Exam 1 Flashcards
concepts
abstractions of human characteristics (like pain, fatigue, obesity)
In a qualitative study = phenomena
construct
abstraction inferred from situations or behaviors - deliverable invented or constructed
I.e. self care
Construct = more complex abstraction than a concept
variables
concepts in quantitative studies
I.e. weight, fatigue, stress
independent variable
presumed cause
dependent variable
presumed effect = O in PICO
Variation in the dependent variable is likely too depend on variation in the independent variable
Is the variable researchers want to understand, explain or predict
data
pieces of info obtained in a study
Quantitative data: data in numeric form
Qualitative data: narrative descriptions
relationship
bond or connection b/w phenomena
I.e b/w smoking and lung cancer
Ex: cause and effect relationship
grounded theory
- research with roots in sociology that seeks to describe and understand the key social psychological processes that occur in social settings
- seek to understand actions by focusing on the main concern or problem that the individual’s behavior is designed to address
Focus on developing social experience
Phenomenology
concerned with lived experiences of humans
Approach to thinking about what life experiences of people are like and what they mean
psychology/philosophy
ethnography
provides a framework for studying partners, lifeways and experiences of a defined cultural group
anthropology
characteristics of good research questions - 3
- identifies the variables
- specifies populations to be studied
- implies possibility of empirical testing
conceptual definition
presents the abstract or theoretical meaning of concepts under study
I.e. pain - discomfort, uncomfortable feeling
*can be an end product in qual studies
operational defintion
specifies what the researcher must do to measure the concept and collect needed info
I.e. for measuring anxiety, tools, scales
phases of quantitative study (5)
- conceptual phase (formulating the problem)
- design and planning phase (sampling)
- empirical phase (collecting data)
- analytic phase (analyzing and interpreting)
- dissemination phase (communicating the findings)
hypothesis
prediction about relationship b/w variables
null hypothesis
statistical hypotheses: state that there is no relationship between IV and DV
I.e. patients age is unrelated to their risk of falling
characteristics of good hypotheses (3)
- states variable and population
- identifies the predicted relationship: converts question into a declarative statement, predicts relationship b/w variables
- is testable
Directional hypothesis
one that specifies not only the existence but the expected direction of the relationship b/w variables
I.e. older patients are more likely to fall than younger patients
nondirectional hypothesis
does not state the direction of the relationship
I.e. there is a relationship b/w age of patient and risk of falling
statistical significance
supports inferences that a hypothesis probably correct or not
means findings are probably reliable and replicable with a new sample
level of significance (p < 0.05)
index of how probable it is that the findings are reliable
.05 level = only 5 times out of 100 would the result be spurious = 95 times out of 100, similar results would be obtained in a new sample
PICOT
population intervention (IV) comparison or control outcome (DV) timeframe
clinical research
involves human subject participants with the aim of generating generalizable knowledge to improve human health and well-being
nursing research
to answer questions and undertake systematic inquiry to generate evidence on problems of interest to nurses
ethics
systematic method of inquiry that helps us to answer how we ought to live and why,
Should we perform clinical research on human participants? Why or why not?
If yes, how should it be done
research design
the overall plan for answering a quantitative study’s research question.
moderator variable
affects the strength or direction of a relationship between the independent and dependent variables.
complex hypothesis
predicts the relationship between two or more independent variables and/or two or more dependent variables
3 principles of Belmont Report
- respect for persons/human dignity
- beneficence
- justice
what does respect for persons/human dignity entail (2)
right to self determination (no coercion, can voluntarily decide to participate),
right to full disclosure (absence of deception, concealment and right to refuse)
informed consent*
what does beneficence entail
persons are treated in an ethical manner by 1. Freedom from harm and exploitation and 2. Maximizing possible benefits and minimizing possible harms
what does justice entail
right to fair treatment
right to privacy and anonymity
fair procedures and outcomes in the selections of subjects
45CFR46 subparts (HHS)
Subpart A: common rule - revised Jan 2019
B - pregnant women, fetuses and neonates
C- prisoners
D - children
CFR Title 21 (FDA)
FDA
Usually physician research
Clinical investigations involving FDA regulated projects or supporting applications to FDA (50 & 56)
who makes up an IRB
Composed of at least 5 members
At least 1 scientific member
At least 1 non scientific member
At least 1 member unaffiliated within the org
Expertise in local org policy, state regulatory parameters and federal CFR
full board IRBs
More than minimal risk to subjects
Not covered under other review categories
Ex: interventions involving physical or emotional discomfort or sensitive data
expedited IRBs
Not greater than minimal risk
Fits one of the 9 expedited review categories
Ex: collection of biospecimens by noninvasive means, research w/ existing documents/record collected for non research purposes in which subject are identifiable.
exempt IRBs
Less than minimal risk
Fits one of 6 exempt categories
Ex: research with de-identified records, anonymous surveys, Research only involving education tests, surveys, interview or observation of public behavior, research on public officials or existing data, public benefit service, taste and food evals, storage and maintenance for secondary research
minimal risk
probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental or psychological exam of healthy persons
how do you know if the research subject to 45CFR46
if it is receiving federal funding
informed consent and what it should include (4)
participants have adequate information about the research, comprehend that info, and can consent to or decline participation voluntarily
Should include study title, why study is being done, what are the study procedures, what will they be asked to do
Broad consent 46.104db
An alternative to traditional informed consent or waiver of informed consent
Applicable to secondary research with identifiable private info or identifiable biospecimens
*does not include return of results as part of the study
HIPAA
at least 18 categories of identifiable health info (name, DOB, geographic locators, MRNs, images, etc.)
how to protect against HIPAA violations
encryption of data, authentication of passwords for those who have access to research study data, software security and electronic and physical security of data storage devices and networks
NIH certificate of confidentiality
any research that involves collection of personally identifiable, sensitive info is potentially eligible for a certificate
If it damages participants financial standing, employability or reputation
Certificate allows researchers to refuse to disclose identifying info on study participants in any civil, criminal, admin or legislative proceeding
data safety monitoring board
An independent committee that reviews interim safety and efficacy data and provides advice on continuing, modifying or terminating the study
Purpose: oversee and monitor clinical trials to ensure participant safety and validity and integrity of the data
falsification
making up results and reporting them
fabrication
manipulating research materials, data, or processes or manipulating data so that the record does not accurately represent research
plagiarism
appropriating another person’s ideas, results or words w/o giving that person appropriate credit
what do you have to have for it to be considered misconduct
has to be deliberate/intentional or repeated noncompliance
problem statement
presents rationale for the study
statement of purpose
summarizes goal of the study
anonymity
safeguard mechanism by which even the researcher cannot link the participant with the information provided
process consent
researcher continually renegotiates consent -usually in qualitative studies
covert data collection
collection of data without participants knowledge and consent - can happen if a researcher wanted to observe people’s behavior in real world settings and worried that doing so openly would affect behavior of interest
can be acceptable if risk are negligible and participants right to privacy hasn’t been violated
deception
involves deliberately withholding information about the study or providing participants with false information
implied consent
when written consent is not obtained because the participants completes a questionnaire or something similar that reflects consent to participate
Researchers often provide an info sheet that contains elements of the informed consent but doesn’t require a signature
what must be shared with the patient under HIPAA if their info is disclosed (3)
- who will receive info,
- what type of info will be disclosed and
- what further disclosures the researcher anticipates
why do qualitative research (3)
- Could be that there is no literature out there
- Looking at something new, unexplored or a rare condition that people have that you can’t get good data on
- Good if you are not in that population and you don’t understand it
emergent design
takes shape as qualitative studies / researchers make ongoing decisions reflecting what they have learned
Based on participants realities and viewpoints
Unfolding as you go
Might shift type participants as you go, change type of questions you are asking
descriptive phenomenology
Descriptions of human experience
What do we know as people
bracketing and what type of study is this associated with
process of identifying and holding in abeyance preconceived beliefs and opinions about phenomenon under study → helps to remove influences that can block access to meaning
*descriptive phenomenology
Interpretive phenomenology = hermeneutics
Understanding the human experience
Putting meaning to it based on what you understand/interpret
cultural behavior
what members do
cultural artifacts
what people make and use
cultural speech
what people say
emic perspective
way members of a culture envision their world - insiders’ view
Local language, concepts or means of expression used by members of the group understudy
etic perspective
outsiders’ interpretation of the experiences of that culture - language used by those doing the research to refer to the same phenomena
fieldwork: what is it and which type of qual study is it associated with?
how ethnographer comes to understand a culture - Use interviews, observations, records, physical evidence
key informant
expert source of information, help them understand and interpret the activities they observe - in the culture