Practice Matters

Is this quality improvement or research?

Imagine you’re a nurse working in the emergency department (ED) of a small hospital who wants to reduce medication errors in your department. You decide to implement a “no interruption zone” for medication preparation. Is this quality improvement (QI) or research? Because of my work as a research consultant, I was recently asked this very question.

In another example, nurses in an oncology clinic noticed that most patients receiving certain neurotoxic chemotherapeutic agents suffered from neuropathy. After finding little information in research literature about helpful nonpharmacologic therapies to combat the neuropathy, the nurses collaborated with the physical therapist on a project. They had some patients who received the chemotherapy drugs participate in exercises and compared them, using a standardized neuropathy scale, with those who did not exercise. Would this qualify as research or QI? And why is it important to know the difference?

Differentiating between research and QI determines future steps in the process. Although each method is rigorous in its own way, QI and research have distinctly different overall aims and processes to reach them. For example, several aspects such as patient rights, privacy, and application of the results are handled differently.

What qualifies as research?

Research is a systematic investigation of phenomena for the purposes of generalizing findings to a population. Researchers aim to add to the current body of knowledge about a particular subject, and results are often published in academic journals. Researchers must follow strict policies, obtain consent from subjects, and report any deviation from the protocol. An Institutional Review Board (IRB) must approve the research project before it starts, and a hospital’s administrative personnel must support the project. (See What is an Institutional Review Board?).

What is an Institutional Review Board (IRB)?An IRB is a committee of health professionals and a community member that reviews and approves research proposals to ensure human rights are protected. The IRB assesses appropriate consent of subjects, design of the study, and maintenance of confidentiality, among other factors. Researchers must sometimes revise the research protocol before it is approved. Most researchers are required to complete a short education program before they can submit a research protocol to the IRB. Evidence of IRB approval is often required for publication of articles related to the research project.

Some helpful questions to ask to determine if your project is research include:


  • What do you hope to accomplish by studying the topic?
  • What is currently known about the topic?
  • What are the patient risks and benefits involved with the study of this topic?

What qualifies as QI?

QI (also called quality assurance) is also systematic, but it aims to improve care, processes, or outcomes within an organization. The purpose of QI is to test a new process using the plan, do, study, act process. This cycle is repeated, and new changes are made to continue to improve the outcome.

Typically, QI results are shared within the organization and might be implemented in other departments. The processes and lessons learned from QI activities can be published; however, it must be clear to the reader that the project was QI and not research. Data published from QI activities are usually aggregated and represented in control charts, histograms, and line graphs.

The hospital should support or approve QI. Some organizations have QI committees that approve and coordinate activities, and some organizations require articles to be approved before submitting for publication.

Some helpful questions to ask to determine if your project is QI include:

  • Has the intervention been used in other healthcare settings or reported in the literature?
  • Will the results of this project directly improve patient care or processes at your hospital?
  • Is the hospital supportive of the project and willing to dedicate employee time and supplies to complete the project?

See below for a summary of the differences between QI and research. (See Differences between QI and research.)

Differences between QI and research

The table below compares QI and research.

QI Research
  • Improves performance or processes to strengthen patient care.

 

  • Findings used for internal improvement.

 

  • Implementation of established evidence-based standards.

 

  • Implementation will result in direct benefit

 

  • Follows the plan, do, study, act cycle

 

 

 

  • Usually involves all or most people participating in the process

 

  • HIPAA covers the use of protected health information for QI purposes

 

 

  • May make changes during the process based upon preliminary data

 

  • The hospital agrees that it is a QI project. Project is not a risk or burden to patients

 

  • The results are not initially intended to be published; may be published as a quality project.*

 

  • Not funded by an external research grant.

 

  • Answers a question or hypothesis to advance general knowledge

 

  • Findings contribute to generalized knowledge outside of the hospital

 

  • Investigates untested methods or standards

 

  • Subjects may not directly benefit from knowledge gained

 

  • Follows a research design (e.g. randomization)

 

 

  • Involves a subset of the population with inclusion and exclusion criteria

 

  • Must get written consent from patients and identify how health information will be protected

 

  • No deviation from set protocol. Data is usually not analyzed until completion

 

  • Approval from the hospital and the institutional review board (IRB) needed

 

 

  • Results are expected to be published and presented outside the hospital

 

 

  • External funding may be sought.

 

*Note: Some hospitals have QI committees that approve all projects. Some hospitals also require all publications to be reviewed by the IRB. Certain publications may require a letter from the IRB stating that the subjects’ rights were protected in the project.

Making the decision

After meeting with both the ED and oncology nurses and explaining the difference between QI and research, they were easily able to classify their projects. The ED nurses determined that the implementation of a “no interruption zone” was QI because it involved implementing an evidence-based process for the purpose of improving care in the department. Their next step was to meet with their manager and nursing practice council to begin the plan, do, study, act cycle.

The oncology nurses correctly determined their project to be research. First, there is little known about this topic in the oncology population. Second, they wanted to compare two groups of patients for the purposes of learning more. The oncology nurses completed the required IRB education and developed a specific research protocol, which included obtaining patient consent.

The need to know

Nurses are with patients 24/7, so we are able to make smart recommendations to improve the quality and safety of patient care. To do that most effectively, it’s important to know how to answer the question “Is this quality improvement or is it research?”

Regardless of the answer, it is important to implement the project systematically. If your project is QI, many hospitals have QI specialists that can help staff with the plan, do, study, act cycle. If your project qualifies as research, the IRB staff often helps new researchers by providing templates. If you have lingering questions about a project, ask your IRB board and they can help.

Selected references

Morris PE, Dracup K. Quality improvement or research? The ethics of hospital project oversight. Am J. Crit Care. 2007;16:424-6.

Shirey MR, Hauck SL, Embree JL, et al. Showcasing differences between quality improvement, evidence-based practice, and research. J Cont Ed. 2011;42(2):57-68.

Katreena Collette Merrill is an assistant professor in the college of nursing at Brigham Young University in Provo, Utah.

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