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JournalReading

IX

Exercise Frequency, Health Risk Factors, and Diseasesof the Elderly

Wolfgang Kemmler, PhD, Simon von Stengel, PhDFrom the Institute of Medical Physics, niversity of !rlangen"#urn$erg %Friedrich"&le'ander niversit(at

!rlangen"#(urn$erg), !rlangen,

*ermany+Presented by Akhmad Yahin,MDu!er"ised by Rachmat #$%Physiatrist

Reason for re ection- .+ Pa/er not relevant to 0ey 1uestion 2+ 3ther reason %/lease s/ecify)-

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study Does this study do it?

.+. 4he study addresses an a//ro/riate and clearly focused 1uestion +i 5es6an7t say

#o

.+2 4he assignment of su$ ects to treatment grou/s is randomised+ ii 5es6an7t say

#o

.+8 &n ade1uate concealment method is used+ iii 5es

6an7t say

#o

.+9 Su$ ects and investigators are 0e/t :$lind7 a$out treatmentallocation+ iv

5es

6an7t say

#o

.+; 4he treatment and control grou/s are similar at the start of thetrial+v

5es6an7t say een grou/s is the treatment underinvestigation+ vi

5es6an7t say

#o

.+? &ll relevant outcomes are measured in a standard, valid andrelia$le >ay+ vii

5es

6an7t say

#o

.+@ What /ercentage of the individuals or clusters recruited into eachtreatment arm of the study dro//ed out $efore the study >ascom/letedA viii

=,;B

.+C &ll the su$ ects are analysed in the grou/s to >hich they >ererandomly allocated %often referred to as intention to treatanalysis)+ ix

5es6an7t say

#oDoes not a//ly

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2+. o> >ell >as the study done to minimise $iasACode as follows : x

igh 1uality %EE)

&cce/ta$le %E)

nacce/ta$le re ect G

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2+8 &re the results of this study directly a//lica$le tothe /atient grou/ targeted $y this guidelineA

5es

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i nless a clear and >ell defined 1uestion is s/ecified, it >ill $e difficult to assess ho> >ell the study has metits o$ ectives or ho> relevant it is to the 1uestion you are trying to ans>er on the $asis of its conclusions+

ii Random allocation of /atients to receive one or other of the treatments under investigation, or to receiveeither treatment or /lace$o, is fundamental to this ty/e of study+

iii &llocation concealment refers to the /rocess used to ensure that researchers are una>are >hich grou/

/atients are $eing allocated to at the time they enter the study+ Research has sho>n that >here allocationconcealment is inade1uate, investigators can overestimate the effect of interventions $y u/ to 9GB+

iv linding refers to the /rocess >here$y /eo/le are 0e/t una>are of >hich treatment an individual /atienthas $een receiving >hen they are assessing the outcome for that /atient+ It can $e carried out u/ to threelevels+ Single $linding is >here /atients are una>are of >hich treatment they are receiving+ In dou$le $lindstudies neither the clinician nor the /atient 0no>s >hich treatment is $eing given+ In very rare cases studiesmay $e tri/le $linded, >here neither /atients, clinicians, nor those conducting the analysis are a>are of>hich /atients received >hich treatment+ 4he higher the level of $linding, the lo>er the ris0 of $ias in thestudy+

v Patients selected for inclusion in a trial must $e as similar as /ossi$le+ 4he study should re/ort anysignificant differences in the com/osition of the study grou/s in relation to gender mi', age, stage of disease

%if a//ro/riate), social $ac0ground, ethnic origin, or co"mor$id conditions+ 4hese factors may $e covered $yinclusion and e'clusion criteria, rather than $eing re/orted directly+ Failure to address this 1uestion, or theuse of ina//ro/riate grou/s, should lead to the study $eing do>ngraded+

vi If some /atients received additional treatment, even if of a minor nature or consisting of advice andcounselling rather than a /hysical intervention, this treatment is a /otential confounding factor that mayinvalidate the results+ If groups were not tre te! e"u ##$% t&e stu!$ s&ou#! 'e re(e)te! u*#ess *o ot&ere+,!e*)e ,s + ,# '#e- If the study is used as evidence it should $e treated >ith caution+

vii 4he /rimary outcome measures used should $e clearly stated in the study+ If t&e out)o.e .e sures re*ot st te!% or t&e stu!$ ' ses ,ts . ,* )o*)#us,o*s o* se)o*! r$ out)o.es% t&e stu!$ s&ou#! 'ere(e)te!- Where outcome measures re1uire any degree of su$ ectivity, some evidence should $e /rovidedthat the measures used are relia$le and have $een validated /rior to their use in the study+

viii 4he num$er of /atients that dro/ out of a study should give concern if the num$er is very high+6onventionally, a 2GB dro/ out rate is regarded as acce/ta$le, $ut this may vary+ Some regard should $e/aid to >hy /atients dro//ed out, as >ell as ho> many+ It should $e noted that the dro/ out rate may $ee'/ected to $e higher in studies conducted over a long /eriod of time+ & higher dro/ out rate >ill normallylead to do>ngrading, rather than re ection of a study+

i' In /ractice, it is rarely the case that all /atients allocated to the intervention grou/ receive the interventionthroughout the trial, or that all those in the com/arison grou/ do not+ Patients may refuse treatment, orcontra"indications arise that lead them to $e s>itched to the other grou/+ If the com/ara$ility of grou/sthrough randomisation is to $e maintained, ho>ever, /atient outcomes must $e analysed according to thegrou/ to >hich they >ere originally allocated irres/ective of the treatment they actually received+ %4his is0no>n as intention to treat analysis+) If it is clear that analysis >as not on an intention to treat $asis, the

study may $e re ected+ If there is little other evidence availa$le, the study may $e included $ut should $eevaluated as if it >ere a non"randomised cohort study+

' Rate the overall methodological 1uality of the study, using the follo>ing as a guide- H,g& "u #,t$ %EE)-Ma ority of criteria met+ ittle or no ris0 of $ias+ Results unli0ely to $e changed $y further research+A))ept '#e %E)- Most criteria met+ Some fla>s in the study >ith an associated ris0 of $ias, 6onclusions maychange in the light of further studies+ Low "u #,t$ %G)- !ither most criteria not met, or significant fla>s relatingto 0ey as/ects of study design+ 6onclusions li0ely to change in the light of further studies+