Module 3: Designing and Assessing Research Studies

Question 1

What are the Steps in Designing a Research Study?

Answer 1

1. SELECT THE RESEARCH TOPIC
2. NARROW DOWN YOUR IDEA
3. PREPARE
4. USE THE RESEARCH QUESTION TO DEVELOP THE SPECIFIC AIM(S)
5. DESIGN THE STUDY

Question 2

WHICH STEP WOULD THESE FIT INTO?

-Exploration of foundational information (ie: bench research)
-Ideas to improve patient/community health
-Increasing effectiveness of services and topics
-Untested concepts in published literature

Answer 2

Step 1 - Selecting the Research Topic

Question 3

WHICH STEP WOULD THESE FIT INTO?

-Review the published literature
-Look for systematic or meta-analyses (good place to start and then fill in with whatever has been published since then)
-See if your research question has already been answered
-See if the foundational information there, or is that where you need to start your research?
-Broadly identify resources needed
-Identify resources available

Answer 3

STEP 3 - Prepare

Question 4

Define Specific Aim?

Answer 4

It tells the reviewer or your participants exactly what you intend to do and why you intend to do it

Keep it simple and use operational terms (identify, compare, differentiate, assess, describe)

Question 5

What are 3 details that the Specific Aim MUST include?

Answer 5

1. Who/Which: the patient, population, or subject that is being studied
2. What: the factor of interest
3. How assessed: the specific outcome being assessed

**It does not have to be written in this specific order, but ALL OF THESE KEY COMPONENTS NEED TO BE THERE

Question 6

(TRUE/FALSE)

The specific aim must include your hypothesis.

Answer 6

FALSE.

You do not yet have to give an idea as to what you think the outcome will be, that is going to be the hypothesis.

Question 7

What is the Hypothesis Statement?

Answer 7

The statement about an expected relationship between variables, or an explanation of an occurrence, that is clear, specific, and testable.

Question 8

What aspects should a Hypothesis Statement have?

Answer 8

1. A clear specific aim should lead to clear hypothesis statement.
2. Your hypothesis should be research-based and well-defined with regard to direction of the expected outcome.
3. Your hypothesis should not be so narrow that any deviation suggests lack of results (unless it has to. be narrow due to the field of study).

Question 9

(EXAMPLE) Which is the hypothesis and which is the specific aim?

Increasing BMI is positively associated with increased CVD incidence in adult patients with T2DM.

To assess the influence on BMI on CVD incidence in patients with uncontrolled T2DM.

Answer 9

The Hypothesis is listed first.

The Specific Aim is listed second.

Question 10

WHICH STEP WOULD THESE FIT INTO?

-Participants/populations that will answer the research questions and are available.
-Gold standard methods whenever possible (if you are testing an untested method, compare it to the gold standard)
-Validated surveys or questionnaires
-Theoretical Models
-Bringing in collaborators for needed expertise (Statistics, Bench methods)

Answer 10

STEP 5 - Design the Study

Question 11

What are Validated Surveys?

Answer 11

A researcher has previously developed the survey and tested it, in the type of population that you’re wanting to use the survey for.

Strengths:
-Asking questions clearly so the targeted population is answering clearly
-Results are reliable.

Question 12

What are Theoretical Models? When are they used?

Answer 12

A blueprint or a guide where you put your area of research or research question in the middle and then it lists the layers of different factors that could contribute to it.

This ensures you are investigating each layer as you look at your overall research project.

They are used for Behavior-Related Research

Question 13

What is Research Quality?

Answer 13

AKA: Methodological Quality; Quality Assessment; Risk of Bias

It is the critical evaluation of the strengths and weaknesses of a study; should be done by anyone conducting or reading research

Question 14

What is the importance of Research Quality?

Answer 14

Reporting research should be CLEAR, COMPLETE, and ACCURATE.

Inaccurate or incomplete reporting can lead to incorrect assumptions.

Question 15

What are some checklists that are used for assessing research quality?

Answer 15

1. CONSORT
2. STROBE
3. PRISMA

Question 16

What is CONSORT and when should it be used?

Answer 16

Consolidated Standards of Reporting Trials = CONSORT

CONSORT contains a “T,” it should be used for RANDOMIZED TRIALS, crossover

Question 17

What is STROBE and when should it be used?

Answer 17

Strengthening the Reporting of Observational Studies in Epidemiology = STROBE

STROBE contains an “O,” it should be used for OBSERVATIONAL studies, cohort, case-control, cross-sectional

Question 18

What is PRISMA and when should it be used?

Answer 18

Preferred Reporting Items for Systematic Reviews and Meta-Analyses = PRISMA

PRISMA contains “S” and “M,” it should be used for SYSTEMATIC AND META-ANALYSES

Question 19

(EXAMPLE) CHOOSE THE PROPER TOOL FOR ASSESSING RESEARCH QUALITY.

Lisa is reviewing a study looking at the prevalence of diabetes in teenagers in the US. Participants were asked to complete a one-time survey about their past medical history.

Answer 19

This is a cross-sectional study design, so STROBE should be used.

Question 20

What is a cross-sectional study design?

Answer 20

A type of research design in which you collect data from many different individuals at one-point in time.

Question 21

(EXAMPLE) CHOOSE THE PROPER TOOL FOR ASSESSING RESEARCH QUALITY.

Jamie is assessing a research article for a weight loss program. Participants are randomly assigned to enroll in a 6-week intervention program or receive regular dietary counseling.

Answer 21

This is a RCT, so CONSORT should be used.

Question 22

(EXAMPLE) CHOOSE THE PROPER TOOL FOR ASSESSING RESEARCH QUALITY.

Crystal is interested in the recent literature on the effectiveness of the ketogenic diet for weight loss in overweight and obese adults. She finds an article that analyzes and summarizes data from 12 studies conducted in the past 5 years.

Answer 22

This is a systematic review, so PRISMA should be used.

Question 23

What are the 6 main components of the check-list tools for assessing research quality?

Answer 23

1. Title and abstract
2. Introduction
3. Methods (*Randomization)
4. Results
5. Discussion
6. Other information (funding, *registration, *protocol)

• specific to CONSORT only.

Question 24

What is Nutrition Informatics?

Answer 24

The effective retrieval, organization, storage, and optimum use of information, data, and knowledge for food and nutrition-related problem solving and decision making. Informatics is supported by the use of information standards, information processes, and information technology.

AKA: It is the intersection of information, nutrition, and technology

Question 25

What allows nutrition professionals to use their knowledge and skills through the support of technology, whether collecting data to document outcomes, for decision support, or streamlining workflow?

Answer 25

Nutrition Informatics

Question 26

What are 7 areas that Nutrition Informatics impacts?

Answer 26

1. Clinical Practice
2. Consumer-Based Nutrition
3. Food and Nutrition Mgmt
4. Retail Organization and Mgmt
5. Public Health
6. Public Policy

(which can all be used to conduct):
7. RESEARCH

Question 27

What is considered Consumer-Based Nutrition?

Answer 27

Informatics from the consumer/patient POV

Examples: apps, wearable devices, social media, mobile health apps, remote monitoring apps

Question 28

In what ways does Nutrition Informatics impact retail organization and management?

Answer 28

1. Consumer purchasing trends
2. Sales hx
3. Inventory Mgmt

Question 29

In what ways does Nutrition Informatics impact food and nutrition management?

Answer 29

1. Staffing and workload statistics
2. Recipe analysis (including nutrient analysis, allergen analysis)

Question 30

In what ways does Nutrition Informatics impact public health?

Answer 30

1. Disease Surveillance
2. Disease Prevention

EXAMPLE: NHANES data

Question 31

What is NHANES?

Answer 31

National Health and Nutrition Examination Survey; a program of studies designed to assess the health and nutritional status of adults and children in the US

It combines interviews and physical exams which leads to producing vital health statistics for the nation, was started in the 1960s.

Results of NHANES is used to determine the prevalence of major diseases and risk factors for disease. They are also the basis for national standards for such measurements as height, weight, and blood pressure.

The data will be used in epidemiological studies and health sciences research, which help develop sound public health policies

Question 32

What is Nutrition Policy?

Answer 32

A set of concerted actions based on a government mandate, that is intended to ensure good health in the population through informed access to safe, healthy, and adequate food.

These government mandates are based on collecting large amounts of information at the individual, community, and national levels and then analyzing the data to determine if a nutrition policy would be effective in improving health.

Question 33

What is an example of a nutrition policy?

Answer 33

NHANES

Question 34

In what ways does Nutrition Informatics impact public policy?

Answer 34

1. Evidence-based policy making (1906 Pure Food & Drug Act, 2018 Artificial trans-fat ban in foods)
2. Measuring policy outcomes

Question 35

In what ways does Nutrition Informatics impact research?

Answer 35

1. Any of the data collected for clinical practice, from consumer-based nutrition, food and nutrition management, retail, and public health and policy can be used in research
2. Research information can be collected from other databases, such as clinical trials databases

Question 36

What are 2 KEY FACTORS in maintaining ethical and legal issues in Nutrition Informatics?

Answer 36

Maintaining participant/patient CONFIDENTIALITY and PRIVACY whether in electronic record keeping, telehealth, mHealth apps, etc.

Question 37

(TRUE/FALSE)

In many cases, especially in research-driven cases, participants must given consent to use their data.

Answer 37

TRUE except for consumer-based nutrition

Question 38

What is data security?

Answer 38

Data should be completely de-identified or only be accessible by authorized personnel

This would be removing any personal-identifying information following HIPAA guidelines

Question 39

HIPAA

Answer 39

Health Insurance Portability & Accountability Act has regulations that mandate the PRIVACY and CONFIDENTIALITY of this protected health information, they give guidelines at 2 levels:

1. EXPERT DETERMINATION METHOD
2. SAFE HARBOR METHOD

Question 40

What is the Expert Determination Method?

Answer 40

It means that a person with appropriate knowledge and experience with generally accepted statistical and scientific principles cannot apply those principles to identify the person involved.

Question 41

What is the Safe Harbor Method?

Answer 41

An easier set of guidelines to follow because they specifically mandate the removal of 18 different types of identifiers. These include (names, all geographic submissions smaller than a state, all dates except for dates that are directly related to an individual, like DOB, admission, discharge, death, etc, etc