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Transcript
Glossary of Lay Terms & Replacement Words for Use in Preparing Consent Forms*
ABDOMINAL
ABSORB
Acceptable
ACIDOSIS
ACUITY
ACUTE
Additional information about
ADENOPATHY
Adequate
ADJUVANT
ADJUVANT TREATMENT
Administer
Administration of
AIDS
Allowing
ANTIBIOTIC
ANTIMICROBIAL
ANTIRETROVIRAL
ADVERSE EFFECT
ALLERGIC REACTION
AMBULATE -ATION -ORY
ANAPHYLAXIS
ANEMIA
ANESTHETIC general
ANESTHETIC local
ANGINA (ANGINA PECTORIS)
ANOREXIA
ANTECUBITAL
ANTIBODY
and protects against infection
ANTICONVULSANT
ANTILIPIDEMIC
ANTITUSSIVE
Appropriate
Approximately
ARRHYTHMIA
ASPIRATION
ASSAY
ASSESS
Assigned
Associated with
ASTHMA
ASYMPTOMATIC
At risk
Audiotape
Informed Consent Replacement Words
Pertaining to body cavity below diaphragm which contains stomach, intestines,
liver, and other organs
Take up fluids, take in
Good / decent / capable
Condition when blood contains more acid than normal
Clearness, keenness, esp. of vision - airways
New, recent, sudden / a quick and severe form of illness in its early stage
Other facts about / more facts about
Swollen lymph nodes (glands)
good
Helpful, assisting, aiding
Added treatment
Give (to)
Giving of
Acquired Immunodeficiency Syndrome; a disease that affects the body’s immune
system; development of the disease or conditions associated with the disease results
from HIV (Human Immunodeficiency Virus)
Letting
Drug that kills bacteria and other germs
Drug that kills bacteria and other germs
Drug that inhibits certain viruses
Negative side effect
Rash, trouble breathing
Walk, able to walk
Serious, potentially life threatening allergic reaction
Decreased red blood cells; low red blood cell count
A drug or agent used to decrease the feeling of pain or eliminate the feeling of
pain by putting you to sleep
A drug or agent used to decrease the feeling of pain or by numbing an area of
your body, without putting you to sleep
Pain resulting from insufficient blood to the heart
Condition in which person will not eat; lack of appetite
Area inside the elbow
Protein made in the body in response to foreign substance; attacks foreign
substance
Drug used to prevent seizures
A drug that decreases the level of fat(s) in the blood
A drug used to relieve coughing
The right / correct
About
Any change from the normal heartbeat (abnormal heartbeat)
Fluid entering lungs
Lab test
To learn about / rate the level (of health/wellness) / judge
Placed in (into a group)
having to do with
A lung disease associated with tightening of the air passages
Without symptoms / having no symptoms or problems
Having the possibility that something negative may happen
A cassette tape that is listened to
-1-
AXILLA
Armpit
Baseline
Benefit
BENIGN
A patient’s medical status before any treatment or research is done
A good effect
Not malignant, usually without serious consequences, but with some exceptions
e.g. benign brain tumor may have serious consequences
Twice a day
Carried by, to make stick together, transported
The extent to which a drug or other substance becomes available to the body
Series of blood tests
Blood will be taken [We will take blood.]
An amount given all at once
The amount of calcium in a give amount of bone
Slow irregular heart beat
Slow heartbeat
Breathing distress caused by narrowing of the airways
If you agree
By phone
BID
BINDING/BOUND
BIOAVAILABILITY
BLOOD PROFILE
Blood will be collected
BOLUS
BONE MASS
BRADYARRHYTHMIAS
BRADYCARDIA
BRONCHOSPASM
By agreeing
By telephone
CARCINOGENIC
CARCINOMA
CARDIAC
CARDIOVERSION
CATHETER
CATHETER indwelling epidural
CENTRAL NERVOUS SYSTEM (CNS)
CEREBRAL TRAUMA
CESSATION
CHD
CHEMOTHERAPY
CHRONIC
CISPLATIN
CLINICAL
Clinical Trial
CLINICALLY SIGNIFICANT
CLINICAL TRIAL
COMA
Commonly
Comparison group
Compensate
Compensation
COMPLETE RESPONSE
Conclude(d)
Confidential/Sensitive
Confidentiality
CONGENITAL
CONJUNCTIVITIS
Consequence
Consider
Consists of
Continue / Continued
Informed Consent Replacement Words
Capable of causing cancer
Type of cancer
Pertaining to the heart
Restoration of normal heart beat by electric shock
A tube for withdrawing or introducing fluids
A tube placed near the spinal cord used for anesthesia during an operation
Brain and spinal cord
Damage to the brain
Stopping
Coronary heart disease
Treatment of disease, usually cancer, by chemical agents
Continuing for a long time / long lasting or long term
A drug used to kill cancer cells
Pertaining to medical care
A medical research study of a new drug, new use of a drug, new device, or new use of a
device in human volunteers
Of major importance for treating or evaluating patients
An experiment in patients
Unconscious state
Most often
A group used to compare results
Repay
Payment or gift to a research subject
Total disappearance of disease
End(ed)
Private
Keeping all information about a research subject private
Occurring prior to birth, due to parent's genetic input
Irritation and redness of the thin membrane covering the eye
Result / effect / outcome
Think about
Includes
Keep on going / Kept on going
-2-
CONSOLIDATION PHASE
CONTROLLED TRIAL
(control) treatment or procedure
Convenient
COOPERATIVE GROUP
CORONARY
CT (CAT) SCAN
CULTURE
CUMULATIVE
Currently receiving
CUTANEOUS
CVA
Decision
Deleted
DERMATOLOGIC
Description
Determine whether
Developed
DIASTOLIC
heart beat
Directly
Discomfort
Discover / discovered
DISTAL
DIURETIC
DOPPLER
DOUBLE BLIND
DYSFUNCTION
DYSPLASIA
Treatment phase intended to make a remission permanent; follows induction
Study in which the experimental treatment or procedure is compared to a
standard
Handy
Association of multiple institutions to perform clinical trials
Pertains to the blood vessels that supply the heart
Computerized (axial) tomography; computerized series of x-rays
Test for infection or organisms that could cause infection
Total sum (of individual events, experiences, treatments)
Now getting
Relating to the skin
Cerebrovascular accident; Stroke
Choice
Erased
Pertaining to the skin
A statement which describes
Learn if / find out if
Put in place
Lower number in blood pressure reading; pertaining to resting or relaxation
phase of
In a direct way
Worry / woe / aches /soreness
Find / found
Toward the end, away from the center of the body
"Water pill" or drug that causes increase in urination
Sound waves
Study in which neither investigators nor subjects know what drug the subject is
receiving / a medical research study in which the subjects and the researchers are not
told which of two or more treatments the subjects are receiving
State of improper function
Abnormal cells
ECHOCARDIOGRAM
Sound wave test of the heart
EDEMA
Increased fluid
Educational background
Level of schooling
EEG
Electroencephalogram; electric brainwave tracing
Effective
Works / works well / works better (than)
Effectiveness
Working ability
EFFICACY
Effectiveness / the usefulness, working ability of a type of treatment
ELECTROCARDIOGRAM
Electrical tracing of the heartbeat or heart rhythm (ECG or EKG)
ELECTROLYTE IMBALANCE
Imbalance of salts or chemicals in the blood
Elevate
Raise
ELEVATION OF LIVER FUNCTION TESTS
Evidence of liver or kidney damage
EMESIS
Vomiting
EMPIRIC
Based on experience
ENDOSCOPIC EXAMINATION
Examination of an internal part of the body with a lighted tube; looking at a part of
the body with a lighted tube
Enrolling
Joining / being in
ENTERAL
By way of the intestines
Entitled to otherwise
Have a right to receive apart from this
EPIDURAL
Informed Consent Replacement Words
Outside the spinal cord
-3-
ERADICATING
Especially
Evaluate
EVALUATED
Evidence of
EXPEDITED REVIEW
Explanation
Exposure to
EXTERNAL
EXTRAVASATE
Getting rid of (such as a disease)
Mainly
Rate the level (of health/wellness); judge
Assessed; examined for medical condition
Signs of / proof of
Rapid review of a protocol by Human Subjects Committee Chair without full
committee approval, permitted with certain low-risk research
A statement which explains
Risk of getting
Outside the body
To leak outside of a blood vessel
FIBRILLATION
FIBROUS
FDA
new drugs
Fever
First degree relative
Follow-up
For example
For study purposes
Increase in body temperature
A patient’s spouse, mother, father, sister, brother, or child
Returning to see the doctor at a later time
For instance
To carry out the study
GENERAL ANESTHESIA
Genetic
GESTATIONAL
Guarantee
Pain prevention by induction of drugged sleep, as in surgery
Passed down from birth parents in the genes
Pertaining to pregnancy
Promise
HEMATOCRIT
HEMATOMA
HEMODYNAMIC
HEMOLYSIS
HEPARIN LOCK
needle or tubing
HEPATOMA
Hereditary
HERITABLE DISEASE
children
HISTOPATHOLOGIC
HOLTER MONITOR
However
HYPERCALCEMIA
HYPERKALEMIA
HYPERNATREMIA
HYPERTENSION
HYPOCALCEMIA
HYPOKALEMIA
HYPONATREMIA
HYPOTENSION
HYPOXIA
Amount of red blood cells in the blood
A bruise, a black and blue mark
Related to blood flow
Breakdown in red blood cells
Needle placed in the arm with blood thinner to keep the blood from clotting inside the
IATROGENIC
Caused by a physician or by treatment
Informed Consent Replacement Words
Irregular beat of the heart or other muscle
Having many fibers, such as scar tissue
U.S. Food and Drug Administration, the branch of federal government which approves
Cancer or tumor of the liver
A trait, condition, or disease passed down from birth parents
A disease which can be transmitted to one's offspring resulting in damage to future
Pertaining to the disease status of body tissues or cells
A portable machine for recording heart beats
But / yet
High blood calcium level
High blood potassium level
High blood sodium level
High blood pressure
Low blood calcium level
Low blood potassium level
Low blood sodium level
Low blood pressure
Low oxygen level in the blood
-4-
IDE
device
IDIOPATHIC
IMMUNOGLOBULIN
IMMUNOSUPPRESSIVE
IMMUNOTHERAPY
IMPAIRED FUNCTION
IMPLANTED
Implemented
In addition
Including
Inclusion criteria
IND
INDUCTION PHASE
INDURATION
INDWELLING
INFARCT
Infected with the…
INFECTIOUS DISEASE
INFLAMMATION
Information
INFUSION
INGESTION
Inheritance
Inherited
Initial
Injury
Interested in…
Interfere
INTERFERON
INTERMITTENT
and beginning
INTERNAL INTERIOR
Intervention
In this community
INTRAMUSCULAR
INTRAPERITONEAL
INTRATHECAL
INTRAVENOUS (IV)
INTRAVESICAL
INTUBATE
INVASIVE PROCEDURE
INVESTIGATIONAL NEW DRUG (IND)
INVESTIGATIONAL METHOD
accepted as standard care
ISCHEMIA
LAPORATOMY
to look at the organs
LETHARGY
Informed Consent Replacement Words
Investigational device exemption, the license to test an unapproved new
medical
Of unknown cause
A combination of antibodies from proteins in the blood
Drug which suppresses the body's immune response, used in transplantation and
diseases caused by disordered immunity
Giving of drugs to help the body's immune (protective) system; usually used to
destroy cancer cells
Abnormal function
Placed in the body
Put in place
Also
Along with
The characteristics a subject must have to be included in a medical research study
Investigational new drug; the license to test an unapproved new drug
Beginning phase or stage of a treatment
Hardening
Remaining in a given location, such as a catheter
Death of tissue because of lack of blood supply
Having / with the …
Disease which is transmitted from one person to next
Swelling which is generally painful, red, and warm
Facts
Introduction of a substance into the body, usually into the blood / a fluid or medicine
delivered not a vein by way of a needle
Eating; taking by mouth
Something passed down from birth parents
A characteristic or condition that is passed down from birth parents
First
Harm
Would like to know about…
Get in the way of
Agent which acts against viruses; Antiviral agent
Occurring (regularly or irregularly) between two time points; alternately
ceasing
Within the body / Inside of the body
A treatment given during the course of a research study
Around here
Into the muscle; within the muscle
Into the abdominal cavity
Into the spinal fluid
Into (within) a vein / to put medicine or fluid into a vein by way of a needle
In the bladder
The placement of a tube into the airway / to insert a tube into the mouth or nose to
assist in breathing
Puncture, opening or cutting of the skin
A new drug which has not yet been approved by the FDA
A treatment method which has not been proven to be beneficial or has not been
Decreased oxygen in a tissue (usually because of decreased blood flow)
A procedure in which an incision is made in the abdominal wall to enable a
physician
Sleepiness
-5-
LEUKOPENIA
LIPID
LIPID PROFILE (panel)
LOCAL ANESTHESIA
LOCALIZED
Long-term extension
LUMEN
LYMPHANGIOGRAPHY
feet)
LYMPHOCYTE
LYMPHOMA
Low white blood cell count
Fat
Fat and cholesterol levels in the blood
Creation of insensitivity to pain in a small local area of the body
Restricted to one area; limited to one area (of the body)
Continuation of a research study
Cavity of an organ or tube (e.g. inside of blood vessel)
An x-ray of the lymph nodes or tissues after injection of dye in lymph vessels (e.g. in
Make it possible to…
MALAISE
MALFUNCTION
MALIGNANCY
MYALGIA
MUCOSA, MUCOUS MEMBRANE
Multi-center
Multiple dose
MYOCARDIAL M. INFARCTION
Allow us to…
A vague feeling of bodily discomfort, feeling bad
Condition in which something is not functioning properly
Cancer or other progressively enlarging and spreading tumor, fatal if not
successfully treated
Health record / chart containing all of the patient’s personal information, doctor’s
notes, nurse’s notes, test results, and treatment information that may be kept by a
hospital or clinic
Type of brain tumor
A drug used to treat infections caused by parasites or other causes of anaerobic
infections
Process of breaking down substances in the cells
Spread of cancer cells from one part of body to another
Myocardial infarction, heart attack
Not serious
Slight
Reduce
Medium level of seriousness
Check on; keep track of; watch carefully
Ease of movement; Ability to move around
Undesired result or complication; serious disease
Death or death rate
Magnetic resonance imaging, body pictures created using magnetic rather than
x-ray energy
Muscle aches
Moist lining of digestive, respiratory, reproductive, and urinary tracts
When more than one hospital or medical school team work on a medical research study
Getting more than one dose of a medicine
Pertaining to the (muscle of the) heart, Heart attack; death of heart muscle
NASOGASTRIC TUBE
Nausea
NCI
NECROSIS
NEOPLASIA
NEUROBLASTOMA
NEUROLOGICAL
NEUTROPENIA
NIH
NON-INVASIVE
Tube from the nose to the stomach
Feeling sick to your stomach
National Cancer Institute
Death of tissue
Tumor, may be non-cancerous or cancerous
A cancer of nerve tissue
Pertaining to the nervous system
Decrease in the main part of the white blood cells
National Institutes of Health
Not breaking, cutting or entering the skin
Medical record
MEDULLOBLASTOMA
METRONIDAZOLE
METABOLIZE
METASTASIS
MI
Mild
MINIMAL
MINIMIZE
Moderate
MONITOR
MOBILITY
MORBIDITY
MORTALITY
MRI
Informed Consent Replacement Words
A type of white blood cell important in the body's defense against infection
A cancer of the lymph nodes (or tissues)
-6-
NOSOCOMIAL PNEUMONIA
Pneumonia acquired in the hospital
Obesity
Obligated
Observe
Obstruction
Obtain
OCCLUSION
Occurs
OHRP
ONCOLOGY
Open label
Very overweight
Have to / must
Watch / look at
Block / blockage
Get / determine
Closing; obstruction
Takes place
Office of Human Research Protections, oversees IRBs and related matters
The study of tumors or cancer
A medical research study in which subjects and researchers are told which treatments
the subjects are receiving (unblinded)
Pertaining to the eye
Best, most favorable or desirable
Given by mouth
Pertaining to the bones
Rare bone disorder characterized by dense bone
Bone disorder characterized by loss of bone leading to increased risk of
fracture
Female sex glands; female organs which release eggs
OPHTHALMIC
OPTIMAL
ORAL ADMINISTRATION
ORTHOPEDIC
OSTEOPETROSIS
OSTEOPOROSIS
OVARIES
Parallel design
PARENTERAL
Participant
Participate / participating
Participation in…
PATENCY
PATHOGENESIS
PERCUTANEOUS
PERFORATION
PERIPHERAL
Permitted
PER OS (PO)
PHARMACOKINETICS
PHASE I
PHASE II
PHASE III
Phase IV
PHLEBITIS
Physician
PLACEBO
PLACEBO EFFECT
PLATELETS
POTENTIAL
Informed Consent Replacement Words
A medical research study comparing the response in two or more groups of subjects
receiving different interventions (treatments)
Administration by injection
Person taking part
Be in / being in / take part in
Being part of…
Condition of being open
The initial cause of a disease
Through the skin
Puncture, tear or hole
Not central
Allowed
By mouth
Study of the way the body absorbs, distributes and gets rid of a drug
Initial study of a new drug in humans to determine limits of tolerance / a medical
research study using healthy volunteers / initial safety testing of a new drug
Second phase of study of a new drug intended to obtain initial information / A later
clinical study looking at a new drug’s dosage, safety, and efficacy in patients
Large scale trial to confirm and expand information on safety and usefulness of a new
drug / A still later controlled, randomized study testing a specific dose of a new drug
and its effectiveness in treating a condition or disease
After a drug has been approved by the FDA and is available for use; a study that looks at
how well the drug is being used in the medical community
Irritation or inflammation of a vein
Doctor
An inactive substance which may resemble an active agent but has no medical
value / a “sugar pill”
Symptom or change of condition seen when a placebo is given; not attributable
to an active drug agent
Small particles in the blood that help with blood clotting
Possible / could be
-7-
POTENTIATE
Prior
PROPHYLAXIS
PROSTHESIS
PRN
PROGNOSIS
PRONE
PROSPECTIVE STUDY
Protected
PROTOCOL
Provide explanations for
Provided / providing
PROXIMAL
PULMONARY
Increase or multiply the effect of a drug or toxin by administration of another
drug or toxin at the same time
An agent that helps another agent work better
Birth outcomes
Before birth
Studies done before / other studies
Virus we did not know about
The main individual who is responsible and accountable for conducting a medical
research study
Before
A drug given to prevent disease or infection
Artifical limbs, such as arms and legs
As needed
Outlook, probable outcomes
Lying on the stomach
Study following patients forward in time
Kept private
Plan of study
Explain why
Given / giving
Closer to the center of the body, away from the end
Pertaining to the lungs
QD
QID
Questionnaire
Every day; daily
Four times a day
Survey form
RADIATION THERAPY
Ramifications
RANDOM
RANDOMIZATION
RENAL
REPLICABLE
X-ray or cobalt treatment
Problems / results / outcomes
By chance
Assignment of treatment group by chance, similar to tossing a coin (when there are two
treatment choices) / like a flip of a coin, a 50-50 chance of receiving a study medicine
or treatment
Reason(ing)
Red blood cell
Get
Before now
Formation of new combinations of genes
Putting back together the original parts or elements
Happen again
Not responding to treatment
About
Regrowth of a structure or of lost tissue
Pattern of administering treatment
Rules
The return or reappearance of a disease
Tied in with
Disappearance of evidence of cancer or other disease / when a medical problem gets
better or goes away for a while
Pertaining to the kidneys
Capable of being duplicated
Researchers / Scientists
People doing the study
POTENTIATOR
Pregnancy outcomes
PRENATAL
Previous Studies
Previously unrecognized virus
Principal investigator (PI)
Rationale
RBC
Receive
Recently discovered
RECOMBINANT
RECONSTITUTION
RECUR
REFRACTORY
Regarding
REGENERATION
REGIMEN
Regulations
RELAPSE
Relevant
REMISSION
Informed Consent Replacement Words
-8-
Research study
Research subject
RESECT
RETROSPECTIVE STUDY
Risk
Risk factor
A process of collecting information about a specific question in order to find an answer
Volunteer who is taking part in a medical research study
Remove or cut out (surgically)
Study looking back over past experience
The possibility of injury or harm
A characteristic or actions of an individual which identify them as having a high
likelihood of developing a specific disease or condition
SARCOMA
Satisfactorily
Schedule an appointment
Screening
A type of cancer
Good enough
Set a time
The process of deciding if someone is qualified to take part in a medical research study
or not
A drug to calm or make less anxious
A type of testes cancer
In a row
Some / a few / a number of
Very serious / life threatening
Types of sex
VD (or STDs)
Unwanted or unintended problems with a drug or treatment
A medical study in which the subjects are not told which of two or more treatments the
subjects are receiving, but the researchers are
Getting one dose of medicine
The place where the medical research study will be carried out
Computer program
Sleepiness
Samples
An instrument to measure the amount of air taken into and exhaled from the lungs
The company, department, or person who is paying for the medical research study
Treatment plan which the majority of the medical community would accept as
appropriate
A determination of the extent of the disease
Narrowing of a duct, tube, or one of the heart valves
Mouth sores; inflammation of the mouth
Arrange in groups for analysis of results (e.g., stratify by age, sex, etc.)
The person who leads the study
How far along the medical research study is
Stunned state in which it is difficult to get a response or the attention of the subject
Under the collarbone
Under the skin
Large / big
Pointed to
Lying on the back
General medical care aimed at symptoms, not intended to improve or cure underlying
SEDATIVE
SEMINOMA
SEQUENTIALLY
Several
Severe
Sexual behaviors
Sexually transmitted diseases
Side effects
Single blinded
Single dose
Site
SOFTWARE
SOMNOLENCE
Specimens
SPIROMETER
Sponsor
STANDARD OF CARE
STAGING
STENOSIS
STOMATITIS
STRATIFY
Study Coordinator
Study phase
STUPOR
SUBCLAVIAN
SUBCUTANEOUS
Substantial
Suggested
SUPINE
SUPPORTIVE CARE
disease
SYMPTOMATIC
Symptoms
SYNDROME
SYSTOLIC
Having symptoms
The medical problems which are noticed by a patient
A condition characterized by a set of symptoms
Top number in blood pressure; pertaining to contraction phase of heart beat
TERATOGENIC
Capable of causing malformations in unborn fetuses
Informed Consent Replacement Words
-9-
TESTES
Male sex glands; male organs which produce sperm
Thank you for volunteering to be in… Thank you, we are glad that you agreed to be in…
The information we collect
What you tell us
Therapy
Medicine or medical care given to a patient for a disease or condition
Thorough
Complete, good
THROMBOSIS
Blood clotting within blood vessels
TID
Three times a day
TITRATION
Gradual alteration of drug dose to determine desired effect or most beneficial
strength of drug
T-LYMPHOCYTES
Type of white blood cells involved in immune reactions
Tolerability
How well a patient can stand a particular medicine or treatment
TOPICAL
Surface; on the skin
TOPICAL ANESTHETIC
Applied to certain area of the skin to reduce pain to specific (limited) area to
which applied
To the extent legally permissible
To the extent allowed by law
TOXICITY
Side effects or undesirable effects of a drug
TRANSDERMAL
Through the skin
TRANSIENTLY
Temporarily
Transmitted
Passed on to other people
TRAUMA
Injury; wound
TREADMILL
Walking machine often used to determine heart function
Treatment
Medicine or medical care given to a patient
Understand
UPTAKE
Utilize
VALVULOPLASTY
VARICES
VASOSPASM
VECTOR
Learn / see
Absorption and incorporation of a substance by living tissue; absorb and
incorporate a substance, taking in of a substance by living tissue
Use
VENIPUNCTURE
VERTICAL TRANSMISSION
Plastic repair of a valve, especially of the heart
Enlarged veins, usually in legs or lining of tube between mouth and stomach
Narrowing of blood vessels due to spasm of vessel walls
A carrier, usually an insect, that carries and transmits disease-causing
microorganisms
Entering vein with a needle, generally through the skin
Spread of disease
Washout period
WBC
Your understanding of…
The time during which a patient’s body gets rid of a medicine once they stop taking it
White blood cell
What you know about…
*Sources:
http://www.stanford.edu/dept/DoR/compliance/hs/medical/glossary.html
http://www.cdc.gov/od/ads/smog.htm
http://www.uth.tmc.edu/ut_general/research_acad_aff/orsc/cphs/glossary.htm
Informed Consent Replacement Words
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