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2METHODS
Homes are centrally randomized to intervention and control groups in blocks of variable size using a computer generated allocation sequence .
500
2METHODS
Randomization is stratified by home size and profit/nonprofit status .
501
2METHODS
Prescribing data retrieval and analysis are performed by blinded personnel .
502
1CONCLUSIONS
Our study will contribute to an improved understanding of the feasibility and acceptability of a multifaceted intervention aimed at translating knowledge to LTC practitioners .
503
1CONCLUSIONS
Lessons learned from this study will be valuable in guiding future research and understanding the complexities of translating knowledge in LTC .
504
3OBJECTIVE
To describe the psychometric properties and identify the minimally important difference ( MID ) of the hepatitis C virus patient-reported outcomes ( HCV-PRO ) instrument .
505
3OBJECTIVE
Chronic HCV infection and associated treatments negatively affect PROs of function and well-being .
506
2METHODS
In a phase 2 trial , HCV-infected patients received direct-acting antivirals ( DAAs ) for 12weeks with peg-interferon/ribavirin ( peg-IFN/RBV ) for 48weeks , or placebo plus peg-IFN/RBV .
507
2METHODS
The HCV-PRO total score , SF-36 PCS and MCS scores , EQ-5D-3L , and EQ VAS were measured at baseline , week 8 , end of DAA treatment ( EODT ) , end of peg-IFN/RBV treatment ( EOT ) , and posttreatment week 24 ( SVR24 ) .
508
2METHODS
Convergent validity of the HCV-PRO was assessed by Pearson 's correlation coefficients .
509
2METHODS
Discriminant validity was assessed by analyzing mean HCV-PRO total scores by EQ-5D anxiety/depression and pain/discomfort domain scores ( none vs. some ) and presence/absence of depression or fatigue adverse events .
510
2METHODS
MID was identified through effect size ( ES ) and receiver-operating characteristic ( ROC ) curve analyses ( HCV-PRO response vs. SF-36 PCS/MCS and EQ VAS MID thresholds ) .
511
4RESULTS
In 74 patients ( 22 % female ; 81 % White ; 51 % 50years ) , correlations ( 0.64-0 .96 ) between HCV-PRO total scores , SF-36 PCS/MCS scores , and EQ VAS scores at all time points supported convergent validity .
512
4RESULTS
HCV-PRO total scores were reduced to 10-30 points in patients impaired by depression , pain , or fatigue symptoms .
513
4RESULTS
Impact of peg-IFN/RBV regimen on HCV-PRO ES increased over time ( EODT -0.76 ; EOT -0.93 ) .
514
4RESULTS
ES and ROC curve analyses indicated an MID of -10 points .
515
1CONCLUSIONS
The HCV-PRO was valid and responsive in the population studied .
516
1CONCLUSIONS
An MID of -10 points represented a threshold of clinical significance for the HCV-PRO .
517
0BACKGROUND
Severe fecal incontinence remains a disabling condition for the patient and a major therapeutic challenge for the physician .
518
0BACKGROUND
A series of observational studies have indicated that placement of an artificial bowel sphincter is associated with marked improvement of continence and quality of life .
519
0BACKGROUND
We have performed a prospective , randomized , controlled trial to evaluate the effect of placement of an artificial bowel sphincter ( Acticon Neosphincter ) on continence and quality of life in a group of severely incontinent adults .
520
2METHODS
Fourteen adults ( male : female , 1:13 ; age range , 44-75 years ) were randomized to placement of the artificial bowel sphincter or to a program of supportive care and were followed for six months from operation or entry into the study .
521
2METHODS
The principal outcome measure was the level of continence , measured with the Cleveland Continence Score , which provides a scale from 0 to 20 , representing perfect control through to total incontinence .
522
2METHODS
Secondary outcome measures were perioperative and late complications in the artificial bowel sphincter group , and the changes in quality of life in both groups .
523
4RESULTS
In the control group , the Cleveland Continence Score was not significantly altered , with an initial value of 17.1 + / - 2.3 and a final value of 14.3 + / - 4.6 at six months .
524
4RESULTS
The artificial bowel sphincter group showed a highly significant improvement , changing from 19.0 + / - 1.2 before placement to 4.8 + / - 4.0 at six months after placement .
525
4RESULTS
One patient in the artificial bowel sphincter group had failure of healing of the perineal wound and explantation of the device ( 14 percent explantation rate ) .
526
4RESULTS
There were two other significant perioperative events of recurring fecal impaction initially after placement in one patient and additional suturing of the perineal wound in another .
527
4RESULTS
There were major improvements in the quality of life for all measures in the artificial bowel sphincter group .
528
4RESULTS
There was significant improvement in all eight subscales of the Medical Outcome Study Short Form-36 measures .
529
4RESULTS
The American Medical Systems Quality of Life score was raised from 39 + / - 6 to 83 + / - 14 and the Beck Depression Inventory showed reduction from a level of mild depression ( 10.8 + / - 9.3 ) to a normal value ( 6.8 + / - 8.7 ) .
530
4RESULTS
No significant changes in any of the quality of life measures occurred for the control group .
531
1CONCLUSIONS
Through a prospective , randomized trial format , we have shown that placement of an artificial bowel sphincter is safe and effective when compared with supportive care alone .
532
1CONCLUSIONS
Perioperative and late problems are likely to continue to occur and between 15 percent and 30 percent of patients may require permanent explantation .
533
1CONCLUSIONS
For the remainder , the device is easy and discrete to use , highly effective in achieving continence , and able to generate a major improvement in the quality of life .
534
3OBJECTIVE
Statins are known to reduce plasma C-reactive protein ( CRP ) concentrations .
535
3OBJECTIVE
Our goal was to define the mechanisms by which CRP was reduced by maximal dose atorvastatin .
536
2METHODS
Eight subjects with combined hyperlipidemia ( 5 men and 3 postmenopausal women ) were enrolled in a randomized , placebo-controlled double-blind , cross over study .
537
2METHODS
Subjects underwent a 15-h primed-constant infusion with deuterated leucine after 8 weeks of placebo and 80mg/day of atorvastatin .
538
2METHODS
CRP was isolated from lipoprotein deficient plasma , ( density > 1.21 g/ml ) by affinity chromatography .
539
2METHODS
Isotopic enrichment was determined by gas chromatography/mass spectrometry .
540
2METHODS
Kinetic parameters were determined using compartmental modeling .
541
2METHODS
Paired t test and Wilcoxon signed ranks test were used to compare differences between placebo and atorvastatin .
542
4RESULTS
Compared with placebo , atorvastatin decreased median CRP pool size by 28.4 % ( 13.313.78 vs 10.263.93 mg ; p = 0.16 ) , associated with a median CRP fractional catabolic rate increase of 39.9 % ( 0.340.06 vs 0.500.11 pools/day ; p = 0.09 ) , with no significant effect on median CRP production rate ( 0.0500.01 vs 0.0490.01 mg/kg/day ; p = 0.78 ) .
543
1CONCLUSIONS
Our data indicate that maximal doses of atorvastatin lower plasma CRP levels by substantially decreasing the median CRP plasma residence time from 2.94 days to 2.0 days , with no significant effect on the median CRP production rate .
544
3OBJECTIVE
To compare the influence on blood pressure , glucose , and lipid levels of a diet rich in monounsaturated fatty acids with an isocaloric , high-carbohydrate diet in 15 NIDDM subjects .
545
2METHODS
A crossover design with diet interventions and wash-out periods of 3 wk was applied .
546
2METHODS
The patients were randomly assigned to a 3-wk treatment with a high-carbohydrate diet containing 50 % of energy as carbohydrate and 30 % of energy as fat ( 10 % of energy as monounsaturated fatty acids ) or an isocaloric diet with 30 % of energy as carbohydrate and 50 % of energy as fat ( 30 % of energy as monounsaturated fatty acids ) .
547
2METHODS
On the last day of the two diets , 24-h ambulatory blood pressure was measured and day profiles of glucose , hormones , and lipids were performed to a test menu rich in carbohydrates .
548
4RESULTS
The diet rich in monounsaturated fat reduced daytime systolic ( 131 + / - 3 vs. 137 + / - 3 mmHg , P < 0.04 ) and 24-h systolic blood pressure ( 126 + / - 8 vs. 130 + / - 10 mmHg , P < 0.03 ) as well as daytime diastolic ( 78 + / - 2 vs. 84 + / - 2 mmHg , P < 0.02 ) and diurnal diastolic blood pressure ( 75 + / - 6 vs. 78 + / - 5 mmHg , P < 0.03 ) as compared with the high-carbohydrate diet .
549
4RESULTS
Evidence of lowered blood glucose levels on the high-monounsaturated diet compared with the high-carbohydrate diet were found with lower fasting blood glucose ( 6.1 + / - 0.3 vs. 6.8 + / - 0.5 mM , P < 0.05 ) , lower average blood glucose levels ( 7.4 + / - 0.5 vs. 8.2 + / - 0.6 mM , P < 0.04 ) , and peak blood glucose responses ( 9.9 + / - 0.6 vs. 11.3 + / - 0.7 mM , P < 0.02 ) .
550
4RESULTS
The two diets had the same impact on lipid levels .
551
1CONCLUSIONS
A diet rich in monounsaturated fat has beneficial effects on blood pressure and glucose metabolism , whereas no adverse effects on lipid composition in NIDDM subjects is detected .
552
0BACKGROUND
The injection of stem cells in the context of acute myocardial infarction ( AMI ) has been tested almost exclusively by anterograde intra-arterial coronary ( IAC ) delivery .
553
0BACKGROUND
The retrograde intravenous coronary ( IVC ) delivery may be an additional route .
554
3OBJECTIVE
To compare the cell distribution and retention pattern in the anterograde and retrograde routes .
555
3OBJECTIVE
To investigate the role of microvascular obstruction by magnetic resonance imaging in cell retention by cardiac tissue after the injection of bone marrow mononuclear cells ( BMMC ) in AMI .
556
2METHODS
This was a prospective , open label , randomized study .
557
2METHODS
Patients with AMI who presented : ( 1 ) successful chemical or mechanical reperfusion within 24 hours of symptom onset and ( 2 ) infarction involving more than 10 % of the left ventricle ( LV ) at the myocardial scintigraphy were included in the study .
558
2METHODS
One hundred million BMMC were injected into the infarction-related artery through IAC route , or vein through the IVC route .
559
2METHODS
One percent of the injected cells were labeled with 99mTc-hexamethyl-propylene-amine-oxime ( 99mTc-HMPAO ) .
560
2METHODS
Cell distribution was evaluated at 4 and 24 hours after the myocardial scintigraphy injection .
561
2METHODS
Cardiac magnetic resonance imaging was performed before cell injection .
562
4RESULTS
Thirty patients were randomized into three groups .
563
4RESULTS
There were no serious adverse events related to the procedure .
564
4RESULTS
The early and late retention of labeled cells was higher in the IAC group than in IVC group , regardless of the presence of microcirculation obstruction .
565
1CONCLUSIONS
The injection using the retrograde approach was feasible and safe .
566
1CONCLUSIONS
Cell retention by cardiac tissue was higher using the anterograde approach .
567
1CONCLUSIONS
More studies are needed to confirm these findings .
568
0BACKGROUND
Maximal consumption of oxygen ( VO ( 2 ) max ) during exercise is used in patients with chronic obstructive pulmonary disease ( COPD ) to stratify perioperative risk .
569
0BACKGROUND
However , the impact of therapeutic hyperoxia ( i.e. , use of supplemental oxygen to prevent hypoxemia during exercise ) on ( VO ( 2 ) max and other ventilatory parameters during maximal exercise in the resting normoxic COPD population is poorly defined .
570
2METHODS
A randomized , double-blind crossover study was performed in which resting normoxic subjects ( n = 16 ) with COPD underwent two standard symptom-limited , ramped-protocol bicycle ergometry cardiopulmonary exercise tests > 5 days apart with FiO ( 2 ) of 0.21 ( control ) and ~ 0.28 ( therapeutic hyperoxia ) .
571
2METHODS
VO ( 2 ) max and other ventilatory parameters were compared using a paired two-sample t-test .
572
4RESULTS
Therapeutic hyperoxia significantly increased VO ( 2 ) max ( 12.2 2.9 vs. 13.6 3.8 ml/kg/min , P = 0.03 ) , partial pressure of end-tidal carbon dioxide , and oxygen saturation and significantly decreased VE-VCO ( 2 ) slope , but it did not affect exercise time , maximum watts achieved , maximum minute ventilation , or change in end-expiratory lung volume .
573
4RESULTS
Three of four subjects with VO ( 2 ) max < 10 ml/kg/min without supplemental oxygen increased VO ( 2 ) max to 10 ml/kg/min on therapeutic hyperoxia and potentially changed perioperative risk category .
574
1CONCLUSIONS
Therapeutic hyperoxia in a resting normoxic COPD population significantly improves VO ( 2 ) max and may change perioperative risk stratification by conventional criteria .
575
1CONCLUSIONS
Further studies are needed to determine if this change in stratification is appropriate .
576
0BACKGROUND
Survivors of advanced Hodgkin disease , who were assigned randomly to treatment by mechlorethamine , vincristine , procarbazine , and prednisone ( MOPP ) ; doxorubicin , bleomycin , vinblastine , and dacarbazine ( ABVD ) ; or MOPP alternating with ABVD in a clinical trial of the Cancer and Leukemia Group B ( protocol 8251 ) , were compared in terms of their psychosocial adaptation and psychosexual function an average of 2.2 years after completion of treatment ( range , 1-5 years ) .
577
0BACKGROUND
The study was undertaken to determine if there were differences among treatments in these functional areas as a consequence of differential long-term gonadal damage in the three regimens .
578
2METHODS
Ninety-three disease-free survivors of advanced Hodgkin disease ( 56 men and 37 women ) were studied ( a minimum of 1 year after completion of treatment ) by an interview conducted over the telephone .
579
2METHODS
Standardized measures were used to assess their psychologic , sexual , family , and vocational functioning , including the following tests : the Psychosocial Adjustment to Illness Scale -- Self Report , the Brief Symptom Inventory , the Profile of Mood States , and the Impact of Event Scale .
580
4RESULTS
Contrary to expectation , no statistically significant differences in survivors ' psychosocial adaptation or psychosexual function were found by treatment arm .
581
4RESULTS
Infertility ( based on survivors ' reports of medical test results and perceptions ) and lower income 1 year before the diagnosis of cancer were significant predictors of poorer adjustment .
582
4RESULTS
Most survivors reported a range of problems that they attributed to having had cancer : 35 % , proven or perceived infertility ; 24 % , sexual problems ; 31 % , health and life insurance problems ; 26 % , a negative socioeconomic effect ; and 51 % , conditioned nausea , associated with visual or olfactory reminders of chemotherapy .
583
1CONCLUSIONS
No significant long-term advantage in psychosocial adaptation or psychosexual function was found for survivors of Hodgkin disease treated by the less gonadally toxic ABVD regimen 1 to 5 years after completion of treatment .
584
0BACKGROUND
Calcitonin gene-related peptide is a pleiotropic neuropeptide with potent vasodilatory properties , which interferes with renin release and might participate in cardiovascular homeostasis .
585
2METHODS
We studied the influence of salt intake on the plasma concentration of calcitonin gene-related peptide , parathyroid hormone and on the renin-aldosterone system in 15 patients with mild hypertension .
586
2METHODS
Each participant was studied after 1 week of high salt intake ( 200 mmol/day ) and after 1 week of low salt intake ( 50 mmol/day ) .
587
2METHODS
The order of the two diet periods was randomized and crossover .
588
2METHODS
Plasma calcitonin gene-related peptide concentration was measured by radioimmunoassay after pre-extraction by reverse chromatography .
589
2METHODS
Seven patients were classified as salt-sensitive and eight as salt-resistant .
590
4RESULTS
In the whole group the low salt intake caused a significant decrease in arterial pressure and the expected increase in plasma renin activity and in plasma aldosterone concentration .
591
4RESULTS
Such changes were accompanied by a significant increase in plasma calcitonin gene-related peptide .
592
4RESULTS
In salt-resistant patients in the sodium-replete state calcitonin gene-related peptide levels tended to be reduced in comparison with salt-sensitive patients .
593
4RESULTS
Sodium depletion , however , caused a more pronounced rise in plasma calcitonin gene-related peptide in salt-resistant hypertensives , who attained levels close to those in salt-sensitive hypertensives .
594
4RESULTS
Interestingly , in salt-resistant hypertensives changes in plasma calcitonin gene-related peptide were closely related to plasma renin activity ( r = 0.71 , P = 0.003 ) , whereas no such correlation was found in salt-sensitive patients .
595
4RESULTS
Parathyroid hormone was not influenced by changes in salt intake .
596
1CONCLUSIONS
In subjects with mild hypertension calcitonin gene-related peptide is sensitive to changes in salt intake in the physiological range .
597
1CONCLUSIONS
Such a response seems to be linked to the individual arterial pressure response to salt , because salt-resistant patients showed reduced calcitonin gene-related peptide levels in the sodium-replete state and a more pronounced calcitonin gene-related peptide increase , closely related to plasma renin activity , during sodium deprivation .
598
3OBJECTIVE
To make a study of the effect of Chaihu Shihuang soup on blood serum level TNF , IL-6 and IL-10 of severe acute pancratitis .
599