CLIN RES-L01-Research Design-(A)-Key Elements to Clinical Research Design

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What is research design

A framework or blueprint for conducting a study, outlining methods, procedures, and strategies for data collection, analysis, and interpretation.

What is the purpose of exploratory research

To explore an area with little information and generate new ideas or questions.

What is the purpose of descriptive research

To describe characteristics or functions of a phenomenon.

What is the purpose of explanatory/analytical research

To explain and test hypotheses.

What is the purpose of experimental research

To establish cause-and-effect relationships.

What is quantitative data

Numerical data analyzed through statistical methods.

What is qualitative data

Non-numerical data, such as interviews and observations, focusing on understanding meanings and experiences.

What are common methods of data collection

Surveys, interviews, experiments, observations, and secondary data sources.

What is a cross-sectional study

A study where data is collected at a single point in time.

What is a longitudinal study

A study where data is collected over an extended period to observe changes and trends.

What is a sampling plan

A plan detailing how participants or data sources are selected, such as probability or non-probability sampling.

What is a data analysis plan

A plan defining how collected data will be processed and analyzed to answer research questions.

What are characteristics of a good research design

Clear purpose, validity, reliability, practicality, flexibility, comprehensive data collection, minimization of bias, control, systematic structure, generalizability, adequate sample size, replicability, and analytical rigor.

What ensures internal validity in research

The design ensures results are due to studied variables, not external factors.

What ensures external validity in research

Findings can be generalized to a larger population or other settings.

What is reliability in research

Producing consistent and repeatable results under the same conditions.

What ensures practicality in research design

Feasibility within time, resources, budget, and expertise, while addressing potential challenges.

Why is flexibility important in research design

Allows for adjustments if unforeseen issues arise while adhering to ethical guidelines.

What minimizes bias in research

Techniques like randomization, control groups, and objective methods.

Why is control important in experimental research

Manages or eliminates extraneous variables to establish cause-and-effect relationships.

What ensures generalizability in research findings

Appropriate sampling methods and external validity.

What is replicability in research

Providing sufficient detail so the study can be repeated by others.

What ensures statistical and analytical rigor in research

Incorporating robust methods and appropriate statistical tests for accurate data interpretation.

What are randomized controlled trials (RCTs)

Gold standard in clinical research where participants are randomly assigned to intervention or control groups to compare treatment effects and eliminate bias.

How does randomization in RCTs help

It eliminates bias and ensures comparability of groups at baseline.

What is an example of an RCT

Testing a new drug for hypertension by comparing outcomes in a drug group and a placebo group.

What are cohort studies

Observational studies grouping participants based on exposure to a risk factor or treatment and tracking outcomes over time.

When are cohort studies useful

When randomization is not feasible or ethical.

What is an example of a cohort study

Examining the long-term effects of smoking on lung cancer by following smokers and non-smokers over several years.

What are case-control studies

Studies selecting participants based on an outcome (e.g., disease) and looking backward to identify risk factors.

When are case-control studies often used

For investigating rare diseases.

What is an example of a case-control study

Examining dietary habits in women with and without breast cancer to identify potential risk factors.

What are cross-sectional studies

Studies analyzing data from a population at a single point in time to assess prevalence of diseases or behaviors.

What is an example of a cross-sectional study

Estimating obesity prevalence in a community by surveying individuals about their weight and height at a specific moment.

What are systematic reviews

Secondary studies that systematically search literature to identify studies meeting specific criteria.

What is a meta-analysis

A statistical method that combines the results of multiple studies to draw broader conclusions.

What is an example of a meta-analysis

Combining results of trials to evaluate statins' effectiveness in reducing cardiovascular risk.

What are case reports

Descriptions of individual cases of diseases, conditions, or medical events, often highlighting rare or unusual findings.

What are case series

Descriptions of outcomes for a group of patients with the same condition or treatment.

What is an example of a case report

Describing a rare side effect of a newly approved medication.

What is an example of a case series

Presenting outcomes of patients treated with experimental therapy for a rare cancer.

What are clinical trials

Studies conducted in phases to evaluate safety, efficacy, and optimal dosing of treatments for regulatory approval.

What is an example of a Phase III clinical trial

Testing a new cancer treatment in a large population to compare survival rates with existing treatments.

What is the focus of Phase I trials

Evaluating safety and tolerability of a drug in healthy volunteers.

What is the focus of Phase II trials

Investigating drug effectiveness and further evaluating safety in patients with the condition.

What is the focus of Phase III trials

Large-scale testing to confirm effectiveness and monitor adverse reactions.

What is the focus of Phase IV trials

Post-marketing studies to monitor long-term effects and gather additional data.

What are pragmatic trials

Trials evaluating interventions' effectiveness in real-world conditions.

What is an example of a pragmatic trial

Assessing a home-based physical activity program's impact on reducing hospital admissions for elderly heart failure patients.