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THERAPY WORKSHEET: page 1 of 2

Citation:

Are the results of this single preventive or therapeutic trial valid? 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 e ually?

Were the groups similar at the start of the trial?

Are the valid results of this randomised trial important? !A"#$% &A$&'$A()*+!, *ccurrence of diabetic -elative -isk neuropathy -eduction --'sual )nsulin )ntensive &%- - %%&ontrol )nsulin &%%vent -ate %xperimental &%%vent -ate %%0123 4153 0123 - 4153 0123 6 7.3

Absolute -isk -eduction A-&%- - %%-

+umber +eeded to (reat ++( ./A--

0123 - 4153 6 2153 891:3 to 01:3;

./2153 6 .< pts, 8.. to 4:;

0<3 &onfidence )nterval 8&); on an ++( 6 . / 8limits on the &) of its A--; 6

=*'- &A$&'$A()*+!, -elative -isk -eduction --&%- - %%&%Absolute -isk -eduction A-&%- - %%+umber +eeded to (reat ++( ./A--

&%-

%%-

THERAPY WOR !HEET: page " of "

Can #ou appl# this valid$ important evidence a%out a treatment in caring for #our patient? >o these results apply to your patient? )s your patient so different from those in the trial that its results can?t help you?

@ow great would the potential benefit of therapy actually be for your individual patient?

"ethod ), f

-isk of the outcome in your patient, relative to patients in the trial1 expressed as a decimal, AAAAAA ++(/B 6 AAAAA/AAAAA 6 AAAAAAAAA 8++( for patients like yours; =our patient?s expected event rate if they received the control treatment, #%%-,AAAAAA

"ethod )), & ' (PEER ) RRR*

. / 8#%%- x ---; 6 ./AAAAAAAA 6 AAAAAAA 8++( for patients like yours; Are your patient?s values and preferences satisfied by the regimen and its conse uences? >o your patient and you have a clear assessment of their values and preferences?

Are they met by this regimen and its conse uences?

Additional +otes:

!Y!TE,AT-C RE.-EW (of Therap#* WOR !HEET: page & of " Citation:

Are the results of this s#stematic revie/ of therap# valid? )s it a systematic review of randomised trials of the treatment you?re interested in?

>oes it include a methods section that describes, finding and including all the relevant trials?

assessing their individual validity?

Were the results consistent from study to study?

Are the valid results of this s#stematic revie/ important? (ranslating odds ratios to ++(s1 (he numbers in the body of the table are the ++(s for the corresponding odds ratios at that particular patient?s expected event rate 8#%%-;1
*dds -atios 8*-; C17< C17 C12< 5: 20 <0 9: :2 :. 49 4C .7 .5 .9 .4 .< .4 .C .9 .. 0 .2 :9 .: 47 .C 44

12

&ontrol %vent -ate


3

8&%-;
45

1C< 1.C 14C 1:C 19C 1<C 17C 10C

C10 4C0 ..C 2. 92 9C :5 99 .C.

C15< .:0 7: 9C :C 42 4< 45 29

C15 .C9 <9 :C 44 .0 .5 4C 92

C12 <4 47 .9 .C 0 5 0 .5

C1<< 92 49 .: 0 5 7 7 .<

C1< 9. 4. .. 5 7 2 2 .4

. (he relative risk reduction 8---; here is .C31 4 (he --- here is 903 : Bor any *-, ++( is lowest when #%%- 6 1<C 9 (he --- here is .3 < (he --- here is 03

!Y!TE,AT-C RE.-EW(of Therap#* WOR !HEET: page " of " Can #ou appl# this valid$ important evidence from a s#stematic revie/ in caring for #our patient? >o these results apply to your patient? )s your patient so different from those in the overview that its results can?t help you? @ow great would the potential benefit of therapy actually be for your individual patient?
"ethod ), )n the table on page ., find the intersection of the closest odds ratio from the overview and the &%- that is closest to your patient?s expected event rate if they received the control treatment 8#%%-;,

"ethod )), (o calculate the ++( for any *- and #%%-,


AAA. - D#%%- x 8. *-;EAAAA ++( 6 *-; 8. - #%%-; x #%%- x 8. -

Are your patient?s values and preferences satisfied by the regimen and its conse uences? >o your patient and you have a clear assessment of their values and preferences?

Are they met by this regimen and its conse uences?

!hould #ou %elieve apparent 0ualitative differences in the efficac# of therap# in some su%groups of patients? Onl# if #ou can sa# 1#es2 to all of the follo/ing: 1. >o they really make biologic and clinical sense? 2. )s the ualitative difference both clinically 8beneficial for some but useless or harmful for others; and statistically significant? 3. Was this difference hypothesised before the study began 8rather than the product of dredging the data;, and has it been confirmed in other, independent studies? 4. Was this one of Fust a few subgroup analyses carried out in this study?

Additional +otes:

3-A4+O!-! WOR !HEET: page & of " Citation:

!ackett Gune .002

Are the results of this diagnostic stud# valid? 5. Was there an independent, blind comparison with a reference 8gold; standard of diagnosis?

6. Was the diagnostic test evaluated in


an appropriate spectrum of patients 8like those in whom it would be used in practice;?

7. Was the reference standard applied


regardless of the diagnostic test result?

Are the valid results of this diagnostic stud# important? !A"#$% &A$&'$A()*+!,
(arget >isorder 8iron deficiency anaemia; #resent Absent 7:. b 47C a 75 d .<CC c 5C0 aIc bId .77C (otals

>iagnostic (est -esult 8serum ferritin;

#ositive 8H2< mmol/$; +egative 8J2< mmol/$; (otals

aIb .CC. cId .<75 aIbIcId 4<70

!ensitivity 6 a/8aIc; 6 7:./5C0 6 0C3 !pecificity 6 d/8bId; 6 .<CC/.77C 6 5<3 $ikelihood -atio for a positive test result 6 $-I6sens/8.-spec;60C3/.<362 $ikelihood -atio for a negative test result6$--68.-sens;/spec6.C3/5<36C1.4 #ositive #redictive Kalue 6 a/8aIb; 6 7:./.CC. 6 7:3 +egative #redictive Kalue 6 d/8cId; 6 .<CC/.<75 6 0<3 #re-test #robability 8prevalence; 6 8aIc;/8aIbIcId; 6 5C0/4<70 6 :43 #re-test-odds 6 prevalence/8.-prevalence; 6 :.3/203 6 C19< #ost-test odds 6 #re-test odds x $ikelihood -atio #ost-test #robability 6 #ost-test odds/8#ost-test odds I .;

=*'- &A$&'$A()*+!,
(arget >isorder #resent >iagnostic (est -esult #ositive +egative (otals c aIc a b d bId .77C Absent aIb cId aIbIcId (otals

!ensitivity 6 a/8aIc; 6 !pecificity 6 d/8bId; 6 $ikelihood -atio for a positive test result 6 $-I6sens/8.-spec;6 $ikelihood -atio for a negative test result6$--68.-sens;/spec6 #ositive #redictive Kalue 6 a/8aIb; 6 +egative #redictive Kalue 6 d/8cId; 6 #re-test #robability 8prevalence; 6 8aIc;/8aIbIcId; 6 #re-test-odds 6 prevalence/8.-prevalence; 6 #ost-test odds 6 #re-test odds x $ikelihood -atio 6

#ost-test #robability 6 #ost-test odds/8#ost-test odds I .; 6

3-A4+O!-! WOR !HEET: page " of "

Can #ou appl# this valid$ important evidence a%out a diagnostic test in caring for #our patient? )s the diagnostic test available, affordable, accurate, and precise in your setting?

&an you generate a clinically sensible estimate of your patient?s pre-test probability 8from practice data, from personal experience, from the report itself, or from clinical speculation; Will the resulting post-test probabilities affect your management and help your patient? 8&ould it move you across a test-treatment threshold?L Would your patient be a willing partner in carrying it out?; Would the conse uences of the test help your patient?

Additional +otes:

PRO4+O!-! WOR !HEET: Citation:

Page & of "

!ackett Gune .002

Are the results of this prognosis stud# valid? 8. Was a defined, representative sample of patients assembled at a common 8usually early; point in the course of their disease?

9. Was patient follow-up sufficiently long


and complete?

10.

Were obFective outcome criteria applied in a blind fashion?

11.

)f subgroups with different prognoses are identified, was there adFustment for important prognostic factors?

12.

Was there validation in an independent group 8test-set; of patients?

PRO4+O!-! WOR !HEET: Page " of " Are the valid results of this prognosis stud# important?

13.

@ow likely are the outcomes over time?

14.

@ow precise are the prognostic estimates?

-f #ou /ant to calculate a Confidence -nterval around the measure of Prognosis:


&linical "easure #roportion 8as in the rate of some prognostic event, etc; where, the number of patients 6 n the proportion of these patients who experience the event 6 p !tandard %rror 8!%; Dp x 8.-p; / nE where p is proportion and n is number of patients (ypical calculation of &) )f p 6 49/2C 6 C19 8or 9C3; M n62C !%6DC19 x 8.-C19; / 2CE 6 C1C2: 8or 21:3; 0<3 &) is 9C3 I/- .102 x 21:3 or 47123 to <4193

n from your evidence, AAAAAAAA

Dp x 8.-p; / nE where p is proportion and n is number of patients

=our calculation, !%, AAAAAAAAAAAA 0<3 &),

p from your evidence, AAAAAAAA

Can #ou appl# this valid$ important evidence a%out prognosis in caring for #our patient? 15. Were the study patients similar to your own?

16.

Will this evidence make a clinically important impact on your conclusions about what to offer or tell your patient?

Additional +otes:

HAR,'AET-O5O4Y WOR !HEET: Page & of " Citation:

!ackett Gune .002

Are the results of this harm stud# valid? 1. Were there clearly defined groups of patients, similar in all important ways other than exposure to the treatment or other cause?

1. Were treatment exposures and clinical


outcomes measured the same ways in both groups 8e1g1, was the assessment of outcomes either obFective 8e1g1, death; or blinded to exposure;?

1. Was the follow-up of study patients


complete and long enough?

>o the results satisfy some diagnostic tests for causation? 0* )s it clear that the exposure preceded the onset of the outcome? 1* )s there a dose-response gradient?

2* )s there positive evidence from


a dechallenge-rechallenge study?

3* )s the association consistent


from study to study?

17.

>oes the association make biological sense?

Are the valid results from this harm stud# important?


Adverse *utcome #resent Absent 8&ase; 8&ontrol; %xposed to the (reatment =es 8&ohort; (otals

a b aIb +o c d cId 8&ohort; (otals aIc bId aIbIcId )n a randomised trial or cohort study, -elative -isk 6 -- 6 Na/8aIb;O/Nc/8cId;O )n a case-control study, *dds -atio 8or -elative *dds; 6 *- 6 ad/bc )n this study,

HAR,'AET-O5O4Y WOR !HEET: Page " of "

!hould these valid$ potentiall# important results of a critical appraisal a%out a harmful treatment change the treatment of #our patient? 1. &an the study results be extrapolated to your patient?

1. 6What are your patient?s risks of the


adverse outcome?
(o calculate the ++@ for any *dds -atio 8*-; and your #atient?s %xpected %vent -ate for this adverse event if they were +*( exposed to this treatment 8#%%-;, ++@ 6 #%%- 8*- - .; I . 1 #%%- 8*- - .; x 8. - #%%-;

1. What are your patient?s preferences,


concerns and expectations from this treatment?

18.

What alternative treatments are available?

Additional +otes:

2 (he +umber of #atients you +eed to treat to @arm one of them1

ECO+O,-C A+A5Y!-! WOR !HEET: Page & of " Citation:

!ackett Gune .002

Are the results of this economic anal#sis valid? 19. )s this report really asking an economic uestion,

20. 21.

comparing well-defined alternative courses of action?

with a specified point-of-view 8a hospital, a ministry of health, or preferably society as a whole; from which the costs and effects are being viewed? 22. With clinically useful expressions of the costs and conse uences of the alternative courses of clinical action? 23. %ffects e ual, and a simple comparison of costs, cost-minimisation analysis1 24. %ffects une ual but measured in the same common unit of health, costeffectiveness analysis1 25. %ffects both une ual and measured in more than one kind of unit of health1 26. &onverted into monetary units, costbenefit analysis1 27. &onverted into personal preferences or utilities 8PA$=s;, cost-utility analysis12 28. >oes it cite good evidence 8that would meet the (herapy, >iagnosis, or *verview Quides; on the efficacy/accuracy of the alternatives?

29.

>oes it identify all the costs and effects you think it should, and did it select credible measures for them?

Are the valid results from this economic anal#sis important? 30. Are the resulting costs or costs/unit of health gained impressive?

31. Are the conclusions unlikely to


change with sensible changes in costs and outcomes?

ECO+O,-C A+A5Y!-! WOR !HEET: Page " of ": A league table of costs to gain one additional uality adFusted life year 8PA$=;,
&ost/PA$= 8R Aug1 .00C; (reatment &holesterol testing and diet therapy 8all adults aged 9C-20; 44C +eurosurgical intervention for head inFury 49C Advice to stop smoking from general practitioner 47C +eurosurgical intervention for subarachnoid haemorrhage 90C Antihypertensive treatment to prevent stroke 8ages 9<-29; 09C #acemaker implantation ..CC @ip replacement ..5C Kalve replacement for aortic stenosis ..9C &oronary artery bypass graft 8left main vessel disease, severe angina; 4C0C Sidney transplant 97.C Treast cancer screening <75C @eart transplantation 759C &holesterol testing and treatment 8incrementally; of all adults aged 4<-:0 .9,.<C @ome haemodialysis .7,42C &oronary artery bypass graft 8one vessel disease, moderate angina; .5,5:C &ontinuous ambulatory periotoneal dialysis .0,57C @ospital haemodialysis 4.,07C %rythropoietin treatment for anaemia in dialysis patients 8assuming .C3 reduction in mortality; <9,:5C +eurosurgical intervention for malignant intracranial tumours .C7,75C %rythropoietin treatment for anaemia in dialysis patients 8assuming no increase in survival; .42,40C adapted from, "ason G, >rummond ", (orrance Q, !ome guidelines on the use of cost-effectiveness league tables1 T"G .00:L:C2,<7C-41

!hould this economic anal#sis %e applied in #our practice? 32. >o the costs in it apply in your own setting?

33.

Are the treatments likely to be as effective in your setting?

34. 35.

)s it worth it? )f a cost-minimisation analysis, is the difference in costs big enough to warrant switching over to the cheaper one?

36.

)f a cost-effectiveness analysis, is the difference in effectiveness great enough for you to want to spend the difference?

37.

)f a cost-utility analysis, where does it lie in your local, current league table?

Additional Comments:

3EC-!-O+ A+A5Y!-! WOR !HEET: Page & of & !ackett -evised Guly 4C, .002 Citation: Are the results of this clinical decision anal#sis valid?

38.

Were all the important clinical strategies and outcomes included?

39.

Are the probabilities credible? 8Was an explicit and sensible process used to identify, select, and combine the best external evidence into probabilities?; Are the utilities credible? 8Were the utilities obtained in an explicit and sensible way from credible sources?;

40.

41.

Was the robustness of the conclusion tested? 8Was the impact of clinically sensible differences in probabilities and utilities determined?;

Are the valid results from this decision anal#sis important? 42. >id one course of action lead to clinically important gains in lifeexpectancy or other utility measure?

43.

Was the same course of action preferred despite clinically sensible changes in probabilities and utilities?

!hould this decision anal#sis %e applied in #our practice? >o the probabilities apply to your patient? )f not, can you adFust them appropriately?

&an your patient state their utilities in a usable and stable form?

Additional +otes:

46-3E5-+E! WOR !HEET: Page & of " Citation:

!ackett -evised Guly 4., .002

Are the recommendations in this guideline valid? 44. Were all important decision options and outcomes clearly specified?

45.

Was the evidence relevant to each decision option identified, validated, and combined in a sensible and explicit way?

46.

Are the relative preferences that key stakeholders attach to the outcomes of decisions 8including benefits, risks and costs; identified and explicitly considered? )s the guideline resistant to clinically sensible variations in practice?

47.

-s this valid guideline or strateg# potentiall# useful? 48. >oes this guideline offer an opportunity for significant improvement in the uality of health care practice?

49.

)s there a large variation in current practice?

50.

>oes the guideline contain new evidence 8or old evidence not yet acted upon; that could have an important impact on management?

51.

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 maFor

impacts on health outcomes or resources 8including opportunity costs;?

46-3E5-+E! WOR !HEET: Page " of ": !hould this guideline or strateg# %e applied in #our practice? 52. What barriers exist to its implementation?

&an they be overcome?

53.

&an you enlist the collaboration of key colleagues?

54.

&an you meet the educational, administrative, and economic conditions that are likely to determine the success or failure of implementing the strategy? 55. credible synthesis of the evidence by a respected body

56.

respected, influential local exemplars already implementing the strategy consistent information from all relevant sources

57. 58.

opportunity for individual discussions about the strategy with an authority 59. user-friendly format for guidelines

60.

implementable within target group of clinicians 8without the need for extensive outside collaboration; 61. freedom from conflict with economic incentives, administrative incentives, patient expectations, and community expectations1

Additional Comments: