Practical Issues of Conducting Epidemiological Studies

57 Pages·2008·2.81 MB·English

by  Pino Aceto

Practical Issues of Conducting
Epidemiological Studies
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29.11.2005 Gitta Schlehofer Qualifizierungsprogramm „Klinische Forschung“ Med. Klinik II
Electromagnetic Fields and Epidemiology / Practical issues of conducting epidemiol. studies / B. Schlehofer, DKFZ Heidelberg, Germany Erice, March/April 2008
Guidelines and Recommendations
(based on: „Good Epidemiological Practise“ (GEP) in Germany issued by the
AG Epidemiologische Methoden der Deutschen Arbeitsgemeinschaft Epidemiologie (DAE))
1. Scientific issue
2. Ethical concerns
3. Study design, writing a project protocol
4. Storing biological specimens
5. Data management: Data quality and protection, accessibility and analysis
6. Statistical analysis
7. Interpretation
8. Presentation of study results, publication, communication and public health
Electromagnetic Fields and Epidemiology / Practical issues of conducting epidemiol. studies / B. Schlehofer, DKFZ Heidelberg, Germany Erice, March/April 2008
1. Ethical concerns
The prime ethical principle is to respect human dignity as well as
human rights.
Epidemiological studies have to ensure that humans are
treated with respect and protected from harm
Recommendation:

Before conducting an epidemiological study obtain the agreement
of the respective Ethic Committee.
(if conducting a research study together with US institutions a certificate is now requested that can
be achieved by completing the online course “Human Participant Protections Education for
Research Teams” from e.g. The National Institutes of Health [http.//www.nih.gov] or the Indiana
University [http://www.research.indiana.edu/]) (caveat: time consuming!)
Electromagnetic Fields and Epidemiology / Practical issues of conducting epidemiol. studies / B. Schlehofer, DKFZ Heidelberg, Germany Erice, March/April 2008
Expl:
Checklist for a non-biomedical research with human subjects
Legal and ethical aspects
Declaration of Helsinki, Version 1996
Statement of the respective Ethic Committee
Data protection
Education of study participants (written and verbal)
Informed consent
Voluntary participation
Right of withdrawal from study participation
(Information of radiological diagnostics in frame of the study)
Signature
Electromagnetic Fields and Epidemiology / Practical issues of conducting epidemiol. studies / B. Schlehofer, DKFZ Heidelberg, Germany Erice, March/April 2008
Expl:
Phrasing for „Data protection“ in epidemiological studies
• “This study follows the regulation on physicians confidentiality
and data protection.”
• “Questionnaires will be anonymous / synonymous
(not containing the names of the participants).”
• “Other party is not allowed to have insight into the
original medical documents.”
Electromagnetic Fields and Epidemiology / Practical issues of conducting epidemiol. studies / B. Schlehofer, DKFZ Heidelberg, Germany Erice, March/April 2008
2. Scientific Issue
When planning an epidemiologic study the scientific topic should
be explicit and operationally defined.
The study goals have to be described as specific and
precise as possible.
In general: The scientific goals have to be defined a priori!
(occasionally, also secondary analyses will be meaningful
explorative analysis)
Electromagnetic Fields and Epidemiology / Practical issues of conducting epidemiol. studies / B. Schlehofer, DKFZ Heidelberg, Germany Erice, March/April 2008
The choice of the study population is
caused by the scientific goal!
Electromagnetic Fields and Epidemiology / Practical issues of conducting epidemiol. studies / B. Schlehofer, DKFZ Heidelberg, Germany Erice, March/April 2008
What has to be considered when
performing a study?
(cid:1) Scientific goal
(cid:1) Literature review
(cid:1) Communication with other scientists in this field
(cid:1) Identification (definition/detection) of data sources
Electromagnetic Fields and Epidemiology / Practical issues of conducting epidemiol. studies / B. Schlehofer, DKFZ Heidelberg, Germany Erice, March/April 2008
Expl:
International multi-centred Case-Control Study of
Cancers of the Brain
and Salivary Gland and Leukaemia
so called „Interphone Study“
co-ordinated by
International Agency for Research on Cancer, Lyon
Study Centres
Australia Canada Denmark England Finland France Germany
Israel Italy Japan New Zealand Norway Scotland Sweden
Data sources I
Primary data
(collected directly)
Definition:
All data will be collected by persons, who are responsible
for the study design and the study method.
(cid:1) Advantage :
Data collection concerning the study question: all data are
relevant for the aim of the study

(cid:2) Disadvantage:
- Data collection relies on the researcher’s responsibility
- Time consuming
- Costly
- If data are missing an additional study will be necessary (cid:4) costs!!!
Electromagnetic Fields and Epidemiology / Practical issues of conducting epidemiol. studies / B. Schlehofer, DKFZ Heidelberg, Germany Erice, March/April 2008