Chapter 6, 7, 8, 9, and 10 Questions with Answers

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Introduction to Clinical Research

Chapter 6, 7, 8, 9, and 10 Questions

I.

Chapter 6: Read pages 31-36 and answer the following questions:

Due date: 12/16/15

1.

What are the 8 common study designs mentioned and what are their goals?

Study Approach

Review/meta-analysis

Correlational (ecological) study

Case series

Cross-sectional survey

Case-control study

Cohort study

Experimental study

Qualitative study

Goal

Synthesize existing knowledge

Compare average levels of exposure and disease in several populations

Describe a group of individuals with a disease

Describe exposure and/or disease status in a population

Compare exposure histories in people with disease

(cases) and people without disease (controls)

Compare rates of new (incident) disease in people with different exposure histories or follow a population forward in time to look for incident diseases

Compare outcomes in participants assigned to an intervention or control group

Seek to understand how individuals and communities perceive and make sense of the world and their experiences

2.

What is the difference between primary, secondary and tertiary studies, and what are their pros and cons?

Primary Study – Collect new data from individuals.

Pros – gives the researcher control over the population and content

Cons – time consuming

Secondary Study – Use existing data to analyze.

Pros – researcher can move fairly quickly from the definition of the study question to the analysis of data

Cons – may have only limited data sets, can’t select population, etc.

Tertiary Study – Write a review article.

Pros – researcher can move fairly quickly from the definition of the study question to the analysis of data

Cons – may have only limited data sets, can’t select population, etc.

3.

How long do clinical studies take? What influences the length of a study?

The time required for collecting and analyzing data varies from study to study.

Primary studies – some call for collection of data one time, others require weeks, months or even years.

Secondary – may be short if you can download information from a website or could take a long time if hospital charts need to be reviewed.

Tertiary – duration depends on library access and the number of publications that need to be acquired, read, and submitted.

4.

Explain the difference between the 3 types of primary focus.

Disease status – case series and case control studies – need population with a certain disease.

Exposure status – cohort studies – need to focus on individuals with a particular exposure.

Population status – cross-sectional studies – need to recruit a study population that is representative of a larger population.

II.

Chapter 7: Read pages 37-41 and answer the following questions

Due Date: 12/16/15

1.

When would you use a narrative review? A systematic review? A meta-analysis?

Narrative Review – to describe a new perspective on a topic that can be supported by the existing literature.

Systematic Review – to compare the findings of previous studies on a well-defined topic.

Meta-analysis – to summarize previous findings using pooled statistics.

2.

What are the first steps for each of these?

Narrative Review – to decide what story the article will tell.

Systematic Review – to decide on the specific objectives of the review, to select the search methods that will be used to find potentially relevant articles, to select inclusion and exclusion criteria for articles.

Meta-analysis – to decide on the specific objectives of the review, to select the search methods that will be used to find potentially relevant articles, to select inclusion and exclusion criteria for articles. Plus, to decide how to assess the quality of the studies and to decide how the results of the studies will be combined into one summary statistic.

3.

What are the 3 things that a review article in the health sciences requires? What are the limitations of review articles?

3 requirements:

An extensive search of the literature

The extraction of key information from relevant articles

The clear and concise presentation of this information

Limitations:

Not all journals publish review articles, so it may be hard to publish

A good review requires meticulous library work, but are sometimes thought of as less rigorous research

III.

Chapter 8: Read pages 43-47 and answer the following questions

Due Date: 12/16/15

1.

What is a correlational study?

It uses population-level data to examine the relationship between exposure rates and disease rates.

2.

Where can you find the data for a correlational study?

The key to success is finding a data source that contains comparable information about the variables of interest. Information about all the variables of interest must be available for a suitable number of populations, which can be grouped by place or time

(all 50 states in the US).

3.

What is the ecological fallacy and why should it be avoided?

The incorrect attribution of population-level statistics to individuals. Even though a population with a higher rate of exposure may have a higher rate of disease, individuals in that population with a high level of exposure do not necessarily have the disease.

IV.

Chapter 9: Read pages 49-52 and answer the following questions

Due Date: 12/16/15

1.

What is a case series and when is it useful?

A case report describes one patient. A case series describes two or more patients who have the same disease condition or who have undergone the same procedure.

Useful for:

Describing the characteristics of and similarities among a group of individuals

Identifying new syndromes and refining case definitions

Clarifying typical disease progression

Developing hypotheses for future research

2.

What details does a case definition include?

Spells out the inclusion and exclusion criteria for the study. Should include a disease description plus any relevant person, place and time information. For example a person must have been diagnosed with whooping cough, been living in a large city, and first sought care during a specified time period.

Why do case series require approval of an ethics committee?

Case series involve primary, confidential medical information. Researchers must pay close attention to protecting the identities of the patients.

V.

Chapter 10: Read pages 53-54 and answer the following questions

Due Date: 12/16/15

1.

What is a cross-sectional survey and why are they used often?

Provides a snapshot of the health status of a population at one point in time. They describe communities, assess population needs, evaluate programs and establish baseline data prior to the initiation of other studies.

They are among the most popular study approaches because they allow for the relatively rapid collection of new data and are relatively inexpensive to complete.

2.

What does “representative” population mean?

Participants must be reasonably representative of some larger population. If the results are intended to reflect the profile of an entire town or other population group, then the study’s sampling strategy must recruit a population that is as diverse.

3.

What is the best way to report results from a cross-sectional survey?

Cross-sectional surveys measure the prevalence of various demographic characteristics, exposure histories, and disease states in one well-defined population at one point in time.

The most common way to report results is the prevalence rate – the portion of the population with a given trait at the time of the survey.

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