Chapter 2 Flashcards
the direct application of scientific discoveries into clinical practice.
Translational research
Successes of scientific breakthroughs in the laboratory or in animal models have not translated into major changes in medical or rehabilitative care for humans in a timely way.
The Translation Gap
Some view it as the development of new drugs, treatments, or devices, whereas others see its purpose to focus on getting research findings into practice.
Translation Continuum
Proof of concept
Efficacy
Gold standard
RTC
Designed to study the efficacy of a new therapy by comparing it to a placebo or standard care.
RTC
Real-world conditions
More generalizable
Inclusion/exclusion criteria is not as strict — Allows for comorbidities
Effectiveness
often eliminates the very patients who would likely be treated with the new therapy.
Major limitations
often artificial, limiting the applicability of findings b/c they are not representative of the variable practice environment that cannot be controlled in the clinical community.
Testing environments
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.
Pragmatic (practical) clinical trials (PTCs)
highlights the human dimensions of health care
Qualitative research
represented obstacles to realizing true health benefits from original research
Translational blocks
5 phase of translational research
T0—Basic Research
T1—Translation to Humans
T2—Translation to Patients
T3—Translation to Practice
T4—Translation to Populations
Represent an interactive pathway in multiple directions, not always starting with basic research questions
The Multimodal Cycle
Federal and nonprofit agencies have created programs with significant funding to support effectiveness studies
Effective Research
the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor or improve the delivery of care
Comparative effectiveness research
Hypothesis and study design are formulated based on information needed to make a clinical decision
Pragmatic Clinical Trials
used to describe an approach to research that is of high quality but developed and implemented in real-world settings
PBE
Umbrella term to describe studies that focus on the impact of results of healthcare practices and interventions.
Outcome research
Comes directly from pt — Can be tested across multiple populations
Goal: engage pt in the development of questions and outcome measures
Patient-Reported Outcomes Measures
Outcomes that measure things that a pt would care about
Patient-Oriented Evidence that Matters
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
Patient-centered outcomes research (PCOR)
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.
Primary outcome
endpoint measures that may also be used to assess the effectiveness of the intervention, as well as side effects, costs, or other outcomes of interest.
Secondary outcomes
focuses on understanding the influence of the environment and resources on whether research findings are actually translated to practice.
Implementation science
An implementation study is focused on:
Ways to change behavior
Incorporating education and training
Team-based efforts
Community engagement
Systemic infrastructure redesign
Implementation studies can address:
Clinical performance audits
Involve variables that describe the intentional activities to deliver services
Typically focus on feasibility, acceptance, adoption, cost, and sustainability
Implementation outcomes
often collected to better understand the context of implementation, including semi-structured interviews, focus groups, and direct observation
Qualitative data
