DISSERTATION Critical Review Assignment 1.docx

7/25/2019 DISSERTATION Critical Review Assignment 1.docx

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HonoursProject MHB913252 S1218907

School of Health and

Social Care

Session 2015-2016

Student Matriculation Number: S1218907

P P di t


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P P di t


Diabetic hot spots: can they bepredicted using temperature

monitoring tools andsubsequently prevent footulceration?


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ContentsAbstract.................................................................................................................

!ntroduction........................................................................................................... "

#ethodology.......................................................................................................... $

%indings............................................................................................................... 1

Discussion............................................................................................................2$

&onclusion........................................................................................................... '2

Ac(no)ledgements..............................................................................................''

*eference +ist...................................................................................................... '

Appendices..........................................................................................................'


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Abstract

Background

Diabetes affects 1 in 11 eo!e and t"is figure is rising raid!# $ t"e !e%e! of diabetic foot

u!ceration &a# a!so increase !acing "uge burdens on "ea!t"care and indi%idua!s' (reat

e&"asis is !aced on se!f$re%ention ractices) *it" te&erature &onitoring t"e ne*strateg# arising' +"e t"eor# is u!ceration is receded b# inf!a&&ation *"ic" cou!d be

&onitored using infrared t"er&o&eters to estab!is" areas of i&ending breakdo*n) gi%ing t"e

indi%idua! re&onition !ike o*ers regarding t"eir foot "ea!t" status' Ho*e%er e%en t"oug"

te&erature &onitoring is uti!ised in ot"er asects of diabetes care) it is not t"e case *it"

diabetic foot u!ceration current!#) *"ereb# no guide!ines are a%ai!ab!e'

,i&

+"erefore t"e ai& of t"is !iterature re%ie* is to assess *"et"er te&erature &onitoring is

fitting for foot ractice b# critica!!# araising current e%idence regarding *"et"er se!f$

te&erature &onitoringtoo!s suc" as infrared t"er&o&eters are effecti%e in redicting and


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onc!usion

4%era!! t"is critica! re%ie* "ig"!ig"ted t"at te&erature &onitoring is a ro&ising ad%ancing

tec"no!og# in "ea!t"care and "as "ad &ain!# ositi%e resu!ts regarding t"e re%ention of

diabetic foot u!ceration an area of increasing focus' Ho*e%er furt"er robust studies need to

take t"e net ste to suort t"ese current findings before suc" too!s are i&!e&ented in

ractice'


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Introduction

Diabetes) according to (a!e and ,nderson 62012 is a co&&on &etabo!ic condition

c"aracterised b# c"ronic "#erg!#cae&ia eit"er fro& a co&!ete !ack of insu!in kno*n as

t#e 1 or re!ati%e !ack of insu!in and increasing insu!in resistance t#e 2' t is a gro*ing

g!oba! issue *or!d*ide affecting a staggering 15 &i!!ion adu!ts 6nternationa! Diabetes

-ederation) 2015' Ho*e%er) t"is is redicted to rise to .2 &i!!ion b# 200' :it"in (reat

Britain) Diabetes ;< 62015 reorted 3'9 &i!!ion eo!e !i%e *it" diabetes *"ic" is redicted

to rise to 5 &i!!ion *it"in t"e decade' -urt"er&ore in Scot!and t"ere are 27.)30 eo!e *it"

diabetes $5'2= of t"e ou!ation> and .1)8.9 reside in (!asgo* 6Mc


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13)7. of t"e diabetic ou!ation "a%e reorted "a%ing a foot u!cer figures fro& (!asgo*

reresent roug"!# a /uarter of t"is tota! at 3)0.5 6Mc "ea!t"care "as s"ifted to Fre%ention is t"e best cureC as art of

"ea!t" ro&otion !ans' +"e &ain current re%entati%e strategies insta!!ed inc!ude atient

education) se!f$insection) regu!ar foot screenings and risk stratification) odiatr# and MD+

inter%ention) /ua!it# aroriate foot*ear and ort"oses 6("os" and o!!ier) 2012'

, stud# b# ,r&strong and Ea%er# 61997 in%estigated t"e effecti%eness of te&erature too!s

i it i i d " !i f t" di b ti f t !i ti " " t


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Methodology

4ctober 2015 brainstor&ing surrounding D-; e&"asised t"e i&act on indi%idua!s)

odiatrists) t"e "ea!t" ser%ice and otentia! ser%ice i&ro%e&ents regarding indicati%e

re%entati%e &easures 6figure 1' +"is faci!itated concetua!isation of t"e researc" toic'

nitia! bro*sing ensued to ea&ine re!i&inar# !iterature 6tab!e 1' , researc" /uestion *ast"en estab!is"ed ,%e#ard 62010 states researc" /uestions focus an initia! "#ot"esis) *"ic"

once ans*ered s"ou!d i&ro%e atient care t"roug" infor&ed reco&&endations and suerior

understanding of t"e subject area o*ing to e%idence based ractice 6BP' +"e P4 too!

de%e!oed t"e researc" /uestion does t"e use of se!f$te&erature &onitoring too!s suc" as

infrared t"er&o&eters 6inter%ention) effecti%e!# redict and subse/uent!# re%ent t"e

de%e!o&ent of foot u!cers 6outco&e in diabetic atients 6ou!ation co&ared to eisting

standard re%entati%e &easures 6co&arison +"e P4 design i&ro%es detection of "ig"

/ua!it# e%idence) faci!itates structured researc" and breakdo*n of t"e /uestion into four

easi!# identifiab!e asects for efficient recise searc"ing 6,s!a& A &&anue!) 2010'


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-igure 1 nitia! Brainstor& Mind&a 6eferences can be found in ,endi 1

Page | 0


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+ab!e 1 nitia! Bro*se

Research Topic Initial Terms Site Papers Returned;ti!ising

te&erature

&onitoring as a

diagnostic

re%entati%e too!

for diabetic foot

u!ceration'

Ite&erature

&onitoringJ

,D

Idiabetic foot

u!cerationJ

a'(; Disco%er a. )082

b.28)000 Kie!ded too &an# non$acade&ic

and irre!e%ant resu!ts

c.19)00

b'(oog!e

c'(oog!e

Sc"o!ar

S( (uide!ines

62013

(uide!ine 11. Manage&ent of Diabetes

Mini&a! guidance on re%entati%e &easures for u!ceration)

on!# foot*ear and ort"oses &entioned'

Patient education is reco&&ended'

+"er&o&etr# can be used to identif# "arcot) and t"en can be

used to &onitor ost diagnosis "arcot disease acti%it#treat&ent as tota! contact casting of affected !i&b s"ou!dcoincide *it" te&erature reduction'

$!acking guidance in re%enting and diagnosing areas of foot

u!ceration'

(uide!ines

62015

( 19 Diabetic -oot Prob!e&s re%ention and &anage&ent

(uidance surrounding re%enting diabetic foot rob!e&s b#

i t" f t ! ! f t" 6 i t !


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, !iterature searc" 6tab!e 2 *as undertaken ear!# o%e&ber 2015 insecting funda&enta!

acade&ic databases> ,MD) ,HE) MDE and Hea!t" Source *ere a!! searc"edsi&u!taneous!# %ia BS4 Host *it" du!icates re&o%ed' oc"rane Eibrar#) ProOuest and

:eb of Science *ere searc"ed searate!# 6,endi 2' Main searc" ter&s inc!uded

Ite&erature &onitoringJ) I"and"e!dJ) IredictingJ) Ire%entingJ) Idiabetic foot u!cerationJ

and suitab!e s#non#&s' Boo!ean oerators and truncation #ie!ded focused roducti%e resu!ts'

efine&ent inc!uded !i&iting ub!ication dates to *it"in 200$2015 $ it *as noted during

initia! researc" &u!ti!e studies *ere conducted broad!# on t"is subject fie!d o%er 1980s$

1990s) succeeded b# a !iterature ga unti! &id$2000s *"en interest sarked again' +"erefore

t"e decision *as &ade to generate t"e &ost recent) udated !iterature for araisa!> "oefu!!#

attaining &ore re!e%ant conc!usions'

Searc" resu!ts *ere e%a!uated and studies inc!uded if t"e# &et redefined e!igibi!it# criteria

6tab!e 3' +"ereafter four studies resided) &anua! searc"ing of references *as undertaken

ensuring otentia! re!e%ant artic!es *ere not o%er!ooked' +"is re%ea!ed su!e&entar# studies>

"o*e%er t"ese *ere t"en discarded after a!#ing suc" criteria'

Eiterature araisa! t"e S( 62015a a!gorit"& for c!assif#ing stud# design for /uestions of


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+ab!e 2 Eiterature Searc" Strateg#

Searchterms

temperature monitoring OR thermometry OR skin temperature OR temperature ttemperature regulation ORinfrared thermometry

AND

selfmonitoring OR selfassessment OR home monitoring OR handheld

AND

dia!etic foot ulceration OR D"# OR foot ulcer OR foot complication OR dia

ulcers OR dia!etic $ound ANDpre%ention OR prediction

Data!ases

searched

,MD) ,HE) oc"rane Eibrar#) MDE) Hea!t" Source ursingN,cade&ic dition) ProOuest

Hea!t" and Medica! o&!ete) ProOuest ursing and ,!!ied Hea!t" Source) :eb of Science

Part of&ournals

searched


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+ab!e 3 e%ie* !igibi!it# riteria


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Findings

Eiterature (at"ering esu!ts

Succeeding t"e !iterature searc") o%er four "undred artic!es *ere gat"ered for screening and

aers di&inis"ed unti! t"e fina! four artic!es re&ained as in figure 2' +"oroug" !iterature

re%ie* tab!es can be found in ,endi ' ,!! four studies 6Ea%er# et a!) 200> Ea%er# et a!)

2007> ,r&strong et a!) 2007> Skafje!d et a!) 2015 *ere rando&ised contro!!ed tria!s 6+s'

,ccording to Sto!berg) or&an and +ro 6200) +s are regarded as t"e strongest t#e of

e%idence> t"e# are designed to "a%e a !o* robabi!it# of bias and !ess &et"odo!ogica! errors

6Burns) o"ric" and "ung) 2011'

Stud# esu!ts

+ab!e 3 dis!a#s secific stud# resu!ts' +"ree studies 6Ea%er# et a! 200> Ea%er# et a! 2007>

,r&strong et a! 2007 found statistica!!# significant reduced u!cer incidence rates in t"e

inter%ention co&ared to contro!s indicating se!fassess&ent infrared t"er&o&eters

secifica!!# +e&+ouc" 6figure 3 aears to be an effecti%e co&!e&entar# too! to standard

D-; H " fi ! d d fi di 6Sk fj !d !


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-igure 2 PSM, -!o* Diagra&

ecords identified t"roug"

database searc"ing

,MD) ,HE) Hea!t" Source)MDE 6n 78

oc"rane Eibrar# 6n

ProOuest Hea!t" $ ursing and,!!ied Hea!t" 6n 28

:eb of Science 6n .3

,dditiona! records identifiedt"roug" ot"er sources

6n10

$eference Eists

ation

Overall Total

= 439

ecords ec!uded after screeningtit!e andNor abstract

6n205

on +s 698

Eetters to t"e aut"or or eert

co&&entaries 61.

NM i i !

ning

ecords after du!icates re&o%ed

6n 393

d d


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+ab!e Studies esu!ts


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-igure 3 +e&+ouc" De%ice

Ea%er# 62007


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,rtic!es *i!! be t"e&atica!!# discussed to ro%ide a concise) s#nt"esised re%ie* of stud#

features' +"e&es *ere identified as areas of notab!e discussion b# t"e re%ie*er> "o*e%er t"is

is b# no &eans abso!ute'

Pri&ar# 4utco&e Measure

Positi%e!#) a!! four studies &easured t"e sa&e ri&ar# c!inica! outco&e foot u!cer incidence $articiants eit"er did or did not de%e!o a D-; 6dic"oto&ous outco&e t"roug"out t"e stud#

course' Ho*e%er) %ariation occurred regarding &et"ods of &easuring u!ceration) *"ic" !i&its

direct co&arison bet*een t"e studies 6Eiberati et a!) 2009' :"i!st) 62015 e&"asise

ractitioners s"ou!d use a standardised diagnostic s#ste& to ensure neutra!it#> t*o studies

6Ea%er# et a!) 200> ,r&strong et a!) 2007 used no or unsecific criteria for u!cerc!assification oor objecti%it#' ncouraging!# t"e re&aining t*o studies 6Ea%er# et a!)

2007> Skafje!d et a!) 2015 uti!ised uni%ersa!!# estab!is"ed *ound grading s#ste&s +"e

;ni%ersit# of +eas :ound !assification 6;+ and :agner ;!cer !assification 6:

resecti%e!#' Mu!ti!e studies 64#ibo et a!) 2001> (u! et a!) 200. co&aring t"e t*o s#ste&s

f d b " i ! ! i id f " i d " i f i ki i


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reduce genera!isabi!it# of t"e findings'n t"ree aers 6Ea%er# et a!) 200> ,r&strong et a!)

2007> Skafje!d et a!) 2015) articiants "ad to be eit"er risk grou 2Q or 3 according to t"e

nternationa! :orking (rou on t"e Diabetic -oot c!assification too! 6tab!e 5' t is i&ortant

to note t"an in one stud# 6Skafje!d et a!) 2015> articiants "ad to be eager to &onitor foot

skin te&erature) t"erefore introducing a sa&!e se!ection bias and reducing t"e eterna!

%a!idit# of t"is tria! 6Po!gar A +"o&as) 2013'

+ab!e 5 nternationa! :orking (rou on Diabetic -oot isk !assification S#ste& 6Bus et a!

62015

Risk +roup ,lassification Risk "actors Present

0 o eri"era! neuroat"#

1 Peri"era! neuroat"#

2 Peri"era! neuroat"# *it" eri"era! arteria! disease 6P,DQ andNor a foot

defor&it#

3 Peri"era! neuroat"# and a "istor# of foot u!ceration or !o*er etre&it#

a&utation

,!! studies ec!uded acti%e u!ceration) infection and "arcot art"roat"# as *e!! as oen

i i "i " !d i ki " i i


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Stud# Met"ods

Sample Size, Justification, and Drop-out:

t is i&ractica! and cost!# to stud# entire target ou!ations $ researc"ers in%estigate

reresentati%e sa&!es and atte&t to genera!ise t"e findings' +"erefore se!ecting an

aroriate sa&!e si?e is i&ortant> in "ea!t" researc" it is i&!ied t"ere is no oti&a!

nu&ber 6Po!gar A +"o&as) 2013' ,!t"oug" genera!!#) !arger sa&!e si?es roduce &ore

accurate resu!ts and ac"ie%es "ig"er o*er' Sa&!e si?es *ere di%erse> t*o studies 6Skafje!d

et a!) 2015 and Ea%er# et a!) 200 "ad notab!# fe*er articiants of 1 and 85) *"i!st t"e

re&aining studies 6Ea%er# et a!) 2007 and ,r&strong et a!) 2007 "ad 173 and 225

resecti%e!# cu&u!ating to 52' 4n!# t"e t*o !arger studies ro%ided justification of

deter&ined sa&!e si?e and increases robustness of t"ese tria!s 6Ea%er# et a! A ,r&strong et

a! 2007' +"e for&er c"ose a o*er of 80= to #ie!d .0 subjects er grou *it" t"e ai& t"at

55 *ou!d co&!ete t"e stud# after accounting for an eected 10= dro out rate' Ho*e%er

t"is target *as not &et eac" treat&ent ar& a!!ocated fe*er t"an .0 articiants and o%era!!

t"e stud# droout rate *as 12'71=) *it" indi%idua! grou droout rates ca!cu!ated "ig"er

t"an anticiated suggesting t"e stud# &a# be s!ig"t!# undero*ered to detect a significant


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-igure Droout Statistics and Rustifications

12',

"/$0

1

a!ery et al "200#$

%ro& 'ut (ercentage ")$

-ustifications and "igures +roup

n%o!untar# :it"dra*a! o!untar# :it"dra*a!


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,

1

1,

2

(a%ery et al 178865

Drop Out Percentage 19 5


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,

11,

S*af+eld et al "2015$

%ro& 'ut (ercentage ")$

-ustifications and "igures +roup

Total

n%o!untar# :it"dra*a! o!untar# :it"dra*a!

o secified reasons

Droout !!ness


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Randomisation, roup !llocation, "oncealment and #lindin$:

,!! studies stated rando&isation *as erfor&ed> "o*e%er Ea%er# et a! 6200 ro%ided no

furt"er infor&ation) t"us t"e reader cannot be certain t"is *as tru!# undertaken' 4ne stud#

Skafje!d et a! 62015 erfor&ed b!ock rando&isation and in addition) atients *it" re%ious

"arcot art"roat"# *ere stratified' +"e re&aining studies erfor&ed si&!e rando&isation

6,r&strong et a!) 2007 A Ea%er# et a!) 2007 b# generated rando&ised !ists> secifica!!# %ia

t"e stud# biostatistician *"o se/uentia!!# assigned atients and co&uter generated

resecti%e!# t"e !atter t"erefore reduces t"e risk of "u&an error and bias' ,dditiona!!# t"is

*as t"e on!# stud# to address rando&isation concea!&ent *"ereb# a!!ocation *as sea!ed in

oa/ue en%e!oes) t"is is a ositi%e asect as a!!ocation concea!&ent is critica! and inf!uences

success of rando&isation 6iera and Bangdi*a!a) 2007) as its absence can !ead to se!ection

bias' ,s Doig and Si&son 62005 "ig"!ig"ted) %ague or unsatisfactor# concea!&ent &et"ods

can roduce 0= greater biased esti&ates of treat&ent effect' egarding grou a!!ocation)

articiants *ere rando&ised e/ua!!#' Ho*e%er) ,r&strong et a! 62007 did not disc!ose

grou sa&!e figures) t"erefore it is unkno*n "o* &an# subjects *ere in eac" grou or if

t"ere *as a ossib!e a!!ocation bias 6as t"is *as t"e stud# rando&ised %ia t"e stud#


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studies is foot u!cer incidence *"ic" is infre/uent and transient) !onger fo!!o* u eriods 6@ 1

#ear *ou!d be referred and is ac"ie%ed b# t"ree studies'

Stud# Design

#aseline "(aracteristics

Positi%e!# a!! four studies resented tab!es according to t"e &et"odo!ogica! guide!ines

4S4+ 2010 State&ent ) *"ic" "ig"!ig"ted stud# treat&ent grous *ere co&arab!e in

base!ine c"aracteristics) *it" Ea%er# et a! 62007 and Skafje!d et a 62015 ro%iding &ore

etensi%e infor&ation' +"ree studies 6Ea%er# et a!) 200> ,r&strong et a!) 2007> Skafje!d et a!

2015 carried out significance testing of base!ine de&ogra"ics desite t"is being ad%ised

against b# t"e 4S4+ grou as being inessentia! and decei%ing dissi&i!arit# regarding

base!ine c"aracteristics are a conse/uence of c"ance rat"er t"an bias 6Mo"er et a!) 2010'

"ontrol "lassification

ac" stud# can be c!assified as acti%e 6ositi%e contro!!ed tria!s consisting of eisting

standard re%entati%e t"era#' ,ccording to Mi!!er and Brod# 62002 and S( 6201 t"is is

fa%ourab!e and ensures studies are &ora!!# sound> if ro%en effecti%e standard t"era# eists


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4utco&e Statistics and ,na!#sis

-or ana!#ses) a!! studies used significance !e%e!s e/ua! to 0'05 or !ess and ro&inent!#

reorted $%a!ues in t"eir resu!ts' :"i!st P %a!ues eress *"et"er an effect eists> it does not

identif# t"e &agnitude of suc" effect' +"erefore in /uantitati%e studies) *"i!st %a!ues

6statistica! significance re&ain essentia!) t"e effect si?e 6substanti%e significance s"ou!d be

t"e funda&enta! finding 6Su!!i%an A -einn) 2012' +"ree studies 6Ea%er# et a! 200> Ea%er#

et a! 2007> ,r&strong et a! 2007 used an indirect &easure of effect si?e kno*n as odds ratios

64 regarding u!cer incidence> a!t"oug" t"is *as not e!icit!# stated 6tab!e .' 4s are

effecti%e *"en outco&es are dic"oto&ous as in t"is case) but genera!!# are uti!ised in case

contro! studies' e%ert"e!ess !iterature 6

"o*e%er 4s can inf!ate effect si?es and are difficu!t to interret b# t"e ub!ic) ractitioners

and e%en researc"ers) t"erefore s"ou!d on!# be reorted if acco&anied b# accurate

c!arification of i&!ication *"ic" *as not t"e case "ere t"us s"ou!d be interreted *it"

caution'


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+ab!e . ffect Si?es

Stud# Statistica! ,na!#sis nterretation

Ea%er# et a!

6200

n"anced t"era# %ersus standard t"era# odds of

de%e!oing foot co&!ication

4 10'3 !arge effect si?e

onfidence inter%a! 61'2$85'3 :idt" 8'1

n"anced t"era# ten ti&es !ess !ike!# to u!cerate co&ared to

standard t"era#'

,s t"e confidence inter%a! does not contain t"e %a!ue of no

effect 64 1) t"en it can be conc!uded t"ere is a statistica!!#

significant corre!ation'

S&a!!er studies usua!!# "a%e *ider confidence inter%a!s and t"is

is t"e s&a!!est of t"e t"ree studies'

Ho*e%er) *ide confidence inter%a! indicates t"e recision of

effect is actua!!# unkno*n and &ore infor&ation is re/uired

e%en t"oug" t"e odds ratio suggests itCs a !arge effect'

Ea%er# et a!

62007

n"anced t"era# %ersus standard t"era# odds of

de%e!oing foot u!ceration

4 '8 &ediu& effect si?e

onfidence inter%a! 61'53$13'1

:idt" 11'.1n"anced t"era# %ersus structured t"era# odds of

de%e!oing foot u!ceration

4 '71 &ediu& effect si?e

onfidence inter%a! 61'.0$13'85

:idt" 12'25

ti&es !ess !ike!# of u!cerating in t"e en"anced t"era# t"an

bot" standard t"era# and structured t"era#'

,s t"e confidence inter%a! does not contain t"e %a!ue of no

effect 64 1) t"en it can be conc!uded t"ere is a statistica!!#

significant corre!ation'

,r&strong n"anced t"era# %ersus standard t"era# odds of n"anced t"era# grou are t"ree ti&es !ess !ike!# to u!cerate


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:"ereas t"e fina! fourt" stud# conducted b# a!ternate aut"ors did not identif# an# statistica!

significance in foot u!cer occurrence bet*een grous'

%iscussion

+"ese resu!ts "a%e etended e%idence) ackno*!edging an interesting !ink regarding raised

te&eratures being indicati%e of i&ending u!ceration and t"at statistica!!# confident

corre!ations &a# eist bet*een uti!ising infrared t"er&o&eters and reduced u!cer incidence)

suorting its use as an ad%antageous adjuncti%e t"era# to eisting t"eraies' e%ert"e!ess)

suboti&a! reorting of %ita! infor&ation or &et"odo!ogica! rocedures a&ong t"e studies

*as a consistent issue' ;nderstandab!# t"is rendered t"e re%ie*er uncertain of bias reducing

asects *"ic" *ere dee&ed to "a%e occurred oor!# or not at a!! i&!#ing reduced interna!

%a!idit#' Ho*e%er) a stud# b# De%ereau et a! 6200 e%a!uated !e%e!s of non$reorted

rocedures to actua! rocedure occurrence !e%e!s in +s and conc!uded readers s"ou!d not

&ake assu&tions regarding non$reorted content' +"is cou!d be a !i&itation of t"e

researc"er) s"o*casing "aste and ineerience' egard!ess c!inicians re!# on ab!# conducted


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"o&e> it *ou!d be beneficia! and uti!ised dai!#' ,!t"oug" t"is cannot be direct!# transferab!e

to +e&+ouc") it reresents initia! inc!ination t"is is an area atients are eager to see

de%e!oed'

(a!e and ,nderson 62012 "ig"!ig"ted &an# s#c"osocia! i&!ications of DM> &ost eo!e

undergo fee!ings of !earned se!f$"e!!essness) o*er!essness or condition consu&tion at

stages and &a# suffer fro& &enta! i!! "ea!t" $ diabetes is !inked to increased risk of

deression' +"is is often associated *it" oorer "#sica! outco&es and &a# create resistance

to or i&act a ersonCs abi!it# to se!f$&anage' F4n t"e ot"er footC) t"is too! "as an oortunit#

if i&!e&ented *it" t"e rig"t rofessiona! suort to integrate &enta! and "#sica! "ea!t" b#

ro&oting se!f$care and atient e&o*er&ent as Diabetes Scot!and 62015 noted) eo!e

need to fee! &enta!!# e&o*ered to go%ern t"eir "#sica! diabetes'

!inica! &!ications

*odiatr+ and ulti-*rofessional "ontet

+*o inc!uded studies "ig"!ig"ted atients using +e&+ouc" contacted stud# ersonne! &ore

fre/uent!# regarding increased te&eratures) c!inica!!# t"is cou!d transfer to increased


32/76

T U.$.. &i!!ion


Hb,1c scores' t &a# a!so be usefu! in inatient settings *"ere !ess t"an "a!f of ad&issions

recei%e foot screening and 1'= of diabetic inatients de%e!o ne* foot !esions 6Hea!t" and

Socia! are nfor&ation entre) 201' urses cou!d &onitor atientCs te&erature for

i&ending u!ceration furt"er i&ro%ing foot c"ecks as art of t"e nationa! inatient

initiati%e of t"e FP for -eetC ca&aign b# t"e Scottis" Diabetes -oot ,ction (rou 6+"e

Scottis" (o%ern&ent) 201'

"ost "onsiderations

egarding "ea!t" econo&ics) +e&+ouc" roug"!# costs V150 or U103 according to Mcurd#

62008' t genera!!# aears to be a !o* cost diagnostic re%entati%e de%ice t"at cou!d be used

as an adjunct *it" standard re%entati%e &easures a%ai!ab!e at t"e HSCs disosa!) co&ared

to t"e eense of u!ceration and a&utation 6-igure '

-igure ,%erage HS osts of Diabetic -oot o&!ications


33/76


&essaging *i!! reduce D-;s and i&ro%e co&!iance' esu!ts of t"ese tria!s are due to be

ub!is"ed in 2018 and 2017 resecti%e!#' t is e%ident t"is is an ad%ancing researc" area *it"

oortunit# for de%e!o&ent and in%est&ent'

%uture )nnovations

+"e Scottis" (o%ern&ent 6201 "ig"!ig"ted its riorit# to i&ro%e de%e!o&ent of

inno%ati%e too!s for diabetes care' 4ne roosa! cou!d be for t"e concets of t*o different

t#es of te&erature &onitoring to &erge de%ices enco&assing E+ t"er&ogra"s) *"ere

atients stand on a t"er&a! !ates or sensors in s"oes to generate fu!! foot genera! %isua!

i&ages) fo!!o*ed b# &ore recise t"er&o&etr# of "ot sots *"ere actua! te&erature figures

are &easured to ro%ide &ore co&re"ensi%e &onitoring'

urrent e%ie* Ei&itations

,ccess to certain journa!s *as restricted) t"erefore fu!! scoe of !iterature *as una%ai!ab!e>

cannot be sure a!! re!e%ant e%idence *as inc!uded' -urt"er&ore) !iterature *as !i&ited to

ng!is" !anguage due to t"e uni!ingua! interreter' e%ie*er ineerience in researc" and


34/76


Conclusion

urrent!# t"ere are no guide!ines surrounding te&erature &onitoring for diabetic foot

u!ceration t"erefore it is not used routine!# b# atients or t"e HS> "o*e%er t"is re%ie*


35/76


Ac*no,ledgeents

*ou!d !ike to eress gratitude to suer%isor Professor Stuart Baird for "is guidance)

ad%ice) inte!!ectua! discussions) reassurance and atience regarding t"is roject' *ou!d a!so


36/76



37/76


,MS+4() D'(' et a!') 1997' nfrared Der&a! +"er&o&etr# for t"e Hig"$isk Diabetic

-oot'*(+sical T(erap+Won!ineX' 6662) ' 1.9$175' W%ie*ed 12 Ranuar# 201.X' ,%ai!ab!e

fro& "ttNNtjourna!'ata'orgNcontentN77N2N1.9'!ong

,MS+4() D'(' et a!') 200' ariabi!it# in ,cti%it# Ma# Precede Diabetic -oot

;!ceration'Dia.etes "areWon!ineX' 7668) ' 1980$198' W%ie*ed 21 -ebruar# 201.X'

,%ai!ab!e fro& "ttNNcare'diabetesjourna!s'orgNcontentN27N8N1980'fu!!

,MS+4() D'(' et a!') 2007' Skin +e&erature Monitoring educes t"e isk for

Diabetic -oot ;!ceration in Hig"$isk Patients' T(e !merican Journal of edicineWon!ineX'

;7862) ' 102$10.' W%ie*ed 10 o%e&ber 2015X' ,%ai!ab!e fro&

"ttNN***'a&j&ed'co&Nartic!eNS0002$93360700739$5Ndf

,MS+4() D'(' A E,K) E',' 1997' Monitoring "ea!ing of acute "arcotCs

art"roat"# *it" infrared der&a! t"er&o&etr#'Journal of Re(a.ilitation Researc( and

DevelopmentWon!ineX' ./63) ' 317$321' W%ie*ed 12 Ranuar# 201.X' ,%ai!ab!e fro&

"ttNN***'re"ab'researc"'%a'go%NjourN97N3N3NdfNar&strong'df

,MS+4() D'(') E,K) E',' A H,


38/76


W%ie*ed 12 Ranuar# 201.X' ,%ai!ab!e fro&

"ttNNcare'diabetesjourna!s'orgNcontentN17N8N835'abstract

B4;E+4) ,'R'M' et a!') 2005' +"e g!oba! burden of diabetic foot disease' +"e Eancet

Won!ineX' 3.. 6998) ' 1719$172' W%ie*ed 1 Ranuar# 201.X' ,%ai!ab!e fro&

"ttNN***'sciencedirect'co&NscienceNartic!eNiiNS010.73.05.7.982

B;S) P'B') 4HH) 'R' A H;()


39/76


D4() ('S' A SMPS4) -' 2005' ando&i?ation and a!!ocation concea!&ent a ractica!

guide for researc"ers'Journal of "ritical "areWon!ineX' 7862) ' 187$191' W%ie*ed 30

Ranuar# 201.X' ,%ai!ab!e fro&

"ttNN***'sciencedirect'co&NscienceNartic!eNiiNS0883910500020

D;() +' A :,D) () 2008' Managing !inica! Prob!e&s in Diabetes' 4ford

B!ack*e!! Pub!is"ing'

DM4DS) M'' A -4S+) ,''M') 201'ana$in$ t(e Dia.etic %oot' 3rded' :est

Susse Ro"n :i!e# A Sons Etd'

-,D) ,'S') SM,E],DH) M' A E,R,) B' 2007' ,ssess&ent and +reat&ent of

Diabetic -oot ;!cer')nternational Journal of "linical *racticeWon!ineX'


40/76


(,E) ','M') A ,DS4) R'') 2012' Diabetes &e!!itus and ot"er disorders of

&etabo!is&' n


41/76



42/76


201.X' ,%ai!ab!e fro& "ttNN***'consort$

state&ent'orgNMediaNDefau!tNDo*n!oadsN4S4+=202010=20!anation=20and

=20!aboration=206BMR'df

M4E,) -'R') H;++4) B' A -(;SS4) D' 2008' Does ana!#sis using I!ast

obser%ation carried for*ardJ introduce bias in de&entia researc" "anadian edicine

!ssociation JournalWon!ineX' ;6=68) ' 751$753' W%ie*ed -ebruar# 201.X' ,%ai!ab!e

fro& "ttNN***'ncbi'n!&'ni"'go%N&cNartic!esNPM2553855N

,+4,E S++;+ -4 H,E+H ,D , EE WX) 2015'

Dia.etic %oot *ro.lems: prevention and mana$ementWon!ineX' ationa! nstitute for Hea!t"

and are ce!!ence' W%ie*ed 21 Dece&ber 2015X' ,%ai!ab!e fro&

"ttNN***'nice'org'ukNguidanceNng19Nc"aterNintroduction

,+4,E S++;S 4- H,E+H) 1999'Researc( )nvolvin$ )ndividuals &it(

>uestiona.le "apacit+ to "onsent: *oints to "onsiderWon!ineX' ationa! nstitutes of Hea!t"'

W%ie*ed 30 Ranuar# 201.X' ,%ai!ab!e fro&

"ttNNgrants'ni"'go%NgrantsNo!ic#N/uestionab!ecaacit#'"t&


43/76


P4E(,) S' A +H4M,S) S',') 2013')ntroduction to Researc( in t(e 1ealt( Sciences

Won!ineX' .t"ed' dinburg" "urc"i!! Ei%ingston' W%ie*ed 17 Ranuar# 201.X' ,%ai!ab!e fro&

"ttsNN***'da*sonera'co&Nreadon!ineN97807020..98

P,+4) R' et a!') 2011' ffecti%eness of inso!es used for t"e re%ention of u!ceration in t"e

neuroat"ic diabetic foot a s#ste&atic re%ie*'Journal of Dia.etes and its "omplications

Won!ineX' 7461) ' 52$.2' W%ie*ed 7 -ebruar# 201.X' ,%ai!ab!e fro&

"ttNN***'sciencedirect'co&NscienceNartic!eNiiNS105.872709000932

P4S++) R' A -,


44/76


nterco!!egiate (uide!ines et*ork' W%ie*ed 7 Dece&ber 2015X' ,%ai!ab!e fro&

"ttNN***'sign'ac'ukNdfNsign11.'df

S4++SH +4EE(,+ (;DES +:4< WS(X) 201' S)5 7: !

$uideline developer;s (and.ooWon!ineX' dinburg" Scottis" nterco!!egiate (uide!ines

et*ork' W%ie*ed 1 -ebruar# 201.X' ,%ai!ab!e fro& "ttNN***'sign'ac'ukNdfNsign50'df

S4++SH +4EE(,+ (;DES +:4< WS(X) 2015a'

et(odolo$ical *rinciplesWon!ineX' Scottis" nterco!!egiate (uide!ines et*ork' W%ie*ed 1.

Dece&ber 2015X' ,%ai!ab!e fro& "ttNN***'sign'ac'ukN&et"odo!og#Ninde'"t&!

S4++SH +4EE(,+ (;DES +:4< WS(X) 2015b' "ritical

!ppraisal: 5otes and "(eclistsWon!ineX' Scottis" nterco!!egiate (uide!ines et*ork'

W%ie*ed 1. Dece&ber 2015X' ,%ai!ab!e fro&"ttNN***'sign'ac'ukN&et"odo!og#Nc"eck!ists'"t&!

S4++SH +4EE(,+ (;DES +:4< WS(X) 2015c' S)5

radin$ S+stem 8999-6786Won!ineX' Scottis" nterco!!egiate (uide!ines et*ork' W%ie*ed 1.

Dece&ber 2015X' ,%ai!ab!e fro&


45/76


S+SS) 'M' et a!') 198.' ;se of !i/uid cr#sta! t"er&ogra"# in t"e e%a!uation of t"e diabetic

foot'Dia.etes "areWon!ineX' =63) ' 2.7$272' W%ie*ed 12 Ranuar# 201.X' ,%ai!ab!e fro&

"ttNNcare'diabetesjourna!s'orgNcontentN9N3N2.7'abstract

S+4EB() H'4') 4M,) (' A +4P) ' 200' ando&i?ed ontro!!ed +ria!s' T(e

!merican Journal of Roent$enolo$+Won!ineX' ;3.6.) ' 1539$15' W%ie*ed 17 Dece&ber

2015X' ,%ai!ab!e fro& "ttNN***'ajron!ine'orgNdoiNdfN10'221Najr'183'.'01831539

S;EE,) ('M' A -) ' 2012' ;sing ffect Si?e or :"# t"e P a!ue s ot

noug"'Journal of raduate edical ducationWon!ineX' /63) ' 279$282' W%ie*ed 1

-ebruar# 201.X' ,%ai!ab!e fro& doi

10'300NR(M$D$12$0015.'1

+H S4++SH (4M+) 201'Dia.etes )mprovement *lanWon!ineX' +"e Scottis"

(o%ern&ent' W%ie*ed 5 -ebruar# 201.X' ,%ai!ab!e fro&

"ttNN***'go%'scotNPub!icationsN201N11N.72N3

,) ,'R' A B,(D:,E,) S'' 2007' !i&inating Bias in ando&i?ed ontro!!ed

+ria!s &ortance of ,!!ocation oncea!&ent and Masking'%amil+ edicineWon!ineX' .=

62) ' 132$137' W%ie*ed 30 Ranuar# 201.X' ,%ai!ab!e fro&


46/76


e $ S( Met"odo!ogica! ,raisa! of ,!! Studies "eck!ist and %idence (rading

Appendi* /0Eiterature e%ie* +ab!es

Appendi* 404S4+ 2010 "eck!ist


47/76


63' :4;DS +,+4,E) 2013')nternational #est *ractice uidelines: 2ound

ana$ement in Dia.etic %oot 'lcersWon!ineX' :ounds nternationa!' W%ie*ed 22 4ctober

2015X' ,%ai!ab!e fro&

"ttNN***'*oundsinternationa!'co&N&ediaNissuesN.73Nfi!esNcontent[10803'df

6' (EP) H' A E,(,)


48/76


=20inde=3,=20a=20=22roof=20of=20concet=22=20stud#=20to=20assess

=20*ound=20"ea!ing=20trajector#'Asage773Aages773$

9AsidBS4MDEAauB"arara=20M

611' E,K) E',' A ,MS+4() D'(' 2007' +e&erature Monitoring to ,ssess)

Predict and Pre%ent Diabetic -oot o&!ications' "urrent Dia.etes ReportsWon!ineX' 66.)

' 1.$19' W%ie*ed 22 4ctober 2015X' ,%ai!ab!e fro&

"ttNNsu3/e/3!'searc"'seria!sso!utions'co&Ngenreartic!eAissn153827Atit!eurrent

=20Diabetes=20eortsA%o!u&e7Aissue.Adate20071201Aatit!e+e&erature

=20&onitoring=20to=20assess=2=20redict=2=20and=20re%ent=20diabetic

=20foot=20co&!ications'Asage1.Aages1.$

9AsidBS4MDEAauEa%er#=20E,


49/76


Appendi* 70%idence of Databases Searc"ed W,MD) ,HE) Hea!t" Source) MDEX

Page | 0


50/76


Page | ,


51/76


Appendi* 7 cont0 Woc"rane Eibrar#X

Page | ,1


52/76


Page | ,2


53/76


Appendi* 7 cont0 WProOuestX

Page | ,'


54/76


Appendi* 7 cont0 W:eb of ScienceX

Page | ,

H j 9132 2 S121890


55/76


Appendi* .a0S( !assif#ing Stud# Design for Met"odo!ogica! ,raisa! 6S() 2015a

Page | ,,


56/76


Appendi* .!0S( Met"odo!ogica! ,raisa! "eck!ist for +s6S() 2015b


57/76



58/76


Appendi* .c0S( (uidance otes for Met"odo!ogica! ,raisa! "eck!ist for +s

6S() 2015b


59/76



60/76


Appendi* .d0S( (rading S#ste&6S() 2015c

Honours Project MHB913252 S1218907


61/76


Appendi* .e0S( Met"odo!ogica! ,raisa! of ,!! Studies "eck!ist Wadated fro& aendi 3bX

Stud+ )dentification 0aver+ et al B6774C 0aver+ et al B677


62/76


1'10 :"ere t"e stud# is carried out at &ore t"an

one site) resu!ts are co&arab!e for a!! sites

annot sa# annot sa# annot sa# ot a!icab!e

Section 2 4%era!! ,ssess&ent of t"e Studies

2'1 +aking into accountc!inica!

considerations)

#our e%a!uations of

t"e &et"odo!og#

used) and t"e

statistica! o*er of

t"e stud#) are #ou

certain t"e o%era!!

effect is due to t"e

stud# inter%ention

;ncertain oor&et"odo!ogica! rigour and

reorting of i&ortant asects'

S&a!! sa&!e si?e *it" no

justification ossib!# &a# be

undero*ered' Ho*e%er t"is

stud# "as an etre&e!# ositi%e

asect *"ic" differentiates it

co&ared to t"e ot"er studies'

(ra"s "ig"!ig"ting te&erature

differences bet*een t"e on!#subject *"o u!cerated and a

subject *"o did not u!cerate

*ere ro%ided' t can c!ear!# be

seen t"at t"e atient *"o

u!cerated) te&erature

differences bet*een rig"t and

!eft sites *ere &ore erratic and

continua!!# resented *it"

"ig"er te&eratures o%er a

eriod of ti&e at t"e site of

u!ceration "ig"!ig"ts

redicti%e asect of stud#'

Kes $ good &et"odo!ogica!rigour and &ost in$det"

reorting of stud# infor&ation'

Earge sa&!e si?e and

justification gi%en &a# "a%e

good o*er' !inica!!#)

inter%entions t"oroug"!# detai!ed

good grounds for reeatabi!it#'

,ddition of t"ird treat&ent ar&

did not i&act t"e resu!ts

significant!#) *as si&i!ar to t"econtro! and t"erefore strengt"ens

t"e difference identified bet*een

t"e inter%ention and contro!

grous'

o oor &et"odo!ogica! rigourand aut"or reorting of i&ortant

asects of t"e stud#) ossib!e bias

&ore e%ident' Eargest sa&!e si?e

is a ositi%e asect) grounds for

good o*er 225 subjects *ere

rando&ised) "o*e%er no

infor&ation regarding a!!ocation

grou si?e or dro outs' So&e

sa&!e si?e justification $ suggested

a sa&!e si?e of 70 er groua!t"oug" 225 subjects *ere

rando&ised nterretation of t"is

stud# is confusing and difficu!t

*"en ana!#sing stud# resu!ts'

nter%ention rotoco!s &ost si&i!ar

to Ea%er# et a! 6200 and as suc"

t"ese studies are &ore co&arab!e'

;ncertain ,ut"or reorti&et"odo!ogica! rigour *as

ade/uate) e%idence of ossi

!o* bias' S&a!!est sa&!e s

no justification suggests st

be undero*ered) a!t"oug"

a i!ot' n addition of t"eor

counse!!ing a!ongside infra

t"er&o&etr# in t"e inter%e

&akes it difficu!t to disting

resu!ts' ou!d t"e t"eor# bacounse!!ing actua!!# "a%e i

t"e resu!ts negati%e!# ,s t

t"e on!# stud# not to s"o*

statistica!!# suorti%e resu

regarding te&erature &on

,!so t"is asect &akes t"e

!ess co&arab!e to t"e ot"e

studies'

2'2 ,re t"e resu!ts of Patient (rou +argeted Patient (rou +argeted Patient (rou +argeted Patient (rou +argeted

Page | "2



63/76


t"e stud# direct!#

a!icab!e to t"e

atient grou

targeted

Diabetics at "ig" risk of

!o*er etre&it#co&!ications

Kes) subjects recruited fro&

a "ig" risk c!inic

Diabetics c!assified as "ig" risk

for !o*er etre&it#co&!ications

Kes

Diabetics c!assified as "ig" risk for

!o*er etre&it# co&!ications o) !i&ited genera!isabi!it# $ a!!

articiants *ere recruited fro&a %eteranCs "ea!t" centret"erefore on!# ;S eterans

inc!uded' +"is ou!ation &a#be of oorer "ea!t" or "a%esignificant &enta! i!! "ea!t" e'g'increased incidence of ost$trau&atic stress disorder orderession'

Hig" risk diabetic atie

uroean aucasian et"origin

Kes) a!! atients studied

aucasian and recruitedc!inics and 1 odiatrist i

or*a#'

2'3 Su&&arise t"e

aut"orsC

conc!usions' ,dd

an# co&&ents of

o*n assess&ent

and an# areas of

uncertaint#'

,ut"orCs onc!usions

nter%ention grou 6infrared

t"er&o&etr# \ standard t"era#

eerienced significant!# fe*er

diabetic foot co&!ications

co&ared to contro! to contro!6standard t"era#' esu!ts

suggest te&erature &onitoring

&a# be an effecti%e too! to

re%ent diabetic foot u!ceration

,ut"orCs onc!usions

nter%ention grou 6infrared

t"er&o&etr# \ standard t"era#

"ad significant!# fe*er u!cers

t"an bot" structured grou

6structured foot ea& \ standardt"era# and contro! grou

6standard t"era#' esu!ts s"o*

infrared t"er&o&etr# can ser%e

as an eas# to use adjuncti%e ear!#

*arning s#ste& to re%ent

diabetic foot u!ceration'

,ut"orCs onc!usions nter%ention

grou 6infrared t"er&o&etr# \

standard t"era# eerienced

statistica!!# significant fe*er u!cers

t"an t"e contro! grou 6standard

t"era#' ncreased te&eraturessee& to redict areas of u!ceration

and se!f$te&erature &onitoring

&a# reduce t"e risk of diabetic foot

u!ceration'

,ut"orCs onc!usions nte

grou 6infrared t"er&o&etr

t"eor# based counse!!ing \

t"era# did not s"o* statis

significant resu!ts co&are

contro! grou 6standard t"e

2' 1o& &ell &as t(e

stud+ done to

minimise .ias

0o& >ualit+ B8-C

$(i$( ris of .ias

1i$( >ualit+ B8EEC

-ver+ lo& ris of .ias

0o& >ualit+ B8-C

$(i$( ris of .ias

!ccepta.le >ualit+ B

$lo& ris of .ias

S((rading

eco&&endation 4ffer te&erature &onitoring de%ices suc" as infraredt"er&o&eters *"en reco&&ending and creating &anage&ent !ans to re%ent

u!ceration'

#

Page | "'

Qote nitia!!# t"is araisa! c"eck!ist *as conducted *it"out t"e acco&an#ing notes 6aendi 3c> ans*ers *ere inconsistent and based so!e!# on t"e assu&tions of set

standard /uestions and set ans*ers *it" !itt!e c!arit# $ as suc" so&e different resu!ts *ere obtained *"ereb# t*o of t"e studies *ere graded a "ig"er /ua!it# 6Ea%er# et a!) 200 and

,r&strong et a!) 2007' -o!!o*ing identification of t"e assistant notes) t"e c"eck!ist *as reeated and found different 6t"e current outco&es' Ea%er# et a! 62007 and Skafje!d et a!

62015 *ere unc"anged fro& t"e first ti&e 6"ig" /ua!it# and accetab!e /ua!it# resecti%e!#> "o*e%er t"e ot"er t*o studies *"ic" *ere re%ious!# of accetab!e /ua!it# *ere

do*ngraded to !o* /ua!it#' +"is *i!! i&act t"e re%ie* outco&e'



64/76


Appendi* /0Eiterature e%ie* +ab!es

1/ibliogra&hiccitationand itle

Studyty&e

uber of(atients

(atientcharacteris

tics

Inter!ention Study Methods engthof

follo,u&

'utcoeeasures

StatisticalAnalysis

(a%ery> (? A?>@iggins> ? R?>

(anctot> D? R?>

,onstantinides>

+? P?> Bamorano>

R? +?> Armstrong>

D? +?> et al? 788/?

@ome

monitoring of foot

skin temperature

to pre%ent

ulceration

+ $,

Standard

+"era#

63 dro

outs 1

co&!eted

stud#'

n"anced

+"era#

1 6 dro

outs 37

co&!eted

stud#'

Particiants adu!ts618$80'

Mean %a!ues

Standard +"era#

,ge 5'8

= Men 52'3

Diabetes duration

12'7 #ears

,&utation Histor#

1 isk categor# &ean

2'1

n"anced

+"era#

2 +reat&ent (rous

(rou 1 Standard +"era# $

i'i' +"eraeutic foot*ear

ii' Diabetic foot education

iii' %er# 10$12 *eeks recei%ed a foot e%a!uation

conducted b# a odiatrist'

(rou 2 n"anced +"era#

Standard t"era# 6i)ii)iii

Pre stud# neuro!ogica! assess&ent

conducted using %ibrator# ercetion

t"res"o!d 6P+ to identif# sensor#

neuroat"#' P+ @25 defined resence

of neuroat"#'

Pre stud# %ascu!ar assess&ent inc!uded

a!ation of eda! u!ses) bot" dorsa!is

edis and osterior tibia!' f one or bot"

u!ses *ere not a!ab!e t"en t"e subject

*as ec!uded'

Patients *ere enro!!ed if t"e# "ad

$ Diabetes 6does not state t#e of

diabetes inc!uded or ='

$&et t"e "ig" risk rofi!e for t"e

. &ont"s

Measure&ent

s e%a!uated at

base!ine and

again at t"e

end of t"e

stud#'

Pri&ar# 4utco&e 2foot complications

e'g' incidence of

foot ulceration?

nfection) c"arcot

foot and a&utation

6additiona! but not

riorit# outco&es'

Secondar# 4utco&e

"unctional

impairment

&easured %ia s"ort

for& "ea!t" sur%e#

6S-$3. re and

ost stud#'

-or a!! ana!#sis a

significance !e%e! of

^ 0'05 6intention to

treat basis'

,na!#sis of ariance

6,4, *as used

to e%a!uate

continuous %ariab!es

bet*een t"e treat&ent

grous'

-is"erCs eact test

*as used to e%a!uate

dic"oto&ous%ariab!es an odds

ratio of 95=

confidence inter%a!

6'

Page | "



65/76


,ge 55

= Men 8'8

Diabetes duration

1'8

,&utation "istor#

1

isk categor# &ean

2'1

\

n"anced +"era# $ Pro%ided *it" a "and"e!d

infrared skin t"er&o&eter 6+e&+ouc"

recorded in a !og book'

$+e&erature &onitoring of bot" feet on plantar

aspect at . sites 6"a!!u) 1st) 3rdA 5t"&et "eads)

centra! &id foot and "ee!

$, difference of 2'2 degrees ce!cius bet*een one

foot and t"e contra!atera! foot indicated subjects

"as to contact a stud# nurse and reduce nu&ber of

stoes carried out unti! t"e te&erature difference

*as reduced'

$Monitoring of foot in t"e &orning and e%ening

$f an area "ad been a&utated t"en an adjacent

area *as used for &easure&ent

$f a site "ad ca!!us it *as sti!! used as a site for

&onitoring'

de%e!o&ent of a diabetic foot u!cer'

Hig" risk *as defined as "a%ing diabetes)

a "istor# of foot u!ceration or !o*er !i&b

a&utation) resence of eri"era!

sensor# neuroat"# *it" !oss of

rotecti%e sensation) e%idence of a foot

defor&it# t"is is re%ious!# identified

risk factors for foot u!cersNa&utations'

nc!usion riteria

$:or!d Hea!t" 4rganisation 6:H4

criteria for diagnosis of Diabetes'

$Must be ab!e to gi%e infor&ed consent

$,du!ts aged 18$80'

$Diabetic foot risk c!assification s#ste&

deter&ined b# nternationa! Diabetic

:orking (rou articiants &ust be

grou 2 or 3'

c!usion riteria

$Presence of oen *ounds

$4en a&utation sites

$,cti%e c"arcot ,rt"roat"#

$Peri"era! %ascu!ar disease

$acti%e foot infection

$de&entia

$i&aired cogniti%e function

$"istor# of a!co"o! or drug abuse *it"in

t"e re%ious #ear'

General comments:

Page | ",



66/76

j

Aim0 )%aluate ho$ effecti%e an at home infrared temperature tool $as to impro%e clinical outcome and functional status of dia!etics $ith high risk feet and $hether it $as a useful early $arning tool of

inflammation and tissue in&ury possi!ly leading foot complications?

Results0 enhanced therapy group had fe$er dia!etic complications 1; ulcer5 compared to 6 ulcers> 7 incidents of charcot foot and 7 incidents of foot infection $hich reCuired amputation in the standard therapy

group this $as statistically significant P28?8;? Patients in standard therapy group $ere more likely to de%elop a foot complication compared to the enhanced therapy group !y ;8?.9 1=49 ,I ;?73?.5?

Secondary outcome of functional status 1measured !y S". infection and charcot arthropathy no mention as to definitionGclassification of ulceration e?g? a foot ulcer as measured !y

HagnerGTe*as classification therefore $hat they classify as an ulcer> other studies may not? Appro%al from ethics committee not mentioned? +ood use of %isual graph sho$ing daily temperature measurements

in a patient that did not ulcerate compared to a patient $ho did? (imitations of study mentioned e?g? longer follo$ up $ould !e preferred and that the outcomes sho$n may !e as a result of increased %igilanceG

increased foot inspection in those using the physical temperature monitoring de%ice? Suggestions regarding future studies made e?g? consider randomising to a . rdpatient group in%ol%ing acti%e screening?

Inter%ention Detail0 standard therapy procedure not e*plained in detail $hat did the dia!etic foot education consist of Hhat type of foot$ear and insoles $ere issued did each participant recei%e standardfoot$earGinsoles or $ere they customised Did patients record ho$ long they $ore shoes for daily Inter%entions of foot$ear> dia!etic foot education and use of temperature monitoring tool relies on patient

compliance? Recording of measurements in log!ook relies on participant honesty? )*planation of ho$ temperature monitoring tool $orks not gi%en?

2/ibliogra&hic

citationand itle

Studyty&e

uberof

(atients

(atientcharacteristics

Inter!ention StudyMethods

ength of

follo,u&

'utcoeeasures

StatisAnal

(a%ery> (? A?>

@iggins> ? R?>

(anctot> D? R?>,onstantinides>

+? P?> Bamorano>

R? +?>

Athanasiou> ?

A?> et al? 7886?

+ 173

Standard

+"era# 58

$ 52

co&!eted

stud#

. dros outs

Particiants adu!ts 618$

80

Mean %a!ues

Standard +"era#

,ge .5

= Men 53'

3 +reat&ent (rous

, edo&eter *as issued to a!! stud# articiants to

record t"eir dai!# acti%it# in a !og book'

(rou 1 Standard +"era#

i'Eo*er !i&b ea&ination e%er# 8 *eeks

euro!ogica!

assess&ent

conducted using

P+ and 10g

&onofi!a&ent

testing nu&ber

of sites *it"

reduced sensation

out of 10'

15 &ont"s Pri&ar# 4utco&e

resence of foot

u!ceration used

re$estab!is"ed

criteria to &easure

t"is'

Secondar# 4utco&e

dai!# use of

-or a!! ana!#ses

!e%e! of ^ 0'0

obser%ation car

6E4- *as us

intent to treat b

,na!#sis of ar

6,4, for i

sa&!es *as us

Page | ""



67/76

j

Pre%enting

dia!etic foot

ulcer recurrence

in high risk

patients

$3 fro&

ad%erse

e%ents

$3 %o!untar#

dro out

Structured

-oot

a&ination

+"era# 5.

50

co&!eted

stud#

. dro outs

$ fro&

ad%erse

e%ents

$2 %o!untar#

dro outs

n"anced

+"era# 59

9

co&!eted

stud#

10 dro outs

$ fro&

ad%erse

e%ents

$. %o!untar#dro outs

+#e 2 Diabetes 5.

Diabetes duration 13'7

,&utation "istor# 18

Structured -oot

a&ination

,ge .'2

= Men 51'7

+#e 2 diabetes 53


,&utation "istor# 1

n"anced +"era#

,ge .5'

= Men 55'9

+#e 2 diabetes 55


,&utation "istor# 13

ii'Patient education rogra& %ia %ideotae addressing

aetio!og# of diabetic foot u!cers) t"e risk factors) safe

se!f$care ractices and *"at ear!# *arning signs to !ook

for'

iii' +"eraeutic inso!es and foot*ear *"ic" *ere

regu!ar!# e%a!uated b# a odiatrist to assess *"et"er an#

needed to be re!acedNreaired'

egu!ar foot insection *as ad%ised and if an# areas of

concern *ere identified t"en t"e# *ere to contact t"e

stud# nurse *"o contacted t"e in%estigator *it"out

re%ea!ing treat&ent grou assign&ent'

(rou 2 Structured -oot a&ination

Standard +"era# 6i)ii)iii

\

Structured -oot a&ination trained to be ab!e to

carr# out a foot ea&ination t*ice dai!# using a &irror

to %isua!ise difficu!t %ie*ing areas of t"e foot e'g'

!antar asect'

4bjecti%e *as to identif# an# redness) disco!ouration)

$armth !y palpation'

ecording of nor&a! and abnor&a! obser%ations *as

conducted in a !og book 6to ro%ide a rotoco! for

e%a!uation *it" t"e additiona! of icture

reresentations'

, se!f$ea&ination c"eck!ist "ad to be co&!eted toensure a!! e!e&ents of t"e foot ea&ination *ere

conducted'

,d%ised to contact stud# nurse of an# abnor&a!

obser%ations'

ascu!ar

assess&ent

inc!uded

a!ation of eda!

u!ses) using t"e

Do!er and

,BP'

nc!usion

riteria

$Diagnosis of

diabetes

$,bi!it# to

ro%ide infor&ed

consent

$,du!ts aged 18$

80$, "istor# of foot

u!ceration

$,BP @ 0'70

c!usion

riteria

$4en *ound

$4en a&utation

$,cti%e c"arcot

art"roat"#

$Se%ere

eri"era! arteria!

disease

$-oot infection

$De&entia

rescribed s"oes

and inso!es

&easured using a

se!f$reorted

/uestionnaire at t"e

end of t"e stud#

ordina! sca!e to

identif# !e%e! of use

e'g' L "ours dai!#

etc'

bet*een$grou

on continuous t

%ariab!es'

$an odds ratio

o&arison of

de%e!o a foot

re!ation to treat

a


68/76

j


Standard t"era# 6i)ii)iii

\

n"anced +"era# trained to use a digita! infrared

t"er&o&eter 6+e&+ouc"' , standardised %ideotae

*as used to train eac" articiant) fo!!o*ed b#

articiant de&onstration back to t"e stud# nurse on

"o* to use t"e t"er&o&eter correct!#' ecorded foot

te&eratures in a !ogbook *it" ictoria! reresentations'

$+e&erature &onitoring of bot" feet on t"e plantar

aspectat . sites 6Ha!!u) 1st) 3rdA 5t"&et "eads) &idfoot

and t"e "ee!

$ f an area "ad been a&utated t"en an adjacent area

*as used for &easure&ent'

, difference of 2'2 degrees ce!cius fro& one footco&ared *it" t"e sa&e site on t"e ot"er foot for @2

da#s t"en articiants "ad to contact t"e stud# nurse and

decrease acti%it# unti! t"e te&eratures returned to

nor&a!'

General comments:

Aim0 )%aluate the effecti%eness of an at home temperature monitoring tool to help high risk dia!etics identify inflammation and areas of their feet $hich are prone to ulceration !efore an ulcer actuall

Results0 the enhanced therapy group had significantly fe$er incidences of ulceration> J/ fold decrease risk of ulcers 13?495 4 ulcers? In comparison to standard therapy 17=?.95 and structured thera

!oth had ;6 ulcerations each essentially identical? aplan:eier sur%i%al analysis sho$ed that the enhanced therapy e*pressed a longer mean time to de%elop an ulcer 1/7=?4 days5 compared to stan

therapy 1.63?4 days5 and structured therapy 1.66?. days5 the o%erall difference !et$een time to de%elop ulcers !y treatment groups $as statistically significant using log rank test 1P28?8;;5? @o$e%er

no difference !et$een the standard and structured therapy for time to ulcerate 1P28?=;85? The enhanced therapy group $as statistically different from !oth the standard therapy 1P28?884=5 and struct

therapy 1P28?88445 in time to ulceration? The test for trend found the enhanced therapy group to !e superior and had a statistically significant trend of sur%i%al compared to standard or structured the

Page | "$



69/76

1P28?8;865? Selfreported daily use of prescri!ed shoes and insoles sho$ed good compliance in all . treatment groups no statistical difference in participants $ho $ore the shoes and insoles for at leas

per day among treatment groups 1standard therapy 3=?49> structured foot therapy 6.?79 and enhanced therapy 3.?895> PJ8?86;?Participants in the enhanced therapy$ho $ere compliant$ith asse

recording foot temperatures 489 of the time $ere less likely to ulcerate 1OR 48?8> PK8?88;5 $hich $as statistically significant? Of those $ho de%eloped an ulcer in the enhanced therapy> 389 did not co

temperature monitoring and participants $ho did not de%elop an ulcer> =79 assessed and recorded their foot temperatures at least 489 of the time? In the structured therapy there $as no statistical d

compliance of recording daily foot assessments in those $ho ulcerated 1/6?;95 and those $ho did not ulcerate 1/.? on a%erage> !ased on pedometer acti%ity> $hene%er an ele%ated tempe

identified there $as a 4;?79 decrease in physical acti%ity?

Study :ethods0 Patient characteristics $ere similar at !aseline 1not statistically significant5? +oodGlarge sample siEe 1;6.5 ;4; completed study total of 77 drop outs $hich $ere e*plained as either %

$ith reasons gi%en e?g? too much to do or due to ad%erse e%ents $ith reasons gi%en e?g? foot trauma :I etc? -ustification of sample siEe $as gi%en and e*plained $as calculated on the !asis of the amo

su!&ects e*pected to ulcerate o%er ;4 months? Planned to ha%e allocation of participants to groups $as then sealed in opaCue en%elopes

concealment? Single !lind study physician !linded 1unfeasi!le to !lind participants due to manual use of temp monitoring tool etc5 participants $ere instructed not to discuss their group allocation

help maintain !linding? +ood length of follo$ up 1;4 months5?Study $as appro%ed !y hospital re%ie$ !oard? Recruitment of participants not mentioned $here $ere they recruited from mentions i

multicentre trial !ut doesnLt gi%en any more details? Inclusion and e*clusion criteria mentioned a!ility to pro%ide informed consent $as mentioned as a prereCuisite for inclusion ho$e%er there $as n

mention if informed consent $as actually o!tained? Primary outcome of foot ulceration $hich $as defined using pre%iously esta!lished criteria #ni%ersity of Te*as Hound ,lassification? No strengths

limitations of the study addressed? No suggestions a!out impro%ing future studies in this research area?

Inter%ention detail0 Standard Therapy0 no e*planation of ho$ lo$er e*tremity e%aluation $as carried outG$hat it consisted of? Patient education program e*plained in further detail %ideotape used t

standardisation? Therapeutic foot$ear and insoles mentioned did each participant recei%e standard foot$earGinsoles Here they customised or prefa!ricated +ood that they e%aluated ho$ long p

foot$ear for daily? Hhen patients inspected their feet did they record findings in a log!ook Daily acti%ity $as monitored !y a pedometer to pro%ide figures on ho$ much people $alked recorded in l

Structured "oot )*am Therapy0 trained to conduct a structured foot e*amination o!ser%ational only> ho$ $as this e*plained to participants Did they each recei%e the same standard training Reco

log!ook $ith pictures for help and had to complete a checklist of elements included in selfe*amination? Purpose of log!ook $as to pro%ide structured e%aluation and to %erify that the e*amination $as

)nhanced therapy0 trained use of temperature monitoring tool $as standardised !y use of a %ideotape to teach participants ho$ to correctly use it follo$ed !y study nurse e%aluating if they used it c

Information of ho$ the temperature monitoring tool $orks $as gi%en? Inter%entions of patient education> therapeutic foot$earGinsoles> foot inspection> structured foot e*amination and use of temperat

reCuires patient compliance? Recording of measurements in log!ook relies on participant honesty?

Page | "0



70/76

3/ibliogra&hiccitationand itle

Studyty&e

uber of&atients

(atientcharacteristics Inter!ention StudyMethods ength offollo, u&

'utcoeeasures Statistical

Armstrong> D?

+?> @oltE

Neiderer> ?>

Hendel> ?>

:ohler> -?>

im!riel> @? R?>

M (a%ery> (? A?

7886?

Skin

temperature

monitoring

reduces the risk

for dia!etic foot

ulceration in high

risk patients

+ 225 Particiants adu!t

%eterans618$80

Mean a!ues

Standard +"era#

,ge .9'7

Se = 9'7 6is t"is &a!eor fe&a!e

Diabetes duration 12'.

#ears

Hb,1c = 7'

euroat"# \ !oss of

sensation 100=

etinoat"# 3'2=

n"anced +"era#

,ge .8'2

Se = 98'2 6is t"is &a!e

or fe&a!e Diabetes duration 13'.

#ears

Hb,1c = 8'1

euroat"# \ !oss of

sensation 100=

2 +reat&ent (rous

(rou 1 Standard +"era# 6ontro!

i'+"eraeutic foot*ear

ii'Diabetic foot education

iii'egu!ar foot care

i%' , structured foot assess&ent *as to be

conducted dai!# and findings recorded in a!ogbook' f an# abnor&a!ities *ere detected

t"en t"e# *ere to contact t"e stud# co$

ordinator as soon as ossib!e'

(rou 2 Der&a! +"er&o&etr#

6n"anced +"era#

Standard t"era# 6i)ii)iii)i%

\

n"anced t"era# using an infrared skint"er&o&eter 6+e&+ouc"

$+e&erature &onitoring of bot" feet at . sites

6not stated) t*ice dai!#'

nc!usion riteria

$+#e 2 diabetes

6recei%ing foot care at

t"e Sout"ern ,ri?ona ,

Hea!t" are S#ste&

$,ges 18$80

$isk ategor# 2or 3 of

t"e nternationa! -oot

isk !assification

S#ste&

c!usion riteria

$,cti%e oen u!cers

$,&utation sites

$-oot infection

$,cti%e c"arcot

,rt"roat"#

$Se%ere eri"era!

%ascu!ar disease 6non$

a!ab!e eda! u!ses or

,BP L0'8 on eit"er

foot

$De&entia or i&aired

18

&ont"s

$

Pri&ar#

&easure

s *ere

obtained

atbase!ine

$-o!!o*

u at 3)

.)9)12

and 18

&ont"s'

Pri&ar# 4utco&e

-oot u!cer

incidence

6roortion of

articiants to

de%e!o an# t#e of

foot u!cer' $,n

u!cer *as defined as

t"e full thicknessloss of the

epidermis or

dermis $ith or

$ithout

in%ol%ement of the

deeper structures

$Pri&ar# endoint

*as nu&ber of

atients in t"e

grous de%e!oing

an# kind of foot

u!cer'

4bjecti%e to

e%a!uate "o*

effecti%e a se!f$

ad&inistered

-or a!! ana!#ses a sta

significance of ^ 5

-or e%a!uation of de

outco&e differences

grous e'g' ti&e to in

u!ceration roducing

contro!!ing for co%ar

Hb,1c) "istor# of aco roortiona! "a?

used'

Ste*ise &ode!!ing

used to se!ect co%ari

b# i!ot stud# e%iden

!iterature

%a!uation of otenti

dic"oto&ous associa

s/uared test *as use

%a!uation of skin te

differences 6co&are

oosite foot at t"e

u!ceration in t"e *ee

an# reu!ceration and

a 1 *eek sa&!e of 5

Page | /



71/76

etinoat"# 23'=

$, te&erature difference of @2'2 degrees

ce!cius bet*een rig"t and !eft foot indicated

atients to contact t"e stud# co$ordinator and

*ere ad%ised to reduce t"eir acti%it# unti! t"e

te&eratures returned to nor&a!'

$e!ained an abso!ute Inor&a!J skin

te&erature !e%e! *ou!d be difficu!t to identif#

due to diabetic disease rocesses'

cogniti%e function

$,cti%e drug or a!co"o!

abuse *it"in !ast #ear

$&aired sig"t 6unab!e

to read t"e big 2'5c&

screen on t"e digita!

t"er&o&eter

$;nab!e to *a!k *it"out

assistance of *"ee!c"air

or crutc"es

te&erature

&onitoring too! to

reduce incidence of

diabetic foot u!cers'

Secondar#

objecti%es t"e

effect of

inter%ention on

u!cer t#e) "ea!t"

re!ated /ua!it# of

!ife) se!f$efficac#)

care satisfaction and

acti%it# &odu!ation'

sa&!ed subjects t"a

u!ceration a Mann$

*as used'

General comments:

Aim0 )%aluate ho$ effecti%e an at home infrared temperature monitoring tool $as in reducing the incidence of foot complications in high risk dia!etic patients at risk of foot ulceration? Study tested h

home temperature monitoring $ould reduce ulcer incidence and positi%ely influence Cuality of life related to health> selfefficacy> care satisfaction and acti%ity modification not addressed in results> to

in future studies

Results0 in total there $ere ;= ulcers o%er the ;3 months 2 3?/9? @o$e%er in the enhanced therapy group had fe$er incidences of ulceration 14 /?695 compared to the standard therapy group 1;/ ;

.?8> ,I ;?83?4> P28?8.3? In addition> the enhanced therapy group $as associated $ith a longer time to ulceration compared to standard therapy group> 1P28?8/5? In addition> proportional standards re

indicated that age> ele%ated foot ulcer classification 1risk category .5 and minority status $ere associated $ith Cuicker time to ulceration than enhanced therapy group> these $as statistically significan

P28?8;> P28?;5 respecti%ely? Of patients that did ulcerate> there $as a temperature difference !et$een the affected foot and contralateral lim! of a /?3 increase at the site of ulceration ; $eek !efore the

de%eloped than in a random 6 consecuti%e day sample of 48 su!&ects $ho did not ulcerate 1P28?88;5?

Study :ethods0 Patient characteristics $ere similar at !aseline 1not statistically significant> PJ8?845? Participants $ere all %eterans $ith dia!etes specific population group states they are a potentia

risk population group does this limit generaliEa!ility +oodGlarge sample siEe 774 largest out of all the studies? No mention of ho$ many completed the study as drop outs $ere not mentioned? )*

sample siEe $as gi%en> calculated on the !ases that $ithin ; year> up to 689 of patients $ith foot ulcer history reulcerate? Felie%ed incidence of ulceration $ould !e 689 in standard therapy and !et$e

enhanced therapy? In this study for an estimated sample siEe of 68 per group 12total 7;8 participants 774 in study5> a log rank test for eCuality of sur%i%al cur%es $ould ==9 po$er to detect /89 dif

po$er for a .89 difference and 3.9 po$er for 749 difference? Interim analyses not performed? No esta!lishment of stopping rules? Randomisation mentioned to the allocation of the 7 groups0 no nu

regarding allocation of randomisation? Process of randomisation gi%en patients $ere consented then randomisation generated %ia a randomised assignment list !y !iostatistician? ,oncealment of ran

not mentioned? Single !linding physician !linded 1unfeasi!le to !lind participants due to manual use of temp monitoring tool etc?5 participants $ere instructed not to discuss their group allocation i

help maintain !linding? During diagnostic e%aluation> the treating physician ne%er conducted temperature monitoring? +ood length of follo$ up 1;3 months longest compared to other studies5? Recru

Page | /1



72/76

mentioned from Southern AriEona A @ealth ,are system single centre trial? :entions that patients $ere consented? No mention of ethics appro%al? Inclusion and e*clusion criteria mentioned0 li

inclusion criteria? Patients $ith sight impairment 1una!le to read thermometer screen5 $ere mentioned as an e*clusion criterion ho$e%er in patient characteristics it states that 7.9 and ./9 of partici

enhanced and structured therapy groups respecti%ely had retinopathy? Outcome measurements0 study definition of $hat they percei%e to !e an ulcer gi%en no use of Hagner classification $hich also i

infectionGischaemia? Some limitations of study addressed e?g? underestimated the sample siEe reCuired? Suggestions for future studies mentioned multicentre trial o%er a longer time period and studies

Cuality of life> functional status> selfefficacy> care satisfaction and cost as this $as not addressed in current study?

Inter%ention Detail0 Standard therapy procedures not e*plained in detail no e*planation as to $hat type of therapeutic foot$ear $as issued> standardised for e%ery patient or customised Did patient

long they $ore shoes for daily No e*planation as to ho$ patients recei%ed dia!etic foot education or process of regular foot care? Participants $ere instructed to perform a structured foot e*aminatio

findings in a log!ook ho$ $as this e*plained to participants to !e carried out Information of ho$ the temperature monitoring tool $orks $as gi%en? Inter%entions reCuire patient compliance? Recor

log!ook relies on patient honesty?

#/ibliogra&hic

citationAnd itle

Studyty&e

uberof

&atients

(atientcharacterist

ics

Inter!ention StudyMethods

ength offollo, u&

'utcoeeasures

Statistical

Page | /2



73/76

Skaf&eld> A?>

I%ersen> :? :?>

@olme> I?> Ri!u>

(?> @%aal> ?> M

ilho%d> F? ?

78;4?

A pilot study

testing the

feasi!ility of skin

temperature

monitoring to

reduce recurrent

foot ulcers in

patients $ith

dia!etes a

feasi!ility study4

+ 1

Standard

+"era# 20

20

co&!eted

stud#

6no dro outs

n"anced

+"era# 21

18

co&!eted

stud#

63 %o!untar#

dro outs

Particiants adu!ts

618$80

,!! articiants

aucasian

Mean a!ues

Standard +"era#

,ge 59'

= Men 75

Diabetes duration

19'5

+#e 1+#e 2

3070

Hb,1c = 7'9

BM 31'1

etinoat"# = 7

Mu!ti!e u!cer"istor# 6= 85

n"anced +"era#

,ge 57'1

= Men 8.

Diabetes duration

17

+#e 1+#e 2

2971

Hb,1c = 8'3

BM 31'

etinoat"# = 0

Mu!ti!e u!cer

"istor# 6= .5

2 +reat&ent (rous

(rou 1 Standard

+"era#6contro!

i'Dai!# foot insection 6!antar) dorsu&

and interdigita! record in a !og book and

contact stud# nurse of an# c"anges)

inc!uding ne* u!cer' ,d"erence to foot

insection *as recorded as a = of da#s

*it" a c"eck indicating foot insection'

ii'usto&ised foot*ear ad%ised to

a!*a#s *ear it

-or genera! &edica! and diabetes care) t"e#

*ere sti!! ab!e to contact t"eir genera!

ractitioners did (Ps kno* t"e# *ere

art of a stud#


6inter%ention

Standard +"era# 6i)ii

\

n"anced t"era# using digita! infrared

t"er&o&eter 6+e&+ouc" &onitoring foot

te&erature' +"e stud# nurse e!ained t"e

urose of t"e t"er&o&eter and "o* to use

it'

$+e&erature &onitoring of !antar asect

of bot" feet at . sites 6not stated

recorded in a !og book dai!#' ,d"erence to

te&erature &onitoring *as recorded as a

nc!usion

riteria:

$Diagnosis of

t#e 1 or t#e

2 diabetes

$,ges 18$80$isk categor#

grou 3 of

Diabetes -oot

isk

!assification

S#ste&

6re%ious

"istor# of foot

u!cer and

eri"era!

neuroat"#

$Must becaab!e of

ro%iding

infor&ed

consent

$Must be

caab!e of

co&!eting a

*ritten

/uestionnaire

$Had to be

*i!!ing to

erfor& foot

skin

te&erature if

assigned to

suc" grou

ossib!e

1 #ear

$!inica! ea&inations

erfor&ed b# ort"oaedic

surgeon and

endocrino!ogist at base!ine

and end of t"e stud# 6:aist

circu&ference) bod#

*eig"t) "eig"t base!ine

on!# to ca!cu!ate BM and

an etensi%e foot

ea&ination *as

conducted a!ation of

u!ses' ,BP) bone) feet

skin and nai! c"anges)

neuro!ogica! assess&ent

6P+ and &onofi!a&ent'

$%a!uation at base!ine and

fo!!o* u %isits e%er# 3&ont"s

:"ere assess&ent of

subjectCs readiness to

record skin foot

te&eratures took !ace

according to ++M stages'

-o!!o*ed b#

$+ai!or stage based

counse!!ing'

5 stages

1' ot using t"et"er&o&eter and does not

intend to'

2' +"inking about using it)

but not in t"e near future'

Pri&ar# outco&e

foot u!cer

occurrence

c!assification b#

t"e Hagner "oot

System? +"is *as

a!so t"e stud#

endoint

articiants

sta#ed in t"e

stud# unti! t"e#

u!cerated or unti!

t"e end of t"e

stud#'

$,t base!ine and

end of stud#)

articiants

co&!eted

/uestionnairesinc!uding

infor&ation on

socio$

de&ogra"ic

%ariab!es 6age)

se) !i%ing

conditions)

education)

e&!o#&ent

status) !ifest#!e

6s&oker)

diabetes re!atedinfor&ation 6t#e

and duration of

diabetes)

associated "ea!t"

rob!e&s) "istor#

-or a!! ana!#ses a sta

significance of t*o$s

ntention to treat basi

Monitoring of foot sk

te&erature *as di%i

L80= or @80=

-or grou co&ariso

continuous %ariab!es

BM) *aist circu&fe

Hb,1c) duration of d

,BP $ indeendent s

tests *ere used'

-or araisa! of t"e e

inter%ention on t"e n

subjects *it" a foot u

eact test *as used'

o&arison of t"e t

regarding foot u!cer

ti&e


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= of da#s *it" foot te&erature

&easure&ents recorded in !ogbook'

$, te&erature difference of @2'0 degrees

ce!cius fro& one foot to t"e oosite at t"e

sa&e site for t*o consecuti%e da#s t"en

t"e# *ere ad%ised to contact stud# nurse

and to &ini&ise "#sica! acti%it# unti!

te&eratures L2'0'

$ecord dai!# "#sica! acti%it# using a

Ste$ounter in a !ogbook during first

*eek

\

+"eor# based counse!!ing suorting t"e

te&erature &onitoring e%er# 3 &ont"s

inc!usion of

bias

c!usion

riteria

$4en u!cers$,cti%e c"arcot

art"roat"#

$,cti%e

osteoe!itis

$sc"ae&ia

6non$a!ab!e

eda! u!ses or

,BP L0'7

3':i!! begin to use it

' Started to use it) but not

on a regu!ar basis 6L80=

of t"e ti&e'

5' ;sing t"er&o&eter

regu!ar!# 6@80= of t"e

ti&e'

of foot u!ceration)

"istor# of

a&utation and

c"arcot

art"roat"#'

$4n co&!etion

of stud#) subjects

a!so co&!eted a

/uestionnaire

regarding use of

custo&ised

foot*ear'

General comments:

Aim0 Test the feasi!ility of foot temperature monitoring in com!ination $ith theory !ased counselling to standard foot care to reduce or pre%ent dia!etic foot ulcer recurrence?

Results0 Throughout the study> the enhanced therapy group e*perienced fe$er incidences of foot ulceration 16 ulcers .=95 compared to standard therapy group 1;8 ulcers 4895> ho$e%er this $as

statistically significant P28?4.7?Also the time to de%elop a foot ulcer did not differ significantly !et$een the t$o groups 1P28?/86> chisCuared at 8? ;/ su!&ects 1 ;/ su!&ects 16895 also recorded foot o!ser%ations J389 of the time? In the enhanced therapy group there $as no as

!et$een temperature monitoring J389 of the time compared to K389 of the time and foot ulcer occurrence time? In the enhanced therapy group> 3 su!&ects e*perienced increased foot temperatures

su!&ects 14895 contacted the study nurse $ith these concerns? and in the standard therapy group> ;7 su!&ects o!ser%ed foot changes of $hich / 1..95 contacted the study nurse? None of these partici

e*perienced foot ulceration? In the enhanced therapy group> 4 su!&ects 17/95 $ore customised foot$ear for J;7h per day compared to 6 su!&ects 1.495 in the standard therapy> ho$e%er this $as not s

significant 1P28?3435?

Study :ethods0 Patient characteristics $ere e*tensi%e and similar at !aseline the only statistically significant difference !et$een groups $as in the urinary al!uminGcreatinine ratio 1789 and as they ha%e an a

increased risk of recurrence? No mention ho$ concealment of randomisation $as carried out? All study procedures $ere performed in the same setting Dia!etes clinic at Oslo uni%ersity hospital? Sing

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study physician !linded 1unfeasi!le to !lind participants due to manual use of temp monitoring tool etc5 ho$ $as !linding maintained No mention that su!&ects $ere instructed not to discuss their

allocation? +ood length of follo$ up 1; year5? Recruitment mentioned < dia!etic outpatient centres and ; podiatrist in Oslo? Study states patients recei%ed full confidentiality and all participants ga%e

$ritten consent? )thics appro%al $as gained? Inclusion and e*clusion criteria mentioned0 slight !ias as patients had to !e $illing to measure foot temperature if they $ere randomised to that group to !

@a%ing ischaemia $as an e*clusion criterion measured !y nonpalpa!le pulses and AFPI K8?6> ho$e%er to !e categorised as ischaemic AFPI is usually K8?4 possi!ly e*cluded non ischaemic patients

measure of foot ulceration $as classified using Hagner scale standardised method that is uni%ersally used therefore can !e generalised? (imitations of study mentioned e?g underpo$ered and it is not

comparison due to use of thermometer and theory !ased counselling? Suggestions of future studies to conduct large scale inter%entions in this area to impro%e patient !eha%iour and foot ulcer recurren

Inter%ention Detail0 Standard therapy0 in foot inspection> no information gi%en on $hat patients $ere told to !e looking for e?g? colour> foot temperature palpation etc Did the nurse use %isual aids or

sho$ them typical $arning signs of foot ulceration Participants $ere ad%ised to $ear customised foot$ear $ere these made as part of the inter%ention and therefore standardised to each su!&ect of t

had participants already !een issued $ith foot$ear pre%iously If so> ho$ old $ere these Some participantLs foot$ear may ha%e !een in !etter condition than others? In the enhanced therapy su!&ects

trained to use thermometer and to conduct daily selfmonitoring of skin temperatures ho$ $as this conducted> %er!ally or %ia standardised %ideotape :inimal information gi%en regarding ho$ the

temperature monitoring tool $orks? No recording of daily acti%ity therefore $hen temperatures ele%ated> ho$ can in%estigators !e sure su!&ects reduced their acti%ity !y half? Inter%entions reCuire pa

compliance? Recording %ia log!ook relies on patient honesty?

Appendi* 404S4+ 2010 ;sed to &ro%e eorting of ando&ised ontro!!ed +ria!s and to ,ssist eaders in ritica! ,raisa!

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DISSERTATION Critical Review Assignment 1.docx

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