Telaah Kritis Uji Terapi [PDF]

Citation preview

Mutiara Tri Florettira 04011181621058



Critical Appraisal Therapy Study (Randomized Controlled Trial) Judul artikel : Three day versus five day treatment with amoxicillin for non-severe pneumonia in young children: a multicentre randomised controlled trial Penulis utama



: G. Agarwal



Jurnal



: BMJ. 2004 Apr 3;328(7443):791







SCREENING Does the study question match your question?







Yes (three day course of amoxicillin for treating community acquired nonsevere pneumonia in children is equally as effective as a five day course







Was the study design appropriate?







Yes (Randomised controlled trial)







Yes (Loss to follow up was 5.4% by day 5, and 6.8% by day 14)







No (follow up was limited to only 15 days)



R: Randomization  Were the recruited patients representative of the target population?







Yes (Participants were children aged 2-59 months with complaints of cough, rapid respiration, or difficulty in breathing)







Was the allocation (assignment) of patients to treatment randomized and concealed? I: Intention to Treat Analysis  Were patients analyzed in the groups to which they were randomized?







Yes (This double blind, placebo controlled, randomised trial)







Yes (We compared baseline and other characteristics and therapeutic failures between the two treatment groups)











Yes (We also performed per protocol analysis for participants with complete follow up and adherence to treatment)



VALIDITY F: Patient Follow-Up  Were all patients who entered the trial properly accounted for at its conclusion? Losses to follow-up should be less than 20% and reasons for drop-out given. 



Was follow-up long enough?



Were all randomized patient data analyzed? If not, was a sensitivity or “worst case scenario” analysis done?



Mutiara Tri Florettira 04011181621058



S: Similar Baseline Characteristics of Patients  Were groups similar at the start of the trial?



B: Blinding  Were patients, health workers, and study personnel “blind” to treatment?  If blinding was impossible, were blinded raters and/or objective outcome measures used? E: Equal Treatment  Aside from the experimental intervention, were the groups treated equally? Conflict of Interest  Are the sources of support and other potential conflicts of interest acknowledged and addressed? Summary of Article’s Validity  Notable study strengths or weaknesses or concerns?







How serious are the threats to validity and in what direction could they bias the study outcomes?







Yes (There were no substantial differences in the baseline characteristics of the treatment groups)







Yes (Block randomisation, with variable sized blocks, was done for each participating site to avoid unblinding)







Tidak ada data pada artikel mengenai intervensi/perlakuan yang diberikan saat penelitian selain intervensi eksperimental)







No (Tidak disebutkan didalam artikel)







Yes (The main strengths of our trial were that it was large, double blind, and multicentre and was conducted over two years covering all four seasons with a minimal loss to follow up and good adherence to treatment. Its limitations are that is was a hospital based study, causes of infection were not investigated, follow up was limited to only 15 days, and children with history of asthma were excluded)







Bisa meningkatkan kemungkinan false positive



Mutiara Tri Florettira 04011181621058



CLINICAL IMPORTANCE



Treated/Exposed Control (Not exposed)



Out come present a= c=



Outcome absent b= d=



a+b c+d



CER *Control event rate)=c/(c+d) EER (experimenal event rate) =a/(a+b) RR (Relative Risik)=(a+b)/(c+d) RRR (relative Risi reduction)/RBI (relative Benefit Increase)=(CER-EER)/CER ARI (Atributable Riskk Reduction)/ABI (Absolut Benefit Increase)-CER-EER NNT (Bnmber Needed tto Treat) 1/RRR RESULTS OF IMPORTANCY



APPLICABILITY ` Similar patient 1. Are your patients similar to those in the study? 2. Are they so different that the results can’t help you Apakah tersedia obat, keahllian, fasilitas, biaya yg diperlukkan? 3. How much of the study effect can you expect for your patients Apakah pasin dan keluarga dapat menerima pemberian obat/pengobatan atas dasar nilai nilai sosial, budaya dan agama? Realistic Interventions 4. Is the intervention realistic in your setting? 5. Does the comparison intervention reflect your current practice? 6. What alternatives are available Right Outcomes 7. Have all the right outcomes been considered? 8. Are the outcomes appropriate to your patient? 9. Does the intervention meet their values and preferences? Overall conclusion



Jawab sesuai dengan keadaan di tempat praktik