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CRITICAL APPRAISAL
Oleh:
Dr. Argo Ismoyo
04012771822004
Program Studi Bedah
Pembimbing:
Dr. Achmad Ridwan, M.O, M.Sc
Reference : Eric S. Hungness & Ezra N. Teitelbaum & Byron F. Santos & Fahd O.
Arafat & John E. Pandolfino & Peter J. Kahrilas & Nathaniel J. Soper
Received: 24 July 2012 / Accepted: 27 August 2012 # 2012 The
Society for Surgery of the Alimentary Tract
No. PICOS
1. Patients In Patient with Aclasia
2. Intervention Peroral esophageal myotomy
3. Comparison Compared to existing standard treatment
laparascopic Heller
4. Outcome Perioperative Outcomes
5. Study Design Cohort study
VALIDITY
Are the results of this diagnostic study valid?
1a. R- Was the assignment of patients to treatments randomised?
What is best? Where do I find the information?
Centralised computer randomisation is No, performed in a nonrandomized fashion.
ideal and often used in multi-centred trials.
Smaller trials may use an independent
person (e.g, the hospital pharmacy) to
“police” the randomization.
1b. R- Were the groups similar at the start of the trial?
What is best? Where do I find the information?
If the randomisation process worked (that is, Yes, diagnose of aclasia, age 18-85 absence
achieved comparable groups) the groups of prior achalasia treatment
should be similar. The more similar the
groups the better it is.
There should be some indication of whether
differences between groups are statistically
significant (ie. p values).
2a. A – Aside from the allocated treatment, were groups treated equally?
What is best? Where do I find the information?
Apart from the intervention the patients in Yes, Both of the treated equally pre operative
the different groups should be treated the and post operative
same, eg., additional treatments or tests.
2b. A – Were all patients who entered the trial accounted for? – and were they
analysed in the groups to which they were randomised?
What is best? Where do I find the information?
Losses to follow-up should be minimal – No, 18 patients underwent POEM and
preferably less than 20%. However, if few from,and 55 patients meeting the same
patients have the outcome of interest, then eligibility criteria underwent LHM.
even small losses to follow-up can bias the After follow up only 16 POEM patients had
results. Patients should also be analysed in per-protocol HRM, and
the groups to which they were randomised – 13 POEM patients completed follow-up TBE
‘intention-to-treat analysis’. at 6 weeks postoperatively
3. M - Were measures objective or were the patients and clinicians kept “blind” to
which treatment was being received?
What is best? Where do I find the information?
It is ideal if the study is ‘double-blinded’ – The study is objective research but patients
that is, both patients and investigators are and clinicians were not blinded because they
unaware of treatment allocation. If the were randomized
outcome is objective (eg., death) then
blinding is less critical. If the outcome is
subjective (eg., symptoms or function) then
blinding of the outcome assessor is critical.
IMPORTANCE
Would the consequences of the test Yes, the test will help our patients in
help your patient? predicting spontaneous preterm labor.