Glossary and Key Terms

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.
Microbiomes:
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.
**Sensitivity:
The ability of a test to correctly identify those with the disease (also called the true positive rate).
**Specificity:
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.
GIP:
Gluten Immunogenic Peptides
Heterodimer:
A protein composed of two polypeptide chains differing in composition in the order, number, or kind of their amino acid residues.
HLA:
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

Cohort:
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.
Efficacy:
The extent to which a specific intervention, procedure, regimen, or service produces a beneficial result under ideal conditions.
Epidemiology:
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).
Safety:
Relative freedom from harm, including from harmful side effects.
Sponsor:
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

Dextrin:
Thickening agent formed from starch.
Gluten-Free:
Below 20-parts per million of gluten.
Maltodextrin:
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.