Chapter 2: Translational Research Flashcards
What is translational research?
The term translational research refers to the direct application of scientific discoveries into clinical practice.
Often described as taking knowledge from “bench to bedside,” this process is much broader in scope.
What is knowledge translation?
A process of identifying clinical problems and accelerating the application of knowledge to improve outcomes and change the provision of care.
What causes translational gaps?
Lag times are often due to sociocultural or scientific barriers, as well as systemic hurdles such as grant awards and institutional approvals, marketing and competition, policy, and regulatory limitations, need for long-term follow-up in clinical trials, limited funding resources, guideline development, and dissemination.
What is efficacy?
Ideal conditions.
Incorporates random assignment to groups to minimize bias.
Specific treatment protocol.
Strict inclusion and exclusion criteria.
Ex: randomized control trials
What are randomized control trials?
RCTs are considered the “gold standard” design to study the efficacy by comparing it to a placebo or standard care.
This approach lets us examine theory and draw generalizations to large populations while controlling for unintended bias.
RCTs must also carefully define and adhere to the treatment protocol and will usually set strict inclusion and exclusion criteria for participants to eliminate possibly confounding factors such as comorbidities.
What is effectiveness?
More generalizable
Treatment more reflective of practice
Inclusion and exclusion criteria not as strict, e.g., allows for comorbidities.
Ex: pragmatic clinical trials
What are pragmatic clinical trials?
PCTs will often incorporate measures of function or quality of life that are considered more relevant for patient satisfaction to understand if treatments have a meaningful effect on patient outcomes.
It has flexible protocols.
What are the translational blocks?
T0: Basic research
- Focus on theory and mechanisms
T1: Translation to humans
- Does it work?
T2: Translation to patients
- Can it work under ideal conditions?
T3: Translation to practice
- Will it work in real-world conditions?
T4: Translation to populations
- Is it worth it?
What is comparative effectiveness research?
Compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor or improve the delivery of care.
What is the purpose of comparative effectiveness research for patients?
This strategy means providing information about which approaches might work best, given their concerns, circumstances, and preferences.
What is the purpose of comparative effectiveness research for clinicians?
It means providing evidence-based information about questions they face daily in practice.
What is the purpose of comparative effectiveness research for insurers and policy makers?
It means producing evidence to help with decisions on how to improve health outcomes, costs, and access to services.
What is practice-based evidence?
Describes an approach to research that is of high quality but developed and implemented in real-world settings.
PBE studies often use observational cohorts, surveys, secondary analysis, or qualitative studies, with diverse samples from several clinical sites, with comprehensive data collection methods that include details on patient characteristics and their care.
What is outcomes research?
An umbrella term to describe studies that focus on the impact of results of healthcare practices and interventions.
What are patient-reported outcome measures?
Any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.
PROMs can be generic or condition specific.
Frequently used in pragmatic studies and becoming more common in randomized trials.
Strong correlation to function.
Has distinct goal of engaging patients in the development of questions and outcome measures.
What is patient-oriented evidence that matters (POEM)?
Refers to outcomes that measure things that a patient would care about like symptoms, quality of life, function, cost of care, length of stay, and so on.
Compare in contrast to disease-oriented evidence.
What is patient-centered outcome research?
Has the distinct goal of engaging patients and other stakeholders in the development of questions and outcome measures, encouraging them to become integral members of the research process.
What are primary outcomes?
Researchers will typically designate one measure as a primary outcome, the one that will be used to arrive at a decision on the overall result of the study and that represents the greatest therapeutic benefit.
What are secondary outcomes?
Secondary outcomes are other endpoint measures that may also be used to assess the effectiveness of the intervention, side effects, costs, or other outcomes of interest.
What are implementation studies?
Implementation science is the next step beyond effectiveness research. It focuses on understanding the influence of environment and resources on whether research findings are translated to practice.
How to put research into practice.
Considers the patient, provider, organizational systems, and policy.
Focused on ways to change behavior, often incorporating education and training, team-based efforts, community engagement, or systemic infrastructure redesign.
What can implementation studies address?
Many types of intervention
Clinical performance audits
The use of patient or provider alerts to remind them of guidelines
The influence of local leaders to adopt best practices
The investigation of consensus as a foundation for problem management
Patient education interventions
What are implementation outcomes?
Implementation outcomes involve variables that describe the intentional activities to deliver services.
They typically focus on feasibility, acceptance, adoption, cost, and sustainability—all serving as indicators of success.
These variables also provide insight into how the program contributes to health outcomes.
