Conducting Research In A Clinical Setting

Question 1

What is critical inquiry

Answer 1

The process of applying the principles of scientific methods: read and interpret professional literature; participate in, plan, and conduct research; evaluate outcome data; and assess new concepts and technologies

Question 2

What are examples of critical inquiry

Answer 2

1. Analyzing and applying research findings to physical therapists practice and education
2. Disseminating the results of research
3. Evaluating the efficacy and effectiveness of both new and established interventions and technologies
4. Participating in, planning, and conducting clinical, basic, or applied research

Question 3

What is premier research grant in the world

Answer 3

RO1 Grant

Lots of money, hard to get

Question 4

What is purpose of APTA Research Agenda

Answer 4

To encourage programs of research among junior investigators and increase awareness of PT scientists around funding agencies.

Question 5

What are APTA scientific research priorities of 2021-2022

Answer 5

1. These priorities are designed to advance evidence-based practice through scientific research by being a resource for PT researchers and other researchers within the rehab field, research funding agencies, the APTA community, and other relevant stakeholders
2. Scientific Research Priorities for the PT Profession are reassessed every 2 years to support the long-range APTA research agenda for PT which is updated every 10 years
3. Population Research
4. Health service research
5. Clinical research

Question 6

What is population research

Answer 6

Type of investigation seeks to characterize, explain, and/or influence the levels and distributions of health within and across populations, such as among individuals and groups, and across time and generations
- this includes ar easel Ike health disparities, social determinants of health and global health
“What does this group look like, what are unique characteristics?”

Question 7

What are action items within population research

Answer 7

1. Disparities - lot of descriptive stuff, able to draw associations as to why some characteristics is prevalent in that group you are looking at.
2. Social determinants of health
3. Interventions

Look at slide for more detail.

Question 8

what is health service research

Answer 8

Type of research investigates how social factors, financing systems, organizational structures and processes, health tech, and personal behaviors affect access to health care, the quality and total cost of health care, and ultimately health and well being
- Research domains are individuals, families, orgs, institutions, communities, and populations.
- Includes areas such as patient experience, personalized medicine, and shared decision making

Question 9

Action items for health service research

Answer 9

1. Delivery models
2. Utilization and cost
3. Payment and insurance

Look at slides for more detail

Question 10

What is clinical research

Answer 10

Type of research investigates safety, effectiveness, and efficacy of diagnosis and diagnostic procedures, treatment regimens and protocols, devices, and technology intended for human use
- includes areas such as genomics, novel tech, and innovation

Question 11

Action items for clinical research

Answer 11

1. Telehealth
2. Value
3. Treatment

Look at slides for more detail

Question 12

What are general themes of clinical research

Answer 12

1. Documenting effectiveness of interventions
2. Validating diagnostic or classification systems
3. Accurately identifying prognostic indicators of functional limitations of disability

Question 13

What do you need to consider when conducting clinical research

Answer 13

1. Facility or institutional resources
2. Patient management
3. Reporting and managing research related injury or illness
4. Modifying and/or terminating the project

Question 14

Facility or institution resource?

Answer 14

1. Access to targeted patient populations and effective mechanisms to identify and recruit participants. Gotta collaborate with the people that have that patient population.
2. Access to research staff
3. IRB/Medical legal support

Question 15

Determining availability of target patient population

Answer 15

1. Scheduling databases
2. Char reviews

Question 16

Who is part of research team

Answer 16

1. PT
   — identifying appropriate participants
   — data collection, analysis, dissemination
2. Physicians
   — identifying appropriate participants
   — Provide perspective on safety and patient management(risks)
   — IDing medical co-intervention that may be confounding factors
3. Administrative support
   — IRB support, scheduling, data management, document management

Question 17

What is IRB support

Answer 17

The institutional review board (IRB) is an administrative body of the institution where the research is being conducted that protects the rights and welfare of human subjects recruited to participate in research activities
— can be local if you are at an academic medical facility or may need to contract out
biggest thing they look at is risk vs. Reward esp with human subjects

Question 18

Patient/participant management (feasibility)

Answer 18

1. Provision of intervention
2. Administration of appropriate outcome measurements
3. Timeframe of outcome measures
4. Risks associated with participation — PT’s are really great at doing this

Question 19

Reporting and managing research related injury or illness?

Answer 19

1. Make certain that the participant receives appropriate medical attention if they are injured.
2. Report the adverse event (AE) to the IRB — have to do this!! Because then IRB has to re-evaluate the risk vs reward thing
3. Determine whether procedures need to be modified to reduce the risk of future events

huge

Question 20

Modifying and/or terminating the project may be required if..

Answer 20

1. An AE occurs as a result of participation in the study
2. New knowledge is acquired regarding risks and therefore safety becomes an issue
3. It has been determined that the intervention is so beneficial to the patient population that withholding it would be considered unethical

Question 21

Where do we start???

Answer 21

Preliminary/pilot data — necessary in the design phase of a clinical trial to determine your ability to complete a project successfully
- determine measurement procedures
- determine whether modifications are necessary to ensure high quality data collection
- generate data to be used in power analyses and estimation of sample sizes
- convincing yourself and possible funding agencies that you are capable of completing a formal project.