Research Exam 1

what is a research question?

a question about a problem that can be studied to gain new information.

what does PICO stand for?

Population

Intervention

Comparison

Outcome

define population

The population being studied which may be defined by their things like disease state, demographics, or setting

define intervention

the treatment in the experiment

define comparison

an alternate treatment or condition

define outcome

the effect of intervention

what does PICOTS stand for?

Population

Intervention

Comparison

Outcome

Timeline

Study setting

define timeline

The length of time patients were followed after initial treatment in the experiment

define study setting

Where the study took place/data was collected

what is a hypothesis?

a research question that can be statistically tested

key elements of a hypothesis

• Precision

• Measurability

• Assists with interpretation of study findings

difference between a research question and hypothesis

• a research question is open ended and guides the direction of research

• a hypothesis is predictive, specific, and testable

do hypotheses have to be causal?

no

what does FINER stand for?

Feasibility

Interesting

Novel

Ethical

Relevant

define feasibility

able to complete within a limited time frame with limited resources

define interesting

assists in achieving other goals

define novel

investigates a new issue or searches out new knowledge

define ethical

must be board reviewed so as not to harm participants

relevant

must be applicable to patient care, health policy, or future research

what acronym helps evaluate the research question and hypothesis?

FINER

what acronym allows you to refine the research question and formulate the hypothesis?

PICOTS

what acronym breaks down the components of a research question?

PICO

advantages of cohort study

• risk assessment

• rare exposures

• multiple outcomes

• less bias: recall, selection, temporal ambiguity

advantages of case-control

• quick

• less expensive

• rare outcomes

• outcomes with long latency/induction periods

• multiple exposures

• fewer subjects needed

advantages of cross-sectional study

• efficient

• data are easy to analyze

advantage of pre-post observational study

no temporal precedence bias

advantages of time series study

• complete description of immediate and sustained tx effects

• controls for maturation

which study type controls for maturation?

time series

advantages of case report

• ID rare occurrences

• ID delayed ADRs

• hypothesis generation

• minimal resources

• high sensitivity

advantages of case series

• high external validity (closer to clinical practice)

• use when RCT cannot be conducted

• cost effective

• time-saving

limitations of case report

• internal validity issues: can’t determine causation, shouldn’t be used for decision-making

• reporting bias

• low specificity

• limited external validity- generalizability

limitations of case series

• internal validity- can’t determine causation, selection, history, maturation, testing, & instrumentation

• bias- selection, measurement

• can’t calculate absolute risk

• incomplete data collection (retrospective)

limitations of cohort study

• length of study

• cost

• selection bias-attrition

limitations of case-control

• selection bias-detection

• exposure misclassification

• misclassification of cases & controls

• temporal ambiguity

limitations of cross-sectional studies

• external validity: non-response

• bias: temporality

• capture data on prevalence not incidence

limitations of pre-post observational study

internal validity

• maturation

• history

• regression to mean (1 group)

limitations of time series study

internal validity

• history

• attrition/mortality

latency

period between exposure and occurence of outcome

case control study

involves comparison of exposure status among individuals with the disease or outcome of interest (cases) and those without the disease or outcome (controls)

cross-sectional studies

the exposure & outcome of interest are measured at the same point in time and are used to ascertain the relationship between the variables of interest

• provide snapshot of presence of outcome and/or exposure status in population

what type of study is often used to determine prevalence?

cross-sectional study

prevalence

proportion of individuals with a disease or outcome of interest at a given point in time

case report

involves study of a single case of new disease or manifestation

case series

study of multiple similar cases

purpose of case reports and series

bring attention to unusual clinical situations that may otherwise have been missed

• can be used to develop new subject areas & generate hypotheses

observational studies

researcher observes the relationship b/w the study variables, mainly independent (intervention or exposure) and dependent (outcome or disease) in a natural setting

• no randomization

key element in observational studies

nonrandomization of independent variable of interest

cohort study

observational study wherein 2 groups (exposed & unexposed) are followed (prospectively or retrospectively) over a period of time until the development of outcome of interest

how are groups determined in cohort studies?

based on exposure status (exposed vs unexposed)

what is the most powerful observational design to study causation? why?

cohort studies

• bc exposure precedes outcomes

cohort studies determine the __________ of the outcome among exposed & unexposed groups

incidence

is there randomization in cohort studies?

no- classification into groups is based on pr/provider choice

what kind of bias is inherent to cohort studies?

selection bias

prospective cohort study

exposed & unexposed groups are classified at baseline and then these groups are followed in future to determine the occurrence of outcome of interest in 2 groups

retrospective cohort study

researcher uses previously collected (historical) data to identify exposure status and occurrence of outcome in the study group

main strength of cohort studies

ability to ascertain temporality when examining the relationship b/w exposure & outcome

phenonmenology

study of lived experience; see the phenomenon thru the eyes or from the perspective of those who lived it

ethnography

researchers immerse themselves in a particular community or organization to observe their behavior and interactions up close

narrative

learn about the topic of interest thru ppl stories

focus groups

facilitated discussions w/in a defined group to gather diverse perspectives

delphi

structured communication technique to build consensus among experts

scoping

describe the available literature on a topic

• less intensive than systemic reviews

• exploratory

• broad question

• likely missing a bias assessment or meta-analysis

systematic

summarize the literature to address a specific question (compilation)

meta-analysis

provide a weighted average of the results of individual studies

steps of scoping review

1. identify research question

2. define inclusion/exclusion criteria

3. create a protocol, including a search strategy

4. conduct the search

5. screen for eligibility (titles/abstracts/full text)

6. extract data

7. summarize evidence

when do you conduct a systematic review?

when existing evidence needs rigorous synthesis to guide clinical decisions

• unresolved clinical questions

• guideline development

steps of systematic review

1. identify research question

2. define inclusion/exclusion criteria

3. create a protocol & strategy

4. conduct the search

5. screen for eligibility

6. extract data & assess quality

7. synthesize data

PRISMA guidelines

ensure the study adheres to the preferred reporting items for systematic reviews & meta-analyses for transparent and complete reporting

describe data analysis in meta-analysis

takes quantitative data extracted from the systematic review and analyzes it mathematically

what type of plot is used for data presentation in systematic meta-analysis?

forest plots

systematic meta-analysis

mathematical & statistical process of combining and analyzing quantitative data synthesized from a systematic review

research design

Overall plan that allows researchers to seek answers to study questions and test hypotheses

validity

Accuracy (of study results)

internal validity

Extent to which the clinical outcome of interest (DV) in a study is caused by treatment (IV)

external validity

Extent to which the results of a study can be generalized to other settings

Which study design group (observational or experimental) can establish causality?

experimental

descriptive study

describe/summarize info about the diseases, events, or characteristics of study subjects without making causal inferences

analytical study

Aimed at understanding relationship and/r causal mechanism that may exist between 2+ variables

prospective study

Researcher collects the data after the study onset by following individuals over a period of time

retrospective study

Involve evaluation of data for past events or existing data

interventional/randomized study

Researcher controls the experiment, defining the treatment and provision of treatment randomly or non-randomly

quasi-experimental study

No randomization in provision of treatment

investigator orientation

Role of investigator in relation to control of independent variables of interest

randomized controlled trial

Experiment that involves randomization of interventions to 2+ groups

observational study

Researcher observes relationship between study variables in a natural setting

What is research methodology?

Focuses on data collection and measurement techniques

quantitative data

Involves numerical or countable information to study research phenomenon

qualitative data

Involves words or textual information

mixed methods

Involve use of quantitative and qualitative data

primary methods

Collect data specifically for research question

secondary methods

Use of data that were collected for a different purpose

simple randomization

Involves the use of a random number generator to allocate participants to study groups

block randomization

Total number of subjects to be enrolled in study is divided into a series of blocks– study will have equal numbers of subjects in each treatment group

• maintains balanced group sizes throughout trial

stratified randomization

Process of ensuring certain baseline characteristics are equal between the groups of a study

group/cluster randomization

Specific group of subjects are selected for randomization such as those enrolled in a clinic or hospital (randomly selected to a specific sequence of treatments or study procedures)

What is blinding?

Process by which those involved in the trial are unaware of what treatment the patients are receiving (aka masking)

open label

Least objective type of design; all individuals in the study are aware of what treatment patients are receiving

single blind

Only one set of individuals is unaware of what the patients are receiving

double blind

Two sets of individuals are unaware of what the patients are receiving (generally patients and providers)

triple blind

Extension of double blind– all sets of individuals involved are unaware of what the patients were receiving