Table of contents
1. Introduction ... 3
2. Problem Statement and Hypothesis ... 3
3. Aims of the study ... 4
4. Objectives ... 4
5. Literature Review ... 5
6. Study design and Methodology ... 6
7. Sampling ... 7
8. Potential Sources of bias and management ... 7
9. Data collection and Analysis ... 7
10. Discussion ... 8
11. Study limitations ... 9
12. Conclusion ... 9
At a local Hospital, an increased number of people admitted and treated for Respiratory Disease have been observed and most of them work at a local Factory. There is a concern that the dust generated by the machinery at the Company would be the contributing factor.
A Case Control Study will be conducted on the Incidence of respiratory disease to prove or disapprove the association between the incident cases of respiratory disease and the exposure to the dust generated by the factory.
The Research Protocol is adapted from the World Health Organization proposed study protocol format (WHO, 2014).
The protocol will state the problem and the hypothesis generated to be tested, the aim and objectives to be achieved and the current knowledge on the topic in a literature review.
A thorough explanation on the choice of the study design, methodology and sampling will be preceded by the study outcome and its measurement methods.
Data collection and analysis using statistical methods with the potential sources of bias are elaborated. A discussion highlighting the prons and cons of this study as well as the study limitations are explained.
A conclusive summary and Ethic statements followed by a list of References will shape the end of this study.
2. Problem Statement and Hypothesis
Current figures at the Hospital show an increased incidence of Respiratory Disease. Furthermore it’s observed that people working from the local factory that generate dust are mostly affected. Is this observation an isolated event or is there an association with a risk factor (exposure)? Is the respiratory disease affecting the general population as well? If yes, to what extend? What is the risk of developing the disease among factory workers and the general population?
Are the following variables age, gender, length of exposure, smoking status and any co-morbidity playing a role in the occurrence of respiratory symptoms?
This study will address these questions by assuming there is no association between exposure to factory generated-dust and the occurrence of respiratory disease. This assumption is called “Null Hypothesis” and if proven wrong, the following alternative hypothesis will be generated:”Exposure to factory generated-dust is associated with the occurrence of respiratory disease”.
As expressed by Bhopal (2008), “Scientists develop and become attached to ideas which they hope to support (and if necessary reject) through their research”; by conducting this study the aforementioned hypothesis will be supported or rejected should the association between exposure to dust and respiratory symptoms proven not evidence-based.
In this context, the aim of the study will focus on establishing the association between exposure and disease occurrence.
3. Aims of the study
The primary purpose of this study is to determine whether there is evidence to support the hypothesis that exposure to factory generated-dust is associated with the occurrence of respiratory disease. Specifically to determine the relative risk of respiratory disease among the factory workers as compared to other groups.
Secondary this research will interrogate the effect of other confounding factors in the development of respiratory disease. Socio-demographic factors (age, gender, smoking status), length of exposure /the use of personal protective equipment and medical history (any co-morbidity, past history of respiratory disease and genetic predisposition) are the main factors of association that will be investigated.