Veidlapa Nr. M-3 (8)
Study Course Description
Reporting and Publishing Guidelines in Clinical and Epidemiological Research
Course Code
SVI_009
Branch of Science
Clinical medicine; Health sciences
ECTS
3.00
Target Audience
Clinical Pharmacy; Health Management; Medicine; Nursing Science; Public Health; Sports Science
LQF
Level 8
Study Type And Form
Full-Time
Study Course Implementer
Course Supervisor
Inese Gobiņa
Structure Unit Manager
Anda Ķīvīte-Urtāne
Structural Unit
Institute of Public Health
Contacts
Riga, Kronvalda bulvaris 9, +371 67338307
About Study Course
Objective
To develop advanced knowledge and skills in publishing clinical and epidemiological research results, based on internationally recognized reporting guidelines and principles of Good Publication Practice.
Preliminary Knowledge
Research methodology, epidemiology, statistics.
Learning Outcomes
Knowledge
1.Demonstrates a comprehensive understanding of the fundamental principles of reporting and publication in clinical and epidemiological research
2.Demonstrates an understanding of quality, transparency and reproducibility in the publication of clinical and epidemiological research
3.Describes the structure, purpose and key principles of internationally recognised reporting guidelines on clinical and epidemiological research (CONSORT, STROBE)
4.Explains the core principles of research publication ethics and good publication practice
Skills
1.Analyses the reporting quality of publications from clinical and epidemiological studies in accordance with corresponding reporting guidelines
2.Applies the CONSORT and STROBE guidelines in the structured reporting of clinical and epidemiological studies
3.Applies the principles of publication ethics and good publication practice in clinical and epidemiological research
Competences
1.Critically evaluates the reporting quality of publications from clinical and epidemiological studies using the STROBE and CONSORT guidelines
2.Plans and implements the reporting and publication of research results in accordance with appropriate international guidelines
3.Integrate CONSORT and STROBE standards and ethical principles of scientific publishing into research practice
Assessment
Individual work
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Critical appraisal of the reporting quality of a scientific publication |
-
|
-
|
|
Select a clinical or epidemiological research publication and, working in groups, critically appraise its reporting quality using the appropriate reporting guidelines (CONSORT or STROBE), formulating the main shortcomings and conclusions through discussion. |
||
Examination
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Critical appraisal of the reporting quality of a scientific publication using the appropriate reporting guideline checklist |
-
|
10 points
|
|
Independently perform a critical appraisal of the reporting quality of a clinical or epidemiological study applying the appropriate reporting guideline checklist (CONSORT or STROBE). |
||
Study Course Theme Plan
FULL-TIME
Part 1
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Study room
|
2
|
Topics
|
Scientific Writing and Principles of Good Publication Practice in Clinical and Epidemiological Studies
Description
Structure of clinical and epidemiological studies Types of scientific publications (original research articles, systematic reviews, meta-analyses, study protocols, etc.) Relationship between manuscript structure and study design ICMJE recommendations: authorship, accountability and conflicts of interest Key issues in publication ethics |
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Study room
|
2
|
Topics
|
Scientific Writing and Principles of Good Publication Practice in Clinical and Epidemiological Studies
Description
Structure of clinical and epidemiological studies Types of scientific publications (original research articles, systematic reviews, meta-analyses, study protocols, etc.) Relationship between manuscript structure and study design ICMJE recommendations: authorship, accountability and conflicts of interest Key issues in publication ethics |
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Study room
|
2
|
Topics
|
Reporting Standards for Epidemiological Studies (STROBE)
Description
Observational study designs (cohort, case–control, cross-sectional studies) Structured reporting of epidemiological study results: the STROBE guidelines |
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Study room
|
2
|
Topics
|
Reporting Standards for Epidemiological Studies (STROBE)
Description
Observational study designs (cohort, case–control, cross-sectional studies) Structured reporting of epidemiological study results: the STROBE guidelines |
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Study room
|
2
|
Topics
|
Reporting standards for clinical trials (SORT)
Description
Reporting requirements for randomised clinical trials: the CONSORT guidelines CONSORT flow diagram |
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Study room
|
2
|
Topics
|
Reporting standards for clinical trials (SORT)
Description
Reporting requirements for randomised clinical trials: the CONSORT guidelines CONSORT flow diagram |
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Study room
|
2
|
Topics
|
Reporting Standards for Different Study Types within the Open Science framework
Description
Reporting standards for different study types (PRISMA, SPIRIT, CARE, STARD) The importance of the EQUATOR Network and reporting standards Study registration and prior publication of research protocols Reporting standards and research publication as as fundamental components of Open Science |
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Study room
|
2
|
Topics
|
Reporting Standards for Different Study Types within the Open Science framework
Description
Reporting standards for different study types (PRISMA, SPIRIT, CARE, STARD) The importance of the EQUATOR Network and reporting standards Study registration and prior publication of research protocols Reporting standards and research publication as as fundamental components of Open Science |
Total ECTS (Creditpoints):
3.00
Contact hours:
16 Academic Hours
Final Examination:
Test
Bibliography
Required Reading
1.
EQUATOR Network: Enhancing the QUAlity and Transparency Of health ResearchSuitable for English stream
2.
Hopewell S, Chan AW, Collins GS, et al (a). CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ. 2025; 388:e081123.Suitable for English stream
3.
Hopewell S, Chan AW, Collins GS, et al (b). CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials. BMJ. 2025 Apr 14;389:e081124.Suitable for English stream
4.
von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9.Suitable for English stream
Additional Reading
1.
Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P; CONSORT NPT Group. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017 Jul 4;167(1):40-47.Suitable for English stream
2.
Page MJ, Moher D, Bossuyt PM, et al. PRISMA 2020 explanation and elaboration: updated guidance and exemplars for reporting systematic reviews. BMJ 2021;372:n160.Suitable for English stream
3.
Vorland CJ, Brown AW, Kilicoglu H, Ying X, Mayo-Wilson E. Publication of Results of Registered Trials With Published Study Protocols, 2011-2022. JAMA Netw Open. 2024;7(1):e2350688.Suitable for English stream
4.
Junqueira DR, Zorzela L, Golder S, Loke Y, Gagnier JJ, Julious SA, et al. CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials. BMJ 2023;381:e073725.Suitable for English stream
Other Information Sources
1.
Wager E, Godlee F, Jefferson T. How to Survive Peer Review. 2002.Suitable for English stream
2.
STROBE Strengthening the reporting of observational studies in epidemiologySuitable for English stream
3.
SPIRIT/CONSORTSuitable for English stream