Lab 3
Drug Information
[ Study Designs]
Presented by:
Moutaz Bellah Yasser
Dept. of Pharmacy Practice & Clinical Pharmacy
mail: moutazbellah-yasser@[Link]
MAIN ELEMENTS OF A JOURNAL ARTICLE
1. Title
2. Abstract: concise overview of the study
3. Introduction (or Background): brief education about the basis for conducting the study, focusing on
the study rationale and purpose.
4. Materials and Methods (or Methods): the design of the study (i.e., details about how the study will be
conducted, and how the outcomes will be measured).
5. Results: provides all data obtained after conducting the study. Tables, charts, and histograms are
frequently used to display the results.
6. Discussion/Conclusion: evaluation of the study results (interpretation of their importance)
7. Acknowledgments: recognizing of individuals who contributed to the study (but are ineligible to
qualify as authors)
8. References: list of articles or documents that support the information provided in the study.
SECONDARY SOURCES
(Search refinement)
3. Filters
B. Validity Filters
- Limit search to a
specific study design
Study Designs
1. DESCRIPTIVE (REPORTS)
2. OBSERVATIONAL
3. EXPERIMENTAL (INTERVENTIONAL)
4. QUASI-EXPERIMENTAL
5. REVIEWS
Study Designs (Primary Research)
Two main variables in health research:
Exposure (Observational)/ versus Disease/Outcome
Intervention (Experimental)
Can be: Can be:
• Medication • Behavioral therapy • Effect of a new or current drug
• Different dose regimen • Vaccine • Improvement of patient condition
• Alternative treatment • Procedure/Surgery • Prevention of further deterioration
• Diet • Environmental toxin • Better quality of life
Study Designs (Primary Research)
Classification of studies based on control group:
1. Case study
2. Case report
No control Descriptive studies
3. Case series
4. Cross-sectional
5. Case-control
Control Analytical studies
6. Cohort
DESCRIPTIVE REPORTS
1. CASE Documentation of a practitioner’s
STUDY experience/thoughts/observations with a single
patient.
DESCRIPTIVE REPORTS
2. CASE Documentation of a single patient in which an
REPORT association is suggested between an observed
effect and an intervention/exposure.
2. CASE REPORT
EXAMPLE
DESCRIPTIVE REPORTS
3. CASE SERIES
Documentation of a practitioner’s
experience/observations with
multiple patients with similar
situations (i.e., multiple case studies)
3. CASE SERIES
EXAMPLE
DESCRIPTIVE REPORTS
CASE STUDY/REPORT/SERIES
ADVANTAGES: DISADVANTAGES
1. Inexpensive, Easy to perform 1. Small sample size
2. Less time-consuming 2. Cannot prove cause-and-effect
3. Identify treatment for rare relationship
disorders 3. Lack control group for comparison
4. Identify medication toxicities 4. Confounding variables
or adverse effects 5. Depends on author’s opinion
OBSERVATIONAL STUDIES
4. CROSS-SECTIONAL STUDY
• Subjects are interviewed/asked about both exposure and outcome
of interest at a single point in time.
• Snapshot/slice of time study:
Data is collected once from each subject/participant.
• Hypothesis-generating study
OBSERVATIONAL STUDIES
4. CROSS-SECTIONAL STUDY
OBSERVATIONAL STUDIES
4. CROSS-SECTIONAL STUDY
• Aim of the study: Identify Prevalence of a disease/condition
(Objective) in the community.
• Also known as ‘Prevalence’ or ‘Survey’ or ‘Questionnaire’
study
OBSERVATIONAL STUDIES
4. CROSS-SECTIONAL STUDY
ADVANTAGES: DISADVANTAGES
1. Inexpensive 1. Only one point in time
2. Less time-consuming 2. Cannot prove cause-and-effect
3. One-time data collection relationship or association
4. No follow-up 3. Confounding variables
4. Potential for bias
OBSERVATIONAL STUDIES
5. CASE - CONTROL
• Subjects with the disease/outcome of interest (Cases) are recruited and
compared to a similar group of subjects without the disease/outcome of
interest (Control)
• Retrospective study:
Data is collected about past exposure (i.e., look backwards in time)
to identify a possible risk factor for the disease/outcome
• Both exposure and outcome are known at the beginning of the study.
OBSERVATIONAL STUDIES
OBSERVATIONAL STUDIES
Reference: ACCP Updates in Therapeutics® 2022: Pharmacotherapy Preparatory Review and Recertification Course
5. CASE – CONTROL
STUDY EXAMPLE
5. CASE – CONTROL
STUDY EXAMPLE
OBSERVATIONAL STUDIES
5. CASE - CONTROL
• Objective: Identify risk factors for the disease/outcome
• Measures the association between the exposure (risk factor) and
outcome by the Odds Ratio [OD]
• Also known as ‘Case-referent’ / ‘Case history’ / ‘Retrospective’ study
• Hypothesis-testing study
OBSERVATIONAL STUDIES
5. CASE-CONTROL STUDY
ADVANTAGES: DISADVANTAGES
1. Inexpensive 1. Retrospective study
2. Less time-consuming 2. Cannot prove cause-and-effect
3. Data already exists relationship
4. No follow-up 3. Confounding variables
5. Study exposures in rare diseases 4. Cannot identify incidence or
prevalence
or diseases that take long periods
5. Potential for bias
to develop.
OBSERVATIONAL STUDIES
6. COHORT STUDY
• Subjects who are exposed to a [risk factor/exposure of interest] are
compared to a control group of subjects who are not-exposed, and followed-
up over time to measure development of the outcome of interest.
• Prospective study (mainly):
Data is collected over time (i.e., look forwards in time)
to measure association between a possible risk factor and the
disease/outcome
• Only Exposure is known at the beginning of the study. Outcome is unknown.
OBSERVATIONAL STUDIES
OBSERVATIONAL STUDIES
Reference: ACCP Updates in Therapeutics® 2022: Pharmacotherapy Preparatory Review and Recertification Course
6. COHORT STUDY
EXAMPLE
OBSERVATIONAL STUDIES
6. COHORT STUDY
• Objective: Identify risk factors for the disease/outcome
• Determines the incidence of a disease
• Measures the association between the exposure (risk factor) and outcome
by the Relative Risk [RR]
• Also known as ‘Prospective’ / ‘Longitudinal’ / ‘Follow-up’ / ‘Incidence’
studies
• Hypothesis-testing study
OBSERVATIONAL STUDIES
6. COHORT STUDY
ADVANTAGES: DISADVANTAGES
1. Prospective: exposure then 1. Prospective study: Expensive
outcome 2. Prospective study: Time-
2. Can test multiple outcomes consuming
3. Prospective study: Loss to follow-
up
4. Multiple confounding factors
5. Potential for selection bias
Study Designs
Question Look for Evidence from
Incidence, Prevalence Cohort studies, Cross-sectional studies
Therapy Clinical trials
Screening Clinical trials
Diagnostic accuracy Clinical trials, Cross-sectional studies
Prognosis Clinical trials, Cohort studies
Harm Clinical trials, Cohort studies, Case-control studies
Etiology Cohort studies, Case-control studies
Week 2 Assignment
Question 1:
Mrs. Salah is a new mother has been breastfeeding her child for 3 months.
The mother has recently been prescribed levofloxacin for treatment of an
infection.
1. What sources should be consulted to determine the appropriateness of this
choice?
2. Is it safe for her to continue breastfeeding during this therapy?
3. What additional information is needed to help shape your search strategy?
Week 2 Assignment (Answer)
Question 1 answer:
Mrs. Salah is a new mother has been breastfeeding her child for 3 months.
The mother has recently been prescribed levofloxacin for treatment of an infection.
1. What sources should be consulted to determine the appropriateness of this choice?
Clinicalkey
2. Is it safe for her to continue breastfeeding during this therapy?
Unknown safety. Recommend to avoid its use if possible due to lack of safety data.
3. What additional information is needed to help shape your search strategy?
If the infection could be treated by other options / Organism causing the infection.
*Results from other sources are acceptable.
Week 2 Assignment
Question 2:
What would be the best search entry if I wish to retrieve articles about the
following topic:
“Smoking as a risk factor for unstable angina”
Find articles that :
- Are published in the last 5 years
- Focus on randomized controlled trials or systematic reviews
Important notes:
- Do not include respiratory conditions (e.g., lung cancer or pneumonia) in
your search.
Week 2 Assignment (Answer)
Question 2 answer:
PubMed search was done as follows:
1st: Search using keywords + Boolean operators:
1. ((unstable angina) AND (smoking)) NOT ((lung cancer)) OR (pneumonia))
or (unstable angina) AND (smoking) NOT (lung cancer) NOT (pneumonia)
2. Initial search without filters retrieved 826 results
3. Using (Last 5 years) filter only: 123 results
4. RCT filter: 6 results
5. SR filter: 2 results
Conclusion: search using keywords and Boolean operators retrieved 6 RCTs and 2 SRs
Week 2 Assignment (Answer)
Question 2 answer (Cont.):
2nd: Search using MeSH terms + Boolean operators:
1. (("Angina, Unstable"[Mesh]) AND ("Smoking"[Mesh])) NOT (("Lung Neoplasms"[Mesh]) OR
("Pneumonia"[Mesh]))
or ((("Angina, Unstable"[Mesh]) AND "Smoking"[Mesh]) NOT "Lung Neoplasms"[Mesh]) NOT
"Pneumonia"[Mesh]
2. Initial search without filters retrieved 157 results
3. Using (Last 5 years) filter only: 9 results
4. + RCT filter: 2 results
5. + SR filter: 0 results
Conclusion: Search using MeSH terms retrieved 2 RCTs and no SRs
Week 2 Assignment (Answer)
Question 2 answer (Cont.):
Name of the article I found is:
1. “Long-Term Effects of an Intensive Prevention Program After Acute Myocardial
Infarction” [[Link]
Or
2. “Patients aged 80 years or older with non-ST-elevation myocardial infarction or
unstable angina pectoris randomised to an invasive versus conservative strategy:
angiographic and procedural results from the After Eighty study”
[[Link]
*Any relevant articles are acceptable.
Week 2 Assignment
ClinicalKey
Is it a 1ry/2ry/3ry source? Why?
Week 2 Assignment (Answer)
ClinicalKey
Is it a 1ry/2ry/3ry source? Why?
Answer:
• Secondary (2ry) source
• Because it is a database that includes book chapters, drug
monographs, clinical guidelines
& It also indexes original research articles.
Week 3 Assignment
Question 1:
A pharmacy student is working on a presentation involving illicit drugs.
She knows that there have been recent news stories about adolescents
using Coricidin™ products for recreational use, and she is curious at
what doses these products are toxic.
• Which resources would be useful for her project?
• What would your search terms be? And what is the result of your
search?
Week 3 Assignment
Question 2:
“Is clonidine effective in the treatment of attention deficit-hyperactivity
disorder?”
The requestor wanted information regarding use of either clonidine or
guanfacine in this disease state.
What sources would you use? And what is your answer to the requestor
bases on these sources?
Week 3 Assignment
Question 3:
What would be the best search entry if I wish to retrieve articles about the following topic:
“The use of blood transfusions and iron chelation as supportive treatment for
β-thalassemia major”
Find articles that :
- Are published in the last year
- Focus on children
Important notes:
- Do not include stem cell transplantation (curative therapy) in your search.
- Do not search for other types of hemoglobinopathies. Focus on β-thalassemia.
THANK YOU