Checklist for Assessing Randomised Clinical Trial Reports

Title : A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute
appendicitis (APPAC trial)
Authors

Are potential conflicts of interest acknowleged?

baru-baru ini telah banyak minat dan peningkatan penggunaan

terapi antibiotik sebagai pengobatan utama untuk acute
appendicitis yang rumit. Namun, penggunaan terapi
antibiotik dalam pengobatan acute appendicitis yang rumit
masih kontroversial.

Introduction

Was the study justified in terms of current knowledge and

potential benefits?

Ya, dibenarkan dan penelitian tersebut berpotensi untuk di teliti

lebih lanjut

Is the objective of the study sufficiently described?

Tujuan dari percobaan APPAC adalah untuk

membandingkan Terapi antibiotik (ertapenem) dengan
emergency appendectomy pada pengobatan CT
scan confirmed uncomplicated acute appendicitis
yang rumit.

Is the source of the subjects (and the location of the trial)

sufficiently described?

Ya di jelaskanan, hal ( 2-3 ) bagian Trial design & Participants

Are inclusion/exclusion criteria adequately defined?

Ya di jelaskan , hal (3) bagian participants

Was the study subject to independent ethical review?

Ya dijelaskan hal (5) bagian Ethics and informed consent

Were the interventions (treatments) adequately defined?

Ya di jelaskan di Hal ( 4) bagian Interventions

Were primary and secondary outcome measures defined?

Ya di jelaskan di Hal ( 3 ) bagian Outcome parameters

Method

Protocol

Were minimum important differences in outcome defined?

Was there an estimate of target sample size with a power
calculation (that is, number of subjects required)?

Ya di jelaskan Hal ( 5 ) bagian Sample size calculation

Were statistical methods for comparative analyses defined?

Ya di jelaskan Hal ( 5 ) bagian Cost analysis

Were stopping rules defined (if applicable)?

Assignment

Was the method used to create the randomisation described?

Ya dijelaskan hal (3) bagian Randomization

Who generated the allocation sequence, who enrolled participants,

and who assigned participants to their groups?

pengacakan ini dibuat peneliti dengan rasio perbandingan 1:1.

Sebanyak 610 amplop buram, disegel, dan secara berurutan
nomor amplop diacak, dicampur dan didistribusikan ke rumah

sakit penelitian, oleh pusat penelitian utama, disetiap masingmasing rumah sakit di wilayah tersebut,Untuk mengacak
pasien, dokter bedah yang independen bertugas akan membuka
nomor urut berikutnya amplop.
Blinding

Were the following defined? Mechanism (e.g. capsules, tablets,

injection); similarity of treatment characteristics (e.g. appearance,
taste); allocation schedule control (location of code and when
broken); evidence for successful blinding among participants
(person doing intervention, outcome assessors, data analysts).

Ya di jelaskan Hal ( 3 )

Results

Was the time and duration of the study specified?

Participant
flow

Should include the number of eligible patients; number (and

reasons) not randomised; number receiving standard treatment and
intervention; withdrawals; number completing trial.

Analysis

Were treatment and control groups comparable in relevant

measures?
Were protocol deviations described and explained?
Is there a clear statement of the estimated effect on primary and
secondary end points including confidence interval?
Are results stated in absolute numbers (10/50 not 50%) where
feasible?
Were the statistical analyses appropriate?
Were confidence intervals given for the main results?
Were adverse effects reported in sufficient detail?

Discussion

Is there an interpretation of findings, sources of bias and

imprecision?
Is there an interpretation of the data in the context of current
knowledge and clinical practice?
Do the conclusions follow from the objective and the results?

Abstract

Is the abstract structured?

Is it consistent with the method, results and discussion?

Graeme Vernon, Austin Health Drug Information, May 2011

Ya di jelaskan