Midterm Flashcards
There are two types of research methods. Name them
quantitative and qualitative
What must a researcher do prior to collecting data from a participant?
Get consent from participants
What are the main principles of ethical research?
informed consent
confidentiality
voluntary participation
What is Research?
“Research is a systematic inquiry that uses disciplined methods to answer questions or solve problems”
Quantitative research methods
Objective
Statistically valid
Deductive reasoning
Numbers
Qualitative research methods
Subjective
Exploratory and open-ended
Inductive reasoning
Narratives
Why do we do research in health sciences?
Quest for knowledge
Innovation and change
Static vs dynamic
Discovery
Theory development and testing
Experimental design
the researcher actively manipulates variables through the introduction of an intervention ie drug research
Non experimental design
data is collected without the manipulation of variables ie comparing diet between nurses who work days versus nights
Quantitative research may be performed within the context of a
theoretical framework
Quantitative research steps:
Ethical approval
Protect of human/animal rights
Pilot study
Collect data
Prepare data (code)
Analyze data
Interpret results
Disseminate findings
The results of a study may be _____ but have no meaningful practice implications
statistically signficant
Naturalistic paradigm
Subjective
Inductive reasoning
Exploratory
Narratives
Interviews
Phenomena
qualitative
Three traditional methods of qualitative research
Grounded theory (Glaser and Strauss, 1967)
Phenomenology (Husserl, Heidegger, VanManen 1900s)
Ethnography
- These methods originate from other disciplines including sociology, philosophy, psychology and anthropology
Research Proposal allows the investigator to:
Specify the problem and related components
Elaborate on the significance of the research to the health profession
Review related literature
Outline the appropriate methodology within an equitable time frame.
A number of factors (such as ___ and ____)of the researcher and budget) should be involved in the ultimate selection.
interest and values
One of the most difficult tasks confronting the beginner is to
select a researchable problem
Indices and abstracts provide
valuable sources for research ideas.
University faculty can be the
impetus for health research.
Limitations
The boundaries of the problem established by factors or people other than the researcher.
Delimitations
The choices made by the researcher which should be mentioned.Theydescribe the boundaries that you have set for the study.
- the things that you are not doing (and why you have chosen not to do them).
- the literature you will not review (and why not).
- the population you are not studying (and why not).
- the methodological procedures you will not use (and why you will not use them).
Assumptions
Condition that is taken for granted and without which the research effort would be impossible.
Believed to be a fact but cannot be verified as one
Definition of Terms
Many research studies employ terms that may have special meaning to the study itself.
Researchers must define each term as it relates to the project at hand
A hypothesis is a:
Logical supposition
Reasonable guess
Suggested answer to a problem or subproblem
A hypothesis provides further direction for the research effort by
setting forth a possible explanation for an occurrence.
Two types of approaches that are appropriate for developing hypothesis statements:
inductive and deductive
Inductive Reasoning
A generalization is made based on relationships that have been observed.
Deductive Reasoning
The researcher begins with a theoretical tenet and then makes a prediction as to how it can be applied to a specific situation.
You notice that the more people drink coffee the more they eat sweets
You continue to observe and this holds true
Qualitative research (in/deductive)
inductive (bottom up)
Theoretically, caffeine lowers blood glucose levels, causing the body to require an intake of glucose
You decide to test this hypothesis by measuring the amount of caffeine and glucose levels of participants (in/deductive)
deductive (top down)
Generally, a hypothesis should: (3)
- Be stated clearly and concisely
- Express the relationship between two or more variables
- Be testable
Hypothesis are proved/not proved. T/F
False
The acceptance or rejection of a hypothesis is based
on fact rather than a preconceived bias
Hypotheses are rephrased into a _____ or ___ form when it is difficult to obtain unequivocal support for them
negative/null form
The null hypothesis asserts that
minor differences between the variables can occur because of chance errors, and thus are not significant differences.
If the researcher rejects a null hypothesis, then..
the research hypothesis is accepted.
When the null hypothesis is rejected…
the researcher will probe deeper into the problem to discover what has caused the difference and how.
Commence a literature review early so that it:
Can help to define the problem statement
Develop components that comprise the setting of the problem
Justify the study
Plan the design
A detailed research plan must be outlined to include:
Sampling techniques
Methodological steps
Instruments employed
Administration of instruments
Data required
Method of analyzing data
Researchers should review such expenditures as:
Subject payments
Duplication of materials
Postage
Travel
Software
Time Schedule
An invaluable device to assist in the budgeting of time and energy
Time is limited and academic deadlines are rarely negotiable
Dividing the research effort into operable portions with realistic dates also helps organization and reduces procrastination.
Time Schedule
An invaluable device to assist in the budgeting of time and energy
Time is limited and academic deadlines are rarely negotiable
Dividing the research effort into operable portions with realistic dates also helps organization and reduces procrastination.
Research Proposal Checklist
The research proposal is the initial step in developing the research project
The investigator should check each area.
what is the point of research?
Disseminate findings
Add new knowledge to the profession
Advance the discipline
Support existing knowledge/practice
How do we share research?
Journals
Conferences (poster and/or oral presentations)
Books
Theses & dissertations
Online platforms
Why read research?
Safety
Bringing theory into practice
Improving clinical practice
Interest
Knowledge
The Abstract
A brief summary of the problems, methods, results, and conclusions of the study
Gives a short rendition of the manuscript
Enables the reader to determine if it is necessary to continue reading the remainder of the report or article
Abstracts for theses and dissertations are usually presented
after the table of contents.
The research report is generally divided into 7 sections:
Introduction
Review of the literature
Methodology
Presentation and analysis of the data
Conclusions and summary
References
Appendix
The Introduction
Introduces the problem and its context
Describes the phenomena or variables to be studied
States the purpose of the research
Identifies the research question or hypothesis to be studied
Reviews the literature
States the significance of the study
Describes the importance of the study
Methodology
Includes a plan of how the study will be conducted so that the hypotheses or research questions can be ascertained.
The writer would choose a research design that best suits the hypotheses or research questions.
Methodology
A description of the subjects
The exact procedure utilized to collect the data
An explanation of the instruments employed in the conduct of the study.
The methodology usually begins with a
description of the sample used in the study.
Information such ___ should be included in methodology when talking about subjects/participants
sex, age, educational level, socioeconomic status, place of residence
References
All material that was cited in the report or article must appear in the reference list.
Appendixes (not usually part of articles)
Include materials that were not appropriate to be included in the body of the paper but will be useful to the reader.
Usually include copies of instruments, keys to those instruments, raw data scores, instructions to subjects, letters of support, and long tables or printouts of secondary data analyses.
Discussion
Interpretation of findings
Implications for practice
Limitations of study
Future research suggestions
Detailed description of subjects is necessary so that
reader can determine if the research sample is representative and can be generalized to other, similar populations.
The Results /Analysis of Data
Study findings
Statistical tests (if applicable)
The significance of the findings
Is humor allowed in articles?
yes, if done professionally
Peer review questions (6)
Substantive-Was the research problem significant to the discipline?
Theoretical-Were the theoretical underpinnings sound?
Methodologic- Were the methods rigorous and appropriate?
Ethical-Were the rights of study participants protected?
Interpretive-Did the researcher properly interpret data and develop reasonable conclusions?
Stylistic-Is the report clearly written, grammatical, and well organized?
Relevant Literature
Provides a framework for the hypothesis and statement of
the problem
– Usually required in the beginning chapters of a thesis or
dissertation
Reviewing relevant literature will enable..
Will enable the researcher to formulate ideas and concepts
from previous work.
– Can be tedious and painstakingly slow
Purpose of the review
gain an understanding of previous
work and to generate new ideas and concepts
Reviewing can help the investigator to:
- Develop an understanding and grounding in theory.
- Define the problem.
- Review the procedures and instruments used.
- Originate new ideas rather than repeat work already accomplished.
- Use the recommendations for further research.
- Critique relevant studies.
Purposes of Reviewing for Researchers (examples):
– Identification of a research problem
– Orientation to what is known and not known
– Determination of gaps or inconsistencies in a
body of research
– Assistance with interpretation of findings
Some Purposes of Reviewing for Nonresearchers
– Acquiring knowledge on a topic
– Evaluating current practices
– Developing evidence-based clinical
protocols and interventions
Steps to consider when beginning a review of the
literature:
- Reading background information
- Gathering the necessary tools
- Listing key words
- Checking preliminary sources, including databases
- Conducting a computer search
- Determining what to read
- Determining the level of evidence
- Finding shortcuts to determining the level of evidence
Primary sources:
– Written by someone who has observed or
participated in an event
– Must be read
– Include: journals, final reports, or books that
contain original research
– Additionally, government publications are good
primary sources for many health topics
Secondary sources:
– Usually textbooks or encyclopedias written by
someone who has not directly observed the
described event.
– Importance of these sources is that they usually
have a bibliography, which provides the reader with
relevant primary sources.
Preliminary sources
- Reference books
- Indices
- Abstracts
- Guidebooks
- Periodicals
– These help the investigator locate primary sources.
– Stats Canada
– CIHI
– Health Canada
Canadian context: aim to stay within this
Evidence-Based Full-Text and
Abstracting Services
save the health researcher an immense
amount of time when seeking high-quality evidence-based information
Grey literature
A term used to describe studies that are not widely distributed, may not
have been published, not peer-reviewed, may be difficult to obtain
* Excluding grey literature can lead to bias and an over-estimation of effects
Integrative Review
- Helps to support EBP
- Looks at research that has been done
- Best if done by more than one researcher as it enhances the objectivity of
the review (and divides the workload) - Follows the same rules as a research study
- Questions should be narrow
- May be focused on specific intervention
- The sample is other studies
Full-text electronic journals and abstracts are available using a
literature search engine
Why Conduct a Computer Search?
Enables you to explore available information by using an online literature
search engine with access to several databases
* Usually broader and more frequently updated than books or periodicals
* Can be run on phrases or words that appear in the titles of written
materials.
Steps to conduct a computer search:
- Specify the research problem
- Select the databases
- Select the descriptors
- Conduct the search
- Increase sensitivity and specificity
- Review the Citation list
As a general rule, useful information must have three attributes:
- It must be relevant to the research effort
- It must be correct
- It must require little effort to procure
Relevance
information must be critically appraised or evaluated for its validity and
research usefulness.
- begins with the applicability of the evidence to your problem
evidence-based medicine (EBM)
A process to systematically find, appraise, and apply research
findings to clinical decisions
evidence-based health care (EBHC):
Addresses prevention/therapy, health care recommendations,
outcomes in health services, decision analysis, economic
analysis, and overview studies such as meta-analysis.
Levels of evidence, beginning with the highest, are:
I Controlled and randomized
II-1 Controlled but not randomized
II-2 Cohort or case control
II-3 Multiple times series
III Expert opinion or case study
Will high levels of evidence exist for all research clinical questions?
No - due to the nature of the problems and research/ethical limitations
To achieve evidence-informed decisions, the health educator or researcher
should
– Develop a focused question concerning the problem(s)
– Search secondary databases and the primary literature for relevant
articles
– Access the validity and usefulness of those articles (determine the level of
evidence)
– Judge the relevance of the evidence to the problem
– Implement the findings in the study or educational program
For all articles reviewed, three basic questions must be asked:
- Are the results of the study valid?
(addresses the accuracy of the results) - What are the results?
(addressed only if you have determined that the results are unbiased
or not a result of chance) - Will the results help me in conducting my study or educational endeavor?
(considers the relevance of the results to your presenting problems)
Information in the literature review should always relate to
the introductory material
Relating the review to intro material will allow the
introduction to flow coherently and
present an organized approach to theory and research
related to your topic
Subheadings are usually based on
the variables and their relationship to the
problem of your study
The theory is usually derived from
any of the social
sciences, and tends to build on the theoretical perspectives
of the health-related literature
Recaps the relevant information relating to theory, previous
research, new insights, and the stated hypotheses?
summarizing
Research problem
An enigmatic, perplexing, or troubling condition
Problem statement
A statement articulating the research problem
and indicating the need for a study
Research questions
The specific queries the researcher wants to answer in addressing the research problem
Hypotheses
The researcher’s predictions about relationships among variables
Statement of purpose
The researcher’s summary of the overall study goal
Research aims or objectives
The specific accomplishments to be achieved
by conducting the study
Sources of Research Problems
Experience and clinical fieldwork
* Health care literature (that which is
relevant to your profession)
* Social issues
* Theory
* Ideas from external sources
Problem statements should… (3)
Should identify the nature, context, and significance of
problem being addressed
* Should be broad enough to include central concerns
* Should be narrow enough to serve as a guide to study
design
Statements of Purpose—Quantitative Studies:
Identify key study variables
* Identify possible relationships among variables
* Indicate the population of interest
* Suggest, through use of verbs, the nature of the inquiry
(e.g., to test…, to compare…, to evaluate…)
Statements of Purpose—Qualitative Studies:
Identify the central phenomenon
Indicate the research tradition (e.g., grounded theory,
ethnography)
Indicate the group, community, or setting of interest
Suggest, through use of verbs, the nature of the inquiry (e.g.,
to describe…, to discover…, to explore…)
Research Questions:
Are sometimes direct rewordings of statements of
purpose, worded as questions
* Are sometimes used to clarify or lend specificity to the
purpose statement
* In quantitative studies, pose queries about the
relationships among variables
Grounded theory
process questions
Phenomenology
meaning questions
Ethnography
cultural description questions
Should the question be answered? Ask yourself three questions:
- will it produce transferable knowledge?
- will it produce knowledge for knowledge sake?
- will it produce applied knowledge?
A hypothesis must
Must always involve at least 2 variables
* Must suggest a predicted relationship between the
independent variable and the dependent variable
* Must contain terms that indicate a relationship (e.g., more
than, different from, associated with)
Ethics
- Ethics refers to well based standards of right and wrong
that prescribe what humans ought to do, usually in terms of
rights, obligations, benefits to society, fairness, or specific
virtues. - Ethical standards also include those that enjoin virtues of
honesty, compassion, and loyalty. And, ethical standards
include standards relating to rights, such as the right to life,
the right to freedom from injury, and the right to privacy.
Why do we have ethics in
research?
- Protect the rights of humans/animals
- Have standards that govern research
To ensure anonymity, explain to the subject that
- most researchers are
interested in group data and that individual scores are compiled with
others. - individuals are identified by number rather than by name.
- Subjects need to understand the importance of the data being
gathered (may be willing to sacrifice privacy)
The health science researcher should treat all data confidentially and
ensure that
- All data is returned anonymously and directly to the research office.
- All data is restored by number
- Unneeded material is destroyed upon completion of the project
Audio and Video Recordings
- Precludes anonymity, this does not mean that they should not be
employed in research - However, it does mean that the researcher should follow 7 guidelines
when utilizing such recordings.
What is the Nuremberg code?
– Established in 1947
– Attempted to provide guidelines to prevent future atrocities in human research.
* Scrutinize the objectives, justification, and methodology of your study with ethical
eyes.
* Failure to consider ethical dilemmas is inexcusable.
Nuremberg Code
- The voluntary consent of the human subject is absolutely essential
- The experiment should be such as to yield fruitful results for the good of society
- The anticipated results will justify the performance of the experiment.
- Avoid all unnecessary physical and mental suffering and injury
- Protect the experimental subject against even remote possibilities of injury,
disability, or death - Be conducted only by scientifically qualified persons.
- Subject should be at liberty to bring the experiment to an end.
- Scientist in charge must be prepared to terminate study.
Tuskegee Syphilis Study
- 400 black men
- Untreated syphilis
- Sponsored by the US
Public Health - Treatment withheld
- Subjects told “bad
blood” - Study progress of
disease
Where is the Helsinki declaration used?
worldwide
The Nuremberg Code provided a _____ in protecting the
rights of human subjects, and it has served as a
______ for other documents, such as the _____
start; foundation; Helsinki declaration
Declaration of Helsinki
- A set of ethical principles for the medical community
regarding human experimentation - Consent/proxy consent
- Respect for the individual, their right to self determination
and the right to make informed decisions regarding
participation in research - Special vigilance for vulnerable populations
- Risk vs benefits
Argument about justification revolves around the interests of:
– The health sciences
– The subjects or patients
– The community
Not every method is allowable simply because it
potentially increases
knowledge and understanding.
The Belmont Report
Released in 1979
– Addressed 3 ethical issues
* Justice
* Respect for persons
* Beneficence
* Has since been revised
Belmont Report now governs
federally supported research
Ethical dilemma in conducting research:
A situation in which the rights of
study participants are in direct
conflict with requirements for a
rigorous study
Guidelines require that each subject be told of any
attendant discomforts and risks reasonably to be expected
Though the health science researcher cannot hope to predict
_______ , he or she should make an effort
to communicate _______.
all risks and consequences; all known ones
Nontherapeutic Research
May be no apparent benefit for the human subjects
Therapeutic Research
At least the experimental group may benefit.
Tri-Council Policy (5 aspects):
- beneficence
- principle of respect for human dignity
- principle of justice
- respect for free and informed consent
- respect for vulnerable persons
- Principle of Beneficence: Above all, do
no harm
- Right to protection from harm and discomfort
– Beneficence—maximize good
– Non-maleficence —minimize harm - Right to protection from exploitation
- Principle of Respect for Human
Dignity
- Right to self-determination (absence of coercion)
- Right to full disclosure (absence of deception or
concealment)
- Principle of Justice
- Right to fair treatment
- Right to privacy (confidentiality,
anonymity)
Procedures for Protecting Study
Participants
- Risk-benefit assessments
- Informed consent
- Confidentiality procedures
- Debriefings and referrals
- Treatment of vulnerable groups
- Institutional Review Boards and
external reviews
Informed consent means that
participants:
- have adequate information about the research
- can comprehend that information
- have free choice in deciding whether to
participate in or withdraw from the study - written document, oral can also be accepted
- designed to protect the inviolability of the subject
When can process consent be used?
qualitative studies
Typical documentation
- A consent form
- Implied consent (e.g., self-
administered questionnaires) - Process consent (qualitative studies)
Informed consent entails making…
the subject fully aware of the
research project and obtaining permission from the subject to go ahead
with the project.
Informed consent is designed to protect the
inviolability of the subject
Functions of informed consent
– To promote individual autonomy
– To protect the patient-subject’s status as a human
being
– To avoid fraud and duress
– To encourage self-scrutiny by the researcher
– To foster rational decision making
How many basic requirements of a written informed consent for adults
8
Some types of research in the health sciences
require additional elements of consent
- Unforeseeable risks
- Additional costs
- Investigator termination
- Termination procedures
- New findings
- Number of subjects
Children in lower grades should provide
oral consent—a
positive statement of willingness to participate—in addition to
parental consent
Beginning in about junior high or middle school, the child’s
____ consent is needed in addition to parental consent
written
double-blind studies
- One-half of the subjects are randomly selected to receive the
experimental product while the other half is given a placebo,
and the results are compared - Neither the researcher nor the subjects know who obtains
the active substance or the placebo; hence the term double-
blind. - Although the researcher values this methodology to earn
accurate results, it possesses many ethical dilemmas.
Confidentiality Procedures
- Anonymity
- Researcher cannot link participant with data
- Right to privacy
- May use ID numbers
- Confidentiality Pledge
Special Treatment of Vulnerable People
- Children
- Mentally or emotionally disabled people
- Severely ill or physically disabled people
- Terminally ill people
- Institutionalized people
- Pregnant women
No special regulations since the aging
population is seen as a heterogeneous group except under two
circumstances:
cognitive impairment and institutionalization
Researchers cannot use ___ as a criterion of ability to consent
age
The elderly population is less likely to engage in research if it is
disruptive to their routine or fails to provide any benefit to them
External review
- Human subjects committees
- Institutional Review Boards (IRBs)
– American; or can refer to hospital review - Research Ethics Boards (REBs—in
Canada)
The REB employs the following
criteria:
– Risks
– Risks versus benefits
– Subject selection
– Informed consent
– Safety and privacy
– Additional considerations (i.e., standards of professional conduct,
local laws and regulations, the mission of the institution)
Accepted submissions require an (REB)
annual review
Intent of the annual review is to determine whether:
changes requested in the past review have taken place
Other ethical issues
- Ethical use of animal subjects
- Research misconduct
Research Misconduct
Truthfulness
* Scrupulousness
* Probity of funds
A research project does not become ethical because it
produces ______… It is ethical or unethical from ______
valuable data; inception
