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.