research design exam 1

research is an _____ process

iterative process

each time a research question is addressed successfully, several new questions emerge

research

systematic investigation

designed to contribute to or develop generalizable knowledge

process and method

program evaluation

provides information to decision makers to help them make judgements about the effectiveness of a program and help improve it

minimal disruption of everyday routines

quality improvement

provides evidence to improve clinical practice and patient outcomes within the setting that it is generated

ex: the effects of hand washing

what is the difference between program evaluation and quality improvement?

the purpose behind the study

program evaluation: makes judgements

quality improvement: makes improvements

research begins with a _____

question

dictates study design

evidence-based medicine (EBM)

the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients

evidence-based practice (EBP)

requires that decisions about health care are based on the best available, current, valid, and relevant evidence

these decisions should be made by those receiving care, informed by the tacit and explicit knowledge of those providing care, within the context of available resources

what are the components of EBP?

practitioner experience

client's situation and values

**EXTERNAL EVIDENCE** (the emphasis)

EBP is _____

timely

fee for service ---> value based payment

what is the quadruple aim?

improved patient experience

better health outcomes

improved staff experience

lower cost of care

the process of EBP

formulate a question based on a clinical problem

identify the relevant evidence

evaluate the evidence

implement useful findings

evaluate the outcomes

cultural identities of a patient include

values (beliefs, preferences, and expectations) and circumstances (co-morbidities, access to care, and support network)

ethics

examination of issues of right and wrong, good and bad, in any area of human interaction

a system of obligation that we have towards others

research ethics

involves the application of fundamental ethical principles to research activities, clinical practice, and quality improvement

risk-benefit ratio

there is always some form of risk for patients

use procedures that are the least risky

determining as minimal to extreme risk and if it is worth it in reimbursements, time, psychological trauma, etc.

ethical principles

beneficence, autonomy, and justice

nuremberg code

the voluntary informed consent of the human subject is absolutely essential

tuskegee syphilis study

no evidence that researchers obtained informed consent from participants and participants were not offered available treatments (violated BENEFICENCE ethical principle)

declaration of helsinki

this protocol should be submitted... to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor of any other kind of undue influence

national research act

mandated for all research to be publicly available

the belmont report

identifies the ethical principles upon which the federal regulations for human subject protections are based

includes respect for persons, beneficence, and justice

belmont ethical principle: respect for persons

the autonomy of the individual must be acknowledged and respected

informed consent

voluntary participation

persons with limited autonomy must receive additional protections

voluntary participation

ability to decide to participate in research and to withdraw at any time, without coercion or undue influence from others

coercion

an overt or implicit threat of harm (such as loss of services or access to programs to which the potential participant is otherwise entitled) is intentionally presented by one person to another in order to obtain compliance or research participation

undue influence

the use of persuasion, authority figures, or the offer of an excessive or inappropriate reward or other overture in order to obtain research participation or complicance

limits in autonomy can be

inherent: limited capacity to understand or process information

situational: prisoners, children, pregnant women, and fetus/neonates

belmont ethical principle: beneficence

researchers' obligation to endeavor to "do no harm," minimize any risks and maximize any benefits of research

risks

include physical, psychological, legal, social, and economic harms

the risks of the subjects must be reasonable in relation to anticipated benefits

belmont ethical principle: justice

treat individuals fairly

design research that its burdens and benefits are shared equitably

fair selection of subjects who are appropriate for the study, selection should not be discriminatory, and subjects have an equal chance of being assigned to an experimental or control group

informed consent (IC) - cornerstone on ethical research

process of education and decision-making that begins with the very first contact with a potential study contact

often misinterpreted as just a "yes" response or signature

PROCESSSS!! ongoing dialog that continues throughout the study

goals of the IC process

a trusting relationship and open dialog

an understanding of the essence of a study so that they can make a truly informed, autonomous decision about whether to participate

potential/enrolled subjects need to know

the study constitutes "research"

it is up to them whether they participate or not

they are free to skip questions or stop participating in the study at any time without having to share their reasons for doing so

cultural considerations in research subjects

trying to remain aware of our own biases

educating ourselves and asking for help

being sensitive to and curious about cultural differences

privacy

control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others

be sensitive when leaving voicemails and be considerate with communication

confidentiality

treatment of information that an individual discloses in a relationship of trust

involves the expectation that information will not be divulged to others -- without permission -- in ways that are inconsistent with the understanding of the original disclosure

only sharing info with the team, keeping documents in a secured location, and ensuring passwords on all identifiable data files

conducting interviews in a discrete location is an example of ____ protection

privacy

institutional review board

review research proposals at convened meetings

evaluates scientific merit of the project, competence of the investigators, risks to subjects, feasibility based on identified resources, and looks at all procedures and voluntary IC

ethical principles underpin good ___

EBP, QI, and research

AOTA best practice recommendations

don't provide intervention activities that are non-purposeful (cones, pegs, arm bike, etc.)

what are the 3 elements of searchable clinical questions?

patient characteristics

patient management

outcome of interest

efficacy of an intervention

help therapists make clinical decisions about implementing interventions

PICO/PIO format

RCTs, nonrandomized control trials, and pretest/posttest without a control group

PICO format

P= patient/population or problem

I= intervention

C= comparison

)= outcome

PICOT

adding Time frame

PICOTS

adding Time frame and Setting

PICOS

adding Study design

PESICO

adding Environment and Stakeholders

usefulness of an assessment

to understand usefulness of assessment and determine if the measures being used have sufficient reliability and validity (help therapists identify the best measure for a specific client need)

psychometric methods, reliability studies, validity studies, sensitivity and specificity studies

description of a condition

to better understand the individuals you work with as therapists

incidence and prevalence studies, group comparison (of existing groups), surveys and interviews

prediction of an outcome

to understand what factors contribute to the prognosis, response, or outcomes in a specific condition (to understand associations made between different factors)

correlational and regression studies, cohort studies

lived experience of a client

to understand the evidence from the client's perspective

SPIDER format

qualitative studies, ethnography, phenomenology, narrative

SPIDER format

S = sample

P = phenomenon of ...

I = interest

D = design

E = evaluation

R = research type

critically appraised topics (CAT)

"at-a-glance" critical appraisal and synthesis of articles that include key findings and the bottom line for occupational therapy practice

evidence exchange

opportunities for members to present critical appraisals of the findings and methods of individual articles at AOTA's annual conference and expo

critically appraised papers (CAP)

evidence exchange to synthesize a clinical bottom line

grey literature

wide variety of documents that can supplement your search for literature

may be more current than research articles

may also be reputable but still need to evaluate

may include annual reports, government documents, white papers, or dissertations

abstract

brief overview of article

explains purpose, participants, methods, and results of the study

introduction

background literature supporting the research and explains why this study is important

usually shows a gap in the literature and therefore need for the study

includes study objectives and hypothesis

methods

details on how the research was conducted (enough for replication) including subjects, sampling methods, criteria for inclusion/exclusion, data collection, analysis procedures, instruments used, and variables used

usually most difficult section to read

results

raw data is reported and key results are often displayed in figures, tables, or graphs for organization

discussion/conclusions

research questions answered

summary and interpretation of results with rationale or conclusions

comparison to other studies' results

implications of study... what the data means in terms of author's clinical question

study's strengths and limitations

future recommendations

references

provided list of resources used in article

digital object identifier (DOI)

a unique and never changing string assigned to online (journal) articles, books, and other works

facilitate retrieving works

must be included in APA reference style

strategies for efficiency in reading at article

read the article 3 times

1. screen the article

2. read through a second time fully

3. read for 3rd time in detail

peer-reviewed

more accurate and relevant

higher quality

articles reviewed by at least 2 experts in field for accuracy of content, research quality and relevance to field

non-peer-reviewed

may or may not be reviewed by editors

some may be good quality, some not

faster print turnaround- useful for current trends in the field

can be biased towards targeted audience

does not go through same scientific inspection

clinical question

to determine solutions to specific clinical problems, understood within a theoretical framework

plan of care design, ends with a solution, outcomes do not contribute to broader understanding beyond immediate situation

research question

broader questions about recurrent phenomena and used to obtain knowledge generalizable beyond individual situations

process ends with more questions, contribute to scientific understanding

research is not always available for clinical questions, leading to the development of ___

research questions

research provides information to base ___

clinical decisions and clinical problem solving

contributes to development of research questions

concepts

symbolically represents observations and experience

not directly observable

ex: work

constructs

represents a model of relationship among 2 or more concepts

cannot be observed

ex: quality of life

variables

operational definition of a concept or constructed assigned numerical values

IV, DV, extraneous or intervening

independent variable

condition, intervention, or characteristic that will predict a cause of a given outcome

variable is being manipulated, may have multiple levels

also called predictor

dependent variable

variable being measured, outcome used in assessment

a response or effect that is presumed to vary depending on the IV

is observed and if part of an experiment, measures the result of manipulation

impact factor

how frequently the average article in a journal has been cited in a particular year used to measure importance or rank of journal by calculating # of times its articles are cited

sometimes used as measure of "reputability" but not always true

reporting guidelines

focus on scientific content of the article

specify a minimum set of items required for a clear and transparent account of what was done and what was found in the research study, reflecting in particular issues that might introduce bias into the research

structured advice, often as a checklist

based on evidence, consensus of relevant stakeholders

critical review

evaluate the evidence to determine if and how it should be used in clinical decision making

determine the study's validity, results, and relevance to site

analytical work style

cautious actions and decisions

likes organization and structure

dislikes involvement with others

asks many questions about specific details

driver work style

takes action and acts decisively

likes control

dislikes inaction

prefers maximum freedom to manage self and others

amiable work style

slow at taking action and making decisions

likes close, personal relationships

dislikes interpersonal conflict

supports and "actively" listens to others

expressive work style

spontaneous actions and decisions, risk taker

not limited by tradition

likes involvement

generates new and innovative ideas

explanatory study designs

seek to evaluate cause and effect between a set of independent and dependent variables

seek to create generalizable knowledge

IV is controlled and DV is measured

different conditions are compared to investigate casual relationship

descriptive studies

qualitative

describe populations

correlational and predictive research (diagnosis, prognosis)

exploratory studies

observational

find relationships

cohort studies and case-control studies

correlational and predictive research (diagnosis, prognosis)

explanatory studies

experimental

cause and effect

cohort studies and case-control studies

types of explanatory study designs

randomized controlled trials

quasi-experimental designs

single subject designs

randomized control trials

can this intervention or treatment work under ideal conditions

compares a treatment/intervention vs comparison group (or control)

50/50 chance of intervention or control, participant will not know which they are in

CONSORT

MeSH database

(Medical Subject Headings) to identify related ideas and to expand or narrow a theme

entry terms

closely related term to MeSH databases, alternate forms/similar words that are grouped together under a MeSH term

exploratory study designs

explore data about personal, environmental, behavioral, or genetic influences that may relate to health outcomes

systematic investigation of relationships among 2 or more variables

ID and DV are usually measured together to determine if they have a predictive relationship

interested in cause and effect

used to predict effect of 1 variable on another OR to test relationships

characterized by timing of data collection relative to occurrence of exposures and outcomes

prospective or retrospective

longitudinal or cross-sectional methods

necessary cause

exposure is required for the occurrence of the effect

without it, there is no effect

sufficient cause

exposure that is sufficient by itself to produce the effect

longitudinal research

follows subjects through time

acquires measurements at prescribed intervals

prospective or retrospective

cross-sectional research

snapshot of a population

studies a group of subjects at ONE POINT IN TIME

exposure and outcome variables measured concurrently

designation of predictor (exposure) and outcome variable depends solely on hypothesis

strengths of longitudinal research

documenting change and establishing correct time sequence of events

confirms if suspected risk factor preceded the outcome or effect

cross-sectional research strengths

provides insight into current health status of population (at 1 point in time)

helps inform decisions how to best allocate public resources

efficiency (no need to follow subjects over long periods of time)

cross-sectional research limitations

reverse caution: use caution when making conclusions about cause and effect relationships

difficult to document temporal sequence

prospective research

information about 1 or more exposure variables (potential risk factors) through direct recording at start of study

exposed and unexposed subject identified as start

subjects followed to monitor subsequent outcomes

data collection and measurement procedures tailored to ensure constructs of greatest relevance are captured

retrospective research

examination of data previously collected

data available must be sufficient to establish each subject's exposure history and outcomes status

often involves SECONDARY ANALYSIS