Title
 Effects of a soft prefabricated thumb orthosis in carpometacarpal osteoarthritis .

 ABSTRACT OBJECTIVE
 To explore the feasibility and assess the effect of a prefabricated soft thumb-base orthosis on pain , hand strength , and activity performance in persons with osteoarthritis of the CMC joint .

 ABSTRACT METHODS
 In this randomized controlled trial , 29 patients received hand exercises only ( control group ) and 30 patients received hand exercises and an orthosis ( orthosis group ) . The primary outcome was pain , while secondary outcomes included grip and pinch strength , and self-reported symptoms and activity performance . Outcome assessments , and measures of grip strength and pain with and without orthosis in the orthosis group , were made after two months .

 ABSTRACT RESULTS
 55 participants ( mean age 70.5 years ) completed all assessments . There were no significant differences between the groups in primary or secondary outcomes after two months . However , in the orthosis group , pain was significantly less when wearing the orthosis than when not wearing it . Participants reported that the orthosis felt uncomfortable during activities involving water and one-third wanted more support of the CMC joint .

 ABSTRACT CONCLUSIONS
 A soft prefabricated orthosis seems to have an immediate pain-relieving effect during use , but no effects in terms of less hand pain , or improved strength or activity performance when not worn .

Title

Effects

of

a

soft

prefabricated

thumb

orthosis

in

carpometacarpal

osteoarthritis

ABSTRACT OBJECTIVE

To

explore

the

feasibility

and

assess

the

effect

of

a

prefabricated

soft

thumb-base

orthosis

on

pain

hand

strength

and

activity

performance

in

persons

with

osteoarthritis

of

the

CMC

joint

ABSTRACT METHODS

In

this

randomized

controlled

trial

patients

received

hand

exercises

only

control

group

and

patients

received

hand

exercises

and

an

orthosis

orthosis

group

The

primary

outcome

was

pain

while

secondary

outcomes

included

grip

and

pinch

strength

and

self-reported

symptoms

and

activity

performance

Outcome

assessments

and

measures

of

grip

strength

and

pain

with

and

without

orthosis

in

the

orthosis

group

were

made

after

two

months

ABSTRACT RESULTS

participants

mean

age

years

completed

all

assessments

There

were

no

significant

differences

between

the

groups

in

primary

or

secondary

outcomes

after

two

months

However

in

the

orthosis

group

pain

was

significantly

less

when

wearing

the

orthosis

than

when

not

wearing

it

Participants

reported

that

the

orthosis

felt

uncomfortable

during

activities

involving

water

and

one-third

wanted

more

support

of

the

CMC

joint

ABSTRACT CONCLUSIONS

A

soft

prefabricated

orthosis

seems

to

have

an

immediate

pain-relieving

effect

during

use

but

no

effects

in

terms

of

less

hand

pain

or

improved

strength

or

activity

performance

when

not

worn


Title
 Effects of different statin treatments on small dense low-density lipoprotein in patients with metabolic syndrome .

 ABSTRACT OBJECTIVE
 To compare the effects of different low-density lipoprotein ( LDL ) cholesterol-lowering statin treatments on small dense LDL ( sd-LDL ) in hypercholesterolemic patients with metabolic syndrome ( MetS ) .

 ABSTRACT METHODS
 Forty hypercholesterolemic MetS patients ? 30 years of age were randomized to rosuvas-tatin ( n = 17 ) or other statins ( n = 23 ) groups . In the other statins group , those taking atorvastatin ( n = 12 ) were also evaluated separately . Statin doses were 10 mg/day rosuvastatin , 20 mg/day atorvas-tatin , 40 mg/day simvastatin , and 40 mg/day pravastatin . Treatment duration was planned to be 8 weeks . Sd-LDL levels were assessed at baseline and at the completion of treatment .

 ABSTRACT RESULTS
 After treatment , sd-LDL levels were significantly reduced in all 3 groups ( from 29.6 + / -24.8 mg/dL to 8.9 + / -8.5 mg/dL in the rosuvastatin group , p = 0.001 ; from 26.2 + / -15 mg/dL to 14.8 + / -9.6 mg/dL in the atorvastatin group , p = 0.02 ; and from 29.1 + / -16.5 mg/dL to 14.7 + / -11.2 mg/dL in the other statins group , p = 0.0001 ) . There was no significant difference in the mean percent changes among groups .

 ABSTRACT CONCLUSIONS
 Significant reduction in sd-LDL levels was observed after 8 weeks of statin treatment in hypercholesterolemic patients with MetS . This effect was similar for all statins and can be considered a class effect .

Title

Effects

of

different

statin

treatments

on

small

dense

low-density

lipoprotein

in

patients

with

metabolic

syndrome

ABSTRACT OBJECTIVE

To

compare

the

effects

of

different

low-density

lipoprotein

LDL

cholesterol-lowering

statin

treatments

on

small

dense

LDL

sd-LDL

in

hypercholesterolemic

patients

with

metabolic

syndrome

MetS

ABSTRACT METHODS

Forty

hypercholesterolemic

MetS

patients

years

of

age

were

randomized

to

rosuvas-tatin

n

or

other

statins

n

groups

In

the

other

statins

group

those

taking

atorvastatin

n

were

also

evaluated

separately

Statin

doses

were

mg/day

rosuvastatin

mg/day

atorvas-tatin

mg/day

simvastatin

and

mg/day

pravastatin

Treatment

duration

was

planned

to

be

weeks

Sd-LDL

levels

were

assessed

at

baseline

and

at

the

completion

of

treatment

ABSTRACT RESULTS

After

treatment

sd-LDL

levels

were

significantly

reduced

in

all

groups

from

mg/dL

to

mg/dL

in

the

rosuvastatin

group

p

from

mg/dL

to

mg/dL

in

the

atorvastatin

group

p

and

from

mg/dL

to

mg/dL

in

the

other

statins

group

p

There

was

no

significant

difference

in

the

mean

percent

changes

among

groups

ABSTRACT CONCLUSIONS

Significant

reduction

in

sd-LDL

levels

was

observed

after

weeks

of

statin

treatment

in

hypercholesterolemic

patients

with

MetS

This

effect

was

similar

for

all

statins

and

can

be

considered

a

class

effect


Title
 Oral breathing increases Pth and vocal effort by superficial drying of vocal fold mucosa .

 ABSTRACT GENERAL
 Oral breathing superficially dehydrates the airway lumen by decreasing the depth of the sol layer in humans and animals . Conversely , nasal breathing can increase the humidity of inspired air . We compared the effects of short-term oral and nasal breathing on Pth and perceived vocal effort in 20 female subjects randomly assigned to two groups : oral breathing ( N = 10 , age 21-32 years ) ; nasal breathing ( N = 10 , age 20-36 years ) . We hypothesized that short-term oral breathing , but not nasal breathing , would increase Pth , and that subjects would perceive this change as an increase in vocal effort . Following 15 minutes of oral breathing , Pth increased at comfortable and low pitch ( p < 0.01 ) with 6 of 10 subjects reporting increased vocal effort . Nasal breathing reduced Pth at all three pitches ( p < 0.01 ) , and 7 of 10 subjects reported decreased vocal effort . Over all subjects , 49 % of the variance in treatment-induced change in Pth was accounted for by change in vocal effort ( R = 0.70 ) . We posit that obligatory oral breathing places healthy subjects at risk for symptoms of increased vocal effort . The facilitatory role of superficial hydration on vocal fold oscillation should be considered in biomechanical models of phonation and in the clinical prevention of laryngeal dryness .

Title

Oral

breathing

increases

Pth

and

vocal

effort

by

superficial

drying

of

vocal

fold

mucosa

ABSTRACT GENERAL

Oral

breathing

superficially

dehydrates

the

airway

lumen

by

decreasing

the

depth

of

the

sol

layer

in

humans

and

animals

Conversely

nasal

breathing

can

increase

the

humidity

of

inspired

air

We

compared

the

effects

of

short-term

oral

and

nasal

breathing

on

Pth

and

perceived

vocal

effort

in

female

subjects

randomly

assigned

to

two

groups

oral

breathing

N

age

years

nasal

breathing

N

age

years

We

hypothesized

that

short-term

oral

breathing

but

not

nasal

breathing

would

increase

Pth

and

that

subjects

would

perceive

this

change

as

an

increase

in

vocal

effort

Following

minutes

of

oral

breathing

Pth

increased

at

comfortable

and

low

pitch

p

with

of

subjects

reporting

increased

vocal

effort

Nasal

breathing

reduced

Pth

at

all

three

pitches

p

and

of

subjects

reported

decreased

vocal

effort

Over

all

subjects

of

the

variance

in

treatment-induced

change

in

Pth

was

accounted

for

by

change

in

vocal

effort

R

We

posit

that

obligatory

oral

breathing

places

healthy

subjects

at

risk

for

symptoms

of

increased

vocal

effort

The

facilitatory

role

of

superficial

hydration

on

vocal

fold

oscillation

should

be

considered

in

biomechanical

models

of

phonation

and

in

the

clinical

prevention

of

laryngeal

dryness


Title
 Noninvasive continuous positive airway pressure in acute respiratory failure : helmet versus facial mask .

 ABSTRACT OBJECTIVE
 Noninvasive continuous positive airway pressure ( nCPAP ) is applied through different interfaces to treat mild acute respiratory failure ( ARF ) in infants . Recently a new pediatric helmet was introduced in clinical practice to deliver nCPAP . The objective of this study was to compare the feasibility of the delivery of nCPAP by the pediatric helmet with delivery by a conventional facial mask in infants with ARF .

 ABSTRACT METHODS
 We conducted a single-center physiologic , randomized , controlled study with a crossover design on 20 consecutive infants with ARF . All patients received nCPAP by helmet and facial mask in random order for 90 minutes . In infants in both trials , nCPAP treatment was preceded by periods of unassisted spontaneous breathing through a Venturi mask . The primary end point was the feasibility of nCPAP administered with the 2 interfaces ( helmet and facial mask ) . Feasibility was evaluated by the number of trial failures defined as the occurrence of 1 of the following : intolerance to the interface ; persistent air leak ; gas-exchange derangement ; or major adverse events . nCPAP application time , number of patients who required sedation , and the type of complications with each interface were also recorded . The secondary end point was gas-exchange improvement .

 ABSTRACT RESULTS
 Feasibility of nCPAP delivery was enhanced by the helmet compared with the mask , as indicated by a lower number of trial failures ( P < .001 ) , less patient intolerance ( P < .001 ) , longer application time ( P < .001 ) , and reduced need for patient sedation ( P < .001 ) . For both delivery methods , no major patient complications occurred .

 ABSTRACT CONCLUSIONS
 The results of this current study revealed that the helmet is a feasible alternative to the facial mask for delivery of nCPAP to infants with mild ARF .

Title

Noninvasive

continuous

positive

airway

pressure

in

acute

respiratory

failure

helmet

versus

facial

mask

ABSTRACT OBJECTIVE

Noninvasive

continuous

positive

airway

pressure

nCPAP

is

applied

through

different

interfaces

to

treat

mild

acute

respiratory

failure

ARF

in

infants

Recently

a

new

pediatric

helmet

was

introduced

in

clinical

practice

to

deliver

nCPAP

The

objective

of

this

study

was

to

compare

the

feasibility

of

the

delivery

of

nCPAP

by

the

pediatric

helmet

with

delivery

by

a

conventional

facial

mask

in

infants

with

ARF

ABSTRACT METHODS

We

conducted

a

single-center

physiologic

randomized

controlled

study

with

a

crossover

design

on

consecutive

infants

with

ARF

All

patients

received

nCPAP

by

helmet

and

facial

mask

in

random

order

for

minutes

In

infants

in

both

trials

nCPAP

treatment

was

preceded

by

periods

of

unassisted

spontaneous

breathing

through

a

Venturi

mask

The

primary

end

point

was

the

feasibility

of

nCPAP

administered

with

the

interfaces

helmet

and

facial

mask

Feasibility

was

evaluated

by

the

number

of

trial

failures

defined

as

the

occurrence

of

of

the

following

intolerance

to

the

interface

persistent

air

leak

gas-exchange

derangement

or

major

adverse

events

nCPAP

application

time

number

of

patients

who

required

sedation

and

the

type

of

complications

with

each

interface

were

also

recorded

The

secondary

end

point

was

gas-exchange

improvement

ABSTRACT RESULTS

Feasibility

of

nCPAP

delivery

was

enhanced

by

the

helmet

compared

with

the

mask

as

indicated

by

a

lower

number

of

trial

failures

P

less

patient

intolerance

P

longer

application

time

P

and

reduced

need

for

patient

sedation

P

For

both

delivery

methods

no

major

patient

complications

occurred

ABSTRACT CONCLUSIONS

The

results

of

this

current

study

revealed

that

the

helmet

is

a

feasible

alternative

to

the

facial

mask

for

delivery

of

nCPAP

to

infants

with

mild

ARF


Title
 VenUS IV ( Venous leg Ulcer Study IV ) - compression hosiery compared with compression bandaging in the treatment of venous leg ulcers : a randomised controlled trial , mixed-treatment comparison and decision-analytic model .

 ABSTRACT BACKGROUND
 Compression is an effective and recommended treatment for venous leg ulcers . Although the four-layer bandage ( 4 LB ) is regarded as the gold standard compression system , it is recognised that the amount of compression delivered might be compromised by poor application technique . Also the bulky nature of the bandages might reduce ankle or leg mobility and make the wearing of shoes difficult . Two-layer compression hosiery systems are now available for the treatment of venous leg ulcers . Two-layer hosiery ( HH ) may be advantageous , as it has reduced bulk , which might enhance ankle or leg mobility and patient adherence . Some patients can also remove and reapply two-layer hosiery , which may encourage self-management and could reduce costs . However , little robust evidence exists about the effectiveness of two-layer hosiery for ulcer healing and no previous trials have compared two-layer hosiery delivering ' high ' compression with the 4 LB .

 ABSTRACT OBJECTIVE
 Part I To compare the clinical effectiveness and cost-effectiveness of HH and 4 LB in terms of time to complete healing of venous leg ulcers . Part II To synthesise the relative effectiveness evidence ( for ulcer healing ) of high-compression treatments for venous leg ulcers using a mixed-treatment comparison ( MTC ) . Part III To construct a decision-analytic model to assess the cost-effectiveness of high-compression treatments for venous leg ulcers .

 ABSTRACT METHODS
 Part I A multicentred , pragmatic , two-arm , parallel , open randomised controlled trial ( RCT ) with an economic evaluation . Part II MTC using all relevant RCT data - including Venous leg Ulcer Study IV ( VenUS IV ) . Part III A decision-analytic Markov model .

 ABSTRACT METHODS
 Part I Community nurse teams or services , general practitioner practices , leg ulcer clinics , tissue viability clinics or services and wound clinics within England and Northern Ireland .

 ABSTRACT METHODS
 Part I Patients aged ≥ 18 years with a venous leg ulcer , who were willing and able to tolerate high compression .

 ABSTRACT METHODS
 Part I Participants in the intervention group received HH . The control group received the 4 LB , which was applied according to standard practice . Both treatments are designed to deliver 40 mmHg of compression at the ankle . Part II and III All relevant high-compression treatments including HH , the 4 LB and the two-layer bandage ( 2 LB ) .

 ABSTRACT METHODS
 Part I The primary outcome measure was time to healing of the reference ulcer ( blinded assessment ) . Part II Time to ulcer healing . Part III Quality-adjusted life-years ( QALYs ) and costs .

 ABSTRACT RESULTS
 Part I A total of 457 participants were recruited . There was no evidence of a difference in time to healing of the reference ulcer between groups in an adjusted analysis [ hazard ratio ( HR ) 0.99 , 95 % confidence interval ( CI ) 0.79 to 1.25 ; p = 0.96 ] . Time to ulcer recurrence was significantly shorter in the 4 LB group ( HR = 0.56 , 95 % CI 0.33 to 0.94 ; p = 0.026 ) . In terms of cost-effectiveness , using QALYs as the measure of benefit , HH had a > 95 % probability of being the most cost-effective treatment based on the within-trial analysis . Part II The MTC suggests that the 2 LB has the highest probability of ulcer healing compared with other high-compression treatments . However , this evidence is categorised as low to very low quality . Part III Results suggested that the 2 LB had the highest probability of being the most cost-effective high-compression treatment for venous leg ulcers .

 ABSTRACT CONCLUSIONS
 Trial data from VenUS IV found no evidence of a difference in venous ulcer healing between HH and the 4 LB . HH may reduce ulcer recurrence rates compared with the 4 LB and be a cost-effective treatment . When all available high-compression treatments were considered , the 2 LB had the highest probability of being clinically effective and cost-effective . However , the underpinning evidence was sparse and more research is needed . Further research should thus focus on establishing , in a high-quality trial , the effectiveness of this compression system in particular .

 ABSTRACT BACKGROUND
 Current Controlled Trials ISRCTN49373072 .

 ABSTRACT BACKGROUND
 This project was funded by the National Institute for Health Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 18 , No. 57 . See the NIHR Journals Library website for further project information .

Title

VenUS

IV

Venous

leg

Ulcer

Study

IV

compression

hosiery

compared

with

compression

bandaging

in

the

treatment

of

venous

leg

ulcers

a

randomised

controlled

trial

mixed-treatment

comparison

and

decision-analytic

model

ABSTRACT BACKGROUND

Compression

is

an

effective

and

recommended

treatment

for

venous

leg

ulcers

Although

the

four-layer

bandage

LB

is

regarded

as

the

gold

standard

compression

system

it

is

recognised

that

the

amount

of

compression

delivered

might

be

compromised

by

poor

application

technique

Also

the

bulky

nature

of

the

bandages

might

reduce

ankle

or

leg

mobility

and

make

the

wearing

of

shoes

difficult

Two-layer

compression

hosiery

systems

are

now

available

for

the

treatment

of

venous

leg

ulcers

Two-layer

hosiery

HH

may

be

advantageous

as

it

has

reduced

bulk

which

might

enhance

ankle

or

leg

mobility

and

patient

adherence

Some

patients

can

also

remove

and

reapply

two-layer

hosiery

which

may

encourage

self-management

and

could

reduce

costs

However

little

robust

evidence

exists

about

the

effectiveness

of

two-layer

hosiery

for

ulcer

healing

and

no

previous

trials

have

compared

two-layer

hosiery

delivering

high

compression

with

the

LB

ABSTRACT OBJECTIVE

Part

I

To

compare

the

clinical

effectiveness

and

cost-effectiveness

of

HH

and

LB

in

terms

of

time

to

complete

healing

of

venous

leg

ulcers

Part

II

To

synthesise

the

relative

effectiveness

evidence

for

ulcer

healing

of

high-compression

treatments

for

venous

leg

ulcers

using

a

mixed-treatment

comparison

MTC

Part

III

To

construct

a

decision-analytic

model

to

assess

the

cost-effectiveness

of

high-compression

treatments

for

venous

leg

ulcers

ABSTRACT METHODS

Part

I

A

multicentred

pragmatic

two-arm

parallel

open

randomised

controlled

trial

RCT

with

an

economic

evaluation

Part

II

MTC

using

all

relevant

RCT

data

including

Venous

leg

Ulcer

Study

IV

VenUS

IV

Part

III

A

decision-analytic

Markov

model

ABSTRACT METHODS

Part

I

Community

nurse

teams

or

services

general

practitioner

practices

leg

ulcer

clinics

tissue

viability

clinics

or

services

and

wound

clinics

within

England

and

Northern

Ireland

ABSTRACT METHODS

Part

I

Patients

aged

years

with

a

venous

leg

ulcer

who

were

willing

and

able

to

tolerate

high

compression

ABSTRACT METHODS

Part

I

Participants

in

the

intervention

group

received

HH

The

control

group

received

the

LB

which

was

applied

according

to

standard

practice

Both

treatments

are

designed

to

deliver

mmHg

of

compression

at

the

ankle

Part

II

and

III

All

relevant

high-compression

treatments

including

HH

the

LB

and

the

two-layer

bandage

LB

ABSTRACT METHODS

Part

I

The

primary

outcome

measure

was

time

to

healing

of

the

reference

ulcer

blinded

assessment

Part

II

Time

to

ulcer

healing

Part

III

Quality-adjusted

life-years

QALYs

and

costs

ABSTRACT RESULTS

Part

I

A

total

of

participants

were

recruited

There

was

no

evidence

of

a

difference

in

time

to

healing

of

the

reference

ulcer

between

groups

in

an

adjusted

analysis

hazard

ratio

HR

confidence

interval

CI

to

p

Time

to

ulcer

recurrence

was

significantly

shorter

in

the

LB

group

HR

CI

to

p

In

terms

of

cost-effectiveness

using

QALYs

as

the

measure

of

benefit

HH

had

a

probability

of

being

the

most

cost-effective

treatment

based

on

the

within-trial

analysis

Part

II

The

MTC

suggests

that

the

LB

has

the

highest

probability

of

ulcer

healing

compared

with

other

high-compression

treatments

However

this

evidence

is

categorised

as

low

to

very

low

quality

Part

III

Results

suggested

that

the

LB

had

the

highest

probability

of

being

the

most

cost-effective

high-compression

treatment

for

venous

leg

ulcers

ABSTRACT CONCLUSIONS

Trial

data

from

VenUS

IV

found

no

evidence

of

a

difference

in

venous

ulcer

healing

between

HH

and

the

LB

HH

may

reduce

ulcer

recurrence

rates

compared

with

the

LB

and

be

a

cost-effective

treatment

When

all

available

high-compression

treatments

were

considered

the

LB

had

the

highest

probability

of

being

clinically

effective

and

cost-effective

However

the

underpinning

evidence

was

sparse

and

more

research

is

needed

Further

research

should

thus

focus

on

establishing

in

a

high-quality

trial

the

effectiveness

of

this

compression

system

in

particular

ABSTRACT BACKGROUND

Current

Controlled

Trials

ABSTRACT BACKGROUND

This

project

was

funded

by

the

National

Institute

for

Health

Research

NIHR

Health

Technology

Assessment

programme

and

will

be

published

in

full

in

Health

Technology

Assessment

Vol

No.

See

the

NIHR

Journals

Library

website

for

further

project

information