CRITICAL APPRAISAL

JURNAL READING

Oleh :

Ilma Putri Dewanti (10711054)

Pembimbing :

dr. A. Ralibi, Sp. B

Pendidikan Klinik Ilmu Bedah

FK UII/ RSUD CARUBAN KAB. MADIUN

2015

Jurnal Terapi

Judul Jurnal : Quality of life in patients with chronic anal fissure after

topical treatment with diltiazem

Penerbit : World Journal Gastrointestinal Surgery. Vol. 4, No.251 - 255, November

27, 2012. World Journal Gastrointestinal Surgery.

Validitas

1a. Apakah

alokasi pasien

terhadap

terapi/perlakuan

dilakukan secara

random?

Tidak Alokasi pasien dilakukan secara penelitian prospektif.

Pasien berturut-turut yang terdaftar secara prospektif

dalam penelitian. Kualitas hidup diukur

dengan survei kesehatan pendek forum 36 (SF-36) sebelum

dan setelah pengobatan 6-minggu dengan diltiazem.

“Consecutive patients were enrolled prospectively into the study. Quality of life was measured with the short-forum 36 health survey (SF-36) before and after 6-wk treatment with diltiazem.”

(Terdapat dalam Materials and Methods halaman252.)

1b. Apakah

randomisasi

dilakukan

tersembunyi?

Tidak (√) Pihak peneliti tidak merandomisasi secara tersembunnyi terhadap

terapi yang diberikan.

(Tidak tercantumkan dalam Materials and Methods halaman252.)

1c. Apakah

antara subyek

penelitian dan

peneliti “blind”

terhadap terapi/

perlakuan yang

akan diberikan?

Tidak(√) Subyek penelitian dan peneliti mengetahui intervensi apa yang

diterima oleh subyek penelitian.

“Patients were advised to squeeze 2 cm of the diltiazem gel onto a finger and to apply this 1 cm inside the anus and to the anal margin. Each patient was given a 6-wk course of the diltiazem gel for twice-daily application, as close to every 12 h as possible. Objective changes were assessed by the inspection of the anus to determine the extent of fissure healing (recorded as “healed” or “persistent”) at baseline and weeks 1, 3 and 6.”

(Terdapat dalam Materials and Methods halaman252.)

2a. Apakah

semua pasien

yang ikut serta

Ya (√)

Tidak

Semuasubyek yang

ikutsertadalampenelitiandiperhitungkandalamhasildankesimpulan,

namunterdapat5 subyek dari kelompok CP dan 6 dari kelompok

dalam penelitian

diperhitungkan

dalam hasil /

kesimpulan?

(apakah

pengamatannya

cukup lengkap?)

AMC yang tidak menyelesaikan penelitian.

“Of the 60 enrolled patients, 49 patients (81.7%) completed the

trial. 5 patients in the CP group and 6 in the AMC group were

excluded due to poor compliance, self discontinuation or adverse

reactions. There was no significant difference regarding treatment

compliance (83.3% vs. 80.0%).”

(Terdapatdalam Resultspada bagianDemographics and clinical

characteristicshalaman85.)

2b.

Apakahpengamat

an yang

dilakukancukuppa

njang?

Ya (√)

Tidak

Intervensi yang dilakukancukuppanjangyaitu14 hari untuk tiap

kelompok, selanjutnya dievaluasi pada hari 1, 7, 14 dan 28

setelah intervensi diberikan.

“Patients were randomly assigned to either CP or AMC groups

using the table of random sampling numbers: the former received

150 mg tablet three times daily (450 mg/day) and the latter 625

mg tablet three times daily (4:1 form of AMC, Amoxicillin 1,500

mg/day) for 14 days..... All patients were instructed to visit the

clinic on days 7, 14, and 28 after initial treatment.”

(TerdapatdalamMaterials and Methodshalaman84.)

2c.

Apakahsubyekdia

nalisispadakelom

pokdimanasubyek

tersebutdikelomp

okkandalamrando

misasi?

Ya (√)

Tidak

Subyekdianalisisberdasarkanpadakelompokdimanasubyektersebu

tdialokasikan. KelompokCPterdiridari25subyekdankelompok

AMCterdiridari24subyek.

(TerdapatpadaTabel3 di bagianResultshalaman86.)

3a.

Selainperlakuan

yang

dieksperimenkan,

apakahsubyekdip

erlakukansama?

Ya (√)

Tidak

Setiap subyek dalam masing-masing kelompok dievaluasi dengan

nasal endoscopy pada hari 1, 7, 14 setelah intervensi dan sinar X

paranasal sinus pada hari 1 dan 14 setelah intervensi.

“Nasal endoscopy and paranasal sinuses X-rays (Waters and

Caldwell views) were also performed in every patient during

the initial visit day for confirmation of the diagnosis and follow up

images were performed to monitor progress and check

effectiveness. Endoscopic examinations were performed on days

1, 7, and 14 and paranasal sinus X-rays on days 1 and 14 (Table

1).”

(TerdapatdalamMaterials and Methodspada bagian Clinical

assessmenthalaman84)

3b.

Apakahkelompok

dalampenelitiansa

mapadaawalpene

litian?

Ya (√)

Tidak

Subyekpadaawalpenelitianadalahsamaberdasarkankriteriainklusid

aneksklusi yang ditetapkanolehpeneliti. Kelompok CP berjumlah

25 dan kelompok AMC berjumlah 24 subyek.

“Any patients who had hypersensitivity to penicillin, cephalosporin

and beta-lactam lineage antibiotics or had been on antibiotics 2

weeks before enrollment were excluded from this study. Patients

who experienced orbital cellulitis or intracranial extension of the

infection or who were required to be hospitalized are considered

to have severe disease are excluded...... Between June 2007

and January 2010, patients over 15 years of age with a clinical

diagnosis of ARS were recruited from the outpatient clinic of

Seoul National University Hospital, Seoul, Korea. The diagnosis of

ARS (presumed bacterial) was made based on the guidelines

provided by the American Academy of Otolaryngology-Head and

Neck Surgery (4). Diagnosis required symptoms consistent with

ARS plus objective findings.

Patients with symptoms of ARS that showed the following

patterns were included; symptoms present for at least 10 days

and up to 28 days; patients with severe disease with presence of

nasal purulence for 3-4 days with high fever; and patients whose

symptoms initially regress but then worsen within the first 10 days.

Symptoms of ARS included at least 2 major symptoms or 1 major

plus 2 minor symptoms.”

(TerdapatdalamMaterials and Methodshalaman84)

Importance

1. 1. Berapa besar

efek terapi?

Perubahan gejala pada hari ke 7, 14 dan 28 menunjukkan hasil yang signifikan untuk kedua kelompok (P< 0,001), namun terdapat relaps pada 1 subyek di

kelompok AMC.

“On their second visit (day 7), complete remission of symptoms or partial improvement of symptoms was seen in 96.0% and 100.0% of patients in the CP and

AMC groups, respectively; on the third visit (day 14), 96.0% and 95.8% of the patients in each group showed improvement; and on the fourth visit (day 28), 100%

and 95.9% showed improvement compared to pretreatment. The change of symptom scores was statistically significant on days 7, 14, and 28 in both

groups (P<0.001), however there was no difference between the two groups in any visit period.

(Terdapat pada Results di bagian Therapeutic outcomeshalaman 85.)

2. 2. Seberapa tepat

estimasi efek

terapi?

Meskipunterdapat11subyek yang tidakmenyelesaikanpenelitian, namuntidakadaperbedaandanpengaruh yang signifikanterhadapperhitunganhasildankesimpulan.

“Of the 60 enrolled patients, 49 patients (81.7%) completed the trial. 5 patients in the CP group and 6 in the AMC group were excluded due to poor compliance,

self discontinuation or adverse reactions. There was no significant difference regarding treatment compliance (83.3% vs. 80.0%).

(TerdapatpadaResults di bagianDemographics and clinical characteristicshalaman

3. Applicable

4. 1. Apakah hasil

penelitian dapat

diterapkan untuk

pasien saya?

Ya, karena tidak ada aspek budaya yang membedakan pada kriteria inklusi maupun eksklusi dalam penelitian ini.

5. 2. Apakah pasien

saya dapat

menerima dan

puas pada terapi

dalam penelitian

ini?

Ya, karena terapi pada penelitian sudah terbukti secara klinis memberikan perbaikan signifikan terhadap rinosinusitis akut yang diduga bakteri.

Simpulan: dari hasil critical appraisal didapatkan bahwa jurnal ini valid, penting dan dapat

diaplikasikan.