Methods Exam 1

latency

period between exposure and occurence of outcome

case control study

Compares the frequency of exposure among cases and controls, the investigator starts by selecting subjects on the basis of the outcome event

cross-sectional studies

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

cross-sectional study

what type of study is often used to determine prevalence?

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

unusual, hypothesis

purpose of case reports and case series are to bring attention to — clinical situations that may otherwise have been missed and can be used to develop new subject areas & generate —

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

cohort study

Subjects at risk for a disease whose exposure status is assessed at baseline and who are followed-up over time to detect incident of disease

exposure

how are groups determined in cohort studies? based on — status

cohort, outcomes

what is the most powerful observational design to study causation? why? — studies because exposure precedes —

incidence

newly diagnosed cases

no

is there randomization in cohort studies?

selection bias

what kind of bias is inherent to cohort studies?

prospective cohort study

subjects’ current exposure and/or outcome is being measured during the study, these studies typically rely on actively recruiting and screening subjects, assessing baseline exposure and risk factors, and subsequently assessing the development of outcomes over a follow-up period at regular intervals

retrospective cohort study

Subjects’ past exposure and/or outcome status is being used, these studies use the same general framework as the prospective cohort study, but previous exposures and disease outcomes are typically measured using stored biological samples or existing records

research design

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

validity

reflects the accuracy of study results

internal validity

Extent to which the clinical outcome of interest (dependent variables) in a study is caused by treatment (independent variables)

external validity

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

experimental

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

descriptive

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

analytical

— study purpose: 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 such as medical records to achieve the research objective

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

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 under consideration

secondary methods

Involve the use of data that were collected for a different purpose such as medical charts and medical claims

simple randomization

Involves the use of a random number generator to allocate participants to study groups, similar to flipping a coin

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

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

double dummy

More than one placebo is used to help treatments look the same in all groups

active control

Consistent with recommended therapy

parallel study

Each subject is only randomized to either a treatment or control group

crossover study

Each subject receives all of the interventions based on a specified sequence of events

carryover

Outcomes that remain/persist after the first treatment phase is complete

washout

Time needed for the outcomes of treatment A to dissipate prior to beginning treatment B

factorial

Designed to evaluate multiple interventions in a single experiment

adaptive

Process of assigning patients to a treatment group based on previous success of the treatment as the trial progresses

superiority

Aims to determine whether or not one treatment is better than another

noninferiority

Aims to determine whether or not 2 interventions are equivalent or nearly equivalent based on a set of acceptance criteria

efficacy

Determines the effects of an intervention under tightly controlled conditions; designed to have very narrow inclusion/exclusion criteria

effectiveness

Designed to determine the effects of the intervention under the conditions that the drug is most often used in the clinical setting

performance bias

Prevents behavior or care changes based on treatment knowledge.

detection bias

Ensures outcome assessment is independent of treatment group.

placebo

An inert substance identical in appearance to the active treatment, used to maintain blinding and control for psychological effects.

historical control

An external patient group observed at a different time, used as the comparison group.

active control

Where there is a known or accepted standard of care or treatment, then participants are randomized to either the intervention or the recommended therapy (SOC)

dose-response

Compares multiple dose levels to evaluate the relationship between dose and efficacy or toxicity.

Interim Analysis

Periodic assessments of safety, efficacy, or futility during the trial, overseen by an independent DSMB.

Subgroup Analysis

Examines outcomes within participant categories (e.g., age, sex) to detect differential treatment effects.

ideal conditions

key question addressed by efficacy "Does it work under — —?"

real world

key question for effectiveness "Does it work in the — —?”

ask, acquire, appraise, apply, assess

What are the 5 Steps of Evidence-Based Practice (EBP)?

ask

Formulate a clear clinical question using PICOTS. EBP

acquire

Search and retrieve relevant literature from databases

appraise

Critically evaluate evidence quality and validity.

apply

Integrate evidence with clinical expertise and patient values

assess

Evaluate outcomes and reflect on the decision process, EBP

AND, OR, NOT

3 boolean operators in literature searching

acquire

in what step of EBM do you search for evidence to answer a question?

ask

In what step of EBM do you collect patient information to formulate a clinical question?

population

In a clinical question, what element of PICOTS is: 50 year-old male patient with high triglycerides

P, C, O, T, S

A patient asks you the following question, “I have been struggling with constipation. Can I take polyethylene glycol 3350 to help?”

What element(s) of PICOTS do you need to ask the patient to have a searchable clinical question? (Select all that apply.)

review article

Provides a synthesis of existing research on a particular topic.

peer-reviewed

Have undergone a rigorous review process by peers in their discipline, before publication.

systematic review

Methodical & thorough literature review focused on a particular research question.

empirical study

Aims to gain new knowledge on a topic through direct or indirect observation and research.

meta-analysis

Combines or contrasts data from different independent studies in a new analysis in order to strengthen the understanding of a topic

research, methodology, plan, analysis, results

5 steps of research process: pose a — question, create your —, implement your —, perform data —, share your —

identify, peer-reviewed, executable

3 parts of finalizing a research question:

1. idea- Brainstorm and — the core concept,

   interest area, or clinical phenomenon you

   wish to investigate

2. literature review- Analyze existing — - studies to identify knowledge gaps and ground your question in theory.

3. keep it feasible- Evaluate scope, resources, time, and variable measurability to ensure the study is highly —

controlled variable

everything you want to remain constant and unchanging

null hypothesis

no difference between therapies

alternative hypothesis

there is a difference between therapies

research question

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

intervention

the treatment in the experiment

comparison

an alternate treatment or condition

outcome

the effect of intervention

Population, Intervention, Comparison, Outcome, Timeline, Study setting

what does PICOTS stand for?

timeline

The length of time after initial treatment

study setting

Where the study took place

hypothesis

a research question that can be statistically tested

open ended, testable

difference between a research question and hypothesis

• a research question is — —and guides the direction of research

• a hypothesis is predictive, specific, and —

no

do hypotheses have to be causal?

Feasibility, Interesting, Novel, Ethical, Relevant

what does FINER stand for?

feasibility

able to complete within a limited time frame with limited resources

interesting

assists in achieving other goals