Successful new method of extracorporeal percutaneous endoscopic gastrostomy ( E-PEG ) . BACKGROUND Although percutaneous endoscopic gastrostomy ( PEG ) has become popular for patients with swallowing disorders as a nutrition support or a decompressant of gastrointestine , perioperative complications associated with PEG have not decreased , especially peristomal infections . To reduce peristomal infections , we designed a new method of gastrostomy by extracorporeal approach under endoscopic observation , named as extra-corporeal PEG ( E-PEG ) . METHODS Experimental studies for E-PEG were performed repeatedly using pigs under general anesthesia to confirm the safety of its procedure for human use . After approval of institutional ethics review board in our university , thirty patients with prior consent participated in this study . The operation time , the incidence rate of complications and the hospital stay were compared between E-PEG and ordinary pull-method PEG groups . RESULTS Two patients ( 6.7 % ) in E-PEG group had postoperative complications , i.e. , aspiration pneumonia and surgical site infection . The operation time of E-PEG group was 5-16 ( mean +/- SD : 10.3 +/- 2.96 ) min as compared to 14-37 ( mean +/- SD : 26.9 +/- 8.39 ) min with pull-method PEG . The postoperative hospital day of E-PEG was within two days except for the two complicated cases . Significance differences of operation time , complication rate and postoperative hospital stay between those groups observed statistically . CONCLUSIONS These results indicate that E-PEG was safe , tolerable and speedy when compared ordinary pull-method PEG .

PEG

extra-corporeal PEG ( E-PEG )

E-PEG

anesthesia

E-PEG

E-PEG

PEG

E-PEG

E-PEG

PEG

operation time

incidence rate of complications

hospital stay

postoperative complications

aspiration pneumonia

surgical site infection

operation time

postoperative hospital day

operation time

complication rate

postoperative hospital stay

safe , tolerable

gastrointestine

pigs under general anesthesia

thirty


Single-dose and multi-dose clindamycin therapy fails to demonstrate efficacy in preventing infectious and inflammatory complications in third molar surgery . The goal of this study was to evaluate the efficacy of single- and multi-dose ( 5-day ) clindamycin therapy for the prevention of inflammatory complications in patients undergoing lower third molar surgical extraction with bone removal . Patients who qualified for the prospective , randomized , double-masked , placebo-controlled trial were randomly divided into three groups : ( 1 ) single dose of oral clindamycin administered preoperatively ( single-dose group ) ; ( 2 ) clindamycin administered preoperatively with continued therapy for 5 days ( 5-day group ) ; and ( 3 ) a placebo group . The following parameters were evaluated on the first , second and seventh days postsurgery : trismus , facial swelling , body temperature , lymphadenopathy , alveolar osteitis and subjective pain sensations . There were 86 patients ( 31 in the single-dose group , 28 in the 5-day group and 27 in the placebo group ) enrolled in the study . There were no statistically significant differences in postoperative inflammatory complications in patients during the first and second days postsurgery . A statistically significant variation in body temperature was reported on the seventh day . Analysis of the postoperative analgesic intake did not show statistically significant differences between examined groups . Clindamycin applied in a single preoperative dose of 600 mg with or without subsequent 5-day therapy does not demonstrate efficacy in prophylaxis for postoperative inflammatory complications after third molar surgery .

clindamycin therapy

clindamycin therapy

placebo-controlled

placebo

placebo

Clindamycin

variation

body temperature

postoperative analgesic intake

efficacy


Effects of application in spring of urea fertiliser on aspects of reproductive performance of pasture-fed dairy cows . AIMS To assess if raising concentrations of crude protein ( CP ) in pasture in spring by the frequent application of urea fertiliser would affect ovarian follicular dynamics , luteal function , onset of oestrus and reproductive performance of dairy cows under farming conditions in New Zealand . METHODS Spring-calved dairy cows were grazed for 101 days in paddocks that were either not fertilised ( Control ; n=20 ) during the course of the study , or were fertilised with 40-50 kg nitrogen ( N ) /ha every 4-6 weeks ( High-N ; n=20 ) . Similar generous pasture allowances were offered to both groups . Concentrations of CP in pasture , urea in serum and progesterone in milk were measured . Ovarian follicular and luteal dynamics were determined using ultrasonography . Oestrous behaviour and the number , time and outcome of inseminations were also recorded . RESULTS Mean concentrations of CP in pasture and urea in serum was higher in the High-N than the Control group ( 25.2 vs 21.6 and 8.3 vs 5.4 mmol/L for CP and urea , respectively ; p < 0.001 ) . Intervals between calving and first oestrus , first insemination and conception , the time of first emergence of a dominant follicle , milk progesterone concentration , and the diameter of the corpus luteum ( CL ) in the first luteal phase did not differ significantly between groups . The interval from calving to first ovulation tended ( p=0.10 ) to be lower and the diameter of the dominant follicle of the oestrous cycle at which cows conceived was greater ( p=0.02 ) in Control than High-N cows . CONCLUSIONS The use of large amounts of urea fertiliser during spring and the consequent increases in concentrations of CP in pasture and urea in serum did not negatively affect any of the parameters of reproductive performance of pasture-fed dairy cows that were assessed in this study .

urea fertiliser

urea fertiliser

not fertilised

fertilised

40-50 kg nitrogen

urea fertiliser

ovarian follicular dynamics

luteal function

onset of oestrus

reproductive performance

Concentrations of CP in pasture

urea in serum

progesterone in milk

Ovarian follicular and luteal dynamics

Mean concentrations of CP in pasture

and

urea in serum

first insemination and conception

milk progesterone concentration

conceived

concentrations of CP in pasture

and

urea in serum

reproductive performance

pasture-fed


Acute prolactin and oxytocin responses and milk yield to infant suckling and artificial methods of expression in lactating women . Breast-feeding is today the major form of infant nutrition in the immediate postpartum period . Despite this , recent trends in modern life-styles have raised obstacles to successful lactation . These include infant illness and maternal responsibilities outside the home , both requiring separation from the mother . While the hormonal dynamics of infant suckling are understood , little is known about the effects of artificial methods of milk expression . A variety of breast pumps exist in the current US market which vary considerably in price and effectiveness . To understand better the ability of these pumps to assist women in the maintenance of lactation , the current study was undertaken to evaluate their effects on milk yield and prolactin and oxytocin release when compared to natural infant suckling . Twenty-three women who were exclusively breast-feeding their infants were randomly assigned to serially use several pumping methods , as well as infant suckling , with blood being taken at 10-minute intervals to determine the hormonal responses . The results reveal variability in the prolactin responses to the artificial pumping methods , with the greatest responses found with an electric pulsatile pump ; these responses compare favorably with those of natural infant suckling . Other methods were less successful in causing prolactin elevations . No differences were seen among the methods in the oxytocin response . The results of this study demonstrate striking differences in the ability of breast-pumping methods to produce an acute and sustained prolactin rise in breast-feeding mothers . The large discrepancies found suggest the need for further studies in to enable women and health care providers to choose the most appropriate method for milk expression . ( ABSTRACT TRUNCATED AT 250 WORDS )

prolactin

oxytocin

milk yield

artificial methods of expression

milk expression

prolactin responses

prolactin elevations

oxytocin response

acute and sustained prolactin rise

women

Twenty-three

women


Neurophysiological double-blind trial of a botulinum neurotoxin type a free of complexing proteins . OBJECTIVE Safety and efficacy of botulinum neurotoxin type A preparation NT 201 ( Xeomin , Merz Pharmaceuticals GmbH , Frankfurt am Main , Germany ) were investigated over 52 weeks in a double-blind , randomized trial with 32 male volunteers . METHODS Electroneurographic assessments with surface electrodes were performed after single injections of NT 201 ( 2 , 4 , 16 , or 32 units ) into the extensor digitorum brevis ( EDB ) muscle and the same dose ( Botox ; Allergan Pharmaceuticals ( Ireland ) Ltd. Westport , Ireland ) into the contralateral EDB . RESULTS All NT 201 and BTXCo doses achieved a statistically significant reduction of the compound muscle action potential M-wave amplitude in the EDB muscle . At week 4 , the highest dose was statistically significantly more effective than the lowest dose ( NT 201 , P = 0.019 ; 95 % confidence interval , 0.195-1.370 ; and BTXCo , P = 0.002 ; 95 % confidence interval , 0.309-1.167 ) . Duration of effect was dose dependent . The mean values of compound muscle action potential M-wave amplitudes in the adjacent muscles ( abductor digiti quinti and abductor hallucis ) were above the predefined threshold of effect , indicating that there was no relevant diffusion-induced reduction of muscle activity . NT 201 and BTXCo were well tolerated . CONCLUSIONS NT 201 is effective and safe in inducing the desired paretic effect .

botulinum neurotoxin type a

single injections of NT 201

extensor digitorum brevis

same dose

into the contralateral EDB

NT 201 and BTXCo

NT 201

BTXCo

NT 201

Safety

efficacy

Electroneurographic

effective

Duration of effect

muscle activity

tolerated

randomized trial with

male

volunteers .


Recombinant human granulocyte-macrophage colony-stimulating factor ameliorates zidovudine-induced neutropenia in patients with acquired immunodeficiency syndrome ( AIDS ) /AIDS-related complex . To evaluate the effect of recombinant granulocyte-macrophage colony-stimulating factor ( GM-CSF ) on patients with acquired immunodeficiency syndrome ( AIDS ) or AIDS-related complex ( ARC ) who were intolerant to zidovudine because of neutropenia , we performed a randomized , open-label study in which patients were assigned to one of two groups . Zidovudine was discontinued in group A patients before instituting GM-CSF treatment and was restarted in a graduated fashion over 4 weeks . Group B patients continued on full-dose ( 1,200 mg/d ) zidovudine therapy while beginning GM-CSF therapy . A total of 17 patients were entered , eight in group A and nine in group B . Five of eight patients in group A and seven of nine in group B had a history of Pneumocystis carinii pneumonia ( PCP ) . All were homosexual males , except one female in group A who was the sex partner of a bisexual male with AIDS . All patients had neutropenia ( absolute neutrophil count [ ANC ] less than 1,000/microL ) while taking full-dose zidovudine . The mean CD4 ( +/- SD ) lymphocyte level was 37 ( +/- 29 ) /microL and 39 ( +/- 44 ) /microL in groups A and B , respectively . After randomization , patients were begun on subcutaneous GM-CSF at a dose of 1.0 microgram/kg/d . Patients in group A received 2 weeks of daily GM-CSF , at which time zidovudine was restarted if the ANC was greater than 1,000/microL ; if the ANC was less than 1,000/microL , the dose of GM-CSF was increased to 3.0 micrograms/kg , and at 2-week intervals either zidovudine was restarted or the dose of GM-CSF was increased to 5 micrograms/kg and then 10 micrograms/kg , to maintain the ANC greater than 1,000/microL . Group B patients received full-dose zidovudine concurrently with GM-CSF administration . The dose of GM-CSF was increased every 2 weeks if necessary to keep the ANC greater than 1,000/microL while maintaining full-dose zidovudine therapy . Patients in each group showed an increase in total white blood cell ( WBC ) count . Neutrophils and eosinophils were responsible for the majority of this increase . Patients in group A had a more rapid increase in WBC than those in group B ; however , by week 8 , the WBC in each group was essentially equal . Viral replication as measured by human immunodeficiency virus ( HIV ) p24 antigen ( Ag ) was decreased in four patients in each group , increased in one patient in each group , and remained unchanged in the remainder . The ability to culture virus from peripheral blood mononuclear cells was not changed by the regimen . The major toxicities of the regimen were fever and malaise . ( ABSTRACT TRUNCATED AT 400 WORDS )

GM-CSF

GM-CSF treatment

GM-CSF therapy

effect

neutropenia

ANC

total white blood cell ( WBC ) count

Neutrophils and eosinophils

increase in WBC

WBC

Viral replication

ability to culture virus

AIDS-related complex ( ARC )

neutropenia

Five

eight

seven

nine

Pneumocystis carinii pneumonia ( PCP )

males

female

male

AIDS

neutropenia


[ Comparison of three analgesic methods for postoperative pain relief and their effects on plasma interleukin-6 concentration following radical surgery for gastric carcinoma ] . OBJECTIVE To compare the efficacy of preemptive epidural analgesia combined with postoperative epidural analgesia , postoperative epidural analgesia alone and intravenous analgesia for postoperative pain relief and their effects on plasma interleukin-6 ( IL-6 ) concentration following radical surgery for gastric carcinoma . METHODS Sixty-six patients with gastric carcinoma scheduled for gastrectomy were randomly divided into 3 groups , namely group P ( n=22 ) , group E ( n=22 ) and group V ( n=22 ) , to receive preemptive epidural analgesia combined with postoperative epidural analgesia , exclusive postoperative epidural analgesia , and exclusive postoperative intravenous analgesia , respectively . Hemodynamic data were recorded for all the patients during the operation , and visual analogue scale ( VAS ) was used to assess the pain intensity at 4 , 8 , 16 , 24 , 48 and 72 h after surgery . Plasma IL-6 concentration was determined before surgery and at 24 , 48 , 72 h after surgery . RESULTS No significant changes occurred in the hemodynamics during the preoperative periods . VAS and IL-6 were lower in group P than in group E and V , and group E had lower measurement than group V ( P < 0.05 ) . CONCLUSION Preemptive epidural analgesia combined with postoperative epidural analgesia provides more satisfactory pain relief and more effectively prevents IL-6 increment than exclusive epidural analgesia or intravenous analgesia after gastrectomy for gastric carcinoma .

postoperative epidural analgesia alone

intravenous analgesia

plasma interleukin-6 concentration

postoperative pain relief

Hemodynamic data

visual analogue scale ( VAS )

pain intensity

Plasma IL-6 concentration

VAS

pain relief

IL-6 increment

postoperative pain

gastric carcinoma

Sixty-six


Low efficacy of mebendazole against hookworm in Vietnam : two randomized controlled trials . Vietnam is participating in a global de-worming effort that aims to treat 650 million school children regularly by 2010 . The treatment used in Vietnam is single dose oral mebendazole ( Phardazone ) 500 mg. We tested the efficacy of single dose mebendazole 500 mg in the therapy of hookworm infection in a randomized double-blind placebo-controlled trial among 271 Vietnamese schoolchildren . The treatment efficacy of single dose mebendazole in children did not differ significantly from placebo , with a reduction in mean eggs per gram of feces relative to placebo of 31 % ( 95 % CI -9 to 56 % , P = 0.1 ) . In light of these findings we then carried out a similar randomized trial comparing triple dose mebendazole , single dose albendazole , and triple dose albendazole against placebo in 209 adults in the same area . The estimated reduction in mean post-treatment eggs per gram of feces relative to placebo was 63 % ( 95 % CI 30-81 % ) for triple mebendazole , 75 % ( 47-88 % ) for single albendazole , and 88 % ( 58-97 % ) for triple albendazole . Our results suggest that single dose oral mebendazole has low efficacy against hookworm infection in Vietnam , and that it should be replaced by albendazole . These findings are of major public health relevance given the opportunity costs of treating entire populations with ineffective therapies . We recommend that efficacy of anti-helminth therapies is pilot tested before implementation of national gut worm control programs .

mebendazole

mebendazole ( Phardazone )

mebendazole

placebo-controlled

mebendazole

placebo

placebo

mebendazole

albendazole

albendazole

placebo

placebo

mebendazole

albendazole

albendazole

albendazole

anti-helminth therapies

mean eggs per gram of feces

low efficacy against hookworm infection


[ Clinical observation on different acupuncture and moxibustion therapies for treatment of postsurgical gastroparesis syndrome ] . OBJECTIVE To optimize therapy of acupuncture and moxibustion for postsurgical gastroparesis syndrome ( PGS ) . METHODS Forty-one cases of PGS were randomly divided into 3 groups in order of visiting . Group A ( n = 17 ) were treated by warming needle moxibustion , group B ( n = 12 ) by acupuncture plus auricular point sticking , and group C ( n = 12 ) by routine acupuncture . Changes of gastric drainage volume , therapeutic times and cured rate were investigated in the 3 groups . RESULTS All the 3 therapeutic methods could significantly decrease gastric drainage volume . The cured rate was 100.0 % and the therapeutic times was ( 7.24 +/- 3.87 ) in the group A , 66.7 % , ( 9.83 +/- 4.60 ) times in the group B and 75.0 % , ( 15.25 +/- 3.81 ) times in the group C , with significant differences in the cured rate and the therapeutic times among the 3 groups ( P < 0.05 , P < 0.01 ) . CONCLUSION The warming needle moxibustion is the best method for PGS , with less therapeutic times , high cured rate and rapid effect .

acupuncture

moxibustion

warming needle moxibustion

routine acupuncture

gastric drainage volume

therapeutic times

cured rate

gastric drainage volume .

cured rate

therapeutic times

cured rate

therapeutic times

therapeutic times

cured rate

effect .

postsurgical gastroparesis syndrome ]

Forty-one

PGS

PGS


Temporal judgements of internal and external events in persons with and without autism . When participants make judgments about the onset of self-initiated movements they typically report the movement occurred earlier than it had [ Obhi , S. S. , & Haggard , P. ( 2004 ) . Free will and free wo n't . American Scientific , 92 , 358-365. ] . One interpretation is that feed-forward processes lead to awareness of the movement prior to execution . Because individuals with autism experience reduced preparatory activity prior to a voluntary movement , the present study sought to determine whether these anticipatory biases are exhibited by persons with autism . Participants watched a dot move in a circle and pressed the spacebar any time after one revolution . A tone either followed the participants ' voluntary movement or was computer generated . Participants in both groups made anticipatory judgements regarding movement initiation ( approximately 100 ms ) . When the movement and tone occurred together this anticipatory bias was also present , regardless of which event participants focused on . Individuals with autism appear to have access to a similar representation of voluntary movements , however this representation may be more variable .

Temporal judgements

judgments

judgements

judgements

movement initiation

voluntary movements

autism

autism

autism

autism


Comparison of three methods to increase knowledge about breast cancer and breast cancer screening in screening mammography patients . RATIONALE AND OBJECTIVES The specific aim of the study was to determine which of several cost-effective interventions is best able to improve the breast cancer knowledge of women who present for screening mammography . MATERIALS AND METHODS A total of 198 English-speaking women , with no personal or family history of breast cancer , were recruited and randomized to four groups when they presented to the clinic for a screening mammogram . All women filled in a demographic data form and answered a questionnaire containing nine questions about breast cancer , risk , and screening to assess their knowledge and perception . Three educational interventions were tested in this study . The first consisted of a brochure , which provided answers to the questionnaire items and addressed the issues in more depth . The second intervention was an educational conversation with a specially trained mammography technologist . She reviewed the subject 's answers to the questionnaire items correcting and/or clarifying them . The third intervention consisted of the brochure together with the conversation with a trained technologist . There was also a control group that just filled in the study questionnaire but did not receive an educational intervention . The same questionnaire was administered by telephone 4 to 6 weeks after the screening experience to all study subjects . Changes in their knowledge and perceptions of breast cancer were measured and compared . RESULTS A statistically significant increase in knowledge was found in all of the three investigated groups compared to the control group . There were no statistically significant differences in the amount of increase between women who underwent different interventions . CONCLUSIONS All three interventions resulted in increased knowledge about breast cancer and screening . No differences in the amount of knowledge increase were found between three interventions tested . The educational brochure seems to represent the most convenient and least costly method to increase knowledge about breast cancer and screening among women who present for screening mammography .

educational interventions

knowledge

breast cancer knowledge

knowledge

knowledge

knowledge

knowledge

screening mammography patients .

198 English-speaking women

breast cancer

screening mammogram


A randomized , double-blind , placebo-controlled trial of pentoxifylline for the treatment of recurrent aphthous stomatitis . OBJECTIVE To evaluate pentoxifylline for the treatment of recurrent aphthous stomatitis . DESIGN A 60-day , randomized , double-blind , placebo-controlled trial with a 60-day no treatment follow-up . SETTING An oral medicine specialist referral center in Manchester . PARTICIPANTS Forty-nine volunteers who passed the initial assessment for recurrent aphthous stomatitis entered a pretrial phase in which their eligibility for the trial phase of the study was assessed . Sixteen subjects were deemed ineligible , and 7 failed to attend or withdrew . The remaining 26 subjects were randomized to placebo or treatment . Six subjects withdrew because of adverse effects , and 1 was unavailable for follow-up . INTERVENTION Pentoxifylline ( also called oxpentifylline ) , 400 mg 3 times daily , or matching placebo . MAIN OUTCOME MEASURE A reduction in the median pain score , ulcer size , number of ulcers , or total number of ulcer episodes . RESULTS Patients taking pentoxifylline had less pain and reported smaller and fewer ulcers compared with baseline . Patients taking placebo reported no improvement in these variables . Patients taking pentoxifylline also reported more ulcer-free days than those taking placebo . However , the differences were small and , with the exception of median ulcer size ( P = .05 ) , did not reach statistical significance . Adverse effects were common with pentoxifylline , but not significantly different from those experienced by patients taking placebo . CONCLUSIONS Although pentoxifylline may have some benefit in the treatment of recurrent aphthous stomatitis , the benefit is limited . It may have a role in the treatment of patients unresponsive to other treatments , but can not yet be recommended as a first-line treatment .

placebo-controlled

pentoxifylline

pentoxifylline

placebo-controlled

Pentoxifylline

placebo

pentoxifylline

placebo

pentoxifylline

placebo

pentoxifylline

placebo

pentoxifylline

median pain score

ulcer size

number of ulcers

total number of ulcer episodes

less pain

smaller and fewer ulcers

no improvement

more ulcer-free days

differences were small

did not reach statistical significance

Adverse effects

not significantly different

aphthous stomatitis

Forty-nine

aphthous stomatitis

Sixteen


Long-term results of a randomized clinical trial of Shouldice , Lichtenstein and transabdominal preperitoneal hernia repairs . INTRODUCTION There is an ongoing debate about the preferred technique for inguinal hernia repair . In this randomized study the long-term results of Shouldice , Lichtenstein and transabdominal preperitoneal ( TAPP ) hernia repair were compared . METHODS Some 280 men with a primary hernia were randomized prospectively to undergo Shouldice , tension-free Lichtenstein or laparoscopic TAPP repair . Patients were examined after 52 months to assess hernia recurrence , nerve damage , testicular atrophy and patient satisfaction . RESULTS Hernia recurrence occurred in six patients after Shouldice repair , and in one patient each after Lichtenstein and TAPP repairs . All recurrences after tension-free repairs were diagnosed within the first year after surgery . Nerve injuries were significantly more frequent after open Shouldice and Lichtenstein repairs . Patient satisfaction was greatest after laparoscopic TAPP repair . CONCLUSION Tension-free repair was superior to the non-mesh Shouldice technique . The open anterior approach to the groin was associated with demonstrable nerve injury , and laparoscopic TAPP repair was the most effective approach in the hands of an experienced surgeon .

laparoscopic TAPP repair

hernia recurrence

nerve damage

testicular atrophy

patient satisfaction

Hernia recurrence

Nerve injuries

Patient satisfaction

nerve injury

men

primary hernia


A randomised trial of radiotherapy compared with cisplatin chemo-radiotherapy in patients with unresectable squamous cell cancer of the esophagus . BACKGROUND AND PURPOSE Following our phase II experience , a randomised trial was undertaken to evaluate the efficacy of adding chemotherapy to radiotherapy in patients with unresectable squamous cell cancer of the esophagus . PATIENTS AND METHODS Patients randomised to the RT group received 50 Gy/25 fx/5 weeks of teletherapy followed 1-2 weeks later with 12 Gy/2 fx of high-dose-rate intra-lumenal brachytherapy spaced a week apart . Following the first 3 years of recruitment , due to unexpected late morbidity , brachytherapy was excluded and the protocol modified to 66 Gy/33 fx/6.5 weeks . The CRT group received identical radiotherapy with concurrent weekly cisplatin at 35 mg/m ( 2 ) for 6-7 cycles . RESULTS Between April 1999 and December 2005 , 125 patients were randomised to a RT ( n=60 ) or CRT group ( n=65 ) . Radiotherapy treatment was completed in 78 % ( 47/60 ) of the RT group and 89 % ( 58/65 ) of the CRT group ( P=0.10 ) . Six or more cycles of cisplatin could be delivered in 63 % ( 41/65 ) , which resulted in RTOG grade 3 neutropenia of 3 % . Late morbidity in the form of ulcers ( 5 % vs. 15 % odds ratio 0.29 , 95 % CI 0.08-1.11 , P=0.08 ) and strictures ( 13 % vs. 28 % , odds ratio 0.40 , 95 % CI 0.16-1.01 , P=0.05 ) was observed in the RT and CRT groups , respectively . At a median follow up of 23 months of all patients alive ( range 6-82 months ) and with 95/125 events , the median , 1 , 2 and 5 year projected survival was 7.1 months , 32.3 % , 22.8 % and 13.7 % vs. 13.4 months , 57.6 % , 38.9 % and 24.8 % for the RT and CRT groups , respectively ( hazard ratio 0.65 , 95 % CI 0.44-0.98 , P=0.038 ) . CONCLUSIONS The addition of concurrent cisplatin to radiotherapy resulted in a modest improvement in survival and was associated with manageable additional acute and late morbidity .

radiotherapy

cisplatin chemo-radiotherapy

adding chemotherapy to radiotherapy

brachytherapy

cisplatin

radiotherapy

efficacy

RTOG grade 3 neutropenia

Late morbidity in the form of ulcers

strictures

survival

modest improvement in survival

manageable additional acute

late morbidity


Women 's responses to information on mammographic breast density . The objective of this study was to determine the negative and positive outcomes of providing mammographic breast density ( MBD ) information to participants of a screening program . A randomized experiment was conducted with a sample of 618 women 50 years or older with MBD greater than 50 % of breast volume . The intervention consisted of reporting the presence of MBD in the screening mammography results letter that was sent along with an information pamphlet . Compared to the controls , more women in the intervention group described the term breast density correctly and recognized it as a risk factor for breast cancer . Although at the 4-week follow-up the intervention group indicated that they were " very likely " to have an annual clinical breast examination more frequently than controls , no differences were detected at 6 months . There were no significant differences on other behavioural or psychological measures , although at the 4-week follow-up the control group perceived their risk for breast cancer , relative to other women their age , as " a lot lower " than did women in the intervention group . The results demonstrate a feasible and non-threatening way to provide women with important personalized information about breast cancer risk .

screening program

controls

annual clinical breast examination

breast density

behavioural or psychological measures

breast cancer risk


Similar effects of rofecoxib and indomethacin on the incidence of heterotopic ossification after hip arthroplasty . BACKGROUND Although indomethacin is effective in preventing heterotopic ossification ( HO ) after primary total hip arthroplasty , side effects are frequently observed . In the last decade a new class of drugs -- the COX-2 selective nonsteroidal anti-inflammatory drugs -- has been developed . To investigate the effect of these COX-2 selective NSAIDs on heterotopic ossification ( HO ) after primary total hip arthroplasty ( THA ) , we conducted a randomized controlled trial using either indomethacin or rofecoxib for 7 days . METHODS 186 patients received either indomethacin 3 times daily , or rofecoxib twice , and 1 placebo , daily for 7 days . HO was graded according to the 1-year postoperative radiographs according to the Brooker classification . RESULTS 12 of the 186 patients included discontinued their medication before the end of the trial due to side effects . The remaining 174 patients were included in the analysis . In the indomethacin group ( n = 89 ) , 77 patients ( 87 % ) showed no HO , 9 showed HO of grade 1 and 3 showed HO of grade 2 according to the Brooker classification . In the rofecoxib group ( n = 85 ) 73 patients ( 86 % ) showed no ossification , 9 showed grade 1 , and 3 showed grade 2 . INTERPRETATION The prophylactic effect of rofecoxib for 7 days in preventing heterotopic ossification after primary total hip arthroplasty is comparable to the effect of indomethacin given for 7 days . These results indicate that the development of HO follows a COX-2 pathway .

indomethacin

COX-2 selective NSAIDs

indomethacin

rofecoxib

indomethacin

rofecoxib

placebo

indomethacin

rofecoxib

rofecoxib

indomethacin

heterotopic ossification

side effects

NSAIDs

heterotopic ossification

HO

discontinued

side effects

showed no HO

showed HO of grade 1

showed HO of grade 2

showed no ossification

showed grade 1

showed grade 2

hip arthroplasty

primary total hip arthroplasty


Development , description , and acceptability of a small-group , behavioral intervention to prevent HIV and hepatitis C virus infections among young adult injection drug users . Young injection drug users ( IDUs ) who are not infected with HIV or hepatitis C virus are at great risk of acquiring one or both of these infections through their sexual or injection behaviors . We describe the development of a behavioral intervention designed to decrease sexual and injection risk behaviors among young IDUs . The intervention was developed through a dynamic and iterative process that involved extensive development activities , focus groups with the target population to pilot individual activities and intervention sessions , and later , pilot testing of the entire intervention . The six-session intervention that emerged from the development process relied on both social-cognitive theories and peer influence models . We also designed a control intervention , trained facilitators to deliver the interventions , and conducted quality assurance of intervention delivery . To better understand intervention trial findings , we asked participants about their intervention experiences and examined potential contamination across arms . Both interventions were delivered with high fidelity and participants in both groups reported positive experiences . More perceived impact was reported for injection risk behaviors than for sexual risk behaviors among participants in the intervention arm . Minimal evidence of contamination was found . Lessons learned can help future researchers to develop stronger interventions for this high-need population .

small-group , behavioral intervention

sexual and injection risk behaviors

perceived impact

injection risk behaviors

sexual risk behaviors

contamination

young adult

drug users

Young

injection drug users ( IDUs )

HIV

hepatitis C virus

young

IDUs


Chemoradiation comparing cisplatin versus carboplatin in locally advanced nasopharyngeal cancer : randomised , non-inferiority , open trial . PURPOSE This single centre , open labelled , randomised non-inferiority trial compared concurrent chemoradiotherapy with carboplatin versus standard concurrent chemoradiotherapy with cisplatin in patients with locoregionally advanced nasopharyngeal cancer ( NPC ) . PATIENTS AND METHODS From August 1999 to December 2004 , 206 patients with locally advanced NPC were randomised with 101 to cisplatin arm and 105 to carboplatin arm . Planned radiotherapy was the same in both groups . All the patients were evaluated for toxicity and survival according to the as-treated principle . RESULTS With a median follow-up of 26.3 months ( range 3-74.6 months ) , 59 % of patients in the cisplatin arm completed the planned concurrent chemoradiation treatment , compared to 73 % in the carboplatin arm . Forty-two percent of cisplatin patients completed the 3 cycles of adjuvant therapy compared to 70 % in the carboplatin group . There were more renal toxicity , leucopenia , and anaemia in the cisplatin group , and more thrombocytopenia in the carboplatin arm . The 3 year disease free survival rates were 63.4 % for the cisplatin group and 60.9 % for the carboplatin group ( p=0.9613 ) ( HR 0.70 , 95 % confidence interval ( CI ) : 0.50-0.98 ) . The 3 year overall survival rates were 77.7 % and 79.2 % for cisplatin and carboplatin groups , respectively ( p=0.9884 ) ( HR 0.83 , 95 % CI : 0.63-1.010 ) . CONCLUSION We concluded that the tolerability of carboplatin based regimen is better than that of the cisplatin regimen . Moreover , the treatment efficacy of carboplatin arm is not different from the standard regimen in the treatment of locoregional advanced stage NPC .

cisplatin

carboplatin

chemoradiotherapy with carboplatin

cisplatin

carboplatin

Planned radiotherapy

carboplatin

cisplatin

toxicity

survival

3 cycles of adjuvant therapy

renal toxicity

leucopenia

anaemia

thrombocytopenia

3 year disease free survival rates

3 year overall survival rates

advanced nasopharyngeal cancer

locoregional advanced stage NPC


Behavioral/psychoeducational group training in therapy for overtaxed men .

overtaxed men .

men


Preliminary analysis of the final multicenter investigation of rheopheresis for age related macular degeneration ( AMD ) trial ( MIRA-1 ) results . PURPOSE To present an initial evaluation of the final data from the Multicenter Investigation of Rheopheresis for age-related macular degeneration ( AMD ) ( MIRA-1 ) trial . This was a 12-month randomized , prospective , multicenter , double-masked , placebo-controlled , Food and Drug Administration approved clinical trial designed to compare rheopheresis treatment with placebo-control treatment . METHODS Patients that had nonexudative age-related macular degeneration ( AMD ) and certain hemorheologic abnormalities were randomized to either rheopheresis or sham treatment in a 2:1 fashion . Best-corrected visual acuity was determined before and at 3 , 6 , 9 , and 12 months following treatment . Adverse events were also recorded . RESULTS A total of 216 patients were randomized . Of these , 18 were not included in the vision or adverse events evaluation because they did not complete one treatment . This decreased the number of patients that were evaluated for adverse events to 198 patients . In this group , there were 27 serious adverse events , but only 1.8 % of treatments were suspended because of adverse events . At 12 months , there were 104 treated patients and 63 placebo patients that had follow-up . The treated patients had a logMAR vision improvement of 0.02 +/- 0.213 , and the placebo patients had a vision improvement of 0.02 +/- 0.20 . This was not statistically significant ( P = .977 ) . The repeated measure P value for the entire time interval was not significant ( P = .69 ) . There appeared to be patients entered into the study that did not meet inclusion criteria . Excluding 37 % of the treated patients and 29 % of the placebo data from the analysis , there appeared to be statistically significant improvement in the treated patients compared to the control patients at 1 year with a P value of .001 ( repeated measures P value = .01 ) . CONCLUSIONS At best this was a flawed study in that 37 % of the treated cases did not meet inclusion criteria , and at worst there was no evidence of effect . Even though the number of serious adverse events is small , because this study did not show an effect in the intent-to-treat group , rheopheresis should not be performed for AMD outside of an approved randomized controlled trial .

rheopheresis

Rheopheresis

placebo-controlled

rheopheresis

placebo-control

rheopheresis

sham treatment

placebo

placebo

rheopheresis

vision

adverse events

logMAR vision improvement

vision improvement

A total of 216 patients


Clinical evaluation of imidapril in congestive heart failure in dogs : results of the EFFIC study . OBJECTIVES The clinical efficacy and safety of imidapril were evaluated in dogs that presented with mild to severe congestive heart failure ( New York Heart Association stage II to IV ) by comparing the success rate of imidapril with a positive control by a non-inferiority approach . METHODS This good , clinical practice compliant , multicentre study ( EFFIC study ) enrolled 142 client-owned dogs and was conducted in 20 locations in France , Belgium and Germany . Dogs of various breed , age and weight were included in the study . These dogs were randomised into two groups that were treated for 84 days with either the test product , imidapril , or the positive control , benazepril , and followed up in parallel over this period . Both treatments were administered at a dose of 0.25 mg/kg once a day with the possibility of doubling this dose to 0.5 mg/kg if considered necessary from a clinical point of view . In addition , concomitant treatment was given to dogs presenting with pulmonary oedema and/or ascites , supraventricular tachyarrhythmia and/or dilated cardiomyopathy . The evolution of the New York Heart Association stage and the " functional signs " score were evaluated as primary efficacy criteria . RESULTS The success rate in the imidapril group was 66 compared with 68 per cent in the benazepril group . Regarding safety , 35 dogs in each group experienced at least one adverse event . Nine dogs in each group experienced at least one serious adverse event . The difference between these results was not statistically significant . CLINICAL SIGNIFICANCE Imidapril is as efficacious and safe as the reference product , benazepril .

imidapril

imidapril

imidapril

imidapril

benazepril

imidapril

benazepril

efficacy and safety

" functional signs " score

success rate

adverse event .

serious adverse

congestive heart failure in dogs :


Efficacy and safety of a very-low-protein diet when postponing dialysis in the elderly : a prospective randomized multicenter controlled study . BACKGROUND A supplemented very-low-protein diet ( sVLPD ) seems to be safe when postponing dialysis therapy . STUDY DESIGN Prospective multicenter randomized controlled study designed to assess the noninferiority of diet versus dialysis in 1-year mortality assessed by using intention-to-treat and per-protocol analysis . SETTING & PARTICIPANTS Italian uremic patients without diabetes older than 70 years with glomerular filtration rate of 5 to 7 mL/min ( 0.08 to 0.12 mL/s ) . INTERVENTION Randomization to an sVLPD ( diet group ) or dialysis . The sVLPD is a vegan diet ( 35 kcal ; proteins , 0.3 g/kg body weight daily ) supplemented with keto-analogues , amino acids , and vitamins . Patients following an sVLPD started dialysis therapy in the case of malnutrition , intractable fluid overload , hyperkalemia , or appearance of uremic symptoms . OUTCOMES & MEASUREMENTS Mortality , hospitalization , and metabolic markers . RESULTS 56 patients were randomly assigned to each group , median follow-up was 26.5 months ( interquartile range , 40 ) , and patients in the diet group spent a median of 10.7 months ( interquartile range , 11 ) following an sVLPD . Forty patients in the diet group started dialysis treatment because of either fluid overload or hyperkalemia . There were 31 deaths ( 55 % ) in the dialysis group and 28 deaths ( 50 % ) in the diet group . One-year observed survival rates at intention to treat were 83.7 % ( 95 % confidence interval [ CI ] , 74.5 to 94.0 ) in the dialysis group versus 87.3 % ( 95 % CI , 78.9 to 96.5 ) in the diet group ( log-rank test for noninferiority , P < 0.001 ; for superiority , P = 0.6 ) : the difference in survival was -3.6 % ( 95 % CI , -17 to +10 ; P = 0.002 ) . The hazard ratio for hospitalization was 1.50 for the dialysis group ( 95 % CI , 1.11 to 2.01 ; P < 0.01 ) . LIMITATIONS The unblinded nature of the study , exclusion of patients with diabetes , and incomplete enrollment . CONCLUSION An sVLPD was effective and safe when postponing dialysis treatment in elderly patients without diabetes .

very-low-protein diet

diet

dialysis

sVLPD ( diet group )

dialysis

sVLPD

sVLPD

dialysis therapy

diet group

sVLPD

dialysis treatment

dialysis group

diet group

dialysis

diet

dialysis group

sVLPD

Efficacy and safety

safe

Mortality

hospitalization

metabolic markers

fluid overload or hyperkalemia

deaths

One-year observed survival rates

survival

The hazard ratio for hospitalization

effective and safe

postponing dialysis

elderly

diabetes

older than 70 years

56 patients

elderly patients

diabetes


Can a home-visit invitation increase Pap smear screening in Samliem , Khon Kaen , Thailand ? Our objective was to assess the efficiency of a home-visit invitation aimed to increase uptake of cervical cancer screening in women between 35 and 60 years of age . From May , 2006 , we conducted a quasi-randomized trial to determine if an in-home education and invitation intervention would increase uptake of cervical cancer screening . We randomly recruited 304 women from the Samliem inner-city community , Khon Kaen , Northeast Thailand , and assigned participants to either the intervention or control zone . Baseline screening coverage interviews were then performed : 58 of 158 women in the intervention zone and 46 of 146 in the control zone were excluded from the study because of having had a Pap smear within 5 years , but these were included in the final analysis . First , 100 women in the intervention group were visited in their homes by one of the researchers , who provided culturally-sensitive health education that emphasized the need for screening . Four months later , post-intervention , screening-coverage interviews were again performed in both groups , in combination with the same health education for 100 women in the control group for a comparison . There was no difference in the baseline Pap smear screening-coverage rate in the intervention vs. control zones ( 36.7 vs. 31.5 % , p=0.339 ) . One hundred women in the intervention group completed the intervention interviews and after four months , 100 women in the intervention group and 100 in the control group also completed the post-intervention interviews . The increased screening-coverage rate in the intervention zone was similar to that of the control zone ( 43.6 vs. 34.9 % , p=0.119 ) ; however , there was a borderline significant increase in the intervention zone compared with baseline ( 36.7 to 43.6 % , p=0.070 ) . Therefore , home visit education and invitation intervention produced only a nominal effect on increasing Pap smear coverage within a 4-month study period .

home-visit invitation

home-visit invitation

intervention

control zone .

screening-coverage interviews

control

screening-coverage rate

cervical cancer

women

35 and 60

women

women

women

women


Use of the electrothermal bipolar vessel system ( EBVS ) in laparoscopic adrenalectomy : a prospective study . BACKGROUND Since laparoscopic adrenalectomy ( LA ) has been adopted as the gold standard for the treatment of adrenal diseases , the development of technology for vascular control and dissection manoeuvres , amongst other things , may play a pivotal role in its further improvement . We report our experience with the electrothermal bipolar vessel sealing ( EBVS ) device for LA . METHODS From January 2004 to January 2006 , 50 patients ( pts ) undergoing LA were selected and randomized for use of the EBVS ( 25 pts , group A ) versus the UltraSonic Shears ( USS ) device ( 25 pts , group B ) . Age , sex , body mass index ( BMI ) , previous surgery and associated diseases were similar between the two groups . The main surgical parameters collected for each patient ( pt ) concerned operative time , major and minor complications , conversion rate , blood loss , hospital stay and histology . RESULTS There was no mortality in either group . The right adrenalectomy mean operative time ( OpT ) was 51.8 mins ( range 40-90 mins ) and 68.6 mins ( range 50-130 mins ) in group A and B , respectively ( P not significant ) . The left adrenalectomy mean OpT was 72.2 mins ( range 55-100 mins ) and 94 mins ( range 65-140 mins ) for group A and B , respectively ( P < 0.05 ) . The mean blood loss was 83 ml ( group A ) and 210 ml ( group B ) ( p < 0.05 ) . Complications were not different for the two groups . The mean hospital stay was 2.9 and 3.1 days in group A and B , respectively ( P not significant ) . CONCLUSIONS EBVS in LA may provide a significantly short operating time and blood loss .

EBVS

no mortality

mean operative time ( OpT )

left adrenalectomy mean OpT

mean blood loss

mean hospital stay

short operating time

blood loss


Dissociation between cortical activation and cognitive performance under pharmacological blood pressure elevation in chronic hypotension . The present study explored the impact of pharmacological blood pressure elevation on cortical activation and reaction time in chronic hypotension . Effects of the sympathomimetic etilefrine were investigated in 50 hypotensive persons based on a randomized , placebo-controlled double blind design . As an indicator of cortical excitability , the contingent negative variation ( CNV ) , induced by a constant foreperiod reaction time task , was assessed at frontal ( F3 , Fz , F4 ) and central ( C3 , Cz , C4 ) scalp sites . Etilefrine provoked a decrease in the frontal and central CNV . In contrast , shorter reaction times were observed following drug administration . The degree of pharmacologically induced blood pressure elevation was correlated to CNV attrition as well as to performance enhancement . Inhibitory effects of baroreceptor activation on cortical excitability and enhanced cerebral blood flow are considered to be involved in mediating the effects of blood pressure elevation on cerebral functioning . Implications for the treatment of chronic hypotension are discussed .

sympathomimetic etilefrine

placebo-controlled

Etilefrine

frontal and central CNV .

reaction times

induced blood pressure elevation

blood pressure elevation

chronic hypotension

chronic hypotension

hypotensive


Fine needle aspiration coupled with real-time PCR : a painless methodology to study adaptive functional changes in skeletal muscle . BACKGROUND AND AIM In this study we developed a new methodology for obtaining human skeletal muscle samples to evaluate gene expression . This approach is based on a fine needle aspiration technique , which allows us to extract a small tissue sample in a significantly less invasive manner than with classic biopsy . METHODS AND RESULTS Multiplex tandem RT-PCR was used to determine the mRNA levels of genes involved in ATP production and mitochondrial biogenesis in muscle tissue . Samples of vastus lateralis muscle were obtained from 21 healthy subjects with different fitness levels . The principal findings in our study show a strong correlation between PGC-1alpha and COX5B ( p < 0.001 ) and between PGC-1alpha and MT-CO2 ( p=0.017 ) expression . Furthermore , a significant positive correlation between mtDNA content and the percentage of MHCI present in the aspired samples were found ( p=0.028 ) . These data are in agreement with current knowledge on skeletal muscle physiology and show the reliability of the proposed method . CONCLUSION This painless methodology can be used to investigate , in vivo , human muscle RNA and DNA adaptations in response to either physiological and/or pharmacological stimuli . This method has major clinical relevance , such as its application in clarifying the mechanisms underling metabolic and systemic disorders .

methodology

fine needle aspiration technique

Multiplex tandem RT-PCR

painless methodology

PGC-1alpha and COX5B

PGC-1alpha and MT-CO2

healthy

different fitness levels


Trace element supplementation after major burns modulates antioxidant status and clinical course by way of increased tissue trace element concentrations . BACKGROUND After major burns , patients can develop nutritional deficiencies including trace element ( TE ) deficiencies . Various complications , such as infections and delayed wound healing , influence the clinical course of such patients . OBJECTIVES We aimed to investigate the effects of large , intravenous doses of TE supplements on circulating and cutaneous TE tissue concentrations , on antioxidant status , and on clinical outcome after major burns . DESIGN This was a prospective , randomized , placebo-controlled trial in 21 patients aged 35 +/- 11 y ( x +/- SD ) with burns on 45 +/- 21 % of their body surface area . Intravenous copper , selenium , and zinc ( TE group ) or vehicle ( V group ) was given with a saline solution for 14-21 d. Blood and urine samples were collected until day 20 , and skin biopsy specimens were collected on days 3 , 10 , and 20 . RESULTS The age of the patients and the severity of their burns did not differ significantly between the groups . Plasma TE concentrations were significantly higher in the TE group . In burned areas , skin contents of both selenium ( P=0.05 ) and zinc ( P=0.04 ) increased significantly by day 20 . Plasma and tissue antioxidant status was improved by supplementation . The number of infections in the first 30 d was significantly lower in the TE group ( P=0.015 ) , with a median number of 2 versus 4 infections per patient in the TE and V groups , respectively , as a result of a reduction in pulmonary infections ( P=0.03 ) . Wound healing was improved in the TE group , with lower requirements for regrafting ( P=0.02 ) . CONCLUSIONS TE supplementation was associated with higher circulating plasma and skin tissue contents of selenium and zinc and improved antioxidant status . These changes were associated with improved clinical outcome , including fewer pulmonary infections and better wound healing .

Trace element supplementation

TE supplements

placebo-controlled

vehicle

TE

tissue trace element concentrations .

skin contents of both selenium

number of infections


Supplementation with iron and riboflavin enhances dark adaptation response to vitamin A-fortified rice in iron-deficient , pregnant , nightblind Nepali women . BACKGROUND Nightblindness affects 16-52 % of pregnant women in areas of Nepal and in some cases persists after vitamin A treatment . Iron and riboflavin affect vitamin A utilization and photoreceptor function , respectively , and pilot data in the study population showed a high prevalence of iron and riboflavin deficiencies . OBJECTIVE The objective was to assess the effect of supplemental iron and riboflavin on pupillary threshold ( PT ) and plasma retinol in nightblind , pregnant Nepali women given vitamin A-fortified rice . DESIGN Nightblind pregnant women were randomly assigned to receive , 6 d/wk under supervision for 6 wk , a vitamin A-fortified rice curry dish providing 850 microg retinal activity equivalents/d with either a 30-mg Fe and 6-mg riboflavin ( FeR + VA ) capsule or a placebo control ( VA only ) capsule . Hemoglobin , erythrocyte riboflavin , and plasma ferritin and retinol were measured before and after the intervention . Dark adaptation was assessed by PT score . RESULTS Women who were iron deficient at baseline ( n=38 ) had significantly greater improvement in PT score with iron and riboflavin supplementation than without ( P=0.05 ) . Iron and riboflavin supplements significantly reduced the prevalences of riboflavin deficiency ( from 60 % to 6 % ; P < 0.0001 ) , iron deficiency anemia ( from 35 % to 15 % ; P < 0.007 ) , and abnormal PT ( from 87 % to 30 % ; P < 0.05 ) from baseline . Mean increases in erythrocyte riboflavin ( P < 0.0001 ) and plasma ferritin ( P=0.01 ) were greater in the FeR + VA group than in the VA only group . CONCLUSIONS Iron deficiency may limit the efficacy of vitamin A to normalize dark adaptation in pregnant Nepali women . Further studies are needed to assess the effect of simultaneous delivery of iron and vitamin A for the treatment of nightblindness .

vitamin A-fortified rice

Iron

riboflavin

supplemental iron and riboflavin

vitamin A-fortified rice curry dish

30-mg Fe

6-mg riboflavin

placebo control

iron

riboflavin

vitamin A

riboflavin deficiency

iron deficiency anemia

abnormal PT

plasma ferritin

iron-deficient , pregnant , nightblind

women

pregnant

women

Nightblind pregnant

women

pregnant


The effectiveness of Picture Exchange Communication System ( PECS ) training for teachers of children with autism : a pragmatic , group randomised controlled trial . OBJECTIVE To assess the effectiveness of expert training and consultancy for teachers of children with autism spectrum disorder in the use of the Picture Exchange Communication System ( PECS ) . METHOD DESIGN Group randomised , controlled trial ( 3 groups : immediate treatment , delayed treatment , no treatment ) . PARTICIPANTS 84 elementary school children , mean age 6.8 years . TREATMENT A 2-day PECS workshop for teachers plus 6 half-day , school-based training sessions with expert consultants over 5 months . OUTCOME MEASURES Rates of : communicative initiations , use of PECS , and speech in the classroom ; Autism Diagnostic Observation Schedule-Generic ( ADOS-G ) domain scores for Communication and Reciprocal Social Interaction ; scores on formal language tests . RESULTS Controlling for baseline age , developmental quotient ( DQ ) and language ; rates of initiations and PECS usage increased significantly immediately post-treatment ( Odds Ratio ( OR ) of being in a higher ordinal rate category 2.72 , 95 % confidence interval 1.22-6.09 , p < .05 and OR 3.90 ( 95 % CI 1.75-8.68 ) , p < .001 , respectively ) . There were no increases in frequency of speech , or improvements in ADOS-G ratings or language test scores . CONCLUSIONS The results indicate modest effectiveness of PECS teacher training/consultancy . Rates of pupils ' initiations and use of symbols in the classroom increased , although there was no evidence of improvement in other areas of communication . TREATMENT effects were not maintained once active intervention ceased .

PECS

PECS teacher training/consultancy .

teachers of children with autism :


Evaluation of the topical hemostatic efficacy and safety of TISSEEL VH S/D fibrin sealant compared with currently licensed TISSEEL VH in patients undergoing cardiac surgery : a phase 3 , randomized , double-blind clinical study . AIM TISSEEL VH is the only commercially available fibrin sealant indicated as an adjunct to conventional methods of hemostasis during cardiac surgery . A next generation fibrin sealant ( TISSEEL VH S/D ) has been developed in frozen , ready-to-use form with an added virus inactivation step ( solvent/detergent [ S/D ] treatment ) to provide added safety and convenience to the currently licensed product . This study was performed to compare efficacy and safety of the two products . METHODS Phase 3 , prospective , randomized , double-blind , multicenter study to compare TISSEEL VH S/D to TISSEEL VH during cardiac surgery . The primary efficacy endpoint was the proportion of patients who achieved hemostasis at the primary treatment site within 5 min , and maintained hemostasis until surgical closure . RESULTS The proportion of patients who achieved hemostasis at the primary treatment site within 5 min , and maintained hemostasis until surgical closure was 88.2 % for TISSEEL VH S/D and 89.6 % for TISSEEL VH in the intent-to-treat population . The difference in proportions , TISSEEL VH S/D minus TISSEEL VH , was 1.4 % with a standard error of 3.70 % . The lower 97.5 % confidence bound of this difference was 8.6 % , which is above the predefined noninferiority margin of 15 % . Therefore , TISSEEL VH S/D is at least as efficacious as TISSEEL VH . The safety profile of TISSEEL VH S/D was very similar to that of currently licensed TISSEEL VH as assessed by the safety endpoints . CONCLUSION TISSEEL VH S/D is safe and effective for use as an adjunct to hemostasis in patients undergoing cardiac surgery .

TISSEEL VH S/D fibrin sealant

currently licensed TISSEEL VH

fibrin sealant ( TISSEEL VH S/D )

TISSEEL VH S/D to TISSEEL VH

efficacy and safety

efficacy and safety

maintained hemostasis

safe

effective

patients undergoing cardiac surgery .


[ Laparoscopic lymphadenectomy as treatment of endometrial cancer ] . AIM This study compares the effects of laparoscopic lymphadenectomy versus those of abdominal lymphadenectomy in patients with endometrial cancer . METHODS A prospective randomized study was performed among 80 patients randomly assigned to laparoscopic lymphadenectomy and to abdominal lymphadenectomy in the treatment of endometrial cancer . Clinical outcomes and complications were compared for 1 year of follow-up . RESULTS Forty patients were assigned to laparoscopic lymphadenectomy and 40 patients to abdominal lymphadenectomy . The laparoscopic approach was associated with a longer operative time ( 234.1 min vs 137.3 min ) but was less painful ( VAS 5.3 vs 7.9 ; P < 0.000 ) and resulted in a shorter hospital stay ( 4.4+/-1 vs 7.9+/-1.2 days ; P < 0.000 ) . At 6 weeks the quality of life was better in patients who had laparoscopic lymphadenectomy ( SF-12 ) . CONCLUSION Laparoscopic lymphadenectomy was associated with a significantly lower rate of major and minor postoperative complications and a better short term quality of life .

Laparoscopic lymphadenectomy

lymphadenectomy

lymphadenectomy

laparoscopic lymphadenectomy

abdominal lymphadenectomy

lymphadenectomy

lymphadenectomy

lymphadenectomy

lymphadenectomy

longer operative time

less painful

shorter hospital stay

quality of life

quality of life

endometrial cancer ]

patients with endometrial cancer .

80 patients

Forty patients


Is Na+ modeling necessary in high flux dialysis ? One important pathogenic factor in dialysis hypotension is the drop in plasma osmolality . Increasing the dialysate Na+ concentration decreases hypotensive episodes . The authors studied 39 patients being treated with high flux dialysis . During a 9 week period , the patients were on a standard Na+ dialysate ( Na+ = 140 meq/L ) basal period ( B ) ; 9 % ( Na+ = 149 meq/L ) linear ( L ) ; step drop ( S ) ; and exponential drop ( E ) . The Na+ program was changed weekly at random . The results obtained with the three Na+ modeling programs were similar . We compared the periods with and without Na+ modeling : no differences were found in weight gained interdialysis , mean blood pressure predialysis and postdialysis , and hemoconcentration . Serum Na+ levels were significantly higher predialysis and postdialysis for those patients on Na+ modeling . Hypotensive episodes and cramps decreased 50 % with Na+ modeling . The amount of hypertonic and normal saline given during dialysis was markedly reduced . Na+ modeling should always be used in patients being maintained on high flux dialysis .

Na+ modeling

Na+

high flux dialysis

standard Na+ dialysate

linear

Na+ program

Na+ modeling

Na+ modeling

Na+ modeling

Na+ modeling

Na+ modeling

high flux dialysis

weight gained interdialysis

hemoconcentration

Serum Na+ levels

Hypotensive episodes and cramps

amount of hypertonic and normal saline


Tacrolimus monotherapy without steroids after liver transplantation -- a prospective randomized double-blinded placebo-controlled trial . Early steroid withdrawal after liver transplantation ( LT ) is desirable in order to reduce steroid side effects . Between February 2000 and August 2004 , 110 patients after LT were included in this prospective , randomized , double-blind , placebo-controlled trial . Randomization was performed before LT . In all patients , tacrolimus was used without induction therapy . All patients received methylprednisolon for 14 days , thereafter a double-blinded medication containing either placebo ( n = 56 ) or methylprednisolon ( n = 54 ) for 6 months , which was completely stopped thereafter . End points were patient and graft survival , acute and chronic rejection , and incidence of steroid side effects during the first year after LT . One-year patient survival was 85.7 % ( placebo ) and 88.8 % ( steroid ) ( p = 0.572 ) . Twenty-seven ( 48.2 % ) and 19 ( 35.2 % ) patients experienced acute rejection ( placebo versus steroid , respectively ; p = 0.116 ) . Two patients in the placebo group but none in the steroid group experienced chronic rejection ( p = 0.257 ) . The rates of side effects were ( placebo versus steroid , respectively ) : CMV infection 25 % versus 33 % ( p = 0.336 ) , post-transplant diabetes 30 % versus 53 % ( p = 0.024 ) , hypertension 39 % versus 52 % ( p = 0.248 ) , hypercholesterolemia 10 % versus 41 % ( p = 0.002 ) and hypertriglyceridemia 32 % versus 54 % ( p = 0.046 ) . In conclusion , early steroid withdrawal after LT is feasible under tacrolimus monotherapy without increased rejection rates and with a lower rate of side effects .

Tacrolimus

placebo-controlled

methylprednisolon

placebo

methylprednisolon

placebo

steroid

tacrolimus

patient and graft survival

acute and chronic rejection

incidence of steroid side effects

patient survival

acute rejection

chronic rejection

rates of side effects

CMV infection

post-transplant diabetes

hypertension

hypercholesterolemia

hypertriglyceridemia

feasible

lower

rate of side effects

liver transplantation

liver transplantation ( LT )

after LT

LT


Propofol and midazolam act synergistically in combination . We have studied interactions between i.v . propofol and midazolam for induction of anaesthesia in 200 unpremedicated female patients undergoing elective gynaecological surgery . Using end-points of " hypnosis " ( loss of response to verbal command ) and " anaesthesia " ( loss of response to a 5-s transcutaneous tetanic stimulus ) , we determined dose-response curves for propofol and midazolam alone and in combination . For hypnosis , synergistic interaction was found ( P less than 0.01 ) , the combination having 1.44 times the potency of the individual agents . Although midazolam failed to produce anaesthesia in the dose range used , the dose of propofol required to produce anaesthesia was reduced by 52 % in the presence of midazolam ( P less than 0.01 ) . The reduction in arterial pressure at induction was the same for the combination as for the individual agents . The cause of the synergism was not clear , but may have been interaction at CNS GABAA receptors .

Propofol

midazolam

propofol

midazolam

propofol

midazolam

midazolam

propofol

midazolam

hypnosis , synergistic interaction

required to produce anaesthesia

arterial pressure at induction


Randomized trial of an allogeneic melanoma lysate vaccine with low-dose interferon Alfa-2b compared with high-dose interferon Alfa-2b for Resected stage III cutaneous melanoma . PURPOSE To compare the overall survival ( OS ) of patients with resected stage III melanoma administered active specific immunotherapy and low-dose interferon alfa-2b ( IFN-alpha-2b ) with the OS achieved using high-dose IFN-alpha-2b . PATIENTS AND METHODS An Ad Hoc Melanoma Working Group of 25 investigators treated 604 patients from April 1997 to January 2003 . Patients were stratified by sex and number of nodes and were randomly assigned to receive either 2 years of treatment with active specific immunotherapy with allogeneic melanoma lysates and low-dose IFN-alpha-2b ( arm 1 ) or high-dose IFN-alpha-2b alone for 1 year ( arm 2 ) . Active specific immunotherapy was injected subcutaneously ( SC ) weekly for 4 weeks , at week 8 , and bimonthly thereafter . IFN-alpha-2b SC was begun on week 4 and continued thrice weekly at 5 MU/m2 for 2 years . IFN-alpha-2b in arm 2 was administered according to the Eastern Cooperative Oncology Group 1684 study regimen . RESULTS Median follow-up time was 32 months for all patients and 42 months for surviving patients . Median OS time exceeds 84 months in arm 1 and is 83 months in arm 2 ( P = .56 ) . Five-year OS rate is 61 % in arm 1 and 57 % in arm 2 . Estimated 5-year relapse-free survival ( RFS ) rate is 50 % in arm 1 and 48 % in arm 2 , with median RFS times of 58 and 50 months , respectively . The incidence of serious adverse events as a result of treatment was the same in both arms , but more severe neuropsychiatric toxicity was seen in arm 2 . CONCLUSION OS and RFS achieved by active specific immunotherapy and low-dose IFN-alpha-2b were indistinguishable from those achieved by high-dose IFN-alpha-2b . Long RFS and OS times were observed in both treatment arms .

high-dose interferon Alfa-2b

high-dose IFN-alpha-2b .

high-dose IFN-alpha-2b alone

IFN-alpha-2b SC

high-dose IFN-alpha-2b .

stage III melanoma

Median follow-up time

Median OS time

Five-year OS rate

incidence of serious adverse events

neuropsychiatric toxicity

Resected stage III cutaneous melanoma

604 patients


Bright light therapy in Parkinson 's disease : a pilot study . Several observations suggest a beneficial effect of melatonin antagonism for Parkinson 's disease ( PD ) . Although bright light therapy ( BLT ) suppresses melatonin release and is an established treatment for depression and sleep disturbances , it has not been evaluated in PD . We examined effects of BLT on motor symptoms , depression , and sleep in PD in a randomized placebo-controlled double-blind study in 36 PD patients , using Parkinson 's Disease Rating Scale ( UPDRS ) I-IV , Beck 's Depression Inventory , and Epworth Sleepiness Scale . All patients received BLT for 15 days in the morning , 30 min daily . Illuminance was 7.500 lux in the active treatment group and 950 lux in the placebo group . Although group differences were small , BLT led to significant improvement of tremor , UPDRS I , II , and IV , and depression in the active treatment group but not in the placebo group . It was very well tolerated . Follow up studies in more advanced patient populations employing longer treatment durations are warranted .

Bright light therapy

melatonin antagonism

bright light therapy ( BLT )

BLT

placebo-controlled

BLT

placebo

BLT

placebo

motor symptoms , depression

sleep

Epworth Sleepiness Scale

Illuminance

tolerated

Parkinson 's disease :

Parkinson 's disease ( PD )

PD

Parkinson 's Disease


Comparison of self-administered vaginal misoprostol versus placebo for cervical ripening prior to operative hysteroscopy using a sequential trial design . OBJECTIVE To compare the impact of 1000-microgram self-administered vaginal misoprostol versus self-administered vaginal placebo at home on preoperative cervical ripening in both premenopausal and postmenopausal women prior to outpatient resectoscopy . DESIGN Randomised , double-blind , placebo-controlled sequential trial . SETTING Norwegian university teaching hospital . SAMPLE Premenopausal and postmenopausal women referred to outpatient resectoscopy . METHODS The women were randomised to either 1000 micrograms of self-administered vaginal misoprostol or self-administered vaginal placebo the evening before outpatient resectoscopy . MAIN OUTCOME MEASURES Preoperative cervical dilatation , acceptability and complications . RESULTS ( a ) Intraoperative findings and distribution of cervical dilatation in the two treatment groups . Values are given as median ( range ) or n ( % ) . ( b ) Acceptability in the two treatment groups . Values are given as completely acceptable , n ( % ) ; fairly acceptable , n ( % ) ; fairly unacceptable , n ( % ) and completely unacceptable , n ( % ) . ( c ) Pain in the two treatment groups . Pain was measured with a visual analogue scale score , scale ranges from 0 ( no pain ) to 10 ( unbearable pain ) . Values are given as median ( range ) . ( d ) Occurrence of adverse effects in the two treatment groups . Values are given as n ( % ) . ( e ) Complications , given as n ( % ) .

self-administered vaginal misoprostol

placebo

self-administered vaginal misoprostol

self-administered vaginal placebo

self-administered vaginal misoprostol

self-administered vaginal placebo

Preoperative cervical dilatation

acceptability

complications

Acceptability

Pain

Pain

Occurrence of adverse effects

Complications

premenopausal and postmenopausal

women

outpatient resectoscopy

Premenopausal and postmenopausal

women

outpatient resectoscopy


Comparison of the impact of vaginal and oral administration of combined hormonal contraceptives on hepatic proteins sensitive to estrogen . OBJECTIVE We evaluated the effects of a new combined hormonal contraceptive vaginal ring ( CVR ) delivering the nonandrogenic progestin Nestorone ( NES ) and ethinyl estradiol ( EE ) on several key estrogen-sensitive hepatic proteins that may be markers for the risk of arterial or venous disease events and on blood pressure ( BP ) . Because the pharmacologic androgenicity of the progestin in these formulations influences the hepatic impact of EE , we selected an oral contraceptive ( OC ) delivering the androgenic progestin levonorgestrel ( LNG ) and EE as the comparator . We also investigated the effect of delivery route , which is known to modify the hepatic effects of estradiol , but has not been widely studied with EE . STUDY METHODS Women , aged 18-34 years , with no contraindications to the use of combined OCs , were randomized to three cycles of treatment with a CVR delivering NES/EE ( 150/15 microg/day ) or a combined OC providing LNG and EE ( 150/30 microg per tablet ) . Each cycle consisted of 21 days of active treatment , followed by 7 days without treatment . During the last weeks of the pretreatment and third treatment cycles , blood samples were obtained for determinations of plasma concentrations of angiotensinogen , an estrogen-sensitive hepatic protein , and serum concentrations of sex hormone-binding globulin ( SHBG ) , total cholesterol ( TC ) , high-density lipoprotein cholesterol ( HDL-C ) , low-density lipoprotein cholesterol ( LDL-C ) , triglycerides ( TG ) and estrogen- and androgen-sensitive proteins . BP was also measured . RESULTS Of 47 women randomized , 45 completed the study ( CVR : 23 ; OC : 22 ) . Within-group comparisons over time by repeated-measure analysis of variance demonstrated statistically significant changes over time with both treatments for all hepatic proteins ( p < .02 ) but not for TC . The within-group effects , presented as relative percent difference [ 95 % confidence interval ( CI ) ] , were greatest for angiotensinogen [ CVR : 227 % ( 195-262 % ) ; OC : 251.3 % ( 218-288 % ) ] and SHBG [ CVR : 306 % ( 237-389 % ) ; OC : 55 % ( 30-86 ) ] . Both treatments were associated with small changes in systolic BP and diastolic BP ( DBP ) , but only the within-group change in DBP for the OC group was statistically significant ( p = .04 ) . Between-treatment comparisons of third treatment cycle mean values were performed by analysis of covariance ( baseline values as covariate ) . No statistically significant between-treatment differences were found for angiotensinogen , sensitive only to estrogen , or BP . Statistically significant treatment differences were found for all estrogen- and androgen-sensitive proteins ( p < or = .002 ) but not for TC . When presented as relative percent difference between the effects of treatment ( CVR-OC/OC ; 95 % CI of percent difference ) , the difference was largest for SHBG ( 159 % [ 117-210 % ] ) ; smaller relative percent differences were found for HDL-C [ 31.9 % ( 18.5-46.8 % ) ] , LDL-C [ 23.6 % ( 33.4 % to -2.4 % ) ] and TG [ 39.0 % ( 14.0-69.4 % ) ] , but not TC . CONCLUSION Vaginal delivery of a combined hormonal contraceptive did not reduce the EE-associated changes in estrogen-sensitive hepatic proteins observed after use of a combined OC . Significant treatment differences between the NES/EE CVR and the LNG/EE OC were found for SHBG , HDL-C , LDL-C , and TG , proteins sensitive to androgen as well as estrogen . No treatment difference was observed for angiotensinogen , which is sensitive only to estrogen . The observed treatment differences were therefore most likely due to the difference in androgenicity between NES and LNG .

hormonal contraceptives

ethinyl estradiol

CVR

NES/EE

LNG

EE

NES/EE CVR

LNG/EE OC

BP

angiotensinogen

systolic BP and diastolic BP

DBP

angiotensinogen

sensitive only to estrogen

BP

TC .

SHBG

HDL-C

LDL-C

TG

oral contraceptive ( OC )

Women

aged 18-34 years

women


Ropivacaine versus lidocaine in digital nerve blocks : a prospective study . BACKGROUND Ropivacaine is a relatively new long-acting amide local anesthetic . Since its introduction in 1996 , it has been used for subcutaneous infiltration ; epidural , intrathecal , and peripheral nerve block surgery ; and postoperative analgesia . However , it has never been used for digital blocks . This prospective , randomized , double-blind study compares the digital block results following the administration of 2.5 ml of 0.75 % ropivacaine solution and 2.5 ml of 2 % lidocaine solution . METHODS From March of 1999 to March of 2001 , 70 adult patients who underwent immediate reconstruction for traumatic injuries of the digits were prospectively randomized into two groups . Group A ( n = 35 ) received 2.5 ml 0.75 % ropivacaine and group B ( n = 35 ) received 2.5 ml of 2 % lidocaine for digital anesthesia . Onset time of anesthetic action , duration of anesthesia , time until first postoperative requirement for pain medication , and digital-brachial artery systolic blood pressure index were recorded and evaluated . Local vascular effects were observed visually . RESULTS No side effects were observed . Lidocaine had the quickest onset of anesthesia , with a mean time of 1.3 minutes ( range , 1 to 2.7 minutes ) . Ropivacaine had a mean onset time of 4.5 minutes ( range , 3.5 to 5.5 minutes ) . The mean duration of postoperative anesthesia for lidocaine was 2.4 hours ( range , 1.4 to 4 hours ) , compared with 21.5 hours for ropivacaine and less requirement for analgesics during the first 24 postoperative hours ( p < 0.05 ) ( range , 19 to 23 hours ) . No significant difference was found between the digital-brachial artery systolic blood pressure index of group A compared with group B . CONCLUSIONS Ropivacaine can be used effectively as a local anesthetic for digital nerve blocks . It can be used for prolonged operations ( > 1.5 hours ) without additional injections and can provide long-lasting postoperative analgesia .

Ropivacaine

lidocaine

Ropivacaine

2.5 ml of 0.75 % ropivacaine solution

2.5 ml of 2 % lidocaine solution

ropivacaine

lidocaine

Lidocaine

Ropivacaine

lidocaine

ropivacaine

Ropivacaine

pain

Local vascular effects

side effects

onset of anesthesia

mean onset time

effectively

digital nerve blocks :

digital nerve blocks .


Pilot comparison between potassium titanyl phosphate laser and bipolar radiofrequency in paediatric tonsillectomy . OBJECTIVES To compare the advantages and disadvantages of potassium titanyl phosphate laser with those of bipolar radiofrequency techniques , in paediatric tonsillectomy . STUDY DESIGN Prospective , randomised , clinical study . PATIENTS AND METHODS From July 2004 to April 2006 , 80 patients aged between 10 and 15 years , with tonsillectomy planned for chronic tonsillitis , were included in the study . Children were prospectively randomised into two equal groups : potassium titanyl phosphate laser tonsillectomy and bipolar radiofrequency tonsillectomy . Operative time and intra-operative blood loss were recorded . Patients were scheduled for follow up during the first , second and fourth post-operative weeks . They were asked to record their pain and discomfort on a standardised visual analogue scale , from zero ( no pain ) to 10 ( severe pain ) . Post-operative complications were also recorded and managed . RESULTS The potassium titanyl phosphate laser group showed a slightly longer operative time ( mean 12 minutes ) than the bipolar radiofrequency group ( mean 10 minutes ) . Intra-operative blood loss was significantly less in the potassium titanyl phosphate laser group ( mean 21 cm3 ) than in the bipolar radiofrequency group ( mean 30 cm3 ) . In the first week , post-operative pain scores were less in the potassium titanyl phosphate laser group than in the bipolar radiofrequency group ( means 7.5 and 8.5 , respectively ) . However , in the second week pain scores increased more in the potassium titanyl phosphate laser group than in the bipolar radiofrequency group ( means 8.5 and 6 , respectively ) . In the fourth week , both groups showed equal and nearly normal pain scores . No case of reactionary post-tonsillectomy haemorrhage was recorded in either group . Only one case of secondary post-tonsillectomy haemorrhage was recorded , in the potassium titanyl phosphate laser group ( 2.5 per cent ) , managed conservatively . CONCLUSION Both the potassium titanyl phosphate and the bipolar radiofrequency techniques were safe and easy to use for tonsillectomy , with reduced operative time , blood loss and complication rates and better post-operative general patient condition . Potassium titanyl phosphate laser resulted in reduced operative bleeding and immediate post-operative pain , compared with the bipolar radiofrequency technique . However , potassium titanyl phosphate laser required slightly more operative time and caused more late post-operative pain than the bipolar radiofrequency technique . The low rate of recorded complications showed that both techniques cause little damage to the tonsillar bed during dissection , thus minimising complications .

potassium titanyl phosphate laser

bipolar radiofrequency

potassium titanyl phosphate laser

bipolar radiofrequency techniques

tonsillectomy

potassium titanyl phosphate laser

tonsillectomy

bipolar radiofrequency

tonsillectomy

potassium titanyl phosphate laser

potassium titanyl phosphate laser

bipolar radiofrequency

potassium titanyl phosphate laser

potassium titanyl phosphate

bipolar radiofrequency

Potassium titanyl phosphate laser

potassium titanyl phosphate laser

longer operative time

Intra-operative blood loss

post-operative pain scores

pain scores

pain scores

safe

easy to use

operative time

blood loss

complication rates

operative bleeding

immediate post-operative pain

operative time

late post-operative pain

paediatric tonsillectomy .


Effect of facial sensory re-training on sensory thresholds . Nearly 100 % of patients experience trauma to the trigeminal nerve during orthognathic surgery , impairing sensation and sensory function on the face . In a recent randomized clinical trial , people who performed sensory re-training exercises reported less difficulty related to residual numbness and decreased lip sensitivity than those who performed standard opening exercises only . We hypothesized that re-training reduces the impaired performance on neurosensory tests of tactile function that is commonly observed post-surgically . We analyzed thresholds for contact detection , two-point discrimination , and two-point perception , obtained during the clinical trial before and at 1 , 3 , and 6 months after surgery , to assess tactile detection and discriminative sensitivities , and subjective interpretation of tactile stimulation , respectively . Post-surgery , the retrained persons exhibited less impairment , on average , than non-retrained persons only in two-point perception ( P < 0.025 ) , suggesting that retrained persons experienced or interpreted the tactile stimuli differently than did non-retrained persons .

facial sensory re-training

orthognathic surgery

sensory re-training exercises

standard opening exercises

re-training

impairment

tactile stimuli


Using the demand-control model of job strain to predict caregiver burden and caregiver satisfaction in the informal caregivers of heart failure patients . OBJECTIVES The demand-control ( D-C ) model of job strain has generated a considerable body of empirical support in predicting psychological health outcomes in the context of work . This study aimed to extend previous work using the D-C model of job strain to predict caregiver burden and satisfaction in the informal caregivers of patients with heart failure . DESIGN AND METHOD Data were gathered from 60 caregiver/patient dyads in a cross-sectional design . Patients with chronic stable heart failure were recruited from out-patient clinics . The dependent variables were caregiver burden and satisfaction . Demand and control were measured using both patient- and caregiver-derived measures . RESULTS The D-C model accounted for 15 and 19 % of the variance in caregiver burden , after controlling for age , gender and relationship to the patient . Lower control was associated with higher burden . The D-C model did not predict caregiver satisfaction . CONCLUSION The D-C model was associated with caregiver burden , but not satisfaction in caregivers , with control being the dominant predictor . Research linking the theory and findings from job strain and informal caregiving studies may elucidate both fields of research . Using the demand-control model of job strain to predict caregiver burden and caregiver satisfaction in the informal caregivers of heart failure patients .

D-C model of job strain

D-C model

D-C model

D-C model

demand-control model of job strain

caregiver burden

caregiver satisfaction

caregiver burden

satisfaction

Demand and control

caregiver burden

caregiver satisfaction

caregiver burden

heart failure patients

60 caregiver/patient dyads


A comparison of acceptance- and control-based strategies for coping with food cravings : an analog study . The present study utilized an analog paradigm to investigate the effectiveness of two strategies for coping with food cravings , which was theorized to be critical to the maintenance of weight loss . Ninety-eight undergraduate students were given transparent boxes of chocolate Hershey 's Kisses and instructed to keep the chocolates with them , but not to eat them , for 48 h. Before receiving the Kisses , participants were randomized to receive either ( a ) no intervention , ( b ) instruction in control-based coping strategies such as distraction and cognitive restructuring , or ( c ) instruction in acceptance-based strategies such as experiential acceptance and defusion techniques . Measures included the Power of Food Scale ( PFS ; a measure of psychological sensitivity to the food environment ) , self-report ratings of chocolate cravings and surreptitiously recorded chocolate consumption . Results suggested that the effect of the intervention depended on baseline PFS levels , such that acceptance-based strategies were associated with better outcomes ( cravings , consumption ) among those reporting the highest susceptibility to the presence of food , but greater cravings among those who scored lowest on the PFS . It was observed that craving self-report measures predicted chocolate consumption , and baseline PFS levels predicted both cravings and consumption . Results are discussed in terms of the implications for weight loss maintenance strategies .

no intervention

analog paradigm

effectiveness

effect

baseline PFS levels

cravings , consumption

craving self-report measures

chocolate consumption

PFS levels

Ninety-eight

Kisses


Lowering of glucose in critical care : a randomized pilot trial . BACKGROUND Similar to cardiac surgery patients , medical-surgical critically ill patients may benefit from intensive insulin therapy . The objectives of this pilot trial were to evaluate the feasibility of a randomized trial of intensive insulin therapy with respect to ( a ) achieving target glucose values in the 2 ranges of 5 to 7 and 8 to 10 mmol/L and ( b ) uncovering problems with the protocol in anticipation of a larger trial . SETTING The trial was conducted in a 15-bed medical-surgical university-affiliated intensive care unit ( ICU ) . METHODS We included patients older than 18 years , expected to be in ICU for more than 72 hours , with a glucose value of more than 10 mmol/L within 48 hours of ICU admission . Exclusion criteria were diabetic ketoacidosis , severe hepatic failure or hepatic resection , pancreatitis , glucose of less than 2.2 mmol/L on admission to hospital , insulin infusion on admission to ICU , planned withdrawal of life support , and inability to obtain informed consent . Patients underwent concealed random allocation to a target glucose range of 5 to 7 or 8 to 10 mmol/L using pretested algorithms of insulin infusions . Dedicated glucometer measurement of arterial glucose values was calibrated daily to values measured in the laboratory . RESULTS We enrolled 20 patients with a mean ( SD ) Acute Physiology and Chronic Health Evaluation ( APACHE ) II score of 32 ( 10.2 ) ; 14 were insulin-dependent pre-ICU , and all were medical admissions . Mean glucose values were different in the 2 groups ( 7.1 +/- 2.6 vs 9.4 +/- 2.1 mmol/L , P < .001 ) . Although the intensive insulin therapy group had more glucose measurements performed than the control group , a similar proportion of values were within the target range ( 682 [ 42.4 % ] of 1607 values in the 5- to 7-mmol/L range ; 250 [ 38.7 % ] of 660 values in the 8- to 10-mmol/L range , P = .35 ) . Glucose values of less than 2.5 mmol/L developed 7 times in 5 patients , 4 of whom were in the intensive insulin therapy group ; however , no adverse consequences were documented . As expected , there were no differences in clinically important outcomes . CONCLUSIONS In this pilot trial of ICU patients with high illness severity , glucose values were in the 2 target ranges only 40 % of the time , using well-accepted initiation and maintenance insulin infusion algorithms . A large randomized trial of glycemic control is feasible in this population to examine clinically important outcomes , but will require refined insulin algorithms and more comprehensive behavior change strategies to achieve target values .

intensive insulin therapy

intensive insulin therapy

insulin infusions

intensive insulin therapy

insulin

insulin

Mean glucose values

glucose measurements

Glucose values

glucose values

older than 18 years

high illness severity


Comparison of split-course radiation therapy and continuous radiation therapy for unresectable bronchogenic carcinoma : 5 year results . One hundred and eighty-eight patients with inoperable or unresectable bronchogenic carcinoma were stratified by cell type , TNM staging , and prior surgery and then randomized into two treatment groups : continuous radiation therapy and split-course radiation therapy . There was no difference in clinical or objective improvement in the two groups . Survival rates for cases of squamous cell carcinoma , small cell carcinoma , and adrenocarcinoma were the same after both regimens of therapy . Split-course therapy resulted in a significantly better survival rate in cases of large cell carcinoma but the number of cases was small . We doubt that the difference is clinically significant . Objective roentgenographic response was accompanied by improved survival in squamous cell carcinoma , but not in the other three cell types . Split-course radiation therapy is superior to continuous radiation therapy because it is better tolerated by the patient and because re-examination of the patient prior to the second half of split-course therapy permits the detection of new metastatic disease that has become manifest during the rest period and spares the patient the futile second half of radiation therapy .

split-course radiation therapy

continuous radiation therapy

continuous radiation therapy

split-course radiation therapy

Survival rates

Split-course therapy

Objective roentgenographic response

improved survival

better tolerated

unresectable bronchogenic carcinoma

One hundred and eighty-eight patients

inoperable

unresectable bronchogenic carcinoma


Effect of low-intensity back exercise on quality of life and back extensor strength in patients with osteoporosis : a randomized controlled trial . UNLABELLED Randomized controlled study in 80 postmenopausal women with osteoporosis was conducted to investigate the effect of a home-based , simple , low-intensity exercise . Low-intensity back-strengthening exercise was effective in improving the quality of life and back extensor strength . INTRODUCTION AND HYPOTHESIS Back-strengthening exercise is effective in increasing back extensor strength and decreasing risk of vertebral fractures . We hypothesized that a home-based , simple , low-intensity exercise could enhance back extensor strength and improve the quality of life and/or spinal range of motion in postmenopausal women in a short-term follow-up . METHODS Eighty postmenopausal women with osteoporosis were randomly assigned to a control group ( n = 38 ) or an exercise group ( n = 42 ) . Subjects were instructed to lift their upper trunk from a prone position antigravity and maintain the neutral position . Isometric back extensor strength , spinal range of motion , and scores for quality of life were evaluated at baseline and 4 months . RESULTS Back extensor strength significantly increased both in the exercise group ( 26 % ) and in the control group ( 11 % ) . Scores for quality of life increased in the exercise group ( 7 % ) , whereas it remained unchanged in the control group ( 0 % ) . There was a significant difference in quality of life score between the groups ( p = 0.012 ) . CONCLUSIONS Low-intensity back-strengthening exercise was effective in improving the quality of life and back extensor strength in patients with osteoporosis .

low-intensity back exercise

control

exercise group

increasing back extensor strength

spinal range of motion

Scores for quality of life increased

quality of life score

osteoporosis

postmenopausal

osteoporosis

postmenopausal

Eighty

postmenopausal

osteoporosis


The relationship between histology and outcome in advanced and recurrent endometrial cancer patients participating in first-line chemotherapy trials : a Gynecologic Oncology Group study . OBJECTIVES To explore associations between histology and outcome in advanced or recurrent endometrial cancer patients participating in Gynecologic Oncology Group chemotherapy trials . METHODS Age , race , performance status , histologic type ( serous=S ; clear cell=CC ; endometrioid=E ) , disease stage , and prior radiation were evaluated using various analytic methods to evaluate the probability of response and identify independent predictors of progression-free survival ( PFS ) and overall survival ( OS ) . RESULTS Single agent or combination chemotherapy regimens including doxorubicin ( A ) ( 12 % ) , doxorubicin/cisplatin ( AP ) ( 63 % ) , doxorubicin/paclitaxel ( AT ) ( 13 % ) , and paclitaxel/doxorubicin/cisplatin ( TAP ) ( 11 % ) were used among 1203 patients treated on 4 randomized clinical trials . Breakdown of disease stage was 7.8 % stage III , 22.8 % stage IV , and 69.4 % recurrent disease . Histologic distribution was 18 % S , 3.7 % CC , 8.5 % mixed , 51.7 % E and 18.1 % other . More S/CC patients enrolled on trials with advanced stage ( III-IV ) disease ( as opposed to recurrent disease ) compared to E patients ( 45 % vs. 24 % , p < 0.05 ) . Overall response rate was 42 % ( E=44 % , S=44 % , CC=32 % ) . Histologic type was not an independent predictor of response . Independent predictors of PFS included race , performance status , disease stage , and CC histology . Histology was also an independent predictor of OS ; the relative hazard ratio for S histology was 1.2 ( 1.02-1.4 ; p=0.03 ) , and for CC was 1.51 ( 1.1-2.07 ; p=0.01 ) . CONCLUSION In patients with advanced/recurrent endometrial cancer treated with A , P and/or T , response was not associated with histology . This exploratory analysis does not support exclusion of S tumors in future trials . Poorer PFS and OS were observed in CC compared to other types , but a lack of benefit from chemotherapy was not shown , and as this histology represents such a small fraction , it does not seem feasible to have separate chemotherapy trials for CC .

chemotherapy

Single agent

combination chemotherapy regimens

doxorubicin ( A )

doxorubicin/cisplatin

doxorubicin/paclitaxel

paclitaxel/doxorubicin/cisplatin

histology

outcome

performance status

histologic type

disease stage

prior radiation

progression-free survival ( PFS )

overall survival ( OS )

disease stage

Histologic distribution

response rate

Histologic type

performance status

disease stage

CC histology

Histology

relative hazard ratio

histology

PFS

OS


A randomized , double-blind , phase II study of two doses of pemetrexed as first-line chemotherapy for advanced breast cancer . PURPOSE Pemetrexed has shown varied response rates in advanced breast cancer . This randomized , double-blind , phase II study was conducted to assess the efficacy and safety of two doses of pemetrexed in a homogeneous population . A secondary objective was to identify molecular biomarkers correlating with response and toxicity . EXPERIMENTAL DESIGN Patients with newly diagnosed metastatic breast cancer or locally recurrent breast cancer received 600 mg/m ( 2 ) ( P600 arm ) or 900 mg/m ( 2 ) ( P900 arm ) of pemetrexed on day 1 of a 21-day cycle . All patients received folic acid and vitamin B ( 12 ) supplementation . RESULTS The P600 ( 47 patients ) and P900 ( 45 patients ) arms had response rates of 17.0 % ( 95 % confidence interval , 7.7-30.8 % ) and 15.6 % ( 95 % confidence interval , 6.5-29.5 % ) with approximately 50 % stable disease per arm , median progression-free survival of 4.2 and 4.1 months , and median times to tumor progression of 4.2 and 4.6 months , respectively . Both arms exhibited minimal toxicity ( grade 3/4 neutropenia < 20 % , leukopenia < 9 % , and other toxicities < 5 % ) . Tumor samples from 49 patients were assessed for the expression levels of 12 pemetrexed-related genes . Folylpolyglutamate synthetase and thymidine phosphorylase correlated with efficacy . Best response rates and median time to tumor progression for high versus low thymidine phosphorylase expression were 27.6 % versus 6.3 % ( P = 0.023 ) and 5.4 versus 1.9 months ( P = 0.076 ) , and for folylpolyglutamate synthetase were 37.5 % versus 10.0 % ( P = 0.115 ) and 8.6 versus 3.0 months ( P = 0.019 ) , respectively . gamma-Glutamyl hydrolase expression correlated with grade 3/4 toxicities : 78.6 % for high versus 27.3 % for low gamma-glutamyl hydrolase ( P = 0.024 ) . CONCLUSION The two pemetrexed doses yielded similar efficacy and safety profiles . Exploratory biomarker analysis identified efficacy and toxicity correlations and warrants further evaluation .

pemetrexed

Pemetrexed

pemetrexed

pemetrexed

folic acid

vitamin B ( 12 )

pemetrexed-related

pemetrexed

efficacy

safety

response

toxicity

response rates

median progression-free survival

median

times to tumor progression

minimal toxicity

neutropenia

leukopenia

other toxicities

efficacy

Best response rates

median

time to tumor progression

grade 3/4 toxicities

efficacy

safety

efficacy

toxicity

advanced breast cancer .

advanced breast cancer .

diagnosed metastatic breast cancer

breast cancer

47 patients )

P900 ( 45 patients