EBM

CRITICAL APPRAISAL

”Use of Statins and the Risk of Death in Patients WithProstate Cancer”

Disusun oleh :

Rizkie Arianti Putri Noor 1102010254

Raditya Sakti Prabowo 1102011217

Dosen Pembimbing :

dr. Endah Purnamasari SpPk

FAKULTAS KEDOKTERAN UNIVERSITAS YARSI

APRIL 2014

EBM

TUGAS EVIDENCE BASED MEDICINE

Skenario

Pria berusia 62 tahun datang ke rumah sakit dengan keluhan sulit buang air kecil dan merasa nyeri saat di keluarkan sejak 2 minggu yang lalu. Pada pemeriksaan colok dubur, teraba prostat yang membesar, permukaan yang keras dan berbenjol-benjol. Setelah dilakukan pemeriksaan radiologi dapat didiagnosis benjolan tersebut adalah kanker prostat. Dokter memberaikan terapi statin. Keluarga pasien menanyakan apakah statin dapat memperpanjang angka harapan hidup dari pasien.

Pertanyaan (foreground question)

Bagaimanakah perbandingan waktu hidup penderita kanker prostat yang diberikan pengobatan dengan statin dan penderita kanker prostat yang tidak menggunakan statin?

PICO

• Population : Pasien laki laki dewasa dengan keluhan sulit buang air kecil.

• Intervention : Menggunakan Statin

• Comparison : Tidak menggunakan statin

• Outcomes : Peningkatan angka hidup yang lebih lama

Pencarian bukti ilmiah

Alamat website : www.web.ebscohost.com

Kata kunci : Prostate Cancer AND Statins AND Death

Limitasi : Januari 2009 – Desember 2014

Hasil Pencarian : 14

Dipilih artikel berjudul :

Use of Statins and the Risk of Death in Patients With Prostate Cancer

REVIEW JURNALPendahuluan

To determine whether the use of statins after prostate cancer diagnosis is associated with adecreased risk of cancer-related mortality and all-cause mortality and to assess whether thisassociation is modified by prediagnostic use of statins.

Metoda

A cohort of 11,772 men newly diagnosed with nonmetastatic prostate cancer between April 1, 1998, and December 31, 2009, followed until October 1, 2012, was identified using a largepopulation-based electronic database from the United Kingdom. Time-dependent Cox proportional hazards models were used to estimate adjusted hazard ratios (HRs) with 95% CIs of mortality outcomes associated with postdiagnostic use of statins, lagged by 1 year to account for latency considerations and to minimize reverse causality, and considering effect modification by prediagnostic use of statins.

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Hasil

During a mean follow-up time of 4.4 years (standard deviation, 2.9 years), 3,499 deaths occurred, including 1,791 from prostate cancer. Postdiagnostic use of statins was associated with a decreased risk of prostate cancer mortality (HR, 0.76; 95% CI, 0.66 to 0.88) and all-cause mortality (HR, 0.86; 95% CI, 0.78 to 0.95). These decreased risks of prostate cancer mortality and all-cause mortality were more pronounced in patients who also used statins before diagnosis (HR, 0.55; 95% CI, 0.41 to 0.74; and HR, 0.66; 95% CI, 0.53 to 0.81, respectively), with weaker effects in patients who initiated the treatment only after diagnosis (HR, 0.82; 95% CI, 0.71 to 0.96; and HR, 0.91; 95% CI, 0.82 to 1.01, respectively).

Kesimpulan

Overall, the use of statins after diagnosis was associated with a decreased risk in prostatecancer mortality. However, this effect was stronger in patients who also used statinsbefore diagnosis.

APAKAH HASIL PENELITIAN TERSEBUT VALID?

A. Petunjuk Primer

1. Apakah terdapat sampel yang representatif, terdefinisi jelas, dan berada pada kondisi yang sama

dalam perjalanan penyakitnya?

Patients and MethodsA cohort of 11,772 men newly diagnosed with nonmetastatic prostate cancer between April 1, 1998, and December 31, 2009, followed until October 1, 2012, was identified using a large population-based electronic database from the United Kingdom.

2. Apakah follow-up cukup lama dan lengkap?

ResultsDuring a mean follow-up time of 4.4 years (standard deviation, 2.9 years), 3,499 deaths occurred, including 1,791 from prostate cancer. Postdiagnostic use of statins was associated with a decreased risk of prostate cancer mortality (HR, 0.76; 95% CI, 0.66 to 0.88) and all-cause mortality (HR, 0.86; 95% CI, 0.78 to 0.95). These decreased risks of prostate cancer mortality and all-cause mortality were more pronounced in patients who also used statins before diagnosis (HR, 0.55;95% CI, 0.41 to 0.74; and HR, 0.66; 95% CI, 0.53 to 0.81, respectively), with weaker effects in patients who initiated the treatment only after diagnosis (HR, 0.82; 95% CI, 0.71 to 0.96; and HR, 0.91; 95% CI, 0.82 to 1.01, respectively)B. Petunjuk sekunder

1. Apakah kriteria outcome yang digunakan obyektif dan tanpa bias?

Data SourcesThis study was conducted by linking the following four large electronic databases from the United Kingdom: the United Kingdom National Cancer Registry, the Clinical Practice Research Datalink (CPRD; previously known as the General Practice Research Database), the Hospital Episode Statistics (HES) database, and

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the Office for National Statistics (ONS) database. The United Kingdom National Cancer Registry contains tumor information, including site of primary growth (coded using the International Classification of Diseases,10th Revision [ICD-10]) and tumor characteristics (such as grade, stage, and primary treatments received, although not consistently recorded). The CPRD contains data on more than 12 million individuals enrolled in more than 650 general practices.15 The HES database contains dates of hospital admissions, primary and secondary diagnoses (coded using the ICD-10 classification), and related procedures (coded using the ICD-10 classification andOffice of Population Censuses and Surveys Classification of Interventions and Procedures, Fourth Version). Finally, the ONS contains the electronic death certificates of all citizens living in the United Kingdom and was used to identify the underlying cause of death (coded using the ICD-10 classification) for all patients who died during follow-up. The study protocol was approved by the Independent Scientific Advisory Committee of the CPRD and the Research Ethics Board of the Jewish General Hospital, Montreal, Quebec, Canada.

2. Bila ditemukan subgrup dengan prognosis yang beda, apakah dilakukan adjustment untuk faktor-

faktor prognostik yang penting?

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3. Apakah dilakukan validasi pada suatu kelompok independen (test-set)?

TIDAK

APA HASILNYA?

1. Bagaimana gambaran outcome menurut waktu?

A total of 11,772 patients newly diagnosed with nonmetastatic prostate cancer met the study inclusion criteria. The mean age at cohort entry was 71.3 years (standard deviation, 8.8 years), with a mean follow-up time of 4.4 years (standard deviation, 2.9 years). The corresponding incidence rates of prostate cancer mortality and all cause mortality were 34.8 per 1,000 per year (95% CI, 33.2 to 36.4 per 1,000 per year) and 67.9 per 1,000 per year (95% CI, 65.7 to 70.2 per 1,000 per year), respectively.

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2. Seberapa tepat perkiraan prognosis?

APAKAH HASIL PENELITIAN INI DAPAT DIAPLIKASIKAN?

1. Apakah pasien dalam penelitian tersebut serupa dengan pasien saya?

YA

2. Apakah hasil tersebut membantu memilih atau menghindari terapi tertentu?

TIDAK

Dalam jurnal penelitian ini tidak disebutkan bahwa pemilihan terapi tertentu mempengaruhi

hasil prognosis kanker prostat.

3. Apakah hasilnya membantu dalam memberikan konseling kepada pasien saya?

YA

Dalam jurnal penelitian ini disebutkan bahwa hasil penggunaan statin dapat memperpanjang

angka harapan hidup pasien penderita kanker prostat.

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