Research Methods: Exam 3

collecting the data upon which a diagnosis can be based.

process of identifying the signs and symptoms of disease & recording the associated data for the purpose of informing a diagnosis.

Assessment

according to the National Library of Medicine (NLM), is "The determination of the nature of a disease or condition, or the distinguishing of one disease or condition from another."

Diagnosis

Diagnostic or assessment findings that are pertinent to other diagnoses and are negative for a particular diagnosis.

Helps rule out items in the differential.

Pertinent negatives

Systematically comparing and contrasting results of diagnostic measures in order to determine from which one of two or more diseases or conditions a patient is suffering.

differential diagnosis

_________ is the information that informs the diagnosis.

Assessment

the final determination of the condition.

diagnosis

A set of signs, symptoms, and tests used in routine clinical care.

diagnositc criteria

Essentially the same as the concept of case definition, which is defined as “a set of standard criteria for classifying whether a person has a particular disease, syndrome, or health condition.

disease classification

3 major categories of diagnostic procedures:

1. Med hx/physical exam.

2. lab tests.

3. imaging.

In U.S., there is a belief in the superior accuracy of imaging, another reason suggested for the significant increase in imagine is _________ medical practice.

defensive

excessive use of diagnostic procedures to avoid lawsuits by showing that every available measure was employed.

defensive medical practice

designed to collect information about a specific problem and differentiate between critical and noncritical causes. covers only the relevant body systems, past medical/surgical history, medications, family, and social history.

focused history

covers all body systems and collects information on the patient's entire health status, including items such as (but not limited to) past medical/surgical history, medications, family, and social history.

complete history

2 types of history:

1. focused.

2. complete.

test that is normally used or the test that has been shown to be the most accurate. The current standard that serves as a basis of comparison for a new diagnostic test in a study.

reference standard test

test that is known to be the most accurate, regardless of cost, invasiveness, or other considerations.

Gold standard test

assessment or diagnostic modality of interest in the research.

index test

The various ranges of disease (such as mild, moderate, severe, etc.) in a population.

Spectrum of disease

When researchers select clinically inappropriate populations for their studies of a diagnostic tests.

spectrum bias

Disease spectrum can influence accuracy of ___________ and diagnosis modalities.

assessment

A diagnostic __________ is the level of test result that is assigned to a positive test.

cutoff

An example of a diagnostic cutoff is an ______ test.

A1c (has 3 diagnostic cutoffs)

provides recommendations about diagnostic criteria, staging of disease severity, and differentiating subtypes of a disease.

diagnostic guideline

offers a standardized set of steps and criteria for guiding diagnosis. Diagnostic algorithms provide the sequence of diagnostic tests to perform.

diagnostic algorithim

usual practice utilized by other clinicians and experts in the region.

tend to vary geographically and are significantly influenced by the history in a region and the experiences of clinicians working near one another.

standard of care

ability of the test to be positive given the person tested has the disease/problem. Expressed as a proportion.

sensitivity

ability of the test to be negative given that the person does not have the disease/problem. Expressed as a proportion.

specificity

likelihood that someone with a positive test result will actually have the disease. It is expressed as a proportion.

the percentage of those with a positive test result who actually have the disease.

Positive predictive value (PPV)

likelihood that someone with a negative test result will actually not have the disease. It is expressed as a proportion. the percent of those with a negative test result who actually do not have the disease.

Negative predictive value (NPV)

proportion of a population with a given disease at a single point in time.

prevalence

both the positive predictive value & the negative predictive value are affected by the ___________ of the disease among the population being tested.

prevalence

measure used for comparing tests in terms of the relative odds of a positive diagnosis among those with the condition vs those without the condition.

diagnostic odds ratio

"the probability of the target disorder before a diagnostic test is ordered."

pretest probability

The odds that the patient has the target disorder, before the test is carried out.

pretest odds

The DOR (diagnostic odds ratio) is dependent on sensitivity and specificity and is not affected by ____________.

prevalence

studies on __________ refer to actions aimed at eradicating, eliminating, or minimizing the impact of disease & disability, or if non of these is feasible, retarding the progress of disease/disability.

treatment

a synonym for treatment is __________, which is defined as "procedures concerned with the remedial tx or prevention of diseases.

therapeutics

studies on _______ explore adverse consequences of tx or the natural progression of disease, as well as harm caused by complications from interactions between treatments.

harm

studies on ________ explore questions such as identification of prevention strategies, evaluation of prevention strategies & programs, efficacy of screening modalities, & the necessity for population screening.

prevention

circumstances in which a given tx should be used.

indications

circumstances in which a given tx should not be used.

contraindications

unintended symptoms from tx, prevention, diagnostic, or screening procedures.

side effects

unintended adverse events, such as injury or death, resulting from tx, diagnostic, prevention, or screening.

complications

mutual or reciprocal action of influence.

interactions

Time considerations: (4)

-time to perform tx.

-time for tx to reach efficacy.

-time for pt to travel.

-time needed to recover from tx.

the _______ or route of administration is how the tx reaches its target location.

(ex: absorption through skin).

mode

the ________ of administration is the technique for performing the tx (ex: holding instrument at specific angle, using specific amount of pressure) as well as who will administer the tx.

method

ability of an intervention to produce the desire beneficial effect.

efficacy

during clinical trials, side effects are referred to as _________ events (AEs). Complications are referred to as serious ________ events and ________ events of special interest.

adverse

degree to which patients are able to sustain a treatment regimen according to how it was prescribed

adherence

act of conforming, acquiescing, or yielding; cooperation or obedience.

compliance

the distinction between compliance and adherence is to do with loss of __________.

control

observation, prospective studies in which the groups in the study are determined by given exposure, characteristic, or risk factor. groups assignment is not random.

cohort studies

retrospective study. subjects divided into cases (those w/ outcome of interest) and controls (those without outcome of interest) & associations are sought between exposures and the outcomes of interest.

case control

aims to reduce the incidence of disease by personal and communal efforts, such as decreasing environmental risks, enhancing nutritional status, immunizing against communicable diseases, or improving water supplies.

primary prevention

aims at reducing the prevalence of disease by shortening its duration.

secondary prevention

consists of measures aimed at softening the impact of long-term disease and disability by eliminating or reducing impairment, disability, and handicap; reducing suffering; and maximizing potential years of useful life.

tertiary prevention

consists of actions that identify patients at risk of overdiagnosis or overmedication and that protect them from excessive medical intervention. Actions that prevent iatrogenesis (adverse effects of preventive, diagnostic, therapeutic, surgical, and other medical, sanitary, and health procedures, interventions or programs).

quaternary prevention

The number of persons needed to be treated, on average, to prevent one more event.

formula: 1/ARR.

NNT

The number of persons needed to be treated, on average, to produce one more adverse event.

Formula: 1/ARI.

NNH

The average number of persons who must undergo a screening test and the ensuing diagnostic and therapeutic procedures in order to prevent one case of the disease of interest.

Formula same as NNT: 1/ARR.

NNS

According to a study by Linde et al (2016), the use of acupuncture as a treatment for episodic migraine will produce one resolved (pain free) migraine after treating four individuals. What type of biostatistic does that result represent?

a. Prevalence

b. NNH

c. NPV

d. Specificity

e. NNT

e. NNT

conversation in which the PSR aims to seek objections or concerns expressed by the healthcare provider related to the use of the product.

sales call

reviews & evaluates data concerning safety/effectiveness of marketed and investigational orthopedic/rehab devices

FDA