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Heldal L et al.

Donation of stem cells from blood or bone marrow: results of a randomised


study of safety and complaints. Bone marrow transplantation (2002) 29: 479-86

(Answerable questions for appraisal): Modified from: John Addison, Pennine Acute

Did the study ask a clearly focused question? (Apakah penelitiannya memiliki
permasalahan yang jelas?)
Answer :
Tidak, hanya membandingkan BSC dan BM

Was this a randomised controlled trial and was it appropriately so? (Apakah ini
merupakan penelitian RCT dan apakah layak dikatakan penelitian RCT?)
Answer :
Ya,Tapi belum layak
Karena, RCT is A study in which the participants are divided by chance into separate groups that
compare different treatments or other interventions. Using chance to divide people into groups means
that the groups will be similar and that the effects of the treatments they receive can be compared more
fairly. At the time of the trial, it is not known which treatment is best. PubMed Health Glossary
(Source: NIH - National Cancer Institute)

Prepared for EBM/EBD tutorial block 17 (PSPDG-UMY)


Were participants appropriately allocated to intervention and control groups? (Apakah
pembagian sampel control dan intervensi sudah tepat ?)
Answer :
Belum, karena pembagian kelompoknya tidak seimbang

Were participants, staff and study personnel ‘blind’ to participants’ study group? (apakah
penelitian ini dilakukan secara blind (partisipan,staff, dan personil peneliti) ?)
Answer :
Tidak karena peneliti mengetahui kelompok mana yg diberi BSC dan BM harvest.

Were all of the participants who entered the trial accounted for at its conclusion? (Apakah
kesimpulannya itu sudah menggambarkan semua data partisipan?)
Answer :
Sudah, untuk yang mengisi kuisioner secara lengkap saja, tapi yang mengisi kuisioner tidak lengkap
tidak dimasukkan ke perhitungan

Were the participants in all groups followed up and data collected in the same way?
(Apakah seluruh kelompok partisipan sudah di follow up dan datanya dikumpulkan
dengan cara yang sama ?)
Answer :
sudah

Did the study have enough participants to minimise the play of chance? (Apakah
subjeknya cukup untuk meminimalkan kemungkinan yang akan terjadi?)
Answer :
Mungkin bia ditambahkan lagi agar jumlahnya sama antara BSC dan BM

How are the results presented, what do they show, and how precise are they? (Bagaimana
hasilnya, apa yang didapatkan, dan seberapa akurat?)
Answer :
Hasilnya berbeda dengan penelitian yg telah dilakukan oleh peneliti sebelumnya.
Hasilnya sudah disajikan dengan jelas dan cukup akurat

Were all important outcomes considered so the results can be applied? (Apakah hasil
penting sudah dipertimbangkan sehingga bisa diaplikasikan?)
Answer :
Belum, karena hasil penelitian tersebut berbeda dengan hasil penelitian sebelumnya, sehingga harus
dilakukan penelitian lagi yang lebih akurat agar hasilnya tetap.

PICO
Elements: Description:
Answer :
PATIENT OR PROBLEM: Healthy, age between 15-62 th.
How would he or she described a Usia, jenis kelamin, hubungan darah, lama follow up, sehat
group of patients?
dan fit untuk dilakukan anestesi umum, tidak memiliki
What were the most important
characteristics of the patient? penyakit hepatitis b, c, hiv, dan keganasan.

Prepared for EBM/EBD tutorial block 17 (PSPDG-UMY)


Answer :
INTERVENTION, EXPOSURE, Bone marrow harvest dengan general anestesi
PROGNOSTIC FACTOR:
What main intervention was he or
she considering?
What did he or she want to
do with this patient?

Answer :
COMPARISON: BSC (leukapheresis)
What was the main alternative
being considered, if any?

Answer :
OUTCOME blood tests, clinical chemistry, physical, psychological and
What was he or she trying to social implications for donors on days 0, +1, +4, +7, +14,
accomplish, measure, improve or
+28 and +90.
affect?

The well-built question could be:


(Primary type of Questions): (Answer )
Type of Question: Pertanyaan dalam Critical appraisal ini disusun
How could he or she berdasarkan: desain penelitian, cara pemilihan sampel,
categorized this question?
jumlah sampel, cara pemberian intervensi, penarikan
kesimpulan

Sedangkan pertanyaan kuisioner berdasar physical,


psychological and social abilities. Yaitu physical and social
limitations, severity of the complaints, global experience as
donors, The number of analgesic tablets, blood
transfusions, requirement of central venous line, the number
and the duration of leukaphereses, duration of
hospitalisation, sick leave and the number of days with
restricted activities were also recorded

(Hierarchy of Evidence) (Answer )


Type of Study: cohort
What could be the best study
design to answer this question?

Assessment: (Optional)

Prepared for EBM/EBD tutorial block 17 (PSPDG-UMY)

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