BIO 550 Data Safety Monitoring If Appropriate

BIO 550 Data Safety Monitoring If Appropriate

Asthma is a chronic lung disease caused by inflammation of the lower airways and episodes of airflow obstruction. Asthma episodes or attacks can vary from mild to life-threatening. In 2007, about 7% percent of the U.S. population was diagnosed with asthma and there have been a growing number of new cases since that time. There are several known risk factors identified as triggers of asthma symptoms and episodes, including inhalation of allergens or pollutants, infection, cold air, vigorous exercise, and emotional upsets. There is also growing evidence relating body-mass index to asthma in both children and adults. Design a study to investigate whether there is such an association.

Choose a study design and justify the reasons you chose the design over others.

Select a statistical measure you would use to describe the association (if there is one) between body mass index and asthma.

In addition, address:

Subject selection

Issues relating to the measurement of both the exposure and the outcome

Potential biases that the study might be prone to, and how they might be handled

Possible confounding factors and effect modifiers and how to overcome their effect

Present the information in a 750-1000-word report, using section headings where each requirement is described and justified under each of the following headings: Study Design, Statistical Measures, Subject Selection, and Measurement Issues.

Refer to the “Key Elements of a Research Proposal.”

You are required to use a minimum of three scholarly resources.

Prepare this assignment according to the APA guidelines found in the APA Style Guide, located in the Student Success Center. An abstract is not required.

This assignment uses a grading rubric. Instructors will be using the rubric to grade the assignment; therefore, students should review the rubric prior to beginning the assignment to become familiar with the assignment criteria and expectations for successful completion of the assignment.

You are required to submit this assignment to LopesWrite. Refer to the directions in the Student Success Center. Only Word documents can be submitted to LopesWrite.

Key Elements of a Research Proposal

If you need a review of study design components, view the resources below.

Review the Key Elements page of the Research Methods Knowledge Base website at http://www.socialresearchmethods.net/kb/guideelements.php

Key Elements of a Research Proposal

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Background / purpose / rationale of the study

Literature review

Hypothesis/key questions

Research objectives

Research methods

• Study design

• Statistical bias

• Procedures/timeline

o Specific steps to be taken to complete the study

o Instruments/data collection methods

o Outcomes

• Proposed data analysis plan

o Statistical analyses planned

o Power analysis if appropriate

• Data safety monitoring if appropriate

Study participants

• Description of participates

• Recruitment of participates

• Confidentiality/human subject’s protection/legal-ethical issues (if appropriate)

• Sampling / rationale

o Inclusion/exclusion criteria

o Number of subjects

Statistical Analysis (only if applicable)

Anticipated Results and Potential Pitfalls

Implications for Practice

Adapted from “Key Elements of a Social Science Research Proposal: Statement of Research Plan” by the Office of Research at Northwestern University at www.research.northwestern.edu