Assignment 2

A) Formulate your research questions

How to solve
Formulate two research questions for two research questions that you will work with.

Research Question Hypotheses

What is the
relationship between We hypothesize that alterations in gut
First best
gut microbiota microbiota composition significantly
research
composition and the contribute to the pathogenesis of
question
development of autoimmune diseases.
autoimmune diseases?
How does long-term
We hypothesize that prolonged exposure to
exposure to air
air pollution is associated with an increased
Second best pollution impact
risk of chronic respiratory diseases and
research respiratory health and
adverse respiratory health outcomes.
question increase the risk of
chronic respiratory
diseases?

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 B) Developing the Search Strategy

How to solve
plan to search the literature (mention the search tool you will use) to identify previous
relevant literature about your two research questions.

Formulate the search strategy that includes the keywords so that you can search for
published papers about the best two research questions (separately). Add them to the
yellow cells in the table below.

Which Research engine will you be using? (For example, PubMed, Google Scholar,
Scopus, etc.): Pubmed
Research Question Search Strategy
What is the
relationship between gut microbiota and autoimmune diseases"
First best
gut microbiota OR "microbiota composition in
research
composition and the autoimmunity" OR "impact of gut
question
development of microbiome on autoimmune disorders.
autoimmune diseases?
How does long-term
exposure to air
"air pollution and respiratory health" OR
Second best pollution impact
"impact of air quality on chronic respiratory
research respiratory health and
diseases" OR "lung function and pollution
question increase the risk of
exposure.
chronic respiratory
diseases?

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 C) Fulfil the Internal Review Board Documents

How to solve
As a continuation of A and B parts, write study protocol for the same two primary
research questions you chose using the following study protocols and fill out the forms
for the ethical committee (you can find them in the Files Tab in channel “General” in Our
Team).

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 Example Study Protocol

X: A cross-sectional study

Authors

A. Amgad1,

Affiliations
1
Faculty of medicine, Helwan University, Cairo, Egypt

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Introduction

Background: Long-term exposure to air pollution in urban environments has become a

growing concern due to its potential impact on respiratory health. Air pollution, containing
particulate matter (PM), nitrogen dioxide (NO2), sulfur dioxide (SO2), and other pollutants,
is known to be associated with various respiratory conditions, including chronic obstructive
pulmonary disease (COPD), asthma, and bronchitis. The adverse health effects of air
pollution on the respiratory system are well-documented.

Rationale: This study aims to investigate how long-term exposure to air pollution impacts
respiratory health and increases the risk of chronic respiratory diseases in urban
populations. Understanding the extent of this association is crucial for public health
initiatives and strategies aimed at mitigating these effects.

Scope: This cross-sectional study will focus on urban populations and their exposure to air
pollution. It will assess the prevalence of chronic respiratory diseases and examine the
relationship between air pollution levels and respiratory health outcomes.

Literature Review: Previous studies have demonstrated a strong link between air pollution
and respiratory diseases, with long-term exposure leading to exacerbation of symptoms
and increased risk of developing chronic conditions. However, there is a need for more
comprehensive data in urban settings to inform targeted interventions.

Justification: A cross-sectional study design is suitable for assessing the current status of
respiratory health in urban populations, identifying potential associations with air pollution,
and providing a foundation for future interventions and strategies.

Hypothesis: We hypothesize that long-term exposure to elevated levels of air pollution in

urban environments is positively associated with the prevalence of chronic respiratory
diseases, including COPD and asthma.

Aim and Objectives

he aim of this study is to assess how long-term exposure to air pollution impacts
respiratory health and increases the risk of chronic respiratory diseases in urban
populations. Specific objectives include:

1. To determine the levels of air pollution in the study area.

2. To assess the prevalence of chronic respiratory diseases in urban residents.

3. To analyze the association between air pollution levels and respiratory health
outcomes.

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 4. To propose strategies and recommendations for mitigating the effects of air
pollution on respiratory health in urban environments.

Methods

Study design, setting, and duration

We will conduct a cross-sectional study in urban areas within the period from Jan 2024 to
Nov 2024.

Participants

Individuals meeting the following criteria will be included in the study:

Inclusion criteria:

• Urban residents aged [add age range] years or older.

• Residents living in the study area for at least [add duration] years.

Exclusion criteria:

• Individuals with pre-existing chronic respiratory diseases before the study period.

Data variables

The following data items will be collected from each participant:

1. Demographic information (age, gender, etc.).

2. Residential history and duration of urban living.
3. Air pollution exposure data (PM, NO2, SO2 levels, etc.).
4. Respiratory health data (symptoms, diagnosis, treatment history, etc.).
5. Other relevant variables (smoking status, occupational exposure, etc.).

Sample size and power calculation

The primary outcome of this study is the prevalence of chronic respiratory diseases in the
study population. Previous data from the literature suggest that chronic respiratory
diseases was 49.4. To detect a similar effect assuming 90% statistical power and 5%
margin of error, a minimum sample of 42 participants will be required for this study.
Sample size was calculated using OpenEpi software.

The primary outcome of this study is prevalence of chronic respiratory diseases in the
study population. Previous data from the literature suggest that chronic respiratory
diseases was 49.4. To detect a similar effect with 10% absolute deviation and 95%
confidence level, a minimum sample of 33 participants will be required for this study.
Sample size was calculated using OpenEpi software.

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Statistical analysis plan

Data of categorical variables as espiratory disease status and smoking status will be
summarized as frequencies and percentages. Data of the quantitative variables as air
pollution levels will be summarized as mean and standard deviation (SD) if normally
distributed or median and interquartile ranges (IQR) if not normally distributed. To test
data normality, we will use the Shapiro-Wilk test.

We will use appropriate statistical tests, such as chi-squared or logistic regression, to

analyze the association between air pollution levels and respiratory health outcomes.

Statistical analysis will be done by the stata software, version 5.1 for windows. A P value
<0.05 will be considered statistically significant.

Ethical considerations

Risks

This study does not expose the participants to any risks.

Benefits

The study has the potential to inform public health strategies aimed at mitigating the
adverse effects of air pollution on respiratory health in urban environments..

IRB or ethical approval

We will obtain IRB/ethical approval.

Informed consent form

A written informed consent will be obtained from each participant prior to enrollment in
the study.

Data protection and confidentiality

The investigators confirm that the study data will be kept confidential and will not be used
outside the research purposes outlined in this study protocol.

References

1. Pope CA, Dockery DW. Health effects of fine particulate air pollution: Lines that
connect. J Air Waste Manag Assoc. 2006;56(6):709-742.

2. Gauderman WJ, Avol E, Lurmann F, Kuenzli N, Gilliland F, Peters J, et al. Childhood

asthma and exposure to traffic and nitrogen dioxide. Epidemiology.
2004;15(4):485-491.

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3. Guarnieri M, Balmes JR. Outdoor air pollution and asthma. Lancet.
2014;383(9928):1581-1592.

4. Künzli N, Perez L, Rapp R, Seethaler R. Quantifying the health impact of air pollution
in decision-making: What role does the burden of disease have? Environ Health
Perspect. 2005;113(10):1425-1430.

5. World Health Organization. Ambient air pollution: A global assessment of exposure

and burden of disease. World Health Organization. 2018.