Laporan Critical Appraisal

Analisis PICOProblem/PatientWanita, 50 tahun, faringitis

InterventionTonsilektomi

ComparisonTidak dilakukan tonsilektomi

OutcomeMencegah kekambuhan infeksi Streptokokus pada faring

Type of QuestionTerapi

Type of StudyRCT

Teknik Pencarian Menuliskan keyword pada situs pencarian Google Scholar Kata kunci yang digunakan adalah : pharyngitis + therapy + randomized controlled trial

Jurnal yang didapatJudul TulisanTonsillectomy Versus Watchful Waiting in Recurrent Streptococcal Pharyngitis in Adults: Randomised Controlled Trial

PenulisOlli-Pekka Alho, Petri Koivunen, Tomi Penna, Heikki Teppo, Markku Koskela,Jukka Luotonen

Nama jurnal dan tahun terbitBMJ, doi:10.1136/bmj.39140.632604.55 (published 8 March 2007)

Validitas

PertanyaanJawabJelaskan dan sebutkan di mana penjelasan tersebut dituliskan

1a. Apakah alokasi pasien terhadap terapi / perlakuan dilakukan secara random?YaPada halaman 1, dalam bahasan Abstract baris ke-4.

Design : Randomised controlled trial.

Halaman 1, dalam bahasan Methods Study Design

... To avoid disparity between group sizes,we used replacement randomisation

1b. Apakah randomisasi dilakukan tersembunyi?YaBaris ke-4 halaman 2 dalam bahasan Methods Study Design.

... A research assistant not involved in the assignment or care of the trial patients generated the randomisation sequence with a computer random number generator. The assistant concealed the allocation sequence from the investigators who enrolled the participants by putting the assigned treatments in sequentially numbered, opaque, sealed envelopes.

1c. Apakah antara subjek penelitian dan peneliti blind terhadap terapi/perlakuan yang akan diberikan?TidakKarena salah satu grup (tonsillectomy group) dipastikan menerima perlakuan pembedahan, maka subjek tahu perlakuan yang akan diberikan kepadanya. Sedangkan peneliti (investigator) maupun asisten peneliti tidak ikut dalam perlakuan/operasi (asisten juga tidak ikut dalam penilaian).

Peneliti

Baris ke-4 halaman 2 dalam bahasan Methods Study Design.

... A research assistant not involved in the assignment or care of the trial patients generated the randomisation sequence with a computer random number generator. The assistant concealed the allocation sequence from the investigators who enrolled the participants by putting the assigned treatments in sequentially numbered, opaque, sealed envelopes.

Subjek penelitian Baris ke-10 halaman 2 dalam bahasan Methods Study Design.

... These were opened sequentially only after an eligible participant had been found and informed consent obtained ...

2a. Apakah semua subjek yang ikut serta dalam penelitian diperhitungkan dalam hasil/kesimpulan?YaPada skema Enrolment and allocation of patients in study di halaman 3, sub judul Results Patients tertulis :

Analysed (intention to treat) (n=34) Analysed (intention to treat) (n=36)

dimana jumlahnya sama dengan jumlah subjek yang dipakai dari awal (n=70)

2b. Apakah pengamatan yang dilakukan cukup panjang?YaTerdapat pada halaman 3 dalam pembahasan Results

All patients were seen at follow-up visits and were followed up for at least the scheduled 90 days, the mean lengths of follow-up being 164 days (SD 63) in the control group and 170 days (SD 12) in the tonsillectomygroup.

2c. Apakah subjek dianalisis pada kelompok di mana subjek tersebut dikelompokkan dalam randomisasi?YaPada bahasan Methods Statistical Analysis halaman 2 dan 3.

... For the primary and secondary end points, all participants were analysed on an intention to treat basis.

All data analyses were done according to a pre-established plan. Descriptive data are given as means (SD) or as medians with interquartile ranges. We used theMann-Whitney U test to compare continuous variables. We constructed survival curves, as they related to the treatment group, according to the Kaplan-Meier method, starting from the date of the randomisation. The differences between the groups were tested with the log rank test.

3a. Selain perlakuan yang dieksperimenkan, apakah subjek diperlakukan sama?YaPada bahasan Methods Surveillance Protocol halaman 2.... Patients were given a prepaid microbiological postal package and the phone number of the study nurse with instructions to order a new package immediately after using one. The package included equipment fortaking a specimen (Transpocult, Orion Diagnostica, Helsinki, Finland).

... All participants were advised to visit their own general practitioner whenever they had acute symptoms suggestive of pharyngitis.

Patients used diaries to record their acute symptoms (fever, throat pain, cough, and rhinitis), episodes of pharyngitis, and visits to a doctor.

... Patients in the tonsillectomy group also documented the duration of postoperative throat pain. At the follow-up visit, we collected the diaries and checked them for completeness.

3b. Apakah kelompok dalam penelitian sama pada awal penelitian?YaDalam bahasan Results Patients halaman 3.

The first patient underwent randomisation in October 2001, and the last participant completed the study inDecember 2005. We screened 298 candidates, 226 of whom were excluded, and two declined to participate. Most of those excluded had too few episodes of pharyngitis or had undocumented or non-streptococcal episodes or chronic tonsillitis. Of the 70 remaining patients who we enrolled, 34 were randomly assigned to the control group and 36 to the tonsillectomy group. All patients were seen at follow-up visits and were followed up for at least the scheduled 90 days ...

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