 10 patients ( 9.1 % ) in the placebo group died . Adverse events , including hyperkalemia , were similar between the groups . CONCLUSIONS Eplerenone was well-tolerated in Japanese patients with HFrEF and showed results consistent with those reported in the EMPHASIS-HF study BACKGROUND Atrial fibrillation ( AF ) is a common arrhythmia that frequently recurs after restoration of sinus rhythm ( SR ) . Identifying risk factors for recurrence may help define the best strategy for secondary prevention . METHODS The GISSI-AF trial enrolled 1,442 patients in SR with at least 2 documented AF episodes in the previous 6 months or after cardioversion in the last 2 weeks . Patients were r and omized to valsartan or placebo ; all other treatments for AF or underlying heart diseases were allowed . Primary end points were time to first recurrence of AF and proportion of patients with > 1 AF episode during 1-year follow-up . We evaluated clinical and electrocardiographic baseline characteristics of all patients to identify independent predictors for AF recurrence using a Cox multivariable model . RESULTS Risk factors for AF recurrence were a history of 2 or more AF episodes in the previous 6 months , independent of the modality of SR restoration , spontaneous ( HR 1.42 , 95 % CI 1.14 - 1.77 , P = .002 ) , or by cardioversion ( HR 1.19 , 95 % CI 1.01 - 1.40 , P = .038 ) , and a lower heart rate during SR ( HR 0.99 , 95 % CI 0.99 - 1.00 , P = .052 ) . The risk factors were the same for > 1 AF recurrence . Patients treated with amiodarone had a lower risk for both end points ( P < .0001 and P = .017 ) , whereas those on diuretics had a greater risk ( P = .009 and P = .003 ) . CONCLUSIONS In the GISSI-AF study population , AF history had significant prognostic value independent of the modality of SR restoration . Amiodarone and diuretic treatment affected the rate of AF recurrence AIM Supraventricular arrhythmia is a major public health problem because of its prevalence and clinical consequences . The first step of the treatment usually consists in restoring sinusal rhythm . The aim of this study is to evaluate results and predictive factors of success of electrical cardioversion . METHODS We studied a series of 143 consecutive electric cardioversion preformed in 131 French patients . RESULTS The rate of successful direct current cardioversion was 91.2 % . Negative predictive factors are the height body mass index and the age of arrhythmia . Atrial flutter is a predictive factor of success . These results agree with published results . Our study highlights the interest of some nonantiarrhythmic drugs received by the patient during the period before the direct current cardioversion . Thus , a spironolactone treatment appears to be a new predictive factor of the success of electrical cardioversion ( success in patients treated with spironolactone : 100 % vs 89 % without , P = 0.04 ) . CONCLUSIONS Our results agree with usual predictive factors of the success of cardioversion . Nevertheless , a new approach is that of the positive effect of spironolactone on cardioversion . A prospect i ve r and omized study is necessary to confirm this result Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more BACKGROUND Patients with congestive heart failure ( CHF ) often have increased aldosterone activity that leads to hypomagnesemia . Hypomagnesemia can induce arrhythmias , an important cause of death in patients with CHF . We determined whether the aldosterone receptor antagonist spironolactone improved magnesium homeostasis and reduced arrhythmias in patients with CHF . METHODS AND RESULTS We r and omized 116 consecutive patients with CHF into placebo control group ( n = 58 ) and spironolactone group ( 20 mg daily , n = 58 ) in addition to conventional therapy . Plasma magnesium concentration ( PMC ) , erythrocyte magnesium concentration ( EMC ) , and erythrocyte magnesium efflux were not different between the 2 groups of patients before treatment . Compared with control patients , patients treated with spironolactone for 6 months had increased PMC and EMC and decreased erythrocyte magnesium efflux . Patients on spironolactone therapy also had a marked decrease of 24-hour mean heart rate , ventricular and atrial premature beats , and the risk of atrial fibrillation/flutter . Pooled data from the 116 patients showed that patients with a higher EMC or a lower sodium-dependent erythrocyte magnesium efflux had a slower heart rate , fewer ventricular premature beats , and a lower risk of atrial fibrillation/flutter . CONCLUSIONS Our results suggest that reducing cellular magnesium efflux and loss may contribute to the spironolactone-reduced arrhythmias in patients with CHF Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies Introduction The aim of this study was to compare the effect of ramipril/canrenone versus ramipril/hydrochlorothiazide ( HCTZ ) combination on atrial fibrillation ( AF ) recurrence in type 2 diabetic hypertensives with and without cardiac autonomic neuropathy ( CAN ) . Material and methods A total of 289 hypertensive type 2 diabetic patients , 95 with CAN , in sinus rhythm but with at least two episodes of AF in the previous 6 months were r and omized to ramipril 5 mg plus canrenone 50 mg ( titrated to 10/100 mg ) or to ramipril 5 mg plus HCTZ 12.5 mg ( titrated to 10/25 mg ) or to amlodipine 5 mg ( titrated to 10 mg ) for 1 year . Clinic blood pressure ( BP ) and a 24-h ECG were evaluated monthly . Patients were asked to report any episode of symptomatic AF and to perform an ECG as early as possible . Serum procollagen type I carboxy-terminal peptide ( PIP ) and carboxy-terminal telopeptide of collagen type I ( CITP ) were evaluated before and after each treatment period . Results Blood pressure was similarly and significantly reduced by all treatments . A total of 51 % of patients with amlodipine had a recurrence of AF , as did 31 % of patients with ramipril/HCTZ ( p < 0.05 vs. amlodipine ) and 13 % of patients with ramipril/canrenone ( p < 0.01 vs. amlodipine and p < 0.05 vs. ramipril/HCTZ ) . A similar trend was found in diabetic patients with CAN . Both combinations reduced PIP and increased CITP , but the effects of ramipril/canrenone were significantly more marked . Conclusions These findings suggest that in type 2 diabetic hypertensives , ramipril/canrenone treatment was more effective than ramipril/HCTZ in reducing AF recurrence . This could be related to the greater improvement in cardiac fibrosis Objective : Postoperative atrial fibrillation ( POAF ) is associated with poor outcomes after coronary artery bypass graft ( CABG ) surgery . We aim ed to assess the additional value of preoperative plasma aldosterone levels , a biomarker promoting proarrhythmic and profibrotic pathways , for predicting POAF after CABG . Methods : We conducted a prospect i ve cohort study involving consecutive patients with left ventricular ejection fraction ( LVEF ) more than 50 % requiring elective CABG in our university hospital . Plasma aldosterone levels , two-dimensional echocardiography including left atrial strain analysis and galectin-3 ( Gal-3 ) examination were assessed before cardiac surgery . The primary endpoint was the occurrence of POAF within 30 days after surgery . Results : POAF occurred in 34 ( 24.8 % ) out of the 137 included patients . Compared with controls , patients experiencing POAF were significantly older ( 73 years old ± 8 vs 65 ± 11 , P < 0.001 ) and had higher preoperative plasma aldosterone levels [ 183 pmol/l ( interquartile range 138–300 ) vs 143 pmol/l ( interquartile range 96.5–216.5 ) , P < 0.01 ] . Age [ odds ratio ( OR ) , 1.088 ; 95 % confidence interval ( CI ) ( 1.038–1.140 ) ; P = 0.0004 ] and plasma aldosterone levels [ OR , 1.007 ; 95 % CI ( 1.003–1.012 ) ; P = 0.0013 ] were independently associated with POAF in multivariate analysis and could therefore be combined to predict the occurrence of POAF [ ‘ Aldoscore ’ , OR , 2.7 ; 95 % CI ( 1.7–4.3 ) ; P < 0.0001 ] . Reverse transcriptase PCR analysis performed on right atrial appendage and plasma examination revealed that Gal-3 was activated in POAF patients . Conclusion : We developed the preoperative ‘ Aldoscore ’ for POAF risk stratification among patients with preserved LVEF requiring elective CABG . This new tool may be helpful to identify good responders to interventions targeting the proarrhythmic and profibrotic pathways of aldosterone OBJECTIVES The aim of this report was to show that the rate of cardiovascular events is increased in patients with either subtype of primary aldosteronism ( PA ) . BACKGROUND Primary aldosteronism involves hypertension ( HTN ) , hypokalemia , and low plasma renin . The two major PA subtypes are unilateral aldosterone-producing adenoma ( APA ) and bilateral adrenal hyperplasia . METHODS During a three-year period , the diagnosis of PA was made in 124 of 5,500 patients referred for comprehensive evaluation and management . Adenomas were diagnosed in 65 patients and idiopathic hyperaldosteronism in 59 patients . During the same period , clinical characteristics and cardiovascular events of this group were compared with those of 465 patients with essential hypertension ( EHT ) r and omly matched for age , gender , and systolic and diastolic blood pressure . RESULTS A history of stroke was found in 12.9 % of patients with PA and 3.4 % of patients with EHT ( odds ratio [ OR ] = 4.2 ; 95 % confidence interval [ CI ] 2.0 to 8.6 ] ) . Non-fatal myocardial infa rct ion was diagnosed in 4.0 % of patients with PA and in 0.6 % of patients with EHT ( OR = 6.5 ; 95 % CI 1.5 to 27.4 ) . A history of atrial fibrillation was diagnosed in 7.3 % of patients with PA and 0.6 % of patients with EHT ( OR = 12.1 ; 95 % CI 3.2 to 45.2 ) . The occurrence of cardiovascular complications was comparable in both subtypes of PA . CONCLUSIONS Patients presenting with PA experienced more cardiovascular events than did EHT patients independent of blood pressure . The
Output:
| Conclusions MRAs seem to be effective in AF prevention , especially regarding recurrent AF episodes |
MS210541 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: In 1998 , the American Heart Association convened Prevention Conference V to examine strategies for the identification of high-risk patients who need primary prevention . Among the strategies discussed was the measurement of markers of inflammation.1 The Conference concluded that “ many of these markers ( including inflammatory markers ) are not yet considered applicable for routine risk assessment because of : ( 1 ) lack of measurement st and ardization , ( 2 ) lack of consistency in epidemiological findings from prospect i ve studies with endpoints , and ( 3 ) lack of evidence that the novel marker adds to risk prediction over and above that already achievable through the use of established risk factors . ” The National Cholesterol Education Program Adult Treatment Panel III Guidelines identified these markers as emerging risk factors,1a which could be used as an optional risk factor measurement to adjust estimates of absolute risk obtained using st and ard risk factors . Since these publications , a large number of peer- review ed scientific reports have been published relating inflammatory markers to cardiovascular disease ( CVD ) . Several commercial assays for inflammatory markers have become available . As a consequence of the exp and ing research base and availability of assays , the number of inflammatory marker tests ordered by clinicians for CVD risk prediction has grown rapidly . Despite this , there has been no consensus from professional societies or governmental agencies as to how these assays of markers of inflammation should be used in clinical practice . On March 14 and 15 , 2002 , a workshop titled “ CDC/AHA Workshop on Inflammatory Markers and Cardiovascular Disease : Applications to Clinical and Public Health Practice ” was convened in Atlanta , Ga , to address these issues . The goals of this workshop were to determine which of the currently available tests should be used ; what results should be used to define high risk ; which patients should be tested ; and the indications for which the tests would be most useful . These Background Diet is known to play a key role in atherogenesis and in the development of cardiovascular events . Dietary factors may mediate these processes acting as potential modulators of inflammation . Potential Links between inflammatory properties of diet and the occurrence of cardiovascular events have not been tested previously . Objective We aim ed to assess the association between the dietary inflammatory index ( DII ) , a method to assess the inflammatory potential of the diet , and incident cardiovascular disease . Methods In the prospect i ve , dynamic SUN cohort , 18,794 middle-aged , Spanish university graduates were followed up for 8.9 years ( median ) . A vali date d 136-item food-frequency question naire was used to calculate the DII . The DII is based on scientific evidence about the relationship between diet and inflammatory biomarkers ( C-reactive protein , IL-1β , IL-4 , IL-6 , IL-10 and TNF-α ) . Cox proportional hazard models were used to estimate hazard ratios ( HR ) and 95 % confidence intervals ( CI ) for the association between the DII and incident cardiovascular disease ( myocardial infa rct ion , stroke or cardiovascular death ) . Results The risk for cardiovascular events progressively increased with each increasing quartile of DII ( ptrend = 0.017 ) . The multivariable-adjusted HR for participants in the highest ( most pro-inflammatory ) vs. the lowest quartile of the DII was 2.03 ( 95 % CI 1.06–3.88 ) . Conclusions A pro-inflammatory diet was associated with a significantly higher risk for developing cardiovascular events Inflammation plays a central role in pancreatic cancer etiology and can be modulated by diet . We aim ed to examine the association between the inflammatory potential of diet , assessed with the Dietary Inflammatory Index ( DII ® ) , and pancreatic cancer risk in the Prostate , Lung , Colorectal and Ovarian Cancer Screening Trial prospect i ve cohort . Our study included 101,449 participants aged 52 - 78 years at baseline who completed both baseline question naire and a diet history question naire . Energy-adjusted DII ( E-DII ) scores were computed based on food and supplement intake . Cox proportional hazards models and time dependent Cox models were used to estimate hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) with participants in the lowest E-DII quintile ( most anti-inflammatory scores ) as referent . After a median 8.5 years of follow-up , 328 pancreatic cancer cases were identified . E-DII scores were not associated with pancreatic cancer risk in the multivariable model ( HRQ5vsQ1 = 0.94 ; 95 % CI = 0.66 - 1.35 ; p-trend = 0.43 ) . Time significantly modified the association ( p-interaction = 0.01 ) . During follow up < 4 years , there was suggestive evidence of an inverse association between E-DII and pancreatic cancer ( HRQ5vsQ1 = 0.60 ; 95 % CI = 0.35 - 1.02 ; p-trend = 0.20 ) while there was a significant positive trend in the follow up ≥4 years ( HRQ5vsQ1 = 1.31 ; 95 % CI = 0.83 - 2.08 ; p-trend = 0.03 ) . Similar results were observed for E-DII from food only . Our study does not support an association between inflammatory potential of diet and pancreatic cancer risk ; however , heterogeneous results were obtained with different follow-up times . These divergent associations may result from the influences of undetected disease in the short-term Previous studies have reported an association between a more pro-inflammatory diet profile and various chronic metabolic diseases . The Dietary Inflammatory Index ( DII ) was used to assess the inflammatory potential of nutrients and foods in the context of a dietary pattern . We prospect ively examined the association between the DII and the incidence of cardiovascular disease ( CVD : myocardial infa rct ion , stroke or cardiovascular death ) in the PREDIMED ( Prevención con Dieta Mediterránea ) study including 7216 high-risk participants . The DII was computed based on a vali date d 137-item food frequency question naire . Multivariate-adjusted hazard ratios ( HR ) and 95 % confidence intervals of CVD risk were computed across quartiles of the DII where the lowest ( most anti-inflammatory ) quartile is the referent . Risk increased across the quartiles ( i.e. , with increasing inflammatory potential ) : HRquartile2 = 1.42 ( 95%CI = 0.97–2.09 ) ; HRquartile3 = 1.85 ( 1.27–2.71 ) ; and HRquartile4 = 1.73 ( 1.15–2.60 ) . When fit as continuous the multiple-adjusted hazard ratio for each additional st and ard deviation of the DII was 1.22 ( 1.06–1.40 ) . Our results provide direct prospect i ve evidence that a pro-inflammatory diet is associated with a higher risk of cardiovascular clinical events The possible relationship between diet-related inflammation and the risk of prediabetes requires further investigation , especially in non-Western population s. We examined the ability of the dietary inflammatory index ( DII ) to predict the risk of prediabetes in a case-control study conducted at specialized centers in Esfahan , Iran . A total of 214 incident cases of prediabetes were selected with the nonr and om sampling procedure , and the 200 controls r and omly selected from the same clinics were frequency-matched on age ( ±5 years ) and sex . DII scores were computed based on dietary intake assessed using a vali date d and reproducible 168-item food-frequency question naire . Linear and logistic regression models were used to estimate multivariable beta estimates and odds ratios ( ORs ) . Subjects in tertile 3 versus tertile 1 ( T3VS1 ) of DII had significantly higher fasting plasma glucose ( DIIT3VS1 : b = 4.49 ; 95 % CI 1.89 , 7.09 ) , oral glucose tolerance ( DIIT3VS1 : b = 8.76 ; 95 % CI 1.78 , 15.73 ) , HbA1c ( DIIT3VS1 : b = 0.30 ; 95 % CI 0.17 , 0.42 ) , low-density lipoprotein ( DIIT3VS1 : b = 16.37 ; 95 % CI 11.04 , 21.69 ) , triglyceride ( DIIT3VS1 : b = 21.01 ; 95 % CI 8.61 , 33.42 ) and body fat ( DIIT3VS1 : b = 2.41 ; 95 % CI 0.56 , 4.26 ) and lower high-density lipoprotein ( DIIT3VS1 : b = -3.39 ; 95 % CI -5.94 , -0.84 ) and lean body mass ( DIIT3VS1 : b = -3.11 ; 95 % CI -4.83 , -1.39 ) . After multivariate adjustment , subjects in the most pro-inflammatory DII group had 19 times higher odds of developing prediabetes compared with subjects in tertile 1 ( DIIT3VS1 : OR = 18.88 ; 95 % CI 7.02 , 50.82 ) . Similar results were observed when DII was used as a continuous variable , ( DIIcontinuous : OR = 3.62 ; 95 % CI 2.50 , 5.22 ) . Subjects who consumed a more pro-inflammatory diet were at increased risk of prediabetes compared with those who consumed a more anti-inflammatory diet SCOPE Low- grade chronic inflammation is associated with several chronic conditions , and diet is known to play a role in chronic inflammation . We aim ed to evaluate the association between the inflammatory potential of the diet and mortality in the Spanish population from the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC-Spain ) . METHODS AND RESULTS The study included 41 199 participants ( 62 % female ) aged 29 - 69 years from five Spanish regions . During 18 years of follow-up 3316 deaths were identified . The dietary inflammatory potential was assessed by means of an inflammatory score of the diet ( ISD ) , calculated using 30 dietetic components and their corresponding inflammatory scores ( weights ) . The association between the ISD and mortality was analyzed by multivariate Cox regression models . There was a significant association between ISD and mortality : subjects classified in the fifth quintile of the ISD ( more proinflammatory diets ) had a hazard ratio of 1.42 ( 95%-confidence interval 1.25 - 1.60 ) as compared with those in the first quintile ; the corresponding figures were 1.89 ( 1.48 - 2.40 ) for cardiovascular diseases mortality and 1.44 ( 1.22 - 1.69 ) for death by cancer . CONCLUSION Consuming more proinflammatory diets , expressed by means of the ISD , is associated with higher mortality ; this effect seems to be stronger for deaths by cardiovascular diseases BACKGROUND Inflammation is known to be related to the leading causes of death including cardiovascular disease , several types of cancer , obesity , type 2 diabetes , depression-suicide and other chronic diseases . In the context of whole dietary patterns , the Dietary Inflammatory Index ( DII ® ) was developed to appraise the inflammatory potential of the diet . OBJECTIVE We prospect ively assessed the association between DII scores and all-cause mortality in two large Spanish cohorts and valuated the consistency of findings across these two cohorts and results published based on other cohorts . DESIGN We assessed 18,566 participants in the " Seguimiento Universidad de Navarra " ( SUN ) cohort followed-up during 188,891 person-years and 6790 participants in the " PREvencion con DIeta MEDiterránea " ( PREDIMED ) r and omized trial representing 30,233 person-years of follow-up . DII scores were calculated in both cohorts from vali date d FFQs . Higher DII scores corresponded to more proinflammatory diets . A total of 230 and 302 deaths occurred in SUN and PREDIMED , respectively . In a r and om-effect meta- analysis we included 12 prospect i ve studies ( SUN , PREDIMED and 10 additional studies ) that assessed the association between DII scores and all-cause mortality . RESULTS After adjusting for a wide array of potential confounders , the comparison between extreme quartiles of the DII showed a positive and significant association with all-cause mortality in both the SUN ( hazard ratio [ HR ] = 1.85 ; 95 % CI : 1.15 , 2.98 ; P-trend = 0.004 ) and the PREDIMED cohort ( HR = 1.42 ; 95 % CI : 1.00 , 2.02 ; P-trend = 0.009 ) . In the meta- analysis of 12 cohorts , the DII was significantly associated with an increase of 23 % in all-cause mortality ( 95 % CI : 16%-
Output:
| Conclusion : The findings proposed that adherence to diets with high DII ® scores was associated with increased WC . |
MS210542 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: STUDY OBJECTIVE An efficacy treatment study is conducted comparing levalbuterol to racemic albuterol for acute pediatric asthma in the emergency department ( ED ) . METHODS This was a prospect i ve , double-blind , r and omized , controlled study involving 129 children ( 2 to 14 years ) , presenting to a pediatric ED with an acute moderate or severe asthma exacerbation . Children were treated using a st and ard ED asthma pathway . Primary outcomes were changes from baseline in clinical asthma score and the percentage of predicted forced expiratory volume in 1 second after the first , third , and fifth treatment . Secondary outcomes included number of treatments , length of ED care , rate of hospitalization , and changes in pulse rate , respiratory rate , and oxygen saturation . Occurrence of adverse events was recorded . RESULTS Sixty-four children in the racemic albuterol and 65 children in the levalbuterol group completed the study . There were no differences between groups in primary outcomes , secondary outcomes , or adverse events . CONCLUSION There was no difference in clinical improvement in children with acute moderate to severe asthma exacerbations treated with either racemic albuterol or levalbuterol The (R)-enantiomer of racemic albuterol produces bronchodilation , whereas the (S)-enantiomer may increase airway reactivity . After oral or intravenous administration of racemic albuterol , the (R)- enantiomer is metabolized several times faster than the (S)-enantiomer ; however , enantiomer disposition after inhaling racemic albuterol with a metered-dose inhaler ( MDI ) is not known . Accordingly , 10 healthy subjects inhaled racemic albuterol with a MDI alone and with a MDI and holding chamber . We measured plasma levels of unchanged (R)- and (S)-albuterol before and up to 4 h after inhalation of racemic albuterol , and determined the unchanged R/S ratio in urine before and at 0.5 , 4 , 8 , and 24 h later . The disposition of albuterol 's enantiomers with a MDI and holding chamber was similar to that with a MDI alone . The area under the curve ( AUC ) of the plasma levels over time was significantly lower for the (S)- than for the (R)-enantiomer-395.5 + /- 141.0 ( SE ) versus 882.7 + /- 126.4 ng . ml(-)(1 ) . min ( p < 0.05)-indicating preferential retention of (S)-albuterol in the lung . The R/S ratio in urine at 0 . 5 h after albuterol was > 1 , reflecting the higher plasma level of the (R)-enantiomer . In conclusion , preferential retention of the (S)- compared with the (R)-enantiomer in the lung could lead to accumulation of the (S)-enantiomer after long-term use of racemic albuterol Objective To compare efficacy and tolerability of levosalbutamol ( Group 1 ) and racemic salbutamol ( Group 2 ) for the treatment of acute exacerbation of asthma in children age 5 to 18 yr . Methods A r and omized double blind clinical study involving 60 children was undertaken between October ’ 06 to December ’ 07 . Results The following baseline clinical characteristic were recorded initially and after giving 3 nebulizations at 20 min intervals in the Ist hour of presentation viz respiratory rate ( RR ) , heart rate ( HR ) , oxygen saturation in room air SPO2 , PEFR ( peak expiratory flow rate ) , serum K+ level and asthma score . In Group 1 patients ( levosalbutamol ) , there was significant increment in SPO2 and PEFR ( P<0.05 ) values with decrease in tachypnea and asthma score while no significant difference was found in pre and post treatment HR & Serum K+ levels . In Group 2 patients although there was clinical improvement in terms of SPO2 , PEFR , RR and asthma score , it result ed in significant tachycardia and decrease in K+ levels . Conclusion Levosalbutamol appears to be more efficacious than racemic salbutamol in terms of improvement in PEFR , SPO2 and asthma score while deleterious effects of tachycardia and fall in serum K+ were seen with racemic salbutamol Objective : To compare levalbuterol and racemic albuterol for the treatment of acute exacerbation of asthma in pediatric population . Design : Prospect i ve , double-blind , r and omized research trial in a pediatric emergency department of an urban tertiary care hospital . Participants : Children 5 to 21 years with a history of asthma presenting to the emergency department in acute exacerbation . Interventions : As per a computer-generated r and omization sequence , patients received either 1.25 mg of levalbuterol or albuterol 2.5 mg via nebulization along with ipratropium hydrochloride . Patients received 3 back-to-back treatments as needed every 20 minutes , maximum of 3 ; 2 mg/kg of oral prednisone was administered to the patients after the second treatment . Baseline respiratory parameters such as oxygen saturations , respiratory rates , and peak flow rates were measured and repeated after every treatment . The decision for further treatments and or hospitalization was made by the treating emergency department physician as per his/her clinical judgement of the respiratory parameters at the end of 3 treatments . Results : Seventy patients completed the study . Most of the patients were in moderate severity of asthma exacerbation . All patients in both groups showed improvement in oxygen saturations , respiratory rates , and peak flow rates . However , no statistically significant difference was observed in the 2 groups regarding the respiratory parameters ( P > 0.05 ) . Conclusion : Levalbuterol is not more efficacious than racemic albuterol in improving respiratory parameters in children presenting with acute exacerbation of asthma Objective . To compare racemic albuterol ( RAC ) with levalbuterol ( LEV ) in continuous form for the treatment of acute pediatric asthma exacerbations in the emergency department . Study design . Children between the ages of 6 and 17 inclusive were enrolled if they had a history of asthma , presented to the emergency department with an acute asthma exacerbation , and had an initial forced expiratory volume in 1 second ( FEV1 ) < 70 % predicted . Patients were then r and omized to receive either 7.5 mg of RAC or 3.75 mg of LEV over 1 hour , in addition to st and ard asthma therapies . Spirometry and asthma scoring were performed at the end of the first hour , and a second hour-long nebulization with the same drug was administered if deemed necessary . Spirometry and asthma scoring were again performed and the final disposition was recorded . As a second , optional part of the study , baseline serum albuterol levels were collected on some patients before treatment . Results . A total of 99 patients completed the study ( 44 RAC and 55 LEV ) . Baseline characteristics were similar except that the RAC group had a higher baseline asthma score . Children in the RAC group had a greater improvement in their FEV1 ( p = .043 ) as well as in their asthma scores ( p = .01 ) after 1 hour of continuous treatment compared to the LEV group . The greater improvement in asthma scores was maintained after the second hour of continuous therapy in the RAC group ( p = .008 ) but not for FEV1 measurements ( p = .57 ) . There were no differences between groups for changes in heart rate , respiratory rate , oxygen saturation , or rates of admission . Conclusions . At the doses used , RAC appears to be superior to LEV with respect to changes in FEV1 and asthma score . There was no significant difference between the drugs with respect to admission rates or side-effect profile Objectives of this study were to compare the pharmacokinetics , pharmacodynamics and safety of single cumulative doses of active (R)-salbutamol given either as the single enantiomer or racemic mixture by inhalation to subjects with mild to moderate asthma . This was a double-blind , crossover , cumulative-dose , r and omized study where all subjects received either four doses of 1.25 mg of (R)-salbutamol or 2.5 mg of racemic ( RS- ) salbutamol by nebulization . The pharmacokinetic parameters were determined by noncompartmental analysis and model-fitting . Changes in FEV(1 ) , plasma potassium , plasma glucose , heart rate , and QTc interval were measured . The potassium and glucose data were fitted to indirect response pharmacodynamic models . The heart rate and QTc data were evaluated using data descriptors . No significant differences in pharmacokinetics of (R)-salbutamol given as either (R)- or (RS)-salbutamol were found with AUC values of 11.90 + /- 4.37 and 11 . 47 + /- 2.88 ng.h/ml . The t(max)of about 2 h reflected serial dosing rather than delayed absorption . The t(1/2)averaged about 3.5 h. The (S)-salbutamol showed AUC of 48.46 + /- 12.11 ng.h/ml with a t(1/2)of about 5 h. The changes in FEV(1)reached a plateau after an initial increase and did not return to pre-drug values for 10 h. All pharmacodynamic parameters were similar whether (R)- or (RS)-salbutamol was given . The exposure to (R)-salbutamol was identical after inhalation of ( R ) - and (RS)-salbutamol by subjects with asthma . Several pharmacological responses including FEV(1)were also similar and there were no unique safety concerns with either treatment UNLABELLED This multicenter , r and omized , double-blind trial compared nebulized levalbuterol ( Lev ) and racemic albuterol ( Rac ) in the treatment of acute asthma . METHODS Adults with acute asthma exacerbations ( FEV(1 ) 20%-55 % predicted ) received prednisone and either Lev ( 1.25 mg , n = 315 ) or Rac ( 2.5 mg , n = 312 ) . Nebulized treatments were administered every 20 minutes in the first hour , then every 40 minutes for 3 additional doses , then as necessary for up to 24 hours . The primary end point was time to meet discharge criteria . Secondary end points included changes in lung function and hospitalization rates . A subset of 160 patients had plasma (S)-albuterol concentrations determined at study entry . RESULTS Time to meet discharge criteria did not differ between the 2 treatments . FEV(1 ) improvement was greater following Lev compared with Rac , both after dose 1 and cumulatively over the entire treatment period ( dose 1 in intent to treat [ ITT ] group : Lev 0.50 + /- 0.43 L , Rac 0.43 + /- 0.37 L ; P = .02 ) , particularly among the 60 % of patients not on recent steroid therapy ( dose 1 : Lev 0.58 + /- 0.47 L , Rac 0.44 + /- 0.37 L ; P < .01 ) , and patients whose entry (S)-albuterol concentrations were in the highest quartile of those measured . A small and similar proportion of Lev-treated ( 7.0 % ) and Rac-treated ( 9.3 % ) patients required hospitalization ( P = .28 ) . Among patients not on steroids , fewer Lev- than Rac-treated patients required admission ( 3.8 % vs 9.3 % , P = .03 ) , as was also the case for patients with high plasma (S)-albuterol concentrations . Asthma relapses ( 5 % in 30 days ) were lower than in previous reports and did not differ between groups . CONCLUSIONS This study suggests that early , regular nebulized beta(2)-agonist and systemic corticosteroid therapy may reduce hospitalization and relapse rates in patients with acute severe asthma . Lev was well tolerated and compared favorably with Rac in improving airway function , particularly in those who were not on inhaled or oral corticosteroids and in those who had high plasma (S)-albuterol concentrations at presentation
Output:
| There were no significant differences in side effects between groups .
Levalbuterol was not superior to albuterol regarding efficacy and safety in subjects with acute asthma .
We suggest that levalbuterol should not be used over albuterol for acute asthma |
MS210543 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract The prophylactic and sporontocidal efficacy of st and ard antimalarials was studied among non-immune adult male volunteers challenged by mosquitoes heavily infected with two strains of chloroquine resistant Plasmodium falciparum from Malaya . The Poo . strain from Trengganu broke through in 12 of 15 men receiving chloroquine 300 mg . ( base ) and primaquine 45 mg . ( base ) at weekly intervals , whereas 8 weeks of this treatment protected all 3 men challenged with the Tay . strain from Kota Tinggi , Johore State . The Poo . strain broke through in 5 men given amodiaquine base 300 mg . and DDS 300 mg . weekly . Proguanil 200 mg . ( 2·1–3·2 mg . per kg . body weight ) given daily for 8 weeks after challenge provided complete suppression of the Poo . strain in 4 men ( and probably a fifth ) , and also of the Tay . strain in 4 men , nor did parasitaemia develop after completion of the prophylactic course . Pyrimethamine 25 mg . given weekly failed to protect 2 of 3 men challenged with Poo . , and the Tay . strain also broke through in both men receiving this regimen . A single dose of 45 mg . ( base ) of primaquine was gametocytocidal for both strains and , in one case of Poo . infection studied , rendered gametocytes non-infective to an efficient vector mosquito fed on the patient 24 hours later Background Resistance of malaria parasites to chloroquine ( CQ ) and sulphadoxine-pyrimethamine ( SP ) is increasing in prevalence in Africa . Combination therapy can both improve treatment and provide important public health benefits if it curbs the spread of parasites harbouring resistance genes . Thus , drug combinations must be identified which minimise gametocyte emergence in treated cases , and so prevent selective transmission of parasites resistant to any of the partner drugs . Methods and Findings In a r and omised controlled trial , 497 children with uncomplicated falciparum malaria were treated with CQ and SP ( three doses and one dose respectively ; n = 91 ) , or six doses of artemether in fixed combination with lumefantrine ( co-artemether [ Coartem , Riamet ] ) ( n = 406 ) . Carriage rates of Plasmodium falciparum gametocytes and trophozoites were measured 7 , 14 , and 28 d after treatment . The infectiousness of venous blood from 29 children carrying P. falciparum gametocytes 7 d after treatment was tested by membrane-feeding of Anopheles mosquitoes . Children treated with co-artemether were significantly less likely to carry gametocytes within the 4 weeks following treatment than those receiving CQ/SP ( 30 of 378 [ 7.94 % ] versus 42 of 86 [ 48.8 % ] ; p < 0.0001 ) . Carriers in the co-artemether group harboured gametocytes at significantly lower densities , for shorter periods ( 0.3 d versus 4.2 d ; p < 0.0001 ) and were less infectious to mosquitoes at day 7 ( p < 0.001 ) than carriers who had received CQ/SP . Conclusions Co-artemether is highly effective at preventing post-treatment transmission of P. falciparum . Our results suggest that co-artemether has specific activity against immature sequestered gametocytes , and has the capacity to minimise transmission of drug-resistant parasites Background The combination of artesunate and mefloquine has been reported to be effective against multi-drug resistant Plasmodium falciparum malaria , which has been reported in Nigeria . The objective of this multi-centre study was to evaluate the efficacy , safety and tolerability of the co-packaged formulation of artesunate and mefloquine in the treatment of uncomplicated malaria in two weight groups : those between 15 – 29 kg and ≥ 30 kg respectively . Methods The trial was conducted in rural communities in the north-east , north- central , south-west and south-eastern parts of Nigeria . The WHO protocol for testing antimalarial drugs was followed . Out patients having amongst other criteria , parasite density of ≥1,000 μl were enrolled . The co-packaged drugs were administered for 3 days at a dosage of artesunate , 4 mg/kg body wt/day and mefloquine , 25 mg/kg/body wt total ) on days 0 , 1 and 2 . Patients were followed up for 28 days with the assessment of the parasitological parameters on days 1 , 2 , 3 , 7 , and 28 . Results Four hundred and forty-six ( 446 ) patients were enrolled and 431 completed the study . Cure rates in both treatment groups was > 90 % at day 28 . The mean parasite clearance times in treatment groups I and II were 40.1 and 42.4 hours respectively . The combination of artesunate and mefloquine showed good gametocidal activity , ( gametocyte clearance time of 42.0 & 45.6 hours in treatment groups I and II respectively ) . There were no serious adverse events . Other adverse events observed were headache , dizziness , vomiting and abdominal discomfort . There was no significant derangement in the haematological and biochemical parameters . Conclusion This co-packaged formulation of artesunate + mefloquine ( Artequin ™ ) is highly efficacious , safe and well-tolerated . It is recommended for the treatment of uncomplicated P. falciparum malaria in Nigeria ABSTRACT The activities of primaquine in combination with quinine or artesunate against asexual- and sexual-stage parasites were assessed in 176 adult Thai patients with uncomplicated Plasmodium falciparum malaria . Patients were r and omized to one of the six following 7-day oral treatment regimens : ( i ) quinine alone , ( ii ) quinine with tetracycline , ( iii ) quinine with primaquine at 15 mg/day , ( iv ) quinine with primaquine at 30 mg/day , ( v ) artesunate alone , or ( vi ) artesunate with primaquine . Clinical recovery occurred in all patients . There were no significant differences in fever clearance times , rates of P. falciparum reappearance , or recurrent vivax malaria between the six treatment groups . Patients treated with artesunate alone or in combination with primaquine had significantly shorter parasite clearance times ( mean ± st and ard deviation = 65± 18 versus 79 ± 21 h ) and lower gametocyte carriage rates ( 40 versus 62.7 % ) than those treated with quinine ( P ≤ 0.007 ) . Primaquine did not affect the therapeutic response ( P > 0.2 ) . Gametocytemia was detected in 98 patients ( 56 % [ 22 % before treatment and 34 % after treatment ] ) . Artesunate reduced the appearance of gametocytemia ( relative risk [ 95 % confidence interval ] = 0.34 [ 0.17 to 0.70 ] ) , whereas combinations containing primaquine result ed in shorter gametocyte clearance times ( medians of 66 versus 271 h for quinine groups and 73 versus 137 h for artesunate groups ; P≤ 0.038 ) . These results suggest that artesunate predominantly inhibits gametocyte development whereas primaquine accelerates gametocyte clearance in P. falciparum malaria Background Artesunate and amodiaquine ( AS&AQ ) is at present the world 's second most widely used artemisinin-based combination therapy ( ACT ) . It was necessary to evaluate the efficacy of ACT , recently adopted by the World Health Organization ( WHO ) and deployed over 80 countries , in order to make an evidence -based drug policy . Methods An individual patient data ( IPD ) analysis was conducted on efficacy outcomes in 26 clinical studies in sub-Saharan Africa using the WHO protocol with similar primary and secondary endpoints . Results A total of 11,700 patients ( 75 % under 5 years old ) , from 33 different sites in 16 countries were followed for 28 days . Loss to follow-up was 4.9 % ( 575/11,700 ) . AS&AQ was given to 5,897 patients . Of these , 82 % ( 4,826/5,897 ) were included in r and omized comparative trials with polymerase chain reaction ( PCR ) genotyping results and compared to 5,413 patients ( half receiving an ACT).AS&AQ and other ACT comparators result ed in rapid clearance of fever and parasitaemia , superior to non-ACT . Using survival analysis on a modified intent-to-treat population , the Day 28 PCR-adjusted efficacy of AS&AQ was greater than 90 % ( the WHO cut-off ) in 11/16 countries . In r and omized comparative trials ( n = 22 ) , the crude efficacy of AS&AQ was 75.9 % ( 95 % CI 74.6–77.1 ) and the PCR-adjusted efficacy was 93.9 % ( 95 % CI 93.2–94.5 ) . The risk ( weighted by site ) of failure PCR-adjusted of AS&AQ was significantly inferior to non-ACT , superior to dihydroartemisinin-piperaquine ( DP , in one Ug and an site ) , and not different from AS+SP or AL ( artemether-lumefantrine ) . The risk of gametocyte appearance and the carriage rate of AS&AQ was only greater in one Ug and an site compared to AL and DP , and lower compared to non-ACT ( p = 0.001 , for all comparisons ) . Anaemia recovery was not different than comparator groups , except in one site in Rw and a where the patients in the DP group had a slower recovery . Conclusion AS&AQ compares well to other treatments and meets the WHO efficacy criteria for use against falciparum malaria in many , but not all , the sub-Saharan African countries where it was studied . Efficacy varies between and within countries . An IPD analysis can inform general and local treatment policies . Ongoing monitoring evaluation is required Background The gametocyte sex ratio of Plasmodium falciparum , defined as the proportion of gametocytes that are male , may influence transmission but little is known of the effects of mefloquine or artesunate-mefloquine on gametocyte sex ratio and on the sex ratio of first appearing gametocytes . Methods 350 children with uncomplicated P. falciparum malaria were enrolled in prospect i ve treatment trial of mefloquine or artesunate-mefloquine between 2007 and 2008 . Gametocytaemia was quantified , and gametocytes were sexed by morphological appearance , before and following treatment . The area under curve of gametocyte density versus time ( AUCgm ) was calculated by linear trapezoidal method . Results 91 % and 96 % of all gametocytes appeared by day 7 and day 14 , respectively following treatment . The overall rate of gametocytaemia with both treatments was 31 % , and was significantly higher in mefloquine than in artesunate-mefloquine treated children if no gametocyte was present a day after treatment began ( 25.3 % v 12.8 % , P = 0.01 ) . Gametocyte clearance was significantly faster with artesunate-mefloquine ( 1.8 ± 0.22 [ sem ] v 5.6 ± 0.95 d ; P = 0.001 ) . AUCgm was significantly lower in the artesunate mefloquine group ( P = 0.008 ) . The pre-treatment sex ratio was male-biased , but post-treatment sex ratio or the sex ratio of first appearing gametocytes , was significantly lower and female-biased two or three days after beginning of treatment in children given artesunate-mefloquine . Conclusion Addition of artesunate to mefloquine significantly modified the emergence , clearance , and densities of gametocytes and has short-lived , but significant , sex ratio modifying effects in children from this endemic area Background Artemisinin-based combination therapy ( ACT ) is being widely promoted as a strategy to counteract the increase in Plasmodium falciparum antimalarial drug resistance . Methods A r and omized , double-blind , placebo-controlled , clinical trial of the efficacy , effect on gametocytes and safety of the addition of artesunate/placebo ( 4 mg/kg/day × 3 d ) to amodiaquine ( 10 mg/kg/day × 3 d ) was conducted in Choco department , a low intensity transmission area in northwest Colombia . Results From 2,137 screened subjects , 85 entered the study : 43 in the amodiaquine plus placebo and 42 in the amodiaquine plus artesunate groups . Potentially eligible cases failed to qualify mostly because they were not available for follow-up visits ( 73 % ) . Based on a per protocol analysis , the therapeutic response to both treatments was high : amodiaquine/placebo 35/36 , 97.2 % ( 95 % CI 85.5–99.9 ) , and amodiaquine/artesunate 32/32 , 100 % ( 89.1–100 ) after PCR genotyping . The Kaplan-Meier
Output:
| In non-comparative longitudinal studies , the use of a single-dose of primaquine was shown to deter the transmission of malaria briefly .
Conclusion Evidence on the transmission blocking effect of artemisinin derivatives and primaquine is conclusive . |
MS210544 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES To ( i ) investigate the influence of different extensions of a laser microgrooved abutment zone on connective tissue attachment and ( ii ) assess the impact of a repeated abutment dis-/reconnection on soft- and hard-tissue healing . MATERIAL S AND METHODS Titanium implants were inserted epicrestally in the lower jaws of six dogs . Healing abutments with either partially ( LP ) or completely ( LC ) laser microgrooved margins or machined surface margins ( M ) were r and omly allocated either to a single (1 × )/repeated ( 2 × ) dis-/reconnection at 4 and 6 weeks ( test ) , respectively , or left undisturbed ( control ) . At 6 and 8 weeks , histomorphometrical ( e.g. most coronal level of bone in contact with the implant [ CBI ] , subepithelial connective tissue attachment [ STC ] ) and immunohistochemical ( Collagen Type-I [ CI ] ) parameters were assessed . RESULTS At control sites , LP/LC groups revealed lower mean CBL ( 8 weeks , 0.95 ± 0.51 vs. 0.54 ± 0.63 vs. 1.66 ± 1.26 mm ) , higher mean STC ( 8 weeks , 82.58 ± 24.32 % vs. 96.37 ± 5.12 % vs. 54.17 ± 8.09 % ) , but comparable CI antigen reactivity . A repeated abutment manipulation was associated with increased mean CBL ( 8 weeks , 1.53 ± 1.09 vs. 0.94 ± 0.17 vs. 1.06 ± 0.34 mm ) , decreased STC ( 8 weeks , 57.34 ± 43.06 % vs. 13.26 ± 19.04 % vs. 37.76 ± 37.08 % ) and CI values . CONCLUSIONS It was concluded that ( i ) LC > LP abutments enhanced subepithelial connective tissue attachment and preserved crestal bone levels , ( ii ) repeated abutment dis-/reconnection during the initial healing phase ( 4 - 6 weeks ) may be associated with increased soft- and hard-tissue changes and ( iii ) LP and LC should be considered using a one abutment , one time approach Previous research has demonstrated the effectiveness of laser-ablated microgrooves placed on implant collars to support direct connective tissue attachments to altered implant surfaces . Such a direct connective tissue attachment serves as a physiologic barrier to the apical migration of the junctional epithelium and prevents crestal bone resorption . The current prospect i ve pre clinical trial sought to evaluate bone and soft tissue healing patterns when laser-ablated microgrooves were placed on the abutment . A canine model was selected for comparison to previous investigations that examined the negative bone and soft tissue sequelae of the implant-abutment microgap . The results demonstrate significant improvement in peri-implant hard and soft tissue healing compared to traditional machined abutment surfaces BACKGROUND : If an implant with a rough surface is exposed to the oral cavity , it may accumulate greater amounts of plaque than a smooth surface , which may lead to severe problems with mucositis and peri-implantitis . The purpose of the present paper was to investigate the early inflammatory response to mucosa-penetrating abutments prepared with varying surface roughness . METHODS : Nine patients had all five of their original abutments exchanged to test abutments for a 4-week period . The test abutments were prepared with five different roughnesses . The surface roughness was measured with an optical profilometer . At the end of the test period , clinical evaluation was performed ; the health of the surrounding mucosa , the amount of accumulated plaque and marginal bleeding were registered . One biopsy was taken from each test abutment . Qualitative and quantitative histological evaluations were performed . RESULTS : There was a statistically significant difference between patients regarding the amount of accumulated plaque on the abutment surfaces and inflammatory cells , but no difference between the surface modifications in relation to plaque accumulation or number of inflammatory cells . CONCLUSION : No relation was found between inflammatory response and abutment surface roughness after an evaluation time of 4 weeks in a human test model The roughness of intraoral hard surfaces plays an important role in bacterial adhesion and colonization . Earlier studies have shown that rough surfaces accumulate up to 25 times more subgingival plaque than do smooth sites . In the present study , the influence of surface smoothing was studied . In six partially edentulous patients waiting for a fixed prosthesis supported by endosseous titanium implants , four titanium abutments with different surface roughness were r and omly placed . After 1 month of intraoral exposure , subgingival plaque sample s from each abutment were compared within each patient by means of differential phase-contrast microscopy . After 3 months , supragingival and subgingival plaque sample s were taken from all abutments for differential phase-contrast microscopy and culturing . Probing depth , recession , and bleeding upon probing were scored at the same visit . Differential phase-contrast microscopy showed that subgingivally , only the two roughest abutments harbored spirochetes after 1 month . After 3 months , subgingivally , the composition of the flora showed little variation on the different abutment types , although spirochetes were only noticed around the roughest abutments . Anaerobic culturing result ed in comparable amounts of colony-forming units for all abutment types , both supragingivally and subgingivally . Subgingivally , the microbiologic composition did not show major interabutment differences . Clinical ly , small differences in probing depth were observed . The roughest abutment showed some attachment gain ( 0.2 mm ) during 3 months , whereas all other abutments had an attachment loss ranging from 0.8 to greater than 1 mm . The results indicate that a reduction in surface roughness ( less than a roughness of 0.2 micron ) had no major effect on the microbiologic composition , supragingivally or subgingivally . These observations indicate the existence of a threshold roughness below which no further impact on the bacterial adhesion and /or colonization should be expected . However , clinical evaluation seems to indicate that a certain surface roughness is necessary for increased resistance to clinical probing OBJECTIVES To histologically evaluate and compare the performance of healing abutments with either hydrophobic or hydrophilic surface properties in humans . MATERIAL S AND METHODS According to a parallel-group design , titanium implants placed in the posterior m and ible and maxilla of 30 patients were r and omly assigned to either ( 1 ) hydrophobic machined ( M ) , ( 2 ) chemically modified hydrophilic ( mod ) acid etched ( MA ) titanium ( Ti ) ( modMA1 ) or ( 3 ) modMA Ti- Zirconium alloy ( modMA2 ) healing abutments and left to heal in a transmucosal position . At 8 weeks , the abutments and a limited soft tissue biopsy were harvested according to a st and ardized procedure and processed for histological analysis ( primary outcomes : percentage epithelial- ( EC ) and subepithelial connective tissue contact ( CTC ) to the abutment surface ) . RESULTS The surgical procedure was associated with an incomplete mucosal coverage of the study abutments in nine patients , and an unintentional submerged healing procedure in three patients . Per protocol analysis ( 18 patients ) has pointed to an improved quantitative EC [ modMA2 ( 53.45 ± 28.25 ) > modMA1 ( 32.25 ± 24.3 ) > M ( 23.15 ± 16.09 ) ] and CTC [ modMA2 ( 75.12 ± 43.22 ) > modMA1 ( 69.41 ± 46.74 ) > M ( 47.63 ± 19.28 ) ] ( % ) to modMA surfaced abutments . CONCLUSIONS It was concluded that modMA surfaces may have the potential to enhance soft tissue adhesion at the transmucosal aspect of titanium dental implants
Output:
| The human histologic studies showed evidence of perpendicular insertion of human gingival fibroblasts into the treated abutment surface .
Laser-ablated , hydrophilic , and oxidized titanium surfaces result ed in this type of attachment .
Epithelial cells seem to slightly favor zirconia and polished titanium surfaces .
Improvements in the surface topography and macro design of dental abutments might improve biocompatibility and adherence to soft tissue ; however , manipulation of soft tissue and second-stage surgery could negate any advantages of the improved surfaces |
MS210545 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: A controlled longitudinal treatment study was carried out to investigate the effect of a behavioral family treatment on Expressed Emotion ( EE ) and to examine the correspondence between EE changes and relapse rates . Subjects were 52 patients with recent onset schizophrenia or related disorders and their parents . After completion of inpatient treatment they were r and omly allocated to individual treatment or individual treatment plus family treatment . The family treatment consisted of education and training in communication and problem-solving skills . Expressed Emotion was measured with the Five-Minute Speech Sample ( FMSS ) . The findings show that family treatment did not have a significant positive effect on EE level . The dichotomous FMSS/EE did not systematic ally change and these findings were comparable with the results of prior EE research . A scoring system that included all subscores of the FMSS was somewhat more sensitive to changes . In the individual treatment condition relapse rates tended to co-occur with a change in FMSS/EE level , irrespective of the direction of this change OBJECTIVE To compare outcomes in psychoeducational multiple-family group treatment vs psychoeducational single-family treatment . METHOD A total of 172 acutely psychotic patients , aged 18 to 45 years , with DSM-III-R schizophrenic disorders were r and omly assigned to single- or multiple-family psychoeducational treatment at six public hospitals in the state of New York . Psychotic relapse , symptom status , medication compliance , rehospitalization , and employment were assessed independently during 2 years of supervised treatment . RESULTS The multiple-family groups yielded significantly lower 2-year cumulative relapse rates than did the single-family modality ( 16 % vs 27 % ) and achieved markedly lower rates in patients whose conditions had not remitted at index hospital discharge ( 13 % vs 33 % ) . The relapse hazard ratio between treatments was 1:3 . The relapse rate for both modalities was less than half the expected rate ( 65 % to 80 % for 2 years ) for patients receiving individual treatment and medication . Rehospitalization rates and psychotic symptoms decreased significantly , and medication compliance was high , to an equal degree in both modalities . CONCLUSION Psychoeducational multiple-family groups were more effective than single-family treatment in extending remission , especially in patients at higher risk for relapse , with a cost-benefit ratio of up to 1:34 OBJECTIVE The present study aims to assess the efficacy of a structured psychoeducational group intervention for adolescents with early-onset psychosis and their families . The intervention was implemented in parallel in 2 separate groups by focusing specifically on problem-solving strategies and structured psychosis-related information to manage daily life difficulties associated with the disease , to mitigate crises , and to prevent relapses . METHOD We performed a 9-month , r and omized , rater-blinded clinical trial involving 55 adolescent patients with early-onset psychosis and either or both of their parents . A psychoeducational problem-solving group intervention ( n = 27 ) was compared with a nonstructured group intervention ( n = 28 ) . The primary outcomes were number of hospitalizations , days of hospitalization , and visits to the emergency department . The secondary outcome measures were clinical variables and family environment . RESULTS Assessment s were performed before and after the intervention . At the end of the group intervention , 15 % of patients in the psychoeducational group and 39 % patients in the nonstructured group had visited the emergency department ( χ² = 3.62 , df = 1 , p = .039 ) . The improvement in negative symptoms was more pronounced in the psychoeducational group ( 12.84 [ 7.87 ] ) than in the nonstructured group ( 15.81 [ 6.37 ] ) ( p = .039 ) . CONCLUSION A parallel psychoeducational group intervention providing written instructions in a structured manner could help adolescents with early-onset psychosis and their parents to manage crises by implementing problem-solving strategies within the family , thus reducing the number of visits to the emergency department . Negative symptoms improved in adolescents in the psychoeducational group . Clinical trial registration information -- Intervention Module AGES ( AGES-CM ) ; http:// clinical trials.gov/ ; NCT02101372 . [ corrected ] Duration of untreated psychosis ( DUP ) has emerged as a reliable predictor of outcome but continues to remain under scientific scrutiny . The present study examines the effect of differential periods of DUP on long-term outcome of first episode schizophrenia at Mumbai , India . This research was a prospect i ve , 10-year follow-up naturalistic study . Hospitalized patients of first episode schizophrenia were selected and followed up . Results showed that the mean DUP was higher for a group which showed clinical recovery on Clinical Global Impression Scale [ 14.0 months ( SD=8.0 ) in recovered and 10.8 months ( SD=5.7 ) in non-recovered group ( P=0.091 ) ] . DUP was not found to be significantly associated with any of the end point parameters of good clinical or social outcome . Thus , this study found that DUP alone does not determine outcome status confirming the role of psychopathological heterogeneity OBJECTIVE Longitudinal studies have begun to clarify the phenotypic characteristics of adolescents and young adults at clinical high risk for psychosis . This 8-site r and omized trial examined whether a 6-month program of family psychoeducation was effective in reducing the severity of attenuated positive and negative psychotic symptoms and enhancing functioning among individuals at high risk . METHOD Adolescents and young adults ( mean age 17.4 ± 4.1 years ) with attenuated positive psychotic symptoms , brief and intermittent psychosis , or genetic risk with functional deterioration were r and omly assigned to 18 sessions of family-focused therapy for individuals at clinical high risk ( FFT-CHR ) in 6 months or 3 sessions of family psychoeducation ( enhanced care [ EC ] ) . FFT-CHR included psychoeducation about early signs of psychosis , stress management , communication training , and problem-solving skills training , whereas EC focused on symptom prevention . Independent evaluators assessed participants at baseline and 6 months on positive and negative symptoms and social-role functioning . RESULTS Of 129 participants , 102 ( 79.1 % ) were followed up at 6 months . Participants in FFT-CHR showed greater improvements in attenuated positive symptoms over 6 months than participants in EC ( F1,97 = 5.49 , p = .02 ) . Negative symptoms improved independently of psychosocial treatments . Changes in psychosocial functioning depended on age : participants more than 19 years of age showed more role improvement in FFT-CHR , whereas participants between 16 and 19 years of age showed more role improvement in EC . The results were independent of concurrent pharmacotherapy . CONCLUSION Interventions that focus on improving family relationships may have prophylactic efficacy in individuals at high risk for psychosis . Future studies should examine the specificity of effects of family intervention compared to individual therapy of the same duration and frequency . Clinical trial registration information-Prevention Trial of Family Focused Treatment in Youth at Risk for Psychosis ; http:// clinical trials.gov/ ; NCT01907282 Aims . Occupational functioning is severely impaired in people with psychosis . Social cognition has recently been found to be a stronger predictor of functioning than neurocognition . This study is the first to investigate if externalizing attributional biases that are typically associated with psychosis play a role in the vocational pathways of people with early psychosis . Methods . A cross-sectional design was used . Fifty participants with early psychosis were recruited from a cohort of 144 participants of the Lambeth Early Onset r and omized control trial at 18-month follow-up . Information on occupational functioning was obtained using case notes and interview . Severity of symptoms was assessed and participants completed measures on attributional style and executive functioning . Results . Although executive functioning and positive symptoms were associated with poor occupational functioning , an externalizing attributional style for failures and reduced engagement in occupational activities during the previous 18 months emerged as the only predictors of poor occupational functioning at 18-month follow-up . Conclusions . An externalizing attributional bias is associated with poor occupational functioning . Further research is needed to investigate the direction of this relationship and whether attributional biases mediate the impact of symptoms and cognitive impairment on functioning The effect of in-patient and individual orientated psychosocial intervention ( IPI ) and in-patient and individual and family orientated intervention ( IPFI ) across levels of expressed emotion ( EE ) on relapse was compared in a group of patients with recent onset schizophrenic disorders . Patients were r and omly assigned to an individual orientated psychosocial intervention programme or to an identical psychosocial programme plus a behavioural family intervention . Seventy-six patients were studied during a 12 month out-patient treatment period after an in-patient treatment programme in which parents followed a psychoeducational programme . Overall relapse rates during the out-patient interventions were low ( 16 % ) . Adding family intervention to the psychosocial intervention did not affect the relapse rate . Patients in low EE families relapsed slightly more often during the psychosocial plus family intervention . In-patient treatment with psychoeducation for parents , followed by an out-patient psychosocial intervention programme , has a favourable impact on relapse . Additional family intervention may increase stress in low EE families , thus affecting relapse in their children At the time of discharge from their first stay in psychiatric hospital , 78 male schizophrenic patients were r and omly assigned to a family intervention ( experimental ) group or a ' st and ard care ' control group and were followed for the next 18 months . The family intervention consisted of both group and individual counselling sessions every 1 - 3 months that focused on education about the illness and on methods of dealing with the patient . There was a significantly lower rate of hospital readmission in the family intervention group than in the control group ( 15.4 % versus 53.8 % , chi 2 = 12.75 , P < 0.01 ) , and the mean hospital-free period for those who were readmitted was significantly longer in the experimental group than in the control group ( 245 days versus 130 days , t = 2.91 , P < 0.01 ) . Moreover , the clinical status and overall level of functioning in patients who were not readmitted were significantly better in experimental subjects than in control subjects . Stratified analysis showed that family intervention and regular use of medication had independent and additive effects on the outcome . During the 18 months after the index discharge patients who did not take medication regularly and who did not receive family intervention were 7.9 times as likely to be readmitted to hospital as patients who took medication regularly and received family intervention BACKGROUND Empirical evidence of the efficacy and effectiveness of psychosocial family intervention and of the specificity of its effects on the course of schizophrenia is limited . The aim was to study the efficacy and effectiveness of psychosocial family intervention with regard to clinical and social functioning and family burden after controlling for compliance and several prognostic factors . METHOD A 2-year r and omized controlled trial with blind assessment s. Fifty patients with DSM-IV schizophrenia and persistent positive symptoms and /or previous clinical relapse were allocated to psychosocial family intervention , individual counselling and st and ard treatment versus individual counselling and st and ard treatment . RESULTS Family intervention was associated with fewer clinical relapses , hospitalizations and major incidents , and an improvement in positive and negative symptoms , social role performance , social relations , employment and family burden . The reduction in hospitalizations in the family intervention group was significantly greater than that observed in the group of patients who refused to participate but this was not the case for the control group . The effects of family intervention were independent of compliance and prognostic factors . CONCLUSIONS Family intervention is effective in severe schizophrenia independently of compliance and prognostic factors BACKGROUND It is unclear if the impact of psychoeducational family intervention for patients with schizophrenia can be sustained over 10 years . In this study , we explored the 14-year effect of psychoeducational family intervention for patients with schizophrenia in a Chinese rural area . METHOD The data from a cluster r and omized control trial ( C RCT ) study of psychoeducational family intervention in a 14-year follow-up was analyzed . All patients with schizophrenia ( n = 326 ) who participated in the C RCT drawn from six townships in Xinjin County of Chengdu in 1994 , of whom 238 ( 73.0 % ) who were still alive , and their informants were followed up in 2008 . The Patients Follow-up Scale , the Positive and Negative Syndrome Scale ( PANSS ) and the Global Assessment of Functioning were used in the follow-up study . RESULTS There were no significant differences of marital status , mean scores of PANSS positive symptoms , negative symptoms , general mental health , and total scores among the psychoeducational family intervention , medication , and control groups in 2008 . The psychoeducational family intervention group had a significantly higher rate of antipsychotic medication and a higher level of work ability than other two groups . The control group had a significantly higher rate of never-treated ( 26.0 % ) than psychoeducational family intervention group ( 6.5 % ) . CONCLUSION Psychoeducational family intervention might be still effective in the 14-year follow-up , especially in patients ' treatment adherence/compliance and social functioning . Psychoeducational family intervention might be more effective in places where family members frequently participated in patients ' care and had a
Output:
| Meta-analytic synthesis showed that FIp improved service user functioning and reduced the likelihood of relapse by the end of treatment .
Psychotic symptoms were significantly reduced in the FIp group at follow up , but this was not evident at end of treatment .
In terms of FIp target mechanisms , carers receiving FIp were more likely to shift from high to low expressed emotion and less likely to report patient focused criticism or engage in conflict communication than carers r and omized to st and ard care .
Carer burden and well-being were improved by the end of treatment but gains were not sustained at follow up .
FIp had no impact on carer emotional over-involvement .
The findings indicate that FIp is an effective intervention for early psychosis service users and their relatives . |
MS210546 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Oxidative stress ( OS ) in acute pancreatitis ( AP ) has been pathologically linked with the systemic inflammatory response and antioxidant supplementation may have a clinical benefit . METHODS In this prospect i ve , r and omised open label , controlled pilot study , patients admitted within 72 hours of onset of pain were r and omised to receive either placebo ( only st and ard medical treatment ; SMT ) or antioxidants ( vitamin C 500 mg , N-acetyl cysteine 200 mg 8 hourly and antoxyl forte 1 capsule hourly with st and ard medical treatment ; SMT + AO ) daily , following informed consent . Patients with co-morbid illness and pregnancy were excluded . Primary efficacy measures were length of hospital stay and complications whilst secondary measures were biochemical markers of oxidative stress ( thiobarbituric acid reactive substances [ TBARS ] and superoxide dismutase [ SOD ] and total antioxidant capacity [ TAC ] and vitamin C ) at Days 1 , 3 and 7 . RESULTS Of 53 patients , 30 patients were r and omised to SMT and 23 patients to SMT + AO . The mean duration of hospital stay in the SMT group ( 10.3 + /- 7 days ) was more compared to SMT + AOT ( 7.2 + /- 5 days ) , but was not statistically significant ( p=0.07 ) , complications were similar in the 2 groups . At Day 7 , OS was significantly lower in the SMT + AO group when compared with the SMT group ( TBARS , p=0.05 ; SOD , p=0.03 ) with a significant increase in FRAP and vitamin C ( p=0.01 ) . CONCLUSIONS Antioxidant supplementation may decrease the length of hospital stay and complication rate in patients with AP , but a larger clinical trial is needed to support this hypothesis . Further , it decreased the OS and improved the antioxidant status in patients with AP OBJECTIVE To investigate the effects of continuous early enteral nutrition ( EEN ) supplemented with glutamine and arginine on gut barrier function in patients with severe acute pancreatitis ( SAP ) . METHODS Thirty two patients with a diagnosis of acute pancreatitis predicted to develop severe disease were r and omized into 2 groups : EEN group ( n = 18 ) and EEN + glutamine and arginine group ( enteral immunonutrition group , n = 14 ) . EEN was initiated when homeostasis was achieved within 72 hours after attack , and both group received isocaloric isonitrogenous nutrition . Glutamine and arginine were administered into jejunum in the enteral immunonutrition group . Serum amylase , plasma diamine oxidase ( DAO ) , C-reactive protein ( CRP ) , plasma endotoxin , urinary excretion of lactulose ( L ) , and mannitol ( M ) were measured , and APACHE-II scores were recorded on days 1 , 7 , and 14 . Complications , and length and cost of hospitalization were recorded as well . RESULTS EEN and enteral immunonutrition were both tolerated well . There was no difference in APACHE-IIscore between the two groups ( P > 0.05 ) . The DAO , CRP , plasma endotoxin , and urinary L/M levels decreased with the course of SAP . However , the plasma endotoxin and urinary L/M on day 7 of the enteral immunonutrition group were ( 10.0 + /- 3.8 ) EU/ml and 0.29 + /- 0.15 respectively , both significantly higher than those of the EEN group [ ( 7.9 + /- 2.8 ) EU/ml and 0.16 + /- 0.08 respectively , both P < 0.05 ] . The length of hospital stay and cost showed no differences between the two groups . CONCLUSION EEN is safe and feasible in treatment of SAP . Enteral immunonutrition containing glutamine and arginine improves the gut barrier function by reducing the gut permeability and decreasing plasma endotoxin level in the early stage of SAP In acute pancreatitis ( AP ) tumor necrosis factor-α mediates multi-organ failure ; in animal models its blockade with pentoxifylline ameliorates AP . The efficacy of pentoxifylline in predicted severe AP ( pSAP ) was tested in a double-blinded , r and omized , control trial . Twenty-eight patients with pSAP were r and omized within 72 hours of diagnosis to pentoxifylline or placebo . Baseline characteristics were similar in both groups . The pentoxifylline group had fewer intensive care unit admissions and shorter intensive care unit and hospital stays of longer than 4 days ( all P < .05 ) . Patients receiving pentoxifylline had no adverse effects . Pentoxifylline within 72 hours of pSAP is safe ; a larger study of pentoxifylline in AP is needed to confirm efficacy . Clinical Trials.gov number : NCT01292005 Thirty patients with acute pancreatitis were allocated to indomethacin suppositories , 50 mg twice daily , or identical-looking placebo suppositories for 7 days in a controlled double-blind trial . The groups of patients were not different with regard to age , sex , etiology , or number of Ranson criteria . The number of days with pain and number of opiate injections were significantly less in patients treated with indomethacin . The median values of serum amylase and serum calcium were not different before or at any day during treatment . Bleeding from the gastrointestinal tract was not seen BACKGROUND / AIMS Experimental and clinical studies demonstrated that probiotics containing lactobacilli significantly improve the outcome of acute pancreatitis . In a prospect i ve , r and omized , double-blinded study the role of " Synbiotic 2000 " , a new synbiotic composition with high colony forming unit ( CFU ) was evaluated in the treatment of severe acute pancreatitis . METHODOLOGY Patients with severe acute pancreatitis were r and omized into two groups . Nasojejunal feeding was commenced within 24 hours after admission in both groups and continued for at least seven days . The first group of patients received four different lactobacilli preparations with 1010 CFU , respectively , and prebiotics containing four bioactive fibers ( inulin , beta-glucan , resistant starch and pectin ) in addition . Patients in the second ( control ) group received only prebiotics . RESULTS 62 patients with severe acute pancreatitis completed the study . Altogether 8 patients died . Lower incidence of multiorgan failure ( MOF ) , septic complications and mortality were detected in the first group compared to the control , but the differences were not significant statistically . The total incidence of systemic inflammatory response syndrome ( SIRS ) and MOF were significantly different between the two groups ( 8 vs. 14 ; p < 0.05 ) . Furthermore , the number patients recovering with complications were significantly less in the first group receiving modern synbiotic therapy compared to the control ( p < 0.05 ) . Finally , lower rate of late ( over 48 hours ) organ failure was detected in the first versus the control group ( 3.0 % vs. 17.2 % ) . CONCLUSIONS The results suggest that early nasojejunal feeding with synbiotics may prevent organ dysfunctions in the late phase of severe acute pancreatitis . In addition , the data also indicate that the infection of pancreatic necrosis may be associated with early phase organ failure Pancreatic infection is the main indication for surgery and the principal determinant of prognosis in acute necrotizing pancreatitis . Previous studies on the effects of antibiotics have not , however , uniformly demonstrated any reduction in the need for surgery or any decrease in mortality among these patients , although the incidence of pancreatic infections was significantly reduced . This single-center r and omized study was design ed to compare early vs. delayed imipenem treatment for acute necrotizing pancreatitis . Ninety patients with acute necrotizing pancreatitis ( C-reactive protein > 150 mg/L , necrosis on CT ) were r and omized within 48 hours either to a group receiving imipenem ( 1.0 g plus cilastatin intravenously 3 times a day ) or a control group . Not included were those who had been started on antibiotics at the referring clinic , those who were taken directly to the intensive care unit for multiorgan failure , and those who refused antibiotics or might have had adverse reactions . Thirty-two patients were excluded because they were over 70 years of age ( not potentionally operable ) or for any study violation . There were 25 patients in the imipenem group and 33 patients in the control group . The main end point was the indication for necrosectomy due to infection ( i.e. , after the initial increase and decrease , there was a second continuous increase in temperature , white blood cell count [ > 30 % ] and C-reactive protein [ > 30 % ] , with other infections ruled out , or bacteria were found on Gram stain of the pancreatic fine-needle aspirate ) . In the control group , imipenem was started when the operative indication was fulfilled . Conservative treatment was continued for at least 5 days before necrosectomy . The study groups did not differ from each other with regard to sex distribution , patient age , etiology , C-reactive protein concentration , and extent of pancreatic necrosis on CT . Two ( 8 % ) of 25 patients in the imipenem group compared to 14 ( 42 % ) of 33 in the control group fulfilled the operative indications ( P = 0.003 ) . Nine patients in the control group responded to delayed antibiotics but five had to undergo surgery . Of those receiving antibiotics , 2 ( 8 % ) of 25 in the early antibiotic ( imipenem ) group needed surgery compared to 5 ( 36 % ) of 14 in the delayed antibiotic ( control ) group ( P = 0.04 ) . Two ( 8 % ) of 25 patients in the imipenem group and 5(15 % ) of 13 patients in the control group died ( P = NS [ no significant difference ] ) . Seven ( 28 % ) of 25 in the imipenem group and 25 ( 76 % ) of 33 in the control group had major organ complications ( P = 0.0003 ) . Based on the preceding criteria , early imipenem-cilastatin therapy appears to significantly reduce the need for surgery and the overall number of major organ complications in acute necrotizing pancreatitis , and reduces by half the mortality rate ; this is not , however , statistically significant in a series of this size BACKGROUND The pharmacological inhibition of exocrine pancreatic secretion with the somatostatin analogue octreotide has been advocated as a specific treatment of acute pancreatitis . AIM To investigate the efficacy of octreotide in acute pancreatitis in a r and omised , placebo controlled trial . METHODS 302 patients from 32 hospitals , fulfilling the criteria for moderate to severe acute pancreatitis within 96 hours of the onset of symptoms , were r and omly assigned to one of three treatment groups : group P ( n=103 ) received placebo , while groups O1 ( n=98 ) and O2 ( n=101 ) received 100 and 200 μg of octreotide , respectively , by subcutaneous injection three times daily for seven days . The primary outcome variable was a score composed of mortality and 15 typical complications of acute pancreatitis . RESULTS The three groups were well matched with respect to pretreatment characteristics . An intent to treat analysis of all 302 patients revealed no significant differences among treatment groups with respect to mortality ( P : 16 % ; O1 : 15 % ; O2 : 12 % ) , the rate of newly developed complications , the duration of pain , surgical interventions , or the length of the hospital stay . A valid for efficacy analysis ( 251 patients ) also revealed no significant differences . CONCLUSIONS This trial shows no benefit of octreotide in the treatment of acute pancreatitis AIM To compare the beneficial effects of early enteral nutrition ( EN ) with prebiotic fiber supplementation in patients with severe acute pancreatitis ( AP ) . METHODS Thirty consecutive patients with severe AP , who required stoppage of oral feeding for 48 h , were r and omly assigned to nasojejunal EN with or without prebiotics . APACHE II score , Balthazar 's CT score and CRP were assessed daily during the study period . RESULTS The median duration of hospital stay was shorter in the study group [ 10 + /- 4 ( 8 - 14 ) d vs 15 + /- 6 ( 7 - 26 ) d ] ( P < 0.05 ) . The median value of days in intensive care unit was also similar in both groups [ 6 + /- 2 ( 5 - 8 ) d vs 6 + /- 2 ( 5 - 7 ) d ] . The median duration of EN was 8 + /- 4 ( 6 - 12 ) d vs 10 + /- 4 ( 6 - 13 ) d in the study and control groups , respectively ( P > 0.05 ) . Deaths occurred in 6 patients ( 20 % ) , 2 in the study group and 4 in the control group . The mean duration of APACHE II normalization ( APACHE II score < 8) was shorter in the study group than in the control group ( 4 + /- 2 d vs 6.5 + /- 3 d , P < 0.05 ) . The mean duration of CRP normalization was also shorter in
Output:
| There was no evidence of any differences in short-term mortality in any of the comparisons ( very low- quality evidence ) .
AUTHORS ' CONCLUSIONS Very low- quality evidence suggests that none of the pharmacological treatments studied decrease short-term mortality in people with acute pancreatitis .
However , the confidence intervals were wide and consistent with an increase or decrease in short-term mortality due to the interventions .
We did not find consistent clinical benefits with any intervention . |
MS210547 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To compare the treatment effects of maxillary anterior teeth retraction with mini-implant anchorage in young adults with Class II division 1 malocclusion undergoing extraction of the maxillary first premolars with similar patients treated by a fixed functional appliance . MATERIAL S AND METHODS Thirty-four young adult female patients ( mean age 16.5 ± 3.2 years , overjet ≥ 6 mm ) with a Class II division 1 malocclusion were divided into two groups : group 1 ( G1 ) , in which overjet correction was obtained with a fixed functional appliance ( FFA ) , and group 2 ( G2 ) , in which upper first premolars were extracted , followed by space closure with MIs as anchor units . Dentoskeletal and soft tissue changes were analyzed on lateral cephalograms taken before ( T1 ) and after ( T2 ) correction of the overjet . RESULTS Both methods were useful in improving the overjet and interincisal relationships . Extrusion and mesial movement of the lower molar , together with lower incisor proclination , were noted in G1 . G2 showed distalization and intrusion of the upper molar . The nasio-labial angle became more obtuse in G2 , while lower lip protrusion was seen for G1 . CONCLUSIONS The two treatment protocol s provided adequate dental compensation for the Class II malocclusion , but did not correct the skeletal discrepancy . There were significant differences in the dental and soft tissue treatment effects between the two treatment protocol INTRODUCTION The esthetic impact of the soft-tissue profile might play a major role in deciding on premolar extraction or non extraction treatment , particularly in borderline patients . The purpose of this study was to compare the esthetic impact of extraction and non extraction therapy on Korean patients . METHODS Panels of 50 dentists and 50 laypersons evaluated r and omly presented pretreatment and posttreatment soft-tissue profiles of 50 extraction and 50 non extraction patients . As subjects in this study , borderline patients were selected based on their initial diagnostic records . Two panels were asked to compare the pretreatment and posttreatment profile tracings and to quantify their perceptions of the esthetic impact of treatment change using a visual analog scale . RESULTS Premolar extraction patients showed greater improvement in facial profile compared with non extraction patients , regardless of the panel . Based on the results of regression analysis to determine the degree of lip protrusion at which the retraction that commonly follows premolar extraction would be needed , the intersection was about 3.0 mm behind the Ricketts ' E-line ; this is far behind the Korean norm . CONCLUSIONS The results indicate that premolar extraction is more beneficial than non extraction treatment in terms of facial profile improvement in Korean borderline patients BACKGROUND No r and omized controlled trial has tried to compare treatment outcomes between the sliding en-masse retraction of upper anterior teeth supported by mini-implants and the two-step sliding retraction technique employing conventional anchorage devices . OBJECTIVE To evaluate skeletal , dental , and soft tissue changes following anterior teeth retraction . DESIGN AND SETTING Parallel-groups r and omized controlled trial on patients with class II division 1 malocclusion treated at the University of Al-Baath Dental School in Hamah , Syria between July 2011 and May 2013 . PARTICIPANTS One hundred and thirty-three patients with an upper dentoalveolar protrusion were evaluated and 80 patients fulfilled the inclusion criteria . R and omization was performed using computer-generated tables ; allocation was concealed using sequentially numbered opaque and sealed envelopes . Fifty-six participants were analysed ( mean age 22.34 ± 4.56 years ) . They were r and omly distributed into two groups with 28 patients in each group ( 1:1 allocation ratio ) . INTERVENTION Following first premolar extraction , space closure was accomplished using either the en-masse technique with mini-implants or the two-step technique with transpalatal arches ( TPAs ) . MAIN OUTCOME MEASURE The antero-posterior displacements of upper incisal edges and upper first molars were measured on lateral cephalograms at three assessment times . Assessor blinding was employed . RESULTS A bodily retraction ( -4.42 mm ; P < 0.001 ) with a slight intrusion ( -1.53 mm ; P < 0.001 ) of the upper anterior teeth was achieved in the mini-implants group , whereas upper anterior teeth retraction was achieved by controlled palatal tipping in the TPA group . CONCLUSIONS When retracting anterior teeth in patients with moderate to severe protrusion , the en-masse retraction based on mini-implants anchorage gave superior results compared to the two-step retraction based on conventional anchorage in terms of speed , dental changes , anchorage loss , and aesthetic outcomes Objective : The objective of this study was to establish whether and how premolar extraction affects the soft tissue profile and incisor inclination in patients with Angle Class II , Division 1 malocclusion . Our primary intention was to identify differences between patients who had four premolars extracted and those who had only two upper premolars removed during camouflage treatment . Our control group consisted of patients with an Angle Class II , Division 1 treated without extraction s. Material s and Methods : These patients ’ lateral cephalograms were cephalometrically analyzed before and after treatment . Computer-assisted analysis of the data using Onyx Ceph ® was followed by a single-factor variance analysis ( one-way ANOVA ) . Results : Our results demonstrate that patients who have undergone camouflage treatment exhibit significantly more retruded upper central incisors than those with extraction s in both jaws , and that their upper incisors are highly significantly more retruded and their m and ibles significantly more retrognathic than those of patients who have not undergone extraction therapy . Conclusion : We did not observe that the patients ’ profiles did become worse after extraction therapy . ZusammenfassungZiel : Es soll dargestellt werden , ob und wie sich eine Prämolarenextraktion auf das Weichteilprofil und die Schneidezahnneigung bei Patienten mit Angle-Klasse II,1 auswirkt . Vor allem sollen Unterschiede zwischen Patienten , bei denen vier Prämolaren extrahiert wurden , und Patienten , denen i m Rahmen einer Camouflage-Beh and lung nur zwei Prämolaren i m Oberkiefer entfernt wurden , ermittelt werden . Als Vergleichsgruppe dienen Patienten mit einer Angle-Klasse II,1 , die ohne Extraktionen beh and elt wurden . Material und Method ik : Die Fernröntgenseitenbilder dieser Patienten wurden vor und nach der Beh and lung kephalometrisch ausgewertet . I m Anschluss an die computergestützte Auswertung der Date n mit Onyx Ceph ® erfolgte eine einfaktorielle Varianzanalyse ( Oneway ANOVA).Ergebnisse : Die Ergebnisse zeigen , dass Patienten mit Camouflage-Beh and lung nach Therapie signifikant retrudierter stehende obere mittlere Schneidezähne als Patienten mit Extraktionen in beiden Kiefern haben und dass sie höchst signifikant retrudierter stehende obere Schneidezähne sowie signifikant retrognather liegende Unterkiefer als Patienten ohne Extraktionstherapie aufweisen . Schlussfolgerung : Eine Profilverschlechterung nach Extraktionstherapie konnte nicht nachgewiesen werden Soft-tissue profiles were examined in 160 orthodontic patients treated with removal of four first premolars . Records of 10- to 30-year-old patients were selected at r and om from five sources : patients treated by Charles H. Tweed on file at the Tweed Foundation , patients treated with the Begg technique by the Kesling-Rocke group , patients from two practice s with pretorqued , preangulated edgewise appliances , and patients with premolars enucleated at an early age . The mean changes for the total sample included an increase of 5.2 degrees in the nasolabial angle , and retraction of the upper and lower lips 3.4 and 3.6 mm to the E line , respectively . For different measurements , between 5 % and 25 % of the sample had values indicating more protrusive lips after treatment . In comparisons among groups , the Tweed patients generally exhibited the greatest lower lip retraction . When profile changes were compared to values representing normal ( or " ideal " ) facial esthetics , it was evident that extraction of four first premolars generally did not result in a " dished-in " profile . Approximately 10 % to 15 % of cases could be defined as excessively flat after treatment . Eighty percent to 90 % of patients treated by extraction of four first premolars had soft-tissue measurements that suggested the profile was improved by treatment or remained satisfactory throughout treatment INTRODUCTION A prospect i ve r and omized study was design ed to compare the skeletal , dental , and soft-tissue profile changes in Class I borderline patients treated with extraction and non extraction by means of the air-rotor stripping ( ARS ) technique and to compare the treatment times . METHODS Twenty-six borderline patients with balanced and orthognathic facial profiles were r and omly divided into 2 groups . In the first group , 13 subjects with a mean age of 18.1 + /- 3.7 years and mean maxillary and m and ibular crowding of 5.7 + /- 1.5 and 5.9 + /- 1.4 mm , respectively , were treated by removal of 4 premolars with minimum anchorage . In the second group , 13 subjects with a mean age of 17.8 + /- 2.4 years and mean maxillary and m and ibular crowding of 5.0 + /- 1.3 and 5.9 + /- 1.3 mm , respectively , were treated with ARS . Lateral cephalometric radiographs and dental models taken before and after treatment were evaluated . RESULTS The initial skeletal , dental , and profile characteristics of both groups were similar . In the first group , the maxillary and m and ibular incisors were slightly retracted , whereas lip positions did not change . In the non extraction group , maintenance of maxillary incisor position , slight protrusion of the m and ibular incisors and the upper and lower lips were observed at the end of treatment . The nasolabial angle decreased significantly . Because of postpubertal growth of the nose and the chin , the lips appeared slightly retrusive after extraction therapy , whereas lip protrusion was compensated in the non extraction group . The main soft-tissue profile differences between the 2 groups were 1 to 1.5 mm more retruded upper and lower lip positions in the extraction patients , but both groups had well-balanced and desirable facial esthetics with all profile measurements within normal limits . Non extraction therapy with ARS reduced treatment time by 8 months . CONCLUSIONS Both extraction and ARS combined with non extraction therapies are effective treatment alternatives for Class I borderline patients with good facial profile and moderate dental crowding This investigation was design ed to compare the esthetic effects of extraction and non extraction treatments . Panels of 58 laypersons and 42 dentists evaluated r and omly presented pre- and posttreatment profiles of 70 extraction and 50 non extraction Class I and II Caucasian patients . The sample s were similar at the outset ; however , at the end of treatment , the extraction patients ' faces were , on average , 1.8 mm " flatter " than the faces of non extraction subjects . The flatter faces were preferred by both panels , dentists more so than laypersons . In general , non extraction treatment was seen as having little effect on the profile , whereas the perceived effect of extraction treatment was a statistically significant function of initial soft tissue protrusion-the greater the initial protrusion , the greater the benefit . The point at which a reduction in protrusion produces a perceived improvement was explored by way of regression analysis . Both panels saw extraction as being potentially beneficial when the lips were more protrusive than 2 to 3 mm behind Ricketts ' E-plane . It is concluded that extraction treatment can produce improved facial esthetics for many patients who present with some combination of crowding and protrusion Aim : It was the aim of this clinical study to compare the skeletal and dentoalveolar effects as well as those on the profile of three different treatment approaches in Class II patients ( camouflage orthodontics , dentofacial orthopedics , and combined orthodontic and surgical treatment ) . Patients and Method : Our study cohort consisted of 60 young adults presenting a skeletal Class II , Division 1 malocclusion : 20 patients whose overjet was reduced by camouflage following premolar extraction , 20 patients whose occlusions were corrected by placement of a fixed functional orthopedic appliance , and 20 who underwent orthognathic surgery ( bilateral sagittal split osteotomy of the m and ible without genioplasty ) . We documented the therapeutic progress using cephalometry . Results : Each patient group achieved a reduction in overjet via their respective treatment . While no treatment-related changes in the maxillary area were assessable , the effects on the m and ible differed . We observed advancement of the bony chin and an increase in m and ibular length in the sagittal-diagonal dimension in the surgical and functional orthopedic groups . However , the extent of the treatment-related changes was significant only in the group of patients that had undergone orthognathic surgery . Only the surgical group presented changes in vertical relationships . Incisor repositioning as an outcome of the respective treatments differed fundamentally , with those in the surgical group revealing significant protrusion of the upper incisors . The maxillary incisors were retruded and m and ibular incisors proclined in the functional orthopedic group , whereas the upper and lower incisors both retruded significantly in the extraction group . Softtissue remodeling bore no linear relationship to treatment-induced skeletal and dental effects . Still , orthognathic surgery led to the most marked profile changes . Treatment using fixed functional orthopedic appliances reduced the convexity of the soft-tissue profile at least moderately . Camouflage orthodontics , on the other h and , result ed in an increase in the nas
Output:
| Retrusion of the upper and lower lips were also verified , with less retraction of the lower lip in 2-premolar extraction groups .
When Class II division 1 malocclusion is treated with premolar extraction s , the NLA increases and the lips are retracted .
However , there is less retraction of the lower lip in the 2-maxillary premolar extraction protocol |
MS210548 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE Studies have shown that perceived racial discrimination is a significant predictor of clinical pain severity among African Americans . It remains unknown whether perceived racial discrimination also alters the nociceptive processing of painful stimuli , which , in turn , could influence clinical pain severity . This study examined associations between perceived racial discrimination and responses to noxious thermal stimuli among African Americans and non-Hispanic Whites . Mistrust of medical research ers was also assessed given its potential to affect responses to the noxious stimuli . METHOD One-hundred and 30 ( 52 % African American , 48 % non-Hispanic White ) community-dwelling older adults with symptomatic knee osteoarthritis completed two study sessions . In session one , individuals provided demographic , socioeconomic , physical and mental health information . They completed question naires related to perceived lifetime frequency of racial discrimination and mistrust of medical research ers . In session two , individuals underwent a series of controlled thermal stimulation procedures to assess heat pain sensitivity , particularly heat pain tolerance . RESULTS African Americans were more sensitive to heat pain and reported greater perceived racial discrimination as well as greater mistrust of medical research ers compared with non-Hispanic Whites . Greater perceived racial discrimination significantly predicted lower heat pain tolerance for African Americans but not non-Hispanic Whites . Mistrust of medical research ers did not significantly predict heat pain tolerance for either racial group . CONCLUSION These results lend support to the idea that perceived racial discrimination may influence the clinical pain severity of African Americans via the nociceptive processing of painful stimuli In Malaysia , it is a common belief among health care workers that females and Indians have lower pain threshold . This experience , although based on anecdotal experience in the healthcare setting , does not allow differentiation between pain tolerance , and pain expression . To determine whether there is a difference in the tolerance to pain between the three main ethnic groups , namely the Malays , Chinese and Indians as well as between males and females . This was a prospect i ve study , using a laboratory pain model ( ischaemic pain tolerance ) to determine the pain tolerance of 152 IMU medical students . The mean age of the students was 21.8 years ( range 18 - 29 years ) . All of them were unmarried . The median of ischaemic pain tolerance for Malays , Chinese and Indians were 639s , 695s and 613s respectively ( p = 0.779 ) . However , statistically significant difference in ischaemic pain tolerance for males and females Indian students were observed . Possible ethnic difference in pain tolerance in casual observation is not verified by this laboratory pain model . Difference in pain tolerance between genders is shown only for Indians Abstract The aim of this study was to examine experimental pain sensitivity in three ethnic groups , African Americans , Hispanic Americans and non‐Hispanic White Americans , and to determine whether ethnic identity is differentially associated with pain sensitivity across ethnic groups . Participants included sixty‐three African American , sixty‐one Hispanic and eighty‐two non‐Hispanic white participants who were assessed using three experimental pain measures : thermal , cold‐pressor and ischemic . Participants ’ ethnic identity was assessed using the Multi‐group Ethnic Identity Measure ( MEIM ) . Ethnic group differences in pain responses were observed , with African American and Hispanic subjects showing lower cold and heat pain tolerances than non‐Hispanic White Americans . In addition , pain range ( i.e. tolerance‐threshold ) was computed for heat , cold and ischemic pain , and the two minority groups again had lower values compared to non‐Hispanic White Americans . Ethnic identity was associated with pain range only for African American and Hispanic groups . Statistically controlling for ethnic identity rendered some of the group differences in pain range non‐significant . These findings indicate that ethnic identity is associated with pain sensitivity in ethnic minority groups , and may partially mediate group differences in pain perception . The results of the present investigation provide evidence of ethnic group differences in responses to experimental pain across multiple noxious stimuli , with both minority groups exhibiting greater sensitivity to laboratory evoked pain compared to non‐Hispanic White Americans & NA ; Ethnic differences in the experience of pain , pain‐related health care utilization and pain‐reducing activities have been reported . Thus , evaluating of such variations is important in clinical and experimental pain . Since clinical pain is greatly influenced by disease‐specific factors ( severity , duration , type and treatment ) , evaluating ethnic differences in experimental pain models may not only provide some information about underlying mechanisms but also may predict or explain group differences in clinical pain . Migraine prevalence within ethnic population s is varied . Capsaicin injection to the forehead of healthy volunteers induces the state of an experimental trigeminal sensitization , which is one of the proposed mechanisms of migraine . The aim of the present study was to investigate ethnic differences between Caucasians and South Indians in this model of trigeminal sensitization . Thirty‐two healthy male volunteers ( 16 South Indians and 16 Danish Caucasians ) were included . Capsaicin ( 100 μg/0.1 ml ) was injected intradermally to the right forehead skin . Pain sensitivity , secondary hyperalgesic area , and pressure pain threshold were assessed . Overall , the model showed significant greater pain responses in South Indians ( 8.75±1.25 cm pain intensity and 9.33±2.32 cm2 hyperalgesic area ) compared to Caucasians ( 6.25±1.95 cm pain intensity and 6.25±1.41 cm2 hyperalgesic area ) . The model may provide important information for further clinical research , e.g. migraine or differences in mechanisms underlying trigeminal sensitization OBJECTIVE A growing body of literature suggests ethnic differences in experimental pain . However , these studies largely focus on adults and the comparison between Caucasians and African Americans . The primary aim of this study is to determine ethnic differences in laboratory-induced pain in a multiethnic child sample . METHOD Participants were 214 healthy children ( mean age = 12.7 , SD = 3.0 years ) . Ninety-eight Caucasian , 58 Hispanic , 34 African American , and 24 Asian children were exposed to four trials of pressure and radiant heat pain stimuli . Pain responses were assessed with self-report measures ( i.e. , pain intensity and unpleasantness ) and behavioral observation ( i.e. , pain tolerance ) . RESULTS Asians demonstrated more pain sensitivity than Caucasians , who evidence d more pain sensitivity than African Americans and Hispanics . The results hold even after controlling for age , sex , SES , and experimenter 's ethnicity . Asians also showed higher anticipatory anxiety compared with other ethnic groups . Anticipatory anxiety accounted for some ethnic differences in pain between Asians , Hispanics , and African Americans . CONCLUSIONS By examining response to laboratory pain stimuli in children representing multiple ethnicities , an understudied sample , the study reveals unique findings compared to the existing literature . These findings have implication s for clinicians who manage acute pain in children from diverse ethnic background s. Future investigations should examine mechanisms that account for ethnic differences in pain during various developmental stages OBJECTIVE Although numerous studies have reported ethnic differences in the prevalence and severity of clinical pain , little is known about how these differences affect the perception of experimental pain . The present experiment examined the effects of ethnicity ( African American vs. white ) on thermal pain responses in a healthy undergraduate population . METHODS Thirty white subjects ( 16 women and 14 men ) and 18 African Americans ( 10 women and 8 men ) participated in the study . Thermal testing included evaluation of the following : warmth thresholds , thermal pain thresholds , thermal pain tolerances , and magnitude estimates of both the intensity and unpleasantness of thermal pain ( at 46 degrees , 47 degrees , 48 degrees , and 49 degrees C ) . RESULTS Although no group differences emerged for warmth thresholds , thermal pain thresholds , or pain intensity ratings , African Americans demonstrated lower thermal pain tolerances than whites . In addition , African Americans had smaller slopes and larger intercepts than whites for ratings of pain unpleasantness . Additional analyses suggested that these findings were a consequence of group differences in thermal pain unpleasantness ratings at the lowest temperatures assessed ( 46 degrees and 47 degrees C ) ; at these temperatures , African Americans rated the stimuli as more unpleasant than whites . Finally , group differences in thermal pain tolerance and thermal pain unpleasantness ratings seemed to partially account for greater self-reported daily pain symptoms among African Americans . CONCLUSIONS Collectively , these findings seem to suggest ethnic differences in the perception of the affective-motivational dimension of thermal pain
Output:
| Racial/ethnic differences in experimental pain sensitivity were more pronounced with suprathreshold than with threshold stimuli , which is important in clinical pain treatment . |
MS210549 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Purpose The primary objective of this study was to evaluate the dose-limiting toxicities ( DLTs ) and identify the maximum-tolerated dose ( MTD ) and recommended dose of nab-paclitaxel plus gemcitabine as a first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma ( PDA ) . Methods Patients with previously untreated advanced PDA were treated with nab-paclitaxel followed by gemcitabine ( 1,000 mg/m2 ) administered intravenously for 30 min on days 1 and 8 and repeated every 21 days . Results Patients received nab-paclitaxel at the following dose levels : 80 mg/m2 ( n = 3 ) , 100 mg/m2 ( n = 6 ) , and 120 mg/m2 ( n = 12 ) . The DLTs evaluated were elevated alanine aminotransferase and febrile neutropenia . However , there had no two out of three to six patients experienced DLTs , the MTD was not met . A total of 93 cycles were administered . The most common grade 3/4 toxicities were neutropenia ( 9.52 % ) , thrombocytopenia ( 4.76 % ) , and sensory neuropathy ( 4.76 % ) . For 12 patients receiving 120 mg/m2 , the overall response rate and disease control rate were 41.67 and 83.33 % , respectively , and the median progression-free survival and overall survival were 5.23 and 12.17 months , respectively . Conclusions Treatment with albumin-bound nab-paclitaxel ( 120 mg/m2 ) plus gemcitabine has a favorable safety profile with an encouraging antitumor effect in Chinese patients BACKGROUND Pancreas adenocarcinoma is the sixth cause of cancer-related death worldwide with an increasing mortality in the Western countries . Recently , the association between nab-paclitaxel ( nab-P ) and gemcitabine ( GEM ) has significantly improved progression-free and overall survival . PATIENTS AND METHODS Patients affected by metastatic pancreas adenocarcinoma were treated at the Department of Abdominal Oncology of the National Cancer Institute of Naples from July 2015 to July 2016 with nab-P at 125 mg per square meter of body-surface area followed by GEM at 1,000 mg per square meter on days 1 , 8 and 15 every 4 weeks . Computed tomography ( CT ) was performed every three months of therapy . Toxicity was grade d with National Cancer Institute-Common Toxicity Criteria ( NCI-CTC ) v4.0 . Objective responses were evaluated with Response Evaluation Criteria in Solid Tumors ( RECIST ) . Analysis of time-to-progression is only descriptive . Pain was evaluated with a visual analogue scale ( VAS ) . RESULTS Twenty-three patients were treated . Median age was 67 years ( range=45 - 81 ) ; 8 patients were ≥70 years old . Performance status ( PS ) Eastern Cooperative Oncology Group ( ECOG ) was 2 in 8 patients , 1 in 10 and 0 in 5 . Twelve patients presented with diffuse hepatic metastases , 4 with carcinosis , 7 with more than one organ involvement . Nab-P was reduced at 100 mg per square meter in all patients . The most common G3/G4 adverse events were neutropenia ( 13.0 % G4 , 8.6 % G3 ; none was febrile ) , neuropathy ( 30.4 % G3 ) and asthenia ( G3 17.3 % ) . The disease control rate was 43.4 % ( partial response+stable disease ( PR+SD ) 10/23 ) . The median time-to-progression was 7.9 months ( 95 % confidence interval (CI)=5.8 - 11.2 ) . After three months of therapy the PS improved in 14 patients , as well as pain in 18 patients . CONCLUSION We present an experience with nab-P and GEM association in a series with poor PS and highly metastatic disease relatively to a previous r and omized study . The schedule is feasible , with nab-P at 100 mg per square meter achieving a good disease control rate , as well as a clinical benefit Background The LAP07 r and omized trial calls into question the role of radiation therapy ( RT ) in the modern treatment of locally advanced pancreatic cancer ( LAPC ) . However , advances in chemotherapy and RT limit application of the LAP07 results to current clinical practice . Here we utilize the National Cancer Data base ( NCDB ) to evaluate the effects of RT in patients receiving chemotherapy for LAPC . Methods Using the NCDB , patients with American Joint Committee on Cancer ( AJCC ) clinical stage T2–4 , N0–1 , M0 adenocarcinoma of the pancreas from 2004 to 2014 were analyzed . Patients were stratified into chemotherapy only ( CT ) and chemoradiation ( CRT ) cohorts . Patients undergoing definitive RT , defined as at least 20 fractions or ≥ 5 Gy per fraction [ i.e. , stereotactic body radiation therapy ( SBRT ) ] were included in the CRT cohort . Propensity-score matching ( PSM ) and l and mark analysis were used to address selection bias and lead-time bias , respectively . Results 13,004 patients met inclusion criteria , of whom 7034 ( 54 % ) received CT and 5970 ( 46 % ) received CRT . After PSM , 5215 patients remained in each cohort . The CRT cohort demonstrated better overall survival ( OS ) compared with CT alone , with median and 1-year OS of 12 versus 10 months , and 50 % and 41 % , respectively ( p < 0.001 ) . On multivariable analysis , CRT was associated with superior OS with hazard ratio of 0.79 ( 95 % confidence interval 0.76–0.83 ) compared with CT alone . Conclusions In our series , addition of definitive radiotherapy to CT was associated with better OS when compared with CT alone in LAPC . Definitive radiotherapy should remain a treatment option for LAPC , but optimal selection criteria remain unclear Purpose For unresectable locally advanced ( UR-LA ) pancreatic cancer , chemoradiotherapy has been recommended by the NCCN guidelines . We design ed a chemoradiotherapy protocol using nab-paclitaxel combined with gemcitabine ( GnP ) for patients with UR-LA pancreatic cancer . The purpose of this phase I study was to determine a recommended dose ( RD ) for this novel regimen . Methods Patients with UR-LA pancreatic cancer were eligible . The frequency of dose-limiting toxicities ( DLTs ) was evaluated , and the RD was determined . Patients were classified according to the design ated dose levels of chemoradiotherapy using the GnP regimen . After additional 6 cycles of the GnP regimen were administered , surgery was considered if the patients had stable disease and tumor marker levels had normalized . Results DLT ( grade 4 thrombocytopenia ) was observed only in 1 of 12 patients , and the RD was set at level 3 . Grade 3–4 leukopenia was observed in 9 ( 75.0 % ) patients , and neutropenia in 7 ( 58.3 % ) . The response rate was 41.7 % , and the disease control rate was 100 % . Conversion surgery was performed in 6 ( 50 % ) patients , and curative resection ( R0 ) was performed in all 6 patients ( 100 % ) . Stratification according to the Evans classification system demonstrated one patient with grade 1b , one with grade 2 , two with grade 3 , and two with grade 4 disease . Conclusion The RD for weekly administration was 800 mg/m2 for gemcitabine and 100 mg/m2 for nab-paclitaxel with a 50.4 Gy radiation . The GnP regimen at this dosage was promising with 6 of 12 patients proceeding to conversion surgery , and should be evaluated further in a phase II trial BACKGROUND In a phase 1 - 2 trial of albumin-bound paclitaxel ( nab-paclitaxel ) plus gemcitabine , substantial clinical activity was noted in patients with advanced pancreatic cancer . We conducted a phase 3 study of the efficacy and safety of the combination versus gemcitabine monotherapy in patients with metastatic pancreatic cancer . METHODS We r and omly assigned patients with a Karnofsky performance-status score of 70 or more ( on a scale from 0 to 100 , with higher scores indicating better performance status ) to nab-paclitaxel ( 125 mg per square meter of body-surface area ) followed by gemcitabine ( 1000 mg per square meter ) on days 1 , 8 , and 15 every 4 weeks or gemcitabine monotherapy ( 1000 mg per square meter ) weekly for 7 of 8 weeks ( cycle 1 ) and then on days 1 , 8 , and 15 every 4 weeks ( cycle 2 and subsequent cycles ) . Patients received the study treatment until disease progression . The primary end point was overall survival ; secondary end points were progression-free survival and overall response rate . RESULTS A total of 861 patients were r and omly assigned to nab-paclitaxel plus gemcitabine ( 431 patients ) or gemcitabine ( 430 ) . The median overall survival was 8.5 months in the nab-paclitaxel-gemcitabine group as compared with 6.7 months in the gemcitabine group ( hazard ratio for death , 0.72 ; 95 % confidence interval [ CI ] , 0.62 to 0.83 ; P<0.001 ) . The survival rate was 35 % in the nab-paclitaxel-gemcitabine group versus 22 % in the gemcitabine group at 1 year , and 9 % versus 4 % at 2 years . The median progression-free survival was 5.5 months in the nab-paclitaxel-gemcitabine group , as compared with 3.7 months in the gemcitabine group ( hazard ratio for disease progression or death , 0.69 ; 95 % CI , 0.58 to 0.82 ; P<0.001 ) ; the response rate according to independent review was 23 % versus 7 % in the two groups ( P<0.001 ) . The most common adverse events of grade 3 or higher were neutropenia ( 38 % in the nab-paclitaxel-gemcitabine group vs. 27 % in the gemcitabine group ) , fatigue ( 17 % vs. 7 % ) , and neuropathy ( 17 % vs. 1 % ) . Febrile neutropenia occurred in 3 % versus 1 % of the patients in the two groups . In the nab-paclitaxel-gemcitabine group , neuropathy of grade 3 or higher improved to grade 1 or lower in a median of 29 days . CONCLUSIONS In patients with metastatic pancreatic adenocarcinoma , nab-paclitaxel plus gemcitabine significantly improved overall survival , progression-free survival , and response rate , but rates of peripheral neuropathy and myelosuppression were increased . ( Funded by Celgene ; Clinical Trials.gov number , NCT00844649 . ) PURPOSE To provide evidence -based recommendations to oncologists and others for treatment of patients with locally advanced , unresectable pancreatic cancer . METHODS American Society of Clinical Oncology convened an Expert Panel of medical oncology , radiation oncology , surgical oncology , gastroenterology , palliative care , and advocacy experts and conducted a systematic review of the literature from January 2002 to June 2015 . Outcomes included overall survival , disease-free survival , progression-free survival , and adverse events . RESULTS Twenty-six r and omized controlled trials met the systematic review criteria . RECOMMENDATIONS A multiphase computed tomography scan of the chest , abdomen , and pelvis should be performed . Baseline performance status and comorbidity profile should be evaluated . The goals of care , patient preferences , psychological status , support systems , and symptoms should guide decisions for treatments . A palliative care referral should occur at first visit . Initial systemic chemotherapy ( 6 months ) with a combination regimen is recommended for most patients ( for some patients radiation therapy may be offered up front ) with Eastern Cooperative Oncology Group performance status 0 or 1 and a favorable comorbidity profile . There is no clear evidence to support one regimen over another . The gemcitabine-based combinations and treatments recommended in the metastatic setting ( eg , fluorouracil , leucovorin , irinotecan , and oxaliplatin and gemcitabine plus nanoparticle albumin-bound paclitaxel ) have not been evaluated in r and omized controlled trials involving locally advanced , unresectable pancreatic cancer . If there is local disease progression after induction chemotherapy , without metastasis , then radiation therapy or stereotactic body radiotherapy may be offered also with an Eastern Cooperative Oncology Group performance status ≤ 2 and an adequate comorbidity profile . If there is stable disease after 6 months of induction chemotherapy but unacceptable toxicities , radiation therapy may be offered as an alternative . Patients with disease progression should be offered treatment per the ASCO Metastatic Pancreatic Cancer Treatment Guideline . Follow-up visits every 3 to 4 months are recommended . Additional information is available at www.asco.org/ guidelines /LAPC and www.asco.org/ guidelines /MetPC and www.as
Output:
| NG has been proven to reduce tumours with an acceptable toxicity profile in metastatic pancreatic cancer .
This analysis further demonstrates the efficacy and safety of NG for treating LAPC |
MS210550 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: In the Physicians ' Health Study , a r and omized , placebo-controlled , double-blind trial of aspirin in the reduction of cardiovascular mortality and beta-carotene in decreasing cancer incidence , 33,223 subjects were eligible and willing to enter the trial . Instead of r and omizing this group immediately , all participants received identical calendar packs that contained active aspirin and beta-carotene placebo . Following an 18-week run-in , only 22,071 subjects who remained eligible and willing and had taken at least 2/3 of their pills were r and omized . We estimated the effect of the run-in as follows : pill taking compliance increased 20 - 41 per cent ; sample size decreased 34 per cent ; duration of follow-up decreased 7 per cent which result ed in a 7 per cent decrease in the expected event rate for the placebo group . To estimate these changes , we made assumptions about compliance and outcome risk for those excluded by the run-in . Our conclusion , however , about the net effect of the run-in on the power of the study remains constant across variations in a number of those assumptions . The power with the run-in , with 22,071 good compliers was typically higher , and never more than negligibly lower , than the power without the run-in , with 33,223 good and poor compliers . In addition , savings from enrolling 11,152 fewer subjects in the trial result ed from the use of the run-in Abstract Nine VA Medical Centers are participating in a 2-year double-blind placebo controlled study of antioxidant treatment for tardive dyskinesia ( TD ) conducted by the Department of Veteran Affairs Cooperative Studies Program . One of the principal outcome measures of this study is the score derived from the instrumental assessment of upper extremity dyskinesia . Dyskinetic h and movements are quantified by assessing the variability associated with steady-state isometric force generated by the patient . In the present report , we describe the training procedures and results of a multi-center reliability assessment of this procedure . Data from nine study centers comprising 45 individual patients with six trials each ( three from left h and and three from right h and ) were reanalyzed by an independent investigator and the results were subjected to reliability assessment . For the statistic of interest ( average coefficient of variation over trials 2 and 3 for each h and , then take the larger of these two values ) , we found very high intraclass correlation coefficients for reliability over all patients across sites ( ICC = 0.995 ) . We also calculated the reliability of the measures across trials within patient for each combination of h and ( right , left , dominant ) , rater group ( site , control ) , and trials set ( all three , trials 2 and 3 ) . For a given h and and trial set , the reliability of the site raters was similar to that of the control . This study demonstrates that instrumental measures for the assessment of dyskinesia are reliable and can be implemented in multi-center studies with minimal training BACKGROUND Even though dietary fiber has been hypothesized to reduce the risk of coronary heart disease , few large epidemiological studies have examined this relation with good methodology . METHODS AND RESULTS The Alpha-Tocopherol , Beta-Carotene Cancer Prevention Study was a r and omized , double-blind , placebo-controlled trial with daily supplementation of alpha-tocopherol and /or beta-carotene . Of the participants , 21930 smoking men aged 50 to 69 years who were free of diagnosed cardiovascular disease and had completed a vali date d dietary question naire at baseline were followed for 6.1 years . We monitored the incidence of major coronary events ( a combination of first nonfatal myocardial infa rct ion and coronary heart disease death ; n = 1399 ) and mortality from coronary heart disease ( n = 635 ) . Both entities had a significant inverse association with dietary fiber , but the association was stronger for coronary death . For men in the highest quintile of total dietary fiber intake ( median , 34.8 g/d ) , the relative risk for coronary death was 0.69 ( 95 % confidence interval , 0.54 to 0.88 ; P < .001 for trend ) compared with men in the lowest quintile of intake ( median , 16.1 g/d ) . With an adjustment for known cardiovascular risk factors , intake of saturated fatty acids , beta-carotene , vitamin C , and vitamin E did not material ly change the result . Water-soluble fiber was slightly more strongly associated with reduced coronary death than water-insoluble fiber , and cereal fiber also had a stronger association than vegetable or fruit fiber . CONCLUSIONS These findings suggest that independent of other risk factors , greater intake of foods rich in fiber can substantially reduce the risk of coronary heart disease , and particularly coronary death , in middle-aged , smoking men Although administration of zinc to human subjects has been reported to interfere with lymphocyte function , this single report has never been confirmed or refuted . We have developed zinc as a lifelong therapy for patients with Wilson 's disease . Interference with lymphocyte function occurring as a side effect of zinc therapy could produce serious problems in our patients . We evaluated lymphocyte mitogenic response and natural killer cell activity in patients with Wilson 's disease treated for 5 years or longer with zinc , in comparison with normal controls , and found no differences . In a second study , we evaluated these same parameters in patients with Wilson 's disease before and after 1 year of zinc therapy , and again found no significant differences . We have seen no indications of immune suppression or increased susceptibility to infections in our patients , who have now been treated with zinc for up to 15 years . We conclude that any side effects from compromised lymphocyte function caused by administration of zinc are not of concern to patients with Wilson 's disease The purpose of this study was to evaluate the effect of selenium ( Se ) in the prevention of human primary liver cancer . Three intervention trials were conducted among the residents at high risk to primary liver cancer ( PLC ) in Qidong county , Jiang-su province , the People ’s Republic of China . This area has the second highest rate of PLC in China . One trial was undertaken among the general population in a township with supplement of table salt fortified with 15 ppm anhydrous sodium selenite ( Se-salt ) for 5 y and the other four townships with similar PLC incidence rate served as the controls using normal table salt . The second trial was undertaken among hepatitis B virus surface antigen carriers ( HBVsAg+ ) receiving supplement of 200 μg Se in form of selenized , yeast ( Se-yeast ) daily vs placebo for 4 y. The third trial was carried out in members of families with high PLC incidence using Se-yeast ( 200 μg of Se daily ) vs placebo for 2 y. The results showed that nutritional supplement of Se could reduce the PLC incidence significantly Purpose The high concentration of carotenoids in the macula , plus evidence linking oxidative stress to age-related macular degeneration ( AMD ) and carotenoids to antioxidation , generated the hypothesis that higher antioxidant intakes can prevent AMD . The aim of this study was to determine whether nutritional supplementation with a targeted nutritional supplement improves visual acuity and visual function in AMD . Methods In this multicenter , prospect i ve open-label r and omized study , 145 patients were r and omly assigned to 2 different treatment groups . Interventions were lutein ( 10 mg ) , zeaxanthin ( 1 mg ) , astaxanthin ( 4 mg ; AZYR SIFI , Catania , Italy ) , and antioxidants/vitamins supplementation formula or no dietary supplementation for 2 years . Primary outcome was mean changes in visual acuity ( VA ) at 12 and 24 months . Other measures included contrast sensitivity ( CS ) and National Eye Institute visual function question naire ( NEI VFQ-25 ) scores at 12 and 24 months . Results Patients in the treated group showed stabilization of VA with significantly ( p=0.003 ) better VA scores ( 81.4±7.2 ) compared to the nontreated group ( 76.8±8.9 ) at 24-month follow-up . An improvement in CS ( p=0.001 ) and final mean NEI VFQ-25 composite scores at 12 and 24 months higher in treated group compared to nontreated group were also shown ( p<0.001 ) . Conclusions Patients treated with lutein/zeaxanthin and astaxanthin together with other nutrients were more likely to report clinical ly meaningful stabilization/improvements in VA , CS , and visual function through 24 months compared with nontreated subjects . Further studies are needed with more patients and for longer periods of time Ageing is associated with impaired immune responses and increased infection-related morbidity . This study assessed the effect of physiological amounts of vitamins and trace elements on immunocompetence and occurrence of infection-related illness . 96 independently living , healthy elderly individuals were r and omly assigned to receive nutrient supplementation or placebo . Nutrient status and immunological variables were assessed at baseline and at 12 months , and the frequency of illness due to infection was ascertained . Subjects in the supplement group had higher numbers of certain T-cell subsets and natural killer cells , enhanced proliferation response to mitogen , increased interleukin-2 production , and higher antibody response and natural killer cell activity . These subjects were less likely than those in the placebo group to have illness due to infections ( mean [ SD ] 23 [ 5 ] vs 48 [ 7 ] days per year , p = 0.002 ) . Supplementation with a modest physiological amount of micronutrients improves immunity and decreases the risk of infection in old age OBJECTIVE To determine whether supplements of vitamin A or vitamin E alone or in combination affect the course of retinitis pigmentosa . DESIGN R and omized , controlled , double-masked trial with 2 x 2 factorial design and duration of 4 to 6 years . Electroretinograms , visual field area , and visual acuity were measured annually . SETTING Clinical research facility . PATIENTS 601 patients aged 18 through 49 years with retinitis pigmentosa meeting preset eligibility criteria . Ninety-five percent of the patients completed the study . There were no adverse reactions . INTERVENTION Patients were assigned to one of four treatment groups receiving 15,000 IU/d of vitamin A , 15,000 IU/d of vitamin A plus 400 IU/d of vitamin E , trace amounts of both vitamins , or 400 IU/d of vitamin E. MAIN OUTCOME MEASURE Cone electroretinogram amplitude . RESULTS The two groups receiving 15,000 IU/d of vitamin A had on average a slower rate of decline of retinal function than the two groups not receiving this dosage ( P = .01 ) . Among 354 patients with higher initial amplitudes , the two groups receiving 15,000 IU/d of vitamin A were 32 % less likely to have a decline in amplitude of 50 % or more from baseline in a given year than those not receiving this dosage ( P = .01 ) , while the two groups receiving 400 IU/d of vitamin E were 42 % more likely to have a decline in amplitude of 50 % or more from baseline than those not receiving this dosage ( P = .03 ) . While not statistically significant , similar trends were observed for rates of decline of visual field area . Visual acuity declined about 1 letter per year in all groups . CONCLUSIONS These results support a beneficial effect of 15,000 IU/d of vitamin A and suggest an adverse effect of 400 IU/d of vitamin E on the course of retinitis pigmentosa BACKGROUND Among apparently healthy men , elevated levels of C-reactive protein ( CRP ) , a marker for systemic inflammation , predict risk of myocardial infa rct ion and thromboembolic stroke . Whether increased levels of CRP are also associated with the development of symptomatic peripheral arterial disease ( PAD ) is unknown . METHODS AND RESULTS Using a prospect i ve , nested , case-control design , we measured baseline levels of CRP in 144 apparently healthy men participating in the Physicians ' Health Study who subsequently developed symptomatic PAD ( intermittent claudication or need for revascularization ) and in an equal number of control subjects matched on the basis of age and smoking habit who remained free of vascular disease during a follow-up period of 60 months . Median CRP levels at baseline were significantly higher among those who subsequently developed PAD ( 1.34 versus 0.99 mg/L ; P=.04 ) . Furthermore , the risks of developing PAD increased significantly with each increasing quartile of baseline CRP concentration such that relative risks of PAD from lowest ( referent ) to highest quartile of CRP were 1.0 , 1.3 , 2.0 , and 2.1 ( Ptrend=.02 ) . Compared with those with no clinical evidence of disease , the subgroup of case patients who required revascularization had the highest baseline CRP levels ( median= 1.75 mg/L ; P= .04 ) ; relative risks from lowest to highest quartile of CRP for this end point were 1.0 , 1.8 , 3.8 , and 4.1 ( Ptrend=.02 ) . Risk estimates were similar after additional control for body mass index , hypercholesterolemia , hypertension , diabetes , and a family history of premature atherosclerosis . CONCLUSIONS These prospect i ve data indicate that among apparently healthy men , baseline levels of CRP predict future risk of developing symptomatic PAD and thus provide further support for the hypothesis that chron
Output:
| Adverse effects were not reported but there was possible increased risk of skin rashes in the multivitamin group .
Adverse effects were not consistently reported in these eye studies , but there is evidence from other large studies that beta-carotene increases the risk of lung cancer in people who smoke or who have been exposed to asbestos .
None of the studies reported quality of life or re source use and costs .
AUTHORS ' CONCLUSIONS Taking vitamin E or beta-carotene supplements will not prevent or delay the onset of AMD .
There is no evidence with respect to other antioxidant supplements , such as lutein and zeaxanthin .
Although generally regarded as safe , vitamin supplements may have harmful effects , and clear evidence of benefit is needed before they can be recommended . |
MS210551 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: & NA ; Tramadol hydrochloride is a synthetic & mgr;‐opioid agonist with additional monoaminergic activity . Tramadol 's analgesic effect has been equated with that of pethidine , with a more favourable side‐effect profile . Tramadol has been the most‐selling prescription analgesic in Germany for several years , and it is now available in many other European countries , but still there is a lack of adequately controlled clinical studies of its analgesic properties . The purpose of this study was to compare the analgesic efficacy of 50 and 100 mg oral tramadol with our st and ard analgesic for postoperative pain treatment , 1000 mg paracetamol + 60 mg codeine , and placebo . A single‐dose , parallel group , double‐blind design was used . One hundred forty‐four patients were enrolled the day after total hip replacement if they had a pain intensity of 60 mm or more on a 0–100 mm visual analogue scale . Treatments were compared on the basis of pain intensity and derived variables ( pain intensity difference , and summed pain intensity differences ) , the need of rescue medication , and a global evaluation . Serum concentrations confirmed rapid and good absorption comparable with the reported in healthy volunteers . The active drug control , paracetamol + codeine , was significantly superior to placebo for all efficacy variables ( P = 0.0002–0.004 ) , confirming good assay sensitivity . Paracetamol + codeine was also significantly superior to both 50 mg tramadol ( P = 0.002–0.03 ) and 100 mg tramadol ( P = 0.002–0.02 ) . There was no difference between placebo and 50 and 100 mg tramadol for any of the efficacy variables . Adverse events were more common with tramadol than with the active control ( P < 0.02 ) , with significantly more emetic episodes after 50 and 100 mg tramadol ( P < 0.05 ) . Thus , this double‐blind , placebo‐ and active drug‐controlled study after orthopaedic surgery shows that 50 and 100 mg oral tramadol is well absorbed but has no significant analgesic effect in doses that are tolerable as single doses by mouth . We emphasize the importance of proper study design with documented assay sensitivity and sufficiently high initial pain intensity for differentiation between analgesics of different potencies A single-blind , parallel-group study was carried out to evaluate the efficacy and safety of an analgesic combining 650 mg of acetaminophen and 25 mg of pentazocine in 129 patients with moderate postoperative pain . Comparisons were made with a combination containing acetaminophen ( 300 mg ) and codeine ( 30 mg ) , a combination containing acetaminophen ( 650 mg ) and propoxyphene napsylate ( 100 mg ) , and a placebo . A nurse observer queried patients at regular intervals over a six-hour period concerning the intensity of pain and the degree of pain relief . The scores obtained were used in the calculation of st and ard measures of analgesic efficacy . Acetaminophen/pentazocine proved to be significantly superior to placebo and equivalent to the other active analgesic combinations . No side effects were reported with acetaminophen/pentazocine , acetaminophen/propoxyphene napsylate , or placebo . One mild side effect was question ably associated with acetaminophen/codeine . This study demonstrates that the combination of acetaminophen and pentazocine is as safe and effective in controlling postoperative pain of moderate severity as other commonly used analgesics Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size In a double‐blind , r and omized , single‐dose trial the analgesic contribution of acetaminophen , 1000 mg , and codeine , 60 mg , was determined . The study was a 2 × 2 factorial experiment in which 120 patients suffering from pain as a result of oral surgery rated their pain intensity and pain relief for up to 5 hours after a single dose of one of : 1000 mg acetaminophen , 60 mg codeine , 1000 mg acetaminophen plus 60 mg codeine , or placebo . The factorial analysis showed that both 1000 mg acetaminophen and 60 mg codeine made a statistically significant ( P < 0.05 ) contribution to the analgesic effectiveness of the combination on all measures of efficacy ( sum of pain intensity differences , largest pain intensity difference , total pain relief , largest pain relief , and time to remedication ) . The incidence of adverse effects did not appear to differ among the treatments , including placebo One hundred sixty-one patients with postoperative pain were treated at a single center in a double-blind , r and omized , parallel study design ed to compare the efficacy and safety of single oral doses of ketoprofen ( 50 and 150 mg ) , an acetaminophen ( 650 mg ) plus codeine ( 60 mg ) combination , and placebo . From 1 through 4 hours after administration of the study drugs , the mean summed pain intensity difference ( SPID ) and time-weighted total pain relief ( TOPAR ) scores for the three active treatments generally were significantly ( P less than 0.05 ) higher than those for placebo but not significantly different from each other . At the 6-hour evaluation , the ketoprofen groups , but not the acetaminophen-codeine group , had higher ( P less than 0.05 ) mean SPID and TOPAR scores than the placebo group , as a result of a shorter duration of pain relief in the acetaminophen-codeine group . The 6-hour TOPAR scores were significantly ( P less than 0.05 ) higher for both ketoprofen groups than for the acetaminophen-codeine group ; the ketoprofen 150 mg group also had significantly ( P less than 0.05 ) higher mean 6-hour SPID and global subjective assessment scores . As a result of a higher frequency of somnolence , there was a significantly ( P less than 0.05 ) greater incidence of central nervous system adverse drug reactions among patients treated with acetaminophen plus codeine than among those treated with 150 mg of ketoprofen . These results indicate that the analgesic efficacy of both 50 and 150 mg doses of ketoprofen equals that of acetaminophen 650 mg plus codeine 60 mg and the duration of the analgesic effect of ketoprofen is significantly longer Background : A r and omized , double‐blind , placebo‐controlled single oral dose study was done in order to examine whether codeine has an additive analgesic effect to that of paracetamol for moderate and strong postoperative pain after abdominal surgery . The maximum recommended single dose of paracetamol 1000 mg ( Paracet ® ) was compared with a combination of a submnximal dose of paracetamol 800 mg plus codeine 60 mg ( Paralgin forte ® ) and placebo for pain relief after Caesarean section in 125 patients & NA ; The objective was to investigate the relationship between pain relief scores produced by placebo and by active interventions in r and omised controlled trials ( RCTs ) . Individual patient categorical pain relief scores from 5 placebo‐controlled single‐dose parallel‐group RCTs in acute postoperative pain were used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) for the different treatments . One hundred and thirty of the 525 patients in the 5 trials had a placebo . Individual patients ' scores with placebo varied from 0 to 100 % of the maximum possible pain relief . The proportion who obtained more than 50 % of the maximum possible pain relief with placebo varied from 7 % to 37 % across the trials ; with the active drugs the variation was from 5 to 63 % . Mean placebo scores were related to the mean score for the active treatments in each study ; the higher the mean active score , the higher the mean placebo score . This relationship disappeared when median values were used . Medical folklore has it that the amount of relief obtained with placebo is one‐third of the maximum possible ( and does not vary ) , and that one‐third of patients respond to placebo . The results show that the amount of relief obtained with placebo varies considerably between patients , that 38 % of patients obtained more than 10 % of the maximum possible relief , and 16 % obtained greater than 50 % . In double‐blind , r and omised parallel‐group studies of high quality placebo scores should not vary . Despite these conditions being met the placebo scores did vary . The previous explanation , of a relationship between the mean placebo scores and the mean scores for the active treatments was not supported The efficacy of diclofenac sodium ( Voltarol ) with and without paracetamol in the control of post-surgical dental & NA ; Ibuprofen , 400 mg , was compared with 300 mg acetaminophen plus 30 mg of codeine and placebo in 120 post‐orthopedic surgery patients with moderate to severe pain . The study was design ed as a double‐blind , single‐dose , parallel‐group analgesic efficacy assay . Estimates of analgesia were obtained up to 6 h using categorical and visual analog measures of pain intensity and pain relief . Estimates of selected elements of mood and of sensory and affective components of pain were obtained at 0 and 2 h using contrasting mood word/phrase pairs and a portion of the McGill Pain Question naire , respectively . Drugs were distinguishable from placebo in total analgesic effect and ibuprofen was more effective than acetaminophen plus codeine , especially in terms of duration . While peak effects were comparable , they occurred 1 h later following ibuprofen . Differences among treatments were more discernible using visual analog measures . Side effects were minimal . Ibuprofen provided greater improvement in selected elements of mood than acetaminophen plus codeine at comparable levels of pain relief . While decreases in the sensory component of pain were most highly associated with pain relief provided by ibuprofen , decreases in the affective component were most highly associated with pain relief following acetaminophen plus codeine . These latter results indicate that mood assessment and the discrimination between sensory and effective components of pain could be particularly useful within analgesic drug assays , especially when comparing analge‐sics of differing pharmacologic class when comparing the result of such assays in pain syndromes characterised by differing pain quality Summary Acetylsalicylic acid(ASA ) was compared with paracetamol(P ) in a double-blind crossover study , in which essentially the same operation was performed on two separate occasions in 32 healthy patients , who required surgical removal of bilateral “ identically ” impacted wisdom teeth . Sixteen patients were given the drugsboth before and after(b & a-group ) the operations ( 0.5 g on the pre-operative evening , followed by 0.5 g × 4 for 3 days ) ; the other 16 patients did not start treatment until 2 hoursafter(a-group ) the operations . A number of objective and subjective factors were assessed , including swelling , bleeding , pain and preference , and were used to make comparisons of the pre- , per- and post-operative courses . About 50 % greater post-operative swelling was associated withASA compared toP , either if medication was begun prior to surgery or if the drugs were given only after operation . In theb & a-group , interference with platelet function and prolonged pre-operative bleeding time were produced byASA ( 8.9 vs 6.5 min ) , but the per-operative blood loss was not significantly increased ( 7.8 vs 7.4 ml ) . In both groupsASA tended to increase post-operative bleeding and the formation of haematomas and ecchymoses . There was no noticeable difference betweenASA and P with respect to pain score , but the preference scores showed a tendency to favourP in both groups . It appears that in
Output:
| New information for remedication shows that the combination extended the duration of analgesia by about one hour compared to treatment with the same dose of paracetamol alone . |
MS210552 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: St and ardized behavioural observations were used to establish the influence of the type of anaesthesia on the mental function and the subjective physical well-being in 60 patients , all men , following urological surgery . The patients were r and omized to two groups , receiving spinal or general anaesthesia . For evaluation of the influence of pre-operative physical condition on post-operative mental function , a supplementary group of 34 patients with pre-existing cardiovascular and /or pulmonary disorders was included in the study . These patients all received spinal anaesthesia . The patients were observed from the day before surgery until 4 weeks after . In all patients a short-lasting temporary decline in mental function was observed . The outcome was not influenced by the type of anaesthesia . In the two groups receiving spinal anaesthesia the decline in post-operative mental function and subjective sense of well-being was most pronounced in patients with a compromised physical condition pre-operatively . Four weeks after surgery , no signs of mental deterioration were present ; however , the subjective sense of physical well-being had not fully returned This study compared the effects of general and regional anesthesia on cognitive and psychosocial functioning in elderly persons . Sixty-four patients between 60 and 86 yr of age undergoing knee arthroplasty were r and omly assigned to receive either general or regional anesthesia . A battery of psychometric tests , including the Satz-Mogel form of the Wechsler Adult Intelligence Scale-Revised , the Wechsler Memory Scale-Revised and the Sickness Impact Profile , and various neuropsychological measures were administered by a blinded observer just before surgery and again 3 months later . Analyses of covariance revealed improvements in most measures that were equivalent between groups . The results indicated that there were no cognitive or psychosocial effects of general or regional anesthesia after 3 months in elderly persons undergoing knee arthroplasty . In this patient population , general anesthesia poses no more risk to long-term mental function than regional anesthesia Background and objectives : Postoperative confusion and delirium is a common complication in the elderly with a poorly understood pathophysiology . The aim of this study was to examine whether the type of anaesthesia ( general or regional ) plays a role in the development of cognitive impairment in elderly patients during the immediate postoperative period . Methods : Forty‐seven patients > 60 yr of age and undergoing major surgery were r and omly allocated to receive either regional or general anaesthesia . The mental status of the patients was assessed preoperatively and during the first three postoperative days with the Mini Mental State Examination . The incidence of delirium was also examined during the same period with the use of DSM III criteria . Results : Overall , during the first three postoperative days , the mean Mini Mental State Examination score decreased significantly ( P < 0.001 ) . However , this decline was very significant only in patients assigned to receive general anaesthesia ( P < 0.001 ) compared to regional anaesthesia . Nine patients developed delirium but the type of anaesthesia did not affect its incidence . The only important factor for the development of delirium was pre‐existing cardiovascular disease irrespective of anaesthesia type ( P < 0.025 ) . Conclusions : Elderly patients subjected to general anaesthesia displayed more frequent cognitive impairment during the immediate postoperative period in comparison to those who received a regional technique Background : Postoperative cognitive dysfunction ( POCD ) is a common complication after cardiac and major non‐cardiac surgery with general anaesthesia in the elderly . We hypothesized that the incidence of POCD would be less with regional anaesthesia rather than general OBJECTIVE --To determine the influence of general or regional anaesthesia on long term mental function in elderly patients . DESIGN -- Prospect i ve study of patients r and omly allocated to receive general or regional anaesthesia . SETTING --The patients ' homes and a large teaching hospital in Cardiff . SUBJECTS--146 Patients aged 60 and over scheduled for elective hip or knee replacement . MAIN OUTCOME MEASURES --Scores achieved in tests of cognitive function and functional competence . RESULTS --72 Patients were allocated to receive general anaesthesia and 74 regional anaesthesia . Anaesthetic technique did not influence the duration of the operation , time to mobilisation postoperatively , requirements for analgesia after the operation , or duration of stay in hospital . Three months after the operation there was an improvement in the score for the recognition component ( 76 ms , 95 % confidence interval 9 to 144 ) and the response component ( 82 ms , 5 to 158 ) of the choice reaction time in the group receiving general anaesthesia compared with the group receiving regional anaesthesia . This was the only significant difference between the two groups in the assessment s of cognitive and functional competence . Eleven patients receiving regional anaesthesia and 12 receiving general anaesthesia reported that their memory and concentration were worse than before the operation , but this was not confirmed by testing . CONCLUSION --Cognitive and functional competence in elderly patients was not detectably impaired after either general or regional anaesthesia when attention was paid to the known perioperative influences on mental function To evaluate whether there is a difference in mental function after general anaesthesia and epidural analgesia , a homogeneous group of 40 elderly men ( age between 60 and 80 ) undergoing transurethral prostatectomy was studied . The study was prospect i ve , r and omised and double blind . Patients with all types of complications believed to impair mental function were excluded . Long‐term , short‐term , verbal and visual memory were tested preoperatively , and 4 days , and 3 weeks postoperatively . In conclusion , we found a significant and equal decline in test performance on the fourth postoperative day . Three weeks postoperatively , however , both groups had returned to or exceeded preoperative levels of performance One hundred and one patients were r and omly allocated to have their peripheral vascular surgery performed under general anaesthesia ( 51 patients ) or spinal anaesthesia ( 50 patients ) . Intraoperative haemodynamic changes were markedly different between the two groups with a higher incidence of hypotension in the spinal group ( 72 % vs 31 % ) and a higher incidence of hypertension in the general anaesthesia group ( 22 % vs 0 % ) . Blood loss was significantly less in the spinal group ( 560 , SD 340 , ml vs 792 , SD 440 , ml ) . Postoperatively three patients from the general anaesthesia group died from causes unrelated to the anaesthesia , and one had a myocardial infa rct . Two patients in the spinal group had myocardial infa rcts , both had been treated for bradycardia and hypotension intraoperatively , and one died . There was a significantly higher incidence of postoperative chest infection in the general anaesthesia group ( 33 % vs 16 % ) . There was no significant difference between the groups in the incidence of postoperative confusion , or lower limb amputation rate or need for further surgery prior to hospital discharge Forty elderly patients ( mean age 78.9 years ) undergoing acute surgery for hip fracture were given at r and om either spinal analgesia with bupivacaine 0.75 % or general anaesthesia with diazepam , fentanly and N2O/O2 . Mental function was studied pre‐operatively with an abbreviated mental test and 1 week and 3 months postoperatively in both groups . Mortality and number of complications was similar in the two groups , but a shorter time of ambulation was seen in the spinal group compared to the general anaesthetic group . No persistent impairment in mental function was found after acute hip surgery under spinal or general anaesthesia and the only advantage of regional technique was a shorter time of ambulation One hundred and sixty‐nine patients ( aged 65–98 years ) were r and omised to receive either local or general anaesthesia for cataract surgery . Cognitive function was assessed using a battery of psychometric tests performed pre‐operatively , and at 24 h , 2 weeks and 3 months postoperatively . Oxygen saturation , blood pressure and heart rate were monitored and the results recorded throughout the anaesthetic and immediate recovery period . In the general anaesthetic group , 19 % of patients experienced at least one episode of oxygen desaturation during the procedure compared with none in the local anaesthetic group . Pulse rate and blood pressure were stable in the local anaesthetic group compared with the general anaesthetic group where marked fluctuations were noted ; 61 % of patients in the general anaesthetic group experienced falls in systolic blood pressure greater than 30 % of the pre‐induction value . No evidence of long‐term postoperative cognitive dysfunction was detected and there was no significant difference between the performances of the two groups The psychological effects of halothane , methoxyflurane , combined analgesic-relaxant anaesthesia , and epidural anaesthesia were assessed before one , and seven days after anaesthesia in 72 patients having operations for varicose veins . Subjective anxiety evaluation ( Hamilton Anxiety Rating Scale ) and personality tests of self- appraisal ( Minnesota Multiphasic Personality Inventory ) as well as of superficial ( Wartegg 's test ) and profound ( Rorschach 's test ) projection showed no significant differences among these methods of anaesthesia . Performance tests measuring memory for design s ( modified Graham-Kendall memory for design s ) , short-term memory ( digit span of Wechsler Adult Intelligence Scale ) , learning ( nonsense word series ) , perception ( symmetry-drawing ) , speed of observation ( Bourdon-Wiersma ) and visualization also revealed no significant psychological changes compared to the control ( epidural anaesthesia ) group . The methods of anaesthesia used therefore showed no harmful psychological effects and are in this respect safe in clinical use This study compared the postoperative mental function in 44 elderly patients following general anaesthesia ( GA ) or spinal anaesthesia ( SA ) with sedation for transurethral resection of prostate . The Mini-Mental State ( MMS ) was done preoperatively and postoperatively at six hours , one day , three days , five days and one month . The geriatric mental status examination was performed preoperatively and one month after the anaesthetic . There was no significant intergroup difference in the MMS score in the preoperative , six hours , one day , three days , five days and 30 days postoperative scores between the GA and SA with sedation groups . A significant intragroup difference between preoperative and postoperative MMS score was detected in the GA group ( P < 0.02 ) and in the SA group with sedation ( P < 0.03 ) . In the GA group , the significant decrease in MMS score occurred at 6 h postoperatively ( P < 0.002 ) whereas in the SA group with sedation , MMS score also decreased significantly at 6 h ( P < 0.005 ) . In conclusion , there was no significant difference in perioperative mental function between the general and spinal anaesthetic groups when supplemental IV sedation was given . In both groups , perioperative mental function decreased significantly at 6 h postoperatively . RésuméDans ce travail , nous comparons les fonctions mentales de 44 patients agés , après une résection trans-urétrale de la prostate sous anesthésie soit générale ( AG ) soil rachidienne avec sédation ( ARS ) . Nous avons fait un examen mental gériatrique ( GEMS ) avant et un mois après l’opération ainsi qu’un examen plus sommaire , le Mini-Mental State ( MMS ) juste avant et 6 , 24 , 72 , et 120 heures de même qu ’ un mois après l’intervention . Avec le MMS , nous n’avons pas identifié de différence significative entre les deux groupes à quelque moment que ce soit . A l’intérieur de chacun des deux groupes cependant , on a noté une baisse des résultats au MMS entre le préet le post-opératoire ( P < 0.02 pour AG et P < 0.03 pour ARS ) qui était détectable six heures après l’intervention ( P < 0.002 pour AG et P < 0.005 pour ARS ) . L’état mental post-opératoire des patients n’était done pas dépendant du type d’anesthésie , qu’elle soil générale ou rachidienne avec sédatifs par vote intraveineuse OBJECTIVE To develop and vali date a clinical prediction rule for postoperative delirium using data available to clinicians preoperatively . DESIGN Prospect i ve cohort study . SETTING General surgery , orthopedic surgery , and gynecology services at Brigham and Women 's Hospital , Boston , Mass. PATIENTS Consenting patients older than 50 years admitted for major elective noncardiac surgery between November 1 , 1990 , and March 15 , 1992 ( N = 1341 ) . MEASUREMENTS All patients underwent preoperative evaluations , including a medical history , physical examination , laboratory tests , and assessment s of physical and cognitive function using the Specific Activity Scale and the Telephone Interview for Cognitive Status . Postoperative delirium was diagnosed using the Confusion Assessment Method or using data from the medical record and the hospital 's nursing intensity index . Patients were followed up for the duration of hospitalization to determine major complication rates , length of stay , and discharge disposition . RESULTS Postoperative delirium occurred in 117 ( 9 % ) of the 1341 patients studied . Independent correlates included age 70 years or older ; self-reported alcohol abuse ; poor cognitive status ; poor functional status ; markedly abnormal preoperative serum sodium , potassium , or glucose
Output:
| In conclusion , it appears that general anesthesia , compared to others , may increase the risk of developing POCD ; however this has not been shown for POD . |
MS210553 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: PURPOSE Increased expression of the multidrug resistance gene ( MDR1 ) has been implicated in osteosarcoma prognosis . This study represents the first prospect i ve assessment of the prognostic value of MDR1 mRNA expression in patients with newly diagnosed extremity osteosarcoma . PATIENTS AND METHODS A series of patients with high- grade , nonmetastatic extremity osteosarcoma were enrolled from six tertiary care institutions and observed prospect ively for tumor recurrence ( median follow-up duration , 30 months ) . All patients were treated with (neo)adjuvant chemotherapy and surgery . Tumors from 123 patients were analyzed for MDR1 mRNA expression . The association of the level of MDR1 expression with the risk of systemic recurrence was examined using survival analyses with traditional and histologic markers as prognostic factors . RESULTS Using the highest MDR1 value for each patient , a dose-response relationship was not identified between the level of MDR1 expression and systemic relapse ( relative risk , 1.15 ; P = .44 ) . Analyses based on biopsy or resection values alone gave similar results ( P = .11 and .41 , respectively , log rank test ) . In multivariate analysis , large tumor size ( > 9 cm ) was the only significant independent predictor of systemic outcome ( relative risk , 2.8 ; P = .002 ) . CONCLUSION We did not identify any correlation between MDR1 mRNA expression and disease progression in patients with osteosarcoma . It is likely that alterations in other genes are involved in resistance to chemotherapy in osteosarcoma and that they play a more critical role than MDR1 in this disease PURPOSE A strong prognostic impact of urokinase-type plasminogen activator ( uPA ) and its inhibitor and plasminogen activator inhibitor type 1 ( PAI-1 ) as individual factors is well established in breast cancer . The improvement in clinical risk assessment gained by combining these factors is evaluated here . PATIENTS AND METHODS uPA and PAI-1 levels were prospect ively measured by enzyme-linked immunosorbent assay in tumor tissue extracts of 761 patients with primary breast cancer . RESULTS In the clinical ly important subgroup of node-negative patients without adjuvant systemic therapy ( n = 269 ; median follow-up , 60 months ) , the clinical value of testing both uPA and PAI-1 is demonstrated . The criterion either or both high identifies with high sensitivity the patients at high relapse risk while keeping more than half in the low-risk group . uPA/PAI-1 is the strongest predictor of disease-free survival and overall survival ; patients with high uPA/PAI-1 have an increased relapse risk ( P < .001 ; relative risk , 4.8 ; 95 % confidence interval [ CI ] , 2.5 to 9.1 ) , in particular for early relapse . Even within risk groups stratified by established criteria ( nodal or menopausal status , tumor size , grade , or steroid hormone receptors ) , uPA/PAI-1 provides significant risk group discrimination . In the whole collective , the significant interaction between uPA/PAI-1 and adjuvant systemic therapy suggests a benefit from adjuvant therapy in high-risk patients as defined by uPA/PAI-1 . CONCLUSION The clinical relevance of the two tumor-invasion factors uPA and PAI-1 is greatest when they are used in combination . The particular combination of uPA and PAI-1 ( both low v either or both high ) is superior to either factor alone and supports risk-adapted individualized therapy decisions
Output:
| A more recently introduced predictive marker is HER-2 for selecting patients with advanced breast cancer for treatment with the therapeutic antibody trastuzumab ( Herceptin ) .
In adjuvant breast cancer , overproduction of HER-2 may also indicate an enhanced sensitivity to high-dose anthracycline-based regimens .
On the other h and , in both early and advanced breast cancer , high concentrations of HER-2 appear to correlate with a lower probability of response to hormone therapy .
Although many different anticancer drugs appear to mediate tumor regression by inducing apoptosis , there is currently no consistent evidence that any of the molecules implicated in this process can be used as predictive markers .
Currently , the only recommended predictive markers in oncology are ER and PR for selecting endocrine-sensitive breast cancers and HER-2 for identifying breast cancer patients with metastatic disease who may benefit from trastuzumab . |
MS210554 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Interventions design ed to narrow the gap between research findings and clinical practice may be effective , but also costly . Economic evaluations are necessary to judge whether such interventions are worth the effort . We have evaluated the economic effects of a tailored intervention to support the implementation of guidelines for the use of antihypertensive and cholesterol-lowering drugs . The tailored intervention was evaluated in a r and omized trial , and was shown to significantly increase the use of thiazides for patients started on antihypertensive medication , but had little or no impact on other outcomes . The increased use of thiazides was not expected to have an impact on health outcomes . Methods and Findings We performed cost-minimization and cost-effectiveness analyses on data from a r and omized trial involving 146 general practice s from two geographical areas in Norway . Each practice was r and omized to either the tailored intervention ( 70 practice s ; 257 physicians ) or control group ( 69 practice s ; 244 physicians ) . Only patients that were being started on antihypertensive medication were included in the analyses . A multifaceted intervention was tailored to address identified barriers to change . Key components were an educational outreach visit with audit and feedback , and computerized reminders . Pharmacists conducted the visits . A cost-minimization framework was adopted , where the costs of intervention were set against the reduced treatment costs ( principally due to increased use of thiazides rather than more expensive medication ) . The cost-effectiveness of the intervention was estimated as the cost per additional patient being started on thiazides . The net annual cost ( cost minimization ) in our study population was US$ 53,395 , corresponding to US$ 763 per practice . The cost per additional patient started on thiazides ( cost-effectiveness ) was US$ 454 . The net annual savings in a national program was modeled to be US$ 761,998 , or US$ 540 per practice after 2 y. In this scenario the savings exceeded the costs in all but two of the sensitivity analyses we conducted , and the cost-effectiveness was estimated to be US$ 183 . Conclusions We found a significant shift in prescribing of antihypertensive drugs towards the use of thiazides in our trial . A major reason to promote the use of thiazides is their lower price compared to other drugs . The cost of the intervention was more than twice the savings within the time frame of our study . However , we predict modest savings over a 2-y period OBJECTIVE Direct physician order entry ( POE ) offers many potential benefits , but evidence suggests that POE requires substantially more time than traditional paper-based ordering methods . The Medical Gopher is a well-accepted system for direct POE that has been in use for more than 15 years . The authors hypothesized that physicians using the Gopher would not spend any more time writing orders than physicians using paper-based methods . DESIGN A r and omized controlled trial of POE using the Medical Gopher system in 11 primary care internal medicine practice s. MEASUREMENTS The authors collected detailed time use data using time motion studies of the physicians and surveyed their opinions about the POE system . RESULTS The authors found that physicians using the Gopher spent 2.2 min more per patient overall , but when duplicative and administrative tasks were taken into account , physicians were found to have spent only 0.43 min more per patient . With experience , the order entry time fell by 3.73 min per patient . The survey revealed that the physicians believed that the system improved their patient care and wanted the Gopher to continue to be available in their practice s. CONCLUSIONS Little extra time , if any , was required for physicians to use the POE system . With experience in its use , physicians may even save time while enjoying the many benefits of POE UNLABELLED What is already known about this subject . Computerized prompts and reminders have been shown to be effective in changing the behaviour of health professionals in a variety of setting s. There is little literature describing or evaluating electronic decision-support for pharmacists . What this study adds . An electronic prompt in dispensing software for a targeted clinical intervention has a significant effect on pharmacists ' behaviour . A markedly increased rate of recording and performing the targeted clinical intervention was found . The effect of the prompt reduces markedly once the prompt is deactivated . AIM To evaluate the effect of an electronic prompt in dispensing software on the frequency of clinical interventions recorded by community pharmacists . METHOD An electronic decision-support prompt identifying patients for a targeted proactive clinical intervention was developed and implemented . Each time an oral antidiabetic agent was dispensed , a prompt was displayed reminding pharmacists to discuss the suitability of aspirin therapy in eligible patients with diabetes . The prompt was r and omly assigned to 31 of 52 metropolitan pharmacies in Melbourne ( Australia ) for 6 weeks , with the remaining pharmacies as controls . RESULTS One hundred and fifty pharmacists in 52 pharmacies recorded a total of 2396 clinical interventions at an intervention rate of 0.92 interventions per 100 patients [ 95 % confidence interval ( CI ) 0.58 , 1.23 ] . Pharmacists recorded a total of 201 target interventions related to aspirin therapy in diabetes at an intervention rate of 2.55 interventions per 100 diabetic patients ( 95 % CI 0.85 , 4.24 ) . All of the targeted clinical interventions were recorded in the prompt arm ; no targeted interventions were recorded in the control group . The effect of the prompt decreased over the study period and was not maintained after prompt deactivation . CONCLUSION An electronic prompt significantly increased pharmacists ' recording of the targeted clinical intervention in diabetic patients . An electronic decision-support prompt has significant potential to promote community pharmacists ' contribution to the quality use of medicines BACKGROUND Adverse drug-related events are common in the elderly , and inappropriate prescribing is a preventable risk factor . Our objective was to determine whether inappropriate prescribing could be reduced when primary care physicians had computer-based access to information on all prescriptions dispensed and automated alerts for potential prescribing problems . METHODS We r and omly assigned 107 primary care physicians with at least 100 patients aged 66 years and older ( total 12 560 ) to a group receiving computerized decision-making support ( CDS ) or a control group . Physicians in the CDS group had access to information on current and past prescriptions through a dedicated computer link to the provincial seniors ' drug-insurance program . When any of 159 clinical ly relevant prescribing problems were identified by the CDS software , the physician received an alert that identified the nature of the problem , possible consequences and alternative therapy . The rate of initiation and discontinuation of potentially inappropriate prescriptions was assessed over a 13-month period . RESULTS In the 2 months before the study , 31.8 % of the patients in the CDS group and 33.3 % of those in the control group had at least 1 potentially inappropriate prescription . During the study the number of new potentially inappropriate prescriptions per 1000 visits was significantly lower ( 18 % ) in the CDS group than in the control group ( relative rate [ RR ] 0.82 , 95 % confidence interval [ CI ] 0.69 - 0.98 ) , but differences between the groups in the rate of discontinuation of potentially inappropriate prescriptions were significant only for therapeutic duplication by the study physician and another physician ( RR 1.66 , 95 % CI 0.99 - 2.79 ) and drug interactions caused by prescriptions written by the study physician ( RR 2.15 , 95 % CI 0.98 - 4.70 ) . INTERPRETATION Computer-based access to complete drug profiles and alerts about potential prescribing problems reduces the rate of initiation of potentially inappropriate prescriptions but has a more selective effect on the discontinuation of such prescriptions Background — Indirect evidence shows that alerting users with clinical decision support systems seems to change behavior more than requiring users to actively initiate the system . However , r and omized trials comparing these methods in a clinical setting are lacking . We studied the effect of both alerting and on-dem and decision support with respect to screening and treatment of dyslipidemia based on the guidelines of the Dutch College of General Practitioners . Methods and Results — In a clustered r and omized trial design , 38 Dutch general practice s ( 77 physicians ) and 87 886 of their patients ( 39 433 men 18 to 70 years of age and 48 453 women 18 to 75 years of age ) who used the ELIAS electronic health record participated . Each practice was assigned to receive alerts , on-dem and support , or no intervention . We measured the percentage of patients screened and treated after 12 months of follow-up . In the alerting group , 65 % of the patients requiring screening were screened ( relative risk versus control=1.76 ; 95 % confidence interval , 1.41 to 2.20 ) compared with 35 % of patients in the on-dem and group ( relative risk versus control=1.28 ; 95 % confidence interval , 0.98 to 1.68 ) and 25 % of patients in the control group . In the alerting group , 66 % of patients requiring treatment were treated ( relative risk versus control=1.40 ; 95 % confidence interval , 1.15 to 1.70 ) compared with 40 % of patients ( relative risk versus control=1.19 ; 95 % confidence interval , 0.94 to 1.50 ) in the on-dem and group and 36 % of patients in the control group . Conclusion — The alerting version of the clinical decision support systems significantly improved screening and treatment performance for dyslipidemia by general practitioners OBJECTIVE Many hospitals utilize antimicrobial management teams ( AMTs ) to improve patient care . However , most function with minimal computer support . We evaluated the effectiveness and cost-effectiveness of a computerized clinical decision support system for the management of antimicrobial utilization . DESIGN A r and omized controlled trial in adult in patients between May 10 and August 3 , 2004 . Antimicrobial utilization was managed by an existing AMT using the system in the intervention arm and without the system in the control arm . The system was developed to alert the AMT of potentially inadequate antimicrobial therapy . MEASUREMENTS Outcomes assessed were hospital antimicrobial expenditures , mortality , length of hospitalization , and time spent managing antimicrobial utilization . RESULTS The AMT intervened on 359 ( 16 % ) of 2,237 patients in the intervention arm and 180 ( 8 % ) of 2,270 in the control arm , while spending approximately one hour less each day on the intervention arm . Hospital antimicrobial expenditures were $ 285,812 in the intervention arm and $ 370,006 in the control arm , for a savings of $ 84,194 ( 23 % ) , or $ 37.64 per patient . No significant difference was observed in mortality ( 3.26 % vs. 2.95 % , p = 0.55 ) or length of hospitalization ( 3.84 vs. 3.99 days , p = 0.38 ) . CONCLUSION Use of the system facilitated the management of antimicrobial utilization by allowing the AMT to intervene on more patients receiving inadequate antimicrobial therapy and to achieve substantial time and cost savings for the hospital . This is the first study that demonstrates in a patient-r and omized controlled trial that computerized clinical decision support systems can improve existing antimicrobial management programs OBJECTIVE : Asthma continues to be 1 of the most common chronic diseases of childhood and affects ∼6 million US children . Although National Asthma Education Prevention Program guidelines exist and are widely accepted , previous studies have demonstrated poor clinician adherence across a variety of population s. We sought to determine if clinical decision support ( CDS ) embedded in an electronic health record ( EHR ) would improve clinician adherence to national asthma guidelines in the primary care setting . METHODS : We conducted a prospect i ve cluster-r and omized trial in 12 primary care sites over a 1-year period . Practice s were stratified for analysis according to whether the site was urban or suburban . Children aged 0 to 18 years with persistent asthma were identified by International Classification of Diseases , Ninth Revision codes for asthma . The 6 intervention- practice sites had CDS alerts imbedded in the EHR . Outcomes of interest were the proportion of children with at least 1 prescription for controller medication , an up-to- date asthma care plan , and the performance of office-based spirometry . RESULTS : Increases in the number of prescriptions for controller medications , over time , was 6 % greater ( P = .006 ) and 3 % greater for spirometry ( P = .04 ) in the intervention urban practice s. Filing an up-to- date asthma care plan improved 14 % ( P = .03 ) and spirometry improved 6 % ( P = .003 ) in the suburban practice s with the intervention . CONCLUSION : In our study , using a cluster-r and omized trial design , CDS in the EHR , at the point of care , improved clinician compliance with National Asthma Education Prevention Program guidelines Background : Recent clinical trials indicate that treatment with lipid modifying therapy improves outcomes in patients with ischemic heart disease ( IHD ) and low levels of high density lipoprotein ( HDL ) cholesterol . The results of these trials , however , have not been widely implemented in clinical practice . Objectives : To develop and test an intervention design ed to increase the rate of prescription of lipid modifying therapy and to determine the relative effectiveness of three different prompts ( progress notes , patient letters , or computer chart reminders ) . Methods : The study was conducted in 11 US Department of
Output:
| Processes of care improved for prescribing and monitoring mostly in hospital setting s , but the few studies measuring clinical outcomes showed small or no improvements .
CONCLUSIONS Almost half of MMIT interventions improved the process of care , but few studies measured clinical outcomes . |
MS210555 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background : The ideal intrathecal isobaric bupivacaine dose for cesarean delivery anesthesia is uncertain . While small doses ( 5–9 mg ) of bupivacaine may reduce side effects such as hypotension , they potentially increase spinal anesthetic failures . This study determined the ED50 and ED95 of intrathecal isobaric bupivacaine ( with adjuvant opioids ) for cesarean delivery . Methods : After institutional review board approval and written informed consent were obtained , 48 parturients undergoing elective cesarean delivery under combined spinal – epidural anesthesia were enrolled in this double-blind , r and omized , dose-ranging study . Patients received a 5- , 6- , 7- , 8- , 9- , 10- , 11- , or 12-mg intrathecal isobaric bupivacaine dose with 10 & mgr;g fentanyl and 200 & mgr;g morphine . Overall anesthetic success was recorded when no intraoperative epidural supplement was required during the cesarean delivery . ED50 and ED95 values for overall anesthetic success were determined using a logistic regression model . Results : ED50 and ED95 values for overall anesthetic success were 7.25 and 13.0 mg , respectively . No advantages for low doses could be demonstrated with regard to hypotension , nausea , vomiting , pruritus , or maternal satisfaction , although this study was underpowered to detect significant differences in secondary outcome variables . Conclusions : The ED50 and ED95 values ( 7.25 and 13.0 mg , respectively ) for intrathecal isobaric bupivacaine in this circumstance are similar to values the authors determined recently for hyperbaric bupivacaine using similar methodology . These ED50 and ED95 values are significantly higher than those advocated in previous reports in which success was cl aim ed using lower intrathecal bupivacaine doses . The current study used stricter criteria to define “ successful ” anesthesia and support the use of larger bupivacaine doses to ensure adequate patient comfort Amethocaine 1 % solution was mixed with equal volumes of water , 0.9 % saline or 10 % dextrose to prepare respectively , hypobaric , isobaric and hyperbaric solutions which were compared for intradural spinal anaesthesia in 60 patients . Thirty patients received 10 mg and 30 patients received 15 mg of amethocaine . Injections were made with the patients in the lateral recumbent position and the operating table was horizontal during and after injection . Equal numbers of patients and equal numbers of males and females received hypobaric , isobaric and hyperbaric solutions . The mean spread of analgesia after the hyperbaric solution was five dermatomes greater than after the other two solutions , but the extent of analgesia was not significantly different whether amethocaine 10 mg or 15 mg was injected . The mean duration of analgesia after the hyperbaric solution was 285 min compared with 332 min and 360 min after the isobaric and hypobaric solutions respectively . The mean duration of analgesia after amethocaine 15 mg was significantly greater than after 10 mg The safety of 0.5 % hyperbaric bupivacaine , as well as the incidence and severity of visceral pain , were evaluated in 36 women undergoing elective cesarean section under spinal anesthesia who , r and omly divided into two groups , received different dose ranges according to height , 7.5–10 mg in group A and 10–12.5 mg in group B. When sensory block to at least the fourth thoracic dermatome was established , surgery was begun and the occurrence and severity of visceral pain recorded ( visual analog scale ) by an observer unaware of patient data . The level of analgesia to pinprick was determined when and if there was onset of pain intraoperatively , and supplementary medication was administered as needed . Hypotension , the incidence of which was similar in both groups , was treated as necessary with ephedrine . No patients experienced pain until after delivery of the infant . Thereafter , moderate to severe pain , in association with peritoneal traction , occurred in 12 patients in group A ( 70.5 % ) but only in 6 patients in group B ( 31.6 % ) . In patients experiencing moderate to severe pain , the mean time between induction of anesthesia and onset of pain was similar in both groups , as was the amount of systemic narcotic given . Total time for regression of sensory analgesia to L5 was longer in patients in group B ( 243.9 versus 195.4 min ) , and the incidence of complete motor blockade was greater in group B. Increasing the amount of 0.5 % hyperbaric bupivacaine per spinal segment reduces the occurrence of moderate to severe visceral pain during elective cesarean section without jeopardizing mother or fetus Background Maternal hypotension occurs in 60–94 % of Cesarean deliveries with 10–15 mg spinal bupivacaine . Reduced doses of bupivacaine may decrease the incidence of hypotension , nausea , and vasopressor use . The primary objective of this study was to compare 4.5 mg and 12 mg doses of intrathecal bupivacaine on maternal hemodynamics . The secondary objective was to determine if anticipated reductions in side effects were reflected in increased patient satisfaction . Methods Following Research Ethics Board approval and informed consent 52 term parturients undergoing elective Cesarean delivery were r and omly assigned to isobaric bupivacaine 4.5 mg or hyperbaric bupivacaine 12 mg for spinal anesthesia . All patients received fentanyl 50 μg and morphine 200 μg intrathecally . Intravenous fluid and vasopressor administration were st and ardized . Maternal hemodynamics , and sensorimotor levels were recorded at regular intervals . Side effects and patient satisfaction were documented . Results Median cepahalad sensory block was C8 in both groups ( NS ) but the intensity of motor block was significantly less ( P < 0.001 ) and of shorter duration ( P < 0.001 ) with bupivacaine 4.5 mg . The proportion of patients requiring ephedrine ( > 70 % ) and the quantities of ephedrine used were similar in both groups ( NS ) . Use of supplemental analgesia , side effects , and measures of patient satisfaction were comparable in both groups . Discussion Intrathecal bupivacaine 4.5 and 12 mg yielded similar sensory block and side effects during Cesarean delivery . Patients receiving 4.5 mg did , however , experience significantly less motor blockade of shorter duration . Context eL’hypotension maternelle se rencontre dans 60’94 % des accouchements par césarienne avec 10’15 mg de bupivacaïne intrathécale . Des doses réduites de bupivacaïne pourraient réduire l’incidence d’hypotension et de nausées , ainsi que l’utilisation de vasopresseurs . L’objectif premier de cette étude était de comparer l’effet de doses intrathécales de bupivacaïne de 4,5 mg et 12 mg respectivement sur l’hémodynamie maternelle . Le deuxième objectif était de déterminer si les réductions anticipées d’effets secondaires se reflétaient par une satisfaction accrue des patientes . MéthodeLe Comité d’éthique de la recherche ayant donné son accord , cinquante-deux parturientes à terme devant subir un accouchement non urgent par césarienne ont été r and omisées en deux groupes pour la rachianesthésie : bupivacaïne isobare 4,5 mg ou bupivacaïne hyperbare 12 mg . Toutes les patientes ont reçu du fentanyl 50 μg et de la morphine 200 μg en intrathécal . L’administration de liquide intraveineux et de vasopresseurs a été st and ardisée . L’hémodynamie maternelle ainsi que les niveaux sensori-moteurs ont été enregistrés à intervalles réguliers . Les effets secondaires et la satisfaction des patientes ont été documentés . RésultatsLe bloc sensitif moyen en direction de la tête était situé à C8 dans les deux groupes ( NS ) , mais l’intensité du bloc moteur était significativement plus faible ( P < 0,001 ) et d’une durée moindre ( P < 0,001 ) avec la bupivacaïne 4,5 mg . La proportion de patientes nécessitant de l’éphédrine ( > 70 % ) et les quantités d’éphédrine administrées étaient similaires dans les deux groupes ( NS ) . L’utilisation d’analgésie supplémentaire , les effets secondaires et la satisfaction des patientes étaient comparables dans les deux groupes . Discussion Dans le cas d’accouchements par césarienne , les doses de 4,5 mget 12 mg de bupivacaïne intrathécale produisent un bloc sensitif et des effets secondaires similaires . Toutefois , les patientes ayant reçu 4,5 mg ont ressenti un bloc moteur plus faible et plus court , et cette différence était significative BACKGROUND Hypotension after spinal anesthesia for cesarean section is common and may result in serious complications despite the use of uterine displacement and volume preloading . Adequate amount of hyperbaric bupivacaine for Japanese parturients whose frames are generally smaller than those of Caucasian counterparts have not yet been examined . We compared the analgesic efficacy and the incidence of hypotension with 8 mg versus 10 mg hyperbaric bupivacaine during spinal anesthesia for cesarean section in Japanese parturients . METHODS Thirty six parturients were r and omly divided into two groups , one receiving 8 mg ( n = 19 ) and the other receiving 10 mg ( n = 17 ) hyperbaric bupivacaine . Sensory block level and the incidence of hypotension were evaluated from the time of injection to delivery . Hypotension was defined as a decrease in systolic blood pressure below 100 mmHg and to less than 80 % of the baseline value . RESULTS 15 minutes after spinal injection , the difference in sensory block level was not significant . Ten minutes after the spinal anesthesia , in 79 % of 8 mg group and in 88 % of 10 mg group , sensory block level reached T 4 . Hypotension occurred in 19 parturients ( 7 in 8 mg group and 12 in 10 mg group ) . The incidence of hypotension was significantly lower in 8 mg group ( 37 % ) than in 10 mg group ( 71 % ) . There were no significant differences either in neonatal Apgar scores or umbilical blood gas pH. CONCLUSIONS Injection of 8 mg hyperbaric bupivacaine is preferable than 10 mg in spinal anesthesia for cesarean section to obtain adequate analgesic efficacy and to avoid maternal hypotension INTRODUCTION Spinal anesthesia is the technique most often applied in cases of scheduled cesarean section . Many authors have tried decreasing the local anesthetic dose by adding opioids to achieve adequate analgesia with greater hemodynamic stability , although the ideal dose remains to be established . Our aim was to analyze hemodynamic stability and quality of analgesia with 2 different regimens for administering spinal hyperbaric bupivacaine . METHODS We design ed a controlled , double-blind trial comparing 2 doses of spinal hyperbaric bupivacaine with fentanyl in 42 patients undergoing elective cesarean section r and omized to 2 groups to receive either the low dose or the conventional one . One group received an 11 mg dose of bupivacaine and the other group received a 6.5 mg dose , combined with 20 microg of fentanyl in both cases . RESULTS The hemodynamic profile and the level of maximum sensory block obtained were similar in the two groups . The motor block was less intense in patients receiving the lower dose and it was necessary to convert 2 patients ( 10 % ) to general anesthesia in that group . CONCLUSIONS Spinal anesthesia with low doses of bupivacaine and fentanyl provides acceptable intraoperative conditions for a high percentage of patients undergoing cesarean section , with a similar incidence of hypotension . The low dose generates a less intense intraoperative motor blockade with similar spread of the sensory block . The low dose was not efficacious for 10 % of the patients who received it Purpose Spinal anesthesia for cesarean section is associated with a high incidence of maternal hypotension . The aim of this study was to assess the efficacy of low-dose bupivacaine with fentanyl to reduce the incidence of hypotension in spinal anesthesia for cesarean section . Methods Forty pregnant women undergoing elective cesarean section were r and omly allocated to two groups ; those receiving 10 mg bupivacaine to group B ( n = 20 ) and those receiving 4 mg bupivacaine plus 25 μg fentanyl to group BF ( n = 20 ) ; the agents were given intrathecally with patients in the sitting position , with a combined spinal-epidural technique . Results Sensory block was adequate for surgery in all patients . Hypotension occurred in all patients in group B ( 100 % ) and in 15 patients in group BF ( 75 % ) . The incidence of hypotension , number of ephedrine treatments , and need for ephed
Output:
| Neonatal outcomes ( Apgar score , acid-base status ) and clinical quality variables ( patient satisfaction , surgical conditions ) showed non-significant differences between LD and CD .
This meta- analysis demonstrates that low-dose bupivacaine in spinal anaesthesia compromises anaesthetic efficacy ( risk of analgesic supplementation : high grade of evidence ) , despite the benefit of lower maternal side-effects ( hypotension , nausea/vomiting : moderate grade of evidence ) |
MS210556 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Loneliness is a prevalent and global problem for adult population s and has been linked to multiple chronic conditions in quantitative studies . This paper presents a systematic review of quantitative studies that examined the links between loneliness and common chronic conditions including : heart disease , hypertension , stroke , lung disease , and metabolic disorders . A comprehensive literature search process guided by the PRISMA statement led to the inclusion of 33 articles that measure loneliness in chronic illness population s. Loneliness is a significant biopsychosocial stressor that is prevalent in adults with heart disease , hypertension , stroke , and lung disease . The relationships among loneliness , obesity , and metabolic disorders are understudied but current research indicates that loneliness is associated with obesity and with psychological stress in obese persons . Limited interventions have demonstrated long-term effectiveness for reducing loneliness in adults with these same chronic conditions . Future longitudinal r and omized trials that enhance knowledge of how diminishing loneliness can lead to improved health outcomes in persons with common chronic conditions would continue to build evidence to support the translation of findings to recommendations for clinical care BACKGROUND Animal-assisted therapy ( AAT ) is cl aim ed to have a variety of benefits , but almost all published results are anecdotal . We characterized the resident population in long-term care facilities desiring AAT and determined whether AAT can objective ly improve loneliness . METHODS Of 62 residents , 45 met inclusion criteria for the study . These 45 residents were administered the Demographic and Pet History Question naire ( DPHQ ) and Version 3 of the UCLA Loneliness Scale ( UCLA-LS ) . They were then r and omized into three groups ( no AAT ; AAT once/week ; AAT three times/week ; n = 15/group ) and retested with the UCLA-LS near the end of the 6-week study . RESULTS Use of the DPHQ showed residents volunteering for the study had a strong life-history of emotional intimacy with pets and wished that they currently had a pet . AAT was shown by analysis of covariance followed by pairwise comparison to have significantly reduced loneliness scores in comparison with the no AAT group . CONCLUSIONS The desire for AAT strongly correlates with previous pet ownership . AAT reduces loneliness in residents of long-term care facilities This study examined the effects of indoor gardening on socialization , activities of daily living ( ADLs ) , and perceptions of loneliness in elderly nursing home residents . A total of 66 residents from two nursing homes participated in this two-phase study . In phase one , experimental group 1 participated once a week for 5 weeks in gardening activities while a control group received a 20-minute visit . While no significant differences were found between groups in socialization or perceptions of loneliness , there were significant pretest-posttest differences within groups on loneliness and guidance , reassurance of worth , social integration , and reliable alliance . The results also demonstrated gardening interventions had a significant effect on three ADLs ( transfer , eating , and toileting ) . Phase two examined differences in the effects of a 5-week versus a 2-week intervention program . Although no significant within-group differences were noted in socialization , loneliness , or ADLs , the 5-week program was more effective in increasing socialization and physical functioning OBJECTIVE The objective of this study was to examine the associations between objective and subjective social support and suicidal ideation in older adults receiving home healthcare services . METHOD Participants were r and omly selected from a sample of older adults newly starting skilled nursing care from a certified home health agency in Westchester County , NY . Research interviewers assessed 522 older adults aged 65 years and older who were receiving home care services . Subjective and objective components of social support were assessed using measures of social network , social interaction patterns , instrumental support , and perceptions of social support . Suicidal ideation was assessed using items from the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition and the Hamilton Depression Rating Scale . RESULTS In bivariate analyses , neither objective ly determined size of social network nor instrumental support was associated with suicidal ideation . However , lower social interaction patterns and lower perceived social support were significantly related to suicidal ideation . After adjusting for potential confounders , only lower perceived support remained significantly associated with suicidal ideation . In post hoc analyses of the perceptions of social support scale items , satisfaction with one 's relationships and feeling useful to family and friends were significantly associated with a lower likelihood of suicidal ideation in the final multivariate logistic regression model controlling for possible confounding variables . CONCLUSIONS Subjective social support is a potentially modifiable risk factor for suicide in later life . Findings suggest that the perception of social support is an important construct to examine in future longitudinal studies examining risk and protective factors for suicidal ideation and behaviors in older adults Pain is common in the aging population , particularly among older residents of nursing homes . It has been found that 50 % of older people living in the community have been experiencing chronic pain , and the number increased to 80 % for older residents of nursing homes . Exercise is an effective non-pharmacological intervention that can reduce pain and improve physical and psychological functions . A quasi-experimental study with a pretest-posttest control group design ed was conducted to evaluate the effects of a physical exercise program ( PEP ) on older residents of nursing homes who have chronic pain . Three-hundred-ninety-six older residents with chronic pain were recruited from 10 nursing homes run by non-governmental organizations in Hong Kong . The average age of the older residents was 85.44 ± 6.29 . Five nursing homes were r and omized to the experimental group with PEP ( n = 225 , age = 85.45 ± 6.25 ) ; the other five nursing homes were r and omized to the control group without the PEP ( n = 171 , age = 85.44 ± 6.35 ) . PEP was an eight-week training program given by a physiotherapist and nurses once a week . It consisted of warm-up exercises , muscle strengthening , stretching , balancing , and self-administered massage to acupressure points . At the end of each PEP session , pamphlets with pictures illustrating the " exercise of the day " were given to the older residents of nursing homes as a tool to enhance their self-management skills . The control group received no training during the eight weeks . Upon completion of the PEP , the experimental group experienced a significantly greater reduction in pain intensity from 4.19 ± 2.25 ( on an 11 point scale ) to 2.67 ± 2.08 , as compared to the control group ( p < .05 ) . In addition , the psychological well-being ( happiness , loneliness , life satisfaction , and depression ) of the experimental group was significantly improved ( p < .05 )
Output:
| The results show that intervention programs are effective to reduce the feeling of loneliness . |
MS210557 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background — Observational studies suggest that skeletonization of the internal thoracic artery ( ITA ) can improve conduit flow and length and reduce deep sternal infections and postoperative pain . We performed a r and omized , double-blind , within-patient comparison of skeletonized and nonskeletonized ITAs in patients undergoing coronary surgery . Methods and Results — Patients ( n=48 ) undergoing bilateral ITA harvest were r and omized to receive 1 skeletonized and 1 nonskeletonized ITA . Intraoperatively , ITA flow was assessed directly and with a Doppler flow probe before and after topical application of papaverine . ITA harvest time and conduit length were recorded . A blinded assessment of pain ( visual analog scale ) and dysesthesia ( physical examination ) was performed at discharge , at 2 weeks , and at a 3-month follow-up . Sternal perfusion was assessed with nuclear imaging ( n=7 ) . Skeletonization required longer ITA harvest times ( 27±1 versus 24±1 minutes ; P=0.04 ) . There was a trend toward increased ITA length in the skeletonized group ( 18.2±0.3 versus 17.7±0.3 cm ; P=0.09 ) . In situ ITA flow was lower in skeletonized arteries ( 7.4±0.9 versus 10.1±1.0 mL/min ; P=0.01 ) and increased significantly after ITA division and papaverine application . Postanastomotic flows were similar between groups . Skeletonization was associated with decreased pain at the 3-month follow-up and a reduction in major sensory deficits at the 4-week and 3-month ( 17 % versus 50 % ; P=0.002 ) follow-ups . Baseline adjusted sternal perfusion was significantly greater by 17±6 % ( P=0.03 ) on the skeletonized side . Conclusions — Skeletonization results in reduced postoperative pain and dysesthesia and increased sternal perfusion at follow-up but does not produce increased conduit flow . ITA skeletonization may be a strategy for reducing morbidity after CABG OBJECTIVE Deep sternal wound infection is a dreaded complication of coronary artery bypass surgery , particularly in patients with diabetes . This study determines whether skeletonization of internal thoracic artery conduits compared with pedicled harvesting reduces the risk of deep sternal wound infection in patients with diabetes undergoing bilateral internal thoracic artery grafting . METHODS We review ed prospect ively gathered data on all patients who have undergone coronary artery bypass grafting and received bilateral internal thoracic artery grafts at our institution since 1990 . We compared patients with diabetes who received skeletonized ( n = 79 ) versus conventional pedicled ( n = 36 ) internal thoracic artery conduits . RESULTS The proportion of patients taking insulin ( 19.0 % vs 14.0 % for skeletonized vs conventional grafts , respectively , P = .6 ) or oral hypoglycemic agents ( 68.4 % vs 69.4 % , P = .9 ) , as well as the prevalence of type I diabetes ( 2.5 % vs 8.3 % , P = .18 ) , were similar in both groups . Patients who received skeletonized grafts were more likely to receive a free rather than an in situ right internal thoracic artery graft ( 93.7 % vs 30.6 % , P < .001 ) . The prevalence of deep sternal wound infection was significantly lower in patients who received skeletonized grafts compared with patients who received conventional grafts ( 1.3 % vs 11.1 % , P = .03 ) . Patients in the skeletonized group were also less likely to develop any ( superficial or deep ) sternal wound infection postoperatively ( 5.1 % vs 22.2 % , P = .03 ) . There was no significant difference in the prevalence of deep sternal wound infection between patients with diabetes who received skeletonized internal thoracic arteries and patients without diabetes who underwent conventional internal thoracic artery grafting ( n = 578 ) ( 1.2 % vs 1.6 % , respectively , P = .8 ) . CONCLUSIONS Skeletonization of internal thoracic artery conduits lowers the risk of deep sternal wound infection in patients with diabetes undergoing bilateral internal thoracic artery grafting . We no longer consider diabetes a contraindication to bilateral internal thoracic artery grafting , provided the internal thoracic arteries are skeletonized BACKGROUND The skeletonization of internal thoracic artery is postulated to improve graft length , early blood flow , sternal blood supply , and postoperative respiratory function . Concern exists that skeletonization may injure internal thoracic artery , precluding good results of surgery . Reports on endothelial function of skeletonized internal thoracic artery are lacking . METHODS A prospect i ve assessment of early clinical outcomes of 357 consecutive patients undergoing coronary artery bypass grafting was performed : 287 patients with nonskeletonized and 70 with skeletonized left internal thoracic artery ( LITA ) . The lengths of LITA and of its discarded distal segment , as well as free LITA blood flow , were measured . The dose-effect relationship for relaxation to acetylcholine was studied in the organ bath . RESULTS Apart from a higher incidence of breaching the pleura with nonskeletonized LITA the clinical outcomes were comparable . The length of skeletonized LITA was 17.8+/-1.14 cm versus 20.3+/-0.52 cm skeletonized ( p = 0.11 ) . The length of discarded LITA was shorter in nonskeletonized artery ( 0.8+/-0.28 cm versus 2.6+/-0.49 cm ; p = 0.022 ) . The free LITA blood flow was 66.3+/-7.42 mL/min in nonskeletonized vessel versus 100.3+/-14.84 mL/min in skeletonized ( p = 0.048 ) . The acetylcholine-induced relaxation was similar in both groups ( maximal relaxation , 80.7%+/-5.95 % in nonskeletonized versus 72.9%+/-9.11 % in skeletonized ; not significant ; negative logarithm of half-maximal effect , 7.43+/-0.18 versus 7.1+/-0.10 , respectively ; p = 0.063 ) . CONCLUSIONS Skeletonization does not damage the endothelial function of the LITA . Higher free blood flow and available LITA length should encourage the use of skeletonized LITA in clinical practice To minimize sternal ischemia , skeletonized internal mammary artery ( IMA ) harvesting has been performed in the last few years . The benefits of skeletonization in high risk patients , such as diabetic patients undergoing bilateral IMA grafting , are unknown . A total of 99 patients underwent isolated coronary artery bypass grafting ( CABG ) using a pedicled bilateral IMA between 6/1/1997 and 5/31/2000 ( group P ) , and 115 patients receiving a skeletonized IMA between 6/1/2001 and 3/31/2002 ( group S ) . An ultrasonic scalpel was used for skeletonization . The perioperative and early angiographic results of CABG using these two techniques were collected prospect ively and compared . There were two ( 1.7 % ) perioperative myocardial infa rct ions in group S and one ( 1.0 % ) in group P ( P = NS ) , none of which were related to the IMA graft . The incidence of mediastinitis was one ( 0.9 % ) in group S and three ( 3.0 % ) in group P , P = NS , however , minor chest wound complications were observed in four ( 3.5 % ) in group S , which was significantly less frequent than the 12 ( 12.1 % ) in group P ( P<0.05 ) . Angiographic control was obtained in 87 patients in group S and 36 in group P , revealing no IMA occlusions in either group . Bilateral skeletonized IMA grafting for diabetic patients is safe and may decrease wound complications OBJECTIVE The incidence of wound infection in coronary artery surgery is low , but there is an appreciable mortality associated with sternal infection . In other fields of surgery there is evidence that an all disposable paper gown and drape system has protective advantages over a fabric system . Using an established wound scoring system ( ASEPSIS ) , we investigated this in a prospect i ve , r and omised trial of patients undergoing cardiac surgery . METHODS 505 patients undergoing isolated coronary artery surgery in a single hospital over an 18 month period were r and omised to either a disposable , paper drape system or re-usable fabric drapes . Allocation was stratified according to whether or not the patient had had previous coronary artery surgery . Patients were followed for 3 months . Total infection scores for each wound were calculated from daily scores collected in hospital together with the scores at six weeks and three months . RESULTS The two r and omised groups were otherwise well matched . Full follow-up information was available for 464 ( 92 % ) patients . There was no evidence of any difference in rates of sternal or leg wound infection between the two groups ( P = 0.87 and 0.62 , respectively ) . Women were more likely to have infected sternal wounds ( P = 0.17 ) and significantly more likely to have infected leg wounds ( P = 0.04 ) . Patients with sternal wound infections had a significantly higher body mass index ( P = 0.001 ) . High Parsonnet scores and increased time on ventilation were significantly associated with leg wound but not sternal infections . For both wound sites , patients with infections had spent longer in the operating theatre . CONCLUSION In a r and omised controlled study of patients undergoing coronary artery surgery we found that the use of paper drapes and gowns conferred no benefit over a reusable fabric in terms of post-operative wound infection . Although females and diabetics are more likely to experience this complication , an important additional risk factor is an extended operating time OBJECTIVE The internal thoracic artery ( ITA ) is the ideal conduit for coronary artery bypass grafting ( CABG ) . The skeletonization technique of this arterial conduit has been proposed to reduce chest wall trauma , increase graft length and facilitate construction of sequential anastomoses . Nevertheless , some surgeons decline this technique because of potentially increased trauma to the ITA with impairment of flow . In this investigation we compared the free flow of skeletonized with that of pedicled ITA grafts . METHODS Two surgeons operated on 80 consecutive patients with coronary artery disease for elective CABG . In group I ( n = 40 ) , the left ITA was dissected using the skeletonization technique . In group II ( n = 40 ) , it was harvested as a pedicled graft . In 23 patients of group I both ITA 's were dissected in skeletonized fashion for complete arterial revascularization . Diluted papaverine was instilled into the lumen of the ITA after distal transection of the vessel in both groups . Free flow of the ITA was registered before and 15 min after intraluminal application of diluted papaverine . Mean arterial pressure was maintained at 70 mmHg . RESULTS Before the application of papaverine , free flow of skeletonized and pedicled ITA grafts was identical between the two groups . After treatment with papaverine maximum free flow was significantly higher in the skeletonized ITA 's ( group I 197.2 ( + /-66.6 ) ml/min ; group II 147.1 ( + /-70.5 ) ml/min ; P < 0.05 ) . There was no significant difference between free flow after dilatation of the left and right ITA in group I ( left 197.2 ( + /-66.6 ) ml/min ; right 198.9 ( + /-61.8 ) ml/min ) . CONCLUSIONS Preparation of the ITA with the skeletonization technique results in significantly , higher free flow capacity than in pedicled grafts . This may increase the safety of arterial revascularization by reducing the risk of ITA hypoperfusion syndrome OBJECTIVE To evaluate the role of intact pleurae regarding the postoperative respiratory functional status in patients undergoing coronary revascularization employing both internal mammary arteries ( IMAs ) , according to the pedunculated or skeletonized technique ( SKT ) with opened or intact pleurae . MATERIAL S AND METHODS Using both IMAs , 299 patients underwent elective coronary revascularization . They were r and omized and divided into group I ( n=82 , undergoing IMA harvesting according to the SKT without opening the pleurae ) ; group II ( n=186 , undergoing IMA harvesting according the pedunculated technique with open pleurae ) ; and group III ( n=31 , undergoing IMA harvesting according the SKT with incidentally opened pleurae ) . There were no differences regarding the preoperative patient characteristics and the anaesthetic and surgical management . RESULTS There were two deaths in group I versus seven in group II and one in group III ( P = ns ) . The number of total arterial myocardial revascularization and arterial composite grafts was significantly higher in groups I and III than in group II , ( P<0.001 and P<0.005 , respectively ) . The incidence of
Output:
| In conclusion , skeletonized ITA appears to reduce the incidence of postoperative SWI in comparison with pedicled ITA after CABG , with this effect being modulated by the presence of diabetes |
MS210558 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: PURPOSE To explore whether progression-free survival ( PFS ) or biochemical PFS can be used as a predictor of overall survival ( OS ) and to investigate the dependence between PFS and OS in men with castrate-resistant prostate cancer . PATIENTS AND METHODS Data from nine Cancer and Leukemia Group B trials that enrolled 1,296 men from 1991 to 2004 were pooled . Men were eligible if they had prostate cancer that had progressed during and rogen deprivation therapy and did not receive prior treatment with chemotherapy , immunotherapy , or other nonhormonal therapy . L and mark analyses of PFS at 3 and 6 months from r and omization/ registration were performed to minimize lead time bias . The proportional hazards model was used to assess the significance effect of PFS rate at 3 and at 6 months in predicting OS . In addition , biochemical progression using the definitions of Prostate-Specific Antigen Working Group ( PSAW ) Criteria PSAWG1 and PSAWG2 were analyzed as time-dependent covariates in predicting OS . RESULTS The median survival time among men who experienced progression at 3 months was 9.2 months ( 95 % CI , 8.0 to 10.0 months ) compared with 17.8 months in men who did not experience progression at 3 months ( 95 % CI , 16.2 to 20.4 months ; P < .0001 ) . Compared with men who did not progress at 3 and at 6 months , the adjusted hazard ratios for death were 2.0 ( 95 % CI , 1.7 to 2.4 ; P < .001 ) and 1.9 ( 95 % CI , 1.6 to 2.4 ; P < .001 ) for men who experienced progression at 3 and 6 months , respectively . In addition , biochemical progression at 3 months predicted OS . The association between PFS and OS was 0.30 ( 95 % confidence limits = 0.26 , 0.32 ) . CONCLUSION PFS at 3 and 6 months and biochemical progression at 3 months predict OS . These observations require prospect i ve validation Summary Progression-free survival ( PFS ) and time to progression ( TTP ) have been reported to correlate with overall survival ( OS ) in several types of cancers . To our knowledge , however , their use in the evaluation of new agents for AGC has not been investigated . We evaluated the potential of PFS and TTP to act as surrogates of OS in clinical trial setting s. R and omized trials of systemic chemotherapy for advanced gastric cancer were identified by comprehensive electronic and manual search . Correlations between PFS/TTP and OS were evaluated . Thirty-six trials with a total of 83 treatment arms and 10,484 patients were selected for analysis . The nonparametric Spearman rank correlation coefficient ( ρ ) between median PFS/TTP and OS was 0.70 ( 95 % CI , 0.59 to 0.82 ) and the correlation coefficient between hazard ratios in PFS/TTP and OS was 0.80 ( 95 % CI , 0.68 to 0.92 ) . Correlation tended to be higher in trials reporting PFS ( ρ = 0.85 ; 0.72–0.97 ) than in those reporting TTP ( ρ = 0.60 ; 0.24–0.97 ) , trials in Non-Asian countries ( ρ = 0.80 ; 0.61–0.99 ) than Asia ( ρ = 0.67 ; 0.39–0.94 ) , trials in patients with measurable lesions only ( ρ = 0.91 ; 0.77–1.00 ) than in those including non-measurable lesions ( ρ = 0.71 ; 0.50–0.93 ) , albeit that none of these differences was significant . Our results indicate that improvements in PFS/TTP in advanced gastric cancer strongly correlate with improvements in OS . Further research is needed to clarify the surrogacy of PFS/TTP for OS or the role of PFS as the true end point in future r and omized clinical trials of chemotherapy for AGC Background : The correlation between efficacy end points in r and omized controlled trials ( RCTs ) of systemic therapy for non-Hodgkin 's lymphoma ( NHL ) was investigated to identify an appropriate surrogate end point for overall survival ( OS ) . Methods : RCTs of previously untreated NHL published from 1990 to 2009 were identified . Associations between absolute differences in efficacy end points were determined using nonparametric Spearman 's rank correlation coefficients ( rs ) . Results : Thirty-eight RCTs representing 85 treatment arms for aggressive NHL and 20 RCTs representing 42 arms for indolent NHL were included . For aggressive NHL , differences in 3-year progression-free survival (PFS)/event-free survival ( EFS ) were high correlated with differences in 5-year OS { rs of 0.90 [ 95 % confidence interval ( CI ) 0.73–0.96 ] } and linear regression determined that a 10 % improvement in 3-year EFS or PFS would predict for a 7 % ± 1 % improvement in 5-year OS . For indolent histology disease , differences in complete response were strongly correlated with differences in 3-year EFS [ rs 0.86 ( 95 % CI 0.35–0.97 ) ] , but there was no correlation between 3-year time-to-event end points and 5-year OS . Conclusions : Improvements in 3-year EFS/PFS are highly correlated with improvements in 5-year OS in aggressive NHL and should be explored as a c and i date surrogate end point . Definition of these relationships may inform future clinical trial design and interpretation of interim trial data We assessed six-month progression-free survival ( PFS ) as an alternative primary efficacy endpoint to overall survival in newly diagnosed glioblastoma multiforme ( GBM ) patients receiving temozolomide ( TMZ ) . A total of 183 patients with newly diagnosed GBM enrolled in 3 phase II protocol s at the University of California-San Francisco were included . Patients were treated with interventions based on the Stupp regimen , each with the added component of a second oral agent given concurrently with radiotherapy and TMZ , followed by its coadministration with adjuvant TMZ . We examined whether progression status at 2 , 4 , and 6 months predicted subsequent survival using the l and mark analysis . The hazard ratios of death as a function of progression status were estimated based on the Cox proportional hazards model after adjustment for putative prognostic factors . Progression status at 2 , 4 , and 6 months were all consistently found to be strong predictors of subsequent survival in all studies . The study -specific hazard ratios associated with progression status at 6 months ranged from 2.03 to 3.39 . The hazard ratios associated with the earlier time points ( 2- and 4-month progression ) all exceeded 2 in magnitude , ranging from 2.29 to 4.73 . P-values were statistically significant for all time points . In this report , we demonstrated a strong association between the endpoints of PFS at 2 , 4 , and 6 months and survival . Patients who showed the signs of early progression were at significantly higher risk of earlier death . Our analysis suggests that 6-month PFS may be an appropriate primary endpoint in the context of phase II upfront GBM trials in the TMZ era Background It is controversial for the use of survival surrogate end points including response rate ( RR ) , disease control rate ( DCR ) , time to progression , and progression-free survival ( PFS ) in trials of molecular targeted agents . Our aim was to determine the correlations of these surrogates with survival in the treatment of advanced non-small-cell lung cancer ( ANSCLC ) with epidermal growth factor receptor tyrosine kinase inhibitors ( EGFR-TKIs ) , gefitinib and erlotinib . Methods Summary data of median survival time ( MST ) and surrogates from prospect i ve trials of EGFR-TKIs in ANSCLC were identified . Patient- or trial-related characteristics were introduced as covariates . Simple and multivariate linear regression models were fitted for MST and each surrogate , respectively . And the significance of each surrogate as a survival marker was compared by calculating the area under their receiver operating characteristic ( ROC ) curves . Results Sixty eligible trials ( 9,903 patients ) were enrolled . RR , DCR , and PFS were all strongly associated with MST . In their simple linear regression models , the coefficient of determination ( R2 ) was 0.83 ( p < 0.000001 ) , 0.58 ( p < 0.0001 ) , and 0.70 ( p < 0.0001 ) , respectively . And in their multivariate linear regression models , the st and ard coefficient was 0.71 ( p < 0.001 ) , 0.40 ( p < 0.001 ) , and 0.74 ( p < 0.001 ) , respectively , while RR and PFS were the preferred survival predictors in the ROC analysis . Conclusion RR or PFS may serve as an appropriate survival surrogate in the clinical trials of EGFR-TKIs for ANSCLC OBJECTIVES Our aim was to review the recommendations given by health technology assessment ( HTA ) institutions in their method ological guidelines concerning the use of surrogate outcomes in their assessment s. In a second step , we aim ed at quantifying the role surrogate parameters take in assessment reports . METHODS We analyzed method ological papers and guidelines from HTA agencies with International Network of Agencies for Health Technology Assessment membership as well as from institutions related to pharmaceutical regulation ( i.e. , reimbursement , pricing ) . We analyzed the use of surrogate outcomes in a sample of HTA reports r and omly drawn from the HTA data base . We checked methods , results ( including evidence tables ) , and conclusions sections and extracted the outcomes reported . We report descriptive statistics on the presence of surrogate outcomes in the reports . RESULTS We identified thirty-four method ological guidelines , twenty of them addressing the issue of outcome parameter choice and the problematic of surrogate outcomes . Overall HTA agencies call on caution regarding the reliance on surrogate outcomes . None of the agencies has provided a list or catalog of acceptable and vali date d surrogate outcomes . We extracted the outcome parameter of 140 HTA reports . Only around half of the reports determined the outcomes for the assessment prospect ively . Surrogate outcomes had been used in 62 percent of the reports . However , only 3.6 percent were based upon surrogate outcomes exclusively . All of them assessed diagnostic or screening technologies and the surrogate outcomes were predominantly test characteristics . CONCLUSIONS HTA institutions seem to agree on a cautious approach to the use of surrogate outcomes in technology assessment . Thorough assessment of health technologies should not rely exclusively on surrogate outcomes Progression-free survival ( PFS ) is an increasingly important end-point in cancer drug development . However , several concerns exist regarding the use of PFS as a basis to compare treatments . Unlike survival , the exact time of progression is unknown , so progression times might be over-estimated ( or under-estimated ) and , consequently , bias may be introduced when comparing treatments . In addition , the assessment of progression is subject to measurement variability which may introduce error or bias . Ideally trials with PFS as the primary end-point should be r and omised and , when feasible , double-blinded . All patients eligible for study should be evaluable for the primary end-point and thus , in general , have measurable disease at baseline . Appropriate definitions should be provided in the protocol and data collected on the case-report forms , if patients with only non-measurable disease are eligible and /or clinical , or symptomatic progression are to be considered progression events for analysis . Protocol defined assessment s of disease burden should be obtained at intervals that are symmetrical between arms . Independent review of imaging may be of value in r and omised phase II trials and phase III trials as an auditing tool to detect possible bias This paper is an overview of the new response evaluation criteria in solid tumours : revised RECIST guideline ( version 1 . 1 ) , with a focus on up date d contents Common end points for phase II trials in patients with glioblastoma multiforme ( GBM ) are six-month progression-free survival ( PFS6 ) and 12-month overall survival ( OS12 ) . OS12 can be accurately measured but may be confounded with subsequent therapies upon progression , whereas the converse is true for PFS6 . Our goal was to assess the relationship between these end points separately for phase II trials in patients with newly diagnosed GBM and patients with recurrent GBM . Data were pooled from 11 North Central Cancer Treatment Group trials for patients with newly diagnosed GBM ( n = 1348 ) . All patients received radiotherapy and pharmaceutical therapy ( before , during , or after radiotherapy ) . Data were pooled from 16 trials that used various pharmaceuticals in treating patients for recurrent GBM ( n = 345 ) . All trial regimens were declared nonefficacious by predefined criteria . Overall per-patient concordance was estimated with a kappa statistic . The relationship between OS12 and PFS6 across study arms was assessed by weighted linear regression and Pearson 's correlation . Simulation was used to determine the agreement of study outcomes when using PFS6 versus OS12 end points . Cox models with progression status as a time-dependent variable and Kaplan-Meier estimators were used to ascertain the association between progression-free survival status and overall survival . At present
Output:
| Not in all solid tumors the treatment-level association between PFS or TTP and OS has been investigated .
According to IQWiG 's framework , only PFS achieved acceptable evidence of surrogacy in metastatic colorectal and ovarian cancer treated with cytotoxic agents . |
MS210559 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: This study was performed to determine the activity of adding continuous infusion ( CI ) of 5-fluorouracil ( 5-FU ) to gemcitabine ( GEM ) vs GEM alone in advanced pancreatic cancer ( APC ) . In all , 94 chemo-naïve patients with APC were r and omised to receive GEM alone ( arm A : 1000 mg m−2 per week for 7 weeks followed by a 2 week rest period , then weekly for 3 consecutive weeks out of every 4 weeks ) or in combination with CI 5-FU ( arm B : CI 5-FU 200 mg m−2 day−1 for 6 weeks followed by a 2 week rest period , then for 3 weeks every 4 weeks ) . Overall response rate ( RR ) was the primary end point and criteria for decision were planned according to the Simon 's optimal two-stage design . The overall RR was 8 % ( arm A ) and 11 % ( arm B ) ( 95 % confidence interval : 0.5–16 % and 2–22 % ) , respectively , and stable disease was 29 and 28 % . The median duration of RR was 34 weeks ( range 25–101 weeks ) for GEM and 26 weeks ( range 16–46 weeks ) for the combination . The median progression-free survival ( PFS ) was 14 weeks ( range 2–65 weeks ) and 18 weeks ( range 4–51 weeks ) , respectively . The median overall survival ( OS ) was 31 weeks ( range 1–101 weeks ) and 30 weeks ( 1–101 weeks ) . Toxicity was mild in both arms . This study does not show promising activity in terms of RR , PFS and OS for the double combination arm in APC PURPOSE This phase III trial compared the efficacy and safety of gemcitabine ( Gem ) plus capecitabine ( GemCap ) versus single-agent Gem in advanced/metastatic pancreatic cancer . PATIENTS AND METHODS Patients were r and omly assigned to receive GemCap ( oral capecitabine 650 mg/m2 twice daily on days 1 to 14 plus Gem 1,000 mg/m2 by 30-minute infusion on days 1 and 8 every 3 weeks ) or Gem ( 1,000 mg/m2 by 30-minute infusion weekly for 7 weeks , followed by a 1-week break , and then weekly for 3 weeks every 4 weeks ) . Patients were stratified according to center , Karnofsky performance score ( KPS ) , presence of pain , and disease extent . RESULTS A total of 319 patients were enrolled between June 2001 and June 2004 . Median overall survival ( OS ) time , the primary end point , was 8.4 and 7.2 months in the GemCap and Gem arms , respectively ( P = .234 ) . Post hoc analysis in patients with good KPS ( score of 90 to 100 ) showed a significant prolongation of median OS time in the GemCap arm compared with the Gem arm ( 10.1 v 7.4 months , respectively ; P = .014 ) . The overall frequency of grade 3 or 4 adverse events was similar in each arm . Neutropenia was the most frequent grade 3 or 4 adverse event in both arms . CONCLUSION GemCap failed to improve OS at a statistically significant level compared with st and ard Gem treatment . The safety of GemCap and Gem was similar . In the subgroup of patients with good performance status , median OS was improved significantly . GemCap is a practical regimen that may be considered as an alternative to single-agent Gem for the treatment of advanced/metastatic pancreatic cancer patients with a good performance status Purpose To evaluate the efficacy and safety of the combination of gemcitabine ( GEM ) and S-1 ( GS ) in comparison to GEM alone ( G ) for unresectable pancreatic cancer . Methods In this multicenter r and omized phase II study , we r and omly assigned unresectable pancreatic cancer patients to either the GS group or the G group . The GS group regimen consists of intravenous 1,000 mg/m2 GEM during 30 min on days 1 and 8 , combined with 80 mg/m2 oral S-1 twice daily on days 1–14 , repeated every 3 weeks . On the other h and , the G group regimen consists of intravenous 1,000 mg/m2 GEM on days 1 , 8 , and 15 , repeated every 4 weeks . The primary endpoint was objective response rate ( ORR ) . Secondary end points included treatment toxicity , clinical response benefit , progression-free survival ( PFS ) , and overall survival . Results We registered 117 patients from 16 institutions between June 2007 and August , 2010 . The ORR of the GS group was 28.3 % , whereas that of the G group was 6.8 % . This difference was statistically significant ( P = 0.005 ) . The disease control rate was 64.2 % in the GS group and 44.1 % in the G group . Median PFS was 6.15 months in the GS group and 3.78 month in the G group . This was also statistically significant ( P = 0.0007 ) . Moreover , the median overall survival ( OS ) of the GS group was significantly longer than that of the G group ( 13.7 months vs. 8.0 months ; P = 0.035 ) . The major grade 3–4 adverse events were neutropenia ( 54.7 % in the GS group and 22.0 % in the G group ) , thrombocytopenia ( 15.1 % in the GS group and 5.1 % in the G group ) , and skin rash ( 9.4 % in the GS group ) . Conclusions The GS group showed stronger anticancer activity than the G group , suggesting the need for a large r and omized phase III study to confirm GS advantages in a specific subset PURPOSE Our purpose in the study was to determine the maximum tolerated dose and dose-limiting toxicity and investigate the clinical pharmacology of S-1 , a combination of tegafur , 5-chloro-2,4-dihydroxypyridine ( CDHP ) , and potassium oxonate . EXPERIMENTAL DESIGN Eligible patients had advanced solid tumors , adequate organ function , and no anticancer therapy in the preceding 4 weeks . Dose level 1 was 30 mg/m(2)/dose , level 2 was 40 mg/m(2)/dose , and level 3 was 35 allmg/m(2)/dose , all of the levels comprising two daily doses . S-1 was administered as a single dose at each level , and its pharmacology was studied . The first course was begun 3 days later and consisted of 28 consecutive treatment days , followed by a 1-week rest . RESULTS Sixteen patients were enrolled ; toxicity could be assessed in all of the 16 and response in 15 . At dose level 1 , two of nine patients developed grade 3 hyperbilirubinemia or diarrhea . Dose-limiting toxicity ( diarrhea ) occurred in all three of the patients at dose level 2 . The protocol was , therefore , amended to include an intermediate dose level ( level 3 ) , which caused grade 3 or 4 diarrhea or hyperbilirubinemia in three of four patients . Dose level 1 was thus considered as the maximum tolerated dose . Other grade 3 or 4 toxic effects at dose level 2 or 3 were granulocytopenia , nausea , and vomiting . The pharmacology of tegafur , CDHP , potassium oxonate , and fluorouracil ( a metabolite of tegafur ) was characterized by rapid absorption and was consistent with first-order kinetics . One patient with colorectal cancer had a durable partial response . CONCLUSIONS The recommended S-1 dose for future studies is 30 mg/m(2 ) twice daily , and diarrhea is the most frequent toxic effect . Additional trials of S-1 in the treatment of patients with solid tumors are warranted Three hundred five patients with advanced pancreatic and gastric carcinoma were r and omly assigned to treatment with fluorouracil , fluorouracil plus doxorubicin ( Adriamycin ) ( FA ) , or fluorouracil plus doxorubicin plus mitomycin ( mitomycin C ) ( FAM ) . All regimens were equivalent with regard to patient survival . There is no reasonable likelihood that either the FA or FAM regimen could produce a meaningful survival advantage over fluorouracil alone . Interval to disease progression , objective response rates , and palliative effects ( improved performance , body weight , or symptoms ) were essentially equivalent among the three regimens . With regard to toxicity , the FAM regimen produced more anorexia , nausea , vomiting , leukopenia , thrombocytopenia , and cumulative bone marrow suppression . Fluorouracil alone produced more stomatitis and diarrhea . Because of a failure to produce improved survival or palliation , unrewarded toxicity , and excessive cost , neither the FA nor FAM regimen can be recommended for the treatment of advanced pancreatic or gastric cancer Background : This r and omised phase II trial compared gemcitabine alone vs gemcitabine and S-1 combination therapy in advanced pancreatic cancer . Methods : Patients were r and omly assigned to 4-week treatment with gemcitabine alone ( 1000 , mg m−2 gemcitabine by 30-min infusion on days 1 , 8 , and 15 ) or gemcitabine and S-1 combination therapy ( 1000 , mg m−2 gemcitabine by 30-min infusion on days 1 and 15 and 40 mg m−2 S-1 orally twice daily on days 1–15 ) . The primary end point was progression-free survival ( PFS ) . Results : Between July 2006 and February 2009 , 106 patients were enrolled . The PFS in gemcitabine and S-1 combination arm was significantly longer than in gemcitabine arm ( 5.4 vs 3.6 months ) , with a hazard ratio of 0.64 ( P=0.036 ) . Overall survival ( OS ) for gemcitabine and S-1 combination was longer than that for gemcitabine monotherapy ( 13.5 vs 8.8 months ) , with a hazard ratio of 0.72 ( P=0.104 ) . Overall , grade 3 or 4 adverse events were similar in both arms . Conclusion : Gemcitabine and S-1 combination therapy demonstrated longer PFS in advanced pancreatic cancer . Improved OS duration of 4.7 months was found for gemcitabine and S-1 combination therapy , though this was not statistically significant PURPOSE To compare clinical benefit response ( CBR ) and quality of life ( QOL ) in patients receiving gemcitabine ( Gem ) plus capecitabine ( Cap ) versus single-agent Gem for advanced/metastatic pancreatic cancer . PATIENTS AND METHODS Patients were r and omly assigned to receive GemCap ( oral Cap 650 mg/m(2 ) twice daily on days 1 through 14 plus Gem 1,000 mg/m(2 ) in a 30-minute infusion on days 1 and 8 every 3 weeks ) or Gem ( 1,000 mg/m(2 ) in a 30-minute infusion weekly for 7 weeks , followed by a 1-week break , and then weekly for 3 weeks every 4 weeks ) for 24 weeks or until progression . CBR criteria and QOL indicators were assessed over this period . CBR was defined as improvement from baseline for > or= 4 consecutive weeks in pain ( pain intensity or analgesic consumption ) and Karnofsky performance status , stability in one but improvement in the other , or stability in pain and performance status but improvement in weight . RESULTS Of 319 patients , 19 % treated with GemCap and 20 % treated with Gem experienced a CBR , with a median duration of 9.5 and 6.5 weeks , respectively ( P < .02 ) ; 54 % of patients treated with GemCap and 60 % treated with Gem had no CBR ( remaining patients were not assessable ) . There was no treatment difference in QOL ( n = 311 ) . QOL indicators were improving under chemotherapy ( P < .05 ) . These changes differed by the time to failure , with a worsening 1 to 2 months before treatment failure ( all P < .05 ) . CONCLUSION There is no indication of a difference in CBR or QOL between GemCap and Gem . Regardless of their initial condition , some patients experience an improvement in QOL on chemotherapy , followed by a worsening before treatment failure Purpose The aim of this study was to evaluate efficacy and safety of gemcitabine plus S-1 ( GS ) combination chemotherapy in patients with unresectable pancreatic cancer . Methods Patients were r and omly assigned to receive GS ( oral S-1 60 mg/m2 daily on days 1–15 every 3 weeks and gemcitabine 1,000 mg/m2 on days 8 and 15 ) or gemcitabine ( 1,000 mg/m2 on days 1 , 8 , and 15 every 4 weeks ) . The primary endpoint was progression-free survival ( PFS ) . Results One hundred and one patients were r and omly assigned . PFS was significantly longer in the GS arm with an estimated hazard ratio ( HR ) of 0.65 ( 95 % CI 0.43–0.98 ; P = 0.039 ; median 5.3 vs 3.8 months ) . Objective response rate ( ORR ) was also better in the GS arm ( 21.6 vs 6 % , P = 0.048
Output:
| CONCLUSIONS Gemcitabine combination therapy provides a modest improvement of survival , but is associated with more toxicity compared with gemcitabine monotherapy |
MS210560 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE Management of the uncomplicated pregnancy prolonged beyond the estimated date of confinement is controversial , particularly when the cervix is unfavorable for induction . The benefit of reducing potential fetal risk with induction of labor must be balanced against the morbidity associated with this procedure . The objective of this study was to compare two strategies for managing postterm pregnancy ( i.e. , immediate induction and expectant management ) . STUDY DESIGN Four hundred forty patients with uncomplicated pregnancies at 41 weeks ' gestation were r and omized to either immediate induction of labor ( n = 265 ) or expectant management ( n = 175 ) . Patients with expectant management underwent nonstress testing and amniotic fluid volume assessment twice per week . Patients in the induction group underwent induction within 24 hours of r and omization . To evaluate the efficacy of intracervical prostagl and in E2 gel , patients in the induction group were r and omized in a 2:1 scheme to receive either 0.5 mg prostagl and in E2 gel or placebo gel intracervically 12 hours before induction of labor with oxytocin . RESULTS The incidence of adverse perinatal outcome ( neonatal seizures , intracranial hemorrhage , the need for mechanical ventilation , or nerve injury ) was 1.5 % in the induction group and 1 % in the expectant management group ( p > 0.05 ) . There were no fetal deaths in either group . There were no differences in mean birth weight or the frequency of macrosomia ( birth weight > or = 4000 gm ) between the two groups ( p > 0.05 ) . Regardless of parity , prostagl and in E2 intracervical gel was not more effective than placebo in ripening the cervix . The cesarean delivery rate was not significantly different in the expectant ( 18 % ) , prostagl and in E2 gel ( 23 % ) , or placebo gel ( 18 % ) groups . CONCLUSIONS Adverse perinatal outcome in otherwise uncomplicated pregnancies of > or = 41 weeks is very low with either of the management schemes described . Thus from the perspective of perinatal morbidity or mortality either management scheme is acceptable In 345 women with a favorable cervical score at due date , labor was either induced by means of intravaginal application of tablets containing 3 mg of prostagl and in E2 or spontaneous onset of labor was awaited until the 42nd week of pregnancy . Eighty percent of the nulliparae and 96.3 % of the multiparae of the induction group gave birth within 24 h of the administration of the first tablet . All pertinent delivery intervals were significantly shorter in this group compared to those women where spontaneous onset of labor was awaited . The rate of operative deliveries was lower in the induction group . With the exception of 1 fetal death 3 days after due date , fetal outcome was excellent in both groups . Elective induction was at least equivalent to awaiting the onset of spontaneous labor and was not associated with higher complication rates due to the method of induction A prospect i ve r and omized controlled trial design ed to investigate selective planned delivery is reported : 264 obstetrically normal women in the 38th week of pregnancy were admitted to this trial and 184 completed it . The infants of mothers in the planned delivery group had higher serum bilirubin levels on the fifth day post partum than control infants but no baby required treatment for hyperbilirubinaemia . Mothers in the planned delivery group required significantly greater amounts of pethidine while control mothers had a significantly higher incidence of meconium staining of the amniotic fluid . However , the infants in the two groups had similar Apgar scores at birth . There was one stillbirth in the control group ; this was due to unrecognized fetal hypoxia during labour induced at 42 weeks for postmaturity In a prospect i ve r and omized study , pregnancies with unfavorable cervix and well established gestational age of at least 42 weeks were selected for management by either antepartum fetal testing or prostagl and in gel induction of labor . Of the 108 pregnancies studied , 57 ( 53 % ) had labor induced and 51 ( 47 % ) continued without intervention . Comparison of the two groups showed no difference in meconium staining , fetal distress , length of first stage of labor , the need for intervention , or the mode of delivery . In terms of Apgar score the neonatal outcome was not significantly different but a greater proportion of the babies ( 7.8 % versus 1.8 % ) in the noninduced group required intubation . Our data show that there is no particular advantage in letting the pregnancy go beyond 42 completed weeks of gestation especially if prostagl and in is available for induction of labor Objecfive To determine the proper management of pregnancy in uncomplicated cases going beyond 42 weeks Objective To compare the impact on perinatal outcome of two different protocol s for antenatal fetal monitoring after 42 weeks gestation Abstract . In a prospect i ve r and omized study spontaneous and oxytocin induced labor “ for convenience ” have been compared with respect to uterine activity , duration of labor , the condition of the fetus and the newborn infant . The study consists of 84 normal patients , of whom 43 were induced at full term by amniotomy and oxytocin infusion using the Cardiff Infusion System Mark II ; 41 patients served as controls . No difference in maternal age , number of previous pregnancies and pelvic score one week before the day of delivery were found between the groups . The following parameters were calculated : duration of labor , uterine activity , amount of bleeding in the third stage of labor , number of early and late decelerations as well as number of episodes of bradycardia in the CTG‐recordings , birth weight , Apgar score one and five minutes post‐delivery and blood gases in mother and child 60 seconds after delivery . No significant differences between the two groups were found . It is concluded that there are no increased risks to mother or fetus compared to normal labor provided that there is cephalic presentation and normal pregnancy , careful selection with respect to the length of pregnancy and the condition of the cervix and that the Cardiff infusion system is used with intrauterine pressure recording and continuous fetal heart monitoring In a prospect i ve , r and omised trial , 111 obstetrically normal pregnant women , who had elective induction of labour performed between 39 and 40 weeks , were compared with 117 controls who were managed expectantly until 41 weeks . Compared with the controls , the patients who had elective induction of labour had significantly less meconium staining in labour and a smaller blood-loss after delivery . The mean length of labour , the amount of pethidine used , and the Apgar scores at 1 minute were similar in the two groups . In the electively induced group , the caesarean-section rate was lower and the use of epidural analgesia more common than in the controls , but the differences were mot statistically signficant . The hour of delivery was similar in the two groups , suggesting that convenience to medical and nursing staff would not be greatly changed by elective induction of labour . There was no evidence that the hazards to mother and child were increased by elective induction , and its use might improve perinatal mortality by reducing the number of unexplained mature stillbirths Nine hundred fifteen of 2171 pregnant patients had no indication for ultrasound at their first prenatal visit and were r and omly assigned to receive either a single routine screening ultrasound or usual prenatal care . The estimated date of confinement was altered in 24.9 % of routine-ultrasound patients and in 11.6 % of usual-care patients through ultrasound examinations obtained for a subsequent clinical indication . Of these , 8.3 % of routine-ultrasound and 5.2 % of usual-care patients had gestational age errors of 2 weeks or more . There were no differences between the groups in inductions for post- date s pregnancy ( 7.0 versus 7.5 % ; P=.87 ) , total inductions ( 22.6 versus 24.9 % ; P=.61 ) , or adverse perinatal outcomes ( 6.7 versus 8.3 % ; P=.63 ) . Both sets of twins were detected in the screened group . In the usual-care group , five of seven pairs of twins ( 71 % ) were diagnosed by 24 weeks'gestation . There was no benefit found from routine ultrasound as performed in this study A r and omized prospect i ve clinical trial of induction of labor at 42 completed weeks gestation versus expectant management in post date s pregnancies was performed . The primary screening test was the 24-hr urinary estriol creatinine ratio . The cesarean section rate was high in both groups and did not differ statistically . Intervention by delivery at 42 weeks decreased the development of small for gestational age infants , but costs slightly more . Twenty-four-hour urinary estriol creatinine ratio determinations predicted fetal distress in labor , but could not predict postmaturity syndrome or infants who were small for gestational age . As expectant management did not differ from induction of labor at 42 weeks from the st and point of maternal outcome , and as the cost difference was small , induction of labor at 42 weeks may be the preferred management as it improves infant outcome The influence of nipple stimulation ( NS ) at term on the duration of pregnancy was investigated among low-risk gravidas in a r and omized prospect i ve study . A significant inverse relationship was found between the duration of pregnancy and both gestational age at recruitment and cervical ( Bishop ) score , although the influence of cervical score was quantitatively small . Nipple stimulation did not influence either the duration of pregnancy or the probability of having a cesarean section or an instrumental delivery . Patient compliance was , however , poor , which may in part account for these findings , as there was an inverse trend between the daily average duration of NS and the duration of pregnancy Three hundred two low-risk obstetric patients with an unfavorable cervical examination and well-established gestational age of at least 287 days were r and omly selected for management by either antepartum fetal testing or prostagl and in gel cervical ripening followed by aggressive induction of labor and delivery . The patients managed by induction of labor had a lower incidence of meconium-stained amniotic fluid , meconium aspiration , low Apgar scores , postmaturity syndrome , fetal distress , and cesarean delivery than did patients managed with antepartum fetal testing . Our data suggest that prostagl and in gel cervical ripening and induction of labor and delivery by 42 weeks ' gestation may be the most appropriate management for patients with well-established gestational age and an unfavorable cervical examination In a prospect i ve r and omized study spontaneous and oxytocin induced labor have been compared with respect to duration of labor and the condition of the fetus and the newborn infant . The study consists of 166 normal patients at full term . No significant differences between the two groups were found , and the results of the study showed that induction of labor between the 40th and 41st week of pregnancy was safe for the fetus . It is concluded that there seems to be no increased risks to mother or fetus from induction of labor compared to normal labor provided that there is cephalic presentation and a normal pregnancy A non-aggressive approach to the management of post- date pregnancies was tested in a clinical trial involving 156 patients who had reached 294 days of amenorrhea and had a pelvic score of 4 or less . Date s had been established with certainty in each case . In half of the patients ( the study group ) no time limit was imposed on the pregnancy , but the women were checked at frequent intervals for any increase in pelvic score and for changes in any of the following : fetal movement count recorded daily by the mother , an oxytocin challenge test , and amnioscopy . The pregnancy ended either through spontaneous contractions or through surgical induction carried out because of a change in any one of the parameters or an increase above 4 in the pelvic score . In the 78 control patients labor was induced surgically on day 294 , even if the pelvic score was low . In the study group , labor started spontaneously in 52 patients ; labor was induced in 17 women after they showed an elevated pelvic score , in 7 because of a pathologic parameter and in one because a mild pre-eclampsia developed . There were 7 cesarean sections in the study group compared with 16 in the control group ( P less than 0.05 ) . The average duration of labor was 6.7 h in the study group , compared with 9.4 h in the control ( P less than 0.01 ) . There was no significant difference between the two groups with regard to meconium staining during labor , pathologic fetal heart rate , or the 5 min Apgar score . In the study group there was one neonatal death as a result of severe congenital heart disease , and in the control group one infant died due to asphyxia . It is concluded that conservative management of prolonged pregnancies , with close supervision , gives better results than routine induction of labor at 42 wk . The importance of the pelvic score as an indication for induction is stressed . A protocol has been developed which can be used in cases of uncertain date s as well OBJECTIVE To determine the cost-effectiveness of induction of labour versus serial fetal monitoring while awaiting spontaneous labour in postterm pregnancies . DESIGN Cost-effectiveness and cost-minimization analyses conducted as part of a Canadian multicentre r and omized clinical trial . SETTING Twenty-two Canadian hospitals , of which 19 were teaching hospitals and 3 were community hospitals . PATIENTS Women with uncomplicated pregnancies of 41 or more weeks ' gestation were r and omly assigned to induction of labour or serial antenatal monitoring . Of the 3418 women enrolled , no data were received on 11 . Therefore , results were based on data from 1701 women in the induction arm of the study and 1706 women in the monitoring arm . MAIN OUTCOME MEASURES Perinatal mortality and neonatal morbidity , rates of cesarean section and health care costs . Hospital costing models were developed specifically for the study . Data on use of major re sources (
Output:
| This benefit is due to the effect of induction of labour after 41 weeks .
Routine induction of labour had no effect on caesarean section .
REVIEW ER 'S CONCLUSIONS Routine early pregnancy ultrasound examination and subsequent adjustment of delivery date appear to reduce the incidence of post-term pregnancy .
Routine induction of labour after 41 weeks gestation appears to reduce perinatal mortality .
There is not enough evidence to evaluate the effects of breast and nipple stimulation , or tests of fetal wellbeing |
MS210561 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective : The present study aim ed to examine and compare memory processing in patients with unilateral temporal lobe epilepsy ( TLE ) before and after surgery using functional magnetic resonance imaging ( fMRI ) . Methods : Seventeen preoperative patients with unilateral TLE ( nine left , eight right ) and eight healthy controls were recruited . They performed a complex visual scene-encoding task during fMRI to measure memory activation in the mesial temporal lobe . Their memory performance was evaluated using st and ardised neuropsychological tests . After unilateral temporal lobe resection ( either temporal lobectomy , selective amygdalohippocampectomy or lesionectomy ) , the same fMRI paradigm and neuropsychological tests were administered to the patient group . Results : Left-TLE patients demonstrated a decline in verbal memory after left temporal lobe resection . Their postoperative verbal and visual memory performance was positively associated with postoperative functional activation in the right mesial temporal lobe , whereas the postoperative memory performance of right-TLE patients was positively associated with postoperative functional activation in the left mesial temporal lobe , contralateral to their respective side of resection . Conclusion : Postoperative memory performance was significantly associated with functional activation contralateral to the side of resection in patients with unilateral TLE , and the function of the contralateral mesial temporal lobe might play an important role in supporting memory performance after temporal lobe resection Objective : To develop a clinical ly applicable memory functional MRI ( fMRI ) method of predicting postsurgical memory outcome in individual patients . Methods : In this prospect i ve cohort study , 50 patients with temporal lobe epilepsy ( 23 left ) and 26 controls underwent an fMRI memory encoding paradigm of words with a subsequent out-of-scanner recognition assessment . Neuropsychological assessment was performed preoperatively and 4 months after anterior temporal lobe resection , and at equal time intervals in controls . An event-related analysis was used to explore brain activations for words remembered and change in verbal memory scores 4 months after surgery was correlated with preoperative activations . Individual lateralization indices were calculated within a medial temporal and frontal region and compared with other clinical parameters ( hippocampal volume , preoperative verbal memory , age at onset of epilepsy , and language lateralization ) as a predictor of verbal memory outcome . Results : In left temporal lobe epilepsy patients , left frontal and anterior medial temporal activations correlated significantly with greater verbal memory decline , while bilateral posterior hippocampal activation correlated with less verbal memory decline postoperatively . In a multivariate regression model , left lateralized memory lateralization index ( ≥0.5 ) within a medial temporal and frontal mask was the best predictor of verbal memory outcome after surgery in the dominant hemisphere in individual patients . Neither clinical nor functional MRI parameters predicted verbal memory decline after nondominant temporal lobe resection . Conclusion : We propose a clinical ly applicable memory fMRI paradigm to predict postoperative verbal memory decline after surgery in the language -dominant hemisphere in individual patients Temporal lobectomy is an effective therapy for medically refractory temporal lobe epilepsy ( TLE ) , but may be complicated by amnestic syndromes . Therefore , pre-surgical evaluation to assess the risk/benefit ratio for surgery is required . Intracarotid amobarbital testing ( IAT ) is currently the most widely used method for assessing pre-surgical memory lateralization , but is relatively invasive . Over the past decade functional MRI ( fMRI ) has been shown to correlate with IAT for language lateralization , and also for memory lateralization in a small number of patients . This study was carried out to compare fMRI during memory encoding with IAT testing for memory lateralization , and to assess the predictive value of fMRI during memory encoding for post-surgical memory outcome . Thirty-five patients with refractory TLE undergoing pre-surgical evaluation for temporal lobectomy and 30 normal subjects performed a complex visual scene-encoding task during fMRI scanning at 1.5 T using a 10-min protocol . Encoding performance was evaluated with subsequent recognition testing . Twenty-three patients also completed the same task again outside the scanner , an average of 6.9 months following surgery . A region of interest ( ROI ) analysis was used to quantify activation within hippocampal and a larger mesial temporal lobe ROI consisting of hippocampus , parahippocampus and fusiform gyrus ( HPF ) as defined by a published template . Normal subjects showed almost symmetrical activation within these ROI . TLE patients showed greater asymmetry . Asymmetry ratios ( ARs ) from the HPF ROI correlated significantly with memory lateralization by intracarotid amobarbital testing . HPF ARs also correlated significantly with memory outcome , as determined by a change in scene recognition between pre-surgical and post-surgical trials . When absolute activation within the HPF ROI was considered , a significant inverse correlation between activation ipsilateral to temporal lobectomy and memory outcome was observed , with no significant correlation in the contralateral HPF ROI . Although further technical improvements and prospect i ve clinical validation are required , these results suggest that mesial temporal memory activation detected by fMRI during complex visual scene encoding correlates with post-surgical memory outcome and supports the notion that this approach will ultimately contribute to patient management Objective : To assess the long-term effects of temporal lobe epilepsy surgery on verbal memory . Methods : We assessed verbal memory performance as measured by a verbal learning test ( “ 15 Words Test , ” a Dutch adaptation of Rey 's Auditory Verbal Learning Test ) before surgery and at three specific times after surgery : 6 months , 2 years , and 6 years in 85 patients ( 34 left temporal lobe [ LTL ] vs. 51 right temporal lobe [ RTL ] ) . An amygdalo-hippocampectomy and a neocortical temporal resection between 2.5 and 8 cm were carried out in all patients . Results : LTL patients showed an ongoing memory decline for consolidation and acquisition of verbal material ( both 2/3 SDs ) for up to 2 years after surgery . RTL patients at first showed a gain in both memory acquisition and consolidation , which vanished in the long term . Breaking the group up into a mesiotemporal ( MTS ) group and a non-MTS group showed clear differences . The group with pure MTS showed an overall lower verbal memory performance than the group without pure MTS , in the LTL group more pronounced than in the RTL group . After surgery , both pathology groups showed an ongoing decline for up to 2 years , but the degree of decline was greater for the LTL patients with MTS compared with the non-MTS group . Becoming and remaining seizure-free after surgery does not result in a better performance in the long term . Predictors of postoperative verbal memory performance at 6 years after surgery were side of surgery , preoperative memory score , and age . Conclusions : The results provide evidence for a dynamic decline of verbal memory functions up to 2 years after left temporal lobectomy , which then levels off PURPOSE Previous studies have shown that structural integrity ( i.e. , presence/absence of mesial temporal sclerosis ( MTS ) ) of the left mesial temporal lobe is associated with verbal memory outcome following left anterior temporal lobectomy ( ATL ) . However , the functional integrity of the left temporal lobe , as exemplified by preoperative verbal memory performance , has also been associated with verbal memory outcome following surgery . We investigated the risk of verbal memory loss in patients with known structural abnormality ( i.e. , left mesial temporal sclerosis by MRI ) and normal preoperative verbal memory performance who undergo left ATL . METHODS Seventeen patients with left temporal lobe epilepsy , MRI-based exclusive left MTS , and normal preoperative verbal memory were identified . Normal verbal memory was defined as performance on both Acquisition ( learning across trials 1 - 5 ) and Retrieval ( long delayed free recall ) portions of the California Verbal Learning Test ( CVLT ) above a T score of 40 ( > 16%ile ) . Postoperative verbal memory outcome was established by incorporating st and ardized regression-based ( SRB ) change scores . RESULTS Postoperative declines across both CVLT Retrieval T scores and Acquisition T scores ( average 20 % and average 15 % declines from baseline scores , respectively ) were measured for the group . The average CVLT Retrieval SRB change score was -2.5 , and the average CVLT Acquisition SRB change score was -1.0 . A larger proportion of patients demonstrated postoperative declines on Retrieval scores than Acquisition scores ( 64.7 % vs 17.6 % , respectively ) . CONCLUSIONS Even in the presence of left MTS , patients exhibiting normal presurgical verbal memory are at risk for verbal memory declines following ATL . These results suggest that the functional integrity of the left mesial temporal lobe may play an important role in the verbal memory outcome in this patient group The contribution of the Wada test ( intracarotid amytal procedure , IAP ) to predicting postoperative memory outcome in left temporal lobe epilepsy ( LTLE ) is becoming increasingly controversial when preoperative neuropsychological evaluation and MRI findings are available . We retrospectively analyzed 59 patients with LTLE who underwent en bloc temporal lobe resection . All patients had valid bilateral IAP test results , complete pre- and postoperative neuropsychological evaluation , and MRI grading on a 5-point scale integrating T 2 signal increase and degree of atrophy . Thirty percent of patients showed postoperative memory decline . Multiple regression analysis revealed that significant predictors of decline [ F(2.56)=22.71 , P<0.001 , r(2)=0.448 ] included preoperative memory learning score [ t=-5.89 , P<0.001 ] and MRI classification [ t=3.10 , P<0.003 ] , but not IAP scores . The IAP is of no added value in the prediction of postoperative memory outcome in LTLE in the presence of comprehensive neuropsychological and MRI data Purpose : In the surgical treatment of mesial temporal lobe epilepsy , there is converging evidence that individually tailored or selective approaches have a favorable cognitive outcome compared to st and ard resections . There is , however , also evidence that due to collateral damage , selective surgery can be less selective than suggested . As part of a prospect i ve transregional research project the present study evaluated the outcome in memory and nonmemory functions , following two selective approaches : a combined temporal pole resection with amygdalohippocampectomy ( TPR+ ) and transsylvian selective amygdalohippocampectomy ( SAH )
Output:
| RESULTS Most of the studies used neuropsychological tests and fMRI ; these methods are considered to have the greatest predictive ability for memory impairment .
Other less frequently used techniques included the Wada test and FDG-PET .
CONCLUSIONS Current evidence supports performing a presurgical assessment of memory function using both neuropsychological tests and functional MRI to predict memory outcome after surgery |
MS210562 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND AND PURPOSE Physical activity reduces the risk of premature death and cardiovascular disease , but the relationship to stroke is less well studied . The objective of this study was to investigate the association between leisure-time physical activity and ischemic stroke in an urban , elderly , multiethnic population . METHODS The Northern Manhattan Stroke Study is a population -based incidence and case-control study . Case subjects had first ischemic stroke , and control subjects were derived through r and om-digit dialing with 1:2 matching for age , sex , and race/ethnicity . Physical activity was recorded through a st and ardized in-person interview regarding the frequency and duration of 14 activities over the 2 prior weeks . Conditional logistic regression was used to calculate odds ratios ( OR ) and 95 % confidence intervals after adjustment for medical and socioeconomic confounders . RESULTS Over 30 months , 369 case subjects and 678 control subjects were enrolled . Mean age was 69.9 + /- 12 years ; 57 % were women , 18 % whites , 30 % blacks , and 52 % Hispanics . Leisure-time physical activity was significantly protective for stroke after adjustment for cardiac disease , peripheral vascular disease , hypertension , diabetes , smoking , alcohol use , obesity , medical reasons for limited activity , education , and season of enrollment ( OR = 0.37 ; 95 % confidence interval=0.25 to 0.55 ) . The protective effect of physical activity was detected in both younger and older groups , in men and women , and in whites , blacks , and Hispanics . A dose-response relationship was shown for both intensity ( light-moderate activity OR = 0.39 ; heavy OR = 0.23 ) and duration ( < 2 h/wk OR = 0.42 ; 2 to < 5 h/wk OR = 0.35 ; > or = 5 h/wk OR = 0.31 ) of physical activity . CONCLUSIONS Leisure-time physical activity was related to a decreased occurrence of ischemic stroke in our elderly , multiethnic , urban subjects . More emphasis on physical activity in stroke prevention campaigns is needed among the elderly Seventy two women drinking 21 units ( 210 g ) or more of alcohol per week were recruited from an opportunistic screening programme in eight English general practice s. The women were r and omized into control and treatment groups . Women in the treatment group received ten minutes advice from their general practitioner to reduce alcohol consumption . At one year follow-up , when analyzed by intention to treat , women in the treatment group had reduced their alcohol consumption from an average of 35 - 24 units per week . Similar reductions were found in the control group ( from 37 - 27 units per week ) . The lack of evidence for a treatment effect may be explained by contamination of the control group by informal interventions In a controlled evaluation of general practitioner (GP)-based brief intervention , 378 excessive drinkers identified opportunistically by screening in 40 group practice s in metropolitan Sydney were assigned to groups receiving : ( i ) a five-session intervention by the GP ( the Alcoholscreen Program ) ; ( ii ) a single session of 5 minutes ' advice by the GP plus a self-help manual ( minimal intervention ) ; ( iii ) an alcohol-related assessment but no intervention ; ( iv ) neither intervention nor assessment . Among all patients allocated to receive it , the Alcoholscreen Program did not result in a significantly greater reduction in consumption at follow-up than control conditions but patients offered Alcoholscreen reported a significantly greater reduction in alcohol-related problems in the period to 6 months follow-up . A greater proportion of patients who returned for the second Alcoholscreen visit were drinking below recommended levels at follow-up than in the remainder of the sample . There was no evidence that minimal intervention or alcohol-related assessment were effective in reducing alcohol consumption or problems . Implication s for further research into GP-based brief interventions are discussed Patients admitted to an emergency surgical ward were screened for alcohol problems and r and omized between an extensive alcohol counseling and a brief assessment followed by feedback of risky alcohol consumption . Some 165 patients were assessed for risk consumption and followed up 6 to 12 months , and it was found that patients in both interventions significantly reduced the amount they drank per occasion although they drank as often as before . The patients had also moved to a stage more ready to change . No differences in effect were found between the interventions . A brief assessment with feedback about risk consumption can be done on an emergency surgical ward by the surgical staff with a few hours of training and may reduce risky alcohol consumption significantly BACKGROUND The U.S. Congress m and ated evaluations , initiated in 1989 , to determine whether extending Medicare benefits to include preventive services would improve health status , reduce costs of care , and improve health risk behaviors of beneficiaries . METHODS The Johns Hopkins Medicare Preventive Services Demonstration was a r and omized trial in which Medicare beneficiaries were assigned either to an intervention group that was offered yearly preventive visits for 2 years and optional counseling visits to their primary care provider or to a control group that received usual care . This report describes the effect of the intervention over a period of 2 years on smoking , problem alcohol use , and sedentary lifestyle . RESULTS Differences were observed between the intervention and control groups in the extent to which changes occurred in smoking and problem alcohol use , but none of the differences was statistically significant . The proportion of smokers who quit was higher in the intervention group than in the control group ( 24.2 vs 17.9 % , P = 0.09 ) . However , a higher proportion of problem drinkers in the control group improved ( 67.1 vs 57.0 % , P = 0.183 ) . There was virtually no difference between the intervention and the control groups in the proportion with improvement in sedentary lifestyle . CONCLUSIONS This study demonstrates the difficulty of bringing about health behavior change in older patients in the course of a yearly preventive visit for 2 years with their primary care physician when the visit encompasses screening and immunizations , as well as health behavior counseling directed by the physician . Further study is required to determine whether a more intense program of counseling for health behavior change among older persons by their primary care providers would be effective OBJECTIVE To compare the effects of three brief methods of reducing alcohol consumption among family practice patients . DESIGN Patients r and omly assigned to one of three interventions were assessed initially and at 3- , 6- , and 12-month follow-up appointments . SETTING Family practice clinic composed of 12 primary care physicians seeing approximately 6000 adults monthly in a small urban community , population 40,000 . PARTICIPANTS Through a screening question naire , 134 men and 131 women were identified as hazardous drinkers ( five or more drinks at least once monthly ) during an 11-month screening of 1420 patients . Of 265 patients approached , 180 agreed to participate and 159 ( 83 men and 76 women ) actually participated in the study . INTERVENTIONS Three interventions were studied : brief physician advice ( 5 minutes ) , two 30-minute sessions with a physician using cognitive behavioural strategies or two 30-minute sessions with a nurse practitioner using identical strategies . MAIN OUTCOME MEASURES Quantity and frequency ( QF ) of drinking were used to assess reduction in hazardous drinking and problems related to drinking over 12 months of follow up . RESULTS No statistical difference between groups was found . The QF of monthly drinking was reduced overall by 66 % ( among men ) and 74 % ( among women ) for those reporting at least one hazardous drinking day weekly at assessment ( N = 96 ) . Men reported drinking significantly more than women . CONCLUSIONS These results indicated that offering brief , specific advice can motivate patients to reduce their alcohol intake . There was no difference in effect between brief advice from their own physician or brief intervention by a physician or a nurse Sixteen general practitioners participated in a controlled trial of the Scottish Health Education Group 's DRAMS ( drinking reasonably and moderately with self-control ) scheme . The scheme was evaluated by r and omly assigning 104 heavy or problem drinkers to three groups - a group participating in the DRAMS scheme ( n = 34 ) , a group given simple advice only ( n = 32 ) and a non-intervention control group ( n = 38 ) . Six month follow-up information was obtained for 91 subjects ( 87.5 % of initial sample ) . There were no significant differences between the groups in reduction in alcohol consumption , but patients in the DRAMS group showed a significantly greater reduction in a logarithmic measure of serum gamma-glutamyl-transpeptidase than patients in the group receiving advice only . Only 14 patients in the DRAMS group completed the full DRAMS procedure . For the sample as a whole , there was a significant reduction in alcohol consumption , a significant improvement on a measure of physical health and well-being , and significant reductions in the logarithmic measure of serum gamma-glutamyl transpeptidase and in mean corpuscular volume . The implication s of these findings for future research into controlled drinking minimal interventions in general practice are discussed OBJECTIVE : To determine effectiveness of advice from general practitioners to heavy drinkers to reduce their excessive alcohol consumption ( 35 U or more a week for men , 21 U or more for women ) . DESIGN : R and omised , controlled double blind trial over 12 months with interim assessment at six months . SETTING : Group practice s ( n = 47 ; list size averaging 10,000 ) recruited from Medical Research Council 's general practice research framework , mostly in rural or small urban setting s. PATIENTS : Patients recruited after question naire survey . Of total of 2571 ( 61.2 % ) of 4203 patients invited for interview who attended , 909 ( 35.4 % ) stated that in past seven days they had drunk above the limits set for study and had not received advice ; they were r and omised to control and treatment groups . INTERVENTIONS : Patients in treatment group were interviewed by general practitioner ( who had had a training session ) and received advice and information about how to reduce consumption and also given a drinking diary . END POINT : Study aim ed at detecting a reduction in proportion of men with excessive alcohol consumption of 30 % in treatment group and 20 % in control group ( for women 40 % and 20 % , respectively ) with a power of 90 % at 5 % level of significance . In addition , corroborative measures such as estimation of gamma-glutamyltransferase activity were included . MEASUREMENTS AND MAIN RESULTS : At one year a mean reduction in consumption of alcohol of 18.2 ( SE 1.5 ) U/week had occurred in treated men compared with a reduction of 8.1 ( 1.6 ) U/week in controls ( p less than 0.001 ) . The proportion of men with excessive consumption at interview had dropped by 43.7 % in the treatment group compared with 25.5 % in controls ( p less than 0.001 ) . A mean reduction in weekly consumption of 11.5 ( 1.6 ) U occurred in treated women compared with 6.3 ( 2.0 ) U in controls ( p less than 0.05 ) , with proportionate reductions of excessive drinkers in treatment and control groups of 47.7 % and 29.2 % respectively . Reduction in consumption increased significantly with number of general practitioner interventions . At one year the mean value for gamma-glutamyltransferase activity had dropped significantly more in treated men ( -2.4 (0.9)IU/l ) than in controls ( + 1.1(1.0)IU/l ; t = 2.7 , p less than 0.01 ) . Reduction in gamma-glutamyltransferase activity tended to increase with number of intervention sessions in men . Changes in gamma-glutamyltransferase activity in women and changes in other indicators in both sexes did not differ significantly between treatment and control groups . CONCLUSIONS : If the results of this study were applied to the United Kingdom intervention by general practitioners could each year reduce to moderate levels the alcohol consumption of some 250000 men and 67500 women who currently drink to excess . General practitioners and other members of the primary health care team should therefore be encouraged to include counselling about alcohol consumption in their preventive activities OBJECTIVE To evaluate the correspondence among measures of self-reported drinking , st and ard biological indicators and the reports of collateral informants , and to identify patient characteristics associated with observed discrepancies among these three sources of research data . METHOD Using data collected from a large-scale clinical trial of treatment matching with alcoholics ( N = 1,726 ) , these three alternative outcome measures were compared at the time of admission to treatment and at 12 months after the end of treatment . RESULTS Patient self-reports and collateral reports agreed most ( 97.1 % ) at treatment admission when heavy drinking was unlikely to be denied . In contrast , liver function tests were relatively insensitive , with positive serum gamma-glutamyl transpeptidase ( GGTP ) values obtained from only 39.7 % of those who admitted to heavy drinking . At 15-month follow-up the correspondence between client self-report and collateral report decreased to 84.7 % , but agreement with blood chemistry values increased to 51.6 % . When discrepancies occurred , they still indicated that the client ' s self-report is more sensitive to the amount of drinking than the biochemical measures . Patients who presented discrepant results tended to have more severe drinking problems , more previous treatments , higher levels of pretreatment drinking and significantly greater levels of cognitive impairment , all of which could potentially interfere with accurate recall . CONCLUSIONS In clinical trials using self-selected research volunteers , biochemical tests and collateral informant reports do
Output:
| Studies also relate heavy per-occasion alcohol use ( binge drinking ) to acute injury risks and alcohol-related life problems ( 4 , 22 ) .
Injury rates are higher for binge drinkers who consume 5 or more drinks on one occasion as infrequently as 3 to 6 times per year , even when average intake is not excessive ( 24 ) .
Even so , few primary care clinicians use recommended screening protocol s or offer treatment ( 33 ) .
Definitions No consistent definitions for the drinking patterns that should be the focus of primary care interventions are available from existing guidelines or research ; however , it is commonly held that less severe alcohol problems are appropriate for brief interventions in primary care , whereas more severe problems need specialty addiction treatment ( 41 ) . |
MS210563 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Therapy with antibiotics influences recovery only in selected cases of COPD exacerbations . We evaluated the efficacy and safety of procalcitonin guidance compared to st and ard therapy with antibiotic prescriptions in patients experiencing exacerbations of COPD . METHODS A total of 208 consecutive patients requiring hospitalization for COPD exacerbation were r and omized at the index exacerbation to procalcitonin-guided or st and ard antibiotic therapy . Patients receiving procalcitonin-guided therapy were treated with antibiotics according to serum procalcitonin levels ; st and ard-therapy patients received antibiotics according to the attending physician . The primary outcome was the antibiotic exposure at the index exacerbation and the subsequent antibiotic requirement for COPD exacerbation within 6 months . Secondary outcomes were clinical recovery , symptom scores , length of hospitalization , ICU stay , death , lung function , exacerbation rate , and time to next exacerbation . RESULTS At the index exacerbation , procalcitonin guidance reduced antibiotic prescription ( 40 % vs 72 % , respectively ; p < 0.0001 ) and antibiotic exposure ( relative risk [ RR ] , 0.56 ; 95 % confidence interval [ CI ] , 0.43 to 0.73 ; p < 0.0001 ) compared to st and ard therapy . Moreover , procalcitonin guidance at the index exacerbation allowed a significant sustained reduction in total antibiotic exposure for up to 6 months ( RR , 0.76 ; 95 % CI , 0.64 to 0.92 ; p = 0.004 ) . Clinical outcome and improvement in FEV(1 ) at 14 days and 6 months did not differ between groups . Within 6 months , the exacerbation rate ( 0.62 vs 0.64 , respectively ) , the rehospitalization rate ( 0.21 vs 0.24 , respectively ) , and mean ( + /- SD ) time to the next exacerbation ( 70.0 + /- 46.1 vs 70.4 + /- 51.9 days , respectively ; p = 0.523 ) were similar in both groups . CONCLUSIONS Procalcitonin guidance for exacerbations of COPD offers a sustained advantage over st and ard therapy in reducing antibiotic use for up to 6 months with a number-needed-to-treat of 3 BACKGROUND The value of azithromycin for treatment of acute bronchitis is unknown , even though this drug is commonly prescribed . We have investigated this question in a r and omised , double-blind , controlled trial . METHODS Adults diagnosed with acute bronchitis , without evidence of underlying lung disease , were r and omly assigned azithromycin ( n=112 ) or vitamin C ( n=108 ) for 5 days ( total dose for each 1.5 g ) . All individuals were also given liquid dextromethorphan and albuterol inhaler with a spacer . The primary outcome was improvement in health-related quality of life at 7 days ; an important difference was defined as 0.5 or greater . Analysis was by intention to treat . FINDINGS The study was stopped by the data -monitoring and safety committee when 220 patients had been recruited . On day 7 , the adjusted difference in health-related quality of life was small and not significant ( difference 0.03 [ 95 % CI -0.20 to 0.26 ] , p=0.8 ) . 86 ( 89 % ) of 97 patients in the azithromycin group and 82 ( 89 % ) of 92 in the vitamin C group had returned to their usual activities by day 7 ( difference 0.5 % [ -10 % to 9 % ] , p>0.9 ) . There were no differences in the frequency of adverse effects ; three patients in the vitamin C group discontinued the study medicine because of perceived adverse effects , compared with none in the azithromycin group . Most patients ( 81 % ) reported benefit from the albuterol inhaler . INTERPRETATION Azithromycin is no better than low-dose vitamin C for acute bronchitis . Further studies are needed to identify the best treatment for this disorder BACKGROUND Reduced duration of antibiotic treatment might contain the emergence of multidrug-resistant bacteria in intensive care units . We aim ed to establish the effectiveness of an algorithm based on the biomarker procalcitonin to reduce antibiotic exposure in this setting . METHODS In this multicentre , prospect i ve , parallel-group , open-label trial , we used an independent , computer-generated r and omisation sequence to r and omly assign patients in a 1:1 ratio to procalcitonin ( n=311 patients ) or control ( n=319 ) groups ; investigators were masked to assignment before , but not after , r and omisation . For the procalcitonin group , antibiotics were started or stopped based on predefined cut-off ranges of procalcitonin concentrations ; the control group received antibiotics according to present guidelines . Drug selection and the final decision to start or stop antibiotics were at the discretion of the physician . Patients were expected to stay in the intensive care unit for more than 3 days , had suspected bacterial infections , and were aged 18 years or older . Primary endpoints were mortality at days 28 and 60 ( non-inferiority analysis ) , and number of days without antibiotics by day 28 ( superiority analysis ) . Analyses were by intention to treat . The margin of non-inferiority was 10 % . This trial is registered with Clinical Trials.gov , number NCT00472667 . FINDINGS Nine patients were excluded from the study ; 307 patients in the procalcitonin group and 314 in the control group were included in analyses . Mortality of patients in the procalcitonin group seemed to be non-inferior to those in the control group at day 28 ( 21.2 % [ 65/307 ] vs 20.4 % [ 64/314 ] ; absolute difference 0.8 % , 90 % CI -4.6 to 6.2 ) and day 60 ( 30.0 % [ 92/307 ] vs 26.1 % [ 82/314 ] ; 3.8 % , -2.1 to 9.7 ) . Patients in the procalcitonin group had significantly more days without antibiotics than did those in the control group ( 14.3 days [ SD 9.1 ] vs 11.6 days [ SD 8.2 ] ; absolute difference 2.7 days , 95 % CI 1.4 to 4.1 , p<0.0001 ) . INTERPRETATION A procalcitonin-guided strategy to treat suspected bacterial infections in non-surgical patients in intensive care units could reduce antibiotic exposure and selective pressure with no apparent adverse outcomes . FUNDING Assistance Publique-Hôpitaux de Paris , France , and Brahms , Germany CONTEXT In previous smaller trials , a procalcitonin ( PCT ) algorithm reduced antibiotic use in patients with lower respiratory tract infections ( LRTIs ) . OBJECTIVE To examine whether a PCT algorithm can reduce antibiotic exposure without increasing the risk for serious adverse outcomes . DESIGN , SETTING , AND PATIENTS A multicenter , noninferiority , r and omized controlled trial in emergency departments of 6 tertiary care hospitals in Switzerl and with an open intervention of 1359 patients with mostly severe LRTIs r and omized between October 2006 and March 2008 . INTERVENTION Patients were r and omized to administration of antibiotics based on a PCT algorithm with predefined cutoff ranges for initiating or stopping antibiotics ( PCT group ) or according to st and ard guidelines ( control group ) . Serum PCT was measured locally in each hospital and instructions were Web-based . MAIN OUTCOME MEASURES Noninferiority of the composite adverse outcomes of death , intensive care unit admission , disease-specific complications , or recurrent infection requiring antibiotic treatment within 30 days , with a predefined noninferiority boundary of 7.5 % ; and antibiotic exposure and adverse effects from antibiotics . RESULTS The rate of overall adverse outcomes was similar in the PCT and control groups ( 15.4 % [ n = 103 ] vs 18.9 % [ n = 130 ] ; difference , -3.5 % ; 95 % CI , -7.6 % to 0.4 % ) . The mean duration of antibiotics exposure in the PCT vs control groups was lower in all patients ( 5.7 vs 8.7 days ; relative change , -34.8 % ; 95 % CI , -40.3 % to -28.7 % ) and in the subgroups of patients with community-acquired pneumonia ( n = 925 , 7.2 vs 10.7 days ; -32.4 % ; 95 % CI , -37.6 % to -26.9 % ) , exacerbation of chronic obstructive pulmonary disease ( n = 228 , 2.5 vs 5.1 days ; -50.4 % ; 95 % CI , -64.0 % to -34.0 % ) , and acute bronchitis ( n = 151 , 1.0 vs 2.8 days ; -65.0 % ; 95 % CI , -84.7 % to -37.5 % ) . Antibiotic-associated adverse effects were less frequent in the PCT group ( 19.8 % [ n = 133 ] vs 28.1 % [ n = 193 ] ; difference , -8.2 % ; 95 % CI , -12.7 % to -3.7 % ) . CONCLUSION In patients with LRTIs , a strategy of PCT guidance compared with st and ard guidelines result ed in similar rates of adverse outcomes , as well as lower rates of antibiotic exposure and antibiotic-associated adverse effects . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N95122877 Introduction Patients with severe acute exacerbations of asthma often receive inappropriate antibiotic treatment . We aim ed to determine whether serum procalcitonin ( PCT ) levels can effectively and safely reduce antibiotic exposure in patients experiencing exacerbations of asthma . Methods In this r and omized controlled trial , a total of 216 patients requiring hospitalization for severe acute exacerbations of asthma were screened for eligibility to participate and 169 completed the 12-month follow-up visit . Patients were r and omized to either PCT-guided ( PCT group ) or st and ard ( control group ) antimicrobial therapy . In the control group , patients received antibiotics according to the attending physician ’s discretion ; in the PCT group , patients received antibiotics according to an algorithm based on serum PCT levels . The primary end point was antibiotic exposure ; secondary end points were clinical recovery , length of hospital stay , clinical and laboratory parameters , spirometry , number of asthma exacerbations , emergency room visits , hospitalizations and need for corticosteroid use due to asthma . Results PCT guidance reduced antibiotic prescription ( 48.9 % versus 87.8 % , respectively ; P < 0.001 ) and antibiotic exposure ( relative risk , 0.56 ; 95 % confidence interval , 0.44 to 0.70 ; P < 0.001 ) compared to st and ard therapy . There were no significant differences in clinical recovery , length of hospital stay or clinical , laboratory and spirometry outcomes in both groups . Number of asthma exacerbations , emergency room visits , hospitalizations and need for corticosteroid use due to asthma were similar during the 12-month follow-up period . Conclusion A PCT-guided strategy allows antibiotic exposure to be reduced in patients with severe acute exacerbation of asthma without apparent harm . Trial registration Chinese Clinical Trial Register ChiCTR-TRC-12002534 ( registered 26 September 2012 Objective : For patients in intensive care units , sepsis is a common and potentially deadly complication and prompt initiation of appropriate antimicrobial therapy improves prognosis . The objective of this trial was to determine whether a strategy of antimicrobial spectrum escalation , guided by daily measurements of the biomarker procalcitonin , could reduce the time to appropriate therapy , thus improving survival . Design : R and omized controlled open-label trial . Setting : Nine multidisciplinary intensive care units across Denmark . Patients : A total of 1,200 critically ill patients were included after meeting the following eligibility requirements : expected intensive care unit stay of ≥24 hrs , nonpregnant , judged to not be harmed by blood sampling , bilirubin < 40 mg/dL , and triglycerides < 1000 mg/dL ( not suspensive ) . Interventions : Patients were r and omized either to the “ st and ard-of-care-only arm , ” receiving treatment according to the current international guidelines and blinded to procalcitonin levels , or to the “ procalcitonin arm , ” in which current guidelines were supplemented with a drug-escalation algorithm and intensified diagnostics based on daily procalcitonin measurements . Measurements and Main Results : The primary end point was death from any cause at day 28 ; this occurred for 31.5 %
Output:
| This up date d meta- analysis of individual participant data from 12 countries shows that the use of procalcitonin to guide initiation and duration of antibiotic treatment results in lower risks of mortality , lower antibiotic consumption , and lower risk for antibiotic-related side effects .
Results were similar for different clinical setting s and types of ARIs , thus supporting the use of procalcitonin in the context of antibiotic stewardship in people with ARIs . |
MS210564 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND The hippocampus , amygdala and related functional circuits have been implicated in the regulation of emotional expression and memory processes , which are affected in major depression . Several recent investigations have reported abnormalities in these structures in adult and elderly depressives . METHODS Elderly DSM-III-R unipolar depressives ( N = 40 ) and normal controls ( N = 46 ) participated in a magnetic resonance imaging study ( 1.0 T ) . Brain images were obtained in the coronal plane . Using established anatomical guidelines for structure delineation , volumetric measurements of left and right hippocampus and anterior hippocampus/amygdala complex were completed under blinded conditions using a semi-automated computer mensuration system , with patients and controls in r and om order . RESULTS Medial temporal volumes did not significantly distinguish either elderly depressed and age-similar normal control subjects , or late onset and early onset depressed patients ( ANCOVA ) . Major overlap of measured volumes existed between patient and control groups . In depressives , hippocampal volumes significantly correlated with age , and cognitive and depression ratings , but not with number of prior depressive episodes or age-at-onset of first depression . CONCLUSIONS Hippocampal volumes do not discriminate a typical clinical population of elderly depressed patients from age-similar normal control subjects . If hippocampal dysfunction contributes to a diagnosis of syndromal depression in the elderly , such dysfunction does not appear to be regularly reflected in structural abnormalities captured by volumetric measurement as conducted . On the other h and , relationships between hippocampal volumes and clinical phenomena in depressives , but not controls , suggest potentially meaningful interactions between hippocampal structure and the expression of major depression in the elderly Subjects at their first psychotic episode show an enlarged volume of the pituitary gl and , but whether this is due to hypothalamic – pituitary – adrenal ( HPA ) axis hyperactivity , or to stimulation of the prolactin-secreting cells by antipsychotic treatment , is unclear . We measured pituitary volume , using 1.5-mm , coronal , 1.5 T , high-resolution MRI images , in 78 patients at the first psychotic episode and 78 age- and gender-matched healthy controls . In all , 18 patients were antipsychotic-free ( 12 of these were antipsychotic-naïve ) , 26 were receiving atypical antipsychotics , and 33 were receiving typical antipsychotics . As hypothesized , patients had a larger pituitary volume than controls ( + 22 % , p<0.001 ) . When divided by antipsychotic treatment , and compared to controls , the pituitary volume was 15 % larger in antipsychotic-free patients ( p=0.028 ) , 17 % larger in patients receiving atypicals ( p=0.01 ) , and 30 % larger in patients receiving typicals ( p<0.001 ) . Patients receiving typicals not only had the largest pituitary volume compared to controls but also showed a trend for a larger pituitary volume compared to the other patients grouped together ( + 11 % , p=0.08 ) . When divided by diagnosis , and compared to controls , the pituitary volume was 24 % larger in patients with schizophrenia/schizophreniform disorder ( n=40 , p<0.001 ) , 19 % larger in depressed patients ( n=13 , p=0.022 ) , 16 % larger in bipolar patients ( n=16 , p=0.037 ) , and 12 % larger in those with other psychoses ( n=9 , p=0.2 ) . In conclusion , the first-episode of a psychotic disorder is associated with a larger pituitary independently of the presence of antipsychotic treatment , and this could be due to activation of the HPA axis . Typical antipsychotics exert an additional enlarging effect on pituitary volume , likely to be related to activation of prolactin-secreting cells . This activation of the hormonal stress response could participate to the important metabolic abnormalities observed in patients with psychosis BACKGROUND Previous studies have shown that major depression is frequently accompanied by hypercortisolemia . There is some evidence suggesting that an increase in the glucocorticoid levels may make hippocampal cells more vulnerable to insults caused by hypoxia , hypoglycemia , or excitatory neurotransmitters . Using magnetic resonance imaging ( MRI ) , the hippocampi of patients with major depression were measured and compared with values observed in control subjects . METHODS Thirty-eight patients with primary unipolar major depression were recruited . Twenty control subjects were matched for age , gender , and years of education . The hippocampal volume was measured from coronal MRI scans in all of the subjects . Patients were also grouped and compared as responders and nonresponders to treatment with fluoxetine of 20 mg/day , for 8 weeks . Hamilton Depression Rating Scale ( HDRS ) was used to determine the severity of depression . RESULTS No significant differences were observed between the hippocampal volumes of patients with major depression and control subjects ; however , a significant correlation was observed between the left hippocampal volume of men and their HDRS baseline values . In addition , female responders had a statistically significant higher mean right hippocampal volume than nonresponders . CONCLUSIONS The results of our study indicate no reduction in the volume of the hippocampus in patients with major depression . Nonetheless , the results do suggest that the effects of disease severity , gender , and treatment response may influence hippocampal volume THE amygdala is a key structure in the brain 's integration of emotional meaning with perception and experience.1 Patients with depression have impaired functioning in emotional tasks involving the amygdala,2 and have abnormal resting amygdala blood flow.3 To better underst and the anatomical basis for these functional changes we measured the volumes of the total amygdala and of the core amygdala nuclei in 20 patients with a history of depression and 20 pair-wise matched controls . Depressed subjects had bilaterally reduced amygdala core nuclei volumes and no significant differences in total amygdala volumes or in whole brain volumes . Since patients with a depression history have bilateral hippocampal volume reduction4 the volume loss in this closely related structure suggests a shared effect on both structures , potentially glucocorticoid-induced neurotoxicity5 mediated by the extensive reciprocal glutamatergic connections BACKGROUND The amygdala has a central role in processing emotions , particularly fear . During functional magnetic resonance imaging ( fMRI ) amygdala activation has been demonstrated outside of conscious awareness using masked emotional faces . METHODS We applied the masked faces paradigm to patients with major depression ( n = 11 ) and matched control subjects ( n = 11 ) during fMRI to compare amygdala activation in response to masked emotional faces before and after antidepressant treatment . Data were analyzed using left and right amygdala a priori regions of interest , in an analysis of variance block analysis and r and om effects model . RESULTS Depressed patients had exaggerated left amygdala activation to all faces , greater for fearful faces . Right amygdala did not differ from control subjects . Following treatment , patients had bilateral reduced amygdala activation to masked fearful faces and bilateral reduced amygdala activation to all faces . Control subjects had no differences between the two scanning sessions . CONCLUSIONS Depressed patients have left amygdala hyperarousal , even when processing stimuli outside conscious awareness . Increased amygdala activation normalizes with antidepressant treatment The purpose of our study was to examine the neuroanatomical correlates of late-onset minor and major depression and to compare them with similar measures obtained from nondepressed controls . Our study groups were comprised of 18 patients with late-onset minor depression , 35 patients diagnosed with late-onset major depression , and 30 nondepressed controls . All subjects were scanned by using a 1 . 5-tesla MRI scanner . Absolute whole brain volume and normalized measures of prefrontal and temporal lobe volumes were obtained and used for comparison among groups . Our findings indicate that patients with minor depression present with specific neuroanatomical abnormalities that are comparable with the major depression group but significantly different from the controls . Normalized prefrontal lobe volumes show a significant linear trend with severity of depression , with volumes decreasing with illness severity . Whole brain volumes did not differ significantly among groups . These findings have broad implication s for the biology of late-life depression and suggest that there may be common neurobiological substrates that underlie all clinical ly significant forms of late-onset mood disturbances Behavioral studies suggest that emotional reactivity in depressed persons predicts subsequent symptom reduction . Using functional magnetic resonance imaging in a prospect i ve study , we show that greater amygdala activation to emotional facial expressions among depressed patients predicts symptom reduction 8 months later , controlling for initial depression severity and medication status . Functional magnetic resonance imaging may thus be used as a method to identify neural markers in depressed patients at risk for poor outcome BACKGROUND Previous magnetic resonance imaging ( MRI ) studies of patients with major depressive disorder ( MDD ) have consistently shown bilateral and unilateral reductions in hippocampal volume relative to healthy controls . Recent structural MRI studies have addressed the question of whether changes in the volume of hippocampal subregions may be associated with MDD . METHODS We used a comprehensive and reliable 3-dimensional tracing protocol that enables delineation of hippocampal subregions ( head , body , tail ) to study changes in the hippocampus of patients with MDD . We recruited 39 MDD patients ( 16 medicated , 23 unmedicated ) and 34 healthy age- and sex-matched controls . We acquired images using a magnetization-prepared rapid acquisition gradient echo sequence on a 1.5-T scanner with a spatial resolution of 1.5 mm x 0.5 mm x 0.5 mm . We performed volumetric analyses , blinded to diagnosis , using the interactive software package Display . All volumes were adjusted for intracranial volume . RESULTS We found a significant reduction in the volume of the hippocampal tail bilaterally , right hippocampal head and right total hippocampus in MDD patients . Medicated MDD patients showed increased hippocampal body volume compared with both healthy controls and unmedicated patients . LIMITATIONS This study was cross-sectional . Further prospect i ve studies are needed to determine the direct effect of antidepressant treatment . CONCLUSION Our results suggest that decreased hippocampal tail and hippocampal head volumes could be trait changes , whereas hippocampal body changes may be dependent on treatment . We showed that long-term antidepressant treatment may affect hippocampal volume in patients with MDD It has been hypothesized that one of the effects of antidepressants is to increase functional connectivity between the cortical mood-regulating and the limbic mood-generating regions . One consequence of this antidepressant effect is thought to be decreased limbic activation in response to negative emotional stimuli . Twelve unmedicated unipolar depressed patients and 11 closely matched healthy comparison subjects completed two magnetic resonance imaging ( MRI ) scanning sessions at baseline and after 6 weeks . Depressed patients received treatment with sertraline between the two sessions . During each MRI session , subjects completed a resting state functional connectivity scan and a conventional block- design negative vs. neutral pictures regional brain activation scan . After 6 weeks of sertraline treatment resting state , functional connectivity between the ACC and limbic regions increased while limbic activation in response to negative versus neutral pictures decreased . The results of this study are consistent with the hypothesis that antidepressant treatment has reciprocal effects on corticolimbic functional connectivity and limbic activation in response to emotional stimuli Abstract Resting state activity in the ventral cingulate may be an important neural marker of symptomatic improvement in depression . The number of task related functional magnetic resonance imaging ( fMRI ) studies correlating blood oxygenation level dependent ( BOLD ) response with symptomatic improvement is limited and method ologies are still evolving . We measured BOLD responses to sad and happy facial stimuli in 12 severely depressed individuals in the early stages of antidepressant treatment ( Time 1 ) and 12 weeks later ( Time 2 ) using event-related fMRI . We calculated correlations between temporal changes in BOLD response and changes in symptom scores . Most subjects improved markedly by Time 2 . At Time 1 , depression severity correlated positively with responses to sad stimuli in the right visual cortex , subgenual cingulate , anterior temporal pole and hippocampus and correlated negatively with responses to happy stimuli in left visual cortex and right cau date . Decreases in individual effect sizes of right subgenual cingulate and right visual cortical responses to sad , but not happy , facial stimuli were correlated with decreases in symptom scores . There are contrasting cortical and subcortical responses to sad and happy stimuli in severe depression . Responses to sad stimuli show the strongest correlates of clinical improvement , particularly in the subgenual cingulate BACKGROUND Hippocampal volumes obtained from a group of medication-free , remitted subjects with recurrent major depressive disorder ( MDD ) were compared against corresponding measures from healthy controls . METHODS Thirty-one subjects with recurrent MDD in full remission , and 57 healthy controls underwent high resolution magnetic resonance imaging ( MRI ) on a GE 3 T scanner . Eight patients with MDD were medication-naive , and twenty-three MDD patients were off antidepressant medications for a mean of 30 months at the time of the MRI study . RESULTS Patients showed smaller total and posterior hippocampal volume relative to controls . Anterior hippocampal volume did not differ between patients and controls . CONCLUSIONS Recurrent depression is associated with smaller hippocampal volume which is most prominent in the posterior hippocampus .
Output:
| Unipolar depression was characterised by reduced brain volume in areas involved in emotional processing , including the frontal cortex , orbitofrontal cortex , cingulate cortex , hippocampus and striatum .
There was also evidence of pituitary enlargement and an excess of white matter hyperintensity volume in unipolar depression . |
MS210565 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND The main goal of this study was to assess frequency , clinical correlates , and independent predictors of fatigue in a homogeneous cohort of well-defined glioblastoma patients at baseline prior to combined radio-chemotherapy . METHODS We prospect ively included 65 glioblastoma patients at postsurgical baseline and assessed fatigue , sleepiness , mean bedtimes , mood disturbances , and clinical characteristics such as clinical performance status , presenting symptomatology , details on neurosurgical procedure , and tumor location and diameter as well as pharmacological treatment including antiepileptic drugs , antidepressants , and use of corticosteroids . Data on fatigue and sleepiness were measured with the Fatigue Severity Scale and the Epworth Sleepiness Scale , respectively , and compared with 130 age- and sex-matched healthy controls . RESULTS We observed a significant correlation between fatigue and sleepiness scores in both patients ( r = 0.26 ; P = .04 ) and controls ( r = 0.36 ; P < .001 ) . Only fatigue appeared to be more common in glioblastoma patients than in healthy controls ( 48 % vs 11 % ; P < .001 ) but not the frequency of sleepiness ( 22 % vs 19 % ; P = .43 ) . Female sex was associated with increased fatigue frequency among glioblastoma patients but not among control participants . Multiple linear regression analyses identified depression , left-sided tumor location , and female sex as strongest associates of baseline fatigue severity . CONCLUSIONS Our findings indicate that glioblastoma patients are frequently affected by fatigue at baseline , suggesting that factors other than those related to radio- or chemotherapy have significant impact , particularly depression and tumor localization BACKGROUND Recurrent glioblastoma multiforme ( GBM ) is resistant to most therapeutic endeavors , with low response rates and survival rarely exceeding six months . There are no clearly established chemotherapeutic regimens and the aim of treatment is palliation with improvement in the quality of life . PATIENTS AND METHODS We report an open-label , uncontrolled , multicenter phase II trial of temozolomide in 138 patients ( intent-to-treat [ ITT ] population ) with glioblastoma multiforme at first relapse and a Karnofsky performance status ( KPS ) > or = 70 . One hundred twenty-eight patients were histologically confirmed with GBM or gliosarcoma ( GS ) by independent central review . Chemotherapy-naïve patients were treated with temozolomide 200 mg/m2/day orally for the first five days of a 28-day cycle . Patients previously treated with nitrosourea-containing adjuvant chemotherapy received 150 mg/m2/day for the first five days of a 28-day cycle . In the absence of grade 3 or 4 toxicity , patients on the 150 mg/m2 dose schedule were eligible for a 200 mg/m2 dose on the next cycle . RESULTS The primary endpoint was six-month progression-free survival assessed with strict radiological and clinical criteria . Secondary endpoints included radiological response and Health-related Quality of Life ( HQL ) . Progression-free survival at six months was 18 % ( 95 % confidence interval ( CI ) : 11%-26 % ) for the eligible-histology population . Median progression-free survival and median overall survival were 2.1 months and 5.4 months , respectively . The six-month survival rate was 46 % . The objective response rate ( complete response and partial response ) determined by independent central review of gadolinium-enhanced magnetic resonance imaging ( MRI ) scans was 8 % for both the ITT and eligible-histology population s , with an additional 43 % and 45 % of patients , respectively , having stable disease ( SD ) . Objective ly assessed response and maintenance of a progression-free status were both associated with HQL benefits ( characterized by improvements over baseline in HQL domains ) . Temozolomide had an acceptable safety profile , with only 9 % of therapy cycles requiring a dose reduction due to thrombocytopenia . There was no evidence of cumulative hematologic toxicity . CONCLUSIONS Temozolomide demonstrated modest clinical efficacy , with an acceptable safety profile and measurable improvement in quality of life in patients with recurrent GBM . The use of this drug should be explored further in an adjuvant setting and in combination with other agents The objective was to set the basis for a prospect i ve , multicentre data collection on newly diagnosed adult glioblastoma patients diagnosed in Lombardia by means of a common data base used by neurological and neurosurgical units of various hospitals , providing epidemiological , therapy and follow-up data . All adult patients with a newly diagnosed glioblastoma in 9 Lombardia hospitals from 31 March 2003 to 31 March 2004 were followed prospect ively by a form elaborated by the Lombardia Neuro-oncology Group . Demographic data were recorded , as well as symptoms at onset , entity of tumour resection , post-surgical Karnofsky Performance Score , radio- and chemotherapy , presence/absence of venous thrombosis , type of antiepileptic treatment , time to tumour progression and survival time ( ST ) . One hundred and thirty-four newly diagnosed glioblastoma patients were enrolled during the first year of the study . Male/female ratio was 1.6:1 . Median age was 61 years . The most common single sign/symptom at disease onset included seizures , followed by mood/cognition changes and headache . In 71 patients , the tumour involved 1 brain lobe at diagnosis . Twenty-five patients underwent biopsy , 51 partial removal and 51 grossly total removal . At analysis of predictive value on ST , grossly total resection and chemotherapy were significantly associated with a longer ST . Age younger than 50 showed a trend to predictive value . A very high proportion of patients were treated with antiepileptic drugs , even in the absence of seizures . Median ST was 12 months in our cohort . Data in newly diagnosed glioblastoma patients in Lombardia are in line with other case series reported in other population BACKGROUND Patients with advanced , incurable cancer receiving anticancer treatment often experience multidimensional symptoms . We hypothesize that real-time monitoring of both symptoms and clinical syndromes will improve symptom management by oncologists and patient outcomes . PATIENTS AND METHODS In this prospect i ve multicenter cluster-r and omized phase-III trial , patients with incurable , symptomatic , solid tumors , who received new outpatient chemotherapy with palliative intention , were eligible . Immediately before the weekly oncologists ' visit , patients completed the palm-based E-MOSAIC assessment ( Edmonton-Symptom- Assessment -Scale , ≤3 additional symptoms , estimated nutritional intake , body weight change , Karnofsky Performance Status , medications for pain , fatigue , nutrition ) . A cumulative , longitudinal monitoring sheet ( LoMoS ) was printed immediately . Eligible experienced oncologists were defined as one cluster each and r and omized to receive the immediate print-out LoMoS ( intervention ) or not ( control ) . Primary analysis limited to patients having uninterrupted ( > 4/6 visits with same oncologist ) patient-oncologist sequences was a mixed model for the difference in patients global quality of life ( G-QoL ; items 29/30 of EORTC-QlQ-c30 ) between baseline ( BL ) and week 6 . Intention-to-treat ( ITT ) analysis included all eligible patients . RESULTS In 8 centers , 82 oncologists treated 264 patients ( median 66 years ; overall survival intervention 6.3 , control 5.4 months ) with various tumors . The between-arm difference in G-QoL of 102 uninterrupted patients ( intervention : 55 ; control : 47 ) was 6.8 ( P = 0.11 ) in favor of the intervention ; in a sensitivity analysis ( oncologists treating ≥2 patients ; 50 , 39 ) , it was 9.0 ( P = 0.07 ) . ITT analysis revealed improvement in symptoms ( difference last study visit-BL : intervention -5.4 versus control 2.1 , P = 0.003 ) and favored the intervention for communication and coping . More patients with high symptom load received immediate symptom management ( chart review , nurse-patient interview ) by oncologists getting the LoMoS. CONCLUSION Monitoring of patient symptoms , clinical syndromes and their management clearly reduced patients ' symptoms , but not QoL. Our results encourage the implementation of real-time monitoring in the routine workflow of oncologist with a computer solution This retrospective study of 133 patients with glioblastoma multiforme evaluates survival times post-radiation in patients stratified in respect to age , presenting symptoms , tumour location , extent of surgery , and radiation dose delivered . Presenting features were coded as seizure , loss of consciousness , headache , speech or visual disturbance , weakness and confusion , as were tumour sites within the brain . Other parameters assessed included side of brain , age , extent of surgery and radiation dose . Statistical evaluation was undertaken by univariate and multivariate analyses to identify factors leading to enhanced survival . The median survival post-radiation was 10 months . A trend to improved early survival was demonstrated in patients presenting with acute and debilitating symptoms . The data presented reveals improved outcomes for patients younger than 60 years , particularly if radical surgery is undertaken with higher dose radiation . It is postulated that patients presenting with acute signs and symptoms are investigated earlier and are referred more promptly for treatment Purpose Optimal long-lasting treatment with sunitinib and sorafenib is limited by dose modifications ( DMs ) due to adverse events ( AEs ) . These AEs may be underrecognized and their influence on health-related quality of life ( HRQL ) underestimated . Improved insight into the relationship between AEs and therapy decisions is needed . To improve decision making around managing symptoms and reduce DMs , this study was set up to explore the influence of patient-reported symptoms on therapy decisions . Methods In this multicenter cohort study , patient characteristics , reasons for and different forms of used dose modifications , and AEs were prospect ively obtained from cancer patients on sunitinib/sorafenib treatment . Used instruments to get insight into AEs were the patient-scored Utrecht Symptom Diary ( USD ) and the professional-scored Common Terminology Criteria for AEs version 3.0 . Results Median total treatment duration in 42 patients was 16 weeks . Median time till dose modification was 10 weeks . DMs occurred mostly due to multiple mild AEs . By using the USD , a higher prevalence of most AEs was found compared to the literature . Sixty percent of the patients experienced a decreased HRQL due to multiple AEs . Conclusions Because severe AEs due to sunitinib/sorafenib treatment seldom occur , it is more important to focus on treating and preventing multiple mild AEs with higher impact on HRQL , when trying to avoid dose modifications . Using patient self-reported measurement methods helps to early recognize symptoms and to differentiate among symptom intensities . This systematic approach might help to achieve the optimal dosing , which might improve PFS and OS PURPOSE Temozolomide is a novel oral alkylating agent with demonstrated efficacy as second-line therapy for patients with recurrent anaplastic astrocytoma and glioblastoma multiforme ( GBM ) . This phase II study was performed to determine the safety , tolerability , and efficacy of concomitant radiation plus temozolomide therapy followed by adjuvant temozolomide therapy in patients with newly diagnosed GBM . PATIENTS AND METHODS Sixty-four patients were enrolled onto this open-label , phase II trial . Temozolomide ( 75 mg/m(2)/d x 7 d/wk for 6 weeks ) was administered orally concomitant with fractionated radiotherapy ( 60 Gy total dose : 2 Gy x 5 d/wk for 6 weeks ) followed by temozolomide monotherapy ( 200 mg/m(2)/d x 5 days , every 28 days for six cycles ) . The primary end points were safety and tolerability , and the secondary end point was overall survival . RESULTS Concomitant radiation plus temozolomide therapy was safe and well tolerated . Nonhematologic toxicities were rare and mild to moderate in severity . During the concomitant treatment phase , grade 3 or 4 neutropenia , thrombocytopenia , or both were observed in 6 % of patients , including two severe infections with Pneumocystis carinii . During adjuvant temozolomide , 2 % and 6 % of cycles were associated with grade 3 and 4 neutropenia or thrombocytopenia , respectively . Median survival was 16 months , and the 1- and 2-year survival rates were 58 % and 31 % , respectively . Patients younger than 50 years old and patients who underwent debulking surgery had the best survival outcome . CONCLUSION Continuous daily temozolomide and concomitant radiation is safe . This regimen of concomitant chemoradiotherapy followed by adjuvant chemotherapy may prolong the survival of patients with glioblastoma . Further investigation is warranted , and a r and omized trial is ongoing BACKGROUND Most patients with glioblastoma are older than 60 years , but treatment guidelines are based on trials in patients aged only up to 70 years . We did a r and omised trial to assess the optimum palliative treatment in patients aged 60 years and older with glioblastoma . METHODS Patients with newly diagnosed glioblastoma were recruited from Austria , Denmark , France , Norway , Sweden , Switzerl and , and Turkey
Output:
| Conclusions Eight out of ten of the most prevalent symptoms in glioma patients are related to the central nervous system and therefore specific for glioma .
Our findings emphasize the importance of tailored symptom care for glioma patients and may aid in the development of specific PROMs for glioma patients in different phases of the disease |
MS210566 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND A prospect i ve study was conducted to compare the effect of an anterolateral approach in the supine position ( ALS ) with that of a direct lateral ( DL ) approach on gait motion , including trunk deflection , in walking after total hip arthroplasty . We hypothesized that trunk deflection in walking after ALS would be significantly improved in comparison with use of the DL approach . METHODS The subjects were 15 patients , with 7 in the ALS group and 8 in the DL group . Walking before and 9 and 28 weeks after surgery was analyzed using 3-dimensional motion analysis . RESULTS Walking velocity , stride length , hip joint range of motion in the sagittal plane in walking , and locomotion range of trunk inclination were significantly improved 28 weeks after surgery in both groups . In gait analysis , there were no significant differences between the 2 groups . CONCLUSION This study was conducted to compare the effect of ALS with that of a DL approach on locomotion in walking after total hip arthroplasty . Hip pain at 9 weeks after surgery was significantly improved using ALS compared to the DL approach , but there were no significant differences in gait function at 28 weeks after surgery using ALS or DL approach . Further long-term studies are required to examine differences between these procedures Introduction Minimally invasive total hip arthroplasty ( THA ) is cl aim ed to be superior to the st and ard technique , due to the potential reduction of soft tissue damage via a smaller and tissue-sparing approach . As a result of the lack of objective evidence of fewer muscle and tendon defects , controversy still remains as to whether minimally invasive total hip arthroplasty truly minimizes muscle and tendon damage . Therefore , the objective was to compare the influence of the surgical approach on abductor muscle trauma and to analyze the relevance to postoperative pain and functional recovery . Material s and methods Between June 2006 and July 2007 , 44 patients with primary hip arthritis were prospect ively included in the study protocol . Patients underwent cementless unilateral total hip arthroplasty either through a minimally invasive anterolateral approach ( ALMI ) ( n = 21 ) or a modified direct lateral approach ( mDL ) ( n = 16 ) . Patients were evaluated clinical ly and underwent MR imaging preoperatively and at 3 and 12 months postoperatively . Clinical assessment contained clinical examination , performance of abduction test and the survey of a function score using the Harris Hip Score , a pain score using a numeric rating scale ( NRS ) of 0–10 , as well as a satisfaction score using an NRS of 1–6 . Additionally , myoglobin and creatine kinase were measured preoperatively , and 6 , 24 and 96 h postoperatively . Evaluation of the MRI images included fatty atrophy ( rating scale 0–4 ) , tendon defects ( present/absent ) and bursal fluid collection of the abductor muscle . Results Muscle and tendon damage occurred in both groups , but more lateral gluteus medius tendon defects [ mDL 3/12mth . : 6 (37%)/4 ( 25 % ) ; ALMI : 3 (14%)/2 ( 9 % ) ] and muscle atrophy in the anterior part of the gluteus medius [ mean-st and ard ( 12 ) : 1.75 ± 1.8 ; mean-MIS ( 12 ) : 0.98 ± 1.1 ] were found in patients with the mDL approach . The clinical outcome was also poorer compared to the ALMI group . Significantly , more Trendelenburg ’s signs were evident and lower clinical scores were achieved in the mDL group . No differences in muscle and tendon damage were found for the gluteus minimus muscle . A higher serum myoglobin concentration was measured 6 and 24 h postoperatively in the mDL group ( 6 h : 403 ± 168 μg/l ; 24 h : 304 ± 182 μg/l ) compared to the ALMI group ( 6 h : 331 ± 143 μg/l ; 24 h : 268 ± 145 μg/l ) . Conclusion Abductor muscle and tendon damage occurred in both approaches , but the gluteus medius muscle can be spared more successfully via the minimally invasive approach and is accompanied by a better clinical outcome . Therefore , going through the intermuscular plane , without any detachment or dissection of muscle and tendons , truly minimizes perioperative soft tissue trauma . Furthermore , MRI emerges as an important imaging modality in the evaluation of muscle trauma in THA BACKGROUND Total hip replacement using a minimally invasive surgical approach is cl aim ed to enable recovering of motor function more quickly . The purpose of this prospect i ve As per the stylesheet , kindly provide section headings for abstract . and r and omized study was to test this cl aim by evaluating early patient functional outcomes by gait analysis . METHODS Seventeen patients were operated on using a traditional anterolateral approach ( AL ) , 16 using a minimally invasive direct anterior approach ( DA ) . Gait analysis was performed the day before surgery , and at 6 and 12 weeks after surgery . Time-distance and kinematics analyses were performed by a recently proposed anatomically-based gait analysis protocol . A static double-leg stance and five walking trials at self-selected speeds were recorded on a 9-m walkway . FINDINGS At 6 weeks follow-up , but in the DA group only , a statistically significant improvement with respect to preoperative status was observed for the percentage of single support and for the stride time . Between 6- and 12-week follow-up , the DA group showed a significant improvement in cadence , stride time and length , walking speed , hip flexion at foot contact , maximum hip flexion in swing , and hip total range of motion in the sagittal and the coronal planes . Between 6 and 12 weeks , the AL group showed significant improvements in opposite foot contact and step time , and in flexion at foot contact , maximum flexion in swing , and range of flexion at the hip joint . INTERPRETATION Minimally invasive DA patients improved in a larger number of gait parameters than patients receiving the traditional AL approach . The majority of improvements occurred between the 6- and 12-week follow-ups OBJECTIVE To investigate the differences in gait biomechanics on the basis of surgical approach 1 year after surgery . DESIGN This was a descriptive laboratory study to investigate the side-to-side differences in walking mechanics at a self-selected walking speed as well as a functional assessment 1 year after total hip arthroplasty ( THA ) . Temporospatial , kinetic , and kinematic data as well as functional outcomes were collected . Two-way analysis of variance was used to assess for between-group differences and limb-to-limb asymmetries . SETTING A controlled laboratory study . PARTICIPANTS This study examined 35 patients with primary , unilateral THA . The THA surgical approaches that were used in these patients included 12 direct lateral , 18 posterior , and 11 anterolateral . All the patients were assessed 1 year after THA . Patients were excluded from the study if they had contralateral hip pain or pathology , or any prior lower extremity total joint replacements . MAIN OUTCOME MEASUREMENTS Three-dimensional lower extremity kinematics and kinetics as well as spatiotemporal variables were collected . In addition , a series of physical performance measures were collected . RESULTS No main effects for the physical performance measures or biomechanical variables were observed among the approach groups . Significant limb-to-limb asymmetries were observed among all the patients , with decreased sagittal plane range of motion , peak extension , and peak vertical ground reaction forces on the operative side . CONCLUSION The results of this study indicated that no significant differences existed among the different surgical approach groups for any study variable . However , 1 year after THA , the patients demonstrated asymmetric gait patterns regardless of surgical approach , which indicated the potential need for continued intervention through physical therapy to regain normal side-to-side symmetry after THA This study examined the effect of the surgical approach used in total hip arthroplasty ( THA ) on gait mechanics six months following surgery . Quantitative gait analysis was performed on 29 subjects : 10 anterolateral ( A-L ) and 10 posterolateral ( P-L ) THA patients and nine able-bodied , velocity-matched subjects . Discriminant function analysis was used to determine the distinction of the groups with respect to sagittal plane hip range of motion , index of symmetry , trunk inclination , pelvic drop , hip abduction , and foot progression angles . The A-L group had the largest trunk inclination ( 3.0+/-2.4 degrees ) and the smallest hip range of motion ( 34.0+/-7.4 degrees ) . Both THA groups demonstrated greater asymmetry as expressed by the smaller symmetry index ( 0.97+/-0.04 for A-L and 0.98+/-0.05 for the P-L ) than the able-bodied group ( 0.99+/-0.01 ) . The classification procedure correctly classified 89 % of the control group cases , 90 % of the A-L cases , and 50 % of the P-L cases . These results support the conclusion that six months following surgery , the gait of the majority ( 85 % ) of THA patients has not returned to normal . The A-L patients displayed distinct gait patterns , while a small percentage ( 30 % ) of the P-L patients demonstrated normal gait . While these differences are statistically significant , the clinical significance is unknown and linked to the duration that they persist BACKGROUND Minimally invasive total hip arthroplasty is purported to allow an improved and faster rehabilitation in the immediate postoperative period because of reduced soft-tissue damage compared with total hip arthroplasty performed with use of a st and ard approach . In the present study , a minimally invasive approach was compared with a traditional st and ard approach in terms of the effect on gait kinematics as demonstrated with gait analysis and electromyography . METHODS Twenty r and omized patients who underwent a primary total hip replacement with use of a minimally invasive modified Watson-Jones approach ( minimally invasive group ) were compared with a group of twenty patients who underwent a total hip arthroplasty with use of a st and ard transgluteal Hardinge approach ( st and ard group ) . All patients received the same cementless implant , inserted with use of st and ard instruments , and all operations were performed by a single , experienced surgeon . The patients were evaluated with use of three-dimensional gait analysis and dynamic electromyograms at three time points : preoperatively , ten days postoperatively , and twelve weeks postoperatively . Temporospatial and joint-kinematic parameters were evaluated . RESULTS There were no significant differences between the two groups with regard to the temporospatial variables of velocity , cadence , step length , and stride length at any tested time point . With regard to the range of motion of the operatively treated hip , the minimally invasive group had a smaller decrease at the ten-day time point in comparison with the st and ard group . However , this finding was not significant . The reduction in the range of motion was mainly caused by reduced hip extension . A compensatory increase in the pelvic tilt was observed in both groups . One patient in the st and ard group showed a positive Trendelenburg gait ten days postoperatively ; it had disappeared completely at the twelve-week time point . CONCLUSIONS With regard to gait kinematics in the early postoperative period ( three months ) , the present study showed no significant benefit for patients who underwent a total hip arthroplasty through a minimally invasive Watson-Jones approach in comparison with those who were managed with a st and ard transgluteal approach Purported advantages of total hip arthroplasty performed with minimally invasive surgical ( MIS ) approaches are less muscle damage and faster recovery . There are little data scientifically evaluating these cl aims . Twenty-four consecutive hips were r and omized to total hip arthroplasty through 1 of 3 MIS approaches ( 2-incision , mini-posterior , and mini-anterolateral ) . Each patient underwent preoperative and postoperative gait analysis . Gait parameters included vertical ground reaction force , velocity , single-leg stance time , limb-loading rate , and abductor torque . All 3 groups demonstrated overall improvements in gait parameters at 6 weeks postoperatively . The anterolateral approach patients showed a decrease in the vertical ground reaction force at mid-stance , whereas the 2-incision and posterior approaches demonstrated no significant change . These results fail to demonstrate any significant advantage of the 2-incision approach over the posterior approach in kinetic gait parameters . Furthermore , the anterolateral approach demonstrates a gait pattern consistent with abductor muscle injury in the early recovery period , despite the MIS approach AIM Different surgical approaches are used in total hip arthroplasty . The present study confronted two surgical techniques , analysing functional recovery in terms of activities of daily living , and ambulation using gait analysis , after a st and ardized rehabilitation protocol . Our hypothesis was that the increased surgical damage could modify the gait pattern and functional recovery . METHODS Thirty patients were r and omly assigned to two homogeneous groups : Group A was treated with intermuscular minimally invasive surgery ( MIS ) ; Group B was treated with st and ard lateral transmuscular approach . Follow up was planned at 30 and 90 days . Instrumental evaluation using gait analysis and functional evaluation using vali date d scales were performed at follow up . RESULTS No differences could be found as for functional scales . At the first follow up , the MIS approach proved to be the most favourable : data showed a longer duration of the swing phase , an improved range of motion of the non-treated hip , a reduced adduction ( all P<0.005 ) and a correct timing of activation of the gluteus medium muscle on the treated side . At the second evaluation , gait analysis demonstrated some benefits of the intermuscular approach ( a better flexion of both hips , and a minor obliquity of the pelvis during the terminal stance ) , but also advantages in the transmus
Output:
| Conclusions In this meta- analysis , gait speed and peak hip flexion within 3 months after surgery were significantly higher in the DAA group than in the ALA group . |
MS210567 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: We have genotyped 14,436 nonsynonymous SNPs ( nsSNPs ) and 897 major histocompatibility complex ( MHC ) tag SNPs from 1,000 independent cases of ankylosing spondylitis ( AS ) , autoimmune thyroid disease ( AITD ) , multiple sclerosis ( MS ) and breast cancer ( BC ) . Comparing these data against a common control data set derived from 1,500 r and omly selected healthy British individuals , we report initial association and independent replication in a North American sample of two new loci related to ankylosing spondylitis , ARTS1 and IL23R , and confirmation of the previously reported association of AITD with TSHR and FCRL3 . These findings , enabled in part by increased statistical power result ing from the expansion of the control reference group to include individuals from the other disease groups , highlight notable new possibilities for autoimmune regulation and suggest that IL23R may be a common susceptibility factor for the major ' seronegative ' diseases Objective . Ankylosing spondylitis ( AS ) is characterized by chronic inflammation leading to ankylosis , but also to low bone mineral density ( BMD ) and vertebral fractures ( VFx ) . Treatment with tumor necrosis factor-α blockers decreases inflammation and has shown to be effective in increasing BMD . We studied the effects of etanercept ( ETN ) on BMD and VFx in patients with AS after 2 years of treatment . Further , we studied changes in bone turnover markers and radiological damage . Methods . Patients with active AS , treated with ETN for 2 years , were included . BMD lumbar spine and hip were measured at baseline and after 2 years , as well as radiological damage ( modified Stoke Ankylosing Spondylitis Spinal Score with the addition of the thoracic spine ) , VFx ( Genant method ) , and change in bone turnover markers . Results . Forty-nine patients with AS were included . After 2 years of ETN , hip BMD increased by 2.2 % ( p = 0.014 ) and lumbar spine BMD by 7.0 % ( p < 0.001 ) . The Bath Ankylosing Spondylitis Disease Activity Index decreased significantly ( p < 0.001 ) , as well as C-reactive protein and erythrocyte sedimentation rate ( p < 0.001 ) . Despite ETN therapy , the number of patients with VFx more than doubled ( from 6 to 15 patients , p = 0.003 ) . Also , the radiological damage increased significantly over time ( from 12.1 to 18.5 , p < 0.001 ) ; however , no significant change in bone turnover markers was found . Conclusion . This prospect i ve longitudinal observational cohort study showed that after 2 years of ETN , BMD of the hip and spine increased significantly , but the number of patients with VFx and the severity of VFx increased as well . Besides that , radiological progression , including the thoracic spine , increased significantly . Thus , the favorable bone-preserving effect is accompanied by unfavorable outcomes on VFx and radiological damage OBJECTIVE To determine the changes in body weight , body composition , and bone density in patients with spondyloarthropathy ( SpA ) receiving anti-tumor necrosis factor-alpha ( TNF-alpha ) treatment . METHODS One hundred six patients with SpA ( 80 men , 26 women ) aged 20 - 71 years were included in a 2-year prospect i ve open study . Fifty-nine patients received infliximab ( 3 or 5 mg/kg/infusion each 6 or 8 weeks ) ; and 47 patients received etanercept ( 25 mg twice a week ) because of persistent active disease despite an optimal treatment , according to ASsessment s in Ankylosing Spondylitis Working Group criteria . Body weight , total body composition ( lean mass , fat mass ) , and spine and femoral bone mineral density ( BMD ; dual-energy x-ray absorptiometry ) were measured at baseline and at 1 and 2 years . RESULTS There was a significant increase in body weight after 1 year ( 2.2 + /- 3.9 kg , i.e. , 3.4 % ; p < 0.0001 ) and 2 years ( 2.2 + /- 4.7 kg , 3.5 % ; p < 0.0001 ) , mostly due to a significant gain in fat mass at 1 year ( 1.4 + /- 2.6 kg , 12.1 % ; p < 0.0001 ) and 2 years ( 1.5 + /- 3.1 kg , 14.5 % , p < 0.0001 ) . Gain in lean mass was also significant at 1 year ( 0.8 + /- 2.2 kg , 1.9 % ; p < 0.0001 ) and 2 years ( 0.9 + /- 2.5 kg , 2 % ; p < 0.0001 ) . At 2 years , lumbar spine and femur BMD increased : + 5.8 + /- 13 % ( p < 0.0001 ) and + 2.26 + /- 4.5 % ( p = 0.001 ) , respectively . CONCLUSION This 2-year prospect i ve study showed a significant increase in body weight at 1 year and 2 years , mostly due to a gain in fat mass and a significant increase in BMD , in patients with SpA receiving anti-TNF-alpha treatment BACKGROUND Ankylosing spondylitis is a chronic immune-mediated inflammatory disease characterised by spinal inflammation , progressive spinal rigidity , and peripheral arthritis . Interleukin 17 ( IL-17 ) is thought to be a key inflammatory cytokine in the development of ankylosing spondylitis , the prototypical form of spondyloarthritis . We assessed the efficacy and safety of the anti-IL-17A monoclonal antibody secukinumab in treating patients with active ankylosing spondylitis . METHODS We did a r and omised double-blind proof-of-concept study at eight centres in Europe ( four in Germany , two in the Netherl and s , and two in the UK ) . Patients aged 18 - 65 years were r and omly assigned ( in a 4:1 ratio ) to either intravenous secukinumab ( 2 × 10 mg/kg ) or placebo , given 3 weeks apart . R and omisation was done with a computer-generated block r and omisation list without a stratification process . The primary efficacy endpoint was the percentage of patients with a 20 % response according to the Assessment of SpondyloArthritis international Society criteria for improvement ( ASAS20 ) at week 6 ( Bayesian analysis ) . Safety was assessed up to week 28 . This study is registered with Clinical Trials.gov , number NCT00809159 . FINDINGS 37 patients with moderate-to-severe ankylosing spondylitis were screened , and 30 were r and omly assigned to receive either intravenous secukinumab ( n=24 ) or placebo ( n=6 ) . The final efficacy analysis included 23 patients receiving secukinumab and six patients receiving placebo , and the safety analysis included all 30 patients . At week 6 , ASAS20 response estimates were 59 % on secukinumab versus 24 % on placebo ( 99·8 % probability that secukinumab is superior to placebo ) . One serious adverse event ( subcutaneous abscess caused by Staphylococcus aureus ) occurred in the secukinumab-treated group . INTERPRETATION Secukinumab rapidly reduced clinical or biological signs of active ankylosing spondylitis and was well tolerated . It is the first targeted therapy that we know of that is an alternative to tumour necrosis factor inhibition to reach its primary endpoint in a phase 2 trial . FUNDING Novartis Introduction The aim of this study was to investigate the effect of three years of tumor necrosis factor-alpha ( TNF-α ) blocking therapy on bone turnover as well as to analyze the predictive value of early changes in bone turnover markers ( BTM ) for treatment discontinuation in patients with ankylosing spondylitis ( AS ) . Methods This is a prospect i ve cohort study of 111 consecutive AS out patients who started TNF-α blocking therapy . Clinical assessment s and BTM were assessed at baseline , three and six months , as well as at one , two , and three years . Z-scores of BTM were calculated to correct for age and gender . Bone mineral density ( BMD ) was assessed yearly . Results After three years , 72 patients ( 65 % ) were still using their first TNF-α blocking agent . In these patients , TNF-α blocking therapy result ed in significantly increased bone-specific alkaline phosphatase , a marker of bone formation ; decreased serum collagen-telopeptide ( sCTX ) , a marker of bone resorption ; and increased lumbar spine and hip BMD compared to baseline . Baseline to three months decrease in sCTX Z-score ( HR : 0.394 , 95 % CI : 0.263 to 0.591 ) , AS disease activity score ( ASDAS ; HR : 0.488 , 95 % CI : 0.317 to 0.752 ) , and physician 's global disease activity ( HR : 0.739 , 95 % CI : 0.600 to 0.909 ) were independent inversely related predictors of time to treatment discontinuation because of inefficacy or intolerance . Early decrease in sCTX Z-score correlated significantly with good long-term response regarding disease activity , physical function and quality of life . Conclusions Three years of TNF-α blocking therapy results in a bone turnover balance that favors bone formation , especially mineralization , in combination with continuous improvement of lumbar spine BMD . Early change in sCTX can serve as an objective measure in the evaluation of TNF-α blocking therapy in AS , in addition to the currently used more subjective measures OBJECTIVE To study the effect of tumor necrosis factor α ( TNFα ) inhibitors on progressive spinal damage in patients with ankylosing spondylitis ( AS ) . METHODS All AS patients meeting the modified New York criteria who had been monitored prospect ively and had at least 2 sets of spinal radiographs a minimum of 1.5 years apart were included in the study ( n=334 ) . The patients received st and ard therapy , which included nonsteroidal antiinflammatory drugs and TNFα inhibitors . Radiographic severity was assessed by the modified Stoke Ankylosing Spondylitis Spine Score ( mSASSS ) . Patients with a rate of AS progression that was ≥1 mSASSS unit/year were considered progressors . Univariable and multivariable regression analyses were done . Propensity score matching and sensitivity analysis were performed . A zero-inflated negative binomial ( ZINB ) model was used to analyze the effect of TNFα inhibitors on the change in the mSASSS with varying followup periods . Potential confounders , such as disease activity ( as assessed by the Bath Ankylosing Spondylitis Disease Activity Index ) , the erythrocyte sedimentation rate , C-reactive protein level , HLA-B27 positivity , sex , age at onset , smoking burden ( number of pack-years ) , and baseline damage , were included in the model . RESULTS TNFα inhibitor treatment was associated with a 50 % reduction in the odds of progression , with an odds ratio ( OR ) of 0.52 ( 95 % confidence interval [ 95 % CI ] 0.30 - 0.88 , P=0.02 ) . Patients with a delay of > 10 years in starting therapy were more likely to experience progression as compared to those who started earlier ( OR 2.4 [ 95 % CI 1.09 - 5.3 ] , P=0.03 ) . In the ZINB model , the use of TNFα inhibitors significantly reduced disease progression when the gap between radiographs was > 3.9 years . The protective effect of TNFα inhibitors was stronger after propensity score matching . CONCLUSION Treatment with TNFα inhibitors appears to reduce radiographic progression in AS patients , especially with early initiation and with longer duration of followup Objective . To evaluate the effect of anti-tumor necrosis factor ( TNF ) therapy on bone mineral density ( BMD ) in patients with active ankylosing spondylitis ( AS ) with low BMD . Methods . Eighty-nine patients with active AS with low BMD were r and omly divided into either a study group or a control group . The study group received etanercept ( 50 mg/week ) or adalimumab ( 40 mg/2 week ) subcutaneously for 1 year . BMD of lumbar spine and femoral neck was measured by dual energy X-ray absorptiometry , and bone turnover markers serum C telopeptide of type-I collagen ( sCTX ) and serum procollagen type-I N propeptide ( PINP ) were detected by ELISA at baseline and at end of study . Results . After 1 year , compared with baseline , there was a significant increase in spine and femoral neck BMD by a mean ± SD of 14.9 % ± 15.6 % ( p < 0.0001 ) and 4.7 % ± 7.9 % ( p < 0.0001 ) in the study group . In the control group , there was a significant decrease in spine and femoral neck BMD by a mean ± SD of −8.6 % ± 9.7 % ( p < 0.0001 ) and −9
Output:
| Summary TNFi therapy improves bone density but not vertebral fracture rates .
Secukinumab improves symptoms and may slow radiographic progression .
Data is lacking regarding the effects of secukinumab on BMD and fractures . |
MS210568 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Nicor and il in conjunction with percutaneous coronary intervention ( PCI ) has been reported to reduce reperfusion injury events and improve cardiac function in patients with acute myocardial infa rct ion ( AMI ) . This multicenter study was undertaken to determine the effectiveness and optimal administration of nicor and il in AMI patients . METHODS AND RESULTS Ninety-two patients with first AMI were r and omly assigned to 1 of 3 groups : intracoronary administration of nicor and il ( Group A ) , combined intravenous and intracoronary administration of nicor and il ( Group B ) , and no nicor and il administration ( Group C ) . The primary endpoint was a composite of the incidence of reperfusion-induced arrhythmia , chest pain , and no-reflow/slow-reflow . The secondary endpoint was the combined rate of improvement in the Thrombolysis in Myocardial Infa rct ion frame count ( cTFC ) and ST resolution ( STR ) . A significant difference was observed in the primary endpoint for Group B as compared with Group C ( p<0.05 ) . In the meantime , a significant improvement was shown in the secondary endpoint for Group B compared with Group C ( p=0.04 and 0.006 for cTFC and STR , respectively ) . CONCLUSIONS Combined intravenous and intracoronary administration of nicor and il reduces reperfusion injury during PCI and improves the cTFC and STR in AMI , and appears to be preferable to intracoronary administration alone A major limitation of the rotational atherectomy ( RA ) procedure is the occurrence of the no-reflow/slow flow phenomenon and the optimal strategy is still evolving . Recent clinical studies have demonstrated the beneficial effects of nicor and il , an adenosine triphosphate (ATP)-sensitive potassium channel opener , on no-reflow in patients with acute myocardial infa rct ion . The purpose of this study was to evaluate the effect of nicor and il on no-reflow/slow flow phenomenon during RA procedures . Sixty-one patients who underwent RA of complex coronary lesions were r and omly divided into 2 groups : ( i ) nicor and il cocktail ( n=24 patients , 37 lesions ) and ( ii ) verapamil cocktail ( n=37 patients , 63 lesions ) . In each group , the drug cocktail mixed with pressurized saline was infused through the 4Fr Teflon sheath of the rotablator system during the RA procedure . In the nicor and il group , the drug cocktail consisted of 24 mg of nicor and il , 5 mg of nitroglycerin , and 10,000 U of heparin . In the verapamil group , the drug cocktail consisted of 10 mg of verapamil , 5 mg of nitroglycerin , and 10,000 U of heparin . Baseline and procedure characteristics did not differ between the 2 groups . RA was performed successfully , and death , Q-wave myocardial infa rct ion , or emergency coronary artery bypass surgery did not occur in any patients . The no-reflow/slow flow phenomenon was observed in 11/63 ( 17.4 % ) lesions of the verapamil group , but in only 1/37 ( 2.7 % ) lesions of the nicor and il group ( p=0.03 ) . No untoward complications were observed during nicor and il infusion . These data indicate that the intracoronary continuous infusion of nicor and il during RA procedures is easy and safe , and prevents no-reflow/slow flow phenomenon more effectively than infusion of verapamil BACKGROUND The objectives of this study were to evaluate the incidence of no-reflow as independent predictor of adverse events and to assess whether baseline pre-procedural treatment options may affect clinical outcomes . METHODS Data were derived from the ISACS-TC registry ( NCT01218776 ) from October 2010 to January 2015 . No-reflow was defined as post-PCI TIMI flow grade s 0 - 1 , in the absence of post-procedural significant ( ≥25 % ) residual stenosis , abrupt vessel closure , dissection , perforation , thrombus of the original target lesion , or epicardial spasm . The outcome measure was in-hospital mortality . RESULTS No-reflow was identified in 128 of 5997 patients who have undergone PCI ( 2.1 % ) . On multivariate analysis , patients with no-reflow were more likely to be older ( OR : 1.20 , 95 % CI : 1.01 - 1.44 ) , to have a history of hypercholesterolemia ( OR : 1.95 , 95 % CI : 1.31 - 2.91 ) and to be admitted with a diagnosis of STEMI ( OR : 2.96 , 95 % CI : 1.85 - 4.72 ) . Angiographic characteristics associated with no-reflow phenomenon were : stenosis ≥50 % of the right coronary artery , presence of multivessel disease and pre-procedural TIMI blood flow grade s 0 - 1 . No-reflow was highly predictive of in-hospital mortality ( 17.2 % vs. 4.2 % ; adjusted OR : 4.60 , 95 % CI : 2.61 - 8.09 ) . Administration of pre-procedural unfractioned heparin or 600 mg clopidogrel loading dose was associated with less incidence of no-reflow ( OR : 0.65 , 95 % CI : 0.43 - 0.99 and 0.61 , 95 % CI : 0.37 - 1.00 , respectively ) . Aspirin , enoxaparin , and 300 mg clopidogrel loading dose , did not significantly impact the occurrence of the no-reflow . CONCLUSIONS We found that pre-procedural administration of 600 mg loading dose of clopidogrel and /or unfractioned heparin is associated with reduced incidence of no-reflow OBJECTIVE Stress hyperglycemia increases the risk of mortality and poor outcomes in patients with acute myocardial infa rct ion ( AMI ) . We aim ed to assess effects of intravenous nicor and il administered before reperfusion on AMI patients with stress hyperglycemia . RESEARCH DESIGN AND METHODS This study consisted of 158 consecutive first AMI patients with stress hyperglycemia who underwent percutaneous coronary intervention ( PCI ) within 24 h from the onset . They were r and omly assigned to receive 12 mg of nicor and il ( n = 81 ) or a placebo ( n = 77 ) intravenously just before reperfusion . Stress hyperglycemia was defined as a blood glucose level > or = 10 mmol/l ( 180 mg/dl ) . We examined various aspects of epicardial flow and microvascular function as immediate data and major adverse cardiac events ( MACEs ) ( coronary heart disease death or unplanned readmission due to congestive heart failure ) as late-phase data . RESULTS The incidence of slow flow after PCI was lower in the nicor and il group ( 13.6 vs. 27.3 % , P < 0.04 ) . ST segment resolution > 50 % was observed in 70.4 and 53.2 % on nicor and il and placebo , respectively ( P < 0.03 ) . Patients treated with nicor and il had a lower peak creatine kinase level ( 3,137 + /- 2,577 vs. 4,333 + /- 3,608 , P < 0.02 ) . Upon Kaplan-Meier analysis , 5 years ' freedom from MACEs was 86.4 % in the nicor and il group and 74.0 % in the placebo ( P < 0.05 ) . CONCLUSIONS Adjunctive therapy with administration of intravenous nicor and il before reperfusion on AMI patients with stress hyperglycemia significantly improves epicardial flow and prevents the occurrence of severe microvascular reperfusion injury , result ing in better outcomes in these patients Nicor and il , an adenosine triphosphate – sensitive potassium channel opener , reduces plasma norepinephrine concentration in patients with ischemic heart disease . However , long-term effects on cardiac sympathetic nerve activity ( CSNA ) as evaluated by 123I-metaiodobenzylguanidine ( MIBG ) scintigraphy have not been determined for patients with acute myocardial infa rct ion ( AMI ) . Methods : We studied 40 patients with their first AMI who were treated with intravenous nicor and il before and after primary coronary angioplasty . After suspension of the initial intravenous nicor and il treatment , 20 patients were r and omized to receive oral nicor and il ( 15 mg/d ) ( group A ) and the other 20 patients received a placebo ( group B ) . All patients were also treated with an angiotensin-converting enzyme ( ACE ) inhibitor or β-blockers . The delayed heart-to-mediastinum count ratio ( H/M ratio ) , delayed total defect score ( TDS ) , and washout rate ( WR ) were determined from 123I-MIBG scintigraphy 3 wk and 6 mo after angioplasty . The left ventricular ( LV ) end-diastolic volume ( EDV ) , LV end-systolic volume ( ESV ) , and LV ejection fraction ( EF ) were determined by contrast left ventriculography , whereas plasma procollagen type III amino-terminal peptide ( PIIINP ) concentrations were also measured at the same time points . Results : Three weeks after angioplasty , TDS , H/M ratios , WR , LVEDV , LVESV , and LVEF were similar in both groups . After 6 mo , all of these parameters had improved in both groups . However , the extent of change in TDS was −9 ± 6 in group A and −5 ± 6 in group B ( P < 0.05 ) , whereas that in the H/M ratio was 0.15 ± 0.13 and 0.07 ± 0.11 ( P < 0.05 ) and that in the WR was −12 % ± 8 % and −5 % ± 11 % ( P < 0.05 ) . The extent of change in LVEDV , LVESV , and LVEF in group A tended to exceed that in group B , but these changes were not statistically significant . We found significant correlations between the percent change in PIIINP and that of TDS from baseline to 6 mo in group A ( r = 0.456 , P < 0.05 ) . Conclusion : Long-term nicor and il therapy can be more beneficial for CSNA and LV remodeling than short-term therapy in patients with AMI Background It has been reported that nicor and il restores blood flow to reperfused myocardium in patients with acute myocardial infa rct ion . However , whether nicor and il might decrease infa rct size remains unclear . The aim of this study was to assess the effect of nicor and il on infa rct size with thallium-201/ ® -methyl-p-iodophenyl pentadecanoic acid ( BMI PP ) dual-isotope single photon emission computed tomography . Methods A total of 62 patients were r and omly assigned to receive intravenous nicor and il ( 4 mg in 5 minutes at admission , immediately followed by 6mg/hr over a 24-hour period ) or placebo . All patients were divided into 4 groups : Group N-a , 16 patients with preexisting angina treated with nicor and il ; N-b , 15 patients without preexisting angina treated with nicor and il ; Ca , 14 patients with preexisting angina given placebo ; C-b , 17 patients without preexisting angina given placebo . Tl-201/ BMI PP imaging was performed in the 62 patients within 7 days after admission . Dual-isotope single photon emission computed tomographic images were quantified by severity index with a polar map . Results The BMI PP severity index was similar among the 4 groups . Only the thallium severity index in the N-a group was significantly less ( P < .05 ) . The ratio of the thallium severity index to that of BMI PP in the N-a group was significantly decreased compared with those of the other groups . Conclusion Nicor and il has a protective effect in patients with acute myocardial infa rct ion and preexisting angina treated with primary balloon angioplasty BACKGROUND Intravenous nicor and il infusion with percutaneous coronary intervention ( PCI ) has been reported to reduce reperfusion injury events and improve cardiac function in patients with acute myocardial infa rct ion ( MI ) . However , there is limited information on the use of intracoronary nicor and il . METHODS AND RESULTS In the present study , 73 patients with acute ST segment elevation MI undergoing PCI were r and omly assigned to the Nicor and il Group ( n=37 ) or the Control Group ( n=36 ) . The composite endpoints were the incidences of ventricular arrhythmia , no-reflow and slow flow . A significant difference in the composite endpoint was observed in the Nicor and il Group when compared with the Control Group ( p=0.037 ) . The occurrence of post Thrombolysis In Myocardial Infa rct ion ( TIMI ) grade 3 was significantly higher in the Nicor and il Group ( p=0.019 ) . Major adverse cardiac events during hospitalization and within 30 days of treatment were similar between the 2 groups . CONCLUSION Administration of intracor
Output:
| Conclusions Nicor and il can improve coronary microcirculation and left ventricular function of patients with AMI after PCI .
Interestingly , female patients may benefit more from nicor and il than male patients in improving heart function |
MS210569 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Objective To study the effect of an incident wrist fracture on functional status in women enrolled in the Study of Osteoporotic Fractures . Design Prospect i ve cohort study . Setting Baltimore , Minneapolis , Portl and , and the Monongahela valley in Pennsylvania , USA Participants 6107 women aged 65 years and older without previous wrist or hip fracture recruited from the community between September 1986 and October 1988 . Main outcome measure Clinical ly important functional decline , defined as a functional deterioration of 5 points in five activities of daily living each scored from 0 to 3 ( equivalent to one st and ard deviation decrease in functional ability ) . Results Over a mean follow-up of 7.6 years , 268 women had an incident wrist fracture and 41 ( 15 % ) of these developed clinical ly important functional decline . Compared with women without wrist fractures , those with incident wrist fractures had greater annual functional decline after adjustment for age , body mass index , and health status . Occurrence of a wrist fracture increased the odds of having a clinical ly important functional decline by 48 % ( odds ratio 1.48 , 95 % confidence interval 1.04 to 2.12 ) , even after adjustment for age , body mass index , health status , baseline functional status , lifestyle factors , comorbidities , and neuromuscular function . Conclusions Wrist fractures contribute to clinical ly important functional decline in older women BACKGROUND There are relatively few studies in the literature that specifically evaluate accelerated rehabilitation protocol s for distal radial fractures treated with open reduction and internal fixation ( ORIF ) . The purpose of this study was to compare the early postoperative outcomes ( at zero to twelve weeks postoperatively ) of patients enrolled in an accelerated rehabilitation protocol with those of patients enrolled in a st and ard rehabilitation protocol following ORIF for a distal radial fracture . We hypothesized that patients with accelerated rehabilitation after volar ORIF for a distal radial fracture would have an earlier return to function compared with patients who followed a st and ard protocol . METHODS From November 2007 to November 2010 , eighty-one patients with an unstable distal radial fracture were prospect ively r and omized to follow either an accelerated or a st and ard rehabilitation protocol after undergoing ORIF with a volar plate for a distal radial fracture . Both groups began with gentle active range of motion at three to five days postoperatively . At two weeks , the accelerated group initiated wrist/forearm passive range of motion and strengthening exercises , whereas the st and ard group initiated passive range of motion and strengthening at six weeks postoperatively . Patients were assessed at three to five days , two weeks , three weeks , four weeks , six weeks , eight weeks , twelve weeks , and six months postoperatively . Outcomes included Disabilities of the Arm , Shoulder and H and ( DASH ) scores ( primary outcome ) and measurements of wrist flexion/extension , supination , pronation , grip strength , and palmar pinch . RESULTS The patients in the accelerated group had better mobility , strength , and DASH scores at the early postoperative time points ( zero to eight weeks postoperatively ) compared with the patients in the st and ard rehabilitation group . The difference between the groups was both clinical ly relevant and statistically significant . CONCLUSIONS Patients who follow an accelerated rehabilitation protocol that emphasizes motion immediately postoperatively and initiates strengthening at two weeks after volar ORIF of a distal radial fracture have an earlier return to function than patients who follow a more st and ard rehabilitation protocol . LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence OBJECTIVE To examine the relative effectiveness of ice therapy and /or pulsed electromagnetic field in reducing pain and swelling after the immobilization period following a distal radius fracture . METHODS A total of 83 subjects were r and omly allocated to receive 30 minutes of either ice plus pulsed electromagnetic field ( group A ) ; ice plus sham pulsed electromagnetic field ( group B ) ; pulsed electromagnetic field alone ( group C ) , or sham pulsed electromagnetic field treatment for 5 consecutive days ( group D ) . All subjects received a st and ard home exercise programme . A visual analogue scale was used for recording pain ; volumetric displacement for measuring the swelling of the forearm ; and a h and -held goniometer for measuring the range of wrist motions before treatment on days 1 , 3 and 5 . RESULTS At day 5 , a significantly greater cumulative reduction in the visual analogue scores as well as ulnar deviation range of motion was found in group A than the other 3 groups . For volumetric measurement and pronation , participants in group A performed better than subjects in group D but not those in group B. CONCLUSION The addition of pulsed electromagnetic field to ice therapy produces better overall treatment outcomes than ice alone , or pulsed electromagnetic field alone in pain reduction and range of joint motion in ulnar deviation and flexion for a distal radius fracture after an immobilization period of 6 weeks Fractures of the proximal humerus , forearm , and wrist account for approximately one third of total osteoporotic fractures in the elderly . Several risk factors for these fractures were evaluated in this prospect i ve study of 739 men and 1,105 women aged > or = 60 years in Dubbo , Australia . During follow-up ( 1989 - 1996 ) , the respective incidences of humerus and of forearm and wrist fractures , per 10,000 person-years , were 22.6 and 33.8 for men and 54.8 and 124.6 for women . Independent predictors of humerus fracture were femoral neck bone mineral density ( FNBMD ) ( relative risk ( RR ) = 2.3 , 95 % confidence interval ( CI ) : 1.2 , 4.5 ) in men and FNBMD ( RR = 2.4 , 95 % CI : 1.7 , 3.5 ) and height loss ( RR = 1.1 , 95 % CI : 1.0 , 1.2 ) in women . For forearm and wrist fractures , risk factors were FNBMD ( men : RR = 1.5 , 95 % CI : 1.0 , 2.3 ; women : RR = 1.5 , 95 % CI : 1.2 , 1.9 ) and height loss ( men : RR = 1.2 , 95 % CI : 1.0 , 1.3 ; women : RR = 1.1 , 95 % CI : 1.0 , 1.2 ) . In addition , dietary calcium ( men : RR = 2.0 , 95 % CI : 1.0 , 3.6 ) and a history of falls ( women : RR = 1.9 , 95 % CI : 1.4 , 2.6 ) were also significant . These data suggest that elderly men and women largely share common risk factors for upper limb fractures and that FNBMD is the primary risk factor Background Distal radius fractures are among the most common fractures and account for approximately one-sixth of all fractures diagnosed . Therapy results after distal radius fracture , especially of elderly patients , are often suboptimal . The inevitable immobilization for several weeks leads to reduction in range of motion , deterioration of muscle strength , malfunction of fine motor skills as well as changes of motor and sensory representations in the brain . Currently , there are no strategies to counteract these immobilization problems . The overall aim of the study is to investigate the therapeutic potential of motor-cognitive approaches ( mental practice or mirror therapy ) on h and function after wrist fracture . Methods / Design This study is a controlled , r and omized , longitudinal intervention study with three intervention groups . One experimental group imagines movements of the fractured upper extremity without executing them ( mental practice ) . The second experimental group receives a mirror therapy program consisting of the performance of functional movement synergies using the unaffected forearm , wrist , and h and . The control group completes a relaxation training regime . Additionally , all patients receive usual care by the general practitioner . We include women aged 60 years and older having a distal radius fracture and sufficient cognitive function . All groups are visited at home for therapy sessions 5 times per week for the first 3 weeks and 3 times per week for weeks 4 to 6 . Measurements are taken at therapy onset , and after 3 , 6 and 12 weeks . The primary outcome measure will assess upper extremity functioning ( Patient-Rated Wrist Evaluation [ PRWE ] ) , while secondary outcome measures cover subjective wrist function ( Disabilities of the Arm and Shoulder ; [ DASH ] , objective impairment ( range of motion , grip force ) and quality of life ( EuroQol-5D , [ EQ5D ] ) . Discussion Results from this trial will contribute to the evidence on motor-cognitive approaches in the early therapy of distal radius fractures . Trial registration The trial is registered at Clinical Trials.gov with registration number NCT01394809 and was granted permission by the Medical Ethical Review Committee of the University of Tübingen in June 2011 Abstract Colles ’ fracture patients who received physiotherapy immediately following cast removal were compared with patients who received no active therapy following cast removal in a prospect i ve r and omised study . Patients who attended physiotherapy achieved significantly greater increases in wrist extension and grip strength after 6 weeks compared to patients who received no active therapy OBJECTIVES to describe changes in physical functioning after fall-related injuries to the limbs in independently living older people . DESIGN prospect i ve cohort study , including a pre-injury assessment and post-injury assessment s at 8 weeks and 5 and 12 months . SETTING the study is part of the larger , population -based prospect i ve and longitudinal Groningen Longitudinal Aging Study on the determinants of health-related quality of life of people aged 57 and over , who are living independently in the north of the Netherl and s. SUBJECTS 171 patients who sustained injuries at various sites on the limbs and who had completed all four assessment s ( 66 % of the eligible population ) . Patients were grouped according to injury site . OUTCOME MEASURE self-reported grade s of difficulties with performing basic and instrumental activities of daily living as measured by the Groningen Activity Restriction Scale . RESULTS 1 year after the injury , pre-injury ( mean ) levels of functioning were not regained in any of the groups studied . However , only those with fractures of the wrist or hip experienced a substantial decrease in ability to perform basic and instrumental activities of daily living between baseline and the final assessment . Furthermore , of the 44 subjects with wrist fractures , seven ( 15.9 % ) needed help with at least one relevant activity at baseline and 18 ( 40.9 % ) at 12 months . Of the 34 subjects with hip fractures , four ( 11.8 % ) needed help with at least one activity at baseline and 18 ( 52.9 % ) at 12 months . Practically no changes were found in any of the groups after 5 months post-injury . CONCLUSIONS not only hip fractures , but also wrist fractures may reduce older people 's chances of remaining independent . Prospect s of further recovery are minimal 5 - 6 months after the injury OBJECTIVE To determine the effect of 2 different postoperative therapy approaches after operative stabilization of the wrist fractures : treatment by a physical therapist with 12 sessions and an unassisted home exercise program . DESIGN R and omized controlled cohort study . SETTING Hospital-based care , primary center of orthopedic surgery . PARTICIPANTS Volunteers ( N=48 ) with fractures of the distal radius after internal fixation with locking plates . There were 46 patients available for follow-up after exclusion of 2 participants due to physiotherapy sessions in excess of the study protocol . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Evaluation of grip strength using a Jamar dynamometer , range of motion ( ROM ) , and Patient Related Wrist Evaluation ( PRWE ) . RESULTS After a 6-week period of postoperative treatment , the patients ( n=23 ) performing an independent home exercise program using a training diary showed a significantly greater improvement of the functionality of the wrist . Grip strength reached 54 % ( P=.003 ) , and ROM in extension and flexion 79 % ( P<.001 ) of the uninjured side . Ulnar and radial abduction was also higher in this group . In contrast , patients who were treated by a physical therapist achieved grip strength equal to 32 % , and ROM in extension and flexion of 52 % of the uninjured side . Patients who were performing the home training after operation recorded an improved wrist function with a nearly 50 % lower value ( P<.001 ) in the PRWE score . CONCLUSIONS In the postoperative rehabilitation of wrist fractures , instructions in a home exercise program are an effective alternative to prescribed physical therapy treatment Background Fracture of the distal radius is a common clinical problem , particularly in older white women with osteoporosis . We report our work towards evidence -based and patient-centred care for adults with these injuries . Methods We developed a systematic programme of research that built on our systematic review of the evidence of effectiveness of treatment interventions for these fractures . We devised schemata showing ' typical ' care pathways and identified over 100 patient management questions . These depicted the more important decisions taken when progressing along each care pathway . We compiled a comprehensive document summarising the evidence available for each decision point from our review s of r and omised trials of treatment interventions . Using these documents , we undertook a formal and structured consultation process involving key players , including a patient representative , to obtain their views on the available evidence and to establish a research agenda . The result ing feedback was then processed and interpreted , using systematic methods . Results Some evidence from
Output:
| The available evidence from RCTs is insufficient to establish the relative effectiveness of the various interventions used in the rehabilitation of adults with fractures of the distal radius . |
MS210570 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND There are limited data to inform the choice between early treatment with continuous positive airway pressure ( CPAP ) and early surfactant treatment as the initial support for extremely-low-birth-weight infants . METHODS We performed a r and omized , multicenter trial , with a 2-by-2 factorial design , involving infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation . Infants were r and omly assigned to intubation and surfactant treatment ( within 1 hour after birth ) or to CPAP treatment initiated in the delivery room , with subsequent use of a protocol -driven limited ventilation strategy . Infants were also r and omly assigned to one of two target ranges of oxygen saturation . The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks ( with an attempt at withdrawal of supplemental oxygen in neonates who were receiving less than 30 % oxygen ) . RESULTS A total of 1316 infants were enrolled in the study . The rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group ( 47.8 % and 51.0 % , respectively ; relative risk with CPAP , 0.95 ; 95 % confidence interval [ CI ] , 0.85 to 1.05 ) after adjustment for gestational age , center , and familial clustering . The results were similar when bronchopulmonary dysplasia was defined according to the need for any supplemental oxygen at 36 weeks ( rates of primary outcome , 48.7 % and 54.1 % , respectively ; relative risk with CPAP , 0.91 ; 95 % CI , 0.83 to 1.01 ) . Infants who received CPAP treatment , as compared with infants who received surfactant treatment , less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia ( P<0.001 ) , required fewer days of mechanical ventilation ( P=0.03 ) , and were more likely to be alive and free from the need for mechanical ventilation by day 7 ( P=0.01 ) . The rates of other adverse neonatal outcomes did not differ significantly between the two groups . CONCLUSIONS The results of this study support consideration of CPAP as an alternative to intubation and surfactant in preterm infants . ( Clinical Trials.gov number , NCT00233324 . OBJECTIVE . Our objective was to determine whether continuous positive airway pressure therapy would safely reduce the need for up-transfer of infants with respiratory distress from nontertiary centers . METHODS . We r and omly assigned 300 infants at > 30 weeks of gestation with respiratory distress to receive either Hudson prong bubble continuous positive airway pressure therapy or headbox oxygen treatment ( st and ard care ) . The primary end point was “ up-transfer or treatment failure . ” Secondary end points included death , length of nursery stay , time receiving oxygen therapy , cost of care , and other measures of morbidity . RESULTS . Of 151 infants who received continuous positive airway pressure therapy , 35 either were up-transferred or experienced treatment failure , as did 60 of the 149 infants given headbox oxygen treatment . There was no difference in the length of stay or the duration of oxygen treatment . For every 6 infants treated with continuous positive airway pressure therapy , there was an estimated cost saving of $ 10000 . Pneumothorax was identified for 14 infants in the continuous positive airway pressure group and 5 in the headbox group . There was no difference in any other measure of morbidity or death . CONCLUSIONS . Hudson prong bubble continuous positive airway pressure therapy reduces the need for up-transfer of infants with respiratory distress in nontertiary centers . There is a clinical ly relevant but not statistically significant increase in the risk of pneumothorax . There are significant benefits associated with continuous positive airway pressure use in larger nontertiary centers A sequential controlled trial of continuous negative pressure versus oxygen in treatment of severe respiratory distress syndrome ( Pa O 2 O 2 70 per cent or greater ) was performed . CNP was applied by means of a newly design ed , inexpensive plastic chamber . Twenty-nine infants with RDS who weighed > 1,000 Gm . and who had no congenital malformations were studied ; there were 14 in the oxygen-treated control group and 15 in the CNP-treated group . Following the study , seven additional infants were treated with CNP . Birth weights , sex , gestational ages , ages , and blood gases at the time of admission to the study were similar . Study failure was defined as a Pa O A controlled trial of elective intervention with continuous inflating pressure ( CIP ) was performed in infants with severe hyaline membrane disease who weighed more than 1000 g at birth . Infants entered the trial if their arterial oxygen tension ( PaO2 ) fell below 60 mmHg while breathing a fractional inspired oxygen concentration ( F1O2 ) greater than 0 - 95 . 11 out of 12 infants in the CIP-treated group and 10 out of 12 in the control group survived . 7 treated and 6 control infants required mechanical ventilation . When CIP was started the Pao2 of the treated infants increased , and they breathed high concentrations of oxygen for a significantly shorter period than the control infants . During the 31-month duration of the trial 107 other infants with severe hyaline membrane disease were admitted who did not meet the criteria for entry to the trial . 37 survived after breathing high concentrations of oxygen ( F1O2 greater than 0 - 60 ) spontaneously without any ventilatory assistance , and the remaining 70 infants were already being ventilated on their arrival in the unit , usually because they had required mechanical ventilation during transfer from other hospitals . The neonatal survival rate for those infants born in this hospital during the study period was 88 % ( 50 out of 57 infants ) and for those referred from other hospitals it was 69 % ( 51 out of 74 infants ) . The maximum further increase in overall survival rate that might have been achieved in our population of infants if CIP had been initiated very early in the course of the illness was 5%--i.e . from 77 % ( 101/131 ) to 82 % ( 107/131 ) OBJECTIVE To determine whether very low birth weight infants ( VLBWIs ) , initially supported with continuous positive airway pressure ( CPAP ) and then selectively treated with the INSURE ( intubation , surfactant , and extubation to CPAP ; CPAP/INSURE ) protocol , need less mechanical ventilation than those supported with supplemental oxygen , surfactant , and mechanical ventilation if required ( Oxygen/mechanical ventilation [ MV ] ) . STUDY DESIGN In a multicenter r and omized controlled trial , spontaneously breathing VLBWIs weighing 800 - 1500 g were allocated to receive either therapy . In the CPAP/INSURE group , if respiratory distress syndrome ( RDS ) did not occur , CPAP was discontinued after 3 - 6 hours . If RDS developed and the fraction of inspired oxygen ( FiO(2 ) ) was > 0.35 , the INSURE protocol was indicated . Failure criteria included FiO(2 ) > 0.60 , severe apnea or respiratory acidosis , and receipt of more than 2 doses of surfactant . In the Oxygen/MV group , in the presence of RDS , supplemental oxygen without CPAP was given , and if FiO(2 ) was > 0.35 , surfactant and mechanical ventilation were provided . RESULTS A total of 256 patients were r and omized to either the CPAP/INSURE group ( n = 131 ) or the Oxygen/MV group ( n = 125 ) . The need for mechanical ventilation was lower in the CPAP/INSURE group ( 29.8 % vs 50.4 % ; P = .001 ) , as was the use of surfactant ( 27.5 % vs 46.4 % ; P = .002 ) . There were no differences in death , pneumothorax , bronchopulmonary dysplasia , and other complications of prematurity between the 2 groups . CONCLUSION CPAP and early selective INSURE reduced the need for mechanical ventilation and surfactant in VLBWIs without increasing morbidity and death . These results may be particularly relevant for re source -limited regions OBJECTIVE To determine whether early versus late treatment with porcine surfactant ( Curosurf ) reduces the requirement of mechanical ventilation in very preterm infants primarily supported by nasal continuous positive airway pressure ( nasal CPAP ) . DESIGN Multicenter r and omized , controlled trial . PATIENTS The study population comprised 60 infants < 30 weeks ' gestation with respiratory distress syndrome ( RDS ) who had an arterial to alveolar oxygen tension ratio ( a/APO2 ) of 0.35 to 0.22 . The cohort from which the study population was generated comprised 397 infants . RESULTS The need for mechanical ventilation or death within 7 days of age was reduced from 63 % in the late-treated infants to 21 % in early-treated infants . Increasing numbers of antenatal steroid doses also improved the outcome , especially in the early-treated infants . Six hours after r and omization mean a/APO2 rose to 0.48 in the early-treated infants compared with 0.36 in the late-treated . The need of mechanical ventilation before discharge was reduced from 68 % in the late-treated to 25 % in the early-treated infants . CONCLUSIONS Nasal CPAP in combination with early treatment with Curosurf significantly improves oxygenation and reduces the subsequent need for mechanical ventilation in infants < 30 weeks ' gestational age with RDS OBJECTIVE : Early surfactant followed by extubation to nasal continuous positive airway pressure ( nCPAP ) compared with later surfactant and mechanical ventilation ( MV ) reduce the need for MV , air leaks , and bronchopulmonary dysplasia . This r and omized , controlled trial investigated whether prophylactic surfactant followed by nCPAP compared with early nCPAP application with early selective surfactant would reduce the need for MV in the first 5 days of life . METHODS : A total of 208 inborn infants who were born at 25 to 28 weeks ' gestation and were not intubated at birth were r and omly assigned to prophylactic surfactant or nCPAP within 30 minutes of birth . Outcomes were assessed within the first 5 days of life and until death or discharge of the infants from hospital . RESULTS : Thirty-three ( 31.4 % ) infants in the prophylactic surfactant group needed MV in the first 5 days of life compared with 34 ( 33.0 % ) in the nCPAP group ( risk ratio : 0.95 [ 95 % confidence interval : 0.64–1.41 ] ; P = .80 ) . Death and type of survival at 28 days of life and 36 weeks ' postmenstrual age and incidence of main morbidities of prematurity ( secondary outcomes ) were similar in the 2 groups . A total of 78.1 % of infants in the prophylactic surfactant group and 78.6 % in the nCPAP group survived in room air at 36 weeks ' postmenstrual age . CONCLUSIONS : Prophylactic surfactant was not superior to nCPAP and early selective surfactant in decreasing the need for MV in the first 5 days of life and the incidence of main morbidities of prematurity in spontaneously breathing very preterm infants on nCPAP This prospect i ve study was undertaken to investigate the efficacy of nasal continuous positive airway pressure ( nCPAP ) in a group of extremely small infants denied access to a neonatal intensive care unit ( NICU ) in South Africa . Consecutive infants weighing less than 1200 g and /or of a gestational age below 28 weeks admitted to the neonatal ward with respiratory distress syndrome ( RDS ) , and who were refused admission to the NICU , received either nCPAP ( Infant Flow System E.M.E. , UK ) of headbox oxygen . Of 22 infants , 11 infants were included in the treatment group ( nCPAP ) and 10 in the control group . Within the first 24 h , two infants ( 18 per cent ) in the nCPAP group and eight infants ( 80 per cent ) in the control group died ( p = 0.007 ) ( survival OR = 18 ; RR = 4.09 ) . A statistically significant improvement in the arterial-alveolar ( a/A ) oxygen ratio occurred in the nCPAP group between postnatal day 1 and day 3 of life ( 0.17 vs. 0.36 ; p < 0.005 ) . Neonatal complications occurred in six ( 55 per cent ) infants who survived the first 24 h of life . Eighty per cent of the infants with intraventricular haemorrhage ( IVH ) died , as well as all the infants who were born before arrival at the hospital . At the time of discharge from hospital , 45 per cent ( five infants ) in the nCPAP group survived vs. 20 per cent ( two infants ) in the control group . The neurodevelopmental outcome of six of the surviving seven infants were evaluated at 1 year of corrected age . The neurodevelopmental outcome as assessed by the Griffith Score was within normal limits in all infants . One infant has sensorineural deafness and one is deaf and has a possible mild spastic diplegia ( both in the treatment group ) . We conclude that nCPAP significantly improves the short-term survival
Output:
| In preterm infants with respiratory distress , the application of CDP as CPAP or CNP is associated with reduced respiratory failure and mortality and an increased rate of pneumothorax . |
MS210571 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Specially design ed Thor-Lo footwear has been shown to reduce the in-shoe foot pressures in diabetic patients at risk of foot ulceration when compared to their own footwear . Fifty at high risk patients 32 ( 64 % ) males , 17 ( 34 % ) type 1 diabetes ) have been provided with this foot wear and have been followed up for 6 months . Mean age was 57.6 ( range , 34 - 78 ) years , duration of diabetes 22.4 ( range , 4 - 50 ) years , Neuropathy Symptom Score 3.36 + /- 2.96 ( mean + /- S.D. ) , Neuropathy Disability Score 16.8 + /- 6.83 , VPT 43.4 + /- 11.8 Volts while 43 ( 86 % ) could not feel a 5.07 or smaller Semmes-Weinstein monofilament . Forty-two ( 84 % ) patients were re-examined at an interim visit 3 months after baseline , while 37 ( 74 % ) completed the study . In-shoe peak forces and pressures were measured using the F-Scan system . No difference was found among the peak force among baseline ( 95.5 + /- 26 kg ) , interim ( 96.5 + /- 33 ) and final visit ( 97.7 + /- 25.2 , P + NS ) . There was no difference in peak pressures at the baseline ( 3.98 + /- 1.42 kg.cm-2 ) , second visit ( 4.13 + /- 2.30 ) and the final visit ( 4.25 + /- 1.51 ) . Nine ( 18 % ) patients developed foot problems and one died during the study . We conclude that no changes in foot pressures were found over a period of 6 months of continuous usage of the specially design ed footwear in a group of diabetic patients at risk of foot ulceration . Further prospect i ve studies are required to evaluate the impact of specially design ed footwear in reducing the rate of foot ulceration OBJECTIVE Little prospect i ve research exists on risk factors for diabetic foot ulcer that considers the independent effects of multiple potential etiologic agents . We prospect ively studied the effects of diabetes characteristics , foot deformity , behavioral factors , and neurovascular function on foot ulcer risk among 749 diabetic veterans with 1,483 lower limbs . RESEARCH DESIGN AND METHODS Eligible subjects included all diabetic enrollees of a general internal medicine clinic without foot ulcer , of whom 83 % agreed to participate . Baseline assessment included history and lower-limb physical examination , tests for sensory and autonomic neuropathy , and measurements of macro- and microvascular perfusion in the foot . Subjects were followed for the occurrence of a full thickness skin defect on the foot that took > 14 days to heal , with a mean follow-up of 3.7 years . RESULTS Using stepwise Cox regression analysis , the following factors were independently related to foot ulcer risk : foot insensitivity to the 5.07 monofilament ( relative risk [ 95 % CI ] ) 2.2 ( 1.5 - 3.1 ) , past history of amputation 2.8 ( 1.8 - 4.3 ) or foot ulcer 1.6 ( 1.2 - 2.3 ) , insulin use 1.6 ( 1.1 - 2.2 ) , Charcot deformity 3.5 ( 1.2 - 9.9 ) , 15 mmHg higher dorsal foot transcutaneous PO2 0.8 ( 0.7 - 0.9 ) , 20 kg higher body weight 1.2 ( 1.1 - 1.4 ) , 0.3 higher ankle-arm index 0.8 ( 0.7 - 1.0 ) , poor vision 1.9 ( 1.4 - 2.6 ) , and 13 mmHg orthostatic blood pressure fall 1.2 ( 1.1 - 1.5 ) . Higher ulcer risk was associated with hammer/claw toe deformity and history of laser photocoagulation in certain subgroups . Unrelated to foot ulcer risk in multivariate models were diabetes duration and type , race , smoking status , diabetes education , joint mobility , hallux blood pressure , and other foot deformities . CONCLUSIONS Certain foot deformities , reduced skin oxygenation and foot perfusion , poor vision , greater body mass , and both sensory and autonomic neuropathy independently influence foot ulcer risk , thereby providing support for a multifactorial etiology for diabetic foot ulceration Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field OBJECTIVE Custom-made footwear is the treatment of choice to prevent foot ulcer recurrence in diabetes . This footwear primarily aims to offload plantar regions at high ulcer risk . However , ulcer recurrence rates are high . We assessed the effect of offloading-improved custom-made footwear and the role of footwear adherence on plantar foot ulcer recurrence . RESEARCH DESIGN AND METHODS We r and omly assigned 171 neuropathic diabetic patients with a recently healed plantar foot ulcer to custom-made footwear with improved and subsequently preserved offloading ( ∼20 % peak pressure relief by modifying the footwear ) or to usual care ( i.e. , nonimproved custom-made footwear ) . Primary outcome was plantar foot ulcer recurrence in 18 months . Secondary outcome was ulcer recurrence in patients with an objective ly measured adherence of ≥80 % of steps taken . RESULTS On the basis of intention-to-treat , 33 of 85 patients ( 38.8 % ) with improved footwear and 38 of 86 patients ( 44.2 % ) with usual care had a recurrent ulcer ( relative risk −11 % , odds ratio 0.80 [ 95 % CI 0.44–1.47 ] , P = 0.48 ) . Ulcer-free survival curves were not significantly different between groups ( P = 0.40 ) . In the 79 patients ( 46 % of total group ) with high adherence , 9 of 35 ( 25.7 % ) with improved footwear and 21 of 44 ( 47.8 % ) with usual care had a recurrent ulcer ( relative risk −46 % , odds ratio 0.38 [ 0.15–0.99 ] , P = 0.045 ) . CONCLUSIONS Offloading-improved custom-made footwear does not significantly reduce the incidence of plantar foot ulcer recurrence in diabetes compared with custom-made footwear that does not undergo such improvement , unless it is worn as recommended OBJECTIVE To assess the efficacy of in-shoe orthoses that were design ed based on shape and barefoot plantar pressure in reducing the incidence of submetatarsal head plantar ulcers in people with diabetes , peripheral neuropathy , and a history of similar prior ulceration . RESEARCH DESIGN AND METHODS Single-blinded multicenter r and omized controlled trial with subjects r and omized to wear shape- and pressure-based orthoses ( experimental , n = 66 ) or st and ard-of-care A5513 orthoses ( control , n = 64 ) . Patients were followed for 15 months , until a study end point ( forefoot plantar ulcer or nonulcerative plantar forefoot lesion ) or to study termination . Proportional hazards regression was used for analysis . RESULTS There was a trend in the composite primary end point ( both ulcers and nonulcerative lesions ) across the full follow-up period ( P = 0.13 ) in favor of the experimental orthoses . This trend was due to a marked difference in ulcer occurrence ( P = 0.007 ) but no difference in the rate of nonulcerative lesions ( P = 0.76 ) . At 180 days , the ulcer prevention effect of the experimental orthoses was already significant ( P = 0.003 ) when compared with control , and the benefit of the experimental orthoses with respect to the composite end point was also significant ( P = 0.042 ) . The hazard ratio was 3.4 ( 95 % CI 1.3–8.7 ) for the occurrence of a submetatarsal head plantar ulcer in the control compared with experimental arm over the duration of the study . CONCLUSIONS We conclude that shape- and barefoot plantar pressure – based orthoses were more effective in reducing submetatarsal head plantar ulcer recurrence than current st and ard-of-care orthoses , but they did not significantly reduce nonulcerative lesions Various foot structures are thought to influence forefoot plantar pressures during walking . High peak plantar pressures ( PPP ) during walking in people with diabetes mellitus ( DM ) and peripheral neuropathy ( PN ) can cause skin breakdown . The question addressed by this study is " What are the primary forefoot structural factors that predict regional PPP during walking in groups of people with and without DM and PN ? " Twenty people with DM and PN ( mean age 55+/-9 years , 6 female , 14 male , BMI = 33+/-8 ) and 20 people without DM , matched for gender , age , and BMI were tested . Measures of foot structure were taken from three-dimensional images constructed from spiral X-ray computed tomography . Peak plantar pressure data were recorded during walking . Hierarchical multiple regression analysis was used to predict regional PPP at the great toe and five metatarsal heads from selected structural and walking variables . Metatarsal phalangeal joint angle ( hammer toe deformity ) was the most important variable predicting pressure , accounting for 19 - 45 % of the PPP variance at five of the six locations in the DM group . Soft tissue thickness , hallux valgus , and forefoot arthropathy were the most important predictors of PPP in the control group . Combinations of structural and walking variables accounted for 47 - 71 % of the variance in the DM group and 52 - 83 % of the variance of PPP during walking in the control group . These structural variables , especially hammer toe deformity , should be considered in attempts to develop strategies to reduce excessive forefoot PPP that may contribute to skin breakdown or other injury OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity A longitudinal double-blind study was conducted to determine the effect of sock fiber composition on the frequency and size of blistering events in long-distance runners . Thirty-
Output:
| The evidence to support to use of padded socks is limited .
There is a suggestion these simple-to-use interventions could be of value , particularly in terms of plantar pressure reduction .
The socks were generally of a sophisticated design with complex use of knit patterns and yarn content .
This systematic review provides limited support for the use of padded socks in the diabetic population to protect vulnerable feet . |
MS210572 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The pharmacy and nursing time requirements , quality of postoperative pain control , and cost of patient-controlled analgesia ( PCA ) and intramuscular ( i.m . ) analgesic therapy were studied . All timings were conducted with a stopwatch on a single nursing unit that primarily receives gynecologic surgery patients . The various work elements involved in each type of therapy were timed individually . Both quality of analgesia and cost were evaluated in a prospect i ve , r and omized study in hysterectomy patients . I.M. patients received meperidine hydrochloride 75 - 100 mg every three to four hours as needed . PCA patients had access to morphine sulfate 1 mg or meperidine hydrochloride 10 mg , with a six-minute lockout period . The patients scored their pain every four hours . Direct costs for PCA were calculated as drug cost plus tubing cost plus form cost plus maintenance cost plus depreciation cost . Direct costs for i.m . therapy consisted of the cost of drugs . The total mean nursing time per patient was 16.9 minutes for PCA and 10.7 minutes for i.m . therapy . Pharmacy time per patient was 5.1 minutes longer for PCA than for i.m . therapy . Thirty-six hysterectomy patients ( 17 i.m . and 19 PCA ) were enrolled in the study of pain control and cost . Among i.m . patients , 64 % of the pain scores were mild or worse , compared with 40 % for PCA patients . The median pain scores were moderate for i.m . patients and mild for PCA patients . Scores tended to be lower for PCA patients at 16 and 20 hours . Although equal numbers of patients in the two groups experienced nausea , i.m . patients needed more doses of antiemetics than PCA patients . ( ABSTRACT TRUNCATED AT 250 WORDS & NA ; Cardiovascular diseases cause more disability and economic loss in industrialized nations than any other group of diseases . In previous work [ Nurs Res 49 ( 2000a ) 1 ] , most coronary artery bypass graft patients ( CABG , N=225 ) reported unrelieved pain and received inadequate analgesics . This study proposed to evaluate a preadmission education intervention to reduce pain and related activity interference after CABG surgery . Patients ( N=406 ) were r and omly assigned to ( a ) st and ard care or ( b ) st and ard care+pain booklet group . Data were examined at the preadmission clinic and across days 1–5 after surgery . Outcomes were pain‐related interference ( BPI‐I ) , pain ( MPQ‐SF ) , analgesics ( chart ) , concerns about taking analgesics ( BQ‐SF ) , and satisfaction ( American Pain Society‐POQ ) . The impact of sex was explored related to primary and secondary outcomes . The intervention group did not have better overall pain management although they had some reduction in pain‐related interference in activities ( t(355)=2.54 , P<0.01 ) and fewer concerns about taking analgesics ( F(1,313)=2.7 , P<0.05 ) on day 5 . Despite moderate 24‐h pain intensity across 5 days , patients in both groups received inadequate analgesics ( i.e. 33 % prescribed dose ) . Women reported more pain and pain‐related interference in activities than men . The booklet was rated as helpful , particularly by women . In conclusion , the intervention did not result in a clinical ly significant improvement in pain management outcomes . In future , an intervention that considers sex‐specific needs and also involves educating the health professionals caring for these patients may influence these results Immediately before they underwent femoral angiography , 45 patients were given one of three types of audiotapes : a relaxation response tape recorded for this study , a tape of contemporary instrumental music , or a blank tape . All patients were instructed to listen to their audiotape during the entire angiographic procedure . Each audiotape was played through earphones . Radiologists were not told the group assignment or tape contents . The patients given the audiotape with instructions to elicit the relaxation response ( n = 15 ) experienced significantly less anxiety ( P less than .05 ) and pain ( P less than .001 ) during the procedure , were observed by radiology nurses to exhibit significantly less pain ( P less than .001 ) and anxiety ( P less than .001 ) , and requested significantly less fentanyl citrate ( P less than .01 ) and diazepam ( P less than .01 ) than patients given either the music ( n = 14 ) or the blank ( n = 16 ) control audiotapes . Elicitation of the relaxation response is a simple , inexpensive , efficacious , and practical method to reduce pain , anxiety , and medication during femoral angiography and may be useful in other invasive procedures The purpose of this comparative study was to examine differences in pain intensity , sleep disturbance , sleep effectiveness , fatigue , and vigor between patients undergoing cholecystectomy who received either patient-controlled analgesia ( PCA ) or intramuscular ( IM ) injections of narcotics for postoperative pain . The PCA group consisted of 16 women , aged 22 - 58 ; the IM group consisted of 10 women , aged 22 - 60 . Data were collected on patients ' postoperative days 1 and 2 . Findings indicated that patients receiving PCA reported less pain on postoperative day 1 and less fatigue on postoperative day 2 than patients receiving IM injections of narcotics BACKGROUND In previous studies comparing patient-controlled-analgesia and intramuscular pain management have been unable to provide conclusive evidence of the benefits of either method of postoperative pain control . AIM The purpose of the study was to compare the efficacy and cost-effectiveness of intravenous patient-controlled-analgesia with intermittent intramuscular morphine for Chinese women in the first 24 hours following elective gynaecological surgery . METHODS A r and omized control design was used . The main outcomes were level of pain and cost for the two types of pain management . Participants indicated their level of pain at rest and when deep breathing or coughing on a 100 mm Visual Analogue Scale , on seven occasions within 24 postoperative hours . Costs for the two types of pain management were based on the costs of equipment , drugs and nursing time . RESULTS A total of 125 women participated in the study . Mean pain level over the 24 hours in the patient-controlled-analgesia group was significantly lower than in the intramuscular group ( P < 0.001 ) . Mean pain level over the seven occasions for the patient-controlled-analgesia group was 11.83 points ( 95 % CI 7.14 - 16.52 ) lower when at rest and 11.73 points ( 95 % CI 5.96 - 17.50 ) lower during motion than the intramuscular group . Cost per patient was $ 81.10 ( Hong Kong ) higher for patient-controlled-analgesia than for intramuscular pain management . Women in the patient-controlled-analgesia group had significantly greater satisfaction with pain management than those in the intramuscular group ( P < 0.001 ) , but reported significantly more episodes of nausea ( P < 0.05 ) . CONCLUSIONS While patient-controlled-analgesia was more costly , it was also more effective than conventional on-dem and intramuscular opioid injections after laparotomy for gynaecological surgery Background and Objectives : To compare the use of patient-controlled analgesia to intermittent intramuscular injections of morphine following major gynecological laparoscopic procedures in order to assess differences in level of pain , sedation , episodes of nausea and /or vomiting , hospitalization time and patient satisfaction with their postoperative analgesia . Methods : Seventy-two patients undergoing major gynecological laparoscopic surgery were r and omized to receive either postoperative analgesia via intermittent intramuscular injection of morphine ( Group 1 ) or patient controlled analgesia ( PCA - Group 2 ) . All patients received anesthesia via a st and ardized protocol . Postoperative pain levels were recorded via a 10 cm visual analogue scale , and sedation scores were recorded on a st and ard PCA form . Episodes of nausea and vomiting were also recorded on the same form . Results : There were no statistically significant differences between intramuscular analgesia and PCA for any of the factors studied . Most significantly it was found that most patients ceased to require either form of parenteral analgesia within 24 hours of their procedure , regardless of the operating time . Conclusion : It is important for the surgeon to be aware of the effects of postoperative analgesia on his or her patients ' level of satisfaction . We do not recommend the use of PCA analgesia following major laparoscopic gynecological surgery Colonic surgery patients were studied to measure : the influence of continuous thoracic epidural analgesia ( TEA ) on a postoperative pain score , the time till onset of defaecation , blood loss , postoperative temperature elevations , rate of bacterial contamination of wounds and urine , and general surgical complications . Group I patients ( n = 57 ) received general anaesthesia and TEA for the operation , followed by continuous TEA ( 0·25 per cent bupivacaine ) for 72 h. Group II patients ( n = 59 ) received general anaesthesia for the operation , followed by systemic analgesia on request . Significant beneficial effects of TEA in group I were demonstrated by lower pain scores in the first 24 h after surgery and earlier defaecation . However , there were fewer temperature elevations in group II . There was no significant difference between the groups in terms of positive bacteriological cultures , blood loss , need for postoperative mechanical ventilation and complications . However , there was a trend toward a higher rate of rectal anastomotic breakdown , increased blood replacement and intensive care therapy , and longer hospitalization in group I. These results do not suggest any significant beneficial therapeutic effect of continuous TEA in colonic surgery compared with a conventional systemic analgesic regimen . In selected patients ( i.e. those with severe pain or those prone to develop postoperative ileus ) continuous TEA may be beneficial OBJECTIVE To examine the effects of adjunctive postoperative massage and vibration therapy on short-term postsurgical pain , negative affect , and physiologic stress reactivity . DESIGN Prospect i ve , r and omized controlled trial . The treatment groups were : ( 1 ) usual postoperative care ( UC ) ; ( 2 ) UC plus massage therapy ; or ( 3 ) UC plus vibration therapy . SETTING The University of Virginia Hospital Surgical Units , Gynecology-Oncology Clinic , and General Clinical Research Center . SUBJECTS One hundred and five ( N = 105 ) women who underwent an abdominal laparotomy for removal of suspected cancerous lesions . INTERVENTIONS All patients received UC with analgesic medication . Additionally , the massage group received st and ardized 45-minute sessions of gentle Swedish massage on the 3 consecutive evenings after surgery and the vibration group received 20-minute sessions of inaudible vibration therapy ( physiotones ) on the 3 consecutive evenings after surgery , as well as additional sessions as desired . OUTCOME MEASURES Sensory pain , affective pain , anxiety , distress , analgesic use , systolic blood pressure , 24-hour urine free cortisol , number of postoperative complications , and days of hospitalization . RESULTS On the day of surgery , massage was more effective than UC for affective ( p = 0.0244 ) and sensory pain ( p = 0.0428 ) , and better than vibration for affective pain ( p = 0.0015 ) . On postoperative day 2 , massage was more effective than UC for distress ( p = 0.0085 ) , and better than vibration for sensory pain ( p = 0.0085 ) . Vibration was also more effective than UC for sensory pain ( p = 0.0090 ) and distress ( p = .0090 ) . However , after controlling for multiple comparisons and multiple outcomes , no significant differences were found . CONCLUSIONS Gentle Swedish massage applied postoperatively may have minor effects on short-term sensory pain , affective pain , and distress among women undergoing an abdominal laparotomy for removal of suspected malignant tissues Although epidural opioids frequently are used to provide postoperative analgesia , several articles have suggested that the analgesia after epidural fentanyl is similar to that after an equal dose of fentanyl given intravenously . To address this issue further , 29 postthoracotomy patients were studied in a r and omized , double-blinded trial comparing a lumbar epidural fentanyl infusion with an intravenous fentanyl infusion for analgesia , plasma fentanyl pharmacokinetics , and respiratory effects for 20 h postoperatively . In all patients in both groups , good analgesia was achieved ( pain score less than 3 , maximum 10 ) over a similar time course , although the patients receiving epidural infusion required a significantly larger fentanyl infusion dose than did the patients receiving intravenous infusion ( group receiving epidural fentanyl infusion : 1.95 + /- 0.45 micrograms.kg-1.h-1 ; group receiving intravenous fentanyl infusion : 1.56 + /- 0.36 micrograms.kg-1.h-1 ; P = 0.0002 ) . The time course for the plasma fentanyl concentrations was similar in the two groups , and plasma fentanyl concentrations were not significantly different at any sampling period ( T7-T20 ; group receiving epidural fentanyl infusion : 1.8 + /- 0.5 ng/ml ; group receiving intravenous fentanyl
Output:
| Types of outcome measures The primary outcome was the relief or reduction of post-operative pain .
Results Overall , there is no strong evidence to support the use of any intervention even though a few interventions showed some benefits .
However , evidence for these benefits was often based on single studies .
Most of the included studies showed that there was no difference between the interventions and the usual care with both being found equally effective .
Implication s for practice There was no strong evidence to support a particular practice .
No intervention was found to be harmful ; however , this does not presume to be evidence of safety . |
MS210573 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Malignant melanoma has been one of the most rapidly increasing cancers within the United States with few modifiable risk factors . This study investigates risk related to dietary factors , which are potentially modifiable . METHODS Newly diagnosed patients with melanoma ( n = 502 ) were recruited from pigment lesion clinics and controls ( n = 565 ) were recruited from outpatient clinics . To investigate the relationship between melanoma and dietary factors in this case-control study , study subjects were requested to complete a food frequency question naire , which assessed diet over the previous year . Using logistic regression , odds ratios ( ORs ) for melanoma were computed for nutrient and alcohol intake . RESULTS Persons in high versus low quintiles of energy-adjusted vitamin D , alpha-carotene , beta-carotene , cryptoxanthin , lutein , and lycopene had significantly reduced risk for melanoma ( ORs < or = 0.67 ) , which remained after adjustment for presence of dysplastic nevi , education , and skin response to repeated sun exposure . Addition of micronutrients from supplements did not add an additional reduction in risk . High alcohol consumption was associated with an increased risk for melanoma , which remained after adjustment for confounders [ OR ( 95 % confidence interval ) in highest versus lowest quintiles , 1.65 ( 1.09 - 2.49 ) ] . CONCLUSIONS Diets consisting of foods rich in vitamin D and carotenoids and low in alcohol may be associated with a reduction in risk for melanoma . These analyses should be repeated in large , prospect i ve studies In a prospect i ve study of 102 patients with pre-neoplasia and /or manifest squamous-cell carcinoma of the lower lip the synchronous occurrence of intra-oral , pharyngeal or laryngeal leukoplakia and carcinoma was assessed . There was a coincidence rate of almost 15 % leukoplakias , including individual carcinomas . This high coincidence is probably due to a combination of various " risk profiles " in patients with threatened or manifest lower-lip cancer . Chronic exposure to sunlight , especially in the presence of a genetic disposition , is the most important risk factor in lower-lip cancer and its preceding stages , while chronic alcoholism and smoking abuse have little etiological significance We prospect ively investigated whether alcohol intake and smoking affect the risk of basal cell carcinoma ( BCC ) in subjects from the United States Radiological Technologists ( USRT ) cohort study . We evaluated 68,371 radiological technologists certified during 1926 - 1982 who were free of cancer at the time they answered a first question naire ( 1983 - 1989 ) and who completed a second question naire ( 1994 - 1998 ) . The first question naire provided baseline information on numerous risk factors , including smoking and alcohol intake , and the second provided self-reported cancer diagnoses . During 698,190 person-years of follow-up , we identified 1,360 cases of BCC : 1,036 in women and 324 in men . Cox proportional hazards regression indicated that the trend in BCC was significantly associated with increased alcohol intake ( P for trend = 0.001 ) . Compared with those who reported no alcohol consumption , those who drank < 1 - 2 , 3 - 6 , 7 - 14 , and > 14 drinks/week had multivariate risks of 1.1 [ 95 % confidence interval ( CI ) , 0.9 - 1.3 ] , 1.3 ( 95 % CI , 1.1 - 1.5 ) , 1.4 ( 95 % CI , 1.2 - 1.7 ) , and 1.0 ( 95 % CI , 0.7 - 1.6 ) , respectively . We found no clear association between smoking and BCC . This is the second large prospect i ve study to report a significant but nonmonotonic trend in increased risk associated with alcohol consumption The aim of this study was to identify factors related to lip cancer ( LC ) considering individual characteristics and sociodemographic factors . A case – control study was carried out in the province of Granada ( And alusia , southern Spain ) . The cases were 105 males with squamous-cell carcinoma of the lip , diagnosed between 1987 and 1989 ( aged 20–70 years ) and identified by means of a population -based Cancer Registry . As controls , a r and omised population al sample of 239 males , stratified by age , was used . Multiple logistic regression analysis showed that risk factors are lifetime cumulative tobacco consumption and alcohol consumption . An interaction was found between alcohol consumption and the smoking habit ( leaving the cigarette on the lip ) : OR=23.6 ; 95 % CI : 3.9–142.0 . Other risk factors identified are clear eyes ( OR=3.5 ; CI : 95 % 1.5–8.0 ) , sun exposure early in life and cumulative sun exposure during outdoor work ( OR=11.9 ; 95 % : CI : 1.3–108.9 ) , and skin reaction to sun exposure ( Fitzpatrick levels ) . Another interaction was found between skin reaction and a previous history of common sporadic warts ( OR=4.4 ; 95 % CI : 1.01–19.1 ) . We conclude that LC is related to phenotype , skin reaction to sun exposure , cumulative and early sunlight exposure , and tobacco and alcohol consumption , as well as a low educational level . Leaving the cigarette on the lip is predictive of LC risk irrespective of cumulative tobacco consumption To determine the relationship between 25(OH ) vitamin D levels and non-melanoma skin cancer ( NMSC ) , we performed a nested case – control study in ambulatory , elderly men enrolled in the Osteoporotic Fractures in Men ( MrOS ) Study . Health habit and medical history , including self-reported history of NMSC were recorded and 25(OH)D levels were measured on serum collected at baseline from a r and om sample of Caucasian MrOS subjects . Mean age ( 73 ± 5 ) , BMI , daily vitamin D and calcium intake were similar in the men with ( n = 178 ) and without NMSC ( n = 930 ) , but higher levels of 25(OH)D were associated with a decreased risk of having a history of NMSC ( Ptrend = 0.04 ) . Men in the highest quintile of 25(OH)D ( > 30 ng/mL ) had 47 % lower odds of NMSC ( 95 % CI : 0.30–0.93 , p = 0.026 ) compared to those in the lowest quintile . Our results suggest that a diagnosis of NMSC is not a surrogate for adequate 25(OH)D levels or increased UV exposure , and high 25(OH)D levels may be associated with a reduced risk of NMSC OBJECTIVES This study evaluated the influence of occupational exposure on cancer risk among female Norwegian nurses . METHODS A historical prospect i ve cohort study was performed . The cohort was established from the Norwegian Board of Health 's registry of nurses and included women who graduated from a nursing school before 1985 . The cohort ( N=43 316 ) was linked to the Cancer Registry of Norway . The observed number of cases was compared with the expected number on the basis of national rates . Time since first employment , period of first employment , and duration of employment were used as indicators of exposure . Poisson regression analyses were used for internal comparisons , adjusting for age , period , and fertility . RESULTS The nurses were followed over 1473931 person-years . During the follow-up ( 1953 - 2002 ) , 6193 cancer cases were observed . The st and ardized incidence ratio ( SIR ) for all cancers combined was close to unity . Significantly lower risks were found for cancers with a known association with alcohol and tobacco consumption and sexual activity . A significantly increased risk was found for breast cancer ( SIR 1.14 , 95 % confidence interval ( 95 % CI ) 1.09 - 1.19 ) , ovarian cancer ( SIR 1.14 , 95 % CI 1.04 - 1.25 ) , malignant melanoma ( SIR 1.15 , 95 % CI 1.04 - 1.28 ) , and borderline significant risk appeared for other skin cancer ( SIR 1.12 , 95 % CI 0.98 - 1.29 ) . A positive trend for increasing time since first exposure was found for breast cancer and malignant melanoma . CONCLUSIONS The results indicate an association between working as a nurse and an increased risk of breast cancer and malignant melanoma . Decreased risks , found for several cancers , indicate favorable lifestyle habits among nurses In a prospect i ve study of self-reported demographic , constitutional , and life-style factors in relation to basal cell carcinoma of the skin , we followed a cohort of 73,366 nurses in the United States who were 34 to 59 years of age in 1980 and who had no previous skin or other cancer . In 4 years of follow-up , compared with women living in the Northeast , women residing in California ( age-adjusted relative risk [ RR ] = 1.57 ; 95 % confidence interval [ CI ] = 1.30 to 1.89 ) and Florida ( RR = 2.12 ; 95 % CI = 1.54 to 2.92 ) were more likely to develop basal cell carcinoma . Compared with women having naturally dark brown hair , the age-adjusted relative risk of basal cell carcinoma was increased among women with red ( RR = 2.45 ; 95 % CI = 1.89 to 3.19 ) , blonde ( RR = 1.37 ; 95 % CI = 1.09 to 1.71 ) , or light brown hair ( RR = 1.27 ; 95 % CI = 1.08 to 1.49 ) and was decreased among women with black hair ( RR = 0.66 ; 95 % CI = 0.41 to 1.06 ) . Risk was positively associated in a dose-response manner both with tendency to sunburn as a child or adolescent and with lifetime number of severe and painful sunburns on the face or arms . These risk factors remained significant predictors of disease when included simultaneously in multivariate analyses . Tendency to tan was associated with decreased risk , although this risk was not significant after controlling for the other constitutional determinants and region . Cigarette smoking did not alter the risk of basal cell carcinoma . These prospect i ve data emphasize the importance of sunlight , and skin response to sunlight , as determinants of basal cell carcinoma among women Objective : To investigate the association between total alcohol intake and intake of different types of alcoholic beverages in relation to the risk of basal cell ( BCC ) and squamous cell ( SCC ) carcinoma of the skin . Design : Prospect i ve cohort study . Setting : Follow-up data from a community-based skin cancer study in Australia . Subjects : R and omly selected sample of 1360 adult residents of the township of Nambour who completed a food frequency question naire in 1992 and were monitored for BCC and SCC until 31 December 2002 . Results : No significant association was found between overall BCC or SCC risk and total alcohol intake , or intake of beer , white wine , red wine or sherry and port . However , among those with a prior skin cancer history , there was a significant doubling of risk of SCC for above-median consumption of sherry and port ( multivariable adjusted relative risk 2.46 , 95 % confidence interval 1.06–5.72 ) compared with abstainers . Conclusions : There are no associations between first occurrence of skin cancers and alcoholic beverage consumption . People with a history of skin cancer who consume above-average quantities of sherry or port may be at a raised risk of SCC , although replication of these findings in different study population s is needed to confirm this possible role of specific alcoholic beverages in secondary keratinocytic skin cancer risk We prospect ively examined the intake of alcoholic beverages in relation to the risk of basal cell carcinoma BCC in two large cohorts of men and women . Alcohol intake was assessed with food frequency question naires every 2 - 4 years , and BCC was ascertained by self-report . We used a pooled logistic regression to model the association between alcohol intake and BCC adjusting for various health , sun exposure , and sun-sensitivity factors . During 8 years of follow-up in women ( 1986 - 1994 ) we recorded 3060 cases of BCC , and during 10 years ( 1986 - 1996 ) , we recorded 3028 cases in men . Significant positive associations were observed between total alcohol intake ( P for trend < 0.0001 ) , alcohol from liquor ( P for trend = 0.003 ) , and white wine ( P for trend = 0.01 ) intake and risk of BCC . Compared with those who abstained , those who drank 0.1 - 4.9 g , 5.0 - 14.9 g , 15.0 - 14.9 g , and 30 g or more alcohol a day had multivariate relative risks of 1.11 [ 95 % confidence interval ( CI ) , 1.03 , 1.19 ] , 1.26 ( 95 % CI , 1.12 , 1.41 ) , 1.29 ( 95 % CI , 1.18 , 1.42 ) , and
Output:
| This study clearly demonstrates that smoking increases the risk of cutaneous squamous cell carcinoma ; however , smoking does not appear to modify the risk of basal cell carcinoma |
MS210574 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The objective of this study was to assess the techniques by which hysterectomies are carried out and to determine the rate of total laparoscopic hysterectomy ( TLH ) . A transversal multicentre study was conducted in 23 gynaecology and obstetrics departments of French University Hospital Centres . The study population comprised only those patients for whom hysterectomy was indicated for benign disease without genital prolapse or urinary stress incontinence . Whereas the rates of performance of hysterectomy by laparotomy and by the vaginal route are comparable [ respectively 40.0 % ( 94 patients ) and 46.8 % ( 110 patients ) ] , the rate of performance of TLH is only 13.2 % ( 31 patients ) . All 23 centres ( 100 % ) carried out hysterectomy by laparotomy and 21 centres ( 91.3 % ) carried out vaginal hysterectomy ; however , only nine centres ( 39.1 % ) carried out TLH . Only seven centres ( 30.4 % ) performed all three types of operation . Of the eight centres whose rate of vaginal hysterectomy was > 60 % , six ( 75 % ) did not carry out TLH . The study suggests that the usage of the TLH technique appears to be limited . The extent of surgical training is a major factor in the choice of technique for hysterectomy OBJECTIVE To compare peroperative parameters of two variants of a laparovaginal hysterectomy in surgical management of gynecological conditions . METHODS A prospect i ve r and omized study of 70 laparovaginal hysterectomies performed by the same two surgeons for disease of female pelvic organs . The following criteria were studied : indication for surgery , previous surgery , duration of the procedure , recovery , hospital stay , blood loss , tissue damage markers , hysterectomy proportions and complication incidence . Statistical analysis was performed using the non-parametric chi(2)-test and non-parametric Fischer 's exact probability test when appropriate , with a level of significance P=0.05 . RESULTS Totals of 38 ( 54.3 % ) laparoscopy-assisted vaginal and 31 ( 45.7 % ) vaginally assisted laparoscopic hysterectomies were performed for fibroma as the main indication . Conversion to laparotomy was applied in only one patient . The VALH group ( P=0.01 ) showed both fewer procedures and shorter hospital stay with insignificant blood loss . CONCLUSION The two variants of a laparovaginal hysterectomy appear to be safe and appropriate , effective procedures for women with gynecological conditions . Furthermore , vaginally assisted laparoscopic hysterectomy has been shown to be superior to laparoscopy-assisted vaginal hysterectomy in terms of shorter operating time and greater palliative effect upon the complex of uterosacral ligaments . Laparoscopic surgery can alter the relationship between vaginal and abdominal hysterectomy Objective To compare laparoscopically assisted vaginal hysterectomy ( LAVH ) and total abdominal hysterectomy ( TAH ) in patients with uterine fibroids Objective To identify differences in the peri‐operative outcome of women undergoing hysterectomy with bilateral salpingo‐oophorectomy performed either by abdominal hysterectomy and bilateral salpingo‐oophorectomy or by laparoscopic‐assisted salpingo‐oophorectomy and vaginal hysterectomy . To identify any potential management implication s , including financial differences , between these two forms of operations Objective To compare the effects of laparoscopic hysterectomy and abdominal hysterectomy in the abdominal trial , and laparoscopic hysterectomy and vaginal hysterectomy in the vaginal trial . Design Two parallel , multicentre , r and omised trials . Setting 28 UK centres and two South African centres . Participants 1380 women were recruited ; 1346 had surgery ; 937 were followed up at one year . Primary outcome Rate of major complications . Results In the abdominal trial laparoscopic hysterectomy was associated with a higher rate of major complications than abdominal hysterectomy ( 11.1 % v 6.2 % , P = 0.02 ; difference 4.9 % , 95 % confidence interval 0.9 % to 9.1 % ) and the number needed to treat to harm was 20 . Laparoscopic hysterectomy also took longer to perform ( 84 minutes v 50 minutes ) but was less painful ( visual analogue scale 3.51 v 3.88 , P = 0.01 ) and result ed in a shorter stay in hospital after the operation ( 3 days v 4 days ) . Six weeks after the operation , laparoscopic hysterectomy was associated with less pain and better quality of life than abdominal hysterectomy ( SF-12 , body image scale , and sexual activity question naires ) . In the vaginal trial we found no evidence of a difference in major complication rates between laparoscopic hysterectomy and vaginal hysterectomy ( 9.8 % v 9.5 % , P = 0.92 ; difference 0.3 % , -5.2 % to 5.8 % ) , and the number needed to treat to harm was 333 . We found no evidence of other differences between laparoscopic hysterectomy and vaginal hysterectomy except that laparoscopic hysterectomy took longer to perform ( 72 minutes v 39 minutes ) and was associated with a higher rate of detecting unexpected pathology ( 16.4 % v 4.8 % , P = < 0.01 ) . However , this trial was underpowered . Conclusions Laparoscopic hysterectomy was associated with a significantly higher rate of major complications than abdominal hysterectomy . It also took longer to perform but was associated with less pain , quicker recovery , and better short term quality of life . The trial comparing vaginal hysterectomy with laparoscopic hysterectomy was underpowered and is inconclusive on the rate of major complications ; however , vaginal hysterectomy took less time Objective . The present study is a prospect i ve r and omized comparison of laparoscopically assisted vaginal hysterectomy ( LH ) with total abdominal hysterectomy ( TAH ) . OBJECTIVE We compared operative time , length of hospital stay , postoperative recovery , return to work , and costs for women undergoing laparoscopically assisted vaginal hysterectomy or abdominal hysterectomy . STUDY DESIGN A prospect i ve r and omized clinical trial of laparoscopically assisted vaginal hysterectomy ( n = 24 ) versus abdominal hysterectomy ( n = 24 ) was carried out in a tertiary care setting . The main outcome variables were operative time , length of hospital stay , and return to work . Secondary outcomes were postoperative pain and return to normal activity as determined by weekly visual analog scales and daily diary . Hospital costs were calculated . RESULTS The laparoscopically assisted vaginal hysterectomy group had longer operative times ( median and quartiles , laparoscopically assisted vaginal hysterectomy 180 [ 139 , 225 ] minutes vs abdominal hysterectomy 130 [ 97 , 155 ] minutes ) , lower requirements for postoperative intravenous analgesia ( patient-controlled analgesia pump , median and quartiles : laparoscopically assisted vaginal hysterectomy 22.1 [ 15.9 , 23.5 ] hours , abdominal hysterectomy 36.7 [ 26.2 , 45.0 ] hours ) , shorter length of hospital stay ( median and quartiles , laparoscopically assisted vaginal hysterectomy 1.5 [ 1.0 , 2.3 ] days , abdominal hysterectomy 2.5 [ 1.5 , 2.5 ] days ) , and quicker return to work ( Kaplan-Meier analysis , P = .03 ) . Both procedures had similar hospital costs ( P = .21 ) . CONCLUSION Laparoscopically assisted vaginal hysterectomy appears to allow patients a more rapid postoperative recovery and an earlier return to work with hospital costs similar to those of abdominal hysterectomy OBJECTIVE We evaluated the advantages and disadvantages of laparoscopic hysterectomy over a 2-year period when this new technique was introduced to several hospitals in Finl and . STUDY DESIGN A nationwide register was founded and a prospect i ve multicenter survey of 1165 laparoscopic hysterectomies was carried out from January 1993 to December 1994 . The operations were performed because of uterine fibroids ( 54 % ) , menorrhagia ( 27 % ) , dysmenorrhea ( 8 % ) , endometriosis ( 2 % ) , and other reasons ( 9 % ) by 68 gynecologists at 30 hospitals . RESULTS The mean operation time was 132 minutes . The patients stayed in hospital for an average of 3.3 days , and the mean convalescence period was 17.9 days , half that after abdominal hysterectomy . Complications occurred in 10.2 % of the procedures : infections in 5.6 % , vascular complications in 1.2 % , urinary tract complications in 2.7 % , and bowel complications in 0.4 % . CONCLUSIONS Laparoscopic hysterectomy offers a short hospital stay and convalescence time to the patient , but effective teaching is imperative to minimize , in particular , the risk of urinary tract injuries BACKGROUND To evaluate clinical outcome and tissue trauma after laparoscopic and abdominal hysterectomy . METHODS Fifty women scheduled for abdominal hysterectomy were r and omized to undergo either laparoscopic ( n = 25 ) or abdominal ( n = 25 ) hysterectomy . Surgical characteristics , hospital stay , convalescence and complications were analyzed . Blood sample s for assay of markers of tissue trauma ( interleukin-6 , C-reactive protein , tumor-associated trypsin inhibitor and tumor-associated antigen CA 125 ) were taken preoperatively , on the first , second and seventh postoperative day and at the follow-up visit four weeks after surgery . RESULTS In uncomplicated hysterectomies ( n = 18 ) the operating time ( 85.3 min versus 57.5 min , p < 0.00001 ) was longer for laparoscopic group but the hospital stay ( 2.1 days versus 3.4 days , p < 0.00001 ) and sick leave ( 21.4 days versus 38.5 days , p < 0.00001 ) were shorter in the laparoscopic group . Postoperative increases in all markers were significant in both groups . The interleukin-6 concentration was highest on the first postoperative day in both groups , that of C-reactive protein on the second postoperative day in both groups , tumor-associated trypsin inhibitor on the seventh postoperative day in the laparoscopic group and on the second postoperative day in the abdominal group and tumor-associated antigen CA 125 on the seventh postoperative day in both groups . Both interleukin-6 and C-reactive protein levels were lower in the laparoscopic group on the first ( p = 0.01 and p = 0.03 , respectively ) and on the second postoperative day ( p = 0.02 and p < 0.001 , respectively ) compared with the abdominal group . No differences were seen in tumor-associated trypsin inhibitor and tumor-associated antigen CA 125 levels between the groups . CONCLUSION Laparoscopic hysterectomy should replace abdominal hysterectomy whenever possible because of a more favorable clinical outcome and less tissue trauma Background . To determine under controlled conditions whether there are significant differences in the duration of hospitalization and recovery between abdominal and vaginal hysterectomy for indications other than uterovaginal prolapse The objective of this study was to compare the results of a modified laparoscopically assisted vaginal hysterectomy ( LAVH ) procedure , using light-endorsed transvaginal section by two puncture trocars , with those of total abdominal hysterectomy ( TAH ) in a prospect i ve , r and omized , short-term study . A new , modified LAVH technique using Endo GIA stapler and two puncture trocars was established . For the laparoscopic phase , each adnexum was dissected , and the vesicouterine junction was identified clearly with the laparoscopic light from the vaginal side . Vaginal-phase surgery was performed as usual . Two hundred patients scheduled for abdominal hysterectomy were r and omized to either LAVH ( n = 100 ) or TAH ( n = 100 ) . Duration of hospitalization , time of surgery , dose of analgesics , and rates of complications were significantly lower in the LAVH group ( p < 0.001 ) . The average operating time was 77 ± 30 min for LAVH and 102 ± 18 min for TAH . The duration of hospitalization was 3.2 ± 0.7 days for LAVH and 5.5 ± 1.3 days for TAH . There were three complications in the LAVH group and 15 in the TAH group . Postoperative meperidine requirements ( 1.2
Output:
| Significantly speedier return to normal activities and other improved secondary outcomes ( shorter duration of hospital stay and fewer unspecified infections or febrile episodes ) suggest that vaginal hysterectomy is preferable to abdominal hysterectomy where possible .
Where vaginal hysterectomy is not possible , laparoscopic hysterectomy is preferable to abdominal hysterectomy , although it brings a higher chance of bladder or ureter injury |
MS210575 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Summary A prospect i ve r and omized double-blind trial comparing the butyrophenone analogue domperidone ( D ) and the synthetic cannabinoid nabilone ( N ) in the treatment of cytotoxic-induced emesis was conducted in 38 patients receiving highly emetogenic chemotherapy regimens ( 70 % containing cisplatin ) . Patients received 20 mg D or 1 mg N the night before chemotherapy and 8-hourly on each chemotherapy day for two consecutive cycles of treatment . Three of 19 patients r and omized to N completed only one cycle because of disease progression ( 2 ) or subjectively adverse effects ( 1 ) . Four of 19 patients completed only one cycle of D because of lack of efficacy ( 3 ) or chemotherapy toxicity ( 1 ) . In all , 32 cycles of N and 33 cycles of D were evaluable for efficacy . The mean number of vomiting episodes in cycle 1 was 4.76 for N and 12.95 for D ( P<0.02 ) . The corresponding values for cycle 2 were 4.27 and 7.69 ( P>0.10 ) , and for cycles 1 and 2 combined , 4.53 for N and 10.81 for D ( P<0.01 ) . Nausea and food intake scores did not differ significantly , although there was a trend towards less nausea and an increased food intake with N. Subjectively adverse effects were more frequent with N and included drowsiness , dizziness , dry mouth , and postural hypotension . N is superior to D for the control of cytotoxic-induced emesis A prospect i ve r and omised double blind crossover trial was conducted comparing the new synthetic cannabinoid nabilone with oral domperidone in a group of children receiving repeated identical courses of emetogenic chemotherapy for a variety of malignant diseases . Eighteen of 23 consecutive eligible children , aged 10 months to 17 years , completed the trial . When taking nabilone they experienced significantly fewer vomiting episodes and less nausea , and two thirds expressed a preference for the drug . The most common side effects of treatment with nabilone were somnolence and dizziness , with one patient being disturbed by hallucinations . The results indicate that nabilone is an effective antiemetic for children having chemotherapy , even for young children . It seems to be superior in this respect to domperidone , and although it has a higher incidence of side effects , these are mostly acceptable to patients . It can be recommended as an alternative to conventional antiemetic treatment throughout childhood The antinausea and antivomiting effects of delta-9-tetrahydrocannabinol ( THC ) in children receiving cancer chemotherapy were compared with those of metoclopramide syrup and prochlorperazine tablets in two double-blind studies . THC was found to be a significantly better antinausea and antivomiting agent , but not all patients obtained relief of nausea and vomiting with THC . In some patients , THC enhanced appetite during a course of chemotherapy . In two patients , a " high " associated with THC administrationwas reported . Drowsiness was reported significantly more frequently with THC Twenty cancer patients who received chemotherapy were entered into a double-blind crossover design antiemetic study comparing 1 mg levonantradol , an investigational synthetic cannabinoid , to 10 mg prochlorperazine . Sixteen patients completed the crossover . For each antiemetic course , four doses of each study medication were given intramuscularly 2 hours before chemotherapy and then 2 , 6 , and 10 hours after chemotherapy administration . There were no statistical differences in patients ' responses to levonantradol and prochlorperazine . The frequency of side effects was greater with levonantradol than with prochlorperazine . The most common side effect of levonantradol were somnolence , dry mouth , dizziness , tachycardia , postural hypotension , and blurred vision , while those for prochlorperazine were somnolence , dry mouth , and tachycardia Nabilone , a synthetic cannabinoid , and Prochlorperazine were compared in a double-blind crossover study of 34 patients with lung cancer undergoing a 3-day schedule of chemotherapy with Cyclophosphamide , Adriamycin and Etoposide . Symptom scores were significantly better for patients on nabilone for nausea , retching and vomiting ( P less than 0.05 ) . Fewer subjects vomited with nabilone ( P = 0.05 ) and the number of vomiting episodes was lower ( P less than 0.05 ) ; no patients on nabilone required additional parenteral anti-emetic . More patients preferred nabilone for anti-emetic control ( P less than 0.005 ) . Adverse effects common with nabilone were drowsiness ( 57 % ) , postural dizziness ( 35 % ) and lightheadedness ( 18 % ) . Euphoria was seen in 14 % and a " high " in 7 % . Erect systolic blood pressure was lower in nabilone patients on Day 1 ( P = 0.05 ) but postural hypotension was a major problem in only 7 % . Nabilone is an effective oral anti-emetic drug for moderately toxic chemotherapy , but the range and unpredictability of its side-effects warrant caution in its use FACTORS INFLUENCING PREFERENCE FOR THC vs. COMPAZINE ( prochlorperazine ) as an antiemetic agent during cancer chemotherapy were studied in 139 patients who received both medications in a double-blind r and omized crossover design trial . Nausea reduction was the main determinant of preference . THC preference was associated with more , rather than fewer , drug-related side effects than Compa-zine , particularly sedation . Patients who reported being anxious or depressed did not experience accentuation of their mood states with either regime . Mood effects , nausea reduction , incidence of side effects , and drug preference were the same in patients under and over 50 years of age . Patients with a history of illicit drug use reported fewer side effects from THC , but reported no difference in drug preference or nausea reduction compared to those patients without a history of illicit use A double blind-cross-over r and omised clinical trial has been conducted to compare the antiemetic effects of tetrahydrocannabinol , thiethylperazine and metoclopramide . There were no significant differences in the antiemetic effects of these drugs . The incidence of adverse reactions as recorded by both the staff and the patients was significantly higher in the tetrahydrocannabinol group than in either the metoclopramide or thiethylperazine groups . This trial has established that in the dosages used tetrahydrocannabinol given by mouth has an antiemetic effect of approximately the same order as thiethylperazine and metoclopramide . However , its adverse effects are sufficiently greater than those of the other agents to prevent is widespread usage for this purpose . Tetrahydrocannabinol taken by mouth is not recommended as a routine antiemetic agent in cancer chemotherapy The antiemetic effect of oral nabilone , a synthetic cannabinoid , given at a dose of 2 mg every 12 hours was compared to oral slow-release capsules of prochlorperazine given at a dose of 10 mg every 12 hours by a double-blind crossover method in 37 patients receiving cancer chemotherapy . Patients received one of the following as the primary emetic stimulus : high-dose cis-dichlorodiammineplatinum(II ) ( DDP ) , low-dose DDP , mechlorethamine , streptozotocin , actinomycin D , or DTIC . Although results varied according to strength of emetic stimulus received , both nabilone and prochlorperazine appeared to produce antiemetic effects . Eighteen of the 37 patients achieved a complete or partial elimination of symptoms : seven with nabilone alone , three with prochlorperazine alone , and eight with each drug . Nabilone appeared to be the more effective antiemetic for patients who received chemotherapy agents other than high dose DDP ; it was equivalent to prochlorperazine for those who did receive high-dose DDP . Side effects from prochlorperazine were limited to mild drowsiness occurring among 35 % of the patients . The side effects from nabilone were drowsiness and dizziness which occurred frequently and were dose-limiting in 25 % of patients Thirty-two patients were entered into a double blind trial of antiemetic support in patients being treated with cisplatin . Patients were allocated to receive either oral nabilone ( 1 mg 8 hourly ) or intravenous metoclopramide ( 1 mg kg−1 3 hourly ) in r and om order over 4 courses . There was no difference between the two treatments in the overall incidence or severity of vomiting , although a subgroup of patients enjoyed a substantial reduction in episodes of vomiting whilst receiving metoclopramide . Side-effects were predictable from the pharmacology of the drugs Summary Twenty nonseminomatous testicular cancer patients not pretreated with emetogenic chemotherapy were included in a crossover study of antiemetic therapy . Patients were r and omly assigned to receive either nabilone ( 2 × 2 mg/day ) or alizapride ( 3 × 150 mg/day ) prior to beginning lowdose cisplatin chemotherapy . Patients on nabilone had significantly fewer episodes of emesis than those on alizapride ( medians , 1.1 vs 2.9;p<0.01 ) . Nabilone was superior to alizapride in giving complete relief from nausea ( medians , 65 % vs 30%;p<0.01 ) , and was more effective in shortening the duration of nausea ( medians , 1.3 h vs 5.1 h;p<0.01 ) ; however , it caused more adverse effects . It is concluded that nabilone has greater antiemetic activity than alizapride in young patients receiving low-dose cisplatin chemotherapy . Nabilone dosage should be reduced to decrease the incidence and degree of adverse reactions while leaving the definite antiemetic activity unchanged Delta‐9‐tetrahydrocannabinol ( THC ) and prochlorperazine ( Compazine ) were found to be equally efficacious in reducing nausea and vomiting associated with cancer chemotherapy across a wide range of chemotherapeutic regimens and tumor types . Both drugs were administered orally one hour before chemotherapy , then every four hours for a total of four doses . Compazine was administered in a fixed dose of 10 mg ; THC was administered by body surface area ( BSA ) : BSA < 1.4 m2 = 7.5 mg ; BSA 1.4‐1.8 m2 = 10 mg ; and BSA > 1.8 m2 = 12.5 mg . Two hundred and fourteen subjects ( 75 % of whom had previously received Compazine with varying results ) were evaluated employing a double‐blind , crossover design . Additional parameters evaluated were study drug effects on appetite , food intake , mood , activity , relaxation , interaction , and concentration . There were significant drug effects with THC : less ability to concentrate ( P < 0.01 ) , less social interaction ( P < 0.05 ) , and less activity ( P < 0.05 ) . There were no significant differences between the two drugs in the level of food intake or appetite . Patients of all ages did equally well on both drugs . Neither past marijuana use nor past Compazine use were related to study drug efficacy . Those patients who correctly identified their THC cycle did better on THC versus those who could not correctly identify which antiemetic they had received ( P < 0.05 ) . There were more drug‐related effects associated with THC , but these did not reduce the patients ' preference for the drug , and were associated with nausea reduction ( P < 0.05 ) Levonantradol is a cannabis derivative . Cannabinoid anti-emetics are being assessed in cancer chemotherapy but have been little used in radiotherapy to date . A pilot study and r and omised trial compared the anti-emetic effect of a st and ard drug ( Chlorpromazine 26 mg ) with Levonantradol at two doses ( 0.5 and 0.75 mg ) in patients receiving palliative single fraction radiotherapy to sites likely to cause nausea and vomiting . Most patients were out- patients . Both drugs were well tolerated . The frequency of vomiting was similar in all three groups in both the pilot study and r and omised trial Eighty evaluable patients receiving chemotherapy were entered on a r and om prospect i ve double-blind study to evaluate the effectiveness of nabilone , a synthetic cannabinoid , compared to prochlorperazine . Most of these patients received cisplatin , a drug that universally produces severe nausea and vomiting , as part of a combination chemotherapy regimen . The patients served as their own controls , receiving either nabilone or prochlorperazine during two consecutive treatment courses with the identical chemotherapy . Side effects consisting of hypotension and lethargy were more pronounced with nabilone . Toxicity , in general , did not preclude antiemetic treatment and in no way interfered with chemotherapy . Sixty patients ( 75 per cent ) reported nabilone to be more effective than prochlorperazine for relief of nausea and vomiting . Of these 60 patients , 46 required further chemotherapy and continued taking nabilone as the antiemetic of choice In a previous study on the antiemetic effect of nabilone ( N ) in patients with lung cancer receiving chemotherapy ( CT ) , we found that N was only moderately effective and that its side effects limited its use , especially in elderly out patients . We , therefore , performed a new study of N in combination with dexamethasone ( DXM ) , a potent antiemetic in itself , to evaluate whether the addition of DXM to N would improve the antiemetic effect and /or reduce the side effects . Forty patients with lung cancer were en
Output:
| The superiority of the anti-emetic efficacy of cannabinoids was demonstrated through meta- analysis |
MS210576 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objectives : The recent National Service Framework for Long Term Conditions recommends that patients participate more in decision making about their care . However , few protocol s exist to support this . One potentially useful method is goal setting , but little has been done to evaluate the added value of increasing patient participation in this way . Therefore , this study examined the impact of an increased participation goal setting protocol in a neurorehabilitation setting . Design : The study was an AB optimised balance block design with each block lasting 3 months , over an 18 month period . Setting and participants : Patients ( n = 201 ) were recruited from an inpatient neurological rehabilitation unit . Interventions : Patients ( n = 100 ) recruited in phase A were involved in “ usual practice ” goal setting . Patients ( n = 101 ) recruited in phase B were involved in “ increased participation ” goal setting , which included a protocol to help them define and prioritise their own goals . Main outcome measures : Patients ’ perceptions of the relevance of goal setting and their autonomy within the process ; the number , type and outcome of goals ; and level of functional ability . Results : Phase B patients ( “ increased participation ” ) set fewer goals , of which significantly more were participation related . These patients perceived the goals to be more relevant , and expressed greater autonomy and satisfaction with goal setting . There were no differences in functional outcomes between the groups . Conclusion : This study has shown that patients prefer increased participation in the goal setting process over st and ard procedures , perceiving their goals as more relevant and rehabilitation more patient centred despite the absence of functional gains . Effective patient centred care can be realised by using structures that help support patients to identify and communicate their priorities . As such , our findings suggest patients would benefit from greater participation in this aspect of clinical decision making Objective : To examine the feasibility of and clinical experiences with goal attainment scaling when used for the evaluation of cognitive rehabilitation in people with acquired brain injury . Design : A prospect i ve observational longitudinal study . Setting : A 21-week cognitive rehabilitation programme and a cognitive programme with varying length in two different Dutch rehabilitation centres . Subjects : Forty-eight consecutive patients with acquired brain injury enrolled during a 15-month period . Interventions : Cognitive rehabilitation programme . Main measure : Goal attainment scaling ; the number of goals was counted ; time to set goals was recorded ; the number of different domains in which goals were set was counted ; goal attainment scaling score was calculated at baseline , one week after the end of the cognitive rehabilitation programme and at six months follow-up ; clinical experiences that could be useful for both clinical and research practice were recorded . Results : The mean ( SD ) age of the patients was 46.1 ( 10.7 ) years ; 29 ( 60 % ) were male ; 186 goals were set with a mean ( SD ) number of 4 ( 1 ) goals per patient . It was possible to set at least three realistic goals per patient within 30 minutes . Most goals were set in the cognitive domain ( i.e. memory and attention ) , followed by the behavioural domain ( i.e. fatigue and aggression ) . Conclusion : It proved possible to set three goals within an acceptable time-frame , to involve patients in the goal - setting procedure , to set realistic goals , and to set goals within relevant domains . Based on clinical experiences , goal attainment scaling is less feasible for research when patients lack insight , or suffer from comorbidity or mood problems Objective : To determine the acceptability and clinical application of two recently developed goal - setting interventions ( Goal Management Training and Identity Oriented Goal Training ) in people with traumatic brain injury . Design : A three parallel group , r and omized controlled pilot study . Setting : Inpatient and community rehabilitation facilities . Subjects : Thirty-four people with moderate to severe traumatic brain injury ( Goal Management Training , n = 12 ; Identity Oriented Goal Training , n = 10 ; usual care , n = 12 ) and their rehabilitation clinicians . Interventions : For both Goal Management Training and Identity Oriented Goal Training participants met face to face with their key worker weekly over a period of 6—8 weeks , during which time the key worker worked to engage them in goal setting and goal performance using the strategy prescribed by their group allocation . Usual care was provided to the other participants . Main measures : Largely qualitative using observation , individual interviews and focus groups . Participants also completed a Goal Attainment Scale at baseline , post intervention and at three months follow-up . Results : Both approaches were acceptable to the majority of participants with many reporting improved mood and goal attainment . Clinicians found working in a different way with patients both challenging and rewarding , with both experimental approaches enhancing a focus on the person 's own goals . Identity Oriented Goal Training seemed particularly helpful in engaging people in the goal - setting process while Goal Management Training appeared particularly helpful in providing a structured framework for error prevention in attempting goal performance . Conclusion : These theoretically informed approaches to goal setting showed promise but were time intensive and at times difficult for practitioners to utilize
Output:
| Conclusion : The main barriers and facilitators to goal - setting during stroke rehabilitation have been identified .
They suggest that current methods of goal - setting during inpatient/early stage stroke or neurological rehabilitation are not fit for purpose |
MS210577 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: In this paper , we employ a classical experiment to determine if welfare reform causes poor women to experience increased levels of clinical anxiety and depression . We organize our analyses around the insights provided by lifestyle change and ecosocial theories of illness . Our data come from the New Jersey Family Development Program ( FDP ) , one of the most highly publicized welfare experiments in the U.S. A sample of 8393 women was r and omly assigned into two groups , one which stressed welfare-to-work and the other which offered traditional welfare benefits . These women were followed from 1992 through 1996 and information on clinical diagnoses was collected quarterly from physician treatment cl aims to the government Medicaid program . Our intention-to-treat estimates show that for short-term welfare recipients FDP decreased the prevalence of anxiety by 40 % and increased depression by 8 % . For black women both anxiety and depression diagnoses declined while Hispanic women experienced a 68 % increase in depression . We discuss several public policy implication s which arise from our work This study aim ed to investigate ( a ) whether it is possible to increase emotional competence ( EC ) in adulthood ; ( b ) whether this improvement results in better mental , physical , and social adjustment ; ( c ) whether this improvement can be maintained 1 year later ; and ( d ) whether these benefits are accompanied by a reduction in stress-hormone secretion ( i.e. , cortisol ) . One hundred and thirty-two participants were r and omly assigned to an EC-enhancing intervention ( in group format ) or to a control group . Participants in the intervention group underwent a specifically design ed 15-hr intervention targeting the 5 core emotional competencies , complemented with a 4-week e-mail follow-up . Results reveal that the level of emotional competencies increased significantly in the intervention group in contrast with the control group . This increase result ed in lower cortisol secretion , enhanced subjective and physical well-being , as well as improved quality of social and marital relationships in the intervention group . No significant change occurred in the control group . Peer reports on EC and quality of relationships confirmed these results . These data suggest that emotional competencies can be improved , with effective benefits on personal and interpersonal functioning lasting for at least 1 year . The theoretical implication s of these results as well as their practical implication s for the construction and the development of effective emotional competencies interventions are discussed Background In the developing world , access to small , individual loans has been variously hailed as a poverty-alleviation tool – in the context of " microcredit " – but has also been criticized as " usury " and harmful to vulnerable borrowers . Prior studies have assessed effects of access to credit on traditional economic outcomes for poor borrowers , but effects on mental health have been largely ignored . Methods Applicants who had previously been rejected ( n = 257 ) for a loan ( 200 % annual percentage rate – APR ) from a lender in South Africa were r and omly assigned to a " second-look " that encouraged loan officers to approve their applications . This r and omized encouragement result ed in 53 % of applicants receiving a loan they otherwise would not have received . All subjects were assessed 6–12 months later with questions about demographics , socio-economic status , and two indicators of mental health : the Center for Epidemiologic Studies – Depression Scale ( CES-D ) and Cohen 's Perceived Stress scale . Intent-to-treat analyses were calculated using multinomial probit regressions . Results R and omization into receiving a " second look " for access to credit increased perceived stress in the combined sample of women and men ; the findings were stronger among men . Credit access was associated with reduced depressive symptoms in men , but not women . Conclusion Our findings suggest that a mechanism used to reduce the economic stress of extremely poor individuals can have mixed effects on their experiences of psychological stress and depressive symptomatology . Our data support the notion that mental health should be included as a measure of success ( or failure ) when examining potential tools for poverty alleviation . Further longitudinal research is needed in South Africa and other setting s to underst and how borrowing at high interest rates affects gender roles and daily life activities . CCT : IS RCT N The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . This study evaluated benefits of a preventive intervention to the living st and ards of recently separated mothers . In the Oregon Divorce Study 's r and omized experimental design , data were collected 5 times over 30 months and evaluated with Hierarchical Linear Growth Models . Relative to their no-intervention control counterparts , experimental mothers had greater improvements in gross annual income , discretionary annual income , poverty threshold , income-to-needs ratios , and financial stress . Comparisons showed the intervention to produce a greater increase in income-to-needs and a greater rise-above-poverty threshold . Benefits to income-to-needs were statistically independent of maternal depressed mood , divorce status , child support , and repartnering . Financial stress reductions were explained by the intervention effect on income-to-needs . The importance of helping disadvantaged families with evidence -based programs is discussed Analyses of data from a r and omized field experiment with 1,801 participants ( A.D. Vinokur , R.H. Price . & Y.Schul , 1995 ) examined the long-term effects of a job- search workshop ( JOBS ) and the independent effects of demographic and psychological factors on reemployment and mental health outcomes . Two years after the JOBS workshop , the experimental group had significantly higher levels of reemployment and monthly income , lower levels of depressive symptoms , lower likelihood of experiencing a major depressive episode in the last year , and better role and emotional functioning compared with the control group . Baseline job- search motivation and sense of mastery had both direct and interactive effects ( with experimental condition ) on reemployment and mental health outcomes , respectively . The interactive effects demonstrated larger benefits for those who had initial low levels of job- search motivation and mastery Conducted process analysis of treatment mediation effects ( Judd & Kenney , 1981 ) on longitudinal data from a large r and omized field experiment with 928 recently unemployed persons . The experimental treatment included an intervention that succeeded in promoting quality reemployment outcomes , as described in earlier reports ( Caplan et al. , 1989 ; Vinokur et al. , 1991 ) . Using Ajzen 's theory of planned behavior ( Ajzen , 1985 , 1988 ) , the analyses examined the mediating effects of job- search self-efficacy , attitude , norms , and intention on job- search behavior . The results provided substantial support for the theory of planned behavior and demonstrated the mediational role of job- search self-efficacy . For both 1- and 4-month posttests , job- search self-efficacy was shown to mediate the effects of the intervention through its direct effects on job- search intention and on short term job- search behavior , as well as through its indirect effects on subjective norms and attitude . However , in the longer term 4-month posttest , exposure to the intervention had a direct effect on job- search behavior . This long-term direct effect of the intervention was hypothesized to reflect the influence of inoculation against setbacks which is essential for sustaining the long-term behavioral efforts involved in job seeking PURPOSE The purpose of this study was to determine the relationship between the working alliance and employment outcomes in persons with severe mental illness receiving vocational services . Another purpose of this study was to determine whether working alliance differences exist between clients receiving evidence -based supported employment services and those receiving traditional stepwise vocational services . DESIGN This study was a secondary analysis of a 2-year r and omized controlled trial comparing two employment programs providing services to people with severe mental illness . RESULTS Contrary to expectations , no overall relationship was found between the working alliance and employment outcomes . As predicted , supported employment participants each assigned to a single vocational worker had more positive working alliances than participants served by a team of vocational workers in the traditional vocational program . CONCLUSIONS / IMPLICATION S The lack of an association between the working alliance and employment outcomes is inconsistent with previous literature . Further research is needed using st and ardized working alliance measures and larger sample s that include both working and nonworking clients . Evidence -based supported employment , which employs individual caseloads , seems to foster better relationships than a team-based vocational approach , although future research is needed to replicate this finding The impact of preventive interventions for the unemployed may vary depending on the context of the labor policies and benefit systems of the country where it is implemented . The Työhön Job Search Program was based on a method developed in the United States for recently unemployed workers . This study examined outcomes of the intervention in the context of the European labor market for participants who had been unemployed for a longer period . A total of 1,261 unemployed Finnish job seekers participated in a r and omized field study . At the 6-month follow-up , the program had a beneficial impact on the quality of reemployment , especially among those who had been unemployed for a moderate time period . The program also significantly decreased psychological distress Drawing on coping re sources theory , we evaluate the impact of a job search intervention on depressive symptoms in a r and omized field experiment at three follow-up periods covering two and one-half years . Baseline depressive symptoms , low social assertiveness , and financial hardship were identified as significant risk variables predicting depressive symptoms at follow-up . These variables then were used to identify high- and low-risk individuals in both experimental and control groups . Results indicated that the job search intervention had its primary impact on persons identified as being at higher risk for depression . Furthermore , the intervention had an impact on both the incidence and prevalence of more severe depressive symptoms among high-risk individuals The process linking unemployment and economic hardship to depression and marital or relationship satisfaction in couples was examined . Using structural equation modeling , the authors tested models in which financial strain and partners ' symptoms of depression influence the behavioral exchange of the couples in terms of social support and social undermining and , in turn , the effects of support and undermining on relationship satisfaction and depressive symptoms . The analyses were based on longitudinal data from 815 recently unemployed job seekers and their spouses or partners . The results demonstrated that financial strain had significant effects on depressive symptoms of both partners , which in turn led the partner to withdraw social support and increase social undermining . Reduced supportive and increase undermining behaviors had additional adverse effects on satisfaction with the relationship and on depressive symptoms Cognitive theories of adherence to difficult courses of action and findings from previous survey research on coping with a major life event -- job loss -- were used to generate a preventive intervention , tested by a r and omized field experiment . The aim was to prevent poor mental health and loss of motivation to seek reemployment among those who continued to be unemployed and to promote high- quality reemployment . Ss were 928 recently unemployed adults from southeastern Michigan , representing a broad range of demographic characteristics ; they were r and omly assigned to either the experimental or control condition . The experimental intervention included training in job seeking with a problem-solving process emphasizing inoculation against setbacks and positive social reinforcement . A pretest was administered , followed by posttests 1 and 4 months after the experiment . The experimental condition yielded higher quality reemployment in terms of earnings and job satisfaction , and higher motivation among those who continued to be unemployed TOPIC Supported Employment ( SE ) can help transition age youth and young adults to obtain employment and develop meaningful careers and financial security . PURPOSE The purpose of this analysis is to examine the role of SE in achieving employment outcomes for youth ( ages 18 - 24 ) and young adults ( ages 25 - 30 ) , compared to outcomes for older adults . Given the importance of employment to the quality of life of young people in establishing work histories and starting careers , it is important to have a better underst and ing of what client and program characteristics result in better employment outcomes . SOURCES USED Data are from the Employment Intervention Demonstration Program ( EIDP ) , a multisite r and omized controlled trial of SE among 1,272 individuals with psychiatric disabilities in 7 states . CONCLUSIONS AND IMPLICATION S FOR PRACTICE Among all study participants , youth and young adults had significantly better outcomes in terms of any employment and competitive employment than older ( > 30 years ) adults . However , in multivariable models of participants r and omly assigned to SE , young adults had significantly better outcomes than youth or older adults . Other significant predictors of employment and competitive employment were future work expectations , not receiving Supplemental Security Income , and receipt of more hours of SE services . Characteristics of youth , young adults and SE programs that enhance employment are discussed in terms of policy and practice Objectives : The aim of the present study was to examine and compare the long-term effectiveness of the Integrated Supported Employment ( ISE ) programme , which consists of individual placement and support ( IPS ) and work-related social skills training , with the IPS programme on the vocational and non-vocational outcomes among individuals with severe mental illness ( SMI ) over a period of 3 years . Method : One hundred and eighty-nine participants with SMI were recruited from two non-government organizations and three day hospitals in Hong Kong and r and omly assigned into the ISE ( n = 58 ) , IPS ( n = 65 ) and traditional vocational rehabilitation ( TVR ) ( n = 66 ) groups . Vocational and non-vocational outcomes of the ISE and IPS participants were collected by a blind and independent assessor at 7 11 , 15 , 21 , 27 , 33 and 39 months after their admission , whereas the TVR groups were assessed only up to the 15th month follow up . Results : After 39 months of service provision , ISE participants obtained higher employment rate ( 82.8 % vs 61.5 %
Output:
| There was mixed evidence for effectiveness of group CBT on symptoms of depression .
An RCT of debt advice found no effect but had poor uptake .
' Job-club ' interventions may be effective in reducing depressive symptoms in unemployed people , particularly those at high risk of depression . |
MS210578 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: To investigate the effects of simultaneous explosive-strength and endurance training on physical performance characteristics , 10 experimental ( E ) and 8 control ( C ) endurance athletes trained for 9 wk . The total training volume was kept the same in both groups , but 32 % of training in E and 3 % in C was replaced by explosive-type strength training . A 5-km time trial ( 5 K ) , running economy ( RE ) , maximal 20-m speed ( V20 m ) , and 5-jump ( 5J ) tests were measured on a track . Maximal anaerobic ( MART ) and aerobic treadmill running tests were used to determine maximal velocity in the MART ( VMART ) and maximal oxygen uptake ( VO2 max ) . The 5 K time , RE , and VMART improved ( P < 0.05 ) in E , but no changes were observed in C. V20 m and 5J increased in E ( P < 0.01 ) and decreased in C ( P < 0.05 ) . VO2 max increased in C ( P < 0.05 ) , but no changes were observed in E. In the pooled data , the changes in the 5 K velocity during 9 wk of training correlated ( P < 0.05 ) with the changes in RE [ O2 uptake ( r = -0.54 ) ] and VMART ( r = 0.55 ) . In conclusion , the present simultaneous explosive-strength and endurance training improved the 5 K time in well-trained endurance athletes without changes in their VO2 max . This improvement was due to improved neuromuscular characteristics that were transferred into improved VMART and running economy Fifteen highly trained distance runners ( & OV0312;O2max 71.1 ± 6.0 ml·min−1·kg−1 , mean ± SD ) were r and omly assigned to a plyometric training ( PLY ; n = 7 ) or control ( CON ; n = 8) group . In addition to their normal training , the PLY group undertook 3 × 30 minutes PLY sessions per week for 9 weeks . Running economy ( RE ) was assessed during 3 × 4 minute treadmill runs ( 14 , 16 , and 18 km·h−1 ) , followed by an incremental test to measure & OV0312;O2max . Muscle power characteristics were assessed on a portable , unidirectional ground reaction force plate . Compared with CON , PLY improved RE at 18 km·h−1 ( 4.1 % , p = 0.02 ) , but not at 14 or 16 km·h−1 . This was accompanied by trends for increased average power during a 5-jump plyometric test ( 15 % , p = 0.11 ) , a shorter time to reach maximal dynamic strength during a strength quality assessment test ( 14 % , p = 0.09 ) , and a lower & OV0312;O2-speed slope ( 14 % , p = 0.12 ) after 9 weeks of PLY . There were no significant differences in cardiorespiratory measures or & OV0312;O2max as a result of PLY . In a group of highly-trained distance runners , 9 weeks of PLY improved RE , with likely mechanisms residing in the muscle , or alternatively by improving running mechanics In this study , we investigated whether a heavy strength training program , as an additive to an endurance running program , would cause significant improvements in 3-km run time in a group of recreationally fit women when compared with endurance-only ( EO ) training . Sixteen women aged between 18 and 27 years of age were r and omly assigned to either an EO group ( n = 9 ) or a concurrent strength and endurance ( CSE ) group ( n = 7 ) . A 10-week training program for both groups consisted of an endurance running program performed three afternoons per week . The CSE group also participated in strength training on the morning of each running session . Testing was conducted pre and post training in a 3-km time trial and measured & OV0312;o2peak , running economy , muscular strength ( 1 repetition maximum ) , and body composition and girth . There was a trend ( P = 0.07 ) toward greater improvement in 3-km performance time for the CSE group ( 106.7 ± 91.4 seconds ) when compared with the EO group ( 77.3 ± 93.0 seconds ) . Further , the CSE group showed an increase in strength levels when compared with the EO group . The CSE group showed significant increases ( P ≤ 0.05 ) in the parallel squat and hamstring curl , and a significant increase ( P ≤ 0.05 ) was also found in upper body strength for the bench press ( 11.9 % increase ) when compared with the EO group . There were no significant differences between the two groups for & OV0312;o2peak , running economy , body composition , or girth measurements . This study found no negative or compatibility problems when heavy strength training was added to an endurance running program , and a nonsignificant increase in improvement for 3-km times was evident The purpose of this study was to examine the efficacy of 11 wk of resistance training to failure vs. nonfailure , followed by an identical 5-wk peaking period of maximal strength and power training for both groups as well as to examine the underlying physiological changes in basal circulating anabolic and catabolic hormones . Forty-two physically active men were matched and then r and omly assigned to either a training to failure ( RF ; n = 14 ) , nonfailure ( NRF ; n = 15 ) , or control groups ( C ; n = 13 ) . Muscular and power testing and blood draws to determine basal hormonal concentrations were conducted before the initiation of training ( T0 ) , after 6 wk of training ( T1 ) , after 11 wk of training ( T2 ) , and after 16 wk of training ( T3 ) . Both RF and NRF result ed in similar gains in 1-repetition maximum bench press ( 23 and 23 % ) and parallel squat ( 22 and 23 % ) , muscle power output of the arm ( 27 and 28 % ) and leg extensor muscles ( 26 and 29 % ) , and maximal number of repetitions performed during parallel squat ( 66 and 69 % ) . RF group experienced larger gains in the maximal number of repetitions performed during the bench press . The peaking phase ( T2 to T3 ) after NRF result ed in larger gains in muscle power output of the lower extremities , whereas after RF it result ed in larger gains in the maximal number of repetitions performed during the bench press . Strength training leading to RF result ed in reductions in resting concentrations of IGF-1 and elevations in IGFBP-3 , whereas NRF result ed in reduced resting cortisol concentrations and an elevation in resting serum total testosterone concentration . This investigation demonstrated a potential beneficial stimulus of NRF for improving strength and power , especially during the subsequent peaking training period , whereas performing sets to failure result ed in greater gains in local muscular endurance . Elevation in IGFBP-3 after resistance training may have been compensatory to accommo date the reduction in IGF-1 to preserve IGF availability Abstract Ramírez-Campillo , R , Álvarez , C , Henríquez-Olguín , C , Baez , EB , Martínez , C , And rade , DC , and Izquierdo , M. Effects of plyometric training on endurance and explosive strength performance in competitive middle- and long-distance runners . J Strength Cond Res 28(1 ) : 97–104 , 2014—The purpose of this study was to examine the effect of a short-term plyometric training program on explosive strength and endurance performance in highly competitive middle- and long-distance runners . Athletes were r and omly assigned to a control group ( CG , n = 18 , 12 men ) and an explosive strength training group ( TG , n = 18 , 10 men ) . Drop jump ( DJ ) from 20 ( DJ20 ) and 40 cm ( DJ40 ) , countermovement jump with arms ( CMJA ) , 20-m sprint time , and 2.4-km endurance run time test were carried out before and after 6 weeks of explosive strength training . Also , the combined st and ardized performance ( CSP ) in the endurance and explosive strength test was analyzed . After intervention , the CG did not show any significant change in performance , whereas the TG showed a significant reduction in 2.4-km endurance run time ( −3.9 % ) and 20-m sprint time ( −2.3 % ) and an increase in CMJA ( + 8.9 % ) , DJ20 ( + 12.7 % ) , and DJ40 ( 16.7 % ) explosive performance . Strength training group also exhibited a significant increase in CSP , although the CG showed significant reduction . We conclude that properly programmed concurrent explosive strength and endurance training could be advantageous for middle- and long-distance runners in their competitive performance , especially in events characterized by sprinting actions with small time differences at the end of the race Sáez Sáez de villarreal , E , Izquierdo , M , and Gonzalez-Badillo , JJ . Enhancing jump performance after combined vs. maximal power , heavy-resistance , and plyometric training alone . J Strength Cond Res 25(12 ) : 3274–3281 , 2011—The purpose of this study was to examine the effects of 5 different stimuli on jumping ability and power production after 7 weeks of training . Sixty-five ( 47 men and 18 women ) physical education students were r and omly assigned to 5 experimental groups that performed : combination of all training methods ( A ) ; heavy-resistance training using full-squat exercise ( i.e. , 56–85 % of 1 RM for 3–6 repetitions ) ( B ) ; power-oriented strength training using a parallel-squat exercise ( i.e. , 100–130 % of load that maximizes power output for 2–6 repetitions ) ( C ) ; power-oriented strength training using a loaded countermovement jumping ( i.e. , 70–100 % of load that maximizes power output for 2–5 repetitions ; countermovement jump [ CMJ ] ) ( D ) ; and plyometric jumping ( E ) . The CMJ ( cm ) , loaded CMJ ( cm ) , maximum rate of force development ( RFDmax ) during early concentric phase of loaded CMJ ( N·s−1 ) and power output during early concentric phase of loaded CMJ ( watts ) were measured before and after 7 weeks of training . Significant improvements in CMJ ( from 7.8 to 13.2 % ) were observed in all groups . Significantly greater increases in power output during loaded jumps were observed in A ( 10–13 % ) and D ( 8–12 % ) groups compared with in the other groups . Significant increases in RFDmax were observed in A ( 20–30 % ) , C ( 18–26 % ) , and D ( 20–26 % ) groups . The results of this study provide evidence to suggest that if training program is design ed and implemented correctly , both traditional slow velocity training and faster power-oriented strength training alone , or in combination with plyometric training , would provide a positive training stimulus to enhance jumping performance The purpose of this study was to examine the effect of 3 volumes of heavy resistance , average relative training intensity ( expressed as a percentage of 1 repetition maximum that represented the absolute kilograms lifted divided by the number of repetitions performed ) programs on maximal strength ( 1RM ) in Snatch ( Sn ) , Clean & Jerk ( C&J ) , and Squat ( Sq ) . Twenty-nine experienced ( .3 years ) , trained junior weight-lifters were r and omly assigned into 1 of 3 groups : low-intensity group ( LIG ; n = 12 ) , moderate-intensity group ( MIG ; n = 9 ) , and high-intensity group ( HIG ; n = 8) . All subjects trained for 10 weeks , 4–5 days a week , in a periodized routine using the same exercises and training volume ( expressed as total number of repetitions performed at intensities equal to or greater than 60 % of 1RM ) , but different programmed total repetitions at intensities of .90–100 % of 1RM for the entire 10-week period : LIG ( 46 repetitions ) , MIG ( 93 repetitions ) , and HIG ( 184 repetitions ) . During the training period , MIG and LIG showed a significant increase ( p < 0.01–0.05 ) for C & J ( 10.5 % and 3 % for MIG and LIG , respectively ) and Sq ( 9.5 % and 5.3 % for MIG and LIG , respectively ) , whereas in HIG the increase took place only in Sq ( 6.9 % , p < 0.05 ) . A calculation of effect sizes revealed greater strength gains in the MIG than in HIG or LIG . There were no significant differences between LIG and HIG training volume-induced strength gains . All the subjects in HIG were unable to fully accomplish the repetitions programmed at relative intensities greater than 90 % of 1RM . The present results indicate that short-term resistance training using moderate volumes of high relative intensity tended to produce higher enhancements in weightlifting performance compared with low and high volumes of high relative training intensities of equal total volume in experienced , trained young weightlifters . Therefore , for the present population of weightlifters , it may be beneficial to use the MIG training protocol to improve the weightlifting program at least in a short-term ( 10 weeks ) cycle of training The present study examines changes in muscle structure and neuromuscular performance induced by 15 weeks of power training with explosive muscle actions . Twenty-three subjects , including 10 controls , volunteered for the study . Muscle biopsies were obtained from the gastrocnemius muscle before and after the training period , while maximal voluntary isometric contractions ( MVC ) and drop jump tests were performed once every
Output:
| In conclusion , a strength training program including low to high intensity resistance exercises and plyometric exercises performed 2 - 3 times per week for 8 - 12 weeks is an appropriate strategy to improve RE in highly trained middle- and long-distance runners |
MS210579 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Correctable weaknesses in the design , conduct , and analysis of biomedical and public health research studies can produce misleading results and waste valuable re sources . Small effects can be difficult to distinguish from bias introduced by study design and analyses . An absence of detailed written protocol s and poor documentation of research is common . Information obtained might not be useful or important , and statistical precision or power is often too low or used in a misleading way . Insufficient consideration might be given to both previous and continuing studies . Arbitrary choice of analyses and an overemphasis on r and om extremes might affect the reported findings . Several problems relate to the research workforce , including failure to involve experienced statisticians and method ologists , failure to train clinical research ers and laboratory scientists in research methods and design , and the involvement of stakeholders with conflicts of interest . Inadequate emphasis is placed on recording of research decisions and on reproducibility of research . Finally , reward systems incentivise quantity more than quality , and novelty more than reliability . We propose potential solutions for these problems , including improvements in protocol s and documentation , consideration of evidence from studies in progress , st and ardisation of research efforts , optimisation and training of an experienced and non-conflicted scientific workforce , and reconsideration of scientific reward systems BACKGROUND AND OBJECTIVE Enrichment strategies which select subjects who appear to respond to the drug have been used in drug studies to demonstrate clinical efficacy . We have used clinical trial simulation techniques to examine factors that are relevant in clinical trial design based on enrichment where poor responders are excluded from the double-blind phase of the study . METHODS Simulations were performed for an analgesic trial design involving an open-dose titration phase ( enrichment phase ) followed by a double-blind , r and omized , placebo-controlled maintenance phase . Enrichment was examined by excluding subjects above a predefined pain score ( cutoff ) from analysis of efficacy for the maintenance phase . Cutoff pain scores ranging from 4 to 7 on a 0 to 10 categorical scale were examined . A data base consisting of chronic pain patients who participated in studies with a new formulation of buprenorphine was used to build the simulation model . Since no data were available for the key model variable " correlation between treatment and placebo response " , values of 0.25 , 0.5 , and 0.75 were used for the simulations . RESULTS A correlation between treatment and placebo effect ranging from 0.75 to 0.25 will cause the likelihood of trial success to vary from 50 % to 95 % . This model also shows that recruitment efficiency will decrease with the use of lower cutoff pain scores . CONCLUSION Prior to using enrichment techniques , investigators must consider the correlation between treatment effect and placebo response to optimize clinical trial design Background Knee osteoarthritis ( OA ) is a major cause of pain and functional limitation in older adults , yet longer-term studies of medical treatment of OA are limited . Objective To evaluate the efficacy and safety of glucosamine and chondroitin sulphate ( CS ) , alone or in combination , as well as celecoxib and placebo on painful knee OA over 2 years . Methods A 24-month , double-blind , placebo-controlled study , conducted at nine sites in the US ancillary to the Glucosamine/chondroitin Arthritis Intervention Trial , enrolled 662 patients with knee OA who satisfied radiographic criteria ( Kellgren/Lawrence grade 2 or 3 changes and baseline joint space width of at least 2 mm ) . This subset continued to receive their r and omised treatment : glucosamine 500 mg three times daily , CS 400 mg three times daily , the combination of glucosamine and CS , celecoxib 200 mg daily , or placebo over 24 months . The primary outcome was a 20 % reduction in Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) pain over 24 months . Secondary outcomes included an Outcome Measures in Rheumatology/Osteoarthritis Research Society International response and change from baseline in WOMAC pain and function . Results Compared with placebo , the odds of achieving a 20 % reduction in WOMAC pain were celecoxib : 1.21 , glucosamine : 1.16 , combination glucosamine/CS : 0.83 and CS alone : 0.69 , and were not statistically significant . Conclusions Over 2 years , no treatment achieved a clinical ly important difference in WOMAC pain or function as compared with placebo . However , glucosamine and celecoxib showed beneficial but not significant trends . Adverse reactions were similar among treatment groups and serious adverse events were rare for all treatments OBJECTIVES Patients with chronic noncancer pain frequently report symptoms of depression and anxiety ( negative affect ) , which are associated with higher ratings of pain intensity and a greater likelihood of being prescribed chronic opioid therapy . The purpose of this secondary analysis was to test the hypothesis that initial levels of negative affect can predict treatment-related outcomes in a double-blind , placebo-controlled study of extended-release ( ER ) hydromorphone among opioid-tolerant patients with chronic low back pain . METHODS Four hundred fifty-nine ( N = 459 ) patients participated in the titration/conversion phase of a multicenter study , of which 268 were r and omized to receive once-daily hydromorphone or placebo . All patients completed the Hospital Anxiety and Depression Scale ( HADS ) at baseline and were divided evenly into Low ( N = 157 ) , Moderate ( N = 155 ) , and High ( N = 147 ) negative affect groups based on their scores . Group differences in numerical pain intensity measures at home and in the clinic , Rol and -Morris Disability ratings , and measures of symptoms from the Subjective Opiate Withdrawal Scale ( SOWS ) throughout the trial were analyzed . RESULTS Two hundred sixty-eight of the initial 459 subjects who entered the 2 to 4-week titration/conversion phase ( pretreatment ) were successfully r and omized to either placebo or ER hydromorphone ; a total of 110 patients then completed this double-blind phase of the study . Those in the Moderate and High negative affect groups tended to drop out more often during the titration/conversion phase because of the adverse effects or lack of efficacy of their prescribed opioid than those in the Low negative mood group ( P < 0.05 ) . Overall , those patients in the Moderate and High groups reported significantly higher pain intensity scores in at-home and in-clinic pain intensity ratings ( P < 0.05 ) , greater disability on the Rol and -Morris Scale ( P < 0.01 ) , and more withdrawal symptoms on the SOWS ( P < 0.05 ) than those in the Low group . Higher negative affect scores also predicted less favorable ratings of the study drug during the titration phase ( P < 0.05 ) . Interestingly , the High negative affect group showed the most improvement in pain in the placebo condition ( P < 0.05 ) . CONCLUSIONS Negative affect is associated with diminished benefit during a trial of opioid therapy and is predictive of dropout in a controlled clinical trial OBJECTIVE To compare the analgesic efficacy and safety of nonprescription doses of naproxen sodium , ibuprofen , and placebo in patients with osteoarthritis ( OA ) of the knee . METHODS In 2 identical multicenter , r and omized , double-blind , placebo-controlled , multidose , parallel- design studies , patients aged > or = 25 years with OA were r and omized to daily doses of naproxen sodium 660 mg , naproxen sodium 440 mg ( patients > or = 65 years ) , ibuprofen 1200 mg , or placebo , for 7 days . RESULTS For investigator and patient assessment of knee joint pain , naproxen sodium ( 440/660 mg ) and ibuprofen were clinical ly effective at relieving pain compared with placebo ( n = 444 ) ; both treatments reduced the mean symptom score by 30 - 45 % , compared with a 20 - 25 % reduction with placebo . Naproxen sodium ( 440/660 mg ) significantly improved all 7 symptoms from baseline compared with placebo , while ibuprofen significantly improved 5 of the symptoms . For the subgroup of patients aged > or = 65 years ( n = 183 ) , naproxen sodium 440 mg was significantly superior to placebo in all symptoms except pain on weight-bearing ; ibuprofen only significantly reduced day pain . For daily diary evaluations , naproxen sodium and ibuprofen were effective in reducing all 6 symptoms ; there was a trend toward higher efficacy for night-time pain with naproxen sodium 440/660 mg compared with ibuprofen . There were no significant differences in adverse event reporting between groups . CONCLUSION Over-the-counter doses of naproxen sodium ( 440/660 mg ) and ibuprofen ( 1200 mg ) effectively relieve pain in patients with mild to moderate OA of the knee . Naproxen sodium provided more effective pain relief for most variables compared with placebo , and for night pain compared with ibuprofen . Efficacy was combined with good safety and tolerability Background : The ancient Indian ( Asian ) Ayurvedic medicinal system uses herbomineral drugs to treat arthritis . Despite centuries of use , very few have been tested by drug trials . RA-11 ( ARTREX , MENDAR ) , a st and ardized multiplant Ayurvedic drug ( Withania somnifera , Boswellia serrata , Zingiber officinale , and Curcuma longa ) is currently used to treat arthritis . Objective : The objective of this study was to evaluate the efficacy and safety of RA-11 in patients with symptomatic osteoarthritis ( OA ) of the knees . Methods : A total of 358 patients with chronic knee pain were screened free-of-cost in “ arthritis camps ” in an Indian metropolis . Ninety patients with primary OA of the knees ( ACR classification ; Arthritis Rheum 1986;29:1039–1049 ) were found eligible ( postanalgesic washout pain visual analog score [ VAS ] ≥40 mm in either or both knees on body weight-bearing activities ) to enroll into a r and omized , double-blind , placebo-controlled , parallel efficacy , single-center , 32-week drug trial ( 80 % power to detect 25 % difference , P = 0.05 , 2-sided ) . Concurrent analgesics/nonsteroidal antiinflammatory drugs and steroids in any form were not allowed . Lifestyle and /or dietary restrictions , as per routine Ayurveda practice s , were not imposed . Pain VAS ( maximum pain in each knee recorded by the patient during the preceding 48 hours ) and modified WOMAC ( Western Ontario McMaster University OA Index , Likert scale , version 3.0 ) were the primary efficacy variables . The WOMAC section on “ physical function difficulty ” was modified for Indian use and vali date d before the trial . Routine laboratory testing was primarily done to monitor drug safety . At baseline , the groups ( active = 45 , placebo = 45 ) were well matched for several measures ( mean pain VAS : active = 6.17 ; placebo = 6.5 ) . Results :1 ) Efficacy : Compared with placebo , the mean reduction in pain VAS at week 16 ( active = 2.7 , placebo = 1.3 ) and week 32 ( active = 2.8 , placebo = 1.8 ) in the active group was significantly ( P < 0.05 , analysis of variance [ ANOVA ] ) better . Similarly , the improvement in the WOMAC scores at week 16 and week 32 were also significantly superior ( P < 0.01 , ANOVA ) in the active group . 2 ) Safety : Both the groups reported mild adverse events ( AE ) without any significant difference . 3 ) Withdrawals : Twenty-eight patients were discontinued . None reported drug-related toxicity . The majority failed follow up/compliance . No differences were observed between the groups . Conclusion : This controlled drug trial demonstrates the potential efficacy and safety of RA- 11 in the symptomatic treatment of OA knees over 32 weeks of therapy Properly conducted r and omised trials can aid clinical decision-making by providing unbiased estimates of the average size of treatment effects . This paper , the first of two , discusses how readers of clinical trials can extract simple estimates of treatment effect size from trial reports when trial outcomes are measured on a continuous scale . When making decisions about therapy for individual patients , these estimates can be modified on the basis of patient characteristics . Modified estimates of treatment effect size can be used to determine if the effect of treatment is likely to be large enough to be " clinical ly worthwhile " . This approach optimises clinical decision-making by combining unbiased estimates of the size of treatment effect from clinical trials with clinical intuition and patient preferences OBJECTIVE To compare the efficacy of etoricoxib 30 mg with the generally maximum recommended dose of celecoxib , 200 mg , in the treatment of osteoarthritis ( OA ) in two identically design ed studies . METHODS Two multi-centre , 26-week , double-blind , placebo-controlled , non-inferiority studies were conducted , enrolling patients who were prior non-steroidal anti-inflammatory drug ( NSAID ) or acetaminophen users . There were 599 patients in study 1 and 608 patients in study 2 r and omized 4:4:1:1 to etoricoxib 30 mg qd , celecoxib 200 mg qd or one of two placebo groups for 12 weeks . After 12 weeks , placebo patients were evenly distributed to et
Output:
| There were no overall differences in effect sizes between enriched and nonenriched design s for pain intensity .
There was a significant difference for a reduction in any adverse events favouring enriched design s for opioids , but not for other analgesics or the outcome serious adverse events .
There was an association between effect size and method ological quality , with failure to blind the outcome assessor and failure to use intention-to-treat analysis being associated with larger effect sizes .
There is no evidence that the use of an enriched study design changes the treatment effect size estimate for pain .
There is some evidence that clinical trials that employ enriched design s report a reduced risk of adverse events in trials for chronic musculoskeletal pain , but it is unclear whether enriched design s influence estimates of serious adverse events .
Features of trial design and study quality were associated with treatment effect estimates |
MS210580 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Prevention of mother to child HIV transmission ( PMTCT ) programmes have great potential to achieve virtual elimination of perinatal HIV transmission provided that PMTCT recommendations are properly followed . This study assessed mothers and infants adherence to medication regimen for PMTCT and the proportions of exposed infants who were followed up in the PMTCT programme . Methods A prospect i ve cohort study was conducted among 282 HIV-positive mothers attending 15 health facilities in Addis Ababa , Ethiopia . Descriptive statistics , bivariate and mulitivariate logistic regression analyses were done . Results Of 282 mothers enrolled in the cohort , 232 ( 82 % , 95 % CI 77 - 86 % ) initiated medication during pregnancy , 154 ( 64 % ) initiated combined zidovudine ( ZDV ) prophylaxis regimen while 78 ( 33 % ) were initiated lifelong antiretroviral treatment ( ART ) . In total , 171 ( 60 % , 95 % CI 55 - 66 % ) mothers ingested medication during labour . Of the 221 live born infants ( including two sets of twins ) , 191 ( 87 % , 95 % CI 81 - 90 % ) ingested ZDV and single-dose nevirapine ( sdNVP ) at birth . Of the 219 live births ( twin births were counted once ) , 148 ( 68 % , 95 % CI 61 - 73 % ) mother-infant pairs ingested their medication at birth . Medication ingested by mother-infant pairs at birth was significantly and independently associated with place of delivery . Mother-infant pairs attended in health facilities at birth were more likely ( OR 6.7 95 % CI 2.90 - 21.65 ) to ingest their medication than those who were attended at home . Overall , 189 ( 86 % , 95 % CI 80 - 90 % ) infants were brought for first pentavalent vaccine and 115 ( 52 % , 95 % CI 45 - 58 % ) for early infant diagnosis at six-weeks postpartum . Among the infants brought for early diagnosis , 71 ( 32 % , 95 % CI 26 - 39 % ) had documented HIV test results and six ( 8.4 % ) were HIV positive . Conclusions We found a progressive decline in medication adherence across the perinatal period . There is a big gap between mediation initiated during pregnancy and actually ingested by the mother-infant pairs at birth . Follow up for HIV-exposed infants seem not to be organized and is inconsistent . In order to maximize effectiveness of the PMTCT programme , the rate of institutional delivery should be increased , the quality of obstetric services should be improved and missed opportunities to exposed infant follow up should be minimized Background The aim of this study was to describe barriers to accessing and accepting highly active antiretroviral therapy ( HAART ) by HIV-positive mothers in the Ug and an Kabarole District 's Programme for the Prevention of Mother to Child Transmission-Plus ( PMTCT-Plus ) . Methods Our study was a qualitative descriptive exploratory study using thematic analysis . Individual in-depth interviews ( n = 45 ) were conducted with r and omly selected HIV-positive mothers who attended this programme , and who : ( a ) never enrolled in HAART ( n = 17 ) ; ( b ) enrolled but did not come back to receive HAART ( n = 2 ) ; ( c ) defaulted/interrupted HAART ( n = 14 ) ; and ( d ) are currently adhering to HAART ( n = 12 ) . A focus group was also conducted to verify the results from the interviews . Results Results indicated that economic concerns , particularly transport costs from residences to the clinics , represented the greatest barrier to accessing treatment . In addition , HIV-related stigma and non-disclosure of HIV status to clients ' sexual partners , long waiting times at the clinic and suboptimal provider-patient interactions at the hospital emerged as significant barriers . Conclusions These barriers to antiretroviral treatment of pregnant and post-natal women need to be addressed in order to improve HAART uptake and adherence for this group of the population . This would improve their survival and , at the same time , drastically reduce HIV transmission from mother to child BACKGROUND The most effective highly active antiretroviral therapy ( HAART ) to prevent mother-to-child transmission of human immunodeficiency virus type 1 ( HIV-1 ) in pregnancy and its efficacy during breast-feeding are unknown . METHODS We r and omly assigned 560 HIV-1-infected pregnant women ( CD4 + count , > or = 200 cells per cubic millimeter ) to receive coformulated abacavir , zidovudine , and lamivudine ( the nucleoside reverse-transcriptase inhibitor [ NRTI ] group ) or lopinavir-ritonavir plus zidovudine-lamivudine ( the protease-inhibitor group ) from 26 to 34 weeks ' gestation through planned weaning by 6 months post partum . A total of 170 women with CD4 + counts of less than 200 cells per cubic millimeter received nevirapine plus zidovudine-lamivudine ( the observational group ) . Infants received single-dose nevirapine and 4 weeks of zidovudine . RESULTS The rate of virologic suppression to less than 400 copies per milliliter was high and did not differ significantly among the three groups at delivery ( 96 % in the NRTI group , 93 % in the protease-inhibitor group , and 94 % in the observational group ) or throughout the breast-feeding period ( 92 % in the NRTI group , 93 % in the protease-inhibitor group , and 95 % in the observational group ) . By 6 months of age , 8 of 709 live-born infants ( 1.1 % ) were infected ( 95 % confidence interval [ CI ] , 0.5 to 2.2 ) : 6 were infected in utero ( 4 in the NRTI group , 1 in the protease-inhibitor group , and 1 in the observational group ) , and 2 were infected during the breast-feeding period ( in the NRTI group ) . Treatment-limiting adverse events occurred in 2 % of women in the NRTI group , 2 % of women in the protease-inhibitor group , and 11 % of women in the observational group . CONCLUSIONS All regimens of HAART from pregnancy through 6 months post partum result ed in high rates of virologic suppression , with an overall rate of mother-to-child transmission of 1.1 % . ( Clinical Trials.gov number , NCT00270296 . Background : Novel strategies are needed to increase retention in prevention of mother-to-child HIV transmission ( PMTCT ) services . We have recently shown that small , incremental cash transfers conditional on attending clinic result ed in increased retention along the PMTCT cascade . However , whether women who receive incentives to attend clinic visits are as adherent to antiretrovirals ( ARV ) as those who do not was unknown . Objective : To determine whether HIV-infected women who received incentives to remain in care were as adherent to antiretroviral treatment and achieved the same level of viral suppression at 6 weeks postpartum as those who did not receive incentives but also remained in care . Methods : Newly diagnosed HIV-infected women at ⩽32 weeks gestational age were recruited at antenatal care clinics in Kinshasa , Democratic Republic of Congo . Women were r and omized in a 1:1 ratio to an intervention or control group . The intervention group received compensation ( $ 5 , plus $ 1 increment at each subsequent visit ) conditional on attending scheduled clinic visits and accepting offered PMTCT services , whereas the control group received usual care . The proportion of participants who remained in care , were fully adherent ( took all their pills at each visit ) or with undetectable viral load at 6 weeks postpartum were compared across group . Results : Among 433 women r and omized ( 216 in intervention group and 217 in control group ) , 332 ( 76.7 % ) remained in care at 6 weeks postpartum , including 174 ( 80.6 % ) in the intervention group and 158 ( 72.8 % ) in the control group , ( P = 0.04 ) . Data on pill count were available for 297 participants ( 89.5 % ) , including 156 ( 89.7 % ) and 141 ( 89.2 % ) in the intervention and control groups , respectively ; 69.9 % ( 109/156 ) and 68.1 % ( 96/141 ) in the intervention and control groups had perfect adherence [ risk difference , 0.02 ; 95 % CI : −0.06 to 0.09 ] . Viral load results were available for 171 ( 98.3 % ) and 155 ( 98.7 % ) women in the intervention and control groups , respectively ; 66.1 % ( 113/171 ) in the intervention group and 69.7 % ( 108/155 ) in the control group had an undetectable viral load ( risk difference , −0.04 ; 95 % CI : −0.14 to 0.07 ) . Results were similar after adjusting for marital status , age , education , baseline CD4 count , viral load , gestational age , and initial ARV regimen . Conclusions : Although the provision of cash incentives to HIV-infected pregnant women led to higher retention in care at 6 weeks postpartum , among those retained in care , adherence to ARVs and virologic suppression did not differ by study group Causes for loss-to-follow-up , including early refusals of and stopping antiretroviral therapy ( ART ) , in Malawi ’s Option B+ program are poorly understood . This study examines the main barriers and facilitators to uptake and adherence to ART under Option B+ . In depth interviews were conducted with HIV-infected women who were pregnant or postpartum in Lilongwe , Malawi ( N = 65 ) . Study participants included women who refused ART initiation ( N = 10 ) , initiated ART and then stopped ( N = 26 ) , and those who initiated ART and remained on treatment ( N = 29 ) . The barriers to ART initiation were varied and included concerns about partner support , feeling healthy , and needing time to think . The main reasons for stopping ART included side effects and lack of partner support . A substantial number of women started ART after initially refusing or stopping ART . There were several facilitators for re-starting ART , including encouragement from community health workers , side effects subsiding , decline in health , change in partner , and fear of future sickness . Amongst those who remained on ART , desire to prevent transmission and improve health were the most influential facilitators . Reasons for refusing and stopping ART were varied . ART-related side effects and feeling healthy were common barriers to ART initiation and adherence . Providing consistent pre-ART counseling , early support for patients experiencing side effects , and targeted efforts to bring women who stop treatment back into care may improve long term health outcomes Introduction To prevent mother-to-child transmission ( MTCT ) of HIV in developing countries , new World Health Organization ( WHO ) guidelines recommend maternal combination antiretroviral therapy ( cART ) during pregnancy , throughout breastfeeding for 1 year and then cessation of breastfeeding ( COB ) . The efficacy of this approach during the first six months of exclusive breastfeeding has been demonstrated , but the efficacy of this approach beyond six months is not well documented . Methods A prospect i ve observational cohort study of 279 HIV-positive mothers was started on zidovudine/3TC and lopinavir/ritonavir tablets between 14 and 30 weeks gestation and continued indefinitely thereafter . Women were encouraged to exclusively breastfeed for six months , complementary feed for the next six months and then cease breastfeeding between 12 and 13 months . Infants were followed for transmission to 18 months and for survival to 24 months . Text message reminders and stipends for food and transport were utilized to encourage adherence and follow-up . Results Total MTCT was 9 of 219 live born infants ( 4.1 % ; confidence interval ( CI ) 2.2–7.6 % ) . All breastfeeding transmissions that could be timed ( 5/5 ) occurred after six months of age . All mothers who transmitted after six months had a six-month plasma viral load > 1,000 copies/ml ( p<0.001 ) . Poor adherence to cART as noted by missed dispensary visits was associated with transmission ( p=0.04 ) . Infant mortality was lower after six months of age than during the first six months of life ( p=0.02 ) . The cumulative rate of infant HIV infection or death at 18 months was 29/226 ( 12.8 % 95 CI : 7.5–20.8 % ) . Conclusions Maternal cART may limit MTCT of HIV to the UNAIDS target of < 5 % for eradication of paediatric HIV within the context of a clinical study , but poor adherence to cART and follow-up can limit the benefit . Continued breastfeeding can prevent the rise in infant mortality after six months seen in previous studies , which encouraged early COB Background Adherence to antiretroviral ( ARV ) drugs is essential for eliminating new pediatric infections of human immunodeficiency virus ( HIV )
Output:
| Results The review demonstrated that stigma , cost of transportation , food deprivation and a woman ’s disclosure or non-disclosure of her HIV status to a partner , family and the community , could limit or define the extent of her adherence to prescribed antiretroviral drugs during pregnancy .
Furthermore , the review indicated that knowledge of HIV status , either before or during pregnancy , was significantly associated with medication adherence .
Women who knew their HIV status before pregnancy demonstrated good adherence while women who found out their HIV infection status during pregnancy were linked with non-adherence to ART .
Conclusion This review revealed several barriers and enablers of adherence among pregnant women taking ART in sub-Saharan Africa .
Major barriers included the fear of HIV infection status disclosure to partners and family members , stigma and discrimination .
A major enabler of adherence in women taking ART was women ’s knowledge of their HIV status prior to becoming pregnant . |
MS210581 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background : Most patients with type 1 diabetes do not achieve their glycemic targets . We aim ed to assess the efficacy of glucose-responsive insulin and glucagon closed-loop delivery for controlling glucose levels in adults with type 1 diabetes . Methods : We conducted a r and omized crossover trial involving 15 adults with type 1 diabetes , comparing st and ard insulin-pump therapy with dual-hormone , closed-loop delivery . Patients were admitted twice to a clinical research facility and received , in r and om order , both treatments . Each 15-hour visit ( from 1600 to 0700 ) included an evening exercise session , followed by a medium-sized meal , a bedtime snack and an overnight stay . During visits that involved closed-loop delivery , basal insulin and glucagon miniboluses were delivered according to recommendations based on glucose sensor readings and a predictive dosing algorithm at 10-minute intervals . During visits involving st and ard insulin-pump therapy ( control visits ) , patients used conventional treatment . Results : Dual-hormone closed-loop delivery increased the percentage of time for which patients ’ plasma glucose levels were in the target range ( median 70.7 % [ interquartile range ( IQR ) 46.1%–88.4 % ] for closed-loop delivery v. 57.3 % [ IQR 25.2%–71.8 % ] for control , p = 0.003 ) and decreased the percentage of time for which plasma glucose levels were in the low range ( bottom of target range [ < 4.0 mmol/L ] , 0.0 % [ IQR 0.0%–3.0 % ] for closed-loop delivery v. 10.2 % [ IQR 0.0%–13.0 % ] for control , p = 0.01 ; hypoglycemia threshold [ < 3.3 mmol/L ] , 0.0 % [ IQR 0.0%–0.0 % ] for closed-loop delivery v. 2.8 % [ IQR 0.0%–5.9 % ] for control , p = 0.006 ) . Eight participants ( 53 % ) had at least 1 hypoglycemic event ( plasma glucose < 3.0 mmol/L ) during st and ard treatment , compared with just 1 participant ( 7 % ) during closed-loop treatment ( p = 0.02 ) . Interpretation : Dual-hormone , closed-loop delivery guided by advanced algorithms improved short-term glucose control and reduced the risk of hypoglycemia in a group of 15 adults with type 1 diabetes . Trial registration : Clinical Trials.gov , no. NCT01297946 OBJECTIVE We estimate the effect size of hypoglycemia risk reduction on closed-loop control ( CLC ) versus open-loop ( OL ) sensor-augmented insulin pump therapy in supervised outpatient setting . RESEARCH DESIGN AND METHODS Twenty patients with type 1 diabetes initiated the study at the Universities of Virginia , Padova , and Montpellier and Sansum Diabetes Research Institute ; 18 completed the entire protocol . Each patient participated in two 40-h outpatient sessions , CLC versus OL , in r and omized order . Sensor ( Dexcom G4 ) and insulin pump ( T and em t : slim ) were connected to Diabetes Assistant (DiAs)—a smartphone artificial pancreas platform . The patient operated the system through the DiAs user interface during both CLC and OL ; study personnel supervised on site and monitored DiAs remotely . There were no dietary restrictions ; 45-min walks in town and restaurant dinners were included in both CLC and OL ; alcohol was permitted . RESULTS The primary outcome —reduction in risk for hypoglycemia as measured by the low blood glucose ( BG ) index (LGBI)— result ed in an effect size of 0.64 , P = 0.003 , with a twofold reduction of hypoglycemia requiring carbohydrate treatment : 1.2 vs. 2.4 episodes/session on CLC versus OL ( P = 0.02 ) . This was accompanied by a slight decrease in percentage of time in the target range of 3.9–10 mmol/L ( 66.1 vs. 70.7 % ) and increase in mean BG ( 8.9 vs. 8.4 mmol/L ; P = 0.04 ) on CLC versus OL . CONCLUSIONS CLC running on a smartphone ( DiAs ) in outpatient conditions reduced hypoglycemia and hypoglycemia treatments when compared with sensor-augmented pump therapy . This was accompanied by marginal increase in average glycemia result ing from a possible overemphasis on hypoglycemia safety OBJECTIVE Inpatient studies suggest that model predictive control ( MPC ) is one of the most promising algorithms for artificial pancreas ( AP ) . So far , outpatient trials have used hypo/hyperglycemia-mitigation or medical-expert systems . In this study , we report the first wearable AP outpatient study based on MPC and investigate specifically its ability to control postpr and ial glucose , one of the major challenges in glucose control . RESEARCH DESIGN AND METHODS A new modular MPC algorithm has been design ed focusing on meal control . Six type 1 diabetes mellitus patients underwent 42-h experiments : sensor-augmented pump therapy in the first 14 h ( open-loop ) and closed-loop in the remaining 28 h. RESULTS MPC showed satisfactory dinner control versus open-loop : time-in-target ( 70–180 mg/dL ) 94.83 vs. 68.2 % and time-in-hypo 1.25 vs. 11.9 % . Overnight control was also satisfactory : time-in-target 89.4 vs. 85.0 % and time-in-hypo : 0.00 vs. 8.19 % . CONCLUSIONS This outpatient study confirms inpatient evidence of suitability of MPC-based strategies for AP . These encouraging results pave the way to r and omized crossover outpatient studies OBJECTIVE To evaluate the feasibility and efficacy of a fully integrated hybrid closed-loop ( HCL ) system ( Medtronic MiniMed Inc. , Northridge , CA ) , in day and night closed-loop control in subjects with type 1 diabetes , both in an inpatient setting and during 6 days at diabetes camp . RESEARCH DESIGN AND METHODS The Medtronic MiniMed HCL system consists of a fourth generation ( 4S ) glucose sensor , a sensor transmitter , and an insulin pump using a modified proportional-integral-derivative ( PID ) insulin feedback algorithm with safety constraints . Eight subjects were studied over 48 h in an inpatient setting . This was followed by a study of 21 subjects for 6 days at diabetes camp , r and omized to either the closed-loop control group using the HCL system or to the group using the Medtronic MiniMed 530 G with threshold suspend ( control group ) . RESULTS The overall mean sensor glucose percent time in range 70–180 mg/dL was similar between the groups ( 73.1 % vs. 69.9 % , control vs. HCL , respectively ) ( P = 0.580 ) . Meter glucose values between 70 and 180 mg/dL were also similar between the groups ( 73.6 % vs. 63.2 % , control vs. HCL , respectively ) ( P = 0.086 ) . The mean absolute relative difference of the 4S sensor was 10.8 ± 10.2 % , when compared with plasma glucose values in the inpatient setting , and 12.6 ± 11.0 % compared with capillary Bayer CONTOUR NEXT LINK glucose meter values during 6 days at camp . CONCLUSIONS In the first clinical study of this fully integrated system using an investigational PID algorithm , the system did not demonstrate improved glucose control compared with sensor-augmented pump therapy alone . The system demonstrated good connectivity and improved sensor performance BACKGROUND Artificial pancreas ( AP ) systems have shown an improvement in glucose control and a reduced risk of nocturnal hypoglycemia under controlled conditions but remain to be evaluated under daily-life conditions . OBJECTIVE To assess the feasibility , safety , and efficacy of the MD-Logic AP in controlling nocturnal glucose levels in the patient 's home . METHODS Two-arm study , each covering four consecutive nights comparing the MD-Logic AP ( ' closed-loop ' arm ) with sensor-augmented pump therapy ( ' control ' arm ) . Fifteen patients ( mean age 19 ± 10.4 yr , A1c 7.5 ± 0.5 % or 58 ± 5.9 mmol/mol , diabetes duration 9.9 ± 8.2 yr ) were r and omly assigned either to ' Group A ' ( first ' closed-loop ' , then ' control ' arm ) or to ' Group B ' ( vice versa ) . Investigators were masked to treatment intervention . Primary endpoints were the time spent with glucose levels below 70 mg/dL and the percentage of nights in which the mean overnight glucose levels were within 90 - 140 mg/dL. Endpoint analyses were based on unmodified sensor glucose readings of the four study nights . RESULTS Time of glucose levels spent below 70 mg/dL was significantly shorter on the closed-loop nights than on control nights , median and interquartile range 3.8 ( 0 , 11.6 ) and 48.7 ( 0.6 , 67.9 ) min , respectively ; p = 0.0034 . The percentage of individual nights in which mean overnight glucose level was within 90 - 140 mg/dL was 67 ( 33 , 88 ) , and 50 ( 25 , 75 ) , under closed-loop and control nights , respectively , with no statistical difference . Secondary endpoint analyses demonstrated significant improvements in hypoglycemia parameters . No serious adverse events were reported . CONCLUSION This interim analysis demonstrates the feasibility , safety , and efficiency of the MD-Logic AP system in home use , and demonstrates an improvement over sensor-augmented pump therapy . ( Clinical Trials.gov identifier NCT01726829 ) A total of 1,441 patients with IDDM were r and omly assigned to receive either intensive ( n = 711 ) or conventional ( n = 730 ) diabetes therapy in the Diabetes Control and Complications Trial ( DCCT ) . The patients were followed for an average of 6.5 years . Subjects were instructed to report all episodes of suspected severe hypoglycemia to their health care team . In addition , at quarterly follow-up visits , each subject was asked about the occurrence of severe hypoglycemia . There were 3,788 episodes of severe hypoglycemia ( requiring assistance ) ; 1,027 of these episodes were associated with coma and /or seizure . A total of 65 % percent of patients in the intensive group vs. 35 % of patients in the conventional group had at least one episode of severe hypoglycemia by the study end ; the overall rates of severe hypoglycemia were 61.2 per 100 patient-years vs. 18.7 per 100 patient-years in the intensive and conventional treatment groups , respectively , with a relative risk ( RR ) of 3.28 . The relative risk for coma and /or seizure was 3.02 for intensive therapy . The increased risk with intensive treatment persisted over each of the 9 years of follow-up in the DCCT and over the calendar years 1984 - 1993 during which the study was conducted . When baseline patient characteristics were examined for effects on the risk of severe hypoglycemia , the relative risk of hypoglycemia for intensive versus conventional treatment was > or = 2 for all subgroups . Several subgroups defined by baseline characteristics , including males , adolescents , and subjects with no residual C-peptide or with a prior history of hypoglycemia , had a particularly high risk of severe hypoglycemia in both treatment groups . Analyses of the cumulative incidence of successive episodes indicated that intensive treatment was also associated with an increased risk of multiple episodes within the same patient ( e.g. , 22 % experienced five or more episodes of severe hypoglycemia within the first 5 years of follow-up vs. 4 % in the conventional group ) . Within both treatment groups , patients who experienced severe hypoglycemia were at increased risk of subsequent episodes . Approximately 30 % of patients in each group experienced a second episode within the 4 months following the first episode of severe hypoglycemia . Within each treatment group , the number of prior episodes of hypoglycemia was the strongest predictor of the risk of future episodes , followed closely by the current HbA1c value . After adjustment for the current quarterly HbA1c level , intensive treatment was still associated with a significantly increased risk of hypoglycemia , indicating that the increased risk with intensive treatment is not completely explained by differences in HbA1c values BACKGROUND The safety and efficacy of continuous , multiday , automated glycaemic management has not been tested in outpatient studies of preadolescent children with type 1 diabetes . We aim ed to compare the safety and efficacy of a bihormonal bionic pancreas versus conventional insulin pump therapy in this population of patients in an outpatient setting . METHODS In this r and omised , open-label , crossover study , we enrolled preadolescent children ( aged 6 - 11 years ) with type 1 diabetes ( diagnosed for ≥1 year ) who were on insulin pump therapy ,
Output:
| INTERPRETATION Artificial pancreas systems uniformly improved glucose control in outpatient setting s , despite heterogeneous clinical and technical factors . |
MS210582 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Objective To determine the prevalence and the prognostic significance of microalbuminuria in patients after aneurysmal subarachnoid hemorrhage ( SAH ) . Design Prospect i ve and observational clinical study . Setting Multidisciplinary intensive care unit . Patients Fifty-one consecutive patients who underwent aneurysm clipping or endovascular surgery after SAH ; 8 patients who underwent surgical clipping for unruptured intracerebral aneurysm served as control . InterventionNone . Measurements and Results General clinical and neurological data were recorded on admission . Urine was collected preoperatively and daily for up to 7 days postoperatively for measuring the urinary microalbumin/creatinine ratio . The Glasgow Coma Scale ( GCS ) score was also determined on admission and daily for up to 7 days after operation . Neurological outcome was assessed using the Glasgow Outcome Scale ( GOS ) at 3 months after stroke . The prevalence rates of microalbuminuria were 74.5 % in SAH and 37.5 % in the control . Among the 51 patients , 25 had unfavorable neurological outcome ( GOS 1–3 ) . The areas under the receiver operator characteristic curves showed that the highest urinary microalbumin/creatinine ratio and the lowest GCS score during the first 8 days were the significant predictors of unfavorable neurological outcome . The threshold value , sensitivity , specificity , and likelihood ratio for the highest urinary microalbumin/creatinine ratio were 200 mg/g , 60 % [ 95 % confidence interval ( CI ) 41–79 ] , 96 % ( 95 % CI 88–100 ) , and 15.6 ( 95 % CI 9.1–26.7 ) , respectively . Conclusions This study confirms a high prevalence of microalbuminuria in the SAH patients , and it suggests that the highest urinary microalbumin/creatinine ratio > 200 mg/g during the first 8 days is a significant predictor of unfavorable neurological outcome Background —Elevated urine albumin excretion ( UAER ) is a modifiable risk factor for renal and cardiovascular disease in type 2 diabetes . Blockade of the renin-angiotensin system lowers UAER , but whether this effect is independent of blood pressure ( BP ) reduction remains controversial . The MicroAlbuminuria Reduction With VALsartan ( MARVAL ) study was design ed to evaluate the BP-independent effect of valsartan on UAER in type 2 diabetic patients with microalbuminuria . Methods and Results —Three hundred thirty-two patients with type 2 diabetes and microalbuminuria , with or without hypertension , were r and omly assigned to 80 mg/d valsartan or 5 mg/d amlodipine for 24 weeks . A target BP of 135/85 mm Hg was aim ed for by dose-doubling followed by addition of bendrofluazide and doxazosin whenever needed . The primary end point was the percent change in UAER from baseline to 24 weeks . The UAER at 24 weeks was 56 % ( 95 % CI , 49.6 to 63.0 ) of baseline with valsartan and 92 % ( 95 % CI , 81.7 to 103.7 ) of baseline with amlodipine , a highly significant between-group effect ( P < 0.001 ) . Valsartan lowered UAER similarly in both the hypertensive and normotensive subgroups . More patients reversed to normoalbuminuria with valsartan ( 29.9 % versus 14.5%;P = 0.001 ) . Over the study period , BP reductions were similar between the two treatments ( systolic/diastolic 11.2/6.6 mm Hg for valsartan , 11.6/6.5 mm Hg for amlodipine ) and at no time point was there a between-group significant difference in BP values in either the hypertensive or the normotensive subgroup . Conclusions —For the same level of attained BP and the same degree of BP reduction , valsartan lowered UAER more effectively than amlodipine in patients with type 2 diabetes and microalbuminuria , including the subgroup with baseline normotension . This indicates a BP-independent antiproteinuric effect of valsartan Microalbuminuria is a strong and independent indicator of increased cardiovascular risk among individuals with and without diabetes . Therefore , microalbuminuria can be used for stratification of risk for cardiovascular disease . Once microalbuminuria is present , cardiovascular risk factor reduction should be more " aggressive . " The nature of the link between microalbuminuria and cardiovascular risk , however , remains poorly understood . There is no strong evidence that microalbuminuria causes atherothrombosis or that atherothrombosis causes microalbuminuria . Many studies have tested the hypothesis that a common risk factor underlies the association between microalbuminuria and cardiovascular disease but , again , have found no strong evidence in favor of this contention . At present , the most likely possibility is that a common pathophysiologic process , such as endothelial dysfunction , chronic low- grade inflammation , or increased transvascular leakage of macromolecules , underlies the association between microalbuminuria and cardiovascular disease , but more and prospect i ve studies of these hypotheses are needed Background —Microalbuminuria is associated with increased risk of cardiovascular events . We assessed whether therapeutic intervention aim ed at lowering urinary albumin excretion would reduce cardiovascular events in microalbuminuric subjects ( 15 to 300 mg/24 hours ) . Methods and Results —From the Prevention of Renal and Vascular Endstage Disease ( PREVEND ) cohort ( n=8592 ) , 1439 subjects fulfilled the inclusion criteria of the PREVEND Intervention Trial ( PREVEND IT ) . Of these subjects , 864 were r and omized to fosinopril 20 mg or matching placebo and to pravastatin 40 mg or matching placebo . The mean follow-up was 46 months , and the primary end point was cardiovascular mortality and hospitalization for cardiovascular morbidity . Mean age was 51±12 years ; 65 % of subjects were male , and 3.4 % had a previous cardiovascular event . Mean cholesterol level was 5.8±1.0 mmol/L , mean systolic/diastolic blood pressure was 130±18/76±10 mm Hg , and median urinary albumin excretion was 22.8 ( 15.8 to 41.3 ) mg/24 hours . The primary end point occurred in 45 subjects ( 5.2 % ) . Fosinopril reduced urinary albumin excretion by 26 % ( P<0.001 ) . Subjects treated with fosinopril showed a 40 % lower incidence of the primary end point ( hazard ratio 0.60 [ 95 % CI 0.33 to 1.10 ] , P=0.098 , log-rank ) . Pravastatin did not reduce urinary albumin excretion , and subjects treated with pravastatin showed a 13 % lower incidence of the primary end point than subjects in the placebo group ( 0.87 [ 0.49 to 1.57 ] , P=0.649 , log-rank ) . Conclusions —In microalbuminuric subjects , treatment with fosinopril had a significant effect on urinary albumin excretion . In addition , fosinopril treatment was associated with a trend in reducing cardiovascular events . Treatment with pravastatin did not result in a significant reduction in urinary albumin excretion or cardiovascular events Urinary albumin excretion is a predictor for cardiovascular mortality and morbidity . We investigated which parameters determine baseline urinary albumin excretion in nondiabetic subjects , without renal disease . In addition , we evaluated the parameters that predict the albuminuria-lowering efficacy of an angiotensin-converting enzyme inhibitor . In this sub study of the Prevention of Renal and Vascular Endstage Disease Intervention Trial , 384 microalbuminuric patients were included . Patient and biochemical characteristics were obtained at baseline and after 3 months of double-blinded , r and omized treatment ( fosinopril 20 mg or placebo ) . Mean age was 51.1±11.5 years , and 65.6 % were male . Median urinary albumin excretion was 22.2 mg per 24 hours . At baseline , mean arterial pressure ( & bgr;st and ardized=0.161 ; P=0.006 ) , urinary sodium excretion ( & bgr;st and ardized=0.154 ; P=0.011 ) , and estimated renal function were independently associated with albumin excretion . In these predominantly normotensive to prehypertensive subjects , fosinopril reduced albumin excretion by 18.5 % versus a 6.1 % increase on placebo after 3 months ( P<0.001 ) . Fosinopril use and blood pressure reduction independently predicted the change in urinary albumin excretion . Baseline urinary albumin excretion independently predicted the antialbuminuric effect of fosinopril ( & bgr;st and ardized=−0.303 ; P<0.001 ) . In conclusion , at baseline , sodium intake and blood pressure were positively associated with urinary albumin excretion . Fosinopril reduced albuminuria more than might be expected from its blood pressure – lowering effect alone , and this effect was more outspoken in subjects with higher baseline albumin excretion . Based on our data , we hypothesize that angiotensin-converting enzyme inhibition may result in superior cardiovascular protection when compared with other blood pressure – lowering agents in subjects with higher baseline levels of albuminuria BACKGROUND Silent brain infa rcts are frequently seen on magnetic resonance imaging ( MRI ) in healthy elderly people and may be associated with dementia and cognitive decline . METHODS We studied the association between silent brain infa rcts and the risk of dementia and cognitive decline in 1015 participants of the prospect i ve , population -based Rotterdam Scan Study , who were 60 to 90 years of age and free of dementia and stroke at base line . Participants underwent neuropsychological testing and cerebral MRI at base line in 1995 to 1996 and again in 1999 to 2000 and were monitored for dementia throughout the study period . We performed Cox proportional-hazards and multiple linear-regression analyses , adjusted for age , sex , and level of education and for the presence or absence of subcortical atrophy and white-matter lesions . RESULTS During 3697 person-years of follow-up ( mean per person , 3.6 years ) , dementia developed in 30 of the 1015 participants . The presence of silent brain infa rcts at base line more than doubled the risk of dementia ( hazard ratio , 2.26 ; 95 percent confidence interval , 1.09 to 4.70 ) . The presence of silent brain infa rcts on the base-line MRI was associated with worse performance on neuropsychological tests and a steeper decline in global cognitive function . Silent thalamic infa rcts were associated with a decline in memory performance , and nonthalamic infa rcts with a decline in psychomotor speed . When participants with silent brain infa rcts at base line were subdivided into those with and those without additional infa rcts at follow-up , the decline in cognitive function was restricted to those with additional silent infa rcts . CONCLUSIONS Elderly people with silent brain infa rcts have an increased risk of dementia and a steeper decline in cognitive function than those without such lesions Few data are available to clarify whether changes in albuminuria over time translate to changes in cardiovascular risk . The aim of the present study was to examine whether changes in albuminuria during 4.8 years of antihypertensive treatment were related to changes in risk in 8206 patients with hypertension and left ventricular hypertrophy in the Losartan Intervention For Endpoint reduction in hypertension ( LIFE ) study . Urinary albumin/creatinine ratio ( UACR ) was measured at baseline and annually . Time-varying albuminuria was closely related to risk for the primary composite end point ( ie , when UACR decreased during treatment , risk was reduced accordingly ) . When the population was divided according to median baseline value ( 1.21 mg/mmol ) and median year 1 UACR ( 0.67 mg/mmol ) , risk increased stepwise and significantly for the primary composite end point from those with low baseline/low year 1 ( 5.5 % ) , to low baseline/high year 1 ( 8.6 % ) , to high baseline/low year 1 ( 9.4 % ) , and to high baseline/high year 1 ( 13.5 % ) values . Similar significant , stepwise increases in risk were seen for the components of the primary composite end point ( cardiovascular mortality , stroke , and myocardial infa rct ion ) . The observation that changes in UACR during antihypertensive treatment over time translated to changes in risk for cardiovascular morbidity and mortality was not explained by in-treatment level of blood pressure . We propose that monitoring of albuminuria should be an integrated part of the management of hypertension . If albuminuria is not decreased by the patient ’s current antihypertensive and other treatment , further intervention directed toward blood pressure control and other modifiable risks should be considered Background and Purpose — The prevalence
Output:
| In the meantime , with several recent systematic review s of published evidence supporting a robust and independent association of CKD with subsequent cerebrovascular disease risk , optimal implementation of established stroke risk reduction strategies in individuals with CKD might improve stroke outcomes . |
MS210583 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Cancer-related cognitive dysfunction has mostly been attributed to chemotherapy ; this explanation , however , fails to account for cognitive dysfunction observed in chemotherapy-naïve patients . In a controlled , longitudinal , multisite study , we tested the hypothesis that cognitive function in breast cancer patients is affected by cancer-related post-traumatic stress . Methods Newly diagnosed breast cancer patients and healthy control subjects , age 65 or younger , underwent three assessment s within one year , including paper- and -pencil and computerized neuropsychological tests , clinical diagnostics of post-traumatic stress disorder ( PTSD ) , and self-reported cognitive function . Analysis of variance was used to compare three groups of participants - patients who did or did not receive chemotherapy and healthy control subjects-on age- and education-corrected cognitive performance and cognitive change . Differences that were statistically significant after correction for false discovery rate were investigated with linear mixed-effects models and mediation models . All statistical tests were two-sided . Results Of 226 participants ( 166 patients and 60 control subjects ) , 206 completed all assessment sessions ( attrition : 8.8 % ) . Patients demonstrated overall cognitive decline ( group*time effect on composite z -score : -0.13 , P = .04 ) and scored consistently worse on Go/Nogo errors . The latter effect was mediated by PTSD symptoms ( mediation effect : B = 0.15 , 95 % confidence interval = 0.02 to 0.38 ) . Only chemotherapy patients showed declined reaction time on a computerized alertness test . Overall cognitive performance correlated with self-reported cognitive problems at one year ( T = -0.11 , P = .02 ) . Conclusions Largely irrespective of chemotherapy , breast cancer patients may encounter very subtle cognitive dysfunction , part of which is mediated by cancer-related post-traumatic stress . Further factors other than treatment side effects remain to be investigated PURPOSE To examine the impact of age and cognitive reserve on cognitive functioning in patients with breast cancer who are receiving adjuvant treatments . PATIENTS AND METHODS Patients with breast cancer exposed to chemotherapy ( n = 60 ; mean age , 51.7 years ) were evaluated with a battery of neuropsychological and psychological tests before treatment and at 1 , 6 , and 18 months after treatment . Patients not exposed to chemotherapy ( n = 72 ; mean age , 56.6 years ) and healthy controls ( n = 45 ; mean age , 52.9 years ) were assessed at matched intervals . RESULTS Mixed-effects modeling revealed significant effects for the Processing Speed and Verbal Ability domains . For Processing Speed , a three-way interaction among treatment group , age , and baseline cognitive reserve ( P < .001 ) revealed that older patients with lower baseline cognitive reserve who were exposed to chemotherapy had lower performance on Processing Speed compared with patients not exposed to chemotherapy ( P = .003 ) and controls ( P < .001 ) . A significant group by time interaction for Verbal Ability ( P = .01 ) suggested that the healthy controls and no chemotherapy groups improved over time . The chemotherapy group failed to improve at 1 month after treatment but improved during the last two follow-up assessment s. Exploratory analyses suggested a negative effect of tamoxifen on Processing Speed ( P = .036 ) and Verbal Memory ( P = .05 ) in the no-chemotherapy group . CONCLUSION These data demonstrated that age and pretreatment cognitive reserve were related to post-treatment decline in Processing Speed in women exposed to chemotherapy and that chemotherapy had a short-term impact on Verbal Ability . Exploratory analysis of the impact of tamoxifen suggests that this pattern of results may be due to a combination of chemotherapy and tamoxifen Purpose Chemotherapy improves the survival rate of stage III colon cancer patients . The combination of oxaliplatin , 5-fluorouracil , and leucovorin ( the FOLFOX4 regimen ) has emerged as the st and ard of care . This prospect i ve study evaluates potential alterations in cognitive function in FOLFOX4-treated patients . Methods We evaluated 57 consecutive colorectal cancer patients who received adjuvant chemotherapy with FOLFOX4 . Patients underwent a complete battery of neuropsychological tests at three different times : before ( T0 ) , at the end ( T1 ) , and 6 months after treatment ( T2 ) . Results We have analyzed cognitive impairment ( Mini Mental State Examination , MMSE ) , visuo-spatial memory ( Clock Drawing Test , CDT , Rey Complex Figure , copy and recall ) , information processing speed ( Trial Making Test-A , TMT-A , and Trial Making Test-B , TMT-B ) , verbal memory ( Rey Auditory Verbal Learning Test , call and recall ) , emotional distress ( Psychological Distress Inventory , PDI ) , anxiety ( State and Trait Anxiety Inventory , STAI-Y1 and Y2 ) , and depression ( Beck Depression Inventory , BDI ) . Then we have calculated , for each test and for each interval of time , mean ± st and ard deviation for the mean . In a subsequent phase , we tested the significance of different results through the ANOVA analysis for repeated measures . In this case , we could not find any statistically significant modification in cognitive function , but we could notice an improvement in emotional performance , anxiety and depression a short time after chemotherapy administration . Conclusions We found no effect on cognitive function related to chemotherapy , the only little modification is about some emotional performance during chemotherapy . These findings may be explained by the central role of the psychological adaptation process , which occurs during the period from diagnosis to completion of treatment and is characterized by anxiety and adjustment depression . Our results seem to rule out any significant cognitive impairment due to adjuvant FOLFOX4 chemotherapy in colon cancer patients A subset of survivors has cognitive impairment after cancer treatment . This is generally subtle , but may be sustained . In October 2006 , the second international cognitive workshop was held in Venice . The workshop included neuropsychologists , clinical and experimental psychologists , medical oncologists , imaging experts , and patient advocates . The main developments since the first Cognitive Workshop in 2003 have been the following . ( i ) studies evaluating cognitive function in patients receiving chemotherapy for cancers other than breast cancer , and in patients receiving hormonal therapy for cancer . ( ii ) The publication of longitudinal prospect i ve studies which have shown that some patients already exhibit cognitive impairment on neuropsychological testing before receiving chemotherapy , and some patients have deterioration in cognitive functioning from pre- to postchemotherapy . ( iii ) Studies of the underlying mechanisms of cognitive impairment both in patients and in animal models . ( iv ) Use of structural and functional imaging techniques to study changes in brain morphology and activation patterns associated with chemotherapy . ( v ) At present cognitive research in cancer is limited by method ological challenges and the lack of st and ardization in neuropsychological studies . The current workshop addressed many of these issues and established an international task force to provide guidelines for future research and information on how best to manage these symptoms OBJECTIVE To evaluate the efficacy of a brief cognitive-behavioral therapy ( CBT ) that is being developed for management of cognitive dysfunction following chemotherapy among breast cancer survivors . Memory and Attention Adaptation Training ( MAAT ) is a brief CBT design ed to improve the quality of life and function among cancer survivors with post-chemotherapy cognitive complaints . METHODS An initial , two-group ( MAAT versus waitlist , no treatment control ) , r and omized clinical trial ( RCT ) was conducted . Forty stage I and II female breast cancer survivors ( mean age = 50 ; SD = 6.4 ) were r and omized to conditions and assessed at baseline , post-treatment ( 8 weeks ) and 2-month follow-up assessment points on measures of : ( 1 ) self-reported daily cognitive failures ; ( 2 ) quality of life ; and ( 3 ) neuropsychological performance . Participants were also assessed for satisfaction with MAAT . RESULTS With education and IQ as covariates , MAAT participants made significant improvements relative to controls on the spiritual well-being subscale of the quality of life measure and on verbal memory , but statistical significance was not achieved on self-report of daily cognitive complaints . However , moderate-to-large effect sizes were observed on these outcomes . Participants gave MAAT high satisfaction ratings . CONCLUSIONS Although this initial RCT is a small study , MAAT participants appear to improve on one measure of quality of life and verbal memory performance relative to no treatment controls and rate MAAT with high satisfaction . These data are encouraging and support the continued development and evaluation of MAAT efficacy Studies suggest that adjuvant chemotherapy for early stage breast cancer ( BC ) is associated with cognitive impairment related to attention , memory , and visuospatial functioning . However , other studies have failed to confirm that relationship . We report one of the first longitudinal , controlled studies of cognitive effects of chemotherapy in older post-menopausal women . Sixty-one post-menopausal women with non-metastatic BC were administered neuropsychological tests before adjuvant therapy ( Time1 ) , six months after treatment ( Time2 ) , and at a final 6-month follow-up ( Time3 ) . Thirty women were treated with chemotherapy ; thirty-one women who received no chemotherapy were controls . Cognitive domains measured included motor , language , attention/concentration/working memory , visuospatial , and memory ( verbal and visual ) . Time-by-treatment interaction was significant in the motor domain ( P = 0.007 ) with poorer performance in women treated with chemotherapy . For the other domains , scores did not significantly vary over time by group . In post-menopausal women , chemotherapy was not associated with changes in cognitive function in areas reported by BC survivors : attention , memory , and information processing . Motor slowing in women treated with chemotherapy could be secondary to peripheral neuropathy rather than an indication of more general declines in cognitive processing . Future studies should control for the independent effects of slowed motor functioning when looking to study possible chemotherapy related cognitive processing deficits Aim : To assess cognitive function prospect ively in women with early breast cancer before , during and after the administration of adjuvant chemotherapy OBJECTIVES To report on the longitudinal cognitive functioning of older women receiving adjuvant chemotherapy for breast cancer . DESIGN Neuropsychological and functional status testing were performed before chemotherapy and 6 months after chemotherapy . SETTING Cancer center . PARTICIPANTS Thirty-one patients aged 65 and older with Stage I to III breast cancer . Of the 31 patients enrolled , three refused post-testing , and 28 were evaluable . MEASUREMENTS The following domains of cognitive function were examined : attention ; verbal memory ; visual memory ; and verbal , spatial , psychomotor , and executive functions . RESULTS Participants had a mean age of 71 ( range 65 - 84 ) : 39 % Stage I , 50 % Stage II , and 11 % Stage III . The number of scores 2 st and ard deviations ( SDs ) below the norm were calculated for each patient before and 6 months after chemotherapy ; 14 ( 50 % ) had no change , 11 ( 39 % ) worsened , and three ( 11 % ) improved ( P=.05 ) . Seven patients ( 25 % ) experienced a decline in cognitive function , defined as a 1-SD decline from pre- to post-testing in two or more neuropsychological domains . Exploratory analyses revealed no significant difference between functional status , comorbidity , and depression scale scores and change in overall quality -of-life scores before and after chemotherapy . CONCLUSION In this cohort of older women receiving adjuvant chemotherapy , a subset experienced a decline in cognitive function from before chemotherapy to 6 months after chemotherapy . Further prospect i ve study is needed to confirm these observations and to identify the subgroup at special risk Long‐term chemotherapy‐related cognitive dysfunction ( CRCD ) affects a large number of cancer survivors . To the authors ' knowledge , to date there is no established treatment for this survivorship problem . The authors herein report results of a small r and omized controlled trial of a cognitive behavioral therapy ( CBT ) , Memory and Attention Adaptation Training ( MAAT ) , compared with an attention control condition . Both treatments were delivered over a videoconference device OBJECTIVE A number of cross-sectional studies have reported reduced cognitive function in cancer patients receiving chemotherapy compared with other cancer patients and healthy controls , suggesting that chemotherapy could be associated with cognitive side-effects . Recently published prospect i ve studies question this hypothesis , but it is still unclear whether cancer patients should regard cognitive problems as a potential risk when receiving chemotherapy . METHODS In the present study we examine whether cancer patients ( n=34 ) receiving chemotherapy differed in cognitive changes during treatment compared with cardiac patients ( n=12 ) and healthy controls ( n=12 ) tested at 3 - 4 months interval . RESULTS Our results showed no differences with respect to changes in cognitive performance over time between cancer patients in chemotherapy , cardiac patients , and healthy controls . In addition , the number of individuals showing reliable decline or improvement on cognitive tests did not differ between groups . CONCLUSION Taken together , our results do not support a hypothesis of cognitive side-effects of st and ard-dose chemotherapy in breast cancer patients PURPOSE Whether adjuvant therapy impairs cognitive function in women with breast cancer ( BC ) is unclear . We determined the effects of adjuvant therapy on cognitive function in women with early BC . METHODS We consecutively and prospect ively enrolled women aged 40 - 69 years who had a positive radiographic finding from the mammography screening program at Stockholm South General Hospital . All women completed the Headminder Web-based neuropsychological battery Cognitive Stability Index ( CSI ) for response speed , processing speed , memory , and attention before diagnosis ( T1 ) , after surgery and before adjuvant treatment ( T2 ) , 6 months after start of adjuvant treatment ( T3 )
Output:
| The majority of studies find cognitive impairment in patients with cancer treated with chemotherapy .
Neuroimaging studies show changes in structure and activation in patients undergoing chemotherapy .
Non-pharmacological treatment is effective for improving cognition and quality of life .
This review highlights the importance of recognizing that this cognitive dysfunction is frequent , mild to moderate in nature but with great impact on quality of life |
MS210584 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Abstract Objective : To estimate the association between maternal age and fetal death ( spontaneous abortion , ectopic pregnancy , stillbirth ) , taking into account a woman 's reproductive history . Design : Prospect i ve register linkage study . Subjects : All women with a reproductive outcome ( live birth , stillbirth , spontaneous abortion leading to admission to hospital , induced abortion , ectopic pregnancy , or hydatidiform mole ) in Denmark from 1978 to 1992 ; a total of 634 272 women and 1 221 546 pregnancy outcomes . Main outcome measures : Age related risk of fetal loss , ectopic pregnancy , and stillbirth , and age related risk of spontaneous abortion stratified according to parity and previous spontaneous abortions . Results : Overall , 13.5 % of the pregnancies intended to be carried to term ended with fetal loss . At age 42 years , more than half of such pregnancies result ed in fetal loss . The risk of a spontaneous abortion was 8.9 % in women aged 20–24 years and 74.7 % in those aged 45 years or more . High maternal age was a significant risk factor for spontaneous abortion irrespective of the number of previous miscarriages , parity , or calendar period . The risk of an ectopic pregnancy and stillbirth also increased with increasing maternal age . Conclusions : Fetal loss is high in women in their late 30s or older , irrespective of reproductive history . This should be taken into consideration in pregnancy planning and counselling Some fraction of any cohort of fetuses alive at a given gestational age will ultimately die before birth . The residual prospect i ve risk of stillbirth as a function of gestational age was calculated from records of the New York City Department of Health covering 370,051 reported births between 1987–1989 , including 2454 stillbirths . In the general population , the prospect i ve risk of stillbirth at 26 weeks was one in 150 and , because the time distributions of live births and stillbirths were not proportionate , the risk changed with gestational age . By 40 weeks ' gestation , it was one in 475 , rising progressively thereafter to one in 375 at 43 weeks . The prospect i ve risk of stillbirth was elevated in certain ethnic groups and increased significantly with advanced maternal age , multiple gestation , and lack of prenatal care . The prospect i ve risk of stillbirth is an important consideration in decisions regarding timing of delivery Recent evidence suggests that conditional cash transfer programs for schooling are effective in raising school enrollment and attendance . However , there is also reason to believe that such programs can affect other outcomes , such as the sexual behavior of their young beneficiaries . Zomba Cash Transfer Program is a r and omized , ongoing conditional cash transfer intervention targeting young women in Malawi that provides incentives ( in the form of school fees and cash transfers ) to current schoolgirls and recent dropouts to stay in or return to school . An average offer of US$ 10/month conditional on satisfactory school attendance – plus direct payment of secondary school fees – led to significant declines in early marriage , teenage pregnancy , and self-reported sexual activity among program beneficiaries after just one year of program implementation . For program beneficiaries who were out of school at baseline , the probability of getting married and becoming pregnant declined by more than 40 percent and 30 percent , respectively . In addition , the incidence of the onset of sexual activity was 38 percent lower among all program beneficiaries than the control group . Overall , these results suggest that conditional cash transfer programs not only serve as useful tools for improving school attendance , but may also reduce sexual activity , teen pregnancy , and early marriage To test the effectiveness of a special health care program for adolescent mothers ( 17 years old or younger ) and their infants , 243 mother-infant pairs were r and omly assigned to one of two groups . All of the mothers were unwed , on Medicaid , and black . The control group received routine well-baby care . The experimental group received routine care and services that included rigorous follow-up , discussion s with the mother about her plans for return to school and use of family planning methods , and extra health teaching . The dropout rate in the experimental group ( 60 % ) was significantly less after 18 months than the control group ( 82 % ) . In spite of the high dropout rate , 91 % of the mothers were located for the 18 month follow-up interview . The repeat pregnancy rate in the experimental group was 12 % after 18 months , and 28 % in the control group . There was no significant difference in the percentage returning to school . After 12 months , the infants in the experimental group were more likely to be fully immunized ( 33 % ) than the infants in the control group ( 18 % ) . Mothers in the special care program who continued to attend clinic used the emergency room less than the mothers who continued to attend in the control group . These results suggest that a comprehensive health care program is one way to bring about better outcomes for both adolescent mothers and their infants OBJECTIVES This study assessed the effects of the Safe Date s program on the primary and secondary prevention of adolescent dating violence . METHODS Fourteen schools were r and omly allocated to treatment conditions . Eighty percent ( n=1886 ) of the eighth and ninth grade rs in a rural county completed baseline question naires , and 1700 ( 90 % ) completed follow-up question naires . RESULTS Treatment and control groups were comparable at baseline . In the full sample at follow-up , less psychological abuse , sexual violence , and violence perpetrated against the current dating partner were reported in treatment than in control schools . In a sub sample of adolescents reporting no dating violence at baseline ( a primary prevention sub sample ) , there was less initiation of psychological abuse in treatment than in control schools . In a sub sample of adolescents reporting dating violence at baseline ( a secondary prevention sub sample ) , there was less psychological abuse and sexual violence perpetration reported at follow-up in treatment than in control schools . Most program effects were explained by changes in dating violence norms , gender stereotyping , and awareness of services . CONCLUSIONS The Safe Date s program shows promise for preventing dating violence among adolescents Abstract Objective : To determine whether a theoretically based sex education programme for adolescents ( SHARE ) delivered by teachers reduced unsafe sexual intercourse compared with current practice . Design : Cluster r and omised trial with follow up two years after baseline ( six months after intervention ) . A process evaluation investigated the delivery of sex education and broader features of each school . Setting : Twenty five secondary schools in east Scotl and . Participants : 8430 pupils aged 13 - 15 years ; 7616 completed the baseline question naire and 5854 completed the two year follow up question naire . Intervention : SHARE programme ( intervention group ) versus existing sex education ( control programme ) . Main outcome measures : Self reported exposure to sexually transmitted disease , use of condoms and contraceptives at first and most recent sexual intercourse , and unwanted pregnancies . Results : When the intervention group was compared with the conventional sex education group in an intention to treat analysis there were no differences in sexual activity or sexual risk taking by the age of 16 years . However , those in the intervention group reported less regret of first sexual intercourse with most recent partner ( young men 9.9 % difference , 95 % confidence interval −18.7 to −1.0 ; young women 7.7 % difference , −16.6 to 1.2 ) . Pupils evaluated the intervention programme more positively , and their knowledge of sexual health improved . Lack of behavioural effect could not be linked to differential quality of delivery of intervention . Conclusions : Compared with conventional sex education this specially design ed intervention did not reduce sexual risk taking in adolescents OBJECTIVE To determine whether the addition of a parental monitoring intervention ( Informed Parents and Children Together [ ImPACT ] ) alone or with " boosters " could enhance ( either broaden or sustain or both ) the effect of a small group , face-to-face adolescent risk reduction intervention Focus on Kids ( FOK ) . METHODS A longitudinal , r and omized , community-based cohort study was conducted of 35 low-income , community-based , in-town setting s. A total of 817 black youths aged 12 to 16 years at baseline were studied . After completion of baseline measures , youths were r and omized to receive a face-to-face intervention alone ( FOK only ) , a face-to-face intervention and a parental monitoring intervention ( FOK plus ImPACT ) , or both of the above plus boosters ( FOK plus ImPACT plus boosters ) . Risk and protective behaviors were assessed at 6 and 12 months after intervention . RESULTS At 6 months ' follow-up , youths in families that were assigned to FOK plus ImPACT reported significantly lower rates of sexual intercourse , sex without a condom , alcohol use , and cigarette use and marginally lower rates of " risky sexual behavior " compared with youths in families that were assigned to FOK only . At 12 months after intervention , rates of alcohol and marijuana use were significantly lower and cigarette use and overall risk intention were marginally lower among FOK plus ImPACT youths compared with FOK only youths . With regard to the boosters delivered at 7 and 10 months , 2 risk behaviors -- use of crack/cocaine and drug selling -- were significantly lower among the youths who were assigned to receive the additional boosters compared with youths without the boosters . The rates of the other risk behaviors and intentions did not differ significantly . CONCLUSIONS The results of this r and omized , controlled trial indicate that the inclusion of a parental monitoring intervention affords additional protection from involvement in adolescent risk behaviors 6 and 12 months later compared with the provision of an intervention that targets adolescents only . At the same time , the results of the present study do not provide sufficient evidence that booster sessions further improve targeted behaviors enough to include them in a combined parent and youth intervention BACKGROUND Maternal obesity and diabetes are both associated with increased risk of congenital central nervous system ( CNS ) malformations in the offspring and may share a common underlying mechanism . Our objective was to evaluate whether gestational diabetes influenced the association of prepregnancy maternal obesity and risks for CNS birth defects . METHODS This Texas population -based case-control study evaluated births occurring January 1997 through June 2001 . Data came from structured telephone interviews . Cases ( n=477 ) were mothers of offspring with anencephaly ( n=120 ) , spina bifida ( n=184 ) , holoprosencephaly ( n=49 ) , or isolated hydrocephaly ( n=124 ) . Controls ( n=497 ) were mothers of live infants without abnormalities r and omly selected from the same hospitals as cases . Response rates were approximately 60 % for both cases and controls . We evaluated maternal obesity ( body mass index > or = 30.0 kg/m ) and risks for CNS birth defects , as well as whether gestational diabetes influenced the risks . RESULTS After adjusting for maternal ethnicity , age , education , smoking , alcohol use , and periconceptional vitamin use , obese women had substantially increased risks of delivering offspring with anencephaly ( odds ratio=2.3 ; 95 % confidence interval=1.2 - 4.3 ) , spina bifida ( 2.8 ; 1.7 - 4.5 ) , or isolated hydrocephaly ( 2.7 ; 1.5 - 5.0 ) , but not holoprosencephaly ( 1.4 ; 0.5 - 3.8 ) . Odds ratios were higher for the joint effects of maternal obesity and gestational diabetes , with evidence for interaction on a multiplicative scale . CONCLUSIONS Maternal obesity and gestational diabetes may increase the risk of CNS birth defects through shared causal mechanisms Since 1975 the Rome Microcythaemia Centre has carried out every year , under the auspices of the health authorities of the Latium region , a screening of thalassaemics among intermediate schoolchildren of Latium . From these campaigns , knowledge about thalassaemias among the young adult population has grown which , in its turn , has result ed in screening of these young adults . Through screening in schools between 1975 and 1982 , of 289 763 students examined , 6838 thalassaemics were identified , 6045 of whom were beta- or delta beta-thalassaemics . The total number of young thalassaemics who are identified at present in the Centre through screenings of schoolchildren and young adults is about 3300 per year . Furthermore , from January 1980 to April 1983 , 110 prospect i ve couples of child-bearing age at risk ( 94 of whom originated from Latium ) were identified at the Centre , and five homozygous fetuses ( three of which originated from Latium ) were diagnosed . These data derive from an area in which the frequency of thalassaemia is only 2.4 % , and they show that the programme in Latium for the prevention of Mediterranean anaemia has been successful OBJECTIVE : The aim of this study was to investigate the influence of maternal age on perinatal and obstetric outcome in women aged 40–44 years and those 45 years or older and to estimate whether adverse outcome was related to intercurrent illness and pregnancy complications . METHODS : National prospect i ve , population -based , cohort study in women aged 40–44 years and those 45 years or older and in a control group of women aged 20–29 years who delivered during the period 1987–2001 . Adjusted odds ratios ( OR ) were calculated after adjustments for significant malformations , maternal pre-existing diseases , and smoking . Main outcome measures were perinatal mortality , intrauterine fetal
Output:
| Results Comprehensive interventions can prevent first pregnancy in adolescence by 15 % and repeat adolescent pregnancy by 37 % .
Appropriate birth spacing ( 18 - 24 months from birth to next pregnancy compared to short intervals < 6 months ) can significantly lower maternal mortality , preterm births , stillbirths , low birth weight and early neonatal deaths . |
MS210585 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The London Daily/Nocturnal Hemodialysis Study , a prospect i ve , comparative , nonr and omized study , directly compared outcomes of quotidian ( daily ) hemodialysis patients with conventional thrice-weekly hemodialysis patients . Patients were assigned to either daily ( short-hours ) hemodialysis ( n = 11 ) or nocturnal hemodialysis ( n = 12 ) and followed up for 5 - 36 months ; all data were directly compared with matched control patients receiving conventional hemodialysis ( n = 22 ) . Outcomes evaluated were adequacy ( urea kinetics ) , nutrition , anemia management , blood pressure and volume control , calcium/phosphorus control , and patient quality of life . In addition , a detailed economic analysis was undertaken . The study showed that both quotidian hemodialysis regimens are more effective than conventional hemodialysis in improving weekly urea clearance . Significant clinical improvements were seen with quotidian therapy in the areas of nutrition ( short-hours daily ) , blood pressure ( both ) , volume control ( short-hours daily ) , calcium/phosphorus control ( nocturnal ) , and quality of life ( both ) . A nonsignificant trend for improvement in anemia management was suggested . The economic analysis showed substantial savings in annualized cost per quality -adjusted life-year in changing from conventional hemodialysis ( carried out in-center , in satellite units , or at home ) to home quotidian hemodialysis . The substantial clinical benefits of home quotidian hemodialysis , combined with the economic advantage shown by this study , clearly justify its expansion . ( The details of this study have recently been published in 11 articles in the American Journal of Kidney Diseases[2003;42(suppl 1 ) ] Observational studies suggest improvements with frequent hemodialysis ( HD ) , but its true efficacy and safety remain uncertain . The Frequent Hemodialysis Network Trials Group is conducting two multicenter r and omized trials of 250 subjects each , comparing conventional three times weekly HD with ( 1 ) in-center daily HD and ( 2 ) home nocturnal HD . Daily HD will be delivered for 1.5 - 2.75 h , 6 days/week , with target eK(t)/V(n ) > or = 0.9/session , whereas nocturnal HD will be delivered for > or = 6 h , 6 nights/week , with target stdK(t)/V of > or = 4.0/week . Subjects will be followed for 1 year . The composite of mortality with the 12-month change in ( i ) left ventricular mass index ( LVMI ) by magnetic resonance imaging , and ( ii ) SF-36 R AND Physical Health Composite ( PHC ) are specified as co- primary outcomes . The seven main secondary outcomes are between group comparisons of : change in LVMI , change in PHC , change in Beck Depression Inventory score , change in Trail Making Test B score , change in pre-HD serum albumin , change in pre-HD serum phosphorus , and rates of non-access hospitalization or death . Changes in blood pressure and erythropoiesis will also be assessed . Safety outcomes will focus on vascular access complications and burden of treatment . Data will be obtained on the cost of delivering frequent HD compared to conventional HD . Efforts will be made to reduce bias , including blinding assessment of subjective outcomes . Because no large-scale r and omized trials of frequent HD have been previously conducted , the first year has been design ated a Vanguard Phase , during which feasibility of r and omization , ability to deliver the interventions , and adherence will be evaluated BACKGROUND Although several studies have shown that simulated annual direct health care costs are substantially lower for patients undergoing more frequent hemodialysis ( HD ) , there is limited information about the economics of daily HD and nocturnal HD . METHODS The London Daily/Nocturnal Hemodialysis Study compared the economics of short daily HD ( n = 10 ) , long nocturnal HD ( n = 12 ) , and conventional thrice-weekly HD ( n = 22 ) in patients over 18 months . A retrospective analysis of patients ' conventional HD costs during the 12 months before study entry was conducted to measure the change in cost after switching to quotidian HD . RESULTS As the data show , annual costs ( in Canadian dollars ) for daily HD are substantially lower than for both nocturnal HD and conventional HD : approximately 67,300 Can dollars , 74,400 Can dollars , and 72,700 Can dollars per patient , respectively . Moreover , marginal changes in operating cost per patient year were - 9,800 Can dollars , -17,400 Can dollars , and + 3,100 Can dollars for the daily HD , nocturnal HD , and conventional HD groups . Because of the increase in number of treatments , treatment supply costs per patient for the daily HD and nocturnal HD study groups were approximately twice those for conventional HD patients . However , average costs for consults , hospitalization days , emergency room visits , and laboratory tests for quotidian HD patients tended to decline after study entry . The major cost saving in home quotidian HD derived from the reduction in direct nursing time , excluding patient training . Total annualized cost per quality -adjusted life-year for the daily HD and nocturnal HD groups were 85,442 Can dollars and 120,903 Can dollars , which represented a marginal change of - 15,090 Can dollars and - 21,651 Can dollars , respectively , reflecting both improved quality of life and reduced costs for quotidian HD patients . CONCLUSION Substantial clinical benefits of home quotidian HD , combined with the economic advantage shown by this study , clearly justify its expansion BACKGROUND Care of patients with end-stage renal disease ( ESRD ) is important and re source intense . To enable ESRD programs to develop strategies for more cost-efficient care , an accurate estimate of the cost of caring for patients with ESRD is needed . METHODS The objective of our study is to develop an up date d and accurate itemized description of costs and re sources required to treat patients with ESRD on dialysis therapy and contrast differences in re sources required for various dialysis modalities . One hundred sixty-six patients who had been on dialysis therapy for longer than 6 months and agreed to enrollment were followed up prospect ively for 1 year . Detailed information on baseline patient characteristics , including comorbidity , was collected . Costs considered included those related to outpatient dialysis care , inpatient care , outpatient nondialysis care , and physician cl aims . We also estimated separately the cost of maintaining the dialysis access . RESULTS Overall annual cost of care for in-center , satellite , and home/self-care hemodialysis and peritoneal dialysis were US $ 51,252 ( 95 % confidence interval [ CI ] , 47,680 to 54,824 ) , $ 42,057 ( 95 % CI , 39,523 to 44,592 ) , $ 29,961 ( 95 % CI , 21,252 to 38,670 ) , and $ 26,959 ( 95 % CI , 23,500 to 30,416 ) , respectively ( P < 0.001 ) . After adjustment for the effect of other important predictors of cost , such as comorbidity , these differences persisted . Among patients treated with hemodialysis , the cost of vascular access-related care was lower by more than fivefold for patients who began the study period with a functioning native arteriovenous fistula compared with those treated with a permanent catheter or synthetic graft ( P < 0.001 ) . CONCLUSION To maximize the efficiency with which care is provided to patients with ESRD , dialysis programs should encourage the use of home/self-care hemodialysis and peritoneal dialysis BACKGROUND Home nocturnal hemodialysis ( HNHD ) can improve clinical and biochemical factors in people with renal failure , but its cost-effectiveness relative to conventional in-center hemodialysis ( IHD ) is uncertain . We hypothesized that HNHD would provide more dialysis treatments at a lower total cost than IHD . METHODS A prospect i ve one-year descriptive costing study was performed at two centers in Toronto , Canada , involving patients enrolled from a HNHD program ( N = 33 ) , and a matched cohort from an IHD program ( N = 23 ) . All costs are expressed as mean weekly amount in Canadian year 2000 dollars . A projected mean annual cost ( PMA ) was calculated also . RESULTS The mean number of treatments per week was much higher with HNHD ( 5.7 vs. 3.0 , P = 0.004 ) . Cost categories found to be less expensive for HNHD were staffing ( weekly $ 210 vs. $ 423 , P < 0.001 , PMA $ 10,932 vs. $ 22,056 ) and overhead and support ( weekly $ 80 vs. $ 238 , P < 0.001 , PMA $ 4179 vs. $ 12,393 ) . There was a trend toward lower costs for hospital admissions and procedures ( weekly $ 23 vs. $ 134 , P = 0.355 , PMA $ 1173 vs. $ 6997 ) and for medications ( $ 172 vs. $ 231 , P = 0.082 , PMA $ 8989 vs. $ 12,029 ) . Costs found to be more expensive for HNHD were the cost of direct hemodialysis material s ( weekly $ 318 vs. $ 126 , P < 0.001 , PMA $ 16,587 vs. $ 6575 ) and capital costs ( weekly $ 118 vs. $ 17 , P < 0.001 , PMA $ 6139 vs. $ 871 ) , with a trend toward higher cost for laboratory tests ( weekly $ 33 vs. $ 26 , P = 0.094 , PMA $ 1744 vs. $ 1364 ) . Physician costs were the same at $ 128 per week ( PMA $ 6650 ) . The weekly mean total cost for health care delivery was 20 % less for HNHD ( $ 1082 vs. $ 1322 , P = 0.006 ) , with projected mean annual costs more than $ 10,000 lower ( $ 56,394 vs. $ 68,935 ) . CONCLUSIONS HNHD provides about three times as many treatment hours at nearly a one-fifth lower cost , with savings evident even when only program and funding -specific costs are considered
Output:
| The higher costs of frequent compared to conventional home hemodialysis were because of higher consumable usage due to dialysis frequency .
Thus , our findings reinforce the conclusions of previous studies showing that home-based conventional and more frequent hemodialysis may provide clinical benefit at reasonable costs |
MS210586 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Exercise can have anti-inflammatory effects in obesity , but the optimal type and intensity of exercise are not clear . This study compared short-term high-intensity interval training ( HIIT ) with moderate-intensity continuous training ( MICT ) in terms of improvement in cardiorespiratory fitness , markers of inflammation , and glucose control in previously inactive adults at elevated risk of developing type 2 diabetes . Thirty-nine inactive , overweight/obese adults ( 32 women ) were r and omly assigned to 10 sessions over 2 wk of progressive HIIT ( n = 20 , four to ten 1-min sessions at ∼90 % peak heart rate , 1-min rest periods ) or MICT ( n = 19 , 20 - 50 min at ∼65 % peak heart rate ) . Before and 3 days after training , participants performed a peak O2 uptake test , and fasting blood sample s were obtained . Both HIIT ( 1.8 ± 0.4 vs. 1.9 ± 0.4 l/min , pre vs. post ) and MICT ( 1.8 ± 0.5 vs. 1.9 ± 0.5 l/min , pre vs. post ) improved peak O2 uptake ( P < 0.001 ) and lowered plasma fructosamine ( P < 0.05 ) . Toll-like receptor ( TLR ) 4 ( TLR4 ) expression was reduced on lymphocytes and monocytes after both HIIT and MICT ( P < 0.05 ) and on neutrophils after MICT ( P < 0.01 ) . TLR2 on lymphocytes was reduced after HIIT and MICT ( P < 0.05 ) . Plasma inflammatory cytokines were unchanged after training in both groups , but MICT led to a reduction in fasting plasma glucose ( P < 0.05 , 5.9 ± 1.0 vs. 5.6 ± 1.0 mmol/l , pre vs. post ) . Ten days of either HIIT or MICT can improve cardiorespiratory fitness and glucose control and lead to reductions in TLR2 and TLR4 expression . MICT , which involved a longer duration of exercise , may be superior for reducing fasting glucose Statin treatment and exercise training can reduce markers of inflammation when administered separately . The purpose of this study was to determine the effect of rosuvastatin treatment and the addition of exercise training on circulating markers of inflammation including C-reactive protein ( CRP ) , monocyte toll-like receptor 4 ( TLR4 ) expression , and CD14+CD16 + monocyte population size . Thirty-three hypercholesterolemic and physically inactive subjects were r and omly assigned to rosuvastatin ( R ) or rosuvastatin/exercise ( RE ) groups . A third group of physically active hypercholesterolemic subjects served as a control ( AC ) . The R and RE groups received rosuvastatin treatment ( 10 mg/d ) for 20 weeks . From week 10 to week 20 , the RE group also participated in an exercise training program ( 3d/wk ) . Measurements were made at baseline ( Pre ) , week 10 ( Mid ) , and week 20 ( Post ) , and included TLR4 expression on CD14 + monocytes and CD14+CD16 + monocyte population size as determined by 3-color flow cytometry . Serum CRP was quantified by enzyme-linked immunosorbent assay . TLR4 expression on CD14 + monocytes was higher in the R group at week 20 . When treatment groups ( R and RE ) were combined , serum CRP was lower across time . Furthermore , serum CRP and inflammatory monocyte population size were lower in the RE group compared with the R group at the Post time point . When all groups ( R , RE , and AC ) were combined , TLR4 expression was greater on inflammatory monocytes ( CD14+CD16 + ) compared with classic monocytes ( CD14+CD16⁻ ) at all time points . In conclusion , rosuvastatin may influence monocyte inflammatory response by increasing TLR4 expression on circulating monocytes . The addition of exercise training to rosuvastatin treatment further lowered CRP and reduced the size of the inflammatory monocyte population , suggesting an additive anti-inflammatory effect of exercise OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity Diet-induced weight gain increases disease risk via disruption of the innate immune system . Flow cytometry is commonly used to assess the immune system ; however , in mice such measurements traditionally require terminal procedures and tissue collection to generate sufficient sample . The present study refined an existing flow cytometry method to reduce the number of mice needed to longitudinally measure monocytes . CD-1 male mice were r and omly assigned to one of the three groups : DS ( diet-induced weight gain + sedentary ) , DE ( diet-induced weight gain + forced treadmill running [ total distance 35,755 ± 1832 m ] ) or NS ( normal weight gain + sedentary ) . DS and DE consumed a 60 % fat diet and NS consumed a 10 % fat diet ad libitum . Saphenous vein blood sample s were collected weekly for a period of six weeks and three-colour flow cytometry was used to measure changes in monocyte ( CD11b+/14 + ) concentration and cell-surface toll-like receptor 4 ( TLR4 ) expression . DS ( 18 % ) and DE ( 17 % ) gained more weight than NS ( P < 0.001 ) . On a group basis , DS expressed 17 % more TLR4 than DE and NS ( P = 0.005 ) . The present study demonstrates that a longitudinal survival model can be used to reduce the number of animals needed to complete flow cytometry experiments . Exercise during diet-induced weight prevented some ( decreased monocyte TLR4 expression ) but not all aspects of innate immune system function Obesity causes innate immune dysfunction , contributing to increased disease risk . Weight loss from a combination of caloric restriction and exercise is the most effective treatment of obesity . We compared forced and voluntary exercise as weight-loss treatments in diet-induced obese ( DIO ) mice and assessed the effects of weight loss on monocyte concentration and cell-surface expression of Toll-like receptor ( TLR ) 2 , TLR4 , CD80 , and CD86 . DIO CD1 male mice were allocated r and omly to 1 of 3 groups ( n = 6 per group ) : voluntary wheel running ( VEX ) ; forced treadmill running ( FEX ) ; and sedentary ( S ) . A fourth ( control ) group ( CN , n = 6 ) of nonDIO mice was included also . During the 8-wk weight-loss treatment , all 4 groups consumed a low-fat ( 10 % fat ) diet . Nonlethal saphenous vein blood sample s collected at baseline , week 4 , and week 8 were analyzed by flow cytometry to assess monocyte concentration and functional receptor expression . The VEX and FEX groups lost significantly more body weight ( 36 % and 27 % , respectively ) over the 8 wk of treatment than did other groups . VEX mice ran 4.4 times more than did FEX animals . VEX mice had higher monocyte concentrations ( 48 % and 58 % , respectively ) than did the CN and FEX groups . Compared with baseline , week 8 cell-surface expression of TLR2 ( 22 % ) , TLR4 ( 33 % ) , and CD86 ( 18 % ) was increased in VEX mice . At week 4 , CD80 expression was 42 % greater for VEX than S mice . The present study confirms that short-term exercise and low-fat diet consumption cause significant weight loss and altered immune profiles Introduction . Physical inactivity and obesity are independent risk factors for atherosclerosis . We analyzed the immunomodulatory capacity of 10-week intensified exercise training ( ET ) in obese and lean athletes . Markers of the innate immune response were investigated in obese ( ONE : ET≤40 km/week ) and lean athletes ( LNE : ET≤40 km/week and LE : ET≥55 km/week ) . Methods . Circulating dendritic cells ( DC ) were analyzed by flow-cytometry for BDCA-1/-2-expression . TLR-2/-4/-7 and MyD88 were analyzed by RT-PCR and Western blot . Circulating oxLDL levels were analyzed by ELISA . Results . BDCA-1 expression at baseline was lower in ONE compared to both other groups ( ONE 0.15 % ; LNE 0.27 % ; LE 0.33 % ; P < .05 ) , but significantly increased in ONE after training ( + 50 % ; P < .05 ) . In contrast , BDCA-2 expression at baseline was higher in ONE ( ONE 0.25 % ; LNE 0.11 % ; LE 0.09 % ; P < .05 ) and decreased in ONE after the 10-week training period ( −27 % ; P < .05 ) . Gene activations of TLR-4 and TLR-7 with corresponding protein increase were found for all three groups ( P < .01/P < .05 ) compared to pre training . A reduction of oxLDL levels was seen in ONE ( −61 % ; P < .05 ) . Conclusions . Intensified exercise induces an increase of BDCA-1 + DCs and TLR-4/-7 in obese athletes . We hereby describe new immune modulatory effects , which — through regular aerobic exercise — modulate innate immunity and pro-inflammatory cytokines in obesity
Output:
| Globally , the animal studies showed a marked tendency towards a down-regulation of TLR2 and 4 expression accompagnied with , a reduced activation of nuclear factorkappaB ( NF-κB ) signaling and cytokine production , and an improvement in insulin sensitivity and body composition .
CONCLUSION While animal studies showed a marked tendency towards TLR2 and 4 down-regulation after chronic endurance exercise , the current evidence in human is not sufficiently robust to conclude any role of TLR in the anti-inflammatory properties of exercise |
MS210587 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Although negative affect is a common precipitant of alcohol relapse , there are few interventions for alcohol dependence that specifically target negative affect . In this stage 1a/1b treatment development study , several affect regulation strategies ( e.g. , mindfulness , prolonged exposure , distress tolerance ) were combined to create a new treatment supplement called affect regulation training ( ART ) , which could be added to enhance cognitive-behavioral therapy ( CBT ) for alcohol dependence . A draft therapy manual was given to therapists and treatment experts before being administered to several patients who also provided input . After two rounds of manual development ( stage 1a ) , a pilot r and omized clinical trial ( N=77 ) of alcohol-dependent out patients who reported drinking often in negative affect situations was conducted ( stage 1b ) . Participants received 12-weekly , 90-minute sessions of either CBT for alcohol dependence plus ART ( CBT+ART ) or CBT plus a healthy lifestyles control condition ( CBT+HLS ) . Baseline , end-of-treatment , and 3- and 6-month posttreatment interviews were conducted . For both treatment conditions , participant ratings of treatment satisfaction were high , with CBT+ART rated significantly higher . Drinking outcome results indicated greater reductions in alcohol use for CBT+ART when compared to CBT+HLS , with moderate effect sizes for percent days abstinent , drinks per day , drinks per drinking day , and percent heavy drinking days . Overall , findings support further research on affect regulation interventions for negative affect drinkers OBJECTIVE To compare the efficacy of Mindfulness-Based Addiction Treatment ( MBAT ) to a Cognitive Behavioral Treatment ( CBT ) that matched MBAT on treatment contact time , and a Usual Care ( UC ) condition that comprised brief individual counseling . METHOD Participants ( N = 412 ) were 48.2 % African American , 41.5 % non-Latino White , 5.4 % Latino , and 4.9 % other , and 57.6 % reported a total annual household income < $ 30,000 . The majority of participants were female ( 54.9 % ) . Mean cigarettes per day was 19.9 ( SD = 10.1 ) . Following the baseline visit , participants were r and omized to UC ( n = 103 ) , CBT ( n = 155 ) , or MBAT ( n = 154 ) . All participants were given self-help material s and nicotine patch therapy . CBT and MBAT groups received 8 2-hr in-person group counseling sessions . UC participants received 4 brief individual counseling sessions . Biochemically verified smoking abstinence was assessed 4 and 26 weeks after the quit date . RESULTS Logistic r and om effects model analyses over time indicated no overall significant treatment effects ( completers only : F(2 , 236 ) = 0.29 , p = .749 ; intent-to-treat : F(2 , 401 ) = 0.9 , p = .407 ) . Among participants classified as smoking at the last treatment session , analyses examining the recovery of abstinence revealed a significant overall treatment effect , F(2 , 103 ) = 4.41 , p = .015 ( MBAT vs. CBT : OR = 4.94 , 95 % CI : 1.47 to 16.59 , p = .010 , Effect Size = .88 ; MBAT vs. UC : OR = 4.18 , 95 % CI : 1.04 to 16.75 , p = .043 , Effect Size = .79 ) . CONCLUSION Although there were no overall significant effects of treatment on abstinence , MBAT may be more effective than CBT or UC in promoting recovery from lapses . ( PsycINFO Data base OBJECTIVE Shame has long been seen as relevant to substance use disorders , but interventions have not been tested in r and omized trials . This study examined a group-based intervention for shame based on the principles of acceptance and commitment therapy ( ACT ) in patients ( N = 133 ; 61 % female ; M = 34 years old ; 86 % Caucasian ) in a 28-day residential addictions treatment program . METHOD Consecutive cohort pairs were assigned in a pairwise r and om fashion to receive treatment as usual ( TAU ) or the ACT intervention in place of 6 hr of treatment that would have occurred at that same time . The ACT intervention consisted of three 2-hr group sessions scheduled during a single week . RESULTS Intent-to-treat analyses demonstrated that the ACT intervention result ed in smaller immediate gains in shame , but larger reductions at 4-month follow-up . Those attending the ACT group also evidence d fewer days of substance use and higher treatment attendance at follow-up . Effects of the ACT intervention on treatment utilization at follow-up were statistically mediated by posttreatment levels of shame , in that those evidencing higher levels of shame at posttreatment were more likely to be attending treatment at follow-up . Intervention effects on substance use at follow-up were mediated by treatment utilization at follow-up , suggesting that the intervention may have had its effects , at least in part , through improving treatment attendance . CONCLUSIONS These results demonstrate that an approach to shame based on mindfulness and acceptance appears to produce better treatment attendance and reduced substance use BACKGROUND We have previously shown that Goal Management Training+Mindfulness Meditation ( GMT+MM ) improves executive functions in polysubstance users enrolled in outpatient treatment . The aim of this study was to establish if GMT+MM has similar positive effects on executive functions in polysubstance users in residential treatment , and if executive functions ' gains transfer to more ecologically valid goal -oriented tasks . METHODS Thirty-two polysbustance users were r and omly allocated to eight weeks of GMT+MM ( n=16 ) or control , i.e. , no-intervention ( n=16 ) ; both groups received treatment as usual . Outcome measures included performance in laboratory tasks of basic and complex executive functions ( i.e. , basic : working memory and inhibition ; complex : planning and self-regulation ) and in an ecological task of goal -directed behavior ( the Multiple Err and s Test - context ualized version , MET-CV ) measured post- interventions . RESULTS Results showed that GMT+MM was superior to control in improving basic measures of working memory ( Letter-number sequencing ; F=4.516 , p=0.049 ) and reflection impulsivity ( Information Sampling Test ; F=6.217 , p=0.018 ) , along with initial thinking times during planning ( Zoo Map Test ; F=8.143 , p=0.008 ) . In addition , GMT+MM was superior to control in improving performance in the MET-CV ( task failures ; F=8.485 , p=0.007 ) . CONCLUSION Our findings demonstrate that GMT+MM increases reflective processes and the achievement of goals in daily activities , furthermore ecological test can detects changes easily than laboratory tasks The current study investigates effects of a brief mindfulness-based instruction set , based on Marlatt 's " urge surfing " technique ( Marlatt & Gordon , 1985 ) , on smoking-related urges and behavior . Undergraduate smokers ( N = 123 ) who were interested in changing their smoking , but not currently involved in a cessation program , participated in a cue exposure paradigm design ed to elicit urges to smoke . They were r and omly assigned either to a group receiving brief mindfulness-based instructions or to a no-instruction control group . Results suggest that groups did not differ significantly on measures of urges . However , those in the mindfulness group smoked significantly fewer cigarettes over a 7-day follow-up period as compared to those in the control group . These findings suggest that the mindfulness techniques may not initially reduce urges to smoke but may change the response to urges . The study provides preliminary data for future studies examining both mechanisms and effectiveness of mindfulness-based interventions for cigarette smoking This pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS Boston University Patricia Cortes Harvard University Claudia Goldin Swarthmore College Jennifer Abstract Objective : Previous trials of catheter-based renal-artery denervation ( RDN ) as treatment modality in resistant hypertension ( rHT ) generated unconvincing results . In the Investigator-Steered Project on Intravascular Denervation for Management of Treatment-Resistant Hypertension ( INSPiRED ; NCT01505010 ) , we optimized selection and management of rHT patients . Methods : With ethical clearance to r and omize 18 patients , three Belgian hypertension centers screened 29 rHT patients on treatment with ≥3 drugs , of whom 17 after optimization of treatment ( age < 70 years ; systolic/diastolic office blood pressure ( BP ) ≥ 140/90 mm Hg ; 24-h BP ≥130/80 mm Hg ; glomerular filtration rate [ eGFR ] ≥ 45 mL/min/1.73 m2 ; body mass index < 40kg/m2 ) were r and omized and 15 were analyzed 6 months later , while medical treatment was continued ( n = 9 ) or combined with RDN by the EnligHTN ™ multi-electrode system ( n = 6 ) . Results : The baseline-adjusted between-group differences amounted to 19.5/10.4 mm Hg ( change in control vs. intervention group , + 7.6/+2.2 vs. −11.9/−8.2 mm Hg ; P = .088 ) for office BP , 22.4/13.1 mm Hg ( + 0.7/+0.3 vs. −21.7/−12.8 ; mm Hg ; P ≤ .049 ) for 24-h BP , the primary efficacy endpoint , and 2.5 mL/min/1.73 m2 ( + 1.5 vs. −1.1 mL/min/1.73 m2 ; P = .86 ) for eGFR , the primary safety endpoint . At 6 month , ECG voltages and the number of prescribed drugs ( P ≤ .036 ) were lower in RDN patients , but quality of life and adherence , captured by question naire and urine analysis were similar in both groups . Changes in BP and adherence were unrelated . No major complications occurred . Conclusions : The INSPiRED pilot suggests that RDN with the EnligHTN ™ system is effective and safe and generated insights useful for the design of future RDN trials Adolescence is a key developmental period for preventing substance use initiation , however prevention programs solely providing educational information about the dangers of substance use rarely change adolescent substance use behaviors . Recent research suggests that mind – body practice s such as yoga may have beneficial effects on several substance use risk factors , and that these practice s may serve as promising interventions for preventing adolescent substance use . The primary aim of the present study was to test the efficacy of yoga for reducing substance use risk factors during early adolescence . Seventh- grade students in a public school were r and omly assigned by classroom to receive either a 32-session yoga intervention ( n = 117 ) in place of their regular physical education classes or to continue with physical-education-as-usual ( n = 94 ) . Participants ( 63.2 % female ; 53.6 % White ) completed pre- and post-intervention question naires assessing emotional self-regulation , perceived stress , mood impairment , impulsivity , substance use willingness , and actual substance use . Participants also completed question naires at 6-months and 1-year post-intervention . Results revealed that participants in the control condition were significantly more willing to try smoking cigarettes immediately post-intervention than participants in the yoga condition . Immediate pre- to post-intervention differences did not emerge for the remaining outcomes . However , long-term follow-up analyses revealed a pattern of delayed effects in which females in the yoga condition , and males in the control condition , demonstrated improvements in emotional self-control . The findings suggest that school-based yoga may have beneficial effects with regard to preventing males ’ and females ’ willingness to smoke cigarettes , as well as improving emotional self-control in females . However additional research is required , particularly with regard to the potential long-term effects of mind – body interventions in school setting s. The present study contributes to the literature on adolescence by examining school-based yoga as a novel prevention program for substance use risk factors Craving , defined as the subjective experience of an urge or desire to use substances , has been identified in clinical , laboratory , and pre clinical studies as a significant predictor of substance use , substance use disorder , and relapse following treatment for a substance use disorder . Various models of craving have been proposed from biological , cognitive , and /or affective perspectives , and , collectively , these models of craving have informed the research and treatment of addictive behaviors . In this article we discuss cra
Output:
| These treatments were successful for reducing dependence , craving , and other addiction-related symptoms by also improving mood state and emotion dysregulation .
The most effective approach was the combination of MBIs with TAU or other active treatments .
However , there is a lack of studies showing the maintenance of the effect over time .
Conclusion The revised literature shows support for the effectiveness of the MBIs . |
MS210588 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background : Patient navigation has been an effective intervention to increase cancer screening rates . This study focuses on predicting outcomes of screening colonoscopy for colorectal cancer among African Americans using different patient navigation formats . Methods : In a r and omized clinical trial , patients more than 50 years of age without significant comorbidities were r and omized into three navigation groups : peer-patient navigation ( n = 181 ) , pro-patient navigation ( n = 123 ) , and st and ard ( n = 46 ) . Pro-patient navigations were health care professionals who conducted culturally targeted navigation , whereas peer-patient navigations were community members trained in patient navigation who also discussed their personal experiences with screening colonoscopy . Two assessment s gathered sociodemographic , medical , and intrapersonal information . Results : Screening colonoscopy completion rate was 75.7 % across all groups with no significant differences in completion between the three study arms . Annual income more than $ 10,000 was an independent predictor of screening colonoscopy adherence . Unexpectedly , low social influence also predicted screening colonoscopy completion . Conclusions : In an urban African American population , patient navigation was effective in increasing screening colonoscopy rates to 15 % above the national average , regardless of patient navigation type or content . Impact : Because patient navigation successfully increases colonoscopy adherence , cultural targeting may not be necessary in some population s. Cancer Epidemiol Biomarkers Prev ; 22(9 ) ; 1577–87 . © 2013 AACR Background : Research comparing the effects of culturally targeted and generic but linguistically appropriate intervention programs is limited . We conducted a r and omized controlled trial comparing the efficacy of a culturally targeted video , a generic video , and a fact sheet ( control ) in promoting mammography screening among Chinese-American immigrants . Methods : We r and omized 664 Chinese-American women from the Washington , DC , and New York City areas who were older than 40 years and nonadherent to annual mammography screening guidelines to three study arms ( each with ∼221 women ) . The outcome was self-reported mammography screening 6 months post intervention . Measures of knowledge , Eastern cultural views , and health beliefs were administered before and after the intervention . Results : The culturally targeted video , the generic video , and the fact sheet increased mammography use by 40.3 % , 38.5 % , and 31.1 % from baseline , respectively . A significant intervention effect was observed only in one subgroup : The culturally targeted video significantly increased mammography screening among low-acculturated women over the fact sheet [ OR , 1.70 ; 95 % confidence interval ( CI ) , 1.04–2.78 ] . Overall , women who obtained a mammogram during the follow-up period reported significantly fewer barriers to screening after intervention than those who had not obtained screening . Both of the video groups reported fewer barriers after intervention than the control group . Conclusions : Both theoretically guided videos increased the likelihood of mammography use to a similar extent . Cultural targeting was only effective for low-acculturated women . Both videos reduced perceived barriers to screening and consequently increased screening behavior . Impact : The results of this study provide empirical evidence on the efficacy of cultural targeting for minority immigrants . Cancer Epidemiol Biomarkers Prev ; 21(11 ) ; 1923–32 . © 2012 AACR In this pilot trial , 15 phobic Asian Americans were r and omly assigned to st and ard one-session treatment ( OSTS ) , culturally adapted one-session treatment ( OST-CA ) , or manualized self-help . At posttreatment , OST ( combined st and ard and culturally adapted ) led to greater reductions in phobic avoidance and anxiety than self-help . Moreover , analyses comparing the two active treatments showed trends favoring OST-CA over OST-S. Results suggest that Asian Americans may benefit most from empirically supported treatments that consider Asian cultural values . ( PsycINFO Data base Record ( c ) 2010 APA , all rights reserved ) BACKGROUND Communication between African American patients and white health care providers has been shown to be of poorer quality when compared with race-concordant patient-provider communication . Fear on the part of patients that providers stereotype them negatively might be one cause of this poorer communication . This stereotype threat may be lessened by a values-affirmation intervention . METHODS In a blinded experiment , we r and omized 99 African American patients with hypertension to perform a values-affirmation exercise or a control exercise before a visit with their primary care provider . We compared patient-provider communication for the 2 groups using audio recordings of the visit analyzed with the Roter Interaction Analysis System . We also evaluated visit satisfaction , trust , stress , and mood after the visit by means of a question naire . RESULTS Patients in the intervention group requested and provided more information about their medical condition ( mean [ SE ] number of utterances , 66.3 [ 6.8 ] in the values-affirmation group vs 48.1 [ 5.9 ] in the control group [ P = .03 ] ) . Patient-provider communication in the intervention group was characterized as being more interested , friendly , responsive , interactive , and respectful ( P = .02 ) and less depressed and distressed ( P = .03 ) . Patient question naires did not detect differences in visit satisfaction , trust , stress , or mood . Mean visit duration did not differ significantly between the groups ( 19.2 minutes in the control group vs 20.5 minutes in the intervention group [ P = .29 ] ) . CONCLUSIONS A values-affirmation exercise improves aspects of patient-provider communication in race-discordant primary care visits . The clinical impact of the intervention must be defined before widespread implementation can be recommended OBJECTIVE Many targeted interventions have been developed and tested with African Americans ( AA ) ; however , AAs are a highly heterogeneous group . One characteristic that varies across AAs is Ethnic Identity ( EI ) . Little research has been conducted on how to incorporate EI into the design of health messages and programs . DESIGN We tested whether tailoring a print-based fruit and vegetable ( F & V ) intervention on EI would enhance program impact . AA adults were recruited from two integrated healthcare delivery systems and then r and omized to receive three newsletters focused on F & V behavior change over three months . One set of newsletters was tailored only on demographic and social cognitive variables ( control condition ) , whereas the other ( experimental condition ) was additionally tailored on EI . MAIN OUTCOME MEASURES The primary outcome for the study was F & V intake , assessed at baseline and three months later using the composite of two brief self-report frequency measures . RESULTS A total of 560 eligible participants were enrolled , of which 468 provided complete 3-month follow-up data . The experimental group increased their daily mean F & V intake by 1.1 servings compared to .8 servings in the control group ( p = .13 ) . Afrocentric experimental group participants showed a 1.4 increase in F & V servings per day compared to a .43 servings per day increase among Afrocentric controls ( p < .05 ) . CONCLUSIONS Although the overall between-group effects were not significant , tailoring dietary messages on ethnic identity may improve intervention impact for some AA subgroups Background : Limited empirical data are available on the effects of genetic counseling and testing among African American women . Objective : To evaluate the effects of genetic counseling and testing in African American women based on different levels of exposure : ( a ) women who were r and omized to culturally tailored ( CTGC ) and st and ard genetic counseling ( SGC ) to women who declined r and omization ( non-r and omized group ) , ( b ) participants and non- participants in genetic counseling , and ( c ) BRCA1 and BRCA2 ( BRCA1/2 ) test result acceptors and decliners . Design : R and omized trial of genetic counseling conducted from February 2003 to November 2006 . Measures : We evaluated changes in perceived risk of developing breast cancer and cancer worry . Results : Women r and omized to CTGC and SGC did not differ in terms of changes in risk perception and cancer worry compared to decliners . However , counseling participants had a significantly greater likelihood of reporting reductions in perceived risk compared to non- participants ( p = 0.03 ) . Test result acceptors also had a significantly greater likelihood of reporting decreases in cancer worry ( p = 0.03 ) . However , having a cancer history ( p = 0.03 ) and a BRCA1/2 prior probability ( p = 0.04 ) were associated with increases in cancer worry . Conclusions : Although CTGC did not lead to significant improvements in perceived risk or psychological functioning , African American women may benefit from genetic counseling and testing . Continued efforts should be made to increase access to genetic counseling and testing among African American women at increased risk for hereditary disease . But , follow-up support may be needed for women who have a personal history of cancer and those with a greater prior probability of having a BRCA1/2 mutation Comparative studies examining the difference between empirically supported substance abuse treatments versus their culturally accommo date d counterparts with participants from a single ethnic minority group are frequently called for in the literature but infrequently conducted in practice . This r and omized clinical trial was conducted to compare the efficacy of an empirically supported st and ard version of a group-based cognitive-behavioral treatment ( S-CBT ) to a culturally accommo date d version ( A-CBT ) with a sample of Latino adolescents primarily recruited from the juvenile justice system . Development of the culturally accommo date d treatment and testing was guided by the Cultural Accommodation Model for Substance Abuse Treatment ( CAM-SAT ) . Seventy Latino adolescents ( mean age = 15.2 ; 90 % male ) were r and omly assigned to 1 of 2 group-based treatment conditions ( S-CBT = 36 ; A-CBT = 34 ) with assessment s conducted at pretreatment , posttreatment , and 3-month follow-up . Longitudinal Poisson mixed models for count data were used to conduct the major analyses . The primary outcome variable in the analytic models was the number of days any substance was used ( including alcohol , except tobacco ) in the past 90 days . In addition , the variables ethnic identity , familism , and acculturation were included as cultural moderators in the analysis . Although both conditions produced significant decreases in substance use , the results did not support a time by treatment condition interaction ; however , outcomes were moderated by ethnic identity and familism . The findings are discussed with implication s for research and practice within the context of providing culturally relevant treatment for Latino adolescents with substance use disorders Colorectal cancer screening has clear benefits in terms of mortality reduction ; however , it is still underutilized and especially among medically underserved population s , including African Americans , who also suffer a disproportionate colorectal cancer burden . This study consisted of a theory-driven ( health belief model ) spiritually based intervention aim ed at increasing screening among African Americans through a community health advisor-led educational series in 16 churches . Using a r and omized design , churches were assigned to receive either the spiritually based intervention or a nonspiritual comparison , which was the same in every way except that it did not contain spiritual/religious content and themes . Trained and certified peer community health advisors in each church led a series of two group educational sessions on colorectal cancer and screening . Study enrollees completed a baseline , 1-month , and 12-month follow-up survey at their churches . The interventions had significant pre – post impact on awareness of all four screening modalities , and self-report receipt of fecal occult blood test , flexible sigmoidoscopy , and colonoscopy . There were no significant study group differences in study outcomes , with the exception of fecal occult blood test utilization , whereas those in the nonspiritual intervention reported significantly greater pre – post change . Both of these community-engaged , theory-driven , culturally relevant approaches to increasing colorectal cancer awareness and screening appeared to have an impact on study outcomes . Although adding spiritual/religious themes to the intervention was appealing to the audience , it may not result in increased intervention efficacy What kinds of evidence reliably support predictions of effectiveness for health and social care interventions ? There is increasing reliance , not only for health care policy and practice but also for more general social and economic policy deliberation , on evidence that comes from studies whose basic logic is that of JS Mill 's method of difference . These include r and omized controlled trials , case-control studies , cohort studies , and some uses of causal Bayes nets and counterfactual-licensing models like ones commonly developed in econometrics . The topic of this paper is the ' external validity ' of causal conclusions from these kinds of studies . We shall argue two cl aims . Cl aim , negative : external validity is the wrong idea ; cl aim , positive : ' capacities ' are almost always the right idea , if there is a right idea to be had . If we are right about these cl aims , it makes big problems for policy decisions . Many advice guides for grading policy predictions give top grade s to a proposed policy if it has two good Mill's- method -of difference studies that support it . But if capacities are to serve as the conduit for support from a method -of-difference study to an effectiveness prediction , much more evidence , and much different in kind , is required . We will illustrate the complexities involved with the case of multisystemic therapy , an internationally adopted intervention to try to diminish antisocial behaviour in young people Fotonovelas — small booklets that portray a dramatic story using photographs and captions — represent a powerful health education tool for low-literacy and ethnic minority audiences . This study evaluated the effectiveness of a depression fotonovela in increasing depression knowledge , decreasing stigma , increasing self-efficacy to recognize depression , and increasing intentions to seek treatment , relative to a text pamphlet . Hispanic adults attending a community adult school ( N = 157 , 47.5 % female , mean age = 35.8 years
Output:
| Research ers did not find consistent evidence supporting implementation of any specific type of adaptation nor increased efficacy with any particular cultural group . |
MS210589 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: UNLABELLED Information on treatment outcome outside clinical trials is sparse . This is the first study that relates surgical and medical quality of care in daily practice with outcome . BACKGROUND In a previous study we showed , that the quality of chemotherapy as described by a guideline and given in daily practice to premenopausal primary breast cancer patients was suboptimal with only 68 % and 53 % of the patients receiving chemotherapy with a dose intensity ( DI ) and relative dose intensity ( RDI ) of > or = 85 % , respectively . Many invalid reasons for delay and dose reductions were identified . PATIENTS AND METHODS Premenopausal node-positive primary breast cancer patients treated from 1988 to 1992 were traced using two national registries . Relevant data were collected from their records . The following treatment-related variables were correlated with prognosis : type of surgery , number of investigated lymph nodes , radiotherapy , chemotherapy , interval between surgery and start of chemotherapy , DI , duration , delays and dose adjustments of chemotherapy and hospital size . RESULTS Twenty-four of the 254 traced patients did not receive any chemotherapy , 230 received the recommended schedule of cyclophosphamide ( C ) , methotrexate ( M ) and 5-fluorouracil ( F ) . The median time of follow-up was 6.7 ( range 0.9 - 10.2 ) years . The 5-year disease-free survival ( DFS ) and overall survival ( OS ) was 61 % and 77 % , respectively . In an univariate analysis DI < 65 % correlated with a worse DFS and OS ( p=0.05 and p=0.03 , respectively ) . The use of chemotherapy correlated with a better DFS ( p=0.03 ) than no use . In a multivariate analysis DI between 65 and 85 % result ed in a better DFS ( p=0.02 ) than DI > or = 85 % and DI < 65 % . CONCLUSION The prognosis of the breast cancer patients in this population was comparable with the results of r and omised trials using adjuvant CMF . The only treatment related variable of value for prognosis was DI . Unexpectedly DI between 65 % and 85 % result ed in the best prognosis in this population . The relevance of this observation remains unclear and warrants further investigation PURPOSE To investigate the effects of the Interactive Breast Cancer CDROM as a decision aid for breast cancer patients with a choice between breast conserving therapy ( BCT ) and mastectomy ( MT ) . PATIENTS AND METHODS Consecutive patients with stage I and II breast cancer were enrolled . A quasi-experimental , longitudinal , and pretest/posttest design was used . Follow-up was scheduled 3 and 9 months after discharge from the hospital . Control patients ( n = 88 ) received st and ard care ( oral information and brochures ) . The CDROM was provided to patients in the experimental condition ( n = 92 ) as a supplement to st and ard procedures . Outcome variables were treatment decision , satisfaction , and quality of life ( QoL ) . RESULTS No effect on treatment decision was found . CDROM patients expressed more general satisfaction with information at 3 and 9 months ( 95 % confidence interval for the difference ( d ) between the means ( d : 4.1 to 12.5 and 5.7 to 14.2 respectively ) . CDROM patients were also more satisfied with their treatment decision at 3 and at 9 months ( d : 0.1 to 0.4 ; 0.2 to 0.5 ) . Moreover , at 9 months , CDROM patients were more satisfied with breast cancer-specific information ( d : 0.9 to 16.5 ) , the decision-making process ( d : 0.1 to 0.4 ) , and communication ( d : 0.2 to 11.0 ) . At 3 and 9 months , a positive effect was found on general health ( d : 0.2 to 14.5 and 0.3 to 15.0 ) . Moreover , at 9 months , CDROM patients reported better physical functioning ( d : 5.1 to 19.8 ) , less pain ( d : -17.9 to -4.5 ) , and fewer arm symptoms ( d : -14.1 to -0.5 ) . CONCLUSION The Interactive Breast Cancer CDROM improved decision making in patients with early-stage breast cancer with a choice between BCT and MT , as evaluated in terms of patients ' satisfaction and BACKGROUND AND PURPOSE The International Breast Cancer Study Group ( IBCSG ) has developed and approach for assessing the impact of adjuvant therapy on quality of life ( QL ) within the framework of international , multilingual clinical trials . The major steps are summarized . Conceptual , method ological and practical issues are discussed with reference to results of two trials closed to accrual ( IBCSG VI , VII ) and one subsequent ongoing trial ( IBCSG IX ) . PATIENTS AND METHODS QL was assessed in pre- and post-menopausal patients with operable breast cancer . Various single-item linear analogue self- assessment ( LASA ) scales were used as indicators of components of QL , including global indicators of well-being , functioning and health perception , and specific indicators of symptoms of disease and treatment . In trials VI and VII , QL was assessed at baseline , during adjuvant treatment and follow-up , and at recurrence . Based on this experience , the QL form was revised for subsequent trials and further investigated in a sub sample of patients r and omized into trial IX . RESULTS In trials VI and VII , the QL indicators were responsive to the impact of biomedical factors at baseline , various adjuvant treatments , changes over the first 18 months , and recurrence . In trial IX , the revised QL form was well accepted by patients and staff . Completing this form did not exceed five minutes . QL differences between on and off cytotoxic treatment strengthen the cl aim that these measures are responsive . Correlations and logistic regression analyses show the expected relationship among the various global and specific indicators . CONCLUSION Results from two trials closed to accrual and an ongoing trial confirm the feasibility , validity and clinical relevance of the IBCSG approach for study ing the impact of adjuvant breast cancer therapy on QL in international clinical trials
Output:
| Most quality indicators evaluated processes of care . |
MS210590 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: BACKGROUND Twin pregnancies after IVF are still frequent and are considered high-risk pregnancies leading to high costs . Transferring one embryo can reduce the twin pregnancy rate . We compared cost-effectiveness of one fresh cycle elective single embryo transfer ( eSET ) versus one fresh cycle double embryo transfer ( DET ) in an unselected patient population . METHODS Patients starting their first IVF cycle were r and omized between eSET and DET . Societal costs per couple were determined empirically , from hormonal stimulation up to 42 weeks after embryo transfer . An incremental cost-effectiveness ratio ( ICER ) was calculated , representing additional costs per successful pregnancy . RESULTS Successful pregnancy rates were 20.8 % for eSET and 39.6 % for DET . Societal costs per couple were significantly lower after eSET ( 7334 euro ) compared with DET ( 10,924 euro ) . The ICER of DET compared with eSET was 19,096 euro , meaning that each additional successful pregnancy in the DET group will cost 19,096 euro extra . CONCLUSIONS One cycle eSET was less expensive , but also less effective compared to one cycle DET . It depends on the society 's willingness to pay for one extra successful pregnancy , whether one cycle DET is preferred from a cost-effectiveness point of view OBJECTIVE To identify factors that influence patient decision making concerning embryo transfer . DESIGN Prospect i ve analysis . SETTING In vitro fertilization unit at a tertiary-care , university-affiliated teaching hospital . PATIENT(S ) Seventy-nine women and 53 men who were referred consecutively for IVF treatment . INTERVENTION(S ) Provision of risk information about complications of twin pregnancy . MAIN OUTCOME MEASURE(S ) Rated desirability of different transfer options and twin pregnancy , together with st and ardized measures of depression and infertility stress . RESULT ( S ) Women 's initial preference for two-embryo transfer ( 2ET ) was related to beliefs that the chance of pregnancy was higher with 2ET vs. elective single-embryo transfer and that the personal chance of twins was relatively likely with 2ET but was not related to a specific desire for twins . Providing risk information increased the desirability of elective single-embryo transfer and decreased the desirability of twin pregnancy among both men and women . CONCLUSION ( S ) Cautious patients , preferring transfer of fewer embryos , balance desires to maximize the chance of pregnancy with acceptance of risks associated with twins . Less-cautious patients may be motivated by beliefs about the influence of age , desires for , and likelihood of twin pregnancy . Information about risks may affect these groups differently and diverse patient motivations may require tailored information to ensure informed consent Survivors of the " vanishing " twin syndrome , which occurred in dichorionic twins only , and singletons that began as singletons , had similar mean gestational duration and birth weights , as well as similar frequencies of maternal and neonatal complications . This similarity persisted when conventional IVF and IVF plus ICSI cases were separately evaluated BACKGROUND Single embryo transfer ( SET ) after IVF/ICSI has been shown to result in an acceptable pregnancy rate in selected subjects . In our unit , SET is routinely carried out among women under the age of 36 in the first or second treatment cycle when a top- quality embryo is available . In order to define further the selection criteria for SET , we have analysed the outcome of elective SET ( eSET ) , including the cumulative pregnancy rate after frozen embryo transfers , performed in the years 2000 - 2002 in the Oulu Fertility Center . METHODS During the study period , a total of 1271 transfers were performed , and in 468 cycles SET ( 39 % of all transfers ) was carried out . Of the SET cycles , in 308 cases a top- quality embryo was transferred on day 2 and extra embryos were frozen . Of these eSET cycles , ICSI was carried out in 87 cycles ( 28 % ) . RESULTS The overall clinical pregnancy rate per transfer was 34.7 % in the eSET cycles . In the eSET ICSI cycles , the clinical pregnancy rate was significantly higher than in the corresponding IVF cycles ( 50.6 versus 28.5 % , P < 0.001 ) . The cumulative pregnancy rate per patient after fresh and frozen embryo transfers was also significantly higher after ICSI ( 71.2 versus 53.4 % , P < 0.01 ) . CONCLUSIONS A high cumulative pregnancy rate per oocyte retrieval can be achieved after eSET in daily clinical practice . The implantation rate of fresh top- quality embryos in the ICSI cycles was significantly higher than in the IVF cycles , possibly due to more successful selection of the embryo for embryo transfer on day 2 after ICSI . In addition , our data suggest that embryo quality is a more important determinant of outcome than the age of the woman BACKGROUND We analysed the difference in maternal , neonatal and total costs after single ( SET ) versus double day 3 embryo transfer ( DET ) . METHODS We performed a two-centre prospect i ve study of women in their first IVF/ICSI cycle choosing between SET or DET . Infertility treatment data were gathered from a data base ; maternal and neonatal outcome data from a case report form ( CRF ) ; health economic data from medical acts registered in the CRF for the outpatient part and from hospital bills . SET was performed in 206/367 ( 56.1 % ) and DET in 161/367 ( 43.9 % ) women . RESULTS In all , 367 transfers yielded 186 positive pregnancy tests , 148 ongoing pregnancies and 136 live deliveries ( 50.7 , 40.3 and 37.1 % per embryo transfer ) of which 15 ( 11.0 % ) were twins . Live birth rate was 37.4 % for SET , 36.6 % for DET . Intention-to-treat analysis showed differences for : duration of pregnancy ( SET : 39.0 + /- 1.4 versus DET : 38.3 + /- 2.2 weeks ; P = 0.055 ) , percentage prematurity ( 8.5 versus 23.8 % ; P = 0.033 ) , percentage of neonates hospitalized ( 5.7 versus 17.9 % ; P = 0.121 ) and duration of neonatal hospitalization ( 6.3 + /- 2.2 versus 10.3 + /- 10.1 days ; P = 0.01 ) . Total cost after DET was higher ( SET : 4700 + /- 3239 versus DET : 8613 + /- 10 105 ; P = 0.105 ) , due to significantly higher neonatal costs ( 451 + /- 957 versus 3453 + /- 8154 ; P < 0.001 ) and not to differences in maternal costs ( 4250 + /- 2882 versus 5160 + /- 4106 ; P = 0.152 ) . CONCLUSIONS This prospect i ve health economic study shows that transfer of a single top quality embryo is equally effective as , but substantially cheaper than , double embryo transfer in women < 38 years of age in their first IVF/ICSI cycle St and ard protocol s for in-vitro fertilization ( IVF ) include transfer of two or three embryos . Not surprisingly , the rate of twin pregnancy after IVF is high ( about 24 % of all pregnancies ) . Routine transfer of one , rather than two , embryos would be expected to result in a much lower rate of twin pregnancies at the cost of a lower take-home baby rate . The aim of this study was to compare hypothetical costs to society incurred by pregnancies achieved with IVF protocol s based on the transfer of one or two embryos . We compared actual ( for two-embryo transfers ) and hypothetical ( for one-embryo transfers ) take-home baby rates ; risks of twin pregnancies ; and costs of sick leave and hospitalization during pregnancy , deliveries , neonatal intensive care , and h and icap care after transfer of one or two embryos . The study showed that even when more treatments might be needed to achieve similar baby take-home rates after transfer of one compared with two embryos , the lower twin pregnancy rate of the former approach caused it to be more cost-efficient than the latter . In conclusion , IVF costs are the sum of fertilization treatment costs and the costs for health care of the pregnant women and their offspring . Considering the association of the latter costs with numbers of embryos transferred , studies of one-embryo transfer protocol s are urgently needed BACKGROUND Transfer of several embryos after IVF results in a high multiple birth rate associated with increased morbidity and high costs for the neonatal care . In a previous r and omized trial we demonstrated that a single embryo transfer ( SET ) strategy , including one fresh single embryo transfer and , if no live birth , one additional frozen-thawed SET , result ed in a live-birth rate that was not substantially lower than after double embryo transfer ( DET ) but markedly reduced the multiple birth rate . METHODS We compared costs for maternal health care and productivity losses and paediatric costs for the SET and DET strategies . In addition , maternal and paediatric outcomes between the two groups were compared . RESULTS The SET strategy result ed in lower average total costs from treatment until 6 months after delivery . There were a few more deliveries with at least one live-born child in the DET group . The incremental cost per extra delivery in the DET alternative was high , 71 940 . The rates of prematurely born and low birthweight children were significantly lower with the SET strategy . There were also markedly fewer maternal and paediatric complications in the SET group . CONCLUSIONS The SET strategy is superior to the DET strategy , when number of deliveries with at least one live-born child , incremental cost-effectiveness ratio and maternal and paediatric complications are taken into consideration . The findings do not support continuing transfers of two embryos in this group of patients Abstract Objective To compare neurological sequelae in twins born after assisted conception with singletons after assisted conception and naturally conceived twins and to assess neurological sequelae in children conceived after in vitro fertilisation ( IVF ) compared with intracytoplasmic sperm injection ( ICSI ) . Design Controlled , national register based , cohort study . Participants Twins ( n = 3393 ) and singletons ( n = 5130 ) conceived by using assisted reproductive technologies and naturally conceived twins ( n = 10 239 ) born in Denmark between 1995 and 2000 . The children 's age at time of follow up was 2 - 7 years . Data sources Children were identified by cross linkage of the national medical birth registry and the national registry for in vitro fertilisation . Neurological and psychiatric diagnoses were retrieved from the national patients ' registry and the Danish psychiatric central registry . Main outcome measures Neurological sequelae , defined as cerebral palsy , mental retardation , severe mental developmental disturbances , and retarded psychomotor development . Further we made separate analyses on the specific cerebral palsy diagnosis . Results The crude prevalence rates per 1000 of neurological sequelae in twins and singletons after assisted conception and in naturally conceived twins were 8.8 , 8.2 , and 9.6 , and of cerebral palsy 3.2 , 2.5 , and 4.0 , respectively . In twins after assisted conception compared with control twins , the odds ratios of neurological sequelae and specifically of cerebral palsy , adjusted for child sex and year of birth , were 0.9 ( 95 % confidence interval 0.6 to 1.4 ) and 0.8 ( 0.4 to 1.6 ) , respectively . The corresponding odds ratios for twins after assisted conception compared with singletons after assisted conception were 1.1 ( 0.7 to 1.7 ) for neurological sequelae and 1.3 ( 0.6 to 2.9 ) for cerebral palsy . The odds ratio of neurological sequelae in children conceived by ICSI was 0.9 ( 0.5 to 1.7 ) ν children conceived by IVF . Conclusions Twins from assisted conception have a similar risk of neurological sequelae as their naturally conceived peers and singletons from assisted conception . Children born after ICSI have the same risk of neurological sequelae as children born after IVF BACKGROUND Elective single embryo transfer ( eSET ) in a selected group of patients ( i.e. young patients with at least one good quality embryo ) reduces the number of multiple pregnancies in an IVF programme . However , the reduced overall multiple pregnancy rate ( PR ) is still unacceptably high . Therefore , a r and omized controlled trial ( RCT ) was conducted comparing eSET and double embryo transfer ( DET ) in an unselected group of patients ( i.e. irrespective of the woman 's age or embryo quality ) . METHODS Consenting unselected patients were r and omized between eSET ( RCT -eSET ) ( n = 154 ) or DET ( RCT -DET ) ( n = 154 ) . R and omization was performed just prior to the first embryo transfer , provided that at least two 2PN zygotes were available . Non- participants received our st and ard transfer policy [ SP-eSET in a selected group of patients ( n = 100 ) , otherwise SP-DET ( n = 122
Output:
| Indiscriminate application of eSET in population s with less than optimal prognosis for live birth will result in a significant reduction in effectiveness compared with DET .
In women aged 38 years and over , eSET may result in a significant reduction in live birth rate compared with DET . |
MS210591 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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***EXAMPLES***
Input: AIMS In the dual antiplatelet therapy ( DAPT ) study , continued thienopyridine beyond 12 months after drug-eluting stent placement was associated with increased mortality compared with placebo . We sought to evaluate factors related to mortality in r and omized patients receiving either drug-eluting or bare metal stents in the DAPT study . METHODS AND RESULTS Patients were enrolled after coronary stenting , given thienopyridine and aspirin for 12 months , r and omly assigned to continued thienopyridine or placebo for an additional 18 months ( while taking aspirin ) , and subsequently treated with aspirin alone for another 3 months . A blinded independent adjudication committee evaluated deaths . Among 11 648 r and omized patients , rates of all-cause mortality rates were 1.9 vs. 1.5 % ( continued thienopyridine vs. placebo , P = 0.07 ) , cardiovascular mortality , 1.0 vs. 1.0 % ( P = 0.97 ) , and non-cardiovascular mortality , 0.9 vs. 0.5 % ( P = 0.01 ) over the r and omized period ( Months 12 - 30 ) . Rates of fatal bleeding were 0.2 vs. 0.1 % ( P = 0.81 ) , and deaths related to any prior bleeding were 0.3 vs. 0.2 % ( P = 0.36 ) , Months 12 - 33 ) . Cancer incidence did not differ ( 2.0 vs. 1.6 % , P = 0.12 ) . Cancer-related deaths occurred in 0.6 vs. 0.3 % ( P = 0.02 ) and were rarely related to bleeding ( 0.1 vs. 0 , P = 0.25 ) . After excluding those occurring in patients with cancer diagnosed before enrolment , rates were 0.4 vs. 0.3 % ( P = 0.16 ) . CONCLUSION Bleeding accounted for a minority of deaths among patients treated with continued thienopyridine . Cancer-related death in association with thienopyridine therapy was mainly not related to bleeding and may be a chance finding . Caution is warranted when considering extended thienopyridine in patients with advanced cancer . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00977938 Background — The impact of changing demographics on causes of long-term death after percutaneous coronary intervention ( PCI ) remains incompletely defined . Methods and Results — We evaluated trends in cause-specific long-term mortality after index PCI performed at a single center from 1991 to 2008 . Deaths were ascertained by scheduled prospect i ve surveillance . Cause was determined via telephone interviews , medical records , autopsy reports , and death certificates . Competing-risks analysis of cause-specific mortality was performed using 3 time periods of PCI ( 1991–1996 , 1997–2002 , and 2003–2008 ) . Final follow-up was December 31 , 2012 . A total of 19 077 patients survived index PCI hospitalization , of whom 6988 subsequently died ( 37 % , 4.48 per 100 person-years ) . Cause was determined in 6857 ( 98.1 % ) . Across 3 time periods , there was a 33 % decline in cardiac deaths at 5 years after PCI ( incidence : 9.8 % , 7.4 % , and 6.6 % ) but a 57 % increase in noncardiac deaths ( 7.1 % , 8.5 % , and 11.2 % ) . Only 36.8 % of deaths in the recent era were cardiac . Similar trends were observed regardless of age , extent of coronary disease , or PCI indication . After adjustment for baseline variables , there was a 50 % temporal decline in cardiac mortality but no change in noncardiac mortality . The decline in cardiac mortality was driven by fewer deaths from myocardial infa rct ion/sudden death ( P<0.001 ) but not heart failure ( P=0.85 ) . The increase in noncardiac mortality was primarily attributable to cancer and chronic diseases ( P<0.001 ) . Conclusions — This study found a marked temporal switch from predominantly cardiac to predominantly noncardiac causes of death after PCI over 2 decades . The decline in cardiac mortality was independent of changes in baseline clinical characteristics . These findings have implication s for patient care and clinical trial design OBJECTIVES : We evaluated the effect of the use of aspirin , nonsteroidal anti-inflammatory drugs ( NSAIDS ) , and anticoagulants on the performance of immunochemical fecal occult blood test ( I-FOBT ) . METHODS : A prospect i ve , cross-sectional study of 1,221 ambulatory patients having total colonoscopy after preparing three I-FOBTs . Information regarding the use of medications was collected from the health medical organization ( HMO ) data base . I-FOBT was analyzed with the OC-MICRO instrument using both ≥75 and 100 ngHb/ml of buffer thresholds to determine positivity . RESULTS : Colorectal cancer ( CRC ) was found in 17 and advanced adenomatous polyp ( AAP ) in 97 patients . A total of 212 patients were using aspirin/NSAIDS at the time of I-FOBT testing . Qualitative analysis for the detection of AAP/CRC reveals a trend for an increased sensitivity with aspirin/NSAIDS use . At the threshold 75 ng/ml for positivity , the sensitivity for the detection of AAP/CRC was 66.7 % for aspirin/NSAIDS use vs. 51.2 % for nondrug takers ( P=0.20 ) , and at the threshold of 100 ng/ml , the sensitivity was 66.7 vs. 46.5 % ( P=0.09 ) . The specificity , however , was not affected by the use of aspirin/NSAIDS . At the threshold of 75 ng/ml for positivity , the specificity for the detection of AAP/CRC was 89.5 % for aspirin/NSAIDS use vs. 91.2 % for nondrug takers ( P=0.47 ) , and at the threshold of 100 ng/ml , the specificity was 92.17 vs. 93.0 % ( P=0.69 ) . A total of 33 patients were using antithrombotics/coagulants at the time of I-FOBT testing . This group was small ; however , it appears that their use was also associated with a trend for increased sensitivity and no change in specificity . CONCLUSIONS : The use of aspirin/NSAIDS and anticoagulants was associated with a trend for increased sensitivity with no change in specificity for the detection of AAP/CRC . This study suggests that there is no need to stop these agents before I-FOBT testing BACKGROUND Despite current treatments , patients who have acute coronary syndromes without ST-segment elevation have high rates of major vascular events . We evaluated the efficacy and safety of the antiplatelet agent clopidogrel when given with aspirin in such patients . METHODS We r and omly assigned 12,562 patients who had presented within 24 hours after the onset of symptoms to receive clopidogrel ( 300 mg immediately , followed by 75 mg once daily ) ( 6259 patients ) or placebo ( 6303 patients ) in addition to aspirin for 3 to 12 months . RESULTS The first primary outcome --a composite of death from cardiovascular causes , nonfatal myocardial infa rct ion , or stroke -- occurred in 9.3 percent of the patients in the clopidogrel group and 11.4 percent of the patients in the placebo group ( relative risk with clopidogrel as compared with placebo , 0.80 ; 95 percent confidence interval , 0.72 to 0.90 ; P<0.001 ) . The second primary outcome --the first primary outcome or refractory ischemia -- occurred in 16.5 percent of the patients in the clopidogrel group and 18.8 percent of the patients in the placebo group ( relative risk , 0.86 ; 95 percent confidence interval , 0.79 to 0.94 ; P<0.001 ) . The percentages of patients with in-hospital refractory or severe ischemia , heart failure , and revascularization procedures were also significantly lower with clopidogrel . There were significantly more patients with major bleeding in the clopidogrel group than in the placebo group ( 3.7 percent vs. 2.7 percent ; relative risk , 1.38 ; P=0.001 ) , but there were not significantly more patients with episodes of life-threatening bleeding ( 2.2 percent [ corrected ] vs. 1.8 percent ; P=0.13 ) or hemorrhagic strokes ( 0.1 percent vs. 0.1 percent ) . CONCLUSIONS The antiplatelet agent clopidogrel has beneficial effects in patients with acute coronary syndromes without ST-segment elevation . However , the risk of major bleeding is increased among patients treated with clopidogrel BACKGROUND Dual-antiplatelet therapy with aspirin and a thienopyridine is a cornerstone of treatment to prevent thrombotic complications of acute coronary syndromes and percutaneous coronary intervention . METHODS To compare prasugrel , a new thienopyridine , with clopidogrel , we r and omly assigned 13,608 patients with moderate-to-high-risk acute coronary syndromes with scheduled percutaneous coronary intervention to receive prasugrel ( a 60-mg loading dose and a 10-mg daily maintenance dose ) or clopidogrel ( a 300-mg loading dose and a 75-mg daily maintenance dose ) , for 6 to 15 months . The primary efficacy end point was death from cardiovascular causes , nonfatal myocardial infa rct ion , or nonfatal stroke . The key safety end point was major bleeding . RESULTS The primary efficacy end point occurred in 12.1 % of patients receiving clopidogrel and 9.9 % of patients receiving prasugrel ( hazard ratio for prasugrel vs. clopidogrel , 0.81 ; 95 % confidence interval [ CI ] , 0.73 to 0.90 ; P<0.001 ) . We also found significant reductions in the prasugrel group in the rates of myocardial infa rct ion ( 9.7 % for clopidogrel vs. 7.4 % for prasugrel ; P<0.001 ) , urgent target-vessel revascularization ( 3.7 % vs. 2.5 % ; P<0.001 ) , and stent thrombosis ( 2.4 % vs. 1.1 % ; P<0.001 ) . Major bleeding was observed in 2.4 % of patients receiving prasugrel and in 1.8 % of patients receiving clopidogrel ( hazard ratio , 1.32 ; 95 % CI , 1.03 to 1.68 ; P=0.03 ) . Also greater in the prasugrel group was the rate of life-threatening bleeding ( 1.4 % vs. 0.9 % ; P=0.01 ) , including nonfatal bleeding ( 1.1 % vs. 0.9 % ; hazard ratio , 1.25 ; P=0.23 ) and fatal bleeding ( 0.4 % vs. 0.1 % ; P=0.002 ) . CONCLUSIONS In patients with acute coronary syndromes with scheduled percutaneous coronary intervention , prasugrel therapy was associated with significantly reduced rates of ischemic events , including stent thrombosis , but with an increased risk of major bleeding , including fatal bleeding . Overall mortality did not differ significantly between treatment groups . ( Clinical Trials.gov number , NCT00097591 [ Clinical Trials.gov ] . PURPOSE Concerns were raised about the safety of antiplatelet thienopyridine derivatives after a r and omized control trial reported increased risks of cancer and cancer deaths in prasugrel users . We investigate whether clopidogrel , a widely used thienopyridine derivative , was associated with increased risk of cancer-specific or all-cause mortality in cancer patients . METHODS Colorectal , breast and prostate cancer patients , newly diagnosed from 1998 to 2009 , were identified from the National Cancer Data Repository . Cohorts were linked to the UK Clinical Practice Research Data link , providing prescription records , and to the Office of National Statistics mortality data ( up to 2012 ) . Unadjusted and adjusted hazard ratios ( HRs ) for cancer-specific and all-cause mortality in post-diagnostic clopidogrel users were calculated using time-dependent Cox regression models . RESULTS The analysis included 10 359 colorectal , 17 889 breast and 13 155 prostate cancer patients . There was no evidence of an increase in cancer-specific mortality in clopidogrel users with colorectal ( HR = 0.98 95 % confidence interval ( CI ) 0.77 , 1.24 ) or prostate cancer ( HR = 1.03 95%CI 0.82 , 1.28 ) . There was limited evidence of an increase in breast cancer patients ( HR = 1.22
Output:
| Further analyses examining clopidogrel showed no significant association with cancer event rate or malignancy-related death .
Conclusions Our results suggest that there is currently insufficient evidence to suggest that thienopyridine exposure is associated with an increased risk of cancer event rate or mortality |
MS210592 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE Patients with completely resected stages I-IV high grade uterine leiomyosarcoma are at high risk for recurrence . No adjuvant treatment has been shown to improve survival , although prospect i ve data are limited . We sought to determine whether adjuvant gemcitabine-docetaxel would yield a 2-year progression-free survival of at least 50 % in this leiomyosarcoma population . METHODS Eligible patients were treated with gemcitabine 900 mg/m(2 ) over 90 min days 1 and 8 plus docetaxel 75 mg/m(2 ) day 8 , every 3 weeks for 4 cycles . CT imaging was performed at baseline , after cycle 4 , and every 3 months . Progression was defined as evidence of new disease on CT . RESULTS Twenty-five patients ( median age 49 ; range , 37 - 73 ) enrolled ; 23 were evaluable ( 1-never treated , 1-ineligible ) . With median follow-up of 49 months for all patients , 10 ( 45 % ) of the 23 evaluable patients remained progression free at 2 years , with a median progression-free survival of 13 months . The median overall survival is not yet reached . Among the 18 patients with stages I or II uterine leiomyosarcoma , 59 % remain progression-free at 2 years , with a median progression-free survival of 39 months . Median overall survival for stages I and II patients is not yet reached with median follow-up duration of 49 months . Sites of first recurrence were : lung only - 3/23 ( 13 % ) ; pelvis only - 5/23 ( 22 % ) ; both - 5 ( 22 % ) . CONCLUSIONS Post-resection gemcitabine-docetaxel for stages I-IV high- grade uterine leiomyosarcoma yields 2-year progression-free survival rates that appear superior to historical rates . Gemcitabine-docetaxel merits further study as part of an adjuvant strategy for patients with completely resected , early-stage uterine leiomyosarcoma PURPOSE To determine the long-term outcome of uterine fibroid therapy ( UFE ) using tris-acryl gelatin microspheres ( TAGM ) . MATERIAL S This was a multicenter prospect i ve study of patients undergoing UFE with TAGM , and during this phase of the study , the clinical outcomes 3 years after treatment were assessed . Measures of outcome included the Ruta Menorrhagia Question naire , patient self- assessment s of symptoms and impact on activities , patient satisfaction and health-related quality of life as measured by the SF-12 . Long-term re-intervention rates were also assessed . The data were analyzed at each interval compared to baseline using appropriate statistical tests . RESULTS Of the 102 patients enrolled , 96 patients had complete baseline data and of these , 69 ( 72 % ) had known outcomes at 3 years after treatment . Sixty-one patients ( 64 % ) completed long-term follow-up without major intervention . An additional 8 patients ( 8.3 % ) underwent fibroid surgery ( 7 hysterectomies and 1 myomectomy ) . Among those without intervention , at 3 years after treatment , the mean Ruta Question naire Score was 19.3 , compared to 47.9 at baseline and 24.5 at 3 months ( P < .01 ) . At baseline , 57 % of patients had extremely heavy bleeding , while only 2 % had that complaint at 36 months . At 36 months , much or moderate improvement in pelvic pain occurred in 83 % of patients , pelvic discomfort in 83 % , and urinary problems in 69 % and 84 % were moderately or very satisfied with their outcome . CONCLUSIONS Over the long-term , UFE using TAGM is effective and safe , with high levels of durable symptom control , improved health-related quality of life and patient satisfaction AIM The purpose of this study was to compare the depth of vascular penetration of non-spherical polyvinyl alcohol ( PVA ) versus trisacryl gelatin microspheres ( MS ) in women undergoing uterine artery embolization ( UAE ) immediately before transabdominal myomectomy . MATERIAL S AND METHODS A total of 17 patients who had been referred for embolization before myomectomy underwent bilateral uterine artery embolization using either 355 - 500 microm PVA ( group A ) or 700 - 900 microm MS ( group B ) . The depth of penetration of the particles was assessed by identifying their presence and location in the resected specimen . RESULTS Of the 17 women enrolled in this study , 10 were in group A and 6 in group B. One woman underwent embolization using both types of particle and was excluded from the analysis . Embolic particles were significantly ( p = 0.048 ) more frequently located within the fibroid ( 4/6 , 67 % ) in Group B than Group A ( 1/10 , 10 % ) . Particles were also identified in the perifibroid tissues in 4/6 ( 67 % ) in Group B and 4/10 ( 40 % ) in Group A , with no statistical difference . There were no procedural complications . CONCLUSION MS particles ( 700 - 900 microm ) penetrate significantly deeper into leiomyomata compared with non-spherical PVA ( 355 - 500 microm ) . MS may therefore confer advantages in UAE , as they may more specifically target the fibroid , allowing an earlier end-point to embolization and minimizing ischaemic damage to normal myometrium and ovaries OBJECTIVE Uterine leiomyoma , or fibroid tumors , are the leading indication for hysterectomy in the United States , but the proportion of women in whom fibroid tumors develop is not known . This study screened for fibroid tumors , independently of clinical symptoms , to estimate the age-specific proportion of black and white women in whom fibroid tumors develop . STUDY DESIGN R and omly selected members of an urban health plan who were 35 to 49 years old participated ( n = 1364 women ) . Medical records and self-report were used to assess fibroid status for those women who were no longer menstruating ( most of whom had had hysterectomies ) . Premenopausal women were screened by ultrasonography . We estimated the age-specific cumulative incidence of fibroid tumors for black and white women . RESULTS Thirty-five percent of premenopausal women had a previous diagnosis of fibroid tumors . Fifty-one percent of the premenopausal women who had no previous diagnosis had ultrasound evidence of fibroid tumors . The estimated cumulative incidence of tumors by age 50 was > 80 % for black women and nearly 70 % for white women . The difference between the age-specific cumulative incidence curves for black and white women was highly significant ( odds ratio , 2.9 ; 95 % CI , 2.5 - 3.4 ; P < .001 ) . CONCLUSION The results of this study suggest that most black and white women in the United States develop uterine fibroid tumors before menopause and that uterine fibroid tumors develop in black women at earlier ages than in white women PURPOSE To compare tris-acryl microspheres and polyvinyl alcohol ( PVA ) microspheres as embolic agents in uterine artery embolization ( UAE ) for uterine leiomyomas in terms of clinical outcome , inflammatory response , and adverse reactions . MATERIAL S AND METHODS A double-blinded r and omized controlled trial was performed , with 27 patients in the tris-acryl microsphere group and 29 in the PVA microsphere group . The primary endpoint was clinical success , defined as a 2-year freedom from subsequent surgery as a result of persistent or deteriorated symptoms . Secondary endpoints included ( i ) posttreatment leiomyoma enlargement , ( ii ) leiomyoma volume reduction at 3 and 9 months , ( iii ) significant residual intratumoral perfusion , ( iv ) increase in inflammatory and stress markers , ( v ) incidence of complications , and ( vi ) duration of hospital stay . RESULTS There was no statistically significant difference between the two groups in patient demographics , clinical presentation , initial tumor findings , change in inflammatory and stress markers after treatment , incidence of complications , and duration of hospital stay . Tris-acryl microspheres were associated with a higher rate of clinical success than PVA microspheres ( 96.3 % [ 26 of 27 ] vs 69 % [ 20 of 29 ] ; P = .012 ) , a lower incidence of posttreatment leiomyoma enlargement ( P = .030 ) , and a lower incidence of significant residual intratumoral perfusion ( P = .030 ) . CONCLUSIONS In the treatment of uterine leiomyomas , UAE with tris-acryl microspheres was associated with a higher clinical success rate , a lower incidence of tumor enlargement , and no significant differences in adverse reactions and inflammatory response compared with the use of PVA microspheres . Tris-acryl microspheres therefore represent the preferred agent for UAE of uterine leiomyomas Objective To evaluate the efficacy of acrylamido polyvinyl alcohol microspheres ( a-PVAM ) as an embolic agent for uterine artery embolization ( UAE ) compared with Tris-acryl gelatin microspheres ( TAGM ) . Design , Setting , Participants Prospect i ve r and omized double-blind noninferiority trial . Conducted at two sites both with regional UAE practice s. Forty-six women with symptomatic leiomyomas . InterventionUAE procedure was performed with either of the two embolic agents . Either 700–900-μm a-PVAM or 500–700-μm TAGM was used . Main Outcome Measures Changes in leiomyoma perfusion , overall uterine volume , and dominant leiomyomas volume measured by contrast-enhanced magnetic resonance imaging at 1 week , 3 months , and 6 months after UAE by a reader blinded to the embolic agent used . Changes in Uterine Fibroid Symptoms and Quality of Life question naire scores were measured at 3 , 6 , and 12 months after UAE . Results Forty-six patients were r and omized and treated under the study protocol ( a-PVAM n = 22 , TAGM n = 24 ) . There were no procedure-related complications . Two patients were excluded from analysis ( one technical failure of the procedure , one withdrawal from study ) . Successful ( > 90 % ) leiomyoma devascularization was observed in 81 % of subjects at 1 week after UAE , 97 % at 3 months after UAE , and 95 % at 6 months after UAE . No significant differences were observed in 14 of 15 outcome measurements , consistent with noninferiority . TAGM was slightly superior to a-PVAM on one comparison ( overall quality of life at 3 months after UAE ) Purpose This study was design ed to compare quality of life ( QoL ) outcomes after uterine artery embolization ( UAE ) or myomectomy . Methods Women with symptomatic fibroids diagnosed by ultrasound who wished to preserve their uterus were r and omized to myomectomy ( n = 81 ) or UAE ( n = 82 ) . Endpoints at 1 year were QoL measured by a vali date d question naire , hospital stay , rates of complications , and need for reintervention . Results UAE patients had shorter hospitalization ( 2 vs. 6 days , p < 0.001 ) . By 1 year postintervention , significant and equal improvements in QoL scores had occurred in both groups ( myomectomy n = 59 ; UAE n = 61 ) . There had been two ( 2.9 % ) major complications among UAE versus 6 ( 8 % ) among myomectomy patients ( not significant ) . By 2 years , among UAE patients ( n = 57 ) there were eight ( 14.0 % ) re interventions for inadequate symptom control compared with one ( 2.7 % ) among myomectomy patients ( n = 37 ) . Half of the women who required hysterectomy had concomitant adenomyosis missed by US . Conclusions UAE and myomectomy both result in significant and equal improvements in QoL. UAE allows a shorter hospital stay and fewer major complications but with a higher rate of reintervention Purpose To report 5-year contrast-enhanced magnetic resonance imaging findings of the REST trial recruits who underwent either uterine artery embolization ( UAE ) or myomectomy . Methods A total of 157 patients were r and omized to UAE or surgery ( hysterectomy or myomectomy ) . Ninety-nine patients who had UAE and eight patients who had myomectomy were analyzed . MRI scans at baseline , 6 months , and 5 years were independently interpreted by two radiologists . Dominant fibroid diameter , uterine volume , total fibroid infa rct ion ( complete 100 % , almost complete 90–99 % , partial < 90 % ) , and new fibroid formation were the main parameters assessed and related to the need for reintervention . Results In the UAE group , mean ± st and ard deviation uterine volume was 670 ± 503 , 422 ± 353 , and 292 ± 287 mL at baseline , 6 months , and 5 years , respectively . Mean dominant fibroid diameter was 7.6 ± 3.0 , 5.8 ± 2.9 , and 5 ± 2.9 cm at baseline , 6 months , and
Output:
| Compared to polyvinyl alcohol , tris-acryl gelatin microsphere showed a significant benefit in improving the overall quality of life and in reducing uterine volume at three and six months , in reducing overall symptom severity at 6 and 12 months , and furthermore in reducing treatment failure .
In addition , tris-acryl gelatin microsphere could significantly reduce leiomyoma volume and decrease < 90 % complete leiomyoma infa rct ion rate at three months .
There were no differences in pain severity , other post-procedural symptoms or medication use in the two groups .
Conclusions : A better effect of tris-acryl gelatin microsphere in leiomyoma embolization for patients with symptomatic leiomyoma |
MS210593 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background The long-term prognosis of diabetic patients with acute myocardial infa rct ion ( AMI ) treated by acute revascularization is uncertain , and the optimal pharmacotherapy for such cases has not been fully evaluated . Methods To eluci date the long-term prognosis and prognostic factors in diabetic patients with AMI , a prospect i ve , cohort study involving 3021 consecutive AMI patients was conducted . All patients discharged alive from hospital were followed to monitor their prognosis every year . The primary endpoint of the study was all-cause mortality , and the secondary endpoint was the occurrence of major cardiovascular events . To eluci date the effect of various factors on the long-term prognosis of AMI patients with diabetes , the patients were divided into two groups matched by propensity scores and analyzed retrospectively . Results Diabetes was diagnosed in 1102 patients ( 36.5 % ) . During the index hospitalization , coronary angioplasty and coronary thrombolysis were performed in 58.1 % and 16.3 % of patients , respectively . In-hospital mortality of diabetic patients with AMI was comparable to that of non-diabetic AMI patients ( 9.2 % and 9.3 % , respectively ) . In total , 2736 patients ( 90.6 % ) were discharged alive and followed for a median of 4.2 years ( follow-up rate , 96.0 % ) . The long-term survival rate was worse in the diabetic group than in the non-diabetic group , but not significantly different ( hazard ratio , 1.20 [ 0.97 - 1.49 ] , p = 0.09 ) . On the other h and , AMI patients with diabetes showed a significantly higher incidence of cardiovascular events than the non-diabetic group ( 1.40 [ 1.20 - 1.64 ] , p < 0.0001 ) . Multivariate analysis revealed that three factors were significantly associated with favorable late outcomes in diabetic AMI patients : acute revascularization ( HR , 0.62 ) ; prescribing aspirin ( HR , 0.27 ) ; and prescribing renin-angiotensin system ( RAS ) inhibitors ( HR , 0.53 ) . There was no significant correlation between late outcome and prescription of beta-blockers ( HR , 0.97 ) or calcium channel blockers ( HR , 1.27 ) . Although st and ard Japanese-approved doses of statins were associated with favorable outcome in AMI patients with diabetes , this was not statistically significant ( 0.67 [ 0.39 - 1.06 ] , p = 0.11 ) . Conclusions Although diabetic patients with AMI have more frequent adverse events than non-diabetic patients with AMI , the present results suggest that acute revascularization and st and ard therapy with aspirin and RAS inhibitors may improve their prognosis BACKGROUND There are limited data describing the presenting characteristics , management , and outcomes of diabetic and nondiabetic patients with an acute coronary syndrome ( ACS ) . OBJECTIVE To examine differences in these factors , patients with ST-segment elevation acute myocardial infa rct ion , non-ST-segment elevation acute myocardial infa rct ion , and unstable angina were enrolled in a large multinational coronary disease registry . METHODS The Global Registry of Acute Coronary Events is a prospect i ve observational study of patients hospitalized with an ACS at 94 hospitals in 14 countries . The study sample consisted of 5403 patients with ST-segment elevation acute myocardial infa rct ion , 4725 with non-ST-segment elevation acute myocardial infa rct ion , and 5988 with unstable angina . RESULTS Approximately 1 in 4 patients presented to participating hospitals with a history of diabetes . Patients with diabetes were older , more often women , with a greater prevalence of comorbidities , and they were less likely to be treated with effective cardiac therapies than nondiabetic patients . Patients with diabetes who developed an ACS were at increased risk for each hospital outcome examined including heart failure , renal failure , cardiogenic shock , and death . These differences remained after adjustment for potentially confounding prognostic factors . CONCLUSIONS A considerable proportion of patients with an ACS has diabetes and is at increased risk for adverse outcomes compared with patients without diabetes . There are certain proven therapeutic strategies that remain underused in the diabetic population . A more widespread awareness of this increased risk and a more diligent use of proven cardiac treatment approaches are indicated for patients with diabetes who develop an ACS The objective of this report was to examine the effects of sex and diabetic status on in-hospital mortality and 12 year survival following hospital discharge among 4109 patients hospitalized between 1974 and 1986 with acute myocardial infa rct ion . Sixteen general hospitals in the Worcester , MA , st and ard metropolitan statistical area were included . The age-adjusted in-hospital case-fatality rate was significantly higher in diabetic women ( 23.3 % ) than in non-diabetic women ( 18.9 % ) ( p < 0.05 ) while no significant difference was noted among men . Over a 12 year follow-up period , the relative risk of dying among diabetic men was 1.56 times that for non-diabetic men ( 95 % CI , 1.43 , 1.68 ) . Diabetic women were 1.57 times as likely to die as non-diabetic women ( 95 % CI , 1.45 , 1.73 ) . Among non-diabetic subjects , men had a 17 % excess risk of death compared to women ( 95 % CI , 1.09 , 1.25 ) . No significant difference in long-term mortality was noted among diabetic persons . Thus , the " female advantage " observed in the non-diabetic population was eliminated among the diabetic patients . R and omized clinical trials are needed in the diabetic population to identify specific therapies to reduce their increased risk of death Background Diabetes mellitus and admission blood glucose are important risk factors for mortality in ST segment elevation myocardial infa rct ion patients , but their relative and individual role remains on debate . Objective To analyze the influence of diabetes mellitus and admission blood glucose on the mortality of ST segment elevation myocardial infa rct ion patients su bmi tted to primary coronary percutaneous intervention . Methods Prospect i ve cohort study including every ST segment elevation myocardial infa rct ion patient su bmi tted to primary coronary percutaneous intervention in a tertiary cardiology center from December 2010 to May 2012 . We collected clinical , angiographic and laboratory data during hospital stay , and performed a clinical follow-up 30 days after the ST segment elevation myocardial infa rct ion . We adjusted the multivariate analysis of the studied risk factors using the variables from the GRACE score . Results Among the 740 patients included , reported diabetes mellitus prevalence was 18 % . On the univariate analysis , both diabetes mellitus and admission blood glucose were predictors of death in 30 days . However , after adjusting for potential confounders in the multivariate analysis , the diabetes mellitus relative risk was no longer significant ( relative risk : 2.41 , 95 % confidence interval : 0.76 - 7.59 ; p-value : 0.13 ) , whereas admission blood glucose remained and independent predictor of death in 30 days ( relative risk : 1.05 , 95 % confidence interval : 1.02 - 1.09 ; p-value ≤ 0.01 ) . Conclusion In ST segment elevation myocardial infa rct ion patients su bmi tted to primary coronary percutaneous intervention , the admission blood glucose was a more accurate and robust independent predictor of death than the previous diagnosis of diabetes . This reinforces the important role of inflammation on the outcomes of this group of patients OBJECTIVES This study was design ed to study the influence of diabetes on the outcome of unstable coronary artery disease ( CAD ) . BACKGROUND Diabetes mellitus is a major contributor to CAD . Despite improvement in the management of patients with unstable coronary syndromes , this condition is still linked to a substantially increased mortality and morbidity among diabetic patients . Recent evidence advocates early revascularization in unstable coronary syndromes . Diabetic patients subjected to coronary interventions under stable conditions have a higher risk for complications and a more dismal prognosis than nondiabetic subjects . Accordingly , it is of considerable interest to obtain further information regarding the best possible management of diabetic patients with unstable CAD . METHODS A total of 2158 patients without and 299 with diabetes mellitus were r and omized to an early invasive or a noninvasive strategy . The severity of CAD was expressed as the number and extent of vessel involvement . RESULTS Three-vessel disease was diagnosed in 42 % of diabetic and 31 % of nondiabetic patients ( p = 0.006 ) . The percentages of patients with ST-depression and troponin-T > 0.03 microg/l at admission were comparable among diabetic and nondiabetic patients . Mortality and reinfa rct ion after 12 months were more frequent among diabetic than nondiabetic patients in both treatment groups . Diabetes remained a strong independent predictor for death and myocardial infa rct ion in multivariable analysis . The invasive strategy reduced event rate in nondiabetic patients from 12.0 % to 8.9 % ( odds ratio [ OR ] = 0.72 ; confidence interval [ CI ] 0.54 to 0.95 ; p = 0.019 ) and in diabetic patients from 29.9 % to 20.6 % ( OR 0.61 ; CI 0.36 to 1.04 ; p = 0.066 ) . In a multivariate analysis including the extent of CAD , diabetes remained a strong independent predictor of the combined end point ( relative risk [ RR ] 2.40 ; CI 1.47 to 3.91 ; p = 0.0001 ) and of mortality ( RR 5.43 ; CI 2.09 to 14.12 ; p = 0.001 ) . CONCLUSIONS An invasive strategy improved outcome for both diabetic and nondiabetic patients with unstable CAD . However , diabetes mellitus remained an independent and important risk factor for death and myocardial infa rct ion in the invasive group . Thus , factors beyond the extent of flow-limiting coronary lesions are of considerable importance for outcome in diabetic subjects with unstable coronary syndromes OBJECTIVES To determine whether type 2 diabetes mellitus and hyperglycemia on admission should be considered independent predictors of mortality in elderly adults with acute coronary syndrome ( ACS ) . DESIGN Prospect i ve cohort study . SETTING Twenty-three hospitals in Italy . PARTICIPANTS Individuals aged 75 and older with non-ST-elevation ACS ( NSTEACS ) ( mean age 82 , 47 % female ) ( N = 645 ) . MEASUREMENTS Diabetic status and blood glucose levels were assessed on admission . Hyperglycemia was defined as glucose greater than 140 mg/dL. Multivariable Cox proportional hazard regression was used to assess the potential confounding effect of major covariates on the association between diabetic status , admission glucose , and 1-year mortality . RESULTS A history of diabetes mellitus was found in 231 participants ( 35.8 % ) , whereas 257 ( 39.8 % ) had hyperglycemia . Hyperglycemia was found in 171 participants with diabetes mellitus ( 70 % ) and 86 ( 21 % ) without diabetes mellitus . Participants with diabetes mellitus were significantly ( P < .05 ) more likely to have had prior myocardial infa rct ion and stroke and had lower ejection fraction and blood hemoglobin . Hyperglycemia was associated with lower ( P < .05 ) ejection fraction and estimated glomerular filtration rate ( eGFR ) . Diabetic status and hyperglycemia were associated with greater 1-year mortality according to univariate analysis ( 54 participants with diabetes mellitus died ( 23.4 % ) , versus 66 ( 15.9 % ) without diabetes mellitus ( hazard ratio ( HR ) = 1.5 95 % confidence interval ( CI ) = 1.0 - 2.1 ) , and 60 participants with hyperglycemia died ( 23.3 % ) , versus 60 ( 15.5 % ) without hyperglycemia ( HR=1.6 ; 95 % CI = 1.1 - 2.2 ) , but this association was not statistically significant after adjustment for ejection fraction , age , blood hemoglobin , and eGFR . CONCLUSION In elderly adults with NSTEACS , diabetes mellitus and hyperglycemia on admission are associated with higher mortality , mostly because of preexisting cardiovascular and renal damage Background Although unstable coronary artery disease is the most common reason for admission to a coronary care unit , the long-term prognosis of patients with this diagnosis is unknown . This is particularly true for patients with diabetes mellitus , who are known to have a high morbidity and mortality after an acute myocardial inf
Output:
| We found no evidence for temporal changes in the incremental mortality risk associated with DM in the setting of MI .
The improvements in management of MI patients during the last decades have not been associated with a reduction of the gap between diabetic and non-diabetic patients |
MS210594 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Purpose : Inherited variations in drug metabolizing enzymes may influence drug efficacy . This phase II study assesses the impact of second-line weekly irinotecan (CPT-11)/docetaxel in non-small cell lung cancer ( NSCLC ) patients , and gauges the uridine diphosphate glucuronosyl transferase ( UGT1A1 ) polymorphism influence in toxicity and antitumor activity . Experimental Design : Fifty-one patients with NSCLC treated with at least one prior chemotherapy regimen were enrolled . Patients received irinotecan 70 mg/m2 followed by docetaxel 25 mg/m2 . Both drugs were given on days 1 , 8 , and 15 every 28 days . UGT1A1 polymorphism were analyzed in blood sample s of 47 patients . The UGT1A1 polymorphism are classified according to the number of TA repeats in the promoter region of this gene . Results : Three patients ( 6 % ) achieved a partial response and nineteen patients ( 37 % ) had stable disease . Median survival was 8 months ( 95 % CI : 4.8–11.2 ) and 1-year survival 30 % . Grade 3–4 hematologic toxicity was low ( less than 10 % of patients ) ; 15 % of patients had grade 3 asthenia and 25 % of patients had grade 3/4 diarrhea . The frequency of UGT1A1 genotypes was as follows : 6/6 49 % , 6/7 36 % , and 7/7 15 % . No differences in toxicity were observed according to UGT1A1 polymorphism . A nonsignificant improvement in time to progression ( 4 vs. 3 months ) and median survival ( 11 vs. 8 months ) was detected in patients with the variant alleles ( 6/7 and 7/7 ) . Conclusions : This weekly irinotecan/docetaxel regimen has shown an acceptable toxicity profile while encouraging median and 1-year survival in heavily pretreated NSCLC patients . The tendency to better prognosis in patients carrying the variant genotypes 6/7 and 7/7 of UGT1A1 gene requires further validation Background : The impact of thymidylate synthase ( TYMS ) and UDP-glucoronosyltransferase 1A ( UGT1A ) germline polymorphisms on the outcome of colorectal cancer ( CRC ) patients treated with irinotecan plus 5-fluorouracil ( irinotecan/5FU ) is still controversial . Our objective was to define a genetic-based algorithm to select patients to be treated with irinotecan/5FU . Methods : Genotyping of TYMS ( 5′TRP and 3′UTR ) , UGT1A1 * 28 , UGT1A9 * 22 and UGT1A7 * 3 was performed in 149 metastatic CRC patients treated with irinotecan/5FU as first-line chemotherapy enrolled in a r and omised phase 3 study . Their association with response , toxicity and survival was investigated by univariate and multivariate statistical analysis . Results : TYMS 3TRP/3TRP genotype was the only independent predictor of tumour response ( OR=5.87 , 95 % confidence interval (CI)=1.68–20.45 ; P=0.005 ) . UGT1A1 * 28/*28 was predictive for haematologic toxicity ( OR=6.27 , 95 % CI=1.09–36.12 ; P=0.04 ) , specifically for neutropenia alone ( OR=6.40 , 95 % CI=1.11–37.03 ; P=0.038 ) or together with diarrhoea ( OR=18.87 , 95 % CI=2.14–166.67 ; P=0.008 ) . UGT1A9 * 1/*1 was associated with non-haematologic toxicity ( OR=2.70 , 95 % CI=1.07–6.82 ; P=0.035 ) . Haplotype VII ( all non-favourable alleles ) was associated with non-haematologic toxicity ( OR=2.11 , 95 % CI=1.12–3.98 ; P=0.02 ) . Conclusion : TYMS and UGT1A polymorphisms influence on tumour response and toxicities derived from irinotecan/5FU treatment in CRC patients . A genetic-based algorithm to optimise treatment individualisation is proposed Oxaliplatin and irinotecan have proven effective in the treatment of gastric cancer . We attempted to determine whether single nucleotide polymorphisms in ERCC1 , GST , TS and UGT1A1 predicted overall survival in gastric cancer patients receiving FOLFOX and /or FOLFIRI chemotherapy . Total genomic DNA was extracted from the whole blood of patients . The PCR-restriction fragment length polymorphism technique was applied in order to detect the known variant sites of ERCC1 , GST , TS and UGT1A1 . The response rate of FOLFOX ( N=75 ) was 24 % . Grade 3 - 4 neutropenia and neurotoxicity were observed at frequencies of 34.7 and 16 % , respectively . TTP and OS of first-line administration of FOLFOX ( N=35 ) were 3.1 months ( 95 % CI , 0.1 - 6.1 months ) and 13.9 months ( 95 % CI , 12.2 - 15.6 months ) , respectively . Only the GSTM1 positive genotype exhibited a significantly better time to progression ( P=0.023 ) . However , significant genotypic variation of TS , GST and ERCC1 , which was assumed to affect the activity of oxaliplatin , was not observed to affect RR , toxicity and overall survival . The response rate of FOLFIRI ( N=74 ) was 23 % . Grade 3 - 4 neutropenia and diarrhea were observed in 55.4 and 9.5 % of cases , respectively . TTP and OS of first-line administration of FOLFIRI ( N=33 ) was 4.9 months ( 95 % CI , 3.5 - 6.4 months ) and 19.0 months ( 95 % CI , 8.5 - 29.5 months ) . The low expression type ( 2R/2R , 2R/3C and 3C/3C ) of TS was associated with a high incidence of grade > or=3 neutropenia . However , significant genotypic variation of UGT1A1 , which was assumed to affect irinotecan toxicity , was not observed to affect RR , toxicity or survival . In this study , the GSTM1 positive genotype evidence d a significantly better time to progression in cases of advanced gastric cancer being treated with FOLFOX . The low expression type ( 2R/2R , 2R/3C and 3C/3C ) of TS was associated with a high incidence of grade > or=3 neutropenia in cases of advanced gastric cancer treated with FOLFIRI PURPOSE Irinotecan plus cisplatin ( IP ) improved survival over etoposide plus cisplatin ( EP ) in Japanese patients with extensive-stage small-cell lung cancer ( E-SCLC ) . To confirm those results and discern the potential role of population -related pharmacogenomics ( PG ) in outcomes , we conducted a large r and omized trial of identical design to the Japanese trial in North American patients with E-SCLC . PATIENTS AND METHODS Patients were r and omly assigned to IP ( irinotecan 60 mg/m(2 ) on days 1 , 8 , and 15 ; cisplatin 60 mg/m(2 ) day 1 , every 4 weeks ) or EP ( etoposide 100 mg/m(2 ) on days 1 through 3 ; cisplatin 80 mg/m(2 ) day 1 , every 3 weeks ) . Blood specimens for genomic DNA analysis were collected before r and om assignment in 169 patients . RESULTS Of 671 patients , 651 were eligible ( 324 and 327 patients in the IP and EP arms , respectively ) . Response rates with IP and EP were 60 % and 57 % , respectively ( P = .56 ) . Median progression-free survival for IP and EP was 5.8 and 5.2 months , respectively ( P = .07 ) . Median overall survival for IP and EP was 9.9 and 9.1 months , respectively ( P = .71 ) . Severe diarrhea was more common with IP ( 19 % v 3 % ) ; severe neutropenia and thrombocytopenia were higher with EP versus IP ( 68 % v 33 % and 15 % v 4 % , respectively ) . PG analysis showed that ABCB1 (C3435T)T/T ( membrane transport ) was associated with IP-related diarrhea ; UGT1A1 (G-3156A)A/A ( drug metabolism ) was associated with IP-related neutropenia . CONCLUSION This large North American trial failed to confirm the previously reported survival benefit observed with IP in Japanese patients . Both regimens produced comparable efficacy , with less hematologic and greater gastrointestinal toxicity with IP . These results emphasize the potential importance of PG in interpreting trials of cancer therapy BACKGROUND The optimum use of cytotoxic drugs for advanced colorectal cancer has not been defined . Our aim was to investigate whether combination treatment is better than the sequential administration of the same drugs in patients with advanced colorectal cancer . METHODS In this open-label , r and omised , phase 3 trial , we r and omly assigned patients ( 1:1 ratio ) with advanced , measurable , non-resectable colorectal cancer and WHO performance status 0 - 2 to receive either first-line treatment with bolus ( 400 mg/m(2 ) ) and infusional ( 2400 mg/m(2 ) ) fluorouracil plus leucovorin ( 400 mg/m(2 ) ) ( simplified LV5FU2 regimen ) , second-line LV5FU2 plus oxaliplatin ( 100 mg/m(2 ) ) ( FOLFOX6 ) , and third-line LV5FU2 plus irinotecan ( 180 mg/m(2 ) ) ( FOLFIRI ) or first-line FOLFOX6 and second-line FOLFIRI . Chemotherapy was administered every 2 weeks . R and omisation was done central ly using minimisation ( minimisation factors were WHO performance status , previous adjuvant chemotherapy , number of disease sites , and centre ) . The primary endpoint was progression-free survival after two lines of treatment . Analyses were by intention-to-treat . This trial is registered at Clinical Trials.gov , NCT00126256 . FINDINGS 205 patients were r and omly assigned to the sequential group and 205 to the combination group . 161 ( 79 % ) patients in the sequential group and 161 ( 79 % ) in the combination group died during the study . Median progression-free survival after two lines was 10·5 months ( 95 % CI 9·6 - 11·5 ) in the sequential group and 10·3 months ( 9·0 - 11·9 ) in the combination group ( hazard ratio 0·95 , 95 % CI 0·77 - 1·16 ; p=0·61 ) . All six deaths caused by toxic effects of treatment occurred in the combination group . During first-line chemotherapy , significantly fewer severe ( grade 3 - 4 ) haematological adverse events ( 12 events in 203 patients in sequential group vs 83 events in 203 patients in combination group ; p<0·0001 ) and non-haematological adverse events ( 26 events vs 186 events ; p<0·0001 ) occurred in the sequential group than in the combination group . INTERPRETATION Upfront combination chemotherapy is more toxic and is not more effective than the sequential use of the same cytotoxic drugs in patients with advanced , non-resectable colorectal cancer . FUNDING Sanofi-Aventis France The primary end point of the study was the analysis of associations between polymorphisms with putative influence on 5-fluorouracil/irinotecan activity and progression-free survival ( PFS ) of patients with advanced colorectal cancer treated with first-line FOLFIRI chemotherapy . Peripheral blood sample s from 146 prospect ively enrolled patients were used for genotyping polymorphisms in thymidylate synthase ( TS ) , methylenetetrahydrofolate reductase ( MTHFR ) , excision repair cross-complementation group-1 ( ERCC 1 ) xeroderma pigmentosum group-D ( XPD ) , X-ray cross-complementing-1 ( XRCC 1 ) , X-ray cross-complementing-3 ( XRCC 3 ) and uridine diphosphate-glucuronosyltransferases-A1 ( UGT1 A1 ) . TS 3′-UTR 6+/6 + and XRCC3 - 241 C/C genotypes were associated with adverse PFS . Hazard ratio for PFS achieved 2.89 ( 95 % confidence interval=1.56–5.80 ; P=0.002 ) in 30 patients ( 20 % ) with both risk genotypes . Risk for Grade III – IV neutropenia was significantly associated with UGT1A1 * 28 7/7 genotype . These promising findings deserve further investigations and their validation
Output:
| There was also no evidence of irinotecan dose , regimen or line of therapy having an impact on this association |
MS210595 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Eighty-seven male inmates from a state prison and 70 inmates from a county jail volunteered as subjects . The subjects , age 20 to 35 yrs , were assigned r and omly into a control or exercise group . Their Vo2max and treadmill performance values were determined before and after a 20 week jogging program . Training intensity was between 85 and 90 percent of maximum heart rate and involved workouts 3 days/week for 15 , 30 , or 45-min duration at the state prison and for 30-min 1 , 3 , or 5 days/week at the country jail . Cardiorespiratory fitness improved in direct proportion to frequency and duration of training . Injury , occurred in 22 % , 24 % and 54 % of the 15 , 30 , and 45-min duration groups and in 0 % , 12 % , and 39 % of the 1 , 3 , and 5-day/week groups , respectively . Attrition result ing from injury occurred in 0 % , 0 % , and 17 % and in 0 % , 4 % , and 6 % of the same respective groups . Attrition due to lack of interest was similar for all training groups ( 25 % ) , but was significantly lower in the control groups ( 10 % ) . Although the results showed a greater increase in cardiorespiratory fitness for the 45-min duration and 5-day/week groups , these programs are not recommened for beginning joggers because of the significantly greater percent of injuries Three hundred fifty male recruits were r and omly allocated to either the st and ard recruit training program ( N = 180 ) or substituted a weighted-march activity for all formal run periods ( N = 170 ) in the physical training program . All injuries were seen at a single medical facility , and the cause , location , and severity of injury were recorded in the medical documents . Lower-limb injuries constituted 79.8 % of all Run injuries and 61.1 % of all Walk injuries . Foot ( 18.9 % ) , knee ( 16.7 % ) , ankle ( 13.3 % ) , and shoulder ( 8.9 % ) were the most common sites of injury in the Walk group . In the Run group , the most common sites were knee ( 32.1 % ) , ankle ( 18.3 % ) , foot ( 11.9 % ) , and shin ( 7.3 % ) . There were two stress fractures ( tibial ) in the Run group and none in the Walk group , giving the Run group an incidence of 1.1 % . There were 10 medical discharges in the Walk group and 16 in the Run group . Ten ( 62.5 % ) of the Run and 2 ( 20 % ) of the Walk discharges were due to lower-limb causes . Of these , only 1 ( 10 % ) of the Walk and 4 ( 25 % ) of the Run injuries were not considered to be pre-existing conditions . Marching ( 30.0 % ) , physical training ( 25.5 % ) , and the obstacle course ( 11.1 % ) were the most frequent causes of injury in the Walk group . In the Run group , the leading causes were running ( 36.6 % ) , physical training ( 19.2 % ) , and the obstacle course ( 14.6 % ) . Running was the major cause of knee injury in the Run group ( 17/35 ) , whereas physical training was the major cause of knee injury in the Walk group ( 5/15 ) . Running was also the major cause of other lower-limb injuries in the Run group ( 19/58 ) , whereas marching was the major cause in the Walk group ( 19/50 ) . Lower-limb injuries were more frequent in the Run group , with running cited as the major cause of these injuries Three hundred fifty male recruits were r and omly allocated to either the st and ard recruit training program ( N = 180 ) or substituted a weighted march activity for all running periods in the physical training program ( N = 170 ) . There were no other differences in the formal training program . The incidence of injury was 37.6 and 46.6 % in the walk and run groups , respectively . The rate of injury was 52.9/100 recruits in the walk group and 61.7/100 in the run group . The exposure incidence was 12.8/1,000 hours of physical training in the walk group and 14.9/1,000 hours in the run group . There was no statistically significantly difference in the total number of injured recruits in the two groups ( 64 vs. 85 , chi(2 ) = 2.90 , p = 0.09 , relative risk [ RR ] = 1.24 ) . There were , however , significantly more lower-limb ( 43 vs. 75 , chi(2 ) = 9.77 , p = 0.0018 , RR = 1.65 ) and knee injuries ( 15 vs. 35 , chi(2 ) = 6.54 , p = 0.011 , RR = 2.14 ) in the Run group . Lower-limb injuries constituted 79.8 % of all Run injuries and 61.1 % of all Walk injuries . Injuries in the Run group produced more morbidity , with nearly double the number of days of restriction , hospitalization , and not fit for duty . St and ardized morbidity rates showed an average of 5.4 days of restriction per injury in the Run group and 3.96 days of restriction per injury in the Walk group . Reduction of running distance in the physical training program result ed in significant reductions in both the incidence of lower-limb injury and the overall severity of injury Objective : To determine if measurable lower extremity alignment is a risk factor for overuse running injuries . Design : Prospect i ve cohort study . Setting : Thirty-two week marathon training program . Patients or Participants : Three hundred fifty-five volunteers from the marathon training program began the study ; 255 finished the study . Interventions : None . Main Outcome Measures : Past training and injury history was determined by question naire , and five lower extremity alignment measures were performed at the beginning of the training program : arch index ( AI ) , heel valgus ( HV ) , knee tubercle-sulcus angle ( TSA ) , knee varus ( KV ) , and leg-length difference ( LLD ) . Overuse injuries , incurred by the runners and categorized by anatomic parts , were recorded during the training period . Results : Ninety subjects experienced overuse injuries . Multivariate analyses with stepwise Poisson regression showed few consistent relationships between alignment and overuse injury rates . Higher AI was protective against overall injuries and knee injuries ; higher HV was protective against knee and foot injuries ; higher TSA was associated with shin injuries ; higher KV was associated with shin injuries ; and low LLD was associated with more overall injuries . Conclusions : Minor variations in lower extremity alignment do not appear conclusively to be major risk factors for overuse injuries in runners . Because of the study limitations and the likely multifactorial nature of running injuries , further study is suggested , perhaps in more novice runners The purpose of this intervention study was to prove that increasing flexibility of the hamstring musculotendinous unit would decrease the number of lower extremity overuse injuries that occur in military infantry basic trainees . Two different companies going through basic training at the same time were used . Hamstring flexibility was checked at the beginning and at the end of the 13-week infantry basic training course . The control company ( N 148 ) proceeded through normal basic training . The intervention company ( N 150 ) followed the same program but added three hamstring stretching sessions to their already scheduled fitness program . All subsequent lower extremity overuse injuries were recorded through the troop medical clinic . Hamstring flexibility increased significantly in the intervention group compared with the control group . The number of injuries was also significantly lower in the intervention group . Forty-three injuries occurred in the control group for an incidence rate of 29.1 % , compared with 25 injuries in the intervention group for an incidence rate of 16.7 % . Thus , in this study , the number of lower extremity overuse injuries was significantly lower in infantry basic trainees with increased hamstring flexibility Sedentary individuals , particularly new military recruits , who start a physical training program have a substantial risk of developing an overuse injury of the lower limb . In this study we investigated the effect of neoprene insoles on the incidence of overuse injuries during 9 weeks of basic military training . The experimental group consisted of 237 r and omly selected new recruits , while 1151 recruits were the control group . Insoles were given to the experimental group and compliance was monitored . A panel of doctors documented and classi fied all injuries occurring during the 9 week period . A total of 54 ( 22.8 % ) and 237 ( 31.9 % ) injuries were reported in the experimental and control groups , re spectively . In both groups , the majority of injuries were overuse ( experimental group , 90.7 % ; control group , 86.4 % ) . The mean weekly incidence of total overuse injuries and tibial stress syndrome was significantly lower ( P < 0.05 ) in the experimental group . The mean incidence of stress fractures was lower in the experimental group but not significantly so ( 0.05 < P < 0.1 ) . This study shows that the incidence of total overuse injuries and tibial stress syndrome during 9 weeks of basic military training can be reduced by wearing insoles The purpose of this study was to evaluate the effect of a health education intervention on running injuries . The intervention consisted of information on , and the sub sequent performance of , st and ardized warm-up , cool- down , and stretching exercises . Four hundred twenty- one male recreational runners were matched for age , weekly running distance , and general knowledge of preventing sports injuries . They were r and omly split into an intervention and a control group : 167 control and 159 intervention subjects participated throughout the study . During the 16-week study , both groups kept a daily diary on their running distance and time , and reported all injuries . In addition , the intervention group was asked to note compliance with the st and ardized program . At the end of the study period , knowledge and attitude were again measured . There were 23 injuries in the control group and 26 in the intervention group . Injury incidence for control and intervention sub jects was 4.9 and 5.5 running injuries per 1000 hours , respectively . The intervention was not effective in re ducing the number of running injuries ; it proved signifi cantly effective ( P < 0.05 ) in improving specific knowl edge of warm-up and cool-down techniques in the intervention group . This positive change can perhaps be regarded as a first step on the way to a change of behavior , which may eventually lead to a reduction of running injuries As the number of runners has increased dramatically , so has the incidence of running-related injuries . In order to determine what training factors are associated with running-related injuries , as well as what percentage of injured runners seeks professional medical attention , a r and om sample of entrants to a 10 kilometer race was asked to complete a question naire . There were 451 respondents , 355 men and 96 women , with a nonre sponse rate of 12.7 % . Nonrespondents did not differ from respondents with regard to age or sex . Forty- seven percent of respondents indicated that they had sustained a running-related injury in the last 2 years . Injured runners differed significantly from noninjured runners in that they were more likely to have ( 1 ) run more miles per week , ( 2 ) run more days per week , ( 3 ) run a faster pace , ( 4 ) run more races in the last year , ( 5 ) stretched before running , and ( 6 ) not participated regularly in other sports . Associated with injury , but not statistically significant , were those who had run mara thons and had done muscle-strengthening exercises . No association was found with regard to the length of time running , running surfaces , part of the foot first contacting the ground , or running intervals , sprints , or hills . Seventy percent of those injured sought profes sional medical care , with 76 % of these having a good or excellent recovery from their injuries . Compliance with medical advice correlated well with treatment suc cess This prospect i ve study of 583 habitual runners used baseline information to examine the relationship of several suspected risk factors to the occurrence of running-related injuries of the lower extremities that were severe enough to affect running habits , cause a visit to a health professional , or require use of medication . During the 12-month follow-up period , 252 men ( 52 % ) and 48 women ( 49 % ) reported at least one such injury . The multiple logistic regression results identified that running 64.0 km ( 40 miles ) or more per week was the most important predictor of injury for men during the follow-up period ( odds ratio = 2.9 ) . Risk also was associated with having had a previous injury in the past year ( odds ratio = 2.7 ) and with having been a runner for less than 3 years ( odds ratio = 2.2 ) . These results suggest that the incidence of lower-extremity injuries is high for habitual runners , and that for those new to running or those who have been previously injured , reducing weekly distance is a reasonable preventive behavior In a prospect i ve study , quantitative measures of the structure of the longitudinal arch of the foot were established and related to the incidence of stress fractures in the bones of the lower limbs of military recruits . In addition , the role of a semirigid orthotic device ( Langer military stress orthotic ) in preventing stress fractures was evaluated as a function of the structure of the longitudinal arch . Femoral and tibial stress fractures were found to be more prevalent in the presence of feet with high arches , whereas the incidence of metatarsal fractures was higher in feet with low arches . The use of an orthotic device reduced the incidence of femoral stress fractures only in the presence of feet with high arches and the incidence of metatarsal fractures only among feet with low arches . The findings
Output:
| Runners can reduce risk of injury by using established training programs that gradually increase distance or time of running and provide appropriate rest .
Orthoses and heel lifts can correct malalignments of the leg .
Prevention addresses factors proven to cause running injuries . |
MS210596 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To evaluate the impact of systematic patient evaluation and patient and provider feedback on the processes and intermediate outcomes of diabetes care in Independent Practice Association model internal medicine practice s. RESEARCH DESIGN AND METHODS Nine practice s providing care to managed care patients were r and omly assigned as intervention or comparison sites . Intervention-site subjects had Annual Diabetes Assessment Program ( ADAP ) assessment s ( HbA(1c ) , blood pressure , lipids , smoking , retinal photos , urine microalbumin , and foot examination ) at years 1 and 2 . Comparison-site subjects had ADAP assessment s at year 2 . At Intervention sites , year 1 ADAP results were review ed with subjects , mailed to providers , and incorporated into electronic medical records with guideline -generated suggestions for treatment and follow-up . Medical records were evaluated for both groups for the year before both the year 1 and year 2 ADAP assessment s. Processes and intermediate outcomes were compared using linear and logistic mixed hierarchical models . RESULTS Of 284 eligible subjects , 103 of 173 ( 60 % ) at the Intervention sites and 71 of 111 ( 64 % ) at the comparison sites participated ; 83 of 103 ( 81 % ) of the intervention-site subjects returned for follow-up at year 2 . Performance of the six recommended assessment s improved in intervention-site subjects at year 2 compared with year 1 ( 5.8 vs. 4.3 , P = 0.0001 ) and compared with comparison-site subjects at year 2 ( 4.2 , P = 0.014 ) . No significant changes were noted in intermediate outcomes . CONCLUSIONS The ADAP significantly improved processes of care but not intermediate outcomes . Additional interventions are needed to improve intermediate outcomes BACKGROUND In the Medicare Modernization Act of 2003 , Congress required the Centers for Medicare and Medicaid Services to test the commercial disease-management model in the Medicare fee-for-service program . METHODS The Medicare Health Support Pilot Program was a large , r and omized study of eight commercial programs for disease management that used nurse-based call centers . We r and omly assigned patients with heart failure , diabetes , or both to the intervention or to usual care ( control ) and compared them with the use of a difference-in-differences method to evaluate the effects of the commercial programs on the quality of clinical care , acute care utilization , and Medicare expenditures for Medicare fee-for-service beneficiaries . RESULTS The study included 242,417 patients ( 163,107 in the intervention group and 79,310 in the control group ) . The eight commercial disease-management programs did not reduce hospital admissions or emergency room visits , as compared with usual care . We observed only 14 significant improvements in process-of-care measures out of 40 comparisons . These modest improvements came at substantial cost to the Medicare program in fees paid to the disease-management companies ( $ 400 million ) , with no demonstrable savings in Medicare expenditures . CONCLUSIONS In this large study , commercial disease-management programs using nurse-based call centers achieved only modest improvements in quality -of-care measures , with no demonstrable reduction in the utilization of acute care or the costs of care Background and objectives Many clinical management guidelines for chronic diseases have been published , but they have not been put into practice by busy clinicians at primary care levels . This study evaluates the implementation of national guidelines incorporated within a structured diabetes and hypertension clinical record ( SR ) in Cape Town in a r and omised controlled trial ( RCT ) . Methods Eighteen public sector community health centres ( CHC ) were r and omly selected and allocated as intervention or control CHC . At each clinic , 25 patients with diabetes and 35 patients with hypertension were enrolled at baseline . Question naires were completed , blood sample s were collected , blood pressure ( BP ) and anthropometric measures were taken and patient records were audited . SR with clinical guideline prompts were introduced at the intervention clinics after training doctors in their use and suggestions to incorporate them in regular patient records . Contact was maintained during the year of intervention with the clinic staff . A follow-up survey was conducted 1 year later to assess BP and HbA1c , and the patient records were examined to ascertain the extent of use of the SR in the intervention clinics . In-depth interviews were conducted with doctors and nurses to record their response to the intervention . Results The intervention evaluated in this RCT had no impact on either diabetes or hypertension control . In the intervention clinics , less than 60 % of the patient folders contained the SR and when present was seldom used . Although the staff were well disposed to the research team , their workload prohibited them from undertaking a true evaluation of the SR , and overall they did not perceive the SR as supporting their current process of patient care . Conclusions No benefit to diabetes of hypertension care by introducing and availability of the staff in the use of the SR was shown in this RCT . The process measures suggest that the SR was not widely used by the healthcare provided in the primary care clinics OBJECTIVE —The purpose of this study was to determine whether implementation of a multicomponent organizational intervention can produce significant change in diabetes care and outcomes in community primary care practice s. RESEARCH DESIGN AND METHODS —This was a group-r and omized , controlled clinical trial evaluating the practical effectiveness of a multicomponent intervention ( TRANSLATE ) in 24 practice s. The intervention included implementation of an electronic diabetes registry , visit reminders , and patient-specific physician alerts . A site coordinator facilitated previsit planning and a monthly review of performance with a local physician champion . The principle outcomes were the percentage of patients achieving target values for the composite of systolic blood pressure ( SBP ) < 130 mmHg , LDL cholesterol < 100 mg/dl , and A1C < 7.0 % at baseline and 12 months . Six process measures were also followed . RESULTS —Over 24 months , 69,965 visits from 8,405 adult patients with type 2 diabetes were recorded from 238 health care providers in 24 practice s from 17 health systems . Diabetes process measures increased significantly more in intervention than in control practice s , giving net increases as follows : foot examinations 35.0 % ( P < 0.0.001 ) ; annual eye examinations 25.9 % ( P < 0.001 ) ; renal testing 28.5 % ( P < 0.001 ) ; A1C testing 8.1%(P < 0.001 ) ; blood pressure monitoring 3.5 % ( P = 0.05 ) ; and LDL testing 8.6 % ( P < 0.001 ) . Mean A1C adjusted for age , sex , and comorbidity decreased significantly in intervention practice s ( P < 0.02 ) . At 12 months , intervention practice s had significantly greater improvement in achieving recommended clinical values for SBP , A1C , and LDL than control clinics ( P = 0.002 ) . CONCLUSIONS — Introduction of a multicomponent organizational intervention in the primary care setting significantly increases the percentage of type 2 diabetic patients achieving recommended clinical outcomes Technology and improved care coordination models can help diabetes educators and providers meet national care st and ards and provide culturally sensitive diabetes education that may improve diabetes outcomes . The purpose of the study was to evaluate the clinical usefulness of a nurse-led diabetes care program ( Comprehensive Diabetes Management Program , CDMP ) for poorly controlled Hispanic type 2 diabetes ( T2DM ) patients in an urban community health center setting . Patients were r and omized to the intervention condition ( IC ; n = 21 ) or an attention control condition ( AC ; n = 18 ) . IC and AC conditions were compared on rates of adherence to national clinical practice guidelines ( blood glucose , blood pressure , foot exam , eye exam ) , and levels of diabetes distress , depression , and treatment satisfaction . IC patients had a significant improvement in A1C from baseline to 12-month follow-up compared with AC ( −1.6 % ± 1.4 % versus −0.6 % ± 1.1 % ; P = .01 ) . The proportion of IC patients meeting clinical goals at follow-up tended to be higher than AC for A1c ( IC = 45 % ; AC = 28 % ) , systolic blood pressure ( IC = 55 % ; AC = 28 % ) , eye screening ( IC = 91 % ; AC = 78 % ) , and foot screening , ( IC = 86 % ; AC = 72 % ) . Diabetes distress and treatment satisfaction also showed greater improvement for IC than AC ( P = .05 and P = .06 , respectively ) , with no differences for depression . The CDMP intervention was more effective than an attention control condition in helping patients meet evidence -based guidelines for diabetes care Abstract Objective . To study the effectiveness of a comprehensive diabetes programme in general practice that integrates patient-centred lifestyle counselling into structured diabetes care . Design and setting . Cluster r and omised trial in general practice s. Intervention . Nurse-led structured diabetes care with a protocol , record keeping , reminders , and feedback , plus training in motivational interviewing and agenda setting . Subjects . Primary care nurses in 58 general practice s and their 940 type 2 diabetes patients with an HbA1c concentration above 7 % , and a body mass index ( BMI ) above 25 kg/m2 . Main outcome measures . HbA1c , diet , and physical activity ( medical records and patient question naires ) . Results . Multilevel linear and logistic regression analyses adjusted for baseline outcomes showed that despite active nurse participation in the intervention , the comprehensive programme was no more effective than usual care after 14 months , as shown by HbA1c levels ( difference between groups = 0.13 ; CI 20.8–0.35 ) and diet ( fat ( difference between groups = 0.19 ; CI 20.82–1.21 ) ; vegetables ( difference between groups = 0.10 ; CI-0.21–0.41 ) ; fruit ( difference between groups = 20.02 ; CI 20.26–0.22 ) ) , and physical activity ( difference between groups = 21.15 ; CI 212.26–9.97 ) , or any of the other measures of clinical parameters , patient 's readiness to change , or quality of life . Conclusion . A comprehensive programme that integrated lifestyle counselling based on motivational interviewing principles integrated into structured diabetes care did not alter HbA1c or the lifestyle related to diet and physical activity . We thus question the impact of motivational interviewing in terms of its ability to improve routine diabetes care in general practice The objective of this study was to identify the baseline frequency of eye examinations for Medicare beneficiaries with diabetes in Montana and to determine whether a direct mail reminder increased eye examinations . Using Medicare Part A and Medicare Part B cl aims data , a cohort of Medicare beneficiaries with diabetes was defined . Eye examination cl aims were identified using billing codes specific for retinal examinations , as well as visits to ophthalmologists and optometrists during which retinal exams were likely to have been performed . A r and om sample of the identified beneficiaries with diabetes received a letter encouraging regular annual retinal examinations . In the first 3-month period after the mailing , the billed eye examination rate for those to whom letters were sent was 2.2 percentage points greater than the rate for those to whom letters were not sent ( 19.4 % vs 17.2 % ; relative risk , 1.13 ; 95 % confidence interval , 1.01 - 1.26 ) . However , 6 months after the letters were sent , there was no longer a significant difference in the rates for these 2 groups ( 32.9 % vs 32.4 % ; relative risk , 1.02 ; 95 % confidence interval , 0.94 - 1.10 ) . In this study , direct mail outreach initially influenced the proportion of Medicare beneficiaries receiving an eye examination , but this pattern was not sustained over the 6-month follow-up period OBJECTIVE To evaluate the effect of adding pharmacists to primary care teams on the management of hypertension and other cardiovascular risk factors in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS We conducted a r and omized controlled trial with blinded ascertainment of outcomes within primary care clinics in Edmonton , Canada . Pharmacists performed medication assessment s and limited history and physical examinations and provided guideline -concordant recommendations to optimize medication management . Follow-up contact was completed as necessary . Control patients received usual care . The primary outcome was a ≥10 % decrease in systolic blood pressure at 1 year . RESULTS A total of 260 patients were enrolled , 57 % were women , the mean age was 59 years , diabetes duration was 6 years , and blood pressure was 129/74 mmHg . Forty-eight of 131 ( 37 % ) intervention patients and 30 of 129 ( 23 % ) control patients achieved the primary outcome ( odds ratio 1.9 [ 95 % CI 1.1–3.3 ] ; P = 0.02 ) . Among 153 patients with inadequately controlled hypertension at baseline , intervention patients ( n = 82 ) were significantly more likely than control patients ( n = 71 ) to achieve the primary outcome ( 41 [ 50 % ] vs. 20 [ 28 % ] ; 2.6 [ 1.3–5.0 ] ; P = 0.007 ) and recommended blood pressure targets ( 44 [ 54 % ] vs. 21 [ 30 % ] ; 2.8 [ 1.4–5.4 ] ; P
Output:
| Both DRS-targeted and general QI interventions were effective , particularly when baseline attendance levels were low .
All commonly used QI components and BCTs were associated with significant improvements , particularly in those with poor attendance .
However , BCTs targeting emotional factors around DRS were under-represented .
Cost-effectiveness increased when DRS attendance was lower and with longer screening intervals .
R and omised controlled trial evidence indicates that QI interventions incorporating specific BCT components are associated with meaningful improvements in DRS attendance compared with usual care .
Interventions generally used appropriate BCTs that target important barriers to screening attendance , with a high probability of being cost-effective . |
MS210597 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE A subset of individuals with bulimia nervosa ( BN ) have borderline personality disorder ( BPD ) symptoms , including chronic negative affect and interpersonal problems . These symptoms predict poor BN treatment outcome in some studies . The broad version of Enhanced Cognitive Behavior Therapy ( CBT-E ) was developed to address co-occurring problems that interfere with treatment response . The current study investigated the relative effects , predictors , and moderators of CBT-E for BN with BPD and co-occurring mood/anxiety disorders . METHOD Fifty patients with BN and threshold or sub-threshold BPD and current or recent Axis I mood or anxiety disorders were r and omly assigned to receive focused CBT-E ( CBT-Ef ) or broad CBT-E ( CBT-Eb ) specifically including an interpersonal module and additional attention to mood intolerance . RESULTS Forty-two percent of the sample reported remission from binge eating and purging at termination . Significant changes across symptom domains were observed at termination and at 6-month follow-up . Though CBT-Ef predicted good outcomes in multivariate models , the severity of affective/interpersonal problems moderated treatment effects : participants with higher severity showed better ED outcomes in CBT-Eb , whereas those with lower severity showed better outcomes in CBT-Ef . Severity of affective/interpersonal BPD symptoms at baseline predicted negative outcomes overall . Follow-up BPD affective/interpersonal problems were predicted by baseline affective/interpersonal problems and by termination EDE score . DISCUSSION This study supports the utility of CBT-E for patients with BN and complex comorbidity . CBT-Ef appears to be more efficacious for patients with relatively less severe BPD symptoms , whereas CBT-Eb appears to be more efficacious for patients with more severe BPD symptoms Eating disorders may be viewed from a transdiagnostic perspective and there is evidence supporting a transdiagnostic form of cognitive behaviour therapy ( CBT-E ) . The aim of the present study was to compare CBT-E with interpersonal psychotherapy ( IPT ) , a leading alternative treatment for adults with an eating disorder . One hundred and thirty patients with any form of eating disorder ( body mass index > 17.5 to < 40.0 ) were r and omized to either CBT-E or IPT . Both treatments involved 20 sessions over 20 weeks followed by a 60-week closed follow-up period . Outcome was measured by independent blinded assessors . Twenty-nine participants ( 22.3 % ) did not complete treatment or were withdrawn . At post-treatment 65.5 % of the CBT-E participants met criteria for remission compared with 33.3 % of the IPT participants ( p < 0.001 ) . Over follow-up the proportion of participants meeting criteria for remission increased , particularly in the IPT condition , but the CBT-E remission rate remained higher ( CBT-E 69.4 % , IPT 49.0 % ; p = 0.028 ) . The response to CBT-E was very similar to that observed in an earlier study . The findings indicate that CBT-E is potent treatment for the majority of out patients with an eating disorder . IPT remains an alternative to CBT-E , but the response is less pronounced and slower to be expressed . Current controlled trials IS RCT N 15562271 What kinds of evidence reliably support predictions of effectiveness for health and social care interventions ? There is increasing reliance , not only for health care policy and practice but also for more general social and economic policy deliberation , on evidence that comes from studies whose basic logic is that of JS Mill 's method of difference . These include r and omized controlled trials , case-control studies , cohort studies , and some uses of causal Bayes nets and counterfactual-licensing models like ones commonly developed in econometrics . The topic of this paper is the ' external validity ' of causal conclusions from these kinds of studies . We shall argue two cl aims . Cl aim , negative : external validity is the wrong idea ; cl aim , positive : ' capacities ' are almost always the right idea , if there is a right idea to be had . If we are right about these cl aims , it makes big problems for policy decisions . Many advice guides for grading policy predictions give top grade s to a proposed policy if it has two good Mill's- method -of difference studies that support it . But if capacities are to serve as the conduit for support from a method -of-difference study to an effectiveness prediction , much more evidence , and much different in kind , is required . We will illustrate the complexities involved with the case of multisystemic therapy , an internationally adopted intervention to try to diminish antisocial behaviour in young people Consistent predictors , and more especially moderators , of response to psychological treatments for eating disorders have not been identified . The present exploratory study examined predictors and moderators of outcome in adult patients who took part in a r and omised clinical trial comparing two leading treatments for these disorders , enhanced cognitive behavioural therapy ( CBT-E ) and interpersonal psychotherapy ( IPT ) . Four potentially important findings emerged . Firstly , patients with a longer duration of disorder were less likely to benefit from either treatment . Second , across the two treatments the presence , at baseline , of higher levels of over-evaluation of the importance of shape predicted a less good treatment outcome . Third DSM-IV diagnosis did not predict treatment outcome . Fourth , with the exception of patients with baseline low self-esteem who achieved a better outcome with CBT-E , it was generally not possible to identify a subgroup of patients who would differentially benefit from one or other treatment OBJECTIVE The aim of this study was to compare two cognitive-behavioral treatments for out patients with eating disorders , one focusing solely on eating disorder features and the other a more complex treatment that also addresses mood intolerance , clinical perfectionism , low self-esteem , or interpersonal difficulties . METHOD A total of 154 patients who had a DSM-IV eating disorder but were not markedly underweight ( body mass index over 17.5 ) , were enrolled in a two-site r and omized controlled trial involving 20 weeks of treatment and a 60-week closed period of follow-up . The control condition was an 8-week waiting list period preceding treatment . Outcomes were measured by independent assessors who were blind to treatment condition . RESULTS Patients in the waiting list control condition exhibited little change in symptom severity , whereas those in the two treatment conditions exhibited substantial and equivalent change , which was well maintained during follow-up . At the 60-week follow-up assessment , 51.3 % of the sample had a level of eating disorder features less than one st and ard deviation above the community mean . Treatment outcome did not depend on eating disorder diagnosis . Patients with marked mood intolerance , clinical perfectionism , low self-esteem , or interpersonal difficulties appeared to respond better to the more complex treatment , with the reverse pattern evident among the remaining patients . CONCLUSIONS These two transdiagnostic treatments appear to be suitable for the majority of out patients with an eating disorder . The simpler treatment may best be viewed as the default version , with the more complex treatment reserved for patients with marked additional psychopathology of the type targeted by the treatment Anorexia nervosa is difficult to treat and no treatment is supported by robust evidence . As it is uncommon , it has been recommended that new treatments should undergo extensive preliminary testing before being evaluated in r and omized controlled trials . The aim of the present study was to establish the immediate and longer-term outcome following “ enhanced ” cognitive behaviour therapy ( CBT-E ) . Ninety-nine adult patients with marked anorexia nervosa ( body mass index ≤ 17.5 ) were recruited from consecutive referrals to clinics in the UK and Italy . Each was offered 40 sessions of CBT-E over 40 weeks with no concurrent treatment . Sixty-four percent of the patients were able to complete this outpatient treatment and in these patients there was a substantial increase in weight ( 7.47 kg , SD 4.93 ) and BMI ( 2.77 , SD 1.81 ) . Eating disorder features also improved markedly . Over the 60-week follow-up period there was little deterioration despite minimal additional treatment . These findings provide strong preliminary support for this use of CBT-E and justify its further evaluation in r and omized controlled trials . As CBT-E has already been established as a treatment for bulimia nervosa and eating disorder not otherwise specified , the findings also confirm that CBT-E is transdiagnostic in its scope OBJECTIVE This r and omized control trial is an evaluation of the effectiveness of enhanced cognitive behavioral treatment ( CBT-E ) for eating disorders adapted for a group setting . The study aim ed to examine the effects of group CBT-E on eating disorder psychopathology and additional maintaining pathology . METHOD A transdiagnostic sample of individuals with eating disorders with a BMI ≥ 18 kg/m2 ( N = 40 ) were r and omized to an immediate-start or delayed-start condition so as to compare therapeutic effects of group CBT-E with a waitlist control . Global Eating Disorder Examination Question naire ( EDE-Q ) scores , BMI , and measures of Clinical Perfectionism , Self-Esteem , Interpersonal Difficulties , and Mood Intolerance were measured across the 8-week control period , throughout the group treatment and at 3-months post-treatment . RESULTS Over 70 % of those who entered the trial completed treatment . The first eight weeks of group CBT-E were more effective at reducing Global EDE-Q scores than no treatment ( waitlist control ) . By post-treatment , good outcome ( a Global EDE-Q within 1 SD of Australian community norms plus BMI ≥ 18.5 ) was achieved by 67.9 % of treatment completers and 66.7 % of the total sample . Symptom abstinence within the previous month was reported by 14.3 % of treatment completers and 10.3 % of the total sample . Significant reductions in Clinical Perfectionism , Self-Esteem , Interpersonal Difficulties , and Mood Intolerance were also observed . DISCUSSION This study demonstrated that a group version of CBT-E can be effective at reducing eating disorder psychopathology in a transdiagnostic sample of individuals with eating disorders . Group CBT-E could provide a means of increasing availability of evidence -based treatment for eating disorders BACKGROUND There are no evidence -based treatments for severe and enduring anorexia nervosa ( SE-AN ) . This study evaluated the relative efficacy of cognitive behavioral therapy ( CBT-AN ) and specialist supportive clinical management ( SSCM ) for adults with SE-AN . METHOD Sixty-three participants with a diagnosis of AN , who had at least a 7-year illness history , were treated in a multi-site r and omized controlled trial ( RCT ) . During 30 out-patient visits spread over 8 months , they received either CBT-AN or SSCM , both modified for SE-AN . Participants were assessed at baseline , end of treatment ( EOT ) , and at 6- and 12-month post-treatment follow-ups . The main outcome measures were quality of life , mood disorder symptoms and social adjustment . Weight , eating disorder ( ED ) psychopathology , motivation for change and health-care burden were secondary outcomes . RESULTS Thirty-one participants were r and omized to CBT-AN and 32 to SSCM with a retention rate of 85 % achieved at the end of the study . At EOT and follow-up , both groups showed significant improvement . There were no differences between treatment groups at EOT . At the 6-month follow-up , CBT-AN participants had higher scores on the Weissman Social Adjustment Scale ( WSAS ; p = 0.038 ) and at 12 months they had lower Eating Disorder Examination ( EDE ) global scores ( p = 0.004 ) and higher readiness for recovery ( p = 0.013 ) compared to SSCM . CONCLUSIONS Patients with SE-AN can make meaningful improvements with both therapies . Both treatments were acceptable and high retention rates at follow-up were achieved . Between-group differences at follow-up were consistent with the nature of the treatments given BACKGROUND Anorexia nervosa ( AN ) is a serious illness leading to substantial morbidity and mortality . The treatment of AN very often is protracted ; repeated hospitalizations and lost productivity generate substantial economic costs in the health care system . Therefore , this study aim ed to determine the differential cost-effectiveness of out-patient focal psychodynamic psychotherapy ( FPT ) , enhanced cognitive-behavioural therapy ( CBT-E ) , and optimized treatment as usual ( TAU-O ) in the treatment of adult women with AN . METHOD The analysis was conducted alongside the r and omized controlled Anorexia Nervosa Treatment of Out Patients ( ANTOP ) study . Cost-effectiveness was determined using direct costs per recovery at 22 months post-r and omization ( n = 156 ) . Unadjusted incremental cost-effectiveness ratios ( ICERs ) were calculated . To derive cost-effectiveness acceptability curves ( CEACs ) adjusted net-benefit regressions were applied assuming different values for the maximum willingness to pay ( WTP ) per additional recovery . Cost-utility and assumptions underlying the base case were investigated in exploratory analyses . RESULTS Costs of in-patient treatment and the percentage of patients who required in-patient treatment were considerably lower in both intervention groups . The unadjusted ICERs indicated FPT and CBT-E to be dominant compared with TAU-O. Moreover , FPT was dominant compared with CBT-E. CEACs showed that the probability for cost-effectiveness of FTP compared with TAU-O and CBT-E was ⩾95 % if the WTP per recovery was ⩾€9825 and ⩾€24 550 , respectively .
Output:
| Despite the limitations , this study provides additional support for CBT-E as a successful treatment across the range of EDs |
MS210598 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To pilot , among women with gestational diabetes mellitus ( GDM ) , the feasibility of a prenatal/postpartum intervention to modify diet and physical activity similar to the Diabetes Prevention Program . The intervention was delivered by telephone , and support for breastfeeding was addressed . RESEARCH DESIGN AND METHODS The goal was to help women return to their prepregnancy weight , if it was normal , or achieve a 5 % reduction from prepregnancy weight if overweight . Eligible participants were identified shortly after a GDM diagnosis ; 83.8 % consented to be r and omly assigned to intervention or usual medical care ( 96 and 101 women , respectively ) . The retention was 85.2 % at 12 months postpartum . RESULTS The proportion of women who reached the postpartum weight goal was higher , although not statistically significant , in the intervention condition than among usual care ( 37.5 vs. 21.4 % , absolute difference 16.1 % , P = 0.07 ) . The intervention was more effective among women who did not exceed the recommended gestational weight gain ( difference in the proportion of women meeting the weight goals : 22.5 % , P = 0.04 ) . The intervention condition decreased dietary fat intake more than the usual care ( condition difference in the mean change in percent of calories from fat : −3.6 % , P = 0.002 ) and increased breastfeeding , although not significantly ( condition difference in proportion : 15.0 % , P = 0.09 ) . No differences in postpartum physical activity were observed between conditions . CONCLUSIONS This study suggests that a lifestyle intervention that starts during pregnancy and continues postpartum is feasible and may prevent pregnancy weight retention and help overweight women lose weight . Strategies to help postpartum women overcome barriers to increasing physical activity are needed OBJECTIVE There is increasing evidence about the importance of factors that impact health beyond health care and individual behavior , yet there is little public and policy discourse about these things in the United States . We surveyed Wisconsin adults to see what they think are the most important factors that affect health . We also examined which interventions they believe would improve health , and whether government should prioritize such interventions . METHODS A phone survey of a r and om sample of 1459 Wisconsin adults was conducted between September 2006 and February 2007 . RESULTS The Wisconsin public believes that health practice s , access to health care , and health insurance are the most important factors affecting health , and that health insurance is a high government priority . Other broader social and economic determinants of health , such as employment , social support , income , housing , and neighborhood factors are seen as less important to health . Although respondents believe that health practice s are important to health , they are less likely to suggest that government prioritize improving individual health practice s. Although the public believes the government should prioritize access to health care and health insurance , they are not as likely to support government implementing social or economic policies in order to improve health . CONCLUSION In light of research demonstrating the importance of social and economic determinants of health , and of ongoing public forums meant to raise awareness of these determinants of health , it will be important to track whether public opinion of Wisconsin adults changes over time to increase attention to the social and economic determinants of health and related policy initiatives Background Women with gestational diabetes ( GDM ) are at high risk of developing diabetes later in life . After a GDM diagnosis , women receive prenatal care to control their blood glucose levels via diet , physical activity and medications . Continuing such lifestyle skills into early motherhood may reduce the risk of diabetes in this high risk population . In the Gestational Diabetes ’ Effects on Moms ( GEM ) study , we are evaluating the comparative effectiveness of diabetes prevention strategies for weight management design ed for pregnant/postpartum women with GDM and delivered at the health system level . Methods / Design The GEM study is a pragmatic cluster r and omized clinical trial of 44 medical facilities at Kaiser Permanente Northern California r and omly assigned to either the intervention or usual care conditions , that includes 2,320 women with a GDM diagnosis between March 27 , 2011 and March 30 , 2012 . A Diabetes Prevention Program-derived print/telephone lifestyle intervention of 13 telephonic sessions tailored to pregnant/postpartum women was developed . The effectiveness of this intervention added to usual care is to be compared to usual care practice s alone , which includes two pages of printed lifestyle recommendations sent to postpartum women via mail . Primary outcomes include the proportion of women who reach a postpartum weight goal and total weight change . Secondary outcomes include postpartum glycemia , blood pressure , depression , percent of calories from fat , total caloric intake and physical activity levels . Data were collected through electronic medical records and surveys at baseline ( soon after GDM diagnosis ) , 6 weeks ( range 2 to 11 weeks ) , 6 months ( range 12 to 34 weeks ) and 12 months postpartum ( range 35 to 64 weeks ) . Discussion There is a need for evidence regarding the effectiveness of lifestyle modification for the prevention of diabetes in women with GDM , as well as confirmation that a diabetes prevention program delivered at the health system level is able to successfully reach this population . Given the use of a telephonic case management model , our Diabetes Prevention Program-derived print/telephone intervention has the potential to be adopted in other setting s and to inform policies to promote the prevention of diabetes among women with GDM.Trial registration Clinical Trials.gov number , NCT01344278 Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results AIMS To report the weight loss findings after the first year of a lifestyle intervention trial among women with gestational diabetes mellitus ( GDM ) . METHODS A total of 1180 women with GDM were r and omly assigned ( 1:1 ) to receive a 4-year lifestyle intervention ( intervention group , n = 586 ) or st and ard care ( control group , n = 594 ) between August 2009 and July 2011 . Major elements of the intervention included 6 face-to-face sessions with study dieticians and two telephone calls in the first year , and two individual sessions and two telephone calls in each subsequent year . RESULTS Among 79 % of participants who completed the year 1 trial , mean weight loss was 0.82 kg ( 1.12 % of initial weight ) in the intervention group and 0.09 kg ( 0.03 % of initial weight ) in the control group ( P = .001 ) . In a prespecified subgroup analysis of people who completed the trial , weight loss was more pronounced in women who were overweight ( body mass index ≥24 kg/m2 ) at baseline : mean weight loss 2.01 kg ( 2.87 % of initial weight ) in the intervention group and 0.44 kg ( 0.52 % of initial weight ) in the control group ( P < .001 ) . Compared with those in the control group , women in the intervention group had a greater decrease in waist circumference ( 1.76 cm vs 0.73 cm ; P = .003 ) and body fat ( 0.50 % vs 0.05 % increase ; P = .001 ) . CONCLUSION The 1-year lifestyle intervention led to significant weight losses after delivery in women who had GDM , and the effect was more pronounced in women who were overweight at baseline The YMCA ’s Diabetes Prevention Program gives you the skills you need and the support you deserve to make lasting healthy lifestyle changes . WHAT IS PREDIABETES ? Prediabetes occurs when blood sugar levels are higher than normal but not high enough for a type 2 diabetes diagnosis . Risk for developing type 2 diabetes may be reduced or eliminated by weight loss , healthier eating and increased physical activity AIMS To explore factors influencing post-natal health behaviours following the experience of gestational diabetes , and to elicit women 's views about the feasibility of lifestyle intervention to prevent diabetes during the first 2 years after childbirth . METHODS Qualitative study using semi-structured interviews with women who had gestational diabetes . In phase 1 ( 31 women ) , interviews explored the experience of gestational diabetes , ideas about future risk of diabetes and factors influencing post-natal health-related behaviours . Statements were developed summarizing women 's views of lifestyle change to prevent diabetes . In phase 2 ( 14 women ) , interviews explored how the passage of time had contributed to changes in health behaviour , and the statements were used to develop views about diabetes interventions . RESULTS Women were aware of their risk of developing diabetes , but did not always act on such knowledge . Pregnancy motivated behaviour changes to benefit the unborn child , but after delivery these changes were often not maintained . Tiredness , maternal attachment and childcare dem and s were prominent barriers in the early post-natal months . Later , work , family and child development became more significant barriers . Many women became more receptive to healthy eating messages around the time of weaning . Women were positive about long-term support for self-management to reduce their diabetes risk . CONCLUSIONS There is potential to reduce the risk of Type 2 diabetes post-natally among women with gestational diabetes . Interventions need to be developed that take into account context ual factors and competing dem and s , are flexible and respond to women 's individual circumstances . R and omized trials of such interventions are warranted OBJECTIVE In this study , we examined patterns of postpartum physical activity among women with recent gestational diabetes mellitus ( GDM ) and psychosocial factors related to this behavior that could be addressed in diabetes prevention interventions . RESEARCH DESIGN AND METHODS A r and om sample of women who had attended diabetes clinics in Sydney , Australia , in the past 6 - 24 months for treatment of GDM were surveyed by telephone . Variables measured included physical activity behaviors , self-efficacy , social support , and barriers to participation . RESULTS Of 226 women who completed the survey ( mean age 33.4 years ) , 26.5 % were classified as sedentary , and only 33.6 % reported sufficient physical activity as recommended by health authorities . Walking was the most popular physical activity , and most women reported no other moderate- or vigorous-intensity activity . Lack of assistance with child care ( 49.1 % ) and insufficient time ( 37.6 % ) were the most common barriers to physical activity . The type of social support most often reported was verbal encouragement ( 39.1 % ) , with more than half of the women never receiving assistance with housework or others exercising with them . Self-efficacy for physical activity was lowest when women were under time pressure or tired . Multivariate analyses showed that sufficient physical activity was associated with high social support ( odds ratio 2.5 [ 95 % CI 1.21 - 3.79 ] ) and high self-efficacy ( 2.09 [ 1.06 - 3.20 ] ) . CONCLUSIONS The prevalence of sufficient physical activity was found to be low and strongly related to social support and self-efficacy . This is an important group to whom diabetes prevention strategies can be targeted Optimal strategies to prevent progression towards overt diabetes in women with recent gestational diabetes remain ill defined . We report a pilot study of a convenient , home based exercise program with telephone support , suited to the early post-partum period . Twenty eight women with recent gestational diabetes were enrolled at six weeks post-partum into a 12 week r and omised controlled trial of Usual Care ( n = 13 ) versus Supported Care ( individualised exercise program with regular telephone support ; n = 15 ) . Baseline characteristics ( Mean ± SD ) were : Age 33 ± 4 years ; Weight 80 ± 20 kg and Body Mass Index ( BMI ) 30.0 ± 9.7 kg/m2 . The primary outcome , planned physical activity { Median ( Range ) } , increased by 60 ( 0
Output:
| Interventions that incorporated these factors were associated with effectiveness .
Education about how to reduce future risk of Type 2 diabetes and using pedometers in interventions were not associated with intervention effectiveness .
Other factors that future interventions should address consist of ' putting others before yourself ' ; ' putting off lifestyle change ' ; ' lack of support from healthcare professionals ' and ' being a healthy role model for families ' .
Conclusion Combining the results of qualitative and quantitative studies can provide a nuanced underst and ing of the effectiveness of physical activity and lifestyle interventions |
MS210599 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Although testing for human papillomavirus ( HPV ) has higher sensitivity and lower specificity than cytology alone for detecting cervical intraepithelial neoplasia ( CIN ) , studies comparing conventional and liquid-based cytology have had conflicting results . METHODS In the first phase of a two-phase multicenter r and omized controlled trial , women aged 35 - 60 years in the conventional arm ( n = 16,658 ) were screened using conventional cytology , and women in the experimental arm ( n = 16,706 ) had liquid-based cytology and were tested for high-risk HPV types using the Hybrid Capture 2 assay . Women in the conventional arm were referred to colposcopy with atypical cells of undetermined significance ( ASCUS ) or higher and those in the experimental arm were referred with ASCUS or higher cytology or with a positive ( > or = 1 pg/mL ) HPV test . Sensitivity and positive predictive value ( PPV ) for detection of cervical intraepithelial neoplasia grade 2 or higher ( CIN2 + ) were calculated . RESULTS The screening methods and referral criterion applied in the experimental arm had higher sensitivity than that in the conventional arm ( relative sensitivity = 1.47 ; 95 % confidence interval [ CI ] = 1.03 to 2.09 ) but a lower PPV ( relative PPV = 0.40 ; 95 % CI = 0.23 to 0.66 ) . With HPV testing alone at > or = 1 pg/mL and at > or = 2 pg/mL , the gain in sensitivity compared with the conventional arm remained similar ( relative sensitivity = 1.43 , 95 % CI = 1.00 to 2.04 and relative sensitivity = 1.41 , 95 % CI = 0.98 to 2.01 , respectively ) but PPV progressively improved ( relative PPV = 0.58 , 95 % CI = 0.33 to 0.98 and relative PPV = 0.75 , 95 % CI = 0.45 and 1.27 , respectively ) . Referral based on liquid-based cytology alone did not increase sensitivity compared with conventional cytology ( relative sensitivity = 1.06 ; 95 % CI = 0.72 to 1.55 ) but reduced PPV ( relative PPV = 0.57 ; 95 % CI = 0.39 to 0.82 ) . CONCLUSIONS HPV testing alone was more sensitive than conventional cytology among women 35 - 60 years old . Adding liquid-based cytology improved sensitivity only marginally but increased false-positives . HPV testing using Hybrid Capture 2 with a 2 pg/mL cutoff may be more appropriate than a 1 pg/mL cutoff for primary cervical cancer screening ABSTRACT R and omized trials have produced sound evidence about the efficacy of screening with human papillomavirus ( HPV ) DNA tests in reducing cervical cancer incidence and mortality . We evaluated the clinical performance and reproducibility of the Abbott RealTime High Risk ( HR ) HPV test compared with that of the HR hybrid capture 2 ( HC2 ) assay as assessed by a noninferiority score test . A r and om sample of 998 cervical specimens ( 914 specimens of cervical intraepithelial neoplasia less severe than grade 2 [ < CIN2 ] and 84 specimens of cervical intraepithelial neoplasia grade 2 or more severe lesions [ ≥CIN2 ] ) , collected in the Florence and Catania cervical Cancer Screening Programs from women aged 25 to 64 and already tested by HR HC2 , were retested with the Abbott RealTime HR HPV test . Absolute specificity was 92.3 % ( 95 % confidence interval [ CI ] , 90.4 to 94.0 ) and 92.6 % ( 95 % CI , 90.7 to 94.2 ) for the Abbott RealTime HR HPV test and the HR HC2 , respectively . Absolute sensitivity was 96.4 % ( 95 % CI , 89.9 to 99.3 ) and 97.6 % ( 95 % CI , 91.7 to 99.7 ) for the Abbott RealTime HR HPV test and the HR HC2 , respectively . The noninferiority score test revealed that the clinical sensitivity and specificity of the Abbott RealTime HR HPV test were not inferior ( P = 0.004 and 0.009 , respectively ) to those of HR HC2 . Overall agreement between the two assays was 96.5 % , with a k value of 0.86 ( CI 95 % , 0.82 to 0.91 ) . We evaluated the intralaboratory reproducibility by retesting 521 sample s at least 4 weeks after the first test ; the crude agreement between the first and second test was 98.5 % , with an overall k value of 0.97 ( CI 95 % , 0.95 to 0.99 ) . This test fully satisfies the requirements of a primary cervical cancer screening test . This assay differentiates between HPV16 , HPV18 , and non-HPV16/18 types in every specimen , but how to use this information in a screening setting still is unclear BACKGROUND Testing for human papillomavirus ( HPV ) DNA is reportedly more sensitive than cytology for the detection of high- grade cervical intraepithelial neoplasia ( CIN ) . The effectiveness of HPV testing in primary cervical screening was assessed in the ARTISTIC trial , which was done over two screening rounds approximately 3 years apart ( 2001 - 03 and 2004 - 07 ) by comparing liquid-based cytology ( LBC ) combined with HPV testing against LBC alone . METHODS Women aged 20 - 64 years who were undergoing routine screening as part of the English National Health Service Cervical Screening Programme in Greater Manchester were r and omly assigned ( between July , 2001 , and September , 2003 ) in a ratio of 3:1 to either combined LBC and HPV testing in which the results were revealed and acted on , or to combined LBC and HPV testing where the HPV result was concealed from the patient and investigator . The primary outcome was the detection rate of cervical intraepithelial neoplasia grade 3 or worse ( CIN3 + ) in the second screening round , analysed by intention to treat . This trial is registered with the International St and ard R and omised Controlled Trial Number IS RCT N25417821 . FINDINGS There were 24 510 eligible women at entry ( 18 386 in the revealed group , 6124 in the concealed group ) . In the first round of screening 233 women ( 1.27 % ) in the revealed group had CIN3 + , compared with 80 ( 1.31 % ) women in the concealed group ( odds ratio [ OR ] 0.97 , 95 % CI 0.75 - 1.25 ; p>0.2 ) . There was an unexpectedly large drop in the proportion of women with CIN3 + between the first and second rounds of screening in both groups , at 0.25 % ( 29 of 11 676 ) in the revealed group and 0.47 % ( 18 of 3866 women ) in the concealed group ( OR 0.53 , 95 % CI 0.30 - 0.96 ; p=0.042 ) . For both rounds combined , the proportion of women with CIN3 + were 1.51 % ( revealed ) and 1.77 % ( concealed ) ( OR 0.85 , 95 % CI 0.67 - 1.08 ; p>0.2 ) . INTERPRETATION LBC combined with HPV testing result ed in a significantly lower detection rate of CIN3 + in the second round of screening compared with LBC screening alone , but the effect was small . Over the two screening rounds combined , co-testing did not detect a higher rate of CIN3 + or CIN2 + than LBC alone . Potential changes in screening methodology should be assessed over at least two screening rounds . FUNDING National Institute of Health Research Health Technology Assessment Programme BACKGROUND Human papillomavirus ( HPV ) testing is more sensitive for the detection of high- grade cervical lesions than is cytology , but detection of HPV by DNA screening in two screening rounds 5 years apart has not been assessed . The aim of this study was to assess whether HPV DNA testing in the first screen decreases detection of cervical intraepithelial neoplasia ( CIN ) grade 3 or worse , CIN grade 2 or worse , and cervical cancer in the second screening . METHODS In this r and omised trial , women aged 29 - 56 years participating in the cervical screening programme in the Netherl and s were r and omly assigned to receive HPV DNA ( GP5+/6 + -PCR method ) and cytology co-testing or cytology testing alone , from January , 1999 , to September , 2002 . R and omisation ( in a 1:1 ratio ) was done with computer-generated r and om numbers after the cervical specimen had been taken . At the second screening 5 years later , HPV DNA and cytology co-testing was done in both groups ; research ers were masked to the patient 's assignment . The primary endpoint was the number of CIN grade 3 or worse detected . Analysis was done by intention to screen . The trial is now finished and is registered , number IS RCT N20781131 . FINDINGS 22,420 women were r and omly assigned to the intervention group and 22 518 to the control group ; 19 999 in the intervention group and 20,106 in the control group were eligible for analysis at the first screen . At the second screen , 19 579 women in the intervention group and 19,731 in the control group were eligible , of whom 16,750 and 16,743 , respectively , attended the second screen . In the second round , CIN grade 3 or worse was less common in the intervention group than in the control group ( 88 of 19 579 in the intervention group vs 122 of 19,731 in the control group ; relative risk 0·73 , 95 % CI 0·55 - 0·96 ; p=0·023 ) . Cervical cancer was also less common in the intervention group than in the control group ( four of 19 579 in the intervention group vs 14 of 19,731 ; 0·29 , 0·10 - 0·87 ; p=0·031 ) . In the baseline round , detection of CIN grade 3 or worse did not differ significantly between groups ( 171 of 19 999 vs 150 of 20,106 ; 1·15 , 0·92 - 1·43 ; p=0·239 ) but was significantly more common in women with normal cytology ( 34 of 19,286 vs 12 of 19,373 ; 2·85 , 1·47 - 5·49 ; p=0·001 ) . Furthermore , significantly more cases of CIN grade 2 or worse were detected in the intervention group than in the control group ( 267 of 19 999 vs 215 of 20,106 ; 1·25 , 1·05 - 1·50 ; p=0·015 ) . In the second screen , fewer HPV16-positive CIN grade 3 or worse were detected in the intervention group than in the control group ( 17 of 9481 vs 35 of 9354 ; 0·48 , 0·27 - 0·85 ; p=0·012 ) ; detection of non-HPV16-positive CIN grade 3 or worse did not differ between groups ( 25 of 9481 vs 25 of 9354 ; 0·99 , 0·57 - 1·72 ; p=1·00 ) . The cumulative detection of CIN grade 3 or worse and CIN grade 2 or worse did not differ significantly between study arms , neither for the whole study group ( CIN grade 3 or worse : 259 of 19 999 vs 272 of 20,106 ; 0·96 , 0·81 - 1·14 , p=0·631 ; CIN grade 2 or worse : 427 of 19 999 vs 399 of 20,106 ; 1·08 , 0·94 - 1·24 ; p=0·292 ) , nor for subgroups of women invited for the first time ( CIN grade 3 or worse in women aged 29 - 33 years : 102 of 3139 vs 105 of 3128 ; 0·97 , 0·74 - 1·27 ; CIN grade 2 or worse in women aged 29 - 33 years : 153 of 3139 vs 151 of 3128 ; 1·01 , 0·81 - 1·26 ; CIN grade 3 or worse in women aged 34 - 56 years : 157 of 16,860 vs 167 of 16 978 ; 0·95 , 0·7
Output:
| Consistent evidence is available indicating that HPV-triage with the Hybrid Capture ( ® ) 2 assay ( Qiagen Gaithersburg , Inc. , MD , USA [ previously Digene Corp. ] ( HC2 ) is more accurate ( higher sensitivity , similar specificity ) than repeat cytology to triage women with equivocal Pap smear results .
Several other tests show at least similar accuracy but mRNA testing with the APTIMA ( ® ) ( Gen-Probe Inc. , San Diego , CA , USA ) test is similarly sensitive but more specific compared to HC2 .
In triage of low- grade squamous intraepithelial lesions ( LSIL ) , HC2 is more sensitive but its specificity is substantially lower compared to repeat cytology .
The APTIMA ( ® ) test is more specific than HC2 without showing a loss in sensitivity .
Identification of DNA of HPV types 16 and /or 18 , or RNA from the five most carcinogenic HPV types allow selecting women at highest risk for CIN3 + but the sensitivity and negative predictive value of these markers are lower than full-range high-risk HPV ( hrHPV ) testing .
After conservative treatment of cervical pre-cancer , HPV testing picks up more quickly , with higher sensitivity and not lower specificity , residual or recurrent high- grade CIN than follow-up cytology .
Primary screening for hrHPV generally detects more CIN2 , CIN3 or cancer compared to cytology at cut-off atypical squamous cells of undetermined significance ( ASC-US ) or LSIL , but is less specific .
Combined HPV and cytology screening provides a further small gain in sensitivity at the expense of a considerable loss in specificity if positive by either test is referred to colposcopy , in comparison with HPV testing only .
R and omised trials and follow-up of cohort studies consistently demonstrate a significantly lower cumulative incidence of CIN3 + and even of cancer , in women aged 30 years or older , who were at enrollment hrHPV DNA negative compared to those who were cytologically negative .
The difference in cumulative risk of CIN3 + or cancer for double negative ( cytology & HPV ) versus only HPV-negative women is small .
There exists a substantial evidence base to support that HPV testing is advantageous both in triage of women with equivocal abnormal cytology , in surveillance after treatment of CIN lesions and in primary screening of women aged 30 years or older . |
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