Week 1 Flashcards
Define single blind study
In a single-blind experiment, the participants do
not know whether they are receiving an
experimental treatment or a placebo
Definite double blind study
In a double-blind experiment, neither the
researchers nor the participants are aware of
which subjects receive the treatment until after
the study is completed
What is the goal of using a placebo?
Eliminate bias that may arise from the expectation that a treatment should produce an effect
B&E: What is Generalizability?
The extent to which the results of a study are
able to be applied to the population of people
that is comparable to the population studied
B&E: What is prevalence?
The number of existing cases of a disease in a
defined population at a specified time
B&E: What is incidence?
The number of new cases of a disease during a given period of time in a defined population
B&E: What is biomedical research?
- Perform scientific investigation
- Experiments
- Observing
- Analyses & Testing
- Find causes of the disease
- Normally wet-lab experiments
B&E: What is applied clinical research?
- Research that benefits humans
- Diagnosis, procedures, medications, devices
- Research effectiveness & safety
B&E: What is epidemiological research?
- Tracking diseases in large population
- Examine association of exposure with disease
What are the preliminary steps to research?
- Topic issue/interest
- Literature search
- Research goal
- Research design
- Data process
B&E: Contrast observational studies from experimental studies ?
- Observational: Don’t have control over exposure
- Experimental: Researchers control exposure & goal is to determine benefit of therapy
B&E: What are three features of a clinical trial?
- Control
- Randomization
- Binding
B&E: Who is unaware in a triple blind study?
- Subjects, researchers, and data analysts are unaware of who is getting treatment or not
B&E: Describe the parameters of Phase 0 studies
- AKA Human micro-dosing studies
1. Gather preliminary data pharmacodynamics and pharmacokinetics
2. Gives no data on safety or efficacy
3. Small number of subjects (10-15) people
B&E: Describe the parameters of Phase I study
- Increase number of subjects (10-100)
- Designed to assess the safety, toxicity, tolerability, PK, PD, of a drug
- Dose ranging and dose escalation
B&E: Describe the parameters of Phase II studies
- Therapeutic exploratory trial
- Efficacy in patients
- Safety issues
- Optimum dose finding
- Often placebo-controlled and often blinded
B&E: How many persons comprise a phase II study?
Small quantity: 20-300 subjects
B&E: Describe the parameters of Phase IIA & Phase IIB studies
- Phase IIA: designed to assess dosing requirement
- Phase IIB: Designed to study the efficacy of a drug
B&E: What quantity of participants comprise Phase III studies?
- Large # of subjects: 300-3,000 subjects
B&E: What can happen after phase III studies?
Drug may be approved by the FDA
B&E: Describe the paramters of Phase III study
- Therapeutic confirmatory trials
- To establish the efficacy of the drug against existing therapy in a larger number of patients, methods of usage, etc.
B&E: Describe the Phase IIIA & Phase IIIB parameters for study
- Phase IIIA: To get sufficient and significant data
- Phase IIIB: Allows the patient to continue the treatment, label expansion, additional data
B&E: Describe the parameters of a phase IV study
- Post-marketing studies
- After the drug is on the market
- Involves safety surveillance
- Determine behavior of drug in real-life situations
- Evaluate action of drug in a situation of missed dosage or over dosage
- Monitor for long term affects
B&E: Describe how Basic Science and Clinical research differ in their aim/purpose?
- Basic Science: how does something work
- Clinical: aimed at likelihood of events being related or even correlated, humans involved research
B&E: True or False, scientific results does not always match/agree clinical results
True
OPC: What are considered the upper cervical vertebrae?
What are considered the lower cervical vertebrae?
- Upper: OA & C2
- Lower: C3-C7
OPC: What is unique about C7?
- No vertebral artery passing through it
- Spinous process in non-bifid
OPC: How is diagnosis made for cervical spine?
- Using articular pillars
OPC: What level of the spine and chest does the trachea bifurcate?
- Posterior: T4
- Anterior: Sternal angle
OPC: What is pectus carinatum?
Sternum is forming ridge out
OPC: What is Pectus Excavatum?
Sternum sunk in (caved in chest)
OPC: List 5 abnormal lung sounds that may be auscultated
- Wheezing
- Stridor
- Barking cough
- Whistle
- Rattle
OPC: What is tactile fremitus?
- refers to the vibration of the chest wall that results from sound vibrations created by speech or other vocal sounds.
OPC: What is tactile fremitus?
- refers to the vibration of the chest wall that results from sound vibrations created by speech or other vocal sounds.
OPC: What is tactile fremitus?
- refers to the vibration of the chest wall that results from sound vibrations created by speech or other vocal sounds.
OPC: What might cause decreased tactile fremitus?
Decreased intensity of tactile fremitus may occur as a result of excessive amounts of air in the lungs (also known as hyperinflation). Hyperinflation can be seen in individuals with pulmonary emphysema, chronic obstructive pulmonary disease (COPD), asthma, or severe airway obstruction.
OPC: What causes increased Tactile Fremitus?
- increased density within the lung tissue.
- This commonly occurs as a result of lung consolidation, which refers to the replacement of the air within healthy lung tissue with another substance; either inflammatory exudate, blood, pus, or cells.
- most common cause of a consolidated lung is a lung infection, such as pneumonia
- partial or total collapse of a lung (known as atelectasis)
- presence of a solid mass in the lungs, such as a tumor.
OPC: Describe the lung sounds Rales
sounds like hair rubbing between fingers in front of ears
OPC: Describe the lung sounds Rhonchi
snore like wheeze. Loud low pitched on stethoscope auscultation.
OPC: Describe the lung sounds Wheezing
musically type of sound and notes changes with breathing. Usually worse with expiration
OPC: Describe the lung sounds pleural friction rub
dry rubbing sound or a grating sound
OPC: What portion of the stethoscope is used to assess egophony?
- Use the bell since egophony is a lower pitched sound
OPC: What is egophony?
- Egophony: The basic idea is that normal lungs (filled with air), do not readily transmit sounds, while consolidated lung tissue more readily transmits sounds. To use egophony during an exam, ask the patient to say ‘e’ as you auscultate over the chest wall. Over normal lung areas, you will hear the same ‘e’ tones. Over consolidated tissue, the ‘e’ sound changes to a nasal quality ‘a’ (aaaaay), like a goat’s bleating, indicating positive egophony
OPC: What is egophony?
- Egophony: The basic idea is that normal lungs (filled with air), do not readily transmit sounds, while consolidated lung tissue more readily transmits sounds. To use egophony during an exam, ask the patient to say ‘e’ as you auscultate over the chest wall. Over normal lung areas, you will hear the same ‘e’ tones. Over consolidated tissue, the ‘e’ sound changes to a nasal quality ‘a’ (aaaaay), like a goat’s bleating, indicating positive egophony
OPC: Define Bronchophony
The spoken word sounds louder with auscultation and increase clarity
OPC: What is Pectoriloquy?
Whisper is heard clearly
OPC: Describe the mechanics of cervical spine
- Typically side bending and rotation occur in the same direction but Fryette’s mechanics do not apply to cervical spine
- Can have group dysfunctions that are flexed and extended
OPC: C spine- what sidebending occurs with right translation?
- Right translation = Left sidebending
OPC: C spine- what sidebending occurs in Left translation?
- Left translation induces Right sidebending
OPC: Compare the diagnosis of AA joint vs OA joint
- AA is rotation L or Right only since that is its primary movement
- OA joint is sidebending and rotation occur in opposite directions making it an exception to the C spine diagnosis rules
OPC: Which C spine has nerve roots emerging above and below it?
C7 has C8 emerging below it and T1 even tho C8 is not a vertebrae
OPC: What is Torticollis?
- Where sternocleidomastoid stretch from the sternum to the skull behind the ear
- Either congenital or acquired
- Attachment of this muscle induces sidebending
OPC: Describe sidebending and rotation for the lower cervical unit
Sidebending and rotation occur in the same direction in flexion, extension and neutral in the lower cervical unit
OPC: Describe the nerve roots for C spine
- In the cervical spine, nerve roots emerge above the same numbered vertebrae
OPC: What are the motor functions disturbed by C5 nerve root impingement
Deltoid weakness
OPC: What are the reflexes disturbed by C5 nerve root impingement?
Biceps tendon reflex
OPC: What sensation is disturbed by C5 nerve root impingement?
lateral arm
Axillary nerve
OPC: What motor innervation is disturbed by C6 nerve roots impingement?
- Wrist extension
- Bicpes
OPC: What reflex is disturbed by C6 nerve roots impingement?
Brachioradialis tendon
OPC: What sensory innervation is disturbed by C6 nerve roots impingement?
- Anterior and lateral forearm
- Musculocutaneous nerve
OPC: What motor innervation is disturbed by C7 nerve roots impingement?
- Wrist flexor
- Finger extensors
OPC: What reflex is disturbed by C7 nerve roots impingement?
Triceps reflex
OPC: What sensory function is disturbed by C7 nerve roots impingement?
Middle finger
OPC: What motor innervation is disturbed by C8 nerve roots impingement?
Finger flexion and intrinsic hand muscles
OPC: What sensory innervation is disturbed by C8 nerve roots impingement?
Medial forearm, medial anterior brachial cutaneous nerve
OPC: What motor innervation is disturbed by T1-T2 nerve roots impingement?
Intrinsic hand muscles
OPC: What sensory innervation is disturbed by T1-T2 nerve roots impingement?
Medial arm
Medial brachial cutaneous nerve
OPC: What causes the most serious injuries to the cervical spine?
Due to injury to the vertebral artery in the upper cervical spine including OA, AA, C2 resulting in hemorrhage or stroke
OPC: In what position/movement does vertebral artery injury occur in the C spine?
- Risk when patient is placed in to extreme extension and rotation in the upper cervical area
Where is the thymus found?
Superior mediastinum
What is the function of the thymus?
- Maturation of T & B cells after they are formed in the bone marrow
- Mostly T cells
Describe the histology of the thymus:
- In young age, there are lots of lymphocytes with some support cells-thymic epithelial cells
- Older ages: lymphocytes are more aggregated into islands, less quantity of Lymphocytes due to thymus shrinking
List the layers of the esophagus
- Inner most is Mucosa
- Submucosa
- Muscularis
- Adventitia
Describe the submucosa and muscularis layers of the esophagus
- Submucosa: mucus glands & lymphatic nodules
- Muscularis: striated skeletal tissue proximal to the mouth, then smooth muscle closer to heart
What is the Azygos vein?
- Final vein in the posterior thorax as it provides redundant pathways for drainage to off-set blockages in the system
- Connects between inferior and superior vena cava
- R side of the thorax that will drain the superior vena cava
- Also have the hemiazygos vein
What is the main thoracic lymphatic duct?
- L duct is the main thoracic duct even tho there is a Right and Left duct
- Empty into jugular vein where the JV joins the subclavian vein
Describe lymphatic drainage of the L and R side of the body
- Entire L side of the patient plus the right lower body will drain into the thoracic duct even tho
- R side of upper body and head will drain into R lymphatic duct
What determine partial pressure of the blood?
Only free, dissolved gas causes a partial pressure
- Does not include O2 attached to Hb
What is oxygen content in the blood
CaO2
- Oxygen in the artery
- Including oxygen as gas in the blood and the HbO2
What is Hb saturation during rest?
75% at tissue
What drives lymphatic fluid movement?
- Via visceral organ contraction including, abdominal and pelvic organs, pulsation of blood vessels, heart, lungs etc.
How does the Bohr effect impact the Ogyhemoglobin dissociation curve>
- Decreasing pH/incrasing H+ will shift curve right to decrease Hb affinity for O2
- Easier to offload O2
What term matches this description?
A scientific process of answering a question
using data from a population.
A study is a scientific process of answering a question
using data from a population.
What is an Epidemiologic study
▪ Studies of populations of patients
▪ Examine the association of exposure with
disease
Why is clinical research different from epidemiological research?
- No control over exposure in epidemiology studies -Researchers control exposure in clinical studies
Compare Experimental vs. Observational Studies
- Experimental: random division of samples, two groups, tx & alternative, compare results
- Observational: without treatment or control, observe and collect data, identify source of risk, prospective or retrospective
List 2 forms of secondary research
- Meta analysis
- Systematic reviews
Why are meta analysis and systematic reviews considered high quality evidence?
Can perform statistical analysis using the data presented
What is a major use of case reports?
- Identification of new trends, symptoms, or diseases that do not fit the known/traditional diagnostic criteria
List 4 advantages of case report studies
- Can help in the identification of new trends or diseases
- Can help detect new drug side effects and potential uses (adverse or beneficial)
- Educational- a way of sharing lessons learned
- Identifies manifestations of a rare disease
What are 4 disadvantagers of case studies?
- May not be generalizable
- Not based on systematic reviews
- Causes or associations may have other explanations
- Can be seen as emphasizing the bizarre or focusing on misleading elements
T/F: Case reports and case studies have statistical analysis since case studies have multiple patients
False, since there is no control group there is no statistical analysis
B&E: What is a case series? What to look for?
- Collections of reports on several patients with unique or interesting conditions
- Is solely observational study, cannot add recommendations or opinions
BSE: What is the lowest hierarchy of evidence?
Case reports/studies since they have no statistical analysis
BSE: Describe cross sectional studies
- Patients studied as a part of a group with a particular identifier
- Frequency of disease and risk factors identified at the same time
BSE: Do cross-sectional studies follow groups studies over a period of time? What can be determined from a cross-sectional study?
- No, this is a prevalence study that is seen during a snapshot of time
- Can determine the prevalence of disease
BSE: List 3 descriptive studies
- Case reports
- Case series
- Cross-sectional studies
BSE: What type of study are case-control studies? What is their purpose?
- Observational study
- Compares the group with the disease to the group without the disease
- Loos retrospective over time for exposure or risk factors
- Opposite of cohort study
- Better for rare diseases
BSE: When picking a control group, what is the best parameter to look for?
The only difference between groups is the presence or absence of disease to limit confounding results
BSE: What is the main results gained from case-controls studies?
- Main outcome measure is the odds ratio
- Odds of disease in exposed vs odds of disease in not exposed
BSE: What are disadvantages of case-control studies?
- Retrospective studies have more problems with data quality becuase they rely on memory
- Not good for evaluating diagnostic tests because it’s already clear that the cases have the condition and the controls do not
- It can be difficult to find a suitable control group
- Insufficient for rare exposures (smaller sample than cohort study)
- Recall may be a a problem
BSE: What are advantages of case-control studies?
- Less time needed to conduct the study because the condition or disease has already occured
- Allow you to simultaneously look at multiple risk factors
- Good for studying rare conditions or diseases
- Useful as intial studies to establish an association
- Relatively inexpensive
BSE: What is another name for cohort studies?
Incidence study
BSE: What do cohort studies do?
- Compare exposure groups to nonexposure groups
- Either retrospective or prospective
- Good for common disorders/disease
- Gives information about incidence of disease in groups
- Exposure determined before the outcome is known
BSE: What is the main out come of cohort studies?
Relative risk: How much does exposure increase risk of disease