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Week13-4_post_Spring20201.pps

HCS 420:
RESEARCH METHODS IN HEALTHCARE

Week 13

Implementing the Study and Quality Control in Healthcare Research

Chapter 17

What is Study Implementation?

Study Implementation

What does study implementation involve?

Study Implementation

Systematic approach to quality control of clinical and lab procedures and of data management

Assembling Resources

What are some examples of resources in healthcare research?

Resources include:

Space, people (i.e. research team members), documents (i.e. manuals, forms), etc.

Assembling Resources

Space
Although conducting research online is possible, most research require some physical space
The Research team
Could range is size from small (investigator & part-time staff) to large (multiple full-time staff)
Leadership and team-building
The Principal Investigator is responsible for leading the research team

Assembling Resources (Contd.)

Study start-up: Period of study activity before the first participant is recruited

IRB approval: Getting the study protocol, consent form, and recruitment materials approved before the study begins

Operations manual and forms development
The protocol can be expanded to create the operations manual
The protocol, information on study organization and policies, and a detailed version of the methods section of the study

Assembling Resources (Contd.)

Database design: Creation and testing of the database that will be used to enter, edit, store, monitor, and analyze the data

Recruitment: Timely recruitment is often the most difficult aspect of may studies
It requires adequate time, staff, resources, funding and expertise

Finalizing the Protocol

Pretests and dress rehearsals: Pretests and pilot studies can be used to evaluate the feasibility, efficiency, and cost of study methods
Pretests are evaluations of specific questionnaires, measures, or procedures that can be carried out by study staff to assess their functionality, appropriateness, and feasibility
Dress rehearsals involves testing plans for clinic visits and other study procedures in a full scale procedure

Finalizing the Protocol

Minor protocol revisions once data collection has begun: In general, make as few changes to the protocol as possible once data collection has begun

Substantive protocol revisions once data collection has begun: Once data collection has begun, major changes (e.g. including different kind of participants or changing the intervention or outcomes are considered serious problems

Finalizing the Protocol

Closeout: In a longitudinal study, this represents the period during which participants complete their last visit in the study

Closeout (contd.)

Points to keep in mind:
Staff should thank participants for their time
Participants should be informed of the results of clinically relevant lab tests
In RCTs, participants may be told their treatment status
Copy of the mailed manuscript should be mailed to participants
After all participants have completed the study, they may be invited to a reception during which the PI thanks them, discusses the results, and answers questions