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MS211300 | ***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 Combination treatments , preferably containing an artemisinin derivative , are recommended to improve efficacy and prevent Plasmodium falciparum drug resistance . Our aim was to show non-inferiority of a new dispersible formulation of artemether-lumefantrine to the conventional crushed tablet in the treatment of young children with uncomplicated malaria . METHODS We did a r and omised non-inferiority study on children weighing 5 - 35 kg with uncomplicated P falciparum malaria in Benin , Kenya , Mali , Mozambique , and Tanzania . The primary outcome measure was PCR-corrected 28-day parasitological cure rate . We aim ed to show non-inferiority ( with a margin of -5 % ) of dispersible versus crushed tablet . We constructed an asymptotic one-sided 97.5 % CI on the difference in cure rates . A computer-generated r and omisation list was kept central ly and investigators were unaware of the study medication administered . We used a modified intention-to-treat analysis . This trial is registered with Clinical Trials.gov , number NCT00386763 . FINDINGS 899 children aged 12 years or younger were r and omly assigned to either dispersible ( n=447 ) or crushed tablets ( n=452 ) . More than 85 % of patients in each treatment group completed the study . 812 children qualified for the modified intention-to-treat analysis ( n=403 vs n=409 ) . The PCR-corrected day-28 cure rate was 97.8 % ( 95 % CI 96.3 - 99.2 ) in the group on dispersible formulation and 98.5 % ( 97.4 - 99.7 ) in the group on crushed formulation . The lower bound of the one-sided 97.5 % CI was -2.7 % . The most common drug-related adverse event was vomiting ( n=33 [ 7 % ] and n=42 [ 9 % ] , respectively ) . No signs of ototoxicity or relevant cardiotoxicity were seen . INTERPRETATION A six-dose regimen of artemether-lumefantrine with the new dispersible formulation is as efficacious as the currently used crushed tablet in infants and children , and has a similar safety profile Background Artemether/lumefantrine ( AL ) has been adopted as the treatment of choice for uncomplicated malaria in Kenya and other countries in the region . Six-dose artemether/lumefantrine tablets are highly effective and safe for the treatment of infants and children weighing between five and 25 kg with uncomplicated Plasmodium falciparum malaria . However , oral paediatric formulations are urgently needed , as the tablets are difficult to administer to young children , who can not swallow whole tablets or tolerate the bitter taste of the crushed tablets . Methods A r and omized , controlled , open-label trial was conducted comparing day 28 PCR corrected cure-rates in 245 children aged 6–59 months , treated over three days with either six-dose of artemether/lumefantrine tablets ( Coartem ® ) or three-dose of artemether/lumefantrine suspension ( Co-artesiane ® ) for uncomplicated falciparum malaria in western Kenya . The children were followed-up with clinical , parasitological and haematological evaluations over 28 days . Results Ninety three percent ( 124/133 ) and 90 % ( 121/134 ) children in the AL tablets and AL suspension arms respectively completed followed up . A per protocol analysis revealed a PCR-corrected parasitological cure rate of 96.0 % at Day 28 in the AL tablets group and 93.4 % in the AL suspension group , p = 0.40 . Both drugs effectively cleared gametocytes and were well tolerated , with no difference in the overall incidence of adverse events . Conclusion The once daily three-dose of artemether-lumefantrine suspension ( Co-artesiane ® ) was not superior to six-dose artemether-lumefantrine tablets ( Coartem ® ) for the treatment of uncomplicated malaria in children below five years of age in western Kenya . Trial registration Clinical Trials.gov ZusammenfassungPädiatrische Medikamentenformulierungen sind ein wichtiger Fortschritt in der Therapie von afrikanischen Kindern , die an Malaria tropica erkrankt sind . In dieser klinischen Studie wurde die Wirksamkeit , Sicherheit und Verträglichkeit einer neuen pädiatrischen Artesunat-Mefloquin Koformulierung i m Vergleich mit einer Tablettenformulierung evaluiert . Einundsiebzig pädiatrische Patienten am Albert Schweitzer Spital in Lambaréné , Gabun , die an unkomplizierter Malaria tropica litten , wurden nach Körpergewicht stratifiziert , um mit der pädiatrischen ( 10 – 20 kg ; n = 41 ) oder der Tabletten-Formulierung ( 20 – 40 kg ; n = 30 ) therapiert zu werden . Die PCR korrigierte Heilungsrate war 100 % am Tag 28 . Die häufigsten Nebenwirkungen waren Erbrechen ( 17 % ) , abdominelle Schmerzen ( 11 % ) und Cephalea ( 17 % ) . Diese Studie bestätigt die hervorragende Wirksamkeit und gute Verträglichkeit von Artesunat-Mefloquin zur Therapie pädiatrischer Patienten in Afrika . Summary Pediatric drug formulations of artemisinin combination therapies are urgently needed for improving the treatment of children suffering from uncomplicated malaria . The aim of this clinical trial was to evaluate the efficacy , safety and tolerability of a novel pediatric fixed-dose granule formulation of artesunate-mefloquine and a new co-blister tablet formulation . A total of 71 children aged 1–13 years suffering from uncomplicated falciparum malaria were stratified into two groups according to weight : 10–20 kg , pediatric group ( n = 41 ) ; 20–40 kg , tablet group ( n = 30 ) . All the children were treated once daily for three days : the pediatric group received the novel granule formulation , the tablet group received the co-blister tablets . The PCR-corrected cure rate on day 28 was evaluated . There was no reappearance of parasitemia during the follow-up period and the day-28 cure rate was therefore 100 % in per- protocol analysis . In intention-to-treat analysis the cure rates were 95 % in the pediatric group and 97 % in the tablet group . The most frequent adverse events were vomiting ( 17 % ) , abdominal pain ( 11 % ) and headache ( 17 % ) . This study confirms the excellent efficacy and favorable safety and tolerability profile of a novel pediatric artesunate-mefloquine formulation for treatment in African children AIMS To assess the haemodynamic , electrocardiographic and glycaemic effects of piperaquine-dihydroartemisinin ( Artekin ) fixed combination therapy in uncomplicated malaria . METHODS Sixty-two Cambodians ( 32 children and 30 adults ) with falciparum or vivax malaria were given Artekin given as four age-based oral doses over 32 h. Supine and erect blood pressure , the electrocardiographic QT interval and plasma glucose were measured before treatment and then at regular intervals during a 4-day admission period as part of efficacy and safety monitoring . QT intervals were rate-corrected ( QTc ) using Bazett 's formula . RESULTS Artekin therapy was well tolerated and all patients responded to treatment . Average parasite and fever clearance times were 19 and 12 h , respectively . The pretreatment mean fall in systolic blood pressure on st and ing was 8 + /- 6 mmHg and 6-hourly measurements over 72 h showed no significant change ( P = 0.48 ) . There was a significant lengthening of the mean QTc to a maximum of 11 ms(0.5 ) ( 95 % confidence interval 4 - 18 ms(0.5 ) ) relative to baseline at 24 h ( P = 0.003 ) . The maximal QTc prolongation observed in any patient was 53 ms(0.5 ) . There was a mean 0.4 mmol l(-1 ) reduction in the post-absorptive plasma glucose during the first 48 h but no episodes of hypoglycaemia ( plasma glucose < 3.0 mmol l(-1 ) ) were observed at any time . CONCLUSIONS Artekin is safe and effective combination therapy for uncomplicated malaria in children and adults . Although piperaquine is a long half-life drug related to other quinoline compounds including chloroquine and quinine , no clinical ly significant cardiovascular or metabolic effects were observed OBJECTIVES Paediatric drug formulations of artemisinin combination therapies and pharmacokinetic data supporting their use in African children are urgently needed for the effective treatment of young children suffering from falciparum malaria in sub-Saharan Africa . PATIENTS AND METHODS In this study , the pharmacokinetic characteristics of a novel paediatric granule formulation of artesunate-mefloquine therapy were evaluated in comparison to the st and ard tablet formulation in the treatment of uncomplicated malaria in paediatric patients . Twenty-four patients were assigned to treatment according to body weight with either a fixed-dose paediatric granule co-formulation ( 10 - 20 kg body weight ) or a free-dose co-blister tablet formulation of artesunate-mefloquine ( > 20 - 40 kg body weight ) . RESULTS Median values for C(max ) ( 861 and 930 ng/mL ) , T(max ) ( 1.5 and 1.5 h ) and AUC(0-)(t ) ( 2,050 and 2,470 ng.h/mL ) were comparable for dihydroartemisinin in the two groups . Exploratory analysis of mefloquine plasma levels revealed a trend towards higher concentrations in the younger age group during the absorption phase ( 2,550 and 1,815 ng/mL , 54 h after initiation of treatment , respectively ) . Median mefloquine concentrations at day 28 were 197 and 343 ng/mL , respectively . CONCLUSIONS The pharmacokinetic characteristics of the two paediatric dosage forms , i.e. the novel fixed-dose co-formulation and the st and ard co-blister of artesunate-mefloquine show comparable results in the two treatment groups . The novel fixed-dose paediatric formulation is an interesting option for outpatient treatment of uncomplicated malaria in African children The bioavailability/pharmacokinetics of dihydroartemisinin and mefloquine following the oral doses of 4 mg/kg body weight artesunate ( Cambodian Pharmaceutical Enterprise ) given concurrently with 10 mg/kg body weight oral mefloquine artesunate ( Cambodian Pharmaceutical Enterprise ) were investigated in 15 healthy Cambodian male volunteers . Both formulations were generally well tolerated . Both produced satisfactory plasma/blood concentration-time profiles . Oral artesunate and mefloquine were rapidly absorbed from gastrointestinal tract with marked inter-individual variation . For the dihydroartemisinin , the median ( 95 % Cl ) Cmax of 748 ( 304 - 1,470 ) ng/ml was observed at 1.5 ( 0.3 - 3.0 ) hours ( tmax ) after drug administration . The median ( 95 % CI ) values for AUC0-infinity , lambda(z ) and tl/2z were 1.673 ( 1.08 - 2.88 ) microg.h/ml , 0.54(0.24 - 1.1)/hour and 1.3 ( 0.6 - 2.9 ) hours , respectively . For mefloquine , a median ( 95 % Cl ) Cmax of 1,000 ( 591 - 1,500 ) ng/ml was observed at 4 ( 2 - 6 ) hours ( tmax ) after drug administration . The median ( 95 % CI ) value for AUC0 - 168h was 3.92 ( 2.88 - 7.02 ) microg.h/ml The safety and efficacy of a novel combination of dihydroartemisinin ( DHA ) and piperaquine , Artekin ( Holleykin Pharmaceuticals ) , were assessed in 106 patients ( 76 children and 30 adults ) with uncomplicated falciparum malaria from 2 remote areas in Cambodia . Age-based doses were given at 0 , 8 , 24 , and 32 h. Mean total DHA and piperaquine doses were 9.1 and 73.9 mg/kg , respectively , for children and 6.6 and 52.9 mg/kg for adults . All patients became aparasitemic within 72 h. Excluding the results for 1 child who died on day 4 , there was a 96.9 % 28-day cure rate ( 98.6 % in children and 92.3 % in adults ) . Patients who had recrudescent infection received low doses of Artekin . Side effects were reported by 22 patients ( 21 % ) but did not necessitate premature cessation of therapy . Although Artekin is a promising and
Output:
| These data provide , for the first time , evidence for improved management of children by use of paediatric formulations , and support the further development and use of paediatric ACTs |
MS211301 | ***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: Psoriasis is a genetically determined disease characterized by hyperproliferation and disordered maturation of the epidermis . Th1 lymphocytes are implicated in its pathogenesis . The vitamin D receptor ( VDR ) is a c and i date modifying gene , having immunosuppressive effects and being involved in anti-proliferative and pro-differentiation pathways in keratinocytes . There is suggestive evidence that the A allele of the A-1012 G polymorphism is associated with down-regulation of the Th1 response , via GATA-3 . The F and T alleles of Fok1 and Taq1 have been associated with increased VDR activity . The present study aim ed to test the hypothesis that the A allele of A-1012 G is protective for occurrence and severity of psoriasis and enhances therapeutic response to vitamin D analogues and that these effects would be additive to those of Fok1 and Taq1 . The study group comprised 206 psoriasis patients who had received topical calcipotriol treatment and 80 controls . There was no significant linkage disequilibrium between any pair of the three polymorphic sites ( P=0.3–0.8 ) . The A , F and T alleles were positively associated with calcipotriol response : AA genotype ( compared to AG/GG ) , odds ratio (OR)=2.18 ( P=0.04 ) ; TT , OR=1.97 ( P=0.03 ) ; AAFF genotype combination , OR=4.11 ( P=0.03 ) ; AATT , OR=5.64 ( P=0.005 ) ; and FFTT , OR=3.22 ( P=0.01 ) . Comparing patients without , to patients with , a family history of psoriasis , the A allele was under represented ( P=0.01 ) and the AAFF genotype combination even more so ( compared to residual genotypes ) ( OR=0.24 ; P=0.005 ) . AAFF was also under-represented in patients without a family history compared to controls ( OR=0.31 ; P=0.04 ) . There were no associations of family history with Fok1 and Taq1 . There were no associations of severity of psoriasis with any polymorphism . In conclusion , the A-1012 G , Fok1 and Taq1 VDR polymorphisms were associated with response to calcipotriol . A-1012 G and Fok1 were associated with susceptibility to non-familial psoriasis The association of Taq 1 and Fok 1 restriction fragment length polymorphisms of the vitamin D receptor with occurrence and outcome of malignant melanoma ( MM ) , as predicted by tumour ( Breslow ) thickness , has been reported previously . We now report a novel adenine – guanine substitution −1012 bp relative to the exon 1a transcription start site ( A-1012 G ) , found following screening by single-str and ed conformational polymorphism of this promoter region . There was a total of 191 MM cases , which were stratified according to conventional Breslow thickness groups , cases being r and omly selected from each group to form a distribution corresponding to the known distribution of Breslow thickness in our area , and this population ( n=176 ) was compared to 80 controls . The A allele was over-represented in MM patients and , with GG as reference , odds ratio ( OR ) for AG was 2.5 , 95 % confidence interval ( CI ) 1.1–5.7 , ( P=0.03 ) and AA 3.3 , CI 1.4–8.1 , ( P=0.007 ) . The outcome was known in 171 of 191 patients and the A allele was related to the development of metastasis , the Kaplan – Meier estimates of the probability of metastasis at 5 years being : GG 0 % ; AG 9 % , CI 4–16 % ; AA 21 % , CI 12–36 % ; ( P=0.008 ) , and to thicker Breslow thickness groups ( P=0.04 ) . The effect on metastasis was independent of tumour thickness and A-1012 G may have predictive potential , additional to Breslow thickness . Neither the Fok 1 nor Taq 1 variants ( f and t ) were significantly related to the development of metastasis , although there was a strong relationship of fftt with the thickest Breslow thickness group ( P=0.005 ) . There was an interaction between the A-1012 G and Fok 1 polymorphisms ( P=0.025 ) and the Fok 1 variant enhanced the effect of the A allele of the A-1012 G polymorphism on metastasis , the probability of metastasis for AAff at 5 years follow-up being 57 % , CI 24–92 % Calcitriol , via its receptor ( VDR ) is a main regulator of PTH secretion and parathyroid cell proliferation . Recently , marked overrepresentation of the polymorphic VDR alleles b , a , and T was found in patients with primary hyperparathyroidism ( pHPT ) , which suggests pathogenic importance in the disease . Using the ribonuclease protection assay , relative VDR and PTH messenger ribonucleic acid ( mRNA ) levels of parathyroid adenomas from 42 patients with sporadic pHPT were related to these VDR polymorphisms . The tumors of patients homozygous for the b , a , or T alleles demonstrated significantly lower VDR and higher PTH mRNA levels than those exhibiting the BB , AA , or tt genotypes ( P < 0.0001 - 0.02 ) , whereas heterozygotes had intermediate values . A similar discrepancy was found when comparing the baT and non-baT haplotypes ( 0.042 + /- 0.005 vs. 0.064 + /- 0.004 for VDR ; 34.4 + /- 3.7 vs. 21.6 + /- 2.2 for PTH ; both P < 0.005 ) . The lower VDR mRNA levels associated with the b , a , and T alleles may affect the calcitriol-mediated control of parathyroid function and thereby contribute to the development of sporadic pHPT
Output:
| In conclusion , data summarized in this review support the concept that the vitamin D endocrine system ( VDES ) is of importance for pathogenesis and progression of MM and other types of skin cancer |
MS211302 | ***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 The trans-septal suturing method has been developed in septoplasty as an alternative to packing . This study was carried out to compare the postoperative results of trans-septal suturing with the anterior Merocel packing technique . The study involved 697 patients who underwent septoplasty . Following surgery , patients were r and omly divided into two groups , one with trans-septal suturing and the other with Merocel packing . Patients were asked to record pain levels using a visual analogue scale . Postoperative symptoms and complications were compared . A total of 697 nasal operations were evaluated in the postoperative period considering pain , bleeding , haematoma , septal perforation synechiae and septal perforation . The results for haemorrhage , haematoma , synechiae and perforation were not statistically different ( p > 0.05 ) between groups . In contrast , the level of postoperative pain in patients undergoing trans-septal suturing was significantly less than in the group who received Merocel packing ( p < 0.05 ) . Patients with Merocel packing had significantly more pain and nasal discomfort when assessed 1 week after intervention . Therefore , the trans-septal suturing technique may be the preferred option to provide higher patient satisfaction Septoplasty is one of the most common otorhinolaryngologic surgical procedure . It is customary to place a pack in the nose as a part of nasal surgery to stop bleeding , enhance apposition of mucosal flaps , and stabilize the operated septal cartilage and bones . But nasal packing is not an innocuous procedure . The most common problem encountered by the patients after septoplasty with nasal pack is the pain and discomfort in post operative period . The study has been performed to compare the complications and outcome of septoplasty with or without nasal packing . Forty four patients were r and omly allocated into two groups , Group A ( n = 21 ) and Group B ( n = 23 ) . In Group A trans-septal suture and in Group B intranasal pack was used following septoplasty . Both groups were compared for postoperative pain , postoperative complications and surgical outcome . Among 44 patients 31 patients were male and 13 patients were female . Most of the patients ie 79.5 % were operated for nasal obstruction . Only one patient had postoperative nasal bleeding requiring nasal pack in Group A. Higher Postoperative pain score , longer hospital stay and more complications were observed in Group B patients . No difference was found in patients ' satisfaction after the operation . Septoplasty can be safely performed without postoperative nasal packing and is preferred to avoid postoperative pain , discomfort and other complications This r and omized study was conducted to evaluate the role of nasal packing following septorhinoplasty . Fifty septorhinoplasty patients were selected ( on a r and om basis ) to either receive or not receive nasal packing . Twenty-three of 25 patients with nasal packing and 22 of 25 patients without nasal packing were available for follow-up . This study suggests that patients with nasal packing are less likely to develop recurrent septal deviation and synechia and more likely to have improvement in the nasal airway . Only one of the patients with nasal packing found the removal of the packing the most uncomfortable part of the surgery . The most impressive and statistically significant finding , however , was the significant difference between the two groups in terms of airway improvement , which was 96 percent in the nasal packing group and 64 percent in the group without nasal packing . There was also a higher incidence of recurrent or residual septal deviation in the group without nasal packing ( 41 percent ) , while the group with nasal packing had only ( 13 percent ) recurrent or residual deviation OBJECTIVES /HYPOTHESIS 1 ) Study outcomes of revision septoplasty using a vali date d disease-specific question naire and a patient satisfaction survey ; 2 ) assess the effect of surgery on the use of medication to treat nasal congestion ; and 3 ) report on sites of persistent septal deviation identified at revision septoplasty . STUDY DESIGN Prospect i ve , single-center outcome study of patients with symptomatic nasal obstruction and persisting septal deviation despite prior septal surgery . METHODS The Nasal Obstruction Symptom Evaluation ( NOSE ) scale was administered preoperatively and at 3 and 6 months following revision surgery . Patients were also question ed regarding ease of breathing and medication use preoperatively and postoperatively , as well as satisfaction with the surgical outcome . Anatomic site(s ) of residual septal deviation were recorded intraoperatively . RESULTS Thirty-nine patients completed the study . Mean NOSE scores decreased significantly from 75.9 preoperatively to 14.9 3 months after revision surgery . Mean Ease-of-Breathing scores over this interval improved from 3/10 preoperatively to 8.5/10 . Both results were sustained at 6 months ( P < 0.0001 ) . Patient satisfaction was very high , and many patients required less medication to treat symptoms of nasal congestion postoperatively . Deviations persisting from prior surgery most commonly involved the dorsal or caudal septum . CONCLUSION In patients who experience ongoing nasal obstruction with a persistent septal deviation despite prior septoplasty , revision surgery significantly improves disease-specific quality of life , results in high patient satisfaction , and may diminish the need for nasal medications postoperatively . Caudal or dorsal deflections may be more difficult to correct , leading to the need for revision surgery . LEVEL OF EVIDENCE 2C The once-common practice of packing the nose after septoplasty was based on a desire to prevent postoperative complications such as bleeding , septal hematoma , and adhesion formation . However , it was since found that not only is nasal packing ineffective in this regard , it can actually cause these complications . Although the consensus in the world literature is that packing should be avoided , to the best of our knowledge , no truly r and omized study has been undertaken in Southwest Asia upon which to justify this recommendation here . Therefore , we conducted a prospect i ve r and omized comparison of the incidence of a variety of postoperative signs and symptoms in 88 patients , 15 years of age and older , who did ( n = 44 ) and did not ( n = 44 ) undergo nasal packing following septoplasty . We found that the patients who underwent packing experienced significantly more postoperative pain , headache , epiphora , dysphagia , and sleep disturbance on the night of surgery . Oral and nasal examinations 7 days postoperatively revealed no significant difference between the two groups in the incidence of bleeding , septal hematoma , adhesion formation , and local infection . Finally , the packing group reported a moderate to high level of pain during removal of the packing . Our findings confirm that nasal packing after septoplasty is not only unnecessary , it is actually a source of patient discomfort and other signs and symptoms Nasal packing may influence the mucociliary clearance of the nose in the postoperative healing phase . In an attempt to overcome some of this problem , a haemostatic septal suturing technique was conceived . In this prospect i ve study , we aim ed to investigate the effects of nasal packing and septal suturing technique on mucociliary clearance by rhinoscintigraphy . Forty-eight adult patients who had undergone septoplasty were included in the investigation . Preoperatively , the patients were allocated into three groups : group 1 , fingerstall packs filled with gauze and smeared with vaseline were used ( 11 male , 4 female ) ; group 2 , silicon septal splint packs were used ( 11 male , 4 female ) ; group 3 , haemostatic septal sutures were used ( 14 male , 4 female ) . Mucociliary clearance was measured by rhinoscintigraphy in all patients before surgery and 6 weeks after surgery . The nasal mucociliary clearance was presented as the velocity ( mm/min ) of nasal mucociliary transport of the 99mTc-MAA droplet . The mean velocity of nasal mucociliary clearances before and after surgery for group 1 , group 2 and group 3 were 1.85 ± 0.67 versus 2.43 ± 0.78 mm/min , 2.36 ± 0.80 versus 2.92 ± 0.96 mm/min and 2.03 ± 0.58 versus 2.62 ± 0.65 mm/min , respectively . A significant difference in nasal mucociliary clearance was observed after surgery in all groups ( p < 0.001 ) . No significant differences were found between the groups regarding mucociliary clearance before and after surgery . Patients with septal deviation have a prolonged mucociliary transit time as compared with postoperative . Nasal packing did not significantly influence the mucociliary clearance in the postoperative healing phase OBJECTIVE The most frequent complaint of patients after septoplasty is severe pain felt during removal of nasal packing placed on the operation . Various methods have been described to decrease pain and to increase patient comfort during removal of nasal packing . However , these methods are not practical . There has been an increase in the number of studies on pre-emptive analgesia use for postoperative pain relief . The aim of this study was to determine whether pre-emptive analgesia decreased pain during removal of Merocel packs placed in septoplasties . METHODS This is a double-blind r and omized , placebo-controlled study . The study included 121 patients who underwent elective septoplasty in our otorhinolaryngology clinic . The patients were r and omly assigned into two groups : study and placebo groups . The study and placebo groups received two tablets of diflunisal 500 mg and placebo , respectively , two and a half hours before removal of nasal packing . Visual analog scale ( VAS ) values immediately after and 5 min after removal of nasal packing , effects of the procedure on patient comfort and its side-effects were evaluated separately . RESULTS VAS values immediately after the removal of nasal packs significantly decreased in the study group ( p<0.001 ) , but there was no significant difference in VAS values obtained after the procedure between the study and placebo groups . Patient discomforts were significantly lower in the diflunisal group ( p<0.001 ) . CONCLUSIONS It can be concluded that pre-emptive analgesia decreases pain during removal of nasal packing placed in septoplasties and increases patient comfort Background : This study compared the effects of nasal packing and transseptal suturing after septoplasty by evaluating olfactory function , pain , and mucociliary clearance . Methods : The study enrolled 39 patients diagnosed with isolated septal deviation . The patients were r and omly assigned to 2 groups . In Group A ( n = 21 ) , transseptal sutures were placed for septal stabilization after the septoplasty . In Group B ( n = 18 ) , both nasal passages were packed with Merocel tampons after the septoplasty . It was made Sniffin Sticks test , sacchranirine test , and pain and discomfort scales preoperatively , 1 week postoperatively and 3 months postoperatively on all patients . Results : There was no postoperative bleeding , submucoperichondrial haematoma , or abscess formation in either group . The postoperative discomfort and pain scores were increased in Group B ( the packing group ) in our study , the mucociliary clearance improved after septoplasty in both groups , and there was no significant difference in mucociliary clearance between the 2 groups . The odor threshold , odor identification , and odor discrimination were significantly increased 3 months postoperatively , but not 1 week postoperatively . Conclusions : Nasal packing causes more discomfort and pain than transseptal suturing , while there was no significant difference in olfactory functions or the mucociliary clearance after septoplasty between nasal packing and transseptal suturing OBJECTIVE To discuss and compare the results of suturing the nasal septum after septoplasty with the results of nasal packing . METHODS A prospect i ve study , which was performed at Prince Hashem Military Hospital in Zarqa , Jordan and Prince Rashed Military Hospital in Irbid , Jordan between September 2005 and August 2006 included 169 consecutive patients that underwent septoplasty . The patients were r and omly divided into 2 groups . After completion of surgery , the nasal septum was sutured in the first group while nasal packing was performed in the second group . RESULTS Thirteen patients ( 15.3 % ) in the first group and 11 patients ( 13 % ) in the second group had minor oozing in the first 24 hours , 4 patients ( 4.8 % ) had bleeding after removal of the pack in the second group . Four patients ( 4.8 % ) developed septal hematoma in the second group . Two patients ( 2.4 % ) had septal perforation in the second group . One patient ( 1.1 % ) in the first group , and 5 patients ( 5.9 % ) in the second group had postoperative adhesions . Five patients ( 5.9 % ) were found to have remnant deviated nasal septum in each group . The operating time was 4 minutes longer in the first group . CONCLUSION Septal suturing after septoplasty offers the following advantages : elimination of discomfort for the patients , minimal complications , the outcome is almost the same as with nasal packing , and finally the hospital stay is less than with nasal packing . Therefore , suturing of the nasal septum after septoplasty should be a preferred alternative to nasal packing The need for nasal packing in septal surgery is not proven though its use is widespread . Post-operative complications , while uncommon , are frequently pack related . Consenting adults were prospect ively r and omized to one of the following : Vaseline gauze nasal packing or 30 Dexon
Output:
| Nonabsorbable nasal packing is no more effective than treatments without packing after septoplasty .
Septal splints and transseptal sutures reduce postoperative pain , headache , and synechia . |
MS211303 | ***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: Introduction Non-invasive hemodynamic monitoring may facilitate resuscitation in critically ill patients . Validation studies examining a transcutaneous Doppler ultrasound technology , USCOM-1A , using pulmonary artery catheter as the reference st and ard showed varying results . In this study , we compared non-invasive cardiac index ( CI ) measurements by USCOM-1A with transthoracic echocardiography ( TTE ) . Methods This study was a prospect i ve , observational cohort study at a university tertiary-care emergency department , enrolling a convenience sample of adult and pediatric patients . Paired measures of CI , stroke volume index ( SVI ) , aortic outflow tract diameter ( OTD ) , velocity time integral ( VTI ) were obtained using USCOM-1A and TTE . Pearson ’s correlation and Bl and –Altman analyses were performed . Results One-hundred and sixteen subjects were enrolled , with obtainable USCOM-1A CI measurements for 99 subjects ( 55 adults age 50 ± 20 years and 44 children age 11 ± 4 years ) in the final analysis . Cardiac , gastrointestinal and infectious illnesses were the most common presenting diagnostic categories . The reference st and ard TTE measurements of CI , SVI , OTD , and VTI in all subjects were 3.08 ± 1.18 L/min/m2 , 37.10 ± 10.91 mL/m2 , 1.92 ± 0.36 cm , and 20.36 ± 4.53 cm , respectively . Intra-operator reliability of USCOM-1A CI measurements showed a correlation coefficient of r = 0.79 , with 11 ± 22 % difference between repeated measures . The bias and limits of agreement of USCOM-1A compared to TTE CI were 0.58 ( −1.48 to 2.63 ) L/min/m2 . The percent difference in CI measurements with USCOM-1A was 31 ± 28 % relative to TTE measurements . Conclusions The USCOM-1A hemodynamic monitoring technology showed poor correlation and agreement to st and ard transthoracic echocardiography measures of cardiac function . The utility of USCOM-1A in the management of critically ill patients remains to be determined Objective . Assess outcome in children treated with inotrope , vasopressor , and /or vasodilator therapy for reversal of fluid-refractory and persistent septic shock . Design . Survey ; case series . Setting . Three pediatric hospitals . Patients . Fifty consecutive patients with fluid-refractory septic shock with a pulmonary artery catheter within 6 hours of resuscitation . Interventions . Patients were categorized according to hemodynamic state and use of inotrope , vasopressor , and /or vasodilator therapy to maintain cardiac index ( CI ) > 3.3 L/min/m2 and systemic vascular resistance > 800 dyne-sec/cm 5 /m 2 to reverse shock . Outcome Measures . Hemodynamic state , response to class of cardiovascular therapy , and mortality . Results . After fluid resuscitation , 58 % of the children had a low CI and responded to inotropic therapy with or without a vasodilator ( group I ) , 20 % had a high CI and low systemic vascular resistance and responded to vasopressor therapy alone ( group II ) , and 22 % had both vascular and cardiac dysfunction and responded to combined vasopressor and inotropic therapy ( group III ) . Shock persisted in 36 % of the children . Of the children in group I , 50 % needed the addition of a vasodilator , and in group II , 50 % of children needed the addition of an inotrope for evolving myocardial dysfunction . Four children showed a complete change in hemodynamic state and responded to a switch from inotrope to vasopressor therapy or vice versa . The overall 28-day survival rate was 80 % ( group I , 72 % ; group II , 90 % ; group III , 91 % ) . Conclusions . Unlike adults , children with fluid-refractory shock are frequently hypodynamic and respond to inotrope and vasodilator therapy . Because hemodynamic states are heterogeneous and change with time , an incorrect cardiovascular therapeutic regimen should be suspected in any child with persistent shock . Outcome can be improved compared with historical literature Objective : To vali date clinical ly cardiac output ( CO ) measurements using femoral artery thermodilution in ventilated children and infants by comparison with CO estimated from the Fick equation via a metabolic monitor . Design : Prospect i ve , comparison study . Setting : Paediatric intensive care unit of a university hospital . Patients : 24 ventilated infants and children , aged 0.3 to 175 months ( median age 19 months ) . Interventions : Oxygen consumption measurements were made and averaged over a 5-min period , at the end of which arterial and mixed venous blood sample s were taken and oxygen saturations measured by co-oximetry , with CO being calculated using the Fick equation . Over this 5-min period , five sets of femoral arterial thermodilution ( FATD ) measurements were made and averaged . One comparison of CO values was made per patient . Results : Mean Fick CO was 2.55 l/min ( range 0.24 to 8.71 l/min ) and mean FATD CO was 2.51 l/min ( range 0.28–7.96 l/min ) . The mean bias was 0.03 l/min ( 95 % confidence interval –0.07 to 0.14 l/min ) , with limits of agreement of –0.45 to 0.52 l/min . When indexed to body surface area , the mean Fick cardiac index became 3.51 l/min per m2 ( 1.52–6.98 l/min per m2 ) and mean FATD 3.49 l/min per m2 ( 1.74–6.84 l/min per m2 ) . The mean bias was 0.02 l/min per m2 ( 95 % confidence interval –0.11 to 0.15 l/min per m2 ) with limits of agreement of –0.57 to 0.61 l/min per m2 . The mean FATD coefficient of variation was 5.8 % ( SEM 0.5 % ) . Conclusions : FATD compares favourably with Fick derived CO estimates in infants and children and may represent an advance in haemodynamic monitoring of critically ill children Objective To compare the assessment of cardiac output ( CO ) in children using the noninvasive Ultrasound Cardiac Output Monitor ( USCOM ) with the invasive pulmonary artery catheter ( PAC ) thermodilution cardiac output measurement . Design and setting Prospect i ve observational study in a tertiary center for pediatric cardiology of a university children 's hospital . Patients Twenty-four pediatric patients with congenital heart disease without shunt undergoing cardiac catheterization under general anesthesia . Measurements and results CO was measured by USCOM using a suprasternal CO Doppler probe in children undergoing cardiac catheterization . USCOM data were compared to CO simultaneously measured by PAC thermodilution technique . Measurements were repeated three times within 5 min in each patient . A mean percentage error not exceeding 30 % was defined as indicating clinical useful reliability of the USCOM . CO values measured by PAC ranged from 1.3 to 5.3 l/min ( median 3.6 l/min ) . Bias and precision were −0.13 and 1.34 l/min , respectively . The mean percentage error of CO measurement by the USCOM compared to PAC thermodilution technique was 36.4 % for USCOM . Conclusions Our preliminary data demonstrate that cardiac output measurement in children using the USCOM does not reliably represent absolute CO values as compared to PAC thermodilution . Further studies must evaluate the impact of incorporating effective aortic valve diameters on CO measurement using the USCOM BACKGROUND It is currently uncertain which hemodynamic monitoring device reliably measures stroke volume and tracks cardiac output changes in pediatric cardiac surgery patients . OBJECTIVE To evaluate the difference between stroke volume index ( SVI ) measured by pressure recording analytical method ( PRAM ) and bioreactance and their ability to track changes after a therapeutic intervention . METHODS A single-center prospect i ve observational cohort study in children undergoing cardiac surgery with cardiopulmonary bypass ( CPB ) was conducted . Twenty children below 20 kg with median ( interquartile range ) weight of 5.3 kg ( 4.1 - 7.8 ) and age of 6 months ( 3 - 20 ) were enrolled . Data were collected after anesthesia induction , at the end of CPB , before fluid administration and after fluid administration . Overall , median-IQR PRAM SVI values ( 23 ml·m(-2 ) , 19 - 27 ) were significantly higher than bioreactance SVI ( 15 ml·m(-2 ) , 12 - 25 , P = 0.0001 ) . Correlation ( r(2 ) ) between the two methods was 0.15 ( P = 0.0003 ) . The mean difference between the measurements ( bias ) was 5.7 ml·m(-2 ) with a st and ard deviation of 9.6 ( 95 % limits of agreement ranged from -13 to 24 ml·m(-2 ) ) . Percentage error was 91.7 % . Baseline SVI appeared to be similar , but PRAM SVI was systematic ally greater than bioreactance thereafter , with the highest gap after the fluid loading phase : 13 ( 12 - 18 ) ml·m(-2 ) vs. 23 ( 19 - 25 ) ml·m(-2 ) , respectively , P = 0.0013 . A multivariable regression model showed that a significant independent inverse correlation with patients ' body weight predicted the CI difference between the two methods after fluid challenge ( β coefficient -0.12 , P = 0.013 ) . CONCLUSIONS Pressure recording analytical method and bioreactance provided similar SVI estimation at stable hemodynamic conditions , while bioreactance SVI values appeared significantly lower than PRAM at the end of CPB and after fluid replacement Background Intraoperative hypovolemia is common and is a potential cause of organ dysfunction , increased postoperative morbidity , length of hospital stay , and death . The objective of this prospect i ve , r and omized study was to assess the effect of goal -directed intraoperative fluid administration on length of postoperative hospital stay . Methods One hundred patients who were to undergo major elective surgery with an anticipated blood loss greater than 500 ml were r and omly assigned to a control group ( n = 50 ) that received st and ard intraoperative care or to a protocol group ( n = 50 ) that , in addition , received intraoperative plasma volume expansion guided by the esophageal Doppler monitor to maintain maximal stroke volume . Length of postoperative hospital stay and postoperative surgical morbidity were assessed . Results Groups were similar with respect to demographics , surgical procedures , and baseline hemodynamic variables . The protocol group had a significantly higher stroke volume and cardiac output at the end of surgery compared with the control group . Patients in the protocol group had a shorter duration of hospital stay compared with the control group : 5 ± 3 versus 7 ± 3 days ( mean ± SD ) , with a median of 6 versus 7 days , respectively ( P = 0.03 ) . These patients also tolerated oral intake of solid food earlier than the control group : 3 ± 0.5 versus 4.7 ± 0.5 days ( mean ± SD ) , with a median of 3 versus 5 days , respectively ( P = 0.01 ) . Conclusions Goal -directed intraoperative fluid administration results in earlier return to bowel function , lower incidence of postoperative nausea and vomiting , and decrease in length of postoperative hospital stay OBJECTIVES To vali date a new device ( PiCCO system ; Pulsion Medical Systems , Munich , Germany ) , we compared cardiac index derived from transpulmonary thermodilution and from pulse contour analysis in pediatric patients after surgery for congenital heart disease . We performed a prospect i ve clinical study in a pediatric cardiac intensive care unit of a university hospital . METHODS Twenty-four patients who had had cardiac surgery for congenital heart disease ( median age 4.2 years , range 1.4 - 15.2 years ) were investigated in the first 24 hours after admission to the intensive care unit . A 3F thermodilution catheter was inserted in the femoral artery . Intracardiac shunts were excluded by echocardiography intraoperatively or postoperatively . Cardiac index derived from pulse contour analysis was documented in each patient 1 , 4 , 8 , 12 , 16 , 20 , and 24 hours after admission to the intensive care unit . Subsequently , a set of three measurements of thermodilution cardiac indices derived by injections into a central venous line was performed and calculated by the PiCCO system . RESULTS The mean bias between cardiac indices derived by thermodilution and those derived by pulse contour analysis over all data points was 0.05 ( SD 0.4 ) L x min x m(-2 ) ( 95 % confidence interval 0.01 - 0.10 ) . A strong correlation between thermodilution and contour analysis cardiac indices was calculated ( Pearson correlation coefficient r = 0.93 ; coefficient of determination r2 = 0.86 ) . CONCLUSIONS Pulse contour analysis is a suitable method to monitor cardiac index over a wide range of indices after surgery for congenital heart disease in pediatric patients . Pulse contour analysis allows online monitoring of cardiac index . The PiCCO device can be recalibrated with the integrated transpulmonary thermodilution within a short time frame OBJECTIVE ( S )
Output:
| By meta-regression analysis , we found no independent effects of study characteristics on weighted mean difference between reference and tested methods .
Although the pooled bias was small , the mean pooled percentage error was in the gray zone of clinical applicability .
In the sub-group analysis , electrical cardiometry was the device that provided the most accurate measurement . |
MS211304 | ***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 There is preliminary support for internet-delivered cognitive behaviour therapy ( iCBT ) as a way of improving access to treatment among older adults with anxiety . The aim of this r and omized controlled trial ( RCT ) was to examine the efficacy , long-term outcomes , and cost-effectiveness of an iCBT program for adults over 60 years of age with anxiety . Successful applicants were r and omly allocated to either the treatment group ( n=35 ) or the waitlist control group ( n=37 ) . The online treatment course was delivered over 8 weeks and provided with brief weekly contact with a clinical psychologist via telephone or secure email . Eighty-four percent of participants completed the iCBT course within the 8 weeks and 90 % provided data at posttreatment . Significantly lower scores on measures of anxiety ( Cohen 's d=1.43 ; 95 % CI : 0.89 - 1.93 ) and depression ( Cohen 's d=1.79 ; 95 % CI : 1.21 - 2.32 ) were found among the treatment group compared to the control group at posttreatment . These lower scores were maintained at 3-month and 12-month follow-up and the treatment group rated the iCBT treatment as acceptable . The treatment group had slightly higher costs ( $ 92.2 ; 95 % CI : $ 38.7 to $ 149.2 ) and Quality -Adjusted Life-Years ( QALYs=0.010 ; 95 % CI : 0.003 to 0.018 ) than the control group at posttreatment and the intervention was found to have a greater than 95 % probability of being cost-effective . The results support iCBT as an efficacious and cost-effective treatment option for older adults with symptoms of anxiety . TRIAL REGISTRATION TRIAL REGISTRATION Australian and New Zeal and Clinical Trials Registry : ACTRN12611000929909 ; https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?ACTRN=12611000929909 Patients with anxiety disorders exhibit excessive neural reactivity in the amygdala , which can be normalized by effective treatment like cognitive behavior therapy ( CBT ) . Mechanisms underlying the brain ’s adaptation to anxiolytic treatments are likely related both to structural plasticity and functional response alterations , but multimodal neuroimaging studies addressing structure – function interactions are currently missing . Here , we examined treatment-related changes in brain structure ( gray matter ( GM ) volume ) and function ( blood – oxygen level dependent , BOLD response to self-referential criticism ) in 26 participants with social anxiety disorder r and omly assigned either to CBT or an attention bias modification control treatment . Also , 26 matched healthy controls were included . Significant time × treatment interactions were found in the amygdala with decreases both in GM volume ( family-wise error ( FWE ) corrected PFWE=0.02 ) and BOLD responsivity ( PFWE=0.01 ) after successful CBT . Before treatment , amygdala GM volume correlated positively with anticipatory speech anxiety ( PFWE=0.04 ) , and CBT-induced reduction of amygdala GM volume ( pre – post ) correlated positively with reduced anticipatory anxiety after treatment ( PFWE⩽0.05 ) . In addition , we observed greater amygdala neural responsivity to self-referential criticism in socially anxious participants , as compared with controls ( PFWE=0.029 ) , before but not after CBT . Further analysis indicated that diminished amygdala GM volume mediated the relationship between decreased neural responsivity and reduced social anxiety after treatment ( P=0.007 ) . Thus , our results suggest that improvement-related structural plasticity impacts neural responsiveness within the amygdala , which could be essential for achieving anxiety reduction with CBT Background Major depression and depressive symptoms are common in patients with a recent myocardial infa rct ion ( MI ) , and depression is associated with adverse cardiovascular outcomes . Anxiety post-MI is less studied , but occurs commonly in patients with heart disease , and is also considered a risk factor for recurrence of cardiac events . Cognitive behavior therapy ( CBT ) is an established therapy for depression and anxiety disorders . To the best of our knowledge , there have not been any studies to determine if internet-based CBT ( iCBT ) can reduce the symptoms of depression and anxiety in patients with a recent MI . The main aim of the U-CARE Heart trial is to evaluate an iCBT intervention for patients with a recent MI . Methods / design This is a r and omized , controlled , prospect i ve study with a multicenter design . A total of 500 participants will be r and omized at a 1:1 ratio , around two months after an acute MI , to either iCBT or to a control group . Both groups will receive an optimal st and ard of care according to guidelines . The intervention consists of a self-help program delivered via the internet with individual online support from a psychologist . Treatment duration is 14 weeks . The primary outcome is change in patients ’ self-rated anxiety and depression symptoms from baseline to end of treatment . An internal pilot study was conducted indicating sufficient levels of study acceptability and engagement in treatment . Discussion The present study is design ed to evaluate an iCBT intervention targeting symptoms of depression and anxiety in a post-MI population . If effective , iCBT has several advantages , and will potentially be implemented as an easily accessible treatment option added to modern st and ard of care . Trial registration This trial was registered with Clinical trials.gov ( identifier : NCT01504191 ) on 19 December 2011 Background Symptoms of anxiety and depression are prevalent in older adults . Aims To compare clinician-guided and self-guided versions of a transdiagnostic internet-delivered cognitive – behavioural therapy ( iCBT ) intervention for adults aged 60 years and above . Method Adults ( n=433 ) with symptoms of anxiety and depression were r and omly allocated to : ( 1 ) clinician-guided treatment ( n=153 ) ; ( 2 ) initial clinician interview followed by self-guided treatment ( n=140 ) ; or ( 3 ) self-guided treatment without interview ( n=140 ) . Results Large reductions ( d ≥1.00 ) in symptoms of depression and anxiety were observed across groups , and sustained at follow-up . No differences were observed in clinical outcomes or satisfaction ratings . Age did not affect outcomes . Conclusions Carefully developed iCBT interventions may significantly reduce symptoms of anxiety and depression in older adults when delivered in either clinician-guided or self-guided formats . Declaration of interest N.T. and B.F.D. developed the Wellbeing Plus Course but derive no financial benefit from it . Copyright and usage © 2016 The Royal College of Psychiatrists . This is an open access article distributed under the terms of the Creative Commons Non-Commercial , No Derivatives ( CC BY-NC-ND ) licence Background Previous studies on Internet-based treatment with minimal therapist guidance have shown promising results for several specific diagnoses . Objective To ( 1 ) investigate the effects of a tailored , therapist-guided , Internet-based treatment for individuals with reoccurring panic attacks , and ( 2 ) to examine whether people in different age groups ( 18–30 years and 31–45 years ) would respond differently to the treatment . Methods We recruited 149 participants from an online list of individuals having expressed an interest in Internet treatment . Screening consisted of online question naires followed by a telephone interview . A total of 57 participants were included after a semistructured diagnostic interview , and they were r and omly assigned to an 8-week treatment program ( n = 29 ) or to a control condition ( n = 28 ) . Treatment consisted of individually prescribed cognitive behavior therapy text modules in conjunction with online therapist guidance . The control group consisted of people on a waitlist who later received treatment . Results All dependent measures improved significantly immediately following treatment and at the 12-month follow-up . The between-group effect size on the primary outcome measure , the Panic Disorder Severity Scale , was d = 1.41 ( 95 % confidence interval 0.81–1.95 ) at posttreatment . The within-group effect size from pretreatment to 12-month follow-up was d = 1.66 ( 95 % confidence interval 1.14–2.35 ) . Age group had no effect , suggesting that age did not influence the outcome . Conclusions Tailoring an Internet-based treatment can be a feasible approach in the treatment of panic symptoms and comorbid anxiety and depressive symptoms . Younger adults benefit as much as adults over 30 years and up to 45 years of age . Trial Registration Clinical trials.gov NCT01296321 ; http://www . clinical trials.gov/ct2/show/NCT01296321 ( Archived by WebCite at http://www.webcitation.org/65wddsqlL BACKGROUND To study the clinical relevance of type of comorbidity and number of comorbid disorders in anxiety disorders . Four groups were compared according to sociodemographic- , vulnerability- and clinical factors : single anxiety disorder , anxiety-anxiety comorbidity , anxiety-depressive comorbidity and " double " comorbidity ( i.e. anxiety and depressive comorbidity ) . METHODS Data were obtained from the Netherl and s Study of Anxiety and Depression ( NESDA ) . A sample of 1004 participants with a current anxiety disorder was evaluated . RESULTS As compared with single anxiety , anxiety-anxiety comorbidity was associated with higher severity , greater chronicity and more treatment . Anxiety-anxiety comorbidity was associated with an earlier age of onset and a more chronic course compared with anxiety-depressive comorbidity , while anxiety-depressive comorbidity was associated with more severe symptoms and more impaired functioning than anxiety-anxiety comorbidity . " Double " comorbidity was associated with higher severity , greater chronicity , more treatment and increased disability . Sociodemographic and vulnerability factors were comparable among the four groups . Limitations A prospect i ve design would be more appropriate to study the outcome . In this study no distinction was made between whether depression or anxiety disorder preceded the current anxiety disorder . CONCLUSIONS It is clinical relevant to diagnose and treat comorbidity among anxiety disorders as it is associated with higher severity and more chronicity . Whereas anxiety-anxiety comorbidity has an earlier age of onset and a more chronic course , anxiety-depressive comorbidity leads to more treatment and impaired functioning . " Double " comorbidity leads to even more severity , chronicity and impairment functioning compared with both anxiety-anxiety and anxiety-depressive comorbidity Transdiagnostic cognitive behaviour therapy ( TD-CBT ) aims to target the symptoms of multiple disorders whereas disorder-specific CBT ( DS-CBT ) targets the symptoms of principal disorders . This study compared the relative benefits of internet-delivered TD-CBT and DS-CBT when provided in clinician-guided ( CG-CBT ) and self-guided ( SG-CBT ) formats for people with a principal diagnosis of Panic Disorder ( PD ) . Participants ( n=145 ) were r and omly allocated to receive TD-CBT or DS-CBT and CG-CBT or SG-CBT . Large reductions in symptoms of PD ( Cohen 's d ≥ 0.71 ; avg . reduction ≥ 36 % ) and moderate-to-large reductions in symptoms of comorbid depression ( Cohen 's d ≥ 0.71 ; avg . reduction ≥ 33 % ) , generalised anxiety disorder ( Cohen 's d ≥ 0.91 ; avg . reduction ≥ 34 % ) and social anxiety disorder ( Cohen 's d ≥ 0.50 ; avg . reduction ≥ 15 % ) were found over the 24-month follow-up period . Highlighting their efficacy and acceptability , no marked and consistent differences were observed between TD-CBT and DS-CBT or CG-CBT and DS-CBT 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 Clinician-guided Internet-based cognitive behavioural therapy ( iCBT ) programs are clinical ly effective at treating specific anxiety disorders . The present study examined the efficacy of a transdiagnostic Internet-based cognitive behavioural treatment ( iCBT ) program to treat more than one anxiety disorder within the same program ( the Anxiety Program ) . Eighty six individuals meeting diagnostic criteria for generalized anxiety disorder ( GAD ) , panic disorder , and /or social phobia were r and omly assigned to a treatment group , or to a waitlist control group . Treatment consisted of CBT based online educational lessons and homework assignments , weekly email or telephone contact from a clinical psychologist , access to a moderated online discussion forum , and automated emails . An intention-to-treat model using the baseline-observation-carried-forward principle was employed for data analyses . Seventy-five percent of treatment group participants completed all 6 lessons within the 8 week program . Post-treatment data was collected from 38/40 treatment group and 38/38 control group participants , and 3-month follow-up data was collected from 32/40 treatment group participants . Relative to controls , treatment group participants reported significantly reduced symptoms of anxiety as measured by the Generalized Anxiety Disorder - 7 Item , Social Phob
Output:
| There was a large effect on generic outcome measures and a moderate effect on comorbidities .
When compared to disorder-specific treatments there were no differences on anxiety and quality of life outcomes , however there were differences in depression outcomes .
Transdiagnostic and tailored iCBT are effective interventions for anxiety disorders and depression . |
MS211305 | ***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 Chronic pain is a common consequence of spinal cord injury ( SCI ) . No therapeutic drugs or drug groups are proven to be superior for neuropathic pain and treatments only aim to convert pain from dull to tolerable levels and not to remove it . OBJECTIVE This study was planned to compare the effect of visual illusion ( VI ) and transcutaneous electrical nerve stimulation ( TENS ) on pain intensity , pain quality and functional capacity in SCI patients with neuropathic pain . METHODS Twenty-four patients were included and r and omly categorized into two groups . In the first group ( n= 12 ) , visual illusion was applied for first two weeks , 1 week wash out period and then TENS was applied for 2 weeks . In second group ( n= 12 ) , TENS was applied firstly , 1 week wash out and then % visual illusion VI were applied . Pain severity , pain quality , and functional capacity were assessed with the visual analog scale ( VAS ) , the neuropathic pain scale ( NPS ) , and the brief pain inventory ( BPI ) , respectively . A pre-post-treatment and cross over design was used . RESULTS Wilcoxon signed-rank tests were used for within group analyses . Mann-Whitney U tests were used for analyses that compared different groups . It was observed that pain intensity decrease immediately after both applications ( VI : p= 0.07 , TENS : p= 0.08 ) . After TENS application for 2 weeks , it was observed that significant decrease in most ( p= 0.04 ) and less ( p= 0.02 ) pain intensity ; while there was no significant decrease in pain intensity after 2 weeks for VI ( p > 0.05 ) . When findings of NPS were analyzed , hot ( p= 0.047 ) , sharp ( p= 0.02 ) , unpleasant ( p= 0.03 ) and deep items ( p= 0.047 ) decreased after VI application . When the results of BPI were detected , they were observed that the negative effect of pain on moving ability ( p= 0.04 ) after visual illusion application and the negative effect of pain on mood ( p= 0.03 ) , relationships with others ( p= 0.04 ) and sleep ( p= 0.04 ) after TENS application decreased significantly . CONCLUSION TENS and VI therapies can be successfully used in clinical practice as an alternative treatment or as a supportive method separetely or together Sciatica is a common pain problem and current pharmacologic therapies have proven inadequate for many patients . The objective of this sham-controlled investigation was to compare a novel non-pharmacologic technique , percutaneous electrical nerve stimulation ( PENS ) , to transcutaneous electrical nerve stimulation ( TENS ) in the management of the radicular pain associated with sciatica . Sixty-four consenting patients with sciatica due to lumbar disc herniation were treated with PENS , TENS and sham-PENS according to a r and omized , single-blinded , cross-over study . All patients had been maintained on a stable oral non-opioid analgesic regimen for at least 6 weeks prior to entering the study . Each treatment modality was administered for a period of 30 min three times per week for 3 weeks , with 1 week ' off ' between each modality . Both PENS and TENS treatments were administered using a stimulation frequency of 4 Hz . The pre-treatment assessment included the health status survey short form ( SF-36 ) , as well as visual analog scales ( VAS ) for radicular pain , physical activity and quality of sleep . The pain VAS was also repeated after each treatment session . At the end of each 3-week treatment block , the SF-36 was repeated . After receiving all three treatment modalities , a global assessment question naire was completed . Both PENS ( 42 % ) and TENS ( 23 % ) were significantly more effective than the sham ( 8 % ) treatments in decreasing VAS pain scores . The daily oral analgesic requirements were also significantly reduced compared to the pre-treatment values with PENS ( P<0.01 ) and TENS ( P<0.05 ) . However , PENS was significantly more effective than TENS ( and sham-PENS ) in improving physical activity and quality of sleep . The SF-36 evaluation confirmed the superiority of PENS ( versus TENS and sham-PENS ) with respect to post-treatment functionality . In the overall assessment , 73 % of the patients reported that PENS was the most desirable modality ( versus 21 % for TENS and 6 % for sham-PENS ) . Finally , 71 % of the patients stated that they would be willing to pay extra to receive PENS therapy compared to 22 % and 3 % for TENS and sham-PENS , respectively . In this sham-controlled study , we concluded that PENS was more effective than TENS when administered at a stimulation frequency of 4 Hz in providing short-term pain relief and improved functionality in patients with sciatica AIM The aim of the study was to compare LASER versus transcutaneous electrical nerve stimulation ( TENS ) in reducing pain and paraesthesia ; and in improving motor and sensory median nerve conduction parameters in mild to moderate carpal tunnel syndrome ( CTS ) . DESIGN R and omised blinded pilot study . Patients and staff administered treatments and outcome measures were blinded . SETTING Outpatient ; Research and Care Rehabilitation Institute . PARTICIPANTS Twenty CTS symptomatic patients . INTERVENTIONS Fifteen sessions of : 1 ) 100 Hz TENS ( 30 minutes ; rectangular waves ; 80 ms width , intensity below muscle contraction ) ; 2 ) combined 830 - 1064 nm LASER ( radiating dose : 250 J cm-2 delivered to the skin overlying the course of the median nerve at the wrist for 100 s at 25 W ( 18 W [ 1064 nm ] + 7 W [ 830 nm ] ) via a fiber-optic probe with a spot size of ~1 cm2 ) . Outcome measures . Visual analogue scale ( VAS ) for pain and paresthesia ; median nerve distal motor latency and sensory nerve conduction velocity . RESULTS LASER improved both positive and negative sensory symptoms . TENS induced clinical improvement but this was not statistically significant and was limited to pain reduction . LASER but not TENS favourably modified the neurophysiological parameters . CONCLUSION High-intensity combined LASER wavelengths of 830 nm and 1064 nm , which produce a better transparency with less scattering and a high energy transfer , are better than TENS in improving both pain and paraesthesia as well as neurophysiological parameters in CTS UNLABELLED Transcutaneous electrical nerve stimulation ( TENS ) is an electrophysical modality used for pain management . This study investigated the dose response of different TENS intensities on experimentally induced pressure pain . One hundred and thirty TENS naïve healthy individuals ( 18 - 64 years old ; 65 males , 65 females ) were r and omly allocated to 5 groups ( n = 26 per group ) : Strong Non Painful TENS ; Sensory Threshold TENS ; Below Sensory Threshold TENS ; No Current Placebo TENS ; and Transient Placebo TENS . Active TENS ( 80 Hz ) was applied to the forearm for 30 minutes . Transient Placebo TENS was applied for 42 seconds after which the current amplitude automatically reset to 0 mA. Pressure pain thresholds ( PPT ) were recorded from 2 points on the h and and forearm before and after TENS to measure hypoalgesia . There were significant differences between groups at both the h and and forearm ( ANOVA ; P = .005 and .002 ) . At 30 minutes , there was a significant hypoalgesic effect in the Strong Non Painful TENS group compared to : Below Sensory Threshold TENS , No Current Placebo TENS and Transient Placebo TENS groups ( P < .0001 ) at the forearm ; Transient Placebo TENS and No Current Placebo TENS groups at the h and ( P = .001 ) . There was no significant difference between Strong Non Painful TENS and Sensory Threshold TENS groups . The area under the curve for the changes in PPT significantly correlated with the current amplitude ( r(2 ) = .33 , P = .003 ) . These data therefore show that there is a dose-response effect of TENS with the largest effect occurring with the highest current amplitudes . PERSPECTIVE This study shows a dose response for the intensity of TENS for pain relief with the strongest intensities showing the greatest effect ; thus , we suggest that TENS intensity should be titrated to achieve the strongest possible intensity to achieve maximum pain relief [ Purpose ] To investigate the effects of transcutaneous electrical nerve stimulation ( TENS ) on pain in patients with spinal cord injury . [ Subjects and Methods ] Fifty-two spinal cord injury patients with central pain were r and omly allocated into two groups TENS and control with 26 subjects per group . The patients in TENS and control groups were treated with TENS and sham TENS for 20 min ( three times a week ) for 12 consecutive weeks , respectively . The two group ’s pain was assessed using visual analog scale ( VAS ) and the McGill Pain Question naire ( including pain rating index-total , pain rating index-affective , pain rating index-sensory , present pain intensity , and number of words chosen ) before and after the treatment . [ Results ] After the intervention , we found significant differences in VAS , pain rating index-total , pain rating index-affective , pain rating index-sensory , present pain intensity , and number of words chosen between the TENS group and the control group . [ Conclusion ] Our results suggest that TENS effectively decreases pain in patients with spinal cord injury Summary Pain and fatigue during movement , but not at rest , are reduced by a onetime 30‐m treatment with active transcutaneous electrical nerve stimulation ( TENS ) in individuals with fibromyalgia . Abstract Because transcutaneous electrical nerve stimulation ( TENS ) works by reducing central excitability and activating central inhibition pathways , we tested the hypothesis that TENS would reduce pain and fatigue and improve function and hyperalgesia in people with fibromyalgia who have enhanced central excitability and reduced inhibition . The current study used a double‐blinded r and omized , placebo‐controlled cross‐over design to test the effects of a single treatment of TENS with people with fibromyalgia . Three treatments were assessed in r and om order : active TENS , placebo TENS and no TENS . The following measures were assessed before and after each TENS treatment : pain and fatigue at rest and in movement ; pressure pain thresholds , 6‐m walk test , range of motion ; 5‐time sit‐to‐st and test , and single‐leg stance . Conditioned pain modulation was completed at the end of testing . There was a significant decrease in pain and fatigue with movement for active TENS compared to placebo and no TENS . Pressure pain thresholds increased at the site of TENS ( spine ) and outside the site of TENS ( leg ) when compared to placebo TENS or no TENS . During active TENS , conditioned pain modulation was significantly stronger compared to placebo TENS and no TENS . No changes in functional tasks were observed with TENS . Thus , the current study suggests TENS has short‐term efficacy in relieving symptoms of fibromyalgia while the stimulator is active . Future clinical trials should examine the effects of repeated daily delivery of TENS , similar to the way in which TENS is used clinical ly on pain , fatigue , function , and quality of life in individuals with fibromyalgia Background : Painful diabetic peripheral neuropathy ( DPN ) is a long-term complication of type 1 and type 2 diabetes that majorly impacts quality of life . Its prevalence increases with age and duration of diabetes . It is more common in patients who have suboptimal glycemic control over several years . Because DPN may be resistant to conventional treatments , it is common for patients to only have partial pain relief . Therefore , new therapeutic options are needed for the condition . Objectives : The aim of the present study was to compare the efficacy of transcutaneous electrical nerve stimulation ( TENS ) and pulsed radiofrequency ( PRF ) lumbar sympathectomy in treating painful DPN . Patients and Methods : Sixty-five patients with painful DPN refractory to conventional treatment were r and omly and evenly assigned to either the TENS or PRF lumbar sympathectomy groups . Pain evaluations were based on the 10-point numerical rating scale ( NRS ) . Subjects were followed for three months and had a total of four study visits ( baseline and 1 week , 1 month , and 3 months after treatment ) . Results : Sixty patients completed all study visits . In both groups , the NRS rating significantly decreased after treatment , with a marked pain reduction observed at the first follow-up evaluation . In the PRF group , the NRS decreased from 6.46 at baseline to 2.76 at the 1 week visit . One and 3 months after treatment , the NRS was 4.30 and 5.13 , respectively ( P < 0.0001 ) . In the TENS group , the NRS decreased from 6.10 at baseline to 3.96 at the 1 week visit . One and 3 months after treatment , the NRS was 5.23 and 5.90 , respectively ( P < 0.0001 ) . Unfortunately , the NRS steady increased almost back to baseline levels in the TENS group . The NRS only slightly increased during the follow-up period in the PRF group , but did not reach baseline levels . Conclusions : Both TENS and PRF lumbar sympathectomy are promising pain relief treatments for painful DNP . However , PR
Output:
| Of the comparisons , we had planned to explore , we were only able to undertake a quantitative synthesis for TENS versus sham TENS .
In this review , we reported on the comparison between TENS and sham TENS .
The quality of the evidence was very low meaning we were unable to confidently state whether TENS is effective for pain control in people with neuropathic pain . |
MS211306 | ***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 : Until recently , renal crisis was the most significant cause of morbidity and mortality in patients with scleroderma ( SSc ) . Nowadays , following the introduction of angiotensin-converting enzyme inhibitors used in renovascular hypertension , pulmonary fibrosis and pulmonary hypertension have become the most common causes of death in SSc . Consequently , the early diagnosis and treatment of pulmonary fibrosis is essential to improve morbidity and mortality in SSc patients . The aim of this study was to investigate the effect of intravenous cyclophoshamide pulse therapy in patients with SSc and evidence of active alveolitis assessed on a high resolution computed tomographic ( H RCT ) scan , and to compare the effect of cyclophosphamide pulse therapy with oral therapy . Sixteen consecutive patients with SSc were allocated alternately to the two treatment groups . Eight patients were treated with monthly cyclophoshamide pulse therapy ( 750 mg/m2 ) for 12 months ; the other eight patients were treated with oral cyclophosphamide ( 2–2.5 mg/kg/day ) for the same period . All patients received concurrently prednisone ( 10 mg/day ) . Pulmonary function tests and H RCT scans were performed before therapy and at 6 and 12 months . In the oral cyclophosphamide group , three patients with a grade I pattern showed regression of disease extent . In the other five patients ( one with grade II and four with grade III ) the pattern and extent of disease remained stable during the study . No statistical differences were found in forced expiratory volume in 1 s , forced vital capacity and total lung capacity during the study period . The diffusing capacity for carbon monoxide increased significantly between baseline and 12 months ( p= 0.043 ) . In the cyclophosphamide pulse therapy group , seven patients with a grade I pattern showed regression of disease extent at 6 months ( p= 0.018 ) and 12 months ( p= 0.012 ) . One patient with grade III remained stable during the study . In both groups the regression of the extent of disease estimated on H RCT was due to a decrease in the ground glass appearance . The extent of the reticular appearance remained stable throughout the study . Our results indicate that cyclophosphamide pulse therapy is effective in suppressing active alveolitis ( ground glass appearance ) . Although in this study it is not possible to compare pulse therapy with oral therapy because of the different pattern seen on H RCT between the two groups , it seems that oral therapy is also effective in suppressing active alveolitis . Neither regimen improved pulmonary involvement when the reticular appearance predominated over the ground glass appearance on H RCT . It is concluded that either pulse or oral cyclophosphamide therapy may improve the outcome of SSc patients Interstitial lung disease ( ILD ) is a noteworthy condition in the treatment of systemic sclerosis ( SSc ) because of its associated mortality and morbidity ; however , the efficacy of various treatments for ILD has been controversial in previous reports . In this study , we examined the efficacy and safety of intravenous cyclophosphamide ( IVCY ) pulse therapy with prednisolone ( PSL ) for the treatment of ILD with SSc . A total of 121 patients with SSc were screened and evaluated for ILD , using high-resolution computed tomography of the chest , pulmonary function testing , and bronchoalveolar lavage . Thirteen patients with active ILD were enrolled in this study . The treatment protocol for ILD was 0.4 g/m2 of body surface area of IVCY monthly plus 0.8 mg/kg of body weight of PSL daily . Two to six doses of IVCY were administered , depending on the remission of ILD . Initial PSL doses were maintained for a month and then gradually tapered to 10 mg daily . An activity index of ILD showed improvements in all patients in the 12 months after the initial intervention ; however , four patients experienced recurrence of ILD after 24 months , and one additional patient had recurrence of ILD after 36 months . Seven patients reached the 48-month point with no recurrence of ILD . This long observational study for 48 months showed the efficacy of IVCY with PSL for active alveolitis in the first year . However , because five patients had recurrence of ILD more than 1 year after the treatment , it would be necessary to consider maintenance therapy for ILD beyond 1 year OBJECTIVE To evaluate the safety and efficacy of monthly intravenous pulses of cyclophosphamide ( CP ) in combination with low or high doses of prednisolone in patients with systemic sclerosis ( SSc ) related interstitial lung disease ( ILD ) with FVC < 70 % of predicted . METHODS An open label , non-parallel arm study , performed in the rheumatology outpatient clinic of a university hospital . Twenty-eight patients with SSc related ILD were evaluated . Endpoint evaluations included the evolution of high resolution computed tomography , pulmonary function tests , skin involvement and dyspnea over 12 months . Patients were treated with monthly IV CP in combination with prednisolone at low ( < 10 mg/day ; n = 12 ) or high doses ( 1 mg/kg/day for 4 weeks , then reducing the prednisolone by 5 mg/day on alternating days each 2 weeks ; n = 16 ) . RESULTS In the low dose steroid group , no improvement was seen for any endpoint at 6 and 12 months of followup . In the high dose steroid group , at 12 months there was significant improvement in the percentage of " ground glass " parenchymal lung involvement ( -5.7 % ; p = 0.003 ) , as well as in the percentage of predicted FVC ( 12.4 % ; p < 0.001 ) , the percentage of predicted DLCO ( 7.3 % ; p = 0.029 ) , the percentage of skin involvement ( -5.4 % ; p = 0.01 ) , and the severity of dyspnea ( p = 0.012 ) . Substantial improvement was seen as early as 6 months . One patient ( low dose group ) died from ILD . CONCLUSION A combination of IV pulse CP with high doses of prednisolone shows promising efficacy in improving the clinical , physiological , and radiological evolution of SSc related ILD with reversal of the underlying alveolitis Lung involvement constitutes nowadays the major cause of morbidity and mortality in scleroderma patients . Pulmonary fibrosis in systemic sclerosis ( SSc ) is thought to be the consequence of interstitial inflammation . Early diagnosis and treatment of active alveolitis is essential to prevent the deterioration of pulmonary function , improving outcome in SSc patients . The aim of the study was to investigate the effect of 1-year treatment with oral cyclophosphamide ( CYC ) on the evolution of interstitial lung disease in scleroderma patients with a diagnosis of active alveolitis . An open-label one-arm monocenteric study was conducted on 33 scleroderma patients with active alveolitis — defined as the presence of areas of ‘ ground-glass attenuation ’ on high-resolution computed tomography and a recent deterioration in lung function — treated with oral CYC 2 mg kg−1 day−1 for 1 year and medium-low dose steroids ( prednisone 25 mg for 3 months and then tapered to 5 mg/day ) . Results showed that diffusing capacity for carbon monoxide ( DLco ) values remained stable after 6 months of treatment and significantly increased after 12 months ( 2.06±1.38 , 2.21±1.62 and 2.39±1.64 mmol/min/kPa , at baseline/6/12 months , respectively ; p<0.001 12th month vs baseline ) vital capacity ( VC ) values slightly increased ( i.e. stabilised ) in the same time frame ( 2.46±0.71 , 2.41±0.76 and 2.56±0.75 l ) . Accordingly , the vast majority of our patients ( n=29 , 87.9 % ) presented a DLco and /or a VC improvement or stabilisation with respect to baseline . Favourable results were more likely to be observed in patients with a lower Wells ’ radiological grade ( grade I ) . In 25 patients followed up for further 12 months after the interruption of therapy , VC and DLco remained stable . Thus , long-term therapy with oral CYC is effective in ameliorating and /or stabilising lung function in scleroderma patients with active alveolitis , with beneficial effects lasting up to 1 year after interruption . The higher efficacy in those patients with an early pulmonary disease stage and a lower radiological grade underlies the importance of an early diagnosis and intervention Thirty-five patients with diffuse systemic sclerosis were studied in a r and omized , placebo-controlled , double-blind study . Seventeen patients received intravenous dexamethasone “ pulse ” therapy , while 18 patients received placebo . Each “ pulse ” consisted of 100 mg dexamethasone in 250 ml 5 % dextrose infused intravenously over 1 h. Pulse therapy was repeated every month for 6 months . Assessment of disease status with various parameters was done at entry and at completion of trial , i.e. after 6 months . Significant improvement in skin involvement was seen in the study group , with the total skin score ( TSS ) decreasing from 28.5±12.2 to 25.8±12.8 , while in the control group , TSS increased from 30.6±13.2 to 34.7±10 . Similarly , significant improvement was noted in the flexion index . Other parametres that included extension index , maximum oral opening , range of movement of joints , functional disability score , Raynaud 's phenomenon ( frequency and duration ) , ESR , proteinuria , chest X-ray , ECG , lung function tests , barium swallow and antinuclear antibody were unchanged . Adverse effects of therapy were limited to an increased incidence of minor chest infections . It is concluded that intravenous pulse dexamethasone may be useful in the treatment of diffuse systemic sclerosis OBJECTIVE The lack of r and omized controlled trials ( RCTs ) in pulmonary fibrosis in systemic sclerosis ( SSc ) has hampered an evidence -based approach to treatment . This RCT was undertaken to investigate the effects of intravenous ( IV ) cyclophosphamide ( CYC ) followed by azathioprine ( AZA ) treatment in pulmonary fibrosis in SSc . METHODS Forty-five patients were r and omized to receive low-dose prednisolone and 6 infusions ( monthly ) of CYC followed by oral AZA , or placebo . Primary outcome measures were change in percent predicted forced vital capacity ( FVC ) and change in single-breath diffusing capacity for carbon monoxide ( DLCO ) . Secondary outcome measures included changes in appearance on high-resolution computed tomography and dyspnea scores . An intent-to-treat statistical analysis was performed . RESULTS At baseline , there were no significant group differences in factors linked to outcome , including severity of pulmonary fibrosis and autoantibody status . Sixty-two percent of the patients completed the first year of treatment . Withdrawals included 9 patients ( 6 from the placebo group ) with significant decline in lung function , 2 with treatment side effects ( both from the active treatment group ) , and 6 with non-trial-related comorbidity . No hemorrhagic cystitis or bone marrow suppression was observed . Estimation of the relative treatment effect ( active treatment versus placebo ) adjusted for baseline FVC and treatment center revealed a favorable outcome for FVC of 4.19 % ; this between-group difference showed a trend toward statistical significance ( P = 0.08 ) . No improvements in DLCO or secondary outcome measures were identified . CONCLUSION This trial did not demonstrate significant improvement in the primary or secondary end points in the active treatment group versus the group receiving placebo . However , for FVC there was a trend toward statistical significance between the 2 groups . This suggests that treatment of pulmonary fibrosis in SSc with low-dose prednisolone and IV CYC followed by AZA stabilizes lung function in a subset of patients with the disease . Therapy was well tolerated with no increase in serious adverse events Objective : Interstitial lung disease ( ILD ) frequently complicates systemic sclerosis ( SSc ) . Cyclophosphamide ( CYC ) is a promising immunosuppressive therapy for SSc-related ILD . Our objective was to investigate the effectiveness of an intravenous CYC ( iv CYC ) pulse regime in SSc-related ILD during treatment and thereafter . Methods : In a prospect i ve observational study ten consecutive patients with SSc-related ILD were treated with iv CYC in a pulse regime lasting from 6 to 24 months . Clinical status , pulmonary functional testing ( PFT ) and high resolution computed tomography ( H RCT ) of the chest were evaluated at enrolment and 6 , 12 and 24 months thereafter . After treatment withdrawal , patients were followed up every 6 months with PFT and chest H RCT to monitor lung disease . Results : Clinical improvement was apparent in 8 out of 10 patients . The median values of forced vital capacity ( FVC ) , forced expiratory volume in the first second ( FEV1 ) and diffusion lung capacity for carbon monoxide ( DLCO ) as well as ground-glass pattern on H RCT did not change significantly after 6 , 12 and 24 months of therapy . The follow-up continued in 8 out of 10 patients after treatment withdrawal for a median of 26.5 months ( range : 12 - 48 months ) . The final median FVC was 54.5 % of predicted value ( interquartile range , IQR= 31.6%-94 % ) . Only one patient suffered a FVC d
Output:
| Despite the limited evidence for their effectiveness , GC are frequently prescribed in SSc patients , mostly in those with the diffuse subset . |
MS211307 | ***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 This study was undertaken to prospect ively evaluate the effect of early stage endometrial cancer , age , and obesity on quality of life ( QOL ) . STUDY DESIGN Women undergoing surgery for endometrial cancer or an adnexal mass determined at surgery to be benign ( controls ) were enrolled preoperatively and followed for 6 months . RESULTS Seventy-nine women completed the study . Functional Assessment of Cancer Therapy ( FACT-G ) scores increased significantly in all women ; however , significant differences by patient weight and age were obtained . Obesity was associated with decreased physical FACT-G and SF-36 scores . Older women had lower SF-36 physical scores , higher emotional scores , and less change over time . CONCLUSION Women with early endometrial cancer had similar changes in QOL as those who received surgery for benign disease . Obese and elderly women had domain alterations . Given the aging population and rising incidence of obesity , these results emphasize the need for QOL interventions in postoperative gynecologic care of these patients OBJECTIVE This study was undertaken to compare the quality of life ( QoL ) in women with early stage endometrial cancer treated with 2 different surgical approaches . STUDY DESIGN Eighty-four women with clinical stage I endometrial cancer were enrolled in a prospect i ve r and omized controlled trial design and treated with laparoscopic or laparotomic approach . Another 40 women matched for demographic characteristics were studied as controls . In patients , before and after surgery , and in their matched controls , QoL was evaluated by using the Short-Form Healthy Survey ( SF-36 ) and the climacteric symptoms using the Kupperman Index ( KI ) . RESULTS After r and omization , no difference was detected in data recorded between the groups . At entry , QoL was similar in both treatment groups but significantly ( P < .05 ) worse in comparison with controls . Throughout the study , QoL was significantly ( P < .05 ) higher in laparoscopic group versus laparotomic group . After KI adjustment our data did not change . CONCLUSION In early stage endometrial cancer , the laparoscopic approach provides significant benefits compared with laparotomy in terms of In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials The objective of this study was to examine and compare two core measures of Quality Of Life ( QOL ) used in cancer clinical trials : the European Organisation for Research and Treatment of Cancer QOL Core Question naire 30 ( EORTC QLQ-30 ) and the Functional Assessment of Chronic Illness Therapy ( FACIT ) , in order to identify which one patients have the strongest preference for using . 68 patients suffering from Carcinomas of an Unknown Primary site ( CUP ) were recruited in a multicentric study ; all of them completed both question naires , administered in a r and omised manner . The criteria were the percentage of preferences , and four indicators of acceptability . The results indicated that an equal proportion of patients preferred the QLQ-C30 ( 19 % ) and FACIT ( 19 % ) . 54 % of patients felt both question naires were acceptable . All the indicators of acceptability favoured the QLQ-C30 . Analysis of open-ended questions shed light on the difficulties encountered by the patients . As no significant preference was observed for one of the question naires , the QLQ-C30 was chosen on the basis of its significantly better acceptability criteria PURPOSE The value of palliative chemotherapy in women with refractory and recurrent ovarian cancer is difficult to quantify , and little is known about patient expectations from these treatments . We evaluated in the current prospect i ve study patient expectations , palliative outcomes of chemotherapy , and the inherent re source utilization in patients undergoing second- or third-line chemotherapy for recurrent or refractory advanced ovarian cancer . METHODS The European Organization for Research and Treatment of Cancer Quality -of-Life Question naire C30 ( EORTC QLQ C30 ) and Functional Assessment of Cancer Therapy-Ovarian ( FACT-O ) question naires were used to assess palliative benefit and an in-house question naire was used to gauge patient expectations . The minimal clinical ly important difference ( MCID ) was calculated by asking women to make a global rating of change and correlating this to the EORTC QLQ C30 . Re source use was recorded and costs were calculated . RESULTS Twenty-seven patients were accrued . Objective response was documented on seven of 27 . The median survival was 11 months . Sixty-five percent of women expected that chemotherapy would make them live longer and 42 % that it would cure them . After two cycles , quality -of-life ( QL ) improvement was seen particularly in global function ( 11 of 21 ) and emotional function ( 13 of 21 ) with EORTC QLQ C-30 . Improvement was sustained for a median of 2 and 3 months , respectively , in these categories . The MCID was calculated to be 0.39 on a seven-point scale for physical function and 0.13 for global function . The mean total cost per patient for the study period was Can $ 12,500 . CONCLUSION Patient expectations from these treatments are often unrealistic . Although objective responses are low , active palliation with chemotherapy is associated with substantive improvement in patients ' emotional function and global QL , with overall costs that seem relatively modest OBJECTIVES To assess the reliability and validity of the Functional Assessment of Cancer Therapy-Vulvar ( FACT-V ) . METHODS Seventy-seven patients treated between January 1996 and January 2001 for cancer of the vulva completed the FACT-V , the Eastern Cooperative Oncology Group Performance Status Rating ( ECOG-PSR ) and the Hospital Anxiety and Depression Scale ( HADS ) once , 20 consecutive patients treated between February 2001 and October 2001 completed the question naires twice , once before surgery and at 2 months follow-up . The FACT-V scores were compared by patients ' performance status , FIGO stage , recurrence , and age , and correlated to the HADS scores . Changes in the FACT-V from baseline to 2 months follow-up were evaluated to establish FACT-V 's responsiveness to change . RESULTS The FACT-V 's internal consistency was adequate ( Chronbach 's alpha range , 0.75 to 0.92 ) . Patients with lower performance status , higher FIGO-stage or recurrent disease received lower FACT-V scores , indicating discriminant validity . The correlation between the FACT-V and the HADS were in the expected direction , indicating convergent and divergent validity . From pre- to post-surgery , scores in nine out of fifteen items of the vulvar cancer-specific subscale improved , while those of five items declined , indicating sensitivity of the vulvar cancer specific items to changes in patients ' well-being . CONCLUSIONS The newly developed FACT-V provides a reliable and valid assessment of the quality of life of women with vulvar cancer . It can be used as a short measure of quality of life within research studies , and to facilitate communication about quality of life issues in clinical practice The purpose of this study was to vali date the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group — Neurotoxicity ( FACT/GOG-Ntx ) question naire . The FACT/GOG-Ntx is the FACT-G plus an eleven-item subscale ( Ntx subscale ) that evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy . Two groups of women with ovarian cancer completed the FACT/GOG-Ntx : one group with known neurotoxicities and one group of chemotherapy-naive women newly diagnosed with ovarian cancer . Levels of patient neuropathy , severity of toxicity , and patient quality of life from diagnosis of ovarian cancer to 12 months post-diagnosis were assessed . The Ntx subscale significantly differentiated the two groups at baseline and 3- and 6-month follow-ups , demonstrating significantly fewer problems among chemotherapy-naive patients than among patients with known neuropathy . The FACT/GOG-Ntx is a reliable and valid instrument for assessing the impact of neuropathy on health-related quality of life . The Ntx subscale demonstrated sensitivity to meaningful clinical distinctions and change over time PURPOSE To compare self-reported quality of life ( QOL ) in patients who did versus did not undergo interval secondary cytoreduction after initial surgery and combination chemotherapy for advanced ovarian cancer and to assess the association between baseline QOL scores and survival . PATIENTS AND METHODS Consenting patients participating in a Gynecologic Oncology Group ( GOG ) phase III treatment trial ( GOG 152 ) completed the Functional Assessment of Cancer Therapy-Ovarian ( FACT-O ) question naire and treatment-specific supplemental questions at the third and sixth chemotherapy cycles and at 6 and 12 months after starting treatment . RESULTS For all patients , QOL decreased approximately 1 unit from the first to second assessment . Significant improvement observed at 6 months ( P < .001 ) was sustained at 12 months , with no appreciable between-group difference . The baseline FACT-O score was associated with overall survival ( P = .048 ) but not progression-free survival . Less neurotoxicity was reported among patients who did ( 38.4 % ) versus did not ( 54.0 % ) undergo interval secondary cytoreduction at the third assessment ( P = .005 ) , and older patients experienced more long-term effects . CONCLUSION This is the first multicenter r and omized trial in ovarian cancer to longitudinally examine self-reported QOL and establish a predictive value of baseline QOL on survival , attributed primarily to the lowest-scoring quartile . Although interval secondary cytoreduction result ed in no notable long-term difference , a clinical ly significant improvement was seen in both arms at 6 and 12 months after starting therapy . Interestingly , there were fewer complaints of neurotoxicity at 6 months among patients who did versus did not undergo interval secondary cytoreduction Objective To prospect ively compare quality of life ( QOL ) outcomes in patients with advanced endometrial cancer treated with whole abdominal irradiation ( WAI ) or doxorubicin-cisplatin ( AP ) chemotherapy . Methods Using the Fatigue Scale ( FS ) , Assessment of Peripheral Neuropathy ( APN ) , Functional Alterations due to Changes in Elimination ( FACE ) , and Functional Assessment of Cancer Therapy-General ( FACT-G ) , QOL was measured at : pre-treatment , end of treatment ( EOT ) , and 3 and 6 months post-treatment . Results 317 of 396 eligible patients provided a baseline QOL assessment . The AP arm produced a statistically significant survival benefit along with greater toxicities , including peripheral neuropathy persisting up to 6 months . WAI patients reported worse FS ( p<0.001 ) and FACE ( p<0.001 ) scores at EOT and poorer FACE scores 3 months post-treatment ( p = 0.004 ) compared to AP patients . APN scores were significantly worse among AP patients at EOT , and 3 and 6 months post-treatment ( p<0.001 for all ) . There is no indication that FACT-G scores differed between the two arms at any assessment point . Conclusions The trade-off for increased survival with AP is its potential for clinical ly significant peripheral neuropathy . This should be discussed with patients , particularly those who work with their h and s or on their feet , in weighing therapeutic choices . Further research is needed to manage side effects having an enduring impact on QOL PURPOSE A Gynecologic Oncology Group ( GOG ) r and omized phase III trial ( GOG 172 ) in optimal stage III epithelial ovarian cancer showed that intravenous ( IV ) paclitaxel plus intraperitoneal ( IP ) cisplatin and paclitaxel significantly lengthened progression-free survival and overall survival compared with IV paclitaxel and cisplatin . The purpose of this report is to comprehensively evaluate the patient-reported outcomes associated with IP versus IV therapy . PATIENTS AND METHODS Four hundred fifteen eligible women were enrolled onto GOG 172 at member institutions . The Functional Assessment of Cancer Therapy-Trial Outcome Index ( FACT-TOI ; which includes physical , functional , and ovarian subscales ) and neurotoxicity ( Ntx ) and abdominal discomfort ( AD ) subscales were used to assess patient-reported outcomes . Assessment s were completed before r and om assignment , before cycle 4 , and 3 to 6 weeks and 12 months after treatment . RESULTS Physical and functional well-being and ovarian cancer symptoms were significantly worse in the IP arm before cycle 4 ( P < .001 ) and 3 to 6 weeks after treatment ( P = .001 for FACT-TOI ) . Patients in the IP arm also reported significantly worse AD before cycle 4 ( P < .001 ) and significantly worse Ntx
Output:
| However , we found no evidence for superior performance by the FACT-G compared with the SF-36 or EORTC and FACIT disease-specific modules versus the QLQ-C30 and FACT-G. There was also little evidence to favor EORTC versus FACIT question naires or vice versa .
The evidence we review ed offered little support for the hypothesis that disease- , symptom- , or treatment-specific instruments are more sensitive and responsive than cancer-specific or generic question naires . |
MS211308 | ***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 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 Although poststress myocardial stunning is regarded as a marker for severe coronary artery disease ( CAD ) , no study has yet compared the diagnostic value of poststress stunning with transient ischemic dilation ( TID ) of the left ventricle ( LV ) for detecting multivessel CAD . METHODS AND RESULTS A total of 271 patients with suspected or known CAD underwent adenosine triphosphate ( ATP ) loading and at-rest gated single-photon emission computed tomography . We assessed myocardial perfusion with a 20-segment model , and analyzed the changes in LV volumetric analysis induced by ATP and an automatically derived TID ratio . In 147 patients with multivessel CAD , the prevalence of multi-territorial ischemia was higher , and the post-ATP increase in end-systolic volume ( ESV ) and TID ratio were greater , than in the 124 with insignificant or single-vessel CAD ( P<0.0001 , for all cases ) . The receiver-operating characteristic curves analysis revealed cutoff values for ESV of 5 ml and a TID ratio of 1.11 . Multivariate logistic regression analysis revealed that the combination of a poststress increase in ESV of ≥5 ml and multi-territorial ischemia best identified multivessel CAD , with a sensitivity of 78 % and a specificity of 84 % , whereas the TID ratio was not shown to be an independent predictor . CONCLUSIONS Post-ATP stress myocardial stunning is superior to the TID ratio for detecting multivessel CAD Background Postischemic global and regional left ventricular ( LV ) dysfunction on stressgated single photon emission computed tomography ( SPECT ) imaging is attributed widely to myocardial stunning . We sought to determine the specificity of gated SPECT for the detection of myocardial stunning after ischemic stress . Methods and Results Twenty-seven patients with an ischemic response to stress on dual-isotope exercise SPECT were enrolled prospect ively . Transthoracic echocardiography was performed just before stress gated SPECT for assessment of regional wall motion and quantitative LV ejection fraction ( LVEF ) . The 17 myocardial segments for each patient were scored for myocardial perfusion by stress gated SPECT , and regional wall motion by stress gated SPECT and echo . Of the 459 myocardial segments , 41 % had perfusion defects , 15 % had stress gated SPECT regional wall motion abnormality , 4.8 % had poststress echo regional wall motion abnormality , and 3.9 % had baseline regional wall motion abnormality . Overall , a stress gated SPECT regional wall motion abnormality had a sensitivity of 100 % and a specificity of 89 % . Among reversible perfusion defects of moderate severity or more , a stress gated SPECT regional wall motion abnormality had a specificity of 41 % and a positive predictive value of 8 % . Stress gated SPECT LVEF was similar to poststress echo LVEF for all patients , but significantly lower in patients with reversible perfusion defects of moderate severity or more . Conclusion Post-stress gated SPECT imaging overestimates global and regional myocardial stunning . Caution should be exercised in interpreting poststress global or regional LV function on stress gated SPECT in scans with reversible ischemia AIMS To prospect ively compare the agreement of left ventricular volumes and ejection fraction by M-mode echocardiography ( echo ) , 2D echo , radionuclide ventriculography and cardiovascular magnetic resonance performed in patients with chronic stable heart failure . It is important to know whether the results of each technique are interchangable , and thereby how the results of large studies in heart failure utilizing one technique can be applied using another . Some studies have compared cardiovascular magnetic resonance with echo or radionuclude ventriculography but few contain patients with heart failure and none have compared these techniques with the current fast breath-hold acquisition cardiovascular magnetic resonance . METHODS AND RESULTS Fifty two patients with chronic stable heart failure taking part in the CHRISTMAS Study , underwent M-mode echo , 2D echo , radionuclude ventriculography and cardiovascular magnetic resonance within 4 weeks . The scans were analysed independently in blinded fashion by a single investigator at three core laboratories . Of the echocardiograms , 86 % had sufficient image quality to obtain left ventricular ejection fraction by M-mode method , but only 69 % by 2D Simpson 's biplane analysis . All 52 patients tolerated the radionuclude ventriculography and cardiovascular magnetic resonance , and all these scans were analysable . The mean left ventricular ejection fraction by M-mode cube method was 39+/-16 % and 29+/-15 % by Teichholz M-mode method . The mean left ventricular ejection fraction by 2D echo Simpson 's biplane was 31+/-10 % , by radionuclude ventriculography was 24+/-9 % and by cardiovascular magnetic resonance was 30+/-11 . All the mean left ventricular ejection fractions by each technique were significantly different from all other techniques ( P<0.001 ) , except for cardiovascular magnetic resonance ejection fraction and 2D echo ejection fraction by Simpson 's rule ( P=0.23 ) . The Bl and -Altman limits of agreement encompassing four st and ard deviations was widest for both cardiovascular magnetic resonance vs cube M-mode echo and cardiovascular magnetic resonance vs Teichholz M-mode echo at 66 % each , and was 58 % for radionuclude ventriculography vs cube M-mode echo , 44 % for cardiovascular magnetic resonance vs Simpson 's 2D echo , 39 % for radionuclide ventriculography vs Simpson 's 2D echo , and smallest at 31 % for cardiovascular magnetic resonance-radionuclide ventriculography . Similarly , the end-diastolic volume and end-systolic volume by 2D echo and cardiovascular magnetic resonance revealed wide limits of agreement ( 52 ml to 216 ml and 11 ml to 188 ml , respectively ) . CONCLUSION These results suggest that ejection fraction measurements by various techniques are not interchangeable . The conclusions and recommendations of research studies in heart failure should therefore be interpreted in the context of locally available techniques . In addition , there are very wide variances in volumes and ejection fraction between techniques , which are most marked in comparisons using echocardiography . This suggests that cardiovascular magnetic resonance is the preferred technique for volume and ejection fraction estimation in heart failure patients , because of its 3D approach for non-symmetric ventricles and superior image quality OBJECTIVES We sought to evaluate the usefulness of a comprehensive assessment of four cardiovascular magnetic resonance imaging (CMR)-derived myocardial viability indexes in the setting of myocardial stunning . BACKGROUND Cardiovascular magnetic resonance imaging allows the simultaneous assessment of several viability indexes . METHODS We studied 40 patients with a first ST-segment elevation myocardial infa rct ion ( MI ) and an open infa rct -related artery . At the first week , using CMR , wall motion ( WM ) , and four viability indexes were determined : wall thickness , WM improvement with low-dose dobutamine , perfusion , and transmural extent of necrosis . We created a comprehensive score based on the presence and the relative power of these viability indexes for predicting normal WM at the sixth month . RESULTS Of 153 dysfunctional segments at the first week , 59 ( 39 % ) exhibited normal WM at the sixth month . According to the odds ratio of viability indexes for predicting normal WM , we developed a five-level predictive score . The proportions of segments showing normal WM at sixth month were as follows ; Level 1 ( 0 indexes ) : 0 of 13 ( 0 % ) ; Level 2 ( normal thickness and /or perfusion ) : 14 of 82 ( 17 % ) ; Level 3 ( dobutamine response ) : 5 of 11 ( 45 % ) ; Level 4 ( non-transmural necrosis ) : 20 of 26 ( 77 % ) ; Level 5 ( non-transmural necrosis and dobutamine response ) : 20 of 21 ( 95 % ) , p < 0.0001 for the trend . These proportions were similar in a matched prospect i ve validation group comprising 16 patients ( 0 % , 18 % , 62 % , 77 % , and 90 % for levels 1 to 5 , respectively , p < 0.0001 for the trend ) . CONCLUSIONS A comprehensive analysis of the four more widely used CMR-derived viability indexes is useful for predicting late systolic function after myocardial infa rct ion Background Reperfusion strategies salvage myocardium at risk in acute myocardial infa rct ion ( MI ) . This clinical study was performed to determine whether areas without evidence of delayed MRI contrast enhancement in MI correspond to viability by means of percent systolic wall thickening ( % SWT ) and enddiastolic wall thickness ( EDWT ) in chronic infa rct ion . Methods Twenty MRI studies were performed in ten patients within 6 days of MI and 3 months post-MI . On a segmental basis the percentage of viable myocardium as defined by contrast-enhanced MRI ( no delayed MRI contrast enhancement ) in acute MI was measured and was compared with % SWT and EDWT in chronic MI . Results Of the 1718 segments in acute infa rct ion in which the percentage of viable myocardium was measured 1333 were found to be completely viable by means of contrast-enhanced MRI ( no delayed MRI contrast enhancement ) . All of these segments revealed % SWT on day 90 post-MI , and 97 % of segments were viable by means of an EDWT of more than 5.5 mm . In 85 segments the proportion of viable myocardium was 50–99 % ( mean 56±8 % ) , with 92 % segments found to be viable by means of % SWT and 92 % by EDWT , and of 156 segments with viable myocardium between 1–49 % ( 36±8 % ) 79 % were found to be viable by means of % SWT and 82 % by EDWT . Corresponding proportions of 144 segments with transmural delayed MRI contrast enhancement in acute MI were 45 % and 17 % . Conclusions In acute reperfused MI viable myocardium as delineated by contrast-enhanced MRI is correlated with clinical parameters of viability . Delayed MRI contrast enhancement resolves nontransmural MI and may become a valuable clinical tool when planning revascularization procedures
Output:
| DE-CMR has a higher sensitivity , whereas LDD-CMR has a higher specificity for the detection of viable stunned myocardium following myocardial infa rct ion . |
MS211309 | ***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 effectiveness of an exercise intervention for people in early and midstage Parkinson 's disease ( stages 2 and 3 of Hoehn and Yahr ) in improving spinal flexibility and physical performance in a sample of community-dwelling older people is described . DESIGN AND SETTING Fifty-one men and women , aged 55 - 84 years , identified through advertisement , local support groups , and local neurologists were enrolled into a r and omized , controlled trial . Subjects were assigned r and omly to an intervention or a usual care arm ( i.e. , no specific exercise ) . Of the original 51 participants , 46 completed the r and omized , controlled trial . Participants in the exercise arm ( n = 23 ) received individual instruction three times per week for 10 weeks . Participants in the usual care arm ( n = 23 ) were " wait listed " for intervention . MEASUREMENTS Changes over 10 weeks in spinal flexibility ( i.e. , functional axial rotation ) and physical performance ( i.e. , functional reach , timed supine to st and ) were the primary outcome measures . RESULTS MANOVA conducted for the three primary outcome variables demonstrated significant differences ( P < or = .05 ) between the two groups . Further analysis using ANOVA demonstrated significant differences between groups in functional axial rotation and functional reach for the intervention compared with the control group . There was no significant difference in supine to sit time . CONCLUSION Study results demonstrate that improvements in axial mobility and physical performance can be achieved with a 10-week exercise program for people in the early and midstages of PD The purpose of this study was to determine if a balance and strength training program could improve equilibrium and strength in persons with stage I-III Parkinsonism . Subjects were pre-tested on strength and balance ( EquiTest ) and r and omized into either a treatment or a control group . The treatment subjects participated in 10 weeks of lower limb strength training and balance exercises design ed to challenge a stable posture and increase limits of stability . Both groups were then posttested on balance , knee flexion , knee extension , and ankle inversion strength . Subjects who received strength and balance training demonstrated significantly improved equilibrium and modest gains in knee flexion and extension strength , while the control group showed no improvement in conditions of destabilizing balance environments and significant declines in strength . Results indicate that 10 weeks of balance and strength training lead to improved equilibrium by producing positive changes in two different control mechanisms . One , training altered the ability to control the motor system when vestibular cues had to be the primary source of reliable feedback ; and two , training helped subjects to override faulty proprioceptive feedback and utilize reliable visual or vestibular cues Objective : To determine whether the Alex and er Technique , alongside normal treatment , is of benefit to people disabled by idiopathic Parkinson 's disease . Design : A r and omized controlled trial with three groups , one receiving lessons in the Alex and er Technique , another receiving massage and one with no additional intervention . Measures were taken pre and post-intervention , and at follow-up , six months later . Setting : The Polyclinic at the University of Westminster , Central London . Subjects : Ninety-three people with clinical ly confirmed idiopathic Parkinson 's disease . Interventions : The Alex and er Technique group received 24 lessons in the Alex and er Technique and the massage group received 24 sessions of massage . Main outcome measures : The main outcome measures were the Self- assessment Parkinson 's Disease Disability Scale ( SPDDS ) at best and at worst times of day . Secondary measures included the Beck Depression Inventory and an Attitudes to Self Scale . Results : The Alex and er Technique group improved compared with the no additional intervention group , pre-intervention to post-intervention , both on the SPDDS at best , p = 0.04 ( confidence interval ( CI ) –6.4 to 0.0 ) and on the SPDDS at worst , p = 0.01 ( CI –11.5 to –1.8 ) . The comparative improvement was maintained at six-month follow-up : on the SPDDS at best , p = 0.04 ( CI –7.7 to 0.0 ) and on the SPDDS at worst , p = 0.01 ( CI –11.8 to –0.9 ) . The Alex and er Technique group was comparatively less depressed post-intervention , p = 0.03 ( CI –3.8 to 0.0 ) on the Beck Depression Inventory , and at six-month follow-up had improved on the Attitudes to Self Scale , p = 0.04 ( CI –13.9 to 0.0 ) . Conclusions : There is evidence that lessons in the Alex and er Technique are likely to lead to sustained benefit for people with Parkinson 's disease BACKGROUND Baseline data collected on each patient at r and omisation in controlled clinical trials can be used to describe the population of patients , to assess comparability of treatment groups , to achieve balanced r and omisation , to adjust treatment comparisons for prognostic factors , and to undertake subgroup analyses . We assessed the extent and quality of such practice s in major clinical trial reports . METHODS A sample of 50 consecutive clinical -trial reports was obtained from four major medical journals during July to September , 1997 . We tabulated the detailed information on uses of baseline data by use of a st and ard form . FINDINGS Most trials presented baseline comparability in a table . These tables were often unduly large , and about half the trials inappropriately used significance tests for baseline comparison . Methods of r and omisation , including possible stratification , were often poorly described . There was little consistency over whether to use covariate adjustment and the criteria for selecting baseline factors for which to adjust were often unclear . Most trials emphasised the simple unadjusted results and covariate adjustment usually made negligible difference . Two-thirds of the reports presented subgroup findings , but mostly without appropriate statistical tests for interaction . Many reports put too much emphasis on subgroup analyses that commonly lacked statistical power . INTERPRETATION Clinical trials need a predefined statistical analysis plan for uses of baseline data , especially covariate-adjusted analyses and subgroup analyses . Investigators and journals need to adopt improved st and ards of statistical reporting , and exercise caution when drawing conclusions from subgroup findings The aim of this study was to evaluate the effects of orofacial physiotherapeutic treatment ( OPT ) on the facial mobility of Parkinson 's disease ( PD ) sufferers . Sixteen participants with PD were allocated r and omly to either the Treatment group or the Control group . A short interview between the physiotherapist and each subject was videotaped , and 10 r and om frames of the videotape were selected to be used in the facial expression assessment . The quantification of facial expressions was achieved by using an objective microcomputer-based measurement system , based on a mathematical model of the face ( FACEM ) . A facial outline is obtained , as well as 12 facial measures , which represent distances between key facial l and marks . The facial assessment was performed on 3 separate occasions , that is , baseline ( pretreatment ) , posttreatment , and follow-up ( 4 weeks later ) . A repeated measures analysis of variance ( MANOVA ) revealed a significant main effect of Time and a significant interaction effect between Time and Group for the Mouth-Opening Measure , suggesting that after treatment , members of the Treatment group opened their mouths to a greater degree than members of the Control group . Within the Treatment group , significant differences between pretreatment and posttreatment scores ( MANOVA ) were found for Mouth-Opening Measure and Mid-Top-Lip Measure . Similarly , Mouth-Opening Measure , Mid-Top-Lip Measure , Lower-Lip Thickness Measure , Top Eyelid/Iris Intersect Measure and Lower Eyelid/Iris Intersect Measure were significant across time from baseline to follow-up in the Treatment group only . No significant differences were found on any of the facial measures during the same period for members of the Control group . These findings suggest that OPT can improve facial movement and that this benefit extends in time , beyond the period of OPT itself . Such an increase in facial mobility can be expected to modify the " Parkinsonian facies " and facilitate the display of facial expressions Rhythmic auditory stimulation ( RAS ) was used as a pacemaker during a 3-week home-based gait-training program for Parkinson 's disease ( PD ) patients ( n = 15 ) . Electromyogram ( EMG ) patterns and stride parameters were assessed before and after the test without RAS to evaluate changes in gait patterns . Data were compared with those of two control groups ( n = 11 ) , who either did not participate in any gait training or who participated in an internally self-paced training program . RAS consisted of audiotapes with metronome-pulse patterns embedded into the on/off beat structure of rhythmically accentuated instrumental music . Patients who trained with RAS significantly ( p < 0.05 ) improved their gait velocity by 25 % , stride length by 12 % , and step cadence by 10 % more than self-paced subjects who improved their velocity by 7 % and no-training subjects whose velocity decreased by 7 % . In the RAS-group , timing of EMG patterns changed significantly ( p < 0.05 ) in the anterior tibialis and vastus lateralis muscles . Evidence for rhythmic entrainment of gait patterns was shown by the ability of the RAS group to reproduce the speed of the last training tape within a 2 % margin of error without RAS Objectives : To accurately establish the incidence of falls in Parkinson 's disease ( PD ) and to investigate predictive risk factors for fallers from baseline data . Methods : 109 subjects with idiopathic PD diagnosed according to the brain bank criteria underwent a multidisciplinary baseline assessment comprising demographic and historical data , disease specific rating scales , physiotherapy assessment , tests of visual , cardiovascular and autonomic function , and bone densitometry . Patients were then prospect ively followed up for one year using weekly prepaid postcards along with telephone follow up . Results : Falls occurred in 68.3 % of the subjects . Previous falls , disease duration , dementia , and loss of arm swing were independent predictors of falling . There were also significant associations between disease severity , balance impairment , depression , and falling . Conclusions : Falls are a common problem in PD and some of the major risk factors are potentially modifiable . There is a need for future studies to look at interventions to prevent falls in PD In a r and omized , single-blind , crossover study , we evaluated physical disability in moderately advanced Parkinson 's disease ( PD ) patients after 4 weeks of normal physical activity and 4 weeks of an intensive physical rehabilitation program . We used a timed motor task and a st and ard assessment of PD severity ( the Unified Parkinson 's Disease Rating Scale [ UPDRS ] with subscales for mentation , activities of daily living [ ADL ] , and motor function ) completed by an investigator blinded to the physical rehabilitation status of the patient . Following physical rehabilitation , there was significant improvement in the UPDRS ADL and motor scores , but no change in mentation score . During the 6 months following physical rehabilitation , patients did not regularly exercise , and the UPDRS scores returned to baseline . We conclude that physical disability in moderately advanced PD objective ly improves with a regular physical rehabilitation program , but this improvement is not sustained when normal activity is resumed Abstract We studied prospect ively the epidemiology , clinical impact and prediction of falls in 59 moderately affected patients with Parkinson 's disease ( PD ) ( mean UPDRS motor score 31.5 ; mean age 61 years ) and 55 controls ( mean age 60 years ) . At baseline , balance and gait were evaluated extensively . The retropulsion test ( response to sudden shoulder pull ) was executed first unexpectedly and five more times following prior warning . All persons used st and ardised scoring forms to document their falls during six months . Thirty patients ( 50.8 % ) and eight controls ( 14.5 % ) fell at least once ( relative risk [ RR ] 6.1 ; 95 % confidence interval [ CI ] 2.5–15.1 , p < 0.001 ) . Recurrent ( ≥ 2 ) falls occurred in 15 patients ( 25.4 % ) , but in only two controls ( RR 9.0 ; 95 % CI 2.0–41.7 ; p=0.001 ) . Recurrent falls were more common among persons taking benzodiazepines ( RR 5.0 ; 95 % CI 1.6–15.5 ; p < 0.01 ) . Sixty-two percent of the falls in patients caused soft tissue injuries , but no fractures occurred . A fear of future falls was common ( 45.8 % of patients ) and was accompanied by restriction of daily activities ( 44.1 % of patients ) . Seventy percent of falls reported by patients were ‘ intrinsic ’ ( due to patient-related factors ) , but falls in controls were mainly ( 50 % ) ‘ extrinsic ’ ( due to environmental factors ) . None of the baseline posture and gait variables predicted falls adequately . The first ‘ unexpected ’ retropulsion test was more often abnormal than all subsequent ( predictable ) tests . Irrespective of its method of execution , the retropulsion test did not predict falls . A combination of asking for prior falls , disease severity and the Romberg test yielded the best overall diagnostic utility ( sensitivity 65 % and specificity 98 % ) . Recurrent fallers were best predicted by disease severity ( RR for Hoehn and Yahr stage 3 was > 100 ; 95 % CI 3.1–585 ) and asking for prior falls ( RR 5.0 ; 95 % CI 1.2–20.9 ) . We conclude that falls are common and disabling , even in relatively early stage PD . Recurrent fallers were best predicted by disease severity and presence of prior falls . Strategies to prevent falls in PD should particularly focus at intrinsic ( patient-related ) factors , such as minimising the use of benzodiazepines Gibberd and others ( 11 April , p 1196 ) and sympathise over the problems they encountered . In a similar controlled trial ' we
Output:
| The studies illustrate that a wide range of approaches are being employed by physiotherapists to treat Parkinson 's disease .
This was confirmed by the UK survey of physiotherapists . |
MS211310 | ***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: RATIONALE Bronchiectasis is a chronic debilitating disease with few evidence -based long-term treatments . OBJECTIVES A r and omized controlled trial assessing the efficacy of nebulized gentamicin therapy over 1 year in patients with non-cystic fibrosis bronchiectasis . METHODS Sixty-five patients were r and omized to either twice-daily nebulized gentamicin , 80 mg , or nebulized 0.9 % saline , for 12 months . All were review ed at three-monthly intervals during treatment and at 3 months ' follow-up . MEASUREMENTS AND MAIN RESULTS At each review the following were assessed : quantitative and qualitative sputum bacteriology ; sputum purulence and 24-hour volume ; FEV(1 ) , FVC , and forced expiratory flow , midexpiratory phase ; exercise capacity ; Leicester Cough Question naire and St. George 's Respiratory Question naire ; and exacerbation frequency . Fifty-seven patients completed the study . At the end of 12 months ' treatment , compared with the saline group , in the gentamicin group there was reduced sputum bacterial density with 30.8 % eradication in those infected with Pseudomonas aeruginosa and 92.8 % eradication in those infected with other pathogens ; less sputum purulence ( 8.7 % vs. 38.5 % ; P < 0.0001 ) ; greater exercise capacity ( 510 [ 350 - 690 ] m vs. 415 [ 267.5 - 530 ] m ; P = 0.03 ) ; and fewer exacerbations ( 0 [ 0 - 1 ] vs. 1.5 [ 1 - 2 ] ; P < 0.0001 ) with increased time to first exacerbation ( 120 [ 87 - 161.5 ] d vs. 61.5 [ 20.7 - 122.7 ] d ; P = 0.02 ) . The gentamicin group had greater improvements in Leicester Cough Question naire ( 81.4 % vs. 20 % ; P < 0.01 ) and St. George 's Respiratory Question naire ( 87.5 % vs. 19.2 % ; P < 0.004 ) score . No differences were seen in 24-hour sputum volume , FEV(1 ) , FVC , or forced expiratory flow , midexpiratory phase . No P. aeruginosa isolates developed resistance to gentamicin . At follow-up , all outcome measures were similar to baseline . CONCLUSIONS Regular , long-term nebulized gentamicin is of significant benefit in non-cystic fibrosis bronchiectasis but treatment needs to be continuous for its ongoing efficacy . Clinical trial registered with www . clinical trials.gov ( NCT 00749866 ) The primary goals of long-term disease management in non-cystic fibrosis bronchiectasis ( NCFB ) are to reduce the number of exacerbations , and improve quality of life . However , currently no therapies are licensed for this . Ciprofloxacin Dry Powder for Inhalation ( Ciprofloxacin DPI ) has potential to be the first long-term intermittent therapy approved to reduce exacerbations in NCFB patients . The RESPIRE programme consists of two international phase III prospect i ve , parallel-group , r and omized , double-blinded , multicentre , placebo-controlled trials of the same design . Adult patients with idiopathic or post-infectious NCFB , a history of ≥2 exacerbations in the previous 12months , and positive sputum culture for one of seven pre-specified pathogens , undergo stratified r and omization 2:1 to receive twice-daily Ciprofloxacin DPI 32.5 mg or placebo using a pocket-sized inhaler in one of two regimens : 28days on/off treatment or 14days on/off treatment . The treatment period is 48weeks plus an 8-week follow-up after the last dose . The primary efficacy endpoints are time to first exacerbation after treatment initiation and frequency of exacerbations using a stringent definition of exacerbation . Secondary endpoints , including frequency of events using different exacerbation definitions , microbiology , quality of life and lung function will also be evaluated . The RESPIRE trials will determine the efficacy and safety of Ciprofloxacin DPI . The strict entry criteria and stratified r and omization , the inclusion of two treatment regimens and a stringent definition of exacerbation should clarify the patient population best positioned to benefit from long-term inhaled antibiotic therapy . Additionally RESPIRE will increase underst and ing of NCFB treatment and could lead to an important new therapy for sufferers . TRIAL REGISTRATION The RESPIRE trials are registered in Clinical Trials.gov , ID number NCT01764841 ( RESPIRE 1 ; date of registration January 8 , 2013 ) and NCT02106832 ( RESPIRE 2 ; date of registration April 4 , 2014 ) RATIONALE Chronic infection with Pseudomonas aeruginosa is associated with an increased exacerbation frequency , a more rapid decline in lung function , and increased mortality in patients with bronchiectasis . OBJECTIVES To perform a r and omized placebo-controlled study assessing the efficacy and safety of inhaled colistin in patients with bronchiectasis and chronic P. aeruginosa infection . METHODS Patients with bronchiectasis and chronic P. aeruginosa infection were enrolled within 21 days of completing a course of antipseudomonal antibiotics for an exacerbation . Participants were r and omized to receive colistin ( 1 million IU ; n = 73 ) or placebo ( 0.45 % saline ; n = 71 ) via the I-neb twice a day , for up to 6 months . MEASUREMENTS AND MAIN RESULTS The primary endpoint was time to exacerbation . Secondary endpoints included time to exacerbation based on adherence recorded by the I-neb , P. aeruginosa bacterial density , quality of life , and safety parameters . All analyses were on the intention-to-treat population . Median time ( 25 % quartile ) to exacerbation was 165 ( 42 ) versus 111 ( 52 ) days in the colistin and placebo groups , respectively ( P = 0.11 ) . In adherent patients ( adherence quartiles 2 - 4 ) , the median time to exacerbation was 168 ( 65 ) versus 103 ( 37 ) days in the colistin and placebo groups , respectively ( P = 0.038 ) . P. aeruginosa density was reduced after 4 ( P = 0.001 ) and 12 weeks ( P = 0.008 ) and the St. George 's Respiratory Question naire total score was improved after 26 weeks ( P = 0.006 ) in the colistin versus placebo patients , respectively . There were no safety concerns . CONCLUSIONS Although the primary endpoint was not reached , this study shows that inhaled colistin is a safe and effective treatment in adherent patients with bronchiectasis and chronic P. aeruginosa infection . Clinical trial registered with http://www.is rct n.org/ ( IS RCT N49790596 ) Recent demonstrations that long-term macrolide therapy can prevent exacerbations in chronic airways diseases have led to a dramatic increase in their use . However , little is known about the wider , potentially adverse impacts of these treatments . Substantial disruption of the upper airway commensal microbiota might reduce its contribution to host defense and local immune regulation , while increases in macrolide resistance carriage would represent a serious public health concern . Using sample s from a r and omized controlled trial , we show that low-dose erythromycin given over 48 weeks influences the composition of the oropharyngeal commensal microbiota . We report that macrolide therapy is associated with significant changes in the relative abundances of members of the Actinomyces genus and with significant increases in the carriage of transmissible macrolide resistance . Determining the clinical significance of these changes , relative to treatment benefit , now represents a research priority . ABSTRACT Long-term macrolide therapy reduces rates of pulmonary exacerbation in bronchiectasis . However , little is known about the potential for macrolide therapy to alter the composition and function of the oropharyngeal commensal microbiota or to increase the carriage of transmissible antimicrobial resistance . We assessed the effect of long-term erythromycin on oropharyngeal microbiota composition and the carriage of transmissible macrolide resistance genes in 84 adults with bronchiectasis , enrolled in the Bronchiectasis and Low-dose Erythromycin Study ( BLESS ) 48-week placebo-controlled trial of twice-daily erythromycin ethylsuccinate ( 400 mg ) . Oropharyngeal microbiota composition and macrolide resistance gene carriage were determined by 16S rRNA gene amplicon sequencing and quantitative PCR , respectively . Long-term erythromycin treatment was associated with a significant increase in the relative abundance of oropharyngeal Haemophilus parainfluenzae ( P = 0.041 ) and with significant decreases in the relative abundances of Streptococcus pseudopneumoniae ( P = 0.024 ) and Actinomyces odontolyticus ( P = 0.027 ) . Validation of the sequencing results by quantitative PCR confirmed a significant decrease in the abundance of Actinomyces spp . ( P = 0.046 ) . Erythromycin treatment did not result in a significant increase in the number of subjects who carried erm(A ) , erm(B ) , erm(C ) , erm(F ) , mef(A/E ) , and msrA macrolide resistance genes . However , the abundance of erm(B ) and mef(A/E ) gene copies within carriers who had received erythromycin increased significantly ( P < 0.05 ) . Our findings indicate that changes in oropharyngeal microbiota composition result ing from long-term erythromycin treatment are modest and are limited to a discrete group of taxa . Associated increases in levels of transmissible antibiotic resistance genes within the oropharyngeal microbiota highlight the potential for this microbial system to act as a reservoir for resistance . IMPORTANCE Recent demonstrations that long-term macrolide therapy can prevent exacerbations in chronic airways diseases have led to a dramatic increase in their use . However , little is known about the wider , potentially adverse impacts of these treatments . Substantial disruption of the upper airway commensal microbiota might reduce its contribution to host defense and local immune regulation , while increases in macrolide resistance carriage would represent a serious public health concern . Using sample s from a r and omized controlled trial , we show that low-dose erythromycin given over 48 weeks influences the composition of the oropharyngeal commensal microbiota . We report that macrolide therapy is associated with significant changes in the relative abundances of members of the Actinomyces genus and with significant increases in the carriage of transmissible macrolide resistance . Determining the clinical significance of these changes , relative to treatment benefit , now represents a research priority IMPORTANCE Macrolide antibiotics have been shown beneficial in cystic fibrosis ( CF ) and diffuse panbronchiolitis , and earlier findings also suggest a benefit in non-CF bronchiectasis . OBJECTIVE To determine the efficacy of macrolide maintenance treatment for adults with non-CF bronchiectasis . DESIGN , SETTING , AND PARTICIPANTS The BAT ( Bronchiectasis and Long-term Azithromycin Treatment ) study , a r and omized , double-blind , placebo-controlled trial conducted between April 2008 and September 2010 in 14 hospitals in The Netherl and s among 83 out patients with non-CF bronchiectasis and 3 or more lower respiratory tract infections in the preceding year . INTERVENTIONS Azithromycin ( 250 mg daily ) or placebo for 12 months . MAIN OUTCOME MEASURES Number of infectious exacerbations during 12 months of treatment . Secondary end points included lung function , sputum bacteriology , inflammatory markers , adverse effects , symptom scores , and quality of life . RESULTS Forty-three participants ( 52 % ) received azithromycin and 40 ( 48 % ) received placebo and were included in the modified intention-to-treat analysis . At end of study , the median number of exacerbations in the azithromycin group was 0 ( interquartile range [ IQR ] , 0 - 1 ) , compared with 2 ( IQR , 1 - 3 ) in the placebo group ( P < .001 ) . Thirty-two ( 80 % ) placebo-treated vs 20 ( 46 % ) azithromycin-treated individuals had at least 1 exacerbation ( hazard ratio , 0.29 [ 95 % CI , 0.16 - 0.51 ] ) . In a mixed-model analysis , change in forced expiratory volume in the first second of expiration ( percent of predicted ) over time differed between groups ( F1,78.8 = 4.085 , P = .047 ) , with an increase of 1.03 % per 3 months in the azithromycin group and a decrease of 0.10 % per 3 months in the placebo group . Gastrointestinal adverse effects occurred in 40 % of patients in the az
Output:
| No r and omised controlled trials have compared the effectiveness and risks of continuous antibiotic therapy versus intermittent antibiotic therapy for bronchiectasis .
High- quality clinical trials are needed to establish which of these interventions is more effective for reducing the frequency and duration of exacerbations , antibiotic resistance and the occurrence of serious adverse events |
MS211311 | ***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 aim of this study was to investigate if cognitive behavior therapy ( CBT ) based on exposure and mindfulness exercises delivered via the Internet would be effective in treating participants with irritable bowel syndrome ( IBS ) . Participants were recruited through self-referral . Eighty-six participants were included in the study and r and omized to treatment or control condition ( an online discussion forum ) . One participant was excluded after r and omization . The main outcome measure was IBS-symptom severity and secondary measures included IBS-related quality of life , GI-specific anxiety , depression and general functioning . Participants were assessed at pre-treatment , post-treatment and 3 month follow-up ( treatment condition only ) . Four participants ( 5 % of total sample ) in the treatment condition did not participate in post-treatment assessment . Participants in the treatment condition reported a 42 % decrease and participants in the control group reported a 12 % increase in primary IBS-symptoms . Compared to the control condition , participants in the treatment group improved on all secondary outcome measures with a large between group effect size on quality of life ( Cohen 's d = 1.21 ) . We conclude that CBT-based on exposure and mindfulness delivered via the Internet can be effective in treating IBS- patients , alleviating the total burden of symptoms and increasing quality of life Acceptance and commitment therapy ( ACT ) interventions for persons with chronic pain have recently received empirical support . ACT focuses on reducing the disabling influences of pain through targeting ineffective control strategies and teaches people to stay in contact with unpleasant emotions , sensations , and thoughts . The aim of the present study was to investigate the effect of a guided internet-delivered ACT intervention for persons with chronic pain . A total of 76 patients with chronic pain were included in the study and r and omized to either treatment for 7 weeks or to a control group that participated in a moderated online discussion forum . Intent-to-treat analyses showed significant increases regarding activity engagement and pain willingness . Measurements were provided with the primary outcome variable Chronic Pain Acceptance Question naire which was in favour of the treatment group . Reductions were found on other measures of pain-related distress , anxiety and depressive symptoms . A six month follow-up showed maintenance of improvements . We conclude that an acceptance based internet-delivered treatment can be effective for persons with chronic pain Background : Although mindfulness meditation interventions have recently shown benefits for reducing stress in various population s , little is known about their relative efficacy compared with relaxation interventions . Purpose : This r and omized controlled trial examines the effects of a 1-month mindfulness meditation versus somatic relaxation training as compared to a control group in 83 students ( M age=25 ; 16 men and 67 women ) reporting distress . Method : Psychological distress , positive states of mind , distractive and ruminative thoughts and behaviors , and spiritual experience were measured , while controlling for social desirability . Results : Hierarchical linear modeling reveals that both meditation and relaxation groups experienced significant decreases in distress as well as increases in positive mood states over time , compared with the control group ( p<.05 in all cases ) . There were no significant differences between meditation and relaxation on distress and positive mood states over time . Effect sizes for distress were large for both meditation and relaxation ( Cohen ’s d=1.36 and .91 , respectively ) , whereas the meditation group showed a larger effect size for positive states of mind than relaxation ( Cohen ’s d=.71 and .25 , respectively ) . The meditation group also demonstrated significant pre-post decreases in both distractive and ruminative thoughts/behaviors compared with the control group ( p<.04 in all cases ; Cohen ’s d=.57 for rumination and .25 for distraction for the meditation group ) , with mediation models suggesting that mindfulness meditation ’s effects on reducing distress were partially mediated by reducing rumination . No significant effects were found for spiritual experience . Conclusions : The data suggest that compared with a no-treatment control , brief training in mindfulness meditation or somatic relaxation reduces distress and improves positive mood states . However , mindfulness meditation may be specific in its ability to reduce distractive and ruminative thoughts and behaviors , and this ability may provide a unique mechanism by which mindfulness meditation reduces distress Background Internet-based cognitive behavior therapy ( ICBT ) has shown promising effects in the treatment of irritable bowel syndrome ( IBS ) . However , to date no study has used a design where participants have been sample d solely from a clinical population . We aim ed to investigate the acceptability , effectiveness , and cost-effectiveness of ICBT for IBS using a consecutively recruited sample from a gastroenterological clinic . Methods Sixty-one patients were r and omized to 10 weeks of ICBT ( n = 30 ) or a waiting list control ( n = 31 ) . The ICBT was guided by an online therapist and emphasized acceptance of symptoms through exposure and mindfulness training . Severity of IBS symptoms was measured with the Gastrointestinal symptom rating scale - IBS version ( GSRS-IBS ) . Patients in both groups were assessed at pre- and post-treatment while only the ICBT group was assessed 12 months after treatment completion . Health economic data were also gathered at all assessment points and analyzed using bootstrap sampling . Results Fifty of 61 patients ( 82 % ) completed the post-treatment assessment and 20 of 30 patients ( 67 % ) in the ICBT group were assessed at 12-month follow-up . The ICBT group demonstrated significantly ( p < .001 ) larger improvements on the IBS-related outcome scales than the waiting list group . The between group effect size on GSRS-IBS was Cohen 's d = 0.77 ( 95 % CI : 0.19 - 1.34 ) . Similar effects were noted on measures of quality of life and IBS-related fear and avoidance behaviors . Improvements in the ICBT group were maintained at 12-month follow-up . The ICBT condition was found to be more cost-effective than the waiting list , with an 87 % chance of leading to reduced societal costs combined with clinical effectiveness . The cost-effectiveness was sustained over the 12-month period . Conclusions ICBT proved to be a cost-effective treatment when delivered to a sample recruited from a gastroenterological clinic . However , many of the included patients dropped out of the study and the overall treatment effects were smaller than previous studies with referred and self-referred sample s. ICBT may therefore be acceptable and effective for only a subset of clinical patients . Study dropout seemed to be associated with severe symptoms and large impairment . Objective and empirically vali date d criteria to select which patients to offer ICBT should be developed . Trial Registration Clinical Trials.gov : Decentering has been proposed as a potential mechanism of mindfulness-based interventions but has received limited empirical examination to date in experimental studies comparing mindfulness meditation to active comparison conditions . In the present study , we compared the immediate effects of mindful breathing ( MB ) to two alternative stress-management techniques : progressive muscle relaxation ( PMR ) and loving-kindness meditation ( LKM ) to test whether decentering is unique to mindfulness meditation or common across approaches . Novice meditators ( 190 female undergraduates ) were r and omly assigned to complete one of three 15-min stress-management exercises ( MB , PMR , or LKM ) presented by audio recording . Immediately after the exercise , participants completed measures of decentering , frequency of repetitive thoughts during the exercise , and degree of negative reaction to thoughts . As predicted , participants in the MB condition reported greater decentering relative to the other two conditions . The association between frequency of repetitive thought and negative reactions to thoughts was relatively weaker in the MB condition than in the PMR and LKM conditions , in which these two variables were strongly and positively correlated . Consistent with the construct of decentering , the relative independence between these two variables in the MB condition suggests that mindful breathing may help to reduce reactivity to repetitive thoughts . Taken together , results help to provide further evidence of decentering as a potential mechanism that distinguishes mindfulness practice from other credible stress-management approaches Background Irritable Bowel Syndrome ( IBS ) is highly prevalent and is associated with a substantial economic burden . Cognitive behavior therapy ( CBT ) has been shown to be effective in treating IBS . The aim of this study was to evaluate the cost-effectiveness of a new treatment alternative , internet-delivered CBT based on exposure and mindfulness exercises . Methods Participants ( N = 85 ) with IBS were recruited through self-referral and were assessed via a telephone interview and self-report measures on the internet . Participants were r and omized to internet-delivered CBT or to a discussion forum . Economic data was assessed at pre- , post- and at 3-month and 1 year follow-up . Results Significant cost reductions were found for the treatment group at $ 16,806 per successfully treated case . The cost reductions were mainly driven by reduced work loss in the treatment group . Results were sustained at 3-month and 1 year follow-up . Conclusions Internet-delivered CBT appears to generate health gains in IBS treatment and is associated with cost-savings from a societal perspective Behavioral training ( BT ) is recommended as a supplementary preventive treatment for migraine . Online interventions have been successful in promoting health behavior change , the evidence for online BT in migraine is limited , however . This r and omized controlled trial aim ed to determine the post-treatment effectiveness of online BT ( n = 195 ) compared to a waitlist control group ( WLC ; n = 173 ) on migraine attack frequency ( primary outcome ) , headache self-efficacy and locus of control ( secondary outcomes ) . BT aims to counteract attacks in the prodromal stage through early detection of prodromal features and self-management via physical relaxation and cognitive behavioral regulation , and was offered with minimal e-mail support in eight online lessons . Results showed that 120 ( 62 % ) participants completed BT . A decrease of 20 - 25 % in migraine attack frequency was found in both conditions without a between-group difference ( ES = 0.02 , p = .71 ) . BT participants improved more than WLC participants on migraine related self-efficacy ( ES = 0.86 , p < .001 ) , developed more internal ( ES = 0.57 , p < .001 ) , and less external control ( ES = 0.78 , p < .001 ) . To conclude , results at post-training did not corroborate that improvements in migraine attack frequency were due to online BT , the waitlist control group improved accordingly . However , positive effects of BT on self-efficacy and locus of control were established . We have to await the long term effects to see if improvements in psychological variables translate to a reduction in migraine headache Mindfulness-based Cognitive Therapy ( MBCT ) has been shown to effectively prevent relapse and reduce residual depressive symptoms ( RDS ) , yet it faces barriers to dissemination . The present study examined Mindful Mood Balance ( MMB ) , the first web-based approach to deliver the core content of MBCT . Of the 107 recurrently depressed individuals screened , 100 elected to enroll in the study and received MMB in an 8-session open trial with 6-month follow-up . Outcomes included depressive symptom severity , rumination and mindful awareness , and program engagement . A quasi-experimental comparison between MMB participants and propensity matched case-controls receiving usual depression care ( UDC ) ( N = 100 ) also was conducted . The full sample and the subgroup with residual depressive symptoms ( N = 42 ) showed significantly reduced depressive severity , which was sustained over six months , and improvement on rumination and mindfulness . Examination of acceptability of MMB indicated that 42 % of participants within the full sample and 36 % of the RDS subgroup completed all 8 sessions and 53 % within the full sample and 50 % within the RDS subgroup completed at least 4 sessions , and that participants engaged with daily mindfulness practice . MMB also was associated with significant reduction in RDS severity as compared to quasi-experimental propensity matched controls . Although the use of a non-r and omized design , with potential unmeasured differences between groups , and short interval of clinical follow-up were limitations , findings from this study support the web-based delivery of MBCT and suggest clinical benefits for participants with histories of depression and with RDS , relative to those receiving usual care alone BACKGROUND AND AIMS In the past decade , a large body of research has demonstrated that internet-based interventions can have beneficial effects on depression . However , only a few clinical trials have compared internet-based depression therapy with an equivalent face-to-face treatment . The primary aim of this study was to compare treatment outcomes of an internet-based intervention with a face-to-face intervention for depression in a r and omized non-inferiority trial . METHOD A total of 62 participants suffering from depression were r and omly assigned to the therapist-supported internet-based intervention group ( n=32 ) and to the face-to-face intervention ( n=30 ) . The 8 week interventions were based on cognitive-behavioral therapy principles . Patients in both groups received the same treatment modules in the same chronological order and time-frame . Primary outcome measure was the Beck Depression Inventory-II ( BDI-II ) ; secondary outcome variables were suicidal ideation , anxiety , hopelessness and automatic thoughts . RESULTS The intention-to-treat analysis yielded no significant between-group difference ( online vs. face-to-face group ) for any of the pre- to post-treatment measurements . At post-treatment both treatment conditions revealed significant symptom changes compared to before the intervention . Within group effect sizes for depression in the online group ( d=1.27 ) and the face-to-face group ( d=1.37 ) can be considered large . At 3-month follow-up , results in the online group remained stable . In contrast to this , participants in the face-to-face group showed significantly worsened depressive symptoms three months after termination of treatment (
Output:
| The studies indicate that mindfulness- and relaxation-based eHealth interventions can have positive effects on patients ’ general health and psychological well-being .
No effects were found for stress or mindfulness .
Conclusion There is some evidence that mindfulness- and relaxation-based eHealth interventions for medical conditions can have positive effects on health outcomes .
Therefore , such interventions might be a useful addition to st and ard medical care . |
MS211312 | ***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 Dietary supplementation with polyphenols , particularly ellagitannins , may attenuate the muscular damage experienced after eccentric exercise , producing delayed-onset muscle soreness . The purpose of this study was to determine whether ellagitannin supplementation from Wonderful variety pomegranate extract ( POMx ) improved recovery of skeletal muscle strength after eccentric exercise . METHODS Recreationally active males were r and omized into a crossover design with either pomegranate extract ( POMx ) or placebo ( PLA ) , each given during a period of 9 d . To produce delayed-onset muscle soreness , subjects performed two sets of 20 maximal eccentric elbow flexion exercises with one arm . Maximal isometric elbow flexion strength and muscle soreness as well as serum measures of creatine kinase , myoglobin , interleukin 6 , and C-reactive protein were made at baseline and 2 , 24 , 48 , 72 , and 96 h after exercise . RESULTS With both treatments , strength was similarly reduced 2 h after exercise ( i.e. , 72 % of baseline ) , and recovery of strength was incomplete after 96 h ( i.e. , 91 % of baseline).However , strength was significantly higher in POMx compared with that in PLA at 48 h ( 85.4 % + /- 2.5 % and 78.3 % + /- 2.6 % , P = 0.01 ) and 72 h ( 88.9 % + /- 2.0 % and 84.0 % + /- 2.0 % , P = 0.009 ) after exercise . Serum markers of inflammation and muscle damage did not provide insight regarding possible mechanisms . CONCLUSIONS Supplementation with ellagitannins from pomegranate extract significantly improves recovery of isometric strength 2 - 3 d after a damaging eccentric exercise The aims of the present study were to : ( 1 ) investigate the effect of a weightlifting training session and time-of-day ( TOD ) upon biological parameters ( i.e. , oral temperature , hematological , C-reactive protein ( CRP ) , and oxidative stress ) and ( 2 ) assess their possible link with muscle damage responses . Nine weightlifters ( 21 ± 0.5 years ) performed , in a r and omized order , three Olympic-Weightlifting sessions ( i.e. , at 08:00 , 14:00 , and 18:00 ) . Blood sample s were collected at rest , 3 min and 48 h after each training session . Between pre- and post-training session , ANOVA showed significant increases in oxidative stress markers at the three TODs ( p < 0.01 ) and significant increases for creatine kinase ( CK ) and lactate dehydrogenase ( LDH ) only at 08:00 and 18:00 ( p < 0.05 ) . At rest , the results showed a significant diurnal variation for the majority of the selected parameters except for malondialdehyde ( MDA ) , total bilirubin , and CRP with higher values observed at 18:00 ( p < 0.05 ) . After the training session , given the higher rate of increase during the morning session , these diurnal variations persisted for temperature and WBC ( p < 0.01 ) and were suppressed for CK , LDH , uric acid ( UA ) , catalase , and glutathione peroxidase . The main significant correlations ( p < 0.001 ) were observed between : ( 1 ) CK and MDA ( r = 0.6 ) and CK and UA ( r = 0.66 and r = 0.82 ) during the morning and evening training sessions ; ( 2 ) CK and CRP only during the morning session ( r = 0.5 ) ; and ( 3 ) CRP and WBC during the three training sessions ( r = 0.8 ) . In conclusion , the present findings : ( 1 ) confirm that the muscle damage responses could be induced by a high level of oxidative stress and ( 2 ) suggest to avoid scheduling training sessions in the morning given the higher muscle damage , inflammatory , and oxidative responses at this TOD Recent research has shown that dietary nitrate has favorable effects on blood flow and exercise performance . The purpose of this r and omized , double-blind , placebo-controlled crossover study was to investigate the acute effects of pomegranate extract on blood flow , vessel diameter , and exercise performance in active individuals . Nineteen men and women ( mean ± SD : age , 22.2 ± 2.2 years ; height , 174.8 ± 10.7 cm ; body mass , 71.9 ± 13.5 kg ) were r and omly assigned to a placebo ( PL ) or pomegranate extract ( PE ) group . Participants performed a maximal oxygen consumption treadmill test to determine peak velocity ( PV ) . Participants returned after 24 - 48 h and ingested either PL or PE . Brachial artery blood flow was assessed using ultrasound at baseline and 30 min post-ingestion ( 30minPI ) . Three treadmill runs to exhaustion were performed at 90 % , 100 % , and 110 % PV . Blood flow was assessed immediately after each exercise bout and 30 min postexercise ( 30minPEx ) . After a 7 - 10 day washout , participants repeated the same procedures , ingesting the opposite supplement . Separate repeated measures ANOVAs were performed for blood flow , vessel diameter , and time to exhaustion ( TTE ) . Blood flow was significantly augmented ( p = 0.033 ) 30minPI with PE in comparison with PL . Vessel diameter was significantly larger ( p = 0.036 ) 30minPEx with PE . Ingestion of PE was found to significantly augment TTE at 90 % ( p = 0.009 ) and 100 % PV ( p = 0.027 ) . Acute ingestion of PE 30 min before exercise may enhance vessel diameter and blood flow and delay fatigue during exercise . Results of the current study indicate that PE is ergogenic for intermittent running , eliciting beneficial effects on blood flow Ageing is thought to be associated with decreased vascular function partly due to oxidative stress . Resveratrol is a polyphenol , which in animal studies has been shown to decrease atherosclerosis , and improve cardiovascular health and physical capacity , in part through its effects on Sirtuin 1 signalling and through an improved antioxidant capacity . We tested the hypothesis that resveratrol supplementation enhances training-induced improvements in cardiovascular health parameters in aged men . Twenty-seven healthy physically inactive aged men ( age : 65 ± 1 years ; body mass index : 25.4 ± 0.7 kg m(-2 ) ; mean arterial pressure ( MAP ) : 95.8 ± 2.2 mmHg ; maximal oxygen uptake : 2488 ± 72 ml O2 min(-1 ) ) were r and omized into 8 weeks of either daily intake of either 250 mg trans-resveratrol ( n = 14 ) or of placebo ( n = 13 ) concomitant with high-intensity exercise training . Exercise training led to a 45 % greater ( P < 0.05 ) increase in maximal oxygen uptake in the placebo group than in the resveratrol group and to a decrease in MAP in the placebo group only ( -4.8 ± 1.7 mmHg ; P < 0.05 ) . The interstitial level of vasodilator prostacyclin was lower in the resveratrol than in the placebo group after training ( 980 ± 90 vs. 1174 ± 121 pg ml(-1 ) ; P < 0.02 ) and muscle thromboxane synthase was higher in the resveratrol group after training ( P < 0.05 ) . Resveratrol administration also abolished the positive effects of exercise on low-density lipoprotein , total cholesterol/high-density lipoprotein ratio and triglyceride concentrations in blood ( P < 0.05 ) . Resveratrol did not alter the effect of exercise training on the atherosclerosis marker vascular cell adhesion molecule 1 ( VCAM-1 ) . Sirtuin 1 protein levels were not affected by resveratrol supplementation . These findings indicate that , whereas exercise training effectively improves several cardiovascular health parameters in aged men , concomitant resveratrol supplementation can blunt these effects Eccentrically biased exercise results in skeletal muscle damage and stimulates adaptations in muscle , whereby indexes of damage are attenuated when the exercise is repeated . We hypothesized that changes in ultrastructural damage , inflammatory cell infiltration , and markers of proteolysis in skeletal muscle would come about as a result of repeated eccentric exercise and that gender may affect this adaptive response . Untrained male ( n = 8) and female ( n = 8) subjects performed two bouts ( bout 1 and bout 2 ) , separated by 5.5 wk , of 36 repetitions of unilateral , eccentric leg press and 100 repetitions of unilateral , eccentric knee extension exercises ( at 120 % of their concentric single repetition maximum ) , the subjects ' contralateral nonexercised leg served as a control ( rest ) . Biopsies were taken from the vastus lateralis from each leg 24 h postexercise . After bout 2 , the postexercise force deficit and the rise in serum creatine kinase ( CK ) activity were attenuated . Women had lower serum CK activity compared with men at all times ( P < 0.05 ) , but there were no gender differences in the relative magnitude of the force deficit . Muscle Z-disk streaming , quantified by using light microscopy , was elevated vs. rest only after bout 1 ( P < 0.05 ) , with no gender difference . Muscle neutrophil counts were significantly greater in women 24 h after bout 2 vs. rest and bout 1 ( P < 0.05 ) but were unchanged in men . Muscle macrophages were elevated in men and women after bout 1 and bout 2 ( P < 0.05 ) . Muscle protein content of the regulatory calpain subunit remained unchanged whereas ubiquitin-conjugated protein content was increased after both bouts ( P < 0.05 ) , with a greater increase after bout 2 . We conclude that adaptations to eccentric exercise are associated with attenuated serum CK activity and , potentially , an increase in the activity of the ubiquitin proteosome proteolytic pathway PURPOSE Vitamin E supplementation may confer a protective effect against eccentrically biased exercise-induced muscle damage through stabilization of the cell membrane and possibly via inhibition of free radical formation . Evidence supporting a protective role of vitamin E after contraction-induced muscle injury in humans is , however , inconsistent . The present study sought to determine the effect of vitamin E supplementation on indices of exercise-induced muscle damage and the postexercise inflammatory response after performance of repeated eccentric muscle contractions . METHODS Young healthy men performed a bout of 240 maximal isokinetic eccentric muscle contractions ( 0.52 rad.s-1 ) after being supplemented for 30 d with either vitamin E ( N = 9 ; 1200 IU.d-1 ) or placebo ( N = 7 ; safflower oil ) . RESULTS Measurements of torque ( isometric and concentric ) decreased ( P < 0.05 ) below preexercise values immediately post- and at 48 h post-exercise . Biopsies taken 24 h postexercise showed a significant increase in the amount of extensive Z-b and disruption ( P < 0.01 ) ; however , neither the torque deficit nor the extent of Z-b and disruption were affected by vitamin E. Exercise result ed in increased macrophage cell infiltration ( P = 0.05 ) into muscle , which was also unaffected by vitamin E. Serum CK also increased as a result of the exercise ( P < 0.05 ) with no effect of vitamin E. CONCLUSION We conclude that vitamin E supplementation ( 30 d at 1200 IU.d-1 ) , which result ed in a 2.8-fold higher serum vitamin E concentration ( P < 0.01 ) , had no affect on indices of contraction-induced muscle damage nor inflammation ( macrophage infiltration ) as a result of eccentrically biased muscle contractions PURPOSE This study investigated the effects of a dietary supplement on exercise-induced markers of cell damage and the inflammatory mediators C-reactive protein ( CRP ) and interleukin-6 ( IL-6 ) . METHODS The supplement contained mixed tocopherols , flavonoids , and docosahexaenoate . Forty healthy , nonsmoking , untrained males ( aged 18 - 35 yr ) were r and omly assigned to receive either the supplement ( N = 20 ) or placebo ( N = 20 ) during the 14-d experimental protocol . Blood sample s were collected on day 0 ( baseline ) , day 7 ( eccentric exercise-induced injury ) , day 10 , and day 14 . OBJECTIVE Markers of cell damage ( creatine kinase ( CK ) and lactate dehydrogenase ( LDH ) ) and inflammation IL-6 and CRP were assessed at these time points in conjunction with subjective range of motion ( ROM ) and perceived pain measurements . Statistical analyses were conducted using nonparametric methods ( P < 0.05 ) . RESULTS Eccentric arm curl exercise was used to induce an acute phase injury response as evidence d by significant ( P < 0.
Output:
| However , the beneficial effects of POM supplementation appeared to be less likely when ( i ) unilateral eccentric exercise was employed , ( ii ) the POM administered was not rich in polyphenols ( < 1·69 g/l ) and ( iii ) insufficient time was provided between POM-ingestion and the assessment of physiological responses/performance ( ≤1 h ) .
The review indicates that POM has the potential to enhance exercise performance and to expedite recovery from intensive exercise .
The findings and recommendations from this review may help to optimise POM-supplementation practice in athletes and coaches to potentially improve exercise-performance and post-exercise recovery |
MS211313 | ***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: Nopal is a plant used in traditional Mexican medicine to treat diabetes . However , there is insufficient scientific evidence to demonstrate whether nopal can regulate postpr and ial glucose . The purpose for conducting this study was to evaluate the glycemic index , insulinemic index , glucose-dependent insulinotropic peptide ( GIP ) index , and the glucagon-like peptide 1 ( GLP-1 ) index , and the effect of nopal on patients with type 2 diabetes after consumption of a high-carbohydrate breakfast ( HCB ) or high-soy-protein breakfast ( HSPB ) on the postpr and ial response of glucose , insulin , GIP , GLP-1 , and antioxidant activity . In study 1 , the glycemic index , insulinemic index , GIP index , and GLP-1 index were calculated for seven healthy participants who consumed 50 g of available carbohydrates from glucose or dehydrated nopal . In study 2 , 14 patients with type 2 diabetes consumed nopal in HCB or HSPB with or without 300 g steamed nopal . The glycemic index of nopal was 32.5±4 , insulinemic index was 36.1±6 , GIP index was 6.5±3.0 , and GLP-1 index was 25.9±18 . For those patients with type 2 diabetes who consumed the HCB+nopal , there was significantly lower area under the curve for glucose ( 287±30 ) than for those who consumed the HCB only ( 443±49 ) , and lower incremental area under the curve for insulin ( 5,952±833 vs 7,313±1,090 ) , and those patients with type 2 diabetes who consumed the HSPB avoided postpr and ial blood glucose peaks . Consumption of the HSPB+nopal significantly reduced the postpr and ial peaks of GIP concentration at 30 and 45 minutes and increased the antioxidant activity after 2 hours measured by the 2,2-diphenyl-1-picrilhidracyl method . These findings suggest that nopal could reduce postpr and ial blood glucose , serum insulin , and plasma GIP peaks , as well as increase antioxidant activity in healthy people and patients with type 2 diabetes AIM OF THE STUDY The aim of this study was to evaluate the acute and chronic effects of OpunDia ( Opuntia ficus-indica ) in obese pre-diabetic men and women . MATERIAL S AND METHODS This double-blind placebo controlled study included participants ( age range of 20 - 50 years ) r and omly assigned to one of the two groups and given a 16-week supply of either the 200 mg OpunDia ( n=15 ) , or placebo ( n=14 ) . The acute phase of the study consisted of an oral glucose tolerance test ( OGTT ) with a 400 mg bolus of OpunDia given 30 min before orally ingesting a 75 g glucose drink . Baseline and post 16-week concentrations of glucose , insulin , hsCRP , adiponectin , proinsulin , Hb1Ac , cholesterol , and a comprehensive metabolic panel were collected along with body composition measured via densitometry ( BOD POD ) . A repeated measures ANOVA was conducted to determine any significant interactions between group and time . Follow-up analysis was performed to determine differences among groups at each time point . Paired t-tests were performed on all variables to determine if any within group differences existed across time . RESULTS There was a statistically significant decrease ( P<0.05 ) in the blood glucose concentrations at the 60 ( 205.92+/-36.90 and 188.84+/-38.43 mg/dL , respectively ) , 90 ( 184.55+/-33.67 and 169.74+/-35.16 mg/dL , respectively ) and 120 min ( 159.24+/-17.85 and 148.89+/-24.86 mg/dL , respectively ) time points with the pre-OGTT compared to the OpunDia bolus trial . There were no between-group differences found with the OGTT time points , area under the curve , blood chemistry variables ( insulin , hsCRP , adiponectin , proinsulin , Hb1Ac ) , diet analysis variables ( carbohydrates , fat , protein and total kcals ) , body composition variables ( fat mass , fat free mass , percent body fat and total body weight ) , or blood chemistry safety parameters ( comprehensive metabolic panel ) pre-to-post 16-week intervention . CONCLUSIONS This study shows the acute blood glucose lowering effects and the long-term safety of the proprietary product OpunDia , thus supporting the traditional use of Opuntia ficus-indica for blood glucose management BACKGROUND The severity of the alcohol hangover may be related to inflammation induced by impurities in the alcohol beverage and byproducts of alcohol metabolism . An extract of the Opuntia ficus indica ( OFI ) plant diminishes the inflammatory response to stressful stimuli . METHODS In this double-blind , placebo-controlled , crossover trial , 64 healthy , young adult volunteers were r and omly assigned to receive OFI ( 1600 IU ) and identical placebo , given 5 hours before alcohol consumption . During 4 hours , subjects consumed up to 1.75 g of alcohol per kilogram of body weight . Hangover severity ( 9 symptoms ) and overall well-being were assessed on a scale ( 0 - 6 ) , and blood and urine sample s were obtained the following morning . Two weeks later , the study protocol was repeated with OFI and placebo reversed . RESULTS Fifty-five subjects completed both the OFI and placebo arms of the study . Three of the 9 symptoms-nausea , dry mouth , and anorexia-were significantly reduced by OFI ( all P<.05 ) . Overall , the symptom index was reduced by 2.7 points on average ( 95 % confidence interval , -0.2 to 5.5 ; P = .07 ) , and the risk of a severe hangover ( > /=18 points ) was reduced by half ( odds ratio , 0.38 ; 95 % confidence interval , 0.16 - 0.88 ; P = .02 ) . C-reactive protein levels were strongly associated with hangover severity ; the mean symptom index was 4.1 ( 95 % confidence interval , 1.2 - 7.1 ; P = .007 ) higher in subjects with morning C-reactive protein levels greater than 1.0 mg/L. In addition , C-reactive protein levels were 40 % higher after subjects consumed placebo compared with OFI . CONCLUSIONS The symptoms of the alcohol hangover are largely due to the activation of inflammation . An extract of the OFI plant has a moderate effect on reducing hangover symptoms , apparently by inhibiting the production of inflammatory mediators Background Oral intake of a specific extract of Opuntia ficus-indica cladode and fruit skin ( OpunDia ™ ) ( OFI ) has been shown to increase serum insulin concentration while reducing blood glucose level for a given amount of glucose ingestion after an endurance exercise bout in healthy young volunteers . However , it is unknown whether OFI-induced insulin stimulation after exercise is of the same magnitude than the stimulation by other insulinogenic agents like leucine as well as whether OFI can interact with those agents . Therefore , the aims of the present study were : 1 ) to compare the degree of insulin stimulation by OFI with the effect of leucine administration ; 2 ) to determine whether OFI and leucine have an additive action on insulin stimulation post-exercise . Methods Eleven subjects participated in a r and omized double-blind cross-over study involving four experimental sessions . In each session the subjects successively underwent a 2-h oral glucose tolerance test ( OGTT ) after a 30-min cycling bout at ~70 % VO2max . At t0 and t60 during the OGTT , subjects ingested 75 g glucose and capsules containing either 1 ) a placebo ; 2 ) 1000 mg OFI ; 3 ) 3 g leucine ; 4 ) 1000 mg OFI + 3 g leucine . Blood sample s were collected before and at 30-min intervals during the OGTT for determination of blood glucose and serum insulin . Results Whereas no effect of leucine was measured , OFI reduced blood glucose at t90 by ~7 % and the area under the glucose curve by ~15 % and increased serum insulin concentration at t90 by ~35 % compared to placebo ( P<0.05 ) . From t60 to the end of the OGTT , serum insulin concentration was higher in OFI+leucine than in placebo which result ed in a higher area under the insulin curve ( + 40 % , P<0.05 ) . Conclusion Carbohydrate-induced insulin stimulation post-exercise can be further increased by the combination of OFI with leucine . OFI and leucine could be interesting ingredients to include together in recovery drinks to resynthesize muscle glycogen faster post-exercise . Still , it needs to be confirmed that such nutritional strategy effectively stimulates post-exercise muscle glycogen re synthesis The effect of a high insoluble-fiber ( IF ) diet containing 15 % cellulose in dry matter , high soluble-fiber ( SF ) diet containing 15 % pectin in dry matter , and low-fiber ( LF ) diet on glycemic control in 6 dogs with alloxan-induced insulin-dependent diabetes mellitus was evaluated . Each diet contained greater than 50 % digestible carbohydrate in dry matter . A crossover study was used with each dog r and omly assigned to a predetermined diet sequence . Each dog was fed each diet for 56 days . Caloric intake was adjusted weekly as needed to maintain each dog within 1.5 kg of its body weight measured prior to induction of diabetes mellitus . All dogs were given pork lente insulin and half of their daily caloric intake at 12-hour intervals . Mean ( + /- SEM ) daily caloric intake was significantly ( P less than 0.05 ) less when dogs consumed the IF diet vs the SF and LF diets ( 66 + /- 3 kcal/kg , 81 + /- 5 kcal/kg , and 79 + /- 4 kcal/kg , respectively ) . Serum alkaline phosphatase activity was significantly ( P less than 0.05 ) higher when dogs consumed the LF diet vs the IF and SF diets ( 182 + /- 37 IU/L , 131 + /- 24 IU/L , and 143 + /- 24 IU/L , respectively ) . Mean postpr and ial plasma glucose concentration measured every 2 hours for 24 hours , beginning at the time of the morning insulin injection , was significantly ( P less than 0.05 ) lower at most blood sampling times in dogs fed IF and SF diets , compared with dogs fed the LF diet . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND The effect of increasing the intake of dietary fiber on glycemic control in patients with type 2 diabetes mellitus is controversial . METHODS In a r and omized , crossover study , we assigned 13 patients with type 2 diabetes mellitus to follow two diets , each for six weeks : a diet containing moderate amounts of fiber ( total , 24 g ; 8 g of soluble fiber and 16 g of insoluble fiber ) , as recommended by the American Diabetes Association ( ADA ) , and a high-fiber diet ( total , 50 g ; 25 g of soluble fiber and 25 g of insoluble fiber ) , containing foods not fortified with fiber ( unfortified foods ) . Both diets , prepared in a research kitchen , had the same macronutrient and energy content . We compared the effects of the two diets on glycemic control and plasma lipid concentrations . RESULTS Compliance with the diets was excellent . During the sixth week , the high-fiber diet , as compared with the the sixth week of the ADA diet , mean daily prepr and ial plasma glucose concentrations were 13 mg per deciliter [ 0.7 mmol per liter ] lower ( 95 percent confidence interval , 1 to 24 mg per deciliter [ 0.1 to 1.3 mmol per liter ] ; P=0.04 ) and mean median difference , daily urinary glucose excretion 1.3 g ( 0.23 ; 95 percent confidence interval , 0.03 to 1.83 g ; P= 0.008 ) . The high-fiber diet also lowered the area under the curve for 24-hour plasma glucose and insulin concentrations , which were measured every two hours , by 10 percent ( P=0.02 ) and 12 percent ( P=0.05 ) , respectively . The high-fiber diet reduced plasma total cholesterol concentrations by 6.7 percent ( P=0.02 ) , triglyceride concentrations by 10.2 percent ( P=0.02 ) , and very-low-density lipoprotein cholesterol concentrations by 12.5 percent ( P=0.01 ) . CONCLUSIONS A
Output:
| Following the PRISMA 2009 guidelines , six electronic data bases ( Food Science and Technology Abstract s ( EBSCO ) , Medline , Scopus , CINAHL , Web of Science and Cochrane ) were search ed for articles investigating the effect of Opuntia spp .
The findings of this review indicate variations in effects between cacti components and products .
Cladode and select Opuntia spp .
products predominately demonstrated significant reductions in serum glucose and insulin , indicating potential as a functional food c and i date .
Prickly Pear fruit was predominately reported to have no significant effects on glucose or insulin .
The quality of evidence appeared to vary based on the type of Opuntia spp .
Studies that used specifically the fruit or cladode had high risk of bias , whereas studies which used combined Opuntia spp .
products had a lower risk of bias .
Conclusion : Currently , there is a lack of evidence to support the recommendation of using Opuntia spp .
fruit products as an alternative or complementary therapy in the reduction of risk or management of Type 2 Diabetes Mellitus . |
MS211314 | ***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 Our purpose was to determine whether intracervical placement of laminaria stalks would improve the effectiveness of inducing termination of pregnancies in the second trimester by intra-amniotic injection of prostagl and in F(2)alpha . STUDY DESIGN This is a prospect i ve r and omized clinical trial conducted at Gynecology Department , Lis Maternity Hospital . Fifty women admitted for indicated second trimester pregnancy termination were r and omly assigned to receive either intracervical placement of laminaria ( n = 25 ) or not ( n = 25 ) , with concurrent use of intra-amniotic injection of prostagl and in F(2)alpha and concentrated oxytocin . The outcome measures were : time from induction to delivery and the side effects and complications of treatment . RESULTS There was no significant difference in the mean interval from induction to delivery in the laminaria and no laminaria groups , being 20 + /- 1.3 ( 8 - 30 ) h versus 19 + /- 1.0 ( 8 - 26 ) h , respectively . In addition , this interval was not different in subgroups of primiparas or multiparas . Other outcome measures such as retained placenta ( 4 % in both groups ) , post-partum hemorrhage ( 4 % in both groups ) gastro-intestinal side effects , fever , and use of analgesia were not significantly different between both groups . CONCLUSION We found no additional value in placing laminaria stalks when using intra-amniotic injection of prostagl and in F(2)alpha followed by concentrated oxytocin infusion for second trimester termination of pregnancy OBJECTIVE To compare the efficacy of surgical evacuation of the uterus with medical evacuation using misoprostol in cases of spontaneous abortion . DESIGN A prospect i ve , r and omized , controlled trial . SETTING A university teaching hospital . PATIENT(S ) Six hundred thirty-five women who aborted spontaneously and who consented to pretreatment r and omization . INTERVENTION(S ) Routine surgical evacuation or medical evacuation of the uterus using misoprostol . MAIN OUTCOME MEASURE(S ) Immediate , short-term ( 2 - 3 weeks ) , and medium-term ( 6 months ) medical complications . RESULT ( S ) There was a significantly lower incidence of immediate and short-term complications in the group treated with misoprostol compared with the surgically treated group . There were also fewer major complications in the 6 months after treatment in the medically treated group . Approximately 50 % of the medically treated group subsequently required surgical evacuation , and these subjects required significantly more analgesia . CONCLUSION ( S ) Treatment with misoprostol can reduce the dem and for surgical evacuation in cases of spontaneous abortion , and its use is associated with fewer medical complications Objective The aim of this r and omized prospect i ve study was to compare efficacy and side effects of saline moistened misoprostol with dry misoprostol , administered 800 μg intravaginally every 6 h up to a maximum of 3 doses in 24 h for second trimester pregnancy termination . Material s and methods A total of 81 women seeking termination of second trimester pregnancy ( 55 fetal death , 17 fetal structural anomaly , 5 chromosomal abnormality , 4 other reasons ) were r and omly assigned to one of two treatment groups : ( 1 ) intravaginal non-moistened ( dry ) misoprostol in group A ( n = 40 ) or ( 2 ) misoprostol moistened with 3 ml of saline in group B ( n = 41 ) . Results All of the patients in either group aborted within 48 h ( 100 % success rate ) . Delivery was achieved in a median ( interquartile range ) of 13 ( 40 ) h with the group A protocol and 12 ( 36 ) h with the group B protocol ( P = 0.652 ) . Delivery with first dose , delivery within 12 h and delivery within 24 h were similar ( P > 0.05 ) in group B ( 34.1 , 87.5 and 60 % , respectively ) and group A ( 25 , 82.9 , 46.3 , respectively ) . Both treatment regimens were tolerable and with similar side effects . Conclusion Misoprostol moistened with saline was not more effective than dry misoprostol for second trimester pregnancy termination BACKGROUND When compared with the conventional surgical evacuation for the treatment of miscarriage , medical evacuation has been largely accepted as an effective and safe management . However , there is a lack of data on the long-term reproductive outcome of these two treatment modalities , which is crucial in patient counselling . The current study evaluates and compares the long-term fertility and pregnancy outcome following these two treatments . METHODS A cohort of 604 women enrolled in a previous r and omized controlled trial comparing medical and surgical evacuation for miscarriage were followed up prospect ively by telephone interview at a median of 6 ( range 4 - 9 ) years using a structured question naire . RESULTS A total of 423 women were contacted and four declined to participate ( response rate 69.4 % ) . Of these , 261 women ( 131 medical and 130 surgical evacuations ) had attempted to become pregnant since the miscarriage . There were no differences in their baseline characteristics including age , reproductive and contraceptive history . The natural conception rates were the same ( 97.7 % , P = 0.99 ) and the cumulative pregnancy rates were similar between groups , being 60 and 80 % at 12 and 24 months respectively . The median time-to-pregnancy was 8 months in both groups ( P = 0.97 ) and the subsequent live birth rates ( 85.2 versus 88.2 % , P = 0.72 ) result ing from the immediate pregnancy following previous treatment were similar . CONCLUSIONS The long-term conception rate and pregnancy outcome are not different following medical or surgical evacuation for miscarriage . Women should be reassured that their long-term fertility potential will not be compromised after medical treatment OBJECTIVE The purpose of this study was to estimate whether the efficacy of treatment with intravaginal misoprostol for first-trimester pregnancy failure is enhanced by the addition of saline solution . STUDY DESIGN Eighty women with embryonic/fetal death or anembryonic pregnancy were assigned r and omly to receive either 800 microg of misoprostol with saline solution ( group I , 41 women ) or without ( group II , 39 women ) . Treatment was repeated on day 3 if the gestational sac remained . Curettage was performed if the gestational sac remained on day 8 or as necessary during at least 30 days of follow-up . Data were analyzed with the Student t test and the chi(2 ) or Fisher exact test . RESULTS By the first follow-up visit , 73 % ( group I ) and 64 % ( group II ) of women passed the gestational sac ( P=.38 ) . By the second follow-up visit , expulsion rates were 83 % and 87 % , respectively ( P=.59 ) . Five subjects in each group underwent curettage . CONCLUSION Misoprostol is effective for the treatment of failed first-trimester pregnancy . The expulsion rate is not improved by adding saline solution BACKGROUND We aim ed to compare patients ' health-related quality of life after a misoprostol strategy to a curettage in women with early pregnancy failure after failed expectant management . METHODS A multicentre r and omized clinical trial was performed in The Netherl and s. In all , 154 women with early pregnancy failure confirmed at ultrasonography who had been managed expectantly unsuccessfully for > or = 1 week were r and omly assigned to undergo either treatment with misoprostol ( n=79 ) or curettage ( n=75 ) . The main outcome measures were health-related quality of life and satisfaction with treatment . RESULTS In the misoprostol strategy 47 % of the women needed additional curettage , as compared to 4 % after curettage . In both groups , health-related quality of life was impaired most severely 2 days after treatment . In the misoprostol group , health-related quality of life was more severely impaired ; after 2 days this was due to more pain and after 2 and 6 weeks this was due to a worse general health perception . Health-related quality of life was temporarily significantly more impaired in women in whom misoprostol failed as compared to women in whom misoprostol treatment was successful . In both treatment groups , an equal percentage of women ( 58 % ) would choose the same treatment in the future . In women treated with misoprostol , however , this choice depended on the initial success of misoprostol : in cases where misoprostol had caused complete evacuation , 76 % of the women would opt for the same treatment , whereas only 38 % of women who needed curettage after unsuccessful misoprostol would do so ( P<0.01 ) . CONCLUSION Our study shows that , although both the misoprostol strategy and the curettage strategy result ed in complete evacuation in the end , women are willing to accept some disadvantages of misoprostol to avoid curettage . A treatment inconvenience using misoprostol is accepted as long as initial evacuation rate is high . This finding should be an integral part of counselling women when deciding upon management of early pregnancy failure A total of 85 women with antepartum fetal death between 14 and 42 weeks gestation was r and omly assigned to one of two regimens of intravenous infusion of the prostagl and in analogue 16‐phenoxy‐17 , 18 , 19 , 20‐tetranor‐PGE2‐methylsulphonamide ( sulprostone ) for inducing labour . Women received either 1 μg/min until delivery or the commonly recommended treatment of 1500 μg in 8 h followed by another , identical course of treatment if delivery did not occur within 24 h. The 1 μg/min dose schedule used half the amount of prostagl and in and result ed in statistically significantly fewer gastrointestinal side‐effects compared with the conventional treatment . All women were delivered vaginally and there were no differences in induction‐to‐delivery intervals between the two treatments . Sulprostone infused at a rate of 1 μg/min result ed in a 50 % chance of being delivered within 12 h and a 90 % chance of being delivered within 24 h , with an overall frequency of side‐effects of 20 % OBJECTIVE To compare the efficacy of intramuscular methotrexate plus vaginal misoprostol to vaginal misoprostol alone in completing abortion in women with non-viable early first trimester pregnancy . METHOD Twenty-one women with non-viable pregnancy up to 49 days gestation were r and omized to receive intramuscular methotrexate , followed 2 days later by vaginal misoprostol or misoprostol alone . We also collected patient satisfaction information . RESULT Complete abortion occurred in all 12 ( 100 % ) women in the combined group and eight of nine ( 89 % , RR = 1.13 , CI 0.89 - 1.42 ) women in the misoprostol only group . Of the women , 75 % rated their experience as good and would choose medical management again . CONCLUSION Either methotrexate plus misoprostol or misoprostol alone effectively completed abortion in women with non-viable early pregnancy and represent acceptable medical alternatives to surgery or expectant management BACKGROUND Responses to miscarriage range from relief to devastation , yet there have been no r and omized controlled studies that demonstrate significant effects of counseling with women who miscarry . OBJECTIVE To test the effects of caring-based counseling , measurement , and time on the integration of loss ( miscarriage impact ) and women 's emotional well-being ( moods and self-esteem ) in the first year after miscarrying . METHOD ANCOVA was used in this r and omized , longitudinal Solomon four-group experimental investigation . Enrolled were 242 ; 185 completed . Outcomes included : self-esteem , overall emotional disturbance , anger , depression , anxiety , confusion , overall miscarriage impact , personal significance , devastating event , lost baby , and isolated . RESULTS During the first year after loss ( a ) caring was effective in reducing overall emotional disturbance , anger , and depression ; and ( b ) time passing led to increased self-esteem and decreased anxiety , depression , anger , confusion , and personal significance of loss . CONCLUSION Caring , measurement , and time had some positive and significant effects on the integration of loss and enhancement of well-being in the first year subsequent to miscarrying AIM To evaluate and compare effectiveness , side effects and patient acceptability between oral and sublingual 600 µg misoprostol for the treatment of incomplete abortion . METHODS A r and omized controlled trial was conducted . Pregnant women of less than 14 weeks gestation , diagnosed with incomplete abortion , were r and omly assigned to receive 600 µg misoprostol orally or sublingually . The patients were evaluated at 48 h after drug administration for complete abortion . RESULTS A total of 64 women were recruited to the study ( 32 in the oral group and 32 in the sublingual group ) . The complete abortion rate was not statistically different between oral and sublingual groups ( 87.5 % versus 84.4 % , P > 0.05 ) . There was no statistical difference in side effects and satisfaction rate . Fever/chills were the most common side effects . CONCLUSION Both sublingual and oral 600 µg misoprostol are useful for the management of incomplete abortion . Side effects and satisfaction rates are not different . Thus , these methods may be used as alternative treatments
Output:
| Limited evidence suggests that women generally seem satisfied with their care .
The available evidence suggests that medical treatment , with misoprostol , and expectant care are both acceptable alternatives to routine surgical evacuation given the availability of health service re sources to support all three approaches . |
MS211315 | ***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 Not all patients with rheumatoid arthritis can tolerate or respond to methotrexate , a st and ard treatment for this disease . There is evidence that antitumour necrosis factor alpha ( TNFalpha ) is efficacious in relief of signs and symptoms . We therefore investigated whether infliximab , a chimeric human-mouse anti-TNFalpha monoclonal antibody would provide additional clinical benefit to patients who had active rheumatoid arthritis despite receiving methotrexate . METHODS In an international double-blind placebo-controlled phase III clinical trial , 428 patients who had active rheumatoid arthritis , who had received continuous methotrexate for at least 3 months and at a stable dose for at least 4 weeks , were r and omised to placebo ( n=88 ) or one of four regimens of infliximab at weeks 0 , 2 , and 6 . Additional infusions of the same dose were given every 4 or 8 weeks thereafter on a background of a stable dose of methotrexate ( median 15 mg/week for > or = 6 months , range 10 - 35 mg/wk ) . Patients were assessed every 4 weeks for 30 weeks . FINDINGS At 30 weeks , the American College of Rheumatology ( 20 ) response criteria , representing a 20 % improvement from baseline , were achieved in 53 , 50 , 58 , and 52 % of patients receiving 3 mg/kg every 4 or 8 weeks or 10 mg/kg every 4 or 8 weeks , respectively , compared with 20 % of patients receiving placebo plus methotrexate ( p<0.001 for each of the four infliximab regimens vs placebo ) . A 50 % improvement was achieved in 29 , 27 , 26 , and 31 % of infliximab plus methotrexate in the same treatment groups , compared with 5 % of patients on placebo plus methotrexate ( p<0.001 ) . Infliximab was well-tolerated ; withdrawals for adverse events as well as the occurrence of serious adverse events or serious infections did not exceed those in the placebo group . INTERPRETATION During 30 weeks , treatment with infliximab plus methotrexate was more efficacious than methotrexate alone in patients with active rheumatoid arthritis not previously responding to methotrexate OBJECTIVE To assess the safety and efficacy of golimumab in methotrexate (MTX)-naive patients with active rheumatoid arthritis ( RA ) . METHODS MTX-naive patients with RA ( n = 637 ) were r and omized to receive placebo plus MTX ( group 1 ) , golimumab 100 mg plus placebo ( group 2 ) , golimumab 50 mg plus MTX ( group 3 ) , or golimumab 100 mg plus MTX ( group 4 ) . Subcutaneous injections of golimumab or placebo were administered every 4 weeks . The dosage of MTX/placebo capsules started at 10 mg/week and escalated to 20 mg/week . The primary end point , the proportion of patients meeting the American College of Rheumatology 50 % improvement criteria ( achieving an ACR50 response ) at week 24 , required significant differences between groups 3 and 4 combined ( combined group ) versus group 1 and significant differences in a pairwise comparison ( group 3 or group 4 versus group 1 ) . RESULTS An intent-to-treat ( ITT ) analysis of the ACR50 response at week 24 did not show a significant difference between the combined group and group 1 ( 38.4 % and 29.4 % , respectively ; P=0.053 ) , while a post hoc modified ITT analysis ( excluding 3 untreated patients ) of the ACR50 response showed statistically significant differences between the combined group and group 1 ( 38.5 % versus 29.4 % ; P=0.049 ) and between group 3 ( 40.5 % ; P=0.038 ) but not group 4 ( 36.5 % ; P=0.177 ) and group 1 . Group 2 was noninferior to group 1 for the ACR50 response at week 24 ( 33.1 % ; 95 % confidence interval lower bound -5.2 % ; predefined delta value for noninferiority -10 % ) . The combination of golimumab plus MTX demonstrated a significantly better response compared with placebo plus MTX in most other efficacy parameters , including response/remission according to the Disease Activity Score in 28 joints . Serious adverse events occurred in 7 % , 3 % , 6 % , and 6 % of patients in groups 1 , 2 , 3 , and 4 , respectively . CONCLUSION Although the primary end point was not met , the modified ITT analysis of the primary end point and other prespecified efficacy measures demonstrated that the efficacy of golimumab plus MTX is better than , and the efficacy of golimumab alone is similar to , the efficacy of MTX alone in reducing RA signs and symptoms in MTX-naive patients , with no unexpected safety concerns Background : Certolizumab pegol is a PEGylated tumour necrosis factor inhibitor . Objective : To evaluate the efficacy and safety of certolizumab pegol versus placebo , plus methotrexate ( MTX ) , in patients with active rheumatoid arthritis ( RA ) . Methods : An international , multicentre , phase 3 , r and omised , double-blind , placebo-controlled study in active adult-onset RA . Patients ( n = 619 ) were r and omised 2:2:1 to subcutaneous certolizumab pegol ( liquid formulation ) 400 mg at weeks 0 , 2 and 4 followed by 200 mg or 400 mg plus MTX , or placebo plus MTX , every 2 weeks for 24 weeks . The primary end point was ACR20 response at week 24 . Secondary end points included ACR50 and ACR70 responses , change from baseline in modified Total Sharp Score , ACR core set variables and physical function . Results : Significantly more patients in the certolizumab pegol 200 mg and 400 mg groups achieved an ACR20 response versus placebo ( p⩽0.001 ) ; rates were 57.3 % , 57.6 % and 8.7 % , respectively . Certolizumab pegol 200 and 400 mg also significantly inhibited radiographic progression ; mean changes from baseline in mTSS at week 24 were 0.2 and −0.4 , respectively , versus 1.2 for placebo ( rank analysis p⩽0.01 ) . Certolizumab pegol-treated patients reported rapid and significant improvements in physical function versus placebo ; mean changes from baseline in HAQ-DI at week 24 were −0.50 and −0.50 , respectively , versus −0.14 for placebo ( p⩽0.001 ) . Most adverse events were mild or moderate , with low incidence of withdrawals due to adverse events . Five patients developed tuberculosis . Conclusion : Certolizumab pegol plus MTX was more efficacious than placebo plus MTX , rapidly and significantly improving signs and symptoms of RA and physical function and inhibiting radiographic progression . Trial registration number : OBJECTIVE To assess the long-term impact of etanercept on fatigue in patients with recent-onset ( mean duration 11 months ) or established ( mean duration 12 years ) rheumatoid arthritis ( RA ) . METHODS Patients participating in either of 2 multicenter , r and omized , double-blind clinical trials were included . In one trial , patients with recent-onset RA received either etanercept 25 mg twice weekly or methotrexate in a double-blind fashion for 12 months , then open label for 12 months . All patients then received open-label etanercept . In the second trial , patients with established RA received etanercept 25 mg or placebo twice weekly for 6 months in a double-blinded fashion , then open-label etanercept . Up to 46 months of followup data were included . Fatigue was measured regularly using the Health Assessment Question naire vitality domain . RESULTS Patients with recent-onset RA who received etanercept had a significantly faster improvement in fatigue than those receiving methotrexate in the first 2 months . Subsequently , patients receiving etanercept and methotrexate had 23 - 29 % and 17 - 24 % reductions in fatigue scores , respectively . In the group with established RA , patients who received etanercept had significantly greater reductions in fatigue than those receiving placebo during the blinded period . Patients initially receiving etanercept sustained a mean fatigue reduction of 25 - 36 % for the entire followup . Patients achieving clinical ly meaningful improvement in fatigue were more likely to meet the American College of Rheumatology improvement criteria . CONCLUSION Etanercept therapy reduces fatigue in patients with recent-onset or established RA . Improvement in fatigue was sustained for up to 46 months , and correlated with other RA-relevant outcomes Background Patient reported outcomes ( PROs ) are especially useful in assessing treatments for rheumatoid arthritis ( RA ) since they measure dimensions of health-related quality of life that can not be captured using strictly objective physiological measures . The aim of this study was to compare the effects of combination etanercept and methotrexate ( ETN + MTX ) versus combination synthetic disease modifying antirheumatic drugs ( DMARDs ) and methotrexate ( DMARD + MTX ) on PRO measures among RA patients from the Asia-Pacific region , a population not widely studied to date . Patients with established moderate to severe rheumatoid arthritis who had an inadequate response to methotrexate were studied . Methods Patients were r and omized to either ETN + MTX ( N = 197 ) or DMARD + MTX ( N = 103 ) in an open-label , active-comparator , multicenter study , with PRO measures design ed as prospect i ve secondary endpoints . The Health Assessment Question naire ( HAQ ) , Functional Assessment of Chronic Illness Therapy Fatigue Scale ( FACIT-Fatigue ) , Medical Outcomes Short Form-36 Health Survey ( SF-36 ) , Hospital Anxiety and Depression Scale ( HADS ) and the Work Productivity and Activity Impairment Question naire : General Health ( WPAI : GH ) were used . Results Significantly greater improvements were noted for the ETN + MTX group at week16 for HAQ mean scores and for proportion of patients achieving HAQ score ≤ 0.5 , compared to patients in the DMARD + MTX group . SF-36 Summary Scores for physical and mental components and for 6 of 8 health domains showed significantly greater improvements at week16 for the ETN + MTX group ; only scores for physical functioning and role-emotional domains did not differ significantly between the two treatment arms . Greater improvements at week16 were noted for the ETN + MTX group for FACIT-Fatigue , HADS , and WPAI : GH mean scores . Conclusion Combination therapy using ETN + MTX demonstrated superior improvements using a comprehensive set of PRO measures , compared to combination therapy with usual st and ard of care DMARDs plus MTX in patients with established rheumatoid arthritis from the Asia-Pacific region . Trial registration clintrials.gov # Objective : The phase III GO-FORWARD study examined the efficacy and safety of golimumab in patients with active rheumatoid arthritis ( RA ) despite methotrexate therapy . Methods : Patients were r and omly assigned in a 3 : 3 : 2 : 2 ratio to receive placebo injections plus methotrexate capsules ( group 1 , n = 133 ) , golimumab 100 mg injections plus placebo capsules ( group 2 , n = 133 ) , golimumab 50 mg injections plus methotrexate capsules ( group 3 , n = 89 ) , or golimumab 100 mg injections plus methotrexate capsules ( group 4 , n = 89 ) . Injections were administered subcutaneously every 4 weeks . The co- primary endpoints were the proportion of patients with 20 % or greater improvement in the American College of Rheumatology criteria ( ACR20 ) at week 14 and the change from baseline in the health assessment question naire-disability index ( HAQ-DI ) score at week 24 . Results : The proportion of patients who achieved an ACR20 response at week 14 was 33.1 % in the placebo plus methotrexate group , 44.4 % ( p = 0.059 ) in the golimumab 100 mg plus placebo group , 55.1 % ( p = 0.001 ) in the golimumab 50 mg plus methotrexate group and 56.2 % ( p<0.001 ) in the golimumab 100 mg plus methotrexate group . At week 24 , median improvements from baseline in HAQ-DI scores were 0.13 , 0.13 ( p = 0.240 ) , 0.38 ( p<0.001 ) and 0.50 ( p<0.001 ) , respectively . During the placebo-controlled portion of the study ( to week 16 ) , serious adverse events occurred in 2.3 % , 3.8 % , 5.6 % and 9
Output:
| AUTHORS ' CONCLUSIONS Treatment with biologic interventions in patients with active RA can lead to a small to moderate improvement in fatigue .
The magnitude of improvement is similar for anti-TNF and non-anti-TNF biologics .
However , it is unclear whether the improvement results from a direct action of the biologics on fatigue or indirectly through reduction in inflammation , disease activity or some other mechanism |
MS211316 | ***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: Sublingual immunotherapy is widely recognized as a viable treatment for allergic rhinitis and asthma , but the optimal dosage is still under debate , expecially with modified allergens . We assessed the clinical effects of a monomeric allergoid across 3 different maintenance doses in mite-monosensitized patients with rhinitis and intermittent asthma . Eighty-nine patients allergic to HDM were r and omized to 3 maintenance doses of monomeric allergoid ( Lais ® , Lofarma ) or medications only . All the patients recorded their symptoms and rescue drug consumption in a diary card from November to February . Additionally , nasal eosinophil count , spirometry and methacholine bronchial challenge were performed at the beginning of the study and after 3 years . The symptom scores showed a clear improvement in all the three active arms versus baseline and versus the controls , irrespective of the dose . Likewise , a similar improvement versus baseline was seen for nasal inflammation and bronchial hyperreactivity . The SLIT with monomeric allergoids produces clinical ly significant results across a wide range of doses . The absence of significant side effects , even at high doses , is probably due to their low level of allergenicity IMPORTANCE The house dust mite ( HDM ) sublingual allergen immunotherapy ( SLIT ) tablet is a potential novel treatment option for HDM allergy-related asthma . OBJECTIVES To evaluate the efficacy and adverse events of the HDM SLIT tablet vs placebo for asthma exacerbations during an inhaled corticosteroid ( ICS ) reduction period . DESIGN , SETTING S , AND PARTICIPANTS Double-blind , r and omized , placebo-controlled trial conducted between August 2011 and April 2013 in 109 European trial sites . The trial included 834 adults with HDM allergy-related asthma not well controlled by ICS or combination products , and with HDM allergy-related rhinitis . Key exclusion criteria were FEV1 less than 70 % of predicted value or hospitalization due to asthma within 3 months before r and omization . Efficacy was assessed during the last 6 months of the trial when ICS was reduced by 50 % for 3 months and then completely withdrawn for 3 months . INTERVENTIONS 1:1:1 r and omization to once-daily treatment with placebo ( n = 277 ) or HDM SLIT tablet ( dosage groups : 6 SQ-HDM [ n = 275 ] or 12 SQ-HDM [ n = 282 ] ) in addition to ICS and the short-acting β2-agonist salbutamol . MAIN OUTCOMES AND MEASURES Primary outcome was time to first moderate or severe asthma exacerbation during the ICS reduction period . Secondary outcomes were deterioration in asthma symptoms , change in allergen-specific immunoglobulin G4 ( IgG4 ) , change in asthma control or asthma quality -of-life question naires , and adverse events . RESULTS Among 834 r and omized patients ( mean age , 33 years [ range , 17 - 83 ] ; women , 48 % ) , 693 completed the study . The 6 SQ-HDM and 12 SQ-HDM doses both significantly reduced the risk of a moderate or severe asthma exacerbation compared with placebo ( hazard ratio [ HR ] : 0.72 [ 95 % CI , 0.52 - 0.99 ] for the 6 SQ-HDM group , P = .045 , and 0.69 [ 95 % CI , 0.50 - 0.96 ] for the 12 SQ-HDM group , P = .03 ) . The absolute risk differences based on the observed data ( full analysis set ) in the active groups vs the placebo group were 0.09 ( 95 % CI , 0.01 - 0.15 ) for the 6 SQ-HDM group and 0.10 ( 95 % CI , 0.02 - 0.16 ) for the 12 SQ-HDM group . There was no significant difference between the 2 active groups . Compared with placebo , there was a reduced risk of an exacerbation with deterioration in asthma symptoms ( HR , 0.72 [ 95 % CI , 0.49 - 1.02 ] for the 6 SQ-HDM group , P = .11 , and 0.64 [ 95 % CI , 0.42 - 0.96 ] for the 12 SQ-HDM group , P = .03 ) and a significant increase in allergen-specific IgG4 . However , there was no significant difference for change in asthma control question naire or asthma quality -of-life question naire for either dose . There were no reports of severe systemic allergic reactions . The most frequent adverse events were mild to moderate oral pruritus ( 13 % for the 6 SQ-HDM group , 20 % for the 12 SQ-HDM group , and 3 % for the placebo group ) , mouth edema , and throat irritation . CONCLUSIONS AND RELEVANCE Among adults with HDM allergy-related asthma not well controlled by ICS , the addition of HDM SLIT to maintenance medications improved time to first moderate or severe asthma exacerbation during ICS reduction , with an estimated absolute reduction at 6 months of 9 to 10 percentage points ; the reduction was primarily due to an effect on moderate exacerbations . Treatment-related adverse events were common at both active doses . Further studies are needed to assess long-term efficacy and safety . TRIAL REGISTRATION clinical trialsregister.eu Identifier : 2010 - 018621 - 19 Sublingual immunotherapy ( SLIT ) with monomeric carbamylated allergoid administered in accordance with the st and ard regimen has proven to be effective and safe . Achieving clinical benefit , however , requires a lengthy period of time so it is not very suitable for short-lasting allergies . We thus performed this study to compare an administration protocol starting in the coseasonal period ( with a 4-day build-up phase ) with a precoseasonal scheme to verify if the former regimen provides the same benefit in a shorter period of time . The prospect i ve , r and omized , drug therapy-controlled study was conducted in 33 rhinitic patients monosensitized to Olea with or without asthma . Ten patients were assigned to the coseasonal therapy with 5000 allergic units (AU)/week for 6 weeks , 11 to the precoseasonal therapy with 3000 AU/week for 10 weeks , and 12 to drug therapy . They were treated from April or May to June 2008 . A visual analog scale ( VAS ) was performed at baseline and after treatment to assess the well being of the patients . Drug consumption was evaluated by means of a monthly diary . There was greater VAS improvement in both the SLIT groups versus the controls , but it was statistically significant only in the coseasonal group ( p < 0.01 ) . Furthermore , there was a reduction in the rescue medication only in the coseasonal SLIT ( p < 0.05 versus drug therapy ) . One mild adverse event was observed . The allergoid SLIT was shown to be effective and safe in Olea allergy in particular when a coseasonal regimen was used Sublingual immunotherapy with monomeric allergoid ( allergoid SLIT ) , given according to the st and ard scheme , has proved effective and safe in many clinical trials . However , its build-up phase requires a long time ranging from 16 days to 14 weeks . This study therefore investigated whether , with a four-day up-dosing , the same benefit could be achieved in a shorter time . Thirty rhinitic and /or asthmatic patients ( 16 M and 14 F , mean age 36±8.2 years ) allergic to house dust mites ( HDM ) with or without other sensitizations were r and omized to allergoid SLIT or st and ard drug therapy . The build-up phase lasted four days . The first day the patients took a 300 AU tablet , the second day two 300 AU tablets , the third day three 300 AU tablets and the fourth day four 300 AU tablets . The total amount taken during the up-dosing was 3000 AU . Patients were then treated for 12 months at the dosage of 2000 AU/week ( total amount of allergen : 104,000 AU/year ) . The symptom score and drug consumption were recorded from November to February on monthly diary cards . At baseline and after 12 months a Visual Analogue Scale ( VAS ) was used to rate the patients ' well-being . Skin prick test reactivity was evaluated before and after the 12-month treatment in both groups using 10 mg/mL histamine as reference . VAS scores rose significantly ( about 45 % ) in both groups in comparison to baseline ( p=0.001 ) . In addition , there was a significantly greater reduction of the global symptoms score ( about 52 % ) - but not in drug consumption - in the SLIT group in comparison to controls ( p=0.0004 ) . The SLIT group showed a highly significant reduction ( about 39 % ) in skin prick test reactivity ( p=0.000003 ) while the control group remained unchanged ( p=0.5226 ) . No severe adverse events were observed . Even with this short four-day up-dosing , the allergoid SLIT proves to be safe . In addition , it is already effective in patients allergic to HDM after 12 months , and significantly reduces allergen-specific skin reactivity BACKGROUND Few studies have compared the effects of immunotherapy and inhaled steroids . The main limitation of such studies is the long duration required to fully appreciate the effects of immunotherapy . OBJECTIVE To compare the effects of inhaled budesonide and sublingual immunotherapy ( SLIT ) in mild persistent asthma for up to 5 years . METHODS Patients with mild persistent asthma and rhinitis due to grass pollen were enrolled in an open r and omized controlled trial . After a run-in season , they were r and omized to either budesonide , 800 microg/d , in the pollen season or continuous grass SLIT for 5 years . All patients received rescue medications . Symptoms were evaluated by diary cards filled out from May to July at baseline and after 3 and 5 years . In-season nasal eosinophils and bronchial hyperresponsiveness were also assessed . RESULTS Fifty-one patients were enrolled and 46 completed the study . The bronchial symptom scores and the use of bronchodilators decreased significantly in both groups , but the improvement was greater in the SLIT patients at 3 and 5 years . The nasal symptom score and the intake of nasal steroids decreased only in the SLIT group , and the difference vs the budesonide group was always significant . In the SLIT group vs the budesonide group , a statistically significant decrease of nasal eosinophils was found at 3 and 5 years ( P < .01 ) . The bronchial hyperresponsiveness improved significantly only in the SLIT group . CONCLUSION In patients with grass pollen-induced asthma , in the long term SLIT was equally effective as inhaled budesonide in treating bronchial symptoms and provided an additional benefit in treating rhinitis symptoms and bronchial hyperresponsiveness RATIONALE Heterogeneity in asthma expression is multidimensional , including variability in clinical , physiologic , and pathologic parameters . Classification requires consideration of these disparate domains in a unified model . OBJECTIVES To explore the application of a multivariate mathematical technique , k-means cluster analysis , for identifying distinct phenotypic groups . METHODS We performed k-means cluster analysis in three independent asthma population s. Clusters of a population managed in primary care ( n = 184 ) with predominantly mild to moderate disease , were compared with a refractory asthma population managed in secondary care ( n = 187 ) . We then compared differences in asthma outcomes ( exacerbation frequency and change in corticosteroid dose at 12 mo ) between clusters in a third population of 68 subjects with predominantly refractory asthma , clustered at entry into a r and omized trial comparing a strategy of minimizing eosinophilic inflammation ( inflammation-guided strategy ) with st and ard care . MEASUREMENTS AND MAIN RESULTS Two clusters ( early-onset atopic and obese , noneosinophilic ) were common to both asthma population s. Two clusters characterized by marked discordance between symptom expression and eosinophilic airway inflammation ( early-onset symptom predominant and late-onset inflammation predominant ) were specific to refractory asthma . Inflammation-guided management was superior for both discordant subgroups leading to a reduction in exacerbation frequency in the inflammation-predominant cluster ( 3.53 [ SD , 1.18 ] vs. 0.38 [ SD , 0.13 ] exacerbation/patient/yr , P = 0.002 ) and a dose reduction of inhaled corticosteroid in the symptom-predominant cluster ( mean difference , 1,829 mug beclomethasone equivalent/d [ 95 % confidence interval , 307 - 3,349 mug ] ; P = 0.02 ) . CONCLUSIONS Cluster analysis offers a novel multidimensional approach for identifying asthma phenotypes that exhibit differences in clinical response to treatment algorithms BACKGROUND No studies have directly compared the effects of immunotherapy and antileukotrienes due to the long time required to appreciate the clinical effects of immunotherapy . We compared the effect of montelukast ( MK ) and
Output:
| Compared with traditional therapy , SLIT add-on therapy was associated with significant improvements in lower and upper airway scores , a higher forced expiratory volume in 1 second , and maximal expiratory flow at 25 % of forced vital capacity , and improved bronchial reactivity .
Drug consumptions were significantly decreased as well .
Airway inflammatory parameters , such as nasal eosinophil infiltration , were markedly improved .
The findings of this study suggested that long-term SLIT add-on therapy is a complementary treatment for adults with asthma in addition to conventional medicine .
It not only reduces symptom scores but also improves lung function and airway inflammation |
MS211317 | ***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: Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items OBJECTIVE To investigate the relationship between the expressions of KAI1 , nm23 , ETS-1 , vascular endothelial growth factor ( VEGF ) and microvascular density ( MVD ) and lymph node metastasis and prognosis in nasopharyngeal carcinoma ( NPC ) . METHODS The Envision immunohistochemical method was used to detect the expressions of KAI1 , nm23 , ETS-1 and VEGF in 50 cases of non-keratinizing carcinoma ( NKC ) with cervical lymph node metastasis , 30 cases of NKC without cervical lymph node metastasis at the primary diagnoses and 30 cases of non-tumor nasopharyngeal tissues ( NP ) . The microvascular density was counted by immunostaining with CD34 . RESULTS ( 1 ) The expression rates of KAI1 and nm23 protein in NKC with cervical lymph node metastasis group and without cervical lymph node metastasis group and NP group increased successively , the difference being significant ( P < 0.05 ) ; The expression rates of ETS-1 and VEGF protein in NKC with cervical lymph node metastasis group and without cervical lymph node metastasis group and NP group increased successively , the difference being significant ( P < 0.05 ) . ( 2 ) In 80 NKC cases , the MVD was respectively lower in KAI1 and nm23 protein positive groups than those in the negative groups ( P < 0.05 ) ; the MVD was respectively higher in ETS-1 and VEGF protein positive groups than those in the negative groups ( P < 0.05 ) . ( 3 ) There was significant difference between the MVD , the number of NKC without cervical lymph node metastasis cases in the single expression of KAI1 or nm23 protein and in common expression of KAI1 and nm23 protein ( P < 0.05 ) , in the same as between the single expression of ETS-1 or VEGF protein and in common expressions of ETS-1 and VEGF protein ( P < 0.05 ) . ( 4 ) There was positive correlation between the expressions of KAI1 and nm23 protein ( P < 0.01 ) , as well as between the expressions of ETS-1 and VEGF protein ( P < 0.01 ) . ( 5 ) the 5-year survival rates of the patients correlated with cervical lymph node metastasis and the expressions of KAI1 , nm23 , ETS-1 and VEGF proteins in NKC ( P < 0.05 ) . CONCLUSIONS The expressions of KAI1 , nm23 , ETS-1 and VEGF proteins were highly related to MVD in NPC , cervical lymph node metastasis and prognosis . They might be considered to be reference indicator for evaluating the cervical lymph node metastasis and prognosis of NPC BACKGROUND Current practice of adding concurrent-adjuvant chemotherapy to radiotherapy ( CRT ) for treating advanced nasopharyngeal carcinoma is based on the Intergroup-0099 Study published in 1998 . However , the outcome for the radiotherapy-alone ( RT ) group in that trial was substantially poorer than those in other trials , and there were no data on late toxicities . Verification of the long-term therapeutic index of this regimen is needed . METHODS Patients with nonkeratinizing nasopharyngeal carcinoma staged T1 - 4N2 - 3M0 were r and omly assigned to RT ( 176 patients ) or to CRT ( 172 patients ) using cisplatin ( 100 mg/m(2 ) ) every 3 weeks for three cycles in concurrence with radiotherapy , followed by cisplatin ( 80 mg/m(2 ) ) plus fluorouracil ( 1000 mg per m(2 ) per day for 4 days ) every 4 weeks for three cycles . Primary endpoints included overall failure-free rate ( FFR ) ( the time to first failure at any site ) and progression-free survival . Secondary endpoints included overall survival , locoregional FFR , distant FFR , and acute and late toxicity rates . All statistical tests were two-sided . RESULTS The two treatment groups were well balanced in all patient characteristics , tumor factors , and radiotherapy parameters . Adding chemotherapy statistically significantly improved the 5-year FFR ( CRT vs RT : 67 % vs 55 % ; P = .014 ) and 5-year progression-free survival ( CRT vs RT : 62 % vs 53 % ; P = .035 ) . Cumulative incidence of acute toxicity increased with chemotherapy by 30 % ( CRT vs RT : 83 % vs 53 % ; P < .001 ) , but the 5-year late toxicity rate did not increase statistically significantly ( CRT vs RT : 30 % vs 24 % ; P = .30 ) . Deaths because of disease progression were reduced statistically significantly by 14 % ( CRT vs RT : 38 % vs 24 % ; P = .008 ) , but 5-year overall survival was similar ( CRT vs RT : 68 % vs 64 % ; P = .22 ; hazard ratio of CRT = 0.81 ,
Output:
| Conclusion : The low expression of nm23-H1 is associated with poorer prognosis in patients with NPC , suggesting that it is a prognostic factor and potential biomarker for survival in NPC |
MS211318 | ***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 ; To increase cardiopulmonary arrest survival , the American Heart Association developed basic and advanced cardiac life support ( ACLS ) courses that expose participants to realistic learning situations . This experimental study compared results of two ACLS classes on measures of knowledge ( content exam ) and resuscitation skills ( performance exam ) . Both the control and experimental groups consisted of physicians , nurses , emergency medical technicians , respiratory therapists , and advanced health care providers . The control group used low‐fidelity simulation ( LFS ) ; the experimental group was exposed to enhanced realism via high‐fidelity simulation ( HFS ) . The findings showed a positive correlation between enhanced practice and learning but no significant correlation between posttest and skills test scores for the LFS and HFS groups . The HFS group did score higher on both cognitive and behavioral tests , but the difference was not statistically significant . Participants from both groups indicated satisfaction with their forms of simulation experience and course design . In addition , participants ' self‐confidence to care for a victim of cardiopulmonary arrest was increased after completing their course ; profession and work experience had no effect on responses . The largest difference noted was in verbal responses to course satisfaction . The experimental group stated that learning using HFS was enjoyable and adamantly recommended that ACLS should only be taught using HFS . Further study is required to assess if practicing beyond the course enhances short‐ and long‐term retention of ACLS techniques Objective : To compare the usefulness for training of a porcine model ( larynx , trachea , and pig skin ) and a manikin model using a Portex cricothyrotomy kit ( PCK ) . Methods : In a prospect i ve r and omised crossover trial , participants in the airway workshop performed crico-thyrotomy using a PCK on the porcine and manikin models ( Tracheostomy Trainer and Case ) . The porcine model was made with larynxes and trachea from freshly slaughtered pigs and covered with a piece of thinned pigskin stapled to a wooden board . Participants were asked to assess the following : reality of skin turgor ; difficulty with skin penetration , l and mark recognition and procedure ; reality of the model ; and preference for each model using a visual analogue scale ( VAS ) of 0–10 cm . The VAS scores for each model were compared . Results : 49 participants were included in the study . Mean ( SD ) VAS scores for the reality of skin turgor , degree of difficulty with skin penetration and l and mark recognition were higher with the porcine model than with the manikin model ( 7.0 ( 2.1 ) vs 4.7 ( 2.0 ) , 6.4 ( 2.4 ) vs 3.6 ( 2.2 ) , 5.1 ( 2.2 ) vs 4.2 ( 2.5 ) , respectively ) . There was no difference between the models in the difficulty of the procedure ( 5.0 ( 2.4 ) vs 4.7 ( 3.2 ) ) . The porcine model had a higher VAS score for overall reality and preference of the model ( 7.1 ( 2.0 ) vs 4.8 ( 2.3 ) and 7.1 ( 2.0 ) vs 4.8 ( 2.2 ) , respectively ) . Conclusion : The porcine model is a more useful training tool than the manikin model for cricothyrotomy with PCK because of its reality and similarity to human anatomy Traditional teaching of laryngoscopy is difficult due to the trainer and trainee lacking a shared view . The Karl Storz BERCI DCI ® Video Laryngoscope provides a video image for the trainer and a direct view identical to that of a st and ard laryngoscope for the trainee . Forty‐nine novice subjects were r and omly assigned to a control group ( n = 24 ) taught using a st and ard Macintosh laryngoscope or a study group ( n = 25 ) taught using the Video Laryngoscope . Following training all subjects were assessed using a st and ard laryngoscope . Under simulated difficult airway conditions the study group performed better in terms of number of attempts ( p = 0.02 ) , number of repositioning manoeuvres required ( p = 0.046 ) and teeth trauma ( p = 0.034 ) . The study group were more confident of the success of their tube placement ( p = 0.035 ) , found it easier than the control group ( p = 0.042 ) and had improved knowledge of airway anatomy ( p = 0.011 ) . We conclude that video laryngoscopy confers benefits in the teaching of tracheal intubation OBJECTIVE : Poor communication and teamwork may contribute to errors during neonatal resuscitation . Our objective was to evaluate whether interns who received a 2-hour teamwork training intervention with the Neonatal Resuscitation Program ( NRP ) demonstrated more teamwork and higher quality resuscitations than control subjects . METHODS : Participants were noncertified 2007 and 2008 incoming interns for pediatrics , combined pediatrics and internal medicine , family medicine , emergency medicine , and obstetrics and gynecology ( n = 98 ) . Pediatrics and combined pediatrics/internal medicine interns were eligible for 6-month follow-up ( n = 34 ) . A r and omized trial was conducted in which half of the participants in the team training arm practice d NRP skills by using high-fidelity simulators ; the remaining practice d with low-fidelity simulators , as did control subjects . Blinded , trained observers viewed video recordings of high-fidelity – simulated resuscitations for teamwork and resuscitation quality . RESULTS : High-fidelity training ( HFT ) group had higher teamwork frequency than did control subjects ( 12.8 vs 9.0 behaviors per minute ; P < .001 ) . Intervention groups maintained more workload management ( control subjects : 89.3 % ; low-fidelity training [ LFT ] group : 98.0 % [ P < .001 ] ; HFT group : 98.8 % ; HFT group versus control subjects [ P < .001 ] ) and completed resuscitations faster ( control subjects : 10.6 minutes ; LFT group : 8.6 minutes [ P = .040 ] ; HFT group : 7.4 minutes ; HFT group versus control subjects [ P < .001 ] ) . Overall , intervention teams completed the resuscitation an average of 2.6 minutes faster than did control subjects , a time reduction of 24 % ( 95 % confidence interval : 12%–37 % ) . Intervention groups demonstrated more frequent teamwork during 6-month follow-up resuscitations ( 11.8 vs 10.0 behaviors per minute ; P = .030 ) . CONCLUSIONS : Trained participants exhibited more frequent teamwork behaviors ( especially the HFT group ) and better workload management and completed the resuscitation more quickly than did control subjects . The impact on team behaviors persisted for at least 6 months . Incorporating team training into the NRP curriculum is a feasible and effective way to teach interns teamwork skills . It also improves simulated resuscitation quality by shortening the duration Current Advanced Cardiac Life Support ( ACLS ) course instruction involves a 2-day course with traditional lectures and limited team interaction . We wish to explore the advantages of a scenario-based performance-oriented team instruction ( SPOTI ) method to implement core ACLS skills for non-English-speaking international paramedic students . The objective of this study was to determine if scenario-based , performance-oriented team instruction ( SPOTI ) improves educational outcomes for the ACLS instruction of Korean paramedic students . Thirty Korean paramedic students were r and omly selected into two groups . One group of 15 students was taught the traditional ACLS course . The other 15 students were instructed using a SPOTI method . Each group was tested using ACLS megacode examinations endorsed by the American Heart Association . All 30 students passed the ACLS megacode examination . In the traditional ACLS study group an average of 85 % of the core skills were met . In the SPOTI study group an average of 93 % of the core skills were met . In particular , the SPOTI study group excelled at physical examination skills such as airway opening , assessment of breathing , signs of circulation , and compression rates . In addition , the SPOTI group performed with higher marks on rhythm recognition compared to the traditional group . The traditional group performed with higher marks at providing proper drug dosages compared to the SPOTI students . However , the students enrolled in the SPOTI method result ed in higher megacode core compliance scores compared to students trained in traditional ACLS course instruction . These differences did not achieve statistical significance due to the small sample size BACKGROUND Recent literature describes " cognitive dispositions to respond " ( CDRs ) that may lead physicians to err in their clinical reasoning . OBJECTIVES To assess learner perception of high-fidelity mannequin-based simulation and debriefing to improve underst and ing of CDRs . METHODS Emergency medicine ( EM ) residents were exposed to two simulations design ed to bring out the CDR concept known as " vertical line failure . " Residents were then block-r and omized to a technical/knowledge debriefing covering the medical subject matter or a CDR debriefing covering vertical line failure . They then completed a written survey and were interviewed by an ethnographer . Four investigators blinded to group assignment review ed the interview transcripts and coded the comments . The comments were qualitatively analyzed and those upon which three out of four raters agreed were quantified . A r and om sample of 84 comments was assessed for interrater reliability using a kappa statistic . RESULTS Sixty-two residents from two EM residencies participated . Survey results were compared by technical ( group A , n = 32 ) or cognitive ( group B , n = 30 ) debriefing . There were 255 group A and 176 group B comments quantified . The kappa statistic for coding the interview comments was 0.42 . The CDR debriefing group made more , and qualitatively richer , comments regarding CDR concepts . The technical debriefing group made more comments on the medical subjects of cases . Both groups showed an appreciation for the risk of diagnostic error . CONCLUSIONS Survey data indicate that technical debriefing was better received than cognitive debriefing . The authors theorize that an underst and ing of CDRs can be facilitated through simulation training based on the analysis of interview comments OBJECTIVE To compare the ' 4-stage ' teaching technique ( demonstration , deconstruction , formulation , performance ) with the traditional ' 2-stage ' teaching technique ( deconstruction , performance ) in laryngeal mask airway ( LMA ) insertion . METHODS Using a prospect i ve r and omised study design , participants were taught LMA insertion on a manikin by either the ' 2-stage ' or ' 4-stage ' teaching method . Subjects were eligible if they had never inserted a LMA . Skill acquisition was assessed immediately following training , and skill retention assessed a number of weeks later . The primary outcome was LMA insertion on a manikin , with successful ventilation within 30 s. Other outcomes included overall time to LMA insertion , and number of errors . Assessors were blinded to the teaching method used for each subject . RESULTS A total of 120 participants were r and omised between the two teaching groups ( 60 subjects in each group ) . Mean time to LMA insertion at acquisition was 39.7 s for 2-stage and 34.7 s for 4-stage ( p>0.05 ) , and proportion completing within 30 s was 41.67 % for 2-stage and 48.33 % for the 4-stage teaching group ( p>0.05 ) . With skill retention assessment , mean time to LMA insertion was 44.3 s for 2-stage and 42.5 s for the 4-stage teaching group ( p>0.05 ) . Proportion completing task within 30 s was 34.0 % for 2-stage and 41.67 % for 4-stage group ( p>0.05 ) . Overall , there was no significant difference found in skill acquisition or in skill retention between the 2 or 4-stage teaching method . CONCLUSION The 2-stage teaching technique is not statistically different to the 4-stage teaching method in efficacy of LMA insertion skill acquisition or retention OBJECTIVES The objective of the study was to compare the learning and retention rates of resident physicians trained in posterior epistaxis management with nasal gauze packing on a simulation model following two training methods . METHODS This was a prospect i ve , repeated- measures study . An objective , criterion-referenced performance st and ard , consisting of the number of major steps completed in the proper sequence , and the number of minor steps completed within a specified time , was used by an evaluator to assess performances . Subjects underwent two pretraining assessment s 1 week prior to and the day of training and then were r and omized to one of two training methods : the traditional " observation " method or a " pause- and -perfect " method . After training , both groups repeated the procedure until meeting the performance st and ard . Subjects were retested 1 and 3 months after training . RESULTS Twenty-eight subjects participated . Baseline performance measures were similar between groups and did not change prior to training . During performance testing , experimental subjects completed a greater percentage of major steps ( 84 % ) and minor steps ( 86 % ) in less time ( 25 minutes ) than the controls ( 65 and 68 % , in 35 minutes ) during the first attempt . All subjects met the st and ard within three attempts . There were no differences in major and minor steps completed between the two groups at either 1 week or 3 months after training , but performance times were shorter in the experimental group . After 3 months , 13 % of control and none of experimental subjects met the performance st and ard . CONCLUSIONS The pause- and -perfect training method produced more rapid progress toward a performance st and ard during the initial attempt and better performance times after 3 months than the traditional , observational training method . Without further practice , this skill deteriorated after 3 months with both methods of training Introduction : Major resuscitation councils endorse the use of
Output:
| Qualitative comparisons of different simulation curricula are limited , although feedback , mastery learning , and higher fidelity were associated with improved learning outcomes .
CONCLUSIONS Technology-enhanced simulation for EM learners is associated with moderate or large favorable effects in comparison with no intervention and generally small and nonsignificant benefits in comparison with other instruction . |
MS211319 | ***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 Postnatal depression affects 10–15 % of all mothers in Western societies and remains a major public health concern for women from diverse cultures . British Pakistani and Indian women have a higher prevalence of depression in comparison to their white counterparts . Research has shown that culturally adapted interventions using Cognitive Behavioural Therapy ( CBT ) may be acceptable and may help to address the needs of this population . The aim of this study was to assess the acceptability and overall experience of the Positive Health Programme by British South Asian mothers . Methods This was a nested qualitative study , part of an exploratory r and omized controlled trial ( RCT ) conducted to test the feasibility and acceptability of a culturally-adapted intervention ( Positive Health Programme or PHP ) for postnatal depression in British South Asian women . In-depth interviews ( N = 17 ) were conducted to determine the views of the participants on the feasibility and acceptability of the intervention . Results The participants found the intervention acceptable and experienced an overall positive change in their attitudes , behaviour , and increased self-confidence . Conclusions The findings suggest that the culturally adapted Positive Health Programme is acceptable to British South Asian women . These results support that culturally sensitive interventions may lead to better health outcomes and overall satisfaction . Trial registration Protocol registered on Clinical trials.gov OBJECTIVE We examined the course and predictors of postpartum depression in the 18 months following interpersonal psychotherapy ( IPT ) . METHOD We enrolled 120 community women with major depression in a 12-week r and omized trial of individual IPT during the postpartum period ( O'Hara , Stuart , Gorman , & Wenzel , 2000 ) . At 6 , 12 , and 18 months posttreatment , women participated in clinical interviews to establish the course of depression over the previous 6 months . We used survival analyses to characterize recovery and recurrence in the follow-up and growth curve modeling techniques to identify predictors of change in depression during the follow-up period . Potential predictors included severity , chronicity , and personal history of depression . RESULTS Of 35 women who recovered with acute treatment , 20 ( 57 % ) achieved sustained recovery during follow-up ; average time to recurrence was 33.40 weeks ( SD = 18.43 weeks ) . Over 80 % of women who did not recover with acute treatment experienced recovery at some point during follow-up ; average time to recovery was 28.60 weeks ( SD = 17.51 weeks ) . Time depressed each month decreased over the follow-up period . Posttreatment depressive severity and length of the index episode predicted changes in depression over time . Posttreatment depression severity , personal history of depression , and weeks of treatment in the follow-up were significant predictors of time depressed during follow-up . CONCLUSIONS IPT result ed in long-term benefits past the termination of acute treatment , even for women who did not initially recover . Though the vast majority of women who did not recover with acute treatment did recover during the follow-up period , continuation of IPT may accelerate the process BACKGROUND A prospect i ve epidemiology study evaluated the role of specific social and psychological variables in the prediction of depressive symptomatology and disorders following childbirth in a community sample . Measures of social support used previously in clinical ly depressed population s facilitated further comparison . METHODS Nulliparous pregnant women ( N = 507 ) were interviewed during pregnancy with the Interview Measure of Social Relationships ( IMSR ) and a context ual assessment of pregnancy-related support and adversity and 427 were followed up at 3 months postpartum with the 30-item GHQ , including six depression items . To establish the clinical representativeness of the GHQ , high GHQ scorers and a r and om sub sample of low scorers were interviewed using the SCAN . Regression models were developed using the GHQ Depression scale ( GHQ-D ) , the IMSR and other risk factor data . RESULTS GHQ-D after childbirth was predicted by lack of perceived support from members of the woman 's primary group and lack of support in relation to the event becoming pregnant ; this held even after controlling for antenatal depression , neuroticism , family and personal psychiatric history and adversity . Informant-rated deficits in provision of social support also predicted later depression . The size of the primary social network group previously found to be related to depression in women , did not predict depressive symptom development . CONCLUSION Predictors of depressive symptom development differ from predictors of recovery from clinical depression in women . Interventions should be design ed to reduce specific deficits in social support observed in particular study population Few interventions for Postnatal Depression ( PND ) have focused on parenting difficulties ; the aim of this research was to investigate the feasibility and evaluate a parenting intervention ( Baby Triple P ) in women with PND . This was a pilot r and omised controlled trial ( RCT ) to evaluate and determine the feasibility of the newly developed Baby Triple P compared with treatment as usual ( TAU ) in women with PND . In all , 27 female participants aged from 18 to 45 years ( mean age = 28.4 years , st and ard deviation ( SD ) = 6.1 ) , with a primary diagnosis of major depression and an infant under 12 months ( mean age = 6.2 months , SD = 3.2 months ) , were recruited from primary care trusts in Greater Manchester , United Kingdom . Participants were r and omly allocated to receive either eight Baby Triple P sessions in addition to TAU or TAU only . Outcomes were assessed at post-treatment ( Time 2 ) and 3 months post-treatment ( Time 3 ) . Self-report outcomes were as follows : Beck Depression Inventory , Oxford Happiness Inventory , What Being the Parent of a New Baby is Like , Postpartum Bonding Question naire and the Brief Parenting Beliefs Scale – baby version . An assessor-rated observational measure of mother – infant interaction , the CARE Index and measure of intervention acceptability were also completed . Significant improvements from Time 1 to Time 2 and Time 1 to Time 3 were observed across both groups . Although women allocated to Baby Triple P showed more favourable improvements , the between-group differences were not significant . However , the intervention was highly acceptable to women with PND . A large-scale RCT is indicated Post-partum depression affects 10 - 13 % of Japanese women , but many do not receive appropriate treatment or support . This intervention study evaluated the effectiveness of home visits by mental health nurses for Japanese women with post-partum depression . Eighteen post-partum women met the inclusion criteria and were r and omly allocated into the intervention ( n = 9 ) or control ( n = 9 ) group at 1 - 2 months after giving birth . The intervention group received four weekly home visits by a mental health nurse . Control group participants received usual care . Two women in the intervention group did not complete the study . Depressive symptoms and quality of life were measured at 1 and 6 weeks ' postintervention . In addition , participants completed an open-ended question naire on satisfaction and meaning derived from the home visits . Women in the intervention group had significant amelioration of depressive symptoms over time and reported positive benefits from the home visits , but there were no statistically significant differences between groups . Significant differences ( P < 0.05 ) were observed at times 2 and 3 between groups in terms of increased median scores of physical , environmental , and global subscales , and the total average score of the World Health Organization/ quality of life assessment instrument . On the psychological subscale , significant differences ( P = 0.042 ) were observed between groups at time 2 . The qualitative analysis of comments about home visitation revealed four categories related to ' setting their mind at ease ' , ' clarifying thoughts ' , ' improving coping abilities ' , and ' removing feelings of withdrawal from others ' . These results suggest that home visits by mental health nurses can contribute to positive mental health and social changes for women with post-partum depression . A larger trial is warranted to test this approach to care BACKGROUND Postnatal depression is a public health problem requiring intervention . To provide effective care , information is needed on the experiences of those with high levels of depressive symptoms who are offered and accept , or decline , psychological intervention postnatally . AIM To provide the first integrated in-depth exploration of postnatal women 's experiences of the identification and management of symptoms of depression and the offer and acceptance of postnatal care by health visitors taking part in the PoNDER trial . SETTING General practice : primary care within the former Trent regional health authority , Engl and . METHOD Thirty women with 6-week Edinburgh Postnatal Depression Scale ( EPDS ) scores ≥ 18 and probable depression completed semi-structured interviews . All women had taken part in the Post-Natal Depression Economic Evaluation and R and omised controlled ( PoNDER ) trial where intervention group health visitors received training in identification of depressive symptoms and provided psychologically informed sessions based on cognitive-behavioural therapy or person-centred counselling principles . RESULTS When accepted , psychological sessions were experienced as positive , effective , and ' ideal care ' . Women approved of using the EPDS but did not underst and the health visitor 's role in supporting women . Seeking help and accepting sessions depended on women 's perspectives of their health visitor as an individual . CONCLUSION Women 's experience of their health visitors providing psychological sessions to help with postnatal depressive symptoms is highly positive . Women will better accept support from health visitors if they recognise their role in postnatal depression and find them easy to relate to on personal matters . There is a case for specific enhancement of interpersonal skills in health visiting , or alternatively offering a choice of health visitors to women
Output:
| Women found the process of seeking help difficult , with several barriers preventing them from both seeking and accepting professional support .
Despite this , women described the support received as beneficial and particularly valued the therapeutic relationship .
Women reported 1 ) feeling more positive and confident after receiving a psychological and /or psychosocial intervention and 2 ) experiencing better relationships with their infant and other family members .
DISCUSSION Although seeking and accepting professional support for PPD was a difficult process , women highly valued mental health care support and perceived it as beneficial . |
MS211320 | ***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 test the effectiveness of different systems of reminding patients about their appointments in order to reduce the rate of failed attendance . The expense in implementing a reminder system for patients was also estimated . Design : A clinical study in a single-h and ed dental practice .Subjects : Patients were reminded about their appointment using either postal , manual telephone or automated telephone reminders ( or all three combined ) . A control group received no reminders . 500 patient attendances were recorded in each group . Results : Patients failed to attend for 130 of the 2500 appointments considered in the study . There was a significant reduction in the failed attendance rate from 9.4 % ( with no reminder ) to a minimum of 3 % when a reminder was given to the patient before the appointment . However , there was no significant difference among the four reminder test groups , indicating that the form of the reminder made no difference to the failure rate . Conclusions : Reminding patients using postal or manual telephone techniques is effective at improving attendance . All of the reminder methods , telephone and postal , provided net cost savings rather than additional The new-patient no-show rate reached 55 percent in an urban , university-based family practice center in mid-1981 . A prospect i ve descriptive study revealed that the no-show rates varied significantly with hour of appointment , patient age , source of referral , delay in appointment date , and chronicity of illness . Study findings led to alterations in the scheduling system , with a subsequent drop in the new-patient no-show rate to 40 percent BACKGROUND The dem and for anticoagulation management is increasing . This has led to care being provided in non-hospital setting s. While clinical studies have similarly demonstrated good clinical care in these setting s , it is still unclear as to which alternative is the most efficient . AIM To determine the costs borne by patients when attending an anticoagulation management clinic in either primary or secondary care and to use this information to consider the cost-effectiveness of anticoagulation management in primary and secondary care , both from the National Health Service and patient perspectives . DESIGN OF STUDY Observational study comparing two cohorts of patients currently attending anticoagulation management clinics . SETTING Four primary care clinics in Birmingham and one in Warwickshire , and the haematology clinics at the University of Birmingham Hospitals Trust and the City Hospital NHS Trust . METHOD The survey of patients attending the clinics was used to ascertain patient costs . This information was then used in conjunction with the findings of a recent r and omised controlled trial to establish cost-effectiveness . RESULTS Patient costs were lower in primary care than in secondary care setting s ; the mean ( st and ard deviation ) costs per visit were Pound Sterling6.78 ( Pound Sterling5.04 ) versus Pound Sterling14.58 ( Pound Sterling9.08 ) . While a previous cost-effectiveness analysis from a health sector perspective alone found a higher cost for primary care , the adoption of the societal perspective lead to a marked change in the result : a similar total cost per patient in both sectors . CONCLUSION There are significantly higher costs borne by patients attending secondary care anticoagulation management clinics than similar patients attending primary care clinics . This study also demonstrates that the perspective adopted in an economic evaluation can influence the final result OBJECTIVE --To ascertain which social and psychological characteristics are associated with patients attending surgeries without appointments . DESIGN -- Prospect i ve study of patients attending an urban centre group practice . SETTING --Urban health centre group practice with five doctors and 12,000 patients in an area of high ( greater than 20 % ) unemployment and social deprivation . PATIENTS --All attenders at the open access surgery and one in four consecutive attenders by appointment , selected sequentially from the first three appointments , during 10 days in January 1989 . Patients participating in the pilot study , reattending during the study period , or attending antenatal clinics were excluded . MAIN OUTCOME MEASURES -- Patients ' attitude to making appointments and reasons for attending , including perception of urgency , with respect to sociodemographic and psychosocial data obtained from a self completed question naire before the consultation . Doctors ' diagnosis and perception of urgency obtained from a separate question naire . RESULTS --86 % ( 141/172 ) Of patients attending without appointments and 96 % ( 139/145 ) with appointments responded to the question naire . The need for consultation was considered to be " very urgent " or " fairly urgent " in significantly more of the open access group than the appointments group ( 89 % , 124/139 v 66 % , 91/138 ; chi 2 = 27.04 , df = 3 ; p less than 0.001 ) , although the doctors did not share the same views . Significantly more patients had self limiting conditions of recent onset in the open access than in the appointments group ( 75 % , 101/135 v 48 % , 59/123 : p less than 0.001 ) . Overall , open access attendance was significantly linked with social support ( 39 % , 48/124 v 26 % , 32/123 ; p less than 0.05 ) and with marital separations or intentions to separate ( 10 % , 9/87 v 0/92 ; 47 % , 32/87 v 22 % , 20/92 respectively ; both p less than 0.001 ) , but the doctors recorded significantly fewer psychological and social problems in these patients ( p less than 0.05 ) . Although almost half those in the appointments group considered that making appointments was inconvenient , more of those in the open access group agreed with this view ( 47 % , 60/129 v 61 % , 80/131 ) . CONCLUSIONS --There was an important link between social support problems and a negative attitude to making appointments . In our previous experience encouraging patients to make appointments has been unsuccessful ; practice s serving areas with a high prevalence of social deprivation providing a mixed open access and appointments system may better serve patients ' needs
Output:
| RESULTS AND CONCLUSIONS The epidemiology of non-attendance has been well described , but there is little work on the reasons for non-attendance . |
MS211321 | ***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 . We performed a r and omised controlled study regarding the effects of and rogen replacement therapy ( ART ) on lower urinary tract symptoms ( LUTS ) in hypogonadal men with benign prostate hypertrophy ( BPH ) . Methods . Fifty-two patients with hypogonadism and BPH were r and omly assigned to receive testosterone ( ART group ) as 250 mg of testosterone enanthate every 4 weeks or to the untreated control group . We compared International Prostate Symptom Score ( IPSS ) , uroflowmetry data , post-voiding residual volume ( PVR ) and systemic muscle volume at baseline and 12 months after treatment . Results . Forty-six patients ( ART group , n = 23 ; control , n = 23 ) were included in the analysis . At the 12-month visit , IPSS showed a significant decrease compared with baseline in the ART group ( 15.7 ± 8.7 vs. 12.5 ± 9.5 ; p < 0.05 ) . No significant changes were observed in the control group . The ART group also showed improvement in maximum flow rate and voided volume ( p < 0.05 ) , whereas no significant improvements were observed in the controls . PVR showed no significant changes in either group . In addition , the ART group showed significant enhancement of mean muscle volume ( p < 0.05 ) , whereas no significant changes were seen in the controls . Conclusion . ART improved LUTS in hypogonadal men with mild BPH Although weight loss associated with human immunodeficiency virus ( HIV ) infection is multifactorial in its pathogenesis , it has been speculated that hypogonadism , a common occurrence in HIV disease , contributes to depletion of lean tissue and muscle dysfunction . We , therefore , examined the effects of testosterone replacement by means of And roderm , a permeation-enhanced , nongenital transdermal system , on lean body mass , body weight , muscle strength , health-related quality of life , and HIV-disease markers . We r and omly assigned 41 HIV-infected , ambulatory men , 18 - 60 yr of age , with serum testosterone levels below 400 ng/dL , to 1 of 2 treatment groups : group I , two placebo patches ( n = 21 ) ; or group II , two testosterone patches design ed to release 5 mg testosterone over 24 h. Eighteen men in the placebo group and 14 men in the testosterone group completed the 12-week treatment . Serum total and free testosterone and dihydrotestosterone levels increased , and LH and FSH levels decreased in the testosterone-treated , but not in the placebo-treated , men . Lean body mass and fat-free mass , measured by dual energy x-ray absorptiometry , increased significantly in men receiving testosterone patches [ change in lean body mass , + 1.345 + /- 0.533 kg ( P = 0.02 compared to no change ) ; change in fat-free mass , + 1.364 + /- 0.525 kg ( P = 0.02 compared to no change ) ] , but did not change in the placebo group [ change in lean body mass , 0.189 + /- 0.470 kg ( P = NS compared to no change ) ; change in fat-free mass , 0.186 + /- 0.470 kg ( P = NS compared to no change ) ] . However , there was no significant difference between the 2 treatment groups in the change in lean body mass . The change in lean body mass during treatment was moderately correlated with the increment in serum testosterone levels ( r = 0.41 ; P = 0.02 ) . The testosterone-treated men experienced a greater decrease in fat mass than those receiving placebo patches ( P = 0.04 ) . There was no significant change in body weight in either treatment group . Changes in overall quality of life scores did not correlate with testosterone treatment ; however , in the subcategory of role limitation due to emotional problems , the men in the testosterone group improved an average of 43 points of a 0 - 100 possible score , whereas those in the placebo group did not change . Red cell count increased in the testosterone group ( change in red cell count , + 0.1 + /- 0.1 10(12)/L ) but decreased in the placebo group ( change in red cell count , -0.2 + /- 0.1 10(12)/L ) . CD4 + and CD8 + T cell counts and plasma HIV copy number did not significantly change during treatment . Serum prostate-specific antigen and plasma lipid levels did not change in either treatment group . Testosterone replacement in HIV-infected men with low testosterone levels is safe and is associated with a 1.35-kg gain in lean body mass , a significantly greater reduction in fat mass than that achieved with placebo treatment , an increased red cell count , and an improvement in role limitation due to emotional problems . Further studies are needed to assess whether testosterone supplementation can produce clinical ly meaningful changes in muscle function and disease outcome in HIV-infected men The male aging process brings about declines in hormonal function including a gradual decline in bioavailable testosterone levels . Animal studies suggest that testosterone modulates cognitive function through enhancing acetylcholine release and up-modulation of nicotinic receptors . Tau protein deposition is also affected by and rogen supplementation in animals . We hypothesize that testosterone replacement in elderly hypogonadal males may improve cognition , in particular the visual-spatial domain . Thirty-six male patients with a new diagnosis of Alzheimer 's disease had their total and bioavailable testosterone levels measured . None of the patients had been on acetylcholinesterase inhibitors . Ten of the 36 patients ( 28 % ) were deemed biochemically hypogonadal ( total testosterone < 240 ng/dl or 7 nmol/l ) . Five of the hypogonadal patients were r and omized to testosterone and five to placebo . Initial Alzheimer 's Disease Assessment Scale cognitive subscale ( ADAScog ) and Mini Mental Status Examination ( MMSE ) ranged from 31 to 19 and from 17 to 22 , respectively . The clock drawing test ( CDT ) and the pentagon-tracing portion of the MMSE were used as measures of visual-spatial abilities . Normal prostate-specific antigen ( PSA ) levels were essential before treatment with intramuscular testosterone , 200 mg every 2 weeks . Measurement of testosterone , complete blood count , lipids , PSA and neuropsychological cognitive tests were repeated at 3 , 6 , 9 and 12 months of treatment . In the testosterone-treated group , levels of total testosterone increased from a mean of 126.4 ng/dl to 341 ng/dl or 3.6 nmol/l to 9.7 nmol/l ( p = 0.11 ) . Bioavailable testosterone also increased from a mean of 48.7 ng/dl to 142 ng/dl or 1.39 nmol/l to 4.05 nmol/l ( p = 0.10 ) . PSA levels were also elevated from a mean of 0.98 to 1.37 ng/ml ( p = 0.07 ) . ADAScog improved from a mean of 25 to 16.3 ( p = 0.02 ) ; MMSE improved from a mean of 19.4 to 23.2 ( p = 0.02 ) , CDT also improved from 2.2 to 3.2 ( p = 0.07 ) . One patient stopped treatment because of hypersexual behavior . The placebo-treated group deteriorated gradually . This small pilot study performed in aging male patients suggests that testosterone could indeed improve cognition , including visual-spatial skills in mild to moderate Alzheimer 's disease CONTEXT Prostate safety is a primary concern when aging men receive testosterone replacement therapy ( TRT ) , but little information is available regarding the effects of TRT on prostate tissue in men . OBJECTIVE To determine the effects of TRT on prostate tissue of aging men with low serum testosterone levels . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled trial of 44 men , aged 44 to 78 years , with screening serum testosterone levels lower than 300 ng/dL ( < 10.4 nmol/L ) and related symptoms , conducted at a US community-based research center between February 2003 and November 2004 . INTERVENTION Participants were r and omly assigned to receive 150 mg of testosterone enanthate or matching placebo intramuscularly every 2 weeks for 6 months . MAIN OUTCOME MEASURES The primary outcome measure was the 6-month change in prostate tissue and rogen levels ( testosterone and dihydrotestosterone ) . Secondary outcome measures included 6-month changes in prostate-related clinical features , histology , biomarkers , and epithelial cell gene expression . RESULTS Of the 44 men r and omized , 40 had prostate biopsies performed both at baseline and at 6 months and qualified for per- protocol analysis ( TRT , n = 21 ; placebo , n = 19 ) . Testosterone replacement therapy increased serum testosterone levels to the mid-normal range ( median at baseline , 282 ng/dL [ 9.8 nmol/L ] ; median at 6 months , 640 ng/dL [ 22.2 nmol/L ] ) with no significant change in serum testosterone levels in matched , placebo-treated men . However , median prostate tissue levels of testosterone ( 0.91 ng/g ) and dihydrotestosterone ( 6.79 ng/g ) did not change significantly in the TRT group . No treatment-related change was observed in prostate histology , tissue biomarkers ( and rogen receptor , Ki-67 , CD34 ) , gene expression ( including AR , PSA , PAP2A , VEGF , NXK3 , CLU [ Clusterin ] ) , or cancer incidence or severity . Treatment-related changes in prostate volume , serum prostate-specific antigen , voiding symptoms , and urinary flow were minor . CONCLUSIONS These preliminary data suggest that in aging men with late-onset hypogonadism , 6 months of TRT normalizes serum and rogen levels but appears to have little effect on prostate tissue and rogen levels and cellular functions . Establishment of prostate safety for large population s of older men undergoing longer duration of TRT requires further study . Trial Registration clinical trials.gov Identifier : NCT00161304 Clinical studies suggest there may be a threshold concentration of serum testosterone below which replacement will result in skeletal and psychological benefit . We evaluated the response to testosterone in men with borderline hypogonadism . A r and omized double-blind placebo-controlled trial in 39 men over age 40 years presenting with sexual dysfunction and a borderline low testosterone level ( total testosterone < 10 nmol/L or free and rogen index < 30 % ) . Patients were r and omized to Testoderm TTS body patch ( 5 mg/day , n = 20 ) or a placebo patch ( n = 19 ) for 6 months , followed by open-label testosterone replacement for a further 6 months in all patients . During the placebo-controlled phase of the study serum testosterone increased significantly on testosterone vs. placebo treatment ( p = 0.004 ) ; this was associated with a decrease in total body fat mass ( p = 0.019 ) and increase in haemoglobin level ( p = 0.036 ) . There were no significant changes in lean body mass , markers of bone turnover , and measures of bone mineral density ( BMD ) . There was evidence of difference in quality of life according to the Male Erectile Dysfunction Quality of Life question naire ( MEDQoL score , p = 0.017 ) , mainly accounted for by deterioration in the placebo arm . When the active treatment period was combined for placebo and testosterone groups , the within-patient analysis showed a significant effect of testosterone to decrease markers of bone resorption ( uNTX/Cr , p = 0.007 ; iFDPD/Cr , p = 0.0006 ) and to increase lean body mass ( p = 0.001 ) . There was little convincing evidence from this study that testosterone replacement is likely to have major benefit in men over age 40 years with borderline hypogonadism and sexual dysfunction . However , there was evidence of suppression in bone resorption and hence longer and larger studies are needed to examine its effect on BMD OBJECTIVE To investigate the effect of testosterone treatment on insulin resistance , glycemic control , and dyslipidemia in Asian Indian men with type 2 diabetes mellitus ( T2DM ) and hypogonadism . METHODS We conducted a double-blind , placebo-controlled , crossover study in 22 men , 25 to 50 years old , with T2DM and hypogonadism . Patients were treated with intramuscularly administered testosterone ( 200 mg every 15 days ) or placebo for 3 months in r and om order , followed by a washout period of 1 month before the alternative treatment phase . The primary outcomes were changes in fasting insulin sensitivity ( as measured by homeostasis model assessment [ HOMA ] in those patients not receiving insulin ) , fasting blood glucose , and hemoglobin A1c . The secondary outcomes were changes in fasting lipids , blood pressure , body mass index , waist circumference , waist-to-hip ratio , and and rogen deficiency symptoms . Statistical analysis was performed on the delta values , with the treatment effect of place
Output:
| Testosterone replacement therapy does not increase PSA levels in men being treated for hypogonadism , except when it is given IM and even the increase with IM administration is minimal |
MS211322 | ***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 examines the evidence demonstrating the effectiveness of sealants in high-caries-risk children and discusses the Research Triangle Institute/University of North Carolina 's ( RTI/UNC ) systematic review . The strict RTI/UNC protocol limited the number of sealant studies that could be included . This analysis exp and ed their criteria to permit additional methods of determining caries risk ( for example , past caries experience , less than two pairs of sound first permanent molars available/child in half-mouth design s ) and outcome measures in addition to DMFS ( that is , percent sealant retention , survival rates , cost-effectiveness , changes in salivary S. mutans levels ) . Nine clinical studies with a r and omized , half-mouth , clinical trial design and seven studies with observational study design s were included . There is good evidence that sealants can be used efficaciously and effectively in high-risk children as long as the sealant is retained . Sealants are more effective in preventing further caries and providing cost savings in a shorter time span if placed in children who have high rather than low caries risk The aim of the investigation was to evaluate the effect of chlorhexidine gel treatment on caries development of approximal tooth surfaces and on salivary counts of Streptococcus mutans . 220 12-year-old schoolchildren , divided into three groups , participated : ( 1 ) chlorhexidine gel group ( n = 72 ) , ( 2 ) placebo gel group ( n = 77 ) , and ( 3 ) control group ( n = 71 ) . The study was carried out double blind with respect to the two gel groups . Group 1 was treated 4 times/year with 1 % chlorhexidine gel and group 2 with a placebo gel . Approximately 1 ml of gel was applied interdentally by means of a flat dental floss . The control group did not receive any gel treatment or flossing . Number of S. mutans in the saliva was estimated on five occasions during the study with the spatula method . After 3 years , the mean approximal caries increment , expressed as new DFS , was 2.50 in the chlorhexidine gel group and 4.30 in the placebo gel group ( p less than 0.05 ) . The corresponding figure in the control group was 5.25 ( p less than 0.001 when compared to group 1 ) . 44 % of the children in the chlorhexidine gel group and 32 % in the placebo gel group did not develop any new approximal caries lesion during the 3-year observation period compared to 18 % in the control group ( group 1 - 3 p less than 0.001 ; group 2 - 3 p less than 0.05 ) . The number of new approximal fillings ( FS ) was 0.24 in the chlorhexidine gel group , 0.75 in the placebo gel group and 0.82 in the control group ( group 1 - 3 p less than 0.01 ; group 2 - 3 p less than 0.05 ) . There was no statistically significant difference between the groups with respect to numbers of S. mutans in saliva . However , there were more individuals with low numbers of S. mutans in the chlorhexidine gel group at the final examination compared to the baseline level ( p less than 0.05 ) The present study compares visible-light Delton with Duraphat fluoride varnish for the prevention of occlusal caries in permanent first molars . A clinical trial was carried out in three groups of 6 - 8-yr-old schoolchildren : a sealant group ( 100 children ) , in which Delton light-polymerized fissure sealant was applied to permanent first molars ; a varnish group ( 98 children ) , in which Duraphat was applied to permanent first molars ; and a control group ( 116 children ) . Replacement ( sealant ) and reapplication ( varnish ) was carried out every 6 months . Percent effectiveness at 24 months ( percentage of saving from caries taking molars as analysis unit ) for those molars initially healthy and with complete occlusal eruption was analyzed . 272 , 252 and 238 molars met the inclusion criteria in the control , varnish and sealant groups , respectively . Of these , 45.2 % , 28.2 % and 10.5 % developed caries after 24 months . The effectiveness was greater in the sealed molars than in the varnished molars ( 62.7 % ) Results of a 3-year clinical trial of Delton fissure sealant resin are reported . 41 % of first molar fissures remained fully sealed after 3 years . Significant differences were found between the levels of resin retention produced by the two operators and retention was significantly better on m and ibular molars than on maxillary molars . In a separate group of 11-year-old children 77 % of fissures were full)’sealed after 3 years The effect of daily toothbrushing with 0.5 % chlorhexidine-containing gel for 12 months was evaluated in a double-blind study in 37 dental students . The active gel did not markedly influence plaque formation , gingival conditions , or caries as compared with placebo gel treatment . Salivary bacterial counts were performed on subgroups of six subjects using chlorhexidine gel and on six using placebo gel . No differences in the effect of treatment on the microorganisms studied in the two subgroups could be detected except for S. sanguis . The percentage of this species decrease in the placebo group and increased in the chlorhexidine group . The difference became significant after 2 weeks . A tendency to a greater reduction of S. mutans noted in the chlorhexidine group was most marked in individuals who had high initial counts of this species . The proportion of S. sanguis , which could grow on chlorhexidinei-containing mitis salivarius medium , increased and after 12 months of chlorhexidine treatment averaged 34 % of cultivable S. sanguis compared with 0.002 % prior to treatment . The number of less sensitive S. sanguis decreased in the 12 months following termination of treatment . There was no observed tendency for the selection or proliferation of other streptococci , gram-negative rods , yeasts , or staphylococci The objective of this study was to compare Delton visible-light fissure sealant with Duraphat fluoride varnish in the prevention of occlusal caries in permanent first molars . A 48-month clinical trial was carried out in three groups of 6- to 8-year-old schoolchildren : a sealant group ( 104 children ) , in which Delton was used ; a varnish group ( 112 children ) , in which Duraphat was used ; and a control group ( 128 children ) . Sealant or varnish was applied to all sound permanent first molars , according to group . Replacement ( sealant ) and reapplication ( varnish ) was carried out every 6 months . A survival analysis was used to describe the molar failures over time in the three groups . A Cox proportional hazards regression model was built to test the influence of group on molar failure . The median survival times were 28.6 months for the control molars and more than 48 months for both sealed and varnished molars . The Cox model indicated a hazard ratio of 0.177 for the sealant vs control comparison , 0.463 for varnish vs control and 0.382 for sealant vs varnish The effects of some oral hygiene measures on Streptococcus mutans and approximal dental caries were evaluated . One hundred and eighty-seven 13-year-old individuals with high levels of salivary S. mutans ( > 106/mL ) were selected . They were r and omly distributed into three groups . Group I initially received professional mechanical toothcleaning , tongue-scraping , chlorhexidine treatment , and oral hygiene instructions concentrated on the approximal surfaces most colonized by S. mutans . The treatment was given four times with intervals of two days , followed by one single treatment every six months throughout the experimental period . The initial treatment period for group II , also consisting of four visits , included the same oral hygiene instructions as for group 1 . The instructions were repeated every six months . Group III was maintained in the preventive program provided by the local Dental Health Office , based on mechanical plaque control and topical use of fluorides and chlorhexidine at individualized intervals . Group I showed a significant immediate reduction of S. mutans in saliva as well as on approximal tooth surfaces . After six months , there were no differences among the three groups regarding these variables . Compared with baseline , there was a significant reduction of S. mutans in all groups . There was no significant difference in caries progression among the three groups . However , the selected " high-risk " individuals in group I developed 0.25 new manifest caries lesions approximallylyear , compared with 0.27 for all children of the same age group in the area . Seventeen individuals had approximal surfaces with consistently high or consistently low S. mutans levels . Forty-six percent of the surfaces with high values developed new or progressive caries , compared with 2 % of the surfaces with low values A 3-year prospect i ve study was design ed to evaluate sealants in preventing the formation and progression of caries in a young adult military population . United States Navy dentists performed dental examinations on recruits being in-processed at the Naval Training Center , San Diego , California . Contralateral molar pairs ( same arch ) without caries or restorations were selected . Occlusal decalcification and lesions limited to enamel were also eligible , but teeth with proximal decalcification were disqualified . The sample consisted of 860 molar pairs in 529 Navy recruits , each contributing one or two pairs . Required annual dental examinations provided follow-up data , with results being recorded on postcards that were mailed back to the investigator . Yearly response rates were as follows : 1 year , 62.2 % ( 483 molar pairs ) ; 2 year , 47.8 % ( 378 molar pairs ) ; and 3 year , 41.4 % ( 317 molar pairs ) . The response rate for pairs having at least one observation during the 3-year follow-up was 72.6 % ( 563 molar pairs ) , with a caries conversion rate of 1.2 % ( 7 teeth ) on sealed teeth and 5.3 % ( 32 teeth ) on control teeth , yielding 35 discordant molar pairs on 33 recruits ( 30 on control teeth and 5 on sealed teeth ) ( p < 0.0001 ) . These results confirm the efficacy of sealants in significantly reducing the rate caries in a young adult military population The aim of this study was to evaluate the effect of professional flossing with NaF and SnF2 gels on caries development on approximal tooth surfaces . Two-hundred- and -eighty 13-year-old schoolchildren were divided into 3 groups : ( 1 ) NaF ( n = 97 ) , ( 2 ) SnF2 ( n = 85 ) , and ( 3 ) placebo gel group ( n = 98 ) . The investigation was carried out double-blind . The children were treated 4 times a year for 3 years with 1 % NaF gel , 1 % SnF2 gel , or placebo gel . The treatment was carried out by dental nurses and the time required per visit was approximately 10 min . After 3 years , the mean approximal caries increment , including initial caries lesions , was 2.8 in the NaF , 2.4 in the SnF2 , and 4.0 in the placebo gel group ( P < 0.05 for SnF2 vs placebo ) ; a reduction compared to the placebo of 30 % and 39 % in the NaF and SnF2 groups , respectively . Thus , professional flossing with NaF or SnF2 gel carried out 4 times a year may be considered as an interesting caries-preventing method for large-scale application in schoolchildren The aim of this study , performed in Bangkok , was to evaluate the possibility of reducing fissure caries development using an antimicrobial varnish , Cervitec . Children aged 7 - 8 years and 12 - 13 years , 251 in each age group , with at least 2 sound contra-lateral permanent molars , were selected . A split mouth method was used with one test and one control tooth within the same jaw . At baseline and after two years all children were investigated for DMFS and DMFT . In addition , the size of any cavities was estimated . From 200 children , plaque sample s of test and control occlusal surfaces were collected at baseline and after one year and processed to estimate the number of mutans streptococci . Mutans streptococci in saliva were estimated by the Strip mutans method . Cervitec varnish , containing 1 per cent chlorhexidine and thymol was applied at baseline , after 3 - 4 and after 8 - 9 months . The results showed that : Cervitec varnish reduced fissure caries development significantly ; the levels of salivary mutans streptococci at baseline were significantly correlated with caries status at baseline and with total caries increment over the two-year period ; caries development in a fissure was significantly correlated to the level of plaque mutans streptococci at that same site ; three months after the last varnish application , a certain reduction of mutans streptococci in plaque could be seen in the test teeth ; comparing the size of the lesions , more large cavities were found in the untreated teeth . It is concluded that varnishes should be considered as further options for prevention of fissure caries , possibly in more individualised programmes or in combination with already established methods A total of 220 children were examined at 4 1/2 years ( 54 months ) after a single application of a pit and fissure sealant . In 110 children , 177 permanent first molars were treated with Nuva-Seal ; and in 110 children , 168 permanent first molars were treated with Delton . Nuva-Seal was completely retained on 35 % of all paired permanent molars , partially retained on
Output:
| Estimates for the number of patients or tooth surfaces needed to treat to prevent a carious event suggest that the effects of these professional treatments are low in patients who are at reduced risk for dental caries . |
MS211323 | ***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 : Patients on dietary , weight-reducing treatment commonly are advised against alcohol consumption . In light of the widespread use of alcoholic beverages and the well-established benefits of light to moderate alcohol consumption in risk reduction , a revision of dietary treatment recommendations may be warranted . OBJECTIVE : To investigate whether daily consumption of moderate amounts of alcohol influences the effectiveness of an energy-restricted diet in overweight and obese subjects . DESIGN : A prospect i ve r and omized clinical trial was conducted , with a 3-months intervention period and two isocaloric dietary regimens containing 6.3 MJ ( 1500 kcal ) each , one with 10 % of energy from white wine and one with 10 % of energy from grape juice . The trial was performed in obese subjects being recruited from the Obesity Outpatient Clinic at the University Hospital , Ulm , who all habitually consumed moderate amounts of alcohol . Out of 87 patients , 49 were eligible to participate and 40 completed the study ( age 48.1±11.4 y , BMI 34.2±6.4 kg/m2 ) . Efficacy parameters were body weight and biomarkers of good health . RESULTS : All subjects achieved significant body weight reduction . Weight loss in the grape juice group and white wine group was 3.75±0.46 and 4.73±0.53 kg , respectively . Percent body fat , waist circumference , blood pressure , blood glucose , insulin , triglycerides , and cholesterol were reduced . The antioxidant status was unchanged , as were liver enzyme activities and other safety parameters . There were no significant differences between the groups . CONCLUSIONS : An energy-restricted diet is effective in overweight and obese subjects used to drinking moderate amounts of alcohol . A diet with 10 % of energy derived from white wine is as effective as an isocaloric diet with 10 % of energy derived from grape juice CONTEXT Epidemiologic data demonstrate that moderate alcohol intake is associated with improved insulin sensitivity in nondiabetic individuals . No controlled-diet studies have addressed the effects of daily moderate alcohol consumption on fasting insulin and glucose concentrations and insulin sensitivity . OBJECTIVE To determine whether daily consumption of low to moderate amounts of alcohol influences fasting insulin and glucose concentrations and insulin sensitivity in nondiabetic postmenopausal women . DESIGN , SETTING , AND PARTICIPANTS R and omized controlled crossover trial of 63 healthy postmenopausal women , conducted at a clinical research center in Maryl and between 1998 and 1999 . INTERVENTIONS Participants were r and omly assigned to consume 0 , 15 , or 30 g/d of alcohol for 8 weeks each as part of a controlled diet . All foods and beverages were provided during the intervention . An isocaloric beverage was provided in the 0-g/d arm . Energy intake was adjusted to maintain constant body weight . MAIN OUTCOME MEASURES Fasting insulin , triglyceride , and glucose concentrations , measured at the end of each dietary period ; insulin sensitivity , estimated with a published index of glucose disposal rate corrected for fat-free mass based on fasting insulin and fasting triglyceride concentrations , compared among treatments with a mixed-model analysis of variance . RESULTS A complete set of plasma sample s was collected and analyzed for 51 women who completed all diet treatments . Consumption of 30 g/d of alcohol compared with 0 g/d reduced fasting insulin concentration by 19.2 % ( P = .004 ) and triglyceride concentration by 10.3 % ( P = .001 ) , and increased insulin sensitivity by 7.2 % ( P = .002 ) . Normal-weight , overweight , and obese individuals responded similarly . Only fasting triglyceride concentration was significantly reduced when comparing 0 and 15 g/d of alcohol ( 7.8 % ; P = .03 ) , and no difference was found between consumption of 15 and 30 g/d of alcohol ; however , there was a significant linear trend ( P = .001 ) . Fasting glucose concentrations were not different across treatments . CONCLUSIONS Consumption of 30 g/d of alcohol ( 2 drinks per day ) has beneficial effects on insulin and triglyceride concentrations and insulin sensitivity in nondiabetic postmenopausal women Epidemiologic studies indicate that alcohol consumption is associated with improved insulin sensitivity ; however , scant experimental evidence confirms this observation . To determine the effects of regular moderate wine consumption on insulin sensitivity , 20 overweight women ( body mass index [ BMI ] , 29.8 + /- 2.2 kg/m2 ) participated in a 20-week free-living r and omized crossover trial . The subjects , serving as their own controls , consumed wine ( 190 mL red wine , 13 % vol/vol ethanol , 5 days per week ) for 10 weeks and abstained for 10 weeks or vice versa . The dependent variables ( body weight , BMI , percent body fat , blood pressure , fasting blood glucose and insulin , blood lipids , dietary intake , and insulin sensitivity by intravenous glucose tolerance test [ IVGTT ] ) were measured at the pretest , at the 10-week crossover , and at the 20-week completion of the study . Data were analyzed at the pretest and at completion of the wine drinking and abstention periods of the study using ANOVA by order of treatment . Fasting glucose remained unchanged ( mean + /- SD ; P > .05 ) throughout the experiment ( pretest , drinking , and abstention , 91.1 + /- 9.2 , 91.6 + /- 9.1 , and 88.5 + /- 11.2 mg/dL ) , as did the measures of insulin sensitivity , fasting insulin ( pretest , drinking , and abstention , 8.6 + /- 3.3 , 8.6 + /- 4.1 , and 9.1 + /- 4.7 microU/mg ) and the insulin sensitivity index ( 3.60 + /- 2.96 , 3.25 + /- 2.17 , and 3.30 + /- 1.84 ) . Body composition and blood lipids also remained unchanged ( P > .05 ) during treatment . Moderate wine consumption at this dose in overweight women did not improve or impair insulin sensitivity , nor did it change any of the known correlates of insulin sensitivity , including body weight and composition , blood lipids , and blood pressure OBJECTIVE To investigate the effect of moderate alcohol consumption on fat distribution , adipose tissue secreted proteins ( adiponectin and resistin ) , and insulin sensitivity in healthy middle-aged men with abdominal obesity . RESEARCH METHODS AND PROCEDURES Thirty-four healthy men between 35 and 70 years old , with increased waist circumference ( > or = 94 cm ) , participated in a r and omized , controlled cross-over design trial . They drank 450 mL of red wine ( 40 grams of alcohol ) or 450 mL of de-alcoholized red wine daily during 4 weeks . At the end of each treatment period , fat distribution , adipose tissue proteins , and insulin sensitivity index ( ISI ) were measured . RESULTS Subcutaneous and abdominal fat contents and body weight did not change after 4 weeks of moderate alcohol consumption . Liver fat ( quip index ) was slightly higher after consumption of red wine ( 6.8 + /- 0.1 ) as compared with de-alcoholized red wine ( 6.5 + /- 0.1 ) but not significantly different ( p = 0.09 ) . Plasma adiponectin concentration increased ( p < 0.01 ) to 6.0 + /- 0.1 microg/mL after 28 days of moderate alcohol consumption compared with de-alcoholized red wine ( 5.5 + /- 0.1 microg/mL ) . Serum resistin concentrations and ISI were not affected by alcohol consumption . Percentage changes in serum resistin correlated significantly with changes in ISI ( r = -0.69 , p < 0.01 ) , whereas this correlation was not present between changes in plasma adiponectin and ISI ( r = 0.31 , p = 0.22 ) . DISCUSSION Moderate alcohol consumption for 4 weeks is not associated with differences in subcutaneous and abdominal fat contents or body weight . Thus , the 10 % increase in adiponectin was not associated with a change in fat distribution or body weight change Objectives . To eluci date whether consumption of two Chinese liquors , tea-flavor liquor ( TFL ) and traditional Chinese liquor ( TCL ) have protective effects on cardiovascular disease ( CVD ) risk factors in healthy human subjects . Methods . Forty-five healthy subjects ( 23 men , 22 women ) , aged 23–28 , were recruited and r and omized into two groups : TFL and TCL , and consumed 30 mL/day ( 45 % ( v/v ) alcohol ) of either liquor for 28 days . Results . Serum high-density lipoprotein cholesterol/low-density lipoprotein cholesterol ( HDL-C/LDL-C ) and apolipoprotein A1 were significantly increased , and total cholesterol ( TC ) and TC/HDL-C were significantly decreased after the intervention in both groups ( P < 0.05 ) . Serum uric acid ( P = 0.004 for TFL , P = 0.001 for TCL ) , glucose ( P < 0.001 for TFL , P < 0.001 for TCL ) and endothelial adhesion molecules ( P < 0.05 ) were significantly decreased after the intervention . ADP-induced whole blood platelet aggregation was also significantly decreased after the intervention in both TFL and TCL groups ( P < 0.05 ) . Conclusions . TFL and TCL consumption had protective effects on CVD risk factors in young humans . However , the results were valid only for 28 days , and that the possibility of adverse effect ( liver , kidney ) of chronic alcohol consumption should be considered Moderate alcohol consumption is associated with increased concentrations of adiponectin . Whether this is the case for both total and high-molecular-weight ( HMW ) adiponectin is uncertain . Furthermore , the rate at which this increase occurs is unclear . Therefore , we examined the effect of moderate alcohol consumption on total and HMW adiponectin . In a r and omized , crossover trial , 24 premenopausal women who were regular alcohol consumers received beer ( ∼26 g alcohol ) or alcohol-free beer daily for 3 weeks preceded by a 1-week washout . Blood sample s were collected weekly after an overnight fast for measurement of total and HMW adiponectin and markers of glucose and lipid metabolism . There was a significant interaction ( P < .05 ) between the 2 treatments over time for both plasma HMW and total adiponectin concentrations . Within 3 weeks , plasma total ( 8.2 % , P = .01 ) and HMW ( 8.2 % , P = .02 ) adiponectin levels were higher after moderate alcohol consumption compared with abstention . Changes over time in total adiponectin were positively associated with changes in HMW adiponectin during the nonalcoholic beer ( r = 0.80 ; 95 % confidence interval , 0.55 - 0.92 ) and beer ( r = 0.82 ; 0.58 - 0.93 ) intervention . Alcohol consumption did not affect the ratio of HMW to total adiponectin or the serum glucose , insulin , hemoglobin A(1c ) , or triglyceride levels compared with abstention during the intervention periods . Both total and HMW adiponectin concentrations are higher after moderate alcohol consumption compared with abstention in premenopausal women . These effects were evident after at least 3 weeks of consumption and occurred concomitantly OBJECTIVE —In a r and omized controlled trial , we assessed the effect of daily moderate alcohol intake on glycemic control in the fasting and postpr and ial states in patients with type 2 diabetes who previously had abstained from alcohol . RESEARCH DESIGN AND METHODS —We r and omly assigned 109 patients ( 41–74 years old ) with established type 2 diabetes who abstained from alcohol to receive 150 ml wine ( 13 g alcohol ) or nonalcoholic diet beer ( control ) each day during a 3-month multicenter trial . The beverages were consumed during dinner . Diet and alcohol consumption were monitored . RESULTS —During the intervention , 17 % of participants ( 12 % from the alcohol group ) dropped out , leaving 91 who completed the trial . Within the alcohol group , fasting plasma glucose ( FPG ) decreased from 139.6 ± 41 to 118.0 ± 32.5 mg/dl after 3 months compared with 136.7 ± 15.4 to 138.6 ± 27.8 mg/dl in the control subjects ( Pv = 0.015 ) . However , alcohol consumption had no effect on 2-h postpr and ial glucose levels ( difference of 18.5 mg/dl in the control group vs. 17.7 mg/dl in the alcohol
Output:
| Although the studies had small sample sizes and were of short duration , the current evidence suggests that moderate alcohol consumption may decrease fasting insulin and HbA1c concentrations among nondiabetic subjects .
Alcohol consumption might improve insulin sensitivity among women but did not do so overall |
MS211324 | ***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 Undernutrition and weight loss are important determinants of clinical outcome in older patients after hip fracture but the effectiveness of nutritional support programs in routine clinical practice remains controversial . AIMS OF THE PROJECT : To determine if oral nutritional supplements given daily for 28 days after hip fracture surgery could prevent weight loss and /or lead to improved clinical outcomes ( mortality rates , discharge destination , activities of daily living or length of hospital stay ) in non-malnourished community-dwelling older women with hip fracture . METHODS One hundred and nine women with BMI range 20 - 30 kg/m(2 ) were allocated to either nutritional supplements ( 352 kcal/day ) or usual hospital nutrition using a quasi-r and omisation technique . Body weight changes were monitored at 4 and 8 weeks and clinical outcomes were recorded at discharge and at 6 months . RESULTS No significant differences in weight change or clinical outcomes were seen between the two groups . Compliance with consuming the nutritional supplements was quite variable and there was a significant negative correlation between the amount of supplement consumed and subsequent weight change ( r=-0.36 , P=0.019 ) . CONCLUSIONS Poor compliance with oral nutritional supplements is an important determinant of the effectiveness of oral nutritional interventions in preventing weight loss after hip fracture . Whilst this may explain the lack of clinical improvements seen , our data do not support the routine use of oral nutritional supplements in non-malnourished hip fracture patients To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results AIMS To investigate whether a nutritional intervention in older women and men with femoral neck fracture had an effect on postoperative complications during hospitalization and on nutritional status at a four-month follow-up . METHODS The design was a r and omized controlled trial . The present study sample consisted of 157 patients aged 70 years and above with femoral neck fracture . The nutritional intervention included , among other things , a nutritional journal to detect nutrition deficiencies and protein-enriched meals for at least four days postoperatively . Further , at least two nutritional and protein drinks were served each day during the whole hospitalization and other factors that would influence the patient 's nutrition were also considered and dealt with . Postoperative complications were registered and patients were assessed using the Mini Nutritional Assessment ( MNA ) scale , including body mass index ( BMI ) , on admission and at a four-month follow-up . RESULTS Malnutrition was common and low MNA scores were associated with postoperative complications such as delirium and decubitus ulcers . There were significantly fewer days of delirium in the intervention group , seven patients in the intervention group developed decubitus ulcers vs. 14 patients in the control group and the total length of hospitalization was shorter . There were no detectable significant improvements regarding nutritional parameters between the intervention and the control group at the four-month follow-up but men improved their mean BMI , body weight and MNA scores in both the intervention and the control groups while women deteriorated in both groups . CONCLUSIONS Malnutrition was common among older people with hip fractures admitted to hospital . The nutritional intervention might have contributed to the patients suffering fewer days with delirium , fewer decubitus ulcers and shorter hospitalization but did not improve the long-term nutritional status , at least not in women . RELEVANCE TO CLINICAL PRACTICE This nutritional intervention , which was included in a multifactorial multidisciplinary intervention , is inexpensive and relatively easy to implement . It has significant effects on complications but no long-term effect on nutritional parameters , at least not in women AIM To evaluate the effects of a protein-rich liquid supplementation , alone or in combination with the anabolic steroid n and rolone decanoate , on body composition , activities of daily living ( ADL ) status and the health-related quality of life ( HRQoL ) after a femoral neck fracture . METHODS Sixty women , aged 83 + /- 5 years ( mean + /- SD ) , BMI < 24 kg/m2 ( 20.4 + /- 2 kg/m2 ) and capable of co-operating , with a femoral neck fracture treated with internal fixation , were r and omised to open treatment during 6 months with a protein-rich liquid formula alone ( PR , Fortimel , 200 ml/day , 20 g protein/day ) or in combination with n and rolone decanoate ( PR/N , Deca-Durabol 25 mg i.m./3 weeks ) or to a control group ( C ) . The patients were re-examined after 6 and 12 months regarding body weight ( BW ) , lean body mass ( LBM , DXA ) , ADL status according to Katz , HRQoL according to EQ 5-D and fracture healing . RESULTS LBM decreased in the C ( -1.2 + /- 2 kg ) and PR groups ( -1.2 + /- 1 kg ) but remained the same in the PR/N group ( 0.3 + /- 1 kg ) ( P < 0.05 between groups ) . ADL remained at a high level in the two intervention groups but declined significantly in the C group ( P < 0.005 between groups ) . The decline in HRQoL was least pronounced in the PR/N group at 6 months ( P < 0.05 between groups ) . Patients with fracture healing complications lost more BW ( P < 0.05 ) and LBM ( P < 0.01 ) than patients with uneventful fracture healing . CONCLUSION Protein-rich liquid supplementation in combination with n and rolone given for 6 months to lean elderly women after a femoral neck fracture may positively affect LBM , ADL and A double-blind comparative study of 1 alpha-OHD3 and placebo was performed on 37 patients with osteoporotic hip fracture without clinical osteomalacia . 1 alpha-OHD3 , in a dose of 1 microgram/day together with 2.5 g CaCO3 , did not heal osteoporosis as judged from determinations of bone mineral density and histomorphometric analyses during four months of treatment . However , 1 alpha-OHD3 seemed to have an effect on fracture healing as concluded from the posttreatment alkaline phosphatase level . Hypercalcemia was common , occurring in six out of 19 patients treated with 1 alpha-OHD3 . It is concluded that treatment of osteoporosis with 1 alpha-OHD3 and calcium is ineffective and potentially dangerous because it frequently causes hypercalcemia Twenty patients underwent simultaneous bilateral medial unicompartmental knee arthroplasty . Pre-operative hip-knee-ankle alignment and valgus stress radiographs were used to plan the desired post-operative alignment of the limb in accordance with established principles for unicompartmental arthroplasty . In each patient the planned alignment was the same for both knees . Overall , the mean planned post-operative alignment was to 2.3 degrees of varus ( 0 degrees to 5 degrees ) . The side and starting order of surgery were r and omised , using conventional instrumentation for one knee and computer-assisted surgery for the opposite side . The mean variation between the pre-operative plan and the achieved correction in the navigated and the non-navigated limb was 0.9 degrees ( sd 1.1 ; 0 degrees to 4 degrees ) and 2.8 degrees ( sd 1.4 ; 1 degrees to 7 degrees ) , respectively . Using the Wilcoxon signed rank test , we found the difference in variation statistically significant ( p < 0.001 ) . Assessment of lower limb alignment in the non-navigated group revealed that 12 ( 60 % ) were within + /- 2 degrees of the pre-operative plan , compared to 17 ( 87 % ) of the navigated cases . Computer-assisted surgery significantly improves the post-operative alignment of medial unicompartmental knee arthroplasty compared to conventional techniques in patients undergoing bilateral simultaneous arthroplasty . Improved alignment after arthroplasty is associated with better function and increased longevity In a double-blind trial , 194 ambulatory elderly patients ( mean age , 74 + /- 8 years ) recovering from acute illnesses were r and omly assigned to receive either ornithine oxoglutarate ( OGO ) or a placebo . Nine subjects withdrew during the study , six in the OGO group and three in the placebo group . OGO and the placebo were administered once daily at a dose of 10 g after lunch for 2 months ; the patients were monitored for a total of 4 months . Efficacy was evaluated in terms of nutritional variables , quality of life and total cost of medical treatment . The analysis involved a total of 185 patients ( 93 in the placebo group and 92 in the OGO group ) . The two groups were comparable at inclusion . After 30 and 60 days of treatment , there was a significant improvement in the following variables in the OGO group relative to the placebo group : appetite ( p < 0.001 ) , body weight ( p < 0.001 ) and independence ( p < 0.01 ) . Two months after the end of treatment , there was still a significant improvement in the quality -of-life index ( p < 0.001 ) and the medical-cost index ( p < 0.03 ) in the OGO group , with an overall cost saving of 37 % . We conclude that OGO seems to be a cost-effective nutritional supplement for elderly convalescent patients OBJECTIVE To investigate the short- and long-term effects of a multidisciplinary postoperative rehabilitation programme in patients with femoral neck fracture . DESIGN AND SUBJECTS A r and omized controlled trial in patients ( n = 199 ) with femoral neck fracture , aged > or= 70 years . METHODS The primary outcomes were : living conditions , walking ability and activities of daily living performance on discharge , 4 and 12 months postoperatively . The intervention consisted of staff education , individualized care planning and rehabilitation , active prevention , detection and treatment of postoperative complications . The staff worked in teams to apply comprehensive geriatric assessment , management and rehabilitation . A geriatric team assessed those in the intervention group 4 months postoperatively , in order to detect and treat any complications . The control group followed conventional postoperative routines . RESULTS Despite shorter hospitalization , significantly more people from the intervention group had regained independence in personal activities of daily living performance at the 4- and 12-month follow-ups ; odds ratios ( 95 % confidence interval ( CI ) ) 2.51 ( 1.00 - 6.30 ) and 3.49 ( 1.31 - 9.23 ) , respectively . More patients in the intervention group had also regained the ability to walk independently indoors without walking aids by the end of the study period , odds ratio ( 95 % confidence interval ) 3.01 ( 1.18 - 7.61 ) . CONCLUSION A multidisciplinary postoperative intervention programme enhances activities of daily living performance and mobility after hip fracture , from both a short-term and long-term perspective BACKGROUND Low-energy fractures of the hip , forearm , shoulder , and spine are known consequences of osteoporosis . OBJECTIVE We evaluated the effect of 1 y of treatment with calcium and vitamin D on bone mineral density ( BMD ) and bone markers in patients with a recent low-energy fracture . DESIGN In a double-blinded design , patients with fracture of the hip ( lower-extremity fracture , or LEF ) or upper extremity ( UEF ) were r and omly assigned to receive 3000 mg calcium carbonate + 1400 IU cholecalciferol or placebo ( 200 IU cholecalciferol ) . BMD of the hip ( HBMD ) and lumbar spine ( LBMD ) were evaluated by dual-energy X-ray absorptiometry , and physical performance was assessed by the timed Up & Go test . Serum concentrations of 25-hydroxycholecalciferol , parathyroid hormone ( PTH ) , telepeptide of type I collagen ( ICTP ) , osteocalcin , and N-terminal propeptide of collagen type I were measured . RESULTS A total of 122 patients were included ( 84 % women ; x + /- SD age : 70 + /- 11 y ) ; 68 % completed the study . In an intention-to-treat analysis ,
Output:
| Protein supplementation may have reduced the number of long term complications and days spent in rehabilitation wards .
While some evidence exists for the effectiveness of oral protein and energy feeds , overall the evidence for the effectiveness of nutritional supplementation remains weak . |
MS211325 | ***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: AIM To assess the calcification process of the carotid plaque by (18)F-sodium fluoride PET/CT imaging . MATERIAL AND METHODS A prospect ively design ed study including 15 patients in whom an atheroma plaque was detected by contrast enhanced CT scan during a neurological work-up was performed . A total of 29 plaques , 19 asymptomatic and 10 symptomatic , were studied . An (18)F-sodium fluoride PET/CT scan was acquired 180min after the i.v . injection of 370 MBq of (18)F-sodium fluoride in all the patients . The images obtained were analyzed visually according to the intensity of the uptake . RESULTS All the plaques showed (18)F-sodium fluoride uptake , regardless of the intensity . However , the plaques of the symptomatic group showed a level of 2 or greater intensity while the intensity in 6 of the 19 in the asymptomatic group was lower than 2 . CONCLUSIONS Although the study is limited by the small number of cases , the results show the feasibility of the technique to study the calcification of the atheroma using (18)F-sodium fluoride and suggest an association between symptomatology and higher uptake of (18)F-sodium fluoride . Thus , these results encourage us to continue this study , with the inclusion of a larger number of patients Background — The pathophysiology of aortic stenosis is incompletely understood , and the relative contributions of valvular calcification and inflammation to disease progression are unknown . Methods and Results — Patients with aortic sclerosis and mild , moderate , and severe stenosis were compared prospect ively with age- and sex-matched control subjects . Aortic valve severity was determined by echocardiography . Calcification and inflammation in the aortic valve were assessed by 18F-sodium fluoride ( 18F-NaF ) and 18F-fluorodeoxyglucose ( 18F-FDG ) uptake with the use of positron emission tomography . One hundred twenty-one subjects ( 20 controls ; 20 aortic sclerosis ; 25 mild , 33 moderate , and 23 severe aortic stenosis ) were administered both 18F-NaF and 18F-FDG . Quantification of tracer uptake within the valve demonstrated excellent interobserver repeatability with no fixed or proportional biases and limits of agreement of ±0.21 ( 18F-NaF ) and ±0.13 ( 18F-FDG ) for maximum tissue-to- background ratios . Activity of both tracers was higher in patients with aortic stenosis than in control subjects ( 18F-NaF : 2.87±0.82 versus 1.55±0.17 ; 18F-FDG : 1.58±0.21 versus 1.30±0.13 ; both P<0.001 ) . 18F-NaF uptake displayed a progressive rise with valve severity ( r2=0.540 , P<0.001 ) , with a more modest increase observed for 18F-FDG ( r2=0.218 , P<0.001 ) . Among patients with aortic stenosis , 91 % had increased 18F-NaF uptake ( > 1.97 ) , and 35 % had increased 18F-FDG uptake ( > 1.63 ) . A weak correlation between the activities of these tracers was observed ( r2=0.174 , P<0.001 ) . Conclusions — Positron emission tomography is a novel , feasible , and repeatable approach to the evaluation of valvular calcification and inflammation in patients with aortic stenosis . The frequency and magnitude of increased tracer activity correlate with disease severity and are strongest for 18F-NaF. Clinical Trial Registration — http://www . clinical trials.gov . Unique identifier : NCT01358513 BACKGROUND The use of non-invasive imaging to identify ruptured or high-risk coronary atherosclerotic plaques would represent a major clinical advance for prevention and treatment of coronary artery disease . We used combined PET and CT to identify ruptured and high-risk atherosclerotic plaques using the radioactive tracers (18)F-sodium fluoride ( (18)F-NaF ) and (18)F-fluorodeoxyglucose ( (18)F-FDG ) . METHODS In this prospect i ve clinical trial , patients with myocardial infa rct ion ( n=40 ) and stable angina ( n=40 ) underwent (18)F-NaF and (18)F-FDG PET-CT , and invasive coronary angiography . (18)F-NaF uptake was compared with histology in carotid endarterectomy specimens from patients with symptomatic carotid disease , and with intravascular ultrasound in patients with stable angina . The primary endpoint was the comparison of (18)F-fluoride tissue-to- background ratios of culprit and non-culprit coronary plaques of patients with acute myocardial infa rct ion . FINDINGS In 37 ( 93 % ) patients with myocardial infa rct ion , the highest coronary (18)F-NaF uptake was seen in the culprit plaque ( median maximum tissue-to- background ratio : culprit 1·66 [ IQR 1·40 - 2·25 ] vs highest non-culprit 1·24 [ 1·06 - 1·38 ] , p<0·0001 ) . By contrast , coronary (18)F-FDG uptake was commonly obscured by myocardial uptake and where discernible , there were no differences between culprit and non-culprit plaques ( 1·71 [ 1·40 - 2·13 ] vs 1·58 [ 1·28 - 2·01 ] , p=0·34 ) . Marked (18)F-NaF uptake occurred at the site of all carotid plaque ruptures and was associated with histological evidence of active calcification , macrophage infiltration , apoptosis , and necrosis . 18 ( 45 % ) patients with stable angina had plaques with focal (18)F-NaF uptake ( maximum tissue-to- background ratio 1·90 [ IQR 1·61 - 2·17 ] ) that were associated with more high-risk features on intravascular ultrasound than those without uptake : positive remodelling ( remodelling index 1·12 [ 1·09 - 1·19 ] vs 1·01 [ 0·94 - 1·06 ] ; p=0·0004 ) , microcalcification ( 73 % vs 21 % , p=0·002 ) , and necrotic core ( 25 % [ 21 - 29 ] vs 18 % [ 14 - 22 ] , p=0·001 ) . INTERPRETATION (18)F-NaF PET-CT is the first non-invasive imaging method to identify and localise ruptured and high-risk coronary plaque . Future studies are needed to establish whether this method can improve the management and treatment of patients with coronary artery disease . FUNDING Chief Scientist Office Scotl and and British Heart Foundation The purpose of this study was to correlate 18F-sodium fluoride accumulation in the common carotid arteries of neurologically asymptomatic patients with cardiovascular risk factors and carotid calcified plaque burden . Methods : Two hundred sixty-nine oncologic patients were examined by 18F-sodium fluoride PET/CT . Tracer accumulation in the common carotid arteries was analyzed both qualitatively and semiquantitatively by measuring the blood-pool – corrected st and ardized uptake value ( target-to- background ratio ) and comparing it with cardiovascular risk factors and calcified plaque burden . Results : 18F-sodium fluoride uptake was observed at 141 sites in 94 ( 34.9 % ) patients . Radiotracer accumulation was colocalized with calcification in all atherosclerotic lesions . 18F-sodium fluoride uptake was significantly associated with age ( P < 0.0001 ) , male sex ( P < 0.0001 ) , hypertension ( P < 0.002 ) , and hypercholesterolemia ( P < 0.05 ) . The presence of calcified plaque correlated significantly with these risk factors but also with diabetes ( P < 0.0001 ) , history of smoking ( P = 0.03 ) , and prior cardiovascular events ( P < 0.01 ) . There was a highly significant correlation between the presence of 18F-sodium fluoride uptake and number of present cardiovascular risk factors ( r = 0.30 , P < 0.0001 ) . Conclusion : Carotid 18F-sodium fluoride uptake is a surrogate measure of calcifying carotid plaque , correlates with cardiovascular risk factors , and is more frequent in patients with a high-risk profile for atherothrombotic events but demonstrates a weaker correlation with risk factors than does calcified plaque burden . This study provides a rationale to conduct further prospect i ve studies to determine whether 18F-sodium fluoride uptake can predict vascular events , or if it may be used to monitor pharmacologic therapy Purpose Arterial inflammation and vascular calcification are regarded as early prognostic markers of cardiovascular disease ( CVD ) . In this study we investigated the relationship between CVD risk and arterial inflammation ( 18F-FDG PET/CT imaging ) , vascular calcification metabolism ( Na18F PET/CT imaging ) , and vascular calcium burden ( CT imaging ) of the thoracic aorta in a population at low CVD risk . Methods Study participants underwent blood pressure measurements , blood analyses , and 18F-FDG and Na18F PET/CT imaging . In addition , the 10-year risk for development of CVD , based on the Framingham risk score ( FRS ) , was estimated . CVD risk was compared across quartiles of thoracic aorta 18F-FDG uptake , Na18F uptake , and calcium burden on CT . Results A total of 139 subjects ( 52 % men , mean age 49 years , age range 21 – 75 years , median FRS 6 % ) were evaluated . CVD risk was , on average , 3.7 times higher among subjects with thoracic aorta Na18F uptake in the highest quartile compared with those in the lowest quartile of the distribution ( 15.5 % vs. 4.2 % ; P < 0.001 ) . CVD risk was on average , 3.7 times higher among subjects with a thoracic aorta calcium burden on CT in the highest quartile compared with those in the lowest two quartiles of the distribution ( 18.0 % vs. 4.9 % ; P < 0.001 ) . CVD risk was similar in subjects in all quartiles of thoracic aorta 18F-FDG uptake . Conclusion Our findings indicate that an unfavourable CVD risk profile is associated with marked increases in vascular calcification metabolism and vascular calcium burden of the thoracic aorta , but not with arterial inflammation Background — 18F-sodium fluoride ( 18F-NaF ) positron-emission tomography has been introduced as a potential noninvasive imaging tool to identify plaques with high-risk characteristics in patients with coronary artery disease . We sought to evaluate the clinical relevance of 18F-NaF uptake using optical coherence tomography ( OCT ) , intravascular ultrasound ( IVUS ) , and coronary computed tomography angiography in patients with coronary artery disease . Methods and Results — The target population consisted of 51 prospect ively enrolled patients ( 93 stenoses ) who underwent 18F-NaF positron-emission tomography before invasive coronary angiography . 18F-NaF uptake was compared with IVUS- and OCT-derived plaque characteristics . In the coronary computed tomography angiography subgroup ( 46 lesions ) , qualitative lesion characteristics were compared between 18F-NaF – positive and 18F-NaF – negative plaques using adverse plaque characteristics . The plaques with 18F-NaF uptake showed significantly higher plaque burden , more frequent posterior attenuation and positive remodeling in IVUS , and significantly higher maximum lipid arc and more frequent microvessels in OCT ( all P<0.05 ) . There were no differences in minimum lumen area and area of calcium between 18F-NaF – positive and 18F-NaF – negative lesions . Among 51 lesions with 18F-NaF – positive uptake , 48 lesions ( 94.1 % ) had at least one of high-risk characteristics . The 18F-NaF tissue-to- background ratio in plaques with high-risk characteristics was significantly higher than in those without ( 1.09 [ 95 % confidence interval , 0.85–1.34 ] versus 0.62 [ 95 % confidence interval , 0.42–0.82 ] , P<0.001 for IVUS definition ; 0.76 [ 95 % confidence interval , 0.54–0.98 ] versus 0
Output:
| In atherosclerosis , most studies report a positive correlation with the burden of CV risk factors and vascular calcification .
A higher uptake was found in culprit plaques/rupture sites in coronary and carotid arteries and it was also linked to high-risk features in histology and intravascular imaging analysis of the plaques .
In aortic stenosis , this tracer displayed an increasing uptake with disease severity .
Sodium fluoride positron emission tomography is a promising non-invasive technique to identify high-risk plaques , which sets ground to a potential use of this tracer in evaluating atherosclerotic disease progression and degenerative changes in aortic valve stenosis . |
MS211326 | ***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 Infected foot wounds in patients with diabetes are the most common reason for diabetes-related hospital admission in the United States . Nonhealing foot wounds are the major precipitant of lower-extremity amputation in the diabetic population . HYPOTHESIS The null hypothesis was that there would be no difference in proportion of healing with or without use of a foot-level mechanical compression device . DESIGN Twelve-week , double-blind , r and omized , controlled trial . SETTING A university teaching hospital and related clinics . PATIENTS One hundred fifteen patients with diabetes , 74 % male , with foot infections requiring incision and debridement . INTERVENTION All patients received either a functioning or placebo ( nonfunctioning ) foot compression device ( Kinetic Concepts Inc , San Antonio , Tex ) . Patients and investigators were blinded to the functionality of the device . PRIMARY OUTCOME MEASURE Proportion of wound healing in each group . RESULTS There was a significantly higher proportion of healing in the active group than in the placebo group ( 39 [ 75 % ] of 52 patients vs 23 [ 51 % ] of 45 ; chi(2 ) = 6.0 ; P<.02 ; odds ratio , 2.9 ; 95 % confidence interval , 1 . 2 - 6.8 ) . In the placebo group , there was no difference in proportion of healing between those identified as compliant ( > /=50 hours of use per week ) vs noncompliant ( P = .10 ) . In patients receiving active units , more patients in the compliant subgroup experienced wound healing ( P<.03 ) . When compared as a whole , there was a significant trend toward an increasing proportion of healing from the placebo-noncompliant to the placebo-compliant to the active-noncompliant to the active-compliant groups ( chi(2)(trend ) = 8.3 ; P<.005 ) . CONCLUSIONS Edema reduction achieved in this study by way of a pump and wrap system may increase the proportion of wound healing in patients after debridement of foot infections in patients with diabetes . Furthermore , the data suggest a potential association between increased compliance with use of the device and an increased trend toward wound healing . Arch Surg . 2000;135:1405 - OBJECTIVE Chronic diabetic foot ulcers are a source of major concern for both patients and health care systems . The aim of this study was to evaluate the effect of hyperbaric oxygen therapy ( HBOT ) in the management of chronic diabetic foot ulcers . RESEARCH DESIGN AND METHODS The Hyperbaric Oxygen Therapy in Diabetics with Chronic Foot Ulcers ( HODFU ) study was a r and omized , single-center , double-blinded , placebo-controlled clinical trial . The outcomes for the group receiving HBOT were compared with those of the group receiving treatment with hyperbaric air . Treatments were given in a multi-place hyperbaric chamber for 85-min daily ( session duration 95 min ) , five days a week for eight weeks ( 40 treatment sessions ) . The study was performed in an ambulatory setting . RESULTS Ninety-four patients with Wagner grade 2 , 3 , or 4 ulcers , which had been present for > 3 months , were studied . In the intention-to-treat analysis , complete healing of the index ulcer was achieved in 37 patients at 1-year of follow-up : 25/48 ( 52 % ) in the HBOT group and 12/42 ( 29 % ) in the placebo group ( P = 0.03 ) . In a sub- analysis of those patients completing > 35 HBOT sessions , healing of the index ulcer occurred in 23/38 ( 61 % ) in the HBOT group and 10/37 ( 27 % ) in the placebo group ( P = 0.009 ) . The frequency of adverse events was low . CONCLUSIONS The HODFU study showed that adjunctive treatment with HBOT facilitates healing of chronic foot ulcers in selected patients with diabetes OBJECTIVE To evaluate the effectiveness of systemic hyperbaric oxygen therapy ( s HBOT ) in addition to a comprehensive protocol in decreasing major amputation rate in diabetic patients hospitalized for severe foot ulcer . RESEARCH DESIGN AND METHODS From August 1993 to August 1995 , 70 diabetic subjects were consecutively admitted into our diabetologic unit for foot ulcers . All the subjects underwent our diagnostic-therapeutic protocol and were r and omized to undergo s-HBOT . Two subjects , one in the arm of the treated group and one in the arm of nontreated group , did not complete the protocol and were therefore excluded from the analysis of the results . Finally , 35 subjects received s-HBOT and another 33 did not . RESULTS Of the treated group ( mean session = 38.8 ± 8) , three subjects ( 8.6 % ) underwent major amputation : two below the knee and one above the knee . In the nontreated group , 11 subjects ( 33.3 % ) underwent major amputation : 7 below the knee and 4 above the knee . The difference is statistically significant ( P = 0.016 ) . The relative risk for the treated group was 0.26 ( 95 % CI 0.08–0.84 ) . The transcutaneous oxygen tension measured on the dorsum of the foot significantly increased in subjects treated with hyperbaric oxygen therapy : 14.0 ± 11.8 mmHg in treated group , 5.0 ± 5.4 mmHg in nontreated group ( P = 0.0002 ) . Multivariate analysis of major amputation on all the considered variables confirmed the protective role of s-HBOT ( odds ratio 0.084 , P = 0.033 , 95 % CI 0.008–0.821 ) and indicated as negative prognostic determinants low ankle-brachial index values ( odds ratio 1.715 , P = 0.013 , 95 % CI 1.121–2.626 ) and high Wagner grade ( odds ratio 11.199 , P = 0.022 , 95 % CI 1.406–89.146 ) . CONCLUSIONS s-HBOT , in conjunction with an aggressive multidisciplinary therapeutic protocol , is effective in decreasing major amputations in diabetic patients with severe prevalently ischemic foot ulcers BACKGROUND The cause of diabetic foot ulcers is multifactorial , e.g. , neuropathy and angiopathy , leading to functional disturbances in the macrocirculation and skin microcirculation . Adequate tissue oxygen tension is an essential factor in infection control and wound healing . Hyperbaric oxygen ( HBO ) therapy , daily sessions of oxygen breathing at 2.5-bar increased pressure in a hyperbaric chamber , has beneficial actions on wound healing including antimicrobial action , prevention of edema and stimulation of fibroblasts . The aim of the present study was to investigate the long-term effect of HBO in treatment of diabetic foot ulcers . METHODS Thirty-eight diabetic patients ( 30 males ) with chronic foot ulcers were investigated in a prospect i ve study . The mean age was 60+/-13 years and the mean diabetes duration 27+/-14 years . All patients were evaluated with measurements of transcutaneous oxygen tension ( tcPO(2 ) ) , peripheral blood pressure , and HbA(1c ) . All patients had a basal tcPO(2 ) value lower than 40 mmHg , which increased to > /=100 mmHg , or at least three times the basic value , during inhalation of pure oxygen . Seventeen patients underwent 40 - 60 sessions of HBO therapy , while 21 patients were treated conventionally . The follow-up time was 3 years . RESULTS 76 % of the patients treated with HBO ( Group A ) had healed with intact skin at a follow-up time of 3 years . The corresponding value for patients treated conventionally ( Group B ) was 48 % . Seven patients ( 33 % ) in Group B compared to two patients ( 12 % ) in Group A went to amputation . Peripheral blood pressure , HbA(1c ) , diabetes duration , and basal values of tcPO(2 ) were similar in both groups . CONCLUSIONS Adjunctive HBO therapy can be valuable for treating selected cases of hypoxic diabetic foot ulcers . It seems to accelerate the rate of healing , reduce the need for amputation , and increase the number of wounds that are completely healed on long-term follow-up . Additional studies are needed to further define the role of HBO , as part of a multidisciplinary program , to preserve a functional extremity , and reduce the short- and long-term costs of amputation and disability OBJECTIVE To study the effect of systemic hyperbaric oxygenation ( HBO ) therapy on the healing course of nonischemic chronic diabetic foot ulcers . RESEARCH DESIGN AND METHODS From 1999 to 2000 , 28 patients ( average age 60.2 + /- 9.7 years , diabetes duration 18.2 + /- 6.6 years ) , of whom 87 % had type 2 diabetes , demonstrating chronic Wagner grade s I-III foot ulcers without clinical symptoms of arteriopathy , were studied . They were r and omized to undergo HBO because their ulcers did not improve over 3 months of full st and ard treatment . All the patients demonstrated signs of neuropathy . HBO was applied twice a day , 5 days a week for 2 weeks ; each session lasted 90 min at 2.5 ATA ( absolute temperature air ) . The main parameter studied was the size of the foot ulcer measured on tracing graphs with a computer . It was evaluated before HBO and at day 15 and 30 after the baseline . RESULTS HBO was well tolerated in all but one patient ( barotraumatic otitis ) . The transcutaneous oxygen pressure ( TcPO(2 ) ) measured on the dorsum of the feet of the patients was 45.6 + /- 18.1 mmHg ( room air ) . During HBO , the TcPO(2 ) measured around the ulcer increased significantly from 21.9 + /- 12.1 to 454.2 + /- 128.1 mmHg ( P < 0.001 ) . At day 15 ( i.e. , after completion of HBO ) , the size of ulcers decreased significantly in the HBO group ( 41.8 + /- 25.5 vs. 21.7 + /- 16.9 % in the control group [ P = 0.037 ] ) . Such a difference could no longer be observed at day 30 ( 48.1 + /- 30.3 vs. 41.7 + /- 27.3 % ) . Four weeks later , complete healing was observed in two patients having undergone HBO and none in the control group . CONCLUSIONS In addition to st and ard multidisciplinary management , HBO doubles the mean healing rate of nonischemic chronic foot ulcers in selected diabetic patients . The time dependence of the effect of HBO warrants further investigations OBJECTIVE ischaemic lower-extremity ulcers in the diabetic population are a source of major concern because of the associated high risk of limb-threatening complications . The aim of this study was to evaluate the role of hyperbaric oxygen in the management of these ulcers . METHOD eighteen diabetic patients with ischaemic , non-healing lower-extremity ulcers were recruited in a double-blind study . Patients were r and omly assigned either to receive 100 % oxygen ( treatment group ) or air ( control group ) , at 2.4 atmospheres of absolute pressure for 90 min daily ( total of 30 treatments ) . RESULTS healing with complete epithelialisation was achieved in five out of eight ulcers in the treatment group compared to one out of eight ulcers in the control group . The median decrease of the wound areas in the treatment group was 100 % and in the control group was 52 % ( p=0.027 ) . Cost-effectiveness analysis has shown that despite the extra cost involved in using hyperbaric oxygen , there was a potential saving in the total cost of treatment for each patient during the study . CONCLUSION hyperbaric oxygen enhanced the healing of ischaemic , non-healing diabetic leg ulcers and may be used as a valuable adjunct to conventional therapy when reconstructive surgery is not possible CONTEXT Concerns about the safety and efficacy of diabetes interventions persist , in part because r and omized clinical trials ( RCTs ) have not measured their effect on patient-important outcomes , ie , death and quality of life ( morbidity , pain , function ) . OBJECTIVE To systematic ally determine the extent to which ongoing and future RCTs in diabetes will ascertain patient-important outcomes . DATA SOURCES On November 10 , 2007 , we search ed primary RCT registries Clinical Trials.gov ( http://www . clinical trials.gov ) , International St and ard R and omized Controlled Trial Number Register ( http://is rct n.org ) , and Australian New Zeal and Clinical Trials Registry ( http://www.anzctr.org.au ) . STUDY SELECTION We identified phase 2 through 4 RCTs enrolling patients with diabetes . Of 2019 RCTs , 1054 proved eligible . We r and omly sample d 50 % of the eligible RCTs ( 527 of 1054 ) and selected 436 registered since registration became m and atory ( 2004 ) . D
Output:
| Neither iloprost nor pentoxifylline had a significant effect on amputation rate compared with conventional therapy .
There is low- to moderate- quality evidence supporting the use of HBOT as an adjunctive therapy to enhance diabetic foot ulcer healing and potentially prevent amputation .
However , there are only sparse data regarding the efficacy of arterial pump devices and pharmacologic interventions |
MS211327 | ***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: Muscle activity has previously been suggested to minimize soft-tissue resonance which occurs at heel-strike during walking and running . If this concept were true then the greatest vibration damping would occur when the input force was closest to the resonant frequency of the soft-tissues at heel-strike . However , this idea has not been tested . The purpose of this study was to test whether muscle activity in the lower extremity is used to damp soft-tissue resonance which occurs at heel-strike during walking . Hard and soft shoe conditions were tested in a r and omized block design . Ground reaction forces , soft-tissue accelerations and myoelectric activity were measured during walking for 40 subjects . Soft-tissue mass was estimated from anthropologic measurements , allowing inertial forces in the soft-tissues to be calculated . The force transfer from the ground to the tissues was compared with changes in the muscle activity . The soft condition result ed in relative frequencies ( input/tissue ) to be closer to resonance for the main soft-tissue groups . However , no increase in force transmission was observed . Therefore , the vibration damping in the tissues must have increased . This increase concurred with increases in the muscle activity for the biceps femoris and lateral gastrocnemius . The evidence supports the proposal that muscle activity damps soft-tissue resonance at heel-strike . Muscles generate forces which act across the joints and , therefore , shoe design may be used to modify muscle activity and thus joint loading during walking and running The foot provides an important source of afferent feedback for balance and locomotion . Sensory feedback from the feet can be altered by st and ing or walking on different surfaces . The purpose was to determine the effects of textured footwear on lower extremity muscle activity , limb kinematics , and joint kinetics while walking . Three-dimensional kinematics and kinetics , as well as muscle EMG , were collected as subjects walked with a smooth and textured shoe insert . Muscle activity was analyzed using a wavelet technique . The textured shoe insert caused a significant reduction in both soleus and tibialis anterior intensity during periods when these muscles are most active . Furthermore , the changes in muscle activity were only seen in the low frequency content of the EMG signal . The foot was significantly more plantar flexed at heel strike with the textured inserts . Small changes were also seen in vertical ground reaction forces and joint moments . It was assumed that the changes in gait patterns were due to a change in sensory feedback caused by the textured shoe insert . The possibilities of altered sensory feedback with footwear are discussed . Sensory feedback from the feet may affect specific motor unit pools during different activities . Changing the texture , without changing the geometry , of a shoe insert can alter muscle activity during walking . This may be useful in the prescription of footwear interventions and suggests that footwear may have sensory as well as mechanical effects Chronic Ankle Instability sprain causes are unclear and many factors or mechanisms may contribute to recurrence of this injury . The aim of the study was to investigate how an ankle destabilization device affects the EMG patterns of the ankle muscles during ankle stabilization against inversion . The left foot was equipped with a mechanical device mounted under the heel of the shoe . This mechanical device induces subtalar joint destabilization necessitating the control of ankle muscles . Surface electrodes were placed over the tibialis anterior , the peroneus longus , the peroneus brevis , the gastrocnemius lateral , and the gastrocnemius medial . Nine healthy subjects ( mean age 37+/-12 yr ; mean mass 68+/-17 kg ; mean height 1.73+/-0.7 m ) were instructed to walk normally along a tape fixed on the floor . The ankle destabilization device altered the walking pattern of all subjects . More specifically , the walking pattern is disturbed result ing in higher amplitude of the EMG activity of the peroneal muscles and the Tibialis Anterior and anticipatory reactions in the peroneal muscles . The results suggest that the ankle destabilization device could be beneficial for rehabilitation programs especially during the training of walking . Using this material may help to a specific reinforcement of muscles involved in anti-inversion ankle movement BACKGROUND To compare kinematics , kinetics and muscle activity during st and ing and walking for healthy subjects using an unstable test shoe ( Masai Barefoot Technology , MBT ) and a stable control shoe . METHODS Eight subjects volunteered for this study . During quiet st and ing , center of pressure excursion and muscle activity were determined . During walking , lower extremity kinematics , kinetics , and muscle electromyographic ( EMG ) signals were determined . Data were collected for the two shoe conditions after a 2week accommodation period . Statistics included repeated measures ANOVAs ( alpha = 0.05 ) and post hoc tests where appropriate . FINDINGS During quiet st and ing , the center of pressure excursion was significantly and substantially greater in the unstable compared to the control shoe . Electromyographic intensity increased in the unstable test shoe for all tested muscles , but only significantly for the tibialis anterior . During locomotion , kinematics were similar in the two shoe conditions except for the initial plantar-dorsiflexion , which showed a significant more dorsiflexed position during the first half of stance in the unstable test shoe compared to the stable control shoe . The angular impulses did not show any significant differences between the two shoe conditions for all three joints but some trends towards a reduction for the knee and hip joint . There were no significant differences in electromyographic activities between the control and the unstable shoe . However , several muscles showed some trends . INTERPRETATION The unstable shoe produced changes and trends in kinematic , kinetic and electromyographic characteristics that seemed to be advantageous for the locomotor system . Further studies should investigate muscle strength , dynamic stability , pain reduction for arthritic knees and injury prevention for high performance athletes when using the unstable shoes OBJECTIVE The purpose of this study was to determine if high-arched and low-arched runners exhibit different injury patterns . DESIGN Non-r and omized , two-group injury survey . BACKGROUND Running-related injuries are thought to be related , in part , to lower extremity structure . High-arched and low-arched runners with their different bony architecture may exhibit very different lower extremity mechanics and , consequently , different injury patterns . It was hypothesized that high-arched runners will exhibit a greater incidence of lateral injuries , skeletal injuries and knee injuries while low-arched runners will show a greater incidence of medial injuries , soft tissue injuries and foot injuries . METHODS Twenty high-arched and 20 low-arched runners were included in this study . Running-related injuries were recorded and divided into injury patterns of medial/lateral , bony/soft tissue and knee/foot and ankle for both high-arched and low-arched runners . A chi(2 ) analysis was then employed in an attempt to associate injury patterns with arch structure . RESULTS High-arched runners reported a greater incidence of ankle injuries , bony injuries and lateral injuries . Low-arched runners exhibited more knee injuries , soft tissue injuries and medial injuries . CONCLUSIONS Based on these results , high and low arch structure is associated with different injury patterns in runners . Relevance . Different injury patterns are present in individuals with extreme high arches when compared to those with extremely low arches . These relationships may lead to improved treatment and intervention strategies for runners based on their predisposing foot structure Abnormal foot morphology has been suggested to contribute to overuse injuries in athletes . This study investigated the relationship between foot type and injury incidence in a large sample of competitive triathletes not wearing foot orthoses during a 6-month retrospective analysis and a 10-week prospect i ve cohort study . Foot alignment was measured using the Foot Posture Index and the Valgus Index , and participants were assigned to supinated , pronated , and normal foot-type groups . Overall , 131 triathletes sustained 155 injuries during the study . Generally , foot type was not a major risk factor for injury ; however , there was a fourfold increased risk of overuse injury during the competition season in athletes with a supinated foot type . The results of this study show that triathletes with a supinated foot type are more likely to sustain an overuse 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 Over-pronation has been cited as a key contributor to many types of running injuries . However , the roles of the extrinsic foot muscles during running have not been adequately identified . The purpose of this study was to examine the muscle functional ( mf ) MRI and EMG responses to perturbations of the foot by running in varus , neutral and valgus wedged shoes . Ten males ran at 3.6 m/s in specially constructed shoes for 5 min with T2-weighted mfMRI collected before and after each run . The change in T2 from before to after each run characterized the level of metabolic activity in each of muscle . Kinematic and EMG data were also collected while subjects ran on a treadmill . There were no T2 differences across the three shoe conditions . In contrast , there was significantly less EMG activity in the tibialis anterior and soleus while wearing the neutral shoe . Overall , the results did not support the theory that muscle activity would increase as the degree of eversion increased . It also appears that surface EMG was more sensitive to differences between conditions than mfMRI . However , this study illustrated that mfMRI may be a useful tool for quantifying muscle activity in cases where surface EMG is inadequate OBJECTIVE To compare walking stance phase rearfoot and forefoot motion , ankle joint moments and extrinsic foot muscle EMG profiles between normal and pes planus feet . DESIGN A cross-sectional comparative study . BACKGROUND Musculoskeletal conditions are often attributed to pes planus , in which motion is assumed to be excessive and the muscle control inadequate . However , many of the speculated differences in mechanics and control between the normal and the pes planus foot have not been quantified . METHODS Kinematic and kinetic data were obtained from video recordings of skin surface markers and a force plate , and EMG was recorded with surface electrodes . Analysis of variance was carried out to compare the group profiles . RESULTS In the pes planus group : the forefoot was less adducted ( P < .05 ) at toe-off , and total transverse plane range of motion , at 8 degrees versus 10 degrees , was less ( P < .01 ) ; the peak plantarflexor ankle moment at push-off was greater ( P < .05 ) ; the invertor moment was greater at foot flat ( P < .05 ) ; for the EMG profiles , activity early in stance , relative to the mean stance phase activity was higher ( P < .01 ) in tibialis anterior and lower ( P < .05 ) in the peronei , soleus and medial and lateral gastrocnemius . CONCLUSIONS Despite reaching statistical significance , the group differences were small for the task of laboratory walking at a natural pace . The main implication s of the differences were for restraint of motion . The expectations of excessive motion and muscle effort in the pes planus group were therefore not substantiated . RELEVANCE Symptomatic pes planus subjects did not reveal the expected biomechanical differences from normal subjects . The underlying causes of symptoms were not identifiable Purpose To identify the incidence of medial tibial stress syndrome ( MTSS ) in a group of naval recruits undergoing a 10-week basic training period and to determine potential risk factors . Method One hundred and twenty-four recruits ( 84 men and 40 women ) were followed prospect ively during basic training . Anthropometric and lower limb biomechanical data were recorded at the start of the program along with injury history and previous sporting activity for the 3 months prior to enlisting . Recruits were monitored during training for development of medial tibial strees syndrome and were asked to complete an exit interview at the end of the program . Results Forty recruits ( 22 men and 18 women ) developed medial tibial stress syndrome , giving an incidence of 35 % . A significant relationship existed between gender and medial tibial stress syndrome ( P= .012 )
Output:
| Some evidence exists that : ( i ) pronated feet demonstrate greater electromyographic activation of invertor musculature and decreased activation of evertor musculature ; ( ii ) foot orthoses increase activation of tibialis anterior and peroneus longus , and may alter low back muscle activity ; and ( iii ) shoes with elevated heels alter lower limb and back muscle activation .
Most studies reported statistically significant changes in electromyographic activation , although these findings were often not well supported when confidence intervals were calculated . |
MS211328 | ***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 efficacy of a communication skills training programme was shown through a r and omised trial . Oncologists ( N=160 ) from 34 cancer centres were allocated to written feedback plus course ; course alone ; written feedback alone or control . Each clinician had 6 – 10 interviews with patients videotaped at baseline and 3 months postintervention . Analysis of videotapes revealed improvements in the communication skills of clinicians r and omised to training ( n=80 ) compared with others ( n=80 ) . A 12-month follow-up assessment is reported here . Robust Poisson conditional analyses of counts of changes in communication behaviours revealed no demonstrable attrition in those who had shown improvement previously , including fewer leading questions , appropriate use of focused and open-ended questions and responses to patient cues . Additional skills , not apparent at 3 months , were now evident ; the estimated effect sizes corresponded to 81 % fewer interruptions ( P=0.001 ) and increased summarising of information to 38 % ( P=0.038 ) . However , expressions of empathy ( 54 % , P=0.001 ) declined . The overall results show that 12 – 15 months postintervention , clinicians had integrated key communication skills into clinical practice and were applying others . This is the first RCT to show an enduring effect of communication skills training with transfer into the clinic Systematic Review Series Series Editors : Cynthia Mulrow , MD , MSc Deborah Cook , MD , MSc The last article in this series outlined methods with which to search the literature for studies on the clinical question that generates a systematic review [ 1 ] . Herein , we discuss the subsequent steps of selecting and appraising studies for a review . Both of these steps involve important judgments that can influence the results of a review . In selecting studies , review ers judge the relevance of the studies to the review question . In appraising studies , review ers judge numerous features of design and analysis . Some of these judgments are easy to make ; others are more difficult and prone to error . To be confident in their decisions , review ers should use methods that are reliable ( the results do not change if the procedure is repeated ) , impartial ( not influenced by the study results ) , and explicit ( unambiguous ) [ 2 ] . These strategies for selection and appraisal are sensible , and they distinguish most systematic review s from most narrative review s. However , evidence to support the importance of some of the methods we suggest is either scant or conflicting ; readers are referred to the original research on these approaches for more details . Selecting Studies for Systematic Review s If review ers perform a comprehensive search of the literature using the methods described previously in this series [ 1 ] , they will probably have assembled a large sample of articles . This sample will include most ( ideally , all ) studies that are relevant to the review question ( that is , the sensitivity of the search will be high ) . Inevitably , because such a wide net is cast , articles not pertinent to the clinical question will be retrieved ( that is , the specificity of the search will be modest ) . Thus , the review ers ' next task is to sort through all of the potentially relevant articles and select those that will be included in the review . To do so , review ers adopt several of the tactics listed in Table 1 and Table 2 for planning and executing the selection process ( in effect , improving the specificity of the search ) ; these tactics are described below . Table 1 . Planning Study Selection Table 2 . Strategies for Selecting and Appraising Studies Begin with a Well-Built Clinical Question Review ers should ensure that the question for review includes the four elements of a well-built clinical question [ 3 , 4 ] : the patients of interest , the main interventions under investigation , the comparison interventions , and the clinical outcomes of interest . By including these four elements , review ers can better focus the selection process . Choose Selection Criteria That Fit the Clinical Question Consider a systematic review of the effectiveness of a drug treatment ( for example , a proton-pump inhibitor ) for patients with a particular disorder ( such as esophageal reflux ) . Review ers need to decide whether to include studies of patients with any symptoms of reflux , only those with classic symptoms , or only those in whom definitive diagnostic tests have confirmed the presence of reflux . In addition , review ers might choose to include studies of patients with different comorbid conditions ; patients from different demographic or geographic or cultural background s ; or patients from different health systems , such as inpatient or community population s. Similarly , review ers should use selection criteria that reflect the main and comparison interventions of interest . In our esophageal reflux example , review ers would need to decide whether to include studies of a particular drug or studies of all agents in that drug 's class and whether to include studies of any dose and regimen or only studies with a specific regimen . For the comparison interventions , the review ers would decide whether to include studies that compare the experimental drug with alternate treatments ( such as antacids or histamine-2-receptor antagonists ) , with placebo , or with both . For the clinical outcomes , review ers have analogous tasks of defining the outcomes and translating them into criteria . In our example , the review ers would start by listing each clinical outcome ( for example , whether the outcome was endoscopic or clinical and whether it focused on cure or persistence ) and then decide whether to include studies that reported any outcome or only those with certain clinical ly important outcomes ( such as improvement in symptoms at 1 year ) . After thoroughly considering each element of the review question , review ers compile a set of explicit selection criteria . When these criteria are not explicit , the results of the review are more prone to error [ 5 , 6 ] . Reporting the selection criteria used in a review is extremely important to readers because the criteria indicate the relevance of the review to the readers ' clinical practice . Specify the Types of Study Design To Be Included After creating selection criteria that appropriately reflect the review question , review ers should consider which study design s to include . Ideally , review ers choose study design s that are most likely to produce valid results . For example , to answer questions about therapy or harm , review ers may want to include r and omized trials [ 7 ] because they provide more accurate estimates of benefit or harm than do cohort studies , casecontrol studies , and case series [ 8 ] . In reality , however , r and omized trials may not be conducted to address questions of harm [ 9 ] . Therefore , review ers need to consider which study design s are likely to be available to answer their question ; this information may necessitate modification of originally conceptualized selection criteria to incorporate observational ( nonexperimental ) studies . Specify Criteria Related to Type and Form of Publication Review ers also need to consider issues related to type and form of publication . Ideally , all of the relevant studies would be published as peer- review ed journal articles . However , some completed studies may be published only as abstract s , in non-peer- review ed form , or not at all . Review ers decide whether to include these incompletely reported studies when planning their literature search . By including all articles in various stages of publication and subjecting them to rigorous critical appraisal , review ers minimize the threat of publication bias ( the preferential reporting of studies with positive results ) [ 10 - 12 ] , which could generate misleading review s. Other studies may be reported more than once . To avoid over-representing duplicate studies in the review , investigators should plan to look for and exclude duplicate publications [ 13 ] . Finally , because studies may be published in different language s and because excluding studies published in different language s may bias the results of review s [ 14 , 15 ] , articles should be included , as appropriate , regardless of the language of publication ( translating as necessary ) . Limited time and re sources , however , may preclude such an approach . Construct and Pretest Selection Forms After deciding on selection criteria , review ers can prepare customized forms that contain checklists of the selection criteria ( Figure 1 ) . Using these forms can simplify the selection process , increase reliability , and provide a record of the judgments made about each study . After drafting form prototypes , review ers pretest these forms for clarity , ease of application , and reliability . To pretest the forms , two or more independent review ers typically apply them to a r and om sample of studies identified by the literature search . Review ers compare their results to identify sources of ambiguity and then revise the forms accordingly . If the revisions are substantial , this process may need to be repeated before the forms can be used . Figure 1 . Example of a form that might be developed for the selection of studies for a systematic review evaluating the efficacy of -blockers for secondary prevention of variceal bleeding . Write a Detailed Protocol Having a selection protocol as part of a larger protocol for the entire review helps review ers in two ways . First , it provides a document that explicitly states the review question and the selection criteria , making the process accountable . Review ers can later return to the protocol for guidance in resolving disagreements about article selection . Second , the selection protocol identifies what work will be done , by whom , in what manner , when , and for what reason ; thus , it provides a mode of communication within the review team . When review ers have a very large sample of studies from which to select , they can simplify this task by review ing all of the titles , then the abstract s , and then the full articles , excluding studies that do not meet one or more selection criteria at each step . In doing so , review ers should record ( on the selection forms ) the reasons for exclusion . After review ers have selected studies for the systematic review , they will move to the next task of critical appraisal . This procedure also requires careful planning . Appraising Studies for Systematic Review s Review ers appraise the studies selected for review with three objectives in mind : 1 ) to underst and the validity of the studies , 2 ) to uncover reasons for differences among study results other than chance , and 3 ) to provide readers with sufficient information with which to judge for themselves the applicability of the systematic review to their clinical practice . To achieve these goals , review ers use the strategies outlined in Table 2 and Table 3 to carefully reexamine many important features of the primary studies . Table 3 . Planning Study Appraisal Examine Important Clinical Features Although the selection criteria for a systematic review define the population , interventions , and outcomes of interest , the appraisal process involves a detailed assessment of the patients ( for example , high , medium , or low risk ) , the study interventions ( for example , frequency , degree , and duration ) , and the outcome measurements ( for example , definitions and degree of surveillance ) AIMS To evaluate the effects of a palliative care education programme on the self-reported knowledge and confidence of 72 community nurses . DESIGN a prospect i ve longitudinal postal question naire survey was conducted . FINDINGS seventy-one ( 99 % ) completed a pre-course question naire , 52 ( 72 % ) a question naire at completion of the course , and 37 ( 51 % ) a question naire one year later . Following the programme , more nurses felt that their professional needs were being met well or very well . Confidence in practice showed an increasing trend over time . Desire for education was lower on course completion than at its start . Palliative Care Nursing Quiz scores rose from a pre-course median of 12.5 to 15 at course completion ( P=0.001 ) which was maintained 1 year later . CONCLUSION the education programme was successful in raising st and ards of knowledge , professional development and confidence . Improvement was maintained one year later Prompted by directives from the GMC , ‘ care of the dying ’ is identified as ‘ core curricula ’ for undergraduate medical education . However , there are many technical and interpersonal challenges faced in learning the practice of palliative medicine . Accordingly , the design and delivery of education programmes need to be both carefully considered and evaluated . Using B and ura ’s Social Cognitive Theory as a driver , appropriate methodology for evaluating a novel education programme in palliative medicine was drafted . A pre- and post-survey of an education programme and palliative care placement for fourth year medical undergraduate students from Liverpool University ( n = 216 ) was completed using a composite question naire containing ; i ) Self-efficacy in Palliative Care Scale ( SEPC ) and ii ) Thanatophobia Scale . Both scales have shown reliability and validity within the sample population . Additionally , a r and omly selected Focus Group was conducted to provide qualitative information on the students ’ experience . A total of 139 pre- and post- question naires ( 64 % ) were completed . Analysis identified significant improvements in perceived efficacy ( SEPC Communication t = −16.41 , P < 0.001 ; SEPC Patient Management t = −22.31 , P < 0.001 ; SEPC Multidisciplinary Teamwork t = −15.56 , P < 0.001 ) . Significant improvements in thanatophobia were also recorded ( z = −7.51 , P < 0.001 ) although some interesting anomalies were noted . This study demonstrates that considered and appropriately structured clinical education has been shown to significantly improve students ’ belief in their ability to practice palliative medicine and to improve their attitude towards care . In accordance with the study ’s theoretical driver , it is reasonable to propose that the engaged active learning will have a positive effect on the future care of dying patients We surveyed primary care physicians about their involvement and perceived skills in palliative care . A survey instrument asked how frequently internal medicine and family practice physicians performed 10 palliative care items . Subjects rated their skills in each area . A majority of physicians always or frequently performed all 10 palliative care items , but fewer than 50 % of respondents adequately attended to the spiritual needs and economic problems of patients . Interest in palliative care was associated with an increased frequency in performing palliative care items ( P = 0.036 ) , while training in palliative care was associated with better perceived performance ( P = 0.05 ) . Only 36 % of respondents had received training in palliative care . Internists and family practitioners provide palliative care to patients , but feel their skills are lacking in certain areas . Training may improve care to patients at the end of life This quasiexperimental study examined the effect of an educational program on attitudes toward caring for terminally ill persons and their families . Participants were 115 undergraduate students : intervention group , N = 49 ; control group , N = 66 . Pre and post-intervention measurements were done with the Frommelt Attitude Toward Care of the Dying Scale ( FATCOD , Form B ) . Students in the intervention group participated in a semester-long ( 15-week , 45-hour ) educational program . Demographic variables , including age , gender , religion , major area of study , influence of religious beliefs , profession , previous education , and past or present experience
Output:
| Overall , a lack of validation and a focus upon the physical aspects of symptom management was apparent . |
MS211329 | ***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 purpose of this study was to provide an experimental test of the theory of change put forth by A. T. Beck , A. J. Rush , B. F. Shaw , and G. Emery ( 1979 ) to explain the efficacy of cognitive-behavioral therapy ( CT ) for depression . The comparison involved r and omly assigning 150 out patients with major depression to a treatment focused exclusively on the behavioral activation ( BA ) component of CT , a treatment that included both BA and the teaching of skills to modify automatic thoughts ( AT ) , but excluding the components of CT focused on core schema , or the full CT treatment . Four experienced cognitive therapists conducted all treatments . Despite excellent adherence to treatment protocol s by the therapists , a clear bias favoring CT , and the competent performance of CT , there was no evidence that the complete treatment produced better outcomes , at either the termination of acute treatment or the 6-month follow-up , than either component treatment . Furthermore , both BA and AT treatments were just as effective as CT at altering negative thinking as well as dysfunctional attributional styles . Finally , attributional style was highly predictive of both short- and long-term outcomes in the BA condition , but not in the CT condition The brief behavioral activation treatment for depression ( BATD ) is a relatively uncomplicated , time-efficient , and cost-effective method for treating depression . Because of these features , BATD may represent a practical intervention within managed care-driven , inpatient psychiatric hospitals . Based on basic behavioral theory and empirical evidence supporting activation strategies , we design ed a treatment to increase systematic ally exposure to positive activities and thereby help to alleviate depressive affect . This study represents a pilot study that extends research on this treatment into the context of an inpatient psychiatric unit . Results demonstrate effectiveness and superiority of BATD as compared with the st and ard supportive treatment provided within the hospital . A large effect size was demonstrated , despite a limited sample size . The authors discuss the limitations of the study and future directions Antidepressant medication is considered the current st and ard for severe depression , and cognitive therapy is the most widely investigated psychosocial treatment for depression . However , not all patients want to take medication , and cognitive therapy has not demonstrated consistent efficacy across trials . Moreover , dismantling design s have suggested that behavioral components may account for the efficacy of cognitive therapy . The present study tested the efficacy of behavioral activation by comparing it with cognitive therapy and antidepressant medication in a r and omized placebo-controlled design in adults with major depressive disorder ( N = 241 ) . In addition , it examined the importance of initial severity as a moderator of treatment outcome . Among more severely depressed patients , behavioral activation was comparable to antidepressant medication , and both significantly outperformed cognitive therapy . The implication s of these findings for the evaluation of current treatment guidelines and dissemination are discussed
Output:
| The results in this study indicate behavioural therapy is an effective treatment for depression with outcomes equal to that of the current recommended psychological intervention . |
MS211330 | ***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: CONTEXT High levels of lipoprotein(a ) are associated with increased risk of myocardial infa rct ion ( MI ) . OBJECTIVE To assess whether genetic data are consistent with this association being causal . DESIGN , SETTING , AND PARTICIPANTS Three studies of white individuals from Copenhagen , Denmark , were used : the Copenhagen City Heart Study ( CCHS ) , a prospect i ve general population study with 16 years of follow-up ( 1991 - 2007 , n = 8637 , 599 MI events ) ; the Copenhagen General Population Study ( CGPS ) , a cross-sectional general population study ( 2003 - 2006 , n = 29 388 , 994 MI events ) ; and the Copenhagen Ischemic Heart Disease Study ( CIHDS ) , a case-control study ( 1991 - 2004 , n = 2461 , 1231 MI events ) . MAIN OUTCOME MEASURES Plasma lipoprotein(a ) levels , lipoprotein(a ) kringle IV type 2 ( KIV-2 ) size polymorphism genotype , and MIs recorded from 1976 through July 2007 for all participants . RESULTS In the CCHS , multivariable-adjusted hazard ratios ( HRs ) for MI for elevated lipoprotein(a ) levels were 1.2 ( 95 % confidence interval [ CI ] , 0.9 - 1.6 ; events/10,000 person-years , 59 ) for levels between the 22nd and 66th percentile , 1.6 ( 95 % CI , 1.1 - 2.2 ; events/10,000 person-years , 75 ) for the 67th to 89th percentile , 1.9 ( 95 % CI , 1.2 - 3.0 ; events/10,000 person-years , 84 ) for the 90th to 95th percentile , and 2.6 ( 95 % CI , 1.6 - 4.1 ; events/10,000 person-years , 108 ) for levels greater than the 95th percentile , respectively , vs levels less than the 22nd percentile ( events/10,000 person-years , 55 ) ( trend P < .001 ) . Numbers of KIV-2 repeats ( sum of repeats on both alleles ) ranged from 6 to 99 and on analysis of variance explained 21 % and 27 % of all variation in plasma lipoprotein(a ) levels in the CCHS and CGPS , respectively . Mean lipoprotein(a ) levels were 56 , 31 , 20 , and 15 mg/dL for the first , second , third , and fourth quartiles of KIV-2 repeats in the CCHS , respectively ( trend P < .001 ) ; corresponding values in the CGPS were 60 , 34 , 22 , and 19 mg/dL ( trend P < .001 ) . In the CCHS , multivariable-adjusted HRs for MI were 1.5 ( 95 % CI , 1.2 - 1.9 ; events/10,000 person-years , 75 ) , 1.3 ( 95 % CI , 1.0 - 1.6 ; events/10,000 person-years , 66 ) , and 1.1 ( 95 % CI , 0.9 - 1.4 ; events/10,000 person-years , 57 ) for individuals in the first , second , and third quartiles , respectively , as compared with individuals in the fourth quartile of KIV-2 repeats ( events/10,000 person-years , 51 ) ( trend P < .001 ) . Corresponding odds ratios were 1.3 ( 95 % CI , 1.1 - 1.5 ) , 1.1 ( 95 % CI , 0.9 - 1.3 ) , and 0.9 ( 95 % CI , 0.8 - 1.1 ) in the CGPS ( trend P = .005 ) , and 1.4 ( 95 % CI , 1.1 - 1.7 ) , 1.2 ( 95 % CI , 1.0 - 1.6 ) , and 1.3 ( 95 % CI , 1.0 - 1.6 ) in the CIHDS ( trend P = .01 ) . Genetically elevated lipoprotein(a ) was associated with an HR of 1.22 ( 95 % CI , 1.09 - 1.37 ) per doubling of lipoprotein(a ) level on instrumental variable analysis , while the corresponding value for plasma lipoprotein(a ) levels on Cox regression was 1.08 ( 95 % CI , 1.03 - 1.12 ) . CONCLUSION These data are consistent with a causal association between elevated lipoprotein(a ) levels and increased risk of MI Background Elevated lipoprotein(a ) [ Lp(a ) ] levels predict cardiovascular events incidence in patients with coronary artery disease ( CAD ) . Genetic variants in the rs3798220 , rs10455872 and rs6415084 single-nucleotide polymorphisms ( SNPs ) in the Lp(a ) gene ( LPA ) correlate with elevated Lp(a ) levels , but whether these SNPs have prognostic value for CAD patients is unknown . The present study evaluated the association of LPA SNPs with incidence of subsequent cardiovascular events in CAD patients after percutaneous coronary intervention ( PCI ) . Methods TaqMan SNP genotyping assays were performed to detect the rs6415084 , rs3798220 and rs10455872 genotypes in 517 Chinese Han patients with CAD after PCI . We later assessed whether there was an association of these SNPs with incidence of major adverse cardiovascular events ( MACE : cardiac death , nonfatal myocardial infa rct ion , ischemic stroke and coronary revascularization ) . Serum lipid profiles were also determined using biochemical methods . Results Only the rs6415084 variant allele was associated with higher Lp(a ) levels [ 41.3 ( 20.8 , 74.6 ) vs. 18.6 ( 10.3 , 40.9 ) mg/dl , p < 0.001 ] . During a 2-year follow-up period , 102 patients suffered MACE , and Cox regression analysis demonstrated that elevated Lp(a ) ( ≥30 mg/dl ) levels correlated with increased MACE ( adjusted HR , 1.69 ; 95 % CI 1.13 - 2.53 ) , but there was no association between LPA genetic variants ( rs6415084 and rs3798220 ) and MACE incidence ( p > 0.05 ) . Conclusions Our data did not support a relationship between genetic LPA variants ( rs6415084 and rs3798220 ) and subsequent cardiovascular events after PCI in Chinese Han CAD patients Background Many patients with coronary heart disease do not achieve recommended LDL-cholesterol levels , due to either intolerance or inadequate response to available lipid-lowering therapy . Microsomal triglyceride transfer protein ( MTP ) inhibitors might provide an alternative way to lower LDL-cholesterol levels . We tested the safety and LDL-cholesterol-lowering efficacy of an MTP inhibitor , AEGR-733 ( Aegerion Pharmaceuticals Inc. , Bridgewater , NJ ) , alone and in combination with ezetimibe . Methods We performed a multicenter , double-blind , 12-week trial , which included 84 patients with hypercholesterolemia . Patients were r and omly assigned ezetimibe 10 mg daily ( n = 29 ) ; AEGR-733 5.0 mg daily for the first 4 weeks , 7.5 mg daily for the second 4 weeks and 10 mg daily for the last 4 weeks ( n = 28 ) ; or ezetimibe 10 mg daily and AEGR-733 administered with the dose titration described above ( n = 28 ) . Results Ezetimibe monotherapy led to a 20–22 % decrease in LDL-cholesterol concentrations . AEGR-733 monotherapy led to a dose-dependent decrease in LDL-cholesterol concentration : 19 % at 5.0 mg , 26 % at 7.5 mg and 30 % at 10 mg . Combined therapy produced similar but larger dose-dependent decreases ( 35 % , 38 % and 46 % , respectively ) . The number of patients who discontinued study drugs owing to adverse events was five with ezetimibe alone , nine with AEGR-733 alone , and four with combined ezetimibe and AEGR-733 . Discontinuations from AEGR-733 were due primarily to mild transaminase elevations . Conclusions Inhibition of LDL production with low-dose AEGR-733 , either alone or in combination with ezetimibe , could be an effective therapeutic option for patients unable to reach target LDL-cholesterol levels OBJECTIVE A minor allele variant ( rs3798220 ) of apolipoprotein(a ) has been reported to be associated with elevated plasma lipoprotein(a ) [ Lp(a ) ] and increased cardiovascular risk . We investigated whether this allele was associated with elevated Lp(a ) and cardiovascular risk in the Women 's Health Study , a r and omized trial of low-dose aspirin , and whether aspirin reduced cardiovascular risk in minor allele carriers . METHODS AND RESULTS Genotypes of rs3798220 were determined for 25,131 initially healthy Caucasian participants . Median Lp(a ) levels at baseline were 10.0 , 79.5 , and 153.9mg/dL for major allele homozygotes , heterozygotes , and minor allele homozygotes , respectively ( P<0.0001 ) . During the 9.9 years of follow-up , minor allele carriers ( 3.7 % ) in the placebo group had twofold higher risk of major cardiovascular events than non-carriers ( age-adjusted hazard ratio (HR)=2.21 , 95 % CI : 1.39 - 3.52 ) . Among carriers , risk was reduced more than twofold by aspirin : for aspirin compared with placebo the age-adjusted HR was 0.44 ( 95 % CI : 0.20 - 0.94 ) ; risk was not significantly reduced among non-carriers ( age-adjusted HR=0.91 , 95 % CI : 0.77 - 1.08 ) . This interaction between carrier status and aspirin allocation was significant ( P=0.048 ) . CONCLUSIONS In the Women 's Health Study , carriers of an apolipoprotein(a ) variant had elevated Lp(a ) , doubled cardiovascular risk , and appeared to benefit more from aspirin than non-carriers Background —Oxidized phospholipids ( OxPL ) circulate on apolipoprotein B-100 particles ( OxPL/apoB ) , and primarily on Lp(a ) lipoprotein ( a ) [ Lp(a ) ] . The relationship of OxPL/apoB levels to future cardiovascular events is not known . Methods and Results —The Bruneck study is a prospect i ve population -based survey of 40- to 79-year-old men and women recruited in 1990 . Plasma levels of OxPL/apoB and lipoprotein ( a ) [ Lp(a ) ] were measured in 765 subjects in 1995 and incident cardiovascular disease ( CVD ) , defined as cardiovascular death , myocardial infa rct ion , stroke , and transient ischemic attack , was assessed from 1995 to 2005 . During the follow-up period , 82 subjects developed CVD . In multivariable analysis , which included traditional risk factors , high sensitivity C-reactive protein ( hsCRP ) , and lipoprotein-associated phospholipase A2 ( Lp-PLA2 ) activity , subjects in the highest tertile of OxPL/apoB had a significantly higher risk of cardiovascular events than those in the lowest tertile ( hazard ratio[95 % CI ] 2.4[1.3 to 4.3 ] , P=0.004 ) . The strength of the association between OxPL/apoB and CVD risk was amplified with increasing Lp-PLA2 activity ( P=0.018 for interaction ) . Moreover , OxPL/apoB levels predicted future cardiovascular events beyond the information provided by the Framingham Risk Score ( FRS ) . The effects of OxPL/apoB and Lp(a ) were not independent of each other but they were independent of all other measured risk factors . Conclusions —This study demonstrates that OxPL/apoB levels predict 10-year CVD event rates independently of traditional risk factors , hsCRP , and FRS . Increasing Lp-PLA2 activity further amplifies the risk of CVD mediated by BACKGROUND Low-density lipoprotein ( LDL ) particle ( P , or molar ) concentration has been shown to be a more sensitive marker
Output:
| The present article is aim ed at outlining the current state of knowledge regarding the clinical value of lipoprotein(a ) ( Lp(a ) ) as a marker of cardiovascular disease ( CVD ) risk by summarizing the results of recent clinical studies , meta-analyses and systematic review s. The literature supports the predictive value of Lp(a ) on CVD outcomes , although the effect size is modest .
Lp(a ) would also appear to have an effect on cerebrovascular outcomes , however the effect appears even smaller than that for CVD outcomes . |
MS211331 | ***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 Total hip or knee replacement is highly successful when judged by prosthesis-related outcomes . However , some people experience long-term pain . Objectives To review published studies in representative population s with total hip or knee replacement for the treatment of osteoarthritis reporting proportions of people by pain intensity . Data sources MEDLINE and EMBASE data bases search ed to January 2011 with no language restrictions . Citations of key articles in ISI Web of Science and reference lists were checked . Study eligibility criteria , participants and interventions Prospect i ve studies of consecutive , unselected osteoarthritis patients representative of the primary total hip or knee replacement population , with intensities of patient-centred pain measured after 3 months to 5-year follow-up . Study appraisal and synthesis methods Two authors screened titles and abstract s. Data extracted by one author were checked independently against original articles by a second . For each study , the authors summarised the proportions of people with different severities of pain in the operated joint . Results Search es identified 1308 articles of which 115 reported patient-centred pain outcomes . Fourteen articles describing 17 cohorts ( 6 with hip and 11 with knee replacement ) presented appropriate data on pain intensity . The proportion of people with an unfavourable long-term pain outcome in studies ranged from about 7 % to 23 % after hip and 10 % to 34 % after knee replacement . In the best quality studies , an unfavourable pain outcome was reported in 9 % or more of patients after hip and about 20 % of patients after knee replacement . Limitations Other studies reported mean values of pain outcomes . These and routine clinical studies are potential sources of relevant data . Conclusions and implication s of key findings After hip and knee replacement , a significant proportion of people have painful joints . There is an urgent need to improve general awareness of this possibility and to address determinants of good and bad outcomes A gait analysis system was used to evaluate the kinematics of the hip and knee during stair ascending and descending after operation with total knee replacement . Patients with 5 ° varus/valgus alignment or less were selected r and omly to receive either a flat or a concave tibial component with retention of the posterior cruciate ligament . Patients who had more than 5 ° varus/valgus alignment and /or an extension defect of 10 ° or more were selected r and omly to receive the concave or posterior-stabilized tibial component with resection of the posterior cruciate ligament . Twenty patients and 17 controls were studied 1–2 years after the operation . Patients had abnormal kinematics during stair ascending and descending . Both knee extension and flexion were reduced . Hip extension tended to decrease , and decreased hip extension moment was noted . RésuméUn system d’analyse de la marche a été utilisé pour évaluer la cinématique de la hanche et du genou pendant la montée et la descente d’escalier après prothèse totale du genou . Les malades avec 5 ° ou moins de varus/valgus ou moins ont été r and omisés pour recevoir un composant tibial plat ou concave avec conservation du ligament croisé postérieur . Les malades qui avaient plus de 5 ° de varus/valgus et/ou un défaut d’extension de 10 ° ou plus ont été r and omisés pour recevoir un composant tibial concave ou un composant postéro-stabilisé avec résection du ligament croisé postérieur . Vingt et un malades et 17 contrôles ont été étudiés une à deux années après l’opération . Les malades avaient une cinématique anormale pendant la montée et la descente l’escalier . L’extension et flexion du genou étaient plus faibles . L’extension de la hanche avait tendance à diminuer et une augmentation du moment de flexion a été noté A cross-sectional , community-based survey of a r and om sample of 1750 of 242,311 Medicare recipients was performed . The patients were at least sixty-five years old and had had a primary or revision knee replacement ( either unilaterally or bilaterally ) between 1985 and 1989 . Three sample s were surveyed separately : a national sample ( to reflect the United States as a whole ) and sample s from Indiana and the western part of Pennsylvania ( sites chosen for convenience to assess the validity of the findings for the national sample on a regional level ) . Each sample was stratified by race , age , residence ( urban or rural ) , and the year of the procedure . Valid and reliable question naires were used to elicit the participants ' assessment s of pain , physical function , and satisfaction two to seven years after the knee replacement . Of the 1486 patients who were eligible for inclusion in the survey , 1193 ( 80.3 per cent ) responded . The mean age of the respondents was 72.6 years . Eight hundred and forty-nine respondents ( 71.2 per cent ) were white , and 849 ( 71.2 per cent ) were women . The participants reported that they had little or no pain in the knee at the time of the survey , regardless of the age at the time of the knee replacement , the body-mass index , or the length of time since the knee replacement . After adjustment for potential confounding variables , predictors of better physical function after the replacement were an absence of problems with the contralateral knee , primary knee replacement ( rather than revision ) ( Indiana sample only ) , and a lower body-mass index ( Indiana and western Pennsylvania sample s ) . Four hundred and fifteen ( 85.2 per cent ) of the 487 patients in the national sample were satisfied with the result of the knee replacement . In what we believe to be the first community-based study of the outcome of knee replacement , patients reported having significant ( p = 0.0001 ) and persistent relief of pain , improved physical function , and satisfaction with the result two to seven years postoperatively . The findings of the present study suggest that age and obesity do not have a negative impact on patient-relevant outcomes ( pain and physical function ) . Dissemination of these findings has the potential to increase appropriate referrals for knee replacement and thereby reduce the pain and functional disability due to osteoarthrosis of the knee We have developed a 12-item question naire for patients having a total knee replacement ( TKR ) . We made a prospect i ve study of 117 patients before operation and at follow-up six months later , asking them to complete the new question naire and the form SF36 . Some also filled in the Stanford Health Assessment Question naire ( HAQ ) . An orthopaedic surgeon completed the American Knee Society ( AKS ) clinical score . The single score derived from the new question naire had high internal consistency , and its reproducibility , examined by test-retest reliability , was found to be satisfactory . Its validity was established by obtaining significant correlations in the expected direction with the AKS scores and the relevant parts of the SF36 and HAQ . Sensitivity to change was assessed by analysing the differences between the preoperative scores and those at follow-up . We also compared change in scores with the patients ' retrospective judgement of change in their condition . The effect size for the new question naire compared favourably with those for the relevant parts of the SF36 . The change scores for the new knee question naire were significantly greater ( p < 0.0001 ) for patients who reported the most improvement in their condition . The new question naire provides a measure of outcome for TKR that is short , practical , reliable , valid and sensitive to clinical ly important changes over time BACKGROUND Little is known about the effects of total knee replacement surgery on the contributions of individual joint moments to the total support moment . A better underst and ing of these effects may enhance rehabilitation protocol s and determine factors related to long-term surgical outcome . METHOD Twenty-one subjects with total knee replacement and 21 controls performed level walking and stair ascent at two testing periods , pre- and 6 months post-surgery . Variables studied included gait velocity , stride length , knee flexion angle , net joint moments of the hip , knee and ankle , and total support moment . Data were analyzed at the first peak vertical ground reaction force . FINDINGS For level walking , the total support moment , knee extensor moment , and knee flexion angle of total knee replacement patients were less than controls at post-surgery . For stair ascent , the patient group total support moment , ankle plantarflexor moment , and knee flexion angle were less than controls at both testing periods , while knee extensor moment was less than controls at post-surgery . Extensor synergies of the total knee replacement patients revealed less knee and more hip contributions during level walking and larger hip contributions during stair ascent to the total support moment than controls at both testing periods . INTERPRETATION A feature of total knee replacement gait , pre- and post-surgery , is a stiff knee attitude which may serve to protect the quadriceps . The larger hip extensor contribution to the total support moment observed in the patients may compensate for the diminished knee extensor contribution during level walking and stair ascent Objective To assess health-related quality of life ( HRQOL ) in a prospect i ve study with 7 years of follow-up in 49 consecutive patients who underwent a total joint replacement because of osteoarthritis . Methods Generic HRQOL was assessed with the short-form 36 ( SF-36 ) and specific HRQOL with the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . Results Out of the 39 subjects who have completed the 7 years of follow-up of this study , 22 ( 56.4 % ) underwent a hip replacement surgery and the other 17 ( 43.6 % ) a knee replacement . Six months after surgery , a significant improvement , compared to preoperative scores , was observed in two of the eight dimensions of the SF-36 ( i.e. physical function and pain ) . The same dimensions , pain and physical function , at the same time , 6 months after surgery , measured by the WOMAC , showed a significant improvement as well , but there was no significant change in the stiffness score . From 6 months to the end of follow-up , changes in SF-36 scores showed a significant improvement in physical function ( p = 0.008 ) , role-physical ( p = 0.004 ) and role-emotional ( p = 0.01 ) while all scores of the WOMAC improved ( p < 0.001 for pain , p < 0.001 for stiffness and p < 0.01 for physical function ) . Conclusion The improvements observed in HRQOL at short term after surgery , are at least maintained over a 7-year follow-up period The role of the posterior cruciate ligament ( PCL ) remains controversial in total knee arthroplasty ( TKA ) , with some surgeons who believe in PCL sacrifice and substitution and others who believe in PCL preservation for stability . Manufacturers have developed both cruciate-substituting/posterior stabilized ( PS ) implants typically used when the ligament is sacrificed and cruciate retaining ( CR ) implants design ed for ligament preservation . However , studies demonstrate excellent clinical results with CR implants despite PCL sacrifice . This study sought to determine functional stability differences between PS and CR TKAs following PCL sacrifice . Eighteen ( 9 matched pairs ) subjects with either a PS or CR TKA and sacrificed PCL and a normal contralateral knee were subjected to physical exam and gait analysis ( walking , stair ascent and descent ) using a staircase model , passive reflective arrays and an optoelectric system . No differences were detected between the two groups among any of the measured parameters ( knee flexion angle , knee flexion moment , knee power absorption , pelvic tilt ) . PCL sacrifice in a well-balanced cruciate retaining TKA did not result in instability during stair descent based on gait parameters . The decision to use a posterior stabilized design when faced with an incompetent PCL intraoperatively should be based on factors other than anticipated instability BACKGROUND Currently there is a limited underst and ing of the factors influencing range of motion by comparing patellar resurfacing vs non-resurfacing in total knee arthroplasty during activities of daily living . A recent meta- analysis of patellar replacement confirms better outcome with patella resurfacing ; however , the result can be influenced by many other factors , such as : component design , surgeon experience , and technical aspects of the surgery . This study compares the biomechanics of the knee in patients after total knee arthroplasty with and without patellar resurfacing during stair climbing . METHODS Forty-seven patients with total knee arthroplasty were assessed at the mean follow-up of 24 months . In all of them a posterior stabilised fixed bearing prosthesis ( Optetrak PS , Exactech ) was implanted . Twenty-six patients were treated without patellar resurfacing and 21 with patellar resurfacing . Clinical evaluations were performed using the International Knee Society and the Hospital for Special Surgery scores . Ten patients with patellar resurfacing and 10 patients without patellar resurfacing were also studied with motion analysis during stair climbing ; 10 healthy subjects were studied for statistical comparison . FINDINGS Clinical passive knee flexion , International Knee Society Function and Hospital for Special Surgery scores were significantly higher in the patellar resurfacing group . During stair climbing , active knee joint range of motion during the stance phase was greater in patients with patellar resurfacing . The maximum adduction moment was significantly higher in the group without patellar resurfacing . INTERPRETATION Patients with patellar resurfacing demonstrated better clinical scores , and kinematic and kinetic data while ascending stairs
Output:
| During stair ascent , knee flexion angle at heel strike and walking velocity were reduced in TKA subjects compared to controls .
Results of other variables were not consistent between studies .
Other results during stair descent were not consistent between studies . |
MS211332 | ***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 examine the feasibility of a routine transradial approach ( TRA ) in primary percutaneous coronary intervention ( PPCI ) for acute ST-segment elevation myocardial infa rct ion ( STEMI ) . Design A single-centre observational study with prospect i ve data collection . Setting A high-volume interventional centre in Amsterdam , The Netherl and s. Patients Procedural data were analysed for 2209 consecutive patients presenting with STEMI without cardiogenic shock , between January 2001 and December 2008 . Interventions PPCI routinely performed by the TRA . Main Outcome Measures The primary outcomes of interest were the need for crossover to another vascular access site , the achievement of procedural success and their trends over time . Secondary outcome measures were trends in total procedural duration , fluoroscopy times and use of equipment . Results In a total of 2209 procedures the radial artery was the primary access site , comprising 96.1 % of all procedures performed during the study period . In 84 cases ( 3.8 % ) access site crossover was needed . Crossover rates decreased from 5.9 % in 2001–2 to 1.5 % in 2007–8 ( p=0.001 ) . The procedural success rate was 94.1 % , which remained stable over the years . Despite an increased complexity of PPCI ( more non-left anterior descending infa rct -related arteries , thrombus aspiration and multivessel PPCI ) , total procedural duration decreased from 38 min ( IQR 28–50 ) in 2001–2 to 24 min ( 18–33 ) in 2007–8 , p<0.001 for trend . Conclusions Systematic use of the TRA in PPCI yields low access site crossover , high procedural success rates and excellent procedural performances . It can therefore represent the primary access site in the vast majority of STEMI patients BACKGROUND : Radial arterial cannulation is most commonly done using palpation , but the use of ultrasound has increased the cannulation success rate . This improvement , albeit significant , has not led to a very high success rate especially in trainees . A modified ultrasound technique for vascular cannulation ( dynamic needle tip positioning ) has been described for peripheral venous cannulation . We therefore assessed the success rate of this technique compared to the palpation technique for radial artery cannulation in adult surgical patients . METHODS : We enrolled patients who were having nonemergent operations that required a radial arterial catheter for intraoperative monitoring . Patients were r and omized to either palpation or dynamic needle tip positioning technique . Arterial cannulation was performed by anesthesia residents or faculty members . The primary end point was successful cannulation on the first pass . Secondary end points were overall 5-minute success rate and number of attempts within 5 minutes . RESULTS : Two hundred sixty patients were evaluated . The first-pass success rate was 83 % in the dynamic needle tip positioning technique group ( n = 132 ) and 48 % in the palpation group ( n = 128 ; P < .001 ) ; relative risk was 2.5 ; 95 % confidence interval , 1.7–3.6 . The overall 5-minute success rate was 89 % in the dynamic needle tip positioning technique group compared to 65 % in the palpation group ( P < .001 ) , relative risk was 2.4 ; 95 % confidence interval , 1.2–1.6 . The number of skin puncture attempts was significantly more in the palpation group ( P < .001 ) . The median cannulation times and interquartile ranges were 81.5 ( 61–122 ) seconds in the dynamic needle tip positioning and 76 ( 48–175 ) seconds ( P = .7 ) in the palpation group . CONCLUSIONS : The use of the ultrasound-guided dynamic needle tip positioning technique increased the first and overall success rates compared to palpation in anesthesia residents and faculty members Background This study observed the efficacy of ultrasonic technique with out-of-plane orientation and in-plane guidance in radial artery puncture and cannulation in intensive care unit ( ICU ) shock patients to eluci date the effect of this technique on the security of cannulation . Material / Methods A total of 88 ICU shock patients , r and omized into a palpation ( control ) group and an ultrasound ( experimental ) group , received continuous intravenous sedation and analgesia . The palpation group patients underwent radial artery cannulation using the traditional palpation pulsation approach , and the ultrasound group patients underwent radial artery cannulation under out-of-plane orientation and in-plane guidance using an ultrasonic apparatus . Data were recorded and compared between the 2 groups . Results ( 1 ) The success rate of the first puncture in the ultrasound group and the palpation group was 80 % and 42 % , respectively ( P<0.05 ) . ( 2 ) The cannulation duration in the ultrasound group and the palpation group was 8.77±6.33 s and 28.7±26.33 s , respectively ( P<0.01 ) . ( 3 ) Incidence of hematoma and staxis around stoma in the ultrasound group was 2.5 % and 5 % , respectively , which was significantly lower than that in the palpation group , which was 20 % and 32.5 % , respectively ( P<0.05 ) . ( 4 ) Time to achieve the early goal -directed therapy in the ultrasound group and the palpation group was 306.73±39.98 min and 356.75±40.97 min , respectively ( P<0.01 ) . Conclusions Compared with the traditional method , radial artery cannulation with out-of-plane orientation and in-plane guidance is a quick and secure cannulation method and is appropriate for use in clinics 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 Previous studies have shown ultrasound guidance (USG)for arterial cannulation being advantageous compared to palpation technique , but little is known about its performance by novices . OBJECTIVE This study was to compare the utility of USG radial artery cannulation with palpation technique in terms of success rate , real-time to placement , number of attempts and complications . MATERIAL AND METHOD After IRB approval , a r and omized prospect i ve study was performed November 2009-October 2010 . Ten third-year residents , having performed USG vascular catheterization as yet less than 3 times , were coached on the pork-phantom during a workshop for real time ultrasound-guided vascular access . For the study patients were r and omized to US-guided technique ( US-group ) and palpation ( P-group ) ; ten patients for each resident . RESULTS One hundred adult patients undergoing neurosurgery were enrolled . There were no statistically significant differences between US-group vs. P-group in success rate ( 78 % vs. 82 % ; p = 0.62 ) , time to success ( 60 ( 12.8 , 547.0 ) vs. 52 ( 6.9 , 639.0 ) sec ; p = 0.22 ) , and number of attempts ( 1 ( 1 , 4 ) vs. 1 ( 1 , 3 ) ; p = 0.79 ) . Most common complication was puncture hematoma ( US-group 26 % vs. P-group 24 % ; p = 0.82 ) . Success was defined as no change in catheterization site , performer and technique . CONCLUSION Regarding success rate , attended time , or number of attempts for radial arterial cannulation , we did not find any benefit of ultrasound guidance compared to palpation technique . Our findings were not in accordance to other trials . However , we have to consider operators in our study being in experienced in ultrasound-guided procedures but not in palpation techniques OBJECTIVES Ultrasound guidance for central venous catheterization improves success rates and decreases complications when compared to the l and mark technique . Prior research has demonstrated that arterial and /or posterior vein wall puncture still occurs despite real-time ultrasound guidance . The inability to maintain visualization of the needle tip may contribute to these complications . This study aims to identify whether long-axis or short-axis approaches to ultrasound-guided vascular access afford improved visibility of the needle tip . METHODS A prospect i ve trial was conducted at a level I trauma center with an emergency medicine residency . Medical students and residents placed needles into vascular access tissue phantoms using long-axis and short-axis approaches . Ultrasound images obtained at the time of vessel puncture were then review ed . Primary outcome measures were visibility of the needle tip at the time of puncture and total time to successful puncture of the vessel . RESULTS All subjects were able to successfully obtain simulated blood from the tissue phantom . Mean time to puncture was 14.8 seconds in the long-axis group and 12.4 seconds in the short-axis group ( P = .48 ) . Needle tip visibility at the time of vessel puncture was higher in the long-axis group ( 24/39 , 62 % ) as opposed to the short-axis group ( 9/39 , 23 % ) ( P = .01 ) . CONCLUSIONS In a simulated vascular access model , the long-axis approach to ultrasound-guided vascular access was associated with improved visibility of the needle tip during vessel puncture . This approach may help decrease complications associated with ultrasound-guided central venous catheterization and should be prospect ively evaluated in future studies OBJECTIVES To identify success rates for radial artery cannulation in a pediatric critical care unit using either palpation or ultrasound guidance to cannulate the radial artery . METHODS A prospect i ve r and omized comparative study of critically ill children who required invasive monitoring in a tertiary referral center was conducted . All patients were r and omized by a stratified block of 4 to either ultrasound-guided or traditional palpation radial artery cannulation . The primary outcomes were the first attempt and total success rates . RESULTS Eighty-four children were enrolled , with 43 r and omized to the palpation technique and 41 to the ultrasound-guided technique . Demographic data between the groups were not significantly different . The total success and first attempt rates for the ultrasound-guided group were significantly higher than those for the palpation group ( success ratio , 2.03 ; 95 % confidence interval , 1.13 - 3.64 ; P = .018 ; and success ratio , 4.18 ; 95 % confidence interval , 1.57 - 11.14 ; P = .004 , respectively ) . The median time to success for the ultrasound-guided group was significantly shorter than that for the palpation group ( 3.3 versus 10.4 minutes ; P < .001 ) . Cannulation complications were lower in the ultrasound-guided group than the palpation group ( 12.5 % versus 53.3 % ; P < .001 ) . CONCLUSIONS The ultrasound-guided technique could improve the success rate and allow for faster cannulation of radial artery catheterization in critically ill children Objective : To determine whether ultrasound guidance increases the success rates , decreases the complication rates , and shortens the time to successful radial artery catheterization in infants and small children . Design : R and omized study . Setting : Single university-affiliated hospital . Patients : Infants and children weighing 3–20 kg , undergoing cardiac surgery for congenital heart disease . Intervention : We r and omly assigned the right and left radial arteries of patients undergoing arterial catheterization to ultrasound-guided technique versus the usual palpation technique . Measurements : The primary study endpoints were the rates of successful cannulation at first and within three attempts . The secondary endpoints were time to radial artery identification , number of attempts for successful cannulation , and rate of complications . Main Results : Compared with palpation , ultrasound-guided radial artery catheterization was successful in 76.3 % versus 35.6 % of first attempts and in 94.9 % versus 50.8 % of arteries after three attempts ( both comparisons , p < 0.01 ) . The median time [ interquartile range ] to identification of the arteries ( 18.5 seconds [ 11.25–27.25 ] vs 30 seconds [ 17.75–39.5 ] ) was significantly shorter ( p < 0.01 ) , the number of attempts [ interquartile range ] at successful cannulation ( 1 [ 1–1 ] vs 2 [ 1–2 ] ) was significantly fewer ( p < 0.01 ) , and the proportion of hematomas ( 5.1 % vs 25.4 % ) was significantly lower ( p < 0.01 ) in the ultrasound group than those in the palpation group . Conclusions : In infants and small children , ultrasound-guided radial artery catheterization was more successful and expeditious than the usual palpation technique Background and objective : In small children , the placement of arterial catheters can be technically challenging for even the most experienced anaesthetist . We investigated whether ultrasound imaging would improve the success rate and reduce time dem and and complications of radial artery cannulation . Method : In this prospect i ve r and omized study , we performed radial artery cannulation in 30 small children ( age 40 ± 33 months ) using two different techniques for localization of the vessel . In Group 1 ( n = 15 )
Output:
| Conclusions Ultrasound‐guided technique for RA access has higher first‐attempt success and lower failure rate compared with palpation alone , with no significant differences in access site hematoma or time to a successful attempt .
These findings support the routine use of US guidance for RA access |
MS211333 | ***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 Experimental studies suggest a relationship between pesticide exposure and renal impairment , but epidemiological evidence is limited . We evaluated the association between exposure to 39 specific pesticides and end-stage renal disease ( ESRD ) incidence in the Agricultural Health Study , a prospect i ve cohort study of licensed pesticide applicators in Iowa and North Carolina . Methods Via linkage to the US Renal Data System , we identified 320 ESRD cases diagnosed between enrolment ( 1993–1997 ) and December 2011 among 55 580 male licensed pesticide applicators . Participants provided information on use of pesticides via self-administered question naires . Lifetime pesticide use was defined as the product of duration and frequency of use and then modified by an intensity factor to account for differences in pesticide application practice s. Cox proportional hazards models , adjusted for age and state , were used to estimate associations between ESRD and : ( 1 ) ordinal categories of intensity-weighted lifetime use of 39 pesticides , ( 2 ) poisoning and high-level pesticide exposures and ( 3 ) pesticide exposure result ing in a medical visit or hospitalisation . Results Positive exposure-response trends were observed for the herbicides alachlor , atrazine , metolachlor , paraquat , and pendimethalin , and the insecticide permethrin . More than one medical visit due to pesticide use ( HR=2.13 ; 95 % CI 1.17 to 3.89 ) and hospitalisation due to pesticide use ( HR=3.05 ; 95 % CI 1.67 to 5.58 ) were significantly associated with ESRD . Conclusions Our findings support an association between ESRD and chronic exposure to specific pesticides , and suggest pesticide exposures result ing in medical visits may increase the risk of ESRD . Clinical trial registration Clinical trials.gov NCT00352924 Background Epidemics of chronic kidney disease ( CKD ) not due to diabetes mellitus ( DM ) or hypertension have been observed among individuals working in hot environments in several areas of the world . Experimental models have documented that recurrent heat stress and water restriction can lead to CKD , and the mechanism may be mediated by hyperosmolarity that activates pathways ( vasopressin , aldose reductase-fructokinase ) that induce renal injury . Here we tested the hypothesis that elevated serum sodium , which reflects serum osmolality , may be an independent risk factor for the development of CKD . Methods This study was a large-scale , single-center , retrospective 5-year cohort study at Center for Preventive Medicine , St. Luke ’s International Hospital , Tokyo , Japan , between 2004 and 2009 . We analyzed 13,201 subjects who underwent annual medical examination of which 12,041 subjects ( age 35 to 85 ) without DM and /or CKD were enrolled . This analysis evaluated age , sex , body mass index , abdominal circumference , hypertension , dyslipidemia , hyperuricemia , fasting glucose , BUN , serum sodium , potassium , chloride and calculated serum osmolarity . Results Elevated serum sodium was an independent risk factor for development of CKD ( OR : 1.03 , 95 % CI , 1.00–1.07 ) after adjusted regression analysis with an 18 percent increased risk for every 5 mmol/L change in serum sodium . Calculated serum osmolarity was also an independent risk factor for CKD ( OR : 1.04 ; 95 % CI , 1.03–1.05 ) as was BUN ( OR : 1.08 ; 95 % CI , 1.06–1.10 ) ( independent of serum creatinine ) . Conclusions Elevated serum sodium and calculated serum osmolarity are independent risk factors for developing CKD . This finding supports the role of limiting salt intake and preventing dehydration to reduce risk of CKD Background Cadmium ( Cd ) , lead ( Pb ) , and mercury ( Hg ) cause toxicological renal effects , but the clinical relevance at low-level exposures in general population s is unclear . The objective of this study is to assess the risk of developing end-stage renal disease in relation to Cd , Pb , and Hg exposure . Methods A total of 118 cases who later in life developed end-stage renal disease , and 378 matched ( sex , age , area , and time of blood sampling ) referents were identified among participants in two population -based prospect i ve cohorts ( 130,000 individuals ) . Cd , Pb , and Hg concentrations were determined in prospect ively collected sample s. Results Erythrocyte lead was associated with an increased risk of developing end-stage renal disease ( mean in cases 76 μg/L ; odds ratio ( OR ) 1.54 for an interquartile range increase , 95 % confidence interval ( CI ) 1.18 - 2.00 ) , while erythrocyte mercury was negatively associated ( 2.4 μg/L ; OR 0.75 for an interquartile range increase , CI 0.56 - 0.99 ) . For erythrocyte cadmium , the OR of developing end-stage renal disease was 1.15 for an interquartile range increase ( CI 0.99 - 1.34 ; mean Ery-Cd among cases : 1.3 μg/L ) . The associations for erythrocyte lead and erythrocyte mercury , but not for erythrocyte cadmium , remained after adjusting for the other two metals , smoking , BMI , diabetes , and hypertension . Gender-specific analyses showed that men carried almost all of the erythrocyte lead and erythrocyte cadmium associated risks . Conclusions Erythrocyte lead is associated with end-stage renal disease but further studies are needed to evaluate causality . Gender-specific analyses suggest potential differences in susceptibility or in exposure biomarker reliability In epidemiologic studies , high arsenic exposure has been associated with adverse kidney disease outcomes . We performed a systematic review of the epidemiologic evidence of the association between arsenic and various kidney disease outcomes . The search period was January 1966 through January 2014 . Twenty-five papers ( comprising 24 studies ) meeting the search criteria were identified and included in this review . In most studies , arsenic exposure was assessed by measurement of urine concentrations or with an ecological indicator . There was a generally positive association between arsenic and albuminuria and proteinuria outcomes . There was mixed evidence of an association between arsenic exposure and chronic kidney disease ( CKD ) , β-2-microglobulin ( β2MG ) , and N-acetyl-β-D-glucosaminidase ( NAG ) outcomes . There was evidence of a positive association between arsenic exposure and kidney disease mortality . Assessment of a small number of studies with three or more categories showed a clear dose-response association between arsenic and prevalent albuminuria and proteinuria , but not with CKD outcomes . Eight studies lacked adjustment for possible confounders , and two had small study population s. The evaluation of the causality of the association between arsenic exposure and kidney disease outcomes is limited by the small number of studies , lack of study quality , and limited prospect i ve evidence . Because of the high prevalence of arsenic exposure worldwide , there is a need for additional well- design ed epidemiologic and mechanistic studies of arsenic and kidney disease outcomes Background The rising prevalence of chronic kidney disease ( CKD ) and subsequent end stage renal failure necessitating renal replacement therapy has profound consequences for affected individuals and health care re sources . This community based study was conducted to identify potential predictors of microalbuminuria in a r and omly selected sample of adults from the North Central Province ( NCP ) of Sri Lanka , where the burden of CKD is pronounced and the underlying cause still unknown . Methods Exposures to possible risk factors were determined in r and omly recruited subjects ( 425 females and 461 males ) from selected areas of the NCP of Sri Lanka using an interviewer administered question naire . Sulphosalicylic acid and the Light Dependent Resister microalbumin gel filtration method was used for initial screening for microalbuminuria and reconfirmed by the Micral strip test . Results Microalbumnuria was detected in 6.1 % of the females and 8.5 % of the males . Smoking ( p < 0.001 ) , alcohol use ( p = 0.003 ) , hypertension ( p < 0.001 ) , diabetes ( p < 0.001 ) , urinary tract infection ( UTI ) ( p = 0.034 ) and consumption of water from wells in the fields ( p = 0.025 ) were associated with microalbuminuria . In the binary logistic regression analysis , hypertension , diabetes mellitus , UTI , drinking well water in the fields , smoking and pesticide spraying were found to be significant predictors of microalbuminuria . Conclusions Hypertension , diabetes mellitus , UTI , and smoking are known risk factors for microalbuminuria . The association between microalbuminuria and consumption of well water suggests an environmental aetiology to CKD in NCP . The causative agent is yet to be identified . Investigations for cadmium as a potential causative agent needs to be initiated BACKGROUND Long-term arsenic exposure is a major global health problem . However , few epidemiologic studies have evaluated the association of arsenic with kidney measures . Our objective was to evaluate the cross-sectional association between inorganic arsenic exposure and albuminuria in American Indian adults from rural areas of Arizona , Oklahoma , and North and South Dakota . STUDY DESIGN Cross-sectional . SETTING & PARTIPANTS : Strong Heart Study locations in Arizona , Oklahoma , and North and South Dakota . 3,821 American Indian men and women aged 45 - 74 years with urine arsenic and albumin measurements . PREDICTOR Urine arsenic . OUTCOMES Urine albumin-creatinine ratio and albuminuria status . MEASUREMENTS Arsenic exposure was estimated by measuring total urine arsenic and urine arsenic species using inductively coupled plasma mass spectrometry ( ICPMS ) and high-performance liquid chromatography-ICPMS , respectively . Urine albumin was measured by automated nephelometric immunochemistry . RESULTS The prevalence of albuminuria ( albumin-creatinine ratio ≥30 mg/g ) was 30 % . Median value for the sum of inorganic and methylated arsenic species was 9.7 ( IQR , 5.8 - 15.6 ) μg per gram of creatinine . Multivariable-adjusted prevalence ratios of albuminuria ( albumin-creatinine ratio ≥30 mg/g ) comparing the 3 highest to lowest quartiles of the sum of inorganic and methylated arsenic species were 1.16 ( 95 % CI , 1.00 - 1.34 ) , 1.24 ( 95 % CI , 1.07 - 1.43 ) , and 1.55 ( 95 % CI , 1.35 - 1.78 ) , respectively ( P for trend < 0.001 ) . The association between urine arsenic and albuminuria was observed across all participant subgroups evaluated and was evident for both micro- and macroalbuminuria . LIMITATIONS The cross-sectional design can not rule out reverse causation . CONCLUSIONS Increasing urine arsenic concentrations were cross-sectionally associated with increased albuminuria in a rural US population with a high burden of diabetes and obesity . Prospect i ve epidemiologic and mechanistic evidence is needed to underst and the role of arsenic as a kidney disease risk factor Background In sub-Saharan Africa , kidney failure has a high morbidity and mortality . Despite this , population -based estimates of prevalence , potential etiologies , and awareness are not available . Methods Between January and June 2014 , we conducted a household survey of r and omly-selected adults in Northern Tanzania . To estimate prevalence we screened for CKD , which was defined as an estimated glomerular filtration rate ≤ 60 ml/min/1.73m2 and /or persistent albuminuria . We also screened for human immunodeficiency virus ( HIV ) , diabetes , hypertension , obesity , and lifestyle practice s including alcohol , tobacco , and traditional medicine use . Awareness was defined as a self-reported disease history and subsequently testing positive . We used population -based age- and gender-weights in estimating prevalence , and we used generalized linear models to explore potential risk factors associated with CKD , including living in an urban environment . Results We enrolled 481 adults from 346 households with a median age of 45 years . The community-based prevalence of CKD was 7.0 % ( 95 % CI 3.8 - 12.3 ) , and awareness was low at 10.5 % ( 4.7 - 22.0 ) . The urban prevalence of CKD was 15.2 % ( 9.6 - 23.3 ) while the rural prevalence was 2.0 % ( 0.5 - 6.9 ) . Half of the cases of CKD ( 49.1 % ) were not associated with any of the measured risk factors of hypertension , diabetes , or HIV . Living in an urban environment had the strongest crude ( 5.40 ; 95 % CI 2.05 - 14.2 ) and adjusted prevalence risk ratio ( 4.80 ; 1.70 -
Output:
| Results of the meta- analysis suggest that exposure to agrochemicals and working in agriculture increase the risk of CKDnT , but this only reached significance for working in agriculture .
When cross-sectional studies were excluded , agrochemical exposure became significant . |
MS211334 | ***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 MicroRNAs ( miRNAs ) can be used as prognostic biomarkers in many types of cancer . We aim ed to identify miRNAs that were prognostic in patients with nasopharyngeal carcinoma . METHODS We retrospectively analysed miRNA expression profiles in 312 paraffin-embedded specimens of nasopharyngeal carcinoma from Sun Yat-sen University Cancer Center ( Guangzhou , China ) and 18 specimens of non-cancer nasopharyngitis . Using an 873 probe microarray , we assessed associations between miRNA signatures and clinical outcome in a r and omly selected 156 sample s ( training set ) and vali date d findings in the remaining 156 sample s ( internal validation set ) . We confirmed the miRNAs signature using quantitative RT-PCR analysis in 156 sample s from a second r and omisation of the 312 sample s , and vali date d the miRNA signature in 153 sample s from the West China Hospital of Sichuan University in Chengdu , China ( independent set ) . We used the Kaplan-Meier method and log-rank tests to estimate correlations of the miRNA signature with disease-free survival ( DFS ) , distant metastasis-free survival ( DMFS ) , and overall survival . FINDINGS 41 miRNAs were differentially expressed between nasopharyngeal carcinoma and non-cancer nasopharyngitis tissues . A signature of five miRNAs , each significantly associated with DFS , was identified in the training set . We calculated a risk score from the signature and classified patients as high risk or low risk . Compared with patients with low-risk scores , patients with high risk scores in the training set had shorter DFS ( hazard ratio [ HR ] 2·73 , 95 % CI 1·46 - 5·11 ; p=0·0019 ) , DMFS ( 3·48 , 1·57 - 7·75 ; p=0·0020 ) , and overall survival ( 2·48 , 1·24 - 4·96 ; p=0·010 ) . We noted equivalent findings in the internal validation set for DFS ( 2·47 , 1·32 - 4·61 ; p=0·0052 ) , DMFS ( 2·28 , 1·09 - 4·80 ; p=0·030 ) , and overall survival ( 2·87 , 1·38 - 5·96 ; p=0·0051 ) and in the independent set for DFS ( 3·16 , 1·65 - 6·04 ; p=0·0011 ) , DMFS ( 2·39 , 1·05 - 5·42 ; p=0·037 ) , and overall survival ( 3·07 , 1·34 - 7·01 ; p=0·0082 ) . The five-miRNA signature was an independent prognostic factor . A combination of this signature and TNM stage had better prognostic value than did TNM stage alone in the training set ( area under receiver operating characteristics 0·68 [ 95 % CI 0·60 - 0·76 ] vs 0·60 [ 0·52 - 0·67 ] ; p=0·013 ) , the internal validation set ( 0·70 [ 0·61 - 0·78 ] vs 0·61 [ 0·54 - 0·68 ] ; p=0·012 ) , and the independent set ( 0·70 [ 0·62 - 0·78 ] vs 0·63 [ 0·56 - 0·69 ] ; p=0·032 ) . INTERPRETATION Identification of patients with the five-miRNA signature might add prognostic value to the TNM staging system and inform treatment decisions for patients at high risk of progression . FUNDING Science Foundation of Chinese Ministry of Health , National Natural Science Foundation of China , Pearl River Scholar Funded Scheme , Guangdong Key Scientific and Technological Innovation Program , Guangdong Natural Science Foundation , Fundamental Research Funds for the Central Universities BACKGROUND The predictive value of microRNAs ( miRNAs ) in tumour cells and infiltrating immune cells for the efficacy of chemoradiation ( CRTX ) in locally advanced head and neck squamous cell carcinoma ( HNSCC ) was evaluated . METHODS Formalin-fixed , paraffin-embedded tumour material was collected from patients with locally advanced HNSCC treated within the ARO-0401 phase III trial with radiotherapy in combination with either 5-fluorouracil/cisplatin ( CDDP-CRTX ) or 5-fluorouracil/mitomycin C ( MMC-CRTX ) . MiRNA and immune profiles were established in a test cohort of 48 oropharyngeal carcinoma ( OPSCC ) cases by Affymetrix miRNA microarrays and the nanoString PanCancer Immune Panel , respectively . Expression of miRNA c and i date s was measured in 149 HNSCC patients by real-time PCR . Interference of miRNA profiles with CRTX efficacy was determined by Kaplan-Meier and Cox regression analysis . RESULTS Expression levels of five miRNAs ( miR-27b , -130b , -200b , -451 and -532 - 5p ) were significantly associated with overall survival after MMC-CRTX . Six different miRNAs ( miR-125b , -146a , -150 , -155 , -187 and -342 - 5p ) were correlated with overall survival after CDDP-CRTX . Validation by real-time PCR confirmed the predictive value of miR-200b and miR-155 in OPSCC , which was absent in hypopharyngeal carcinomas . MiR-146a was revealed as a prognostic marker for both CRTX regimens . MiR-200b expression was mainly associated with distant metastasis , whereas miR-155 correlated with local recurrence . MiR-155 and miR-146a were identified as surrogate markers for tumour-infiltrating lymphocytes . CONCLUSIONS MiR-200b and miR-155 were established as potential markers for personalised treatment selection of two st and ard regimens of CRTX . The predictive role of miR-155 deserves further investigation , especially within the framework of clinical trials of CRTX/immune checkpoint inhibitor combinations Background : Breast Cancer ( BC ) is the leading cause of deaths in Indian women . Emerging reports reveal alarming evidence of increasing incidence and mortality of BC among young Indian women in addition to the late presentation and poor prognosis . Despite the significant incidence , there is a lack of reliable data re sources and comprehensive epidemiologic studies relating to BC . The objective of this protocol is to conduct a full-scale systematic review and meta-analyses on the incidence , prevalence , and mortality of BC in 29 states and seven union territories of India . Methods : Data sources used will be Cochrane Review , MEDLINE , PubMed , Scopus , Science Direct , Web of Science , and international and national cancer registries such as World Health Organization , International Agency for Research on Cancer ( IARC ) , and National Centre for Disease Information and Research (NCDIR)-National Cancer Registry Program initiated by Indian Council of Medical Research . Relevant data will be extracted using a predefined data collection form . A defined search strategy will be implemented along with selection criteria to obtain full-text articles of relevant studies . This study protocol was prepared according to the Preferred Reporting Items for Systematic Review s and Meta- Analysis for Protocol s 2015 guidelines . Odds ratios ( ORs ) will be used to measure effect size . The r and om or fixed-effects meta-analyses model will be employed to aggregate the pooled estimates ( ORs ) with 95 % confidence intervals ( CIs ) separately . A forest plot will be produced to assess ORs and 95 % CIs . Publication bias will be assessed using funnel plot , and Egger regression will be applied to test the symmetry of the funnel plot . Ethics and dissemination : This proposed study will be based on published studies and the data from cancer registries . Therefore , human research ethics approval is not required . The results of this study will be published in a peer- review ed journal . PROSPERO registration no : CRD42018084003 Background : The role of miRNA-mediated regulation of RECK in keratinized tumors is unclear . Results : miRNAs express differentially in subtypes of OSCCs , and keratinization-associated miRNAs inversely correlate with RECK in oral cancer cells . Conclusion : miR-7 and miR-21 negatively regulate the tumor suppressor gene RECK . Significance : Keratinization-associated miRNAs may serve as novel targets to reduce tumor aggressiveness . MicroRNAs ( miRNAs ) are small non-coding RNAs that posttranscriptionally regulate gene expression during many biological processes . Recently , the aberrant expressions of miRNAs have become a major focus in cancer research . The purpose of this study was to identify deregulated miRNAs in oral cancer and further focus on specific miRNAs that were related to patient survival . Here , we report that miRNA expression profiling provided more precise information when oral squamous cell carcinomas were subcategorized on the basis of clinicopathological parameters ( tumor primary site , histological subtype , tumor stage , and HPV16 status ) . An innovative radar chart analysis method was developed to depict subcategories of cancers taking into consideration the expression patterns of multiple miRNAs combined with the clinicopathological parameters . Keratinization of tumors and the high expression of miR-21 were the major factors related to the poor prognosis of patients . Interestingly , a majority of the keratinized tumors expressed high levels of miR-21 . Further investigations demonstrated the regulation of the tumor suppressor gene reversion-inducing cysteine-rich protein with kazal motifs ( RECK ) by two keratinization-associated miRNAs , miR-7 and miR-21 . Transfection of miR-7 and miR-21-mimics reduced the expression of RECK through direct miRNA-mediated regulation , and these miRNAs were inversely correlated with RECK in CAL 27 orthotopic xenograft tumors . Furthermore , a similar inverse correlation was demonstrated in CAL 27 cells treated in vitro by different external stimuli such as trypsinization , cell density , and serum concentration . Taken together , our data show that keratinization is associated with poor prognosis of oral cancer patients and keratinization-associated miRNAs mediate deregulation of RECK which may contribute to the aggressiveness of tumors
Output:
| These results indicate that miRNAs have potential clinical value as prognostic biomarkers in HNC , with miR-21 , 125b , 34c-5p and 18a , in particular , showing great potential as prognostic molecular markers . |
MS211335 | ***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 aim of this study was to evaluate the surgical impact of benign ovarian mass on ovarian reserve as measured by serum follicle stimulating hormone ( FSH ) , estradiol ( E2 ) and anti-Müllerian hormone ( AMH ) levels , antral follicle count ( AFC ) and ovarian volumes . In addition , the differences in ovarian reserve impairment between endometrioma cystectomy and non-endometrioma cystectomy were investigated . Methods In this prospect i ve study , 22 patients of reproductive age ( range , 18.35 years ) with benign ovarian masses were enrolled to undergo laparoscopic cystectomy . Of whom 12 had endometriomas and 10 had non-endometriomas . On early follicular phase ( day 3 ) of the cycle preceding the operation and three months after the laparoscopic cystectomy , serum levels of FSH , E2 and AMH , AFC and ovarian volumes were measured in all patients . Data were analyzed with Mann-Whitney U-test and Wilcoxon rank test using SPSS ver . 12.0 for statistic analysis . Results Median level of serum AMH was significantly decreased from 5.48 ng/mL ( interquartile range [ IQR ] , 2.80 - 7.47 ) before cystectomy to 2.56 ng/mL ( IQR , 1.74 - 4.32 ) 3 months postoperation ( P<0.05 ) . On the other h and , no significant differences in FSH , E2 , AFC and ovarian volumes were found between the preoperative and three months postoperative levels . In a subgroup analysis of the pathologic type of the ovarian cyst , postoperative serum AMH levels were significantly decreased in the endometrioma group , but not in the non-endometrioma group . Conclusion Serum AMH levels were significantly decreased after laparoscopic cystectomy without any changes of other ovarian reserve tests OBJECTIVE To compare the effects of laparoscopic bipolar electrocoagulation with laparotomic hemostatic suturing during unilateral ovarian cystectomy on the ovarian reserve . METHODS A prospect i ve r and omized trial was conducted on 59 women with unilateral benign ovarian cysts who underwent laparoscopic ovarian cystectomy by a stripping technique ( n = 30 ) or open laparotomy with hemostatic suturing ( n = 29 ) . Serum anti-Müllerian hormone ( AMH ) , antral follicle count ( AFC ) , and ovarian stromal peak systolic velocity ( PSV ) at the 1st , 3rd , and 6th postoperative cycle were used to assess the ovarian reserve . RESULTS Preoperative AMH levels did not differ significantly ( P = 0.18 ) between the laparoscopy and laparotomy groups . In the laparoscopy group , there was a significant decrease in AMH levels , AFC , and PSV at the 3rd and 6th postoperative cycles compared with the 1st postoperative cycle , with an insignificant decrease between the 3rd and 6th cycles . In the laparotomy group , nonsignificant decreases in AMH levels , AFC , and PSV were detected at the 1st , 3rd , and 6th postoperative cycle and between the 3rd and 6th cycles . CONCLUSION Laparoscopic ovarian cystectomy is associated with a significant reduction in ovarian reserve . This is a consequence of damage to the ovarian vascularity and the removal of an increased amount of ovarian tissue STUDY OBJECTIVE To evaluate damage to ovarian reserve following laparoscopic cystectomy of benign ovarian cysts . DESIGN Prospect i ve study ( Canadian Task Force classification II-3 ) . SETTING Tertiary gynecologic endoscopic unit at a university-affiliated hospital . PATIENTS Thirty-one patients who underwent excision of monolateral ( n=25 ) or bilateral ( n=6 ) benign ovarian cysts . INTERVENTIONS Serial transvaginal ultrasound examinations during the first and third postsurgical menstrual cycles . The following ovarian echographic variables were evaluated : antral follicle count , ovarian volume , stromal blood flow , and side of ovulation . Two types of statistical analysis were performed : a paired analysis comparing operated and intact ovaries of the same patient and a prospect i ve analysis comparing ecographic characteristics of the operated gonad at first and second evaluation . MEASUREMENTS AND MAIN RESULTS Antral follicle count and stromal blood flow were not significantly affected by surgery . While ovarian volume was similar in the operated and in the contralateral intact gonad at the first ultrasound evaluation , the volume of the operated ovary was significantly reduced at the second assessment . The median ( interquartile range ) of the percentage of this reduction was 33 % ( 18%-81 % ) . This progressive reduction was confirmed by prospect ively analyzing the operated ovaries . An increased probability of ovulation in the intact gonad was observed at both assessment s. CONCLUSION Laparoscopic excision of ovarian cysts is associated with damage to ovarian reserve , at least immediately after surgery . This effect does not appear to be consequent to an injury to ovarian vascularization OBJECTIVE To evaluate safety and efficacy , in terms of spillage risk and ovarian tissue preservation , of mesial incision for laparoscopic dermoid cystectomy . DESIGN R and omized controlled trial . SETTING University . PATIENT(S ) Sixty-seven women with dermoid cysts . INTERVENTION(S ) Laparoscopic dermoid cystectomy performed by mesial incision ( 33 patients , study group ) or antimesial incision ( 34 patients , control group ) . MAIN OUTCOME MEASURE(S ) Spillage of intracystic content rate , operative times , chemical peritonitis rate , and intraoperative blood loss ( ΔHb ) as primary outcomes . Postoperative ovarian reserve ( ΔFSH levels , basal antral follicle number , mean ovarian diameter , and peak systolic velocity at 3 and 12 months after surgery ) as secondary outcome . RESULT ( S ) Spillage of intracystic content rate and operative time were significantly lower in the study than in the control group . None developed chemical peritonitis . ΔHb was higher in the study group but not significantly . During the follow-up , median FSH values were significantly lower in the study group , with no differences in the E(2 ) levels . Moreover , median basal antral follicle number , median ovarian diameter , and median peak systolic velocity were significantly higher in the study group . CONCLUSION ( S ) Ovarian mesial-side incision appears to be a safe as well as tissue-sparing technique . CLINICAL TRIAL REGISTRATION NUMBER Background To evaluate the impact of the presence of endometrioma and laparoscopic cystectomy on ovarian reserve as assessed by serum anti-Müllerian hormone ( AMH ) level . In addition , factors related to the decline in ovarian reserve were analyzed . Methods From June 2013 to January 2014 , we prospect ively included 40 women with endometriomas as the study group ( group A ) , 36 women with tubal factor infertilities as control group 1 ( group B ) and 22 women with the other benign ovarian cysts as control group 2 ( group C ) . The women with ovarian cysts underwent laparoscopic cystectomy . Serum AMH levels were determined preoperatively and at 1 month after surgery . Results The endometrioma group had lower AMH levels ( 1.53 ± 1.37 ng/ml ) compared with the other benign ovarian cyst group ( 2.20 ± 1.23 ng/ml ) and the tubal factor infertility group ( 2.82 ± 1.74 ng/ml ) . The rate of serum AMH decline 1 month after surgery in the endometrioma group ( 0.62 ± 0.35 ) was larger than the decline in the other benign ovarian cyst group ( 0.32 ± 0.30 ) . The preoperative AMH level showed a significant correlation with patient age ( group A , r = −0.32 ; group B , r = −0.54 ; group C , r = −0.71 ) ; there was a statistically significant correlation between the rate of serum AMH decline and endometrioma diameter as well as with the preoperative serum AMH level . In addition , the rate of serum AMH decline was larger for bilateral endometriomas than for unilateral endometriomas , but there was no similar correlation in the other benign ovarian cyst group . The rate of AMH decline after surgery in the subgroup of > 7 cm was significantly higher than in the subgroup of ≤7 cm . Conclusions Ovarian endometriomas per se may damage ovarian reserve , and cystectomy of endometriomas may cause greater damage to ovarian reserve compared with other benign ovarian cysts . The operation-related damage to the ovarian reserve was positively related to whether the endometriomas were bilateral , as well as cyst size ( especially for cysts > 7 cm ) , but was negatively related to the preoperative serum AMH level . Age was a negative factor that affected the ovarian reserve OBJECTIVE To determine whether the stripping technique by laparoscopy is a tissue-sparing procedure . DESIGN Prospect i ve study . SETTING University hospital . PATIENT(S ) Forty-two women , 21 to 35 years of age , who had a unilateral ovarian cyst ( 26 endometriomas , 7 serous , 6 dermoid , and 3 mucinous cysts ) . INTERVENTION(S ) Laparoscopic excision of ovarian cysts by using the stripping technique . MAIN OUTCOME MEASURE(S ) Histologic analysis of the excised specimens was done to evaluate the presence and nature of ovarian tissue adjacent to the cyst wall . RESULT ( S ) Recognizable ovarian tissue adjacent to the cyst wall was present in 15 of 42 excised specimens ( 36 % ) . A significant difference was present for endometriomas versus non-endometriosis cysts ( ovarian tissue was present in 14 of 26 specimens [ 54 % ] vs. 1 of 16 specimens [ 6 % ] ; P<.005 ) . No specimen showed the normal follicular pattern observed in healthy ovaries . CONCLUSION ( S ) The stripping technique appears to be a tissue-sparing procedure . In 36 % of the cysts , ovarian tissue is excised together with the cyst wall , but this tissue does not show the morphologic characteristics observed in normal ovarian tissue CONTEXT The interindividual variation in the age-related decline of ovarian follicles is wide . Hence , it is important to identify reliable , sensitive , and specific markers to assess the ovarian reserve of the individual woman . OBJECTIVE The aim of this study was to characterize the relation between age and ovarian reserve parameters in a population of healthy women with regular menstrual cycle . DESIGN AND SETTING We conducted a prospect i ve , population -based , cross-sectional study . PARTICIPANTS A total of 366 health care workers aged 21 - 41 years employed at a University Hospital were included . INTERVENTIONS There were no interventions . MAIN OUTCOME MEASURES Serum anti-Müllerian hormone ( AMH ) concentration , antral follicle count ( AFC ) , antral follicle size categories ( small : 2 - 4 mm ; intermediate : 5 - 7 mm ; and large : 8 - 10 mm ) , and ovarian volume were measured . RESULTS Serum AMH level declined by 5.6 % per year ( 95 % confidence interval 3.7 - 7.4 % , P < .001 ) , AFC ( 2 - 10 mm ) declined by 4.4 % per year ( 3.2 - 5.7 % , P < .001 ) , and ovarian volume declined by 1.1 % per year ( 0.2 - 2.0 , P = .002 ) , respectively . The mean proportion of small follicles decreased with age ( P = .04 ) , the proportion of intermediate follicles displayed no significant change with age ( P = .58 ) , and the mean proportion of large follicles increased with age ( P < .001 ) . The prevalence of large follicles increased with decreasing serum AMH concentration [ odds ratio 1.04 per 1 pmol/L ( 1.02 - 1.06 ) , P < .001 , area under the curve 0.66 ] , and with decreasing total AFC [ odds ratio 1.04 per follicle ( 1.02 - 1.05 ) , P < .001 , area under the curve 0.62 ] . CONCLUSION Chronological age was inversely related to serum AMH concentration , total AFC , and ovarian volume . Subclasses of AFC sized 2 - 4 and 5 - 7 mm decreased with increasing age , whereas AFC sized 8 - 10 mm increased with increasing age . Within AFC , a shift toward larger follicles with increasing age was observed . The occurrence of large follicles was more strongly related to biological age in terms of AMH and AFC than chronological age OBJECTIVE To determine whether different methods of hemostasis and pathologic subtypes would lead to significant differences regarding ovarian reserve after laparoscopic ovarian cystectomy . STUDY DESIGN Data were prospect ively collected from 129 patients who underwent laparos
Output:
| CONCLUSION Excision of benign nonendometriotic ovarian cyst(s ) seems to result in a marked reduction of circulating anti-Müllerian hormone .
It remains to be established whether this reflects a real compromise to ovarian reserve |
MS211336 | ***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: INTRODUCTION The aim of this study was to evaluate the effectiveness of early orthodontic treatment with the Twin-block appliance for the treatment of Class II Division 1 malocclusion . This was a multi-center , r and omized , controlled trial with subjects from 14 orthodontic clinics in the United Kingdom . METHODS The study included 174 children aged 8 to 10 years with Class II Division 1 malocclusion ; they were r and omly allocated to receive treatment with a Twin-block appliance or to an initially untreated control group . The subjects were then followed until all orthodontic treatment was completed . Final skeletal pattern , number of attendances , duration of orthodontic treatment , extraction rate , cost of treatment , and the child 's self-concept were considered . RESULTS At the end of the 10-year study , 141 patients either completed treatment or accepted their occlusion . Data analysis showed that there was no differences between those who received early Twin-block treatment and those who had 1 course of treatment in adolescence with respect to skeletal pattern , extraction rate , and self-esteem . Those who had early treatment had more attendances , received treatment for longer times , and incurred more costs than the adolescent treatment group . They also had significantly poorer final dental occlusion . CONCLUSIONS Twin-block treatment when a child is 8 to 9 years old has no advantages over treatment started at an average age of 12.4 years . However , the cost of early treatment to the patient in terms of attendances and length of appliance wear is increased INTRODUCTION Our aim in this prospect i ve r and omized clinical study was to assess the prevalence rate of eruption of palatally displaced canines , diagnosed at an early developmental stage with posteroanterior radiographs and consequently treated by rapid maxillary expansion . METHODS A sample of 60 subjects in the early mixed dentition with palatally displaced canines diagnosed on posteroanterior radiographs was enrolled in the trial . Their age range at the first observation ( T1 ) was 7.6 to 9.6 years , with a prepubertal stage of skeletal maturity ( CS1 or CS2 ) . The 60 subjects were r and omly allocated to the treatment group ( TG , 35 subjects ) or the no-treatment group ( NTG , 25 subjects ) . The TG was treated with a b and ed rapid maxillary exp and er ; after expansion , all patients were retained with the exp and er in place for 6 months . Thereafter , the exp and er was removed , and the patients wore a retention plate at night for a year . The NTG received no treatment . All subjects were reevaluated in the early permanent dentition ( T2 ) ( postpubertal CS4 ) . The number of dropouts was recorded . The main outcome recorded at T2 was successful or unsuccessful eruption of the maxillary permanent canines . The starting forms at T1 for measurements on posteroanterior and panoramic films were compared in the 2 groups with the Mann-Whitney U test ( P < 0.05 ) . The prevalence rates of successful and unsuccessful treatments in the TG were compared with those in NTG with chi-square tests ( P < 0.05 ) . From T1 to T2 , there were 3 dropouts in each group . RESULTS The final sample comprised 32 subjects in the TG and 22 subjects in the NTG . No statistically significant differences were found for any variable at T1 . The prevalence rates of successful eruption of the maxillary canines were 65.7 % ( 21 subjects ) in the TG and 13.6 % ( 3 subjects ) in the NTG . The comparison was statistically significant ( chi-square = 12.4 ; P < 0.001 ) . Subjects with palatally displaced canines in the early mixed dentition do not have transverse deficiency of the maxillary arch . CONCLUSIONS The use of a rapid maxillary exp and er as an early interceptive approach is effective for increasing the rate of eruption of palatally displaced canines INTRODUCTION There are disparities in access to orthodontic treatment for children from low-income families . Systematic programs of limited-care interceptive and preventive orthodontics have been proposed as a solution . The purpose of this r and omized clinical trial was to compare dental outcomes and funding eligibility from a group of Medicaid patients r and omized to receive interceptive orthodontics ( IO ) in the mixed dentition or observation ( OBS ) . METHODS One hundred seventy Medicaid-eligible children were r and omized to receive IO or OBS and followed for 2 years , when complete data were available on 72 and 74 children , respectively . The 2-year changes in the peer assessment rating ( PAR ) were compared using the Student t test . The proportions of children no longer eligible for Medicaid funding as defined by h and icapping labiolingual deviation ( HLD ) scores less than 25 at the 2-year follow-up were compared with the chi-square test . RESULTS The IO patients had significantly greater decreases in the PAR scores--50%-compared with the OBS subjects , -6 % ( P < 0.001 ) . Negative and positive overjet and maxillary alignment were the components most affected by IO ; they decreased by 11.0 , 7.2 , and 3.7 PAR points , respectively ( P < 0.001 ) . Overbite showed little change . At the 2-year follow-up , 80 % of the IO patients ' malocclusions that qualified initially were no longer deemed medically necessary by the HLD index , compared with 6 % in the OBS group ( P < 0.001 ) . CONCLUSIONS IO significantly reduces the severity of malocclusions and moves most from the " medically necessary " category to elective but does not produce finished results for most patients . Overjet and alignment were most readily corrected by interceptive treatment . Deep overbites were the least susceptible to IO correction In a 2-phased , parallel , r and omized trial of early ( preadolescent ) versus later ( adolescent ) treatment for children with severe ( > 7 mm overjet ) Class II malocclusions who initially were developmentally at least a year before their peak pubertal growth , favorable growth changes were observed in about 75 % of those receiving early treatment with either a headgear or a functional appliance . After a second phase of fixed appliance treatment for both the previously treated children and the untreated controls , however , early treatment had little effect on the subsequent treatment outcomes measured as skeletal change , alignment , and occlusion of the teeth , or length and complexity of treatment . The differences created between the treated children and untreated control group by phase 1 treatment before adolescence disappeared when both groups received comprehensive fixed appliance treatment during adolescence . This suggests that 2-phase treatment started before adolescence in the mixed dentition might be no more clinical ly effective than 1-phase treatment started during adolescence in the early permanent dentition . Early treatment also appears to be less efficient , in that it produced no reduction in the average time a child is in fixed appliances during a second stage of treatment , and it did not decrease the proportion of complex treatments involving extraction s or orthognathic surgery INTRODUCTION Many research ers have examined the prevalence of dental injuries in children and adolescents . The purpose of this study was to examine the prevalence and incidence of incisor trauma in subjects who participated in a r and omized clinical trial design ed to investigate early growth modifications in the treatment of Class II malocclusion . METHODS The subjects were r and omized to 3 treatment groups during the initial phase of the study : ( 1 ) headgear or biteplane , ( 2 ) bionator , and ( 3 ) observation ( no treatment ) . All 3 groups underwent phase 2 treatment with fixed appliances . Incisor injury was scored at every data collection point with the Ellis index by a blinded examiner using dental casts , intraoral photos , and panoramic and periapical x-rays . RESULTS Twenty-five percent of the subjects had incisor trauma at the baseline examination , and 28 % experienced new or worsening maxillary incisor injury during the study . No significant differences were found with regard to sex and prevalence of injury at baseline . No differences in incidence of trauma were found between the 3 treatment groups throughout the study ( P = 0.19 ) ; however , boys were more likely to experience maxillary incisor injury ( odds ratio estimate , 2.37 ; 95 % CI , 1.33 , 4.21 ) , and those with an injury at baseline were more likely to experience an additional injury ( odds ratio estimate , 1.81 ; 95 % CI , 1.03 , 3.17 ) . CONCLUSIONS Early orthodontic treatment did not affect the incidence of incisor injury . The majority of the injuries before and during treatment were minor ; therefore , the cost-benefit ratio of orthodontic treatment primarily to prevent incisor trauma is unfavorable OBJECTIVE To investigate the effectiveness of early class III protraction facemask treatment in children under 10 years of age at 3-year follow-up . DESIGN Multicentre r and omized controlled trial . SUBJECTS AND METHODS Seventy-three patients were r and omly allocated , stratified for gender , into early class III protraction facemask group ( PFG ) ( n = 35 ) and a control/no treatment group ( CG ) ( n = 38 ) . OUTCOMES Dentofacial changes were assessed from lateral cephalograms and occlusal changes using the peer assessment rating ( PAR ) . Self-esteem was assessed using the Piers-Harris children 's self-concept scale , and the psychosocial impact of malocclusion with oral aesthetic subjective impact score ( OASIS ) question naire . Temporom and ibular joint ( TMJ ) signs and symptoms were also recorded . The time points for data collection were at registration ( DC1 ) , 15 months later ( DC2 ) and 3 years post- registration ( DC3 ) . RESULTS The following mean skeletal and occlusal changes occurred from the class III starting point to DC3 ( 3-year follow-up ) : SNA , PFG moved forwards + 2·3 ° ( CG forward + 1·6 ° ; P = 0·14 ) ; SNB , PFG moved forwards + 0·8 ° ( CG forward + 1·5 ° , P = 0·26 ) ; ANB , PFG class III base improved + 1·5 ° ( CG stayed about the same at + 0·1 ° ; P = 0·001 ) . This contributed to an overall difference in ANB between PFG and CG of + 1·4 ° in favour of early protraction facemask treatment . The overjet was still improved by + 3·6 mm in the PFG and changed a small amount + 1·1 mm in the CG ( P = 0·001 ) . A 21 % improvement in PAR was shown in the PFG and the CG worsened by 8·4 % ( P = 0·02 ) . There was no increase in self-esteem ( Piers-Harris score ) for PFG compared with the CG ( P = 0·56 ) and no statistically significant difference in the impact of malocclusion ( OASIS ) between groups in terms of the changes from DC1 to DC3 ( P = 0·18 ) . TMJ signs and symptoms were very low at DC1 and DC3 . CONCLUSIONS The favourable effect of early class III protraction facemask treatment undertaken in patients under 10 years of age , is maintained at 3-year follow-up in terms of ANB , overjet and % PAR improvement . The direct protraction treatment effect at SNA is still favourable although not statistically significantly better than the CG . Seventy per cent of patients in PFG had maintained a positive overjet which we have defined as ongoing treatment success . Early protraction facemask treatment does not seem to influence self-esteem or reduce the patient 's personal impact of their malocclusion at 3-year follow-up INTRODUCTION The objective of this 3-arm parallel r and omized clinical trial was to compare the effectiveness of temporary anchorage devices ( TADs ) , Nance button palatal arches , and headgear for anchorage supplementation in the treatment of patients with malocclusions that required maximum anchorage . This trial was conducted between August 2008 and February 2013 in 2 orthodontic departments in the United Kingdom . METHODS The study included 78 patients ( ages , 12 - 18 years ; mean age , 14.2 years ) who needed maximum anchorage . Eligibility criteria included no active caries , exemplary oral hygiene , and maximum anchorage required . OUTCOME The primary outcome was mesial molar movement during the period in which anchorage supplementation was required . The secondary outcomes were duration of anchorage reinforcement , number of treatment visits , number of casual and failed appointments , total treatment time , dento-occlusal change , and patients ' perceptions of the method of anchorage supplementation . R AND OMIZATION Treatment allocation was implemented by contacting via the Internet the r and omization center at the University of Nottingham , Clinical Trials Unit . The r and omization was based on a computer-generated pseudo-r and om code with r and om permuted blocks of r and omly varying size . BLINDING A research assistant who was blinded to the group allocation recorded all data . INTERVENTION The patients were r and omly allocated to receive anchorage supplementation with TADs , a Nance button on a palatal arch , or headgear . They were all treated with maxillary and m and ibular preadjusted edgewise fixed appliances with 0.022-in slot prescription brackets . They were followed until orthodontic treatment was complete . RESULTS Seventy-eight patients were r and omized in a 1:1:1 ratio among the 3 groups . The baseline characteristics were similar in the groups , and they were treated for an average of 27.4 months ( SD , 7.1 months ) ; 71 completed orthodontic treatment . The data were analyzed on a per- protocol basis and showed no differences in the effectiveness of anchorage supplementation between
Output:
| The results suggest a lack of evidence to prove that early treatment carries additional benefit over and above that achieved with treatment commencing later ; however , this does not necessarily imply that early treatment is ineffective . |
MS211337 | ***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 Diminished control of st and ing balance , traditionally indicated by greater postural sway magnitude and speed , is associated with falls in older adults . Tai Chi ( TC ) is a multisystem intervention that reduces fall risk , yet its impact on sway measures vary considerably . We hypothesized that TC improves the integrated function of multiple control systems influencing balance , quantifiable by the multi-scale “ complexity ” of postural sway fluctuations . Objectives To evaluate both traditional and complexity-based measures of sway to characterize the short- and potential long-term effects of TC training on postural control and the relationships between sway measures and physical function in healthy older adults . Methods A cross-sectional comparison of st and ing postural sway in healthy TC-naïve and TC-expert ( 24.5±12 yrs experience ) adults . TC-naïve participants then completed a 6-month , two-arm , wait-list r and omized clinical trial of TC training . Postural sway was assessed before and after the training during st and ing on a force-plate with eyes-open ( EO ) and eyes-closed ( EC ) . Anterior-posterior ( AP ) and medio-lateral ( ML ) sway speed , magnitude , and complexity ( quantified by multiscale entropy ) were calculated . Single-legged st and ing time and Timed-Up– and -Go tests characterized physical function . Results At baseline , compared to TC-naïve adults ( n = 60 , age 64.5±7.5 yrs ) , TC-experts ( n = 27 , age 62.8±7.5 yrs ) exhibited greater complexity of sway in the AP EC ( P = 0.023 ) , ML EO ( P<0.001 ) , and ML EC ( P<0.001 ) conditions . Traditional measures of sway speed and magnitude were not significantly lower among TC-experts . Intention-to-treat analyses indicated no significant effects of short-term TC training ; however , increases in AP EC and ML EC complexity amongst those r and omized to TC were positively correlated with practice hours ( P = 0.044 , P = 0.018 ) . Long- and short-term TC training were positively associated with physical function . Conclusion Multiscale entropy offers a complementary approach to traditional COP measures for characterizing sway during quiet st and ing , and may be more sensitive to the effects of TC in healthy adults . Trial Registration Clinical Trials.gov 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 This work analyses the short-term physiological and neurophysiological effects of a brisk walking programme in ageing , healthy , active men . Twenty-one men 63 to 72 years of age were recruited and separated into 2 groups . One group performed a walking programme ( WP ) ( n = 11 ) and another served as control ( C ) group ( n = 10 ) . The walking programme lasted for twelve weeks and included five sessions per week . Several parameters were assessed before and after the programme for the WP group . The same tests were performed ( separated by twelve weeks ) in group C. During each assessment , the subjects were put through static and dynamic balance tests , spatio-temporal gait analysis , body composition measurements and determination of aerobic capacity and bone mineral density . The statistic analysis showed a significant improvement in dynamic balance performance , especially in lateral sway when the subjects kept their eyes open , an increase of VO(2 ) max and loss of fat mass in the WP group . However , no alterations appeared in spatiotemporal gait characteristics , static balance performance , lean mass or bone mineral density ( total body and hip ) . According to these results , this walking programme may have positive effects on preventing ageing subjects from falling BACKGROUND Taiji ( T'ai Chi ) has been shown to have generally positive effects on functional balance . However , few studies have investigated the mechanisms by which Taiji may improve balance . The goal of this study was to evaluate changes in sensory and biomechanical balance mechanisms as a consequence of a traditional Taiji exercise program for healthy older adults that intentionally emphasized both Taiji forms and Qigong meditation . MATERIAL / METHODS This was a r and omized controlled trial with blind testers . Forty-nine healthy older adults ( mean age 80.4 , SD . 8.6 ) were r and omized to participate in Taiji-Qigong ( TQ ) training ( N=33 ) or a wait-list control group ( WC , N=16 ) . TQ instruction was provided 1 hour/session , 3 sessions a week for six months . Somatosensory , visual , and vestibular ratios of the Sensory Organization Test , and quiet stance Base of Support ( BoS ) and feet opening angle measures were collected prior to instruction ( T0 ) , at two months ( T2 ) , and six months ( T6 ) . RESULTS TQ group vestibular ratio scores ( normalized to T0 ) were + 22 % and + 47 % greater than WC at T2 and T6 , respectively . The TQ group exhibited an increase in quiet stance BoS over time but not feet opening angle , indicating that the increase in BoS was due to the adoption of wider stances . CONCLUSIONS Improved use of vestibular input and wider stances are two mechanisms by which Taiji-Qigong training may improve healthy older adults ' balance . Further study is needed to evaluate other balance mechanisms and the individual and combined effects of different aspects of traditional Taiji practice The prevention of injury associated with falls in older people is a public health target in many countries around the world . Although there is good evidence that interventions such as multifactorial fall prevention and individually prescribed exercise are effective in reducing falls , the effect on serious injury rates is unclear . Historically , trials have not been adequately powered to detect injury endpoints , and variations in case definition across trials have hindered meta- analysis . It is possible that fall-prevention strategies have limited effect on falls that result in injuries or are ineffective in population s who are at a higher risk of injury . Further research is required to determine whether fall-prevention interventions can reduce serious injuries . Prevention of Falls Network Europe ( ProFaNE ) is a collaborative project to reduce the burden of fall injury in older people through excellence in research and promotion of best practice ( www.profane.eu.org ) . The European Commission funds the network , which links clinicians , members of the public , and research ers worldwide . The aims are to identify major gaps in knowledge in fall injury prevention and to facilitate the collaboration necessary for large-scale clinical research activity , including clinical trials , comparative research , and prospect i ve meta- analysis . Work is being undertaken in a 4-year program . As a first step , the development of a common set of outcome definitions and measures for future trials or meta- analysis was considered BACKGROUND Balance disorders increase considerably with age due to a decrease in posture regulation quality , and are accompanied by a higher risk of falling . Conversely , physical activities have been shown to improve the quality of postural control in elderly individuals and decrease the number of falls . The aim of this study was to evaluate the impact of two types of exercise on the visual afferent and on the different parameters of static balance regulation . METHODS Static postural control was evaluated in 44 healthy women aged over 60 years . Among them , 15 regularly practice d proprioceptive physical activities ( Group I ) , 12 regularly practice d bioenergetic physical activities ( Group II ) , and 18 controls walked on a regular basis ( Group III ) . RESULTS Group I participants displayed lower sway path and area values , whereas Group III participants displayed the highest , both in eyes-open and eyes-closed conditions . Group II participants displayed intermediate values , close to those of Group I in the eyes-open condition and those of Group III in the eyes-closed condition . Visual afferent contribution was more pronounced for Group II and III participants than for Group I participants . CONCLUSIONS Proprioceptive exercise appears to have the best impact on balance regulation and precision . Besides , even if bioenergetic activity improves postural control in simple postural tasks , more difficult postural tasks show that this type of activity does not develop a neurosensorial proprioceptive input threshold as well , probably on account of the higher contribution of visual afferent In a well-executed golf swing , golfers must maintain good balance and precise control of posture . Golfing also requires prolonged walking over uneven ground such as a hilly course . Therefore , repeated golf practice may enhance balance control and confidence in the golfers . The objective is to investigate whether older golfers had better balance control and confidence than non-golfing older , healthy adults . This is a cross-sectional study , conducted at a University-based rehabilitation center . Eleven golfers and 12 control subjects ( all male ; mean age : 66.2 ± 6.8 and 71.3 ± 6.6 years , respectively ) were recruited . Two balance control tests were administered : ( 1 ) functional reach test which measured subjects ’ maximum forward distance in st and ing ; ( 2 ) sensory organization test ( SOT ) which examined subjects ’ abilities to use somatosensory , visual , and vestibular inputs to control body sway during stance . The modified Activities-specific Balance Confidence ( ABC ) determined subject ’s balance confidence in daily activities . The golfers were found to achieve significantly longer distance in the functional reach test than controls . They manifested significantly better balance than controls in the visual ratio and vestibular ratio , but not the somatosensory ratio of the SOT . The golfers also reported significantly higher balance confidence score ratios . Furthermore , older adults ’ modified ABC score ratios showed positive correlations with functional reach , visual and vestibular ratios , but not with somatosensory ratio . Golfing is an activity which may enhance both the physical and psychological aspects of balance control . Significant correlations between these measures reveal the importance of the balance control under reduced or conflicting sensory conditions in older adults ’ balance confidence in their daily activities . Since cause- and -effect could not be established in the present cross-sectional study , further prospect i ve intervention design is warranted OBJECTIVES To compare the effects of short-term and long-term Tai Chi training on the sensorimotor and balance performance of able-bodied subjects . DESIGN A nonr and omized cross-sectional controlled trial . SETTING Sport laboratory . PARTICIPANTS Forty-eight healthy subjects , 16 with 3 months of experience in Tai Chi training , 16 with 1 to 3 years of experience in Tai Chi training , and 16 with no experience in Tai Chi training . INTERVENTION Experimental . MAIN OUTCOME MEASURES The reflex contraction latencies ( reaction time ) of medial hamstrings and gastrocnemius after perturbation , the active knee joint angle-repositioning error , and the balance time on a tilt board were measured and analyzed with 1-way analysis of covariance . Significant results were further analyzed with post hoc linear contrasts . RESULTS Long-term Tai Chi practitioners had a significantly faster reflex reaction time in hamstrings ( P<.000 ) and gastrocnemius ( P=.043 ) muscles and a longer balance time on a tilt board ( P<.000 ) than short-term Tai Chi practitioners and nonpractitioners . Both long- and short-term Tai Chi practitioners had significantly less knee joint angle-repositioning error than nonpractitioners ( P=.001 and P=.027 , respectively ) . CONCLUSIONS Tai Chi training of more than 1 year might have the benefits of faster hamstrings and gastrocnemius reflex reaction and improved knee joint position sense ( JPS ) . These changes might be associated with an improved dynamic st and ing balance . Better knee JPS was shown in subjects with 3 months of Tai Chi practice , but this had not led to a significant improvement in balance Background Evidence , mainly from cross-sectional studies , suggests that physical activity is a potentially important modifiable factor associated with physical performance and strength in older age . It is unclear whether the benefits of physical activity accumulate across life or whether there are sensitive periods when physical activity is more influential . Purpose To examine the associations of leisure-time physical activity across adulthood with physical performance and strength in midlife , and to test whether there are cumulative benefits of physical activity . Methods Using data on approximately 2400 men and women from the UK Medical Research Council National Survey of Health and Development , followed up since birth in March 1946 , the associations of physical activity levels during leisure time self-reported prospect ively at ages 36 , 43 , and 53 years with grip strength , st and ing balance , and chair rise times , assessed by nurses at age 53 years ( in 1999 ) , were examined in 2010 . Results There were independent positive effects of physical activity at all three ages on chair rise performance , and at ages 43 and 53 years on st and ing balance performance , even after adjusting for covariates . These results were supported by evidence of cumulative effects found when using structured life course models . Physical activity and grip strength were not associated in women and , in men , only physical activity at age 53 years was associated with grip strength . Conclusions There are cumulative benefits of physical activity across adulthood on physical performance in midlife . Increased activity should be promoted early in adulthood to ensure the maintenance of physical performance in later life OBJECTIVES To assess inter-rater reliability and validity of the Newcastle Ottawa Scale ( NOS ) used for method ological quality assessment of cohort studies included in systematic review s. STUDY DESIGN AND SETTING Two review ers independently applied the NOS to 131 cohort studies included in eight meta-analyses . Inter-rater reliability was calculated using kappa ( κ ) statistics . To assess validity , within each meta- analysis , we generated a ratio of pooled estimates for each quality domain . Using a r and om-effects model , the ratios of odds ratios for each meta- analysis were combined to give an overall estimate of differences in effect estimates . RESULTS Inter-rater reliability varied from substantial for length of follow-up ( κ = 0.68 , 95 % confidence interval [ CI ] = 0.47 , 0.89 ) to poor for selection of the nonexposed cohort and demonstration that the outcome was not present at the outset of the
Output:
| Results Limited evidence provided by a small number of RCTs , and evidence from observational studies of moderate method ological quality , suggest that free-living PA of between one and 21 years ’ duration improves measures of balance in older healthy community-dwelling adults .
Statistical analysis of observational studies found significant effects in favour of more active groups for neuromuscular measures such as gait speed ; functionality using Timed Up and Go , Single Leg Stance , and Activities of Balance Confidence Scale ; flexibility using the forward reach test ; and strength using the isometric knee extension test and ultrasound .
A significant effect was also observed for less active groups on a single sensory measure of balance , the knee joint repositioning test . |
MS211338 | ***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: We investigated the clinical response of 10 patients with plaque psoriasis to multiple treatments with photodynamic therapy , using topical application of 5-aminolaevulinic acid followed by exposure to broad-b and visible radiation . Treatment was performed up to 3 times per week , with a maximum of 12 treatments , using a light dose of 8 Jcm(-2 ) delivered at a dose-rate of 15 mW cm(-2 ) . Eight patients showed a clinical response . Out of 19 treated sites , 4 cleared , 10 responded but did not clear and 5 showed no improvement . Of the 4 sites that cleared only 1 did so fully , after 7 treatments , 45 days after the start of therapy . Of the 10 sites that responded partially , the greatest reduction in scale , erythema and in duration index occurred after a minimum of 3 and a maximum of 8 treatments . The intensity of 5-aminolaevulinic acid-induced protoporphyrin IX fluorescence , recorded prior to the first treatment , varied between sites on the same patient as well as between patients . There was also a variation in fluorescence intensity recorded from the same site immediately prior to subsequent treatments , although the pretreatment levels generally decreased as the study progressed and then increased as psoriasis relapsed . Biopsies confirmed that fluorescence was localized throughout the epidermis and stratum corneum , but the level was not consistent between sections taken within the same biopsy . We also observed fluorescence at sites distant from the ones that received 5-aminolaevulinic acid , which was not present prior to the start of the treatment programme , but found no evidence of elevated levels of plasma porphyrins . The level of discomfort associated with this therapy increased with increasing values of the calculated photodynamic dose , defined as the product of the initial photosensitizer concentration and the percentage reduction in fluorescence following irradiation . Therefore , although clinical efficacy improved with multiple treatments , unpredictable response and patient discomfort make ALA-PDT unsuitable for the treatment of psoriasis Summary Background The optimum treatment frequency for narrowb and ( TL‐01 ) ultraviolet B ( NB‐UVB ) in psoriasis is not yet known . We have previously found three times weekly to be preferable to five times weekly treatment in our population OBJECTIVE Our purpose was to demonstrate the efficacy of the 308-nm excimer laser for treatment of psoriasis . METHODS This study was a multicenter open trial from 5 dermatology practice s ( one university-based and 4 private practice s ) . Up to 30 patients per center with stable mild to moderate plaque-type psoriasis constituted the study population . Patients received 308-nm ultraviolet B doses to affected areas . The initial dose was based on multiples of a predetermined minimal erythema dose . Subsequent doses were based on the response to treatment . Treatments were scheduled twice weekly for a total of 10 treatments . The main outcome measure was 75 % clearing of the target plaque . Time to clearing was analyzed by Kaplan-Meier methods , accounting for truncated observations . RESULTS One hundred twenty-four patients were enrolled in the study , and 80 completed the entire protocol . The most common reason for exiting from the study was noncompliance . Of the patients who met the protocol requirements of 10 treatments or clearing , 72 % ( 66/92 ) achieved at least 75 % clearing in an average of 6.2 treatments . Eighty-four percent of patients ( 95 % confidence interval [ CI ] , 79%-87 % ) reached improvement of 75 % or better after 10 or fewer treatments . Fifty percent of patients ( 95 % CI , 35%-61 % ) reached improvement of 90 % or better after 10 or fewer treatments . Common side effects included erythema , blisters , hyperpigmentation , and erosions , but they were well tolerated . CONCLUSIONS Monochromatic 308-nm excimer laser treatment appears to be effective and safe for psoriasis . It requires fewer patient visits than conventional phototherapy , and , unlike those treatments , the laser targets only the affected areas of the skin , sparing the surrounding uninvolved skin Targeted broadb and ultraviolet B ( UVB ) phototherapy as well as 308-nm excimer laser have been reported to significantly improve or clear localized psoriatic plaques within 5 to 10 treatments when medium fluences [ i.e. 4 - 6 multiples of minimal erythema doses ( MED ) ] were used . Our study was conducted to determine the effects of different concentrations of topical 8-methoxypsoralen ( 8-MOP ) cream when used in combination with targeted UV phototherapy with regard to number of treatments and cumulative UV doses to clear localized psoriasis . Ten evaluable patients with stable plaque-type psoriasis completed the study . Three different concentrations of 8-MOP creams ( 0.001 % , 0.01 % and 0.1 % ) were applied prior to irradiation with 4 MEDs of targeted narrowb and UVB ( NB-UVB ) , whereas 0.001 % 8-MOP cream was used in conjunction with 5 J/cm(2 ) UVA . All irradiations took place once weekly for 12 weeks . Psoriasis severity index ( PSI ) score was used to evaluate the efficacy of the treatment . With area-under-the-curve analysis , 0.1 % 8-MOP/NB-UVB was superior to other modalities in reducing the PSI scores . The number of treatments and cumulative NB-UVB doses necessary to achieve PSI-95 , a 95 % reduction in the scores , was also lower in the 0.1 % 8-MOP/NB-UVB group , although the differences were not statistically significant . We conclude that topical 8-MOP cream enhances the therapeutic effects of targeted NB-UVB phototherapy without significantly increasing the short-term adverse effects BACKGROUND Ultraviolet radiation has been used for curative purpose s in dermatologic conditions , especially in the last 30 years . OBJECTIVES We analyzed the efficacy of monochromatic excimer light in psoriasis , palmoplantar pustulosis , vitiligo , mycosis fungoides and alopecia areata , and to examine potential new indications . METHODS Two hundred seventy-nine patients with common and persistent skin diseases were enrolled in an open prospect i ve study : 152 patients with stable and localized plaque psoriasis , 47 with palmoplantar psoriasis , 7 with palmoplantar pustulosis , 32 with vitiligo , 11 with prurigo nodularis , 9 with mycosis fungoides stage Ia , 8 with alopecia , 5 with localized scleroderma , 5 with genital lichen sclerosus , and 3 with granuloma annulare . The 308 nm excimer light was used at a power density of 48 mW/cm(2 ) . An average of 12 sessions ( range , 6 - 18 ) , one session per week , was performed and yielded a total dose range of 4 - 12.5 J/cm(2 ) . Clinical response was assessed using photos , biopsies , and specific clinical scores . Patients were monitorized for 6 and 12 months for psoriasis , 12 months for mycosis fungoides , and 4 months for the remaining conditions . RESULTS We observed complete remission in more than 50 % of patients with plaque psoriasis and palmoplantar dermatoses , respectively , complete remission in all patients affected by mycosis fungoides , excellent repigmentation in one third of vitiligo patients , hair regrowth in three patients with alopecia areata , an overall improvement in prurigo nodularis , a partial remission in patients affected by localized scleroderma , and a complete remission in most of the patients with genital lichen sclerosus and granuloma annulare . CONCLUSIONS Our study confirms the use of monochromatic excimer light as a valid choice for the treatment of psoriasis , vitiligo , and mycosis fungoides ; we also observed and report for the first time that monochromatic excimer light produces a therapeutic response in prurigo nodularis , localized scleroderma , genital lichen sclerosus , and granuloma annulare BACKGROUND Psoralen-UVA ( PUVA ) and narrowb and UVB ( 311-nm ) therapy are considered to be first-line phototherapies for patients with moderate to severe psoriasis . To reduce side effects as a result of systemic resorption of psoralens , topical PUVA therapies have been developed and proven to be effective in the treatment of psoriasis . OBJECTIVE We sought to evaluate the combination therapy of narrowb and UVB plus cream PUVA on selected psoriatic plaques compared with narrowb and UVB or cream PUVA alone . METHODS A total of 30 patients ( Psoriasis Area and Severity Index score of 8 - 15 ) were included in the r and omized study . The combination therapy consisting of narrowb and UVB whole-body irradiation followed by cream PUVA therapy for selected psoriatic plaques was evaluated in 10 patients with chronic plaque-stage psoriasis . For comparison , the therapeutic efficacy , number of treatments , and cumulative UV doses until remission ( Psoriasis Area and Severity Index score < 4 ) of cream PUVA therapy or narrowb and UVB alone was determined in 10 patients , respectively . RESULTS Both monotherapies induced clearance of psoriatic lesions in all patients within 5 to 7 weeks . Mean number of treatments for cream PUVA was 24 + /- 5 ; for narrowb and UVB was 21 + /- 3 . The mean cumulative UVA dose was 45.0 + /- 16.3 J/cm(2 ) and the mean cumulative UVB dose was 17.1 + /- 4.1 J/cm(2 ) . Combination therapy result ed in complete clearance of lesions in all patients after 3 to 4 weeks . Mean number of treatment was 14 + /- 2 , mean cumulative UVA dose was 18.7 + /- 4.7 J/cm(2 ) , and mean cumulative UVB dose was 8.2 + /- 3.3 J/cm(2 ) . The number of treatments ( P < .001 , analysis of variance ) , UVA dose ( P < .001 , t test ) , and UVB dose ( P < .001 , t test ) were significantly reduced compared with both monotherapies . CONCLUSIONS Our results indicate that a combination therapy of narrowb and UVB plus cream PUVA appears to have a significantly higher efficacy compared with either monotherapy . The cumulative UV doses were significantly lower in the combination therapy . We conclude that cream PUVA can be used in addition to narrowb and UVB for areas that tend to clear less quickly than the rest of the body Background : Phototherapy is an effective treatment for generalized plaque psoriasis , but is inconvenient and dosimetry is limited by the minimal erythema dose ( MED ) . Objective : This pilot study evaluated the efficacy , safety , and feasibility of excimer laser utilizing a supra-erythemogenic phototherapy strategy ( phototherapy well beyond the MED dose ) to treat generalized psoriasis . Methods : In this 9-month study , 13 patients with psoriasis involving > 10 % but < 30 % body surface area received laser treatment twice weekly for 12 weeks , with 6 months of post-treatment follow-up . The primary endpoint was percentage of patients achieving Psoriasis Area and Severity Index ( PASI ) 75 . Results : Of the 12 patients who completed the treatment phase , 54 % achieved PASI 75 . During the 6-month follow-up period 83 % maintained PASI 50 with no treatment . Limitations : This pilot study had a small sample size . Conclusion : The laser is an effective treatment with a favorable remission rate . With enhanced power in the near future , laser is likely to become more promising for generalized psoriasis Summary Topical photochemotherapy with psoralen and its derivatives 4.5′,8‐trimethylpsoralen ( TMP ) and 8‐methoxypsoralen ( 8‐MOP ) , with UVA irradiation , was evaluated with regard to minimum phototoxic dose , concentration , timing of UVA irradiation and systemic and local side‐effects , in healthy volunteers . Psoralen ( 0.005 % ) in aqueous gel was found to be superior to TMP and 8‐MOP in aqueous gel . No hyperpigmentation was seen after topical PUVA treatment with psoralen in aqueous gel . Patients with plaque‐type psoriasis ( n = 7 ) , palmoplantar psoriasis ( n = 7 ) and hyperkeratotic eczema ( n = 2 ) were treated . Topical PUVA therapy was effective in most psoriasis patients , without the occurrence of local or systemic side‐effects . Moreover , hyperkeratotic eczema patients who did not respond to conventional therapy showed partial remission . These results indicate that topical PUVA therapy with psoralen in aqueous gel is a useful therapeutic modality for treatment of psoriasis patients , and patients with recalcitrant dermatoses such as palmoplantar psoriasis and hyperkeratotic eczema PUVA-bath therapy has proven to avoid many side effects associated with oral 8-methoxypsoralen ( 8-MOP ) treatment . In order to investigate the effectiveness of topical PUVA-bath therapy ( PUVA-soak therapy ) on chronic palmoplantar dermatoses , 30 patients with plaque-type psoriasis , pustular psoriasis
Output:
| Topical PUVA and targeted UVB phototherapy are very effective in the treatment of localized psoriasis .
Topical PUVA seems more effective than non-laser targeted UVB phototherapy .
On the other h and , PDT has low efficacy and high percentage of side effects in treating localized psoriasis |
MS211339 | ***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 /hypothesisThe aim of the present study was to investigate re source utilisation and associated costs in patients with diabetic foot ulcers and to analyse differences in re source utilisation between individuals with or without peripheral arterial disease ( PAD ) and /or infection . Methods Data on re source utilisation were collected prospect ively in a European multicentre study . Data on 1,088 patients were available for the analysis of re source use , and data on 821 patients were included in the costing analysis . Costs were calculated for each patient by multiplying the country-specific direct and indirect unit costs by the number of re sources used from inclusion into the study up to a defined endpoint . Country-specific costs were converted into purchasing power st and ards . Results Re source use and costs varied between outcome groups and between disease severity groups . The highest costs per patient were for hospitalisation , antibiotics , amputations and other surgery . All types of re source utilisation and costs increased with the severity of disease . The total cost per patient was more than four times higher for patients with infection and PAD at inclusion than for patients in the least severe group , who had neither . Conclusions /interpretationImportant differences in re source use and costs were found between different patient groups . The costs are highest for individuals with both peripheral arterial disease and infection , and these are mainly related to substantial costs for hospitalisation . In view of the magnitude of the costs associated with in-hospital stay , reducing the number and duration of hospital admissions seems an attractive option to decrease costs in diabetic foot disease OBJECTIVE Determine the cost-effectiveness of extracellular matrix ( ECM ) relative to human fibroblast-derived dermal substitute ( HFDS ) on diabetic foot ulcer ( DFU ) wound closure . METHOD Outcomes data were obtained from a 12-week , r and omised , clinical trial of adults aged 18 years or older diagnosed with type 1 or type 2 diabetes with a DFU . Patients were treated with either ECM or HFDS treatment . A two-state Markov model ( healed and unhealed ) with a 1-week cycle length was developed using wound-closure rates from the trial to estimate the number of closed-wound weeks and the expected DFU cost per patient . Results were recorded over 12 weeks to estimate the number of closed-wound weeks per treatment and the average cost to achieve epithelialisation ( primary outcome ) . The perspective of the analysis was that of the payer , specifically the Centers for Medicare and Medicaid Services . No cost discounting was performed because of the short duration of the study . RESULTS The study consisted of 26 patients , with 13 in each group . In the ECM group , 10 wounds closed ( 77 % ) , with an average closure time of 36 days ; 11 wounds closed in the HFDS group ( 85 % ) , with an average closure time of 41 days . There was no significant difference between these results ( p=0.73 ) . Over 12 weeks , the expected cost per DFU was $ 2522 ( £ 1634 ) for ECM and $ 3889 ( £ 2524 ) for HFDS . Patients treated with HFDS incurred total treatment costs that were approximately 54 % higher than those treated with ECM . Sensitivity analyses revealed that the total cost of care for two applications of HFDS was more costly than eight applications of ECM by approximately $ 500 ( £ 325 ) . CONCLUSION In patients with DFU , ECM yielded similar clinical outcomes to HFDS but at a lower cost . Health-care providers should consider ECM as a cost-saving alternative to HFDS . DECLARATION OF INTEREST A.M. Gilligan , and C.R. Waycaster , are employees of Smith & Nephew Inc .. This study was funded by Smith & Nephew Inc .. A.L. L and sman , reports no conflicts of interest BACKGROUND Despite significant advances , the treatment of diabetic foot ulcers ( DFUs ) remains a major therapeutic challenge for clinicians , surgeons , and other health care professionals . There is an urgent need for new strategies with clinical ly effective interventions to treat DFUs to reduce the burden of care in an efficient and cost-effective way . OBJECTIVE This r and omized trial evaluated and compared the clinical effectiveness , tolerability , and costs of clostridial collagenase ointment ( CCO ) debridement to that of debridement using saline moistened gauze ( SMG ) and selective sharp debridement for the treatment of DFUs . METHODS R and omized , controlled , parallel group , multicenter , open-label , 12-week study of 48 patients with neuropathic DFUs r and omized to 4 weeks of treatment with either CCO or SMG after baseline surgical debridement . The primary end point was the condition of the ulcer bed at the end of treatment as measured using a st and ardized wound assessment tool . Secondary end points were the percentage of reduction in wound area and therapeutic response rates . Adverse events were monitored for the tolerability analysis . In addition , a comparative cost-effectiveness analysis was performed from the perspective of the Centers for Medicare and Medicaid Services as a payer . RESULTS Both the CCO and SMG groups had significantly improved wound assessment scores after 4 weeks of treatment ( CCO , -2.5 , P = 0.007 ; SMG , -3.4 , P = 0.006 ) . Only CCO treatment result ed in a statistically significant decrease from baseline in the mean wound area at the end of treatment ( P = 0.0164 ) and at the end of follow-up ( P = 0.012 ) . In addition , the CCO group exhibited a significantly better response rate at the end of follow-up compared with the SMG group ( 0.92 vs 0.75 , P < 0.05 ) . Reported adverse events were similar between the 2 treatment groups . None of the reported adverse events were considered to be related to treatment . The economic analysis indicated that the direct mean costs per responder in the physician office setting of care were $ 832 versus $ 1042 for the CCO group versus the SMG group , whereas the direct mean costs per responder in the hospital outpatient department setting were $ 1607 versus $ 1980 . CONCLUSIONS CCO treatment provides equivalent debridement of DFUs similar to SMG while fostering better progress toward healing as measured by decreasing wound area over time and improved response rates at the end of follow-up . In addition , CCO yields a more favorable cost-effectiveness ratio in both the physician office and hospital outpatient department setting s of care . Clinical Trials.gov identifier : NCT01056198 OBJECTIVE To estimate the annual , per-patient incremental burden of diabetic foot ulcers ( DFUs ) . RESEARCH DESIGN AND METHODS DFU patients and non-DFU patients with diabetes ( controls ) were selected using two deidentified data bases : ages 65 + years from a 5 % r and om sample of Medicare beneficiaries ( St and ard Analytical Files , January 2007–December 2010 ) and ages 18–64 years from a privately insured population ( OptumInsight , January 2007–September 2011 ) . Demographics , comorbidities , re source use , and costs from the payer perspective incurred during the 12 months prior to a DFU episode were identified . DFU patients were matched to controls with similar pre-DFU characteristics using a propensity score methodology . Per-patient incremental clinical outcomes ( e.g. , amputation and medical re source utilization ) and health care costs ( 2012 U.S. dollars ) during the 12-month follow-up period were measured among the matched cohorts . RESULTS Data for 27,878 matched pairs of Medicare and 4,536 matched pairs of privately insured patients were analyzed . During the 12-month follow-up period , DFU patients had more days hospitalized ( + 138.2 % Medicare , + 173.5 % private ) , days requiring home health care ( + 85.4 % Medicare , + 230.0 % private ) , emergency department visits ( + 40.6 % Medicare , + 109.0 % private ) , and outpatient/physician office visits ( + 35.1 % Medicare , + 42.5 % private ) than matched controls . Among matched patients , 3.8 % of Medicare and 5.0 % of privately insured DFU patients received lower limb amputations . Increased utilization result ed in DFU patients having $ 11,710 in incremental annual health care costs for Medicare , and $ 16,883 for private insurance , compared with matched controls . Privately insured matched DFU patients incurred excess work-loss costs of $ 3,259 . CONCLUSIONS These findings document that DFU imposes substantial burden on public and private payers , ranging from $ 9–13 billion in addition to the costs associated with diabetes itself OBJECTIVE ischaemic lower-extremity ulcers in the diabetic population are a source of major concern because of the associated high risk of limb-threatening complications . The aim of this study was to evaluate the role of hyperbaric oxygen in the management of these ulcers . METHOD eighteen diabetic patients with ischaemic , non-healing lower-extremity ulcers were recruited in a double-blind study . Patients were r and omly assigned either to receive 100 % oxygen ( treatment group ) or air ( control group ) , at 2.4 atmospheres of absolute pressure for 90 min daily ( total of 30 treatments ) . RESULTS healing with complete epithelialisation was achieved in five out of eight ulcers in the treatment group compared to one out of eight ulcers in the control group . The median decrease of the wound areas in the treatment group was 100 % and in the control group was 52 % ( p=0.027 ) . Cost-effectiveness analysis has shown that despite the extra cost involved in using hyperbaric oxygen , there was a potential saving in the total cost of treatment for each patient during the study . CONCLUSION hyperbaric oxygen enhanced the healing of ischaemic , non-healing diabetic leg ulcers and may be used as a valuable adjunct to conventional therapy when reconstructive surgery is not possible This prospect i ve observational study was carried out to assess the annual preventive and curative treatment costs for diabetic foot problems . Measures of re source use over the 1-year study period were taken for 151 patients whose lesions covered the entire Wagner classification . Treatment was provided under the current protocol s of a multidisciplinary team . The 1993 market prices for health services were used to convert units of health service utilization to expenditures by the social insurance system and the patients . The severity of the foot problems determined the medical cost . Preventive care ( 47 cases ) , represented an average cost per case of US$ 880 ( 1 US$ 1993=BEF 30.65 ) . Curative care ( 120 cases ) , including diagnostic tests , wound dressings , antibiotic therapy , revascularization and off loading techniques result ed in a mean cost of US$ 5227 per ulcer . Care for the 16 most severe wounds and amputations involved hospitalization and surgery at a mean cost per ulcer of US$ 31716 . The most important cost contributers were hospitalizations ( 72 % ) , drugs ( 11 % ) and diagnostic examinations ( 4 % ) . Preventive treatment for diabetic foot problems can represent a significant saving for the social insurance system as well as for the patients Abstract Objective : To calculate costs for the management of deep foot infections and to identify the most important factors related to treatment costs . Design : Costs for in-hospital care , surgery , investigations , antibacterials , visits to the foot-care team , orthopaedic appliances and topical treatment were calculated retrospectively from diagnosis until healing or death . Multiple regression analysis was used to identify factors that independently affect costs . Setting : A multidisciplinary foot-care team . Patients : 220 prospect ively followed patients with diabetes mellitus and deep foot infections who were referred to the team from 1986 to 1995 . Main Outcome Measures and Results : Total cost for healing without amputation was Swedish kronor (SEK)136 600 per patient , while the corresponding cost for healing with minor amputation was SEK260 000 and with major amputation was SEK234 500 . All costs were quoted in SEK at 1997 price levels ( £ 1 sterling and $ US1 equalled approximately SEK12.50 and SEK7.64 , respectively ) . The cost of antibacterials was 4%of total costs . The cost of topical treatment was 51 % of total costs and related to wound healing time . Number of weeks between diagnosis of deep foot infection and healing , and number of surgical procedures were variables that explained 95 % of costs in the multiple regression analysis . It was not possible to find any parameters present at diagnosis that could contribute to an explanation of total treatment costs . Conclusions : Topical treatment accounted for the largest proportion of total costs and the most important cost driving factors were wound healing duration and repeated surgery . Costs of antibacterials should not be used as an argument in the choice between early amputation and conservative treatment Diabetic foot ulcers ( DFUs ) are a leading cause of morbidity and hospitalisation among patients with diabetes . We analysed cl aims data for Medicare part B diabetic foot ulcer patients treated with Negative Pressure Wound Therapy at home ( N = 1135 ) and diabetic foot ulcer patients from a published meta- analysis of r and omised controlled wet-to-moist therapy . The expected costs of care for the two treatments were also compared . A significantly greater proportion of wounds treated with NPWT achieved a successful treatment endpoint compared with wet-to-moist therapy at both 1
Output:
| Despite heterogeneity of foot complications and geographic variations , the search methodology revealed substantial costs and further healthcare burden for people with diabetes .
Amputations due to suboptimally treated foot infections contribute to the already high rates of hospitalizations and readmissions .
Moreover , the findings suggest that the cost of amputation in the US is generally higher compared to the cost in European countries . |
MS211340 | ***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 Objective : To evaluate the cost-effectiveness of caspofungin versus liposomal amphotericin B ( L-AmB ) for empirical antifungal therapy in patients with persistent fever and neutropenia in Sweden . Methods : With a decision-analytic model , the expected direct costs , life-years lost and quality adjusted life-years lost were estimated for an average patient in Sweden . Efficacy/tolerability data were obtained from analysis of a r and omized , double-blind multinational trial . Life expectancy , medical re source use and unit costs data were gathered from the literature and expert opinion . Probabilistic sensitivity analysis was used to evaluate the impact of uncertainty in data on outcomes . Results : The direct cost with caspofungin amounted to 233,851 SEK ( 95 % uncertainty interval 225,091–242,210 ) and with L-AmB to 271,921 SEK ( 262,935–281,363 ) , a difference of 38,070 SEK ( 31,745–44,811 ) favouring caspofungin . Treatment with caspofungin result ed in 0.25 ( 0.01–0.55 ) quality -adjusted life-years ( QALYs ) saved in comparison to L-AmB. Given the uncertainty in the estimates there is a > 95 % probability that caspofungin is economically dominant over L-AmB , i.e. cost-saving and QALY-saving . Conclusion : Given the underlying assumptions and data used , caspofungin is expected to be cost-effective with at least comparable outcomes compared to L-AmB for the empirical treatment of patients with suspected fungal infections in Sweden Given that the rationale for empirical antifungal therapy in neutropenic children is limited and based on adult patient data , we performed a prospect i ve , r and omized , controlled trial that evaluated 110 neutropenic children with persistent fever . Those at high risk for invasive fungal infections ( IFI ) received caspofungin ( Arm C ) or liposomal amphotericinB ( Arm B ) ; those with a lower risk were r and omized to receive Arm B , C , or no antifungal treatment ( Arm A ) . Complete response to empirical antifungal therapy was achieved in 90/104 patients ( 86·5 % ) : 48/56 at high risk ( 85·7 % ) [ 88·0 % in Arm B ; 83·9 % in Arm C ( P = 0·72 ) ] , and 42/48 at low risk ( 87·5 % ) [ 87·5 % in control Arm A , 80·0 % Arm B , 94·1 % Arm C ; ( P = 0·41 ) ] . None of the variables tested by multiple logistic regression analysis showed a significant effect on the probability to achieve complete response . IFI was diagnosed in nine patients ( 8·2 % , 95 % confidence interval , 3·8–15·0 ) . This r and omized controlled study showed that empirical antifungal therapy was of no advantage in terms of survival without fever and IFI in patients aged < 18 years and defined with low risk of IFI . Higher risk patients , including those with relapsed cancer , appear to be the target for empirical antifungal therapy during protracted febrile neutropenia In 2005 , several groups , including the European Group for Blood and Marrow Transplantation , the European Organization for Treatment and Research of Cancer , the European Leukemia Net and the Immunocompromised Host Society created the European Conference on Infections in Leukemia ( ECIL ) . The main goal of ECIL is to elaborate guidelines , or recommendations , for the management of infections in leukemia and stem cell transplant patients . The first sets of ECIL slides about the management of invasive fungal disease were made available on the web in 2006 and the papers were published in 2007 . The third meeting of the group ( ECIL 3 ) was held in September 2009 and the group up date d its previous recommendations . The goal of this paper is to summarize the new proposals from ECIL 3 , based on the results of studies published after the ECIL 2 meeting : ( 1 ) the prophylactic recommendations for hematopoietic stem cell transplant recipients were formulated differently , by splitting the neutropenic and the GVHD phases and taking into account recent data on voriconazole ; ( 2 ) micafungin was introduced as an alternative drug for empirical antifungal therapy ; ( 3 ) although several studies were published on preemptive antifungal approaches in neutropenic patients , the group decided not to propose any recommendation , as the only r and omized study comparing an empirical versus a preemptive approach showed a significant excess of fungal disease in the preemptive group OBJECTIVE To evaluate the cost-effectiveness of caspofungin versus liposomal amphotericin B as empiric antifungal treatment in patients with neutropenic fever in Italy . METHODS The cost-effectiveness of caspofungin versus liposomal amphotericin B was evaluated using a decision-tree model . Patients were stratified by presence or absence of baseline infection . Model outcomes included success in terms of resolution of fever , resolution of baseline infection , absence of breakthrough infection , survival , and quality -adjusted life years ( QALYs ) saved . Discontinuation because of nephrotoxicity or other adverse events were included in the model . Efficacy and safety data were based on a r and omized , double-blind , multinational trial of caspofungin compared to liposomal amphotericin B ( Walsh 2004 ) . Information on life expectancy , quality of life , medical re source consumption , and costs was obtained from the literature . RESULTS The caspofungin estimated total treatment cost amounted to 8351 euros ( 95 % uncertainty interval 7801 euros-8903 euros ) , which is 3470 euros ( 2575 euros-4382 euros ) less than with liposomal amphotericin B. Treatment with caspofungin result ed in 0.25 ( -0.11 ; 0.59 ) QALYs saved in comparison to treatment with liposomal amphotericin B. Probabilistic sensitivity analysis demonstrated a 93 % probability that caspofungin was economically dominant , i.e. , cost and QALY saving , and a probability of more than 99 % that the costs per QALY saved were below 20,000 euros , a commonly accepted threshold for cost-effectiveness . Additional analyses with alternative doses of liposomal amphotericin B confirmed these findings . CONCLUSION Given the underlying assumptions , our economic evaluation demonstrated that caspofungin is cost-effective compared to liposomal amphotericin B in empiric antifungal treatment of patients with neutropenic fever in Italy Micafungin , a clinical ly important echinoc and in antifungal drug , needs to be investigated as empirical therapy in febrile neutropenia in comparison with azole compounds . A prospect i ve r and omized study was conducted to compare clinical outcomes between micafungin and intravenous itraconazole as an empirical therapy for febrile neutropenia in hematological malignancies . The antifungal drug ( micafungin 100 mg or itraconazole 200 mg IV once daily ) was given for high fever that was sustained despite the administration of appropriate antibiotics . Treatment success was determined by composite end points based on breakthrough invasive fungal infection ( IFI ) , survival , premature discontinuation , defervescence , and treatment of baseline fungal infection . Duration of fever , hospital stay , and overall survival ( OS ) were studied . A total of 153 patients were r and omized to receive micafungin or itraconazole . The overall success rate was 7.1 % point higher in the micafungin group ( 64.4 vs. 57.3 % , p = 0.404 ) , satisfying the statistical criteria for the non-inferiority of micafungin . The duration of fever and hospital stay were significantly shorter in the micafungin group ( 6 vs. 7 days , p = 0.014 ; 22 vs. 27 days , p = 0.033 , respectively ) . Grade 3 adverse events including hyperbilirubinemia ( 2 vs. 7 ) , elevation of transaminase levels ( 2 vs. 4 ) , electrolyte imbalance ( 1 vs. 2 ) , atrial fibrillation ( 1 vs. 0 ) , and anaphylaxis ( 1 vs. 0 ) occurred in 7 and 13 patients in the micafungin ( 10.4 % ) and itraconazole ( 18.8 % ) groups , respectively . Micafungin , when compared with itraconazole , had favorably comparable success rate and toxicity profiles on febrile neutropenia in patients with hematological malignancies . In addition , it showed superior effect on shortening the hospital stay BACKGROUND Patients with neutropenia and persistent fever are often treated empirically with amphotericin B or liposomal amphotericin B to prevent invasive fungal infections . Antifungal triazoles offer a potentially safer and effective alternative . METHODS In a r and omized , international , multicenter trial , we compared voriconazole , a new second-generation triazole , with liposomal amphotericin B for empirical antifungal therapy . RESULTS A total of 837 patients ( 415 assigned to voriconazole and 422 to liposomal amphotericin B ) were evaluated for success of treatment . The overall success rates were 26.0 percent with voriconazole and 30.6 percent with liposomal amphotericin B ( 95 percent confidence interval for the difference , -10.6 to 1.6 percentage points ) ; these rates were independent of the administration of antifungal prophylaxis or the use of colony-stimulating factors . There were fewer documented breakthrough fungal infections in patients treated with voriconazole than in those treated with liposomal amphotericin B ( 8 [ 1.9 percent ] vs. 21 [ 5.0 percent ] , P=0.02 ) . The voriconazole group had fewer cases of severe infusion-related reactions ( P<0.01 ) and of nephrotoxicity ( P<0.001 ) . The incidence of hepatotoxicity was similar in the two groups . Patients receiving voriconazole had more episodes of transient visual changes than those receiving liposomal amphotericin B ( 22 percent vs. 1 percent , P<0.001 ) and more hallucinations ( 4.3 percent vs. 0.5 percent , P<0.001 ) . Parenteral voriconazole was changed to the oral formulation in 22 percent of the voriconazole group , with a reduction in the mean duration of hospitalization by one day in all patients ( P=0.17 ) but by two days in patients at high risk ( P=0.03 ) . CONCLUSIONS Voriconazole is a suitable alternative to amphotericin B preparations for empirical antifungal therapy in patients with neutropenia and persistent fever BACKGROUND With use of data from the Prospect i ve Antifungal Therapy ( PATH ) Alliance registry , we performed this multicenter , prospect i ve , observational study to assess the epidemiologic characters and outcomes of invasive fungal infection ( IFI ) in hematopoietic stem cell transplant ( HSCT ) recipients . METHODS Sixteen medical centers from North America reported data on adult HSCT recipients with proven or probable IFI during the period July 2004 through September 2007 . The distribution of IFIs and rates of survival at 6 and 12 weeks after diagnosis were studied . We used logistic regression models to determine risk factors associated with 6-week mortality for allogeneic HSCT recipients with invasive aspergillosis ( IA ) . RESULTS Two hundred thirty-four adult HSCT recipients with a total of 250 IFIs were included in this study . IA ( 59.2 % ) was the most frequent IFI , followed by invasive c and idiasis ( 24.8 % ) , zygomycosis ( 7.2 % ) , and IFI due to other molds ( 6.8 % ) . Voriconazole was the most frequently administered agent ( 68.4 % ) ; amphotericin B deoxycholate was administered to a few patients ( 2.1 % ) . Ninety-three ( 46.7 % ) of 199 HSCT recipients with known outcome had died by week 12 . The 6-week survival rate was significantly greater for patients with IA than for those with invasive c and idiasis and for those with IFI due to the Zygomycetes or other molds ( P < .07 ) . The 6-week mortality rate for HSCT recipients with IA was 21.5 % . At 6 weeks , there was a trend toward a worse outcome among allogeneic HSCT recipients with IA who received myeloablative conditioning ( P = .07 ) ; absence of mechanical ventilation or/ and hemodialysis ( P = .01 ) were associated with improved survival . CONCLUSIONS IA remains the most commonly identified IFI among HSCT recipients , but rates of survival in persons with IA appear to have improved , compared with previously reported data . Invasive c and idiasis and IFI due to molds other than Aspergillus species remain a significant problem in HSCT recipients The safety and efficacy profile of caspofungin and micafungin in Japanese patients with fungal infections were directly compared in this prospect i ve , r and omized , double-blind study . The proportion of patients who
Output:
| Other differences in outcomes among antifungals were not statistically significant .
From the rank probability plot , caspofungin appeared to be the most effective agent for all-cause mortality and fungal infection-related mortality , whereas micafungin tended to be superior for treatment response .
The results were stable after excluding RCTs with high risk of bias , whereas micafungin had the lowest fungal infection-related mortality .
Conclusions Our results highlighted the necessity of empiric antifungal treatment and indicates that echinoc and ins appeared to be the most effective agents for empiric treatment of febrile neutropenic patients based on mortality and treatment response . |
MS211341 | ***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 — A large proportion of disabled stroke survivors live at home and are supported by informal caregivers . Identification of determinants of caregiver burden will help to target caregiver interventions . Methods — Data on patient , caregiver , and health and social support characteristics were collected prospect ively over 1 year in 232 stroke survivors in a r and omized trial of caregiver training . The contribution of these variables to caregiver burden score ( CBS ) and quality of life ( QOL ) measures at 3 months and 1 year was analyzed using regression models . Results — Stroke patients had a mean age of 74±11 years , and 120 ( 52 % ) were men . The mean age of caregivers was 65.7±12.5 years , 149 ( 64 % ) were females , and 116 ( 50 % ) had received caregiver training . The mean CBS was 48±13 and 38±11 ( score range of bad to good 88 to 22 ) and QOL score was 75±16 and 75±15 ( score range of bad to good 0 to 100 ) at 3 months and 1 year , respectively . CBS and QOL correlated with each other and with patient ( age , dependency , and mood ) , caregiver ( age , gender , mood , and training ) , and support ( social services and family networks ) variables . Of these , only patient and caregiver emotional status , caregiver age and gender , and participation in caregiver training were independent predictors of either outcome at 3 months . Patient dependency and family support were additional independent predictors at 1 year . Social services support predicted institutionalization but not caregiver outcomes . Conclusion — Advancing age and anxiety in patients and caregivers , high dependency , and poor family support identify caregivers at risk of adverse outcomes , which may be reduced by caregiver training OBJECTIVE The objective of this study was to evaluate the strengths and weaknesses of a group support program and a home visiting program for family caregivers of stroke patients . It also examined the best fit between intervention variant and family caregiver and patient characteristics . van den Heuvel 's previous effect study showed positive effects of the same intervention program , but unlike our present study differences between the two support variants could not be measured . METHODS Of 257 family caregivers who were included and r and omly assigned to an intervention variant or a control group , 127 family caregivers completed the intervention in either the group program or the home visiting program . RESULTS Evaluation data showed that both intervention variants had been helpful and feasible , but home visit participants missed peer contact and follow-up contacts were missed in both intervention programs . In comparison to the home visiting program , the group program participants showed more benefit especially with respect to informational and emotional components . Caregivers ' preference for type of intervention revealed that both types of intervention had its supporters . Those that preferred the group program could be clearly characterised : they were burdened , lived with a more psychologically h and icapped relative , were using active coping strategies more frequently or lived in a region which is considered to be more sociable . CONCLUSION The present study adds extensively to van den Heuvel 's effect study with respect to discriminative aspects of group and home intervention programs and their respective benefits for specific family caregiver groups . PRACTICE IMPLICATION S In order to suitably match an intervention type with specific caregiver characteristics the intervention provider should utilize caregiver self- selection or undertake professional screening of caregiver burden . Telephone contacts should be offered in addition to the interventions BACKGROUND : Few studies have examined the factors associated with depression in informal caregivers of HIV-infected persons . OBJECTIVE : To investigate the relationship between depression and caregiver burden among informal caregivers of HIV-infected individuals . DESIGN : Cross-sectional study using baseline data from an ongoing r and omized trial of a supportive telephone intervention . PARTICIPANTS : One hundred seventy-six dyads of HIV patients and their informal caregiver . MEASUREMENTS : Depression was defined as a Beck Depression Inventory > 10 . A Caregiver Strain Index > 6 identified informal caregivers with a high caregiver burden . We used logistic regression to identify characteristics that were associated with depression in the informal caregiver . RESULTS : Informal caregivers were 42 years old ( SD , 13 ) , 53 % female , 59 % nonwhite , and 30 % had education beyond high school . Forty-seven percent of informal caregivers were the patient ’s partner , 18 % a friend , and 35 % a family member . Twenty-seven percent of informal caregivers had a high caregiver burden , and 50 % were depressed . We found significantly greater odds of informal caregiver depression with high caregiver burden ( OR , 6.08 ; 95 % CI , 2.40 to 15.4 ) , informal caregiver medical comorbidity besides HIV ( OR , 2.32 ; 95 % CI , 1.09 to 4.92 ) , spending all day together ( OR , 3.92 ; 95 % CI , 1.59 to 9.69 ) , having to help others besides the HIV patient ( OR , 2.55 ; 95 % CI , 1.14 to 5.74 ) , and duration of the HIV patient ’s diagnosis ( OR , 1.01 per month ; 95 % CI , 1.00 to 1.01 ) . CONCLUSIONS : High caregiver burden was strongly associated with depression among HIV-infected individuals ’ informal caregivers , who themselves had difficult life circumstances . Informal caregivers of HIV patients may be in need of both mental health services and assistance in caregiving Purpose : To evaluate the feasibility and effectiveness of early supported discharge ( ESD ) following acute stroke . Method : An ESD scheme was compared to conventional rehabilitation in a r and omized controlled trial . All patients admitted with acute stroke were considered for inclusion . Eighty-eight ( 20.2 % ) were found to be eligible and 82 were r and omized either to early supported discharge ( n=42 ) or conventional rehabilitation ( n=40 ) . The primary outcome measure was the Nottingham Extended Activities of Daily Living Scale . The General Health Question naire , the Montgomery Aasberg Depression Rating Scale , mortality , placement and patient and carer satisfaction served as secondary outcome measures . Results : Median length of stay was reduced from 31 days in the conventional hospital rehabilitation group to 22 days in the early supported discharge group ( p=0.09 ) . No differences were found regarding primary outcome . The General Health Question naire score showed a significant difference in favour of the early supported discharge group at three months ( 19.5/24 , p = 0.02 ) , but not at six . At six months , the proportion of patients being dead or in institution showed a trend of being higher in the conventional rehabilitation group ( OR 3.8 , 95 % CI 0.8 - 23 ) . Conclusions : Early supported discharge after stroke is feasible and it is possible that it has benefits compared with conventional rehabilitation Family caregivers , the “ second victims ” or hidden patients in dementia care , are at risk for social isolation , stress , depression , and mortality . Telephone-based support ( telesupport groups ) represents a practical , low-burden , low-cost source of emotional support . The present study evaluated the feasibility and effectiveness of professionally led telephone-based support groups for female family caregivers of community-dwelling dementia patients . Recruited through various community sources , 103 female caregivers were r and omized to the telesupport group treatment or a control condition . Effects on caregiver burden , depression , and personal gains were evaluated at 6 months , the main end point . Older care-givers ( ≥65 ) in telesupport reported lower depression than control group caregivers did The present research describes the association between objective and subjective caregiver burden experienced by families and friends of individuals with chronic mental illness . Although there has been a significant quantity of research conducted about burden and mental illness , the findings have been equivocal because of varying definitions of burden and varying sampling procedures . The present research utilizes a st and ardized interview instrument for caregivers . Caregivers were named by a stratified r and om sample of clients who have been certified as severely mentally disabled and have received publicly-funded community mental health services in the state of Ohio during the 1990 fiscal year . Data were collected by the first author and a research assistant during telephone interviews between August 1991 and May 1992 . One hundred and eighty-nine caregivers were interviewed . Findings showed that the majority of caregivers are female , white , and aged 50 years or more . Parents comprise the largest group of caregivers and slightly more than one third of clients live with the caregiver . The relationship between caregiver and client is generally described as positive ; however , the interviews were conducted during a period when the clients ' symptomatology was more under control than previously in the relationship . Caregivers state that the clients need help much more often than they ask for it in all categories of possible help . Considering caregiver burden in relation to caregiver behaviors , time management is a somewhat frequent problem that is very troublesome to the caregiver . Considering client behaviors in relation to caregiver burden , embarrassing behaviors are most troublesome and occur with moderate frequency . The surprise element of these behaviors seems to be the most problematic Purpose : This paper explores the perceived health and reported level of strain in the primary carers of severely brain injured individuals , 15 - 18 months after discharge from inpatient rehabilitation . Method : Seventy carers took part in a prospect i ve descriptive study utilizing a semistructured interview and st and ardized measures including the SF36 , The Carer Strain Index and the Relative Question naire . Functional consequences for the injured person were also assessed . Results : The SF36 demonstrated a trend towards lower perceived health for carers than that reported in the general population . Neither perceived health status nor level of strain differed significantly according to the type of injury sustained ( haemorrhagic or traumatic ) nor initial severity of injury . Factors that contributed to carers having worse health status included the injured person 's level of disability and interpersonal factors such as the nature of the relationship , with spouses having lower perceived health status than parents . Conclusions : Irrespective of cause of injury , generalised health consequences result for the carers of those with disabling consequences of brain injury . Factors independent of the injured individual themselves ( such as the nature of the relationship to the carer ) need to be taken into consideration when exploring wellbeing of carers and planning services This investigation evaluates the moderating influence of social support on the negative effects of stress for family caregivers and vali date s the Perceived Stress Scale as a st and ard of measurement . Seventy-five family caregivers to older adults with heart failure were interviewed in their homes about perceived stress , depressive symptoms , and social support after hospital discharge . The Perceived Stress Scale demonstrated internal consistency . Social support did not moderate the effects of stress on depressive symptoms . Lack of a significant association between salivary cortisol and the Perceived Stress Scale did not support testing of construct validity . Stress levels , however , frequently vary due to caregiving dem and s and additional influencing factors ABSTRACT Objective : Despite response variability , cholinesterase inhibitors are recommended in mild to moderate Alzheimer 's disease . Dose titration is common ; however r and omized controlled trials ( RCTs ) have mainly investigated fixed-dose regimens . We examined practice patterns and outcomes of 6 ± 1.5-month rivastigmine therapy . Methods : Prospect i ve , pharmacoepidemiologic , naturalistic study of 175 evaluable patients with mild to moderate Alzheimer 's disease ( + 151 caregivers ) from 52 centers in Belgium on 6 ± 1.5 month ( titrated ) rivastigmine treatment . Main outcome measures : Measured at baseline ( enrollment ) and follow-up ( 6 ± 1.5 months ) . For patients : Mini-Mental State Exam ( MMSE ) , Activities of Daily Living ( ADL ) , Neuropsychiatric Inventory ( NPI ) , Global Deterioration Scale ( GDS ) scores ; treatment response ( improvement , maintenance , or decline less than normative slope ) . For caregivers : hours/week spent caring ; Zarit Caregiver Burden Scale ( ZCBS ) , 12‐item version of General Health Question naire ( GHQ‐12 ) , Instrumental Activities of Daily Living ( IADL ) scores . Results : Patients ’ MMSE and NPI scores ( p < 0.001 ) improved from baseline to follow-up , but not ADL and GDS scores . Treatment response was 89.1 % of patients for MMSE ( including 60.6 % with improvement ) and 77.7 % for NPI ( including 57.1 % with improvement ) . Quadratic curves were fitted for the average daily dose and the MMSE and NPI scores ; with a trend towards average daily dose of 6.0 ± 3.0 mg/day . Caregivers ’ ZCBS ( p = 0.036 ) and GHQ‐12 ( p = 0.029 ) scores improved , but not IADL scores and time spent caring . Conclusions : Patients ’ MMSE and ADL scores confirmed the meta-analyses of rivastigmine efficacy trials , while NPI scores exceeded efficacy results . Proportionately more patients responded to ( titrated ) treatment than in fixed-dose RCTs . Caregivers reported less burden ( similar to meta- analysis ) and better general health over the study period . Where efficacy and effectiveness results diverge , the benefit is in ‘ real-world ’ effectiveness . Large sample , multi-country replications , less sensitive to censoring secondary to missing data and powered to permit advanced modeling , as well as RCTs with adaptive design s to accommo
Output:
| RESULTS The construct of caregiver burden is not st and ardized , and many terms are used to describe burden . |
MS211342 | ***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: Neurohypophysial hormones are thought to be involved in alterations in fluid balance during pregnancy and delivery . In the course of normal pregnancy intravascular volume is increased whereas sodium restriction is thought to reduce plasma volume and cardiac output . In the present study , we measured the effect of long-term severe sodium restriction on vasopressin ( AVP ) and oxytocin ( OT ) levels during normal pregnancy and after delivery . Fifty-nine healthy nulliparous women were r and omized either for a low sodium diet ( 20 mmol sodium daily ) or for a normal diet from week 12 of pregnancy onwards . Circulating plasma levels and urinary excretion of AVP and OT , their neurophysins ( Np-AVP and Np-OT ) and AVP bound to platelets were determined at regular intervals during pregnancy and after delivery . After completion of the study , women on a sodium-restricted diet were compared with control women on a normal diet using repeated measurement ANOVA with adjustment for potentially confounding variables . After r and omization , a reduction in urinary sodium excretion of , on average , 40 - 82 % was found . In general , no effect of sodium restriction could be demonstrated on the various parameters ( 0.53 < P < 0.98 ) with the exception of a significantly lower 24-h urinary AVP excretion by non-smokers with sodium restriction compared with non-smokers having a normal diet ( P = 0.018 ) . For all parameters , clear changes were found in the course of pregnancy and puerperium ( P < 0.0001 to P < 0.005 ) . Platelet-bound AVP decreased and Np-OT increased during pregnancy . After birth , free plasma AVP , platelet-bound AVP , OT , osmolality , sodium and potassium increased , while Np-AVP and Np-OT decreased . Although elevated Np-AVP and Np-OT levels during pregnancy seem to indicate increased release of neurohypophysial hormones , pregnancy up to 36 weeks of gestation is accompanied by low circulating AVP and OT levels . Long-term severe sodium restriction diminishes urinary AVP excretion in ( non-smoking ) pregnant women , without changing circulating levels of AVP and OT , despite the known reduction in circulating volume . The reduced circulating ( platelet-bound ) AVP levels during pregnancy , whether or not in combination with severe sodium restriction , support the absence of significant non-osmotic stimulation of AVP during pregnancy Sodium restriction can reduce blood pressure in hypertensive patients . The present study indicates that if hypertension is well controlled then the reemergence of hypertension can be decreased by the use of a reduced sodium intake . The present paper demonstrates that in such patients on a normal salt diet , 90 % become hypertensive within 6 months while only 40 % of people on a reduced sodium diet become hypertensive . It is proposed that a high sodium intake activates a number of amplifiers that causes a shift of the dose-response curve to sodium to the left and if not prevented or interrupted leads to the development of hypertension Background Decreasing salt consumption can prevent cardiovascular diseases ( CVD ) . Practically , it is difficult to promote people ’s awareness of daily salt intake and to change their eating habits in terms of reducing salt intake for better cardiovascular health . Health education programs visualizing daily dietary salt content and intake may promote lifestyle changes in patients at high risk of cardiovascular diseases . Methods / Design This is a cluster r and omized trial . A total of 800 high-CVD-risk patients attending diabetes and hypertension clinics at health centers in Muang District , Chiang Rai province , Thail and , will be studied with informed consent . A health center recruiting 100 participants is a cluster , the unit of r and omization . Eight clusters will be r and omized into intervention and control arms and followed up for 1 year . Within the intervention clusters the following will be undertaken : ( 1 ) salt content in the daily diet will be measured and shown to study participants ; ( 2 ) 24-hour salt intake will be estimated in overnight-collected urine and the results shown to the participants ; ( 3 ) a dietician will assist small group health education classes in cooking meals with less salt . The primary outcome is blood pressure change at the 1-year follow-up . Secondary outcomes at the 1-year follow-up are estimated 24-hoursalt intake , incidence of CVD events and CVD death . The intention-to-treat analysis will be followed . Blood pressure and estimated 24-hour salt intake will be compared between intervention and control groups at the cluster and individual level at the 1-year follow-up . Clinical CVD events and deaths will be analyzed by time-event analysis . Retinal blood vessel calibers of CVD-risk patients will be assessed cross-sectionally . Behavioral change to reduce salt intake and the influencing factors will be determined by structured equation model ( SEM ) . Multilevel regression analyses will be applied . Finally , the cost effectiveness of the intervention will be analyzed . Discussion This study is unique as it will recruit the individuals most vulnerable to CVD morbidity and mortality by applying the general Framingham CVD risk scoring system . Dietary salt reduction will be applied as a prioritized , community level intervention for the prevention of CVD in a developing country . Trial registration IS RCT The aim of the present study was to evaluate the effects of a normal-sodium ( 120 mmol sodium ) diet compared with a low-sodium diet ( 80 mmol sodium ) on readmissions for CHF ( congestive heart failure ) during 180 days of follow-up in compensated patients with CHF . A total of 232 compensated CHF patients ( 88 female and 144 male ; New York Heart Association class II-IV ; 55 - 83 years of age , ejection fraction < 35 % and serum creatinine < 2 mg/dl ) were r and omized into two groups : group 1 contained 118 patients ( 45 females and 73 males ) receiving a normal-sodium diet plus oral furosemide [ 250 - 500 mg , b.i.d . ( twice a day ) ] ; and group 2 contained 114 patients ( 43 females and 71 males ) receiving a low-sodium diet plus oral furosemide ( 250 - 500 mg , b.i.d . ) . The treatment was given at 30 days after discharge and for 180 days , in association with a fluid intake of 1000 ml per day . Signs of CHF , body weight , blood pressure , heart rate , laboratory parameters , ECG , echocardiogram , levels of BNP ( brain natriuretic peptide ) and aldosterone levels , and PRA ( plasma renin activity ) were examined at baseline ( 30 days after discharge ) and after 180 days . The normal-sodium group had a significant reduction ( P<0.05 ) in readmissions . BNP values were lower in the normal-sodium group compared with the low sodium group ( 685+/-255 compared with 425+/-125 pg/ml respectively ; P<0.0001 ) . Significant ( P<0.0001 ) increases in aldosterone and PRA were observed in the low-sodium group during follow-up , whereas the normal-sodium group had a small significant reduction ( P=0.039 ) in aldosterone levels and no significant difference in PRA . After 180 days of follow-up , aldosterone levels and PRA were significantly ( P<0.0001 ) higher in the low-sodium group . The normal-sodium group had a lower incidence of rehospitalization during follow-up and a significant decrease in plasma BNP and aldosterone levels , and PRA . The results of the present study show that a normal-sodium diet improves outcome , and sodium depletion has detrimental renal and neurohormonal effects with worse clinical outcome in compensated CHF patients . Further studies are required to determine if this is due to a high dose of diuretic or the low-sodium diet The Hypertension Prevention Trial ( HPT ) was a r and omized , controlled , multicenter ( four clinics , four re source centers ) trial design ed to test the feasibility of achieving and sustaining dietary changes in the intake of calories , sodium , and potassium and to assess the effect of those changes on blood pressure in a normotensive population . The trial involved 841 men and women ( plus a test cohort of 78 ) who , at the first baseline ( BL ) examination , were in the age range of 25 - 49 years and had diastolic blood pressure ( DBP ) greater than or equal to 76 but less than 100 mm Hg ( average of two readings ) , and at the examination prior to r and omization ( BL 2 ) had DBP greater than or equal to 78 but less than 90 mm Hg ( also averaged ) . Participants were r and omly assigned to a control treatment group ( no dietary counseling ) or to one of four dietary treatment groups involving counseling design ed to reduce calorie intake , reduce sodium intake , reduce sodium and calorie intake , and reduce sodium and increase potassium intake . Dietary counseling was provided primarily in group setting s and was aim ed at changing participants ' shopping , cooking , and eating habits related to a design ated treatment assignment . The effect of dietary counseling was measured through changes in urinary excretion of sodium and potassium , changes in body weight , and changes in reported food intake based on 24-hour food records . Blood pressure changes during the 3-year course of followup were based on measurements taken at 6-month intervals from enrollment using a r and om-zero sphygmomanometer . This chapter provides a general description of the design and methods of the HPT and the underlying rationale for decisions affecting the design BACKGROUND The beneficial effects of potassium-enriched salt on blood pressure have been reported in a few short-term trials . The long-term effects of potassium-enriched salt on cardiovascular mortality have not been carefully studied . OBJECTIVE The objective was to examine the effects of potassium-enriched salt on cardiovascular disease ( CVD ) mortality and medical expenditures in elderly veterans . DESIGN Five kitchens of a veteran retirement home were r and omized into 2 groups ( experimental or control ) and veterans assigned to those kitchens were given either potassium-enriched salt ( experimental group ) or regular salt ( control group ) for approximately 31 mo . Information on death , health insurance cl aims , and date s that veterans moved in or out of the home was gathered . RESULTS Altogether , 1981 veterans , 768 in the experimental [ x ( + /-SD ) age : 74.8 + /- 7.1 y ] and 1213 in the control ( age : 74.9 + /- 6.7 y ) groups , were included in the analysis . The experimental group had better CVD survivorship than did the control group . The incidence of CVD-related deaths was 13.1 per 1000 persons ( 27 deaths in 2057 person-years ) and 20.5 per 1000 ( 66 deaths in 3218 person-years ) for the experimental and control groups , respectively . A significant reduction in CVD mortality ( age-adjusted hazard ratio : 0.59 ; 95 % CI : 0.37 , 0.95 ) was observed in the experimental group . Persons in the experimental group lived 0.3 - 0.90 y longer and spent significantly less ( approximately US Dollars 426/y ) in inpatient care for CVD than did the control group , after control for age and previous hospitalization expenditures . CONCLUSIONS This study showed a long-term beneficial effect on CVD mortality and medical expenditure associated with a switch from regular salt to potassium-enriched salt in a group of elderly veterans . The effect was likely due to a major increase in potassium and a moderate reduction in sodium intakes The Hypertension Prevention Trial ( HPT ) was a r and omized unmasked multicenter trial design ed to address questions concerning the feasibility and efficacy of dietary intervention in the primary prevention of hypertension . Participants in the diet treatments were given counseling to achieve and sustain changes in calorie , sodium , and /or potassium intake . Diet composition , sodium and potassium excretion , and body weight were assessed for all participants at 6-mo intervals over 3 y. This paper provides information about extent and possible sources of bias in the dietary assessment methodology used in the HPT . Estimates of nutrient intake were derived from food records , urinalysis , and measurement of body weight . Reported potassium intake increased and sodium intake declined to a greater degree during the study than did potassium and sodium excretion . Our results indicate that repeated assessment s of diet , which depend upon participant recording , may not accurately represent usual diet in a dietary trial BACKGROUND Despite the reported benefits , weight loss is not always advised for older adults because some observational studies have associated weight loss with increased mortality . However , the distinction between intentional and unintentional weight loss is difficult to make in an observational context , so the effect of intentional weight loss on mortality may be clarified in the setting of a r and omized controlled trial . OBJECTIVE The objective was to determine the effect of intentional weight loss on all-cause mortality by using follow-up data from a r and omized trial completed in 1995 that included a weight-loss arm . DESIGN The Trial of Nonpharmacologic Intervention in the Elderly ( TONE ) used a 2 × 2 factorial design to determine the effect of dietary weight loss , sodium restriction , or both on blood
Output:
| Despite collating more event data than previous systematic review s of r and omised controlled trials , there is insufficient power to confirm clinical ly important effects of dietary advice and salt substitution on cardiovascular mortality in normotensive or hypertensive population s. Our estimates of the clinical benefits from advice to reduce dietary salt are imprecise , but are larger than would be predicted from the small blood pressure reductions achieved .
Our findings do not support individual dietary advice as a means of restricting salt intake . |
MS211343 | ***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 s on this page have been chosen and edited by Dr Trevor Watts Abstract Failure rates were higher for glass ionomer ( GIC ) , but caries progression was more likely on tooth surfaces adjacent to amalgam ( AM ) restorations The purpose of this study was to evaluate the efficacy of non-invasive methods of treatment for active incipent occlusal caries . Anamnesis , professional prophylaxis , and visual inspection were used to classify 250 Brazilian pre-school-children . First permanent decayed molars ( n=98 ) from thirty-one subjects ( 6 years+ 6 months ) were selected and divided into three groups . Group 1 : fissure sealants with resin-modified glass ionomer - Vitremer ( n=29 ) ; Group 2 : fluoride varnish -Duraphat ( n=36 ) and control group : tooth brushing and 0.2 percent NaF weekly mouthwashes ( n=33 ) . Four clinical evaluations were carried out over three , six , nine , and twelve months . Caries activity and progression were observed through clinical and radiographic evaluation . The results were analyzed by Fisher = s Exact test . After twelve months , the results showed 100 percent of arrestment of caries activity for Group 1 , 83.3 percent for group 2 , and 72.7 percent for control group . At the same time , the results showed 0 percent of caries progression for group 1 , 5.5 percent for Group 2 , and 6.1 percent for control group . Group 1 showed a better inactivation property than the other groups ( p<0.05 ) . There were no statistically significant differences in caries progression among these groups ( p>0.05 ) . It was concluded that this non-invasive methods were able to arrest the progression of occlusal caries , but fissure sealant showed better results in controlling caries activity There is limited evidence from clinical trials on the dose response of sodium fluoride dentifrices at concentrations above 1100 ppm fluoride ion , with respect to caries efficacy . This r and omized , double-blind study examined the anti-caries effectiveness of sodium fluoride dentifrices containing 1700 ppm , 2200 ppm and 2800 ppm fluoride ion relative to an 1100 ppm fluoride ion control . A population of 5439 elementary schoolchildren , aged 6 - 15 years , was recruited from an urban central Ohio area with a low fluoride content water supply ( < 0.3 ppm ) . Subjects were examined by visual-tactile and radiographic examination at baseline and after 1 , 2 , and 3 years of using the sodium fluoride dentifrices . Subjects were stratified according to gender , age and baseline DMFS scores derived from the visual-tactile baseline examination and r and omly assigned to one of four treatment groups : 0.243 % sodium fluoride ( 1100 ppm fluoride ion ) , 0.376 % sodium fluoride ( 1700 ppm fluoride ion ) , 0.486 % sodium fluoride ( 2200 ppm fluoride ion ) , and 0.619 % sodium fluoride ( 2800 ppm fluoride ion ) . All products were formulated with the same fluoride compatible silica abrasive . Results after 1 year provided evidence of a positive sodium fluoride dose response . Compared to the 1100 ppm fluoride treatment group , the 1700 ppm fluoride treatment group had an 11.0 % reduction in DMFS that was not statistically significant , while the 2200 ppm and 2800 ppm fluoride treatment groups showed statistically significant ( P<0.05 ) reductions of 18.6 % and 20.4 % , respectively . The reductions in caries delivered by the higher fluoride dentifrices were present across all tooth surface types , but were most pronounced for occlusal surfaces . Results at years 2 and 3 were confounded by a concurrent fluoride rinse program , which involved portions of the study population . While the trends for the higher fluoride dentifrices observed at year 1 remained at years 2 and 3 , the difference observed between treatments were substantially less and failed to reach statistical significance ( P<0.05 ) . Collectively , the data demonstrate that the 2200 ppm and the 2800 ppm fluoride treatments delivered statistically significantly greater caries efficacy than the 1100 ppm fluoride treatment . This large-scale clinical trial provides evidence of a positive statistically significant dose relationship between dental caries and sodium fluoride in a dentifrice at levels above 1100 ppm fluoride at year 1 The aim of this study was to compare the longevity and cariostatic effects of everyday conventional glass-ionomer and amalgam restorations in primary teeth . The material s consisted of 515 Ketac-Fil glass-ionomer restorations and 543 Dispersalloy amalgam restorations prepared in 666 children , from 3 to 13 years of age , by 14 dentists within the Danish Public Dental Health Service in the municipalities of Vaerlose and Hillerød . The restorations , of which 79 % were of the Class II type , were in contact with 593 unrestored surfaces in adjacent primary and permanent teeth . After 3 years , 6 % of the patients had dropped out of the study , and 33 % of the teeth were exfoliated with the restoration in situ . A further 37 % of the glass-ionomer and 18 % of the amalgam restorations were recorded as failed ( p < 0.001 ) . The frequency of failures was highest for Class II glass-ionomer restorations , which showed a 50 % median survival time of only 34½ months , because of many fractures , while the 75 % survival time for Class II amalgam restorations just exceeded the actual 36 months ( p < 0.001 ) . Caries progression was most often recorded in surfaces adjacent to amalgam restorations , and 21 % of these surfaces needed restorative treatment vs. 12 % of the surfaces adjacent to glass-ionomer restorations ( p < 0.01 ) . The three-year results indicated that conventional glass ionomer is not an appropriate alternative to amalgam for all types of restorations in primary teeth . In particular , the short longevity of Class II glass-ionomer restorations could not be compensated for by the reduced caries progression and need for restorative therapy of adjacent surfaces OBJECTIVE To examine the effect of reported toothbrushing frequency and method of rinsing after brushing on caries experience and increment . METHODS Data are presented from 2621 adolescents ( mean age 12.5 years at outset ) participating in a 3-year double-blind caries clinical trial . At baseline , examiners question ed each participant about their toothbrushing habits , and at subsequent examinations , this information was obtained using a self-administered computer-based question naire . Participants used a fluoride-containing dentifrice throughout and clinical examinations were conducted using a mirror , CPITN probe and fibre-optic transillumination . RESULTS The reported brushing frequency increased throughout the trial . Caries experience at baseline was inversely related to toothbrushing frequency with mean DMFS=9.66 , 8.12 and 7.63 respectively for < 1/day , 1/day and > 1/day brushers ( P<0.001 ) . Mean 3-year DMFS increments of 8.90 , 6.63 and 5.48 ( P<0.01 ) were observed in those reporting to brush < 1/day , 1/day or > 1/day , on not less than two of the three clinical examinations during the trial . Caries increment was also significantly related to the cl aim ed method used to rinse post-brushing . Overall frequency of brushing and rinsing method accounted for over 50 % of the explained variance in the ANOVA model used to analyse the DMFS increments . CONCLUSIONS Stated toothbrushing frequency and rinsing method after brushing were found to be strongly correlated with caries experience and caries increment . These factors should be reflected in the design of oral health education material and taken into account in the design and analysis of caries clinical trials Abstract Restorations made of a combination of resin modified glass ionomer cement ( RMGIC ) and composite resin ( CR ) – open s and wich fillings – have been recommended for use in proximal boxes of molar cavities . The aim of this study was to compare the clinical behaviour over time of RMGIC/CR s and wich restorations versus CR restorations in Class II molar cavities . During a period of 2 years , a total of 220 restorations were placed in 118 patients by one operator ( VV ) . A r and om block allocation was used to allocate cavities to one of the two restorative techniques . Bitewing radiographs and photographs were taken at baseline and at annual recall appointments . At present , a total of 210 restorations have been evaluated after 1 year and 141 restorations after 2 years . All restorations were evaluated using a modification of USPHS criteria . A total of three RMGIC/CR and two CR restorations ( 2.8 % ) were rated as failures caused by endodontic complications or major fractures . Twenty-eight teeth were reported to have postoperative sensitivity at the baseline evaluation 1 week following placement . Nine RMGIC/CR ( 8.5 % ) and four CR ( 4.9 % ) restorations with minor fractures were rated Charlie but were still acceptable . Bitewing radiographs revealed progression of carious lesions in proximal surfaces of originally intact or restored teeth adjacent to five ( 5.9 % ) RMGIC/CR restorations and eight ( 10.9 % ) CR restorations . No statistically significant differences between the two types of restoration were observed with respect to marginal adaptation , discoloration and caries progression . However , a higher number of large CR fillings exhibited postoperative sensitivity at baseline compared to moderate CR or extensive and moderate RMGIC/CR restorations BACKGROUND The biofilm that forms and remains on tooth surfaces is the main etiological factor in caries and periodontal disease . Prevention of caries and periodontal disease must be based on means that counteract this bacterial plaque . OBJECTIVE To monitor the incidence of tooth loss , caries and attachment loss during a 30-year period in a group of adults who maintained a carefully managed plaque control program . In addition , a comparison was made regarding the oral health status of individuals who , in 1972 and 2002 , were 51 - 65 years old . MATERIAL AND METHODS In 1971 and 1972 , more than 550 subjects were recruited . Three hundred and seventy-five subjects formed a test group and 180 a control group . After 6 years of monitoring , the control group was discontinued but the participants in the test group was maintained in the preventive program and was finally re-examined after 30 years . The following variables were studied at Baseline and after 3 , 6 , 15 and 30 years : plaque , caries , probing pocket depth , probing attachment level and CPITN . Each patient was given a detailed case presentation and education in self-diagnosis . Once every 2 months during the first 2 years , once every 3 - 12 months during years 3 - 30 , the participants received , on an individual need basis , additional education in self-diagnosis and self-care focused on proper plaque control measures , including the use of toothbrushes and interdental cleaning devices ( brush , dental tape , toothpick ) . The prophylactic sessions that were h and led by a dental hygienist also included ( i ) plaque disclosure and ( ii ) professional mechanical tooth cleaning including the use of a fluoride-containing dentifrice/paste . RESULTS Few teeth were lost during the 30 years of maintenance ; 0.4 - 1.8 in different age cohorts . The main reason for tooth loss was root fracture ; only 21 teeth were lost because of progressive periodontitis or caries . The mean number of new caries lesions was 1.2 , 1.7 and 2.1 in the three groups . About 80 % of the lesions were classified as recurrent caries . Most sites , buccal sites being the exception , exhibited no sign of attachment loss . Further , on approximal surfaces there was some gain of attachment between 1972 and 2002 in all age groups . CONCLUSION The present study reported on the 30-year outcome of preventive dental treatment in a group of carefully monitored subjects who on a regular basis were encouraged , but also enjoyed and recognized the benefit of , maintaining a high st and ard of oral hygiene . The incidence of caries and periodontal disease as well as tooth mortality in this subject sample was very small . Since all preventive and treatment efforts during the 30 years were delivered in one private dental office , caution must be exercised when comparisons are made with longitudinal studies that present oral disease data from r and omly selected subject sample PURPOSE To assess the effect of ozone on the microbial flora and clinical severity of primary root caries . METHODS 26 patients with 70 primary root carious lesions ( PRCLs ) were entered . Each PRCL was classified in terms of color , cavitation , size , hardness , distance from the gingival margin and severity . Overlying plaque was then removed and each lesion dried . A biopsy was taken from half of each PRCL using a sterile excavator . Subsequently , the remaining lesions were exposed to ozone gas for a period of either 10 seconds ( n = 35 ) or 20 seconds ( n = 35 ) and a further biopsy was taken . RESULTS Using a paired Student t-test , a significant ( P < 0.001 ) difference ( mean + /- SE ) in total micro
Output:
| However , the current evidence base for HealOzone is insufficient to conclude that it is a cost-effective addition to the management and treatment of occlusal and root caries . |
MS211344 | ***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 used data from a multinational phase III r and omized , double-blind , vehicle-controlled trial to evaluate the cost-effectiveness of tirilazad mesylate ( Freedox ) in the treatment of aneurysmal subarachnoid hemorrhage . In men , therapy with 6 mg/kg per day of tirilazad mesylate was associated with significantly increased survival , increased cost of care , and ratios of cost per death averted that compare favorably with the ratios of other life and death interventions . In women , it appeared to have no effects on costs or survival . Further clinical studies may provide additional information about the cost-effectiveness of this intervention PURPOSE The purpose of this study was to determine the cost-effectiveness of carotid endarterectomy for treating asymptomatic patients with > or = 60 % internal carotid stenosis , based on outcomes reported in the Asymptomatic Carotid Atherosclerosis Study ( ACAS ) . METHODS A cost-effectiveness analysis was performed using a Markov decision model in which the probabilities for base-case analysis ( average age , 67 years ; 66 % male ; perioperative stroke plus death rate , 2.3 % ; ipsilateral stroke rate during medical management , 2.3 % per year ) were based on ACAS . The model assumed that patients who had TIAs or minor strokes during medical management crossed over to surgical treatment , and used the NASCET data to model the outcome of these now-symptomatic patients . Average cost of surgery ( $ 8500 ) , major stroke ( $ 34,000 plus $ 18,000 per year ) , and other costs were based on local cost determinations plus a review of the published literature . Cost-effectiveness was calculated as the incremental cost of surgery per quality -adjusted life year ( QALY ) saved when compared with medical treatment , discounting at 5 % per year . Sensitivity analysis was performed to determine the impact of key variables on cost-effectiveness . RESULTS In the base-case analysis , surgical treatment improved quality -adjusted life expectancy from 7.87 to 8.12 QALYs , at an incremental lifetime cost of $ 2041 . This yielded an incremental cost-effectiveness ratio of $ 8,000 per QALY saved by surgical compared with medical treatment . The high cost of care after major stroke during medical management largely offset the initial cost of endarterectomy in the surgical group . Furthermore , 26 % of medically managed patients eventually underwent endarterectomy because of symptom development , which also decreased the cost differential . Sensitivity analysis demonstrated that the relative cost of surgical treatment increased substantially with increasing age , increasing perioperative stroke rate , and decreasing stroke rate during medical management . CONCLUSION For the typical asymptomatic patient in ACAS with > or = 60 % carotid stenosis , our results indicate that carotid endarterectomy is cost-effective when compared with other commonly accepted health care practice s. Surgery does not appear cost-effective in very elderly patients , in setting s where the operative stroke risk is high , or in patients with very low stroke risk without surgery Cost-effectiveness analyses of stroke management are hampered by paucity of economic data . We made an up date of the direct and indirect costs of stroke in Sweden ( population , 8.5 million ) . Methods Direct costs ( ie , the costs for hospital and outpatient care and social services ) were estimated on the basis of two prospect i ve population -based studies of stroke and of two nationwide cross-sectional inventories of bed-days and diagnoses . Indirect costs ( ie , the costs for loss of productivity and early retirement ) were based on official statistics . Results The direct annual costs of care for stroke patients in 1991 equaled 7836 million Swedish krona ( SKr ) ( $ 1306 million in US dollars ) , and the indirect costs , 2430 million SKr ( $ 405 million ) . The cost of stroke care was 1208 SKr ( $ 201 ) per inhabitant in Sweden . The expected direct costs per patient from first stroke to death were 440 000 SKr ( $ 73 333 ) . When prestroke costs for other diseases and advanced age were subtracted , the sum was reduced to 180 000 SKr ( $ 30 000 ) . Conclusions Costs for hospital and outpatient care and social services accounted for 76 % of Swedish stroke costs and for 24 % of costs for loss of production and early retirement . Only 41 % of direct costs were stroke-related Stroke occurs in more than 500 000 persons annually and is the leading cause of long-term illness and the third leading cause of death in the United States [ 1 ] . The debilitating nature of a new-onset stroke is compounded by a high risk for subsequent neurologic and cardiac events [ 2 - 4 ] . The annual cost of stroke in the United States , including the indirect costs of lost productivity , has been estimated to be $ 15 billion to $ 30 billion [ 5 ] . Cardiovascular sources of emboli may account for 15 % to 45 % of all strokes [ 6 ] . Transesophageal echocardiography has allowed placement of a higher-frequency ultrasonic transducer closer to cardiac structures , thereby producing images with better resolution than those produced by transthoracic echocardiography . Transesophageal echocardiography has substantially improved the identification of thrombi in the left atrium and left atrial appendage . When surgical inspection is used as the gold st and ard , the sensitivity and specificity of transesophageal echocardiography have been shown to exceed 99 % [ 7 ] . Transesophageal echocardiography has also improved detection of patent foramen ovale , atrial septal defects , atrial septal aneurysms , spontaneous echocardiographic contrast in the left atrium [ 8 - 14 ] , and protruding atheromata in the ascending aorta and aortic arch [ 15 , 16 ] . Recent studies [ 16 , 17 ] showed that patients with cardiovascular sources of emboli have a worse prognosis than do patients without cardiovascular sources of emboli . Identification of potential sources of emboli is an important step in reducing recurrent strokes and future expenditures . Anticoagulation has repeatedly been shown to be beneficial in subgroups of patients at risk for stroke [ 18 ] . The extent of the benefit of anticoagulation in patients who have had stroke and who have documented or possible thrombi on transesophageal echocardiography is currently unknown and must be weighed against the increased risk for intracranial hemorrhage in such patients . The indications for cardiovascular imaging in patients who have had stroke are inconsistent [ 19 ] . Performance of cardiovascular imaging varies among physicians : Some physicians routinely order echocardiography , some use echocardiography in accordance with the patient 's clinical history , and some rarely order cardiac imaging studies in patients who have had stroke . Concern about the cost of echocardiography may influence practice patterns . To evaluate the benefits , risks , and costs of different diagnostic approaches , we performed a cost-effectiveness analysis of common cardiovascular imaging strategies used in patients who have had stroke . Methods Design A Markov decision analysis [ 20 ] was done by using a commercially available computer program ( Decision-Maker 7.0 , Pratt Medical Group , Boston , Massachusetts ) to evaluate nine diagnostic strategies in a hypothetical cohort of 65-year-old patients in normal sinus rhythm with new-onset stroke ( Figure 1 ) . ( See the Glossary for definitions of terms . ) The treat-none and treat-all strategies did not include imaging . In the all-transthoracic , all-transesophageal , and all-sequential strategies , imaging was done in all patients . In the selective-transthoracic , selective-esophageal , and selective-sequential-1 strategies , imaging was done only in patients who had a history of cardiac problems ( left ventricular dysfunction or valvular disease ) . The selective-sequential-2 strategy used a sequential approach in patients with a history of cardiac problems and used transesophageal echocardiography in patients with no such history . Figure 1 . Nine possible diagnostic strategies for patients with stroke . The cohort consisted of patients with four types of underlying pathologic condition : thrombi in the left atrium , other potential cardiac sources of emboli , aortic plaque only , and no identifiable cardiovascular source of emboli ( Figure 2 ) . Identification of the underlying condition depended on the imaging strategy used ( Figure 1 ) . For example , the all-transesophageal strategy identified all potential sources of emboli , the all-transthoracic strategy identified only some of the sources , and the treat-none strategy identified none of the sources . Anticoagulation was started on the basis of the results of the imaging studies . For the imaging strategies included in the base-case analysis , only patients with thrombus received anticoagulants ; other patients received aspirin . Figure 2 . Health states for the Markov model . The cohort was then followed through monthly cycles for events , including recurrent cerebrovascular accident , intracranial hemorrhage , gastrointestinal bleeding , and death ( Figure 2 ) . Event and mortality rates were calculated on the basis of the underlying condition and treatment . Costs and outcomes for each health state were summed over the cycles . Patients in the cohort were followed over a lifetime horizon to provide the most relevant analysis from a societal perspective . Major Clinical Assumptions Several assumptions were necessary to implement the Markov model . First , patients had no obvious clinical cause of stroke ( that is , no evidence of periprocedural stroke , recent myocardial infa rct ion , prosthetic valve , known endocarditis , and so on ) . Second , patients were not receiving anticoagulants or antiplatelet agents at the time of stroke . Third , the subtype of ischemic stroke ( such as lacunar or cortical ) was independent of the underlying condition . Fourth , transesophageal echocardiography did not cause enough discomfort to decrease quality of life . Fifth , given the same underlying condition , the risk for recurrent stroke was independent of the history of cardiac disease ( angina , valvular disease , and so on ) . Sixth , only the first major complication after stroke was considered in the analysis ( for example , patients could not have both recurrent stroke and intracranial hemorrhage ) . Finally , new-onset and recurrent strokes were assumed to have similar relative effects on quality of life and on risk for death . Results of Diagnostic Imaging and Occurrence of Subsequent Events We performed a systematic review of the literature to gather the best available evidence about the prevalence of various cardiovascular sources of emboli in patients who have had stroke . A MEDLINE search from 1990 to 1995 was done by using cerebrovascular accident and transesophageal echocardiography as keywords ( before 1990 , transesophageal echocardiography was not a keyword ) . References from papers identified in the MEDLINE search were used to find relevant studies published before 1990 . Studies were chosen if they reported the prevalence of potential cardiovascular sources of emboli identified by transesophageal echocardiography in a defined cohort of patients who had had stroke [ 8 - 1417 , 21 , 22 ] ( Table 1 and Table 4 ) . Studies were distinguished with respect to four characteristics : patient selection ( all patients who had had stroke rather than only patients referred for echocardiography ) , performance of intracardiac contrast studies , blinding of image readers to clinical history , and use of multiple readers . Only single-plane and biplane probes were used in the studies . Thrombi in the left atrium or left atrial appendage were more often identified in studies with selected patients , but other cardiac sources of emboli were identified at similar rates in selected and nonselected patients . Major findings on transesophageal echocardiography did not significantly differ among the studies with regard to use of echocardiographic contrast , blinded readers , or multiple readers . In the papers in which it was mentioned , positive cardiac history was generally defined as atrial fibrillation ( patients with atrial fibrillation were excluded from our cohort ) , decreased left ventricular function , or valvular disease known at the time of transthoracic or transesophageal echocardiography . Rates of identification of aortic plaques varied widely , in part because of poor st and ardization of diagnostic criteria . Because no group of studies was clearly superior in design and conduct , base-case imaging results were obtained from the mean of the results weighted by the number of participants in each study . Table 1 . Systematic Review of the Literature on Transesophageal Echocardiography after Stroke , 1989 - 1995 Table 4 . Table 1 . Continued Secondary event rates and mortality rates ( including the rate of death from nonvascular causes ) were determined by using the best available estimates in the literature ( Table 2 ) [ 1 - 418 , 23 - 30 ] . The estimated relative risk reduction for recurrent stroke ( that is , efficacy ) with anticoagulation ranged from 0 % [ 23 ] to 84 % [ 24 ] . Meta-analyses of studies of patients with atrial fibrillation estimated the efficacy of anticoagulation to be 60 % to 67 % and the efficacy of aspirin to be 33 % compared with that of no therapy [ 18 , 25 ] . Ezekowitz and colleagues [ 26 ] estimated a relative risk reduction of 40 % for anticoagulation in patients with a history of atrial fibrillation and stroke , a patient population that may be similar to our patients who had stroke and documented thrombus in the left atrium or left atrial appendage . We chose a relative risk reduction of 33 % for anticoagulation compared with aspirin and used a wide range ( 17 % to 67 % ) for sensitivity analysis . Table 2 . Input Variables Prospect i ve information on the incidence of intracranial hemorrhage with anticoagulation after a stroke is also scarce . In a previous decision analysis , Eck
Output:
| Different studies addressing the cost-effectiveness of screening asymptomatic carotid stenosis result ed in strikingly divergent conclusions , from being cost-effective to being detrimental . |
MS211345 | ***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 Depression is one of the most disabling diseases , and causes a significant burden both to the individual and to society . WHO data suggests that depression causes 6 % of the burden of all diseases in Europe in terms of disability adjusted life years ( DALYs ) . Yet , the knowledge of the economic impact of depression has been relatively little research ed in Europe . AIMS OF THE STUDY The present study aims at estimating the total cost of depression in Europe based on published epidemiologic and economic evidence . METHODS A model was developed to combine epidemiological and economic data on depression in Europe to estimate the cost . The model was populated with data collected from extensive literature review s of the epidemiology and economic burden of depression in Europe . The cost data was calculated as annual cost per patient , and epidemiologic data was reported as 12-month prevalence estimates . National and international statistics for the model were retrieved from the OECD and Eurostat data bases . The aggregated annual cost estimates were presented in Euro for 2004 . RESULTS In 28 countries with a population of 466 million , at least 21 million were affected by depression . The total annual cost of depression in Europe was estimated at Euro 118 billion in 2004 , which corresponds to a cost of Euro 253 per inhabitant . Direct costs alone totalled dollar 42 billion , comprised of outpatient care ( Euro 22 billion ) , drug cost ( Euro 9 billion ) and hospitalization ( Euro 10 billion ) . Indirect costs due to morbidity and mortality were estimated at Euro 76 billion . This makes depression the most costly brain disorder in Europe , accounting for 33 % of the total cost . The cost of depression corresponds to 1 % of the total economy of Europe ( GDP ) . DISCUSSION Our cost results are in good agreement with previous research findings . The cost estimates in the present study are based on model simulations for countries where no data was available . The predictability of our model is limited to the accuracy of the input data employed . As there is no earlier cost-of-illness study conducted on depression in Europe , it is , however , difficult to evaluate the validity of our results for individual countries and thus further research is needed . CONCLUSION The cost of depression poses a significant economic burden to European society . The simulation model employed shows good predictability of the cost of depression in Europe and is a novel approach to estimate the cost-of-illness in Europe . IMPLICATION S FOR HEALTH CARE PROVISION AND POLICIES : Health and social care policy and commissioning must be evidence -based . The empirical results from this study confirm previous findings , that depression is a major concern to the economic welfare in Europe which has consequences to both healthcare providers and policy makers . One important way to stop this explosion in cost is through increased research efforts in the field . Moreover , better detection , prevention , treatment and patient management are imperatives to reduce the burden of depression and its costs . Mental healthcare policies and better access to healthcare for mentally ill are other challenges to improve for Europe . IMPLICATION S FOR FURTHER RESEARCH This study has identified several research gaps which are of interest for future research . In order to better underst and the impact of depression to European society long-term prospect i ve epidemiology and cost-of-illness studies are needed . In particular data is lacking for Central European countries . On the basis of our findings , further economic evaluations of treatments for depression are necessary in order to ensure a cost-effective use of European healthcare budgets Identifying data -driven subtypes of major depressive disorder ( MDD ) is an important topic of psychiatric research . Currently , MDD subtypes are based on clinical ly defined depression symptom patterns . Although a few data -driven attempts have been made to identify more homogenous subgroups within MDD , other studies have not focused on using human genetic data for MDD subtyping . Here we used a computational strategy to identify MDD subtypes based on single-nucleotide polymorphism genotyping data from MDD cases and controls using Hamming distance and cluster analysis . We examined a cohort of Mexican-American participants from Los Angeles , including MDD patients ( n=203 ) and healthy controls ( n=196 ) . The results in cluster trees indicate that a significant latent subtype exists in the Mexican-American MDD group . The individuals in this hidden subtype have increased common genetic substrates related to major depression and they also have more anxiety and less middle insomnia , depersonalization and derealisation , and paranoid symptoms . Advances in this line of research to vali date this strategy in other patient groups of different ethnicities will have the potential to eventually be translated to clinical practice , with the tantalising possibility that in the future it may be possible to refine MDD diagnosis based on genetic data Background Due to a lack of evidence , there is no consistent age of onset to define early onset ( EO ) versus later onset ( LO ) major depressive disorder ( MDD ) . Fractional anisotropy ( FA ) , derived from diffusion tensor imaging ( DTI ) , has been widely used to study neuropsychiatric disorders by providing information about the brain circuitry , abnormalities of which might facilitate the delineation of EO versus LO MDD . Method In this study , 61 pairs of untreated , non-elderly , first-episode MDD patients and healthy controls ( HCs ) aged 18–45 years old received DTI scans . The voxel-based analysis method ( VBM ) , classification analysis , using the Statistical Package for the Social Sciences ( SPSS ) , and regression analyses were used to determine abnormal FA clusters and their correlations with age of onset and clinical symptoms . Results Classification analysis suggested in the best model that there were two subgroups of MDD patients , delineated by an age of onset of 30 years old , by which MDD patients could be divided into EO ( 18–29 years old ) and LO ( 30–45 years old ) groups . LO MDD was characterized by decreased FA , especially in the white matter ( WM ) of the fronto-occipital fasciculus and posterior limb of internal capsule , with a negative correlation with the severity of depressive symptoms ; in marked contrast , EO MDD showed increased FA , especially in the WM of the corpus callosum , corticospinal midbrain and inferior fronto-occipital fasciculus , while FA of the WM near the midbrain had a positive correlation with the severity of depressive symptoms . Conclusion Specific abnormalities of the brain circuitry in EO vs. LO MDD were delineated by an age of onset of 30 years old , as demonstrated by distinct abnormal FA clusters with opposite correlations with clinical symptoms . This DTI study supported the evidence of an exact age for the delineation of MDD , which could have broad multidisciplinary importance . Trial Registration Clinical Trials.gov This paper describes the application of prospect i ve longitudinal data from an epidemiological sample of young adults to define subtypes of major depression . Depression was classified on a spectrum from subthreshold manifestation of symptoms and duration at one end , to cases with recurrent episodes of depression meeting duration criteria for major depressive episodes at the other . There was a direct relationship between the severity of depression over the longitudinal course and both duration and recurrence of depressive episodes . The subgroup of depression with recurrence of both brief and longer duration episodes could be discriminated on most of the indicators of validity including symptoms , impairment , family history , and suicide attempts . In light of the young age of this cohort , the strong history of suicide attempts and other complications of depression among the subjects with recurrent depression was striking . These findings underscore the importance of employing course as a classification criterion of depression , and the inclusion of subthreshold episodes of depression in the characterization of course
Output:
| These symptom-based subtypes were associated with differences in biomarker profiles and functional connectivity , but results have not sufficiently been replicated .
Although the review ed work provides many leads for future research , the method ological differences across studies and lack of replication preclude definitive conclusions about the existence of clinical ly useful and generalizable biological subtypes |
MS211346 | ***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: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results Functional outcome , stability at radiographic investigation and ankle joint torque after anatomical reconstruction of the lateral ankle ligaments were evaluated in patients with early postoperative mobilization versus those with cast immobilization . Thirty patients with chronic lateral ligament instability of the ankle underwent anatomical reconstruction of the ligaments . Postoperatively the patients were r and omly allocated to two groups : Group A ( n=15 ) were immobilized in a below-knee plaster for 6 weeks and Group B ( n=15 ) underwent early controlled range of motion training using an Air-Cast ankle brace . The functional results were evaluated using a scoring scale and objective results using st and ardized stress radiographs . Also eccentric and concentric muscle torque at 60 degrees/s was measured in plantar flexion and dorsiflexion , respectively . The functional results were satisfactory in 12/15 ankles in Group A and 14/15 in Group B ( n.s . ) . All the patients with satisfactory results regained normal range of motion . Patients with unsatisfactory results had either residual pain or recurrent instability . In Group B , the strength measurements revealed significantly higher peak torque values after three months in plantar flexion at 60 degrees/s . Six months postoperatively , the torque values did not differ significantly between the groups . Also , there was no group difference in the laxity of the ankle joint , including both anterior talar translation test and talar tilt test , at the two-year follow-up . One patient had a superficial wound infection . We conclude that after the reconstruction of chronic lateral ligament instability of the ankle the functional and stability results were equally good with early postoperative mobilization and 6-week immobilization . However , using early mobilization plantar flexion strength was regained earlier than with cast immobilization , without any risk of short- or medium-term complications , such as increased ankle laxity . We recommend early mobilization after anatomical reconstruction of the lateral ankle ligaments To study the efficacy of an injury prevention program in a r and omized trial , 12 teams ( 180 players ) in a male senior soccer division were followed up for 6 months . The 12 teams were allocated at r and om to two groups of six teams , one being given a prophylactic program and the other serving as control . The program was based on previous studies of injury mechanisms . It comprised ( 1 ) correction of training , ( 2 ) provision of optimum equipment ; ( 3 ) prophylactic ankle taping ; ( 4 ) controlled rehabilitation ; ( 5 ) exclusion of players with grave knee instability ; ( 6 ) information about the impor tance of disciplined play and the increased risk of injury at training camps ; and ( 7 ) correction and supervision by doctor(s ) and physiotherapist(s ) . The injuries in the test teams were 75 % fewer than in the controls . The most common types of soccer injuries , sprains and strains to ankles and knees , were all significantly reduced . It is concluded that the pro posed prophylactic program , including close supervi sion and correction by doctors and physiotherapists , significantly reduces soccer injuries Abstract We compared sport-specific skills in 23 athletes with functionally unstable ankle joints to those of 18 healthy volunteers by performing a Japan test as well as a specially design ed single-leg jumping test . For external stabilization of the ankle , an Aircast brace , a Ligafix Air brace , a Malleoloc brace and a tape b and age were applied . For the Japan test in the group with uninjured ankle joints , the best results were obtained when wearing the Aircast brace , followed by tape b and age , Ligafix brace and no stabilizing device in descending order . The worst results were presented by the group with the Malleoloc brace . However , there were no significant differences among these devices . In the group with functionally unstable ankle joints , the best score was achieved with the tape b and age , followed by the Ligafix brace , Malleoloc brace and Aircast brace . The unstabilized group showed significantly worse results compared with all other groups . In the single-leg jumping test , the stabilizing devices had no negative influence on the jumping capability in the uninjured ankle joints . Additionally , there was no significant difference among the orthoses . Volunteers with unstable ankle joints experienced a significant improvement of jumping performance with most of the devices . The best results were achieved with the Aircast brace , followed by the Malleoloc brace , Ligafix brace and tape b and age . However , there was no significant difference among these orthoses . While the reaction time of the volunteers was the same for all test situations , the time for dynamically stabilizing the ankle joint appeared to be significantly worse in those ankle joints without a brace . For athletic activities , which are dominated by movement patterns comparable to the Japan test as well as the jumping test used , these stabilizing devices seem to have no negative effect on sport-specific capabilities STUDY DESIGN R and omized controlled trial with pretraining , posttraining , and follow-up repeated measures . OBJECTIVE To determine the effectiveness of a 4-week elastic resistance exercise program on balance in subjects with and without a history of sprained ankles . BACKGROUND Several research ers have suggested that improving balance may help alleviate the symptoms of functional ankle instability and reduce the rate of recurrent ankle sprains . METHODS AND MEASURES Forty subjects ( 20 males , 20 females ; 20 subjects with chronic ankle instability [ CAI ] , 20 healthy ) participated in the study . Ten subjects ( 5 males , 5 females ) from each CAI and healthy group were r and omly assigned to either the exercise or control group , result ing in a total of 4 groups . Total travel distance of the center of pressure , monitored using a force platform , was measured before training , after 4 weeks of training , and at a 4-week follow-up . RESULTS There were no interactions between gender , ankle sprain history , or training groups . Balance significantly improved in subjects with and without a history of ankle sprains following 4 weeks of elastic resistance exercises . Mean improvement in balance for the exercise group following training , reflected through a decrease in total travel distance , was -11.1 cm ( 95 % confidence interval : -14.0 to -8.2 cm ) . These improvements in balance were retained 4 weeks after training . CONCLUSIONS Balance was improved after 4 weeks of elastic resistance exercise in subjects with and without a history of lateral ankle sprains . Balance improvements persisted 4 weeks following the treatment cessation Objective : To examine the effects of a four-week balance training programme on ankle kinematics during walking and jogging in those with chronic ankle instability . A secondary objective was to evaluate the effect of balance training on the mechanical properties of the lateral ligaments in those with chronic ankle instability . Design : R and omized controlled trial . Setting : Laboratory . Subjects/ patients : Twenty-nine participants ( 12 males , 17 females ) with self-reported chronic ankle instability were r and omly assigned to a balance training group or a control group . Intervention : Four weeks of supervised rehabilitation that emphasized dynamic balance stabilization in single-limb stance . The control group received no intervention . Main outcome measures : Kinematic measures of rearfoot inversion/eversion , shank rotation , and the coupling relationship between these two segments throughout the gait cycle during walking and jogging on a treadmill . Instrumented ankle arthrometer measures were taken to assess anterior drawer and inversion talar tilt laxity and stiffness . Results : No significant alterations in the inversion/eversion or shank rotation kinematics were found during walking and jogging after balance training . There was , however , a significant decrease in the shank/rearfoot coupling variability during walking as measured by deviation phase after balance training ( balance training posttest : 13.1 ° ± 6.2 ° , balance training pretest : 16.2 ° ± 3.3 ° , P = 0.03 ) , indicating improved shank/rearfoot coupling stability . The control group did not significantly change . ( posttest : 16.30 ° ± 4.4 ° , pretest : 18.6 ° ± 7.1 ° , P40.05 ) There were no significant changes in laxity measures for either group . Conclusions : Balance training significantly altered the relationship between shank rotation and rearfoot inversion/eversion in those with chronic ankle instability Background Ankle sprains are common injuries that often lead to functional ankle instability ( FAI ) , which is a pathology defined by sensations of instability at the ankle and recurrent ankle sprain injury . Poor postural stability has been associated with FAI , and sports medicine clinicians rehabilitate balance deficits to prevent ankle sprains . Subsensory electrical noise known as stochastic resonance ( SR ) stimulation has been used in conjunction with coordination training to improve dynamic postural instabilities associated with FAI . However , unlike static postural deficits , dynamic impairments have not been indicative of ankle sprain injury . Therefore , the purpose of this study was to examine the effects of coordination training with or without SR stimulation on static postural stability . Improving postural instabilities associated with FAI has implication s for increasing ankle joint stability and decreasing recurrent ankle sprains . Methods This study was conducted in a research laboratory . Thirty subjects with FAI were r and omly assigned to either a : 1 ) conventional coordination training group ( CCT ) ; 2 ) SR stimulation coordination training group ( SCT ) ; or 3 ) control group . Training groups performed coordination exercises for six weeks . The SCT group received SR stimulation during training , while the CCT group only performed coordination training . Single leg postural stability was measured after the completion of balance training . Static postural stability was quantified on a force plate using anterior/posterior ( A/P ) and medial/lateral ( M/L ) center-of-pressure velocity ( COPvel ) , M/L COP st and ard deviation ( COPsd ) , M/L COP maximum excursion ( COPmax ) , and COP area ( COParea ) . Results Treatment effects comparing posttest to pretest COP measures were highest for the SCT group . At posttest , the SCT group had reduced A/P COPvel ( 2.3 ± 0.4 cm/s vs. 2.7 ± 0.6 cm/s ) , M/L COPvel ( 2.6 ± 0.5 cm/s vs. 2.9 ± 0.5 cm/s ) , M/L COPsd ( 0.63 ± 0.12 cm vs. 0.73 ± 0.11 cm ) , M/L COPmax ( 1.76 ± 0.25 cm vs. 1.98 ± 0.25 cm ) , and COParea ( 0.13 ± 0.03 cm2 vs. 0.16 ± 0.04 cm2 ) than the pooled means of the CCT and control groups ( P < 0.05 ) . Conclusion Reduced values in COP measures indicated postural stability improvements . Thus , six weeks of coordination training with SR stimulation enhanced postural stability . Future research should examine the use of SR stimulation for decreasing recurrent ankle sprain injury in physically active individuals with FAI STUDY DESIGN Within-group repeated measures . OBJECTIVES To determine the effect of a semi-rigid prophylactic ankle stabilizer ( PAS ) on performance of subjects with post-acute , unilateral ankle sprains who have mechanically stable ankles , but are functionally impaired . BACKGROUND Most studies on PAS performance to date are limited to subjects with noninjured , nonimpaired ankles . No research has been reported to determine the effect PASs have on performance in subjects who have a mechanically stable , nonacute ankle sprain with functional impairment . METHODS AND MEASURES Twenty-five subjects ( 8 men and 17 women ; average height = 168.91 + /- 33.02 cm , average weight = 61.10 + /- 29.5 kg , and average age = 16.2 + /- 6 years ) met the qualification criteria of the study . Subjects had unilateral grade I or II lateral ankle sprains of 3 to 4 weeks duration and were cleared medically to return to activities of daily living . Each subject 's injured ankle was mechanically stable as determined by physical exam but was functionally impaired as determined by instability during the modified Rhomberg test . Separate 2 x 2 ANOVAs with repeated measures on brace condition ( Aircast SportStirrup and nonbraced control ) and test session ( test session 1
Output:
| Neuromuscular training alone appears effective in the short term but whether this advantage would persist on longer-term follow-up is not known .
While there is insufficient evidence to support any one surgical intervention over another surgical intervention for chronic ankle instability , it is likely that there are limitations to the use of dynamic tenodesis .
After surgical reconstruction , early functional rehabilitation appears to be superior to six weeks immobilisation in restoring early function |
MS211347 | ***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: S100B is a protein which exerts both detrimental and neurotrophic effects , depending on its concentration in brain tissue . An increase of S100B in micromolar concentrations is observed in traumatic brain conditions and is associated with poor outcome . Micromolar levels of extracellular S100B in vitro may have deleterious effects . However , in nanomolar concentrations S100B has multiple neurotrophic effects in vitro may in vivo be regarded as a hallmark of neuroprotective efforts . This pilot study addresses the hypothesis that S100B serum concentrations may be of predictive validity for the response to antidepressant treatment in patients with major depression . S100B plasma levels were determined in 25 patients with major depression and 25 matched healthy controls using an immunofluorimetric s and wich assay . S100B plasma levels were significantly higher in major depressive patients than in healthy controls and positively correlated with treatment response after 4 weeks of treatment . In a linear regression model , a significant predictive effect was found only for S100B and severity of depressive symptoms upon admission . These results suggest that neuroprotective functions of S100B counterbalance neurodegenerative mechanisms that are involved in the pathophysiology of major depression and in the response to antidepressant treatment Background Acute management of traumatic brain injury ( TBI ) , in particular mild TBI , focuses on the detection of the 5–7 % who may be harboring potentially life-threatening intracranial hemorrhage ( IH ) using CT scanning . Guidelines intending to reduce unnecessary head CT scans using available clinical variables to detect those at high IH risk have shown varying results . Recently , the Sc and inavian Neurotrauma Committee ( SNC ) derived a new set of high-IH risk variables for adults with TBI using an evidence -based literature review . Unlike previous guidelines , the SNC guideline incorporates serum values of the brain protein S100B with clinical variables . Methods We performed a nested cohort study of adults with mild TBI presenting to six emergency departments in New York and Pennsylvania within 6 h of injury . Patients were managed according to existing guidelines for CT selection . All patients underwent head CT scanning and serum S100B measurement , as well as prospect i ve collection of clinical variables , as a requirement of the parent study . Using the SNC guidelines , S100B values and clinical variables were applied to these subjects , classifying each into one of five pre-defined severity categories , as well as predicting the need for head CT scanning to identify IH . This classification was then compared to actual head CT results to determine guideline sensitivity and specificity . Results In total , 662 adults ( mean age 42 years , range 18–96 ; 258 females , 549 Caucasians ) were available for analysis ; 36 ( 5 % ) had IH on head CT scan . The SNC guidelines had a sensitivity of 97 % ( 95 % CI , 84–100 % ) and a specificity of 34 % ( 95 % CI , 30–37 % ) for the detection of IH on head CT . Application of the SNC guidelines would have result ed in a CT reduction of 32 % ( 211/662 patients ) . One patient with low-risk mild TBI and a S100B level under 0.10 μg/L had a traumatic CT abnormality and would have been discharged with strict adherence to the guidelines . However , this patient did not need any intervention for the injury and had a good outcome . Conclusion Using the SNC guideline could save approximately one third of CT scans in a pre-selected cohort of mild TBI patients with little or no impact on patient outcome Rationale S100B is an astrocytic , calcium-binding protein which in nanomolar concentrations has neuroprotective and regenerating effects on neurons and glial cells . Increased levels have been shown to be positively correlated with therapeutic response in major depression . Event-related potentials ( ERP ) have been reported to be impaired in depressed patients . Objectives The aim of our study was to assess the relationship between S100B and visually evoked ERP in depression . Methods ERP and S100B serum concentration were studied in 18 patients with major depression , before and after 4 weeks of antidepressant treatment . Results The S100B concentration in patients was increased at intake and after 4 weeks of treatment compared to healthy controls . Initially increased P3-latency normalized and P2-latency significantly decreased after 4 weeks of treatment , although only in patients with clearly elevated initial S100B levels ( mean plus 2 SD of the healthy controls ) . Conclusion The neuroregenerative activity of moderately increased S100B levels in major depression might be a factor contributing to a decrease of prolonged ERP parameters in major depression during antidepressant treatment Disturbances in the serotonergic system are considered to be implicated in the pathophysiology of depressive disorders . The possible role of the neurotrophic factor S100 beta , which is suspected to regulate regeneration of serotonergic synapses , has not been investigated in depressive disorders . The S100 beta concentration in the cerebrospinal fluid was measured in 11 patients with the current diagnosis of mild or moderate depressive episodes ( DSM-IV ) and in 11 matched control patients . Using the t test for paired sample s , the presence of a depressive episode was significantly associated with an elevation of the cerebrospinal fluid concentration of S100 beta ( t = 2.6 , d.f . = 10 , p = 0.024 ) . Replications of this finding in severely depressed patients are necessary to confirm the association between neurotrophic factor S100 beta and depressive disorders
Output:
| The results indicated that elevated S100B levels might be associated with mood episodes in affective disorders . |
MS211348 | ***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 lateral window approach to maxillary sinus augmentation is a well-accepted treatment option in implant dentistry . The most frequent complication reported with traditional techniques has been the perforation of the Schneiderian membrane , with perforation rates ranging from 11 % to 56 % . The purpose of this retrospective , consecutive case series from two private practice s was to report on the rate of Schneiderian membrane perforations and arterial lacerations when a piezoelectric surgical unit was used in conjunction with h and instrumentation to perform lateral window sinus elevations . METHODS Clinical data ( Schneiderian membrane perforation , Underwood septa , and laceration of the lateral arterial blood supply to the maxillary sinus ) were obtained retrospectively from two private practice s and pooled for analysis . The information was collated after an exhaustive chart review . Fifty-six consecutively treated lateral window sinus lifts were performed on 50 partially or completely edentate patients . RESULTS Zero perforations of the Schneiderian membrane occurred during the piezoelectric preparation of the lateral antrostomies , whereas two perforations were noted during subsequent membrane elevations using h and instrumentation . In both instances , membrane perforations were associated with sinus septa . The overall sinus perforation rate was 3.6 % . Arterial branches of the posterior superior alveolar artery were encountered in 35 cases , and there were zero instances of arterial laceration . CONCLUSIONS This retrospective case series from clinical private practice s confirmed that a lateral window approach to sinus elevation incorporating piezoelectric technology in conjunction with h and instrumentation was an effective means to achieve sinus elevation while minimizing the potential for intraoperative complications . Further prospect i ve and r and omized controlled studies are warranted to qualify these observations Elevation of the sinus floor allows the correct number and length of oral implants to be placed . The sinus membrane is dissected blindly , usually by a crestal approach , but several internal configurations of the maxillary sinus or intrasinus septa can cause problems . We studied 150 sinuses from 40 male cadavers , and 35 r and omised male patients by anatomical dissection and computed tomography . Forty-six subjects ( 61 % ) had no bony septa or had septa less than 4 mm . Twenty-nine ( 39 % ) had bony septa of which seven were incomplete , one had a complete bony septum in each maxillary sinus , and 20 had symmetrical bony septa . We present the results of a study of bony intramaxillary sinus septa and the potential problems they can cause during elevation of the sinus floor PURPOSE The purpose of this study was to compare Unilab Surgibone ( USB ) ( Mississauga , Ontario , Canada ) , a bone xenograft ( bovine ) , with platelet-rich plasma ( PRP ) and USB without PRP to augment the human maxillary sinus in preparation to receive dental implants . PATIENTS AND METHODS Patients who had bilateral pneumatized maxillary sinuses were included . Sinuses on one side were augmented with the USB-PRP combination and formed the study group , whereas the opposite-side sinuses were augmented with USB alone and served as controls . Bone biopsy specimens were taken during implant placement at 6.8 ± 0.9 months after maxillary sinus floor augmentation . Resonance frequency analysis measurements were performed at implant placement ( first control ) and before the prosthetic stage ( second control ) , at 6.5 ± 0.7 months after implant surgery . RESULTS There were 10 patients ( 7 men and 3 women ; mean age , 53.7 ± 0.8 years ) . Integration between new bone and residual grafts was histologically observed in all sample s. The volumes of soft tissue were 59.9 % ± 7.5 % and 57.8 % ± 4.4 % in the control and study groups , respectively ; residual graft , 21.9 % ± 6.6 % and 23.6 % ± 5.9 % , respectively ; new bone , 15.8 % ± 4.8 % and 16.0 % ± 3.8 % , respectively ; and trabecular bone , 64.7 % ± 22.5 % and 69.1 % ± 18.6 % , respectively . A positive correlation was found between new bone volume and trabecular bone volume ( P = .0001 ) . The mean Implant Stability Quotient ( ISQ ) values were 71.7 ± 4.9 and 70.3 ± 5.7 in the control and study groups , respectively , at first control and 75.4 ± 6.4 and 74.4 ± 6.4 , respectively , at second control . The mean ISQ values at second control in both groups were significantly higher than at first control ( P = .043 and P = .028 , respectively ) . No statistically significant differences were observed between groups ( P > .05 ) . CONCLUSION The combination of USB and PRP does not have any effect on new bone formation and implant stabilization
Output:
| In view of their high overall prevalence and significant morphologic variability , 3D radiographic imaging prior to sinus floor augmentation may help to reduce complication rates in the presence of maxillary sinus septa |
MS211349 | ***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 of the study : to examine the costs and cost-effectiveness of ‘ second-generation ’ telecare , in addition to st and ard support and care that could include ‘ first-generation ’ forms of telecare , compared with st and ard support and care that could include ‘ first-generation ’ forms of telecare . Design and methods : a pragmatic cluster-r and omised controlled trial with nested economic evaluation . A total of 2,600 people with social care needs participated in a trial of community-based telecare in three English local authority areas . In the Whole Systems Demonstrator Telecare Question naire Study , 550 participants were r and omised to intervention and 639 to control . Participants who were offered the telecare intervention received a package of equipment and monitoring services for 12 months , additional to their st and ard health and social care services . The control group received usual health and social care . Primary outcome measure : incremental cost per quality -adjusted life year ( QALY ) gained . The analyses took a health and social care perspective . Results : cost per additional QALY was £ 297,000 . Cost-effectiveness acceptability curves indicated that the probability of cost-effectiveness at a willingness-to-pay of £ 30,000 per QALY gained was only 16 % . Sensitivity analyses combining variations in equipment price and support cost parameters yielded a cost-effectiveness ratio of £ 161,000 per QALY . Implication s : while QALY gain in the intervention group was similar to that for controls , social and health services costs were higher . Second-generation telecare did not appear to be a cost-effective addition to usual care , assuming a commonly accepted willingness to pay for QALYs . Trial registration number : IS RCT N 43002091 INTRODUCTION We wanted to examine how Danes use the Internet for health-related purpose s. How much are the existing possibilities used ? Who are the users ? What are the consequences of this use ? MATERIAL S AND METHODS In October 2005 - -as part of a large EU supported study --a telephone survey was carried out among 1000 r and omly selected Danes between the age of 15 and 80 . RESULTS 60 % of the Danish population use the Internet to seek health-related information . The Internet is especially used for health purpose s by people with a high education , by women , by people with poor health and by people with children . Every fourth Dane experiences feelings of reassurance or relief after having read about illness on the Internet and this number is 3 times higher than the number of people that experience concern and anxiety . 3 % state that they have changed their medication after having read information on the Internet and this is done without prior contact to their doctor . 8 % of Danes have at some point consulted their doctor over the Internet , and if given the opportunity , 58 % would read their own patient record online . CONCLUSIONS For many Danes it is common practice to use the Internet for health-related purpose s. However , the position of the general practitioner as the primary source of health-related information is not threatened . Danes use the Internet as a supplement to their doctor and many -- especially women -- use the Internet information in their dialogue with their doctor . Danes increasingly seek solutions to enable them to get online contact with the different players in the health care sector BACKGROUND Pediatric subspecialists are often separated from the children who need them by distance , time , or socioeconomic factors . The Electronic Children 's Hospital of the Pacific is an Internet-based store- and -forward pediatric consultation system established to overcome these barriers . OBJECTIVE To characterize the use of the Electronic Children 's Hospital of the Pacific and its impact on access to specialty care , the quality of the care provided , and cost savings . DESIGN Prospect i ve trial . SETTING Twenty-two military treatment facilities in the Pacific . PARTICIPANTS Primary care providers , pediatric consultants , and 5 review ers . MAIN OUTCOME MEASURES Consult response time , physician panel review , and evacuation cost avoidance . RESULTS There were 267 cases from 16 sites . The mean + /- SD response time by a consultant was 32 + /- 8 hours . The panel review deemed that the initial diagnosis was changed or modified in 15 % ( 39/267 ) of the cases , the diagnostic plan was changed or modified in 21 % ( 57/267 ) , and the treatment plan was changed or modified in 24 % ( 64/267 ) ( P < .01 for all ) . Routine air evacuations to a tertiary care medical center were avoided in 32 cases ( 12 % ) , with an estimated cost savings of $ 185 408 . CONCLUSIONS The Electronic Children 's Hospital of the Pacific improved the quality of patient care by providing expeditious specialty consultation . Significant cost avoidance in this military pediatric population was documented . Store- and -forward Internet-based teleconsultation is an effective means of providing pediatric subspecialty consultation to a population of underserved children Background Missed appointments are known to interfere with appropriate care and to misspend medical and administrative re sources . The aim of this study was to test the effectiveness of a sequential intervention reminding patients of their upcoming appointment and to identify the profile of patients missing their appointments . Methods We conducted a r and omised controlled study in an urban primary care clinic at the Geneva University Hospitals serving a majority of vulnerable patients . All patients booked in a primary care or HIV clinic at the Geneva University Hospitals were sent a reminder 48 hrs prior to their appointment according to the following sequential intervention : 1 . Phone call ( fixed or mobile ) reminder ; 2 . If no phone response : a Short Message Service ( SMS ) reminder ; 3 . If no available mobile phone number : a postal reminder . The rate of missed appointment , the cost of the intervention , and the profile of patients missing their appointment were recorded . Results 2123 patients were included : 1052 in the intervention group , 1071 in the control group . Only 61.7 % patients had a mobile phone recorded at the clinic . The sequential intervention significantly reduced the rate of missed appointments : 11.4 % ( n = 122 ) in the control group and 7.8 % ( n = 82 ) in the intervention group ( p < 0.005 ) , and allowed to reallocate 28 % of cancelled appointments . It also proved to be cost effective in providing a total net benefit of 1846 . - EUR/3 months . A satisfaction survey conducted with 241 patients showed that 93 % of them were not bothered by the reminders and 78 % considered them to be useful . By multivariate analysis , the following characteristics were significant predictors of missed appointments : younger age ( OR per additional decade 0.82 ; CI 0.71 - 0.94 ) , male gender ( OR 1.72 ; CI 1.18 - 2.50 ) , follow-up appointment > 1year ( OR 2.2 ; CI : 1.15 - 4.2 ) , substance abuse ( 2.09 , CI 1.21 - 3.61 ) , and being an asylum seeker ( OR 2.73 : CI 1.22 - 6.09 ) . Conclusion A practical reminder system can significantly increase patient attendance at medical outpatient clinics . An intervention focused on specific patient characteristics could further increase the effectiveness of appointment reminders IMPORTANCE Hospital readmissions are common and costly , and no single intervention or bundle of interventions has reliably reduced readmissions . Virtual wards , which use elements of hospital care in the community , have the potential to reduce readmissions , but have not yet been rigorously evaluated . OBJECTIVE To determine whether a virtual ward-a model of care that uses some of the systems of a hospital ward to provide interprofessional care for community-dwelling patients -can reduce the risk of readmission in patients at high risk of readmission or death when being discharged from hospital . DESIGN , SETTING , AND PATIENTS High-risk adult hospital discharge patients in Toronto were r and omly assigned to either the virtual ward or usual care . A total of 1923 patients were r and omized during the course of the study : 960 to the usual care group and 963 to the virtual ward group . The first patient was enrolled on June 29 , 2010 , and follow-up was completed on June 2 , 2014 . INTERVENTIONS Patients assigned to the virtual ward received care coordination plus direct care provision ( via a combination of telephone , home visits , or clinic visits ) from an interprofessional team for several weeks after hospital discharge . The interprofessional team met daily at a central site to design and implement individualized management plans . Patients assigned to usual care typically received a typed , structured discharge summary , prescription for new medications if indicated , counseling from the resident physician , arrangements for home care as needed , and recommendations , appointments , or both for follow-up care with physicians as indicated . MAIN OUTCOMES AND MEASURES The primary outcome was a composite of hospital readmission or death within 30 days of discharge . Secondary outcomes included nursing home admission and emergency department visits , each of the components of the primary outcome at 30 days , as well as each of the outcomes ( including the composite primary outcome ) at 90 days , 6 months , and 1 year . RESULTS There were no statistically significant between-group differences in the primary or secondary outcomes at 30 or 90 days , 6 months , or 1 year . The primary outcome occurred in 203 of 959 ( 21.2 % ) of the virtual ward patients and 235 of 956 ( 24.6 % ) of the usual care patients ( absolute difference , 3.4 % ; 95 % CI , -0.3 % to 7.2 % ; P = .09 ) . There were no statistically significant interactions to indicate that the virtual ward model of care was more or less effective in any of the prespecified subgroups . CONCLUSIONS AND RELEVANCE In a diverse group of high-risk patients being discharged from the hospital , we found no statistically significant effect of a virtual ward model of care on readmissions or death at either 30 days or 90 days , 6 months , or 1 year after hospital discharge . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01108172 Background Computer-based decision support systems are a promising method for incorporating research evidence into clinical practice . However , evidence is still scant on how such information technology solutions work in primary healthcare when support is provided across many health problems . In Finl and , we design ed a trial where a set of evidence -based , patient-specific reminders was introduced into the local Electronic Patient Record ( EPR ) system . The aim was to measure the effects of such reminders on patient care . The hypothesis was that the total number of triggered reminders would decrease in the intervention group compared with the control group , indicating an improvement in patient care . Methods From July 2009 to October 2010 all the patients of one health center were r and omized to an intervention or a control group . The intervention consisted of patient-specific reminders concerning 59 different health conditions triggered when the healthcare professional ( HCP ) opened and used the EPR . In the intervention group , the triggered reminders were shown to the HCP ; in the control group , the triggered reminders were not shown . The primary outcome measure was the change in the number of reminders triggered over 12 months . We developed a unique data gathering method , the Repeated Study Virtual Health Check ( RSVHC ) , and used Generalized Estimation Equations ( GEE ) for analysing the incidence rate ratio , which is a measure of the relative difference in percentage change in the numbers of reminders triggered in the intervention group and the control group . Results In total , 13,588 participants were r and omized and included . Contrary to our expectation , the total number of reminders triggered increased in both the intervention and the control groups . The primary outcome measure did not show a significant difference between the groups . However , with the inclusion of patients followed up over only six months , the total number of reminders increased significantly less in the intervention group than in the control group when the confounding factors ( age , gender , number of diagnoses and medications ) were controlled for . Conclusions Computerized , tailored reminders in primary care did not decrease during the 12 months of follow-up time after the introduction of a patient-specific decision support system . Trial registration Clinical Trial.gov Background Telephone or text-message reminders have been shown to significantly reduce the rate of missed appointments in different medical setting s. Since text-messaging is less re source -dem and ing , we tested the hypothesis that text-message reminders would be as effective as telephone reminders in an academic primary care clinic . Methods A r and omized controlled non-inferiority trial was conducted in the academic primary care division of the Geneva University Hospitals between November 2010 and April 2011 . Patients registered for an appointment at the clinic , and for whom a cell phone number was available , were r and omly selected to receive a text-message or a telephone call reminder 24 hours before the planned appointment . Patients were included each time they had an appointment . The main outcome was the rate of unexplained missed appointments . Appointments were not missed if they were cancelled or re-scheduled before or independently from the intervention . We defined non-inferiority as a difference below 2 % in the rate of missed appointments and powered the study accordingly . A satisfaction survey was conducted among a r and om sample of 900 patients ( response rate 41 % ) . Results 6450 patients were included , 3285 in the text-message group and 3165 in the telephone group . The rate of missed appointments was similar in the text-message group ( 11.7 % , 95 % CI : 10.6 - 12.8 ) and in the telephone group ( 10.2 % , 95 % CI : 9.2 - 11.3 p = 0.07 ) . However , only text message reminders were cost-effective . No patient reported any disturbance by any type of reminder in the satisfaction survey . Three quarters of surveyed patients recommended its regular implementation in the clinic . Conclusions Text-message reminders
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| RESULTS The majority of studies support the feasibility/acceptance of telemedicine for use in primary care , although it varies significantly by demographic variables , such as gender , age , and socioeconomic status , and telemedicine has often been found more acceptable by patients than healthcare providers .
Outcomes data are limited but overall suggest that telemedicine interventions are generally at least as effective as traditional care .
Cost analyses vary , but telemedicine in primary care is increasingly demonstrated to be cost-effective .
CONCLUSIONS Telemedicine has significant potential to address many of the challenges facing primary care in today 's healthcare environment . |
MS211350 | ***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 A commonly reported problem with the conduct of multicentre r and omised controlled trials ( RCTs ) is that recruitment is often slower or more difficult than expected , with many trials failing to reach their planned sample size within the timescale and funding originally envisaged . The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies : the UK Medical Research Council ( MRC ) and the Health Technology Assessment ( HTA ) Programme . Methods The cohort of trials was identified from the administrative data bases held by the two funding bodies . 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria . The full scientific applications and subsequent trial reports su bmi tted by the trial teams to the funders provided the principal data sources . Associations between trial characteristics and recruitment success were tested using the Chi-squared test , or Fisher 's exact test where appropriate . Results Less than a third ( 31 % ) of the trials achieved their original recruitment target and half ( 53 % ) were awarded an extension . The proportion achieving targets did not appear to improve over time . The overall start to recruitment was delayed in 47 ( 41 % ) trials and early recruitment problems were identified in 77 ( 63 % ) trials . The inter-relationship between trial features and recruitment success was complex . A variety of strategies were employed to try to increase recruitment , but their success could not be assessed . Conclusion Recruitment problems are complex and challenging . Many of the trials in the cohort experienced recruitment difficulties . Trials often required extended recruitment periods ( sometimes supported by additional funds ) . While this is of continuing concern , success in addressing the trial question may be more important than recruitment alone We investigated whether a short course in communication skills for physicians would improve the quality of informed consent in a r and omized clinical adjuvant trial on breast cancer . In this prospect i ve , case-controlled intervention study , physicians and research nurses who introduced the cancer treatment trial to patients at three of the participating hospitals first attended a one-day communication skills course . The quality of informed consent was then evaluated by addressing a st and ardized question naire , QuIC , to trial patients at the three intervention hospitals and at control hospitals . Response rate was 90.0 % ( n = 288 ) . Of the patients treated by the intervention group , 73 % were very satisfied with the information received compared with 56 % of those of the control group ( p = 0.003 ) . The patients of the intervention group considered the time given for making their decision sufficient more often than those of the controls ( 98 % vs. 90 % , p=0.004 ) . The patients of the intervention group recalled more often than those of the controls that the physician had also offered other therapeutic options than the trial treatment ( 91 % vs. 97 % , p=0.032 ) . They also understood the main aim of the study better than the patients of the controls ( 89 % vs. 78 % , p=0.030 ) . In conclusion , a short communication skills course for the trial physicians and nurses improved the quality of informed consent and patient satisfaction in the trial BACKGROUND Previous research has shown that communication between members of multidisciplinary teams ( MDTs ) is often suboptimal and communication about trials between MDTs and their patients is difficult . Educational interventions can help dyadic exchanges with different aspects of trial recruitment but less work has focussed on team interventions . METHODS 22 multidisciplinary cancer teams in the UK participated in an RCT of a novel Teams Talking Trials ( TTT ) Workshop aim ed at improving the following : awareness , involvement , communication and recruitment to cancer trials . MDTs were r and omised following either 6 or 12 months of audits , which were repeated after the intervention . Audits included numbers approached about trials , team members ' attitudes , involvement and awareness of their teams ' trial portfolios . RESULTS There was no significant difference in the rate of approaching patients about trials post workshop ( estimated improvement 22 % higher regression coefficient of 0.2 , exp . (0.2)=1.22 ) . There was improvement in team members ' involvement in trials in 4 areas ( p≤0.04 ) : the pressure to enter patients into RCTs , the likelihood of a start-up meeting to discuss a newly accepted trial , the informational role played by individuals and recognition of this HCP 's role by other team members . Also , confidence in communication about RCTS increased and awareness of different aspects of trial management improved on all 14 aspects ( p=0.001 ) . CONCLUSION Attendance by teams at focussed workshops design ed to enhance communication and trial recruitment improved several aspects of team functioning , but a significant impact on the number of patients approached could not be demonstrated Background Poor recruitment to r and omised controlled trials ( RCTs ) is a widespread problem . Provision of interventions aim ed at supporting or incentivising clinicians may improve recruitment to RCTs . Objectives To quantify the effects of strategies aim ed at improving the recruitment activity of clinicians in RCTs , complemented with a synthesis of qualitative evidence related to clinicians ' attitudes towards recruiting to RCTs . Data sources A systematic review of English and non-English articles identified from : The Cochrane Library , Ovid MEDLINE , Ovid EMBASE , Ovid PsycINFO , Ebsco CINAHL , Index to Theses and Open SIGLE from 2001 to March 2011 . Additional reports were identified through citation search es of included articles . Study eligibility criteria Quantitative studies were included if they evaluated interventions aim ed at improving the recruitment activity of clinicians or compared recruitment by different groups of clinicians . Information about host trial , study design , participants , interventions , outcomes and host RCT was extracted by one research er and checked by another . Studies that met the inclusion criteria were assessed for quality using a st and ardised tool , the Effective Public Health Practice Project tool . Qualitative studies were included if they investigated clinicians ' attitudes to recruiting patients to RCTs . All results / findings were extracted , and content analysis was carried out . Overarching themes were abstract ed , followed by a meta summary analysis . Studies that met the inclusion criteria were assessed for quality using the Critical Appraisal Skills Programme qualitative checklist . Data extraction Data extraction was carried out by one research er using predefined data fields , including study quality indicators , and verified by another . Results Eight quantitative studies were included describing four interventions and a comparison of recruiting clinicians . One study was rated as strong , one as moderate and the remaining six as weak when assessed for quality using the Effective Public Health Practice Project tool . Effective interventions included the use of qualitative research to identify and overcome barriers to recruitment , reduction of the clinical workload associated with participation in RCTs and the provision of extra training and protected research time . Eleven qualitative studies were identified , and eight themes were abstract ed from the data : underst and ing of research , communication , perceived patient barriers , patient – clinician relationship , effect on patients , effect on clinical practice , individual benefits for clinicians and methods associated with successful recruitment . Meta summary analysis identified the most frequently reported subthemes to be : difficulty communicating trial methods , poor underst and ing of research and priority given to patient well-being . Overall , the qualitative studies were found to be of good quality when assessed using the Critical Appraisal Skills Programme checklist . Conclusions There were few high- quality trials that tested interventions to improve clinicians ' recruitment activity in RCTs . The most promising intervention was the use of qualitative methods to identify and overcome barriers to clinician recruitment activity . More good quality studies of interventions are needed to add to the evidence base . The meta summary of qualitative findings identified underst and ing and communicating RCT methods as a key target for future interventions to improve recruitment . Reinforcement of the potential benefits , both for clinicians and for their patients , could also be a successful factor in improving recruitment . A bias was found towards investigating barriers to recruitment , so future work should also encompass a focus on successfully recruiting trials Abstract Objective To evaluate a training intervention aim ed at improving healthcare professionals ' communication with cancer patients about r and omised clinical trials . Design Before and after evaluation of training programme . Setting Members of the National Cancer Research Network , Scottish Trials Network , and the Welsh Cancer Trials Network Participants 101 healthcare professionals ( 33 clinicians and 68 research nurses ) . Intervention Four modules delivered by a trained facilitator using videotapes and interactive exercises to cover general issues about discussing r and omised clinical trials with patients , problems specific to adjuvant trials , trials with palliation as the goal , and trials where patients had a strong preference for one treatment arm . Main outcome measures Before and after the intervention , participants were videotaped discussing a trial with an actor portraying a patient . These consultations were assessed for presence of information required by good clinical practice guidelines . The actor patients gave an assessment after each interview . Participants reported their self confidence about key aspects of trial discussion . Results Analysis of the videotaped consultations showed that , after intervention , significantly more participants displayed key communication behaviours such as explaining r and omisation ( 69 v 81 , odds ratio 2.33 , P = 0.033 ) , checking patients ' underst and ing ( 11 v 31 , odds ratio 3.22 , P = 0.002 ) , and discussing st and ard treatment ( 73 v 88 , odds ratio 4.75 , P = 0.005 ) and side effects ( 69 v 85 , odds ratio 3.29 , P = 0.006 ) . Participants ' self confidence increased significantly ( P < 0.001 ) across all areas . Actor patients ' ratings of participants ' communication showed significant improvements for 12/15 key items . Conclusion This intensive 8 hour intervention significantly improved participants ' confidence and competence when communicating about r and omised clinical trials Objective The aim of the study was to investigate how doctors considered and experienced the concept of equipoise while recruiting patients to r and omized controlled trials ( RCTs ) . Study Design and Setting In-depth interviews with 32 doctors in six publicly funded pragmatic RCTs explored their perceptions of equipoise as they undertook RCT recruitment . The RCTs varied in size , duration , type of complex intervention , and clinical specialties . Interview data were analyzed using qualitative content and thematic analytical methods derived from grounded theory and synthesized across six RCTs . Results All six RCTs suffered from poor recruitment . Doctors wanted to gather robust evidence but experienced considerable discomfort and emotion in relation to their clinical instincts and concerns about patient eligibility and safety . Although they relied on a sense of community equipoise to justify participation , most acknowledged having “ hunches ” about particular treatments and patients , some of which undermined recruitment . Surgeons experienced these issues most intensely . Training and support promoted greater confidence in equipoise and improved engagement and recruitment . Conclusion Recruitment to RCTs is a fragile process and difficult for doctors intellectually and emotionally . Training and support can enable most doctors to become comfortable with key RCT concepts including equipoise , uncertainty , patient eligibility , and r and omization , promoting a more resilient recruitment process in partnership with patients Background : The optimal treatment for localised oesophageal squamous cell carcinoma ( SCC ) is uncertain . We assessed the feasibility of an RCT comparing neoadjuvant treatment and surgery with definitive chemoradiotherapy . Methods : A feasibility RCT in three centres examined incident patients and reasons for in eligibility using multi-disciplinary team meeting records . Eligible patients were offered participation in the RCT with integrated qualitative research involving audio-recorded recruitment appointments and interviews with patients to inform recruitment training for staff . Results : Of 375 patients with oesophageal SCC , 42 ( 11.2 % ) were eligible . Reasons for eligibility varied between centres , with significantly differing proportions of patients excluded because of total tumour length ( P=0.002 ) . Analyses of audio-recordings and patient interviews showed that recruiters had challenges articulating the trial design in simple terms , balancing treatment arms and explaining the need for r and omisation . Before analyses of the qualitative data and recruiter training no patients were r and omised . Following training in one centre 5 of 16 eligible patients were r and omised . Conclusions : An RCT of surgical vs non-surgical treatment for SCC of the oesophagus is not feasible in the UK alone because of the low number of incident eligible patients . A trial comparing diverse treatment approaches may be possible with investment to support the recruitment process Purpose Few studies have compared the instructiveness of real patient contacts with simulated patient ( SP ) contacts . Although most of these studies found no difference , students often comment that the instructiveness of both encounters is dissimilar . The aims of this study were to evaluate which contact ( real patient or SP ) is perceived as most instructive by students and which variables contribute to this . Method The authors performed an experiment involving 163 first-year medical students , r and omized to having a real patient contact ( n = 61 ) or SP contact ( n = 102 ) . Quantitative ( question naires ) and qualitative ( focus groups ) methods were used to evaluate the perceived instructiveness of the contact . Results The general instructiveness of both real patient contacts and SP contacts was marked high . Several differences between the evaluations of real patient contacts and SP contacts were found . For example , students considered real patient contacts less helpful in practicing communication skills and considered the real patients ' feedback less relevant . The focus group interviews yielded explanations for many of the differences found . Students regarded real patients as more authentic . However , SPs were better informed about the purpose of the consultation and provided the student with more specific feedback . Conclusions Students consider authenticity an important advantage of real patients . Their difficult recruitment is an important disadvantage , however , SPs have important advantages compared with real patients —for example , their feedback . The choice of real patient contacts or SP contacts for medical education depends on factors like the phase of the curriculum and the aim of the
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| Recruiter training programmes were well received and some increased recruiters ’ self-confidence in communicating key RCT concepts to patients .
There was , however , little evidence that this training increased actual recruitment rates or patient underst and ing , satisfaction , or levels of informed consent .
Conclusions There is a need to develop recruiter training programmes that can lead to improved recruitment and informed consent in r and omised trials |
MS211351 | ***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 Treatments for small-cell lung cancer ( SCLC ) after failure of platinum-based chemotherapy are limited . We assessed safety and activity of nivolumab and nivolumab plus ipilimumab in patients with SCLC who progressed after one or more previous regimens . METHODS The SCLC cohort of this phase 1/2 multicentre , multi-arm , open-label trial was conducted at 23 sites ( academic centres and hospitals ) in six countries . Eligible patients were 18 years of age or older , had limited-stage or extensive-stage SCLC , and had disease progression after at least one previous platinum-containing regimen . Patients received nivolumab ( 3 mg/kg bodyweight intravenously ) every 2 weeks ( given until disease progression or unacceptable toxicity ) , or nivolumab plus ipilimumab ( 1 mg/kg plus 1 mg/kg , 1 mg/kg plus 3 mg/kg , or 3 mg/kg plus 1 mg/kg , intravenously ) every 3 weeks for four cycles , followed by nivolumab 3 mg/kg every 2 weeks . Patients were either assigned to nivolumab monotherapy or assessed in a dose-escalating safety phase for the nivolumab/ipilimumab combination beginning at nivolumab 1 mg/kg plus ipilimumab 1 mg/kg . Depending on tolerability , patients were then assigned to nivolumab 1 mg/kg plus ipilimumab 3 mg/kg or nivolumab 3 mg/kg plus ipilimumab 1 mg/kg . The primary endpoint was objective response by investigator assessment . All analyses included patients who were enrolled at least 90 days before data base lock . This trial is ongoing ; here , we report an interim analysis of the SCLC cohort . This study is registered with Clinical Trials.gov , number NCT01928394 . FINDINGS Between Nov 18 , 2013 , and July 28 , 2015 , 216 patients were enrolled and treated ( 98 with nivolumab 3 mg/kg , three with nivolumab 1 mg/kg plus ipilimumab 1 mg/kg , 61 with nivolumab 1 mg/kg plus ipilimumab 3 mg/kg , and 54 with nivolumab 3 mg/kg plus ipilimumab 1 mg/kg ) . At data base lock on Nov 6 , 2015 , median follow-up for patients continuing in the study ( including those who had died or discontinued treatment ) was 198·5 days ( IQR 163·0 - 464·0 ) for nivolumab 3 mg/kg , 302 days ( IQR not calculable ) for nivolumab 1 mg/kg plus ipilimumab 1 mg/kg , 361·0 days ( 273·0 - 470·0 ) for nivolumab 1 mg/kg plus ipilimumab 3 mg/kg , and 260·5 days ( 248·0 - 288·0 ) for nivolumab 3 mg/kg plus ipilimumab 1 mg/kg . An objective response was achieved in ten ( 10 % ) of 98 patients receiving nivolumab 3 mg/kg , one ( 33 % ) of three patients receiving nivolumab 1 mg/kg plus ipilimumab 1 mg/kg , 14 ( 23 % ) of 61 receiving nivolumab 1 mg/kg plus ipilimumab 3 mg/kg , and ten ( 19 % ) of 54 receiving nivolumab 3 mg/kg plus ipilimumab 1 mg/kg . Grade 3 or 4 treatment-related adverse events occurred in 13 ( 13 % ) patients in the nivolumab 3 mg/kg cohort , 18 ( 30 % ) in the nivolumab 1 mg/kg plus ipilimumab 3 mg/kg cohort , and ten ( 19 % ) in the nivolumab 3 mg/kg plus ipilimumab 1 mg/kg cohort ; the most commonly reported grade 3 or 4 treatment-related adverse events were increased lipase ( none vs 5 [ 8 % ] vs none ) and diarrhoea ( none vs 3 [ 5 % ] vs 1 [ 2 % ] ) . No patients in the nivolumab 1 mg/kg plus ipilimumab 1 mg/kg cohort had a grade 3 or 4 treatment-related adverse event . Six ( 6 % ) patients in the nivolumab 3 mg/kg group , seven ( 11 % ) in the nivolumab 1 mg/kg plus ipilimumab 3 mg/kg group , and four ( 7 % ) in the nivolumab 3 mg/kg plus ipilimumab 1 mg/kg group discontinued treatment due to treatment-related adverse events . Two patients who received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg died from treatment-related adverse events ( myasthenia gravis and worsening of renal failure ) , and one patient who received nivolumab 3 mg/kg plus ipilimumab 1 mg/kg died from treatment-related pneumonitis . INTERPRETATION Nivolumab monotherapy and nivolumab plus ipilimumab showed antitumour activity with durable responses and manageable safety profiles in previously treated patients with SCLC . These data suggest a potential new treatment approach for a population of patients with limited treatment options and support the evaluation of nivolumab and nivolumab plus ipilimumab in phase 3 r and omised controlled trials in SCLC . FUNDING Bristol-Myers Squibb BACKGROUND Nivolumab , a fully human IgG4 programmed death 1 ( PD-1 ) immune-checkpoint-inhibitor antibody , disrupts PD-1-mediated signaling and may restore antitumor immunity . METHODS In this r and omized , open-label , international phase 3 study , we assigned patients with nonsquamous non-small-cell lung cancer ( NSCLC ) that had progressed during or after platinum-based doublet chemotherapy to receive nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks or docetaxel at a dose of 75 mg per square meter of body-surface area every 3 weeks . The primary end point was overall survival . RESULTS Overall survival was longer with nivolumab than with docetaxel . The median overall survival was 12.2 months ( 95 % confidence interval [ CI ] , 9.7 to 15.0 ) among 292 patients in the nivolumab group and 9.4 months ( 95 % CI , 8.1 to 10.7 ) among 290 patients in the docetaxel group ( hazard ratio for death , 0.73 ; 96 % CI , 0.59 to 0.89 ; P=0.002 ) . At 1 year , the overall survival rate was 51 % ( 95 % CI , 45 to 56 ) with nivolumab versus 39 % ( 95 % CI , 33 to 45 ) with docetaxel . With additional follow-up , the overall survival rate at 18 months was 39 % ( 95 % CI , 34 to 45 ) with nivolumab versus 23 % ( 95 % CI , 19 to 28 ) with docetaxel . The response rate was 19 % with nivolumab versus 12 % with docetaxel ( P=0.02 ) . Although progression-free survival did not favor nivolumab over docetaxel ( median , 2.3 months and 4.2 months , respectively ) , the rate of progression-free survival at 1 year was higher with nivolumab than with docetaxel ( 19 % and 8 % , respectively ) . Nivolumab was associated with even greater efficacy than docetaxel across all end points in subgroups defined according to prespecified levels of tumor-membrane expression ( ≥1 % , ≥5 % , and ≥10 % ) of the PD-1 lig and . Treatment-related adverse events of grade 3 or 4 were reported in 10 % of the patients in the nivolumab group , as compared with 54 % of those in the docetaxel group . CONCLUSIONS Among patients with advanced nonsquamous NSCLC that had progressed during or after platinum-based chemotherapy , overall survival was longer with nivolumab than with docetaxel . ( Funded by Bristol-Myers Squibb ; CheckMate 057 Clinical Trials.gov number , NCT01673867 . ) BACKGROUND Patients with advanced squamous-cell non-small-cell lung cancer ( NSCLC ) who have disease progression during or after first-line chemotherapy have limited treatment options . This r and omized , open-label , international , phase 3 study evaluated the efficacy and safety of nivolumab , a fully human IgG4 programmed death 1 ( PD-1 ) immune-checkpoint-inhibitor antibody , as compared with docetaxel in this patient population . METHODS We r and omly assigned 272 patients to receive nivolumab , at a dose of 3 mg per kilogram of body weight every 2 weeks , or docetaxel , at a dose of 75 mg per square meter of body-surface area every 3 weeks . The primary end point was overall survival . RESULTS The median overall survival was 9.2 months ( 95 % confidence interval [ CI ] , 7.3 to 13.3 ) with nivolumab versus 6.0 months ( 95 % CI , 5.1 to 7.3 ) with docetaxel . The risk of death was 41 % lower with nivolumab than with docetaxel ( hazard ratio , 0.59 ; 95 % CI , 0.44 to 0.79 ; P<0.001 ) . At 1 year , the overall survival rate was 42 % ( 95 % CI , 34 to 50 ) with nivolumab versus 24 % ( 95 % CI , 17 to 31 ) with docetaxel . The response rate was 20 % with nivolumab versus 9 % with docetaxel ( P=0.008 ) . The median progression-free survival was 3.5 months with nivolumab versus 2.8 months with docetaxel ( hazard ratio for death or disease progression , 0.62 ; 95 % CI , 0.47 to 0.81 ; P<0.001 ) . The expression of the PD-1 lig and ( PD-L1 ) was neither prognostic nor predictive of benefit . Treatment-related adverse events of grade 3 or 4 were reported in 7 % of the patients in the nivolumab group as compared with 55 % of those in the docetaxel group . CONCLUSIONS Among patients with advanced , previously treated squamous-cell NSCLC , overall survival , response rate , and progression-free survival were significantly better with nivolumab than with docetaxel , regardless of PD-L1 expression level . ( Funded by Bristol-Myers Squibb ; CheckMate 017 Clinical Trials.gov number , NCT01642004 . ) PURPOSE In phase I/II trials , the cytotoxic T lymphocyte-associated antigen-4-blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma . This phase III study evaluated overall survival ( OS ) and other safety and efficacy end points in patients with advanced melanoma treated with tremelimumab or st and ard-of-care chemotherapy . PATIENTS AND METHODS Patients with treatment-naive , unresectable stage IIIc or IV melanoma were r and omly assigned at a ratio of one to one to tremelimumab ( 15 mg/kg once every 90 days ) or physician 's choice of st and ard-of-care chemotherapy ( temozolomide or dacarbazine ) . RESULTS In all , 655 patients were enrolled and r and omly assigned . The test statistic crossed the prespecified futility boundary at second interim analysis after 340 deaths , but survival follow-up continued . At final analysis with 534 events , median OS by intent to treat was 12.6 months ( 95 % CI , 10.8 to 14.3 ) for tremelimumab and 10.7 months ( 95 % CI , 9.36 to 11.96 ) for chemotherapy ( hazard ratio , 0.88 ; P = .127 ) . Objective response rates were similar in the two arms : 10.7 % in the tremelimumab arm and 9.8 % in the chemotherapy arm . However , response duration ( measured from date of r and om assignment ) was significantly longer after tremelimumab ( 35.8 v 13.7 months ; P = .0011 ) . Diarrhea , pruritus , and rash were the most common treatment-related adverse events in the tremelimumab arm ; 7.4 % had endocrine toxicities . Seven deaths in the tremelimumab arm and one in the chemotherapy arm were considered treatment related by either investigators or sponsor . CONCLUSION This study failed to demonstrate a statistically significant survival advantage of treatment with tremelimumab over st and ard-of-care chem
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| The analysis of data showed that CTLA‐4 inhibitors seem to be associated with a higher risk of all‐ and high‐ grade hepatotoxicity compared with control regimens , whereas PD‐1 inhibitors seem to be associated with a lower risk of all‐ and high‐ grade hepatotoxicity compared with control regimens |
MS211352 | ***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 Intermediate or surrogate endpoints for survival can shorten time lines for drug approval . We aim ed to assess circulating tumour cell ( CTC ) count as a prognostic factor for survival in patients with progressive , metastatic , castration-resistant prostate cancer receiving first-line chemotherapy . METHODS We identified patients with progressive metastatic castration-resistant prostate cancer starting first-line chemotherapy in the IMMC38 trial . CTCs were isolated by immunomagnetic capture from blood sample s at baseline and after treatment . Baseline variables , including CTC count , titre of prostate-specific antigen ( PSA ) , and concentration of lactate dehydrogenase ( LDH ) , and post-treatment variables ( change in CTCs and PSA ) were tested for association with survival with Cox proportional hazards models . Concordance probability estimates were used to gauge discriminatory strength of the informative factors in identifying patients at low-risk and high-risk of survival . FINDINGS Variables associated with high risk of death were high LDH concentration ( hazard ratio 6.44 , 95 % CI 4.24 - 9.79 ) , high CTC count ( 1.58 , 1.41 - 1.77 ) , and high PSA titre ( 1.26 , 1.10 - 1.45 ) , low albumin ( 0.10 , 0.03 - 0.39 ) , and low haemoglobin ( 0.72 , 0.64 - 0.81 ) at baseline . At 4 weeks , 8 weeks , and 12 weeks after treatment , changes in CTC number were strongly associated with risk , whereas changes in PSA titre were weakly or not associated ( p>0.04 ) . The most predictive factors for survival were LDH concentration and CTC counts ( concordance probability estimate 0.72 - 0.75 ) . INTERPRETATION CTC number , analysed as a continuous variable , can be used to monitor disease status and might be useful as an intermediate endpoint of survival in clinical trials . Prospect i ve recording of CTC number as an intermediate endpoint of survival in r and omised clinical trials is warranted Purpose : To detect insulin-like growth factor-IR ( IGF-IR ) on circulating tumor cells ( CTC ) as a biomarker in the clinical development of a monoclonal human antibody , CP-751,871 , targeting IGF-IR . Experimental Design : An automated sample preparation and analysis system for enumerating CTCs ( CellTracks ) was adapted for detecting IGF-IR – positive CTCs with a diagnostic antibody targeting a different IGF-IR epitope to CP-751,871 . This assay was used in three phase I trials of CP-751,871 as a single agent or with chemotherapy and was vali date d using cell lines and blood sample s from healthy volunteers and patients with metastatic carcinoma . Results : There was no interference between the analytic and therapeutic antibodies . Eighty patients were enrolled on phase I studies of CP-751,871 , with 47 ( 59 % ) patients having CTCs detected during the study . Before treatment , 26 patients ( 33 % ) had CTCs , with 23 having detectable IGF-IR – positive CTCs . CP-751,871 alone , and CP-751,871 with cytotoxic chemotherapy , decreased CTCs and IGF-IR – positive CTCs ; these increased toward the end of the 21-day cycle in some patients , falling again with retreatment . CTCs were commonest in advanced hormone refractory prostate cancer ( 11 of 20 ) . Detectable IGF-IR expression on CTCs before treatment with CP-751,871 and docetaxel was associated with a higher frequency of prostate-specific antigen decline by > 50 % ( 6 of 10 versus 2 of 8 patients ) . A relationship was observed between sustained decreases in CTC counts and prostate-specific antigen declines by > 50 % . Conclusions : IGF-IR expression is detectable by immunofluorescence on CTCs . These data support the further evaluation of CTCs in pharmacodynamic studies and patient selection , particularly in advanced prostate cancer In clinical ly organ-confined prostate cancer patients , bloodstream tumour cell dissemination generally occurs , and may be enhanced by surgical prostate manipulation . To evaluate cancer-cell seeding impact upon patient recurrence-free survival , 155 patients were prospect ively enrolled then followed . Here , 57 patients presented blood prostate cell shedding preoperatively and intraoperatively ( group I ) . Of the 98 preoperatively negative patients , 53 ( 54 % ) remained negative ( group II ) and 45 ( 46 % ) became intraoperatively positive ( group III ) . Median biological and clinical recurrence-free time was far shorter in group I ( 36.2 months , P<0.0001 ) than in group II ( 69.6 months ) but did not significantly differ in group II and III ( 69.6 months vs 65.0 ) . Such 5-year follow-up data show that preoperative circulating prostate cells are an independent prognosis factor of recurrence . Moreover , tumour h and ling induces cancer-cell seeding but surgical blood dissemination does not accelerate cancer evolution BACKGROUND The purpose of this study was to evaluate the association of circulating tumour cell ( CTC ) counts , before and after commencing treatment , with overall survival ( OS ) in patients with castration-resistant prostate cancer ( CRPC ) . EXPERIMENTAL DESIGN A 7.5 ml of blood was collected before and after treatment in 119 patients with CRPC . CTCs were enumerated using the Cell Search System . RESULTS Higher CTC counts associated with baseline characteristics portending aggressive disease . Multivariate analyses indicated that a CTC > or=5 was an independent prognostic factor at all time points evaluated . Patients with baseline CTC > or=5 had shorter OS than those with < 5 [ median OS 19.5 versus > 30 months , hazard ratio ( HR ) 3.25 , P=0.012 ] ; patients with CTC > 50 had a poorer OS than those with CTCs 5 - 50 ( median OS 6.3 versus 21.1 months , HR 4.1 , P<0.001 ) . Patients whose CTC counts reduced from > or=5 at baseline to < 5 following treatment had a better OS compared with those who did not . CTC counts showed a similar , but earlier and independent , ability to time to disease progression to predict OS . CONCLUSION CTC counts predict OS and provide independent prognostic information to time to disease progression ; CTC dynamics following therapy need to be evaluated as an intermediate end point of outcome in r and omised phase III trials Purpose : The TAX-327 study r and omized 1,006 men with metastatic hormone-refractory prostate cancer to receive 3-weekly docetaxel , weekly docetaxel , or mitoxantrone , each with prednisone . Experimental Design : We used the TAX-327 data base to address ( a ) the relationship between quality of life ( QoL ) and pain ; ( b ) whether minimally symptomatic patients benefit from treatment or have treatment-related decline in QoL ; ( c ) the relationships between prostate-specific antigen ( PSA ) response , pain response , and QoL response ; ( d ) the times at which these responses are first observed ; and ( e ) whether PSA , pain , and /or QoL response predict for overall survival . Results : At baseline , 374 of 815 men assessed for QoL had major pain ; of these , 92 % had substantial impairment of QoL compared with 75 % without major pain ( P < 0.001 ) . Men with minimal symptoms had prolonged survival ( median , 25.6 months ) compared with symptomatic patients ( median , 17.1 months ; P = 0.009 ) ; they were more likely to have initial deterioration of QoL if treated with weekly docetaxel . PSA response and pain response , but not QoL response , were independently associated with survival in l and mark analysis . Median times to PSA and pain response were 44 and 27 days , respectively ; some men had initial increase in serum PSA before subsequent decline . Conclusions : Symptoms other than pain contribute to impaired QoL in men with hormone-refractory prostate cancer . Those with minimal symptoms have prolonged survival . Both pain and PSA response are associated with survival but are not adequate to use as surrogate end points in phase 3 studies . Early increases in serum PSA ( up to 12 weeks ) should be ignored when determining response or progression PURPOSE We report a prospect i ve study examining the ability of preoperative nested reverse transcriptase polymerase chain reaction ( RT-PCR ) for prostate-specific antigen ( PSA ) and prostate-specific membrane antigen ( PSM ) to predict pathologic stage and biochemical recurrence in patients with clinical ly localized prostate cancer treated with radical prostatectomy . PATIENTS AND METHODS One hundred forty-one patients were entered onto the study . Preoperative evaluation included clinical T stage , serum PSA , biopsy Gleason score , and serum RT-PCR for PSA/PSM . Univariate and multivariate logistic regression models , Kaplan-Meier estimates , and Cox proportional hazards modeling were used to identify predictors of pathologic stage and biochemical failure . RESULTS Seventy-three patients ( 51.8 % ) were RT-PCR positive for PSA , PSM , or both . In the multivariate logistic regression model , only initial PSA was an independent predictor of pathologic stage as defined by organ-confined disease ( odds ratio [ OR ] , 1.06 ; 95 % confidence interval [ CI ] , 1.00 to 1.13 ; P = .026 ) or organ-/specimen-confined disease ( OR , 1.09 ; 95 % CI , 1.02 to 1.16 ; P = .009 ) . Overall Kaplan-Meier biochemical relapse-free survival ( bRFS ) was 85 % at 59 months . Multivariate analysis of predictors for bRFS with the Cox proportional hazards model indicated that only initial PSA ( OR , 1.05 ; 95 % CI , 1.02 to 1.09 ; P = .004 ) and biopsy Gleason score ( OR , 3.57 ; 95 % CI , 1.37 to 9.58 ; P = .009 ) were independent predictors of biochemical failure . RT-PCR status did not predict pathologic stage or biochemical failure . Repeat analysis excluding 27 patients who received preoperative and rogen-deprivation therapy did not change the results . CONCLUSION Combined nested RT-PCR for PSA and PSM is not an independent predictor of pathologic stage or biochemical failure in patients with localized prostate cancer undergoing radical prostatectomy . This assay has no clinical utility in this patient population The development of tumor biomarkers ready for clinical use is complex . We propose a refined system for biomarker study design , conduct , analysis , and evaluation that incorporates a hierarchal level of evidence scale for tumor marker studies , including those using archived specimens . Although fully prospect i ve r and omized clinical trials to evaluate the medical utility of a prognostic or predictive biomarker are the gold st and ard , such trials are costly , so we discuss more efficient indirect " prospect ive-retrospective " design s using archived specimens . In particular , we propose new guidelines that stipulate that 1 ) adequate amounts of archived tissue must be available from enough patients from a prospect i ve trial ( which for predictive factors should generally be a r and omized design ) for analyses to have adequate statistical power and for the patients included in the evaluation to be clearly representative of the patients in the trial ; 2 ) the test should be analytically and preanalytically vali date d for use with archived tissue ; 3 ) the plan for biomarker evaluation should be completely specified in writing before the performance of biomarker assays on archived tissue and should be focused on evaluation of a single completely defined classifier ; and 4 ) the results from archived specimens should be vali date d using specimens from one or more similar , but separate , studies PURPOSE We previously reported evidence of hematogenous dissemination of prostate cells during radical retropubic prostatectomy , and we now provide clinical and molecular reverse transcriptase-polymerase chain reaction ( RT-PCR ) followup of that patient cohort . MATERIAL S AND METHODS A total of 101 men with clinical ly localized prostate cancer were prospect ively enrolled in the study . The prostate specific antigen ( PSA ) RT-PCR assay was performed on peripheral venous blood sample s preoperatively in 101 , during surgery in 29 , during and up to 12 weeks after surgery in 50 and at least 1 year postoperatively in 65 patients . Correlation with clinical ( PSA ) indicators of recurrence was performed . RESULTS Of the 101 patients 9 demonstrated biochemical evidence of prostate cancer progression ( median followup 22 months ) . Of the 50 men with perioperative molecular results the RT-PCR positive rate increased from 22 % preoperatively in 11 to 48 % in 24 ( p = 0.02 ) and then decreased to 10 % in 4 of 40 men at 1 year postoperatively ( p = 0.07 ) . Molecular followup at a minimum of 1 year after radical retropubic prostatectomy was obtained in
Output:
| Initially , reverse transcriptase polymerase chain reaction ( RT-PCR ) based methods were utilized with weak correlation between their positive detection and patients ' outcome .
More recent immunological techniques have indicated a reproducible correlation with outcome . |
MS211353 | ***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 Acute pulmonary embolism ( PE ) can worsen quality of life due to persistent dyspnea or exercise intolerance . OBJECTIVE Test if tenecteplase increases the probability of a favorable composite patient-oriented outcome after submassive PE . METHODS Normotensive patients with PE and right ventricular ( RV ) strain ( by echocardiography or biomarkers ) were enrolled from eight hospitals . All patients received low-molecular-weight heparin followed by r and om assignment to either a single weight-based bolus of tenecteplase or placebo , administered in a double-blinded fashion . The primary composite outcome included : ( i ) death , circulatory shock , intubation or major bleeding within 5 days or ( ii ) recurrent PE , poor functional capacity ( RV dysfunction with either dyspnea at rest or exercise intolerance ) or an SF36 ( ® ) Physical Component Summary ( PCS ) score < 30 at 90-day follow-up . RESULTS Eighty-three patients were r and omized ; 40 to tenecteplase and 43 to placebo . The trial was terminated prematurely . Within 5 days , adverse outcomes occurred in three placebo-treated patients ( death in one and intubation in two ) and one tenecteplase-treated patient ( fatal intracranial hemorrhage ) . At 90 days , adverse outcomes occurred in 13 unique placebo-treated patients and five unique tenecteplase-treated patients Thus , 16 ( 37 % ) placebo-treated and six ( 15 % ) tenecteplase-treated patients had at least one adverse outcome ( exact two-sided P = 0.017 ) . CONCLUSIONS Treatment of patients with submassive pulmonary embolism with tenecteplase was associated with increased probability of a favorable composite outcome BACKGROUND The role of fibrinolytic therapy in patients with intermediate-risk pulmonary embolism is controversial . METHODS In a r and omized , double-blind trial , we compared tenecteplase plus heparin with placebo plus heparin in normotensive patients with intermediate-risk pulmonary embolism . Eligible patients had right ventricular dysfunction on echocardiography or computed tomography , as well as myocardial injury as indicated by a positive test for cardiac troponin I or troponin T. The primary outcome was death or hemodynamic decompensation ( or collapse ) within 7 days after r and omization . The main safety outcomes were major extracranial bleeding and ischemic or hemorrhagic stroke within 7 days after r and omization . RESULTS Of 1006 patients who underwent r and omization , 1005 were included in the intention-to-treat analysis . Death or hemodynamic decompensation occurred in 13 of 506 patients ( 2.6 % ) in the tenecteplase group as compared with 28 of 499 ( 5.6 % ) in the placebo group ( odds ratio , 0.44 ; 95 % confidence interval , 0.23 to 0.87 ; P=0.02 ) . Between r and omization and day 7 , a total of 6 patients ( 1.2 % ) in the tenecteplase group and 9 ( 1.8 % ) in the placebo group died ( P=0.42 ) . Extracranial bleeding occurred in 32 patients ( 6.3 % ) in the tenecteplase group and 6 patients ( 1.2 % ) in the placebo group ( P<0.001 ) . Stroke occurred in 12 patients ( 2.4 % ) in the tenecteplase group and was hemorrhagic in 10 patients ; 1 patient ( 0.2 % ) in the placebo group had a stroke , which was hemorrhagic ( P=0.003 ) . By day 30 , a total of 12 patients ( 2.4 % ) in the tenecteplase group and 16 patients ( 3.2 % ) in the placebo group had died ( P=0.42 ) . CONCLUSIONS In patients with intermediate-risk pulmonary embolism , fibrinolytic therapy prevented hemodynamic decompensation but increased the risk of major hemorrhage and stroke . ( Funded by the Programme Hospitalier de Recherche Clinique in France and others ; PEITHO EudraCT number , 2006 - 005328 - 18 ; Clinical Trials.gov number , NCT00639743 . ) BACKGROUND Elevated blood concentrations of troponin proteins or brain natriuretic peptide ( BNP ) worsen the prognosis of patients with pulmonary embolism ( PE ) . Novel biomarkers that reflect mechanisms of right ventricle ( RV ) damage from PE may provide additional prognostic value . We compare the prognostic use of BNP , troponin I , D-dimer , monocyte chemoattractant protein-1 , matrix metalloproteinase , myeloperoxidase , C-reactive protein , and caspase 3 as biomarkers of RV damage and adverse outcomes in submassive PE . METHODS This article used a prospect i ve cohort study of normotensive ( systolic blood pressure always > 100 mm Hg ) patients with computed tomographic angiography-diagnosed PE . All patients underwent echocardiography and phlebotomy at diagnosis , and survivors had another echocardiography 6 months later . We tested each biomarker for prognostic significance , requiring a lower limit 95 % CI > 0.50 for the area under the receiver operating characteristic curve ( AUROC ) with a reference st and ard positive of RV hypokinesis on either echocardiogram . Biomarkers with prognostic significance were dichotomized at the concentration that yielded highest likelihood ratio positive and mortality rates compared ( Fisher exact test ) . RESULTS We enrolled 152 patients with complete data . Thirty-seven ( 24 % , 95 % CI 18%-32 % ) had RV hypokinesis . Only BNP and troponin had significant AUROC values as follows : 0.71 ( 95 % CI 0.60 - 0.81 ) and 0.71 ( 95 % CI 0.62 - 0.82 ) , respectively . Overall mortality was 13/153 ( 8.5 % ) ; mortality rate for BNP > 100 versus < or = 100 pg/mL was 23 % versus 3 % ( P = .003 ) , respectively . Mortality rate for troponin I > 0.1 versus < or = 0.1 ng/mL was 13 % versus 6 % ( P = .205 ) , respectively . CONCLUSIONS Of 8 mechanistically plausible biomarkers , only BNP and troponin I had significant prognostic use with BNP having an advantage for predicting mortality BACKGROUND The Pulmonary Embolism Quality of Life question naire ( PEmb-QoL ) is a 40-item question naire to measure health-related quality of life in patients with pulmonary embolism . It covers six 6 dimensions : frequency of complaints , limitations in activities of daily living , work-related problems , social limitations , intensity of complaints , and emotional complaints . Originally developed in Dutch and English , we prospect ively vali date d a German version of the PEmb-QoL. METHODS A forward-backward translation of the English version of the PEmb-QoL into German was performed . German-speaking consecutive adult patients aged ≥18 years with an acute , objective ly confirmed pulmonary embolism discharged from a Swiss university hospital ( 01/2011 - 06/2013 ) were recruited telephonically . Established psychometric tests and criteria were used to evaluate the acceptability , reliability , and validity of the German PEmb-QoL question naire . To assess the underlying dimensions , an exploratory factor analysis was performed . RESULTS Overall , 102 patients were enrolled in the study . The German version of the PEmb-QoL showed a good internal consistency ( Cronbach 's alpha ranging from 0.72 to 0.96 ) , item-total ( 0.53 - 0.95 ) and inter-item correlations ( > 0.4 ) , and test-retest reliability ( intra-class correlation coefficients 0.59 - 0.89 ) for the dimension scores . A moderate correlation of the PEmb-QoL with SF-36 dimension and summary scores ( 0.21 - 0.83 ) indicated convergent validity , while low correlations of PEmb-QoL dimensions with clinical characteristics ( -0.16 - 0.37 ) supported discriminant validity . The exploratory factor analysis suggested four underlying dimensions : limitations in daily activities , symptoms , work-related problems , and emotional complaints . CONCLUSION The German version of the PEmb-QoL question naire is a valid and reliable disease-specific measure for quality of life in patients with pulmonary embolism Over the ensuing seven months she had three more clinical relapses , each accompanied by reappearance in the stools of either the organism or its cytotoxin , or both . Each improvement after vancomycin ( eight to 14-daycourses ) was accompanied by disappearance of the organism . At one point she was given cholestyramine , but she was unable to tolerate it . Her illness was punctuated by malnutrition and episodes of heart failure . She was given no other antibiotics . After the sixth relapse maintenance treatment with oral vancomycin 125 mg eight-hourly was begun . With this regimen diarrhoea was controlled and stools over the next 10 weeks remained negative for C difficile and its cytotoxin . There was no adverse reaction to vancomycin throughout The role of low-dose thrombolysis in the reduction of pulmonary artery pressure in moderate pulmonary embolism ( PE ) has not been investigated . Because the lungs are very sensitive to thrombolysis , we postulated that effective and safe thrombolysis might be achieved by a lower dose of tissue plasminogen activator . The purpose of the present study was to evaluate the role of this " safe dose " thrombolysis in the reduction of pulmonary artery pressure in moderate PE . During a 22-month period , 121 patients with moderate PE were r and omized to receive a " safe dose " of tissue plasminogen activator plus anticoagulation ( thrombolysis group [ TG ] , n = 61 patients ) or anticoagulation alone ( control group [ CG ] , n = 60 ) . The primary end points consisted of pulmonary hypertension and the composite end point of pulmonary hypertension and recurrent PE at 28 months . Pulmonary hypertension and the composite end point developed in 9 of 58 patients ( 16 % ) in the TG and 32 of 56 patients ( 57 % ) in the CG ( p < 0.001 ) and 9 of 58 patients ( 16 % ) in the TG and 35 of 56 patients ( 63 % ) in the CG ( p < 0.001 ) , respectively . The secondary end points were total mortality , the duration of hospital stay , bleeding at the index hospitalization , recurrent PE , and the combination of mortality and recurrent PE . The duration of hospitalization was 2.2 ± 0.5 days in the TG and 4.9 ± 0.8 days in the CG ( p < 0.001 ) . The combination of death plus recurrent PE was 1 ( 1.6 % ) in TG and 6 ( 10 % ) in the CG ( p = 0.0489 ) . No bleeding occurred in any group , and despite a positive trend in favor of a " safe dose " thrombolysis , no significant difference was noted in the rate of individual outcomes of death and recurrent PE when assessed independently . In conclusion , the results from the present prospect i ve r and omized trial suggests that " safe dose " thrombolysis is safe and effective in the treatment of moderate PE , with a significant immediate reduction in the pulmonary artery pressure that was maintained at 28 months Background The PEmb-QoL is a vali date d 40-item question naire to quantify health-related quality of life in patients having experienced pulmonary embolism ( PE ) . It covers six health dimensions : frequency of complaints , activities of daily living limitations , work-related problems , social limitations , intensity of complaints , and emotional complaints . Originally developed in Dutch and English , we sought to prospect ively vali date the psychometric properties of a French version of the PEmb-QoL. Methods We performed a forward and backward translation of the English version of the PEmb-QoL into French . French-speaking consecutive adult patients with an acute , objective ly confirmed PE admitted to the emergency department of a Swiss university hospital between 08/2009 and 09/2011 were recruited telephonically . We used st and ard psychometric tests and criteria to evaluate the acceptability , reliability , and validity of the French version of the PEmb-QoL. We also performed an exploratory factor analysis . Results Overall , 102 patients were enrolled in the study . The French version of the PEmb-QoL showed good reliability ( internal consistency , item – total and inter-item correlations ) , reproducibility ( test-retest reliability ) , and validity ( convergent , discriminant ) in French-speaking patients with PE . The exploratory factor analysis suggested three underlying dimensions : limitations in daily activity ( items 4b-m , 5a-d ) , symptoms ( items 1a-h and 7 ) , and emotional complaints ( items 9a-f and j ) . Conclusion We successfully vali date d
Output:
| Persistent RV dysfunction , impaired functional status , diminished exercise capacity , and reduced QoL are common in PE survivors . |
MS211354 | ***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 : Dopamine , a natural catecholamine with hypophysiotropic properties , is used as a first choice drug for inotropic and vasoactive support in pediatric intensive care . In infants and children , the pituitary gl and plays a crucial role as a regulator of growth , metabolism , maturation and , possibly , immune function . We evaluated the effect of dopamine infusion ( 5 & mgr;g/kg/min iv ) on the dynamics of prolactin , growth hormone , and thyrotropin secretion and on the thyroid axis in critically ill infants and children . Design : Prospect i ve , r and omized , controlled , open‐labeled , clinical study . Setting : Intensive care unit of a university hospital over a 9‐month period . Patients and Methods : The study population consisted of infants and children recovering from cardiovascular surgery . The group was stratified into two age groups ( infants aged 12 to 90 days [ n = 18 ] and children aged 0.3 to 6.7 yrs [ n = 15 ] ) and was studied dynamically ( blood sampling every 20 mins for 3 hrs ) on two consecutive days , after r and omization for dopamine withdrawal on the first or the second day . Serum prolactin , growth hormone , insulin‐like growth factor‐1 , thyrotropin , thyroxine ( T4 ) , triiodothyronine ( T3 ) , and reverse triiodothyronine ( reverse T3 ) concentrations were measured . Measurements and Main Results : In the newborns , dopamine was found to suppress prolactin , growth hormone , and thyrotropin secretion consistently , rebound releases starting within 20 mins after dopamine withdrawal . One day later , prolactin concentrations were ten times higher , pulsatile growth hormone secretion was augmented , thyrotropin was unchanged , but T3 was increased by 30 % and the T3/reverse T3 ratio was inverted . In the children , dopamine suppressed prolactin and thyrotropin ( but not growth hormone ) secretion , rebound releases starting within 20 mins after dopamine withdrawal . One day later , prolactin concentrations were at least twice as high , thyrotropin was increased ten‐fold , T4 was augmented by 14 % , T3 by 30 % and the T3/reverse T3 ratio had doubled . Neither in newborns nor in children did dopamine withdrawal appear to affect the low serum insulin‐like growth factor‐1 concentrations . Conclusions : The data indicate that dopamine infusion induces or aggravates partial hypopituitarism and the euthyroid sick syndrome in critically ill infants and children . ( Crit Care Med 1994 ; 22:1747–1753 We tested the hypothesis that the administration of recombinant human growth hormone ( rHGH ) and exercise would increase lean body mass ( LBM ) and muscle strength in burned children to a greater extent than rHGH or exercise separately . Children , ages 7 - 17 yr , with > 40 % body surface area burned , were r and omized into groups . One group ( GHEX , n = 10 ) participated in a 12-wk in-hospital physical rehabilitation program supplemented with an exercise program and received 0.05 mg . kg(-1 ) . day(-1 ) of rHGH . A second exercising group ( SALEX , n = 13 ) received saline . A third group ( GH , n = 10 ) received a similar dose of rHGH as GHEX and participated in a 12-wk , home-based physical rehabilitation program without exercise . The fourth group ( Saline , n = 11 ) received saline and participated in a 12-wk , home-based physical rehabilitation program without exercise . The mean ( + /-SE ) percent change in lean body mass after 12 wk was not significantly different between GHEX ( 9.0 + /- 2.1 % ) , SALEX ( 5.4 + /- 1.6 % ) , and GH ( 5.8 + /- 1.8 % ) groups ( P = 0.33 ) . However , the mean percent change in muscle strength was significantly greater in the GHEX ( 36.2 + /- 5.4 % ) and SALEX ( 42.6 + /- 10.0 % ) groups than in the GH ( -7.4 + /- 4.7 % ) or Saline ( 6.7 + /- 4.4 % ) groups ( P = 0.008 ) . In summary , rHGH GHEX , SALEX , and GH alone produced similar improvements in LBM . However , muscle strength was only increased via exercise BACKGROUND Recombinant human growth hormone ( rhGH ) has been shown to favorably modulate the acute-phase response and may improve the clinical outcome . OBJECTIVE To examine whether rhGH attenuates the elevated tumor necrosis factor alpha ( TNF-alpha ) levels that correlate with increased multiorgan failure and mortality in burned adults and children . DESIGN Twenty children with burns of greater than 40 % of the total body surface area were r and omly divided into 2 groups to receive placebo ( n = 10 ) or rhGH , 0.2 mg/kg per day intramuscularly ( n = 10 ) . SETTING Pediatric burn hospital . MAIN OUTCOME MEASURE Serum TNF-alpha levels by enzyme-linked immunoassay at baseline ( day 0 ) and at 21 and 42 days after injury . For statistical analysis , we used the Kruskal-Wallis and Friedman tests . RESULTS No significant differences in age ( mean + /- SD , 6.2+/-1.6 vs 5.0+/-1.2 years ) or percentage of total body surface area burn ( mean + /- SD , 65.1%+/-8.2 % vs 57.1%+/-5.2 % ) could be shown between the groups given rhGH and placebo . Baseline TNF-alpha levels were elevated from reference values in both groups . Twenty-one and 42 days after rhGH administration , serum TNF-alpha levels were significantly decreased from those at baseline ( P<.05 ) . No significant decrease in TNF-alpha levels was observed in the placebo group ( P = .5 ) . CONCLUSIONS Recombinant human growth hormone significantly lowers serum TNF-alpha levels after burn injury . This is consistent with the beneficial effect that rhGH has on the acute-phase response Objective To determine whether the beneficial effects of growth hormone persist throughout the prolonged hypermetabolic and hypercatabolic response to severe burn . Summary Background Data The hypermetabolic response to severe burn is associated with increased energy expenditure , insulin resistance , immunodeficiency , and whole body catabolism that persists for months after injury . Growth hormone is a potent anabolic agent and salutary modulator of posttraumatic metabolic responses . Methods Seventy-two severely burned children were enrolled in a placebo-controlled double-blind trial investigating the effects of growth hormone ( 0.05 mg/kg per day ) on muscle accretion and bone growth . Drug or placebo treatment began on discharge from the intensive care unit and continued for 1 year after burn . Total body weight , height , dual-energy x-ray absorptiometry , indirect calorimetry , and hormone values were measured at discharge , then at 6 months , 9 months , and 12 months after burn . Results were compared between groups . Results Growth hormone subjects gained more weight than placebo subjects at the 9-month study point ; this disparity in weight gain continued to exp and throughout the remainder of the study . Height also increased in the growth hormone group compared with controls at 12 months . Change in lean body mass was greater in those treated with growth hormone at 6 , 9 , and 12 months . Bone mineral content was increased at 9 and 12 months ; this was associated with higher parathormone levels . Conclusions Low-dose recombinant human growth hormone successfully abates muscle catabolism and osteopenia induced by severe burn The beneficial effects of growth hormone on wound healing in severely burned children were studied . Forty patients who were 2 to 18 years old , with 40 % or more total body surface area ( TBSA ) and 20 % or more TBSA full-thickness flame or scald burns , were r and omized in a double-blind study to receive placebo or 0.1 mg/kg/day recombinant human growth hormone ( rHGH ) until the first donor site healed or to receive 0.2 mg/kg/day rHGH or placebo from admission throughout hospitalization . Patients receiving 0.2 mg/kg/day rHGH demonstrated significantly higher serum IGF-1 levels at 4.8 + /- 1.7 U/mL compared to placebos at 1.6 + /- 0.4 U/mL ( p less than 0.05 ) and a significant decrease in donor-site healing times compared to placebo ( p less than 0.05 ) . Length of hospital stay ( LOS/%TBSA ) was decreased from 0.80 + /- 0.10 days/%TBSA burned in the placebo group to 0.54 + /- 0.04 days/%TBSA burned in the 0.2 mg/kg/day treatment group ( p less than 0.05 ) . This translates , for the average 60 % TBSA burned patient , to a decrease in LOS from 46 to 32 days Objectives To describe the sequential changes in the growth hormone (GH)/insulin-like growth factors axis and their relationship with nitrogen balance in children following cardiac surgery . Design Prospect i ve , descriptive study . Setting Pediatric intensive care unit of a university hospital . Patients Twenty three postoperative cardiac surgical patients after bypass . Interventions Blood and urine sample s were taken on days 1 , 2 , and 7 of pediatric intensive care unit admission . An intraanesthesia , presurgery sample was also obtained . Measurements and Main Results Serum concentrations of insulin , insulin growth factor-I ( IGF-I ) , insulin growth factor binding proteins 1 and 3 ( IGFBP-1 and IGFBP-3 ) , growth hormone binding protein ( GHBP ) , and urinary concentrations of GH and free cortisol ( UFC ) were measured on days 1 , 2 , and 7 of the study period . C-reactive protein and prealbumin , were also measured in blood sample s as conventional markers of inflammatory or nutritional status . Pediatric Risk of Mortality II score and UFC were used as indicators of acute stress . The nitrogen balance and urinary nitrogen urea excretion were used as markers of catabolic state . Urinary concentrations of GH were high from days 1 to 7 . Plasma concentrations of IGF-I and GHBP were low and remained low throughout the study period . IGFBP-3 levels were below normal but without reaching statistical significance . The IGFBP-1 levels were initially high but descended progressively toward normal values . Urinary nitrogen urea production was persistently elevated and was associated with a negative nitrogen balance . No relationship was found between nitrogen balance and IGF-I , prealbumin , or C-reactive protein . Conclusions A GH-resistant state is observed in postoperative children following cardiac surgery . Stress response is characterized by an elevation of growth hormone secretion that is not followed by the corresponding increment in IGF-I and IGFBP-3 concentrations . These hormonal changes may be permissive for the catabolic state of these patients . IGF-I and IGFBP-1 and -3 are not related to either nitrogen balance or urinary nitrogen urea excretion Very preterm infants developing bronchopulmonary dysplasia frequently show a compromised growth in the neonatal period especially when steroids are given to facilitate weaning from the ventilator . The aim of this study was to evaluate the short-term effect of dexamethasone ( DEXA ) on the GH-IGF axis in ventilated very preterm infants developing bronchopulmonary dysplasia . We studied 10 very preterm artificially ventilated infants with bronchopulmonary dysplasia [ median ( range ) gestational age 27.5 wk ( 25.9 - 32.0 wk ) , median ( range ) birth weight 970 g ( 610 - 2150 g ) ] immediately before and 2 d after the start of DEXA treatment . On both days of study , serum GH profiles were obtained , and serum IGF-I and IGF binding protein ( IGFBP ) −1 and −3 levels were measured . The ventilation score and the nutritional intake were calculated . Before the start of DEXA treatment , the median serum mean GH level was 12.0 μg/L ( 6 - 28.4 μg/L ) , whereas 2 d after the start of DEXA treatment the median serum mean GH level declined significantly to a value of 4.4 μg/L ( 1.7 - 11.9 μg/L ) . During DEXA treatment , mean , baseline , and maximal GH levels ( Pulsar analysis ) were significantly lower compared with pretreatment levels ( p < 0.01 , p < 0.01 , and p < 0.05 , respectively ) . Serum IGF-I and IGFBP-3 levels did not decline during DEXA . Serum IGFBP-1 levels were significantly lower compared with pretreatment levels ( p < 0.01 ) . Serum GH levels during DEXA treatment were correlated with neither the time interval between the administration of DEXA and the second GH profile nor the cumulative DEXA dose administered . Ventilation score and nutritional int
Output:
| RESULTS There were evidence s that rhGH in burned pediatric patients can reduce exogenous albumin requirement , with a improvement in Lean Body Mass , and accelerate site-donor wound healing , with no effects on mortality .
Possibly can reduce the length of hospital stay .
Hyperglycemia was the most frequently reported adverse event .
This review suggests that the early application of rhGH to st and ard treatment in pediatric severe burned patients has the potential to improve some aspects from outcome . |
MS211355 | ***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 determine the effects of stopping and restarting two types of exercise programs in older adults . DESIGN A controlled , longitudinal study that utilized r and om assignment of volunteers . Treatments were exercise programs design ed to improve cardiovascular or neuromuscular fitness . MEASUREMENTS Dependent variables measured before and after implementation of treatments were : maximum oxygen consumption , oxygen pulse , treadmill and cycle training workloads , quadriceps isokinetic peak torque , quadriceps isokinetic total work , and quadriceps training workload . MAIN RESULTS Exercise training was highly effective in improving cardiovascular endurance or muscular strength . Ten weeks of exercise detraining result ed in small losses in newly gained cardiovascular capacity but more noticeable losses in muscular strength . Exercise retraining was accomplished easily using cardiovascular or resistive exercises . The functional benefits of restarting a cardiovascular exercise program appeared additive despite a 10-week intervening period of exercise detraining . In this age group , cardiovascular exercise produced limited improvements in muscular strength , and resistive exercise training positively influenced cardiovascular exercise performance . CONCLUSIONS Older adults are fairly resilient to 10 weeks of cardiovascular detraining and retain newly gained muscular strength for at least 5 weeks , despite an interruption of formal exercise . An occasional missed exercise session or temporary cessation of habitual exercise should not be a cause for distress in exercising older adults . Instead , they should realize the case with which they may restart their exercise program and also appreciate the generalized fitness benefits that can be ascribed to becoming more active BACKGROUND Intensive exercise training can lead to improvement in strength and functional performance in older people living at home and nursing home residents . There is little information whether intensive physical exercise may be applicable and effective in elderly patients suffering from the acute sequelae of injurious falls or hip surgery . OBJECTIVE To assess the feasibility , safety and efficacy of intensive , progressive physical training in rehabilitation after hip surgery . DESIGN Prospect i ve , r and omised , placebo-controlled intervention study of a 3-months training intervention and a 3-months ' follow-up . SETTING Physical training 6 - 8 weeks after hip surgery . SUBJECTS Twenty-eight ( 15 intervention , 13 control ) elderly patients with a history of injurious falls admitted to acute care or inpatient rehabilitation because of acute fall-related hip fracture or elective hip replacement . METHODS Progressive resistance and functional training to improve strength and functional performance . RESULTS No training-related medical problems occurred in the study group . Twenty-four patients ( 86 % ) completed all assessment s during the intervention and follow-up period . Adherence was excellent in both groups ( intervention : 93 , 0+/-13 , 5 % versus control : 96 , 7+/-6 , 2 % ) . Training significantly increased strength , functional motor performance and balance and reduced fall-related behavioural and emotional problems . Some improvements in strength persisted during 3-months follow-up while other strength variables and functional performances were lost after cessation of training . Patients in the control group showed no change in strength , functional performance and emotional state during intervention and follow-up . CONCLUSIONS Progressive resistance training and progressive functional training are safe and effective methods to increase strength and functional performance during rehabilitation in patients after hip surgery and a history of injurious falls . Because part of the training improvements were lost after stopping the training , a continuing training regime should be established OBJECTIVE To determine clinical effectiveness of strength training in children with spastic cerebral palsy . DESIGN Prospect i ve before and after trial in which subjects participated in a 6-week strength training program . All received before and after isometric strength evaluation of eight muscle groups in both lower extremities with a h and -held dynamometer , 3-D gait analysis at free and fast speeds , administration of the Gross Motor Function Measure ( GMFM ) , and assessment of energy expenditure during gait . SETTING Pediatric rehabilitation center at a tertiary care hospital . PATIENTS Eleven children met inclusion criteria for participation . Six had spastic diplegia , were limited community ambulators , and demonstrated less than 50 % of normal muscle strength . Five had spastic hemiplegia and demonstrated a 20 % strength asymmetry in at least two muscles across extremities . RESULTS Each group had significant strength gains in the muscles targeted . The entire cohort had higher gait velocity primarily as a result of increased cadence , with greater capacity to walk faster . GMFM Dimension 5 also improved , with no change in energy expenditure . Asymmetry in strength improved in hemiplegia , with no change in asymmetry in support times or joint motion across extremities . CONCLUSIONS This study reinforced the relationship of strength to motor function in cerebral palsy and further demonstrated the effectiveness of strengthening in this population Background and Purpose — To evaluate the efficacy of supervised high-intensity progressive resistance training ( PRT ) on lower extremity strength , function , and disability in older , long-term stroke survivors . Methods — Forty-two volunteers aged 50 years and above , 6 months to 6 years after a single mild to moderate stroke , were r and omized into either a control group of upper extremity stretching or a PRT group that received a 12-week supervised high-intensity resistance training program consisting of bilateral leg press ( LP ) , unilateral paretic and nonparetic knee extension ( KE ) , ankle dorsiflexion ( DF ) , and plantarflexion ( PF ) exercises . Functional performance was assessed using the 6-minute walk , stair-climb time , repeated chair-rise time , and habitual and maximal gait velocities . Self-reported changes in function and disability were evaluated using the Late Life Function and Disability Instrument ( LLFDI ) . Results — Single-repetition maximum strength significantly improved in the PRT group for LP ( 16.2 % ) , paretic KE ( 31.4 % ) , and nonparetic KE ( 38.2 % ) with no change in the control group . Paretic ankle DF ( 66.7 % versus −24.0 % ) , paretic ankle PF ( 35.5 % versus −20.3 % ) , and nonparetic ankle PF ( 14.7 % versus −13.8 % ) significantly improved in the PRT group compared with the control . The PRT group showed significant improvement in self-reported function and disability with no change in the control . There was no significant difference between groups for any performance-based measure of function . Conclusions — High-intensity PRT improves both paretic and nonparetic lower extremity strength after stroke , and results in reductions in functional limitations and disability STUDY DESIGN A r and omized clinical trial . OBJECTIVES To examine the relative efficacy of three active therapies for chronic low back pain . SUMMARY OF BACKGROUND DATA There is much evidence documenting the efficacy of exercise in the conservative management of chronic low back pain , but many questions remain regarding its exact prescription and method of application . The most successful method must be identified to enable refinement of future rehabilitation programs to target the specific needs of the patient with chronic low back pain and the budget of the healthcare provider . METHODS One hundred forty-eight patients with chronic low back pain were r and omized to one of the following treatments , which they attended twice a week for 3 months : 1 ) modern active physiotherapy , 2 ) muscle reconditioning on training devices , or 3 ) low-impact aerobics . Pretherapy and posttherapy , objective measurements of lumbar mobility were performed , and question naires were administered inquiring about self-rated pain and disability , and psychosocial factors . Similar question naires were administered 6 months after therapy . The data were analyzed using the intention-to-treat principle . RESULTS Of the 148 patients , 16 ( 10.8 % ) dropped out of the therapy . One hundred thirty-seven question naires ( 93 % ) were available for analysis at all three time points . After therapy , significant reductions were observed in pain intensity , frequency , and disability ; Fear-Avoidance Beliefs about physical activity ( FABQactivity ) ; and " praying/hoping , " " catastrophizing , " and " pain behavior " coping strategies -- each with no group differences in the extent of the response . These effects were maintained over the subsequent 6 months , with the exception of disability and FABQactivity for the physiotherapy group . There were small but significant posttherapy increases in lumbar mobility , with aerobics and devices showing a greater response than physiotherapy . CONCLUSION The general lack of treatment specificity suggests that the main effects of the therapies were educed not through the reversal of physical weaknesses targeted by the corresponding exercise modality , but rather through some " central " effect , perhaps involving an adjustment of perception in relation to pain and disability . The direct costs associated with administering physiotherapy were three times as great , and devices four times as great , as those for aerobics . Administration of aerobics as an efficacious therapy for chronic low back pain has the potential to relieve some of the huge financial burden associated with the condition OBJECTIVE To test the effects of a high intensity home-based progressive strength training program on the clinical signs and symptoms of osteoarthritis ( OA ) of the knee . METHODS Forty-six community dwelling patients , aged 55 years or older with knee pain and radiographic evidence of knee OA , were r and omized to a 4 month home based progressive strength training program or a nutrition education program ( attention control ) . Thirty-eight patients completed the trial with an adherence of 84 % to the intervention and 65 % to the attention control . The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis ( WOMAC ) index pain and physical function subscales . Secondary outcomes included clinical knee examination , muscle strength , physical performance measures , and question naires to measure quality of life variables . RESULTS Patients in the strength training group who completed the trial had a 71 % improvement in knee extension strength in the leg reported as most painful versus a 3 % improvement in the control group ( p < 0.01 ) . In a modified intent to treat analysis , self-reported pain improved by 36 % and physical function by 38 % in the strength training group versus 11 and 21 % , respectively , in the control group ( p = 0.01 for between group comparison ) . In addition , those patients in the strength training group who completed the trial had a 43 % mean reduction in pain ( p = 0.01 vs controls ) , a 44 % mean improvement in self-reported physical function ( p < 0.01 vs controls ) , and improvements in physical performance , quality of life , and self-efficacy when compared to the control group . CONCLUSION High intensity , home based strength training can produce substantial improvements in strength , pain , physical function and quality of life in patients with knee OA Bourbonnais D , Bilodeau S , Lepage Y , Beaudoin N , Gravel D , Forget R : Effect of force-feedback treatments in patients with chronic motor deficits after a stroke . Am J Phys Med Rehabil 2002;81:890–897 . Objective To assess the effects a motor reeducation approach based on static dynamometers used to provide feedback on the force produced . Design The study design was a single-blind , r and omized , controlled trial . Chronic stroke subjects participated in a 6-wk , thrice-weekly , force-feedback program of either the upper paretic limb ( n = 13 ) or the lower paretic limb ( n = 12 ) . Baseline and postintervention assessment s of the performance of both the upper and the lower limb were measured for each subject , the untreated paretic limb of each group serving as a control for the other group . Results With the exception of the h and grip force , strength measurements of the treated limb increased after completion of the treatment . The outcome measurements of the upper limb of the subjects included in the upper paretic limb were not significantly different after treatment from those measured in the lower paretic limb . In contrast , gait velocity and the distance walked in 2 min increased after treatment in the lower paretic limb as compared with the upper paretic limb , whereas the scores in the Fugl-Meyer test for the lower limb and the timed up- and -go test did not increase for either group after treatment . Conclusion The results indicate that treatment of the lower limb based on force feedback produces an improvement of gait velocity PURPOSE Pulmonary rehabilitation programs are effective in patients with severe chronic obstructive pulmonary disease ( COPD ) in the short term , but their long-term effects are not known . We investigated the short- and long-term effects of a 6-month outpatient rehabilitation program in patients with severe COPD . SUBJECTS AND METHODS One hundred patients were r and omly assigned to receive either an exercise training program that included cycling , walking , and strength training ( n = 50 ) or usual medical care ( n = 50 ) . Thirty-four patients in the training group were evaluated after 6 months ( end of training ) , and 26 were evaluated after 18 months of follow-up . In the control group , 28 patients were evaluated at 6 months and 23 after 18 months . We measured pulmonary function , 6-minute walking distance , maximal exercise capacity , peripheral and respiratory muscle strength , and quality of life ( on a 20 to 140-point scale ) , and estimated the cost-effectiveness of the program . RESULTS At 6 months , the training group showed improvement in 6-minute walking distance [ mean difference ( training - control ) of 52 m ; 95 % confidence interval ( CI ) , 15 to 89 m ] , maximal work load ( 12 W ; 95 % CI , 6 to 19 W ) , maximal oxygen uptake ( 0.26 liters/min ; 95 % CI , 0.07 to 0.45 liters/min ) , quadriceps force ( 18 Nm ; 95 % CI , 7
Output:
| Across conditions , PRE was shown to improve the ability to generate force , with moderate to large effect sizes that may carry over into an improved ability to perform daily activities . |
MS211356 | ***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: Women who exchange sex for money or other goods , that is , female sex workers , are at increased risk of experiencing physical and sexual violence from both paying and intimate partners . Exposure to violence can be exacerbated by alcohol use and HIV/STI risk . The purpose of this study is to examine the efficacy of a HIV/STI risk reduction and enhanced HIV/STI risk reduction intervention at decreasing paying and intimate partner violence against Mongolian women who exchange sex and engage in harmful alcohol use . Women are recruited and r and omized to either ( a ) four sessions of a relationship-based HIV/STI risk reduction intervention ( n = 49 ) , ( b ) the same HIV/STI risk reduction intervention plus two additional motivational interviewing sessions ( n = 58 ) , or ( c ) a four session control condition focused on wellness promotion ( n = 59 ) . All the respondents complete assessment s at baseline ( preintervention ) as well as at immediate posttest , 3 and 6 months postintervention . A multilevel logistic model finds that women who participated in the HIV/STI risk reduction group ( OR = 0.14 , p < .00 ) , HIV/STI risk reduction and motivational interview group ( OR = 0.46 , p = .02 ) , and wellness ( OR = 0.20 , p < .00 ) group reduced their exposure to physical and sexual violence in the past 90 days . No significant differences in effects are observed between conditions . This study demonstrates the efficacy of a relationship-based HIV/STI risk reduction intervention , a relationship-based HIV/STI risk reduction intervention combined with motivational interviewing , and a wellness promotion intervention in reducing intimate and paying partner violence against women who exchange sex in Mongolia . The findings have significant implication s for the impact of minimal intervention and the potential role of peer networks and social support in reducing women ’s experiences of violence in re source poor setting Summary Background Although structured psychological treatments are recommended as first-line interventions for depression , only a small fraction of people globally receive these treatments because of poor access in routine primary care . We assessed the effectiveness and cost-effectiveness of a brief psychological treatment ( Healthy Activity Program [ HAP ] ) for delivery by lay counsellors to patients with moderately severe to severe depression in primary health-care setting s. Methods In this r and omised controlled trial , we recruited participants aged 18–65 years scoring more than 14 on the Patient Health Question naire 9 ( PHQ-9 ) indicating moderately severe to severe depression from ten primary health centres in Goa , India . Pregnant women or patients who needed urgent medical attention or were unable to communicate clearly were not eligible . Participants were r and omly allocated ( 1:1 ) to enhanced usual care ( EUC ) alone or EUC combined with HAP in r and omly sized blocks ( block size four to six [ two to four for men ] ) , stratified by primary health centre and sex , and allocation was concealed with use of sequential numbered opaque envelopes . Physicians providing EUC were masked . Primary outcomes were depression symptom severity on the Beck Depression Inventory version II and remission from depression ( PHQ-9 score of < 10 ) at 3 months in the intention-to-treat population , assessed by masked field research ers . Secondary outcomes were disability , days unable to work , behavioural activation , suicidal thoughts or attempts , intimate partner violence , and re source use and costs of illness . We assessed serious adverse events in the per- protocol population . This trial is registered with the IS RCT N registry , number IS RCT N95149997 . Findings Between Oct 28 , 2013 , and July 29 , 2015 , we enrolled and r and omly allocated 495 participants ( 247 [ 50 % ] to the EUC plus HAP group [ two of whom were subsequently excluded because of protocol violations ] and 248 [ 50 % ] to the EUC alone group ) , of whom 466 ( 95 % ) completed the 3 month primary outcome assessment ( 230 [ 49 % ] in the EUC plus HAP group and 236 [ 51 % ] in the EUC alone group ) . Participants in the EUC plus HAP group had significantly lower symptom severity ( Beck Depression Inventory version II in EUC plus HAP group 19·99 [ SD 15·70 ] vs 27·52 [ 13·26 ] in EUC alone group ; adjusted mean difference −7·57 [ 95 % CI −10·27 to −4·86 ] ; p<0·0001 ) and higher remission ( 147 [ 64 % ] of 230 had a PHQ-9 score of < 10 in the HAP plus EUC group vs 91 [ 39 % ] of 236 in the EUC alone group ; adjusted prevalence ratio 1·61 [ 1·34–1·93 ] ) than did those in the EUC alone group . EUC plus HAP showed better results than did EUC alone for the secondary outcomes of disability ( adjusted mean difference −2·73 [ –4·39 to −1·06 ] ; p=0·001 ) , days out of work ( −2·29 [ –3·84 to −0·73 ] ; p=0·004 ) , intimate partner physical violence in women ( 0·53 [ 0·29–0·96 ] ; p=0·04 ) , behavioural activation ( 2·17 [ 1·34–3·00 ] ; p<0·0001 ) , and suicidal thoughts or attempts ( 0·61 [ 0·45–0·83 ] ; p=0·001 ) . The incremental cost per quality -adjusted life-year gained was $ 9333 ( 95 % CI 3862–28 169 ; 2015 international dollars ) , with an 87 % chance of being cost-effective in the study setting . Serious adverse events were infrequent and similar between groups ( nine [ 4 % ] in the EUC plus HAP group vs ten [ 4 % ] in the EUC alone group ; p=1·00 ) . Interpretation HAP delivered by lay counsellors plus EUC was better than EUC alone was for patients with moderately severe to severe depression in routine primary care in Goa , India . HAP was readily accepted by this previously untreated population and was cost-effective in this setting . HAP could be a key strategy to reduce the treatment gap for depressive disorders , the leading mental health disorder worldwide . Funding Wellcome Trust Background The Healthy Activity Programme ( HAP ) , a brief behavioural intervention delivered by lay counsellors , enhanced remission over 3 months among primary care attendees with depression in peri-urban and rural setting s in India . We evaluated the sustainability of the effects after treatment termination , the cost-effectiveness of HAP over 12 months , and the effects of the hypothesized mediator of activation on clinical outcomes . Methods and findings Primary care attendees aged 18–65 years screened with moderately severe to severe depression on the Patient Health Question naire 9 ( PHQ-9 ) were r and omised to either HAP plus enhanced usual care ( EUC ) ( n = 247 ) or EUC alone ( n = 248 ) , of whom 95 % completed assessment s at 3 months , and 91 % at 12 months . Primary outcomes were severity on the Beck Depression Inventory – II ( BDI-II ) and remission on the PHQ-9 . HAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up ( difference in mean BDI-II score between 3 and 12 months = −0.34 ; 95 % CI −2.37 , 1.69 ; p = 0.74 ) , with lower symptom severity scores than participants who received EUC alone ( adjusted mean difference in BDI-II score = −4.45 ; 95 % CI −7.26 , −1.63 ; p = 0.002 ) and higher rates of remission ( adjusted prevalence ratio [ aPR ] = 1.36 ; 95 % CI 1.15 , 1.61 ; p < 0.009 ) . They also fared better on most secondary outcomes , including recovery ( aPR = 1.98 ; 95 % CI 1.29 , 3.03 ; p = 0.002 ) , any response over time ( aPR = 1.45 ; 95 % CI 1.27 , 1.66 ; p < 0.001 ) , higher likelihood of reporting a minimal clinical ly important difference ( aPR = 1.42 ; 95 % CI 1.17 , 1.71 ; p < 0.001 ) , and lower likelihood of reporting suicidal behaviour ( aPR = 0.71 ; 95 % CI 0.51 , 1.01 ; p = 0.06 ) . HAP plus EUC also had a marginal effect on WHO Disability Assessment Schedule score at 12 months ( aPR = −1.58 ; 95 % CI −3.33 , 0.17 ; p = 0.08 ) ; other outcomes ( days unable to work , intimate partner violence toward females ) did not statistically significantly differ between the two arms . Economic analyses indicated that HAP plus EUC was dominant over EUC alone , with lower costs and better outcomes ; uncertainty analysis showed that from this health system perspective there was a 95 % chance of HAP being cost-effective , given a willingness to pay threshold of Intl$16,060—equivalent to GDP per capita in Goa — per quality -adjusted life year gained . Patient-reported behavioural activation level at 3 months mediated the effect of the HAP intervention on the 12-month depression score ( β = −2.62 ; 95 % CI −3.28 , −1.97 ; p < 0.001 ) . Serious adverse events were infrequent , and prevalence was similar by arm . We were unable to assess possible episodes of remission and relapse that may have occurred between our outcome assessment time points of 3 and 12 months after r and omisation . We did not account for or evaluate the effect of mediators other than behavioural activation . Conclusions HAP ’s superiority over EUC at the end of treatment was largely stable over time and was mediated by patient activation . HAP provides better outcomes at lower costs from a perspective covering publicly funded healthcare services and productivity impacts on patients and their families . Trial registration IS RCT N registry IS RCT Background Violence against women and girls ( VAWG ) is an urgent global health problem . Root causes for VAWG include the individual- and family-level factors of alcohol abuse , mental health problems , violence exposure , and related adverse experiences . Few studies in low- and middle-income countries ( LMIC ) have assessed the effectiveness of psychological interventions for reducing VAWG . This r and omized controlled trial , part of the What Works to Prevent Violence Against Women and Girls consortium , examines the effectiveness of a common elements treatment approach ( CETA ) for reducing VAWG and comorbid alcohol abuse among families in Zambia . Methods / design Study participants are families consisting of three persons : an adult woman , her male husb and or partner , and one of her children aged 8–17 ( if available ) . Eligibility criteria include experience of moderate-to-severe intimate partner violence by the woman and hazardous alcohol use by her male partner . Family units are r and omized to receive CETA or treatment as usual . The primary outcome is VAWG as measured by the Severity of Violence Against Women Scale , assessed along with secondary outcomes at 24 months post-baseline . Interim assessment s are also conducted at 4–5 months ( following CETA completion ) and 12 months post-baseline . Conclusions This ongoing trial is one of the first in sub-Saharan Africa to evaluate the use of an evidence -based common elements approach for reducing VAWG by targeting a range of individual- and family-level factors , including alcohol abuse . Results of this trial will inform policy on what interventions work to prevent VAWG in LMIC with local perspectives on scale up and wider implementation Background Counselling for Alcohol Problems ( CAP ) , a brief intervention delivered by lay counsellors , enhanced remission and abstinence over 3 months among male primary care attendees with harmful drinking in a setting in India . We evaluated the sustainability of the effects after treatment termination , the cost-effectiveness of CAP over 12 months , and the effects of the hypothesized mediator ‘ readiness to change ’ on clinical outcomes . Methods and findings Male primary care attendees aged 18–65 years screening with harmful drinking on the Alcohol Use Disorders Identification Test ( AUDIT ) were r and omised to either CAP plus enhanced usual care ( EUC ) ( n = 188 ) or EUC alone ( n = 189 ) , of whom 89 % completed assessment s at 3 months , and 84 % at 12 months . Primary outcomes were remission and mean st and ard ethanol consumed in the past 14 days , and the proposed mediating variable was readiness to change at 3 months . CAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up , with the proportion with remission ( AUDIT score < 8 : 54.3 % versus 31.9 % ; adjusted prevalence ratio [ aPR ] 1.71 [ 95 % CI 1.32 , 2.22 ] ; p < 0.001 ) and abstinence in the past 14 days ( 45.1 % versus 26.4 % ; adjusted odds ratio 1.92 [ 95 % CI 1.19 , 3.10 ] ; p = 0.008 ) being significantly higher in the CAP plus EUC arm than in the EUC alone arm
Output:
| The dedicated mental health treatments targeting depression or alcohol misuse consistently reduced levels of these outcomes .
In contrast to the dedicated mental health interventions , the integrated interventions did not consistently reduce mental ill health or alcohol misuse compared to control conditions .
Conclusions Too few studies have been conducted to judge whether mental health treatments may provide a beneficial strategy to prevent or reduce IPV in LMIC . |
MS211357 | ***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 This study was design ed to define more completely the clinical spectrum and consequences of stress cardiomyopathy ( SC ) beyond the acute event . BACKGROUND Stress cardiomyopathy is a recently recognized condition characterized by transient cardiac dysfunction with ventricular ballooning . METHODS Clinical profile and outcome were prospect ively assessed in 136 consecutive SC patients . RESULTS Patients were predominantly women ( n = 130 ; 96 % ) , but 6 were men ( 4 % ) . Ages were 32 to 94 years ( mean age 68 + /- 13 years ) ; 13 ( 10 % ) were < or=50 years of age . In 121 patients ( 89 % ) , SC was precipitated by intensely stressful emotional ( n = 64 ) or physical ( n = 57 ) events , including 22 associated with sympathomimetic drugs or medical/surgical procedures ; 15 other patients ( 11 % ) had no evident stress trigger . Twenty-five patients ( 18 % ) were taking beta-blockers at the time of SC events . Three diverse ventricular contraction patterns were defined by cardiovascular magnetic resonance ( CMR ) imaging , usually with rapid return to normal systolic function , although delayed > 2 months in 5 % . Right and /or left ventricular thrombi were identified in 5 patients ( predominantly by CMR imaging ) , including 2 with embolic events . Three patients ( 2 % ) died in-hospital and 116 ( 85 % ) have survived , including 5 % with nonfatal recurrent SC events . All-cause mortality during follow-up exceeded a matched general population ( p = 0.016 ) with most deaths occurring in the first year . CONCLUSIONS In this large SC cohort , the clinical spectrum was heterogeneous with about one-third either male , < or=50 years of age , without a stress trigger , or with in-hospital death , nonfatal recurrence , embolic stroke , or delayed normalization of ejection fraction . Beta-blocking drugs were not absolutely protective and SC was a marker for increased noncardiac mortality . These data support exp and ed management and surveillance strategies including CMR imaging and consideration for anticoagulation OBJECTIVE To compare left ventricular ( LV ) systolic and diastolic function in patients with apical ballooning syndrome ( ABS ) and those with acute myocardial infa rct ion ( AMI ) using 2-dimensional Doppler echocardiography and strain rate imaging ( SRI ) . PATIENTS AND METHODS We prospect ively enrolled patients with newly diagnosed AMI and ABS who had akinetic apical walls . Both 2-dimensional Doppler echocardiography and SRI were performed on hospital day 1 or within 24 hours of primary percutaneous coronary intervention . RESULTS Twenty-four patients with AMI and 13 patients with ABS ( mean + /- SD age , 63+/-15 vs 73+/-12 years ; P=.03 ) were prospect ively enrolled in the study from October 3 , 2005 through July 12 , 2006 . The mean + /- SD LV end-diastolic volume was larger ( 58.1+/-9.1 vs 45.2+/-10.6 mL/m(2 ) ; P<.001 ) and the mean + /- SD LV ejection fraction was lower ( 35%+/-6 % vs 43%+/-9 % ; P=.006 ) in patients with ABS compared with patients with AMI . The early diastolic mitral annular velocity was similar ( 0.06+/-0.02 vs 0.06+/-0.02 m/s ; P=.85 ) in both groups , but the ratio of early diastolic mitral valve inflow velocity to early diastolic mitral annulus velocity was higher in patients with AMI than in patients with ABS ( 16.3+/-6.9 vs 12.2+/-3.2 ; P=.05 ) . The systolic strain rate was decreased at the apex in both groups ( P=.98 ) . Both the early diastolic strain rate of the apex ( 0.64+/-0.24 vs 0.48+/-0.30 s(-1 ) ; P=.04 ) and the postsystolic shortening index of the apex ( 61%+/-15 % vs 45%+/-23 % ; P=.006 ) were higher in the patients with ABS than in those with AMI . However , early diastolic SR was higher in the akinetic apical walls of patients with AMI with recovery than those with no recovery ( 0.64+/-0.35 vs 0.43+/-0.25 s(-1 ) ; P=.04 ) and was similar between akinetic apical walls of patients with AMI with recovery and the akinetic apical walls of ABS . CONCLUSION Compared with patients with AMI , those with ABS showed the functional paradox of worse initial LV systolic function with larger LV size but better LV diastolic function . The early systolic strain rate and postsystolic shortening were greater in patients with ABS than in those with AMI ; hence , these measurements can be helpful in distinguishing ABS from AMI and in detecting myocardial viability Objectives : To determine the incidence , clinical characteristics , and the coronary angiographic features of patients with apical ballooning syndrome ( ABS ) among those recruited into a large , prospect i ve , international , multicenter trial . Background : ABS is an important entity in the differential diagnosis of ST‐elevation myocardial infa rct ion ( STEMI ) . Current data regarding ABS are limited to single center registries . Methods : Patients with ABS were identified , based on the Mayo Clinic diagnostic criteria , from those enrolled into the HORIZONS‐AMI trial . Quantitative angiography was performed by a core laboratory to identify the frequency and severity of coronary artery disease . Results : Among the 2,648 patients who had left ventriculography in addition to coronary angiography , 12 patients were identified with ABS . All patients were female and they were compared to the remaining 571 female patients with STEMI . Compared with patients with STEMI ( 97.9 % of our cohort ) , patients with ABS ( 2.1 % ) had a lower prevalence ( 42 % vs. 100 % , P < 0.05 ) and severity ( number of plaques measuring > 30 % diameter stenosis per patient : 0.58 ± 0.90 vs. 4.13 ± 2.68 , P < 0.0001 ) of coronary artery disease . There were no in‐hospital deaths or major adverse cardiovascular events ( MACE ) in the ABS group vs. 2.1 % and 3.7 % respectively in the STEMI group , nor at 2‐year follow up ( death : 0 % vs. 5.5 % , MACE : 0 % vs. 19.4 % ) , but these differences were not statistically significant . Conclusions : In HORIZONS‐AMI , ABS was identified exclusively in women ( 2.1 % of female patients , 0.5 % of all patients ) and MACE were absent in this uncommon but important group of patients . Coronary artery disease was often present in patients with ABS , but its prevalence and severity was significantly less compared with STEMI patients . © 2011 Wiley Periodicals , AIMS Typical tako-tsubo cardiomyopathy ( TTC ) mimics acute anterior myocardial infa rct ion ( AMI ) and the differential diagnosis is challenging before coronary angiography ( CA ) is performed ; it demonstrates reduced or absent ante grade flow in the left anterior descending artery ( LAD ) in AMI , whereas there is no such flow limiting in TTC . At the acute phase , we tested the usefulness of the distal LAD flow visualization by transthoracic Doppler echocardiography ( TDE ) to distinguish between these two diseases . For this purpose , we prospect ively enrolled 28 consecutive patients with TTC ( 75 ± 10 years , 93 % females ) who were compared with 28 consecutive patients with AMI treated successfully by primary angioplasty ( 66 ± 12 years , 79 % females ) . All the patients underwent the assessment of the distal LAD flow just before CA , using colour and pulsed-wave TDE . In addition , the symmetric involvement of wall motion abnormalities ( WMAs ) based on the extent of the disease far beyond one coronary territory in TTC was search ed by TDE . Non-invasive coronary flow reserve ( CFR ) by TDE , in the distal LAD , was also performed within 1 day after admission . RESULTS Before CA , the distal LAD flow was visible in 38 of 56 cases ( 68 % ) in the whole population , in all cases with TTC and in 10 cases with AMI ( 36 % ) . The sensitivity ( Se ) and specificity ( Sp ) of the LAD flow visualization for the diagnosis of TTC were 100 and 64 % , respectively , with a diagnostic accuracy of 82 % . In comparison , the pattern of WMA yielded a Se of 75 % and Sp of 86 % , and a diagnostic accuracy of 80 % . With the combination of both tools , the Se and Sp to detect TTC were 75 and 96 % respectively , with a diagnostic accuracy of 86 % . After CA , the acute CFR was less severely impaired in the TTC group when compared with the AMI group ( 2.2 ± 0.5 vs. 1.7 ± 0.6 , P < 0.01 ) despite a worse LV systolic dysfunction . CONCLUSION Non-invasive evaluation of the distal LAD flow could be helpful to differentiate TTC from AMI , and its combination with the pattern of WMA improved slightly its diagnostic accuracy . Furthermore , the acute CFR is less severely impaired in TTC compared with AMI despite poorer LV systolic dysfunction , suggesting that other mechanisms than direct microcirculatory damage are also involved in the pathogenesis of WMAs in TTC BACKGROUND Although the relationship between malignancies and catecholamine-induced myocardial stunning remains largely speculative , it has been suggested that the presence of cancer may lower the threshold for stress stimuli and /or may aggravate cardiac adrenoreceptor sensitivity . We sought to investigate whether associations exist between a previous or current diagnosis of malignancy , diagnostic parameters during hospitalization and death in takotsubo . METHODS AND RESULTS The 154 takotsubo patients were retrospectively identified between May 2008 and December 2014 . Previous history of malignancy was identified in 44 patients ( 28.5 % ) . Cardiac arrest was present at admission in 13 patients ( 8.4 % ) . Intra-aortic balloon pump was inserted in 16 patients ( 10.4 % ) . In patients with malignancy , higher B-type natriuretic peptide ( BNP ) , leukocyte and C-reactive protein ( CRP ) peaks could be observed during the hospital phase . Initial impairment of left ventricular ejection fraction was negatively related to BNP , leukocyte , and CRP peaks . At a median follow-up of 364 days , all-cause death occurred in 41 patients ( 26.6 % ) and cardiac death in 12 patients ( 7.7 % ) . Multivariate Cox regression analysis identified malignancy ( hazard ratio 4.77 ( 1.02 - 22.17 ) , leukocyte peak and age as independent predictors of cardiac death . Malignancy ( 2.62 ( 1.26 - 5.44 ) , leukocyte peak ( 1.05 ( 1.01 - 1.08 ) and initial cardiac arrest ( 6.68 ( 2.47 - 18.01 ) were identified as independent predictors of overall mortality . CONCLUSIONS In the present takotsubo patients , the prevalence of malignancy was high and may have affected cardiovascular outcomes through the activation of inflammatory and neurohormonal mechanisms . ( Circ J 2016 ; 80 : 2192 - 2198 ) Objective Takotsubo syndrome ( TS ) mimics acute coronary syndrome ( ACS ) but has a distinct pathophysiology . While in-hospital adverse outcomes appear similar to those presenting with an ACS , data on longer term postdischarge risk are conflicting . This study sought to assess the long-term prognosis of patients discharged alive after TS . Methods The clinical profile and in-hospital and long-term outcomes were prospect ively assessed in consecutive patients with TS . Survival in patients with TS was compared with two representative age-matched and gender-matched comparison cohorts : a hospitalised ACS cohort and a community cohort without known cardiovascular disease ( CVD ) . Results Two hundred and -twenty-five patients with TS ( 216 women , mean age 63.7±11.8 years ) were included . In-hospital mortality was 1.8 % and 1.9 % for patients with TS and ACS , respectively . Of the 219 patients with TS with postdischarge follow-up , at a mean follow-up of 4.8±3.2 years , there were 19 ( 8.3 % ) deaths , 18 of which were from non-cardiac causes . When compared with the cohort without prior CVD , postdischarge patients with TS were at increased mortality risk ( HR 2.00 , 95 % CI 1.26 to 3.17 , p=0.003 ) , but mortality in postdisch
Output:
| In conclusion , TTS has significantly different clinical characteristics than ACS .
However , the in-hospital and long-term overall mortality rates are not trivial for TTS patients , and some presenting features ( underlying diseases , male sex , advanced age , low LVEF and shock ) were significantly associated with all-cause mortality |
MS211358 | ***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 Susceptibility variants identified by genome-wide association studies ( GWAS ) have modest effect sizes . Whether such variants provide incremental information in assessing risk for common ' complex ' diseases is unclear . We investigated whether measured and imputed genotypes from a GWAS data set linked to the electronic medical record alter estimates of coronary heart disease ( CHD ) risk . Methods Study participants ( n = 1243 ) had no known cardiovascular disease and were considered to be at high , intermediate , or low 10-year risk of CHD based on the Framingham risk score ( FRS ) which includes age , sex , total and HDL cholesterol , blood pressure , diabetes , and smoking status . Of twelve SNPs identified in prior GWAS to be associated with CHD , four were genotyped in the participants as part of a GWAS . Genotypes for seven SNPs were imputed from HapMap CEU population using the program MACH . We calculated a multiplex genetic risk score for each patient based on the odds ratios of the susceptibility SNPs and incorporated this into the FRS . Results The mean ( SD ) number of risk alleles was 12.31 ( 1.95 ) , range 6 - 18 . The mean ( SD ) of the weighted genetic risk score was 12.64 ( 2.05 ) , range 5.75 - 18.20 . The CHD genetic risk score was not correlated with the FRS ( P = 0.78 ) . After incorporating the genetic risk score into the FRS , a total of 380 individuals ( 30.6 % ) were reclassified into higher-(188 ) or lower-risk groups ( 192 ) . Conclusion A genetic risk score based on measured/imputed genotypes at 11 susceptibility SNPs , led to significant reclassification in the 10-y CHD risk categories . Additional prospect i ve studies are needed to assess accuracy and clinical utility of such reclassification BACKGROUND Both genetic and lifestyle factors contribute to individual-level risk of coronary artery disease . The extent to which increased genetic risk can be offset by a healthy lifestyle is unknown . METHODS Using a polygenic score of DNA sequence polymorphisms , we quantified genetic risk for coronary artery disease in three prospect i ve cohorts - 7814 participants in the Atherosclerosis Risk in Communities ( ARIC ) study , 21,222 in the Women 's Genome Health Study ( WGHS ) , and 22,389 in the Malmö Diet and Cancer Study ( MDCS ) - and in 4260 participants in the cross-sectional BioImage Study for whom genotype and covariate data were available . We also determined adherence to a healthy lifestyle among the participants using a scoring system consisting of four factors : no current smoking , no obesity , regular physical activity , and a healthy diet . RESULTS The relative risk of incident coronary events was 91 % higher among participants at high genetic risk ( top quintile of polygenic scores ) than among those at low genetic risk ( bottom quintile of polygenic scores ) ( hazard ratio , 1.91 ; 95 % confidence interval [ CI ] , 1.75 to 2.09 ) . A favorable lifestyle ( defined as at least three of the four healthy lifestyle factors ) was associated with a substantially lower risk of coronary events than an unfavorable lifestyle ( defined as no or only one healthy lifestyle factor ) , regardless of the genetic risk category . Among participants at high genetic risk , a favorable lifestyle was associated with a 46 % lower relative risk of coronary events than an unfavorable lifestyle ( hazard ratio , 0.54 ; 95 % CI , 0.47 to 0.63 ) . This finding corresponded to a reduction in the st and ardized 10-year incidence of coronary events from 10.7 % for an unfavorable lifestyle to 5.1 % for a favorable lifestyle in ARIC , from 4.6 % to 2.0 % in WGHS , and from 8.2 % to 5.3 % in MDCS . In the BioImage Study , a favorable lifestyle was associated with significantly less coronary-artery calcification within each genetic risk category . CONCLUSIONS Across four studies involving 55,685 participants , genetic and lifestyle factors were independently associated with susceptibility to coronary artery disease . Among participants at high genetic risk , a favorable lifestyle was associated with a nearly 50 % lower relative risk of coronary artery disease than was an unfavorable lifestyle . ( Funded by the National Institutes of Health and others . ) BACKGROUND Effective medical therapies are lacking for the treatment of neurofibromatosis type 1-related plexiform neurofibromas , which are characterized by elevated RAS-mitogen-activated protein kinase ( MAPK ) signaling . METHODS We conducted a phase 1 trial of selumetinib ( AZD6244 or ARRY-142886 ) , an oral selective inhibitor of MAPK kinase ( MEK ) 1 and 2 , in children who had neurofibromatosis type 1 and inoperable plexiform neurofibromas to determine the maximum tolerated dose and to evaluate plasma pharmacokinetics . Selumetinib was administered twice daily at a dose of 20 to 30 mg per square meter of body-surface area on a continuous dosing schedule ( in 28-day cycles ) . We also tested selumetinib using a mouse model of neurofibromatosis type 1-related neurofibroma . Response to treatment ( i.e. , an increase or decrease from baseline in the volume of plexiform neurofibromas ) was monitored by using volumetric magnetic resonance imaging analysis to measure the change in size of the plexiform neurofibroma . RESULTS A total of 24 children ( median age , 10.9 years ; range , 3.0 to 18.5 ) with a median tumor volume of 1205 ml ( range , 29 to 8744 ) received selumetinib . Patients were able to receive selumetinib on a long-term basis ; the median number of cycles was 30 ( range , 6 to 56 ) . The maximum tolerated dose was 25 mg per square meter ( approximately 60 % of the recommended adult dose ) . The most common toxic effects associated with selumetinib included acneiform rash , gastrointestinal effects , and asymptomatic creatine kinase elevation . The results of pharmacokinetic evaluations of selumetinib among the children in this trial were similar to those published for adults . Treatment with selumetinib result ed in confirmed partial responses ( tumor volume decreases from baseline of ≥20 % ) in 17 of the 24 children ( 71 % ) and decreases from baseline in neurofibroma volume in 12 of 18 mice ( 67 % ) . Disease progression ( tumor volume increase from baseline of ≥20 % ) has not been observed to date . Anecdotal evidence of decreases in tumor-related pain , disfigurement , and functional impairment was observed . CONCLUSIONS Our early-phase data suggested that children with neurofibromatosis type 1 and inoperable plexiform neurofibromas benefited from long-term dose-adjusted treatment with selumetinib without having excess toxic effects . ( Funded by the National Institutes of Health and others ; Clinical Trials.gov number , NCT01362803 . ) IMPORTANCE The use of mitogen-activated protein kinase ( MAPK ) kinase ( MEK ) inhibitors has become more common in the treatment of systemic cancer . These agents have been associated with a central serous-like retinopathy in some patients . Recognition of such retinal findings and the relatively benign nature of these events is important to avoid unnecessary intervention , including the cessation of a potentially life-prolonging medication . OBJECTIVES To evaluate the presence and characteristics of subretinal fluid ( SRF ) associated with the use of MEK inhibitors in the treatment of systemic cancer and to correlate the presence of SRF with visual acuity and symptoms over time . DESIGN , SETTING , AND PARTICIPANTS Post hoc analysis was conducted of prospect ively collected data from 51 patients with locally advanced or metastatic cancer undergoing treatment with the MEK inhibitor binimetinib in 1 of 4 clinical trials . All clinical trial participants underwent complete ophthalmic examination by retina specialists at a private practice in Boston , Massachusetts , and were monitored between February 29 , 2012 , and January 8 , 2014 . The examination included Snellen-measured visual acuity , dilated fundus examination , and spectral-domain optical coherence tomography at baseline , biweekly for 2 months , then monthly for the remainder of their trial participation . Post hoc design and data analysis were performed between December 1 , 2013 , and June 20 , 2014 . MAIN OUTCOMES AND MEASURES Visual symptoms , visual acuity , fundus appearance , and the presence and characteristics of SRF noted on optical coherence tomography . The characteristics of angiograms performed at the discretion of the treating physician were review ed . RESULTS Of the 51 participants , 18 ( 35 % ) were men ; the mean ( SD ) age was 60 ( 13 ) years ( range , 32 - 87 years ) . Forty-six ( 90 % ) study participants developed SRF during the study period , with 9 ( 20 % ) experiencing symptoms at any point . The mean ( SD ) central retinal thickness of 39 study participants who developed SRF at the first visit increased from 280 ( 26 ) µm at baseline to 316 ( 43 ) µm at the first visit after starting binimetinib treatment ( paired t test , P < .001 ) . On examination , SRF appeared as elevated , yellow-orange pockets in the fovea and /or along the arcades . Corresponding optical coherence tomographic imaging revealed SRF beneath the interdigitation zone . The fovea was affected in 37 of 46 ( 80 % ) individuals ; the location of SRF accumulation varied . Visual symptoms were mild and mainly transient , occurring in 9 participants with SRF ( 20 % ; 95 % CI , 10%-33 % ) . Only 2 participants ( 4 % ) were found to have SRF at the last study visit after discontinuation of treatment with binimetinib . Both had Snellen-measured visual acuity of 20/25 or better . CONCLUSIONS AND RELEVANCE The presence of SRF was common in study participants undergoing treatment with the MEK inhibitor binimetinib . Visual symptoms were mild and mainly transient . The presence of SRF did not lead to permanent ocular sequelae . Cessation of life-extending treatment with MEK inhibitors is not indicated when SRF is present Background — Whether knowledge of genetic risk for coronary heart disease ( CHD ) affects health-related outcomes is unknown . We investigated whether incorporating a genetic risk score ( GRS ) in CHD risk estimates lowers low-density lipoprotein cholesterol ( LDL-C ) levels . Methods and Results — Participants ( n=203 , 45–65 years of age , at intermediate risk for CHD , and not on statins ) were r and omly assigned to receive their 10-year probability of CHD based either on a conventional risk score ( CRS ) or CRS + GRS ( + GRS ) . Participants in the + GRS group were stratified as having high or average/low GRS . Risk was disclosed by a genetic counselor followed by shared decision making regarding statin therapy with a physician . We compared the primary end point of LDL-C levels at 6 months and assessed whether any differences were attributable to changes in dietary fat intake , physical activity levels , or statin use . Participants ( mean age , 59.4±5 years ; 48 % men ; mean 10-year CHD risk , 8.5±4.1 % ) were allocated to receive either CRS ( n=100 ) or + GRS ( n=103 ) . At the end of the study period , the + GRS group had a lower LDL-C than the CRS group ( 96.5±32.7 versus 105.9±33.3 mg/dL ; P=0.04 ) . Participants with high GRS had lower LDL-C levels ( 92.3±32.9 mg/dL ) than CRS participants ( P=0.02 ) but not participants with low GRS ( 100.9±32.2 mg/dL ; P=0.18 ) . Statins were initiated more often in the + GRS group than in the CRS group ( 39 % versus 22 % , P<0.01 ) . No significant differences in dietary fat intake and physical activity levels were noted . Conclusions — Disclosure of CHD risk estimates that incorporated genetic risk information led to lower LDL-C levels than disclosure of CHD risk based on conventional risk factors alone . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01936675
Output:
| A recent systematic review of 21 r and omized , controlled trials suggested that fish-oil supplementation during pregnancy reduces the risk of both preterm delivery and low birth weight.2 It is therefore possible that the positive effect in relation to preterm birth might outweigh the potential for an increased risk of hemorrhage |
MS211359 | ***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 effects of CAHPS health plan performance information on plan choices and decision processes by New Jersey Medicaid beneficiaries . DATA SOURCES / STUDY SETTING The study sample was a statewide sample of all new Medicaid cases that chose Medicaid health plans during April 1998 . The study used state data on health maintenance organization ( HMO ) enrollments and survey data for a subset of these cases . STUDY DESIGN An experimental design was used , with new Medicaid cases r and omly assigned to experimental or control groups . The experimental group received a CAHPS report along with the st and ard enrollment material s , and the control group did not . DATA COLLECTION The HMO enrollment data were obtained from the state in June 1998 , and evaluation survey data were collected from July to October 1998 . PRINCIPAL FINDINGS No effects of CAHPS information on HMO choices were found for the total sample . Further examination revealed that only about half the Medicaid cases said they received and read the plan report and there was an HMO with dominant Medicaid market share but low CAHPS performance scores . The subset of cases who read the report and did not choose this dominant HMO chose HMOs with higher CAHPS scores , on average , than did those in an equivalent control group . CONCLUSIONS Health plan performance information can influence plan choices by Medicaid beneficiaries , but will do so only if they actually read it . These findings suggest a need for enhancing dissemination of the information as well as further education to encourage informed choices Most plan report cards that compare the performance of health plans have framed the decision about plan choice as an opportunity to get better- quality care . This study uses a controlled experimental design to examine the effect of reframing the health plan choice decision to one that emphasizes protecting oneself from possible risk . The findings show that framing the health plan decision using a risk message has a consistent and significant positive impact on how consumers comprehend , value , and weight comparative performance information OBJECTIVE To assess whether presentation approaches design ed to be more meaningful result in greater weighting of quality information in decisions . An emerging body of research indicates that the way information is presented affects how it is interpreted and how it is weighted in decisions . Comparative health plan performance reports are not being used by consumers possibly because the information presented is difficult to use . The next generation of these reports should be design ed to support decision making . DESIGN AND STUDY PARTICIPANTS The study uses a controlled experimental design . Participants ( n = 162 ) were r and omly assigned to different conditions and asked to complete tasks related to using quality information and making health plan selection s. Dependent variables included the amount of weight given to quality information in choices and decision accuracy . RESULTS Some presentation approaches make it easier for users to process and integrate quality data into their choices . However , other presentation formats influence consumers ' decisions in ways that undermine their self-interest . CONCLUSIONS Findings indicate that presenting quality data in a more evaluable format increases the weight it carries in consumer decisions . Every change made in the presentation of comparative data has the potential to influence decisions . Those who disseminate information have a responsibility to be aware of how they use that influence and to direct it in productive and defensible ways . The alternative is to manipulate people in ways that are unknown , are not thought out , or are not defensible , but are no less manipulative Many consumers are offered two or more employer-sponsored health insurance plans , and competition among health plans for subscribers is promoted as a mechanism for balancing health care costs and quality . Yet consumers may not receive the information necessary to make informed health plan choices . This study tests the effects on health plan choice of providing supplemental decision-support material s to inform consumers about expected health plan costs . Our main finding is that such information induces consumers to bear more risk , especially those in relatively good health . Thus our results suggest that working-age , privately insured consumers currently may be over-insuring for medical care Abstract Objective : To assess whether crude league tables of mortality and league tables of risk adjusted mortality accurately reflect the performance of hospitals . Design : Longitudinal study of mortality occurring in hospital . Setting : 9 neonatal intensive care units in the United Kingdom . Subjects : 2671 very low birth weight or preterm infants admitted to neonatal intensive care units between 1988 and 1994 . Main outcome measures : Crude hospital mortality and hospital mortality adjusted using the clinical risk index for babies ( CRIB ) score . Results : Hospitals had wide and overlapping confidence intervals when ranked by mortality in annual league tables ; this made it impossible to discriminate between hospitals reliably . In most years there was no significant difference between hospitals , only r and om variation . The apparent performance of individual hospitals fluctuated substantially from year to year . Conclusions : Annual league tables are not reliable indicators of performance or best practice ; they do not reflect consistent differences between hospitals . Any action prompted by the annual league tables would have been equally likely to have been beneficial , detrimental , or irrelevant . Mortality should be compared between groups of hospitals using specific criteria —such as differences in the volume of patients , staffing policy , training of staff , or aspects of clinical practice —after adjusting for risk . This will produce more reliable estimates with narrower confidence intervals , and more reliable and rapid conclusions . Key messages League tables are being used increasingly to evaluate hospital performance in the United Kingdom In annual league tables the rankings of nine neonatal intensive care units in different hospitals had wide and overlapping confidence intervals and their rankings fluctuated substantially over six years Annual league tables of hospital mortality were inherently unreliable for comparing hospital performance or for indicating best practice s The UK government 's commitment to using annual league tables of outcomes such as mortality to monitor services and the spread of best practice s should be reconsidered Prospect i ve studies of risk adjusted outcome in hospitals grouped according to specific characteristics would provide better information and be a better use of re OBJECTIVE To determine whether an intervention design ed to inform and guide patients in choosing a primary care provider ( PCP ) could increase satisfaction and trust . DESIGN A r and omized controlled trial conducted at the Santa Clara Medical Center of the Kaiser Permanente Medical Care Program in Northern California . PATIENTS AND METHODS Patients needing a PCP were r and omly assigned to Informed Choice ( provider-level information offered ) , Guided Choice ( PCP names provided based on the similarity of patients ' and practitioners ' patient-centered beliefs , and patients then chose ) , or Usual Care . One year later , mailed question naires asked about patients ' trust and satisfaction , perceptions of the choice process , and trust and satisfaction with Kaiser Permanente . More than 5000 adult patients were linked with a PCP as part of the project , and completed surveys were returned by 2437 patients . RESULTS Neither intervention arm generated better matches on patient-practitioner beliefs than Usual Care ; however , trust and satisfaction were higher among Guided Choice patients . Across study arms , patient-practitioner belief discrepancy showed a consistent positive association with trust , satisfaction , and attitudes toward Kaiser Permanente . CONCLUSIONS The discrepancy between patient and practitioner beliefs about care is an important determinant of trust and satisfaction , and involving patients in the selection of their PCP can have an independent positive effect . It should be possible to build on the experience of this project to develop programs that better match patients and practitioners within managed care plans OBJECTIVE To examine the effect of providing the Medicare & You h and book on consumers ' attitudes and behavior regarding health plan decision making . DATA SOURCE A national sample of 3,738 Medicare beneficiaries who were surveyed in late 1999 and early 2000 was employed . Data were collected using a mail survey with telephone follow-up ; the response rate was 76 percent . STUDY DESIGN Medicare beneficiaries were r and omly assigned to a control group that received no Medicare-related in formation as part of the study , or to a treatment group that received a copy of the 2000 version of the Medicare & You h and book as part of a national mailing . Half of the treat men t group ( the " re-mail " group ) received a second copy of the h and book along wit h their mail survey instrument . PRINCIPAL FINDINGS The control and treatment groups did not differ regarding their level of satisfaction with or confidence in their current choice of health plan according to predicted mean values . Treatment group beneficiaries had a significantly higher propensity to either change or consider changing health plans relative to beneficiaries in the control group . Controlling for other factors , 5 percent of treatment group members switched health insurance plans during the prior month compared to 3 percent of control group members . there were no significant differences in predicted values between the re-mail and no re-mail groups in any of the models . Type of supplemental insurance was also highly related to all three outcomes . CONCLUSIONS Findings from this and a prior parallel study suggest th at messages contained in the Medicare & You h and book can have an influence on beneficiaries and the Medicare market . Thus , careful attention should be given to the wording and intent of these messages . This is particularly relevant given the current administration 's emphasis on increasing enrollment in Medicare+Choice plans and findings from earlier research reporting that beneficiaries felt the h and book was pressuring them to enroll in managed care OBJECTIVE To examine the effect of providing new Medicare information material s on consumers ' attitudes and behavior about health plan choice . DATA SOURCE New and experienced Medicare beneficiaries who resided in the Kansas City metropolitan statistical area during winter 1998 - 99 were surveyed . More than 2,000 computer-assisted telephone interviews were completed across the two beneficiary population s with a mean response rate of 60 percent . STUDY DESIGN Medicare beneficiaries were r and omly assigned to a control group or one of three treatment groups that received varying amounts and types of new Medicare information material s. One treatment group received the Health Care Financing Administrations 's pilot Medicare & You 1999 h and book , a second group received the same version of the h and book and a Medicare version of the Consumer Assessment of Health Plans ( CAHPS ) report , and a third treatment group received the Medicare & You bulletin , an abbreviated version of the h and book . PRINCIPAL FINDINGS Results of the study suggest that the federal government 's new consumer information material s are having some influence on Medicare beneficiaries ' attitudes and behaviors about health plan decision making . Experienced beneficiary treatment group members were significantly more confident with their current health plan choice than control group members , but new beneficiaries were significantly less likely to use the new material s to choose or change health plans than control group members . In general the effects on confidence and health plan switching did not vary across the different treatment material s. CONCLUSIONS The 1999 version of the Medicare & You material s contained a message that it is not necessary to change health plans . This message appears to have decreased the likelihood of using the new material s to choose or change plans , whereas other material s to which beneficiaries are exposed may encourage plan switching . Because providing more information to beneficiaries did not result in commensurate increases in confidence levels or rate of health plan switching , factors other than the amount of information , such as how the information is presented , may be more critical than volume This evaluation tested if Consumer Assessment of Health Plans Study ( CAHPS ) information on plan performance affected health plan choices by new beneficiaries in Iowa Medicaid . New cases entering Medicaid in selected counties during February through May 2000 were assigned r and omly to experimental or control groups . The control group received st and ard Medicaid enrollment material s , and the experimental group received these material s plus a CAHPS report . We found that CAHPS information did not affect health plan choices by Iowa Medicaid beneficiaries , similar to previously reported findings for New Jersey Medicaid . However , it did affect plan choice in an earlier laboratory experiment . The value of this information may be limited to a subset of We assessed the efficacy of material s that integrated comparative information on cost , benefits , and quality for employer-based retiree health plans and Medicare Advantage plans in a r and omized experiment to test the impact of content and format . Results indicate that older consumers who received the intervention material s found the material s easier to use , gained greater knowledge about Medicare from them , were more likely to value comparative quality information , were more likely to select higher quality plans , and were more likely to choose a plan that reflected the dimensions they found most important compared to older consumers receiving the control material CONTEXT Publicly released report cards on hospital performance are increasingly common , but whether they are an effective method for improving quality of care remains uncertain . OBJECTIVE To evaluate whether the public release of data on cardiac quality indicators effectively stimulates hospitals to undertake quality improvement activities that improve health care processes and patient outcomes . DESIGN , SETTING , AND PATIENTS Population -based cluster r and omized trial ( Enhanced Feedback for Effective Cardiac Treatment [ EFFECT ] ) of 86 hospital corporations in Ontario , Canada , with patients admitted for acute myocardial infa rct ion ( AMI ) or congestive heart failure ( CHF ) . INTERVENTION Participating hospital corporations were r and omized to early ( January 2004 ) or delayed ( September 2005 ) feedback of a public report card on their baseline performance ( between April 1999 and March 2001 ) on a set of 12 process-of-care indicators for AMI and 6 for CHF . Follow-up performance data ( between April 2004 and March 2005 ) also were collected . MAIN OUTCOME MEASURES The co primary outcomes were composite AMI and CHF indicators based on 12 AMI and 6 CHF process-of-care indicators . Secondary outcomes were the individual process-of-care indicators , a hospital report card impact survey , and all-cause AMI and CHF mortality . RESULTS The publication of the early feedback hospital report card did not result in a significant systemwide improvement in the early feedback group in either the composite AMI process-of-care indicator ( absolute change , 1.5 % ; 95 % confidence interval [ CI ] , -2.2 % to 5.1 % ; P = .43 ) or the composite CHF process-of-care indicator ( absolute change , 0.6 % ; 95 % CI , -4.5 % to 5.7 % ; P = .81 ) . During the follow-up period , the mean 30-day AMI mortality rates were 2.5 % lower ( 95 % CI , 0.1 % to 4.9 % ; P = .045 ) in the early feedback group compared with
Output:
| No effects for the composite process-of-care indicators for either condition were found , but there were some improvements in the individual process-of-care indicators .
There was an effect on the mortality rates for acute myocardial infa rct ion .
The small body of evidence available provides no consistent evidence that the public release of performance data changes consumer behaviour or improves care .
Evidence that the public release of performance data may have an impact on the behaviour of healthcare professionals or organisations is lacking |
MS211360 | ***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: The aim of the study was to determine the fate of demineralized freeze-dried bone allograft ( DFDBA ) used in conjunction with a barrier membrane in the management of extraction sockets and deficient alveolar ridges , and to compare the amount of bone formed with that found in untreated sites . Ten biopsies were obtained from 8 grafted patients . Five biopsies were harvested from untreated sites during routine implant placement and analyzed for comparison . In the socket management procedure , DFDBA was packed tightly into the socket and covered with an exp and ed polytetrafluoroethylene ( e-PTFE ) membrane . Primary closure was achieved in all cases . In the ridge regeneration procedure , cortical columns were placed in the ridge projecting outward approximately 3 mm to create and maintain space for DFDBA particles packed between them ; the columns were then covered by an e-PTFE membrane . Healing time ranged from 8 to 23 months . At the time of implant placement , bone cores ( 7 mm x 2 mm ) were harvested , fixed in 10 % formalin solution , and prepared for histologic examination . At the light microscopic level , no inflammation or fibrous encapsulation was observed . New bone formation on and around DFDBA particles was widespread . Histomorphometric analysis of the grafted specimens and untreated sites was carried out using the trabecular bone volume ( TBV ) index . The TBV in the maxillary test specimens was 55.03 % , as compared to 57.33 % of control cores . Unaltered DFDBA made up 8.7 % of the test specimens . In the m and ibular biopsies , the TBV was 56.6 % , while for the controls it was 40.9 % . The volume of DFDBA still present was 2.45 % . The results tended to indicate that treatment with DFDBA in conjunction with cell occlusive membranes will result in new bone formation , predominantly by the process of conduction , which appears to be similar in amount and nature to that found in cores harvested from healed nonfunctional edentulous areas BACKGROUND Reduction of alveolar height and width after tooth extraction may present problems for implant placement , especially in the anterior maxilla where bone volume is important for biologic and esthetic reasons . Different graft material s have been proposed to minimize the reduction in ridge volume . The aim of this study was to compare radiographic and histomorphometric results of magnesium-enriched hydroxyapatite ( MHA ) and calcium sulfate ( CS ) grafts in fresh sockets after tooth extraction s. METHODS Forty-five fresh extraction sockets with three bone walls were selected in 15 patients . A split-mouth design was used : 15 sockets on the right side of the jaw received MHA , 15 sockets on the left side received CS , and 15 r and om unfilled sockets were considered the control ( C ) group . Intraoral digital radiographs were taken at baseline and at 3 months after graft material placement . At 3 months , cylinder bone sample s were obtained for histology and histomorphometry analysis . RESULTS The difference in mean radiographic vertical bone level from baseline to 3 months was -2.48 + /- 0.65 mm in the CS group , -0.48 + /- 0.21 mm in the MHA group , and -3.75 + /- 0.63 mm in the unfilled C group . Statistically significant differences ( P < 0.05 ) were found between CS and MHA groups and between MHA and C groups . Histologic examination revealed bone formation in all treated sites ; trabecular bone assessment did not differ among apical , mesial , and coronal portions of the specimens . Mean vital bone measurements for CS , MHA , and C groups were 45.0 % + /- 6.5 % , 40.0 % + /- 2.7 % , and 32.8 % + /- 5.8 % , respectively . Statistically significant differences ( P < 0.05 ) were found among all groups . Connective tissue percentages averaged 41.5 % + /- 6.7 % for the CS group , 41.3 % + /- 1.3 % for the MHA group , and 64.6 % + /- 6.8 % for the C group . Statistically significant differences ( P < 0.05 ) were found between CS and C groups and between MHA and C groups . The CS-grafted sockets showed 13.9 % + /- 3.4 % residual implant material , whereas the MHA-treated sockets showed 20.2 % + /- 3.2 % residual material . The difference between the groups was statistically significant ( P < 0.05 ) . CONCLUSIONS Radiographs revealed a greater reduction of alveolar ridge in the CS group than in the MHA group . Histologic examination showed more bone formation and faster resorption in the CS group and more residual implant material in the MHA group BACKGROUND The placement of different graft material s and /or the use of occlusive membranes to cover the extraction socket entrance are techniques aim ed at preserving/reducing alveolar ridge resorption . The use of grafting material s in fresh extraction sockets has , however , been question ed because particles of the grafted material have been found in alveolar sockets 6 - 9 months following their insertion . AIM The aims of the study were to ( i ) . evaluate whether alveolar ridge resorption following tooth extraction could be prevented or reduced by the application of a bioabsorbable polylactide-polyglycolide sponge used as a space filler , compared to natural healing by clot formation , and ( ii ) . evaluate histologically the amount and quality of bone tissue formed in the sockets , 6 months after the use of the bioabsorbable material . MATERIAL AND METHODS Thirty-six patients , undergoing periodontal therapy , participated in this study . All patients were scheduled for extraction of one or more compromised teeth . Following elevation of full-thickness flaps and extraction of teeth , measurements were taken to evaluate the distance between three l and marks ( mesio-buccal , mid-buccal , disto-buccal ) on individually prefabricated stents , and the alveolar crest . Twenty-six alveolar sockets ( test ) were filled with a bioabsorbable polylactide-polyglycolide acid sponge ( Fisiograft ) , while 13 sockets ( controls ) were allowed to heal without any filling material . The flaps were sutured with no attempt to achieve primary closure of the surgical wound . Re-entry for implant surgery was performed 6 months following the extraction s. Thirteen biopsies ( 10 test and three control sites ) were harvested from the sites scheduled for implant placement . RESULTS The clinical measurements at 6 months revealed , in the mesial-buccal site , a loss of bone height of 0.2 mm ( 1.4 SD ) in the test and 0.6 mm ( 1.1 SD ) in the controls ; in the mid-buccal portion a gain of 1.3 mm ( 1.9 SD ) in the test and a loss of 0.8 mm ( 1.6 SD ) in the controls ; and in the distal portion a loss of 0.1 mm ( 1.1 SD ) in the test and of 0.8 ( 1.5 SD ) mm in the controls . The biopsies harvested from the test sites revealed that the new bone formed at 6 months was mineralized , mature and well structured . Particles of the grafted material could not be identified in any of the 10 test biopsies . The bone formed in the control sites was also mature and well structured . CONCLUSION The results of this study indicate that alveolar bone resorption following tooth extraction may be prevented or reduced by the use of a bioabsorbable synthetic sponge of polylactide-polyglycolide acid . The quality of bone formed seemed to be optimal for dental implant insertion OBJECTIVES To histologically analyze the early angiogenesis-osteogenesis interplay in post- extraction sockets augmented with magnesium-enriched hydroxyapatite ( Mg-enriched HA ) . MATERIAL AND METHODS Ten post- extraction sites underwent post- extraction ridge preservation procedure . According to r and omization , sites were divided into two balanced groups and bone specimens were collected 2 or 4 months after surgery . Sections were stained with hematoxylin/eosin , Masson-Goldner trichrome , and tartrate-resistant acid phosphatase ( TRAP ) , respectively . Furthermore , indirect immunohistochemistry was performed using alkaline phosphatase , CD34 and caveolin-1 antibodies . Mean values and st and ard deviations were calculated for each outcome variable . Data were then compared using one-way ANOVA test . P < 0.05 was considered statistically significant . RESULTS Histomorphometric analysis presented 15.0 % ( ±3.5 ) regenerated bone after 2 months of healing . After 4 months , regenerated bone increased 5.1-fold up to 77.4 % ( ± 8.6 ) ( P < 0.001 ) . On the contrary , vessels and capillary reduced from 645 ( ±33 ) to 255 ( ± 94 ) ( caveolin-1 expression , P = 0.008 ) . These findings were confirmed by CD34 expression ( 301 ± 95 and 88 ( ±24 ) , respectively , at 2 and 4 months ( P = 0.046 ) . CONCLUSIONS Within the limits of the present r and omized controlled study , it can be concluded that Mg-enriched HA is a suitable material for socket preservation and ensures early angiogenesis and early osteogenesis The aim of this study was to investigate the healing of human extraction sockets filled with Bio-Oss particles ( Geistlich Pharma AG , Wolhusen , Switzerl and ) . In 21 subjects , providing a total of 31 healing sites , at least one tooth was scheduled for extraction and the extraction sites for implant therapy . The dimensions of the alveolar ridge at the extraction sites were considered insufficient and required augmentation concomitant with tooth extraction . There were three treatment groups . In group A , the extraction sockets were covered with a Bio-Gide membrane ( Geistlich Pharma AG ) and in group B the extraction sockets were filled with Bio-Oss . The extraction sockets in group C were left to heal spontaneously . Biopsies from the extraction sites were collected at the time of implant installation . Sample s from group A showed large amounts of lamellar bone and bone marrow and small proportions of woven bone . Sites grafted with Bio-Oss ( group B ) were comprised of connective tissue and small amounts of newly formed bone surrounding the graft particles . Only 40 % of the circumference of the Bio-Oss particles was in contact with woven bone . Sites from group C were characterized by the presence of mineralized bone and bone marrow BACKGROUND Various material s have been used immediately following tooth extraction to fill and /or cover the socket in an attempt to limit or prevent ridge resorption . The purpose of the present pilot study was to establish a reliable model to investigate the effect of various bone graft and bone replacement material s on extraction socket healing . This study also compared healing extraction sockets 6 to 8 months postimplantation of a bioactive glass ( BG ) or demineralized freeze-dried bone allograft ( DFDBA ) to an unfilled socket control ( C ) . METHODS Following tooth extraction , a total of 30 sockets in 19 patients were r and omly divided into 3 treatment groups : 10 sockets received BG , 10 sockets DFDBA , and 10 sockets served as unfilled controls . Primary coverage was achieved by flap advancement over each socket . Six to 8 months post extraction at time of implant placement , histological cores of the treatment sites were obtained . These cores were processed , undecalcified sections prepared and stained with Stevenel blue/van Gieson 's picric fuchsin , and histomorphometrically analyzed . Vital bone , connective tissue and marrow , and residual graft particles were reported as a percentage of the total core . RESULTS A model system was described in humans and used to evaluate the healing response in the 3 treatment groups . Results concluded that mean vital bone present was 59.5 % for BG- , 34.7 % for DFDBA- , and 32.4 % for C-treated sites . These differences were not statistically significant . However , the residual implant material was significantly higher in DFDBA-treated ( 13.5 % ) versus BG-treated sockets ( 5.5 % ) . CONCLUSIONS Although the differences in percent vital bone were not statistically significant among the 3 treatment groups in this pilot study , BG material was observed to act as an osteoconductive material which had a positive effect on socket healing at 6 to 8 months post extraction . Further research following implant placement in treated and control sockets is warranted to determine if bone implant contact is improved in BG-filled versus unfilled sockets To solve some of the problems inherent in bone regeneration , various types of graft material s , matrix , putty , and gel delivery systems have been developed . These deliver demineralized bone matrix ( DBM ) to a graft site and maintain it in an appropriate position to achieve favorable results . This prospect i ve study review ed 10 cases of extraction immediate grafting with a putty – DBM delivery system . Five patients were male and 5 female . At intervals ranging from 4 to 21 months post extraction grafting , bone cores were harvested at the time of surgical insertion of Replace endosteal two-stage implants . All patients were restored with single-tooth self-st and ing prostheses . Bone quality and quantity in
Output:
| When comparing the percentage of newly formed bone using various grafting material s with NH , calcium sulfate , magnesium enriched hydroxyapatite , and porcine-derived bone grafts offered the best outcomes .
However , due to the heterogeneity of the included studies , the search was extended to determine which type of graft result ed in greatest bone formation . |
MS211361 | ***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 optimal haemoglobin concentration ( [ Hb ] ) for patients with end-stage renal failure is uncertain . In particular , it is unclear whether Hb normalization may be an advantage to such patients who are otherwise well . METHODS A prospect i ve , r and omized , double-blind cross-over study was completed in 14 haemodialysis patients ( 12 male ) aged between 23 and 65 years over a period of 18 months , using a variety of measures to examine the effect of epoetin at target [ Hb ] of 10 g/dl ( [Hb](10 ) ) and 14 g/dl ( [Hb](14 ) ) . Patients were r and omized to maintain one or other of the target levels for 6 weeks before being crossed over to the alternative [ Hb ] . Baseline data ( mean [ Hb ] : 8.5+/-0.2 g/dl ) were also included selectively . Six patients were known to be hypertensive . Comparisons were made between 24-h ambulatory blood pressure levels ( ABP ) , echocardiographic findings and estimates of blood volume ( BV ) , plasma volume ( PV ) and Hb mass . Quality of life estimates were obtained using the Sickness Impact Profile ( SIP ) , and epoetin dosage requirements at target [ Hb ] were assessed . RESULTS Daytime and nocturnal ABP ( systolic and diastolic ) were not different at the respective target [ Hb ] , although nocturnal diastolic levels were higher compared with baseline ( 73+/-4 mmHg ) at both [Hb](10 ) ( 83+/-3 , P:<0.01 ) and [Hb](14 ) ( 81+/-6 , P:<0.05 ) . Significant reductions in cardiac output ( 5.2+/-0.3 vs 6.6+/-0.5 l/min , P:<0.01 ) and left ventricular end-diastolic diameter ( 4.8+/-0.2 vs 5.2+/-0.2 cm , P:<0 . 001 ) were found at [Hb](14 ) compared with [Hb](10 ) . Left ventricular mass index was correlated with both PV ( P:<0.001 ) and BV ( P:<0.01 ) , but not with Hb mass . The PV decreased as the [ Hb ] rose ( P:<0.001 ) but BV remained unchanged . Quality of life was significantly improved at [Hb](14 ) compared with [Hb](10 ) for both total score ( 6 . 5+/-1.7 vs 13.4+/-3.0 , P:=0.01 ) and psychosocial dimension score ( 5 . 4+/-1.9 vs 15.4+/-4.0 , P:<0.01 ) . The maintenance weekly dose of epoetin required was 80 % higher at [Hb](14 ) compared with [Hb](10 ) ( P:<0.001 ) . CONCLUSION These data suggest there may be a significant haemodynamic and symptomatic advantage in maintaining a physiological [ Hb ] in haemodialysis patients . Although untoward effects were not identified in this study at [Hb](14 ) , a substantially higher dose of epoetin is required to maintain this level BACKGROUND Renal anemia is an important determinant for left ventricular hypertrophy in dialysis patients and an independent prognosis parameter for the cardiovascular survival in dialysis patients . In addition , an autonomic dysfunction is associated with the uremic state and influences the cardiovascular risk in patients with end-stage renal disease ( ESRD ) . METHODS We investigated in this prospect i ve longitudinal study the effect of hemoglobin normalization by a chronic treatment with recombinant human erythropoietin ( rhEPO ) on cardiovascular prognosis parameters in 23 patients on chronic hemodialysis with renal anemia ( hemoglobin concentration < or = 10.5 g/dL ) and echocardiographically proven left ventricular hypertrophy . We studied muscle sympathetic nerve activity measured by microneurography ; cardiopulmonary baroreflex activity by lower-body negative pressure ( LBNP- ) testing ; left ventricular structure and mass index ( LVMI ) by echocardiography ; blood pressure by 24-hour readings ; peripheral blood flow and vascular resistance by plethysmography before ( U1 ) and after 7 months of chronic rhEPO treatment ( U2 ) . RESULTS In the anemic state , mean ( + /- SD ) muscle sympathetic nerve activity in ESRD was elevated ( U1 rest , 34 + /- 13 bursts per minute ) and cardiopulmonary baroreflex response during LBNP markedly lacking ( U1 -15 mm Hg , 34 + /- 13 bursts per minute ) reflecting a severely impaired autonomic function . Normalization of the hemoglobin concentration by chronic rhEPO treatment ( U1 , 10.5 + /- 0.9 g/dL versus U2 , 13.4 + /- 3.1 g/dL , P < 0.001 ) did not influence sympathetic nerve activity ( U2 , 34 + /- 15 bursts per minute , NS ) and cardiopulmonary baroreflex sensitivity did not change ( U2 -15 mm Hg , 37 + /- 16 bursts per minute , NS ) . LVMI decreased significantly after chronic treatment with rhEPO ( U1 , 134 + /- 26 g/m2 versus U2 , 97 + /- 25 g/m2 , P < 0.001 ) and left ventricular geometry developed from an asymmetric to a symmetric configuration ( U1 , relative wall thickness 0.58 versus U2 , 0.43 , P < 0.001 ) . Under treatment with rhEPO , 24-hour systolic and diastolic blood pressure did not increase ( systolic U1 , 132 + /- 4 mm Hg versus U2 , 128 + /- 3 mm Hg , NS , and diastolic U1 , 76 + /- 2 mm Hg versus U2 , 73 + /- 2 mm Hg , NS ) . Peripheral blood flow ( U1 , 6.1 + /- 3.3 mL/100 mL/min versus U2 , 6.2 + /- 0.6 mL/100 mL/min , NS ) as well as forearm vascular resistance ( U1 , 15.7 + /- 3.3 mm Hg/mL/100 mL versus U2 , 14.9 + /- 3.1 mm Hg/mL/100 mL , NS ) did not change by chronic rhEPO treatment . CONCLUSION Normalization of hemoglobin by chronic rhEPO treatment in dialysis patients has beneficial cardiovascular effects with regression of left ventricular hypertrophy and improvement of left ventricular geometry . However , a reduction of sympathetic overactivity or a re setting of baroreceptor sensitivity by a rhEPO treatment in dialysis patients in the medium-term could not be demonstrated . The reason for this may be the complex and multifactorial pathomechanism of autonomic dysfunction and cardiovascular disease in ESRD Target hematocrit/hemoglobin values in dialysis patients are still controversial . The Spanish Cooperative Renal Patients Quality of Life Study Group ( including 34 hemodialysis units ) conducted a prospect i ve , 6-mo study of the effect on patient functional status and quality of life of using epoetin to achieve normal hematocrit in hemodialysis patients with anemia . The possible adverse effects of increased hematocrit , patient hospitalization , and epoetin requirements were also studied . The study included 156 patients ( age range , 18 to 65 yr ) . Given the minimal experience in the safety of increasing hematocrit in dialysis patients to normal levels with epoetin , stable patients on hemodialysis who had received epoetin treatment for at least 3 mo and had a stable hemoglobin level of > or = 9 g/dl were included in the study . Patients with antecedents of congestive cardiac failure , ischemic cardiopathy , diabetes mellitus , uncontrolled hypertension , cerebrovascular accident or seizures , malfunction of the vascular access or severe comorbidity ( defined by a comorbidity index ) , and those over 65 yr of age were excluded from the study . Quality of life was measured with the Sickness Impact Profile ( SIP ) and Karnofsky scale . Patients completed question naires at home at onset and conclusion of the 6-mo study . Mean hematocrit increased from 30.9 to 38.4 % and hemoglobin from 10.2 to 12.5 g/dl during the study . Health indicator scores improved significantly : mean Physical Dimension ( SIP ) from 5.38 to 4.1 ( P < 0.005 ) ; mean Psychosocial Dimension from 9.2 to 7 ( P < 0.001 ) ; mean global SIP from 8.9 to 7.25 ( P < 0.001 ) ; mean Karnofsky scale score from 75.6 to 78.4 ( P < 0.01 ) . ( SIP is scaled so that lower scores represent better functional status , and vice versa for the Karnofsky scale ) . Therefore , functional status and quality of life improved with increased hematocrit . No deaths occurred . Three patients ( 2 % ) were censored for hypertension and nine ( 5.7 % ) for thrombosis of the vascular access . The cumulative probability of thrombosis of the vascular access was 0.067 . The average epoetin dose rose from 93 + /- 62 U/kg per wk at onset to 141 + /- 80 U/kg per wk at conclusion , a 51 % increase . The number of patients hospitalized decreased and hospital lengths of stay were shorter during the study period than in the same patients in the 6-mo period preceding the study ( P < 0.05 ) . Nine patients ( 5.7 % ) had thrombosis of the vascular access . There were no changes in the prevalence of arterial hypertension , but three patients ( 2 % ) showed hypertension that was difficult to control . It is concluded that normalization of hematocrit in selected hemodialysis patients , i.e. , nondiabetic patients without severe cardiovascular or cerebrovascular comorbidities , improves quality of life and decreases morbidity without significant adverse effects BACKGROUND In patients with end-stage renal disease , anemia develops as a result of erythropoietin deficiency , and recombinant human erythropoietin ( epoetin ) is prescribed to correct the anemia partially . We examined the risks and benefits of normalizing the hematocrit in patients with cardiac disease who were undergoing hemodialysis . METHODS We studied 1233 patients with clinical evidence of congestive heart failure or ischemic heart disease who were undergoing hemodialysis : 618 patients were assigned to receive increasing doses of epoetin to achieve and maintain a hematocrit of 42 percent , and 615 were assigned to receive doses of epoetin sufficient to maintain a hematocrit of 30 percent throughout the study . The median duration of treatment was 14 months . The primary end point was the length of time to death or a first nonfatal myocardial infa rct ion . RESULTS After 29 months , there were 183 deaths and 19 first nonfatal myocardial infa rct ions among the patients in the normal-hematocrit group and 150 deaths and 14 nonfatal myocardial infa rct ions among those in the low-hematocrit group ( risk ratio for the normal-hematocrit group as compared with the low-hematocrit group , 1.3 ; 95 percent confidence interval , 0.9 to 1.9 ) . Although the difference in event-free survival between the two groups did not reach the prespecified statistical stopping boundary , the study was halted . The causes of death in the two groups were similar . The mortality rates decreased with increasing hematocrit values in both groups . The patients in the normal-hematocrit group had a decline in the adequacy of dialysis and received intravenous iron dextran more often than those in the low-hematocrit group . CONCLUSIONS In patients with clinical ly evident congestive heart failure or ischemic heart disease who are receiving hemodialysis , administration of epoetin to raise their hematocrit to 42 percent is not recommended We administered recombinant human erythropoietin to 25 anemic patients with end-stage renal disease who were undergoing hemodialysis . The recombinant human erythropoietin was given intravenously three times weekly after dialysis , and transfusion requirements , hematocrit , ferrokinetics , and reticulocyte responses were monitored . Over a range of doses between 15 and 500 units per kilogram of body weight , dose-dependent increases in effective erythropoiesis were noted . At 500 units per kilogram , changes in the hematocrit of as much as 10 percentage points were seen within three weeks , and increases in ferrokinetics of three to four times basal values , as measured by erythron transferrin uptake , were observed . Of 18 patients receiving effective doses of recombinant human erythropoietin , 12 who had required transfusions no longer needed them , and in 11 the hematocrit increased to 35 percent or more . Along with the rise in hematocrit , four patients had an increase in blood pressure , and a majority had increases in serum creatinine and potassium levels . No organ dysfunction or other toxic effects were observed , and no antibod
Output:
| Providing EPO for a hemoglobin level of more than 10 to 11 g/dl had a cost-effectiveness higher than that of doing so for other hemoglobin levels . |
MS211362 | ***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 : While the incidence of amyotrophic lateral sclerosis ( ALS ) is similar across the world ( range , 1.0 to 2.5/100 000 ) , a latitude gradient from north to south has been observed . Objective : To determine the incidence of ALS in Puglia , a region of south eastern Italy , and to test the latitude gradient hypothesis comparing the present study with findings in studies conducted with the same design in a northern latitude . Methods : Puglia ( 4 086 613 residents in 2001 ) is the site of a multicentre-multi source prospect i ve population based registry established in 1997 . All incident ALS cases during the period 1998–99 were enrolled and followed up . Cases were classified using the first and the revised El Escorial criteria . Results : During the study period 130 cases were enrolled . The annual crude incidence for ALS in Puglia for the two year period 1998–99 was 1.6/100 000 ( 95 % confidence interval , 1.3 to 1.9 ) . The incidence was higher for men ( incidence rate ( IR ) = 2.1 ( 1.7 to 2.7 ) than for women ( IR = 1.2 ( 0.9 to 1.5 ) ) in all age groups , with a male to female ratio of 1.6 . For both men and women , the incidence increased through age 75 and declined rapidly afterwards . The mean annual incidence adjusted by age and sex to the 2001 Italian population was 1.7/100 000 ( 1.4 to 2.0 ) . Conclusions : ALS incidence is within a narrow range across countries , with a peak between 65 and 75 years and a higher incidence in men . A north to south latitude gradient of ALS incidence is not supported by the results of cohort studies The present study set out to define the possible effect of reduced glutathione ( GSH ) , the substrate of glutathione peroxidase ( GSH-Px ) , a free radical inactivating enzyme , in amyotrophic lateral sclerosis ( ALS ) . Thirty-two patients affected by definite ALS seen in our institution between August 1993 and July 1994 were admitted to the study . The effect of GSH was studied in an open , crossover , r and omized study . GSH was given at the dose of 600 mg each day intramuscularly for 12 weeks . The patients , taken sequentially , were r and omly assigned to two groups . The first group received the drug while the second received only symptomatic therapies for 12 weeks . After a week of wash-out , the second group received GSH and the first only symptomatic therapies for 12 weeks . The rate of progression of the diseases was compared in the two groups . Clinical evaluation included manual test for muscle strength , Norris scale , bulbar scale , and forced vital capacity ( FVC ) percent . No significant difference was found in the progression of ALS in the two periods , although a slight slowing of the disease progression rate was found during the period of treatment , probably related to the open design of the study . Our data do not show any significant effect of reduced glutathione in modifying the progression of ALS.SommarioLo scopo del lavoro è stato definire il possibile effetto del glutatione ridotto ( GSH ) , il substrato della glutatione perossidasi ( GSH-Px ) , un enzima inattivatore dei radicali liberi , nella sclerosi laterale amiotrofica ( SLA ) . Sono stati ammessi nello studio 32 pazienti affetti da SLA definita visitati nel nostro Istituto dall'agosto 1993 a luglio 1995 . L'effetto del GSH è stato studiato in uno studio in aperto , crossover , r and omizzato . Il GSH è stato somministrato alla dose di 600 mg per via intramuscolare per 12 settimane . I pazienti sono stati assegnati a caso , secondo l'ordine di visita , a due gruppi . Per le prime 12 settimane il primo gruppo ha ricevuto il farmaco e il secondo solo terapie sintomatiche . Dopo un wash-out di una settimana , il secondo gruppo ha ricevuto il GSH e il primo solo terapie sintomatiche per altre 12 settimane . È stata confrontata la velocità di progressione dei sintomi nei due gruppi . La valutazione clinica comprendeva test manuali per la forza muscolare , la scala di Norris , una scala bulbare e la capacità vitale forzata ( FVC ) . Non è stata trovata alcuna differenza significativa nella velocità di progressione della SLA nei due periodi , anche se è stato osservato un lieve rallentamento nella velocità di progressione durante il perrodo di trattamento , forse dovuto al disegno in aperto dello studio . I nostri dati non dimostrano alcun effetto significativo del glutatione ridotto nel modificare la progressione della SLA Nutritional etiology of amyotrophic lateral sclerosis ( ALS ) , and other motor neuron disorders , can not be ignored even though many trials of nutritional therapy have not , thus far , yielded any benefit to the sufferers . Possibly the nutrients available , or the dosages used , have not been adequate to the circumstances ; perhaps an as-yet-unknown nutrient is deficient , poorly absorbed or under-utilized Based on the hypothesis that free radicals play a general role in the neurodegenerative process in motor neuron disease , we tested selegiline in a group of patients affected by amyotrophic lateral sclerosis ( ALS ) to examine whether it might modify the progression of the disease . Patients were admitted if they were 25–80 years old and had a confirmed diagnosis of ALS with symptoms lasting no longer than 24 months . Patients with familial ALS , pure progressive bulbar palsy , primary lateral sclerosis or progressive muscle atrophy were excluded ; a total of 111 patients were recruited . Fifty-three patients were r and omly assigned to receive the drug ( selegiline 10 mg/day orally for 6 months ) and the remaining 58 were considered ALS controls . Mortality was similar in the two groups ( 4 and 5 patients respectively ) , though the difference was not statistically significant . Among the survivors , mean MRC and Norris disability scores and forced vital capacity were fairly similar in the two groups at all times and no statistically significant difference between treated and untreated patients was found . The results did not change when the data were related to age , duration and characteristics of onset of the disease . The rate of progression was significantly more rapid in patients with bulbar symptoms in both groups . Our data do not show any significant effect of selegiline in modifying the progression of ALS In this paper we present results from a double blind cross over trial with deprenyl , a selective and irreversible monoamine oxidase-B ( MAO-B ) inhibitor , in 10 patients suffering from amyotrophic lateral sclerosis . The patients were r and omised in such a way that half of the patients started with the active drug and half with the placebo treatment . Each patient was given 10 mg deprenyl ( eldepryl , 10 mg tablets ) per day for 12 weeks and then placebo for the same length of time . There was a drug free period of 12 weeks between the courses . The neurological status of the patients were evaluated every six weeks by using Norris , spinal and bulbar scores and it was observed that all cases deteriorated in their clinical status during the 36 weeks of the controlled study . MAO-B activity in blood platelets was completely inhibited during treatment with deprenyl . In the preliminary analysis performed so far , no obvious retardation in the progress of the disease could be observed with deprenyl treatment BACKGROUND The cause of amyotrophic lateral sclerosis ( ALS ) is not known , and there is no effective treatment . Cell death may be caused by oxidative damage . Selegiline hydrochloride ( Eldepryl ) is a monoamine oxidase-B inhibitor with antioxidant properties . OBJECTIVE To determine if selegiline affects the clinical course of patients with ALS . DESIGN Six-month , double-blind , placebo-controlled study of 133 patients with classical ALS and symptoms for less than 3 years . The primary end point to indicate effectiveness was the rate of change of the Appel ALS total score , an index of disease severity that incorporates strength and function in limbs , respiratory function , and bulbar function . RESULTS Of the 133 patients , 67 were r and omized to receive selegiline and 66 to receive placebo . One hundred four patients ( 53 in the selegiline group and 51 in the placebo group ) completed the 6-month trial . Both groups were comparable for baseline characteristics and mean Appel ALS total score ( 70.5 points for the selegiline group and 70.6 for the placebo group ) . There was no difference in the rate of progression as measured by the Appel ALS total score , showing an average increase of 22 points in 6 months . The monthly rate of change was 3.4 for the selegiline group and 3.5 for the placebo group . There was 1 adverse reaction : worsening depression . Seven patients died during the study ( 4 in the selegiline group and 3 in the placebo group ) . CONCLUSION Selegiline treatment had no significant effect on the rate of clinical progression or outcome of ALS Oxidative stress may contribute to the pathogenesis of amyotrophic lateral sclerosis ( ALS ) . We therefore examined prospect ively whether individuals who regularly use supplements of the antioxidant vitamins E and C have a lower risk of ALS than nonusers . The study population comprised 957,740 individuals 30 years of age or older participating in the American Cancer Society 's Cancer Prevention Study II . Information on vitamin use was collected at time of recruitment in 1982 ; participants then were followed up for ALS deaths from 1989 through 1998 via linkage with the National Death Index . During the follow‐up , we documented 525 deaths from ALS . Regular use of vitamin E supplements was associated with a lower risk of dying of ALS . The age‐ and smoking‐adjusted relative risk was 0.99 ( 95 % confidence interval [ CI ] , 0.69–1.41 ) among occasional users , 0.59 ( 95 % CI , 0.36–0.96 ) in regular users for less than 10 years , and 0.38 ( 95 % CI , 0.16–0.92 ) in regular users for 10 years or more as compared with nonusers of vitamin E ( p for trend = 0.004 ) . In contrast , no significant associations were found for use of vitamin C or multivitamins . These results suggest that vitamin E supplementation could have a role in ALS prevention . Ann Neurol Between 1983 and 1988 we treated 36 patients with sporadic amyotrophic lateral sclerosis ( ALS ) by an array of antioxidants and added other drugs to the regimen whenever a patient reported deterioration . Our customary prescription sequence was N-acetylcysteine ( NAC ) ; vitamins C and E ; N-acetylmethionine ( NAM ) ; and dithiothreitol ( DTT ) or its isomer dithioerythritol ( DTE ) . Patients with a history of heavy exposure to metal were also given meso 2,3-dimercaptosuccinic acid ( DMSA ) . NAC , NAM , DTT , and DTE were administered by subcutaneous injection or by mouth or by both routes , the other vitamins and DMSA by mouth alone . The hospital pharmacy supplied NAC and NAM injections fluid as 100 ml bottles of 5.0 and 5.85 % solutions , respectively . DTT was delivered in special double-walled capsules of 200 mg . DTT/DTE injection fluid was added to the NAC and NAM bottles , the final DTT/DTE concentrations never exceeding 0.5 % . DMSA was provided in 250 mg capsules . All of the 36 patients used NAC and DTT/DTE ; 29 also used vitamins C and E ; 21 also used NAM ; and 7 also used DMSA , DMSA , NAM , vitamins C and E were tolerated well . In many patients , DTT , DTE , NAC and NAM induced pain , redness and swelling at the injection sites in that order of decreasing frequency . DTT and DTE did often and NAC did sometimes cause gastric pain , nausea and other abdominal discomfort . Comparison of survival in the treated group and in a cohort of untreated historical controls , disclosed a median survival of 3.4 years ( 95 % confidence interval : 3.0 - 4.2 ) in the treated and of 2.8 ( 95 % confidence interval 2.2 - 3.1 ) years in the control patients . This difference may be explained by self- selection of our highly motivated treated group and by its initial survival of diagnosis for an average of 8.5 months before onset of treatment . We conclude that antioxidants neither seem to harm ALS patients , nor do they seem to prolong survival Summary .Increasing evidence has suggested that oxidative stress may be involved in the pathogenesis of amyotrophic lateral sclerosis ( ALS ) . The antioxidant vitamin E ( alpha-tocopherol ) has been shown to slow down the onset and progression of the paralysis in transgenic mice expressing a mutation in the superoxide dismutase gene found in certain forms of familial ALS . The current study , a double blind , placebo-controlled , r and omised , stratified , parallel-group clinical
Output:
| No significant differences were demonstrated in secondary outcome measures .
AUTHORS ' CONCLUSIONS There is insufficient evidence of efficacy of individual antioxidants , or antioxidants in general , in the treatment of people with amyotrophic lateral sclerosis . |
MS211363 | ***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: UNLABELLED Gastrointestinal stromal tumors ( GISTs ) are gaining the interest of research ers because of impressive metabolic response to the targeted molecular therapeutic drug imatinib mesylate . Initial reports suggest an impressive role for (18)F-FDG PET in follow-up of therapy for these tumors . However , the role of (18)F-FDG PET versus that of CT has not been established . Therefore , we compared the roles of (18)F-FDG PET and CT in staging and evaluation of early response to imatinib mesylate therapy in recurrent or metastatic GIST . METHODS The study included 54 patients who underwent (18)F-FDG PET and CT scans within 3 wk before initiation of imatinib mesylate therapy . Forty-nine of these patients underwent repeat scans 2 mo after therapy . The numbers of sites or organs containing lesions on (18)F-FDG PET and CT scans were compared . Corresponding lesions on (18)F-FDG PET and CT scans or those confirmed to be malignant in appearance by other imaging modalities or on follow-up were considered true positives . Lesions seen on (18)F-FDG PET or CT scans but not seen or confirmed to be of benign appearance with other imaging modalities or on follow-up were considered false positives . Measurements of the maximum st and ard uptake value ( SUV ) on (18)F-FDG PET scans and tumor size on CT scans were used for quantitative evaluation of early tumor response to therapy . RESULTS A total of 122 and 114 sites and /or organs were involved on pretherapy (18)F-FDG PET and CT scans , respectively . The sensitivity and positive predictive values ( PPVs ) for CT were 93 % and 100 % ; whereas these values for (18)F-FDG PET were 86 % and 98 % . However , the differences between these values for CT and (18)F-FDG PET were not statistically significant ( P = 0.27 for sensitivity and 0.25 for PPV ) . This suggests comparable performance of (18)F-FDG PET and CT in staging GISTs . Repeat scans at 2 mo after therapy showed agreement between (18)F-FDG PET and CT scans in 71.4 % of patients ( 57.1 % having a good response to therapy and 14.3 % lacking a response ) . Discrepant results between (18)F-FDG PET and CT were recorded for 28.6 % of the patients . (18)F-FDG PET predicted response to therapy earlier than did CT in 22.5 % of patients during a longer follow-up interval ( 4 - 16 mo ) , whereas CT predicted lack of response to therapy earlier than (18)F-FDG PET in 4.1 % . One patient did not undergo long-term follow-up . These findings suggest that (18)F-FDG PET is superior to CT in predicting early response to therapy in recurrent or metastatic GIST patients . CONCLUSION The performances of (18)F-FDG PET and CT are comparable in staging GISTs before initiation of imatinib mesylate therapy . However , (18)F-FDG PET is superior to CT in predicting early response to therapy . Thus , (18)F-FDG PET is a better guide for imatinib mesylate therapy AIM The aim of this study was to evaluate the utility of positron emission tomography with 18F-fluorodeoxyglucose ( FDG-PET ) in monitoring response in refractory GIST . METHODS This multicenter study prospect ively evaluated 21 patients with locally advanced and /or metastatic GIST refractory to with high-dose imatinib ( 800 mg/day ) treated with doxorubicin 15 - 20 mg/m2/weekly for 4 cycles , followed by imatinib maintenance ( 400 mg/day ) . CT and FDG-PET were performed at baseline and after completion of therapy . RESULTS Mean baseline tumor size on CT was 5.9 cm . Median progression-free survival ( PFS ) was 219 days ( range 62 - 1108 ) . Three out of 21 patients ( 14 % ) had partial responses ( PR ) under RECIST criteria , 12 patients ( 57 % ) remained stable ( SD ) and 6 showed progression ( PD ) of the disease during treatment ( 29 % ) . Six patients had PR by FDG-PET , 15 showed SD ( n=9 ) or PD ( n=6 ) based on EORTC criteria . Patients with a PFS < 6 mo showed a significantly higher ∑SUVmax at baseline ( 26.04±13.4 ) than those with PFS≥6 mo ( 9.82±5.0 ) ( P<0.05 ) . A correlation was found between PET response and PFS : PR 14±6.1 mo , SD 5.5±0.8 mo and PD 3.5±4.1 mo ( P<0.05 ) . A residual SUVmax < 5 after treatment correlated with improved PFS ( 314±315 days vs 131±91 days ) ( P<0.01 ) . Survival curves showed a significant association between PET response and PFS ( P<0.05 ) . Patients with wild-type genotype KIT ( KIT-WT ) showed a significantly lower baseline SUVmax ( 5.36±1.4 ) than non-WT KIT ( 8.40±3.6 ) ( P<0.05 ) . CONCLUSION FDG-PET is useful in assessing response of GIST refractory to imatinib and correlates with the presence of KIT-WT . Baseline ∑SUVmax can predict response to treatment in this series Purpose This multicenter phase 2 study assessed the tolerability and efficacy of motesanib , an oral inhibitor of Kit , platelet-derived growth factor receptor ( PDGFR ) , and vascular endothelial growth factor receptors ( VEGFR ) , in patients with imatinib-resistant gastrointestinal stromal tumors ( GIST ) . Methods Patients with advanced GIST who failed imatinib mesylate after ≥8 weeks of treatment with ≥600 mg daily received motesanib 125 mg orally once daily continuously for 48 weeks or until unacceptable toxicity or disease progression occurred . The primary endpoint was confirmed objective tumor response per RECIST and independent review . Secondary endpoints included progression-free survival ( PFS ) , time to progression ( TTP ) ; objective response by 18FDG-PET and by changes in tumor size and /or density ( Choi criteria ) ; pharmacokinetics and safety . Results In the patients evaluable for response ( N = 102 ) , the objective response rate was 3 % ; 59 % of patients achieved stable disease , with 14 % achieving durable stable disease ≥24 weeks ; 38 % had disease progression . Higher objective response rates were observed per 18FDG-PET ( N = 91 ) ( 30 % ) and Choi criteria ( 41 % ) . The median PFS was 16 weeks ( 95 % CI = 14–24 weeks ) ; the median TTP was 17 weeks ( 95 % CI = 15–24 weeks ) . The most common motesanib treatment-related grade 3 adverse events included hypertension ( 23 % ) , fatigue ( 9 % ) , and diarrhea ( 5 % ) . Motesanib did not accumulate with daily dosing . Conclusions In this study of patients with imatinib-resistant GIST , motesanib treatment result ed in acceptable tolerability and modest tumor control as evident in the proportion of patients who achieved stable disease and durable stable disease Summary Objectives To determine the quantitative parameters of DCE-US for predicting early functional response of patients with metastatic gastrointestinal stromal tumors ( GIST ) . Material s and methods Phase II multicentre clinical trial in patients with metastatic GIST treated with masatinib mesylate ( 7.5 mg/kg daily by oral route ) Patients followed using three different imaging techniques : 1 ) DCE-US before treatment and on days 1 , 7 , 15 and after 1 , 2 , 4 , 6 months and every 3 months . 2 ) CT assessment s , using RECIST criteria , before treatment , after 2 , 4 , 6 months and then every 3 months . 3 ) FDG PET before treatment and after 1 month . Results Twenty patients included and followed-up for up to 36 months , with 269 DCE-US examinations performed . No significant changes in the 7 selected DCE-US variables on day 1 and 7 vs baseline . On day 15 , significant reductions in all the variables related to blood volume recorded : area under the curve ( AUC ) ( p = 0 . 004 ) , area under the wash-in ( AUWI ) ( p = 0.002 ) , area under the wash-out ( AUWO ) ( p = 0.002 ) and Peak Intensity ( p = 0.005 ) . Also slope of wash-in changed significantly ( p = 0.003 ) . An important reduction in St and ard Uptake Values ( SUV ) recorded in 7/11 patients ( PFS > 18 months ) . Decrease in DCE-US AUC , AUWI and AUWO values on day 7 were predictive of PET-CT results . Conclusions AUC AUWI , AUWO are the DCE-US parameters related to blood volume that at D 15 can predict the response of GISTs to treatment with masatinib . Additional studies are ongoing PURPOSE The aim of this study was to identify factors predicting initial and late resistance of GI stromal tumor ( GIST ) patients to imatinib and to document the dose-response relationship in the prognostic subgroups . This study is based on the European Organisation for Research and Treatment of Cancer-Italian Sarcoma Group-Australasian Gastrointestinal Trials Group r and omized trial comparing two doses of imatinib in advanced disease . PATIENTS AND METHODS Initial resistance was defined as progression within 3 months of r and omization , and late resistance was defined as progression beyond 3 months . Investigated cofactors include imatinib dose , age , sex , performance status , original disease site , site and size of lesions at trial entry , and baseline hematologic and biologic parameters . RESULTS Initial resistance was recorded for 116 ( 12 % ) of 934 assessable patients and was independently predicted by the presence of lung and absence of liver metastases , low hemoglobin level , and high granulocyte count . Among 818 patients who were alive and progression free at 3 months , 347 subsequent progressions were recorded , and late resistance was independently predicted by high baseline granulocyte count , primary tumor outside of the stomach , large tumor size , and low initial imatinib dose . The impact of initial dose on late resistance was mainly significant in patients with a high baseline granulocyte count ( > 5.10(9)/L ) and in patients with tumors of GI origin outside of the stomach and small intestine . CONCLUSION Our study identifies patients for whom initial and /or long-term treatment needs to be improved and patients who require a high initial dose . Correlation of these results with immunohistochemistry and molecular parameters may further help to underst and the biologic mechanisms of resistance Background : Malignant gastrointestinal stromal tumours ( GISTs ) are a rare subset of aggressive mesenchymal tumours specific to the gastrointestinal system . They are both locally aggressive and can metastasize . The aim of this analysis was to report on our experience of the utility of coincidence positron emission tomography ( co-PET ) based on an 18F-FDG gamma camera in assessing treatment response to imatinib using CT as the comparator and the final clinical outcome as the end point . Methods : We compared the results of CT and PET scans as predictors of outcome in a consecutive series of patients treated at the Prince of Wales hospital . All patients had biopsy-proven malignant GIST and were on treatment with the targeted pharmacotherapeutic agent imatinib . The majority of the patients were receiving treatment as part of the r and omized trial of the European Organization for Research and Treatment of Cancer , the Australian Gastrointestinal Trials Group and the Italian Sarcoma Group , comparing 400 with 800 mg ( 400 mg b.i.d . ) . The monitoring of tumour response was achieved by serial CT measurements according to the RECIST criteria . Concurrent 18F-FDG co-PET studies were performed within a mean of 2.8 days from the CT scan and were interpreted by a consensus panel of 2 nuclear medicine physicians . Results : A total of 18 patients were recruited into the study , with a total of 74 lesions . There were 47 liver lesions , 31 of which were identified on the initial 18F-FDG co-PET scans ( 63 % ) . There were 10 primary lesions ( 4 stomach , 4 duodenal , 2 small bowel ) , 9 of which were demonstrated on initial 18F-FDG co-PET examinations ( 90 % ) . There were 17 extrahepatic metastatic sites , 15 of which were visualized on the initial 18F-FDG study ( 88 % ) . Of the 18 patients , 8 showed concordant improvement on both CT and 18F-FDG co-PET criteria . One patient showed concordant worsening and 1 was not FDG avid . Eight patients initially showed discordance . 18F-FDG co-P
Output:
| (18)F-FDG PET has a significant value in assessing treatment response to imatinib or other drugs in GIST patients .
(18)F-FDG PET allows an early assessment of treatment response and is a strong predictor of clinical outcome |
MS211364 | ***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 Physicians have difficulty keeping up with new evidence from medical research . METHODS We developed the McMaster Premium LiteratUre Service ( PLUS ) , an internet-based addition to an existing digital library , which delivered quality - and relevance -rated medical literature to physicians , matched to their clinical disciplines . We evaluated PLUS in a cluster-r and omized trial of 203 participating physicians in Northern Ontario , comparing a Full-Serve version ( that included alerts to new articles and a cumulative data base of alerts ) with a Self-Serve version ( that included a passive guide to evidence -based literature ) . Utilization of the service was the primary trial end-point . RESULTS Mean logins to the library rose by 0.77 logins/month/user ( 95 % CI 0.43 , 1.11 ) in the Full-Serve group compared with the Self-Serve group . The proportion of Full-Serve participants who utilized the service during each month of the study period showed a sustained increase during the intervention period , with a relative increase of 57 % ( 95 % CI 12 , 123 ) compared with the Self-Serve group . There were no differences in these proportions during the baseline period , and following the crossover of the Self-Serve group to Full-Serve , the Self-Serve group 's usage became indistinguishable from that of the Full-Serve group ( relative difference 4.4 ( 95 % CI -23.7 , 43.0 ) . Also during the intervention and crossover periods , measures of self-reported usefulness did not show a difference between the 2 groups . CONCLUSION A quality - and relevance -rated online literature service increased the utilization of evidence -based information from a digital library by practicing physicians Abstract OBJECTIVE : To determine if a simple educational intervention can increase resident physician literature search activity . DESIGN : R and omized controlled trial . SETTING : University hospital-based internal medicine training program . PATIENTS / PARTICIPANTS : Forty-eight medical residents rotating on the general internal medicine service . INTERVENTIONS : One-hour didactic session , the use of well-built clinical question cards , and practical sessions in clinical question building . MEASUREMENTS AND MAIN RESULTS : Objective data from the library information system that included the number of log-ons to MEDLINE , search ing volume , abstract s viewed , full-text articles viewed , and time spent search ing . Median search activity as measured per person per week ( control vs intervention ) : number of log-ons to MEDLINE ( 2.1 vs 4.4 , P<.001 ) ; total number of search sets ( 24.0 vs 74.2 , P<.001 ) ; abstract s viewed ( 5.8 vs 17.7 , P=.001 ) ; articles viewed ( 1.0 vs 2.6 , P=.005 ) ; and hours spent search ing ( 0.8 vs 2.4 , P<.001 ) . CONCLUSIONS : A simple educational intervention can markedly increase resident search ing activity PURPOSE The study assesses potential for improving residents ' evidence -based medicine search ing skills in MEDLINE through real-time librarian instruction . SUBJECTS Ten residents on a rotation in a neonatal intensive care unit participated . METHODOLOGY Residents were r and omized into an instruction and a non-instruction group . Residents generated questions from rounds and search ed MEDLINE for answers . Data were collected through observation , search strategy analysis , and surveys . Librarians observed search es and collected data on questions , search ing skills , search problems , and the test group 's instruction topics . Participants performed st and ardized search es before , after , and six-months after intervention and were scored using a search strategy analysis tool ( 1 representing highest score and 5 representing lowest score ) . Residents completed pre- and post-intervention surveys to measure opinions about MEDLINE and search satisfaction . RESULTS Post-intervention , the test group formulated better questions , used limits more effectively , and reported greater confidence in using MEDLINE . The control group expressed less satisfaction with retrieval and demonstrated more errors when limiting . The test and control groups had the following average search scores respectively : 3.0 and 3.5 ( pre-intervention ) , 3.3 and 3.4 ( post-intervention ) , and 2.0 and 3.8 ( six-month post-intervention ) . CONCLUSION Data suggest that measurable learning outcomes were achieved . Residents receiving instruction improved and retained search ing skills six-months after intervention BACKGROUND The " Just-in-time Information " ( JIT ) librarian consultation service was design ed to provide rapid information to answer primary care clinical questions during patient hours . This study evaluated whether information provided by librarians to answer clinical questions positively impacted time , decision-making , cost savings and satisfaction . METHODS AND FINDING A r and omized controlled trial ( RCT ) was conducted between October 2005 and April 2006 . A total of 1,889 questions were sent to the service by 88 participants . The object of the r and omization was a clinical question . Each participant had clinical questions r and omly allocated to both intervention ( librarian information ) and control ( no librarian information ) groups . Participants were trained to send clinical questions via a h and -held device . The impact of the information provided by the service ( or not provided by the service ) , additional re sources and time required for both groups was assessed using a survey sent 24 hours after a question was su bmi tted . The average time for JIT librarians to respond to all questions was 13.68 minutes/ question ( 95 % CI , 13.38 to 13.98 ) . The average time for participants to respond their control questions was 20.29 minutes/ question ( 95 % CI , 18.72 to 21.86 ) . Using an impact assessment scale rating cognitive impact , participants rated 62.9 % of information provided to intervention group questions as having a highly positive cognitive impact . They rated 14.8 % of their own answers to control question as having a highly positive cognitive impact , 44.9 % has having a negative cognitive impact , and 24.8 % with no cognitive impact at all . In an exit survey measuring satisfaction , 86 % ( 62/72 responses ) of participants scored the service as having a positive impact on care and 72 % ( 52/72 ) indicated that they would use the service frequently if it were continued . CONCLUSIONS In this study , providing timely information to clinical questions had a highly positive impact on decision-making and a high approval rating from participants . Using a librarian to respond to clinical questions may allow primary care professionals to have more time in their day , thus potentially increasing patient access to care . Such services may reduce costs through decreasing the need for referrals , further tests , and other courses of action . TRIAL REGISTRATION Controlled-Trials.com IS RCT N96823810 The effect of introducing user fees on the frequency and quality of MEDLINE search ing with GRATEFUL MED by physicians in clinical setting s was tested . After training and free use ( prior study ) , consenting participants were r and omly allocated to pay search ing costs ( pay group ) or continue without fees ( no pay group ) . Fifty-nine physicians participated . Among the prior study 's frequent search ers , the pay group search ed at less than one third of the rate of those assigned to no pay . For less frequent search ers in the prior study , only 48 % of those assigned to pay did any search es , compared with 85 % for the no pay group ( P = 0.006 ) , and for those who did search , their frequency was almost half . However , there was no significant difference in the quality of search es ; both groups demonstrated about equivalent recall ( P = 0.77 ) , but significantly lower precision ( P = 0.03 ) than for the librarian 's independent search es . Similarly , there was no difference in the proportion of search es affecting clinical decisions for the two groups . Thus , imposing user charges for online search ing in clinical setting s after a period of free use adversely affects search ing quantity , but not quality . MEDLINE providers should consider whether user fees will undermine its benefits OBJECTIVE To determine if a preceptor and individualized feedback improves the performance of physicians in search ing MEDLINE in clinical setting s. DESIGN R and omized controlled trial with 2 to 10 months follow-up . SETTING A 300-bed teaching hospital . PARTICIPANTS All 392 physicians and physicians-in-training from 6 major clinical departments were invited to participate if they made patient-care decisions during the study period ; 79.4 % agreed . INTERVENTIONS All participants were given 2 hours of basic training , then r and omized to a control group ( no further intervention ) or an intervention group in which each person chose a clinical preceptor experienced in MEDLINE search ing and received individualized feedback from a study librarian on each of their 1st 10 search es . MAIN OUTCOME MEASURES The number and proportion of relevant and irrelevant references retrieved for 1st , 4th , and 8th search es of participants were compared with independent librarian search es on the same topics . RESULTS Intervention group members did not search more often than controls ( 5.9 search es per month versus 4.7 , respectively ; P = 0.26 ) and there were no significant differences in the quality of search es . Rather , search performance for both groups improved , with the average number of relevant references retrieved per search increasing from 4.5 to 7.4 ( P < 0.01 ) . The librarian retrieved more relevant citations than participants for the 1st search ( P = 0.001 ) but not for the 4th ( P = 0.60 ) or 8th ( P = 0.76 ) search es . CONCLUSIONS A program of assigning preceptors and providing feedback on individual search es did not enhance the quantity or quality of search es . Soon after a basic introduction to search ing , however , clinicians in both groups improved their search performance A double-blind r and omised controlled trial was conducted on a group of Hong Kong hospital clinicians . The objective was to test if a three-hour educational workshop ( with supervised h and s-on practice ) is more effective ( than no training ) to improve clinical question formulation , information-seeking skills , knowledge , attitudes , and search outcomes . The design was a post-test-only control group ; recruitment by stratified r and omization ( by profession ) , blocked at 800 . End-user training was more effective than no training in improving clinical question formulation , in raising awareness , knowledge , confidence and use of data bases , but had made no impact on preference for secondary data bases . It changed the attitude of clinicians to become more positive towards the use of electronic information services ( EIS ) . Participants had higher search performance and outcomes ( satisfaction with information obtained ( NNT = 3 ) , EIS satisfaction ( NNT = 3 ) and success in problem solving ( NNT = 4 ) ) . The workshop improved knowledge and skills in evidence -based search ing , but this effect gradually eroded with time . Search logs confirmed that follow-up is required if effects are to be sustained . Longer effects on search behaviours appear to be positive . A r and omised controlled trial is valuable in identifying cause- and -effect relations and to quantify the magnitude of the effects for management decision-making Background To practice Evidence -Based Medicine ( EBM ) , physicians must quickly retrieve evidence to inform medical decisions . Internal Medicine ( IM ) residents receive little formal education in electronic data base search ing , and have identified poor search ing skills as a barrier to practicing EBM . Objective To design and implement a data base search ing tutorial for IM residents on inpatient rotations and to evaluate its impact on residents ’ skill and comfort search ing MEDLINE and filtered EBM re sources . Design R and omized controlled trial . Residents r and omized to the search ing tutorial met for up to 6 1-hour small group sessions to search for answers to questions about current hospitalized patients . Participants Second- and 3rd-year IM residents . Measurements Residents in both groups completed an Objective Structured Search ing Evaluation ( OSSE ) , search ing for primary evidence to answer 5 clinical questions . OSSE outcomes were the number of successful search es , search times , and techniques utilized . Participants also completed self- assessment surveys measuring frequency and comfort using EBM data bases . Results During the OSSE , residents who participated in the intervention utilized more search ing techniques overall ( p < .01 ) and used PubMed ’s Clinical Queries more often ( p < .001 ) than control residents . Search ing “ success ” and time per completed search did not differ between groups . Compared with controls , intervention residents reported greater comfort using MEDLINE ( p < .05 ) and the Cochrane Library ( p < .05 ) on post-intervention surveys . The groups did not differ in comfort using ACP Journal Club , or in self-reported frequency of use of any data bases . Conclusions An inpatient EBM search ing tutorial improved search ing techniques of IM residents and result ed in increased comfort with MEDLINE and the Cochrane Library , but did not impact overall search ing success Over the past decade , on-line data bases have become increasingly popular among health care professionals . As a group , these ' end-users ' report utilizing data bases to keep abreast of medical progress , to conduct research and to address specific patient care issues . Throughout the literature , medical professionals ( ' content experts ' ) have proved to be less effective search ers than librarians ( ' search experts ' ) . The potential implication s of this discrepancy are worrysome . For any given clinical scenario , for example , published reports may reach contradictory conclusions . A poorly skilled search er may not retrieve enough articles to appreciate this fact . Optimizing search ing skills is therefore a worthwhile goal . As a first step , many medical schools introduce students to on-line data bases , most notably MEDLINE . Residency is an ideal time to continue this training . A recognized obstacle to provide residents with formal MEDLINE instruction is time constraint . We therefore conducted this study to ascertain the impact an individual 1-hour tutorial session would have on MEDLINE utilization among obstetrics and gynecology residents training at an academic medical centre . Outcome measures included MEDLINE search frequency , duration , recall , precision and search er satisfaction . Search recall measures the search er 's ability to retrieve articles deemed relevant to the question at h and . Search precision
Output:
| CIRT is an information and communication technology commonly used in healthcare setting s. Interventions promoting CIRT adoption by healthcare professionals have shown some success in improving search ing skills and use of electronic data bases . |
MS211365 | ***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 relation of dietary intakes of sucrose , meat , and fat , and anthropometric , lifestyle , hormonal , and reproductive factors to colon cancer incidence , data were analyzed from a prospect i ve cohort study of 35,215 Iowa ( United States ) women , aged 55–69 years and without a history of cancer , who completed mailed dietary and other question naires in 1986 . Through 1990 , 212 incident cases of colon cancer were documented . Proportional hazards regression was used to adjust for age and other risk factors . Risk factors found to be associated significantly with colon cancer included : ( i ) sucrose-containing foods and beverages other than ice cream/milk ; relative risks ( RR ) across the quintiles=1.00 , 1.73 , 1.56 , 1.54 , and 2.00 ( 95 % confidence intervals [ CI ] for quintiles two and five exclude 1.0 ) ; ( ii ) sucrose ; RR across the quintiles=1.00 , 1.70 , 1.81 , 1.82 , and 1.45 ( CI for quintiles two through four exclude 1.0 ) ; ( iii ) height ; RR=1.23 for highest to lowest quintile ( P for trend-0.02 ) ; ( iv ) body mass index ; RR=1.41 for highest to lowest quintile ( P for trend=0.03 ) ; and ( v ) number of livebirths , RR=1.59 for having had one to two livebirths and 1.80 for having had three or more livebirths compared with having had none ( P for trend=0.04 ) . These data support hypotheses that sucrose intake or being tall or obese increases colon cancer risk ; run contrary to the hypothesis that increased parity decreases risk ; support previous findings of no association with demographic factors other than age , cigarette smoking , or use of oral contraceptives or estrogen replacement therapy ; and raise questions regarding previous associations with meat , fat , protein , and physical activity . Cancer Causes and Control 1994 , 5 , 38–52 Studies of colon cancer risk in males have reported strong positive associations with obesity , particularly with central adiposity . The association has been weaker and less consistent for women . In a prospect i ve cohort study of women , body measurements were taken directly ; fat mass and fat‐free mass being estimated by bioelectrical impedance analysis and central adiposity by waist circumference and waist‐to‐hip ratio ( WHR ) . Among 24,072 women followed on average for 10.4 years , 212 colon cancers were ascertained via the population cancer registry . We review ed medical records of all cases and classified them according to anatomic site and stage . The central adiposity measures of WHR ( hazard ratio per 0.1 unit increase = 1.31 , 95 % confidence interval ( CI ) 1.08–1.58 ) and waist circumference ( hazard ratio per 10 cm increase = 1.14 , 95 % CI 1.02–1.28 ) were positively associated with colon cancer risk . There was little or no association between other anthropometric measures and risk of colon cancer . There was some evidence that the associations were stronger for proximal tumors , but no evidence that risk differed by stage for any of the anthropometric measures . Central adiposity appears to be associated with colon cancer risk in women . © 2005 Wiley‐Liss , The authors chose to examine the association between body mass index ( BMI ) and incident colorectal cancer across the spectrum of BMI , including underweight persons , because detailed prospect i ve cohort data on this topic in Asians is scarce , as is data on underweight persons ( BMI , < 18.5 kg/m2 ) in any population BACKGROUND Several studies of male colon cancer have found positive associations with body size and composition . It is uncertain whether this relationship is due to non-adipose mass , adipose mass , distribution of adipose mass such as central adiposity , or all three . METHODS In a prospect i ve cohort study of men aged 27 - 75 at recruitment in 1990 - 1994 , body measurements were taken by interviewers . Fat mass and fat-free mass ( FFM ) were estimated from bioelectrical impedance analysis . Waist circumference and waist-to-hips ratio ( WHR ) estimated central adiposity . Incident colon cancers were ascertained via the population cancer registry . Altogether , 16,556 men contributed 145,433 person-years and 153 colon cancers . RESULTS Rate ratios ( RRs ) comparing men in the fourth quartile with those in the first quartile were as follows : FFM 2.3 [ 95 % confidence interval ( CI ) 1.4 - 3.7 ] ; height 1.9 ( 95 % CI 1.1 - 3.1 ) ; waist circumference 2.1 ( 95 % CI 1.3 - 3.5 ) ; WHR 2.1 ( 95 % CI 1.3 - 3.4 ) ; fat mass 1.8 ( 95 % CI 1.1 - 3.0 ) ; and body mass index 1.7 ( 95 % CI 1.1 - 2.8 ) . When continuous measures of FFM and WHR were modeled together , the RR for FFM per 10 kg was 1.37 ( 95 % CI 1.04 - 1.80 ) and the RR for WHR per 0.1 unit was 1.65 ( 95 % CI 1.28 - 2.13 ) . After adjustment for FFM and WHR , the RRs for fat mass and body mass index were no longer statistically significant . CONCLUSION Male colon cancer appears to be related to body size and composition by two different pathways , via central adiposity and via non-adipose mass In most studies , body mass index ( BMI ) has been associated with increased risk of colorectal or colon cancer in men , but the relation is weaker and less consistent for women , possibly because of interactions with age or hormone replacement therapy . The authors examined the relation between BMI and colorectal cancer incidence in a large , prospect i ve US cohort of 307,708 men and 209,436 women from the NIH-AARP Diet and Health Study . During follow-up of the cohort from 1995 to 2000 , 2,314 cases of colorectal cancer were observed in men and 1,029 in women . BMI was related to increased risk of incident colon cancer , but not rectal cancer , for both men and women . For men , relative risks of colon cancer for a BMI of 18.5-<23 , 23-<25 , 25-<27.5 , 27.5-<30 , 30-<32.5 , 32.5-<35 , 35-<40 , and > or = 40 kg/m(2 ) were 1.0 ( referent ) , 1.11 , 1.22 , 1.44 , 1.53 , 1.57 , 1.71 , and 2.39 , respectively ( 95 % confidence interval : 1.59 , 3.58 ; p-trend < 0.0005 ) . Corresponding relative risks for women were 1.0 , 1.20 , 1.29 , 1.31 , 1.28 , 1.13 , 1.46 , and 1.49 ( 95 % confidence interval : 0.98 , 2.25 ; p-trend = 0.02 ) . BMI was related to colon cancer risk for younger ( aged 50 - 66 years ) but not older ( aged 67 - 71 years ) women . The association was not modified by hormone replacement therapy in women or physical activity in men or women Abstract Objective : Epidemiologic data relating obesity to risk of colorectal cancer in women have been inconclusive . Two recent studies have suggested that the association may be modified by estrogen status ; BMI was positively associated with colorectal cancer risk among women with high estrogen exposures [ premenopausal women , and postmenopausal women who currently received postmenopausal hormone therapy ( PMH ) ] . We prospect ively investigated the role of BMI in colorectal cancer risk along with the modifying effects of estrogen in a large cohort from the Women 's Health Study . Methods : Among 39,876 apparently healthy women aged ≥45 years at baseline ( 54 % of them were postmenopausal ) , 37,671 were eligible for the present study . During an average of 8.7 years of follow-up , 202 women had a confirmed diagnosis of colorectal cancer . Baseline BMI was calculated by dividing self-reported weight in kilograms by height in meters squared . Results : The multivariate relative risks ( RRs ) and 95 % confidence interval ( CI ) of colorectal cancer were 1.72 ( 1.12–2.66 ) for 27–29.9 kg/m2 , and 1.67 ( 1.08–2.59 ) for ≥30 kg/m2 , as compared with BMI < 23 kg/m2(p for trend = 0.02 ) . This positive association was seen primarily in the proximal colon ( p for trend = 0.004 ) . When the association was further examined according to PMH use among postmenopausal women , we found that both current and never users with higher BMI were at a greater risk of colorectal cancer ( p for interaction between BMI and PMH use = 0.33 ) . As compared with BMI < 23 kg/m2 , the multivariate RRs and 95 % CI for 27–29.9 and ≥30 kg/m2 were 1.98 ( 0.98–3.99 ) and 1.41 ( 0.65–3.06 ) among current users , and 1.05 ( 0.42–2.65 ) and 2.91 ( 1.40–6.06 ) among never users . Conclusions : These data suggest that higher BMI was associated with an elevated risk of colorectal cancer , and the positive relationship was not altered by estrogen exposure among postmenopausal women Objective To examine the relation between body mass index ( kg/m2 ) and cancer incidence and mortality . Design Prospect i ve cohort study . Participants 1.2 million UK women recruited into the Million Women Study , aged 50 - 64 during 1996 - 2001 , and followed up , on average , for 5.4 years for cancer incidence and 7.0 years for cancer mortality . Main outcome measures Relative risks of incidence and mortality for all cancers , and for 17 specific types of cancer , according to body mass index , adjusted for age , geographical region , socioeconomic status , age at first birth , parity , smoking status , alcohol intake , physical activity , years since menopause , and use of hormone replacement therapy . Results 45 037 incident cancers and 17 203 deaths from cancer occurred over the follow-up period . Increasing body mass index was associated with an increased incidence of endometrial cancer ( trend in relative risk per 10 units=2.89 , 95 % confidence interval 2.62 to 3.18 ) , adenocarcinoma of the oesophagus ( 2.38 , 1.59 to 3.56 ) , kidney cancer ( 1.53 , 1.27 to 1.84 ) , leukaemia ( 1.50 , 1.23 to 1.83 ) , multiple myeloma ( 1.31 , 1.04 to 1.65 ) , pancreatic cancer ( 1.24 , 1.03 to 1.48 ) , non-Hodgkin 's lymphoma ( 1.17 , 1.03 to 1.34 ) , ovarian cancer ( 1.14 , 1.03 to 1.27 ) , all cancers combined ( 1.12 , 1.09 to 1.14 ) , breast cancer in postmenopausal women ( 1.40 , 1.31 to 1.49 ) and colorectal cancer in premenopausal women ( 1.61 , 1.05 to 2.48 ) . In general , the relation between body mass index and mortality was similar to that for incidence . For colorectal cancer , malignant melanoma , breast cancer , and endometrial cancer , the effect of body mass index on risk differed significantly according to menopausal status . Conclusions Increasing body mass index is associated with a significant increase in the risk of cancer for 10 out of 17 specific types examined . Among postmenopausal women in the UK , 5 % of all cancers ( about 6000 annually ) are attributable to being overweight or obese . For endometrial cancer and adenocarcinoma of the oesophagus , body mass index represents a major modifiable risk factor ; about half of all cases in postmenopausal women are attributable to overweight or obesity BACKGROUND Several recent large prospect i ve cohort studies have failed to demonstrate the presumed protective effect of fruit , vegetable , and dietary fiber consumption on colorectal cancer risk . To further explore this issue , we have examined these associations in a population that consumes relatively low amounts of fruit and vegetables and high amounts of cereals . METHODS We examined data obtained from a food-frequency question naire used in a population -based prospect i ve mammography screening study of women in central Sweden . Women with colorectal cancer diagnosed through December 31 , 1998 , were identified by linkage to
Output:
| Both of general and central obesity were positively associated with the risk of CRC in this meta- analysis |
MS211366 | ***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 mechanisms through which multisystemic therapy ( MST ) decreased delinquent behavior were assessed in 2 sample s of juvenile offenders . Sample 1 included serious offenders who were predominantly rural , male , and African American . Sample 2 included substance-abusing offenders who were predominantly urban , male , and Caucasian . Therapist adherence to the MST protocol ( based on multiple respondents ) was associated with improved family relations ( family cohesion , family functioning , and parent monitoring ) and decreased delinquent peer affiliation , which , in turn , were associated with decreased delinquent behavior . Furthermore , changes in family relations and delinquent peer affiliation mediated the relationship between caregiver-rated adherence and reductions in delinquent behavior . The findings highlight the importance of identifying central change mechanisms in determining how complex treatments such as MST contribute to ultimate outcomes This article examined the long-term effects of multisystemic therapy ( MST ) vs. individual therapy ( IT ) on the prevention of criminal behavior and violent offending among 176 juvenile offenders at high risk for committing additional serious crimes . Results from multiagent , multi method assessment batteries conducted before and after treatment showed that MST was more effective than IT in improving key family correlates of antisocial behavior and in ameliorating adjustment problems in individual family members . Moreover , results from a 4-year follow-up of rearrest data showed that MST was more effective than IT in preventing future criminal behavior , including violent offending . The implication s of such findings for the design of violence prevention programs are discussed OBJECTIVE Although several treatments for adolescent substance abuse have been identified as promising by review ers and federal agencies , treatment effects extending beyond 12 months have not been demonstrated in r and omized clinical trials . The primary purpose of this report was to examine the 4-year outcomes of an evidence -based treatment of substance-abusing juvenile offenders . METHOD Eighty of 118 substance-abusing juvenile offenders participated in a follow-up 4 years after taking part in a r and omized clinical trial comparing multisystemic therapy ( MST ) with usual community services . A multi method ( self-report , biological , and archival measures ) assessment battery was used to measure the criminal behavior , illicit drug use , and psychiatric symptoms of the participating young adults . RESULTS Analyses demonstrated significant long-term treatment effects for aggressive criminal activity ( 0.15 versus 0.57 convictions per year ) but not for property crimes . Findings for illicit drug use were mixed , with biological measures indicating significantly higher rates of marijuana abstinence for MST participants ( 55 % versus 28 % of young adults ) . Long-term treatment effects were not observed for psychiatric symptoms . CONCLUSIONS Findings provide some support for the long-term effectiveness of an evidence d-based family-oriented treatment of substance-abusing juvenile offenders . The clinical , research , and policy implication s of these findings are noted Hospitalization and out-of-home placement data for 113 youth participating in a r and omized trial comparing home-based multisystemic therapy ( MST ; n = 57 ) with hospitalization(n = 56 ) for psychiatric crisis stabilization were analyzed following the completion of MST treatment — approximately 4 months post approval for emergency psychiatric hospitalization . Analyses showed that MST prevented any hospitalization for 57 % of the participants in the MST condition and reduced the overall number of days hospitalized by 72 % . Importantly , the reduction in use and length of hospitalization was not offset by increased use of other placement options , as MST reduced days in other out-of-home placements by 49 % . The cost implication s for the viability of MST as an alternative to hospitalization for youth presenting psychiatric emergencies are discussed OBJECTIVE The primary purpose of this study was to determine whether multisystemic therapy ( MST ) , modified for use with youths presenting psychiatric emergencies , can serve as a clinical ly viable alternative to inpatient psychiatric hospitalization . METHOD One hundred sixteen children and adolescents approved for emergency psychiatric hospitalization were r and omly assigned to home-based MST or inpatient hospitalization . Assessment s examining symptomatology , antisocial behavior , self-esteem , family relations , peer relations , school attendance , and consumer satisfaction were conducted at 3 times : within 24 hours of recruitment into the project , shortly after the hospitalized youth was released from the hospital ( 1 - 2 weeks after recruitment ) , and at the completion of MST home-based services ( average of 4 months postrecruitment ) . RESULTS MST was more effective than emergency hospitalization at decreasing youths ' externalizing symptoms and improving their family functioning and school attendance . Hospitalization was more effective than MST at improving youths ' self-esteem . Consumer satisfaction scores were higher in the MST condition . CONCLUSIONS The findings support the view that an intensive , well-specified , and empirically supported treatment model , with judicious access to placement , can effectively serve as a family- and community-based alternative to the emergency psychiatric hospitalization of children and adolescents OBJECTIVE This study presents findings from a 1-year follow-up to a r and omized clinical trial comparing multisystemic therapy ( MST ) , modified for use with youths presenting psychiatric emergencies , with inpatient psychiatric hospitalization . METHOD One hundred fifty-six children and adolescents approved for emergency psychiatric hospitalization were r and omly assigned to home-based MST or inpatient hospitalization followed by usual services . Assessment s examining mental health symptoms , out-of-home placement , school attendance , and family relations were conducted at five times : within 24 hours of recruitment , shortly after the hospitalized youth was released from the hospital ( 1 - 2 weeks after recruitment ) , at the completion of MST ( average of 4 months postrecruitment ) , and 10 and 16 months postrecruitment . RESULTS Based on placement and youth-report measures , MST was initially more effective than emergency hospitalization and usual services at decreasing youths ' symptoms and out-of-home placements and increasing school attendance and family structure , but these differences generally dissipated by 12 to 16 months postrecruitment . Hospitalization produced a rapid , but short-lived , decrease in externalizing symptoms based on caregiver reports . CONCLUSION Findings suggest that youths with serious emotional disturbance might benefit from continuous access to a continuum of evidence -based practice s titrated to clinical need The effectiveness and transportability of multisystemic therapy ( MST ) were examined in a study that included 118 juvenile offenders meeting DSM-III-R criteria for substance abuse or dependence and their families . Participants were r and omly assigned to receive MST versus usual community services . Outcome measures assessed drug use , criminal activity , and days in out-of-home placement at posttreatment ( T2 ) and at a 6-month posttreatment follow-up ( T3 ) ; also treatment adherence was examined from multiple perspectives ( i.e. , caregiver , youth , and therapist ) . MST reduced alcohol , marijuana , and other drug use at T2 and total days in out-of-home placement by 50 % at T3 . Reductions in criminal activity , however , were not as large as have been obtained previously for MST . Examination of treatment adherence measures suggests that the modest results of MST were due , at least in part , to difficulty in transporting this complex treatment model from the direct control of its developers . Increased emphasis on quality assurance mechanisms to enhance treatment fidelity may help overcome barriers to transportability The effects of multisystemic therapy ( MST ) in treating violent and chronic juvenile offenders and their families in the absence of ongoing treatment fidelity checks were examined . Across 2 public sector mental health sites , 155 youths and their families were r and omly assigned to MST versus usual juvenile justice services . Although MST improved adolescent symptomology at posttreatment and decreased incarceration by 47 % at a 1.7-year follow-up , findings for decreased criminal activity were not as favorable as observed on other recent trials of MST . Analyses of parent , adolescent , and therapist reports of MST treatment adherence , however , indicated that outcomes were substantially better in cases where treatment adherence ratings were high . These results highlight the importance of maintaining treatment fidelity when disseminating complex family-based services to community setting Multisystemic therapy ( MST ) delivered through a community mental health center was compared with usual services delivered by a Department of Youth Services in the treatment of 84 serious juvenile offenders and their multiproblem families . Offenders were assigned r and omly to treatment conditions . Pretreatment and posttreatment assessment batteries evaluating family relations , peer relations , symptomatology , social competence , and self-reported delinquency were completed by the youth and a parent , and archival records were search ed at 59 weeks postreferral to obtain data on rearrest and incarceration . In comparison with youths who received usual services , youths who received MST had fewer arrests and self-reported offenses and spent an average of 10 fewer weeks incarcerated . In addition , families in the MST condition reported increased family cohesion and decreased youth aggression in peer relations . The relative effectiveness of MST was neither moderated by demographic characteristics nor mediated by psychosocial variables OBJECTIVE This study examined the effects of an innovative treatment model that was design ed to reduce treatment dropout among substance abusing or dependent juvenile offenders . METHOD One hundred eighteen delinquents who met diagnostic criteria for substance abuse or dependence were r and omly assigned to receive either home-based multisystemic therapy ( N=58 ) or treatment that was provided by the usual community services ( N=60 ) . RESULTS In the multisystemic therapy condition , 98 % ( N=57 ) of the families completed a full course of treatment , which lasted an average of 130 days . In contrast , 78 % ( N=47 ) of the families assigned to treatment through the usual community services received no mental health or substance abuse treatment in the 5 months after referral . CONCLUSIONS The serious and long-st and ing problem of high dropout rates in the substance abuse field can be greatly attenuated by services that increase accessibility and place greater responsibility for engagement on service providers The development and validation of family-based alternatives to out-of-home placements for children is an important goal in the mental health services field . The rigorous evaluation of such alternatives , however , can be difficult to accomplish . The purpose of this article is to describe initial barriers experienced during the pilot study of a r and omized trial , funded by the National Institute of Mental Health , conducted in a field setting , and the strategies that were used to overcome these barriers . The r and omized trial is examining home-based multisystemic therapy as an alternative to the psychiatric hospitalization of youths presenting psychiatric emergencies . The pilot study illuminated the interface of treatment and services research issues , prompting significant changes in the project 's clinical procedures , organization , and supervisory processes , as well as in the project 's interface with existing community re sources for serving youths with serious emotional disturbances BACKGROUND MST is an intensive home- and community-based intervention for youths with serious antisocial behaviour and other serious clinical problems , which has been effective at reducing out-of-home placements and producing favourable long-term clinical outcomes in the US . The aims of the study were to determine the degree to which these outcomes would be replicated in Norway for youths with serious behaviour problems and to conduct a r and omised trial of MST by an independent team of investigators . METHOD Participants were 100 seriously antisocial youths in Norway who were r and omly assigned to Multisystemic Therapy ( MST ) or usual Child Welfare Services ( CS ) treatment conditions . Data were gathered from youths , parents , and teachers pre- and post-treatment . RESULTS MST was more effective than CS at reducing youth internalising and externalising behaviours and out-of-home placements , as well as increasing youth social competence and family satisfaction with treatment . DISCUSSION This is the first study of MST outside of the US and one of the first not conducted by the developers of MST . The findings replicate those obtained by MST 's developers and demonstrate the generalisability of short-term MST effects beyond the US Two important theoretical assumptions of family therapy were examined : ( a ) Child behavior problems are associated with cross-generational coalitions , and ( b ) treatment of these coalitions using family therapy leads to decreases in individual symptomatology . Ss were 45 delinquent adolescents assigned to multisystemic therapy ( MST ) or individual therapy and 16 well-adjusted adolescents . Pretreatment and posttreatment assessment s included measures of observed family relations and self-reported symptoms . Cross-generational coalitions were more evident in families of delinquents vs. families of well-adjusted adolescents . In addition , changes in adolescent and paternal symptoms in the MST group were linked with changes in marital relations . Implication s for systemic conceptualizations of symptom maintenance and change are highlighted
Output:
| MAIN RESULTS The most rigorous ( intent-to-treat ) analysis found no significant differences between MST and usual services in restrictive out-of-home placements and arrests or convictions .
Pooled results that include studies with data of varying quality tend to favor MST , but these relative effects are not significantly different from zero .
The study sample size is small and effects are not consistent across studies ; hence , it is not clear whether MST has clinical ly significant advantages over other services .
There is inconclusive evidence of the effectiveness of MST compared with other interventions with youth .
There is no evidence that MST has harmful effects |
MS211367 | ***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 efficacy of an innovative smoking cessation intervention targeted to a multiethnic , economically disadvantaged HIV-positive population . Design : A two-group r and omized clinical trial compared a smoking cessation intervention delivered by cellular telephone with usual care approach . Methods : Current smokers from a large , inner city HIV/AIDS care center were recruited and r and omized to receive either usual care or a cellular telephone intervention . The usual care group received brief physician advice to quit smoking , targeted self-help written material s and nicotine replacement therapy . The cellular telephone intervention received eight counseling sessions delivered via cellular telephone in addition to the usual care components . Smoking-related outcomes were assessed at a 3-month follow-up . Results : The trial had 95 participants and 77 ( 81.0 % ) completed the 3-month follow-up assessment . Analyses indicated biochemically verified point prevalence smoking abstinence rates of 10.3 % for the usual care group and 36.8 % for the cellular telephone group ; participants who received the cellular telephone intervention were 3.6 times ( 95 % confidence interval , 1.3 - 9.9 ) more likely to quit smoking compared with participants who received usual care ( P = 0.0059 ) . Conclusions : These results suggest that individuals living with HIV/AIDS are receptive to , and can be helped by , smoking cessation treatment . In addition , smoking cessation treatment tailored to the special needs of individuals living with HIV/AIDS , such as counseling delivered by cellular telephone , can significantly increase smoking abstinence rates over that achieved by usual care Background Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones . This social cognitive theory-based intervention ( called “ STUB IT ” ) used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques . Objective The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation . Methods A r and omized controlled trial was conducted with 6-month follow-up . Participants had to be 16 years of age or over , be current daily smokers , be ready to quit , and have a video message-capable phone . Recruitment targeted younger adults predominantly through radio and online advertising . Registration and data collection were completed online , prompted by text messages . The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date , role model , and timing of messages . Extra messages were available on dem and to beat cravings and address lapses . The control group also set a quit date and received a general health video message sent to their phone every 2 weeks . Results The target sample size was not achieved due to difficulty recruiting young adult quitters . Of the 226 r and omized participants , 47 % ( 107/226 ) were female and 24 % ( 54/226 ) were Maori ( indigenous population of New Zeal and ) . Their mean age was 27 years ( SD 8.7 ) , and there was a high level of nicotine addiction . Continuous abstinence at 6 months was 26.4 % ( 29/110 ) in the intervention group and 27.6 % ( 32/116 ) in the control group ( P = .8 ) . Feedback from participants indicated that the support provided by the video role models was important and appreciated . Conclusions This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone . However , there was sufficient positive feedback about the ease of use of this novel intervention , and the support obtained by observing the role model video messages , to warrant further investigation . Trial registration Australian New Zeal and Clinical Trials Registry Number : ACTRN12606000476538 ; http://www.anzctr.org.au/trial_view.aspx?ID=81688 ( Archived by WebCite at http://www.webcitation.org/5umMU4sZi AIMS To assess Sweet Talk , a text-messaging support system design ed to enhance self-efficacy , facilitate uptake of intensive insulin therapy and improve glycaemic control in paediatric patients with Type 1 diabetes . METHODS One hundred and twenty-six patients fulfilled the eligibility criteria ; Type 1 diabetes for > 1 year , on conventional insulin therapy , aged 8 - 18 years . Ninety-two patients were r and omized to conventional insulin therapy ( n = 28 ) , conventional therapy and Sweet Talk ( n = 33 ) or intensive insulin therapy and Sweet Talk ( n = 31 ) . Goal - setting at clinic visits was reinforced by daily text-messages from the Sweet Talk software system , containing personalized goal -specific prompts and messages tailored to patients ' age , sex and insulin regimen . RESULTS HbA(1c ) did not change in patients on conventional therapy without or with Sweet Talk ( 10.3 + /- 1.7 vs. 10.1 + /- 1.7 % ) , but improved in patients r and omized to intensive therapy and Sweet Talk ( 9.2 + /- 2.2 % , 95 % CI -1.9 , -0.5 , P < 0.001 ) . Sweet Talk was associated with improvement in diabetes self-efficacy ( conventional therapy 56.0 + /- 13.7 , conventional therapy plus Sweet Talk 62.1 + /- 6.6 , 95 % CI + 2.6 , + 7.5 , P = 0.003 ) and self-reported adherence ( conventional therapy 70.4 + /- 20.0 , conventional therapy plus Sweet Talk 77.2 + /- 16.1 , 95 % CI + 0.4 , + 17.4 , P = 0.042 ) . When surveyed , 82 % of patients felt that Sweet Talk had improved their diabetes self-management and 90 % wanted to continue receiving messages . CONCLUSIONS Sweet Talk was associated with improved self-efficacy and adherence ; engaging a classically difficult to reach group of young people . While Sweet Talk alone did not improve glycaemic control , it may have had a role in supporting the introduction of intensive insulin therapy . Scheduled , tailored text messaging offers an innovative means of supporting adolescents with diabetes and could be adapted for other health-care setting s and chronic diseases Background Prevention of the onset of depression in adolescence may prevent social dysfunction , teenage pregnancy , substance abuse , suicide , and mental health conditions in adulthood . New technologies allow delivery of prevention programs scalable to large and disparate population s. Objective To develop and test the novel mobile phone delivery of a depression prevention intervention for adolescents . We describe the development of the intervention and the results of participants ’ self-reported satisfaction with the intervention . Methods The intervention was developed from 15 key messages derived from cognitive behavioral therapy ( CBT ) . The program was fully automated and delivered in 2 mobile phone messages/day for 9 weeks , with a mixture of text , video , and cartoon messages and a mobile website . Delivery modalities were guided by social cognitive theory and marketing principles . The intervention was compared with an attention control program of the same number and types of messages on different topics . A double-blind r and omized controlled trial was undertaken in high schools in Auckl and , New Zeal and , from June 2009 to April 2011 . Results A total of 1348 students ( 13–17 years of age ) volunteered to participate at group sessions in schools , and 855 were eventually r and omly assigned to groups . Of these , 835 ( 97.7 % ) self-completed follow-up question naires at postprogram interviews on satisfaction , perceived usefulness , and adherence to the intervention . Over three-quarters of participants viewed at least half of the messages and 90.7 % ( 379/418 ) in the intervention group reported they would refer the program to a friend . Intervention group participants said the intervention helped them to be more positive ( 279/418 , 66.7 % ) and to get rid of negative thoughts ( 210/418 , 50.2%)—significantly higher than proportions in the control group . Conclusions Key messages from CBT can be delivered by mobile phone , and young people report that these are helpful . Change in clinician-rated depression symptom scores from baseline to 12 months , yet to be completed , will provide evidence on the effectiveness of the intervention . If proven effective , this form of delivery may be useful in many countries lacking widespread mental health services but with extensive mobile phone coverage . Clinical Trial Australia New Zeal and Clinical Trials Registry ( ACTRN ) : 12609000405213 ; http://www.anzctr.org.au/trial_view.aspx?ID=83667 ( Archived by WebCite at http://www.webcitation.org/64aueRqOb INTRODUCTION Substantial evidence indicates that cigarette smoking among people living with HIV/AIDS ( PLWHA ) represents a significant public health concern . However , few efforts to assess smoking cessation interventions targeting this population have been reported . In this brief report , 3-month outcomes from an ongoing treatment trial for PLWHA who smoke are described . METHODS Study participants were recruited from a large HIV care center serving a diverse population of PLWHA . A two-group r and omized design was used to compare the efficacy of usual-care ( UC ) smoking cessation treatment versus a cell phone intervention ( CPI ) . Follow-ups were conducted at the HIV clinic 3 months postenrollment . Using an intent-to-treat approach , a series of multiple regression models were used to compare smoking outcomes in the 2 groups . RESULTS Four hundred and seventy-four participants were enrolled and r and omized , UC ( n = 238 ) and CPI ( n = 236 ) . Mean age in the sample was 44.8 ( SD = 8.1 ) years , and the majority were male ( 70.0 % ) , Black ( 76.6 % ) , and had an education level of high school or less ( 77.5 % ) . At follow-up , participants in the CPI group were 4.3 ( 95 % CI = 1.9 , 9.8 ) times more likely to be abstinent ( 7 day ) compared with those in the UC group . Similarly , significant point estimates were observed for the other smoking outcomes of interest . CONCLUSIONS Findings from this preliminary report indicate that a smoking cessation intervention for PLWHA consisting of cell phone-delivered proactive counseling results in significantly higher abstinence rates compared with a st and ard care approach . Evaluation of the long-term ( 6-month and 12-month ) efficacy of the CPI approach is ongoing Adherence to antiretroviral therapy ( ART ) represents one of the strongest predictors of progression to AIDS , yet it is difficult for most patients to sustain high levels of adherence . This study compares the efficacy of a personalized cell phone reminder system ( ARemind ) in enhancing adherence to ART versus a beeper . Twenty-three HIV-infected subjects on ART with self-reported adherence less than 85 % were r and omized to a cellular phone ( CP ) or beeper ( BP ) . CP subjects received personalized text messages daily ; in contrast , BP subjects received a reminder beep at the time of dosing . Interviews were scheduled at weeks 3 and 6 . Adherence to ART was measured by self-report ( SR , 7-day recall ) , pill count ( PC , past 30 days at baseline , then past 3 weeks ) , Medication Event Monitoring System ( MEMS ; cumulatively at 3 and 6 weeks ) , and via a composite adherence score constructed by combining MEMS , pill count , and self report . A mixed effects model adjusting for baseline adherence was used to compare adherence rates between the intervention groups at 3 and 6 weeks . Nineteen subjects completed all visits , 10 men and 9 females . The mean age was 42.7 ± 6.5 years , 37 % of subjects were Caucasian and 89 % acquired HIV heterosexually . The average adherence to ART was 79 % by SR and 65 % by PC at baseline in both arms ; over 6 weeks adherence increased and remained significantly higher in the ARemind group using multiple measures of adherence . A larger and longer prospect i ve study is needed to confirm these findings and to better underst and optimal reminder messages and user fatigue This paper describes the results of a controlled multicenter study on the effect of the computer assistance in the intensive insulin therapy . The patient collective consisted of 50 diabetics , r and omly divided in two groups with 25 patients per group . The Multiple Subcutaneous Injection ( MSI ) group was treated with the usually intensive regimen . The treatment in the Computer Assisted Meal Related Insulin Therapy ( CAMIT ) group was performed with the aid of a specialized pocket computer . Only in the CAMIT group during the study we observed a significant decrease : in the mean blood glucose ( BG ) with 1.6+/-0.4 mmol/l ( P<0.05 ) , in the BG amplitudes by 1.0+/-0.3 mmol/l ( P<0.05 ) , and in the hypoglycemia frequency-from 2.0+/-0.4 to 1.2+/-0.3 ( P<0.01 ) hypoglycemic episodes weekly . The HbA(1 ) values fell in the MSI group by 3.7
Output:
| Interventions for other conditions showed suggestive benefits in some cases , but the results were not consistent .
No evidence of publication bias was demonstrated on visual or statistical examination of the funnel plots for either disease management or health behaviours .
Text messaging interventions increased adherence to ART and smoking cessation and should be considered for inclusion in services . |
MS211368 | ***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 To demonstrate the use of risk-benefit analysis for comparing multiple competing interventions in the absence of r and omized trials , we applied this approach to the evaluation of five anticoagulants to prevent thrombosis in patients undergoing orthopedic surgery . Methods Using a cost-effectiveness approach from a clinical perspective ( i.e. risk benefit analysis ) we compared thromboprophylaxis with warfarin , low molecular weight heparin , unfractionated heparin , fondaparinux or ximelagatran in patients undergoing major orthopedic surgery , with sub-analyses according to surgery type . Proportions and variances of events defining risk ( major bleeding ) and benefit ( thrombosis averted ) were obtained through a meta- analysis and used to define beta distributions . Monte Carlo simulations were conducted and used to calculate incremental risks , benefits , and risk-benefit ratios . Finally , net clinical benefit was calculated for all replications across a range of risk-benefit acceptability thresholds , with a reference range obtained by estimating the case fatality rate - ratio of thrombosis to bleeding . Results The analysis showed that compared to placebo ximelagatran was superior to other options but final results were influenced by type of surgery , since ximelagatran was superior in total knee replacement but not in total hip replacement . Conclusions Using simulation and economic techniques we demonstrate a method that allows comparing multiple competing interventions in the absence of r and omized trials with multiple arms by determining the option with the best risk-benefit profile . It can be helpful in clinical decision making since it incorporates risk , benefit , and personal risk acceptance PURPOSE Within the last two decades , a new underst and ing of the biology of myelodysplastic syndrome ( MDS ) has developed . With this underst and ing , new classification systems , such as the WHO diagnostic criteria , and the International Prognostic Scoring System and response criteria guidelines reported by the International Working Group ( IWG ) have been developed . We report the combined results of three previously reported clinical trials ( n = 309 ) with azacitidine using the WHO classification system for MDS and acute myeloid leukemia ( AML ) and IWG criteria for response . PATIENTS AND METHODS Data from three sequential Cancer and Leukemia Group B trials with azacitidine were recollected and reanalyzed as part of the New Drug Application process . The trials were conducted with either intravenous or subcutaneous azacitidine ( 75 mg/m2/d for 7 days every 28 days ) . RESULTS Complete remissions were seen in 10 % to 17 % of azacitidine-treated patients ; partial remissions were rare ; 23 % to 36 % of patients had hematologic improvement ( HI ) . The median number of cycles to first response was three , and 90 % of responses were seen by cycle 6 . Using current WHO criteria , 103 patients had AML at baseline ; 35 % to 48 % had HI or better responses . The median survival time for the 27 AML patients r and omly assigned to azacitidine was 19.3 months compared with 12.9 months for the 25 patients assigned to observation . Furthermore , azacitidine did not increase the rate of infection or bleeding above the rate caused by underlying disease . CONCLUSION Azacitidine provides important clinical benefits for patients with high-risk MDS Acute myeloid leukemia ( AML ) patients aged ≥60 years tolerate st and ard induction chemotherapy poorly . Therapy with azacitidine at a dose of 75 mg/m2/day for 7 days appears to be better tolerated , and is approved by the Food and Drug Administration ( FDA ) for the treatment of elderly AML patients with bone marrow ( BM ) blast counts of 20–30 % . Here , we report the results of a prospect i ve , phase 2 , open‐label study that evaluated the tolerability and efficacy of a 5‐day regimen of single‐agent subcutaneous azacitidine 100 mg/m2/day administered every 28 days in 15 elderly patients with newly diagnosed AML , 14 of whom had BM blast counts > 30 % . The overall response rate was 47 % . Complete remission , partial remission , and hematologic improvement were achieved by 20 , 13 , and 13 % of patients , respectively . Median overall survival was 355 days for the entire cohort , and 532 days for responders . Median time to best response was 95 days , and median treatment duration was 198 days ( range = 13–724 days ) . Grade 3–4 hematologic toxicities comprised predominantly febrile neutropenia ( 40 % ) and thrombocytopenia ( 20 % ) . Febrile neutropenia was the most common cause of hospitalization . Nonhematologic toxicities , consisting of injection‐site skin reactions and fatigue ( Grade s 1–2 ) , occurred in 73 % ( n = 11 ) of patients . No treatment‐related deaths occurred during the study . The dose and schedule of therapy remained constant in all but four patients . The findings of this study suggest that administration of subcutaneous azacitidine 100 mg/m2/day for 5 days every 28 days is a feasible , well‐tolerated , and effective alternative to st and ard induction chemotherapy in elderly patients with AML Abstract This phase II trial treated elderly or frail patients with acute myeloid leukemia ( AML ) with single-agent subcutaneous azacytidine at 100 mg/m2 , on 5 of 28 days for up to six cycles . Treatment was stopped for lack of response , or continued to progression in responders . The primary endpoint was response within 6 months . A response rate ≥ 34 % was considered a positive trial outcome . From September 2008 to April 2010 , 45 patients from 10 centers ( median age 74 [ 55–86 ] years ) were accrued . Patients received four ( 1–21 ) cycles . Best response was complete response/complete response with incomplete recovery of neutrophils and /or platelets ( CR/CRi ) in eight ( 18 % ; 95 % confidence interval [ CI ] : 8–32 % . ) , 0 ( 0 % ) partial response ( PR ) , seven ( 16 % ) hematologic improvement , 17 ( 38 % ) stable disease . Three non-responding patients stopped treatment after six cycles , 31 patients stopped early and 11 patients continued treatment for 8–21 cycles . Adverse events ( grade ≥ III ) were infections ( n = 13 ) , febrile neutropenia ( n = 8) , thrombocytopenia ( n = 7 ) , dyspnea ( p = 6 ) , bleeding ( n = 5 ) and anemia ( n = 4 ) . Median overall survival was 6 months . Peripheral blood blast counts , grouped at 30 % , had a borderline significant association with response ( p = 0.07 ) . This modified azacytidine schedule is feasible for elderly or frail patients with AML in an outpatient setting with moderate , mainly hematologic , toxicity and response in a proportion of patients , although the primary objective was not reached The myelodysplastic syndromes ( MDSs ) are heterogeneous with respect to clinical characteristics , pathologic features , and cytogenetic abnormalities . This heterogeneity is a challenge for evaluating response to treatment . Therapeutic trials in MDS have used various criteria to assess results , making cross- study comparisons problematic . In 2000 , an International Working Group ( IWG ) proposed st and ardized response criteria for evaluating clinical ly significant responses in MDS . These criteria included measures of alteration in the natural history of disease , hematologic improvement , cytogenetic response , and improvement in health-related quality of life . The relevance of the response criteria has now been vali date d prospect ively in MDS clinical trials , and they have gained acceptance in research studies and in clinical practice . Because limitations of the IWG criteria have surfaced , based on practical and reported experience , some modifications were warranted . In this report , we present recommendations for revisions of some of the initial criteria Azacitidine 's efficacy in therapy-related myeloid neoplasms ( t-MN ) has not been well-studied . In our retrospective review of 84 t-MN patients treated with azacitidine , median overall survival ( OS ) was 14.5 months and overall response rate was 43 % , including 11 % complete remission , 4 % marrow complete remission , and 11 % partial remission . In patients who underwent allogeneic transplant ( 25 % ) , median OS was 19.2 versus 12.8 months ( P=0.023 ) for those who did not . Response rates were comparable to those reported for de novo myelodysplastic syndrome . When we analyzed outcomes according to five scoring systems , only the Global MD And erson Risk Model predicted survival with statistical significance The phase III AZA-001 study established that azacitidine significantly improves overall survival compared with conventional care regimens ( hazard ratio 0.58 [ 95 % confidence interval 0.43–0.77 ] , P<0.001 ) . This analysis was conducted to investigate the relationship between treatment response and overall survival . AZA-001 data were analyzed in a multivariate Cox regression analysis with response as a time-varying covariate . Response categories were “ Overall Response ” ( defined as complete remission , partial remission , or any hematologic improvement ) and “ Stable Disease ” ( no complete or partial remission , hematologic improvement , or progression ) or “ Other ” ( e.g. disease progression ) . Achieving an Overall Response with azacitidine reduced risk of death by 95 % compared with achieving an Overall Response with the conventional care regimens ( hazard ratio 0.05 [ 95%CI : 0.01–0.43 ] , P=0.006 ) . Sensitivity analyses indicated that significantly improved overall survival remained manifest for patients with a hematologic improvement who had never achieved complete or partial remission ( hazard ratio 0.19 [ 95%CI : 0.08–0.46 ] , P<0.001 ) . Stable Disease in both azacitidine-treated and conventional care-treated patients was also associated with a significantly reduced risk of death ( hazard ratio 0.09 , [ 95%CI : 0.06–0.15 ] ; P<0.001 ) . These results demonstrate azacitidine benefit on overall survival compared with conventional care regimens in patients with higher-risk myelodysplastic syndromes who achieve hematologic response but never attain complete or partial remission , in addition to the survival advantage conferred by achievement of complete or partial remission . This study was registered with clinical trials.gov ( NCT00071799 ) This prospect i ve phase II study evaluated the efficacy of azacitidine (Aza)+erythropoietin ( Epo ) in transfusion-dependent patients with lower-risk myelodysplastic syndrome ( MDS ) . Patients ineligible for or refractory to full-dose Epo+granulocyte colony stimulation factors for > 8 weeks and a transfusion need of ⩾4 units over 8 weeks were included . Aza 75 mg m−2 d−1 , 5/28 days , was given for six cycles ; non-responding patients received another three cycles combined with Epo 60 000 units per week . Primary end point was transfusion independence ( TI ) . All patients underwent targeted mutational screen for 42 c and i date genes . Thirty enrolled patients received ⩾one cycle of Aza . Ten patients discontinued the study early , 7 due to adverse events including 2 deaths . Thirty-eight serious adverse events were reported , the most common being infection . Five patients achieved TI after six cycles and one after Aza+Epo , giving a total response rate of 20 % . Mutational screening revealed a high frequency of recurrent mutations . Although no single mutation predicted for response , SF3A1 ( n=3 ) and DNMT3A ( n=4 ) were only observed in non-responders . We conclude that Aza can induce TI in severely anemic MDS patients , but efficacy is limited , toxicity substantial and most responses of short duration . This treatment can not be generally recommended in lower-risk MDS . Mutational screening revealed a high frequency of mutations Hypomethylating agents , such as 5-azacitidine ( 5-AZA ) and 5-aza-2’-deoxycytidine ( decitabine ) , have recently been approved for the treatment of myelodysplastic syndromes ( MDS ) . Several r and omized trials have shown favorable results concerning response rate , survival , transformation to acute leukemia , and quality of life . In these trials , treatment was administered continuously until progression . In the retrospective study presented here , we evaluated the outcome of patients with higher risk MDS or secondary acute myeloid leukemia ( sAML ) treated with a limited number of 5-AZA cycles . A total of 32 patients received 5-AZA alone ( n = 30 ) or in combination with valproic acid and all-trans retinoic acid ( n = 2 ) . 5-AZA was administered subcutaneously at a fixed dose of 75 mg/m2 daily for 7 days and repeated every 28 days . 5-AZA was given for a median of four courses . Treatment was continued for two more cycles as consolidation in patients who had achieved complete remission ( CR ) , marrow CR , or stable disease with hematologic improvement . The overall response rate was 50 % according to the modified International Working Group criteria . Complete remissions were achieved in 15.6 % and stable disease in
Output:
| Conclusions Indirect comparison of alternative azacitidine dosing regimens in MDS and AML shows a benefit for the 7-day regimen in attaining ORR . |
MS211369 | ***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 incidence of mesothelioma is rising rapidly in the UK . There is no generally accepted st and ard treatment . The BTS recommends active symptom control ( ASC ) . It is not known whether chemotherapy in addition prolongs survival or provides worthwhile palliation with acceptable toxicity . Palliation as recorded by patients has been fully reported for only two regimens : mitomycin , vinblastine , and cisplatin ( MVP ) , and vinorelbine ( N ) . The BTS and collaborators planned to conduct a phase III r and omised trial comparing ASC only , ASC+MVP , and ASC+N in 840 patients with survival as the primary outcome measure . The aim of the present study was to assess the acceptability of the trial design to patients and the suitability of two st and ard quality of life ( QL ) question naires for mesothelioma . Methods : Collaborating centres registered all new patients with mesothelioma . Those eligible and giving informed consent completed EORTC QLQ-C30+LC13 and FACT-L QL question naires and were r and omised between all three or any two of ( 1 ) ASC only , ( 2 ) ASC+4 cycles of MVP , and ( 3 ) ASC+12 weekly doses of N. Results : During 1 year , 242 patients were registered of whom 109 ( 45 % ) were r and omised ( 55 % of the 197 eligible patients ) . Fifty two patients from 20 centres were r and omised to an option including ASC only . This translates into a rate of 312 per year from 60 centres interested in collaborating in the phase III trial . The EORTC QL question naire was superior to FACT-L in terms of completeness of data and patient preference . Clinical ly relevant palliation was achieved with ASC . Conclusion : The planned phase III trial is feasible BACKGROUND With the rising incidence of malignant mesothelioma ( MM ) , it is important to optimise treatment to control symptoms , maintain quality of life and , if possible , prolong life . We have analysed prospect ively collected data to evaluate a frequently used palliative chemotherapy regimen . PATIENTS AND METHODS Between October 1986 and May 2002 all patients with inoperable pleural mesothelioma were considered for treatment with MVP ( mitomycin C 8 mg/m2 every 6 weeks , vinblastine 6 mg/m2 every 3 weeks and cisplatin 50 mg/m2 every 3 weeks ) chemotherapy . Symptoms were assessed by physician assessment at baseline and after each cycle of chemotherapy . RESULTS One hundred and fifty patients were treated with MVP for mesothelioma . Forty-three per cent had a performance status ( PS ) 2 or worse . The response rate was 15.3 % , with 68.6 % having stable disease . Sixty-nine per cent reported an improvement in symptoms ; in particular there were good responses for pain ( 71 % ) , cough ( 62 % ) and dyspnoea ( 50 % ) . The most common grade 3/4 toxicity was neutropenia ( 22 % ) . Median overall survival was 7 months , with 1-year survival 31 % and 2-year survival 11 % . Median survival for patients with PS 0/1 was 10 months , and was 6 months for patients with PS 2/3 . Poor prognostic factors in univariate analysis included poor PS , weight loss , mixed or sarcomatoid histology , low haemoglobin and high white blood cell count . Excluding pathological subtype , the prognostic significance of poor PS and weight loss were retained in multivariate analysis . CONCLUSIONS Palliation of symptoms in MM is achievable with current cisplatin-based treatments PURPOSE To evaluate the therapeutic impact of a simple combination chemotherapy regimen on symptoms related to malignant mesothelioma . MATERIAL S AND METHODS Between October 1986 and June 1997 , 39 patients with advanced inoperable malignant mesothelioma were treated with palliative MVP ( mitomycin-C 8 mg/m2 q. six weeks , vinblastine 6 mg/m2 q. three weeks and cisplatin 50 mg/m2 q. three weeks ) chemotherapy and assessed for objective response and relief of symptoms . RESULTS Eight of 39 patients ( 20 % ) achieved an objective partial response with a median duration of nine months : only five patients had progression of disease during chemotherapy . Twenty-four of 39 ( 62 % ) had an overall improvement in their symptomology with particularly good responses for pain ( 79 % ) . These benefits were independent of performance status . Resolution of symptoms was achieved in all responding patients within two treatment cycles . There was no statistically significant difference in duration and incidence of symptom response in those patients achieving radiological PR compared with those with no change and more than 60 % of patients with radiological no change obtained useful symptom control . The treatment was well tolerated with only four patients developing grade 3 leucopenia and three with grade 3 nausea . CONCLUSIONS MVP is a well tolerated regimen and its use in malignant mesothelioma provides useful symptomatic benefit . These results should be the basis for further trials of MVP in the management of mesothelioma with symptom control as a principal endpoint PURPOSE To examine the individual and joint effect of various pretreatment clinical characteristics on the survival of patients with mesothelioma treated by the Cancer and Leukemia Group B ( CALGB ) . PATIENTS AND METHODS Between June 1984 and September 1994 , 337 patients with malignant mesothelioma and no prior chemotherapy were accrued to seven phase II studies conducted by the CALGB which screened the efficacy of 10 treatment regimens or dose levels . The eligibility criteria for all studies were virtually identical . Patient characteristics include the following : age older than 60 years ( 63 % ) ; male ( 83 % ) ; performance status ( PS ) of 0 or 1 ( 81 % ) ; chest pain ( 60 % ) ; definite asbestos exposure ( 62 % ) ; > 5 % weight loss ( 41 % ) ; and pleural involvement ( 94 % ) . Median survival time ( MST ) for the 10 treatment regimens ranged from 3.9 to 9.8 months ( overall=7.2 ; 95 % confidence interval [ CI ] , 6.5 to 8.3 ) , with 1-year survival between 14 % and 50 % ( overall=27 % ; 95 % CI , 23 to 33 % ) . RESULTS Cox survival models and exponential regression trees were used to examine the prognostic importance of pretreatment patient characteristics . Univariate analyses show that patients with poor Eastern Cooperative Oncology Group PS , chest pain , dyspnea , platelet count ( PLT ) > 400,000/microL , weight loss , serum lactate dehydrogenase ( LDH ) level > 500 IU/L , pleural involvement , low hemoglobin ( HGB ) level , high WBC count , and increasing age over 75 years have a worse prognosis . With decreasing risk ratio , multivariate Cox analyses showed that pleural involvement , LDH > 500 IU/L , poor PS , chest pain , PLT > 400,000/microL , nonepithelial histology , and increasing age older than 75 years jointly predict poor survival . PS was the most important prognostic split in the regression tree . Terminal nodes were amalgamated to form six distinct prognostic subgroups with MST ( 2-year survival ) of 13.9 ( 38 % ) in 36 patients , 9.5 ( 21 % ) in 36 patients , 9.2 ( 10 % ) in 146 patients , 6.5 ( 3 % ) in 33 patients , 4.4 ( 0 % ) in 73 patients , and 1.4 ( 0 % ) in 13 patients ( p<0.0001 ) . CONCLUSIONS The subgroup with the best survival ( MST=13.9 months ) included patients with PS=0 and age younger than 49 years , and patients with PS=0 , age of 49 years or older , and HGB > or = 14.6 . The worst survival ( MST= 1.4 months ) occurred for patients with PS= 1/2 and WBC > or = PURPOSE Patients with malignant pleural mesothelioma , a rapidly progressing malignancy with a median survival time of 6 to 9 months , have previously responded poorly to chemotherapy . We conducted a phase III trial to determine whether treatment with pemetrexed and cisplatin results in survival time superior to that achieved with cisplatin alone . PATIENTS AND METHODS Chemotherapy-naive patients who were not eligible for curative surgery were r and omly assigned to receive pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 , or cisplatin 75 mg/m2 on day 1 . Both regimens were given intravenously every 21 days . RESULTS A total of 456 patients were assigned : 226 received pemetrexed and cisplatin , 222 received cisplatin alone , and eight never received therapy . Median survival time in the pemetrexed/cisplatin arm was 12.1 months versus 9.3 months in the control arm ( P = .020 , two-sided log-rank test ) . The hazard ratio for death of patients in the pemetrexed/cisplatin arm versus those in the control arm was 0.77 . Median time to progression was significantly longer in the pemetrexed/cisplatin arm : 5.7 months versus 3.9 months ( P = .001 ) . Response rates were 41.3 % in the pemetrexed/cisplatin arm versus 16.7 % in the control arm ( P < .0001 ) . After 117 patients had enrolled , folic acid and vitamin B12 were added to reduce toxicity , result ing in a significant reduction in toxicities in the pemetrexed/cisplatin arm . CONCLUSION Treatment with pemetrexed plus cisplatin and vitamin supplementation result ed in superior survival time , time to progression , and response rates compared with treatment with cisplatin alone in patients with malignant pleural mesothelioma . Addition of folic acid and vitamin B12 significantly reduced toxicity without adversely affecting survival time PURPOSE This report describes the data and analysis leading to the approval of pemetrexed ( LY 231514 , MTA , Alimta , Eli Lilly and Co. , Indianapolis , IN ) by the U.S. Food and Drug Administration ( FDA ) of a New Drug Application for the treatment of malignant pleural mesothelioma ( MPM ) . EXPERIMENTAL DESIGN The FDA review of the efficacy and safety of pemetrexed assessed in a r and omized clinical trial of 448 patients with unresectable MPM comparing pemetrexed plus cisplatin with cisplatin alone , as well as pre clinical pharmacology and chemistry data , are described . The basis for marketing approval is discussed . RESULTS In one r and omized , single-blind , multicenter international trial , 226 patients were r and omized to the pemetrexed and cisplatin arm and 222 patients were r and omized to cisplatin alone . Median survival times were 12.1 months for pemetrexed and cisplatin and 9.3 months for cisplatin ( P = 0.021 ; hazard ratio , 0.766 ; 95 % confidence interval , 0.61 - 0.96 ) . Myelosuppression , predominantly neutropenia , was the most common toxicity of pemetrexed plus cisplatin . Other common adverse events were fatigue , leucopenia , nausea , dyspnea , vomiting , chest pain , anemia , thrombocytopenia , and anorexia . CONCLUSIONS Pemetrexed in combination with cisplatin was approved by the FDA on February 4 , 2004 for the treatment of patients with MPM whose disease is either unresectable or who are otherwise not c and i date s for curative surgery . The recommended dose of pemetrexed is 500 mg/m(2 ) intra venous infusion over 10 minutes on day 1 of each 21-day cycle in combination with 75 mg/m(2 ) cisplatin infused over 2 hours beginning 30 minutes after the pemetrexed infusion . Patients must receive oral folic acid and vitamin B(12 ) injections before the start and during therapy to reduce severe toxicities . Patients should also receive corticosteroids with the chemotherapy to decrease the incidence of skin rash . Approval was based on a demonstration of survival improvement in a single r and omized trial . Response rates and time to tumor progression were not included in product labeling because of inconsistencies in assessment s among the investigators , independent radiologic review ers , and the FDA , reflecting the difficulty of radiographic assessment s in malignant mesothelioma . Complete prescribing information is available on the FDA Web site at http://www . fda .gov/cder/approval/index.htm PURPOSE Multitargeted antifolate ( MTA ; LY231514 ) has broad pre clinical antitumor activity and inhibits a variety of intracellular enzymes involved in the folate pathways . This study was design ed to ( 1 ) determine the maximum-tolerated dose ( MTD ) , dose-limiting toxicities ( DLT ) , and pharmacokinetics of M
Output:
| Pemetrexed disodium in combination with cisplatin and with folic acid and vitamin B(12 ) supplementation may improve survival when used in combination with cisplatin in good performance status patients . |
MS211370 | ***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: Increased circulating levels of hepatotoxic bile acids may contribute to the cholestasis characteristic of cystic fibrosis-related liver disease . The aims of this study were to compare serum bile acid profiles in patients with cystic fibrosis with and without liver disease , and to evaluate the effect of treatment with ursodeoxycholic acid , a non-hepatotoxic bile acid , on liver biochemistry and serum bile acids in patients with cystic fibrosis-related liver disease . Fasting and postpr and ial serum bile acid levels were analysed in 15 patients ( nine males ; median age 18 years ) with cystic fibrosis-related liver disease and compared with serum bile acid levels in 18 cystic fibrosis patients ( 12 males ; median age 22 years ) without liver disease and 10 control subjects . Fasting and postpr and ial serum levels of primary and secondary serum bile acids were analysed using high-performance liquid chromatography . Liver biochemistry and serum bile acids were measured in six cystic fibrosis patients with liver disease before and 6 months after treatment with ursodeoxycholic acid 20 mg/kg/day and compared with six control patients with cystic fibrosis-related liver disease . Total fasting and postpr and ial serum bile acid levels were significantly ( P < 0.01 ) elevated in patients with liver disease compared to those without liver disease and controls . The fasting glycine conjugates of cholic acid , chenodeoxycholic acid and deoxycholic acid , and the fasting and postpr and ial taurine conjugates of cholic acid and chenodeoxycholic acid were significantly ( P < 0.05 ) elevated in liver disease patients compared to patients without liver disease and controls . After 6 months ' treatment with ursodeoxycholic acid , although the serum was significantly saturated with ursodeoxycholic acid and significant improvements in liver biochemistry were observed in the treatment group , there was no significant reduction in the levels of individual serum bile acids . Although circulating levels of potentially hepatotoxic serum bile acids are elevated in patients with cystic fibrosis-related liver disease , improvements in liver biochemistry associated with ursodeoxycholic acid treatment can not be attributed solely to alterations in levels of endogenous bile acids Liver disease is increasingly recognized as a major cause of morbidity in cystic fibrosis ( CF ) . Preliminary data suggest that ursodeoxycholic acid ( UDCA ) may be beneficial for treatment of this manifestation . We performed a double-blind , multicenter trial in these patients to establish efficacy and safety of UDCA in terms of the improvement of clinical and nutritional indicators besides st and ard liver function tests . We also intended to establish whether taurine supplementation has a beneficial effect in patients receiving UDCA . From June to December 1990 , we enrolled in 12 centers 55 CF patients with liver disease ( 39 male subjects ; median age , 13.8 years ) . They were r and omly assigned to receive for 1 year one of the following treatments : UDCA ( 15 mg/kg body weight daily ) plus taurine ( 30 mg/kg body weight daily ) , UDCA plus placebo , placebo plus taurine , or double placebo . Clinical and laboratory evaluations were performed every 3 months . After 1 year , deterioration of overall clinical conditions , as indicated by the Shwachman-Kulczycki score ( SKS ) , occurred in patients who received placebo but not in those who received UDCA ( P = .025 ) . Patients treated with UDCA also showed an improvement in gamma-glutamyl transpeptidase ( GGT ) ( P = .004 ) and 5'-nucleotidase ( P = .006 ) levels . Treatment with taurine was followed by a significant increase in serum prealbumin levels ( P = .053 ) , a trend toward a reduction in fat malabsorption , and no effect on the biochemical profile . No severe side effects occurred with any treatment . Thus , we concluded that UDCA administration improves clinical and biochemical parameters in CF patients with liver disease . Taurine supplementation may be indicated in patients with severe pancreatic insufficiency and poor nutritional status Ursodeoxycholic acid administration has been reported to improve cholestasis and inflammatory activity in primary biliary cirrhosis and , in an uncontrolled study , also in young adults with cystic fibrosis ( CF ) and chronic cholestasis . As an improvement in nutritional status was also observed in these young adult patients , we investigated whether the administration of a medium dose of ursodeoxycholic acid ameliorates the nutritional status of malnourished young adult CF patients with chronic liver disease . The study included 51 patients ( 27 male patients and 24 female patients ; age range , 8–32 years ; median , 14 ) with body mass percentiles < 90 % . Patients were r and omly assigned to receive either ursodeoxycholic acid ( 10–12 mg/kg/day ) alone or with taurine ( 18–22 mg/kg/day ) . Patients were followed in a crossover fashion within each group ; 6 months of treatment was r and omly alternated with 6 months of placebo . Nine patients dropped out before concluding the study . Liver function tests , nutritional status , and coefficients of fat absorption were determined at entry and after each 6 months of placebo or treatment . Nutritional status and fat absorption were not significantly modified by either treatment . Liver function tests improved after ursodeoxycholic acid administration only in patients with concomitant chronic liver disease . Our findings indicate that 6 months of therapy with a medium dose of ursodeoxycholic acid , either alone or with taurine , does not improve the nutritional status of young malnourished CF patients . Higher doses given for longer periods might be worth investigating BACKGROUND Ursodeoxycholic acid ( UDCA ) is beneficial in cholestasis related to cystic fibrosis ( CF ) . High-dose treatment has been recommended to compensate for bile salt malabsorption . We compared the results of low-dose ( 10 mg/kg/day ) and high-dose ( 20 mg/kg/day ) UDCA treatment on liver biochemistry after 3 and 12 months ' treatment . METHODS Thirty CF patients ( age > 5 years ) with biochemical cholestasis and compensated liver disease were r and omized for low-dose ( n = 17 ) or high-dose ( n = 13 ) UDCA . Baseline clinical variables were comparable . RESULTS After 1 year one patient had died of liver failure ( low dose ) , and three had dropped out because of pruritus ( one in each group ) or personal choice ( low dose ) . In the high-dose group improvement in gamma-glutamyl transferase values was more pronounced after 3 months and 1 year ( P < 0.004 ) , and improvement of alanine aminotransferase was better after 1 yer ( P < 0.02 ) . Improvement of alkaline phosphatase and aspartate aminotransferase was comparable . Complete normalization of liver enzymes and bilirubin occurred more often in the high-dose group . CONCLUSION High-dose UDCA induces a better response of liver biochemistry values than low-dose UDCA in CF patients with cholestatic liver disease The efficacy and safety of ursodeoxycholic acid for the treatment of primary sclerosing cholangitis were evaluated in a prospect i ve , r and omized , double-blind , placebo-controlled trial . Fourteen patients with primary sclerosing cholangitis documented by cholestatic serum enzyme pattern , liver histological appearance and endoscopic retro grade cholangiography were included in the trial . Six patients received ursodeoxycholic acid ( 13 to 15 mg/kg body wt/day ) , and eight patients received placebo . Two patients had to be withdrawn from the study , one because of UDCA-related diarrhea and the other because of worsening of the disease during placebo treatment . Patients in the ursodeoxycholic acid group improved significantly during 1 yr of treatment with respect to serum levels of bilirubin ( median = -50 % ) , alkaline phosphatase ( median = -67 % ) , gamma-glutamyltransferase ( median = -53 % ) , AST ( median = -54 % ) and ALT ( median = -36 % ) compared with the placebo group , but not with respect to serum levels of hydrophobic bile acids . During ursodeoxycholic acid treatment , histopathological features also improved significantly , as evaluated by multiparametric score . Expression of human leukocyte antigen class I molecules appeared to be markedly reduced on liver cells after ursodeoxycholic acid treatment . We conclude that ursodeoxycholic acid is beneficial in reducing disease activity in patients with primary sclerosing cholangitis Previous studies from our groups have demonstrated improvements in biochemical markers of liver function when cystic fibrosis patients with associated liver disease were administered oral ursodeoxycholic acid . The magnitude of the response was somewhat less than that found when comparable doses ( 10 to 15 mg/kg body wt/day ) of ursodeoxycholic acid are given to other liver disease patients ; this may be explained by the bile acid malabsorption that is characteristic of the disease . For this reason a dose-response study was carried out in nine cystic fibrosis patients with liver disease to establish whether improved efficacy could be obtained with higher doses . Ursodeoxycholic acid in doses of 5 , 10 and 15 mg/kg body wt/day was given orally for consecutive 2-mo periods in a replicated Latin-square design . After this , all patients received 20 mg/kg body wt/day . Liver function , individual serum bile acids and biliary bile acid composition were determined at entry and at the end of each treatment period . Our data demonstrate that the magnitude of the biochemical improvement in serum liver enzymes was significantly greater with higher doses of ursodeoxycholic acid ; at 20 mg/kg body wt/day it was similar to that reported for patients with other liver diseases administered lower doses . Biliary ursodeoxycholic acid enrichment increased with increasing doses , attaining 42 % + /- 6 % of the total biliary bile acids with the highest dose . Fasting serum ursodeoxycholic acid concentrations increased during ursodeoxycholic acid administration but were variable and correlated poorly with the dose of ursodeoxycholic acid administered , whereas no correlation was found between serum ursodeoxycholic acid concentration and the proportion of ursodeoxycholic acid in bile . ( ABSTRACT TRUNCATED AT 250 WORDS Cholesterol gallstones are dissolved in man by chenodeoxycholic acid ( CDCA ) and ursodeoxycholic acid ( UDCA ) . To test the comparative efficacy of these two cholelitholytic bile acids , 223 gallstones patients were r and omly treated with either UDCA or CDCA at two different doses : 7 to 8 mg per kg per day and 14 to 15 mg per kg per day . Efficacy and factors influencing dissolution ( dose , size of the stones , and time ) were evaluated after 3 , 6 , and 12 months of treatment . UDCA was significantly more efficacious than was CDCA after 3 and 6 months of treatment , whereas after 12 months , no significant differences were observed . UDCA was equally effective at high and low doses , both on small and large stones . CDCA was significantly more effective at high doses and on small stones . Seventy-four per cent of the total dissolutions with UDCA and 42 % with CDCA occurred within the first 6 months of treatment . Diarrhea and hypertransaminasemia occurred only in the CDCA-treated patients . We conclude that UDCA seems to be the bile acid of choice in dissolving cholesterol gallstones This was a prospect i ve open study that examined the quantitative and qualitative analysis of hepatobiliary scintigraphy ( DISIDA ) in detecting liver involvement in cystic fibrosis ( CF ) . Forty-four adult and pediatric patients ( median age , 12.1 years ; range , 1.1 - 36.3 years ) were divided into three groups : group 1 , no evidence of liver involvement ( n = 8) ; group 2 , biochemical evidence of liver involvement on two or more occasions ( n = 26 ) ; and group 3 , clinical evidence of liver disease ( n = 10 ) . In groups 1 and 2 , the most common qualitative scintigraphic finding was focal intrahepatic retention of tracer ( 26/34 patients , 12 of whom had normal findings on ultrasonography ) . This finding corresponds to focal cholestasis and may warrant treatment with the choleretic agent ursodeoxycholic acid ( UDCA ) . In the group 3 patients , the abnormal qualitative scintigraphic appearances ( heterogeneous uptake of tracer and nodular liver outline ) added little to the findings on ultrasonography ; however , these patients had a prolonged mean hepatic clearance time compared with those in groups 1 and 2 ( one-way ANOVA ; P < .015 ) . It is proposed that scintigraphy with DISIDA has a role in the detection of early liver involvement in cystic fibrosis BACKGROUND In primary biliary cirrhosis the hepatic lesions may result , at least in part , from the intracellular accumulation of potentially toxic endogenous bile acids . Preliminary work suggests that the administration of ursodiol ( also called ursodeoxycholic acid ) , a hydrophilic bile acid without hepatotox
Output:
| There is insufficient evidence to justify is its routine use in cystic fibrosis |
MS211371 | ***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: 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 Recent studies have suggested that there is a positive impact of patient-centered care ( PCC ) on both the patient-physician relationship and subsequent patient health-related behaviors . One recent prospect i ve study reported a significant relationship between the degree of PCC experienced by patients during their hospitalization for acute myocardial infa rct ion ( AMI ) and their postdischarge cardiac symptoms . A limitation of this study , however , was a lack of information regarding the technical quality of the AMI care , which might have explained at least part of the differences in outcomes . The present study was undertaken to test the influence of both PCC and technical care quality on outcomes among AMI patients . METHODS We analyzed data from a national sample of 1,858 veterans hospitalized for an initial AMI in a Department of Veterans Affairs medical center during fiscal years 2003 and 2004 for whom data had been compiled on evidence -based treatment and who had also completed a Picker question naire assessing perceptions of PCC . Cox proportional hazards models were used to estimate the relationship between PCC and survival 1-year postdischarge , controlling for technical quality of care , patient clinical condition and history , admission process characteristics , and patient sociodemographic characteristics . We hypothesized that better PCC would be associated with a lower probability of death 1-year postdischarge , even after controlling for patient characteristics and the technical quality of care . RESULTS Better PCC was associated with a significantly but modestly lower hazard of death over the 1-year study period ( hazard ratio 0.992 , 95 percent confidence interval 0.986 - 0.999 ) . CONCLUSIONS Providing PCC may result in important clinical benefits , in addition to meeting patient needs and expectations Progress towards the Millennium Development Goals ( MDGs ) has been uneven . Inequalities in child health are large and effective interventions rarely reach the most in need . Little is known about how to reduce these inequalities . We describe and explain the equity impact of a women ’s group intervention in India that strongly reduced the neonatal mortality rate ( NMR ) in a cluster-r and omised trial . We conducted secondary analyses of the trial data , obtained through prospect i ve surveillance of a population of 228 186 . The intervention effects were estimated separately , through r and om effects logistic regression , for the most and less socio-economically marginalised groups . Among the most marginalised , the NMR was 59 % lower in intervention than in control clusters in years 2 and 3 ( 70 % , year 3 ) ; among the less marginalised , the NMR was 36 % lower ( 35 % , year 3 ) . The intervention effect was stronger among the most than among the less marginalised ( P-value for difference = 0.028 , years 2 - 3 ; P-value for difference = 0.009 , year 3 ) . The stronger effect was concentrated in winter , particularly for early NMR . There was no effect on the use of health-care services in either group , and improvements in home care were comparable . Participatory community interventions can substantially reduce socio-economic inequalities in neonatal mortality and contribute to an equitable achievement of the unfinished MDG agenda BACKGROUND Community mobilisation through participatory women 's groups might improve birth outcomes in poor rural communities . We therefore assessed this approach in a largely tribal and rural population in three districts in eastern India . METHODS From 36 clusters in Jharkh and and Orissa , with an estimated population of 228 186 , we assigned 18 clusters to intervention or control using stratified r and omisation . Women were eligible to participate if they were aged 15 - 49 years , residing in the project area , and had given birth during the study . In intervention clusters , a facilitator convened 13 groups every month to support participatory action and learning for women , and facilitated the development and implementation of strategies to address maternal and newborn health problems . The primary outcomes were reductions in neonatal mortality rate ( NMR ) and maternal depression scores . Analysis was by intention to treat . This trial is registered as an International St and ard R and omised Controlled Trial , number IS RCT N21817853 . FINDINGS After baseline surveillance of 4692 births , we monitored outcomes for 19 030 births during 3 years ( 2005 - 08 ) . NMRs per 1000 were 55.6 , 37.1 , and 36.3 during the first , second , and third years , respectively , in intervention clusters , and 53.4 , 59.6 , and 64.3 , respectively , in control clusters . NMR was 32 % lower in intervention clusters adjusted for clustering , stratification , and baseline differences ( odds ratio 0.68 , 95 % CI 0.59 - 0.78 ) during the 3 years , and 45 % lower in years 2 and 3 ( 0.55 , 0.46 - 0.66 ) . Although we did not note a significant effect on maternal depression overall , reduction in moderate depression was 57 % in year 3 ( 0.43 , 0.23 - 0.80 ) . INTERPRETATION This intervention could be used with or as a potential alternative to health-worker-led interventions , and presents new opportunities for policy makers to improve maternal and newborn health outcomes in poor population s. FUNDING Health Foundation , UK Department for International Development , Wellcome Trust , and the Big Lottery Fund ( UK ) Objective The objective of this study was to describe the involvement of patients or their representatives in quality management ( QM ) functions and to assess associations between levels of involvement and the implementation of patient-centred care strategies . Design A cross-sectional , multilevel study design that surveyed quality managers and department heads and data from an organizational audit . Setting R and omly selected hospitals ( n = 74 ) from seven European countries ( The Czech Republic , France , Germany , Pol and , Portugal , Spain and Turkey ) . Participants Hospital quality managers ( n = 74 ) and heads of clinical departments ( n = 262 ) in charge of four patient pathways ( acute myocardial infa rct ion , stroke , hip fracture and deliveries ) participated in the data collection between May 2011 and February 2012 . Main Outcome Measures Four items reflecting essential patient-centred care strategies based on an on-site hospital visit : ( 1 ) formal survey seeking views of patients and carers , ( 2 ) written policies on patients ' rights , ( 3 ) patient information literature including guidelines and ( 4 ) fact sheets for post-discharge care . The main predictors were patient involvement in QM at the ( i ) hospital level and ( ii ) pathway level . Results Current levels of involving patients and their representatives in QM functions in European hospitals are low at hospital level ( mean score 1.6 on a scale of 0 to 5 , SD 0.7 ) , but even lower at departmental level ( mean 0.6 , SD 0.7 ) . We did not detect associations between levels of involving patients and their representatives in QM functions and the implementation of patient-centred care strategies ; however , the smallest hospitals were more likely to have implemented patient-centred care strategies . Conclusions There is insufficient evidence that involving patients and their representatives in QM leads to establishing or implementing strategies and procedures that facilitate patient-centred care ; however , lack of evidence should not be interpreted as evidence of no effect BACKGROUND We design ed this observational cohort study to assess the association between patient-centered communication in primary care visits and subsequent health and medical care utilization . METHODS We selected 39 family physicians at r and om , and 315 of their patients participated . Office visits were audiotaped and scored for patient-centered communication . In addition , patients were asked for their perceptions of the patient-centeredness of the visit . The outcomes were : ( 1 ) patients ' health , assessed by a visual analogue scale on symptom discomfort and concern ; ( 2 ) self-report of health , using the Medical Outcomes Study Short Form-36 ; and ( 3 ) medical care utilization variables of diagnostic tests , referrals , and visits to the family physician , assessed by chart review . The 2 measures of patient-centeredness were correlated with the outcomes of visits , adjusting for the clustering of patients by physician and controlling for confounding variables . RESULTS Patient-centered communication was correlated with the patients ' perceptions of finding common ground . In addition , positive perceptions ( both the total score and the subscore on finding common ground ) were associated with better recovery from their discomfort and concern , better emotional health 2 months later , and fewer diagnostic tests and referrals . CONCLUSIONS Patient-centered communication influences patients ' health through perceptions that their visit was patient centered , and especially through perceptions that common ground was achieved with the physician . Patient-centered practice improved health status and increased the efficiency of care by reducing diagnostic tests and referrals PURPOSE / OBJECTIVES To describe community-based participatory processes used to develop promotore training on cancer research , and to assess the feasibility of training promotores from rural communities to disseminate cancer research information . DESIGN Prospect i ve , cohort design . SETTING Rural communities in the state of Kansas . SAMPLE 34 Spanish-speaking promotores attended an information session ; 27 enrolled and 22 completed training . METHODS With input from a community advisory board , the authors developed a leadership and cancer curriculum and trained Spanish-speaking promotores to disseminate information on cancer research . Promotores completed pretraining and post-training surveys in Spanish to assess demographic characteristics and changes in knowledge of cancer , cancer treatment and cancer research studies , and intent to participate in cancer research . MAIN RESEARCH VARIABLES Cancer knowledge , awareness of cancer clinical trials , interest in participating in cancer clinical research studies . FINDINGS Compared to pretraining , after training , promotores were more likely to correctly define cancer , identify biopsies , describe cancer stages , and report ever having heard of cancer research studies . CONCLUSIONS Completion rates of the training and willingness to participate in cancer research were high , supporting the feasibility of training promotores to deliver community-based education to promote cancer research participation . IMPLICATION S FOR NURSING Nursing professionals and research ers can collaborate with promotores to disseminate cancer education and research among underserved rural Latino communities in Kansas and elsewhere . Members of these communities appear willing and interested in improving their knowledge of cancer and cancer clinical trials Purpose : This article uses an interactional analysis instrument to characterize patient-centered care in the primary care setting and to examine its relationship with health care utilization . Methods : Five hundred nine new adult patients were r and omized to care by family physicians and general internists . An adaption of the Davis Observation Code was used to measure a patient-centered practice style . The main outcome measures were their use of medical services and related charges monitored over 1 year . Results : Controlling for patient sex , age , education , income , self-reported health status , and health risk behaviors ( obesity , alcohol abuse , and smoking ) , a higher average amount of patient-centered care recorded in visits throughout the 1-year study period was related to a significantly decreased annual number of visits for specialty care ( P = .0209 ) , less frequent hospitalizations ( P = .0033 ) , and fewer laboratory and diagnostic tests ( P = .0027 ) . Total medical charges for the 1-year study were also significantly reduced ( P = .0002 ) , as were charges for specialty care clinic visits ( P = .0005 ) , for all patients who had a greater average amount of patient-centered visits during that same time period . For female patients , the regression equation predicted 15.47 % of the variation in total annual medical charges compared with male patients , for whom 31.18 % of the variation was explained by the average percent of patient-centered care , controlling for sociodemographic variables , health status , and health risk behaviors . Conclusions : Patient-centered care was associated with decreased utilization of health care services and lower total annual charges . Reduced annual medical care charges may be an important outcome of medical visits that are patient-centered Background Patients are increasingly seen as active partners in healthcare . While patient involvement in individual clinical decisions has been extensively studied , no trial has assessed how patients can effectively be involved in collective healthcare decisions affecting the population . The goal of this study was to test the impact of involving patients in setting healthcare improvement priorities for chronic care at the community level . Methods Design : Cluster r and omized controlled trial . Local communities were r and omized in intervention ( priority setting with patient involvement ) and control sites ( no patient involvement ) . Setting : Communities in a canadian region were required to set priorities for improving chronic disease management in primary care , from a list of 37 vali date d quality indicators . Intervention : Patients were consulted in writing , before participating in face-to-face deliberation with professionals . Control : Professionals established priorities among themselves , without patient involvement . Participants : A total of 172 individuals from six communities participated in the study , including 83 chronic disease patients , and 89 health professionals . Outcomes : The primary outcome was the level of agreement between patients ’ and professionals ’ priorities . Secondary outcomes included professionals ’ intention to use the selected quality indicators , and the costs of patient involvement . Results Priorities established with patients were more aligned with core generic components of the Medical Home and Chronic Care Model , including : access to primary care , self-care support , patient participation in clinical decisions , and partnership with community organizations ( p < 0.01 ) . Priorities established by professionals alone placed more emphasis on the technical quality of single disease management . The involvement intervention fostered mutual influence between patients and professionals , which result ed in a 41 % increase in agreement on common priorities ( 95%CI : + 12 % to
Output:
| Studies engaged patients at multiple levels of the health care system and suggested that in-person deliberation with health system leadership was most effective .
Studies involving patient engagement in research focused on increasing study participation .
Discussion PFACs engage communities through individual projects but evidence of their impact on outcomes is lacking . |
MS211372 | ***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: AIMS We evaluated the feasibility and the acute performance of the everolimus-eluting bioresorbable vascular scaffolds ( BVS ) for the treatment of patients presenting with ST-segment elevation myocardial infa rct ion ( STEMI ) . METHODS AND RESULTS The present investigation is a prospect i ve , single-arm , single-centre study , reporting data after the BVS implantation in STEMI patients . Quantitative coronary angiography and optical coherence tomography ( OCT ) data were evaluated . Clinical outcomes are reported at the 30-day follow-up . The intent-to-treat population comprises a total of 49 patients . The procedural success was 97.9 % . Pre-procedure TIMI-flow was 0 in 50.0 % of the patients ; after the BVS implantation , a TIMI-flow III was achieved in 91.7 % of patients and the post-procedure percentage diameter stenosis was 14.7 ± 8.2 % . No patients had angiographically visible residual thrombus at the end of the procedure . Optical coherence tomography analysis performed in 31 patients showed that the post-procedure mean lumen area was 8.02 ± 1.92 mm(2 ) , minimum lumen area 5.95 ± 1.61 mm(2 ) , mean incomplete scaffold apposition area 0.118 ± 0.162 mm(2 ) , mean intraluminal defect area 0.013 ± 0.017 mm(2 ) , and mean percentage malapposed struts per patient 2.80 ± 3.90 % . Scaffolds with > 5 % malapposed struts were 7 . At the 30-day follow-up , target-lesion failure rate was 0 % . Non-target-vessel revascularization and target-vessel myocardial infa rct ion ( MI ) were reported . A non-target-vessel non-Q-wave MI occurred . No cases of cardiac death or scaffold thrombosis were observed . CONCLUSION In the present series , the BVS implantation in patients presenting with acute MI appeared feasible , with high rate of final TIMI-flow III and good scaffold apposition . Larger studies are currently needed to confirm these preliminary data Objective of this study was to assess the clinical performance of bioresorbable vascular scaffold ( BVS ) compared to everolimus-eluting stent ( EES ) in subjects with ST-segment elevation myocardial infa rct ion ( STEMI ) . We included all consecutive patients with STEMI who underwent percutaneous coronary intervention ( PCI ) with BVS implantation in centers participating to the Italian ABSORB Prospect i ve Registry ( BVS-RAI ) and PCI with EES in the same centers during the same period . The 2 groups were compared . The primary end point was patient-oriented composite end point ( POCE ) including cardiac death , myocardial infa rct ion , and target lesion revascularization ( TLR ) at the longest available follow-up . BVS or EES thrombosis at follow-up was also evaluated . Of the 563 patients with STEMI included , 122 received BVS and 441 EES . Procedural success was obtained in 549 ( 97.5 % ) cases without significant differences between the 2 groups ( BVS 99.3 % vs EES 97.0 % , p = 0.2 ) . At a median of 220-day ( interquartile range 178 to 369 ) follow-up , no significant differences were observed in terms of POCE ( BVS 4.9 % vs EES 7.0 % , p = 0.4 ) ; death ( BVS 0.8 % , EES 2.0 % , p = 0.4 ) , MI ( BVS 4.1 % , EES 2.0 % , p = 0.2 ) , TLR ( BVS 4.1 % , EES 4.5 % , p = 0.8 ) , device thrombosis ( BVS 2.5 % , EES 1.4 % , p = 0.4 ) . All TLR cases were successfully managed with re-PCI in both groups . A propensity matching of the study population s showed no significant differences regarding POCE at the longest available follow-up ( odds ratio 0.53 , 0.1 to 4.3 ) . In conclusion , in this direct prospect i ve comparison , BVS was associated with similar clinical results compared to EES in the STEMI setting . Larger and adequately powered r and omized trials are needed to fully assess the potential clinical benefit of BVS versus the current st and ard of care in patients with STEMI BACKGROUND In patients with coronary artery disease who receive metallic drug-eluting coronary stents , adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall . Bioresorbable vascular scaffolds have been developed to attempt to improve long-term outcomes . METHODS In this large , multicenter , r and omized trial , 2008 patients with stable or unstable angina were r and omly assigned in a 2:1 ratio to receive an everolimus-eluting bioresorbable vascular ( Absorb ) scaffold ( 1322 patients ) or an everolimus-eluting cobalt-chromium ( Xience ) stent ( 686 patients ) . The primary end point , which was tested for both noninferiority ( margin , 4.5 percentage points for the risk difference ) and superiority , was target-lesion failure ( cardiac death , target-vessel myocardial infa rct ion , or ischemia-driven target-lesion revascularization ) at 1 year . RESULTS Target-lesion failure at 1 year occurred in 7.8 % of patients in the Absorb group and in 6.1 % of patients in the Xience group ( difference , 1.7 percentage points ; 95 % confidence interval , -0.5 to 3.9 ; P=0.007 for noninferiority and P=0.16 for superiority ) . There was no significant difference between the Absorb group and the Xience group in rates of cardiac death ( 0.6 % and 0.1 % , respectively ; P=0.29 ) , target-vessel myocardial infa rct ion ( 6.0 % and 4.6 % , respectively ; P=0.18 ) , or ischemia-driven target-lesion revascularization ( 3.0 % and 2.5 % , respectively ; P=0.50 ) . Device thrombosis within 1 year occurred in 1.5 % of patients in the Absorb group and in 0.7 % of patients in the Xience group ( P=0.13 ) . CONCLUSIONS In this large-scale , r and omized trial , treatment of noncomplex obstructive coronary artery disease with an everolimus-eluting bioresorbable vascular scaffold , as compared with an everolimus-eluting cobalt-chromium stent , was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year . ( Funded by Abbott Vascular ; ABSORB III Clinical Trials.gov number , NCT01751906 . ) BACKGROUND The first CE-approved bioresorbable vascular scaffold ( BVS ) is effective at treating simple lesions and stable coronary artery disease , but it has yet to be assessed versus the best-in-class drug-eluting stents ( DES ) . OBJECTIVES This study sought to compare the performance of a BVS with that of everolimus-eluting stents ( EES ) and biolimus-eluting stents ( BES ) in all-comer patients . METHODS The EVERBIO II ( Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents II ) trial was a single-center , assessor-blinded study of 240 patients r and omly assigned in a 1:1:1 ratio to EES , BES , or BVS . The only exclusion criterion was a reference vessel diameter > 4.0 mm , which precluded treatment with BVS . The primary endpoint was angiographic late lumen loss ( LLL ) at 9 months . Secondary endpoints included patient-oriented major acute coronary events ( MACE ) ( death , myocardial infa rct ion [ MI ] , and any revascularization ) , device-oriented MACE ( cardiac death , MI , and target lesion revascularization ) , and stent thrombosis at the 9-month clinical follow-up . RESULTS Follow-up angiography was performed in 216 patients ( 90.7 % ) at 9 months . In-stent LLL was similar between patients treated with BVS ( 0.28 ± 0.39 mm ) and those treated with EES/BES ( 0.25 ± 0.36 mm ; p = 0.30 ) . Clinical outcomes were similar at 9 months : the patient-oriented MACE rate was 27 % in BVS and 26 % in the EES/BES group ( p = 0.83 ) and the device-oriented MACE rate was 12 % in BVS and 9 % in the EES/BES group ( p = 0.6 ) . CONCLUSIONS New-generation metallic DES ( EES/BES ) were not superior to BVS in terms of angiographic LLL and clinical outcomes . ( Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents [ EVERBIO II ] ; NCT01711931 ) OBJECTIVES This study sought to perform clinical and imaging assessment s of the DESolve Bioresorbable Coronary Scaffold ( BCS ) . BACKGROUND BCS , which is drug eluting , may have potential advantages compared with conventional metallic drug-eluting stents . The DESolve system , design ed to provide vessel support and neointimal suppression , combines a poly-l-lactic acid-based scaffold with the antiproliferative myolimus . METHODS The DESolve First-in-Man ( a non-r and omized , consecutive enrollment evaluation of the DESolve myolimus eluting bioresorbable coronary stent in the treatment of patients with de novo native coronary artery lesions ) trial was a prospect i ve multicenter study enrolling 16 patients eligible for treatment . The principal safety endpoint was a composite of cardiac death , myocardial infa rct ion , and clinical ly indicated target lesion revascularization . The principal imaging endpoint was in-scaffold late lumen loss ( LLL ) assessed by quantitative coronary angiography ( QCA ) at 6 months . Intravascular ultrasound ( IVUS ) and optical coherence tomography ( OCT ) imaging was performed at baseline and 6 months ; multislice computed tomography ( MSCT ) was performed at 12 months . RESULTS Acute procedural success was achieved in 15 of 15 patients receiving a study scaffold . At 12 months , there was no scaffold thrombosis and no major adverse cardiac events directly attributable to the scaffold . At 6 months , in-scaffold LLL ( by QCA ) was 0.19 ± 0.19 mm ; neointimal volume ( by IVUS ) was 7.19 ± 3.56 % , with no evidence of scaffold recoil or late malapposition . Findings were confirmed with OCT and showed uniform , thin neointimal coverage ( 0.12 ± 0.04 mm ) . At 12 months , MSCT demonstrated excellent vessel patency . CONCLUSIONS This study demonstrated the feasibility and efficacy of the DESolve BCS . Results showing low in-scaffold LLL , low % neointimal volume at 6 months , no chronic recoil , and maintenance of lumen patency at 12 months prompt further study . ( DESolve First-in-Man ; EudraCT number 2011 - 000027 - 32 )
Output:
| Our meta- analysis suggests a significantly higher risk of TVMI with BRS compared with conventional stents and no significant differences in the rates of occurrence of the other outcomes during one-year follow-up . |
MS211373 | ***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: Little is known about the effects of successful psychotherapy on brain function in subjects with anxiety disorders . The present study aim ed to identify changes in brain activation following cognitive-behavioral therapy ( CBT ) in subjects suffering from specific phobia . Using functional magnetic resonance imaging ( fMRI ) , brain activation to spider videos was measured in 28 spider phobic and 14 healthy control subjects . Phobics were r and omly assigned to a therapy-group ( TG ) and a waiting-list control group ( WG ) . Both groups of phobics were scanned twice . Between scanning sessions , CBT was given to the TG . Before therapy , brain activation did not differ between both groups of phobics . As compared to control subjects , phobics showed greater responses to spider vs. control videos in the insula and anterior cingulate cortex ( ACC ) . CBT strongly reduced phobic symptoms in the TG while the WG remained behaviorally unchanged . In the second scanning session , a significant reduction of hyperactivity in the insula and ACC was found in the TG compared to the WG . These results propose that increased activation in the insula and ACC is associated with specific phobia , whereas an attenuation of these brain responses correlates with successful therapeutic intervention Significance Functional MRI ( fMRI ) is 25 years old , yet surprisingly its most common statistical methods have not been vali date d using real data . Here , we used resting-state fMRI data from 499 healthy controls to conduct 3 million task group analyses . Using this null data with different experimental design s , we estimate the incidence of significant results . In theory , we should find 5 % false positives ( for a significance threshold of 5 % ) , but instead we found that the most common software packages for fMRI analysis ( SPM , FSL , AFNI ) can result in false-positive rates of up to 70 % . These results question the validity of a number of fMRI studies and may have a large impact on the interpretation of weakly significant neuroimaging results . The most widely used task functional magnetic resonance imaging ( fMRI ) analyses use parametric statistical methods that depend on a variety of assumptions . In this work , we use real resting-state data and a total of 3 million r and om task group analyses to compute empirical familywise error rates for the fMRI software packages SPM , FSL , and AFNI , as well as a nonparametric permutation method . For a nominal familywise error rate of 5 % , the parametric statistical methods are shown to be conservative for voxelwise inference and invalid for clusterwise inference . Our results suggest that the principal cause of the invalid cluster inferences is spatial autocorrelation functions that do not follow the assumed Gaussian shape . By comparison , the nonparametric permutation test is found to produce nominal results for voxelwise as well as clusterwise inference . These findings speak to the need of validating the statistical methods being used in the field of neuroimaging Neurofunctional mechanisms underlying cognitive behavior therapy ( CBT ) are still not clearly understood . This functional magnetic resonance imaging ( fMRI ) study focused on changes in brain activation as a result of one-session CBT in patients suffering from spider phobia . Twenty-six female spider phobics and 25 non-phobic subjects were presented with spider pictures , generally disgust-inducing , generally fear-inducing and affectively neutral scenes in an initial fMRI session . Afterwards , the patients were r and omly assigned to either a therapy group ( TG ) or a waiting list group ( WG ) . The scans were repeated one week after the treatment or after a one-week waiting period . Relative to the non-phobic participants , the patients displayed increased activation in the amygdala and the fusiform gyrus as well as decreased activation in the medial orbitofrontal cortex ( OFC ) during the first exposure . The therapy effect consisted of increased medial OFC activity in the TG relative to the WG . Further , therapy-related reductions in experienced somatic anxiety symptoms were positively correlated with activation decreases in the amygdala and the insula . We conclude that successful treatment of spider phobia is primarily accompanied by functional changes of the medial OFC . This brain region is crucial for the self-regulation of emotions and the relearning of stimulus-reinforcement associations BACKGROUND The study aim ed to identify brain activation during direct and automatic processing of phobogenic stimuli in specific phobia . METHODS Responses to phobia-related and neutral pictures ( spiders and mushrooms ) were measured by means of event-related functional magnetic resonance imaging during two different tasks . In the identification task , subjects were asked to identify the object ( spider or mushroom ) . In a dem and ing distraction task , subjects had to match geometric figures displayed in the foreground of the pictures . RESULTS Phobics showed greater responses to spiders versus mushrooms in the left amygdala , left insula , left anterior cingulate gyrus ( ACC ) , and left dorsomedial prefrontal cortex ( DMPFC ) during the identification task and in the left and right amygdala during the distraction task . All of these activations were also significantly increased compared to control subjects who did not show stronger brain activation to spiders versus mushrooms under any task condition . CONCLUSIONS Our findings propose specific neural correlates of automatic versus direct evaluation of phobia-relevant threat . While the amygdala , especially the right amygdala , seems to be crucially involved in automatic stimuli processing , activation of areas such as the insula , ACC and DMPFC is rather associated with direct threat evaluation and requires sufficient attentional re sources BACKGROUND Neurocircuitry models of anxiety disorders suggest dysregulated mechanisms encompassing both automatic and elaborate threat processing . However , the extent to which these processes might be differentially modified by psychotherapy and the neural basis of such changes are unknown . We examined the effects of cognitive-behavioral therapy ( CBT ) in patients with anxiety disorder on brain responses to subliminal and supraliminal threat . METHODS 3-Tesla functional magnetic resonance imaging was used to assess neural responses to disorder-related stimuli , presented during two backward-masking conditions employed to manipulate stimulus awareness . In 28 spider-phobic patients r and omly assigned to a therapy group or a waiting-list control group scanning was performed before and after completing CBT or a waiting period . Scanning was performed one time in 16 healthy control subjects . Self-report and behavioral measures were used to relate CBT-mediated brain activation changes with symptom improvement . RESULTS Untreated patients demonstrated abnormal hyperactivation in the amygdala , fusiform gyrus , insula , anterior cingulate cortex , and dorsomedial prefrontal cortex . Successful CBT was reflected in an overall downregulation in these fear circuitry structures , especially in the right amygdala and anterior cingulate cortex , with reductions in amygdala responsiveness associated with self-reported symptom improvement . However , subliminal threat induced a pattern of right-lateralized hyperactivation in the amygdala and fusiform gyrus that was subject to intersession habituation across groups without showing significant sensitivity to CBT . CONCLUSIONS These results challenge prevailing models that emphasize a role for amygdala automaticity in the maintenance of anxiety . Our results suggest CBT-related changes in neural activation associated with fear responses to consciously perceived threat Anxiety disorder patients were repeatedly found to overestimate the association between disorder-relevant stimuli and aversive outcomes despite r and om contingencies . Such an illusory correlation ( IC ) might play an important role in the return of fear after extinction learning ; yet , little is known about how this cognitive bias emerges in the brain . In a functional magnetic resonance imaging study , 18 female patients with spider phobia and 18 healthy controls were exposed to pictures of spiders , mushrooms and puppies followed r and omly by either a painful electrical shock or nothing . In advance , both patients and healthy controls expected more shocks after spider pictures . Importantly , only patients with spider phobia continued to overestimate this association after the experiment . The strength of this IC was predicted by increased outcome aversiveness ratings and primary sensory motor cortex activity in response to the shock after spider pictures . Moreover , increased activation of the left dorsolateral prefrontal cortex ( dlPFC ) to spider pictures predicted the IC . These results support the theory that phobia-relevant stimuli amplify unpleasantness and sensory motor representations of aversive stimuli , which in turn may promote their overestimation . Hyper-activity in dlPFC possibly reflects a pre-occupation of executive re sources with phobia-relevant stimuli , thus complicating the accurate monitoring of objective contingencies and the unlearning of fear Behavioural studies suggest that phobic subjects are hypersensitive in the processing of phobia-related linguistic stimuli . We used functional magnetic resonance imaging ( fMRI ) to investigate blood oxygen level dependent ( BOLD ) brain activation to phobia-relevant words in spider phobic and non-phobic subjects . Phobia-related versus phobia-unrelated words elicited increased activation in prefrontal cortex , insula , and posterior cingulate cortex in spider phobics , while these effects were absent in controls . Furthermore , between-group comparisons confirmed that differential activations within these brain regions were specifically due to increased responses to phobia-related stimuli in phobics . Our results provide first insights into brain activation patterns when phobics are confronted with phobia-specific linguistic information und suggest a neural network for the processing of these threatening stimuli BACKGROUND The amygdala is implicated as a key brain structure in fear processing . Studies exploring this process using the paradigm of fear conditioning have implicated the amygdala in fear acquisition and in generating behavioral fear responses . As such , fear extinction could be expected to induce a reduction in amygdala activity . However , exposure in specific phobia has never been shown persistently to reduce amygdala activity . METHODS By means of event-related functional magnetic resonance imaging , responses to phobia-related , general threat , and neutral pictures were measured before and 2 weeks after an intensive exposure session in 20 subjects with specific phobia for spiders and compared with healthy control subjects . RESULTS Phobic subjects showed increased amygdala activity at baseline . This hyperactivity was significantly reduced 2 weeks after exposure therapy . Furthermore , a significant reduction of hyperactivity in anterior cingulate cortex and insula was found postexposure . CONCLUSIONS To our knowledge , this is the first study demonstrating the effect of exposure on the amygdala in specific phobia . Our findings suggest that exposure therapy can have an effect on subcortical structures Visiting the dentist is often accompanied by apprehension or anxiety . People , who suffer from specific dental phobia ( a disproportional fear of dental ) procedures show psychological and physiological symptoms which make dental treatments difficult or impossible . For such purpose s , hypnosis is often used in dental practice as an alternative for a number of treatments adjuvant or instead of sedation or general anaesthetics , as medication is often associated with risks and side effects . This is the first study to address the effects of a brief dental hypnosis on the fear processing structures of the brain in dental phobics using functional magnetic resonance imaging ( fMRI ) . 12 dental phobics ( DP ; mean 34.9years ) and 12 healthy controls ( CO ; mean 33.2years ) were scanned with a 3 T MRI whole body-scanner observing brain activity changes after a brief hypnotic invervention . An fMRI event-related design symptom provocation task applying animated audio-visual pseudor and omized strong phobic stimuli was presented in order to maximize the fearful reactions during scanning . Control videos showed the use of familiar electronic household equipment . In DP group , main effects of fear condition were found in the left amygdala and bilaterally in the anterior cingulate cortex ( ACC ) , insula and hippocampu ( R < L ) . During hypnosis DP showed a significantly reduced activation in all of these areas . Reduced neural activity patterns were also found in the control group . No amygdala activation was detected in healthy subjects in the two experimental conditions . Compared to DP , CO showed less bilateral activation in the insula and ACC in the awake condition . Findings show that anxiety-provoking stimuli such as undergoing dental surgery , endodontic treatments or insufficient anaesthetics , can be effectively reduced under hypnosis . The present study gives scientific evidence that hypnosis is a powerful and successful method for inhibiting the reaction of the fear circuitry structures
Output:
| Analyses including ROI-based studies revealed differences between phobics and healthy subjects in several regions of the limbic circuit .
However , when focusing on whole-brain analysis , only the anterior midcingulate cortex differentiated SP from controls .
The inclusion of ROI-based results artificially inflates group differences in fMRI meta-analyses . |
MS211374 | ***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 prospect i ve , r and omized study of 158 patients undergoing in-vitro fertilization ( IVF ) and embryo transfer was conducted to evaluate whether a shortened exposure of oocytes to spermatozoa enhances oocyte development , and subsequently influences the IVF outcome . A comparison was made between conventional treatment time and shorter exposure of retrieved oocytes to spermatozoa . Fertilization and cleavage rates , embryo quality , implantation and pregnancy rates in the study group ( short exposure ) versus controls ( st and ard IVF procedure ) were evaluated . Fertilization ( 56 versus 61 % ) and cleavage rates ( 96 versus 92 % ) were similar in the two groups respectively . However , embryo quality was significantly higher in the study group ( P < 0.05 ) . Moreover , the pregnancy and implantation rates were significantly increased ( 42.4 versus 26 % per embryo transfer , and 16 versus 10 % respectively ; P < 0.05 ) . Our results demonstrated that shorter exposure of oocytes to spermatozoa is superior to the st and ard time in IVF and may have a favourable effect on implantation rates by improving embryo quality OBJECTIVE To confirm whether brief exposure of human oocytes to spermatozoa in vitro results in equivalent fertilization rates and possibly better quality embryos than overnight coincubation and to determine if there was a difference in outcome with regard to the type of culture medium used . DESIGN Prospect i ve distribution of gametes between treatments in sequential patients . SETTING Assisted reproductive technology program in private hospital . PATIENT(S ) Consecutively treated subfertile couples entering an infertility program . INTERVENTION(S ) Assisted reproductive technology treatment for infertility involving oocyte retrieval and in vitro fertilization . MAIN OUTCOME MEASURE(S ) When possible , the outcome of fertilization and embryo quality were compared when gametes were coincubated for 1 hour or overnight . Two different formulations of human tubal fluid were compared in some cases . RESULT ( S ) There was no statistically significant difference in fertilization rates between a brief or overnight coincubation of gametes or between the two treatment groups with regard to the type of culture medium used . The quality of the embryos was significantly better in the 1-hour exposure group . The embryos in Basal XI human tubal fluid medium were of significantly better morphological quality than their siblings in D3 + human tubal fluid medium . CONCLUSION ( S ) Coincubation of oocytes and spermatozoa for a shorter period produced embryos of superior morphological quality than the generally accepted overnight protocol . A simple glucose and phosphate-free human tubal fluid medium result ed in early cleavage embryos of better morphological quality than a medium supplemented with glucose , taurine , and glutathione Human oocyte development was evaluated after a reduced time exposure to spermatozoa in vitro . A total of 119 patients were assigned to two study groups in a r and omized prospect i ve study in which each patient 's oocytes were exposed to spermatozoa for either 1 h ( group 1 - 58 patients ) or the st and ard 16 h incubation period ( group 2 - 61 patients ) . The fertilization rate obtained in group 1 was higher than in group 2 ( 285/393 , 73 % , and 272/410 , 66 % respectively ) , suggesting that the spermatozoa-oocyte interaction occurs within 1 h. This was confirmed in a study in vitro using fluorescently labelled spermatozoa and normal oocyte-cumulus complexes . Spermatozoa enter the cumulus complex within 15 min , traverse the cumulus layer within 3 h , and first appear in the oocyte cortex at 4 h post-insemination . The incidence of polyspermy was higher in oocytes exposed to spermatozoa for 16 h ( 3 % ) than for 1 h ( 1 % ) . There was no difference in the cleavage rate or morphological characteristics of embryos from both study groups . However , when evaluating the timing of embryo development , group 1 generated a significantly higher percentage of four to five cell embryos when compared to group 2 ( 55 versus 39 % ; P < 0.001 ) , documented at 40 h post-insemination . The implantation and pregnancy rates for group 1 were 11 and 28 % , while the corresponding rates for group 2 were 8 and 15 % . This suggests that a reduced exposure of oocyte to spermatozoa favours embryo viability , possibly due to a decrease in potential damage from sperm metabolic waste products Purpose : Recent studies showed a beneficial effect of reducing the time of sperm – oocyte interaction on fertilization , division , and implantation rates of the oocytes obtained from r and omized patients . In the present study , the effects of reduced insemination time on fertilization and embryo development were evaluated by using sibling oocytes from the same patient . Methods : A total of 464 oocytes from 36 patients was r and omly allocated to be inseminated for either 1 hr ( reduced ) or 18 hr ( regular ) . Results : Fertilization rates were not significantly different between reduced ( 135/229 ; 59 % ) and regular ( 150/235 ; 64 % ) groups . Cleavage rates and embryo quality were similar in both groups . A total of 135 embryos ( 73 from the reduced and 62 from the regular group ) was transferred to 36 patients . Thirty-four embryos implanted in 18 patients ( 25.2 % implantation and 50.0 % pregnancy rates ) . Conclusions : Fertilization , cleavage , and embryo development from 1-hr insemination is comparable , not superior , to those from an 18-hr insemination time , which is commonly used in in vitro fertilization programs . These data suggest that reduced insemination time can be used during in vitro fertilization to avoid unnecessarily longer exposure to spermatozoa BACKGROUND Traditionally oocytes have been exposed to sperm overnight , for 16 - 20 h. This long period of co-incubation , however , has been shown to create problems with high levels of reactive oxygen species ( ROS ) , which may affect embryo viability and cause hardening of the zona pellucida . Recently , a positive effect of reducing the co-incubation time to 90 - 120 min was reported . The objective of this study was to evaluate whether a further reduction of the co-incubation period could benefit the outcome of IVF . METHODS In this prospect i ve study , 777 sibling oocytes from 81 women undergoing IVF were divided via alternate allocation to co-incubation for either 30 s ( ultrashort co-incubation ) ( group A ) or for 90 min ( st and ard co-incubation ) ( group B ) . Endpoints were normal fertilization ( two-pronuclear , 2PN ) , polyspermy ( > 2PN ) , embryo quality ( EQ ) , clinical pregnancy ( CP ) and implantation ( IR ) . RESULTS The normal fertilization rates of the two groups were comparable : group A 58.6 % versus group B 58.0 % . Significantly lower rates of polyspermy were seen in group A compared to group B ( 2.8 versus 7.2 % , P = 0.008 ) . No statistically significant differences in EQ , CP or IR were seen . CONCLUSION This is the first study demonstrating the achievement of good fertilization rates in IVF with ultrashort co-incubation . Significantly lower rates of polyspermy were seen in the group with ultrashort compared to the st and ard co-incubation group . Further studies are , however , needed in order to evaluate whether ultrashort co-incubation has any effect on the outcome of IVF Comparisons were made among techniques used to treat male factor infertility . Patients with semen quality below that recognized by World Health Organization criteria as normal had a better success rate when treated by gamete intrafallopian transfer than by in vitro fertilization ( 25 % v. 7 % pregnancy rate per patient ) . When < 2 x 10(6 ) motile sperm were recovered , the fertilization rate and embryo cleavage rate were higher for microdrop insemination than for conventional insemination . When 7000 - 370,000 motile sperm were recovered , microdrop insemination result ed in a higher fertilization rate ( 46 % ) and a higher incidence of pregnancies ( 23 % of patients treated ) than subzonal sperm microinjection ( SUSM ) . However , for patients with 5000 - 50,000 motile sperm , the immediate transfer of SUSM oocytes to the Fallopian tube increased pregnancy rates for this technique to 24 % of patients treated . Direct microinjection of epididymal sperm from azoospermic men into the cytoplasm of oocytes result ed in pronuclear formation in 27 % of oocytes ; in comparison , pronuclear formation occurred in 5 % of SUSM oocytes . These data led to formulation of a logical treatment programme for male factor infertility Altering the coincubation time for spermatozoa and oocytes in vitro leads to varying results . Some authors suggest that longer exposure of spermatozoa to oocytes through coincubation is detrimental to fertilization and /or embryo development , possibly because of reactive oxygen species produced by the spermatozoa ( 1–5 ) . Other studies indicate that a decreased exposure time does not alter fertilization rates ( 3,6–9 ) and may even improve such rates ( 10–13 ) . In this report , we describe the results of our r and omized study on the effects of two coincubation times on in vitro fertilization ( IVF ) rates and embryo quality OBJECTIVE To examine the benefits of short coincubation of gametes compared to prolonged incubation in in vitro fertilization ( IVF ) . DESIGN Prospect i ve r and omized controlled study . SETTING Hospital-based fertility center . PATIENT(S ) One hundred thirty patients ( group 1 ) and 129 patients ( group 2 ) . INTERVENTION(S ) Oocytes from group 1 were exposed to spermatozoa for 2 hours , and oocytes from group 2 were exposed to spermatozoa for 20 hours . MAIN OUTCOME MEASURE(S ) Fertilization and cleavage rates , embryo quality , and pregnancy and implantation rates were evaluated . Estradiol ( E(2 ) ) and progesterone ( P(4 ) ) levels were measured in the wells of culture dishes after 2-hour exposure of oocytes/zygotes to spermatozoa in group 1 and after 20-hour exposure in both the groups . RESULT ( S ) There was no difference between the two groups in the fertilization rate and the number of embryos obtained . However , the proportion of grade 1 embryos was significantly higher among group 1 compared to group 2 patients . Clinical pregnancy and implantation rates were significantly higher among group 1 compared to group 2 . The significantly higher levels of E(2 ) and P(4 ) in the 20-hour cultures compared with the 2-hour cultures may have been detrimental to embryo quality , pregnancy , and implantation rates . CONCLUSION ( S ) Coincubation of gametes for 2 hours with st and ard or high insemination concentrations of spermatozoa significantly improved embryo quality and the pregnancy and implantation rates compared with overnight incubation of gametes Purpose Evaluate the effect of short gamete incubation on fertilization rate and embryo quality . Methods A prospect i ve study has been performed . Two thous and five hundred and forty seven sibling oocytes from 240 couples undergoing IVF attempts were allocated to a short ( 1 h ) or a st and ard ( 18 h ) insemination procedure . Diploid fertilization rate ( two pronuclei , 2PN ) , polyspermy ( > 2PN ) and embryo quality were compared . Results The fertilization rate was statistically lower in the short insemination group compared to the st and ard insemination one ( 64.9 % and 70.1 % ; P = 0.039 ) , with a similar polyspermy rate observed between the two groups . A slight , but non significant , increase was observed concerning good embryo quality rate in the short insemination group when compared to the st and ard insemination , both at day 2 ( 60.1 vs. 58.1 % ; P = 0.06 ) and day 3 ( 53.2 vs. 48.5 % ; P = 0.22 ) . Conclusion This new study highlights that a 1 h gamete exposure decreases the fertilization rate and does not improve embryo quality compared with a st and ard 18 h insemination procedure Abstract Purpose : To investigate whether very short exposure ofmature oocytes to sperm in vitro may affect the fertilizationrates , embryo cleavage rates , and embryo quality betweensibling oocytes in the same patient . Methods : Sibling oocytes of the same patient from 23 oocyte collection cycles were r and omly allocated to the study group , with a 1-hr or 3-hr sperm — oocyte incubation , or the controlgroup with the st and ard overnight gamete co-incubation . The fertilization rates , cleavage rates , and subsequentembryo quality were evaluated . Results : Our results showed no statistically significant differencesin fertilization rates , embryo cleavage rates , and quality of the embryos between the study group and thecontrol group . Conclusions : Since the present study showed that long exposureof the oocyte to sperm has no advantage over shortexposure , we prefer shortening the oocyte —
Output:
| Reduced gamete exposure time may be associated with beneficial outcomes . |
MS211375 | ***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: AIM To determine prevalence of known diabetes in those more than 20 years of age in Chennai city . METHODOLOGY Urban population was selected for the survey . Assuming the prevalence of known diabetes as 5.0 % in those aged > 20 years , the cluster sample size calculated to estimate it with 95 % CI and + /- 10 % precision , was 25800 individuals of all ages . This population obtained from 200 households in each of 30 r and omly selected corporation divisions of the city , was surveyed by social workers by house to house enquiry . General information and health status of every member of the household were recorded on prescribed forms . This survey was conducted during January-July , 1998 . RESULTS Among 26,066 individuals of all ages 779 had known diabetes and 99.4 % of them had type 2 diabetes . The prevalence of known diabetes was 2.9 % for all ages and both sexes combined . Crude and age-st and ardized prevalence was 4.9 % ( 95 % CI 4.6 - 5.2 ) for those aged > 20 years . The st and ardized prevalence was 10.5 % ( 95 % CI 9.8 - 11.2 ) in those aged > or = 40 years . The prevalence was significantly high ( P < 0.05 ) in females . CONCLUSION The prevalence of known diabetes was low in total population but increased in those aged > 20 and further increased in those aged > or = 40 years . The causes for high prevalence in > or = 40 year age group needs to be explored in this population AIMS To compare the impact on weight and exercise of a 2-year church-based diabetes risk reduction programme in four churches in South Auckl and , New Zeal and . METHODS A prospect i ve non-r and omized controlled study of a modular lifestyle and diabetes awareness intervention programme applying community development principles . The study involved four complete church congregations , two Samoan and two Tongan , with 516 participants at commencement . Risk of Type 2 diabetes is high among both ethnic groups . RESULTS Overall , 285 subjects were available for their second assessment . In one intervention church , weight gain was controlled ( vs. control 0 + /- 4.8 vs. + 3.1 + /- 9.8 kg , respectively ; P=0.05 ) , diabetes knowledge ( + 46 + /- 26 % vs. + 4 + /- 17 % ; P<0.001 ) and regular exercise ( at least 3 days per week : + 22 % vs. -8 % ; P=0.032 ) increased and readiness to change weight ( P=0.007 ) shifted towards maintenance ( e.g. maintenance + 41 % vs. + 8 % , respectively ) . The other intervention church increased diabetes knowledge ( + 19 + /- 24 vs. + 8 + /- 25 ; P<0.024 ) , but no other significant personal changes occurred . Attendance and perceived utility of the programme were greater in the first intervention church . CONCLUSIONS A moderate intensity , community-based , structured diabetes awareness and lifestyle programme can reduce diabetes risk , but increasing diabetes knowledge alone is not necessarily associated with healthier lifestyle choices . Continuous and detailed monitoring of penetration of interventions may be essential to help guide the timing of interventions and identify the need for additional strategies to increase participation and motivation AIMS To evaluate the acceptability and impact of a pilot diabetes awareness and exercise programme in a mainly Polynesian workforce . METHOD Comparison of change in question naire and anthropometric measurements in two hospital ancillary workforces . One group ( n = 108 ) received one community diabetes educator presentation , one video presentation and a 4 month exercise programme . The other group ( n = 99 ) served as controls . RESULTS Baseline diabetes knowledge was poor ( total score 26 ( SD 13 % ) ) and subjects were largely unfit with a high body mass index ( 31.5 ( 7.1 ) kg/m2 ) . The exercise sessions were well attended , although attendance declined over the 4 months . Increased diabetes knowledge was retained in the intervention group after 6 months when compared with controls ( total score 35(14)% vs 26(12)% respectively , p < 0.001 ) . One month after the termination of the programme , the proportion reporting regular exercise activity ( at least 30 minutes for 3 days per week ) had increased by 2 % in the intervention group but declined by 9 % in the control group ( p < 0.05 ) . CONCLUSIONS Diabetes knowledge and exercise can be increased in unfit subjects by the combination of culturally tailored exercise techniques and community diabetes educator/video presentations
Output:
| A range of training , management , funding and organizational barriers existed in the implementation of these lay educator programmes .
Conclusions .
Peer-to-peer support and education programmes in diabetes have been considered useful in New Zeal and . |
MS211376 | ***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: Rationale Impaired emotion processing in schizophrenia predicts broader social dysfunction and has been related to negative symptom severity and amygdala dysfunction . Pharmacological modulation of emotion-processing deficits and related neural abnormalities may provide useful phenotypes for pathophysiological investigation . Objectives We used an acute benzodiazepine challenge to identify and modulate potential emotion-processing abnormalities in 20 unaffected first-degree relatives of individuals with schizophrenia , compared to 25 control subjects without a family history of psychosis . Methods An oral 1 mg dose of the short-acting anxiolytic benzodiazepine alprazolam was administered in a balanced crossover placebo-controlled double-blind design , preceding identical 3 T fMRI sessions approximately 1 week apart . Primary outcomes included fMRI activity in amygdala and related regions during two facial emotion-processing tasks : emotion identification and emotion memory . Results Family members exhibited abnormally strong alprazolam-induced reduction in amygdala and hippocampus activation during emotion identification , compared to equal reduction in both groups for the emotion memory task . Conclusions GABAergic modulation with alprazolam produced differential responses in family members vs. controls , perhaps by unmasking underlying amygdalar and /or GABAergic abnormalities . Such pharmacological fMRI paradigms could prove useful for developing drugs targeting specific neural circuits to treat or prevent schizophrenia PURPOSE Social cognition captures affect recognition , social cue perception , " theory of mind , " empathy , and attributional style . The aim of our study was to assess social cognition in schizophrenia in patients being treated with first-generation antipsychotic drugs ( FGAs ) , n=28 ( perphenazine and haloperidol , FGAs ) or with second-generation antipsychotic drugs ( SGAs ) , n=56 ( olanzapine and clozapine , SGAs ) . SUBJECTS AND METHODS Eighty-four patients completed the Facial Expression Recognition Test , the Voice Emotion Recognition Test , the Short Recognition Memory Test for Faces , and the Reading the Mind in the Eyes Test . Patients also completed the Visual Object and Space Perception Test ( VOSP ) as a control task , which would not engage social cognition . The patients were compared with fifty healthy controls matched for age and gender . RESULTS There were no significant differences on social cognitive performance between the FGA- and SGA-treatment groups . Nor was olanzapine superior to clozapine , FGAs or both . However , patients treated with FGAs performed significantly worse on VOSP compared to both groups treated with SGAs , a 10 % difference . CONCLUSIONS We can not conclude that SGAs were associated with better social cognition than FGAs . However , there were small but significant advantages for SGAs in non-social visual processing function , as evaluated with the VOSP
Output:
| Evidence to date suggests few sex differences in FEP in schizophrenia ; both men and women across the schizophrenia spectrum have deficits in FEP |
MS211377 | ***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 purpose of this study was to investigate the physiological and psychological effects of massage on delayed onset muscle soreness ( DOMS ) . METHODS Eighteen volunteers were r and omly assigned to either a massage or control group . DOMS was induced with six sets of eight maximal eccentric contractions of the right hamstring , which were followed 2 h later by 20 min of massage or sham massage ( control ) . Peak torque and mood were assessed at 2 , 6 , 24 , and 48 h postexercise . Range of motion ( ROM ) and intensity and unpleasantness of soreness were assessed at 6 , 24 , and 48 h postexercise . Neutrophil count was assessed at 6 and 24 h postexercise . RESULTS A two factor ANOVA ( treatment v time ) with repeated measures on the second factor showed no significant treatment differences for peak torque , ROM , neutrophils , unpleasantness of soreness , and mood ( p > 0.05 ) . The intensity of soreness , however , was significantly lower in the massage group relative to the control group at 48 h postexercise ( p < 0.05 ) . CONCLUSIONS Massage administered 2 h after exercise induced muscle injury did not improve hamstring function but did reduce the intensity of soreness 48 h after muscle insult Abstract The aim of this study was to examine the effect of wearing graduated compression stockings on physiological and perceptual variables during and after intermittent ( Experiment 1 ) and continuous ( Experiment 2 ) running exercise . Fourteen recreational runners performed two multi-stage intermittent shuttle running tests with 1 h recovery between tests ( Experiment 1 ) . A further 14 participants performed a fast-paced continuous 10-km road run ( Experiment 2 ) . Participants wore commercially available knee-length graduated compression stockings ( pressure at ankle 18 – 22 mmHg ) beneath ankle-length sports socks ( experimental trials ) or just the latter ( control trials ) in a r and omized counterbalanced design ( for both experiments ) . No performance or physiological differences were observed between conditions during intermittent shuttle running . During the 10-km trials , there was a reduction in delayed-onset muscle soreness 24 h after exercise when wearing graduated compression stockings ( P < 0.05 ) . There was a marked difference in the frequency and location of soreness : two participants in the stockings trial but 13 participants in the control trial indicated soreness in the lower legs . Wearing graduated compression stockings during a 10-km road run appears to reduce delayed-onset muscle soreness after exercise in recreationally active men The aim of this investigation was to eluci date the efficacy of repeated cold water immersions ( CWI ) in the recovery of exercise induced muscle damage . A r and omised group consisting of eighteen males , mean ± s age , height and body mass were 24 ± 5 years , 1.82 ± 0.06 m and 85.7 ± 16.6 kg respectively , completed a bout of 100 drop jumps . Following the bout of damaging exercise , participants were r and omly but equally assigned to either a 12 min CWI ( 15 ± 1 ° C ; n = 9 ) group who experienced immersions immediately post-exercise and every 24 h thereafter for the following 3 days , or a control group ( no treatment ; n = 9 ) . Maximal voluntary contraction ( MVC ) of the knee extensors , creatine kinase activity ( CK ) , muscle soreness ( DOMS ) , range of motion ( ROM ) and limb girth were measured pre-exercise and then for the following 96 h at 24 h increments . In addition MVC was also recorded immediately post-exercise . Significant time effects were seen for MVC , CK , DOMS and limb girth ( p < 0.05 ) indicating muscle damage was evident , however there was no group effect or interaction observed showing that CWI did not attenuate any of the dependent variables ( p > 0.05 ) . These results suggest that repeated CWI do not enhance recovery from a bout of damaging eccentric contractions . Key pointsCryotherapy , particularly cold water immersions are one of the most common interventions used in order to enhance recovery post-exercise . There is little empirical evidence demonstrating benefits from cold water immersions . Research evidence is equivocal , probably due to method ological inconsistencies . Our results show that the cryotherapy administered did not attenuate any markers of EIMD or enhance the recovery of function . We conclude that repeated cold water immersions are ineffective in the recovery from heavy plyometric exercise and suggest athletes and coaches should use caution before using this intervention as a recovery strategy PURPOSE Venous hemodynamics evaluated during walking better reflect changes that occur under active physiologic conditions than do conventional static modes of exercise such as tip-toe exercise , knee bending , or dorsiflexion . We prospect ively studied the efficacy of air-plethysmography ( APG ) in monitoring venous hemodynamics during ambulation , and with this method we determined the hemodynamic effects of graduated elastic compression stockings on the lower limb during walking at various speeds . METHODS The residual volume fraction ( RVF% ) during treadmill walking was monitored with APG in 10 limbs with primary chronic venous insufficiency (CVI)(CEAP(2 - 4 ) ) at four speeds ( 1.0 , 1.5 , 2.0 and 2.5 km/h consecutively ) , with and without elastic compression ( 21 mm Hg at the ankle ) . The method was vali date d in comparison with st and ard APG , which is based on tip-toe exercise . RVF obtained during treadmill walking at 1.5 km/h was correlated with RVF measured with st and ard APG in 30 subjects : 12 healthy volunteers , 11 patients with primary CVI , and 7 postthrombotic limbs . Data were analyzed with nonparametric statistics . RESULTS RVF measurements during walking were reproduced with an intra-day coefficient of variation of 5.1 % to 16.5 % . RVF during walking correlated well with RVF during st and ard APG ( tip-toe ) ( r = 0.5 , P = .004 ) . At each of the investigated walking speeds , stockings improved venous hemodynamics by decreasing RVF , from a median of 50.5 % without stockings to 40.5 % with stockings at 1.0 km/h ( 19.8 % decrease ) , from 49 % to 39.5 % at 1.5 km/h ( 19.4 % decrease ) , from 50.5 % to 41 % at 2.0 km/h ( 18.8 % decrease ) , and from 53 % to 45.5 % at 2.5 km/h ( 14.2 % decrease ) ( all speeds , P < .02 ) . Efficacy of the stockings in decreasing RVF ( percent change in RVF ) was similar across the spectrum of examined speeds ( P = .47 ) . During walking with elastic stockings , nominal RVF values were also similar across the spectrum of walking speeds , except at 2.5 km/h ( P = .012 ) . During walking without stockings , RVF did not change with treadmill speed , nor did it differ from that obtained with conventional APG ( tip-toe ) ( P = .46 ) . The percentage decrease in RVF generated with elastic stockings correlated with the venous filling index ( r = 0.73 , P = .017 ) at 1.0 km/h . CONCLUSIONS APG is a reproducible and valid method for monitoring venous hemodynamics during walking . Graduated elastic compression stockings significantly improved venous hemodynamics by reducing RVF in limbs with primary CVI at all examined walking speeds ( 1.0 to 2.5 km/h ) . The effect was linearly correlated with the amount of reflux ( 1.0 km/h ) . The modified application of APG during walking offers a new noninvasive method for assessment of venous hemodynamics in limbs with CVI , enabling quantification of the actual effect of elastic compression therapy during ambulation PURPOSE The aim of this study was to determine whether compression garments improve intermittent-sprint performance and aid performance or self-reported recovery from high-intensity efforts on consecutive days . METHODS Following familiarization , 14 male rugby players performed two r and omized testing conditions ( with or without garments ) involving consecutive days of a simulated team sport exercise protocol , separated by 24 h of recovery within each condition and 2 weeks between conditions . Each day involved an 80-min high-intensity exercise circuit , with exercise performance determined by repeated 20-m sprints and peak power on a cart dynamometer ( single-man scrum machine ) . Measures of nude mass , heart rate , skin and tympanic temperature , and blood lactate ( La- ) were recorded throughout each day ; also , creatine kinase ( CK ) and muscle soreness were recorded each day and 48 h following exercise . RESULTS No differences ( P=.20 to 0.40 ) were present between conditions on either day of the exercise protocol for repeated 20-m sprint efforts or peak power on a cart dynamometer . Heart rate , tympanic temperature , and body mass did not significantly differ between conditions ; however , skin temperature was higher under the compression garments . Although no differences ( P=.50 ) in La- or CK were present , participants felt reduced levels of perceived muscle soreness in the ensuing 48 h postexercise when wearing the garments ( 2.5+/-1.7 vs 3.5+/-2.1 for garment and control ; P=.01 ) . CONCLUSIONS The use of compression garments did not improve or hamper simulated team-sport activity on consecutive days . Despite benefits of reduced self-reported muscle soreness when wearing garments during and following exercise each day , no improvements in performance or recovery were apparent Objective : To compare the effects of three types of full-body compression garments ( Skins , Adidas and Under Armour ) on repeat-sprint and throwing performance in cricket players . Methods : Following familiarisation , 10 male cricket players performed four r and omised exercise sessions ( 3 garments and a control ) . Each session involved a 30 min repeat-sprint exercise protocol comprising 20 m sprints every minute , separated by submaximal exercise . Throwing tests included a pre-exercise and a postexercise maximal distance test and accuracy throwing tests . During each session , measures of heart rate , skin temperature , change in body mass , rate of perceived exertion and perceived muscle soreness were recorded . Capillary blood sample s were analysed before and after exercise for lactate , pH , O2 saturation and O2 partial pressure , and 24 h after exercise for creatine kinase ( CK ) . Ratings of perceived muscle soreness were also obtained 24 h after exercise . Results : No significant differences ( p>0.05 ) were evident in repeat-sprint performance ( 10 m , 20 m time or total submaximal distance covered ) or throwing performance ( maximum distance or accuracy ) . No significant differences ( p>0.05 ) were observed in heart rate , body mass change or blood measures during exercise . Significant differences ( p<0.05 ) were observed by way of higher mean skin temperature , lower 24 h postexercise CK values and lower 24 h postexercise ratings of muscle soreness when wearing compression garments . Analysis between respective br and s of compression garments revealed no statistical differences ( p>0.05 ) . Conclusions : No benefit was noted when wearing compression garments for repeat-sprint or throwing performance ; however , the use of the garments as a recovery tool , when worn after exercise , may be beneficial to reduce postexercise trauma and perceived muscle soreness PURPOSE This study was conducted to determine if 6 wk of supplementation with vitamins E and C could alleviate exercise-induced muscle damage . We studied 22 runners during a 50-km ultramarathon . METHODS Subjects were r and omly assigned to one of two groups : ( a ) placebos ( PL ) or ( b ) antioxidants ( AO ) ( 1000 mg vitamin C and 300 mg RRR-alpha-tocopheryl acetate ) . Blood sample s were obtained before supplementation ( baseline ) , 24 h pre- , 12 h pre- , and 1 h prerace ; midrace , postrace , 2 h postrace , and for 6 d postrace . Plasma alpha-tocopherol ( alpha-TOH ) , ascorbic acid ( AA ) , and muscle damage markers ( creatine kinase ( CK ) and lactate dehydrogenase ( LDH ) ) , as well as maximal voluntary contraction ( MVC ) of the hamstring and quadriceps were assessed . RESULTS With supplementation , plasma alpha-TOH and AA increased in the AO but not the PL group . LDH and CK increased in response to the race ; LDH peaked at postrace and CK reached maximal values 2 h and 1 d postrace ; neither was affected by treatment . Adjusting for between-subject differences in baseline CK values revealed that men had higher levels of CK than did women throughout the study . Correcting CK values for lean body mass ( kg ) eliminated sex differences , but not changes over time . CK was significantly correlated ( R = 0.52 , P < 0.0001 ) with C-reactive protein , an acute phase response marker . MVC decreased 14 - 26 % in all groups in response to the run . Eccentric hamstring ( EH ) torque and concentric quadriceps ( CQ ) power exhibited the largest deficits , 26 and 24 % , respectively , with no effect of treatment . CQ recovered at a faster rate in women than in men . CONCLUSION Antioxidants appeared to have no effect on exercise-induced increases in muscle damage or recovery , but important sex differences were observed BACKGROUND The true frequency of deep-vein thrombosis ( DVT ) during long-
Output:
| These results indicate that compression garments are effective in enhancing recovery from muscle damage |
MS211378 | ***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 Recent increases in incidence and survival of oropharyngeal cancers in the United States have been attributed to human papillomavirus ( HPV ) infection , but empirical evidence is lacking . PATIENTS AND METHODS HPV status was determined for all 271 oropharyngeal cancers ( 1984 - 2004 ) collected by the three population -based cancer registries in the Surveillance , Epidemiology , and End Results ( SEER ) Residual Tissue Repositories Program by using polymerase chain reaction and genotyping ( Inno-LiPA ) , HPV16 viral load , and HPV16 mRNA expression . Trends in HPV prevalence across four calendar periods were estimated by using logistic regression . Observed HPV prevalence was reweighted to all oropharyngeal cancers within the cancer registries to account for nonr and om selection and to calculate incidence trends . Survival of HPV-positive and HPV-negative patients was compared by using Kaplan-Meier and multivariable Cox regression analyses . RESULTS HPV prevalence in oropharyngeal cancers significantly increased over calendar time regardless of HPV detection assay ( P trend < .05 ) . For example , HPV prevalence by Inno-LiPA increased from 16.3 % during 1984 to 1989 to 71.7 % during 2000 to 2004 . Median survival was significantly longer for HPV-positive than for HPV-negative patients ( 131 v 20 months ; log-rank P < .001 ; adjusted hazard ratio , 0.31 ; 95 % CI , 0.21 to 0.46 ) . Survival significantly increased across calendar periods for HPV-positive ( P = .003 ) but not for HPV-negative patients ( P = .18 ) . Population -level incidence of HPV-positive oropharyngeal cancers increased by 225 % ( 95 % CI , 208 % to 242 % ) from 1988 to 2004 ( from 0.8 per 100,000 to 2.6 per 100,000 ) , and incidence for HPV-negative cancers declined by 50 % ( 95 % CI , 47 % to 53 % ; from 2.0 per 100,000 to 1.0 per 100,000 ) . If recent incidence trends continue , the annual number of HPV-positive oropharyngeal cancers is expected to surpass the annual number of cervical cancers by the year 2020 . CONCLUSION Increases in the population -level incidence and survival of oropharyngeal cancers in the United States since 1984 are caused by HPV infection OBJECTIVE To design a reliable and vali date d self-administered question naire whose purpose is to assess dysphagia 's effects on the quality of life ( QOL ) of patients with head and neck cancer . DESIGN Cross-sectional survey study . METHODS Focus groups were convened for question naire development and design . The M. D. And erson Dysphagia Inventory ( MDADI ) included global , emotional , functional , and physical subscales . One hundred consecutive adult patients with a neoplasm of the upper aerodigestive tract who underwent evaluation by our Speech Pathology team completed the MDADI and the Medical Outcomes Study 36-Item Short Form Health Survey ( SF-36 ) . Speech pathologists completed the Performance Status Scale for each patient . Validity and reliability properties were calculated . Analysis of variance was used to assess how well the MDADI discriminated between groups of patients . RESULTS The internal consistency reliability of the MDADI was calculated using the Cronbach alpha coefficient . The Cronbach alpha coefficients of the MDADI subscales ranged from 0.85 to 0.93 . Test-retest reliability coefficients of the subscales ranged from 0.69 to 0.88 . Spearman correlation coefficients between the MDADI subscales and the SF-36 subscales demonstrated construct validity . Patients with primary tumors of the oral cavity and oropharynx had significantly greater swallowing disability with an adverse impact on their QOL compared with patients with primary tumors of the larynx and hypopharynx ( P<.001 ) . Patients with a malignant lesion also had significantly greater disability than patients with a benign lesion ( P<.001 ) . CONCLUSIONS The MDADI is the first vali date d and reliable self-administered question naire design ed specifically for evaluating the impact of dysphagia on the QOL of patients with head and neck cancer . St and ardized question naires that measure patients ' QOL offer a means for demonstrating treatment impact and improving medical care . The development and validation of the MDADI and its use in prospect i ve clinical trials allow for better underst and ing of the impact of treatment of head and neck cancer on swallowing and of swallowing difficulty on patients ' QOL OBJECTIVE To evaluate changes in patient-perceived swallowing function over time following transoral robotic surgery ( TORS ) for primary T1 and T2 oropharyngeal squamous cell carcinomas . DESIGN Prospect i ve case series . SETTING Academic tertiary referral center . PATIENTS Forty-two patients with T1 or T2 oropharyngeal squamous cell carcinomas . INTERVENTION TORS-assisted resection of indicated tumors . MAIN OUTCOME MEASURES Changes in patient-perceived swallowing function over time ( using the M. D. And erson Dysphagia Inventory ) and gastrostomy tube dependence . RESULTS Between March 19 , 2007 , and April 21 , 2010 , forty-two patients with primary T1 or T2 oropharyngeal squamous cell carcinomas underwent TORS-assisted resection . Most ( 76 % [ 32 of 42 ] ) patients had stage III disease ; 93 % ( 39 of 42 ) of patients underwent staged neck dissection . The median postoperative follow-up time was 17 months ( range , 4 - 40 months ) . There were no complications or tumor recurrences . Postoperative chemotherapy use predicted gastrostomy tube retention for longer than 3 months ( P = .01 ) . Immediate mean postoperative M. D. And erson Dysphagia Inventory scores in each assessed domain ( global , emotional , physical , and functional ) decreased compared with preoperative baseline scores ; however , ongoing improvement in all domains was observed over time . Nodal status ( P = .049 ) , follow-up time of less than 12 months ( P = .03 ) , and preoperative physical scores of less than 100 ( P = .01 ) predicted poorer physical M. D. And erson Dysphagia Inventory outcomes . Positive pathological margins predicted poorer functional scores ( P = .03 ) . CONCLUSIONS After TORS-assisted resection of T1 and T2 oropharyngeal squamous cell carcinomas , approximately one-third of patients will experience a sustained decrease in perceived swallowing function . However , ongoing improvement of swallowing function over time is likely even after 12 months . Patients receiving adjuvant chemotherapy after TORS should be counseled about the possibility of prolonged gastrostomy tube dependence OBJECTIVE To describe and show the feasibility of a new surgical technique for transoral robotic surgery ( TORS ) radical tonsillectomy . DESIGN A prospect i ve , phase 1 clinical trial . SETTING Academic , tertiary referral center . PATIENTS A total of 27 participants were prospect ively selected using a volunteer sample . All eligible patients agreed to participate in the study . INTERVENTIONS Patients underwent TORS radical tonsillectomy for previously untreated invasive squamous cell carcinoma of the tonsillar region without free-flap reconstruction , staged neck dissection , and adjuvant therapy . MAIN OUTCOME MEASURES Outcome measures included final pathologic margin status , need for short- and long-term tracheotomy tube placement , and need for gastrostomy tube feedings among patients with a minimum 6-month follow-up . The incidence of significant postoperative complications was recorded . RESULTS No mortality occurred . Final margins found to be negative for cancer were achieved in 25 of 27 patients ( 93 % ) . Surgical complications included 1 case each of postoperative mucosal bleeding , delirium tremens , unplanned tracheotomy for temporary exacerbation of sleep apnea , and hypernasality and 2 cases of moderate trismus . Twenty-six of 27 patients ( 96 % ) were swallowing without the use of a gastrostomy . CONCLUSIONS Radical tonsillectomy using TORS is a new technique that offers excellent access for resection of carcinomas of the tonsil with acceptable acute morbidity . Future reports will focus on long-term oncologic and functional outcomes OBJECTIVES /HYPOTHESIS To investigate the feasibility of transoral robotic surgery as a method of surgical treatment of oropharyngeal squamous cell carcinoma . STUDY DESIGN Prospect i ve case study . METHODS Forty-five patients with previously untreated oropharyngeal squamous cell carcinoma underwent transoral robotic surgical removal of the tumor with or without neck dissection and with or without adjuvant therapy . Patients were observed and data were recorded on surgical time , blood loss , surgical complications , tracheostomy tube course , enteral feeding , and resumption of oral diet , speech outcomes , swallowing outcomes , and tumor recurrence . RESULTS All 45 patients underwent complete transoral robotic surgical excision with simultaneous unilateral or bilateral neck dissection . Margins were negative for tumor . Mean operating time for tumor removal was 71.3 minutes for the last 35 cases . There were 15 stage T1 tumors , 18 T2 tumors , 3 T3 tumors , and 9 T4a tumors . Twenty-six patients had base of tongue primary tumors and 19 had tonsillar fossa tumors . Fourteen patients had a tracheostomy tube placed at surgery , and all patients had their tracheostomy tube removed ( mean duration of use , 7.0 days ) . Twenty-two patients ( 48.9 % ) had a nasogastric feeding tube placed , and all patients had their feeding tube removed ( mean duration of use , 12.5 days ) . Eight patients had percutaneous gastrostomy ( PEG ) tubes placed , and all eight eventually had their PEG tubes removed ( mean duration of use , 140.3 days ) . Average hospital stay was 3.8 days . There were no major complications and no procedure was aborted because of an inability to remove the tumor . CONCLUSIONS Transoral robotic surgery is a safe and efficacious method of surgical treatment of oropharyngeal neoplasms . Advantages of the technique include adequate ability to visualize and manipulate with two h and s lesions in the base of tongue . Patients were able to retain or rapidly regain oropharyngeal function in the majority of cases OBJECTIVES To determine the oncologic and functional outcomes in patients undergoing primary transoral robotic surgery followed by adjuvant therapy as indicated with a minimum of 18-month follow-up for advanced oropharyngeal carcinoma . DESIGN Prospect i ve single-center cohort study . SETTING Academic university health system and tertiary referral center . PATIENTS Forty-seven adults with newly diagnosed and previously untreated advanced oropharyngeal carcinoma . INTERVENTION Transoral robotic surgery with staged neck dissection and adjuvant therapy as indicated . MAIN OUTCOME MEASURES Margin status , recurrence , disease-specific and disease-free survival , gastrostomy tube dependence , and safety and efficacy end points . RESULTS In the 47 patients enrolled with stages III and IV advanced oropharyngeal carcinoma , mean follow-up was 26.6 months . There was no intraoperative or postoperative mortality . Resection margins were positive in 1 patient ( 2 % ) . At last follow-up , local recurrence was identified in 1 patient ( 2 % ) , regional recurrence in 2 ( 4 % ) , and distant recurrence in 4 ( 9 % ) . Disease-specific survival was 98 % ( 45 of 46 patients ) at 1 year and 90 % ( 27 of 30 patients ) at 2 years . Based on pathologic risk stratification , 18 of 47 patients ( 38 % ) avoided chemotherapy , and 5 patients ( 11 % ) did not receive adjuvant radiotherapy and concurrent chemotherapy in their treatment regimen . At minimum follow-up of 1 year , only 1 patient required a gastrostomy tube . CONCLUSIONS This novel transoral robotic surgery treatment regimen offers disease control , survival , and safety commensurate with st and ard treatments and an unexpected beneficial outcome of gastrostomy dependency rates that are markedly lower than those reported with st and ard nonsurgical therapies BACKGROUND The aim of this study was to assess the quality of life of patients with oropharyngeal squamous cell carcinoma after transoral robotic surgery ( TORS ) . METHODS Short Form (SF)-8 and Performance Status Scale ( PSS ) question naires were completed prior to surgery , 6 and 12 months of follow-up . RESULTS In all , 38 patients treated with TORS followed by adjuvant therapy as indicated were prospect ively enrolled . For PSS Eating and Diet domains , significant decreases occurred at 6 months ( p ≤ .001
Output:
| Feeding tube rates were the most commonly reported functional outcome .
Crude end points of functional recovery after TORS ± adjuvant therapy suggest promising swallowing outcomes , depending on the functional measure reported |
MS211379 | ***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 increments in plasma zinc concentrations after an oral dose of elemental zinc ( 50 mg ) as the sulphate were used to assess the intestinal absorption of the metal in 11 patients with dermatitis herpetiformis ( DH ) before starting a gluten-free diet , 12 patients with newly diagnosed celiac disease ( CD ) , 10 patients known to have CD , and 15 healthy volunteers . The areas under the plasma zinc increment curve plotted against time were determined for 3 ( AUC3 ) and 6 ( AUC6 ) h. The AUC3 in healthy volunteers was 401 + /- 48 mumol 1(-1 ) 3 h ( mean + /- SD ) ; it was reduced in newly diagnosed CD 187 + /- 76 mumol 1(-1 ) 3 h ( p less than 0.001 ) , and in dermatitis herpetiformis 206 + /- 87 mumol 1(-1 ) 3 h ( p less than 0.01 ) ; but it was normal in the known CD 396 + /- 204 mumol 1(-1 ) 3 h , the wide variation reflecting the variable compliance with a previously instituted gluten-free diet . The AUC6 was similarly affected , healthy volunteers 700 + /- 111 mumol 1(-1 ) 6 h , new CD 380 + /- 169 mumol 1(-1 ) 6 h ( p less than 0.01 ) ; dermatitis herpetiformis 471 + /- 107 mumol 1(-1 ) 6 h ( p less than 0.01 ) ; known CD 725 + /- 380 mumol 1(-1 ) 6 h. The AUC3 was more consistently abnormal than conventional tests of small intestinal function . In a prospect i ve study the AUC3 and AUC6 improved and reflected compliance with a gluten-free diet Studies of zinc status in insulin-dependent diabetes mellitus ( IDDM ) have shown contradictory results . Zinc is essential for many enzymes involved in the human metabolism and may play a role in the bio synthesis and storage of insulin in the B-cell . We therefore prospect ively followed 26 patients ( 14 males and 12 females ) with newly diagnosed IDDM in order to determine the plasma zinc variation at the time of diagnosis and after 1 , 3 , 6 , 12 and 24 months . Seventy-two healthy persons ( 36 males and 36 females ) served as controls . Only minor differences in plasma zinc were demonstrated during the first 2 years of IDDM . A sex difference was found in healthy controls but only after 24 months in the diabetics . Quantitative changes of the B-cell function , development of insulin antibodies , age , body weight and serum albumin did not correlate with the course of plasma zinc Two main diabetic groups were investigated , viz , one consisting of 19 diabetic children with newly diagnosed insulin-dependent diabetes mellitus ( IDDM ) ( median age 10 years ) where a prospect i ve study was made , and one where a retrospective examination was performed of 73 patients ( median age 14 years ) with a mean duration of IDDM of 7 years ; 83 healthy school children ( median age 13 years ) served as controls . In both groups of diabetic children more zinc was excreted in the urine than in the controls . At onset of IDDM , serum and blood clot zinc concentrations were reduced with a gradual increase towards normal within 1 month of insulin therapy . The zinc concentrations in hair did not differ from those of the controls . No correlation were found between zinc levels in serum , blood clots , urine and hair on one h and and the concentrations of albumin and glucose in serum and urine on the other Disturbances of zinc homeostasis have been observed in several diseases , including diabetes mellitus . To further characterize the association between zinc and diabetes , we recruited 75 patients with type 1 or type 2 diabetes and 75 nondiabetic sex-/age-matched control subjects in order to analyze differences concerning human zinc transporter 8 ( hZnT-8 ) expression , single nucleotide polymorphisms ( SNPs ) in the genes of hZnT-8 as well as metallothionein 1A and serum/intracellular zinc . Furthermore , we investigated the relation between insulin and zinc homeostasis in type 2 diabetic subjects and consoli date d our results by in vitro analysis of the effect of insulin on cellular zinc status and by analysis of the modulation of insulin signal transduction by intracellular zinc homeostasis . Concerning the expression of hZnT-8 and the SNPs analyzed , we did not observe any differences between diabetic and control subjects . Serum zinc was significantly lower in diabetic patients compared to controls , and intracellular zinc showed the same tendency . Interestingly , type 2 diabetes patients treated with insulin displayed lower serum zinc compared to those not injecting insulin . In vitro analyses showed that insulin leads to an increase in intracellular zinc and that insulin signaling was enhanced by elevated intracellular zinc concentrations . In conclusion , we show that type 1 and type 2 diabetic patients suffer from zinc deficiency , and our results indicate that zinc supplementation may qualify as a potential treatment adjunct in type 2 diabetes by promoting insulin signaling , especially in zinc-deficient subjects Rheumatoid arthritis ( RA ) is a chronic autoimmune inflammatory disease , which mainly involves the joints . RA is prevalent worldwide with increasing prevalence in elderly people . The mechanism of RA pathogenesis is still undefined , and it is interplaying between genetic susceptibility and environmental factors . Although risk factors for RA are not fully established , various studies have focused on the role of trace elements in association with RA . Trace elements act as co-factors for most of the enzymes , and their deficiency is associated with many untoward effects on human health . The homeostatic alterations in the metabolism of trace elements may partly be due to inflammatory response in RA . The objective of the present study was to determine the serum concentrations and correlation of zinc , copper , and iron in RA patients and healthy controls . The study comprised of 61 RA patients and 61 age- and sex-related healthy individuals of Pakistani population . Serum levels of Zn , Cu , and Fe were measured in all the participants by atomic absorption spectrophotometer . Serum Zn and Fe were significantly reduced in the RA patients than those in the healthy controls . Serum Cu concentrations were found elevated in the RA patients . Correlation studies of trace elements determine that there was negative correlation between Zn and Cu in the RA patients and no correlation in the control group . It is very important to explore the deficiency of essential trace metals in biological sample s of the RA patients in different population s which may be helpful for diagnosis and supplementary management of rheumatoid arthritis patients The urinary excretion of zinc in individuals with insulin-dependent diabetes mellitus ( IDDM ) is approximately doubled . In the absence of a compensatory mechanism , this hyperzincuria should induce a deficient or marginal Zn status . We examined parameters of Zn status in plasma and in blood cells with respect to urinary Zn losses and Zn supplementation . We measured Zn levels in the urine , plasma , and erythrocytes of 14 IDDM subjects and 15 nondiabetics who kept dietary records for 3 consecutive days . Subsequently , six IDDM subjects and seven nondiabetics were supplemented with 50 mg Zn daily for 28 days . We measured the above parameters , as well as mononuclear leukocyte Zn ( MNL-Zn ) and the plasma subfraction of albumin-bound Zn ( alb-Zn ) . The total plasma Zn-binding capacity was also assessed . Plasma copper and erythrocyte Cu were monitored as indicators of potential Zn toxicity . Individuals with IDDM displayed the expected hyperzincuria , but had normal blood Zn parameters . Zincuria increased by a similar amount in both groups during supplementation , as did the MNL-Zn content . However , erythrocyte Zn ( e-Zn ) was refractory , so a trend toward lower e-Zn among IDDM subjects persisted during Zn supplementation . Hemoglobin A1c ( HbA1c ) increased markedly in the Zn-supplemented IDDM group . Despite their chronic hyperzincuria , individuals with IDDM appear not to be Zn-deficient . Large-dose Zn supplementation increases MNL-Zn and induces an undesirable elevation of HbA1c in all individuals . This is especially disconcerting for those with IDDM , and may reflect an exacerbation of a chronic " Zn diabetes . " These data suggest a potential for toxicity from large-dose Zn supplementation
Output:
| The data presented in our work , although very heterogeneous in the manner of collecting and investigating sample s , have proved to be extremely consistent in witnessing a deficiency of zinc in serum and plasma of patients compared to controls |
MS211380 | ***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 aripiprazole once-monthly ( AOM ) , a long-acting injectable suspension of aripiprazole , as acute treatment in patients with schizophrenia ( DSM-IV-TR ) . METHOD Adults experiencing an acute psychotic episode were r and omized to 12 weeks of double-blind treatment with AOM 400 mg or placebo ( October 2012-August 2013 ) . The primary efficacy outcome was change from baseline to endpoint ( week 10 ) in Positive and Negative Syndrome Scale ( PANSS ) total score . The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale ( CGI-S ) score . Secondary efficacy outcomes included change from baseline in PANSS positive and negative subscale and Personal and Social Performance Scale ( PSP ) scores . The study took place from October 2012 through August 2013 . RESULTS Patients ( N = 340 ; 79 % male , 66 % black ) were r and omized to AOM ( n = 168 ) or placebo ( n = 172 ) . Least squares ( LS ) mean change from baseline to endpoint ( week 10 ) favored AOM versus placebo in PANSS total ( treatment difference , -15.1 [ 95 % CI , -19.4 to -10.8 ] ; P < .0001 ) and CGI-S ( treatment difference , -0.8 [ 95 % CI , -1.1 to -0.6 ] ; P < .0001 ) scores , as it did at all other timepoints through 12 weeks ( all P ≤ .0005 ) . LS mean change from baseline in PANSS positive and negative subscale and PSP scores favored AOM versus placebo ( P < .0001 ) . Common ( > 10 % ) treatment-emergent adverse events ( AOM vs. placebo ) were increased weight ( 16.8 % vs 7.0 % ) , headache ( 14.4 % vs. 16.3 % ) , and akathisia ( 11.4 % vs 3.5 % ) . CONCLUSIONS Symptoms and functioning improved with AOM 400 mg versus placebo in patients with acute schizophrenia , with acceptable safety and tolerability . These data suggest that AOM 400 mg is a viable treatment option for patients experiencing an acute schizophrenia episode . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT01663532 BACKGROUND Persons with schizophrenia often come in contact with the criminal justice system ( CJS ) . This analysis of subjects with schizophrenia and a history of contact with the CJS estimated and compared mean cumulative function ( MCF ) of treatment failure events when treated with paliperidone palmitate ( PP ) or oral antipsychotics ( OAs ) . All events identified during the full study period of the Paliperidone Palmitate Research in Demonstrating Effectiveness ( PRIDE ) trial were evaluated . METHODS Subjects were r and omly assigned to flexibly dosed , monthly , injectable PP ( 78 - 234 mg ) or daily OA in a 15-month prospect i ve , open-label , multicenter US study ( May 5 , 2010-December 9 , 2013 ) . Subjects could continue participation after a treatment failure event . Multiple treatment failures in individual subjects were analyzed as recurrent events . Analyses estimated MCF of treatment failure events and MCF of institutionalizations ( arrests , incarcerations , or psychiatric hospitalizations ) during the 15-month study period . RESULTS The ITT population included 226 ( PP ) and 218 ( OA ) subjects , of whom 41.2 % and 40.4 % , respectively , completed 15 months of follow-up . The MCF of treatment failures and institutionalizations differed significantly in favor of PP compared with OA ( P=0.007 and P=0.005 , respectively ) . Overall , TEAEs were reported by 86.3 % of subjects in the PP group and 81.7 % in the OA group . CONCLUSIONS This pragmatic analysis suggests that , compared with OA , PP is not only more effective in delaying median time to treatment failure , but it also reduces the number of treatment failures and institutionalizations per person-year follow-up . CLINICAL TRIALS REGISTRATION Clinical trials.gov identifier : NCT01157351 Abstract Background QUALIFY was a 28-week , r and omized , open-label , head-to-head trial that assessed improvements across multiple measures in stable patients with schizophrenia with aripiprazole once-monthly 400 mg vs paliperidone palmitate . Methods Secondary effectiveness assessment s included physician-rated readiness for work using the Work Readiness Question naire , the Clinical Global Impression – Severity and Clinical Global Impression – Improvement scales , and quality of life with the rater-blinded Heinrichs-Carpenter Quality of Life Scale . Patients assessed their treatment satisfaction and quality of life with Subjective Well-Being under Neuroleptic Treatment−short version and Tolerability and Quality of Life question naires . Results Odds of being ready for work at week 28 were significantly higher with aripiprazole once-monthly 400 mg vs paliperidone palmitate ( adjusted odds ratio , 2.67 ; 95 % CI , 1.39−5.14 ; P=.003 ) . Aripiprazole once-monthly 400 mg produced numerically or significantly greater improvements from baseline vs paliperidone palmitate in all Quality of Life Scale items . With aripiprazole once-monthly 400 mg vs paliperidone palmitate at week 28 , there were significantly more Clinical Global Impression – Severity and Clinical Global Impression – Improvement responders ( adjusted odds ratio , 2.26 ; P=.010 , and 2.51 ; P=.0032 ) and significantly better Clinical Global Impression – Improvement scores ( least squares mean treatment difference , −0.326 ; 95 % CI , −0.60 to −0.05 ; P=.020 ) . Numerically larger improvements with aripiprazole once-monthly 400 mg vs paliperidone palmitate were observed for patient-rated scales Subjective Well-Being under Neuroleptic Treatment−short version and Tolerability and Quality of Life . Partial correlations were strongest among clinician-rated and among patient-rated scales but poorest between clinician and patient-rated scales . Conclusions Consistently greater improvements were observed with aripiprazole once-monthly 400 mg vs paliperidone palmitate across all measures . Partial correlations between scales demonstrate the multidimensionality of various measures of improvement . More patients on aripiprazole once-monthly 400 mg were deemed ready to work by the study end . Trial registry National Institutes of Health registry , NCT01795547 , https:// clinical trials.gov/ct2/ results ? id = NCT01795547 OBJECTIVE To directly compare aripiprazole once-monthly 400 mg ( AOM 400 ) and paliperidone palmitate once-monthly ( PP ) on the Heinrichs-Carpenter Quality -of-Life Scale ( QLS ) , a vali date d health-related quality of life and functioning measure in schizophrenia . METHOD This 28-week , r and omized , non-inferiority , open-label , rater-blinded , head-to-head study ( QUALIFY ) of AOM 400 and PP in adult patients ( 18 - 60 years ) comprised oral conversion , initiation of AOM 400 or PP treatment , and continuation with intramuscular injections every 4weeks . The primary endpoint assessed non-inferiority and superiority on QLS total score analyzed using a mixed model for repeated measurements . RESULTS Of 295 r and omized patients , 100/148 ( 67.6 % ) of AOM 400 and 83/147 ( 56.5 % ) of PP patients completed 28weeks of treatment . A statistically significant least squares mean difference in change from baseline to week 28 on QLS total score ( 4.67 [ 95%CI : 0.32;9.02 ] , p=0.036 ) confirmed non-inferiority and established superiority of AOM 400 vs PP . There were also significant improvements in Clinical Global Impression - Severity scale and the Investigator 's Assessment Question naire for AOM 400 vs PP , and pre-defined sub-group analyses revealed a consistent pattern of significance favoring AOM 400 in patients ≤35years . Common treatment-emergent adverse events in the treatment continuation phase were more frequent with PP vs AOM 400 , and adverse events were the most frequent reason for discontinuation ( 27/137 [ 19.7 % ] for PP and 16/144 [ 11.1 % ] for AOM 400 ) . All-cause discontinuation was numerically lower with AOM 400 . CONCLUSION Superior improvements on clinician-rated health-related quality of life and a favorable tolerability profile suggest greater overall effectiveness for aripiprazole once-monthly vs paliperidone palmitate . Clinical Trials.gov identifier : NCT01795547 This study assessed the efficacy and the safety of a dosing regimen that was revised from earlier studies for the investigational injectable atypical antipsychotic paliperidone palmitate ( approved in the USA , August 2009 ) for adult patients with acutely exacerbated schizophrenia . The patients ( N = 652 ) were r and omly assigned ( 1:1:1:1 ) to paliperidone palmitate at 25 , 100 , or 150 mg eq. or placebo in this 13-week double-blind study . The patients received an injection of paliperidone palmitate at 150 mg eq. or placebo in the deltoid muscle on day 1 and the assigned fixed dose or placebo in the deltoid or muscle on day 8 and then once monthly ( days 36 and 64 ) . No oral supplementation was used . Target plasma levels were achieved by day 8 in all paliperidone palmitate groups . The mean change in Positive and Negative Syndrome Scale total score from baseline to end point improved significantly ( P ≤ 0.034 ) in all the paliperidone palmitate dose-groups versus placebo . Paliperidone palmitate treatment with this revised dosing regimen led to the achievement of rapid and consistent therapeutically effective plasma levels that were maintained by once-monthly dosing in either the deltoid or gluteal muscle . Common treatment-emergent adverse events ( ≥2 % of patients in any of the treatment groups ) that occurred more frequently in the total paliperidone palmitate group versus the placebo group ( with ≥1 % difference ) were injection-site pain ( 7.6 % vs 3.7 % ) , dizziness ( 2.5 % vs 1.2 % ) , sedation ( 2.3 % vs 0.6 % ) , pain in the extremity ( 1.6 % vs 0.0 % ) , and myalgia ( 1.0 % vs 0.0 % ) . The paliperidone palmitate treatment was efficacious and generally tolerated across the dose range ( 25 , 100 , or 150 mg eq. ) in adult patients with acutely exacerbated schizophrenia . Abbreviations : BMI - body mass index , CGI-S - Clinical Global Impression-Severity , EPS - extrapyramidal symptoms , ER - extended release , ITT - intent-to-treat , LAI - long-acting injectable , PANSS - Positive and Negative Syndrome Scale , PK - pharmacokinetic , PSP - Personal and Social Performance Scale , TEAE - treatment-emergent adverse events , VAS - Visual Analogue OBJECTIVE The superiority of risperidone long-acting injection ( RLAI ) over oral typical and atypical antipsychotics demonstrated in previous studies may be related to the improved drug compliance . The aim of the 12-week r and omized , single-blind study was to test whether the superiority of RLAI remained among hospitalized patients that drug compliance could be optimally controlled . METHODS Fifty hospitalized stable schizophrenic patients , who had maintained on oral risperidone for more than 3 months , were r and omized to the RLAI and oral risperidone group . Finally 49 patients ( 98 % ) completed the study , and no dose change of oral risperidone , or RLAI was noted among all patients . RESULTS The RLAI group showed significantly increased positive score of Positive and Negative Syndrome Scale ( PANSS ) than the risperidone group ( 0.72 + /- 3.52 vs. -1.24 + /- 3.81 , p = 0.022 ) , but without significance difference for the PANSS total , negative and general psychopathology scores . The RLAI group also showed a significantly improved Udvalg for Kliniske Undersogelser ( UKU ) Scale ( p = 0.037 ) , social life domains of Short-Form Health Survey ( SF-36 ) ( p = 0.011 ) , and reduced prolactin level ( p = 0.001 ) . CONCLUSION The
Output:
| Poor psychosocial function was predicted by longer treatment duration , severe symptoms , poor cognition and poor insight .
Functioning was assessed by either a single or a combination of measures , but was not the primary outcome in most studies .
Conclusion : Long-acting injectable atypical antipsychotics are beneficial for recovery of psychosocial function in comparison with placebo , but the magnitude of superiority over oral antipsychotic treatment was small .
Severe psychopathology at baseline predicted poor psychosocial function . |
MS211381 | ***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 Few prospect i ve studies have examined the mortality of vegetarians . OBJECTIVE We present results on mortality among vegetarians and nonvegetarians in the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC-Oxford ) . DESIGN We used a prospect i ve study of men and women recruited throughout the United Kingdom in the 1990s . RESULTS Among 64,234 participants aged 20 - 89 y for whom diet group was known , 2965 had died before age 90 by 30 June 2007 . The death rates of participants are much lower than average for the United Kingdom . The st and ardized mortality ratio for all causes of death was 52 % ( 95 % CI : 50 % , 54 % ) and was identical in vegetarians and in nonvegetarians . Comparing vegetarians with meat eaters among the 47,254 participants who had no prevalent cardiovascular disease or malignant cancer at recruitment , the death rate ratios adjusted for age , sex , smoking , and alcohol consumption were 0.81 ( 95 % CI : 0.57 , 1.16 ) for ischemic heart disease and 1.03 ( 95 % CI : 0.90 , 1.16 ) for all causes of death . CONCLUSIONS The mortality of both the vegetarians and the nonvegetarians in this study is low compared with national rates . Within the study , mortality from circulatory diseases and all causes is not significantly different between vegetarians and meat eaters , but the study is not large enough to exclude small or moderate differences for specific causes of death , and more research on this topic is required OBJECTIVE The aim of this study was to determine the effect of plant-based diets on weight loss . METHODS Participants were enrolled in a 6-mo , five-arm , r and omized controlled trial in 2013 in South Carolina . Participants attended weekly group meetings , with the exception of the omnivorous group , which served as the control and attended monthly meetings augmented with weekly e-mail lessons . All groups attended monthly meetings for the last 4 mo of the study . Diets did not emphasize caloric restriction . RESULTS Overweight adults ( body mass index 25 - 49.9 kg/m(2 ) ; age 18 - 65 y , 19 % non-white , and 27 % men ) were r and omized to a low-fat , low-glycemic index diet : vegan ( n = 12 ) , vegetarian ( n = 13 ) , pesco-vegetarian ( n = 13 ) , semi-vegetarian ( n = 13 ) , or omnivorous ( n = 12 ) . Fifty ( 79 % ) participants completed the study . In intention-to-treat analysis , the linear trend for weight loss across the five groups was significant at both 2 ( P < 0.01 ) and 6 mo ( P < 0.01 ) . At 6 mo , the weight loss in the vegan group ( -7.5 % ± 4.5 % ) was significantly different from the omnivorous ( -3.1 % ± 3.6 % ; P = 0.03 ) , semi-vegetarian ( -3.2 % ± 3.8 % ; P = 0.03 ) , and pesco-vegetarian ( -3.2 % ± 3.4 % ; P = 0.03 ) groups . Vegan participants decreased their fat and saturated fat more than the pesco-vegetarian , semi-vegetarian , and omnivorous groups at both 2 and 6 mo ( P < 0.05 ) . CONCLUSIONS Vegan diets may result in greater weight loss than more modest recommendations Importance Defining what represents a macronutritionally balanced diet remains an open question and a high priority in nutrition research . Although the amount of protein may have specific effects , from a broader dietary perspective , the choice of protein sources will inevitably influence other components of diet and may be a critical determinant for the health outcome . Objective To examine the associations of animal and plant protein intake with the risk for mortality . Design , Setting , and Participants This prospect i ve cohort study of US health care professionals included 131 342 participants from the Nurses ' Health Study ( 1980 to end of follow-up on June 1 , 2012 ) and Health Professionals Follow-up Study ( 1986 to end of follow-up on January 31 , 2012 ) . Animal and plant protein intake was assessed by regularly up date d vali date d food frequency question naires . Data were analyzed from June 20 , 2014 , to January 18 , 2016 . Main Outcomes and Measures Hazard ratios ( HRs ) for all-cause and cause-specific mortality . Results Of the 131 342 participants , 85 013 were women ( 64.7 % ) and 46 329 were men ( 35.3 % ) ( mean [ SD ] age , 49 [ 9 ] years ) . The median protein intake , as assessed by percentage of energy , was 14 % for animal protein ( 5th-95th percentile , 9%-22 % ) and 4 % for plant protein ( 5th-95th percentile , 2%-6 % ) . After adjusting for major lifestyle and dietary risk factors , animal protein intake was not associated with all-cause mortality ( HR , 1.02 per 10 % energy increment ; 95 % CI , 0.98 - 1.05 ; P for trend = .33 ) but was associated with higher cardiovascular mortality ( HR , 1.08 per 10 % energy increment ; 95 % CI , 1.01 - 1.16 ; P for trend = .04 ) . Plant protein was associated with lower all-cause mortality ( HR , 0.90 per 3 % energy increment ; 95 % CI , 0.86 - 0.95 ; P for trend < .001 ) and cardiovascular mortality ( HR , 0.88 per 3 % energy increment ; 95 % CI , 0.80 - 0.97 ; P for trend = .007 ) . These associations were confined to participants with at least 1 unhealthy lifestyle factor based on smoking , heavy alcohol intake , overweight or obesity , and physical inactivity , but not evident among those without any of these risk factors . Replacing animal protein of various origins with plant protein was associated with lower mortality . In particular , the HRs for all-cause mortality were 0.66 ( 95 % CI , 0.59 - 0.75 ) when 3 % of energy from plant protein was substituted for an equivalent amount of protein from processed red meat , 0.88 ( 95 % CI , 0.84 - 0.92 ) from unprocessed red meat , and 0.81 ( 95 % CI , 0.75 - 0.88 ) from egg . Conclusions and Relevance High animal protein intake was positively associated with cardiovascular mortality and high plant protein intake was inversely associated with all-cause and cardiovascular mortality , especially among individuals with at least 1 lifestyle risk factor . Substitution of plant protein for animal protein , especially that from processed red meat , was associated with lower mortality , suggesting the importance of protein source OBJECTIVE To describe the lifestyle characteristics and nutrient intakes of the Oxford cohort of the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC ) . DESIGN Cohort of men and women recruited through general practice s or by post to include a high proportion of non meat-eaters . Dietary , anthropometric and lifestyle data were collected at baseline and four diet groups were defined . SETTING United Kingdom . PARTICIPANTS In total , 65 429 men and women aged 20 to 97 years , comprising 33 883 meat-eaters , 10 110 fish-eaters , 18 840 lacto-ovo vegetarians and 2596 vegans . RESULTS Nutrient intakes and lifestyle factors differed across the diet groups , with striking differences between meat-eaters and vegans , and fish-eaters and vegetarians usually having intermediate values . Mean fat intake in each diet group was below the UK dietary reference value of 33 % of total energy intake . The mean intake of saturated fatty acids in vegans was approximately 5 % of energy , less than half the mean intake among meat-eaters ( 10 - 11 % ) . Vegans had the highest intakes of fibre , vitamin B1 , folate , vitamin C , vitamin E , magnesium and iron , and the lowest intakes of retinol , vitamin B12 , vitamin D , calcium and zinc . CONCLUSIONS The EPIC-Oxford cohort includes 31 546 non meat-eaters and is one of the largest studies of vegetarians in the world . The average nutrient intakes in the whole cohort are close to those currently recommended for good health . Comparisons of the diet groups show wide ranges in the intakes of major nutrients such as saturated fat and dietary fibre . Such variation should increase the ability of the study to detect associations of diet with major cancers and causes of death OBJECTIVE To explore the potential role of the endogenous peptide YY ( PYY ) in the long-term regulation of body weight and energy homeostasis . RESEARCH METHODS AND PROCEDURES Fasting and postpr and ial plasma PYY concentrations were measured after an overnight fast and 30 to 180 minutes after a st and ardized meal in 29 ( 21 men/8 women ) non-diabetic subjects , 16 of whom had a follow-up visit 10.8 + /- 1.4 months later . Ratings of hunger and satiety were collected using visual analog scales . Resting metabolic rate ( RMR ) ( 15-hour RMR ) and respiratory quotient ( RQ ) were assessed using a respiratory chamber . RESULTS Fasting PYY concentrations were negatively correlated with various markers of adiposity and negatively associated with 15-hour RMR ( r = -0.46 , p = 0.01 ) . Postpr and ial changes in PYY ( area under the curve ) were positively associated with postpr and ial changes in ratings of satiety ( r = 0.47 , p = 0.01 ) . The maximal PYY concentrations achieved after the meal ( peak PYY ) were negatively associated with 24-hour RQ ( r = -0.41 , p = 0.03 ) . Prospect ively , the peak PYY concentrations were negatively associated with changes in body weight ( r = -0.58 , p = 0.01 ) . DISCUSSION Our data indicate that the endogenous PYY may be involved in the long-term regulation of body weight . It seems that this long-term effect was not exclusively driven by the modulation of food intake but also by the control of energy expenditure and lipid metabolism Long-term dietary intake influences the structure and activity of the trillions of microorganisms residing in the human gut , but it remains unclear how rapidly and reproducibly the human gut microbiome responds to short-term macronutrient change . Here we show that the short-term consumption of diets composed entirely of animal or plant products alters microbial community structure and overwhelms inter-individual differences in microbial gene expression . The animal-based diet increased the abundance of bile-tolerant microorganisms ( Alistipes , Bilophila and Bacteroides ) and decreased the levels of Firmicutes that metabolize dietary plant polysaccharides ( Roseburia , Eubacterium rectale and Ruminococcus bromii ) . Microbial activity mirrored differences between herbivorous and carnivorous mammals , reflecting trade-offs between carbohydrate and protein fermentation . Foodborne microbes from both diets transiently colonized the gut , including bacteria , fungi and even viruses . Finally , increases in the abundance and activity of Bilophila wadsworthia on the animal-based diet support a link between dietary fat , bile acids and the outgrowth of microorganisms capable of triggering inflammatory bowel disease . In concert , these results demonstrate that the gut microbiome can rapidly respond to altered diet , potentially facilitating the diversity of human dietary lifestyles Regular walnut consumption is associated with better health . We have previously shown that eight weeks of walnut consumption ( 43 g/day ) significantly improves lipids in healthy subjects . In the same study , gut microbiome was evaluated . We included 194 healthy subjects ( 134 females , 63 ± 7 years , BMI 25.1 ± 4.0 kg/m2 ) in a r and omized , controlled , prospect i ve , cross-over study . Following a nut-free run-in period , subjects were r and omized to two diet phases ( eight weeks each ) ; 96 subjects first followed a walnut-enriched diet ( 43 g/day ) and then switched to a nut-free diet , while 98 subjects followed the diets in reverse order . While consuming the walnut-enriched diet , subjects were advised to either reduce fat or carbohydrates or both to account for the additional calories . Fecal sample s were collected from 135 subjects at the end of the walnut-diet and the control-diet period for microbiome analyses . The 16S rRNA gene sequencing data was clustered with a 97 % similarity into Operational Taxonomic Units ( OTUs ) . UniFrac distances were used to determine diversity between groups . Differential abundance was evaluated using the Kruskal – Wallis rank sum test . All
Output:
| We found robust evidence for short- to moderate-term beneficial effects of plant-based diets versus conventional diets ( duration ≤ 24 months ) on weight status , energy metabolism and systemic inflammation in healthy participants , obese and type-2 diabetes patients .
Initial experimental studies proposed novel microbiome-related pathways , by which plant-based diets modulate the gut microbiome towards a favorable diversity of bacteria species , yet a functional “ bottom up ” signaling of plant-based diet-induced microbial changes remains highly speculative . |
MS211382 | ***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 improve medication appropriateness and adherence in elderly patients with multimorbidity , we developed a complex intervention involving general practitioners ( GPs ) and their healthcare assistants ( HCA ) . In accordance with the Medical Research Council guidance on developing and evaluating complex interventions , we prepared for the main study by testing the feasibility of the intervention and study design in a cluster r and omised pilot study . Setting 20 general practice s in Hesse , Germany . Participants 100 cognitively intact patients ≥65 years with ≥3 chronic conditions , ≥5 chronic prescriptions and capable of participating in telephone interviews ; 94 patients completed the study . Intervention The HCA conducted a checklist-based interview with patients on medication-related problems and reconciled their medications . Assisted by a computerised decision-support system ( CDSS ) , the GPs discussed medication intake with patients and adjusted their medication regimens . The control group continued with usual care . Outcome measures Feasibility of the intervention and required time were assessed for GPs , HCAs and patients using mixed methods ( question naires , interviews and case vignettes after completion of the study ) . The feasibility of the study was assessed concerning success of achieving recruitment targets , balancing cluster sizes and minimising drop-out rates . Exploratory outcomes included the medication appropriateness index ( MAI ) , quality of life , functional status and adherence-related measures . MAI was evaluated blinded to group assignment , and intra-rater/inter-rater reliability was assessed for a sub sample of prescriptions . Results 10 practice s were r and omised and analysed per group . GPs/HCAs were satisfied with the interventions despite the time required ( 35/45 min/patient ) . In case vignettes , GPs/HCAs needed help using the CDSS . The study made no patients feel uneasy . Intra-rater/inter-rater reliability for MAI was excellent . Inclusion criteria were challenging and potentially inadequate , and should therefore be adjusted . Outcome measures on pain , functionality and self-reported adherence were unfeasible due to frequent missing values , an incorrect manual or potentially invalid results . Conclusions Intervention and trial design were feasible . The pilot study revealed important limitations that influenced the design and conduct of the main study , thus highlighting the value of piloting complex interventions . Trial registration number IS RCT N99691973 ; Results BACKGROUND Beliefs concerning the causes of mental illness may help to explain why there are significant disparities in the rates of formal mental health service use among racial/ethnic minority elderly as compared with their white counterparts . This study applies the cultural influences on mental health framework to identify the relationship between race/ethnicity and differences in 1 ) beliefs on the cause of mental illness , 2 ) preferences for type of treatment , and 3 ) provider characteristics . METHOD Analyses were conducted using baseline data collected from participants who completed the cultural attitudes toward healthcare and mental illness question naire , developed for the Primary Care Research in Substance Abuse and Mental Health for the Elderly study , a multisite r and omized trial for older adults ( 65 + ) with depression , anxiety , or at-risk alcohol consumption . The final sample consisted of 1,257 non-Latino whites , 536 African Americans , 112 Asian Americans , and 303 Latinos . RESULTS African Americans , Asian Americans , and Latinos had differing beliefs regarding the causes of mental illness when compared with non-Latino whites . Race/ethnicity was also associated with determining who makes healthcare decisions , treatment preferences , and preferred characteristics of healthcare providers . CONCLUSIONS This study highlights the association between race/ethnicity and health beliefs , treatment preferences , healthcare decisions , and consumers ' preferred characteristics of healthcare providers . Accommodating the values and preferences of individuals can be helpful in engaging racial/ethnic minority patients in mental health services BACKGROUND General Practitioners ( GPs ) often have to simultaneously tackle multiple health problems of older patients . A patient-centred process that engages the patient in setting health priorities for treatment is needed . We investigated whether a structured priority- setting consultation reconciles the often-differing doctor-patient views on the importance of problems . DESIGN Cluster r and omised controlled trial with 40 GPs and their 317 consecutively recruited older patients . PROCEDURE Following a geriatric assessment , patients and doctors independently rated the importance of each uncovered problem . GPs then selected priorities with their patients in a consultation . Trained intervention GPs held a structured consultation and utilised the list of uncovered patient problems with their importance ratings to agree priorities . Untrained control GPs only used the patient 's problem list without importance ratings . MAIN OUTCOME Doctor-patient agreement on independent importance ratings two weeks after the priority- setting consultation . ANALYSIS Weighted kappa ( κw ) and multilevel logistic regression model . RESULTS Intervention GPs and their patients determined mutual priorities for 20 % of individual problems . In this process , GPs often succeeded in convincing their patients of the importance of vaccinations , lifestyle and cognitive issues . Likewise , patients convinced their GPs to prioritise their social and functional problems . Further treatment plans ensued in 84 % of these priority areas . The regression model adjusting for clusters and baseline characteristics did not demonstrate significant differences in doctor-patient agreement on problems between groups a two weeks later . CONCLUSION Differing views on the importance of health problems between GPs and older patients were not sustainably reconciled . The special consultation facilitated identification of priority problems for treatment despite differences in perceived importance of problems between patients and GPs . German clinical trials register drks 00000792 BACKGROUND It is unknown what minimal benefit in disease-free survival older patients with breast cancer require from adjuvant systemic therapy , and if this differs from that required by younger patients . We prospect ively examined patients ' preferences for adjuvant chemotherapy ( aCT ) and adjuvant hormonal therapy ( aHT ) , factors related to minimally-required benefit , and patients ' self-reported motivations . PATIENTS AND METHODS Fifty-two younger ( 40 - 64 years ) and 29 older ( ≥ 65 years ) women with a first primary , invasive tumor were interviewed post-surgery , prior to receiving aCT/aHT recommendation . RESULTS The proportions of younger versus older participants who would accept , refuse , or were undecided about therapy were 92 % versus 62 % , 4 % versus 24 % , and 4 % versus 14 % for aCT , and 92 % versus 59 % , 8 % versus 17 % , and 0 % versus 24 % for aHT . The proportion of older participants who would refuse rather than accept aCT was larger than that of younger participants ( P = .005 ) . No significant difference was found for aHT ( P = .12 ) . Younger and older participants ' minimally-required benefit , in terms of additional 10-year disease-free survival , to accept aCT ( median , 5 % vs. 4 % ; P = .13 ) or aHT ( median , 10 % vs. 8 % ; P = .15 ) did not differ . Being single/divorced/widowed ( odds ratio [ OR ] , 0.16 ; P = .005 ) , presence of geriatric condition ( inability to perform daily activities , incontinence , severe sensory impairment , depression , polypharmacy , difficulties with walking ; OR , 0.27 ; P = .047 ) , and having a preference to make the treatment decision either alone or after considering the clinician 's opinion ( active role ; OR , 0.15 ; P = .012 ) were independently related to requiring larger benefits from aCT . The most frequent motivations for/against therapy included the wish to survive/avoid recurrence , clinician 's recommendation , side effects , and treatment duration ( only aHT ) . CONCLUSION Whereas older participants were less willing to accept aCT than younger participants , no significant difference was found for aHT . However , a majority of older participants would still accept both therapies . Adjuvant systemic therapy should be discussed with eligible patients regardless of age Background : Decision aids have been shown to be useful in selected situations to assist patients in making treatment decisions . Important features such as the format of decision aids and their graphic presentation of data on benefits and harms of treatment options have not been well studied . Methods : In a r and omized trial with a 3 × 2 factorial design , we investigated the effects of decision aid format ( decision board , decision booklet with audiotape , or interactive computer program ) and graphic presentation of data ( pie graph or pictogram ) on patients ' comprehension and choices of 3 treatments for anticoagulation , identified initially as “ treatment A ” ( warfarin ) , “ treatment B ” ( acetylsalicylic acid ) and “ treatment C ” ( no treatment ) . Patients aged 65 years or older without known atrial fibrillation and not currently taking warfarin were included . The effect of blinding to the treatment name was tested in a before – after comparison . The primary outcome was change in comprehension score , as assessed by the Atrial Fibrillation Information Question naire . Secondary outcomes were treatment choice , level of satisfaction with the decision aid , and decisional conflict . Results : Of 102 eligible patients , 98 completed the study . Comprehension scores ( maximum score 10 ) increased by an absolute mean of 3.1 ( p < 0.01 ) after exposure to the decision aid regardless of the format or graphic presentation . Overall , 96 % of the participants felt that the decision aid helped them make their treatment choice . Unblinding of the treatment name result ed in 36 % of the participants changing their initial choice ( p < 0.001 ) . Interpretation : The decision aid led to significant improvement in patients ' knowledge regardless of the format or graphic representation of data . Revealing the name of the treatment options led to significant shifts in declared treatment preferences Objectives Deprescribing has been proposed as a way to reduce polypharmacy in frail older people . We aim ed to reduce the number of medicines consumed by people living in residential aged care facilities ( RACF ) . Secondary objectives were to explore the effect of deprescribing on survival , falls , fractures , hospital admissions , cognitive , physical , and bowel function , quality of life , and sleep . Methods Ninety-five people aged over 65 years living in four RACF in rural mid-west Western Australia were r and omised in an open study . The intervention group ( n = 47 ) received a deprescribing intervention , the planned cessation of non-beneficial medicines . The control group ( n = 48 ) received usual care . Participants were monitored for twelve months from r and omisation . Primary outcome was change in the mean number of unique regular medicines . All outcomes were assessed at baseline , six , and twelve months . Results Study participants had a mean age of 84.3±6.9 years and 52 % were female . Intervention group participants consumed 9.6±5.0 and control group participants consumed 9.5±3.6 unique regular medicines at baseline . Of the 348 medicines targeted for deprescribing ( 7.4±3.8 per person , 78 % of regular medicines ) , 207 medicines ( 4.4±3.4 per person , 59 % of targeted medicines ) were successfully discontinued . The mean change in number of regular medicines at 12 months was -1.9±4.1 in intervention group participants and + 0.1±3.5 in control group participants ( estimated difference 2.0±0.9 , 95%CI 0.08 , 3.8 , p = 0.04 ) . Twelve intervention participants and 19 control participants died within 12 months of r and omisation ( 26 % versus 40 % mortality , p = 0.16 , HR 0.60 , 95%CI 0.30 to 1.22 ) There were no significant differences between groups in other secondary outcomes . The main limitations of this study were the open design and small participant numbers . Conclusions Deprescribing reduced the number of regular medicines consumed by frail older people living in residential care with no significant adverse effects on survival or other clinical outcomes . Trial Registration Australian New Zeal and Clinical Trials Registry Purpose Lung cancer chemotherapy decisions in patients ≥70 years old are complex because of toxicity , comorbidity and the limited data on patient preferences . We examined the relationships between preferences and chemotherapy use in this group of patients . Methods and patients We used a question naire describing four hypothetical lung cancer treatment options . Eighty-three elderly ( ≥70 years old ) lung cancer patients were informed about their diagnosis and therapeutic choices and then asked to choose one of the four options . Patients had previously been included in a prospect i ve study to explore geriatric evaluation in an oncology unit and all had given written informed consent . Results Older patients ( n=83 ) diagnosed with lung cancer ( non-small- and small-cell lung cancer ) from January 2006 to February 2008 were recruited from a single centre . The mean patient age was 77 years ( range : 70–91 ) . Eighty-one patients ( 97.6 % ) were men . Non-small-cell lung cancer ( NSCLC ) was the diagnosis in 63 patients ( 76 % ) . Most patients selected active treatment ( 38.6 % most survival benefit , 18 % less survival benefit ) and 31.3 % selected no active treatment . Elderly lung cancer patients were significantly more likely to accept aggressive treatments despite high reported toxicities . Although most of the patients were symptomatic at diagnosis , the “ symptom relief ” option was chosen less frequently than the options that could prolong survival . Factors significantly related to patients ’ attitude toward chemotherapy were age ( p<0.001 ) , frailty ( p=0.0039 ) , depression and poor performance status ( PS ) . Conclusion Elderly lung cancer patients want to be involved in the decision-making process . Survival was the main treatment objective for more than half of the patients in this study . We have not found other published studies about elderly lung cancer patients ’
Output:
| Only seven of the identified tools showed somewhat favorable characteristics for a potential use of the respective method in the context of polypharmacy . |
MS211383 | ***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 effects of 2 forms of exercise , i.e. , a 6-week trial of treadmill training with virtual reality ( TT + VR ) that targets motor and cognitive aspects of safe ambulation and a 6-week trial of treadmill training alone ( TT ) , on brain activation in patients with Parkinson disease ( PD ) . Methods : As part of a r and omized controlled trial , patients were r and omly assigned to 6 weeks of TT ( n = 17 , mean age 71.5 ± 1.5 years , disease duration 11.6 ± 1.6 years ; 70 % men ) or TT + VR ( n = 17 , mean age 71.2 ± 1.7 years , disease duration 7.9 ± 1.4 years ; 65 % men ) . A previously vali date d fMRI imagery paradigm assessed changes in neural activation pretraining and post-training . Participants imagined themselves walking in 2 virtual scenes projected in the fMRI : ( 1 ) a clear path and ( 2 ) a path with virtual obstacles . Whole brain and region of interest analyses were performed . Results : Brain activation patterns were similar between training arms before the interventions . After training , participants in the TT + VR arm had lower activation than the TT arm in Brodmann area 10 and the inferior frontal gyrus ( cluster level familywise error – corrected [ FWEcorr ] p < 0.012 ) , while the TT arm had lower activation than TT + VR in the cerebellum and middle temporal gyrus ( cluster level FWEcorr p < 0.001 ) . Changes in fall frequency and brain activation were correlated in the TT + VR arm . Conclusions : Exercise modifies brain activation patterns in patients with PD in a mode-specific manner . Motor-cognitive training decreased the reliance on frontal regions , which apparently result ed in improved function , perhaps reflecting increased brain efficiency Introduction Physical rehabilitation is commonly used in patients with Parkinson ’s disease ( PD ) to improve their health and alleviate the symptoms . Objective We compared the effects of three programs , strength training ( ST ) , aerobic training ( AT ) , and physiotherapy , on motor symptoms , functional capacity , and electroencephalographic ( EEG ) activity in PD patients . Methods Twenty-two patients were recruited and r and omized into three groups : AT ( 70 % of maximum heart rate ) , ST ( 80 % of one repetition maximum ) , and physiotherapy ( in groups ) . Subjects participated in their respective interventions twice a week for 12 weeks . The assessment s included measures of disease symptoms ( Unified Parkinson ’s Disease Rating Scale [ UPDRS ] ) , functional capacity ( Senior Fitness Test ) , and EEG before and after 12 weeks of intervention . Results The PD motor symptoms ( UPDRS-III ) in the group of patients who performed ST and AT improved by 27.5 % ( effect size [ES]=1.25 , confidence interval [CI]=−0.11 , 2.25 ) and 35 % ( ES=1.34 , CI=−0.16 , 2.58 ) , respectively , in contrast to the physiotherapy group , which showed a 2.9 % improvement ( ES=0.07 , CI=−0.85 , 0.99 ) . Furthermore , the functional capacity of all three groups improved after the intervention . The mean frequency of the EEG analysis mainly showed the effect of the interventions on the groups ( F=11.50 , P=0.0001 ) . Conclusion ST and AT in patients with PD are associated with improved outcomes in disease symptoms and functional capacity Background Synthesis of multiple r and omized controlled trials ( RCTs ) in a systematic review can summarize the effects of individual outcomes and provide numerical answers about the effectiveness of interventions . Filtering of search es is time consuming , and no single method fulfills the principal requirements of speed with accuracy . Automation of systematic review s is driven by a necessity to expedite the availability of current best evidence for policy and clinical decision-making . We developed Rayyan ( http://rayyan.qcri.org ) , a free web and mobile app , that helps expedite the initial screening of abstract s and titles using a process of semi-automation while incorporating a high level of usability . For the beta testing phase , we used two published Cochrane review s in which included studies had been selected manually . Their search es , with 1030 records and 273 records , were uploaded to Rayyan . Different features of Rayyan were tested using these two review s. We also conducted a survey of Rayyan ’s users and collected feedback through a built-in feature . Results Pilot testing of Rayyan focused on usability , accuracy against manual methods , and the added value of the prediction feature . The “ taster ” review ( 273 records ) allowed a quick overview of Rayyan for early comments on usability . The second review ( 1030 records ) required several iterations to identify the previously identified 11 trials . The “ suggestions ” and “ hints , ” based on the “ prediction model , ” appeared as testing progressed beyond five included studies . Post rollout user experiences and a reflexive response by the developers enabled real-time modifications and improvements . The survey respondents reported 40 % average time savings when using Rayyan compared to others tools , with 34 % of the respondents reporting more than 50 % time savings . In addition , around 75 % of the respondents mentioned that screening and labeling studies as well as collaborating on review s to be the two most important features of Rayyan . As of November 2016 , Rayyan users exceed 2000 from over 60 countries conducting hundreds of review s totaling more than 1.6 M citations . Feedback from users , obtained mostly through the app web site and a recent survey , has highlighted the ease in exploration of search es , the time saved , and simplicity in sharing and comparing include-exclude decisions . The strongest features of the app , identified and reported in user feedback , were its ability to help in screening and collaboration as well as the time savings it affords to users . Conclusions Rayyan is responsive and intuitive in use with significant potential to lighten the load of review ers The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement is a guideline design ed to improve the transparency and quality of the reporting of r and omised controlled trials ( RCTs ) . In this article we present an extension to that statement for r and omised pilot and feasibility trials conducted in advance of a future definitive RCT . The checklist applies to any r and omised study in which a future definitive RCT , or part of it , is conducted on a smaller scale , regardless of its design ( eg , cluster , factorial , crossover ) or the terms used by authors to describe the study ( eg , pilot , feasibility , trial , study ) . The extension does not directly apply to internal pilot studies built into the design of a main trial , non-r and omised pilot and feasibility studies , or phase II studies , but these studies all have some similarities to r and omised pilot and feasibility studies and so many of the principles might also apply . The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct . We followed recommended good practice to develop the extension , including carrying out a Delphi survey , holding a consensus meeting and research team meetings , and piloting the checklist . The aims and objectives of pilot and feasibility r and omised studies differ from those of other r and omised trials . Consequently , although much of the information to be reported in these trials is similar to those in r and omised controlled trials ( RCTs ) assessing effectiveness and efficacy , there are some key differences in the type of information and in the appropriate interpretation of st and ard CONSORT reporting items . We have retained some of the original CONSORT statement items , but most have been adapted , some removed , and new items added . The new items cover how participants were identified and consent obtained ; if applicable , the prespecified criteria used to judge whether or how to proceed with a future definitive RCT ; if relevant , other important unintended consequences ; implication s for progression from pilot to future definitive RCT , including any proposed amendments ; and ethical approval or approval by a research review committee confirmed with a reference number . This article includes the 26 item checklist , a separate checklist for the abstract , a template for a CONSORT flowchart for these studies , and an explanation of the changes made and supporting examples . We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials . Editor ’s note : In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites Forced-rate lower-extremity exercise has recently emerged as a potential safe and low-cost therapy for Parkinson 's disease ( PD ) . The efficacy is believed to be dependent on pedaling rate , with rates above the subjects ' voluntary exercise rates being most beneficial . In this study , we use functional connectivity magnetic resonance imaging ( MRI ) to further eluci date the mechanism underlying this effect . Twenty-seven PD patients were r and omized to complete 8 weeks of forced-rate exercise ( FE ) or voluntary-rate exercise ( VE ) . Exercise was delivered using a specialized stationary bicycle , which can augment patients ' voluntary exercise rates . The FE group received assistance from the cycle . Imaging was conducted at baseline , end of therapy , and after 4 weeks of follow-up . Functional connectivity ( FC ) was determined via seed-based correlation analysis , using activation-based seeds in the primary motor cortex ( M1 ) . The change in FC after exercise was compared using linear correlation with pedaling rate . Results of the correlation analysis showed a strong positive correlation between pedaling rate and change in FC from the most affected M1 to the ipsilateral thalamus . This effect persisted after 4 weeks of follow-up . These results indicate that a plausible mechanism for the therapeutic efficacy of high-rate exercise in PD is that it improves thalamo-cortical connectivity The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement is a guideline design ed to improve the transparency and quality of the reporting of r and omised controlled trials ( RCTs ) . In this article we present an extension to that statement for r and omised pilot and feasibility trials conducted in advance of a future definitive RCT . The checklist applies to any r and omised study in which a future definitive RCT , or part of it , is conducted on a smaller scale , regardless of its design ( eg , cluster , factorial , crossover ) or the terms used by authors to describe the study ( eg , pilot , feasibility , trial , study ) . The extension does not directly apply to internal pilot studies built into the design of a main trial , non-r and omised pilot and feasibility studies , or phase II studies , but these studies all have some similarities to r and omised pilot and feasibility studies and so many of the principles might also apply . The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct . We followed recommended good practice to develop the extension , including carrying out a Delphi survey , holding a consensus meeting and research team meetings , and piloting the checklist . The aims and objectives of pilot and feasibility r and omised studies differ from those of other r and omised trials . Consequently , although much of the information to be reported in these trials is similar to those in r and omised controlled trials ( RCTs ) assessing effectiveness and efficacy , there are some key differences in the type of information and in the appropriate interpretation of st and ard CONSORT reporting items . We have retained some of the original CONSORT statement items , but most have been adapted , some removed , and new items added . The new items cover how participants were identified and consent obtained ; if applicable , the prespecified criteria used to judge whether or how to proceed with a future definitive RCT ; if relevant , other important unintended consequences ; implication s for progression from pilot to future definitive RCT , including any proposed amendments ; and ethical approval or approval by a research review committee confirmed with a reference number . This article includes the 26 item checklist , a separate checklist for the abstract , a template for a CONSORT flowchart for these studies , and an explanation of the changes made and supporting examples . We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials . Editor ’s note : In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites 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
Output:
| Our results indicate that various forms of physical exercise may lead to changes in various markers of neuroplasticity . |
MS211384 | ***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: Plasma concentrations of amino acids are frequently elevated in insulin-resistant states , and a protein-enriched diet can impair glucose metabolism . This study examined effects of short-term plasma amino acid ( AA ) elevation on whole-body glucose disposal and cellular insulin action in skeletal muscle . Seven healthy men were studied for 5.5 h during euglycemic ( 5.5 mmol/l ) , hyperinsulinemic ( 430 pmol/l ) , fasting glucagon ( 65 ng/l ) , and growth hormone ( 0.4 microg/l ) somatostatin clamp tests in the presence of low ( approximately 1.6 mmol/l ) and increased ( approximately 4.6 mmol/l ) plasma AA concentrations . Glucose turnover was measured with D-[6,6-(2)H(2)]glucose . Intramuscular concentrations of glycogen and glucose-6-phosphate ( G6P ) were monitored using (13)C and (31)P nuclear magnetic resonance spectroscopy , respectively . A approximately 2.1-fold elevation of plasma AAs reduced whole-body glucose disposal by 25 % ( P < 0.01 ) . Rates of muscle glycogen synthesis decreased by 64 % ( 180 - -315 min , 24 plus minus 3 ; control , 67 plus minus 10 micromol center dot l(-1 ) center dot min(-1 ) ; P < 0.01 ) , which was accompanied by a reduction in G6P starting at 130 min ( DeltaG6P(260 - -300 min ) , 18 plus minus 19 ; control , 103 plus minus 33 micromol/l ; P < 0.05 ) . In conclusion , plasma amino acid elevation induces skeletal muscle insulin resistance in humans by inhibition of glucose transport/phosphorylation , result ing in marked reduction of glycogen synthesis
Output:
| Based on current evidence , we found that BCAA is a useful biomarker for early detection of IR and later diabetic risk .
These factors might not only contribute to the elevated BCAA level but also show obvious associations with insulin resistance .
Genes related to BCAA catabolism might serve as potential targets for the treatment of IR associated metabolic disorders . |
MS211385 | ***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 Hydration with topical emollients forms the backbone of treatment for mild atopic dermatitis ( AD ) , but few r and omized controlled trials have assessed their efficacy in young children . OBJECTIVES Assess the efficacy and tolerability of long-term emollient therapy in the treatment of moderate to severe xerosis in young children with AD . METHODS This was a phase III , multicentre , double-blind , r and omized , vehicle-controlled trial . Children ( n = 251 ) aged 2 - 6 years with AD-associated xerosis were r and omized 1 : 1 to a 28-day treatment with an emollient combining glycerol and paraffin or its vehicle . Non-responders at the end of the double-blind period were treated open label with emollient until day 84 . Responders stopped treatment until re assessment on day 56 . Those who relapsed after stopping treatment were treated open label with emollient until day 84 . RESULTS During the double-blind period , xerosis score ( XS ) of the scoring atopic dermatitis ( SCORAD ) index , objective SCORAD and visual analogue score decreased and skin hydration increased more in the emollient group than in the vehicle group ( P < 0.001 for all measures ) . More patients were responders with emollient than with vehicle ( 66.1 % vs. 45.6 % , P < 0.001 ) . During the open-label period , stopping emollient treatment led to relapse but improvement returned if treatment was restarted with emollient . Regular use of the emollient also yielded improvement in children who did not initially respond . Adverse events were similar in the two groups , and no treatment-related severe adverse events were reported . CONCLUSIONS Long-term therapy with emollient is effective and well tolerated for the treatment of xerosis in children with atopic dermatitis Background : Atopic dermatitis ( AD ) is characterized by barrier abnormalities , including insufficient ceramides in the stratum corneum ( SC ) . Objective : To measure the effects of a new moisturizer ( CRM ) containing a ceramide precursor in improving skin barrier function in patients with controlled atopic dermatitis . Methods : In this r and omized , intra-individual comparison , investigator-blinded study , CRM was applied to the test area of one lower leg for 27 days ( the other leg remained as untreated control ) . Evaluations at baseline and day 28 included transepidermal water loss ( TEWL ) , skin hydration by corneometry , dryness severity , Raman spectroscopy , and collection of adverse events . Results : After 4 weeks of treatment , results showed a significantly greater reduction of TEWL and clinical dryness scores , and increased skin hydration ( all p < 01 ) in the CRM-treated than untreated area . A significantly higher level of ceramide ( p < 05 ) and a trend toward increased water content was observed with Raman in the SC for CRM than for the control . There were no related AEs . Conclusion : Skin barrier function and hydration were significantly improved after CRM treatment New treatment modalities are needed in atopic dermatitis . We evaluated the pharmacokinetics , safety , tolerability , and efficacy of topical cis-urocanic acid ( cis-UCA ) cream in r and omised vehicle-controlled double-blinded clinical trials . The subjects received 5 % cis-UCA emulsion cream and control vehicle on volar forearms after right-left r and omisation . Study 1 : 16 healthy subjects received one dose on the skin and , a week later , on DMSO-irritated skin . Study 2 : 16 healthy subjects received 2 daily doses for 10 days . Study 3 : 13 patients with mild to moderate disease were treated on selected skin lesions twice daily for 28 days . Study treatments were well tolerated . cis-UCA remained close to endogenous levels in plasma and urine . cis-UCA reduced transepidermal water loss ( TEWL ) both in healthy subjects and in the patients . Eczema area severity index and physician 's global assessment improved from baseline with both treatments . cis-UCA cream improved skin barrier function and suppressed inflammation in the human skin Patients with atopic dermatitis ( AD ) have an epidermal barrier dysfunction , which allows invasion of allergens to occur . Stratum corneum skin barrier is formed by corneocytes and extracellular lipids extruded from the epidermal lamellar bodies . In a controlled , r and omized , double-blinded , right-left comparison study we investigated the effect of pimecrolimus ( PIM ) cream compared with triamcinolone acetonide cream ( TA ) on the skin barrier in 15 patients with symmetrical elbow lesions of AD . In punch biopsies , before and after treatment , skin lipid bilayer and lamellar body structure were examined by transmission electron microscopy ( TEM ) . Partial Eczema Area and Severity Index ( pEASi ) , stratum corneum hydration , and transepidermal water loss ( TEWL ) were monitored on days 1 , 8 and 22 . The pEASi was significantly more improved with TA compared with PIM , whereas stratum corneum hydration was slightly more improved after treatment with PIM . The TEM revealed a strong reduction in lamellar bodies in lesional skin of AD ; only 32 % of the lamellar bodies were normal . A significantly higher number of normal lamellar bodies was found after 3 weeks of treatment with PIM ( 58 % ; p < 0.005 ) . An increase in lamellar bodies also occurred with TA treatment ( 46 % ; p < 0.05 ) ; however , significantly less than with PIM ( p < 0.05 ) . Clinical score and TEWL were more improved after treatment with TA , whereas the lamellar bodies were more normal after treatment with PIM Background : Pruritus ani ( PA ) is defined as intense chronic itching affecting perianal skin . Objective : We aim ed to determine the efficacy of topical tacrolimus treatment in atopic dermatitis ( AD ) patients who have PA . Methods : The study included 32 patients with AD who were suffering PA . Patients were r and omized into two groups . In total , 16 patients used 0.03 % tacrolimus ointment and 16 patients used vaseline as placebo . All groups applied topical treatments to their perianal area twice daily for 4 weeks . The treatments were then reversed for 4 weeks after a 2 weeks wash out period . Results : In total , 32 patients with AD who had refractory anal itching were enrolled in this study . None of the patients had obtained successful results with previous treatments . There was a statistically significant decrease in the recorded EASI , DLQI and itching scores for the tacrolimus group compared to the placebo group at weeks 4 and 6 of treatment ( p < 0.05 ) . Conclusion : Topical tacrolimus treatment was well tolerated and effective in controlling persistent PA in AD patients Background : No study has clearly demonstrated the steroid-sparing effect of emollients in the treatment of atopic dermatitis ( AD ) . Aim : Evaluating the effect of an emollient containing oat extracts on the amount of topical corticosteroids used in infants with moderate to severe AD . Study Design : During 6 weeks , 173 infants under 12 months old treated for inflammatory lesions by moderate- and /or high-potency topical corticosteroids r and omly received the emollient or not ( control group ) . Methods : Evaluation of corticosteroid consumption by weighing the tubes , disease severity by the Scoring Atopic Dermatitis Index ( SCORAD ) , and infants ’ and parents ’ quality of life by Infant ’s Dermatitis Quality of Life Index and Dermatitis Family Impact scores at D0 , D21 and D42 . Results : Compared to the control group , the amount of moderate- and high-potency corticosteroids used in 6 weeks decreased by 7.5 % ( not significant ) and 42 % ( p < 0.05 ) , respectively , in the emollient group . The SCORAD index , and infants ’ and parents ’ quality of life significantly improved ( p < 0.0001 ) in both groups . Conclusion : The emollient treatment significantly reduced the high-potency topical corticosteroid consumption in infants with AD Parental education is important in managing childhood atopic dermatitis ( AD ) . We evaluated the long-term effects of a 2-day parental education program ( PEP ) on childhood AD . In an investigator-blinded , r and omized controlled trial , 59 children age 6 months to 6 years with moderate to severe AD and their mothers were recruited in Japan . Participants were given a booklet about AD and received conventional treatment alone or in combination with a 2-day PEP comprising three lectures , three practical sessions , and a group discussion . The primary outcome was evaluation of eczema severity using SCORing Atopic Dermatitis ( SCORAD ) at 6 months . Secondary outcomes included changes in symptom scores , amount of corticosteroid used , parental quality of life as determined according to the Dermatitis Family Impact question naire , and change in parental anxiety regarding the use of corticosteroids in their children . Participants in the PEP group had a significantly lower SCORAD score than those in the control group at 6 months ( mean difference 10.0 , 95 % confidence interval [ CI ] = 2.3 - 17.7 , p = 0.01 ) and objective SCORAD score ( mean difference 7.1 , 95 % CI = 0.8 - 13.5 , p = 0.03 ) . The sleeplessness symptom score ( mean difference 1.6 , 95 % CI = 0.0 - 3.1 , p = 0.048 ) and corticosteroid anxiety score ( p = 0.02 ) in the PEP group were significantly better than in the control group at 6 months . There was no significant difference between groups in the amount of corticosteroid used or quality of life . The PEP had positive long-term effects on eczema severity and parental anxiety about corticosteroid usage Abstract Background : Atopic dermatitis ( AD ) is a disease with multifactorial etiology . Staphylococcus aureus is one of the predominant environmental factors acting on the course and intensity of the disease . Objectives : The aims of the study were to evaluate the efficacy and safety of clothing made of cellulose fibers with seaweed enriched with silver ions in the treatment of children with AD . Methods : A prospect i ve , r and omized and double-blinded controlled selection was done to recruit 19 children with diagnosis of AD . This sample was divided in two groups with similar demographic and clinical characteristics ( the “ control ” group of seven children who wore placebo clothing and the “ trial textile ” group of 12 children who wore clothing with the new textile ) . The severity of AD and clinical response were assessed by the SCORAD index , the intensity of pruritus and the changes in sleep characteristics , at the start of the study and after 7 and 90 d. Results : The SCORAD index improvement in the group with the fiber under study was statistically significant after the first 7 d of treatment ( p < 0.001 ) and was reduced by about 45 % after 90 d. There was also a statistically relevant reduction of the intensity of pruritus and an improvement in the sleep quality after the initial 7 d and at day 90 . Conclusion : The results showed that the textile clothing with seaweed enriched with silver ions brings a quicker improvement of the patients in the first days in opposition to the use of st and ard all-cotton clothes . The results also reinforce the importance of non-pharmacological measures , like clothing , in the management of patients with a diagnosis of AD Introduction : The natural cyclic tetrahydropyrimidine , ectoine , is a low-molecular , water-binding , organic osmolyte . Previously , topical application of ectoine to healthy human skin was shown to improve skin hydration as well as skin barrier function . Objectives : We therefore speculated that topical application of ectoine would be beneficial for patients with atopic dermatitis ( AD ) , in which a genetically defined defect in skin barrier function is of major pathogenetic relevance . We assessed the efficacy of an ectoine-containing cream ( EHK02 - 01 ) in the management of 65 patients with mild to moderate AD in a r and omized , intra-individual , double-blind , multi-center trial , in which the efficacy of ectoine was compared to a nonsteroidal anti-inflammatory cream previously found to primarily act on skin barrier function and therefore with a comparable mode of action . Methods : Sixty-five patients with mild to moderate AD aged 18 - 65 years were enrolled . The patients applied EHK02 - 01 and the control cream on two symmetrical lesions twice daily for 28 days . At the beginning , after 7 and after 28 days , treated skin areas were assessed by modified , objective local SCORAD ( Scoring Atopic Dermatitis ) and IGA ( Investigator 's Global Assessment ) as well as the patients ' judgment of efficacy and their assessment of pruritus . Results : EHK02 - 01 was found to be very well tolerated . Even more important , efficacy of EHK02 - 01 treatment was equivalent to that achieved with the reference product . Conclusion : These results indicate that topical treatment with EHK02 - 01 may represent a novel option for the treatment of patients with AD Natural oils are advocated and used throughout the world as part of neonatal skin care , but there is an absence of evidence to support this practice . The goal of the current study was to ascertain the effect of olive oil and sunflower seed oil on the biophys
Output:
| Studies on the topical treatment of atopic dermatitis largely supported the recommended use of topical corticosteroids and topical calcineurin inhibitors .
Lipoxin A4 , an eicosanoid with anti-inflammatory properties , and a 5 % cis-urocanic acid emulsion cream were effective in the treatment of atopic dermatitis , although studies were small .
Adjunct therapy with bleach baths , natural oils , and textiles all showed some benefit ; however , studies are limited .
SUMMARY There is strong evidence for the use of topical anti-inflammatory therapies in the treatment of atopic dermatitis .
There is little evidence to suggest that one emollient is better than others |
MS211386 | ***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 monitored plasma and skeletal muscle markers of free-radical-mediated damage following maximum eccentric and concentric exercise , to examine the potential role of free radicals in exercise-induced muscle damage . Fourteen male volunteers performed either ( 1 ) a bout of 70 maximum eccentric and a bout of 70 maximum concentric muscle actions of the forearm flexors ( the bouts being separated by 4 weeks ; n = 8) or ( 2 ) a bout of 80 maximum eccentric and a bout of 80 maximum concentric muscle actions of the knee extensors ( the bouts being separated by 1 week ; n=6 ) . Plasma markers of lipid peroxidation , thiobarbituric acid-reactive substances ( TBARS ) and diene-conjugated compounds ( DCC ) were monitored in the arm protocol and skeletal muscle markers of oxidative lipid and protein damage , malondialdehyde ( MDA ) and protein carbonyl derivatives ( PCD ) respectively , were monitored in the leg protocol . In both protocol s , the contralateral limb was used for the second bout and the order of the bouts was r and omised between limbs . Repeated measures ANOVA indicated significant changes from baseline following eccentric arm work on the measures of serum creatine kinase activity ( P < 0.05 ) , maximum voluntary torque production ( P < 0.01 ) and relaxed arm angle ( P < 0.01 ) . Subjective muscle soreness peaked 2 days after eccentric arm work ( P < 0.05 , Wilcoxon test ) . However , there were no changes in the plasma levels of TBARS or DCC following the eccentric or concentric arm exercise . Immediately after concentric leg exercise , skeletal muscle PCD concentrations was significantly higher than that observed immediately after eccentric work ( P < 0.05 ) . However , no significant difference between the eccentric and concentric knee extensor bouts was observed on the measure of skeletal muscle MDA concentration . The results of this study offer no support for the involvement of oxygen free radicals in exercise-induced muscle damage OBJECTIVES : The ability to maximally generate active muscle tension during resistance training has been established to be a primary determinant for strength development . The influence of intrasession rest intervals may have a profound effect on strength gains subsequent to short-term high intensity training . The purpose of this study was to examine the effects of rest interval on strength and functional performance after four weeks of isokinetic training . METHODS : Fifteen healthy college aged individuals were r and omly assigned to either a short rest interval group ( group 1 , n = 8) or a long rest interval group ( group 2 , n = 7 ) . Subjects were evaluated for quadriceps and hamstring isokinetic strength at 60 ( five repetitions ) and 180 ( 30 repetitions ) degrees/second and functional performance with the single leg hop for distance test . One leg of each subject was r and omly assigned to a four week , three days/week isokinetic strength training programme for concentric knee extension and flexion performed at 90 degrees/second . Subjects in group 1 received a 40 second rest interval in between exercise sets , whereas subjects in group 2 received a 160 second rest period . RESULTS : A two factor analysis of variance for the pre-test -- post-test gain scores ( % ) showed significantly greater improvements for isokinetic hamstring total work and average power at 180 degrees/second for the trained limb of subjects in group 2 than their contralateral non-trained limb and the subjects in group 1 . Significantly greater improvements for the single leg hop for distance were also found for the trained limbs of subjects in both groups as compared with the non-trained limbs . CONCLUSIONS : The findings indicate that a relatively longer intrasession rest period result ed in a greater improvement in hamstring muscle strength during short term high intensity training The effects of warm underwater water-jet massage on neuromuscular functioning , selected biochemical parameters ( serum creatine kinase , lactic dehydrogenase , serum carbonic anhydrase , myoglobin , urine urea and creatinine ) and muscle soreness were studied among 14 junior track and field athletes . Each subject spent , in a r and omized order , two identical training weeks engaged in five strength/power training sessions lasting 3 days . The training weeks differed from each other only in respect of underwater water jet massage treatments . These were used three times ( 20 min each ) during the treatment week and not used during the control week . During the treatment week continuous jumping power decreased and ground contact time increased significantly less ( P < 0.05 ) and serum myoglobin increased more than during the control week . It is suggested that underwater water-jet massage in connection with intense strength/power training increases the release of proteins from muscle tissue into the blood and enhances the maintenance of neuro-muscular performance capacity The effect of a combination of a warm-up , stretching exercises and massage on subjective scores for delayed onset muscle soreness ( DOMS ) and objective functional and biochemical measures was studied . Fifty people , r and omly divided in a treatment and a control group , performed eccentric exercise with the forearm flexors for 30 min . The treatment group additionally performed a warm-up and underwent a stretching protocol before the eccentric exercise and massage afterwards . Functional and biochemical measures were obtained before , and 1 , 24 , 48 , 72 and 96h after exercise . The median values at the five post-exercise time points differed significantly for DOMS measured when the arm was extended ( p = 0.043 ) . Significant main effects for treatment were found on the maximal force ( p = 0.026 ) , the flexion angle of the elbow ( p = 0.014 ) and the creatine kinase activity in blood ( p = 0.006 ) . No time-by-treatment interactions were found . DOMS on pressure , extension angle and myoglobin concentration in blood did not differ between the groups . This combination of a warm-up , stretching and massage reduces some negative effects of eccentric exercise , but the results are inconsistent , since some parameters were significantly affected by the treatment whereas others were not , despite the expected efficacy of a combination of treatments . The objective measures did not yield more unequivocal results than the subjective DOMS scores It was hypothesized that athletic massage administered 2 hours after eccentric exercise would disrupt an initial crucial event in acute inflammation , the accumulation of neutrophils . This would result in a diminished inflammatory response and a concomitant reduction in delayed onset muscle soreness ( DOMS ) and serum creatine kinase ( CK ) . Untrained males were r and omly assigned to a massage ( N = 7 ) or control ( N = 7 ) group . All performed five sets of isokinetic eccentric exercise of the elbow flexors and extensors . Two hours after exercise , massage subjects received a 30-minute athletic massage ; control subjects rested . Delayed onset muscle soreness and CK were assessed before exercise and at 8 , 24 , 48 , 72 , 96 , and 120 hours after exercise . Circulating neutrophils were assessed before and immediately after exercise , and at 30-minute intervals for 8 hours ; cortisol was assessed before and immediately after exercise , and at 30-minute intervals for 8 hours ; cortisol was assessed at similar times . A trend analysis revealed a significant ( p < 0.05 ) treatment by time interaction effect for 1 ) DOMS , with the massage group reporting reduced levels ; 2 ) CK , with the massage group displaying reduced levels ; 3 ) neutrophils , with the massage group displaying a prolonged elevation ; and 4 ) cortisol , with the massage group showing a diminished diurnal reduction . The results of this study suggest that sports massage will reduce DOMS and CK when administered 2 hours after the termination of eccentric exercise . This may be due to a reduced emigration of neutrophils and /or higher levels of serum cortisol Manual massage is commonly assumed to enhance long term muscle recovery from intense exercise , partly due to its ability to speed healing via enhanced muscle blood flow . We tested these assumptions by daily ( for four days ) massaging the quadriceps muscles of one leg on subjects who had previously completed an intense bout of eccentric quadriceps work with both legs . Immediate post-exercise isometric and dynamic quadriceps peak torque measures had declined to approximately 60 - 70 % of pre-exercise values in both legs . Peak torques for both the massage and control leg tended to slowly return toward pre-exercise values through the subsequent four days ( 96 hrs ) . There was no significant difference between the isometric and dynamic peak torques between massage and control legs up to 96 hours post-exercise . Leg blood flow was estimated by determining femoral artery and vein mean blood velocities via pulsed Doppler ultrasound velocimetry . Massage of the quadriceps muscles did not significantly elevate arterial or venous mean blood velocity above resting levels , while light quadriceps muscle contractions did . The perceived level of delayed onset muscle soreness tended to be reduced in the massaged leg 48 - 96 hours post-exercise . It was concluded that massage was not an effective treatment modality for enhancing long term restoration of post-exercise muscle strength and its use for this purpose in athletic setting s should be question ed The purpose of this study was to compare the analgesic effect of pulsating ultrasound treatment and placebo on delayed onset of muscle soreness produced by an eccentric exercise bout . In addition , the effect of pulsed ultrasound on muscular performance following an eccentric exercise bout was studied . Eighteen untrained subjects were r and omly assigned to : 1 ) ultrasound ( A ) [ N = 6 ] over the areas of concentrated muscle soreness , i.e. proximal vastus lateralis and distal vastus medialis ; 2 ) placebo ultrasound ( B ) [ N = 6 ] ; and 3 ) no therapeutic intervention ( C ) [ N = 6 ] . Baseline data were recorded for maximum isometric knee extension contraction ( MVC ) , maximum knee extension torque ( MT ) , knee extension work ( W ) , and soreness perception ( SP ) . All values were subsequently reassessed 24 and 48 hours after intense muscular activity . Immediately following the 24 hour re assessment the A group received ultrasound treatment , the B group received placebo ultrasound , while the C group received no treatment . Percent deviation from baseline of SP , MVC , MT and W were significantly less for A than B and C ( p less than 0.05 ) at 48 hours post muscle soreness bout . These data indicate that pulsed ultrasound accelerates restoration of normal muscle performance , and thus is effective in decreasing delayed onset of muscle soreness . The mechanism for decreasing soreness perception in the muscle is unknown , but may be related to decreasing intramuscular pressure and /or decreasing the inflammatory response
Output:
| However , most suggest that post-exercise massage may alleviate symptoms of DOMS .
CONCLUSIONS Massage therapy may be a promising treatment for DOMS . |
MS211387 | ***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: Epidemiologic studies have failed to support the hypothesis that circulating and rogens are positively associated with prostate cancer risk and some recent studies have even suggested that high testosterone levels might be protective particularly against aggressive cancer . We tested this hypothesis by measuring total testosterone , and rostanediol glucuronide , and rostenedione , DHEA sulfate , estradiol , and sex hormone – binding globulin in plasma collected at baseline in a prospect i ve cohort study of 17,049 men . We used a case-cohort design , including 524 cases diagnosed during a mean 8.7 years follow-up and a r and omly sample d subcohort of 1,859 men . The association between each hormone level and prostate cancer risk was tested using Cox models adjusted for country of birth . The risk of prostate cancer was ∼30 % lower for a doubling of the concentration of estradiol but the evidence was weak ( Ptrend = 0.07 ) . None of the other hormones was associated with overall prostate cancer ( Ptrend ≥ 0.3 ) . None of the hormones was associated with nonaggressive prostate cancer ( all Ptrend ≥ 0.2 ) . The hazard ratio [ HR ; 95 % confidence interval ( 95 % CI ) ] for aggressive cancer almost halved for a doubling of the concentration of testosterone ( HR , 0.55 ; 95 % CI , 0.32 - 0.95 ) and and rostenedione ( HR , 0.51 ; 95 % CI , 0.31 - 0.83 ) , and was 37 % lower for a doubling of the concentration of DHEA sulfate ( HR , 0.63 ; 95 % CI , 0.46 - 0.87 ) . Similar negative but nonsignificant linear trends in risk for aggressive cancer were obtained for free testosterone , estradiol , and sex hormone – binding globulin ( Ptrend = 0.06 , 0.2 , and 0.1 , respectively ) . High levels of testosterone and adrenal and rogens are thus associated with reduced risk of aggressive prostate cancer but not with nonaggressive disease . ( Cancer Epidemiol Biomarkers Prev 2006;15(1):86–91 PURPOSE Several lines of evidence suggest that diet and weight gain may be important environmental factors implicated in prostate carcinogenesis , especially in tumor progression . The purpose of this study was to evaluate obesity at different ages in a well-characterized cohort of prostate cancer patients treated with prostatectomy and to develop a prognostic model that incorporates body mass index ( BMI ) as a measure of obesity . EXPERIMENTAL DESIGN We carried out a prospect i ve study of 526 patients registered at the M.D. And erson Cancer Center from 1992 to 2001 . Kaplan-Meier and Cox proportional hazard analyses were done . RESULTS During an average follow-up of 54 months , 97 ( 18 % ) post-prostatectomy patients experienced biochemical failure . Patients who were obese ( BMI > or = 30 kg/m2 ) at diagnosis had a higher rate of biochemical failure than nonobese men ( P = 0.07 ) . Those obese at 40 years had an even greater rate of biochemical failure ( P = 0.001 ) . Higher BMI at diagnosis [ hazard ratio ( HR ) , 1.07 ; P = 0.01 ] and Gleason score = 7(4 + 3 ) and > or = 8 ( HR , 3.9 ; P = 0.03 and HR , 10.0 ; P < or = 0.001 , respectively ) remained significant independent predictors of biochemical failure in multivariate analysis . Men who gained weight at the greatest rate ( > 1.5 kg/y ) between 25 years and diagnosis progressed significantly sooner ( mean time , 17 months ) than those who exhibited a slower weight gain ( mean time , 39 months ; P(trend ) = 0.005 ) . The inclusion of obesity to the clinical nomogram improved performance . CONCLUSIONS Our findings vali date the importance for a role of obesity in prostate cancer progression and suggest a link to the biological basis of prostate cancer progression that can be therapeutically exploited Background : Prior prospect i ve cohort studies found that obesity was associated with increased risk of prostate cancer death . However , in the last 20 years dramatic changes in both the extent of obesity and prostate cancer screening and treatment have occurred . Whether the association between obesity and aggressive disease has changed as a result of these temporal changes is unclear . Methods : The study population consisted of 2,832 men treated by anatomic radical retropubic prostatectomy between 1985 and 2004 by a single surgeon . We evaluated the associations of obesity ( body mass index ≥30 kg/m2)with tumor stage and grade using logistic regression and with biochemical progression using Cox proportional hazards regression . We examined whether these associations have changed over the last 20 years . Results : On multivariable analysis , the strength of the positive association between obesity and high- grade disease increased over time whereas the strength of the positive association between obesity and positive surgical margins decreased over time . The strength of the positive association between obesity and extraprostatic extension fluctuated over time , although the strongest and only statistically significant association was among men treated since 2000 . The association between obesity and biochemical progression was strongest among men treated since 1995 ( relative risk , 1.90 ; 95 % confidence interval , 1.09 - 3.30 ; P = 0.02 ) . Conclusions : In the current study , with the exception of positive surgical margins , the positive association between obesity and high- grade disease , advanced stage , and biochemical progression after radical retropubic prostatectomy was in general strongest among men treated in the last 10 years . The reasons for these findings are not clear , although factors possibly related to prostate-specific antigen – based screening and /or other temporal changes in prostate cancer diagnosis and treatment may play a role PURPOSE Obesity has been proposed as an independent risk factor for patients undergoing surgery or radiotherapy ( RT ) for prostate cancer . Using body mass index ( BMI ) as a measure of obesity , we tested its role as a risk factor for patients receiving salvage RT after prostatectomy . METHODS AND MATERIAL S Rates of subsequent biochemical relapse were examined in 90 patients who underwent salvage RT between 1984 and 2004 for biochemical failure after radical prostatectomy . Median follow-up was 3.7 years . The BMI was tested as a continuous and categorical variable ( stratified as < 25 , 25-<30 , and > or=30 kg/m(2 ) ) . Univariate and multivariate proportional hazards regression analyses were performed for clinical , pathologic , and treatment factors associated with time to relapse after salvage RT . RESULTS There were 40 biochemical failures after salvage RT with a median time to failure of 1.2 years . The BMI was not associated with adverse clinical , pathologic , or treatment factors . On multivariate analysis , obesity was independently significant ( hazard ratio [ HR ] , 1.2 ; p = 0.01 ) , along with RT dose ( HR , 0.7 ; p = 0.003 ) and pre-RT prostate-specific antigen level ( HR , 1.2 ; p = 0.0003 ) . CONCLUSIONS This study is weakly suggestive that obesity may be a risk factor for salvage RT patients . Whether this results from greater biologic aggressiveness or technical inadequacies can not be answered by this study . Given the very high failure rate observed for severely obese patients , we propose that technical difficulties with RT are at play . This hypothesis is supported by the RT literature and could be prospect ively investigated . Techniques that optimize targeting , especially in obese patients , perhaps seem warranted at this time PURPOSE We examined the impact of obesity on disease specific and overall survival in patients with prostate cancer . MATERIAL S AND METHODS We identified 7,274 men from the Cancer of the Prostate Strategic Urological Research Endeavor data base with clinical ly localized prostate cancer , known body mass index and clinicopathological disease characteristics . Patients were classified by body mass index as normal ( less than 25 kg/m(2 ) ) , overweight ( 25 to 29.9 kg/m(2 ) ) , obese ( 30 to 34.9 kg/m(2 ) ) and severely obese ( 35 kg/m(2 ) or greater ) . Associations between body mass index and need for secondary treatment , disease specific survival and overall survival were analyzed using univariate and multivariate models . RESULTS Patients were classified by body mass index category as normal ( 28.8 % ) , overweight ( 50 % ) , obese ( 16.4 % ) and very obese ( 4.8 % ) . Mean followup was 51.3 + /- 38.5 months . During followup there were 1,044 deaths with 220 ( 21.1 % ) from prostate cancer . Stratified by body mass index category the groups differed with regard to the need for secondary treatment ( p = 0.05 ) and overall mortality ( p < 0.01 ) but there were no significant differences with regard to disease specific survival ( p = 0.09 ) . On multivariate analysis age 65 to 74 years ( HR 2.4 , p = 0.002 ) , age older than 75 years ( HR 3.2 , p = 0.0001 ) , high risk disease ( HR 1.6 , p < 0.0001 ) , conservative treatment ( HR 1.2 , p < 0.0001 ) and presence of diabetes ( HR 1.6 , p < 0.0001 ) were associated with decreased overall survival . Only conservative treatment ( HR 1.4 , p < 0.0001 ) , high risk disease ( HR 8.4 , p < 0.0001 ) and intermediate risk disease ( HR 2.5 , p = 0.004 ) were associated with decreased disease specific survival . CONCLUSIONS In a prospect i ve , community based cohort we were unable to establish a relationship between body mass index and prostate cancer disease specific survival or overall survival BACKGROUND The influence of excess body weight on the risk of death from cancer has not been fully characterized . METHODS In a prospect ively studied population of more than 900,000 U.S. adults ( 404,576 men and 495,477 women ) who were free of cancer at enrollment in 1982 , there were 57,145 deaths from cancer during 16 years of follow-up . We examined the relation in men and women between the body-mass index in 1982 and the risk of death from all cancers and from cancers at individual sites , while controlling for other risk factors in multivariate proportional-hazards models . We calculated the proportion of all deaths from cancer that was attributable to overweight and obesity in the U.S. population on the basis of risk estimates from the current study and national estimates of the prevalence of overweight and obesity in the U.S. adult population . RESULTS The heaviest members of this cohort ( those with a body-mass index [ the weight in kilograms divided by the square of the height in meters ] of at least 40 ) had death rates from all cancers combined that were 52 percent higher ( for men ) and 62 percent higher ( for women ) than the rates in men and women of normal weight . For men , the relative risk of death was 1.52 ( 95 percent confidence interval , 1.13 to 2.05 ) ; for women , the relative risk was 1.62 ( 95 percent confidence interval , 1.40 to 1.87 ) . In both men and women , body-mass index was also significantly associated with higher rates of death due to cancer of the esophagus , colon and rectum , liver , gallbladder , pancreas , and kidney ; the same was true for death due to non-Hodgkin 's lymphoma and multiple myeloma . Significant trends of increasing risk with higher body-mass-index values were observed for death from cancers of the stomach and prostate in men and for death from cancers of the breast , uterus , cervix , and ovary in women . On the basis of associations observed in this study , we estimate that current patterns of overweight and obesity in the United States could account for 14 percent of all deaths from cancer in men and 20 percent of those in women . CONCLUSIONS Increased body weight was associated with increased death rates for all cancers combined and for cancers at multiple specific sites Increasing body mass index ( BMI ) is associated with shorter time to prostate‐specific antigen ( PSA ) failure after radical prostatectomy . Whether BMI is associated with time to PSA failure was investigated in men treated with and rogen suppression therapy ( AST ) and radiation therapy ( RT ) for clinical ly localized prostate cancer Greater body mass index ( BMI ) is associated with shorter time to prostate‐specific antigen ( PSA ) failure following radical prostatectomy and radiation therapy ( RT ) . Whether BMI is associated with prostate cancer‐specific mortality ( PCSM ) was investigated in a large r and omized trial of men treated with RT and and rogen deprivation therapy ( ADT ) for locally advanced prostate cancer BACKGROUND In the European R and omized Study of Screening for Prostate Cancer ( ERSPC , Rotterdam region ) , men aged 55 - 74 years are screened for prostate cancer by prostate-specific antigen ( P
Output:
| Elevated BMI is associated with risk of prostate cancer-specific mortality in prospect i ve cohort studies and biochemical recurrence in prostate cancer patients . |
MS211388 | ***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: People with diabetes are more likely to be hospitalized and to have longer duration s of hospital stay than those without diabetes . A recent survey estimated that 22 % of all hospital inpatient days were incurred by people with diabetes and that hospital inpatient care accounted for half of the 174 billion USD total U.S. medical expenditures for this disease ( 1 ) . These findings are due , in part , to the continued expansion of the worldwide epidemic of type 2 diabetes . In the U.S. alone , there are ∼1.6 million new cases of diabetes each year , with an over all prevalence of 23.6 million people ( 7.8 % of the population , with one-fourth of the cases remaining undiagnosed ) . An additional 57 million American adults are at high risk for type 2 diabetes ( 2 ) . Although the costs of illness-related stress hyperglycemia are not known , they are likely to be considerable in light of the poor prognosis of such patients ( 3–6 ) . There is substantial observational evidence linking hyperglycemia in hospitalized patients ( with or without diabetes ) to poor outcomes . Cohort studies as well as a few early r and omized controlled trials ( RCTs ) have suggested that intensive treatment of hyperglycemia improved hospital outcomes ( 5–8 ) . In 2004 , this evidence led the American College of Endocrinology ( ACE ) and the American Association of Clinical Endocrinologists ( AACE ) , in collaboration with the American Diabetes Association ( ADA ) and other medical organizations , to develop recommendations for treatment of inpatient hyperglycemia ( 9 ) . In 2005 , the ADA added recommendations for treatment of hyperglycemia in the hospitalto itsannual St and ards of Medical Care ( 10 ) . Recommendations from the ACE and the ADA generally endorsed tight glycemic control in critical care units . For patients in general medical and surgical units , where RCT evidence regarding treatment targets was lacking , glycemic goals similar to those advised for out patients were advocated ( 9 , Objectives : To examine the predisposing factors for hypoglycemia in medical-surgical intensive care unit patients treated with intensive insulin therapy and to assess its association with mortality . Design : Nested-cohort study within a r and omized controlled trial . Setting : Tertiary care intensive care unit . Participants : Medical-surgical intensive care unit patients with admission blood glucose of > 6.1 mmol/L or 110 mg/dL who were enrolled in a r and omized controlled trial comparing intensive insulin therapy with conventional insulin therapy . Interventions : None . Exposure : Hypoglycemia was defined as blood glucose ≤2.2 mmol/L or 40 mg/dL and intensive care unit mortality was the primary outcome . Measurements and Main Results : Among the 523 patients included in the study , hypoglycemia occurred in 84 ( 16 % ) . Intensive insulin therapy was independently associated with increased risk of hypoglycemia ( adjusted odds ratio , 50.65 ; 95 % confidence interval , 17.36–147.78 ; p < .0001 ) . Other variables associated with an increased risk of hypoglycemia included female gender , diabetes , Acute Physiology and Chronic Health Evaluation II , mechanical ventilation , continuous veno-venous hemodialysis , and intensive care unit length of stay . When adjusted to potential confounders , hypoglycemia was not significantly associated with increased mortality ( adjusted hazard ratio , 1.31 ; 95 % confidence interval , .70–2.46 ; p = .40 ) . Patients with admission blood glucose of ≤10 mmol/L had an increased mortality with hypoglycemia ( adjusted hazard ratio , 4.43 ; 95 % confidence interval , 1.36–14.44 ; p = .01 ) . Crude analysis showed significant association of mortality with blood glucose levels of ≤1.2 mmol/L ( adjusted hazard ratio , 2.92 ; 95 % confidence interval , 1.05–8.11 ; p = .04 ) . When adjusted analysis was performed , similar trend was seen but was not statistically significant ( adjusted hazard ratio , 2.56 ; 95 % confidence interval , .85–7.70 ; p = .10 ) . Conclusions : Our study showed significant increase of hypoglycemia with intensive insulin therapy . Although hypoglycemia was not independently associated with increased risk of death , increased mortality could not be excluded with severe hypoglycemia and in patients admitted with blood glucose of ≤10 Admission hyperglycemia has been associated with increased hospital mortality in critically ill patients ; however , it is not known whether hyperglycemia in patients admitted to general hospital wards is associated with poor outcome . The aim of this study was to determine the prevalence of in-hospital hyperglycemia and determine the survival and functional outcome of patients with hyperglycemia with and without a history of diabetes . We review ed the medical records of 2030 consecutive adult patients admitted to Georgia Baptist Medical Center , a community teaching hospital in downtown Atlanta , GA , from July 1 , 1998 , to October 20 , 1998 . New hyperglycemia was defined as an admission or in-hospital fasting glucose level of 126 mg/dl ( 7 mmol/liter ) or more or a r and om blood glucose level of 200 mg/dl ( 11.1 mmol/liter ) or more on 2 or more determinations . Hyperglycemia was present in 38 % of patients admitted to the hospital , of whom 26 % had a known history of diabetes , and 12 % had no history of diabetes before the admission . Newly discovered hyperglycemia was associated with higher in-hospital mortality rate ( 16 % ) compared with those patients with a prior history of diabetes ( 3 % ) and subjects with normoglycemia ( 1.7 % ; both P < 0.01 ) . In addition , new hyperglycemic patients had a longer length of hospital stay , a higher admission rate to an intensive care unit , and were less likely to be discharged to home , frequently requiring transfer to a transitional care unit or nursing home facility . Our results indicate that in-hospital hyperglycemia is a common finding and represents an important marker of poor clinical outcome and mortality in patients with and without a history of diabetes . Patients with newly diagnosed hyperglycemia had a significantly higher mortality rate and a lower functional outcome than patients with a known history of diabetes or normoglycemia Introduction Intensive insulin therapy ( IIT ) with tight glycemic control may reduce mortality and morbidity in critically ill patients and has been widely adopted in practice throughout the world . However , there is only one r and omized controlled trial showing unequivocal benefit to this approach and that study population was dominated by post-cardiac surgery patients . We aim ed to determine the association between IIT and mortality in a mixed population of critically ill patients . Methods We conducted a cohort study comparing three consecutive time periods before and after IIT protocol implementation in a Level 1 trauma center : period I ( no protocol ) ; period II , target glucose 80 to 130 mg/dL ; and period III , target glucose 80 to 110 mg/dL. Subjects were 10,456 patients admitted to intensive care units ( ICUs ) between 1 March 2001 and 28 February 2005 . The main study endpoints were ICU and hospital mortality , Sequential Organ Failure Assessment score , and occurrence of hypoglycemia . Multivariable regression analysis was used to evaluate mortality and organ dysfunction during periods II and III relative to period I. Results Insulin administration increased over time ( 9 % period I , 25 % period II , and 42 % period III ) . Nonetheless , patients in period III had a tendency toward higher adjusted hospital mortality ( odds ratio [ OR ] 1.15 , 95 % confidence interval [ CI ] 0.98 , 1.35 ) than patients in period I. Excess hospital mortality in period III was present primarily in patients with an ICU length of stay of 3 days or less ( OR 1.47 , 95 % CI 1.11 , 1.93 There was an approximately fourfold increase in the incidence of hypoglycemia from periods I to III . Conclusion A policy of IIT in a group of ICUs from a single institution was not associated with a decrease in hospital mortality . These results , combined with the findings from several recent r and omized trials , suggest that further study is needed prior to widespread implementation of IIT in critically ill patients BACKGROUND The role of intensive insulin therapy in patients with severe sepsis is uncertain . Fluid resuscitation improves survival among patients with septic shock , but evidence is lacking to support the choice of either crystalloids or colloids . METHODS In a multicenter , two-by-two factorial trial , we r and omly assigned patients with severe sepsis to receive either intensive insulin therapy to maintain euglycemia or conventional insulin therapy and either 10 % pentastarch , a low-molecular-weight hydroxyethyl starch ( HES 200/0.5 ) , or modified Ringer 's lactate for fluid resuscitation . The rate of death at 28 days and the mean score for organ failure were co primary end points . RESULTS The trial was stopped early for safety reasons . Among 537 patients who could be evaluated , the mean morning blood glucose level was lower in the intensive-therapy group ( 112 mg per deciliter [ 6.2 mmol per liter ] ) than in the conventional-therapy group ( 151 mg per deciliter [ 8.4 mmol per liter ] , P<0.001 ) . However , at 28 days , there was no significant difference between the two groups in the rate of death or the mean score for organ failure . The rate of severe hypoglycemia ( glucose level , < or = 40 mg per deciliter [ 2.2 mmol per liter ] ) was higher in the intensive-therapy group than in the conventional-therapy group ( 17.0 % vs. 4.1 % , P<0.001 ) , as was the rate of serious adverse events ( 10.9 % vs. 5.2 % , P=0.01 ) . HES therapy was associated with higher rates of acute renal failure and renal-replacement therapy than was Ringer 's lactate . CONCLUSIONS The use of intensive insulin therapy placed critically ill patients with sepsis at increased risk for serious adverse events related to hypoglycemia . As used in this study , HES was harmful , and its toxicity increased with accumulating doses . ( Clinical Trials.gov number , NCT00135473 . OBJECTIVE To determine the safety and efficacy of an intensive insulin regimen compared with a conventional insulin regimen in general intensive care unit patients . METHODS A phase II , r and omised controlled trial was conducted in 70 critically ill patients in a closed multidisciplinary ICU of a university-affiliated tertiary hospital . We assessed patient characteristics at baseline . Trial process measures included number of blood glucose measurements per day and number in target range , type and quantity of caloric intake , patient outcome and insulin dosing . The primary outcome was the median blood glucose concentration . Secondary outcome measures were incidence of hypoglycaemia ( blood glucose level < 2.2 mmol/L ) , clinical sequelae of hypoglycaemia and hospital mortality . RESULTS Thirty-five patients were r and omised to each of the two groups . More blood glucose sample s were taken per day in the intensive insulin group ( 16 versus 9 ) , but the number of sample s in the normoglycaemic range was 48.5 % , compared with 79.8 % within the target glucose range in the conventional insulin group . The median ( interquartile range ) blood glucose concentrations in the intensive and conventional insulin therapy groups were 5.4 ( 5.1 - 5.7 ) mmol/L and 7.9 ( 7.2 - 9.0 ) mmol/L , respectively ( difference , 2.5 mmol/L ; P < 0.0001 ) . Five patients ( 14.3 % ) in the intensive insulin therapy group became hypoglycaemic versus none in the conventional insulin therapy group . There were no detected clinical sequelae of hypoglycaemia . CONCLUSION The intensive insulin regimen was effective in achieving the target blood glucose concentration , with clear separation from the conventional insulin regimen . Although the incidence of hypoglycaemia was increased , there was no detectable harm Objective Elevated blood glucose is associated with poor outcome in patients resuscitated from out-of-hospital cardiac arrest ( OHCA ) . Our aim was to determine whether strict glucose control with intensive insulin treatment improves outcome of OHCA patients . Design A r and omized , controlled trial . Setting Two university hospital intensive care units . Patients Ninety patients resuscitated from OHCA with ventricular fibrillation detected as the initial rhythm were treated with therapeutic hypothermia . Interventions Patients were r and omized into two treatment groups : a strict glucose control group ( SGC group ) , with a blood glucose target of 4–6 mmol/l , or a moderate glucose control group ( MGC group ) , with a blood glucose target of 6–8 mmol/l . Both groups were treated with insulin infusion for 48 h , because a control group with no treatment was considered unethical . Measurements and results Baseline data were similar in both groups . In the SGC group 71 % of the glucose measurements were within the target range compared with 41 % in the MGC group . Median glucose
Output:
| Until further studies prove otherwise , nonsurgical patients requiring glycemic management are best served with less intensive regimens than their surgical counterparts .
Based on the results of this review and data from the four included studies , glycemic management for medical patients in the intensive care unit should differ from that of surgical patients . |
MS211389 | ***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 adverse effects of alcohol on brain function result , in part , from inflammatory processes . The sex-specific neuropsychiatric consequences and inflammatory status of active alcohol dependence and early remission from dependence have not been investigated . METHODS Neuropsychiatric symptoms , inflammatory factors , and liver enzymes were compared in a prospect i ve cohort study of adults with ( n=51 ) or without ( n=31 ) a current or recent history of alcohol dependence . RESULTS Neuropsychiatric profiles were similar in adults with current or recent alcohol dependence regardless of sex . In male and female participants measures of depression ( female p<0.05 , male p<0.001 ) , anxiety ( female p<0.001 , male p<0.001 ) , and memory complaints ( female p<0.001 , male p<0.05 ) were elevated , relative to non-dependent controls . Significant sex × alcohol dependence history interactions were observed for plasma levels of tissue inhibitor of metalloproteinase 1 ( TIMP-1 ) and brain derived neurotrophic factor ( BDNF ) , with women in the alcohol dependent group exhibiting increased levels of both analytes ( p<0.05 ) relative to controls . Positive correlations between TIMP-1 levels and measures of depression ( r2=0.35 , p<0.01 ) , anxiety ( r2=0.24 , p<0.05 ) and memory complaints ( r2=0.44 , p<0.01 ) were found in female , but not male , participants . CONCLUSIONS Though neuropsychiatric profiles were similar for men and women with current or recent alcohol dependence , plasma factors associated with increases in depression , anxiety , and memory impairment differed and support the need to tailor treatments based on sex Background : Minimal hepatic encephalopathy ( MHE ) is common in cirrhosis but its pathophysiologic basis remains undefined . We evaluated whether the presence of MHE was associated with severity of liver disease , ammonia levels or the presence of inflammation and assessed factors determining neuropsychological deterioration accompanying induction of hyperammonemia . Methods : Eighty four cirrhotics were studied . A neuropsychological test battery was performed and blood taken for ammonia , WCC , CRP , nitrate/nitrite , IL-6 and amino acids , before and after , induction of hyperammonemia by administration of a solution mimicking the amino acid composition of haemoglobin ( 60 ) or placebo ( 24 ) . Results : The presence and severity of MHE were independent of severity of liver disease and ammonia concentration but markers of inflammation were significantly higher in those with MHE compared with those without . Induction of hyperammonemia produced deterioration in one or more neuropsychological tests by ≥1 SD in 73.3 % . This was independent of the magnitude of change in plasma ammonia and severity of liver disease but was significantly greater in those with more marked inflammation . Conclusion : Our data show that inflammation is an important determinant of the presence and severity of MHE . The change in neuropsychological function following induced hyperammonemia is greater in those with more severe inflammation AIMS The aim of the study was to investigate factors hypothesized to influence the relapse process , with a focus on the role of self-efficacy , alcohol dependence and cognitive functioning . DESIGN The study was conducted in the context of a controlled trial of a relapse prevention programme . Subjects were assessed prior to treatment , at immediate conclusion of treatment and at 6- and 12-month follow-up . SETTING The study was conducted in an Alcohol Treatment Unit ( ATU ) in Scotl and . PARTICIPANTS Subjects were 60 male problem drinkers who were patients at the ATU . They were heavy drinkers , with corresponding high levels of alcohol dependence and alcohol-related harm . MEASUREMENTS The independent variables were post-treatment self-efficacy , alcohol dependence , cognitive functioning , level of depression and alcohol consumption prior to admission to treatment . The dependent variables were post-treatment drinking behaviour and functioning and time to lapse and relapse . FINDINGS Although the methodology does not allow identification of causality , support was found for the hypothesis that post-treatment self-efficacy was an intervening variable between treatment and outcome . Higher post-treatment self-efficacy predicted better outcome at 6-month follow-up and was associated with a reduced risk of lapse and relapse over the 12-month follow-up . Poorer cognitive functioning was significantly associated with being categorized as a problem drinker at 6-month follow-up and with higher risk of a lapse over the 12-month follow-up . Level of alcohol dependence did not predict outcome . CONCLUSIONS It was concluded that post-treatment self-efficacy rating is a predictor of treatment outcome and time to lapse and relapse and that cognitive functioning is a predictor of treatment outcome and time to lapse
Output:
| Main findings : Although literature on the role of inflammation in alcohol use-related cognitive deficiency remains scarce , current findings indicate that pro-inflammatory processes indeed result in exacerbation of several domains of cognitive deterioration .
Interestingly , microglia , the immune cells of the brain , appear to exert initial compensatory neuroprotective functionalities upon acute ethanol exposure while chronic alcohol intake seems to attenuate these responses and overall microglial activity . |
MS211390 | ***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: Background : Psychiatric advance directives are intended to enable self-determined treatment for patients who lose decisional capacity , and thus reduce the need for coercive interventions such as police transport , involuntary commitment , seclusion and restraints , and involuntary medications during mental health crises ; whether PADs can help prevent the use of these interventions in practice is unknown . Aims : This study examined whether completion of a Facilitated Psychiatric Advance Directive ( F-PAD ) was associated with reduced frequency of coercive crisis interventions . Method : The study prospect ively compared a sample of PAD completers ( n = 147 ) to non-completers ( n = 92 ) on the frequency of any coercive interventions , with follow-up assessment s at 6 , 12 , and 24 months . Repeated- measures multiple regression analysis was used to estimate the effect of PADs . Models controlled for relevant covariates including a propensity score for initial selection to PADs , baseline history of coercive interventions , concurrent global functioning and crisis episodes with decisional incapacity . Results : F-PAD completion was associated with lower odds of coercive interventions ( adjusted OR = 0.50 ; 95 % CI = 0.26–0.96 ; p < 0.05 ) . Conclusions : PADs may be an effective tool for reducing coercive interventions around incapacitating mental health crises . Less coercion should lead to greater autonomy and self-determination for people with severe mental illness Background Crises and ( involuntary ) admissions have a strong impact on patients and their caregivers . In some countries , including the Netherl and s , the number of crises and ( involuntary ) admissions have increased in the last years . There is also a lack of effective interventions to prevent their occurrence . Previous research has shown that a form of psychiatric advance statement – joint crisis plan – may prevent involuntary admissions , but another study showed no significant results for another form . The question remains which form of psychiatric advance statement may help to prevent crisis situations . This study examines the effects of two other psychiatric advance statements . The first is created by the patient with help from a patient 's advocate ( Patient Advocate Crisis Plan : PACP ) and the second with the help of a clinician only ( Clinician facilitated Crisis Plan : CCP ) . We investigate whether patients with a PACP or CCP show fewer emergency visits and ( involuntary ) admissions as compared to patients without a psychiatric advance statement . Furthermore , this study seeks to identify possible mechanisms responsible for the effects of a PACP or a CCP . Methods / Design This study is a r and omised controlled trial with two intervention groups and one control condition . Both interventions consist of a crisis plan , facilitated through the patient 's advocate or the clinician respectively . Out patients with psychotic or bipolar disorders , who experienced at least one psychiatric crisis during the previous two years , are r and omly allocated to one of the three groups . Primary outcomes are the number of emergency ( after hour ) visits , ( involuntary ) admissions and the length of stay in hospital . Secondary outcomes include psychosocial functioning and treatment satisfaction . The possible mediator variables of the effects of the crisis plans are investigated by assessing the patient 's involvement in the creation of the crisis plan , working alliance , insight into illness , recovery style , social support , locus of control , service engagement and coping with crises situations . The interviews take place before r and omisation , nine month later and finally eighteen months after r and omisation . Discussion This study examines the effects of two types of crisis plans . In addition , the results offer an underst and ing of the way these advance statements work and whether it is more effective to include a patients ' advocate in the process of creating a psychiatric advance statement . These statements may be an intervention to prevent crises and the use of compulsion in mental health care . The strength and limitations of this study are discussed . Trial registration Current Controlled Trails NTR1166 At an antenatal clinic in St. Thomas 's Hospital , London , 246 expectant mothers were r and omly allocated to hold either their own maternity case notes or the st and ard co-operation card . Information was collected on three occasions during their care on attitudes and health behaviour . Clinical outcomes were recorded and the effects of the two systems on clinic administration were observed . More of the notes group expressed satisfaction with most aspects of their care and delivery and significantly more of the notes group felt well informed and satisfied with their companion during labour . There were no differences in clinical outcomes between the two groups except that , for no identifiable systematic reason , there were more assisted deliveries among the notes group . A number of administrative advantages result ed from mothers holding their own notes and although initial reservations were found amongst professional staff interviewed at the start of the study , the results proved persuasive and the practice of giving mothers their own notes is now to be extended throughout the department BACKGROUND An advance directive is a statement of a person 's preferences for treatment , should he or she lose capacity to make treatment decisions in the future . AIMS To evaluate whether use of advance directives by patients with mental illness leads to lower rates of compulsory readmission to hospital . METHOD In a r and omised controlled trial in two psychiatric services in inner London , 156 in- patients about to be discharged from compulsory treatment under the Mental Health Act were recruited . The trial compared usual psychiatric care with usual care plus the completion of an advance directive . The primary outcome was the rate of compulsory readmission . RESULTS Fifteen patients ( 19 % ) in the intervention group and 16 ( 21 % ) in the control group were readmitted compulsorily within 1 year of discharge . There was no difference in the numbers of compulsory readmissions , numbers of patients readmitted voluntarily , days spent in hospital or satisfaction with psychiatric services . CONCLUSIONS Users ' advance instruction directives had little observable impact on the outcome of care at 12 months BACKGROUND Patients and doctors often have divergent views on care needs . AIMS To examine whether providing patients with an opportunity to identify and discuss their needs would improve communication and induce changes in care . METHOD Patients with schizophrenia ( n=134 ) were r and omly allocated to either st and ard care or use of the Two-Way Communication Checklist ( 2-COM ) . Before seeing their clinician for a routine follow-up , participants in the active intervention group were given 2-COM , a list of 20 common needs , and told to indicate those areas they wanted to discuss with their doctor . Outcomes were assessed immediately and again after 6 weeks . RESULTS Using 2-COM induced a stable improvement of patient-reported quality of patient-doctor communication ( B=0.33 , P=0.031 ) , and induced changes in management immediately after the intervention ( OR=3.7 , P=0.009 ; number needed to treat , 6 ) . Treatment change was more likely in patients with more reported needs , and needs most likely to induce treatment change displayed stronger associations with non-medication than with medication changes . CONCLUSIONS A simple intervention to aid people in discussion of their needs results in improved communication and changes in management The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas Abstract Objective To investigate whether a form of advance agreement for people with severe mental illness can reduce the use of inpatient services and compulsory admission or treatment . Design Single blind r and omised controlled trial , with r and omisation of individual patients . The investigator was blind to allocation . Setting Eight community mental health teams in southern Engl and . Participants 160 people with an operational diagnosis of psychotic illness or non-psychotic bipolar disorder who had experienced a hospital admission within the previous two years . Intervention The joint crisis plan was formulated by the patient , care coordinator , psychiatrist , and project worker and contained contact information , details of mental and physical illnesses , treatments , indicators for relapse , and advance statements of preferences for care in the event of future relapse . Main outcome measures Admission to hospital , bed days , and use of the Mental Health Act over 15 month follow up . Results Use of the Mental Health Act was significantly reduced for the intervention group , 13 % ( 10/80 ) of whom experienced compulsory admission or treatment compared with 27 % ( 21/80 ) of the control group ( risk ratio 0.48 , 95 % confidence interval 0.24 to 0.95 , P = 0.028 ) . As a consequence , the mean number of days of detention ( days spent as an inpatient while under a section of the Mental Health Act ) for the whole intervention group was 14 compared with 31 for the control group ( difference 16 , 0 to 36 , P = 0.04 ) . For those admitted under a section of the Mental Health Act , the number of days of detention was similar in the two groups ( means 114 and 117 , difference 3 , −61 to 67 , P = 0.98 ) . The intervention group had fewer admissions ( risk ratio 0.69 , 0.45 to 1.04 , P = 0.07 ) . There was no evidence for differences in bed days ( total number of days spent as an inpatient ) ( means 32 and 36 , difference 4 , −18 to 26 , P = 0.15 for the whole sample ; means 107 and 83 , difference −24 , −72 to 24 , P = 0.39 for those admitted ) . Conclusions Use of joint crisis plans reduced compulsory admissions and treatment in patients with severe mental illness . The reduction in overall admission was less . This is the first structured clinical intervention that seems to reduce compulsory admission and treatment in mental health services Psychiatric advance directives ( PADs ) statutes presume competence to complete these documents , but the range and dimensions of decisional competence among people who actually complete PADs is unknown . This study examines clinical and neuropsychological correlates of performance on a measure to assess competence to complete PADs and investigates the effects of a facilitated PAD intervention on decisional capacity . N=469 adults with psychotic disorders were interviewed at baseline and then r and omly assigned to either a control group in which they received written material s about PADs or to an intervention group in which they were offered an opportunity to meet individually with a trained facilitator to create a PAD . At baseline , domains on the Decisional Competence Assessment Tool for PADs ( DCAT-PAD ) were most strongly associated with IQ , verbal memory , abstract thinking , and psychiatric symptoms . At one-month follow-up , participants in the intervention group showed more improvement on the DCAT-PAD than controls , particularly among participants with pre-morbid IQ estimates below the median of 100 . The results suggest that PAD facilitation is an effective method to boost competence of cognitively-impaired clients to write PADs and make treatment decisions within PADs , thereby maximizing the chances their advance directives will be valid Background The use of compulsory treatment under the Mental Health Act ( MHA ) has continued to rise in the UK and in other countries . The Joint Crisis Plan ( JCP ) is a statement of service users ' wishes for treatment in the event of a future mental health crisis . It is developed with the clinical team and an independent facilitator . A recent pilot RCT showed a reduction in the use of the MHA amongst service users with a JCP . The JCP is the only intervention that has been shown to reduce compulsory treatment in this way . The CRIMSON trial aims to determine if JCPs , compared with treatment as usual , are effective in reducing the use of the MHA in a range of treatment setting s across the UK . Methods / Design This is a 3 centre , individual-level , single-blind , r and omised controlled trial of the JCP compared with treatment as usual for people with a history of relapsing psychotic illness in Birmingham , London and Lancashire/Manchester . 540 service users will be recruited across the three sites . Eligible service users will be adults with a diagnosis of a psychotic disorder ( including bipolar disorder ) , treated in the community under the Care Programme Approach with at least one admission to a psychiatric inpatient ward in the previous two years . Current in patients and those subject to a community treatment order will be excluded to avoid any potential perceived pressure to participate . Research assessment s will be conducted at baseline and 18 months . Following the baseline assessment , eligible service users will be r and omly allocated to either develop a Joint Crisis Plan or continue with treatment as usual . Outcome will be assessed at 18 months with assessors blind to treatment allocation . The primary outcome is the proportion of service users treated or otherwise detained under an order of the Mental Health Act ( MHA ) during the follow-up period , compared across r and omisation groups . Secondary outcomes include overall costs , service user engagement , perceived coercion and therapeutic relationships . Sub-analyses will explore the effectiveness of the JCP in reducing use of the MHA specifically for Black Caribbean and Black African service users ( combined ) . Qualitative investigations with staff and service users will explore the acceptability of the JCPs . Discussion JCPs offer a potential solution to the rise of compulsory treatment for
Output:
| The evidence gap remains regarding user-held , personalised , accessible clinical information for people with psychotic illnesses for many of the outcomes of interest .
However , based on moderate quality evidence , this review suggests that there is no effect of the intervention on hospital or outpatient appointment use for individuals with psychotic disorders . |
MS211391 | ***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 consumption of green tea has been associated with cardiovascular and metabolic diseases . There have been some studies on the influence of green tea on the mineral status of obese subjects , but they have not yielded conclusive results . The aim of the present study is to examine the effects of green tea extract on the mineral , body mass , lipid profile , glucose , and antioxidant status of obese patients . A r and omized , double-blind , placebo-controlled study was conducted . Forty-six obese patients were r and omly assigned to receive either 379 mg of green tea extract , or a placebo , daily for 3 months . At baseline , and after 3 months of treatment , the anthropometric parameters , blood pressure , and total antioxidant status were assessed , as were the levels of plasma lipids , glucose , calcium , magnesium , iron , zinc , and copper . We found that 3 months of green tea extract supplementation result ed in decreases in body mass index , waist circumference , and levels of total cholesterol , low-density cholesterol , and triglyceride . Increases in total antioxidant level and in zinc concentration in serum were also observed . Glucose and iron levels were lower in the green tea extract group than in the control , although HDL-cholesterol and magnesium were higher in the green tea extract group than in the placebo group . At baseline , a positive correlation was found between calcium and body mass index , as was a negative correlation between copper and triglycerides . After 3 months , a positive correlation between iron and body mass index and between magnesium and HDL-cholesterol , as well as a negative correlation between magnesium and glucose , were observed . The present findings demonstrate that green tea influences the body 's mineral status . Moreover , the results of this study confirm the beneficial effects of green tea extract supplementation on body mass index , lipid profile , and total antioxidant status in patients with obesity The effect of the phenolic compounds in wine was examined in this study by performing radioiron-absorption measurements from extrinsically labeled test meals in 33 human subjects . In four separate studies we observed that absorption was 2- to 3-fold higher from white wine containing a low concentration of polyphenols than from two red wines containing a 10-fold higher concentration of polyphenols . The interaction between the polyphenols and alcohol in wine was evaluated by reducing the alcohol content of the wines by approximately 90 % . When the alcohol concentration was reduced , there was a significant 28 % decrease in nonheme-iron absorption with red wine but no effect with white wine . The inhibitory effect of red wines with reduced alcohol content was about twofold greater when they were consumed with a small bread roll than when taken without food . Our findings indicate that the inhibitory effect of phenolic compounds in red wine is unlikely to affect iron balance significantly Hydroxytyrosol ( HT ) is a main phenolic component of olive oil . In this study , we investigated the safety and effects produced by HT purified ( 99.5 % ) from olive mill waste . HT was administered at a daily dosage of 45 mg for 8 weeks to volunteers with mild hyperlipidemia ( n=14 ) . We measured markers of cardiovascular disease risk , enzyme markers of several clinical conditions , hematology , antioxidant parameters , vitamins and minerals at baseline ( T0 ) , 4 weeks ( T4 ) and 8 weeks ( T8 ) . The values obtained at T4 and T8 were compared with baseline . We found that the HT dose administered was safe and mostly did not influence markers of cardiovascular disease , blood lipids , inflammatory markers , liver or kidney functions and the electrolyte balance . Serum iron levels remained constant but a significant ( P<0.05 ) decrease in ferritin at T4 and T8 was found . Serum folate and red blood cell folate levels were also reduced at T4 and T8 . Finally , vitamin C increased by two-fold at T4 and T8 compared with levels at baseline . These results indicate a physiologically relevant antioxidant function for HT through increasing endogenous vitamin C levels Tumour necrosis factor-alpha ( TNF alpha ) is a mediator of reactive oxygen species , which are implicated in endothelial dysfunction and atherosclerosis . Type II diabetes is associated with endothelial dysfunction and elevated circulating TNF alpha . We hypothesized that reducing serum levels of TNFalpha , using pentoxifylline , would improve endothelial function . Thirteen subjects [ age 58+/-2 ( S.E.M. ) years ] with Type II diabetes ( disease duration 74+/-13 months ) undertook a r and omized , crossover study of 8 weeks pentoxifylline and 8 weeks placebo . Endothelium-dependent and -independent vasodilation in resistance arteries was assessed via bilateral forearm venous occlusion plethysmography during intra-brachial infusions of acetylcholine ( ACh ) , sodium nitroprusside ( SNP ) and N(G)-monomethyl-L-arginine ( L-NMMA ) . High-resolution ultrasound of the brachial artery in response to ischaemia was used to determine endothelium-dependent conduit vessel flow-mediated dilation ( FMD ) , and endothelium-independent conduit function was assessed by sublingual administration of glyceryl trinitrate ( GTN ) . Serum concentrations of TNF alpha were also determined . Pentoxifylline lowered serum TNF alpha from 4.1+/-0.7 to 2.9+/-0.6 pg x ml(-1 ) ( P=0.001 ) . Forearm blood flow ( FBF ) responses at each dose of ACh did not differ with treatment ( P=0.4 ) . Similarly , FBF responses to SNP ( P=0.8 ) and L-NMMA ( P=0.2 ) did not differ . There was also no significant difference in brachial artery diameter during FMD ( P=0.2 ) or GTN administration ( P=0.06 ) . Despite lowering serum TNF alpha concentration , pentoxifylline at a dose of 400 mg three times a day for 8 weeks did not improve vascular function in either conduit or resistance vessels in this group of Type II diabetic subjects OBJECTIVE Endothelial function is an independent predictor of prognosis in heart failure ( HF ) subjects . Statins , beyond their lipid lowering role , exert beneficial effect in patients with atherosclerosis . In the present study we examined the impact of low and intermediate dose atorvastatin treatment on endothelial function , bone marrow-derived endothelial progenitor cells ( EPC ) mobilization and inflammatory status according to HF patient status . METHODS We studied the effect of 4 weeks administration of atorvastatin in 26 patients with ischemic HF . The study was carried out on two separate arms , one with atorvastatin 40 mg/d and one with atorvastatin 10 mg/d ( r and omized , double-blind , cross-over design ) . The number of circulating CD34(+)/CD133(+)/KDR(+ ) EPCs was evaluated by flow cytometry . Endothelial function was evaluated by flow mediated dilation ( FMD ) in the brachial artery . Serum levels of tumor necrosis factor alpha ( TNF-α ) were measured by ELISA . RESULTS Treatment with atorvastatin 40 mg/d significantly increased circulating EPC ( p = 0.002 ) , FMD ( p = 0.001 ) and reduced TNF-α ( p = 0.01 ) compared to baseline . Similarly , treatment with atorvastatin 10 mg/day increased circulating EPC ( p = 0.01 ) , FMD ( p = 0.08 ) and reduced TNF-α ( p = 0.01 ) compared to baseline . Interestingly , with 40 mg/day atorvastatin treatment the increase in EPC was higher in subjects categorized as NYHA class II compared to subjects categorized as NYHA class III ( p = 0.03 ) . CONCLUSIONS Our results confirmed the distinct impact of atorvastatin treatment on the restoration of endothelial function due to EPC mobilization in ischemic HF subjects . Moreover , these findings provide the potential clinical significance of EPC status monitoring to individualize treatment in HF subjects Nutraceuticals have generated interest as a way to mitigate the cognitive decline in older adults . The aim of this systematic review was to determine the evidence for these cl aims from the scientific literature in r and omised , double-blinded , controlled trials ( duration : ≥1 year ; participants : n≥100 ; age(mean ) : ≥65 years ) . Following Preferred Reporting Items for Systematic Review s and Meta-Analyses ( PRISMA ) guidelines , we search ed four electronic data bases ( PubMed , Scopus , CINAHL and Web of Science ) and identified twenty-five studies published between the 15·June·2006 and 14·June·2016 . Interventions included B-vitamins , n-3 fatty acids , antioxidant vitamins and herbs . Of the B-vitamin studies , four found benefits to cognition with supplementation . The first of these B-vitamin studies , in individuals with mild cognitive impairment ( n 266 ; duration = 2 years ) , included benefit to executive function ( P=0·015 ) and improvements in the Mini-Mental State Examination ( MMSE ) among participants with baseline homocysteine above 11·3 µmol/l ( P<0·001 ) . In the same sample , the second study found cognitive benefits of B-vitamins dependent on the higher baseline plasma n-3 fatty acid status . The third B-vitamin study ( n 900 ; duration = 2 years ) reported improved performance in immediate ( P=0·046 ) and delayed recall ( P=0·013 ) , whereas the fourth study ( n 856 ; duration = 2 years ) reported slower rate of cognitive decline in the MMSE ( P=0·05 ) . One study investigating DHA treatment ( n 402 ; duration = 1·5 years ) revealed the slower rate of cognitive change in apoE e4 non-carriers ( P=0·03 ) . As only five included studies revealed notable benefits , presently based on the specific compounds explored here , there is not compelling evidence to support the use nutraceuticals to improve cognition in the elderly . Future long-term trials of nutraceuticals should investigate interactions with lifestyle , blood biomarkers and genetic risk factors Background : Tea has been shown to be a potent inhibitor of nonheme iron absorption , but it remains unclear whether the timing of tea consumption relative to a meal influences iron bioavailability . Objective : The aim of the study was to investigate the effect of a 1-h time interval of tea consumption on nonheme iron absorption in an iron-containing meal in a cohort of iron-replete , nonanemic female subjects with the use of a stable isotope ( 57Fe ) . Design : Twelve women ( mean ± SD age : 24.8 ± 6.9 y ) were administered a st and ardized porridge meal extrinsically labeled with 4 mg 57Fe as FeSO4 on 3 separate occasions , with a 14-d time interval between each test meal ( TM ) . The TM was administered with water ( TM-1 ) , with tea administered simultaneously ( TM-2 ) , and with tea administered 1 h postmeal ( TM-3 ) . Fasted venous blood sample s were collected for iron isotopic analysis and measurement of iron status biomarkers . Fractional iron absorption was estimated by the erythrocyte iron incorporation method . Results : Iron absorption was 5.7 % ± 8.5 % ( TM-1 ) , 3.6 % ± 4.2 % ( TM-2 ) , and 5.7 % ± 5.4 % ( TM-3 ) . Mean fractional iron absorption was found to be significantly higher ( 2.2 % ) when tea was administered 1 h postmeal ( TM-3 ) than when tea was administered simultaneously with the meal ( TM-2 ) ( P = 0.046 ) . An ∼50 % reduction in the inhibitory effect of tea ( relative to water ) was observed , from 37.2 % ( TM-2 ) to 18.1 % ( TM-3 ) . Conclusions : This study shows that tea consumed simultaneously with an iron-containing porridge meal leads to decreased nonheme iron absorption and that a 1-h time interval between a meal and tea consumption attenuates the inhibitory effect , result ing in increased nonheme iron absorption . These findings are not only important in relation to the management of iron deficiency but should also inform dietary advice , especially that given to those at risk of deficiency . This trial was registered at clinical trials.gov as NCT02365103 Abstract Background Iron deficiency anemia ( IDA ) remains a global health issue , affecting mainly children and adolescent and pregnant women . Because of problems associated with current iron compounds used in both supplementation and fortification areas , there is an emerging interest in new natural iron sources to combat IDA . Objective The objective of this study was to compare the iron absorption of iron-enriched Aspergillus oryzae [ Aspiron ( ASP ) ] with FeSO4 in humans . Methods Iron absorption was assessed using stable isotope and serum iron response methods after oral intake of iron by healthy women in 2 separate studies . In the first study , ASP was intrinsically labelled with 58Fe into a dry form containing 8 % iron . Subjects ( n = 16 , 18–35 y ) were r and omly assigned to consume liquid semipurified meals labelled with 2 stable iron isotopes , 57FeSO
Output:
| Polyphenols did not appear to interfere with iron status , and most studies reported improvements in inflammatory markers and lipid profile . |
MS211392 | ***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 explore the effectiveness and safety of laparoscopic presacral neurectomy ( LPN ) in treating endometriosis-associated pain . METHODS Totally 64 patients with endometriosis were divided into two groups using prospect i ve non-r and om method . Patients in the control group received only the conventional laparoscopic resection of endometriosis lesions , while patients in the LPN group underwent LPN in addition to the resection of endometriosis lesions . The pre-operative pain scores , intra-operative staging results , surgical duration , intra-surgical blood loss , post-operative pain relief were compared between these two groups . RESULTS These two groups showed no significant differences in terms of age , body weight , pre-operative pain score , surgery staging , surgical duration , and intra-operative blood loss ( all P > 0.05 ) . All patients were followed up for 6 to 18 months ( median : 12.8 months ) . The post-operative pain relief rate was 89.28 % ( 25/ 28 ) in LPN group and 61.29 % ( 19/31 ) in the control group ( P = 0.030 ) . CONCLUSION LPN can effectively and safely in treating endometriosis and its associated pain OBJECTIVE The purpose of this study was to assess the effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis that was treated with conservative surgical intervention . STUDY DESIGN One hundred forty-one sexually active women of fertile age with chronic severe dysmenorrhea caused by endometriosis were treated with conservative laparoscopic surgery . Patients were assigned r and omly to not receive ( group A ) or receive ( group B ) presacral neurectomy . At 6 and 12 months after the surgical procedures , the cure rate was evaluated in each patient . The frequency and severity of dysmenorrhea , dyspareunia , and chronic pelvic pain were also evaluated at the same time intervals . RESULTS The cure rate was significantly higher in group B compared with group A at a follow-up examination at 6 months ( 87.3 % vs 60.3 % ) and 12 months ( 85.7 % vs 57.1 % ) . At follow-up visits , the frequency and severity of dysmenorrhea , dyspareunia , and chronic pelvic pain were significantly lower in both groups compared with baseline values ; in particular , significantly lower values were observed in group B versus group A for the severity . CONCLUSION Presacral neurectomy improves the cure rate in women who are treated with conservative laparoscopic surgery for severe dysmenorrhea caused by endometriosis A quantitative systematic review , or meta- analysis , uses statistical methods to combine the results of multiple studies . Meta-analyses have been done for systematic review s of therapeutic trials , diagnostic test evaluations , and epidemiologic studies . Although the statistical methods involved may at first appear to be mathematically complex , their purpose is simple : They are trying to answer four basic questions . Are the results of the different studies similar ? To the extent that they are similar , what is the best overall estimate ? How precise and robust is this estimate ? Finally , can dissimilarities be explained ? This article provides some guidance in underst and ing the key technical aspects of the quantitative approach to these questions . We have avoided using equations and statistical notations ; interested readers will find implementations of the described methods in the listed references . We focus here on the quantitative synthesis of reports of r and omized , controlled , therapeutic trials because far more meta-analyses on therapeutic studies than on other types of studies have been published . For practical reasons , we present a stepwise description of the tasks that are performed when statistical methods are used to combine data . These tasks are 1 ) deciding whether to combine data and defining what to combine , 2 ) evaluating the statistical heterogeneity of the data , 3 ) estimating a common effect , 4 ) exploring and explaining heterogeneity , 5 ) assessing the potential for bias , and 6 ) presenting the results . Deciding Whether To Combine Data and Defining What To Combine By the time one performs a quantitative synthesis , certain decisions should already have been made about the formulation of the question and the selection of included studies . These topics were discussed in two previous articles in this series [ 1 , 2 ] . Statistical tests can not compensate for lack of common sense , clinical acumen , and biological plausibility in the design of the protocol of a meta- analysis . Thus , a reader of a systematic review should always address these issues before evaluating the statistical methods that have been used and the results that have been generated . Combining poor- quality data , overly biased data , or data that do not make sense can easily produce unreliable results . The data to be combined in a meta- analysis are usually either binary or continuous . Binary data involve a yes/no categorization ( for example , death or survival ) . Continuous data take a range of values ( for example , change in diastolic blood pressure after antihypertensive treatment , measured in mm Hg ) . When one is comparing groups of patients , binary data can be summarized by using several measures of treatment effect that were discussed earlier in this series [ 3 ] . These measures include the risk ratio ; the odds ratio ; the risk difference ; and , when study duration is important , the incidence rate . Another useful clinical measure , the number needed to treat ( NNT ) , is derived from the inverse of the risk difference [ 3 ] . Treatment effect measures , such as the risk ratio and the odds ratio , provide an estimate of the relative efficacy of an intervention , whereas the risk difference describes the intervention 's absolute benefit . The various measures of treatment effect offer complementary information , and all should be examined [ 4 ] . Continuous data can be summarized by the raw mean difference between the treatment and control groups when the treatment effect is measured on the same scale ( for example , diastolic blood pressure in mm Hg ) , by the st and ardized mean difference when different scales are used to measure the same treatment effect ( for example , different pain scales being combined ) , or by the correlation coefficients between two continuous variables [ 5 ] . The st and ardized mean difference , also called the effect size , is obtained by dividing the difference between the mean in the treatment group and the mean in the control group by the SD in the control group . Evaluating the Statistical Heterogeneity of the Data This step is intended to answer the question , Are the results of the different studies similar ( homogeneous ) ? It is important to answer this question before combining any data . To do this , one must calculate the magnitude of the statistical diversity ( heterogeneity ) of the treatment effect that exists among the different sets of data . Statistical diversity can be thought of as attributable to one or both of two causes . First , study results can differ because of r and om sampling error . Even if the true effect is the same in each study , the results of different studies would be expected to vary r and omly around the true common fixed effect . This diversity is called the within- study variance . Second , each study may have been drawn from a different population , depending on the particular patients chosen and the interventions and conditions unique to the study . Therefore , even if each study enrolled a large patient sample , the treatment effect would be expected to differ . These differences , called r and om effects , describe the between- study variation with regard to an overall mean of the effects of all of the studies that could be undertaken . The test most commonly used to assess the statistical significance of between- study heterogeneity is based on the chi-square distribution [ 6 ] . It provides a measure of the sum of the squared differences between the results observed and the results expected in each study , under the assumption that each study estimates the same common treatment effect . A large total deviation indicates that a single common treatment effect is unlikely . Any pooled estimate calculated must account for the between- study heterogeneity . In practice , this test has low sensitivity for detecting heterogeneity , and it has been suggested that a liberal significance level , such as 0.1 , should be used [ 6 ] . Estimating a Common Effect The questions that this step tries to answers are , 1 ) To the extent that data are similar , what is their best common point estimate of a therapeutic effect , and 2 ) how precise is this estimate ? The mathematical process involved in this step generally involves combining ( pooling ) the results of different studies into an overall estimate . Compared with the results of individual studies , pooled results can increase statistical power and lead to more precise estimates of treatment effect . Each study is given a weight according to the precision of its results . The rationale is that studies with narrow CIs should be weighted more heavily than studies with greater uncertainty . The precision is generally expressed by the inverse of the variance of the estimate of each study . The variance has two components : the variance of the individual study and the variance between different studies . When the between- study variance is found to be or assumed to be zero , each study is simply weighted by the inverse of its own variance , which is a function of the study size and the number of events in the study . This approach characterizes a fixed-effects model , as exemplified by the Mantel-Haenszel method [ 7 , 8 ] or the Peto method [ 9 ] for dichotomous data . The Peto method has been particularly popular in the past . It has the advantage of simple calculation ; however , although it is appropriate in most cases , it may introduce large biases if the data are unbalanced [ 10 , 11 ] . On the other h and , r and om-effects models also add the between- study variance to the within- study variance of each individual study when the pooled mean of the r and om effects is calculated . The r and om-effects model most commonly used for dichotomous data is the DerSimonian and Laird estimate of the between- study variance [ 12 ] . Fixed- and r and om-effects models for continuous data have also been described [ 13 ] . Pooled results are generally reported as a point estimate and CI , typically a 95 % CI . Other quantitative techniques for combining data , such as the Confidence Profile Method [ 14 ] , use Bayesian methods to calculate posterior probability distributions for effects of interest . Bayesian statistics are based on the principle that each observation or set of observations should be viewed in conjunction with a prior probability describing the prior knowledge about the phenomenon of interest [ 15 ] . The new observations alter this prior probability to generate a posterior probability . Traditional meta- analysis assumes that nothing is known about the magnitude of the treatment effect before r and omized trials are performed . In Bayesian terms , the prior probability distribution is noninformative . Bayesian approaches may also allow the incorporation of indirect evidence in generating prior distributions [ 14 ] and may be particularly helpful in situations in which few data from r and omized studies exist [ 16 ] . Bayesian analyses may also be used to account for the uncertainty introduced by estimating the between- study variance in the r and om-effects model , leading to more appropriate estimates and predictions of treatment efficacy [ 17 ] . Exploring and Explaining Heterogeneity The next important issue is whether the common estimate obtained in the previous step is robust . Sensitivity analyses determine whether the common estimate is influenced by changes in the assumptions and in the protocol for combining the data . A comparison of the results of fixed- and r and om-effects models is one such sensitivity analysis [ 18 ] . Generally , the r and om-effects model produces wider CIs than does the fixed-effects model , and the level of statistical significance may therefore be different depending on the model used . The pooled point estimate per se is less likely to be affected , although exceptions are possible [ 19 ] . Other sensitivity analyses may include the examination of the residuals and the chi-square components [ 13 ] and assessment of the effect of deleting each study in turn . Statistically significant results that depend on a single study may require further exploration . Cumulative Meta- Analysis STUDY OBJECTIVE To assess the long-term effectiveness of presacral neurectomy ( PSN ) in women with severe dysmenorrhea due to endometriosis treated with conservative laparoscopic surgical intervention . DESIGN R and omized , controlled trial ( Canadian Task Force classification I ) . SETTING University-affiliated department of obstetrics and gynecology . PATIENTS One hundred forty-one sexually active women of reproductive age . INTERVENTION Conservative laparoscopic surgery without ( group A ) or with ( group B ) PSN . MEASUREMENTS AND MAIN RESULTS At entry and 24-months after surgical procedures , cure rates ; frequency and severity of dysmenorrhea , dyspareunia , and chronic pelvic pain ; and quality of life were evaluated . At follow-up visit , the cure rate was significantly ( P<0.05 ) higher in group B ( 83.3 % ) than in group A ( 53.3 % ) . The frequency and severity of dysmenorrhea , dyspareunia , and chronic pelvic pain were significantly ( P<0.05 ) lower in both groups compared with baseline values , and only severity was significantly ( P<0.05 ) lower in group B. A significant ( P<0.05 ) improvement in quality of life was observed after surgery in both groups and was significantly ( P<0.05 ) increased in group B compared with group A. CONCLUSION PSN improves long-term cure rates and quality of life in women treated with conservative laparoscopic surgery for severe dysmenorrhea due to endometriosis OBJECTIVE Our objective was to evaluate the efficacy of presacral neurectomy combined with conservative surgery for the treatment of pelvic pain associated with endometriosis . STUDY DESIGN In a r and omized , controlled study performed in a tertiary institution 71 patients with moderate or severe endometriosis and midline dysmenorrhea were r and omly assigned to conservative surgery alone ( n = 36 ) or conservative surgery and presacral neurectomy ( n = 35 ) . Main outcome measures were relief of dysmenorrhea , pelvic pain , and deep dyspareunia after surgery according to a multidimensional and an analog pain scale . RESULTS Presacral neurectomy markedly reduced the midline component of menstrual pain , but no statistically significant differences were observed between the two groups in the frequency and severity of dysmenorrhea , pelvic pain , and dyspareunia in the long-term follow-up . After presacral neurectomy , constipation developed or worsened in 13 patients and urinary urgency occurred in three and a painless first stage of labor in two . CONCLUSION Presacral neurectomy should be combined
Output:
| Overall , in well-selected patients , conservative surgery with adjunctive PN may provide greater relief from midline pain and a similarly low rate of operative complications relative to conservative surgery alone but may increase the risk of constipation postoperatively . |
MS211393 | ***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 proximal femoral nail ( PFN ) is a recently introduced intramedullary system , design ed to improve treatment of unstable trochanteric fractures of the hip . In a multicentre prospect i ve clinical study , the intra-operative use , complications and outcome of treatment using the PFN ( n = 211 ) were compared with those using the gamma nail ( GN ) ( n = 213 ) . The intra-operative blood loss was lower with the PFN ( 220 ml v 287 ml , p = 0.001 ) . Post-operatively , more lateral protrusion of the hip screws of the PFN ( 7.6 % ) was documented , compared with the gamma nail ( 1.6 % , p = 0.02 ) . Most local complications were related to suboptimal reduction of the fracture and /or positioning of the implant . Functional outcome and consolidation were equal for both implants . Generally , the results of treatment of unstable trochanteric fractures were comparable for the PFN and GN . The pitfalls and complications were similar , and mainly surgeon- or fracture-related , rather than implant-related We investigated whether a proximal femoral nail can be implanted without a distal locking screw in AO/OTA 31-A1 and 31-A2 pertrochanteric stable femur fractures . A multicentre , r and omised study was conducted in six level-two trauma centres in our area ( Puglia , Italy ) . A total of 333 patients received their allocated intervention ( 162 in the locking group [ LG ] and 171 in the unlocking group [ UG ] ) and 266 patients were included in the final analysis at 1year . Our data showed no statistically significant difference between the two groups at 1-year follow-up for ability to walk , SF-36 question naire results , residual pain ( visual analogue scale [ VAS ] score ) and level of overall satisfaction . There were also no statistically significant differences between groups for mortality and length of hospital stay . Conversely , the UG was associated with shorter operation and fluoroscopy times , shorter surgical incision length , and less blood loss and residual thigh pain . Pertrochanteric stable fractures ( 31-A1 , 31-A2 ) can be treated successfully with intramedullary nails without distal locking , reducing patient and clinical personnel radiation exposure and sanitary costs ( surgery time and screws costs ) Background : Most hip fractures are treated surgically , with use of either internal fixation or prosthetic replacement of the femoral head . The presence of these implants increases the risk of a later femoral fracture in susceptible osteoporotic patients . The purpose of this study was to analyze the incidence of and risk factors for implant-related fractures of the femur after previous hip fracture surgery . Methods : Over a ten-year period from January 1988 to December 1997 , 6230 patients ( median age , eighty-two years ; male : female ratio , 1247:4983 ) who sustained a total of 6696 hip fractures were admitted to the Edinburgh Orthopaedic Trauma Unit . Demographic information on the patients and details of the original treatment of the hip fracture were prospect ively coded and entered into a trauma data base . All subsequent readmissions due to a femoral fracture related to the implant were prospect ively audited and extracted for the purpose s of this study . Results : One hundred and forty-one patients sustained an ipsilateral fracture of the femur at a median of twenty-four weeks following the original hip fracture surgery . Survivorship analysis of the hip fracture population revealed an overall rate of subsequent femoral fracture of 2.9 % at five years , which increased to 5.1 % at ten years . The median age and gender distribution of the patients who sustained a subsequent femoral fracture were similar to those of the hip fracture population as a whole . Two-thirds of the fractures propagated from the tip of the implant . Analysis of the subsequent fractures according to the type of implant used to treat the original fracture revealed considerable differences in incidence . The incidence was relatively high in the patients initially treated with a Gamma nail ( 18.74 fractures per 1000 person-years ) or a cementless hemiarthroplasty ( 11.72 per 1000 person-years ) and was relatively low in those treated with a compression hip screw ( 4.46 per 1000 person-years ) , cannulated screws ( 4.50 per 1000 person-years ) , or a primary arthroplasty with cement ( 6.2 per 1000 person-years ) . The highest incidence of fracture was seen in the patients who had required an arthroplasty with cement as a revision procedure following failure of a primary implant ( 22.39 per 1000 person-years ) . Conclusions : Implant-related fractures following hip fracture surgery are more common than has previously been appreciated . The risk of later ipsilateral femoral fracture is increased by the use of a Gamma nail or a cementless hemiarthroplasty to treat the original hip fracture The aim of this non-r and omised prospect i ve study was to evaluate the short-term outcome of Gamma nail and dynamic hip screw ( DHS ) fixation in the treatment of subtrochanteric hip fractures due to low-energy trauma in the elderly . All of the 1,624 femoral hip fractures in 1,511 patients of the Oulu Hospital , aged over 49 years , were prospect ively registered from 1991−1999 using special forms . Seventy-three ( 4.5 % ) of the fractures were subtrochanteric . After exclusions , 58 patients constituted the final study group . Of these , 43 were treated with Gamma nails and 15 with DHS . Background factors before the fracture , complications , reoperations and functional parameters at 4 months were recorded using st and ardised forms . Intraoperative and hospital data were collected from patient records . The Seinsheimer fracture types IIIA , IIC and V were the most common fracture patterns when the Seinsheimer classification system was used , and Fielding II and AO 31A3.3 , respectively , were the most common types in the Fielding and AO classification system . There were four ( 9 % ) intraoperative complications in the Gamma nail group as compared to none in the DHS group . On the other h and , postoperative complications were more common in the DHS group ( 27 % ) than in the Gamma nail group ( 7 % ) . We recognised a correlation between certain fracture types and the likelihood of typical intra- or postoperative complications or difficulties with both devices : In Gamma nailing , difficulty in closed reduction as well as the rate of open reduction and the use of supplementary fixation were most frequent in the Seinsheimer IIC fractures . It is also noticeable that all of the postoperative device failures and fracture displacements of the DHS group occurred in the Seinsheimer type IIIA category . Detailed fracture classification is essential for the choice of the fixation device , and the present study confirms the presumption that , despite the perioperative problems associated with Gamma nailing , this technique may be preferable to plate fixation for specific fracture types with medial cortical comminution , such as Seinsheimer type IIIA.RésuméLe but de cette étude prospect i ve non r and omisée est d’évaluer l’évolution à court terme du traitement par clou Gamma ou par vis DHS des fractures sous-trochantériennes par traumatisme à basse énergie chez le sujet agé . Parmi les 1,624 fratures de la hanche enregistrées chez 1,511 patients de plus de 49 ans , de janvier 1989 à decembre 1996 , 73 ( 4,5 % ) étaient des fractures sous-trochantériennes . Le groupe d’étude était de 58 patients do nt 43 traités par clou Gamma et 15 avec vis DHS . Les antécédents , les complications et les paramètres fonctionnels à 4 mois étaient notés avec recueil st and ardisé et les informations sur l’hospitalisation étaient relevées dans les dossiers des patients . Les fractures les plus fréquentes étaient de type Seinsheimer IIIA , IIC , et V ou de type Fielding II et AO 31A3 dans ce dernier système . Il y avait 4 complications opératoires dans le groupe Gamma et aucune dans le groupe DHS t and is que les complications post-opératoires étaient plus fréquentes dans le groupe DHS que dans l’autre . Il existait une corrélation entre certains types de fractures et la survenue de complications avec les 2 matériels utilisés : dans le groupe Gamma la difficulté de réduction et la nécessité d’une fixation complémentaire étaient plus fréquent avec les fractures de type Seinsheimer IIC ; dans le groupe DHS tous les échecs de fixation survenaient pour des fractures de type Seinsheimer IIIA . La classification précise des fractures est essentielle pour le choix du matériel . L’étude présente confirme que l’ostéosynthèse par clou Gamma est préférable lorsqu’il existe une comminution corticale interne comme dans les fractures de type Seinsheimer IIIA INTRODUCTION Few clinical studies have analyzed the utility of distal interlocking screws in stable and unstable intertrochanteric fractures treated with intramedullary devices . We performed a prospect i ve analysis comparing short unlocked versus short dynamic and short static distal locked intramedullary nails . MATERIAL S AND METHODS Nine level-II trauma centres were involved in the study . 240 patients over the age of 65 with a stable ( AO/OTA 31-A1 ) or unstable intertrochanteric fracture ( AO/OTA 31-A2 ) were prospect ively investigated . The same type of nail was used in every patient . Patients were r and omly divided into 3 groups according to the type of distal locking used . Intra-operative variables were examined and patients were followed clinical ly and radiographically at 1 , 3 , 6 , 12 months postoperatively . All complications were recorded . RESULTS A total of 212 patients completed 1 year of follow-up visits . In the Unlocking Group ( UG ) the operation time , blood loss , fluoroscopy time , total length of incision were significantly decreased compared to both the Dynamic Group ( DG ) and the Static Group ( SG ) ( p < 0.05 ) . Conversely , no reliable differences in intraoperative variables were noted between the Dynamic Group and the Static Group ( p > 0.05 ) . In terms of time of fracture union we found no differences among the three Groups ( p > 0.05 ) . Moreover , no cases of limb shortening > 1 cm or varus collapse were detected in any group . The 3 Groups were similar in terms of HHS , SF-12 and Barthel index results at 1-year follow-up ( p > 0.05 ) . Finally , no significant differences were demonstrated across the three Groups in terms of major complications . CONCLUSIONS This clinical study further confirms the hypothesis that short intramedullary nails do not need to be locked for stable and unstable intertrochanteric fractures Objectives : This study compared the torsional properties of stable intertrochanteric femur fractures in a cadaveric bone model using 2 different distal fixation strategies : unlocked long cephalomedullary nailing versus dynamically locked nailing . Methods : Fourteen matched pairs of cadaveric femora were r and omly assigned to 1 of 2 distal fixation treatment groups : a single distal interlock screw placed in the dynamic orientation or no distal screw fixation . A stable 2-part intertrochanteric fracture was produced . Specimens were potted and mounted in a double gimbal fixture , facilitating unconstrained motion in the sagittal and coronal planes . Specimens were cyclically loaded dynamically in both internal and external rotation . Range of motion , internal and external rotation stiffness , torsion stiffness , torsion yield , and ultimate torsion magnitude were calculated . Results : The sample s instrumented with a distal locking screw reported statistically significantly greater internal ( 1.54 ± 0.81 N·m per degree vs. 1.08 ± 0.35 N·m per degree ; P = 0.026 ) and external rotational stiffness ( 1.42 ± 0.72 N·m per degree vs. 0.86 ± 0.36 N·m per degree ; P = 0.009 ) . Sample s with locked distal fixation were statistically stiffer and displayed statistically less displacement at the yield and peak torque . The yield torque was statistically significantly higher in the sample s without distal fixation ( 14.2 ± 3.3 N·m per degree vs. 10.6 ± 3.8 N·m per degree ; P = 0.037 ) . The peak torque was comparable between locked and unlocked sample s ( 15.0 ± 4.6 N·m per degree vs. 16.2 ± 4.2 N·m per degree ; P = 0.492 ) . Conclusions : Distal locking of femoral intramedullary nails increases the stiffness of the nail – femur construct . Unlocked sample s displayed statistically significant higher yield torque while maintaining comparable peak torque as the locked sample s. This study indicates that treating stable intertrochanteric fractures with unlocked long intramedullary nails may be an acceptable option , although further clinical study will be needed to test this assertion
Output:
| Conclusion : The present meta- analysis suggests that intramedullary nailing without distal locking is reliable and acceptable option for treating intertrochanteric fracture .
The advantages are reduced operative time , decreased fluoroscopy time , smaller size of incision and decreased complication rate . |
MS211394 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Objectives Primary : To compare the effectiveness of intensive group and individual interventions for smoking cessation in a primary health care setting ; secondary : to identify the variables associated with smoking cessation . Methods Three-pronged clinical trial with r and omisation at the individual level . We performed the following : an intensive individual intervention ( III ) , an intensive group intervention ( IGI ) and a minimal intervention ( MI ) . Included in the study were smokers who were prepared to quit smoking . Excluded from the study were individuals aged less than 18 years or with severe mental conditions or terminal illnesses . The outcome measure was continued abstinence at 12 months confirmed through CO-oximetry ( CO ) . The analysis was based on intention to treat . Results In total , 287 smokers were recruited : 81 in the III , 111 in the IGI , and 95 in the MI . Continued abstinence at 12 months confirmed through CO was 7.4 % in the III , 5.4 % in the IGI , and 1 % in the MI . No significant differences were noted between III and MI on the one h and , and between IGI and MI on the other [ RR 7.04 ( 0.9 - 7.2 ) and RR 5.1 ( 0.6 - 41.9 ) , respectively ] . No differences were noted between IGI and III [ RR 0.7 ( 0.2 - 2.2 ) ] . In multivariate analysis , only overall visit length showed a statistically significant association with smoking cessation . Conclusions The effectiveness of intensive smoking interventions in this study was lower than expected . No statistically significant differences were found between the results of individual and group interventions .Trial registration numberIS RCT Smoking cessation treatment is now integrated into many health-care systems and a major research effort is under way to improve current success rates . Until now results from r and omized clinical trials have been reported in many different ways , leading to problems of interpretation . We propose six st and ard criteria comprising the ' Russell St and ard ' ( RS ) . These criteria are applicable to trials of cessation aids where participants have a defined target quit date and there is face-to-face contact with research ers or clinic staff , as follows . ( 1 ) Follow-up for 6 months ( RS6 ) or 12 months ( RS12 ) from the target quit date or the end of a predefined ' grace period ' ; ( 2 ) self-report of smoking abstinence over the whole follow-up period allowing up to five cigarettes in total ; ( 3 ) biochemical verification of abstinence at least at the 6-month or 12-month follow-up point ; ( 4 ) use of an ' intention-to-treat ' approach in which data from all r and omized smokers are included in the analysis unless they have died or moved to an untraceable address ( participants who are included in the analysis are counted as smokers if their smoking status at the final follow-up can not be determined ) ; ( 5 ) following-up ' protocol violators ' and using their true smoking status in the analysis ; and ( 6 ) collecting follow-up data blind to smokers ' allocation to trial group . We believe that these criteria provide the best compromise between practicability and surrogacy for long-term cessation and will enable meaningful comparison between studies . There may be good reasons why other outcome criteria would also be reported , and studies that involve interventions with special groups or where there is no design ated target quit date or face to face contact would need to adapt these criteria accordingly OBJECTIVE To evaluate the smoking cessation efficacy of nicotine patch therapy as an adjunct to low-intensity , primary care intervention . DESIGN R and omized , placebo-controlled , double-blind , multisite trial . SETTING S Twenty-one primary care sites in Nebraska . PATIENTS A total of 369 smokers of 20 or more cigarettes per day . INTERVENTION Two brief primary care visits for smoking intervention with 10 weeks of active or placebo-patch therapy . MAIN OUTCOME MEASURES Confirmed self-reported abstinence 3 , 6 , and 12 months after the quit day . RESULTS Compared with placebo control subjects , participants assigned nicotine patches had higher 3-month ( 23.4 % vs 11.4 % ; P < .01 ) and 6-month ( 18.5 % vs 10.3 % ; P < .05 ) abstinence rates . The 1-year abstinence rates for the active and placebo patch groups were 14.7 % and 8.7 % , respectively ( P = .07 ) . Of smokers aged 45 years and older , 9 ( 18.8 % ) of 48 using active patches compared with 0 of 31 using placebo patches achieved 12-month abstinence ( chi 2 = 6.56 ; P < .05 ) . Among those with high nicotine dependency scores ( Fagerstrom score > or = 7 ) , 1-year abstinence rates were significantly higher in the nicotine patch group ( 19.1 % ) compared with the placebo group ( 5.0 % ) ( chi 2 = 10.7 ; P = .001 ) . However , there was no significant difference in 1-year quit rates for participants with low Fagerstrom scores ( < 7 ) . CONCLUSIONS Nicotine patch therapy enhanced 6 month quit rates as an adjunct to brief primary care intervention . The highest quit rates were achieved by participants who specifically contacted the site to enroll in the study or to obtain a prescription for nicotine patches . Differences in participant selection factors may account , in part , for the lower smoking cessation rates associated with primary care intervention . Duration of counseling , patient age , and Fagerstrom scores may be important factors related to the long-term smoking cessation success of nicotine patch therapy Background Cigarette smoking is the major risk factor for chronic obstructive pulmonary disease ( COPD ) . But a fewer smoking cessation measures were conducted in communities for smokers with COPD in China . The aim of our study was to assess the preventive effects of behavioral interventions for smoking cessation and potential impact factors in smokers with COPD in China . Methods In a r and omised controlled smoking cessation trial 3562 patients with COPD who were current smoker were allocated to intervention group received behavioral intervention and control group received the usual care for two years . The primary efficacy endpoint was the complete and continuous abstinence from smoking from the beginning of month 24 to the end of month 30 . Participants were followed up at month 48 . Results Continuous smoking abstinence rates from month 24 to 30 were significantly higher in participants receiving behavioral intervention than in those receiving usual care ( 46.4 % vs 3.4 % , p < 0.001 ) . Continuous abstinence rates from months 24 to 36 ( 45.8 % vs 4.0 % ) and months 24 to 48 ( 44.3 % vs 5.1 % ) were also higher in participants receiving behavioral intervention than in those control group . Family members or family physicians/nurses smoking were first identified to influence smoking cessation . Conclusions Behavioral intervention doubled the smoking cessation rate in patients with COPD and was complied well by the general practitioners . The family members and family physicians/nurses smoking were the main risk factors for smoking cessation . Trial registration Chinese Clinical Trials Registration ( ChiCTR-TRC-12001958 ) Background Although effective smoking cessation interventions exist , information is limited about their cost-effectiveness and cost-utility . Objective To assess the cost-effectiveness and cost-utility of an Internet-based multiple computer-tailored smoking cessation program and tailored counseling by practice nurses working in Dutch general practice s compared with an Internet-based multiple computer-tailored program only and care as usual . Methods The economic evaluation was embedded in a r and omized controlled trial , for which 91 practice nurses recruited 414 eligible smokers . Smokers were r and omized to receive multiple tailoring and counseling ( n=163 ) , multiple tailoring only ( n=132 ) , or usual care ( n=119 ) . Self-reported cost and quality of life were assessed during a 12-month follow-up period . Prolonged abstinence and 24-hour and 7-day point prevalence abstinence were assessed at 12-month follow-up . The trial-based economic evaluation was conducted from a societal perspective . Uncertainty was accounted for by bootstrapping ( 1000 times ) and sensitivity analyses . Results No significant differences were found between the intervention arms with regard to baseline characteristics or effects on abstinence , quality of life , and addiction level . However , participants in the multiple tailoring and counseling group reported significantly more annual health care – related costs than participants in the usual care group . Cost-effectiveness analysis , using prolonged abstinence as the outcome measure , showed that the mere multiple computer-tailored program had the highest probability of being cost-effective . Compared with usual care , in this group € 5100 had to be paid for each additional abstinent participant . With regard to cost-utility analyses , using quality of life as the outcome measure , usual care was probably most efficient . Conclusions To our knowledge , this was the first study to determine the cost-effectiveness and cost-utility of an Internet-based smoking cessation program with and without counseling by a practice nurse . Although the Internet-based multiple computer-tailored program seemed to be the most cost-effective treatment , the cost-utility was probably highest for care as usual . However , to ease the interpretation of cost-effectiveness results , future research should aim at identifying an acceptable cutoff point for the willingness to pay per abstinent participant Background The prevalence of smoking in Spain is high in both men and women . The aim of our study was to evaluate the role of gender in the effectiveness of a specific smoking cessation intervention conducted in Spain . Methods This study was a secondary analysis of a cluster r and omized clinical trial in which the r and omization unit was the Basic Care Unit ( family physician and nurse who care for the same group of patients ) . The intervention consisted of a six-month period of implementing the recommendations of a Clinical Practice Guideline . A total of 2,937 current smokers at 82 Primary Care Centers in 13 different regions of Spain were included ( 2003 - 2005 ) . The success rate was measured by a six-month continued abstinence rate at the one-year follow-up . A logistic mixed-effects regression model , taking Basic Care Units as r and om-effect parameter , was performed in order to analyze gender as a predictor of smoking cessation . Results At the one-year follow-up , the six-month continuous abstinence quit rate was 9.4 % in men and 8.5 % in women ( p = 0.400 ) . The logistic mixed-effects regression model showed that women did not have a higher odds of being an ex-smoker than men after the analysis was adjusted for confounders ( OR adjusted = 0.9 , 95 % CI = 0.7 - 1.2 ) . Conclusions Gender does not appear to be a predictor of smoking cessation at the one-year follow-up in individuals presenting at Primary Care Centers . Clinical Trials.gov IdentifierNCT00125905 OBJECTIVES To determine the long-term effect of a community-based risk reduction intervention at five years after completion of a one-year r and omized clinical trial and to determine the sustainability of the beneficial effects seen one year after the intervention . METHODS 30- to 59- year-old African American siblings of prob and s with premature coronary heart disease ( CHD ) were r and omized for care of multiple CHD risk factors to either one year of community-based care ( CBC ) provided by a nurse practitioner/community health worker team or enhanced usual care ( EUC ) . At five years , 307 ( 84.6 % ) of the siblings returned for reevaluation . MAIN OUTCOME MEASURES Changes in and achievement of goal levels of low-density lipoprotein cholesterol ( LDL-C ) , systolic and diastolic blood pressure ( SBP and DBP , respectively ) , and smoking cessation at five years . RESULTS No significant differences were seen between groups in mean LDL-C , SBP , and DBP or in the overall percentages achieving goal LDL-C , blood pressure , or smoking status . Changes after completion of the intervention suggest that the CBC group lost the beneficial effects for mean LDL-C and for percentage at goal LDL-C , while the EUC group continued to improve . CBC was associated with greater sustainability and less refractoriness of one-year results for LDL-C and blood pressure goals . CONCLUSIONS Although no group differences were found in mean risk factor levels at five years , data indicate that CBC is both feasible and associated with earlier sustainability of positive risk factor changes compared with EUC BACKGROUND Smoking-related morbidity and mortality , and benefits associated with quitting , extend across the life span . Health care provider interventions enhance quitting . The present study examined perceived influence of physician advice to quit and characteristics of subjects receiving this advice . METHODS Subjects were 1,454 smokers ages 50 + with at least one physician visit in the past year . Subjects were surveyed at baseline for receipt of and reactions to physician advice to quit and for smoking , health , and demographic characteristics . RESULTS Over half of subjects welcomed physician advice to quit , about half said the advice influenced their quitting decision " extremely " or " quite a lot , " and about one-third indicated that it increased their confidence in quitting . Physicians were more likely to advise sicker patients , indicated by poorer health status , at least one past year hospitalization , and presence of cardiovascular , cerebrovascular , or respiratory diseases . CONCLUSIONS Midlife and older smokers
Output:
| Behavioural interventions were effective and had a dose – response effect .
Both nicotine replacement and bupropion therapy were safe and effective , with no observed differences .
Conclusions Multicomponent/complex interventions in PC are effective and safe , appearing to achieve greater long-term continuous smoking cessation than usual care and counselling alone .
Our results show that smoking interventions should include more than one component and a strong follow-up of the patient to maximise results |
MS211395 | ***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 SAFETY and efficacy of sublingual ( sublingual-swallow ) immunotherapy ( IT ) with house dust mite extract were evaluated in 30 children ( 6 - 15 2/3 years of age ) over the first 12 months of an ongoing study . The cumulative dose was 570 micrograms Der p I ( five times that administered with subcutaneous therapy ) . SAFETY One patient on active treatment dropped out after 8 weeks because of a subjective feeling of severe weakness , question ably induced by the therapy . Five patients on active therapy and one patient on placebo reported minor local side effects . EFFICACY Pulmonary symptoms were reduced after 12 months in actively treated asthmatics , but this was not consistent with the lack of improvement in bronchial reactivity , skin sensitivity and specific IgG and IgG4 against D.pt . in this group . In patients with rhinitis nasal sensitivity was reduced in the placebo group without concomitant improvement in the nasal symptom score . Specific IgE ( D.pt . and D.f . ) increased significantly more in the active treatment group after 3 and 12 months . We conclude that sublingual IT over 12 months with the fivefold Der p 1 dose of subcutaneous IT was well tolerated , but there was no consistent clinical or immunological benefit compared to placebo BACKGROUND House dust extract is used in conventional immunotherapy for house dust-mite ( HDM ) allergic rhinitis in Japan . However , an alternative administration route is desired . The aims of the present double blind , placebo-controlled trial were to evaluate the therapeutic efficacy and safety of sublingual immunotherapy ( SLIT ) with house dust extract in pediatric patients with HDM allergic rhinitis . METHODS The study population comprised 31 subjects ( 21 males and 10 females ) aged from 7 to 15 years old . Twenty patients ( the active group ) received house dust extract and 11 received placebo via sublingual administration . Extract or placebo ( 1 ml ) was administered at 10-fold dilution once weekly for 40 weeks . During the study period , the subjects recorded their daily nasal symptoms and use ( dose and frequency ) of other medications in a nasal allergy diary . RESULTS The symptom scores in the active group began to decrease about 24 weeks after initiation of treatment and significant differences between the active and placebo groups were observed after 30 weeks . The average scores for the last four weeks of the study were significantly lower than those for the first four weeks in the active group but not in the placebo group . The only local adverse effect was a bitter taste reported by one patient . There were no other local or systemic adverse effects associated with SLIT . CONCLUSIONS Our results suggest that SLIT with house dust extract for more than 30 weeks is safe and effective treatment for HDM allergic rhinitis in children The aim of this study was to evaluate the clinical and immunologic effects of sublingual-swallow immunotherapy ( SLIT ) . A six-month , multicenter , double-blind , placebo-controlled trial was carried out in 59 patients aged 6 to 18 years with allergic rhinitis who were sensitized to mites only . Patients were r and omly assigned to placebo or SLIT with a st and ardized Dermatophagoides pteronyssinus (D.p.)/D. farinae ( D.f ) 50/50 extract . Nasal symptom scores and use of medications were recorded . Skin sensitivity , mite-specific IgE , IgG4 , and IgG4/IgE were evaluated before and after treatment . The skin sensitivity , total nasal symptom scores and medication consumption did not differ significantly after treatment . Specific IgG4 ( both p < 0.001 ) and IgG4/IgE to D.p . and D.f ( p = 0.010 , p = 0.001 , respectively ) increased significantly in the treatment group . Specific IgE increased significantly in both placebo and SLIT groups after treatment but did not differ between the two groups . The medication was well tolerated . SLIT did not significantly improve clinical manifestations of allergic rhinitis when used for 6 months . We demonstrated SLIT did significantly increase specific IgG4 and IgG4/IgE compared to treatment with placebo BACKGROUND House dust mite ( HDM ) allergy is associated with persistent allergic rhinitis ( AR ) and allergic asthma . OBJECTIVE To investigate the efficacy and safety of a SQ HDM sublingually administered immunotherapy tablet ( ALK , Hørsholm , Denmark ) in adults and adolescents with HDM respiratory allergic disease and report the AR results . METHODS Six hundred four subjects at least 14 years old with HDM AR and mild to moderate HDM allergic asthma were r and omized 1:1:1:1 to double-blinded daily treatment with 1 , 3 , 6 SQ-HDM or placebo . End-of-treatment rhinoconjunctivitis symptoms and medication score were predefined extrapulmonary end points . A subgroup analysis was conducted post hoc in subjects with a total combined rhinitis score ( TCRS ) > 0 ( ie , with AR symptoms and /or AR medication use during the 4-week baseline period ) . The subgroup was comprised of 498 subjects ( 82 % ) . RESULTS In the subgroup , the absolute difference in end-of-treatment TCRS between 6 SQ-HDM and placebo was -0.78 ( 95 % confidence interval -1.47 to -0.07 , relative difference 28.8 % , P = .0357 ) . Furthermore , a significant difference was found for the total score of the Rhinitis Quality of Life Question naire with St and ardized Activities RQLQ(S ) and for the individual domains : activities , sleep , non-nose and non-eye symptoms , and nasal symptoms . For the TCRS and Rhinitis Quality of Life Question naire score , a dose response was seen , with numerically lower , nonsignificant differences for 1 and 3 SQ-HDM . The predefined analysis for the entire trial population showed no statistically significant difference between the placebo and actively treated groups . No safety concerns were observed . CONCLUSION Efficacy in mild to severe AR of 6 SQ-HDM compared with placebo was demonstrated by statistically significant improvements in TCRS and Rhinitis Quality of Life Question naire score in subjects with AR present at baseline . The treatment was well tolerated . TRIAL REGISTRATION EudraCT , no 2006 - 001795 - 20 ; Clinical Trials.gov , identifier NCT00389363 BACKGROUND Although sublingual immunotherapy ( SLIT ) has been demonstrated to be a safe and efficient treatment in children with seasonal allergic rhinitis ( AR ) , there is little evidence on the efficacy of SLIT with house-dust-mite ( HDM ) extract in children with isolated perennial AR . OBJECTIVES We sought to assess the clinical efficacy and safety of HDM-SLIT in children with isolated allergic rhinitis-conjunctivitis mono-sensitized to HDM without asthma symptoms . METHODS Twenty-two children ( aged 5 - 10 years ) with perennial AR and conjunctivitis symptoms mono-sensitized to Dermatophagoides pteronyssinus and Dermatophagoides farinae were enrolled . During a 2 months run-in period , symptom and medication scores , lung functions , bronchial hyperreactivity , nasal provocation and skin prick tests were evaluated . Subjects were r and omized to active or placebo using a double-blind method . A total of eighteen subjects were r and omised to receive either active SLIT or placebo for 12 months . Daily symptom and medication scores , baseline lung functions , bronchial hyperreactivity , nasal provocation and skin prick tests were recorded and re-evaluated at the end of treatment . RESULTS After one year of treatment , no significant differences were detected in the between groups and within group comparisons based on total rhinitis symptom/medication scores ( p > 0.05 ) . Skin reactivity to Dermatophagoides pteronyssinus was significantly reduced in HDM-SLIT compared to placebo group ( p = 0.018 ) . A significant reduction in nasal sensitivity was observed in SLIT group after one year treatment when compared to baseline ( p = 0.04 ) . Total conjunctivitis symptoms were reduced significantly in both active and lacebo group at the end of treatment compared to baseline . The proportion of patients with non-specific bronchial hyperreactivity increased to almost 3-fold in placebo group compared to baseline . CONCLUSION HDM-SLIT was not superior to placebo in reducing isolated rhinoconjunctivitis symptoms within 12 months of treatment . However , HDM-SLIT has a modulating effect on allergen-specific nasal and skin reactivity in isolated perennial AR children . CLINICAL TRIAL REGISTRATION The trial was registered at Anzctr.org.au number , ACTRN12613000315718 Background Sublingual immunotherapy ( SLIT ) is recommended for allergic diseases . However , clinical studies containing evidence -based data of this treatment in young children , which is rarely reported in the literature , are needed . This study was design ed to assess the efficacy and safety of SLIT in children , including very young children . Methods Two hundred sixty-four children aged 3–13 years old ( 133 children , 3–5 years old ) with Dermatophagoides farinae – induced allergic rhinitis with or without asthma treated by st and ard pharmacotherapy had r and omly received either SLIT ( SLIT group ) or no SLIT ( control group ) for 12 months . Symptoms , medications , visual analog scale ( VAS ) and presence of adverse events ( AEs ) were assessed at monthly visits . Skin-prick test and Dermatophagoides farinae – specific IgE and IgG4 were measured before and after treatment . Results Both treatments were effective in the global clinical scores during the first seven visits when compared with baseline ( all , p < 0.01 ) , and SLIT showed lower symptoms scores and VAS scores throughout this period ( all , p < 0.01 ) . These improvements continued until the later visits only in the SLIT group . Also , the asthma medication consumption was decreased by SLIT treatment only at the end of study ( p < 0.01 ) . The specific IgG4 was significantly increased after SLIT treatment when compared with the control group , but no significant change of specific IgE was observed in either groups . In the SLIT group , there was no significant difference between children less than or more than 5 year old in terms clinical efficacy , onset of action , immunologic parameters , and safety . No severe systemic AEs were reported . Conclusion SLIT is effective and well-tolerated in children with allergic rhinitis 3–13 years old Background : It has been reported that both sublingual ( SLIT ) and subcutaneous ( SCIT ) allergen-specific immunotherapy have clinical efficacy , yet there are rather few comparative placebo studies of children . We aim ed to investigate the clinical and immunological efficacy of mite-specific SLIT and SCIT versus a placebo in rhinitis and asthma in children . Methods : The outcomes of this 1-year , r and omized , placebo-controlled , double-blind , double-dummy study were symptom and medication scores , visual analog scores ( VAS ) , titrated skin prick tests , nasal and bronchial allergen provocation doses , serum house dust mite-specific immunglobulin E ( HDM-sIgE ) , sIgG4 , IL-10 and IFN-γ levels . Results : Clinical and laboratory parameters were evaluated in 30 patients . SCIT significantly diminished symptom and medication scores for rhinitis and asthma ( p = 0.03 and p = 0.05 for rhinitis ; p = 0.01 and p = 0.05 for asthma ) and VAS . SLIT also reduced VAS , symptoms associated with rhinitis and asthma as well as medication usage for rhinitis , but this reduction was not significant when compared with the placebo . Skin reactivitiy to HDM and HDM-sIgE levels was reduced significantly in both immunotherapy groups . Serum IL-10 levels and nasal provocative doses increased significantly with both SCIT and SLIT . Nasal eosinophil increments after nasal challenge decreased with two treatment modes , but bronchial provocative doses and sputum eosinophil increments after bronchial challenge were reduced only with SCIT . In both treatment arms , there was no change in IFN-γ levels . Serum sIgG4 levels increased significantly only in the SCIT group . Conclusion : Based on the limited number of patients at the end of the 1-year immunotherapy , the clinical efficacy of SCIT on rhinitis and asthma symptoms was more evident when compared with the placebo Immunotherapy in elderly patients is controversial , and there is still no evidence supporting this treatment 's safety and efficacy in this population . This study was performed to evaluate the safety and efficacy of specific sublingual immunotherapy for house dust mite ( HDM ) allergens in patients over 60 years of age with allergic rhinitis and a confirmed allergy to HDM BACKGROUND Non-injective routes of immunotherapy are thought to be valuable therapeutic options for respiratory allergy . We investigated the clinical efficacy and the effects of sublingual/oral immunotherapy on conjunctival allergic inflammation in patients with mite-induced respiratory allergy . METHODS We used a double-blind placebo-controlled design . 20 patients with mite-induced rhinoconjunctivitis ( six of whom also had mild asthma ) were r and omly assigned sublingual/oral immunotherapy ( n=10 ) or placebo ( n=10 ) for 2 years . We assessed symptom score by diary cards and inflammatory-cell infiltrate
Output:
| Our meta- analysis indicates that SLIT provided significant symptom relief and reduced the need for medications in PAR .
In this study , significant evidence was obtained despite heterogeneity with regard to the use of mite extract . |
MS211396 | ***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 presence of contrast material s on computed tomography ( CT ) images can cause problems in the attenuation correction of positron emission tomography ( PET ) images . These are because of errors converting the CT attenuation of contrast to 511-keV attenuation and by the change in tissue enhancement over the duration of the PET emission scan . Newer CT-based attenuation correction ( CTAC ) algorithms have been developed to reduce these errors . Methods To evaluate the effectiveness of the modified CTAC technique , we performed a retrospective analysis on 20 patients , comparing PET images using unenhanced and contrast-enhanced CT scans for attenuation correction . A phantom study was performed to simulate the effects of contrast on radiotracer concentration measurements . Results There was a maximum difference in calculated radiotracer concentrations of 5.9 % within the retrospective data and 7 % within the phantom data . Conclusion Using a CTAC algorithm that de-emphasizes high-density areas , contrast-enhanced CT can be used for attenuation mapping without significant errors in quantitation Objectives The aim of this prospect i ve study was to assess the influence of different normalization procedures on relative changes in st and ardized uptake values ( SUV ) of 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography ( FDG-PET ) for the assessment of chemotherapy response in patients with colorectal carcinoma ( CRC ) and nonsmall cell lung carcinoma ( NSCLC ) . Methods In 97 patients with CRC ( n = 48 ) and NSCLC ( n = 49 ) , FDG-PET was performed before and during the course of chemotherapy . Relative changes in SUV ( ΔSUV ) were determined after correction for injected dose and bodyweight , lean body mass , body surface area or a combination of bodyweight and plasma glucose . The predictive value for overall and progression-free survival with respect to the different normalized ΔSUVs was assessed . Results In both CRC and NSCLC , no differences were seen in the degree of change between the four SUV-normalizations during chemotherapy . Cox regression analysis for overall survival showed significant hazard ratios of 1.14–1.16 per 10 % SUV change in CRC and 1.10–1.13 in NSCLC and for progression-free survival hazard ratios of 1.15 per 10 % ΔSUV change in CRC and 1.10–1.12 in NSCLC . Conclusion Relative changes in SUV is a strong predictor for survival in both CRC and NSCLC . None of the four normalization methods showed statistical advantage over the other . Therefore , simplifying the methods for analysis of FDG-PET data can improve the incorporation of FDG-PET in clinical treatment – response monitoring and may facilitate application in multicentre trials UNLABELLED This study evaluated various quantitative criteria for analysis of breast imaging with PET using the radiolabeled glucose analog 18F-fluorodeoxyglucose ( FDG ) . METHODS In a prospect i ve study , 73 patients with abnormal mammography or palpable breast masses scheduled for biopsy were investigated with PET . A total of 97 breast tumors were evaluated by histology , including 46 benign and 51 malignant tumors . Using a whole-body PET scanner , attenuation-corrected images were acquired between 40 and 60 min after tracer injection . For Patlak analysis , dynamic data acquisition was obtained in 24 patients . To differentiate between benign and malignant breast tumors , receiver operating characteristic curves were calculated using incrementally increasing threshold values for tumor/ nontumor ratios based on average and maximum activity values per region of interest , st and ardized uptake values ( corrected for partial volume effect , normalized to blood glucose , partial volume effect and blood glucose , using the lean body mass as well as the body surface area ) and calculating the FDG influx rate ( K ) assessed by Patlak analysis . RESULTS Quantification of FDG uptake in breast tumors provided objective criteria for differentiation between benign and malignant tissue with similar diagnostic accuracy as compared with visual analysis . Applying correction for partial volume effect and normalization by blood glucose yielded the highest diagnostic accuracy . CONCLUSIONS These quantitative methods provided accurate evaluation of PET data for differentiating benign from malignant breast tumors . Quantitative assessment is recommended to complement visual image interpretation with the potential benefit of reduced interobserver variability UNLABELLED St and ardized uptake values ( SUVs ) are widely used to measure 18F-fluorodeoxyglucose ( FDG ) uptake in various tumors . It has been reported that normalization of FDG uptake for patient body weight ( SUVbw ) overestimates FDG uptake in heavy patients , as their fraction of body fat ( with low FDG uptake ) is often increased . The objective of this study was to determine if " normalization of FDG uptake for the body surface area " ( SUVbsa ) is independent of the patient 's body size and is more reliable than SUVbw . METHODS FDG-PET images were acquired on 44 patients ( body weight range : 45 - 115 kg ) with cancer . SUVbw [ ( mCi/g of tissue)/(mCi injected/patient body weight in g ) ] and SUVbsa [ ( mCi/g of tissue)/(mCi injected/patient BSA in m2 ) ] were determined for the liver . Since most observers are accustomed to using the SUVbw , the two values were compared by setting the mean SUVbsa equal to that of SUVbw . RESULTS SUVbw and SUVbsa were 3.42 + /- 0.85 ( mean + /- s.d . ) and 3.42 + /- 0.60 , respectively . The st and ard deviation of the SUVbsa was smaller than that of SUVbw . More importantly , there was a strong positive correlation between SUVbw and , not only body weight ( r = 0.75 ) but also BSA ( r = 0.68 ) , whereas only a weak correlation between SUVbsa and body weight ( r = 0.41 ) or BSA ( r = 0.38 ) was found with a near flat regression line . CONCLUSION SUVbw overestimates FDG uptake in large patients . SUVbsa appears preferable to SUVbw , since it is minimally affected by the body size 18F-FDG PET is increasingly being used to monitor the early response of malignant tumors to chemotherapy . Underst and ing the reproducibility of st and ardized uptake values ( SUVs ) is an important prerequisite in estimating what constitutes a significant change . Methods : Twenty-six patients were studied on 2 separate occasions ( mean interval ± SD , 3 ± 2 d ; range , 1–5 d ) . A static PET/CT scan was performed 94 ± 9 min after the intravenous injection of 383 ± 15 MBq of 18F-FDG . Mean and maximum SUVs ( SUVmean and SUVmax , respectively ) were determined for regions of interest drawn around the tumor on the first study and for the same regions of interest transferred to the second study . Results : SUVmean in tumors ranged from 1.49 to 17.48 and SUVmax ranged from 2.99 to 24.09 . The correlation between SUVmean determined on the 2 separate visits was 0.99 ; the mean difference between the 2 measurements was 0.01 ± 0.27 SUV . The 95 % confidence limits for the measurements were ±0.53 . For SUVmax , the mean difference was −0.05 ± 1.14 SUV . Conclusion : Our study demonstrates that repeated measurements of SUVmean performed a few days apart are highly reproducible . A decrease of 0.5 in the SUV is statistically significant Over the years several analytical methods have been proposed for the measurement of glucose metabolism using fluorine-18 fluorodeoxyglucose ( [18F]FDG ) and positron emission tomography ( PET ) . The purpose of this study was to evaluate which of these ( often simplified ) methods could potentially be used for clinical response monitoring studies in breast cancer . Prior to chemotherapy , dynamic [18F]FDG scans were performed in 20 women with locally advanced ( n=10 ) or metastasised ( n=10 ) breast cancer . Additional PET scans were acquired after 8 days ( n=8 ) , and after one , three and six courses of chemotherapy ( n=18 , 10 and 6 , respectively ) . Non-linear regression ( NLR ) with the st and ard two tissue compartment model was used as the gold st and ard for measurement of [18F]FDG uptake and was compared with the following methods : Patlak graphical analysis , simplified kinetic method ( SKM ) , SUV-based net influx constant ( " Sadato " method ) , st and ard uptake value [ normalised for weight , lean body mass ( LBM ) and body surface area ( BSA ) , with and without corrections for glucose ( g ) ] , tumour to non-tumour ratio ( TNT ) , 6P model and total lesion evaluation ( TLE ) . Correlation coefficients between each analytical method and NLR were calculated using multilevel analysis . In addition , for the most promising methods ( Patlak , SKM , SUVLBMg and SUVBSAg ) it was explored whether correlation with NLR changed with different time points after the start of therapy . Three methods showed excellent correlation ( r>0.95 ) with NLR for the baseline scan : Patlak10–60 and Patlak10–45 ( r=0.98 and 0.97 , respectively ) , SKM40–60 ( r=0.96 ) and SUVLBMg ( r=0.96 ) . Good correlation was found between NLR and SUV-based net influx constant , TLE and SUVBSAg ( 0.90<r<0.95 ) . The 6P model and TNT had the lowest correlation ( r≤0.84 ) . SUV was least accurate in predicting changes in [18F]FDG uptake over time during therapy . For all methods , correlation with NLR was significantly lower for bone metastases than for other ( primary or metastatic ) tumour lesions ( P<0.05 ) . In conclusion , three methods with different degrees of complexity appear to be promising alternatives to NLR for measuring glucose metabolism in breast cancer : Patlak , SKM and SUV ( normalised for LBM and with a correction for plasma glucose ) The aim of chemotherapy for mesothelioma is to palliate symptoms and improve survival . Measuring response using CT is challenging because of the circumferential tumor growth pattern . This study aims to evaluate the role of serial 18F-FDG PET in the assessment of response to chemotherapy in patients with mesothelioma . Methods : Patients were prospect ively recruited and underwent both 18F-FDG PET and conventional radiological response assessment before and after 1 cycle of chemotherapy . Quantitative volume-based 18F-FDG PET analysis was performed to obtain the total glycolytic volume ( TGV ) of the tumor . Survival outcomes were measured . Results : Twenty-three patients were suitable for both radiological and 18F-FDG PET analysis , of whom 20 had CT measurable disease . After 1 cycle of chemotherapy , 7 patients attained a partial response and 13 had stable disease on CT assessment by modified RECIST ( Response Evaluation Criteria in Solid Tumors ) criteria . In the 7 patients with radiological partial response , the median TGV on quantitative PET analysis fell to 30 % of baseline ( range , 11%–71 % ) . After 1 cycle of chemotherapy , Cox regression analysis demonstrated a statistically significant relationship between a fall in TGV and improved patient survival ( P = 0.015 ) . Neither a reduction in the maximum st and ardized uptake value ( P = 0.097 ) nor CT ( P = 0.131 ) demonstrated a statistically significant association with patient survival . Conclusion : Semiquantitative 18F-FDG PET using the volume-based parameter of TGV is feasible in mesothelioma and may predict response to chemotherapy and patient survival after 1 cycle of treatment . Therefore , metabolic imaging has the potential to improve the care of patients receiving chemotherapy for mesothelioma by the early identification of responding patients . This technology may also be useful in the assessment of new systemic treatments for mesothelioma Objectives Peristalsis can lead to confusing FDG PET bowel uptake artefacts and potential for recording inaccurate mean st and ardised uptake value ( SUV ) measurements in PET-CT scans . Accordingly , we investigate the influence of different SUV normalisations on FDG PET uptake of the bowel and assess which one(s ) have least dependence on body size factors in patients with and without the introduction of the anti-peristalsis agent N-butylscopolamine ( Buscopan ) . Methods This study consisted of 92 prospect i ve oncology patients , each having a whole body 18F-FDG PET scan . Correlations were investigated between height , weight , glucose , body mass index ( bmi ) , lean body mass ( lbm ) and body surface area ( bsa ) with maximum and mean SUV recorded for bowel normalised to weight ( SUVw ) , lbm ( SUVlbm ) , bsa ( SUVbsa ) and blood glucose corrected versions ( SUVwg , SUVlbmg , SUVbsag ) . Results St and ardised uptake value normalisations were significantly different between control and Buscopan groups with less variability experienced within individual SUV normalisations by the administration of Buscopan . Mean SUV normalisations accounted for 80 % of correlations in the control group and 100 % in the Buscopan group . Further , > 86 % of all correlations across both groups were dominated by mean SUV normalis
Output:
| Scanner and reconstruction parameters can significantly affect SUV measurements . |
MS211397 | ***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 efficiency and safety of postoperative use of propacetamol was estimated in 30 patients by means of double blind placebo controlled method . The first group consisted of 15 patients to whom propacetamol was introduced intravenously in single dose of 2 g along with patient controlled anesthesia with promedol . Placebo in combination with patient control anesthesia were used in 15 patients from the 2nd group . Intravenous introducing of propacetamol in dose of 2 g in 15 minutes provides relief of pain intensity in postoperative period . So it permits to consider propacetamol as basic non-opioid analgesic . In early postoperative period combination of propacetamol and opioid analgesic ( promedol ) reduces dem and s in the latter by 44 % BACKGROUND Propacetamol is widely used in the management of postoperative pain . It decreases morphine requirements but its effect on the incidence of morphine-related adverse effects remains unknown . METHODS Patients ( 550 ) were r and omly assigned to receive propacetamol or a placebo over the first 24 h after operation in a blinded study . Intravenous morphine titration was performed , after which morphine was administered s.c . every 4 h according to their pain score . Pain was assessed using a visual analogue scale ( VAS ) . The primary end-point was the incidence of morphine-related adverse effects . The main secondary end-points were morphine requirements and VAS score . RESULTS After morphine titration , the VAS score and the number of patients with pain relief did not differ between groups . Morphine requirements were decreased in the propacetamol group ( 21 vs 14.5 mg , P<0.001 ) but the incidence of morphine-related adverse effects did not differ between groups ( 42 vs 46 % , not significant ) . In patients with moderate pain ( n=395 ) , morphine requirements decreased by 37 % ( P<0.001 ) and the percentage of patients requiring no morphine was greater ( 21 vs 8 % , P=0.002 ) in the propacetamol group . In patients with severe pain ( n=155 ) , morphine requirements decreased by 18 % ( P=0.04 ) in the propacetamol group and the number of patients who did not require morphine ( 3 vs 8 % ) did not differ significantly . CONCLUSIONS Although propacetamol induced a small morphine-sparing effect , it did not change the incidence of morphine-related adverse effects in the postoperative period . Moreover , no benefit could be demonstrated in patients with severe postoperative pain In order to compare the morphine‐sparing effect , analgesic efficacy and tolerance of nefopam and propacetamol given at their highest recommended doses , 120 patients undergoing elective hepatic resection were r and omly assigned to receive postoperative intravenous patient‐controlled analgesia with morphine alone , or in combination with nefopam ( 20 mg.4 h‐1 ) or propacetamol ( 2 g.6 h‐1 ) . Compared with the control group ( 43 [ 7–92 ] mg ) , median [ range ] cumulative morphine consumption for 24 h after the study started was halved in the nefopam group ( 21 [ 3–78 ] mg , p < 0.001 ) and 20 % lower in the propacetamol group ( 35 [ 6–84 ] mg , p = 0.15 ) . Analgesia was superior in the nefopam group despite the lower morphine consumption . Adverse effects were comparable in the three groups , except for significantly more nausea in the control group ( 39 % vs. 17 and 26 % in the nefopam and propacetamol groups , respectively ) and more sweating in the nefopam group ( 17 % vs. 0 and 3 % in the control and propacetamol groups , respectively ) . Overall patient satisfaction was better ( p < 0.001 ) in patients given nefopam ( 97 % ) than those receiving morphine alone ( 82 % ) or propacetamol ( 74 % ) Purpose The concept of balanced analgesia suggests that a combination of analgesic drugs may enhance analgesia and reduce side effects after surgery . This study evaluated the effect of the combination of propacetamol ( Prodafalgan ) and ketoprofen ( Profenid ) after surgery of a hemiated disc of the lumbar spine . Methods After r and omization . 60 patients received : placebo ( group 1 ) ; 2 g propacetamol ( group 2 ) ; 50 mg ketoprofen ( group 3 ) ; or a combination of 2 g propacetamol and 50 mg ketoprofen ( group 4 ) . Drugs were administered every six hours for two days after surgery . The patients used morphine with patient controlled analgesia pumps ( bolus 1 mg ; lock out time 10 min ) and were evaluated with a visual analogue scale ( VAS ) at rest and movement every six hours for two days . Side effects were noted . Results The patient characteristics and surgery were identical for each of the four groups . The VAS scores throughout the study were lower in group 4 than in groups 1 , 2 and 3 both at rest ( P < 0.05 ) and on movement ( P < 0.01 ) . The cumulative dose of morphine at 48 hr was lower in group 4 than in group 1 ( 23.4 ± 5 mg vs 58.9 ± 9 mg ; P < 0.01 ) or group 2 ( 23.4 ± 5 mg vs 43.4 ± 6.6 mg ; P < 0.05 ) and similar to that in group 3 ( 34.2 ± 4.5 mg ) . The incidence of side effects was similar in all groups . Conclusion The combination of propacetamol and ketoprofen reduced pain scores both at rest and on movement . The drug combination did not reduce the morphine consumption and incidence of side effects . RésuméButLe concept d’analgésie balancée suggère que I’association de drogues analgésiques en postopératoire peut permettre d’améliorer I’analgésie et réduire les effets secondaires . Cette étude a évalué I’intérêt d’une association de propacetamol ( Prodafalgan ) et de ketoprofen ( Profenid ) pour I’analgésie après chirurgie d’une hernie discale lombaire . MéthodesAprès r and omisation 60 patients ont reçu : un placebo ( groupe 1 ) ; 2 g de propacetamol ( groupe 2 ) ; 50 mg de ketoprofen ( groupe 3 ) ; où I’association de 2 g de propacetamol et 50 mg de ketoprofen ( groupe 4 ) . Les produits analgésiques ont été administrés toutes les six heures pendant 48 h. Les patients utilisaient de la morphine grâce à une pompe d’analgésie autocontrôlée pendant 48 h ( bolus 1 mg ; période réfractaire 10 mm ) et la douleur était évaluée par échelle visuelle analogique toutes les six heures au repos et au mouvement . Les effets secondaires étaient notés toutes les six heures . Result atsLes patients et la chirurgie étaient similaires dans les quatre groupes . Les scores d’EVA etaient plus bas pendant les 48 heures de I’étude dans le groupe 4 par rapport à ceux des groupes 1 , 2 et 3 au repos ( P < 0.05 ) comme au mouvement ( P < 0.01 ) . Les doses cumulées de morphine étaient significativement plus basses à 48 h dans le groupe 4 par rapport au groupe 1 ( 23.4 ± 5 mg vs 58.9 ± 9 mg ; P < 0.01 ) . groupe 2 ( 23.4 ± 5 mgvs 43.4 ± 6.6 mg ; P < 0.05 ) et pas significativement différentes de celles du groupe 3 ( 34.2 ± 4.5 mg ) . L’incidence des effets secondaires était similaire dans tous les groupes . Conclusion L’association de propacetamol et ketoprofen a réduit les scores de douleur au repos et au mouvement par rapport aux groupes traités par une seule drogue analgésique . Lassociation propacetamol-ketoprofen n’a pas significativement réduit la consommation de morphine et les effets secondaires Iiés à la morphine We assessed the analgesic efficacy of IV propacetamol and ketorolac in a double-blinded , placebo-controlled study involving patients undergoing total hip or knee replacement procedures . On the first morning after major joint replacement surgery , 164 patients experiencing moderate-to-severe pain were r and omly assigned to receive an IV infusion of propacetamol ( 2 g ) , ketorolac ( 15 or 30 mg ) , or placebo ( saline ) . Patient-controlled analgesia with morphine was made available as a “ rescue ” analgesic on patient ’s request during the 6-h postdosing evaluation period . The median time to onset of analgesia with propacetamol ( 8 [ 95 % confidence interval 6,10 ] min ) was shorter than ketorolac 15 mg ( 14 [ 7,16 ] min ) , and placebo ( 16 [ 8 ; not estimable ] min ) although the differences did not reach statistical significance . However , compared with ketorolac 30 mg , propacetamol had a shorter duration of analgesia ( 3.5 [ 2;5.4 ] vs 6 [ 3.3 ; not estimable ] h ) . Analysis of pain intensity and pain relief scores demonstrated that propacetamol produced a significantly greater improvement in pain relief than saline from 45 min until 5 h after the injection . Propacetamol was not significantly different from ketorolac 15 mg and 30 mg with respect to the main analgesic efficacy variables during the 6-h assessment period . The most frequently reported adverse event with propacetamol was injection site pain ( 28 % vs 19 % for ketorolac 15 mg , 29 % for ketorolac 30 mg , and 10 % for placebo , respectively ) . In conclusion , propacetamol ( 2 g IV ) possesses a similar analgesic efficacy to ketorolac ( 15 or 30 mg IV ) after total hip or knee replacement surgery We have evaluated the morphine-sparing effect of rectal paracetamol during the first 24 h after abdominal hysterectomy in a placebo-controlled , double-blind study . We studied 72 patients receiving patient-controlled analgesia ( PCA ) with i.v . morphine after a st and ardized anaesthetic , allocated r and omly to receive rectal paracetamol 1.3 g , diclofenac 50 mg or placebo , after wound closure and at 8 and 16 h. Suppositories were blinded by the hospital pharmacy . Study violations excluded data from seven patients . Patient data , morphine doses during anaesthesia and recovery , and sedation and nausea scores were comparable . Mean morphine consumption during PCA was 35.0 ( SD 20.4 ) mg , 32.7 ( 27.4 ) mg and 54.9 ( 28.3 ) mg in the paracetamol ( n = 24 ) , diclofenac ( n = 20 ) and placebo ( n = 21 ) groups , respectively ( P < 0.05 ) . Morphine sparing during PCA for paracetamol and diclofenac ( 36 % vs 40 % over 24 h ) was significant from 4 h. Global scores of average pain over 24 h were lower after diclofenac compared with paracetamol ( P < 0.01 ) and placebo ( P = 0.08 ) . We conclude that rectal paracetamol was an efficacious adjuvant analgesic after regular dosing UNLABELLED We assessed the relative morphine consumption in a combined analgesic regimen ( on-dem and morphine plus the nonopioids propacetamol or ketorolac ) after gynecologic surgery . Two hundred women r and omly received two i.v . doses of propacetamol 2 g or ketorolac 30 mg in a double-blinded , double-dummy trial . Patients were monitored for 12 h , and the following efficacy variables were assessed : total dose of morphine , pain intensity , and global efficacy . Safety and tolerability were evaluated by the occurrence of adverse events , especially the presence and intensity of gastrointestinal symptoms . Hemostatic variables were measured 30 and 60 min after the first infusion ; arterial blood pressure , heart and respiratory rates , sedation scores , and renal and hepatic function were also assessed . Total morphine requirements were not significantly different between the propacetamol ( 10.6 + /- 4.8 mg ) and ketorolac ( 10.2 + /- 4.4 mg ) groups . The evolution of pain intensity and the global efficacy also showed similar patterns in the two groups : 70.2 % of patients in the propacetamol group rated the efficacy as " good/ excellent " compared with 68.2 % in the ketorolac group . There were no clinical ly significant changes in vital signs or laboratory values and no observed differences between the two groups , although ketorolac slightly , but not significantly , prolonged the bleeding time . Epigastric pain was present in 9 % and 15 % of patients receiving propacetamol and ketorolac , respectively . There were two adverse events in the propacet
Output:
| Acetaminophen administration was not associated with a decrease in the incidence of morphine-related adverse effects or an increase in patient satisfaction .
Adding acetaminophen to PCA was associated with a morphine-sparing effect of 20 % ( mean , -9 mg ; CI -15 to -3 mg ; P=0.003 ) over the first postoperative 24 h. CONCLUSION Acetaminophen combined with PCA morphine induced a significant morphine-sparing effect but did not change the incidence of morphine-related adverse effects in the postoperative period |
MS211398 | ***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 C-reactive protein ( CRP ) , intercellular adhesion molecule-1 ( ICAM-1 ) , vascular cell adhesion molecule-1 ( VCAM-1 ) , and E-selectin are systemic inflammatory markers ( IM ) that positively correlate with cardiovascular ( CV ) risk . Despite the known CV effects of atypical antipsychotics , there is limited prospect i ve data on IM changes during treatment . METHODS The IM outcomes were compared between antipsychotic treatment groups in the CATIE ( Clinical Antipsychotic Trials of Intervention Effectiveness ) schizophrenia trial phase 1 with subjects with laboratory assessment s at baseline and 3 months ( n = 789 ) . RESULTS There were significant treatment differences in CRP , E-selectin , and ICAM-1 at 3 months , with a differential impact of baseline values on the CRP and ICAM-1 results . In overall comparisons , quetiapine and olanzapine had the highest median levels for CRP , and olanzapine for E-selectin and ICAM-1 . Olanzapine was significantly different after baseline adjustment than perphenazine ( p = .001 ) for E-selectin , and in those with low baseline CRP ( < 1 mg/L ) , olanzapine was significantly different than perphenazine ( p < .001 ) , risperidone ( p < .001 ) , and ziprasidone ( p = .002 ) for CRP . Perphenazine had the lowest 3-month ICAM-1 levels in subjects with baseline ICAM-1 above the median , but the differences were not statistically significant versus olanzapine ( p = .010 ) , quetiapine ( p = .010 ) , and risperidone ( p = .006 ) after controlling for multiple comparisons . The 18-month repeated measures CRP analysis confirmed the significantly higher values for olanzapine in those with low baseline CRP . CONCLUSIONS This analysis provides further evidence for differential antipsychotic metabolic liabilities as measured by changes in systemic inflammation . C-reactive protein might emerge as a useful target for CV risk outcomes in schizophrenia patients Objective The present study aim ed to examine the changes in pro-inflammatory cytokines and body weight during 6-month risperidone treatment in drug naïve , first-episode schizophrenia . Methods Sixty-two drug naïve , first-episode schizophrenia ( SZ group ) and 60 healthy individuals ( control group ) were enrolled in the study . Serum interleukin-1β ( IL-1β ) , interleukin-6 ( IL-6 ) , tumor necrosis factor-α ( TNF-α ) levels , and body weight were measured at baseline for both groups , and repeated for the SZ group at five different time points during 6-month risperidone treatment . Results At baseline , serum IL-1β , IL-6 , and TNF-α levels in the SZ group ( 53.28 ± 12.62 , 33.98 ± 14.13 , 50.08 ± 12.86 pg/mL , respectively ) were significantly higher than those in the control group ( 23.49 ± 15.27 , 15.53 ± 7.16 , 32.12 ± 15.23 pg/mL , respectively ) ( p 's < 0.001 ) . Within the SZ group , serum IL-1β levels decreased significantly at 2 weeks ( 48.02 ± 16.00 pg/mL , p < 0.01 ) and 1 month ( 44.70 ± 16.63 pg/mL , p < 0.001 ) , but then gradually increased at 2 months ( 48.49 ± 18.87 pg/mL ) , 3 months ( 50.59 ± 18.48 pg/mL ) and 6 months ( 53.64 ± 16.22 pg/mL ) to the levels comparable to baseline ; serum IL-6 levels changed significantly over the course of treatment ( p = 0.001 ) , but reached the levels comparable to baseline at 6 months ( 37.13 ± 13.23 pg/mL ) ; serum levels of TNF-α increased significantly at 3 months ( 55.02 ± 16.69 pg/mL , p < 0.01 ) and 6 months ( 58.69 ± 13.57 pg/mL , p < 0.001 ) ; steady and significant weight gain was observed at each follow-up time point ( p 's < 0.001 ) , from 56.71 ± 9.25 kg at baseline to 62.72 ± 9.53 kg at 6 months . Conclusions Risperidone treatment is associated with changes in serum pro-inflammatory cytokines levels and weight . There is an initial anti-inflammatory effect that reduces with treatment , potentially due to its weight gain side effect The second generation antipsychotics clozapine and olanzapine are known to cause weight gain . However , only clozapine is associated with drug-induced fever . Cytokines have been linked to the induction of both weight gain and drug-induced fever . We investigated these potential side effects of clozapine and olanzapine and studied their differential effects on cytokine secretion . Thirty patients suffering from schizophrenia , schizophreniform disorder or schizoaffective disorder were treated with either clozapine ( mean modal dose : 266.7+/-77.9 mg ) or olanzapine ( 21.2+/-2.5 mg ) in a r and omized , double-blind , 6-week study . Body mass index ( BMI ) , tympanic temperature , and plasma levels of leptin and cytokines ( tumor necrosis factor-alpha ( TNF-alpha ) , soluble TNF receptor 1 and 2 ( sTNFR-1/2 ) , soluble interleukin-2 receptors ( sIL-2R ) , interleukin-6 ) were determined weekly . BMI , leptin and cytokines significantly increased over time , except interleukin-6 and sTNFR-1 in the olanzapine group . All cytokines numerically increased compared to baseline already during the first week of treatment in both groups . Leptin , TNF-alpha , sTNFR-1 , sTNFR-2 and sIL-2R levels correlated with the BMI . Five patients who received clozapine ( 33 % ) developed drug-induced fever ( > /=38 degrees C ) . In these , interleukin-6 peak levels were significantly ( p<0.01 ) higher than in those patients treated with clozapine who did not develop fever . In conclusion , increase of BMI appears to be related to clozapine 's and olanzapine 's similar effects on cytokine systems , whilst drug-induced fever appears to be related to clozapine 's differential effects on interleukin-6
Output:
| Our meta‐ analysis found decreased IL‐2 and IL‐6 post‐treatment levels in FEPOur meta‐ analysis found decreased IL‐2 and IL‐6 post‐treatment levels in FEP.IL‐6 and IL‐2 , and possibly IL‐1&bgr ; , could be considered as state markers .
TNF‐&agr ; , IL‐17 , and IFN‐&ggr ; might represent trait markers in drug‐naïve FEP .
Relevant sensitivity analysis confirmed these findings .
IL‐1&bgr ; had high between‐ study heterogeneity .
IL‐6 and IL‐2 , and possibly IL‐1&bgr ; , could be considered state markers , decreasing after antipsychotic treatment , whilst TNF‐&agr ; , IL‐17 , and IFN‐&ggr ; might be considered trait markers . |
MS211399 | ***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 Background Accumulation of epicardial fat ( EF ) is associated with increased cardio-metabolic risks and coronary events , independently of traditional cardiovascular risk factors . Therefore , the reduction of EF volume ( EFV ) may be associated with reduced cardio-metabolic risks and future cardiovascular events . Sodium-glucose co-transporter-2 ( SGLT2 ) inhibitors reduce body fat including visceral fat and cardiovascular events in patients with type 2 diabetes . However , it has still been unknown whether SGLT2 inhibitors can reduce EFV . Methods Type 2 diabetic patients with HbA1c 6.5–9.0 % and body mass index ( BMI , kg/m2 ) ≥25.0 were enrolled in this single arm pilot study . Participants were administered luseogliflozin 2.5 mg daily and the dosage was tolerated to be increased up to 5.0 mg daily . EFV [ median ( interquartile range ) , cm3 ] was measured by magnetic resonance imaging . Primary endpoint was the decrease in EFV at 12 weeks . Visceral fat area ( VFA , cm2 ) and liver attenuation index ( LAI ) measured by the abdominal computed tomography , and skeletal muscle index ( SMI ) and body fat ( % ) measured by the whole body dual-energy X-ray absorptiometry were also determined at baseline and at 12 weeks . Results Nineteen patients ( mean age : 55 ± 12 years ; 26 % female ) completed this study . Luseogliflozin treatment significantly reduced EFV at 12 weeks [ 117 ( 96–136 ) to 111 ( 88–134 ) , p = 0.048 ] . The body weight , BMI , systolic and diastolic blood pressure , HbA1c , fasting plasma glucose , insulin , homeostasis model assessment -insulin resistance ( HOMA-IR ) , triglycerides , SMI , and body fat were significantly reduced by luseogliflozin at 12 weeks . The reduction of EFV was significantly correlated with the reduction of C-reactive protein ( r = 0.493 , p = 0.019 ) . Neither VFA nor LAI were significantly reduced by the luseogliflozin treatment . No severe adverse events were observed . Conclusions Our data suggest that luseogliflozin could reduce the EFV in parallel with the improvement of systemic micro-inflammation and the reduction of body weight in Japanese patients with type 2 diabetes . The reduction of muscle mass after the administration of SGLT2 inhibitors may require a particular attention . Trial registration umin.ac.jp , BACKGROUND We investigated the adipokines adiponectin , leptin and resistin as serum biomarkers of beta-cell function in patients with type 1 diabetes . METHODS One hundred and eighteen patients with type 1 diabetes ( 20.3 ± 7.5 years ) diagnosed < 5 years underwent st and ardized mixed meal test ( MMTT ) for 2 h. Systemic concentrations of C-peptide , adiponectin , leptin and resistin obtained during MMTT were measured and compared between patient groups by multiple regression analysis . RESULTS Patients were divided by their adipokine levels in subgroups above or below the median level ( ' high versus low ' ) . High adiponectin levels ( > 10.6 µg/mL ) were associated with lower C-peptide compared to the low adiponectin subgroup ( p < 0.03 ) . Increased leptin or resistin concentrations associated positively with beta-cell function even after adjustment for metabolic confounders ( p < 0.04 ) . The described associations between adipokines and C-peptide concentrations persisted in Spearman correlation tests ( p < 0.05 ) . Serum adipokines fell during MMTT ( p < 0.05 ) . CONCLUSIONS Serum adipokine levels differentially correlate with beta-cell function in type 1 diabetes independent of BMI or metabolic control . Serum adipokines should be investigated as biomarkers of beta-cell function in prospect i ve studies and intervention trials in type 1 diabetes Background Glycosuria produced by sodium – glucose co-transporter-2 ( SGLT-2 ) inhibitors is associated with weight loss . SGLT-2 inhibitors reportedly might reduce the occurrence of cardiovascular events . Epicardial adipose tissue ( EAT ) is a pathogenic fat depot that may be associated with coronary atherosclerosis . The present study evaluated the relationship between an SGLT-2 inhibitor ( dapagliflozin ) and EAT volume . Methods In 40 diabetes mellitus patients with coronary artery disease ( 10 women and 30 men ; mean age of all 40 patients was 67.2 ± 5.4 years ) , EAT volume was compared prospect ively between the dapagliflozin treatment group ( DG ; n = 20 ) and conventional treatment group ( CTG ; n = 20 ) during a 6-month period . EAT was defined as any pixel that had computed tomography attenuation of − 150 to − 30 Hounsfield units within the pericardial sac . Metabolic parameters , including HbA1c , tumor necrotic factor-α ( TNF-α ) , and plasminogen activator inhibitor-1 ( PAI-1 ) levels , were measured at both baseline and 6-months thereafter . Results There were no significant differences at baseline of EAT volume and HbA1c , PAI-1 , and TNF-α levels between the two treatment groups . After a 6-month follow-up , the change in HbA1c levels in the DG decreased significantly from 7.2 to 6.8 % , while body weight decreased significantly in the DG compared with the CTG ( − 2.9 ± 3.4 vs. 0.2 ± 2.4 kg , p = 0.01 ) . At the 6-month follow-up , serum PAI-1 levels tended to decline in the DG . In addition , the change in the TNF-α level in the DG was significantly greater than that in the CTG ( − 0.5 ± 0.7 vs. 0.03 ± 0.3 pg/ml , p = 0.03 ) . Furthermore , EAT volume significantly decreased in the DG at the 6-month follow-up compared with the CTG ( − 16.4 ± 8.3 vs. 4.7 ± 8.8 cm3 , p = 0.01 ) . Not only the changes in the EAT volume and body weight , but also those in the EAT volume and TNF-α level , showed significantly positive correlation . Conclusion Treatment with dapagliflozin might improve systemic metabolic parameters and decrease the EAT volume in diabetes mellitus patients , possibly contributing to risk reduction in cardiovascular events Background Discrepancies are present in the literature on resting myocardial mechanics in patients with uncomplicated type 2 diabetes mellitus ( T2DM ) . Data are noticeably sparse regarding circumferential function and torsional mechanics . Resting deformation imaging may not be sensitive enough to detect subtle dysfunctions . The aim of this study was thus to comprehensively evaluate myocardial mechanics in patients with T2DM at rest and to investigate whether dobutamine stress echocardiography could unmask functional alterations that would remain otherwise subtle at rest . Methods Forty‐four patients with T2DM and 35 healthy control subjects of similar age and sex were prospect ively recruited . After conventional echocardiography , myocardial mechanics was evaluated at rest and during low‐dose dobutamine stress echocardiography ( target heart rate , 110 beats/min ) . Results Patients with T2DM presented with altered global diastolic function but preserved systolic function . Deformation imaging indexes were similar between groups at rest , but significant differences were noticed under dobutamine infusion for longitudinal strain ( −21.2 ± 2.4 % vs −24.2 ± 2.5 % , P < .001 ) , circumferential strain ( apex , −32.3 ± 5.3 % vs −36.3 ± 5.3 % , P = .002 ; papillary muscle , −25.6 ± 3.2 % vs −28.0 ± 3.6 % , P = .001 ; base , −23.2 ± 3.6 % vs −25.3 ± 3.8 % , P = .03 ) , apical ( 11.2 ± 4.4 ° vs 14.1 ± 6.3 ° , P = .020 ) and basal ( −12.2 ± 3.3 ° vs −14.3 ± 3.9 ° , P = .021 ) rotation , and twist ( 21.9 ± 5.9 ° vs 26.8 ± 8.3 ° , P = .007 ) . Multivariate analysis identified epicardial fat , dyslipidemia , and fasting glycaemia as significant contributors to the changes from rest to dobutamine . Conclusions These findings demonstrate the usefulness of dobutamine stress echocardiography in establishing impairments in myocardial mechanics in patients with uncomplicated T2DM . Systemic metabolic disturbances and epicardial fat act as the main contributors to the blunted response to dobutamine stress in these patients . HighlightsRegional myocardial dysfunction is imperceptible at rest in patients with uncomplicated T2DM.DB stress reveals early regional myocardial dysfunction and can serve as a diagnostic tool . Cardiac functional reserve is lost in response to myocardial stress . Factors responsible for the blunted myocardial response to & bgr;‐adrenergic stimulation are delineated . These findings enable better underst and ing of the central origin of exercise intolerance in patients with T2DM BACKGROUND Epicardial fat thickness ( EFT ) is associated with increased cardio metabolic risk . Recent studies have suggested that there is a strong relationship between diabetes and EFT . Although the relationship between EFT and coronary artery disease ( CAD ) is well known , the possible impact of diabetes on the relationship between EFT and extent and complexity of CAD was not fully investigated . AIM We aim ed to investigate the relationship between EFT and extent and complexity of CAD in patients with non-ST elevation myocardial infa rct ion ( NSTEMI ) with and without diabetes . METHODS We prospect ively included 454 patients with NSTEMI ( mean age : 61.8 ± 10.4 years ) in the present study . Patients were classified into two groups according to their diabetes status ( diabetic group and non-diabetic group ) . EFT was measured by transthoracic echocardiography on the right ventricle in individuals having the left lateral decubitus position . SYNTAX score was used to define the extent and complexity of CAD . High-sensitivity C-reactive protein ( hs-CRP ) and other biochemical markers were measured in all participants . RESULTS Diabetic patients had higher EFT values compared with non-diabetics ( p < 0.05 ) . EFT is independently associated with diabetes , SYNTAX score , and hs-CRP in all patients ( p < 0.05 , for all ) . When patients were divided into two groups , as diabetic and non-diabetic , the association between EFT and SYNTAX score was stronger in diabetic patients compared with non-diabetics ( r = 0.635 ; p < 0.001 vs. r = 0.179 ; p = 0.003 ) . CONCLUSIONS Epicardial fat thickness is associated with SYNTAX score in both diabetic and non-diabetic patients . Furthermore , there is a stricter relationship between EFT and SYNTAX score in diabetic patients We report a method of fast adipose tissue ( FAT ) assessment to characterize the quantity , and distribution of abdominal adipose tissue . Whole-volume coverage of the abdomen was obtained using 31 contiguous transverse T(1)-weighted images from 16 obese females . A radiologist manually traced all adipose tissue volumes in the images , while a physiologist used an automated method to measure adipose tissue in a single image at the level of the umbilicus . Automated analysis of the umbilicus-level image was significantly correlated with values obtained by manual analysis of the entire abdomen ( p < 0 . 001 ) . There was good agreement between the automated umbilicus-level image method and the manual whole abdomen method for subcutaneous adipose tissue ( r(2 ) = 0.958 ) , visceral adipose tissue ( r(2 ) = 0 . 753 ) , and total adipose tissue ( r(2 ) = 0.941 ) . The automated method required 6 min vs 2 h for the manual method CONTEXT Hyperglycemia and insulin resistance frequently occur in critically ill patients even without a history of diabetes . OBJECTIVE Our objective was to study the role of adipose tissue hormonal production in the development of insulin resistance in cardiac surgery patients . PARTICIPANTS , INTERVENTIONS , AND SETTING S : Fifteen patients with elective cardiac surgery underwent blood sampling before , at the end , and 6 , 12 , 24 , 48 , and 120 h after the end of their operation . Epicardial and sc adipose tissue sampling was done at the beginning and at the end of surgery in the Department of Cardiac Surgery . MAIN OUTCOME MEASURES We measured serum concentrations and sc and epicardial adipose tissue mRNA expression of IL-6 , monocyte chemoattractant protein
Output:
| Conclusions Our meta- analysis suggests that the amount of EFT is significantly higher in DM patients than in non-DM patients |
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