Validity Worksheet

PROGNOSIS WORKSHEET

Is the research valid? ( ) Yes Comments

1. Was a defined, representative sample of
patients assembled at a common (usually ( ) No
early) point in the course of their disease?
2. Was patient follow-up sufficiently long and ( ) Yes
complete? ( ) No
3. Were objective outcome criteria applied in ( ) Yes
a "blind" fashion? ( ) No
4. If subgroups with different prognoses are ( ) Yes
identified, was there adjustment for important
prognostic factors? ( ) No
5. Was there validation in an independent ( ) Yes
group ("test-set") of patients? ( ) No

THERAPY WORKSHEET

Is the research valid? ( ) Yes Comments

1a. Was the assignment of patients to
treatments randomised? ( ) No
1b. Was the randomisation list
concealed?
1c. Were subjects and clinicians blind to
which treatment was being received?
2a. Were all subjects who entered the trial ( ) Yes
accounted for at its conclusion?
2b. Were they analysed in the groups to which ( ) No
they were randomised?
3a. Aside from the experimental treatment, ( ) Yes
were the groups treated equally?
3b. Were the groups similar at the start of the ( ) No
trial?
 DIAGNOSIS WORKSHEET

Is the research valid? ( ) Yes Comments

1. Was there an independent, blind
comparison with a reference ("gold") standard ( ) No
of diagnosis?
2. Was the diagnostic test evaluated in an ( ) Yes
appropriate spectrum of patients (like those in
whom it would be used in practice)? ( ) No
3. Was the reference standard applied ( ) Yes
regardless of the diagnostic test result?
( ) No

HARM/ETIOLOGY WORKSHEET

Are the results of this harm

study valid?

Were there clearly defined groups of patients,

similar in all important ways other than
exposure to the treatment or other cause?

Were treatment exposures and clinical

outcomes measured the same ways in both
groups (e.g., was the assessment of outcomes
either objective (e.g., death) or blinded to
exposure)?

Was the follow-up of study patients complete

and long enough?

Do the results satisfy some "diagnostic tests

for causation"?
Is it clear that the exposure preceded the
onset of the outcome?
Is there a dose-response gradient?
Is there positive evidence from a
"dechallenge-rechallenge" study?
Is the association consistent from study to
study?
Does the association make biological sense?
Apakah hasil penelitian ini bahaya yang valid?

Apakah ada kelompok yang jelas pasien, mirip dalam semua hal penting selain
paparan pengobatan atau penyebab lain?

Apakah pengobatan eksposur dan hasil klinis diukur dengan cara yang sama pada
kedua kelompok (misalnya, adalah hasil penilaian baik obyektif (misalnya,
kematian) atau dibutakan paparan)?

Apakah tindak lanjut dari pasien studi yang lengkap dan cukup lama?

Apakah hasil memuaskan beberapa "tes diagnostik untuk sebab-akibat"?

Apakah jelas bahwa paparan mendahului timbulnya hasilnya?
Apakah ada gradien dosis-respons?
Apakah ada bukti positif dari studi "dechallenge-rechallenge"?
Apakah asosiasi konsisten dari penelitian untuk studi?
Apakah asosiasi masuk akal biologis?
Sumur-Dibangun, Pertanyaan Pasien Berorientasi Klinis

pertanyaan Komponen

Pertanyaan Anda
P - Pasien atau Penduduk

Jelaskan karakteristik paling penting dari

pasien.
(misalnya, usia, penyakit / kondisi, jenis kelamin)

I - Intervensi; Faktor prognosis; Paparan

Jelaskan intervensi utama.

(misalnya, obat atau perawatan lainnya, diagnostik / test skrining)

C - Perbandingan (jika sesuai)

Jelaskan alternatif utama yang dipertimbangkan.

(misalnya, plasebo, terapi standar, tidak ada perawatan, standar emas)

O - Hasil

Jelaskan apa yang Anda capai, mengukur,

memperbaiki, mempengaruhi.
(misalnya, penurunan mortalitas atau morbiditas, meningkatkan daya ingat, akurat
dan
tepat waktu diagnosis)

Pertanyaan tegap klinis: