Maritime Health Research and Education-NET/RESEARCH PROJECTS/Sars-COVID-19 in private hospital operators: causative factors and antibody assessment

Background/rationale

• Explain the background and why the investigation is done

Objectives

• State the research questions, and prespecified hypotheses

Methods

Study design

• Case control study, number of cases and number of controls, why is this study design adequate?

Setting

• Where is the data collected (no names) type of hospital departments
• Data collection dates, periods
• Number of participants cases and controls

Participants

• How are the participants selected age gender, job
• Inclusion and exclusion criteria for cases
• Inclusion and exclusion criteria for controls

Variables

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

Data sources/ measurement

• Sources of data and details of methods of data collection,
• How is the data collected - personal interview, mail, paper questionnaire

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 Hospital and University of Trieste are complied with. Confidentiality in handling personal information is done according to the rules set out by the Italian Data Protection Agency. There are no personal sensitive information included so approval from the Ethics Committee or written informed consent is not necessary.

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 the information from the participants will be confidential and only used for scientific purposes.

Abstract

150-200 word