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Epidemiology and Research Study Design: September 2017
Epidemiology and Research Study Design: September 2017
ل ي من ل ع م ل قي في ي ع ق ب ح ألج ء ل في ه ل ص س
ل س لحي ل س ..س ف ق لك ه ش ح ألن في م ل ب ئي
ب ل أم ل ع من ألم ل ضيح ل خ ئص كل ن مع
أم ي تي ل م ب ل فيق لف ئ
أخ تع يل ب يخ 2017-09-27
Study Design
toال رضي The first step in an epidemiological Study is to define the hypothesis
be tested. This should include a precise definition of the exposure(s) and
outcome(s) under study
ضح ن تح ي ت يجب ل ه نفي ث ت ال ل من ج ء بحث هي ضع لف ضي ل ي ي ل
outcomeل يج exposureقيق ع مل ل ع
فالدراسا البحثي في الصح هي عبارة عن محاول الثبا او نفي فرضي طبي معين تربط بين عوامل تعرض
محددة ( ) exposureمع االصاب بمرض معين ( ) outcome
احتم لي االص ب بسرط ن الثد فحص العالق م بين تن ل طع بنسب ده ن ع لي بشكل ا ضح يراد هن تقيي
ده ن ع لي يمكن اعتب ره اكثر عرض لالص ب بسرط ن الثد بمعن اخر :هل الذين يتن ل ن كمي
Does hepatitis B virus infection increase the risk of liver cancer? هذه هي الفرضي
الكبد ال ب ئي هل االص ب بفير س التB يزيد احتم لي االص ب بسرط ن الكبد
الكبد ال ب ئي قي س العالق بين الت اذا الدراس التي نريد القي ب ت دف لفB االص ب بسرط ن الكبد
The second step in an epidemiological Study is to decide which study design will
be the most appropriate test that specific study hypothesis
لف ضي س ل س الخ ل ن ل ني هي تح ي ن ط ل
We can follow up people who happen to be or not be infected with the hepatitis B
virus, to see whether their risks of liver cancer are different.
These studies are observational, because the role of the investigator is merely To
observe what happens, noting who is exposed or unexposed and who has or has
not developed the outcome of interest.
ال ليس ك لك ؟ ح ?? ألم بغ ي ل سobservational --- س من ل ل يع ه هل ف ت ال
من ه ج ء كobservational ف ي س ق ئ ع ف ل م ي غي ع ه ه ف ط ل ق م بع ل
) ل الح فال ي م تعريض ل يض ال ع مل ض في خ جي (ب ع ليس ه لك تج
ي ال حث بع ل ت ثير ع
كين من مج ع من ال
خال اع هم عال معين
م ال
الي ال حث ب
مح ل ل ثير ع
) االس ج ب (ال ئج
Hammadjo2012@yahoo.com WhatsApp +966561523465 Twitter : @hammadjo2012
Training Specialist
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Example 1 : A study took random sample of adults and asked them about their bedtime habits. The
data showed that people who drank a cup of tea before bedtime were more likely to go to sleep earlier
than those who didn't drink tea.
A-Observational study
B-Experiment
This study was a survey that looked at if people drank tea or not and when they went to bed
بل ي سج ل ئج ل ل ح من هؤالء الش من الي له م ي ه ل قل ل ل ف ط ت ت م ق من ي
ق م بع ل م ن
Example 2 : Another study took a group of adults and randomly divided them into two groups.
One group was told to drink tea every night for a week, while the other group was told not to drink tea
that week. Researchers then compared when each group fell asleep.
B-Experiment
Answer : Experiment
ضح ج ه ع ص ه ل من ل س
This study randomly assigned people to groups. ل ج ع ين تم ت سيم الش
One group was given a treatment and the other group was not.
ليال ل ل ع ل ج ع ال ل ش ه ل خل ل جي ل ف من لعال ( ل ل ج ع ين ع يت ن ح
) س
This was an experiment.
One group was directed to use social media sites as they usually do.
One group was blocked from social media sites.
B-Experiment
Example 4 : Another study took a random sample of people and examined their social media habits.
Each person was classified as either a light, moderate, or heavy social media user. The researchers
looked at which groups tended to be happier.
B-Experiment
لبحث عن صفا ي د ت سي م ل ج وعتين فيتم تو يع م عشو ئيا د س في ل مشا20 مثال لو ل ينا
لتي كت عطي ا الس ا لسح معين ت اما ك ا تلط الصاة ة لجنس مثال مشت ك كالع
) ش خططت من ثم يتم لسح ة ضعت في عا غط ت
2-Controlled Clinical Trial: a trial in which participants are assigned to two or more different
treatment groups. In Clinical Evidence, we use the term to refer to controlled trials in which
treatment is assigned by a method other than random allocation. When the method of allocation
is by random selection, the study is referred to as a randomized controlled trial (RCT). Non-
randomized controlled trials are more likely to suffer from bias than RCTs.
نس ي ه س تأثي ل لعال ع ين ح ه ت س ) ل م ل (عي في كال ل عين ي م قسم ألش
تس خ عال ق تع الق لك لعال ال تع ع الخ لtreatment group ع ل
ت سي ا ختيا لعين ل ن الختالف هو ةط ي،، controlled group
كين ت سي م عشو ئيا ل ي م خ يRandomized Controlled Trial (RCT): ال في ل
ع ين لRandomly
Analytical study
is observational study
ل س ل الث ل لي ،غ ل يأتي ب لسؤ بحيث ي ف لك ل ي ه ل يي بين ن ه نأتي ل ء ألهم الخ
س ي ب م ك تح ي ن ل س ل س لك ي ضح لك كيفي ت في ه ل س تم ج ءه ي
A-Cohort Study:
Cohort تع ي ج ع
-- A non-experimental study design that follows a group of people (a cohort), and then looks at
how events differ among people within the group.
Step 4 : the incidence of the disease in the exposed individuals is compared with the
incidence in those not exposed
في ألف ل ع ضين مع ح ثه في أ ل ك ل ين لم ي ع ض ل ي م م ن ح: ل بع ل
ألمثط ستوضح لك ةش ل أف ل
Example:
In 1980, 89 538 registered nurses in the USA, aged 34 to 59 years and with no past
history of cancer, completed a previously validated dietary questionnaire designed to
measure individual consumption of total fat, saturated fat, linoleic acid and
cholesterol, as well as other nutrients.
The nurses were then classified in five groups of similar size according to their levels
of fat intake, followed up in time and the incidence of breast cancer in each of these
groups measured and compared
: ت ضيح ل
Group study = cohort = participant : USA Nurse مج ع ل س هم م ضي ل الي ل ح
Exposure/ Non Exposure = consumption of fat ه ك ي ل ه ل ي ي م س الك ع مل ل ع
Outcome = incidence of breast cancer ل ل يج هي الص ب بس
In, the US nurses (the‘cohort’) were classified into five groups (quintiles) according
to their levels of fat intake.The incidence of breast cancer (‘outcome’) was then
measured and compared across these quintiles.
Example 2
A total of 22 707 men were enrolled into the study: 3454 were positive for hepatitis
B surface antigen (HBsAg) and 19 253 were negative.
These men were then followed up and the incidence of hepatocellular carcinoma
among HBsAg carriers was compared with the incidence among
noncarriers
ل ب ئي ل ل مس كين ن يج م يج بي ب ج 3454من ل جن ن ئج لعي B ( hepatitisث ل :بع
) ل ي م )B surface antigen (HBsAg
Prospective cohort studies (which track participants forward in time) are more reliable than
retrospective cohort studies.
-starting point is the identification of ‘cases’ of the disease (or condition) of interest,
and of suit- able ‘controls’ without that disease (or condition).
Cases and controls are then compared to assess whether there were any differences
in their past exposure to putative risk factors
خ الف بي م في ل ضي من حيث تع ض م ك ه لك بع لك ي م م ن ل ج ع ين ل ييم في
سه ل ل لع مل خ
ن بين ل ج ع ين في ي ع ق بع مل ل بع لك ج يت ل
Examples:
Study was conducted in Singapore to investigate the role of diet in breast cancer.
Two hundred Chinese women with histologically confirmed breast cancer and 420
controls without this disease participated in the study. A dietary questionnaire was
used to measure past dietary intake. Cases and controls were then compared to
assess whether there were any differences in their past intake of selected foods and
nutrients
As you Notice here : Women with (‘cases’) and without (‘controls’) breast cancer
were identified and their past diet (‘exposure’) compared.
Cases --- Two hundred Chinese women with histologically confirmed breast cancer
Example 2 :
Study was carried out in Taiwan to assess whether hepatitis B infection played a role
in the etiology of primary hepa- tocellular carcinoma. A total of 128 histologically or
cytologically confirmed cases of hepatocellular carcinoma and 384 controls without
the disease were included in the study.
Of the cases, 77% were carriers of the hepatitis B sur- face antigen (HbsAg)
Compared with only 28% of the controls
In this example : In
,subjects with (‘cases’) and without (‘controls’) hepatocellular
carcinoma were identified and the frequencies of the HBsAg carrier status
(‘exposure’) in the two groups were compared
1-The major difference between cohort and case–control methods is In the selection
of study subjects. In a cohort study, subjects are selected who are initially free of
disease and are then followed over time.
الخ الف ل ئيسي ه في ي خ ي م ض ل س
ي م م بع ه لف من ل من في ل ي ي م خ ي م ض ل س خ لي من المcohort study في
2- Case–control studies are particularly suitable for investigating rare diseases such
as cancer.
A cohort study would require the follow-up of a large number of individuals for a
long period of time in order to accrue enough cases of a rare disease.
4- case–control study starts with subjects who have already developed the
condition of interest,
لم ي ب صال م ن م مع ش صي ب ل ه ل من ل س ي ب س ش
مع لف من ل من ل ي ن بط ع مل ل ع ل لك ف ل س الت ب الن، بل
cohort study ك في ح ل الال ل
so there is no need to wait for time to elapse between an exposure and the
manifestation of disease as in cohort studies.
Example :
الحظ م ي ي
A sample of 1815 study subjects was selected from a well defined population
(healthy blood donors in certain prefectures of Japan)
. لي ب ني صح ء م عين ب ل في بعض ل ح ف لعي ه تم خ ي ه من مج ع س
ب ل لعي ب ع، الصح ء ل عين ب ل س ب هم الش لعي خ من مج ع مح من الس
م ج مس في لسجال خ من مج ع س ني مح
and a Blood sample taken from each of Them at a particular point in time to
measure both the levels of H. pylori antibodies (‘exposure’ and the levels Of
pepsinogen I and II(‘outcome’).
H.Pylori ل الجس مس من ال من ل ي من كل ح في م في ف ر مح بع لك تم خ عي
Quasi Experiment
شه لج يي
Control group س س نه الي ج مج ع ض ط ل من ل مي ي ه ل