HARM WORKSHEET

Citation :

Are the results of this harm study valid ?

Were there clearly defined groups of patients,

similar in all important ways other than
exposure to the treatment or other cause ?
Were treatments/exposures and clinical
outcomes measured in the same ways in both
groups (was the assessment of outcomes
either objective or blinded to exposure) ?
Was the follow-up of study patients complete
and long enough ?
Do the results satisfy some diagnostic test for causation?
Is it clear that the exposure preceded the onset
of the outcome ?
Is there a dose-response gradient ?
Is there positive evidence from
a dechallenge-rechallenge study ?
Is the association consistent from study to
study ?
Does the association make biological sense ?

Are the valid results from this harm study important ?

Adverse outcome
Present Absent Totals
(case) (control)
Yes
Exposed to a b a+ b
(cohort)
the treatment
No
c d c+d
(cohort)
Totals a+c b+d a+b+c+d

In a randomised trial or cohort study : relative risk = RR = a/(a+b) / c/(c+d)

In a case-control study : odds ratio (or relative odds) = OR = ad/bc
Should these valid, potentially important results change the treatment of your patient ?

Is your patient so different from those in the

study that its results dont apply ?
What are your patients risks of the adverse
event ?
To calculate the NNH (number of patients
you need to treat to harm one of them) for
any odds ratio (OR) and your patients
expected event rate for this adverse event if
they were not exposed to this treatment
(PEER) :
PEER(OR I) + I
NNH =
PEER(OR I) x (I PEER)

What are your patients preference,

concerns and expectations from this
treatment ?
What alternative treatments are available ?

Additional notes :
 PROGNOSIS WORKSHEET CRITICAL APPARISAL

Citation : Prognostic indicators of early and late death in

children admitted to
District hospital in Kenya : cohort study
(Berkley JA, et al.BMJcom 2003; 326:361)

Are the results this prognosis study valid ?

Was a defined, representative sample Kriteria sample yaitu pasien yang

of patients assembled at common
(usually early) point in the course of
their disease?
mondok di RS dan meninggal atau
keluar RS, umur > 90 hari dari 1 ulki
1998-30 juni 2001, kriteria ekslusi
pasien yang mondok karena trauma
atau prosedur elektif. Pengamatan
mulai dari masuk RS sampai
meninggal atau keluar RS. Tidak ada
perhitungan jumlah sample. Gejala
klinis didefinisikan jelas, penentuan
skor tidak jelas.

Was patient follow up sufficiency long Tidak jelas ditentukan waktu

and complete? pengamatan, yang ada yaitu
pengamatan dilakukan mulai dirawat
sampai dengan pasien meninggal atau
keluar dari rumah sakit. Semua apsien
yang masuk dalam penelitian diikuti
sampai timbulnya outcome..

Were objectives outcome criteria Outcome yaitu hidup dan kematian

applied in blind fashion? (segera, awal dan lambat), dan
didefinsikan dengan jelas.

If subgroups with different prognoses

are identified :
Was there adjustment for Diterangkan adanya perhitungan
important prognosis factors? terhadap faktor prognostik dengan
penyesuaian/adjusted.
Was there validation in an
independent group of test-set
patients?
Are the valid results of this prognosis study important?

How likely are the outcomes overtime? Perhitungan dengan likelihood ratio.

How precise are the prognostic

estimates?

Can you apply this valid, important evidence about prognosis in carring for your
patient?

Were the study patients similar to your Pasien pada peneltian ini ada
own? kesamaan dengan pasien yang kami
rawat, yang berbeda yaitu kedaan
lingkungan, dan kejadian HIV
Will this evidence make clinically Hasil penelitian tidak dapat
important impact on your conclusions menunjukkan dengan jelas tentang
about what to offer or tell your patient? factor prognosis yang diteliti.
 DIAGNOSIS WORKSHEET CRITICAL APPARISAL

Citation : Testing for Helycobacter pylory infection :

validation and diagnostic yield of a near patient
test in primary care
(Duggan AE, et al. BMJ 1999; 319:1236-39)

Are the results this diagnosis study valid ?

Was there an independent, blind Tidak disebutkan secara jelas adanya

comparison with a reference (gold)
standard diagnosis?
Was the diagnostic test evaluated in an
appropriate spectrum of patients (like
those in whom it would we use in
practice?
pembutaan dalam pemeriksaan, tetapi
secara eksplisit tampaknya pemeriksa
tidak mengetahui hasil masing masing
pemeriksaan ( gold standard yaitu cara
ELISA dan tes Flexure.)
Tes dilakukan terhadap pasien dengan
keluhan dyspepsia, yang merupakan
salah satu dari gejala umum infeksi
Helyco bacter

Was the reference standard applied

regardless of the diagnostic test result?

Was the test (or cluster of tests)

validated in second, independent group
of patients?

Are the valid results of this diagnosis study important?

Sensitivitas : 90/134 = 67% (95% CI 59%-75%)

Spesifisitas : 236/241= 98% (95% CI 95%-99%)
LR + : 67%/(1-98%)=67%/2% = 34
LR - : (1-67%)/98%=33%/98%=35
PPV : 90/95 = 95%
NPV : 230/280=82%
Pretest probability (prevalence) : 90+44/90+5+44+236=
133/375= 35%
Pre test odds :35%/(1-35%)=35%/65%=0,54
Post test odds: 0,54 X34=18
Post test probability = 18/(18+1)=95%

Can you apply this valid, important evidence about a diagnosis in carring for your
patient?
Is the diagnostic test available, Tes belum tersedia ditempat saya
affordable, accurate, and precise in bekerja
your setting?

Can you generate in your clinically

sensible estimate of your patients pre
test probability?
From personal experience,
prevalence statistic, practice
databases, or primary studies

Are the study patients similar to

your own?
Is it unlikely that the disease
possibilities have changed since Pasien pada penelitian ini adalah
this evidence was gathered? pasien dewasa (umur 18-72 tahun)

Will the resulting post-test probabilities

affect your management and help your
patient?
Could it move us across a test-
treatment threshold?
Would you patient be a willing
partner in carrying it out?
Would the consequences of the
test help your patient?
 THERAPY WORKSHEET CRITICAL APPARISAL

Citation :

Are the results of the single preventive or therapeutic tria valid ?

Was the assignment of patients to

treatment randomized?
Was the randomized list concealed?
Was follow-up of patients sufficiently
long and complete?
Wee all patients analyzed in the groups
to which they were randomized?
Were patients an clinicians kept blind
to treatment?
Were the groups treated equally, apart
from the experimental treatment?
Were the groups similar at the start of
the trial?

Are the valid results of this randomized trial important ?

Relative Risk Reduction (RRR) :

Control event rate (CER)-Experimental Event Rate (EER)
CER
=

Absolute Risk Reduction (ARR) :

CER EER =

Number Needed to treat (NNT) :

1/ARR =

95% CI on an NNT = 1/(limits on the CI of its ARR =

Can you applay this valid, important evidence about therapy in carring for your
patient?
 Do these results apply to your patient?
Is your patient so different from those in
the study that is results cannot apply?
Is the treatment feasible in your
setting?
What are you patients potential benefits and harm from the therapy?
Method I : f Risk of the outcome in your patient,
relative to patients in the trial
Expressed as a decimal : ________
NNT/f =

(NNT for patiens like yours)

Method II:1/(PEER X RRR) Your patients EER if they Received the
control treatment (PEER)
=

(NNT for patients like yours)

Are your patients values preferences satisfied by the regimen
and its consequences?
Do your patient and you have a clear
assessment of their values and
preferences?
Are they met by this regimen and its
consequences?

Additional notes :

ECONOMIC EVALUATION
Citation :

Are the results of the single preventive or therapeutic tria valid ?

Is the report asking an economic

question :
That compared all well=defined
course of action?
With a specified point of view
from which the cost and
outcomes are being viewed?
Dose the economic analysis cite valid
evidence on the efficacy of the
alternatives?
Does this economic analysis identify all
the costs and effects we think it should
and select credible and accurate
measures for the them?
Was the type of analysis appropriate
for the question posed?
Was the robustness of the conclusion
tested?

Are the valid results of this economic analysis important?

Are the resulting costs or cost/unit of

health gained clinically significant?
Did the results of this economic
analysis change with sensible changes
to costs and effectiveness?

Are the valid, important results of this economic analysis applicable to our
patients/ practice?

Do the costs in the economic analysis

apply in our setting?
Re the treatments likely to be effective
in our setting?
 SYSTEMATIC REVIEW ( of the Therapy) WORKSHEET CRITICAL
APPARISAL

Citation :

Are the results of the single preventive or therapeutic tria valid ?

Is it systematic review of randomized

trials of the treatment you are
interested in?
Dose in 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 he valid results of this systematic review important?

Translating oods ratios to NNTs. The numbers in the body of this table are the
NNTs for the corresponding odds ratios at that particular patients expected event
rate (PEER)
Can you apply this valid, important evidence from a systematic review in
caring for your patient?

Do these results apply to your patient?

Is your patient so different from
those in the overview that its
results cant help you?

How great would the potential

benefit of therapy actually be for
your individual patient?
o Method I :
Find the intersection of
the closest odds ratio
from the overview and the
CER that is closest to
your patients expected
event rate if they received
the control treatment
(PEER)

o Method II :
TO calculated the NNT
for any OR and PEER.

Are your patients values and Preferences satisfied by regimen and

Its consequences?
DO your patients and you have
a clear assessment of their
values and preferences?

Are they met by this regiment

and its consequences?

Should you believe apparent qualitative differences in the efficacy of therapy in

some subgroups of patients? Only if you can say yes to al of the following :

1.Do they really make biologic and clinical sense?

2.Is the qualitative difference both clinically (beneficial for some but useless or
harm for others) and statistically significant?
3.Was this difference hypothesis before the study began ( rather than the product
of dredging the data), and has it been confirmed in other, independent studies?
4.Was this one of just a few subgroup analysis carried out in this study?

Additional notes :
 GUIDELINES WORKSHEET CRITICAL APPARISAL

Citation :

Are the recommendations In this guideline valid?

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?

3.Are the relative preference that key

stakeholders attach to the outcomes
of decisions ( including benefits, risks
and costs) identified and explicitly
considered?

4.Is the guideline resistant to clinically

sensible variations in practice?

Is the valid guideline or strategy potentially useful?

1.Does this guideline offer an

opportunity for significant
improvement in the quality of health
care practice?

2.Is there a large variation in current

practice?
3.Does the guideline contain new
evidence ( or old evidence not yet
acted upon) that could have an
important impact on management?
4.Would the guidelines 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 major
impacts on health outcomes or
resources (including opportunity
costs)?

Should this guideline or strategy be applied in your practice?

1.What barriers exist to its

implementation?

Can they be overcome ?

2.Can you enlist the collaboration of

key colleagues?

3.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 (without the
need for extensive outside
collaboration)
Freedom from conplict with
economic incentives,patient
expectations, and community
expectaions

Additional comments :