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###24566233 |
BACKGROUND Utilization rates ( URs ) for implantable cardioverter-defibrillators ( ICDs ) for primary prevention of sudden cardiac death ( PPSCD ) are lacking in the community . |
OBJECTIVE The purpose of this study was to establish the ICD UR in central Indiana . |
METHODS A query run on 2 hospitals in a health information exchange database in Indianapolis identified patients between 2011 and 2012 with left ventricular ejection fraction ( EF ) 0.35 . |
METHODS ICD eligibility and utilization were determined from chart review . |
RESULTS We identified 1863 patients with at least 1 low EF study . |
RESULTS Two cohorts were analyzed : 1672 patients without and 191 patients with International Classification of Diseases , Ninth Revision , Clinical Modification procedure code 37.94 for ICD placement . |
RESULTS We manually reviewed a stratified ( by hospital ) random sample of 300 patients from the no-ICD procedure code cohort and found that 48 ( 16 % ) had no ICD but had class I indications for ICD . |
RESULTS Eight of 300 ( 2.7 % ) actually had ICD implantation for PPSCD . |
RESULTS Review of all 191 patients in the ICD procedure code cohort identified 70 with ICD implantation for PPSCD . |
RESULTS The ICD UR ( ratio between patients with ICD for PPSCD and all with indication ) was 38 % overall ( 95 % confidence interval [ CI ] 28 % -49 % ) . |
RESULTS URs were 48 % for males ( 95 % CI 34 % -61 % ) , 21 % for females ( 95 % CI 16 % -26 % , P = .0002 vs males ) , 40 % for whites ( 95 % CI 27 % -53 % ) , and 37 % for blacks ( 95 % CI 28 % -46 % , P = .66 vs whites ) . |
CONCLUSIONS ICD UR is 38 % among patients meeting class I indications , suggesting further opportunities for improving guideline compliance . |
CONCLUSIONS This study also illustrates limitations in calculating ICD UR using large electronic repositories without hands-on chart review . |
###22005747 |
OBJECTIVE The study 's purpose was to analyze the effects of exercise training on exercise tolerance and left ventricular systolic function and structure in heart failure patients with preserved , mild , and moderate to severe reduction of left ventricular ejection fraction ( LVEF ) . |
METHODS Ninety-eight patients with moderate to severe ( n = 34 ) , mild ( n = 33 ) , and preserved ( n = 31 ) LVEF were randomly assigned to exercise training plus usual care ( n = 65 ) or usual care alone ( n = 33 ) in a randomization ratio of 2:1 . |
METHODS Left ventricular function , left ventricular dimensions , and exercise tolerance were assessed before and after each intervention . |
RESULTS Exercise tolerance and LVEF increased with exercise training in all patient groups , whereas they remained unchanged after usual care alone . |
RESULTS Exercise training increased the mean ratio of early to late mitral inflow velocities ( E/A ratio ) and decreased deceleration time ( DT ) of early filling in patients with mild and preserved LVEF . |
RESULTS In patients with moderate to severe systolic dysfunction and advanced diastolic dysfunction ( DT < 160 ms ) , exercise training decreased E/A ratio and increased DT , both of which were unchanged after usual care alone . |
RESULTS In the remaining patients ( DT > 160 ms ) , exercise training also improved mitral inflow patterns . |
RESULTS Exercise training decreased left ventricular dimensions in patients with mild and moderate to severe reduction of LVEF but not in patients with preserved LVEF . |
CONCLUSIONS These results indicate that exercise training can improve the course of heart failure independent of the degree of baseline left ventricular dysfunction . |
###22367233 |
OBJECTIVE To investigate the feasibility of implementing a Sleep Education Program ( SEP ) for improving sleep in adult family home ( AFH ) residents with dementia , and the relative efficacy of SEP compared with usual care control in a pilot randomized controlled trial . |
METHODS Thirty-seven AFH staff-caregivers and 47 residents with comorbid dementia and sleep disturbances . |
METHODS SEP consisted of four training sessions with staff-caregivers to develop and implement individualized resident behavioral sleep plans . |
METHODS Treatment fidelity to the SEP was assessed following the National Institutes of Health ( NIH ) Behavior Change Consortium model utilizing trainer observations and staff-caregiver reports . |
METHODS Resident sleep was assessed by wrist actigraphy at baseline , 1-month posttreatment , and 6-month follow-up . |
METHODS Caregiver reports of resident daytime sleepiness , depression , and disruptive behaviors were also collected . |
RESULTS Each key area of treatment fidelity ( SEP delivery , receipt , enactment ) was identified , measured , and yielded significant outcomes . |
RESULTS Staff-caregivers learned how to identify sleep scheduling , daily activity , and environmental factors that could contribute to nocturnal disturbances and developed and implemented strategies for modifying these factors . |
RESULTS SEP decreased the frequency and disturbance level of target resident nocturnal behaviors and improved actigraphically measured sleep percent and total sleep time over the 6-month follow-up period compared with the control condition . |
CONCLUSIONS Results suggest behavioral interventions to improve sleep are feasible to implement in adult family homes and merit further investigation as a promising intervention for use with AFH residents with dementia . |
###16632233 |
OBJECTIVE To compare the effects of prandial insulin therapy focusing on postprandial glucose control vs. basal insulin therapy focusing on fasting glucose control in patients with type 2 diabetes . |
METHODS This was an open-label , randomized , parallel , three-arm multicenter trial in patients with type 2 diabetes starting insulin treatment . |
METHODS Patients ( n = 159 ) were randomly assigned to 24-week treatment with 3x daily insulin lispro , 3x daily lispro mid mixture ( MidMix ; 50 % lispro , 50 % protaminated lispro ) , or 1x daily insulin glargine ; oral antihyperglycemic agents were discontinued . |
METHODS Primary end point was the postprandial glucose excursion 2 h after breakfast at the end of study . |
METHODS Secondary outcomes included HbA1c , self-monitored blood glucose profiles , hypoglycemic episodes , body weight , and patient satisfaction . |
RESULTS At the end of study , glucose excursions 2 h after breakfast were significantly lower with lispro and MidMix than with glargine ( P < .001 for each vs. glargine ) : lispro , -0.6 + / -2.0 mmol/l ; MidMix , +0.8 + / -2.4 mmol/l ; glargine , +2.5 + / -2.4 mmol/l . |
RESULTS Fasting glucose decreases were significantly greater with glargine ( -2.6 + / -2.4 mmol/l ) than with lispro or MidMix ( -0.9 + / -2.2 mmol/l ; +0.9 + / -1.8 mmol/l ) . |
RESULTS Nevertheless , HbA1c decreased by 1.1 % ( lispro ) and 1.2 % ( MidMix ) , vs. 0.3 % with glargine . |
RESULTS Hypoglycemic episodes were rare with 1-1 .5 self-reported episodes per 100 patient-days . |
CONCLUSIONS In patients with type 2 diabetes starting insulin , 3x daily prandial treatment with a rapid-acting analog focusing on postprandial glucose values enabled better control of postprandial and circadian blood glucose profiles than once-daily glargine , in spite suboptimal fasting glucose levels , which targets fasting glucose values . |
CONCLUSIONS These results support studies suggesting that control of postprandial hyperglycemia plays a key role in achieving HbA1c targets . |
###22891807 |
BACKGROUND Female sex workers who inject drugs ( FSW-IDUs ) are at risk of acquiring HIV , sexually transmitted infections ( STI ) and blood-borne infections through unprotected sex and sharing injection equipment . |
BACKGROUND We conducted a 22 factorial randomized controlled trial to evaluate combination interventions to simultaneously reduce sexual and injection risks among FSW-IDUs in Tijuana and Ciudad Juarez , Mexico . |
METHODS FSW-IDUs 18 years reporting sharing injection equipment and unprotected sex with clients within the last month were randomized to one of four conditions based on an a priori randomization schedule , blinding interviewer/counselors to assignment . |
METHODS Due to the extreme vulnerability of this population , we did not include a control group that would deny some women access to preventive information . |
METHODS All women received similar information regardless of group allocation ; the difference was in the way the information was delivered and the extent to which women had an interactive role . |
METHODS Each condition was a single 60-minute session , including either an interactive or didactic version of an injection risk intervention and sexual risk intervention . |
METHODS Women underwent interviewer-administered surveys and testing for HIV , syphilis , gonorrhea , Chlamydia , and Trichomonas at baseline and quarterly for 12 months . |
METHODS Combined HIV/STI incidence will be the primary outcome . |
METHODS Secondary outcomes are proportionate reductions in sharing of injection equipment and unprotected sex with clients . |
CONCLUSIONS Of 1,132 women , 548 ( 48.4 % ) were excluded ( 88.9 % were ineligible ; 11.1 % refused to participate or did not return ) ; 584 eligible women enrolled ( 284 in Tijuana ; 300 in Ciudad Juarez ) . |
CONCLUSIONS All 584 participants completed the baseline interview , provided biological samples and were randomized to one of the four groups . |
CONCLUSIONS During follow-up , 17 participants ( 2.9 % ) were lost to follow-up , of whom 10 ( 58.8 % ) had died , leaving 567 participants for analysis . |
CONCLUSIONS This study appears to be the first intervention to attempt to simultaneously reduce injection and sexual risk behaviors among FSW-IDUs . |
CONCLUSIONS The factorial design will permit analysis to determine whether the combination of the two interactive interventions and/or its respective components are effective in reducing injection and/or sexual risks , which will have direct , tangible policy implications for Mexico and potentially other resource-poor countries . |
BACKGROUND NCT00840658 . |
###16728906 |
OBJECTIVE To compare oral risperidone and intramuscular ( IM ) haloperidol , both in combination with IM lorazepam , in the management of acute agitation and psychosis in the medical emergency department . |
METHODS In this prospective , randomized , placebo-controlled , double-blind study of 30 patients presenting to the emergency department with acute agitation and/or psychosis , three groups of 10 patients received oral and IM medications : 1 ) 2 mg oral risperidone and 2 mg IM lorazepam ; 2 ) 5 mg oral haloperidol and 2 mg IM lorazepam ; 3 ) oral placebo and 2 mg IM lorazepam . |
METHODS Each treatment group received both an injection and a tablet to reduce treatment group variability . |
METHODS Patients were evaluated using the Brief Psychiatric Rating Scale ( BPRS ) and the Positive and Negative Syndrome Scale ( PANSS ) before receiving medication and at 30 and 90 minutes after medication was administered . |
METHODS The intergroup mean percent reductions in rating scale scores were compared using ANOVA , chi-square , and Kruskal-Wallis tests . |
RESULTS There were no statistically significant differences among the groups at any point . |
RESULTS The two groups receiving an antipsychotic plus lorazepam showed a trend towards increased symptom reduction compared with the group receiving lorazepam alone , although this trend was not statistically significant . |
CONCLUSIONS Lorazepam alone was as effective as lorazepam plus haloperidol or lorazepam plus risperidone in this small trial . |
CONCLUSIONS While not statistically significant , a trend toward better outcomes with combined treatment warrants further study . |
###19442372 |
OBJECTIVE To prospectively evaluate the efficacy of routine ultrasound-guided fine-needle aspiration cytology ( FNAC ) of thyroid nodules in an endemic area and to analyze the factors influencing it . |
METHODS Patients with thyroid nodules were randomly subjected to either conventional palpation-guided fine-needle aspiration cytology ( PFNAC ) or ultrasound-guided fine-needle aspiration cytology ( USFNAC ) . |
METHODS The results of cytology were compared with the final histopathologic diagnosis in 112 patients who had undergone surgery . |
METHODS The performance of both methods was individually analyzed in solid nodules , cystic nodules , and solitary and multinodular goitres . |
RESULTS Overall , USFNAC showed a significantly higher sensitivity ( 83.3 % vs 54.6 % , p < .001 ) , positive predictive value ( 100 % vs 85.7 % , p < .001 ) , and greater diagnostic accuracy ( 96.5 % vs 89.1 % , p = .052 ) compared with PFNAC . |
RESULTS The sensitivity of USFNAC was significantly higher compared with that of PFNAC in cystic and complex nodules ( 75 % vs 50 % , p < .001 ) but not in solid nodules ( 77.8 % vs 75 % , p > .05 ) . |
RESULTS USFNAC was more sensitive and more accurate than PFNAC for detection of malignancy in multinodular goitres ( 66.7 % vs 50 % , p < .05 ; 95.6 % vs 86.2 % , p < .05 , respectively ) . |
CONCLUSIONS The superiority of `` routine '' USFNAC over PFNAC is mainly due to its better performance in cystic nodules and multinodular goitres . |
CONCLUSIONS Hence , routine USFNAC can be recommended in areas where such lesions constitute the majority of thyroid nodules . |
###21908036 |
BACKGROUND Dalcetrapib modulates cholesteryl ester transfer protein ( CETP ) activity to raise high-density lipoprotein cholesterol ( HDL-C ) . |
BACKGROUND After the failure of torcetrapib it was unknown if HDL produced by interaction with CETP had pro-atherogenic or pro-inflammatory properties . |
BACKGROUND dal-PLAQUE is the first multicentre study using novel non-invasive multimodality imaging to assess structural and inflammatory indices of atherosclerosis as primary endpoints . |
METHODS In this phase 2b , double-blind , multicentre trial , patients ( aged 18-75 years ) with , or with high risk of , coronary heart disease were randomly assigned ( 1:1 ) to dalcetrapib 600 mg/day or placebo for 24 months . |
METHODS Randomisation was done with a computer-generated randomisation code and was stratified by centre . |
METHODS Patients and investigators were masked to treatment . |
METHODS Coprimary endpoints were MRI-assessed indices ( total vessel area , wall area , wall thickness , and normalised wall index [ average carotid ] ) after 24 months and ( 18 ) F-fluorodeoxyglucose ( ( 18 ) F-FDG ) PET/CT assessment of arterial inflammation within an index vessel ( right carotid , left carotid , or ascending thoracic aorta ) after 6 months , with no-harm boundaries established before unblinding of the trial . |
METHODS Analysis was by intention to treat . |
METHODS This trial is registered at ClinicalTrials.gov , NCT00655473 . |