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THERAPY WORKSHEET: page 1 of 2

Title of the article : .


First athors : .
!or"al : .
A. #A$%&%TY: Are the reslts of this si"gle pre'e"ti'e or therapetic trial 'ali()
Was the assignment of patients to treatments
randomised?
and was the randomisation list concealed?
Were all patients who entered the trial accounted
for at its conclusion?
and were they analysed in the groups to
which they were randomised?
Were patients and clinicians kept blind
to which treatment was being received?
Aside from the experimental treatment,
were the groups treated equally?
Were the groups similar at the start of the trial?
THERAPY WORKSHEET* PA+E 1 OF 2
ccurrence of diabetic
neuropathy
!elative !isk
!eduction
!!!
Absolute !isk
!eduction
A!!
"umber "eeded
to #reat
""#
$sual %nsulin
&ontrol 'vent
!ate
&'!
%ntensive
%nsulin
'xperimental
'vent !ate
''!
&'! ( ''!
&'!
&'! ( ''! )*A!!
+,-. /,0. +,-. ( /,0. 1
2).
+,-.
+,-. ( /,0. 1
-,0.
34,5. to +,5.6
)*-,0. 1 )7
pts,
3)) to /56
,. %-PORTA./E
Sa0ple calclatio"s8
123 /o"fi(e"ce %"ter'al 4/%5 o" a" ..T 6 1 7 4li0its o" the /% of its ARR5 6

Yor calclatio"s8
!elative !isk
!eduction
!!!
Absolute !isk
!eduction
A!!
"umber "eeded
to #reat
""#
&'! ''! &'! ( ''!
&'!
&'! ( ''! )*A!!
THERAPY WORKSHEET: page 2 of 2
/. APP$%/A,%$%TY: /a" 8o appl8 this 'ali(9 i0porta"t e'i(e"ce a:ot a
treat0e"t i" cari"g for 8or patie"t)
1. Do these results apply to your patient?
%s your patient so different from those
in the trial that its results can9t help
you?
:ow great would the potential benefit
of therapy actually be for your
individual patient?
;ethod %8 f f 1 !isk of the outcome in your patient,
relative to patients in the trial, expressed as a
decimal 1 <<<,
""# for patients like yours 1 ""#*f 1 <,,,* <
1 <<<
;ethod %%8 1 7 4PEER ; RRR5 PEER 1 =our patient9s expected event rate if
they received the control treatment 1 <<,,
3""# for patients like yours6 1
) * 3>''! x !!!6 1 )* <<<<,1 <<<
2. Are your patients values and preferences satisfied by the regimen and its
consequences?
?o your patient and you have a clear
assessment of their values and
preferences?
Are they met by this regimen and its
consequences?
A((itio"al .otes:
SYSTE-AT%/ RE#%EW 4of Therap85 WORKSHEET: page 1 of 2
/itatio":
Are the reslts of this s8ste0atic re'ie< of therap8 'ali()
%s it a systematic review of randomised trials
of the treatment you9re interested in?
?oes it include a methods section that
describes8
finding and including all the relevant
trials?
assessing their individual validity?
Were the results consistent from study to
study?
Are the 'ali( reslts of this s8ste0atic re'ie< i0porta"t)
#ranslating odds ratios to ""#s, #he numbers in the body of the table are the ""#s for the
corresponding odds ratios at that particular patient9s expected event rate 3>''!6,
dds !atios 3!6
@,+ @,07 @,0 @,27 @,2 @,-7 @,- @,77 @,7
,@7 /@+
)
)5+ )@4 05 -+ 7+ 7/ 4- 4)
/
,)@ ))@ 25 74 45 5- 5) /2 /4 /)
&ontrol ,/@ -) 4@ 5@ /4 /@ )2 )4 )5 ))
'vent ,5@ 4- 5@ // )0 )4 )/ )@ + 0
!ate ,4@ 4@ /- )+ )7 )/ )@ + 0 2
3&'!6 ,7@
5
50 /7 )0 )4 )) + 0 2 -
,2@ 44 /0 /@ )- )5 )@ + 2 -
,+@ )@)
4
-4 4- 54 /2 // )0 )7 )/
7
)
#he relative risk reduction 3!!!6 here is )@.,
/
#he !!! here is 4+.
5
Aor any !, ""# is lowest when >''! 1 ,7@
4
#he !!! here is ).
7
#he !!! here is +.
SYSTE-AT%/ RE#%EW4of Therap85 WORKSHEET: page 2 of 2
/a" 8o appl8 this 'ali(9 i0porta"t e'i(e"ce fro0 a s8ste0atic re'ie< i" cari"g for
8or patie"t)
?o these results apply to your patient?
%s your patient so different from those
in the overview that its results can9t
help you?
:ow great would the potential benefit
of therapy actually be for your
individual patient?
;ethod %8 %n the table on page ), find
the intersection of the closest odds
ratio from the overview and the &'!
that is closest to your patient9s
expected event rate if they received
the control treatment 3>''!68
;ethod %%8 #o calculate the ""# for
any ! and >''!8
BBB) ( C>''! x 3) (
!6DBBBB
""# 1 3) ( >''!6 x >''! x 3) (
!6
Are your patient9s values and preferences satisfied by the regimen and its
consequences?
?o your patient and you have a clear
assessment of their values and
preferences?
Are they met by this regimen and its
consequences?
Shol( 8o :elie'e appare"t =alitati'e (iffere"ces i" the efficac8 of therap8 i" so0e
s:grops of patie"ts) O"l8 if 8o ca" sa8 >8es? to all of the follo<i"g:
), ?o they really make biologic and clinical sense?
/, %s the qualitative difference both clinically 3beneficial for some but useless or harmful for
others6 and statistically significant?
5, Was this difference hypothesised before the study began 3rather than the product of
dredging the data6, and has it been confirmed in other, independent studies?
4, Was this one of Eust a few subgroup analyses carried out in this study?
A((itio"al .otes:
&%A+.OS%S WORKSHEET: page 1 of 2 Fackett Gune )++-
/itatio":
Are the reslts of this (iag"ostic st(8 'ali()
), Was there an independent, blind
comparison with a reference
3gold6 standard of diagnosis?
/, Was the diagnostic test evaluated
in an appropriate spectrum of
patients 3like those in whom it
would be used in practice6?
5, Was the reference standard
applied regardless of the
diagnostic test result?
Are the 'ali( reslts of this (iag"ostic st(8 i0porta"t)
=$! &AH&$HA#%"F8
#arget ?isorder #otals
>resent Absent
?iagnostic
#est !esult
>ositive a b aIb
"egative c d cId
#otals aIc bId aIbIcId
Fensitivity 1 a*3aIc6 1 Fpecificity 1 d*3bId6 1
Hikelihood !atio for a positive test result 1 H!I1sens*3)(spec61
Hikelihood !atio for a negative test result1H!(13)(sens6*spec1
>ositive >redictive Jalue 1 a*3aIb6 1
"egative >redictive Jalue 1 d*3cId6 1
>re(test >robability 3prevalence6 1 3aIc6*3aIbIcId6 1
>re(test(odds 1 prevalence*3)(prevalence6 1
>ost(test odds 1 >re(test odds x Hikelihood !atio 1
>ost(test >robability 1 >ost(test odds*3>ost(test odds I )6 1
&%A+.OS%S WORKSHEET: page 2 of 2
/a" 8o appl8 this 'ali(9 i0porta"t e'i(e"ce a:ot a (iag"ostic test i" cari"g
for 8or patie"t)
%s the diagnostic test available,
affordable, accurate, and precise in
your setting?
&an you generate a clinically
sensible estimate of your patient9s
pre(test probability 3from practice
data, from personal experience, from
the report itself, or from clinical
speculation6
Will the resulting post(test
probabilities affect your management
and help your patient? 3&ould it move
you across a test(treatment
threshold?K Would your patient be a
willing partner in carrying it out?6
Would the consequences of the test
help your patient?
A((itio"al .otes:
PRO+.OS%S WORKSHEET: Page 1 of 2 Fackett Gune )++-
/itatio":
Are the reslts of this prog"osis st(8 'ali()
), Was a defined, representative sample of
patients assembled at a common 3usually
early6 point in the course of their disease?
/, Was patient follow(up sufficiently long and
complete?
5, Were obEective outcome criteria applied in
a blind fashion?
4, %f subgroups with different prognoses are
identified, was there adEustment for
important prognostic factors?
7, Was there validation in an independent
group 3test(set6 of patients?
PRO+.OS%S WORKSHEET: Page 2 of 2
Are the 'ali( reslts of this prog"osis st(8 i0porta"t)
), :ow likely are the outcomes over time?
/, :ow precise are the prognostic
estimates?
%f 8o <a"t to calclate a /o"fi(e"ce %"ter'al aro"( the 0easre of Prog"osis:
&linical ;easure Ftandard 'rror 3F'6 #ypical calculation of &%
>roportion 3as in the rate of
some prognostic event, etc6
where8
the number of patients 1 n
the proportion of these patients
who experience the event 1 p
Cp x 3)(p6 * nD
where p is proportion and n is
number of patients
%f p 1 /4*-@ 1 @,4 3or 4@.6 L
n1-@

F'1C@,4 x 3)(@,46 * -@D 1 @,@-5
3or -,5.6
+7. &% is 4@. I*( ),+- x -,5. or
/2,-. to 7/,4.
n from your evidence8 BBBBBBBB
p from your evidence8 BBBBBBBB
Cp x 3)(p6 * nD
where p is proportion and n is
number of patients
=our calculation8
F'8 BBBBBBBBBBBB
+7. &%8
/a" 8o appl8 this 'ali(9 i0porta"t e'i(e"ce a:ot prog"osis i" cari"g for 8or
patie"t)
), Were the study patients similar to your
own?
/, Will this evidence make a clinically
important impact on your conclusions
about what to offer or tell your patient?
A((itio"al .otes:
+@%&E$%.ES WORKSHEET: Page 1 of 2 Fackett !evised Guly /), )++-
/itatio":
Are the reco00e"(atio"s i" this gi(eli"e 'ali()
1. Were all important decision options and
outcomes clearly specified?
2. Was the evidence relevant to each
decision option identified, validated, and
combined in a sensible and explicit way?
A. Are the relative preferences that key
stakeholders attach to the outcomes of
decisions 3including benefits, risks and
costs6 identified and explicitly
considered?
B. %s the guideline resistant to clinically
sensible variations in practice?
%s this 'ali( gi(eli"e or strateg8 pote"tiall8 sefl)
), ?oes this guideline offer an opportunity
for significant improvement in the quality
of health care practice?
%s there a large variation in current
practice?
?oes the guideline contain new evidence
3or old evidence not yet acted upon6 that
could have an important impact on
management?
Would the guideline affect the
management of so many people, or
concern individuals at such high risk, or
involve such high costs that even small
changes in practice could have maEor
impacts on health outcomes or resources
3including opportunity costs6?
+@%&E$%.ES WORKSHEET: Page 2 of 2:
Shol( this gi(eli"e or strateg8 :e applie( i" 8or practice)
), What barriers exist to its implementation?
&an they be overcome?
/, &an you enlist the collaboration of key
colleagues?
5, &an you meet the educational,
administrative, and economic conditions
that are likely to determine the success or
failure of implementing the strategy?
credible synthesis of the evidence by
a respected body
respected, influential local exemplars
already implementing the strategy
consistent information from all
relevant sources
opportunity for individual discussions
about the strategy with an authority
user(friendly format for guidelines
implementable within target group of
clinicians 3without the need for
extensive outside collaboration6
freedom from conflict with economic
incentives, administrative incentives,
patient expectations, and community
expectations,
A((itio"al /o00e"ts:

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