Occupational Epidemiology/Research tools/Ongoing projects/Risk Communication in Seafaring/Draft Protocol guide

Title page

• Article title
• Authors
• Afiliaciones
• Contact, name, mail, afiliacion

Abstract

100-150 palabras

Introduction Background/rationale

• Explain the scientific background and rationale for the investigation being done

Objectives

• State the research questions, including any prespecified hypotheses

Methods

Study design

• Present key elements of study design early in the paper

Setting

• Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection

Participants

• (a) Give the eligibility criteria, and the sources and methods of selection of participants

Variables

• Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable

Data sources/ measurement

• For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than one group

Bias

• Describe any efforts to address potential sources of bias

Study size

• Explain how the study size was arrived at
• Quantitative variables
• Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why

Statistical methods

• a) Describe all statistical methods, including those used to control for confounding
• (b) Describe any methods used to examine subgroups and interactions
• (c) Explain how missing data were addressed
• (d) If applicable, describe analytical methods taking account of sampling strategy
• (e) Describe any sensitivity analyses

Informed consent

The participants will be explained the purpose and details of the study through confirming the consent from the beginning of the questionnaire before the start. All of information from the participants will be confidential and only used for scientific purpose.

Ethical requirements

The ethical rules for database research in Denmark and for the University of Southern Denmark are complied with. Confidentiality in handling personal information is done according to the rules set out by the Danish Data Protection Agency. There are no personal sensitive information included so approval from the Ethics Committee or written informed consent is not necessary. Data and results will be used for the public health master thesis in the University of Southern Denmark.

Informed consent

The participants will be explained the purpose and details of the study through consent from the beginning of the questionnaire before the start. All of information from the participants will be confidential and only used for scientific purpose.

Chronogram

Where and when will the tasks be completed