Ebm Terapy DK 1

8/13/2019 Ebm Terapy DK 1

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THERAPY WORKSHEET

Citation:

Chloramphenicol versus ampicillin plus gentamicin for community

acquired very severe pneumonia among children aged 2-59 months in low

resource settings: multicentre randomised controlled trial (SPEAR study)



are the result of single preventive or therapeutic trial valid

Was the assignment of patients to

treatments randomized?

Yes, (method).

Was the randomization list concealed? Yes,individual patient assigment were

placed in opaque sealed envelopes

Was follow-up of patients sufficiently

long and complete?

Yes, follow up to the patient until 21

days. All participants evaluates at home

and at 10 days and 21 days.

Were all patients analyzed in the groups

to which they were randomized?

Yes, all randomised children were

incluaed in the intention to treat analysis

for the primary outcome of treatment

failure at five days

Were patients, clinicians, and study

personnel kept “blind” to treatment?

No. non blind.

Were the groups treated equally, apart

from the experimental treatment?

Yes, the group were treated equally,

evaluated at 48 hours at 10 and 21 days.

Were the groups similar at the start of

the trial apart from the experimentaltherapy?

Yes, criteria inclusion ang aclusion of the

study.



are the valid result of this randomized trial important?

What is the magnitude of the treatment

effect?

CEER, EER, RRR, ARR, NNT

How precise is the estimate of the treatment

effect?

CI



Your calculation

yes no Total

control 77 402 479

experiment 54 425 479

Relative riskreduction (RRR)

Absolute riskreduction

(ARR)

Numberneeded to

treat (NNT)

CER EER CER − EERCER

CER − EER 1/ARR

77/479=0,160=16%

54/479=0,110=11%

16%-11%16%

=31%

16%-11%

=5%

1/5%

=20 pasien



Can you apply this valid, important evidence about therapy in

caring for your patient?

Do these results apply to our patient?

Is our patient so different fromthose in the study that its resultscannot apply?

No,

Is the treatment feasible in oursetting?

Yes, it is discable, because there areampicilin ang gentamicin

What are our patient’s potential benefits and harms from the therapy?Method I : f Risk of the outcome in our patient,

relative to patients in the trial.Expressed as a decimal:______NNT/f=___20___/____1__=___20___

(NNT for patients like ours)Method II : 1/(PEER × RRR) Our patient’s expected event rate if

they received the control treatment(PEER) =______1/(PEER × RRR)=1/________=______

(NNT for patients like ours)



Method II : 1/(PEER × RRR) Our patient’s expected event rate if

they received the control treatment(PEER) =______1/(PEER ×

RRR)=1/________=______

(NNT for patients like ours)

Are our patient’s values and preferences satisfied by the regimen andits consequences? YES

Do we and our patient have a clearassessment of their values andpreferences?

YES

Are they met by this regimen andits consequences?

YES

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Ebm Terapy DK 1