RESEARCH METHODOLOGY
(part D, seminars)
- introduction
LECTURER: PhD Halina Piecewicz-Szczęsna (Halina
Petsevich-Stchesna) - assistant professor at the
Department of Epidemiology and Clinical Research
Methodology
Program
STRUCTURE: Course RESEARCH METHODOLOGY (parts D,
seminars) consists of 3 seminars (5 h) which end with written
research report or project.
Seminars: without grade
METHODOLOGY - THE SUBJECTS of labs and seminars
SEMINARS (5 h, part D)
1. The process of conducting scientific research. Key concepts in the
design and implementation of a scientific study (goal, research
hypotheses, formulating a clinical question). 2h
2. The method of the choice of population for research. Research
methods. Analysis of the results of clinical trials. 2h
3. A meta-analysis, systematic reviews. 1h
When?
Seminars (part D)
2024-05-08 – 2h,
2024-05-15 – 2h,
2024-05-22 – 1h,
List of Textbooks
1. Kenneth Schulz & David A. Grimes, Essential Concepts
in Clinical Research. Randomised Controlled Trials and
Observational Epidemiology, 2nd Edition Elsevier 2018.
2. The research handbook, Annetine Staff and Karin C.
Lødrup Carlsen et al. Oslo University Hospital, Oslo 2017
EPIDEMIOLOGY DEPARTMENT
REGULATIONS:
The seminars are compulsory
Department Epidemiology and Clinical Research
Methodology provides 5 seminars which end with written
research project/report.
Please do not hesitate to contact lecturer
PhD Halina Piecewicz-Szczęsna (Halina Petsevich-
Stchesna) on e-mail: halpiec@gmail.com in case of any
queries.
Conditions for obtaining a credit
for the subject:
1. Attendance
2. Preparing research report or project.
Information for students
Development of a research proposal / project or
report
Your final report should contain:
I. Title of the research
II. Introduction: Background information and statement
of the research problem (scientific justification for the
study)
III. Research objective
IV. Methodology (method: RCT or CCT or kohort study or
case-control study without meta-analysis and systematic
review and cross-sectional study!)
Work plan - describe how do it
V. Short information about results and utilization and
dissemination of research results
VI. Reference/s
II. Please send me to
mystudentsfinal@gmail.com
III. Deadline 2024-05-30
NAME AND SURNAME:…………XXXXXX XXXXXXX…………Group of students: XX
Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate
COVID-19
Introduction: The effectiveness of ivermectin to shorten symptom duration or prevent hospitalization among outpatients with mild to
moderate symptomatic COVID-19 is unknown.
Objective: To evaluate the efficacy of ivermectin, 400 μg/kg, daily for 3 days compared with placebo for the treatment of early mild to
moderate COVID-19.
Methodology: double-blind, randomized, placebo-controlled platform trial, was designed to evaluate repurposed therapies in outpatients
with mild to moderate COVID-19.
A randomized control trial is undertaken to test how efficient and safe Ivermectin is in treating patients. There will be the experimental
group who will receive Ivermectin treatment while the control group receives a placebo along with reasonable care to substitute for the
lack of Ivermectin treatment.
Work plan:
A total of 1591 participants aged 30 years and older with confirmed COVID-19, experiencing 2 or more symptoms of acute infection for 7
days or less, were enrolled.
Interventions: Participants were randomized to receive ivermectin, 400 μg/kg (n = 817), daily for 3 days or placebo (n = 774).
Main outcomes and measures: Time to sustained recovery, defined as at least 3 consecutive days without symptoms. There were 7
secondary outcomes, including a composite of hospitalization or death by day 28.
Results: Among 1800 participants who were randomized 1591 completed the trial.
The hazard ratio (HR) for improvement in time to recovery was 1.07. The median time to recovery was 12 days (IQR, 11-13) in the
ivermectin group and 13 days (IQR, 12-14) in the placebo group.
There were 10 hospitalizations or deaths in the ivermectin group and 9 in the placebo group.
The most common serious adverse events were COVID-19 pneumonia (ivermectin [n = 5]; placebo [n = 7]) and venous thromboembolism
(ivermectin [n = 1]; placebo [n = 5]).
Conclusions and utilization and dissemination of research results: Among outpatients with mild to moderate COVID-19, treatment with
ivermectin, compared with placebo, did not significantly improve time to recovery. These findings do not support the use of ivermectin in
patients with mild to moderate COVID-19.
References
1. Naggie S, Boulware DR, Lindsell CJ, Stewart TG, Gentile N, Collins S, McCarthy MW, Jayaweera D, Castro M, Sulkowski M, McTigue K, Thicklin F, Felker GM, Ginde AA, Bramante CT, Slandzicki AJ, Gabriel A, Shah NS, Lenert LA, Dunsmore SE, Adam SJ, DeLong A, Hanna G, Remaly A,
Wilder R, Wilson S, Shenkman E, Hernandez AF; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-6) Study Group and Investigators. Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized
Clinical Trial. JAMA. 2022 Oct 25;328(16):1595-1603. doi: 10.1001/jama.2022.18590. PMID: 36269852; PMCID: PMC9587497.
2. Leon Caly, Julian D. Druce, Mike G. Catton, David A. Jans, Kylie M. Wagstaff, The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro, Antiviral Research, Volume 178, 2020, 104787, ISSN 0166-3542, https://doi.org/10.1016/j.antiviral.2020.104787.
(https://www.sciencedirect.com/science/article/pii/S0166354220302011)
3. Cunha, J. P. (Ed.). (2021, April 20). Side Effects of Stromectol (Ivermectin), Warnings, Uses. RxList. https://www.rxlist.com/stromectol-side-effects-drug-center.htm.
4. Harvard Health Publishing, Harvard Medical School. (2021, April 22). Treatments for COVID-19. Harvard Health. https://www.health.harvard.edu/diseases-and-conditions/treatments-for-covid-19.
5. Shaffer, L. (2020, May 15). 15 drugs being tested to treat COVID-19 and how they would work. Nature News. https://www.nature.com/articles/d41591-020-00019-9
Preparing research project
A positive grade is obtained by a student who receives at least
6 points / 10 points. When evaluating, the following criteria are
taken into account:
1) Demonstrating knowledge and understanding of the subject
- 0-2 points
2) Compatibility of formulated statements with the state of
current knowledge - 0-2 points
3) Terminological and linguistic correctness - 0-2 points
4) Proper presentation of content and practical tasks - 0-2
points
5) Student's creativity - 0-2 points
A positive result (pass without grade):
at least 6 points is required to receive a pass.
