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2.types of Studies

Type of study analysis and collection of data for research

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0% found this document useful (0 votes)

37 views

2.types of Studies

Type of study analysis and collection of data for research

Uploaded by

salmagintoki

We take content rights seriously. If you suspect this is your content, claim it here.

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Download as PDF, TXT or read online on Scribd

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‫بسم اهلل الرمحن الرحيم‬

‫‪Types Of Studies‬‬
❖Levels of evidence

2 Dr. Omar Aldossary

❑ Case reports & Case series :

➢ Case reports definition:

A detailed report of the diagnosis, treatment, and follow-up of an
individual patient. Case reports also contain some demographic
information about the patient (for example, age, gender, ethnic
origin).

✓A case report is a description of important scientific observations

that are missed or undetectable in clinical trials.
✓ This includes a rare or unusual clinical condition, a previously
unreported or unrecognized disease, unusual side effects to
therapy or response to treatment, and unique use of imaging
modalities or diagnostic tests to assist diagnosis of a disease.

3 Dr. Omar Aldossary

❑ Case reports & Case series :

➢ Case series definition :

A group or series of case reports involving patients who were
given similar treatment. Reports of case series usually contain
detailed information about the individual patients. This includes
demographic information (for example, age, gender, ethnic origin)
and information on diagnosis, treatment, response to treatment, and
follow-up after treatment.

❖ Case reports and case series or case study research are

descriptive studies that are prepared for illustrating novel,
unusual, or atypical features identified in patients in medical
practice, and they potentially generate new research questions.

4 Dr. Omar Aldossary

❑ Case reports & Case series :

▪ The Principles For Case Reports & Case Series :

✓ Recognition and description of a new disease.

✓ Recognition of rare manifestations of a known disease.
✓ Elucidation of the mechanisms of a disease.
✓ Detection of adverse or beneficial side effects of drugs (and
other treatments).
✓ Medical education and audit.

5 Dr. Omar Aldossary

❑ Case reports & Case series :

➢ Advantages and disadvantages of case reports and case studies :

Advantages Disadvantages
• One case to initiate a signal (case
• No control (uncontrolled)
report)
• Provide stronger evidence with
• Difficult to compare different cases
multiple cases (cases series)

• Observational • Cases may not be generalizable

• Educational • Selection bias
• Easy to do (fast and no financial
• Unknown future outcome/follow-up
support needed)
• Identify rare manifestations of a
disease or drug
6 Dr. Omar Aldossary
❑ Cross-sectional study:
➢Definition :
“an analytic investigation in which subjects are sampled at a
fixed point or period of time, and then the association between the
concurrent presence or absence of risk factors and diseases are
investigated”. (Raymond S. Greenberg et el-1995)

7 Dr. Omar Aldossary

❑ Cross-sectional study:

8 Dr. Omar Aldossary

❑ Cross-sectional study:
✓ Steps In Conducting Cross-Sectional Studies :
1) State the criteria for the (disease / condition) clearly,
2) Define co-variables to be measured ,
3) Examine ethical issues,
4) Identify the reference population,
5) Inclusion / exclusion criteria,
6) Determine minimum number of Sample required,
7) Select study subjects through appropriate sampling procedure,
8) Define measurement procedures,
9) Carry out data collection ,
10)Clinical examination ( Laboratory investigations),
11)Clinical records and other documents,
12)Interviews and Questionnaires,
13)Summarize data,
14)Analyze and interpret finding,
9 15)Report. Dr. Omar Aldossary
❑ Cross-sectional study:

❖ Advantages Of Cross-Sectional Studies :

➢ Provides estimate of the disease burden (prevalence).
➢ Relatively short duration.
➢ Easy and quick .
➢ Less costly.
➢ Useful for chronic conditions with low case fatality.
➢ Starting point for cohort study for screening existing diseases.
➢ Provide wealth of data for further research.
➢ Allow a risk statement, although these are not precise.

10 Dr. Omar Aldossary

❑ Cross-sectional study:

❖ Disadvantages Of Cross-Sectional Studies :

➢ Does not provide estimate of disease occurrence (incidence).
➢ No direct estimate of risk possible.
➢ Rare diseases, short duration, high case fatality not detected.
➢ Natural history of disease information minimal.
➢ Prone for biases from selective survival.
➢ Not possible to establish temporality.
➢ Therefore, it is a weak design for proving causality.

11 Dr. Omar Aldossary

❑ Case-Control study:

➢ Definition :
A study that compares two groups of people: those with the disease
or condition under study (cases) and a very similar group of people
who do not have the disease or condition (controls).
✓ Researchers study the medical and lifestyle histories of the
people in each group to learn what factors may be associated with
the disease or condition.
✓ For example, one group may have been exposed to a particular
substance that the other was not.
✓ Also called retrospective study.

12 Dr. Omar Aldossary

❑ Case-Control study:

13 Dr. Omar Aldossary

❑ Case-Control study:

✓ Strength Of Case-control Study :

❖ Weaknesses
(Potential Biases) Of
Case-control Study :

14 Dr. Omar Aldossary

❑ Case-Control study:

15 Dr. Omar Aldossary

❑ Cohort study:

➢ Definition :
Cohort studies are a type of longitudinal, non-experimental,
observational study, “an approach that follows research
participants over a period of time (often many months or years)”.

✓ Specifically, cohort studies recruit and follow participants who

share a common characteristic, such as a particular occupation or
demographic similarity.

✓ A research study that compares a particular outcome (such as

lung cancer) in groups of individuals who are alike in many ways
but differ by a certain characteristic (for example, female nurses
who smoke compared with those who do not smoke).

16 Dr. Omar Aldossary

❑ Cohort study:
▪ What is the purpose of a cohort study ?
✓ The main purpose of the cohort study is to estimate the risk or
rate of an outcome among a cohort of individuals.
✓ A cohort study initially starts by identifying a large group of
people that are free of the outcome of interest.

17 Dr. Omar Aldossary

❑ Cohort study:
✓A major advantage of cohort studies :
✓ Clarity of Temporal Sequence, because in a cohort study, subjects are
known to be disease-free at the beginning of the observation period when
their exposure status is established.
✓The possibility to study multiple exposures and multiple outcomes in one
cohort.
✓Facilitate Study of Rare Exposures, even rare exposures can be studied.
✓Allow Examination of Multiple Effects of a Single Exposure, e.g. the
combined effect of multiple exposures on disease risk can be determined.
✓Hypothesis generation.
✓A cohort study is considered to be a relatively easy way to pick up
associations between many exposures and outcomes.
✓Finally, because a cohort study has usually broader inclusion criteria and
less exclusion criteria compared to an RCT, its results may be more
generalizable to clinical practice.
18 Dr. Omar Aldossary
❑ Cohort study:

❖ Disadvantages of Cohort Studies :

▪ You may have to follow large numbers of subjects for a long time.
▪ They can be very expensive and time consuming.
▪ They are not good for rare diseases.
▪ They are not good for diseases with a long latency.
▪ Differential loss to follow up can introduce bias.
▪ If one uses records that were not designed for the study, the
available data may be of poor quality.
▪ There is frequently an absence of data on potential confounding
factors if the data was recorded in the past.
19 Dr. Omar Aldossary
❑ Randomized Controlled Trial (RCT) :
➢ Definition :
A randomized controlled trial (RCT) is an experimental form of
impact evaluation in which the population receiving the program or
policy, intervention is chosen at random from the eligible
population, and a control group is also chosen at random from the
same eligible population.

✓ Randomized controlled trials (RCT) are prospective studies

that measure the effectiveness of a new intervention or
treatment. Although no study is likely on its own to prove
causality, randomization reduces bias and provides a rigorous tool
to examine cause-effect relationships between an intervention and
outcome.

20 Dr. Omar Aldossary

❑ Randomized Controlled Trial (RCT) :
✓A major advantage :
✓ The major advantage of RCTs is the straightforward
investigation of cause–effect relationships with minimal bias
and confounding factors.
✓ Randomization minimizes allocation bias and selection
bias.
✓ Blinding minimizes performance bias.

❖ Disadvantages :
➢ Power calculation might demand vast samples size, which
require more resources from the investigators.
➢ Validity requires multiple sites, which will be difficult to
manage.
21 Dr. Omar Aldossary
❑ Randomized Controlled Trial (RCT) :

❖Strengths
➢ Only type of study able to establish causation,
➢ Ability to assign and administer treatment or intervention in a
precise, controlled way,
➢ Decreases selection bias and minimizes confounding due to
unequal distribution in a chosen population,
➢ Measurements can be chosen precisely making it easier to
make observations consistently (especially parametric data),
➢ Blinding is easier improving credibility.

22 Dr. Omar Aldossary

❑ Randomized Controlled Trial (RCT) :

❖Weaknesses :
➢ High cost.
➢ Increased time (clinical practice may move on while the study is
being performed).
➢ Logistically challenging (e.g. Difficulty organizing/supervising
multiple sites & locations).
➢ Results may not always mimic real life treatment situation (e.g.
Inclusion / exclusion criteria; highly controlled setting).
➢ Risk of choosing treatments or subjects whose consent is not
valid or unethical treatment is involved.

23 Dr. Omar Aldossary

❑ Steps In Designing A Study :
✓ Following are the steps for dental research:
1. Formation of research question with its aim and objectives.
2. Hypothesis formation- e.g. null hypothesis for comparative study.
3. Decide type of Study with its outcome measures.
4. Data collection - qualitative and quantitative.
5. Deciding about study population with sampling method and
sample size estimation
6. Randomization and blinding in comparative study.
7. Check validity and reliability of the method.
8. Selection of proper statistical tests (parametric and non-
parametric).
24 Dr. Omar Aldossary
❑ Exercises :

•A