Key Terms for Session One: Patient Centered Outcomes Research

Comparative Effectiveness Research:
The direct comparison of existing health care interventions to determine which work best for which patients and which pose the greatest benefits and harms.
Patient Centered Outcomes Research (PCOR):
Addresses questions that patients and their families care about in clinical settings.
Patient Centered Outcomes Research Institute (PCORI):
An organization that funds PCOR and involves patients throughout their funding process.
Patient Engagement:
The inclusion of patients in the research process, from topic selection through study design and conduct to dissemination of findings.
Patient Reported Outcomes:
Any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.

Key Terms for Session Two: Gluten-Exposed: What Is It All About?

Antibodies (Ab):
Proteins used by the immune system to identify and neutralize pathogens such as bacteria and viruses. They are also known as immunoglobulins (Ig).
Immunoglobulin A (IgA) and immunoglobulin G (IgG):
The names of the two types of antibodies that attack tTG. This tissue is evaluated when someone is tested for celiac disease.
The communities of microorganisms that live on or in people, plants, soil, oceans, and the atmosphere. Microbiomes maintain healthy function of these diverse ecosystems.
Negative Predictive Value:
The probability that subjects with a negative screening test truly do not have the disease.
Positive Predictive Value:
The probability that subjects with a positive screening test truly do have the disease.
Protective Factors:
Decrease the chances of a negative health outcome occurring. Risk factors increase the chances of a negative health outcome occurring.
The ability of a test to correctly identify those with the disease (also called the true positive rate).
The ability of the test to correctly identify those without the disease (also called the true negative rate).
Transglutaminase (tTG):
A tissue normally present in the intestines. A person with celiac disease produces antibodies directed at this tissue.
Villous Atrophy:
Happens when the microscopic, finger-like tentacles that line the wall of your small intestine erode away, leaving a virtually flat surface.

Key Terms for Session Three: Celiac Genetic Testing

Alpha and Beta:
Protein chains on immune cells.
DQ2 and DQ8:
HLA gene variants that predispose to celiac disease.
DQA and DQB:
Two genes tested for in the celiac genetic test.
Gluten Immunogenic Peptides
A protein composed of two polypeptide chains differing in composition in the order, number, or kind of their amino acid residues.
Human Leukocyte Antigen
in cis:
Two genes linked on the same chromosome.
in trans:
Two genes on opposite chromosomes.

Key Terms for Session Four: Introduction to Drug Development

A group of individuals who share a characteristic at some specific time and who are then followed forward in time, with data being collected at one or more suitable intervals.
The extent to which a specific intervention, procedure, regimen, or service produces a beneficial result under ideal conditions.
Rates, incidence, and prevalence of disease.
FDA (U.S. Food and Drug Administration):
Responsible for ensuring the safety of the public.
GCPs (Good Clinical Practices):
An international ethical and scientific quality standard for trials involving human subjects.
GLPs (Good Laboratory Practices):
Regulations governing pre-clinical/toxicology studies.
GMPs (Good Manufacturing Practices):
Quality assurance practices to ensure products are controlled and manufactured to a quality standard.
IND (Investigational New Drug Application):
Submitted to FDA to request permission to study a drug in humans for the first time. In limited circumstances, you can apply to FDA for an IND Exemption.
NDA/BLA (New Drug Application/Biologics License Application):
Submitted to FDA after a Phase 3 trial to request permission to label and market a drug or biologic.
Randomized Placebo Controlled Trial:
A study in which people are allocated at random (by chance alone) to receive one of several clinical interventions. One of these interventions is the standard of comparison or control, often a placebo (inactive intervention/drug).
Relative freedom from harm, including from harmful side effects.
An individual, company, institution, or organization responsible for initiating and managing a clinical trial.

Key Terms for Session Five: The Gluten-Free Diet: Beyond The Basics

Thickening agent formed from starch.
Below 20-parts per million of gluten.
Gluten-free carbohydrates derived from the partial hydrolysis of starch (as of corn or potatoes).
Manufacturing Advisory Statements:
Voluntary label from the food manufacturer; the presence of such a statement does not mean it contains allergen, and the absence of a statement does not mean it was manufactured in a dedicated facility.
Yeast extract:
Food additives and flavorings; typically gluten-free.