METHODOLOGY CHECKLIST: CASE-CONTROL STUDIES

KARSINOMA EPIDERMOID SERVIKS UTERI

PERAN AKTIVITAS PROLIFERASI TERHADAP RESPON RADIASI HISTOLOGI
PADA PASIEN RSUP DR KARIADI SEMARANG
Dik Puspasari
Submit: April, 2002. Approved: May, 2002
This research dedicated as a requirement for completing study Doctor Specialist
Pathology Anatomy.
Critical Appraisal written by:
Julius King (22010111130126)
Hanif Prasetyo (22010111130127)
Aulia Rizqi Mulyani (22010111130128)
Yana Cynthia Dewi (22010111130129)
Agatha Novell (22010111130130)
Section 1: Internal validity
In an well conducted case control
In this study the criterion is:
study:
1.1 The study addresses an appropriate This research concerns about carsinoma serviks
and clearly focused question
uteris proliferation activity that roles to
radiation therapy.
Selection of subjects
1.2 The cases and controls are taken Yes.
from comparable populations
Control: Cell proliferation activity levels before
therapy in groups that has good histology
radiation response
Case: Cell proliferation activity levels before
therapy in groups that has poor histology
radiation response
1.3 The same exclusion criteria are
Not mentioned. Selection of case and control
used for both cases and controls
samples is done randomly.
1.4 What percentage of each group
Totally 66 samples with percentage:
(cases and controls) participated in Cases: 33 samples (50%)
the study?
Control : 33 samples (50%)
1.5 Comparison is made between cases Based on the histopathological assessment of
and controls to establish their
radiation response in cervical biopsies after
similarities or differences
radiation therapy complete:
Good radiation response: in biopsy not found
many potent malignant cells, only malignant cells
that already dead or degeneratived are found.

Poor radiation response: in biopsy not only

potent malignant cells but also died cells are
found.
1.6 Cases are clearly defined and
differentiated from controls
1.7 It is clearly established that
controls are non-cases
Assessment
1.8 Measures will have been taken to
prevent knowledge of primary
exposure influencing case
ascertainment
1.9 Exposure status is measured in a
standard, valid and reliable way

Yes
Yes

Not addressed

Adequately
addressed

Confounding
1.10 The main potential confounders are Well covered
identified and taken into account in
the design and analysis

Exposure status is measured in

a standard, valid and reliable
way. The exposure such as
proliferation activity of cell that
define by granule AgNOR rate
in 100 cell, it observed with
light microscope with 1000x
zoom:
Low
proliferation
cell:
granule<4
High
proliferation
cell:
granule>4

The main potential confounders

are identified and taken into
account in the design and
analysis. Confounding variable
such as age and cell
differentiation of the patient in
which the data are taken from
PA Log Book, medical record,
and histopathological
specimen. With result:

In T test, the

Statistical analysis
1.11 Confidence intervals are provided

not significant
age
differences
from the
patients
p=0.612
In Chi-Square
Test, the not
significant
levels of cell
differences
p=0,082

not provided

Section 2: Overall assessment of the study

2.1 How well was the study done to
The study is nicely done (+) to minimize the risk
minimize the risk of bias or
of bias or confounding because confounding
confounding?
factor is added to be reconsidered in data
Code ++, +, or analysis. The other factors already been in
inclusion criteria. Sample with factor that not
meet the requirement not included in the
experiment.
2.2 Taking into account clinical
We are certain that the overall effect is due to the
considerations, your evaluation of exposure being investigated
the methodology used, and the
Based on clinical considerations :
statistical power of the study, are
According to the theory that immature
you certain that the overall effect is
cells that grow rapidly (high proliferal
due to the exposure being
activity) is a radiosensitive cells, in which
investigated?
the tumor is radiosensitive be destroyed by
irradiation.
Based on research methods: which is case
control, with a view of causation between
exposure (proliferative activity) and effects
(radiological response).
Based on statistical evaluation: Chi-square
test obtained a meaningful relationship
between cell proliferation activity before
therapy in radiology good response group
and poor radiological response with p =
0.0001.With odds ratio = 16.7, which

means ECUC patients with low activity

proliferation 16, 7 times more at risk of
getting ugly radiological response than
patients with high proliferation activity.
2.3 Are the results of this study
directly applicable to the patient
group targeted by this guideline?

The results of this study is directly applicable

Good radiological response shown in
patients with epidermoid carcinoma of the
uterine cervix stage IIA-IV with high
proliferative activity indicated by the
number of AgNOR granules> = 4 on
AgNOR staining of patient tissue biopsies

Section 3: Description of the study (Note: The following information is required for
evidence tables to facilitate cross-study comparisons. Please complete all sections for
which information is available).
3.1 Do we know who the study was
funded by?
3.2 How many centres are patients
recruited from?
3.3 What is the social setting (ie type
of environment in which they live)
of patients in the study?
3.4 What criteria are used to decide
who should cases?

Unknown. Not mentioned in the experiment.

1(parafin block archive: biopsy of cervix uteri
epidermoid carcinoma in RSUP dr. Kariadi)
Unknown. Not mentioned in the experiment.

3.5 What criteria are used to decide

who should be controls?

3.6 What exposure or risk factor is

investigated in the study? (Include
dosage where appropriate)
-

Biopsy result of cervix uteri epidermoid

carcinoma patients (3rd stadium)
Only received complete external radiation
therapy only with good histological radiation
respond and high proliferation activity
Hb >10 g%
Biopsy result of cervix uteri epidermoid
carcinoma patients (3rd stadium)
Only received complete external radiation
therapy only with poor histological radiation
respond and low proliferation activity
Hb >10 g%
Damage of cancer cells after radiation
therapy
Cell proliferation activity:
a Cell cycle time
b S-phase time
c Volume doubling time

d Mitotic Index
e Growth fraction rate
f S-phase fraction
G1-S-G2 fraction AgNOR coloring