Quality Improvement Vs. Research Publishing QI

Quality Improvement versus Research

 

Flow Chart : QI vs. Research (click here to view)

Quality Improvement/Process Improvement (QI/PI) and Research may both involve the evaluation of human subjects.
QI/PI activity is governed by Joint Commission and Hospital standards, while Research is governed by federal regulation, under IRB surveillance. 

Definitions:

QI/PI has been defined as “systematic, data-guided activities designed to bring about immediate improvement in the health care delivery (Lynn J, et al. The ethics of using quality improvement methods in health care. Ann Intern Med 2007;146:666-674). Joint Commission standard PI1.10 states “the hospital collects data to monitor performance…to monitor the stability of existing processes, identify opportunities for improvement, identify changes that lead to improvement or sustained improvement”
Unlike research such projects are not subject to formal review before collection of data. The intent to publish a quality improvement project is insufficient criterion for determining if the project involves research.  The Reading Hospital and medical Center Department of Quality recommends notification of the Department when PI/QI projects are initiated, in order to track such projects and assure optimal collaboration within the organization.

Research  is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” (46 CFR102(d)).  A highly structured federal regulatory process must be followed, as described under the IRB Section. 

The distinction between these areas may be vague in some cases. Indeed, a given project may be considered both PI/QI and research. Processes are in place at the Hospital to address the confusion in the field, which is likely to evolve over the coming years. 

QI versus Research:

Indicators that help determine whether a project is QI/PI or research

Indicators that a project is PI/QI:

• Evaluates procedures that are no greater than minimal risk to patients
• Includes only usual care practices
• Interventions offered to all
• Continuous monitoring, data collection and assessment, allowing ongoing modification to correct deficiencies and make improvement
• Researchers may be involved to provide expertise with respect to evaluation or assessment methods
• External sponsor may provide limited support but are not involved in implementation and/or evaluation plans

Indicators that a project is research and should be reviewed by IRB:

• Testing of issues that go beyond current knowledge based on science and experience
• Random allocation of patients into different intervention groups
• Deliberate delay of feedback of data from those monitoring the implementation, especially if this is done to avoid bias
• Involvement of researchers who have no ongoing commitment to local improvement
• Funding or substantial participation by parties outside the organization that direct implementation and/or evaluation protocols
  (modified from Platteborze L, et al. Performance improvement/research advisory panel: a model for determining whether a project is a performance or quality improvement activity or research. Military Medicine 2010;175:290-291;  Johansson AC. Perspective:medical education research and the institutional review board; reexamining the process. Academic Medicine 2011;86:809-817)