DOI: 10.1097/JPN.0000000000000107
EXPERT OPINION
E
NEONATAL
Katherine E. Gregory, PhD, RN
Differentiating Between Research and Quality Improvement ealthcare is increasingly focused on improving patient care outcomes while decreasing healthcare costs. As a result, greater efforts have been dedicated to implementing evidence-based practice, which relies on clinical research findings to guide practice and quality improvement (QI) to assess whether or not changes made in practice have had an influence on patient care outcomes. Differentiating between a research study and a QI project can be difficult, as both often involve defining a problem, developing and implementing an intervention or change to address the problem, and then analyzing the effect of that change on the problem of interest. Overlap between these 2 approaches exists. However, there are some differences that can help determine whether or not the work to be conducted qualifies as a research study or a QI project. Understanding these differences is important to clinical nurses so that they may have the ability to determine whether or not a project qualifies as research or QI, and, in turn, be prepared to address any ethical considerations and ensure that all regulations are followed.
H
DEFINING RESEARCH According to the National Institutes of Health, research is defined as A systematic, intensive study intended to increase knowledge or understanding of the subject studied, a systematic study specifically directed toward applying new knowledge to meet a recognized need, or a systematic application of knowledge to the production of useful materials, devices, and systems or methods, including design, development, and improvement of prototypes and new processes to meet specific requirements.1 Disclosure: The author has disclosed that she has no significant relationships with, or financial interest in, any commercial companies pertaining to this article. No funding was received in support of this work.
100
www.jpnnjournal.com
Research must be conducted in a methodical order, following a series of steps and a standard protocol. These rules are broadly similar from one research study to another, but they may vary slightly between the different fields of science. Regardless of the field, research must be organized and undergo planning, including an assessment of the literature on the topic, identification of a specific problem or question, development of a research methodology, the collection of data, and a data analysis plan. Interpretation and dissemination of the study findings via publication and presentation are a priority in research. Research is typically conducted independent of routine medical care and, in the majority of cases, involves human subjects who are participants. All research involving human subjects requires review and approval by the institutional review board (IRB) within an institution. The IRB is responsible for reviewing scientific integrity and ensuring the protection of the human subjects from any risks that may be associated with participating in the research study. The human subjects have an opportunity to decide about being involved in the research study and can withdraw their participation at any time as part of the informed consent process. Research endeavors can be costly and often rely on funding from outside the hospital or university. The key principles of research are noted in Table 1.
DEFINING QUALITY IMPROVEMENT The Institute of Medicine is a recognized leader and advisor on improving healthcare across the United States. It defines quality in healthcare as a direct correlation between the level of improved health services and the desired health outcomes of individuals and populations.2 In the landmark publication, Crossing the Quality Chasm, the Institute of Medicine outlined 6 specific aims that a healthcare system must fulfill to deliver quality care: April/June 2015
Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
EXPERT OPINION
E
NEONATAL
Table 1. Four key principles of research and quality improvement Research
Quality improvement
Form and test hypotheses Systematically study a problem of interest following a structured protocol Collect, analyze, and interpreter the findings of data collection Disseminate the findings
Focus on systems and processes Establish measures to determine if a specific change actually leads to an improvement in systems and processes Analyze data to improve systems related to processes and outcomes (ie, cost, productivity, quality) Use the findings to improve quality of care
1. Safe: Care should be as safe for patients in healthcare facilities as in their homes. 2. Effective: The science and evidence behind healthcare should be applied and serve as the standard in the delivery of care. 3. Efficient: Care and service should be costeffective, and waste should be removed from the system. 4. Timely: Patients should experience no waits or delays in receiving care and service. 5. Patient-centered: The system of care should revolve around the patient, respect patient preferences, and put the patient in control. 6. Equitable: Unequal treatment should be a fact of the past; disparities in care should be eradicated. Meeting these specific aims to ensure quality care for all patients remains a challenge for the majority of healthcare settings. Focused QI projects are one strategy that can help a specific healthcare setting achieve highquality care for patients and families. Quality improvement is a process of systematic, data-guided activities designed to bring about immediate, positive changes in the delivery of healthcare in particular settings.3 These projects are typically institution specific, although collaborative approaches including multiple institutions focused on QI relevant to a specific patient population have evolved. For example, neoQIC, the Neonatal Quality Improvement Collaborative of Massachusetts (www.neoqic.org), and CPQCC, California Perinatal Quality Care Collaborative (www.cpqcc.org), have been established with the goal of improving care and outcomes for pregnant mothers and newborns throughout their respective states. The goal of QI is to analyze data to improve systems related to processes and outcomes (ie, cost, productivity, quality).4 Quality improvement is considered an expectation by society for clinical practice to continuously improve. The risk to patients participating in QI projects is low. And, because of the collective nature of health care practice, patients are expected to participate in QI initiatives as part of normal healthcare operations and to help improve the quality of care for The Journal of Perinatal & Neonatal Nursing
others.3 Thus, the IRB review and informed consent process that exists for human subjects involved in research does not currently apply to the majority of QI projects. Quality improvement projects typically rely on clinical care resources, unlike research initiatives where grant funding is often required. Quality improvement work is published less frequently than research but does indeed make an important contribution to the literature on a specific patient care outcome or process. When QI work is published, it is important that the authors make it clear that the publication is the result of a QI initiative and not that of a research study. While not as highly structured as the research process, QI projects do need to follow a plan that ensures aims are defined, measures of change are established, changes that are likely to result in improvement are selected, and these changes are appropriately tested. The Institute for Healthcare Improvement (www.ihi.org) has proposed a model that relies on the Plan-Do-Study-Act cycle for testing a change in the real work setting. This approach is used for action-oriented learning, which involves planning the change, trying or doing the change, observing the results, and acting on what is learned so that the change may be further refined for the purpose of improving a process or outcome.5 The learning from this approach can then contribute to future QI projects in helping to determine what changes should be selected, how teams will know if the change is a measurable improvement, and, finally, by starting back at the first step of defining the work that is going to be accomplished in the context of a QI.
DETERMINING THE DIFFERENCES BETWEEN RESEARCH AND QI Some projects are clearly research; for example, a randomized trial testing the effect of a new drug on a therapeutic outcome in a specific patient population. Other projects are clearly QI; for example, the redesign of a system within the newborn intensive care unit for preparing and storing breast milk so that it is fed in a timely manner to preterm infants. However, the www.jpnnjournal.com
Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
101
EXPERT OPINION
E
NEONATAL
Table 2. Differences between a research study and a QI project6 Research study
QI Project
Intent
Designed to develop, not generally to implement knowledge
Design
Systematic, methodological approach to the scientific process
Setting Benefit
Single or multisite settings Greater scientific community and clinicians
Generalizable findings Oversight
Yes Institution, IRB, government, and funding agencies responsible for the project Variable, risks, and benefits Requires informed consent IRB always required Ethically justified by weighting risks to individual vs societal benefits from the development of new knowledge Publication and presentation reported as the IRB-approved research study
Subject risk Informed consent IRB required Ethical justification Dissemination plan
Apply known solutions to a focused problem or process, typically related to cost, productivity, or quality Less rigorous methodology, often involves a Plan-Do-Study-Act test of change Most often, a single setting and situation Subjects involved in the QI project and the institution where the project was conducted No Institution where the project is being conducted None or minimal No informed consent IRB typically not required Considered an expectation by society for clinical practice to continuously improve Internal communication, publication, and presentations reported as the QI work
Abbreviations: IRB, institutional review board; QI, quality improvement.
definitions of research and QI overlap with one another and the differences between these types of projects can become less clear. This can result in confusion when describing various research or improvement activities. This confusion is made worse by the fact that many who conduct QI on a specific topic also have a research interest in the same topic. When there is ambiguity about the type of work being conducted, the team leaders are required to reflect on the intent, design, setting, benefit, and generalizability of the project findings. In addition, the oversight required, risk to participants, and ethical justification for the project need to be considered as part of determining which type of project the team is conducting. Table 2 outlines the distinctions between research and QI and are important for teams to understand so that they can be sure to conduct their project in accordance with all regulatory guidelines. The IRB or research compliance office within many institutions has implemented a QI checklist that can help teams navigate this process. If you are planning to conduct a project and unsure whether or not it qualifies as research or QI, contact the IRB and ask for guidance in making this decision.
CONCLUSION Both research and QI have an important place in delivering evidence-based practice and ensuring ongoing improvement of patient care outcomes. There is over-
102
www.jpnnjournal.com
lap in the definitions of research and QI, but some clear differences exist. It is important for team leaders and those engaged in research and QI to understand these differences and ensure that they follow all regulatory guidelines within their institution. —Katherine E. Gregory, PhD, RN Senior Nurse Scientist Department of Pediatric Newborn Medicine Department of Nursing Brigham and Women’s Hospital Boston, Massachusetts
References 1. National Institutes of Health. Glossary & acronym list. http:// grants.nih.gov/grants/glossary.htm. Published 2015. Accessed February 20, 2015. 2. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press; 2002. 3. Baily MA, Bottrell M, Lynn J, Jennings B, Hastings C. The ethics of using QI methods to improve health care quality and safety. Hastings Cent Rep. 2006;36(4):S1–S40. 4. Shirey MR, Hauck SL, Embree JL, et al. Showcasing differences between quality improvement, evidence-based practice, and research. J Contin Educ Nurs. 2011;42(2):57–68; quiz 69–70. 5. Institute for Healthcare Improvement. Plan-Do-StudyAct worksheet. http://www.ihi.org/resources/Pages/Tools/ PlanDoStudyActWorksheet.aspx. Published 2015. Accessed February 25, 2015. 6. Arndt JV, Netsch DS. Research study or QI project. J Wound Ostomy Cont Nurs. 2012;39(4):371–375.
April/June 2015
Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
EXPERT OPINION
E
NEONATAL
Katherine E. Gregory, PhD, RN
Differentiating Between Research and Quality Improvement ealthcare is increasingly focused on improving patient care outcomes while decreasing healthcare costs. As a result, greater efforts have been dedicated to implementing evidence-based practice, which relies on clinical research findings to guide practice and quality improvement (QI) to assess whether or not changes made in practice have had an influence on patient care outcomes. Differentiating between a research study and a QI project can be difficult, as both often involve defining a problem, developing and implementing an intervention or change to address the problem, and then analyzing the effect of that change on the problem of interest. Overlap between these 2 approaches exists. However, there are some differences that can help determine whether or not the work to be conducted qualifies as a research study or a QI project. Understanding these differences is important to clinical nurses so that they may have the ability to determine whether or not a project qualifies as research or QI, and, in turn, be prepared to address any ethical considerations and ensure that all regulations are followed.
H
DEFINING RESEARCH According to the National Institutes of Health, research is defined as A systematic, intensive study intended to increase knowledge or understanding of the subject studied, a systematic study specifically directed toward applying new knowledge to meet a recognized need, or a systematic application of knowledge to the production of useful materials, devices, and systems or methods, including design, development, and improvement of prototypes and new processes to meet specific requirements.1 Disclosure: The author has disclosed that she has no significant relationships with, or financial interest in, any commercial companies pertaining to this article. No funding was received in support of this work.
100
www.jpnnjournal.com
Research must be conducted in a methodical order, following a series of steps and a standard protocol. These rules are broadly similar from one research study to another, but they may vary slightly between the different fields of science. Regardless of the field, research must be organized and undergo planning, including an assessment of the literature on the topic, identification of a specific problem or question, development of a research methodology, the collection of data, and a data analysis plan. Interpretation and dissemination of the study findings via publication and presentation are a priority in research. Research is typically conducted independent of routine medical care and, in the majority of cases, involves human subjects who are participants. All research involving human subjects requires review and approval by the institutional review board (IRB) within an institution. The IRB is responsible for reviewing scientific integrity and ensuring the protection of the human subjects from any risks that may be associated with participating in the research study. The human subjects have an opportunity to decide about being involved in the research study and can withdraw their participation at any time as part of the informed consent process. Research endeavors can be costly and often rely on funding from outside the hospital or university. The key principles of research are noted in Table 1.
DEFINING QUALITY IMPROVEMENT The Institute of Medicine is a recognized leader and advisor on improving healthcare across the United States. It defines quality in healthcare as a direct correlation between the level of improved health services and the desired health outcomes of individuals and populations.2 In the landmark publication, Crossing the Quality Chasm, the Institute of Medicine outlined 6 specific aims that a healthcare system must fulfill to deliver quality care: April/June 2015
Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
EXPERT OPINION
E
NEONATAL
Table 1. Four key principles of research and quality improvement Research
Quality improvement
Form and test hypotheses Systematically study a problem of interest following a structured protocol Collect, analyze, and interpreter the findings of data collection Disseminate the findings
Focus on systems and processes Establish measures to determine if a specific change actually leads to an improvement in systems and processes Analyze data to improve systems related to processes and outcomes (ie, cost, productivity, quality) Use the findings to improve quality of care
1. Safe: Care should be as safe for patients in healthcare facilities as in their homes. 2. Effective: The science and evidence behind healthcare should be applied and serve as the standard in the delivery of care. 3. Efficient: Care and service should be costeffective, and waste should be removed from the system. 4. Timely: Patients should experience no waits or delays in receiving care and service. 5. Patient-centered: The system of care should revolve around the patient, respect patient preferences, and put the patient in control. 6. Equitable: Unequal treatment should be a fact of the past; disparities in care should be eradicated. Meeting these specific aims to ensure quality care for all patients remains a challenge for the majority of healthcare settings. Focused QI projects are one strategy that can help a specific healthcare setting achieve highquality care for patients and families. Quality improvement is a process of systematic, data-guided activities designed to bring about immediate, positive changes in the delivery of healthcare in particular settings.3 These projects are typically institution specific, although collaborative approaches including multiple institutions focused on QI relevant to a specific patient population have evolved. For example, neoQIC, the Neonatal Quality Improvement Collaborative of Massachusetts (www.neoqic.org), and CPQCC, California Perinatal Quality Care Collaborative (www.cpqcc.org), have been established with the goal of improving care and outcomes for pregnant mothers and newborns throughout their respective states. The goal of QI is to analyze data to improve systems related to processes and outcomes (ie, cost, productivity, quality).4 Quality improvement is considered an expectation by society for clinical practice to continuously improve. The risk to patients participating in QI projects is low. And, because of the collective nature of health care practice, patients are expected to participate in QI initiatives as part of normal healthcare operations and to help improve the quality of care for The Journal of Perinatal & Neonatal Nursing
others.3 Thus, the IRB review and informed consent process that exists for human subjects involved in research does not currently apply to the majority of QI projects. Quality improvement projects typically rely on clinical care resources, unlike research initiatives where grant funding is often required. Quality improvement work is published less frequently than research but does indeed make an important contribution to the literature on a specific patient care outcome or process. When QI work is published, it is important that the authors make it clear that the publication is the result of a QI initiative and not that of a research study. While not as highly structured as the research process, QI projects do need to follow a plan that ensures aims are defined, measures of change are established, changes that are likely to result in improvement are selected, and these changes are appropriately tested. The Institute for Healthcare Improvement (www.ihi.org) has proposed a model that relies on the Plan-Do-Study-Act cycle for testing a change in the real work setting. This approach is used for action-oriented learning, which involves planning the change, trying or doing the change, observing the results, and acting on what is learned so that the change may be further refined for the purpose of improving a process or outcome.5 The learning from this approach can then contribute to future QI projects in helping to determine what changes should be selected, how teams will know if the change is a measurable improvement, and, finally, by starting back at the first step of defining the work that is going to be accomplished in the context of a QI.
DETERMINING THE DIFFERENCES BETWEEN RESEARCH AND QI Some projects are clearly research; for example, a randomized trial testing the effect of a new drug on a therapeutic outcome in a specific patient population. Other projects are clearly QI; for example, the redesign of a system within the newborn intensive care unit for preparing and storing breast milk so that it is fed in a timely manner to preterm infants. However, the www.jpnnjournal.com
Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
101
EXPERT OPINION
E
NEONATAL
Table 2. Differences between a research study and a QI project6 Research study
QI Project
Intent
Designed to develop, not generally to implement knowledge
Design
Systematic, methodological approach to the scientific process
Setting Benefit
Single or multisite settings Greater scientific community and clinicians
Generalizable findings Oversight
Yes Institution, IRB, government, and funding agencies responsible for the project Variable, risks, and benefits Requires informed consent IRB always required Ethically justified by weighting risks to individual vs societal benefits from the development of new knowledge Publication and presentation reported as the IRB-approved research study
Subject risk Informed consent IRB required Ethical justification Dissemination plan
Apply known solutions to a focused problem or process, typically related to cost, productivity, or quality Less rigorous methodology, often involves a Plan-Do-Study-Act test of change Most often, a single setting and situation Subjects involved in the QI project and the institution where the project was conducted No Institution where the project is being conducted None or minimal No informed consent IRB typically not required Considered an expectation by society for clinical practice to continuously improve Internal communication, publication, and presentations reported as the QI work
Abbreviations: IRB, institutional review board; QI, quality improvement.
definitions of research and QI overlap with one another and the differences between these types of projects can become less clear. This can result in confusion when describing various research or improvement activities. This confusion is made worse by the fact that many who conduct QI on a specific topic also have a research interest in the same topic. When there is ambiguity about the type of work being conducted, the team leaders are required to reflect on the intent, design, setting, benefit, and generalizability of the project findings. In addition, the oversight required, risk to participants, and ethical justification for the project need to be considered as part of determining which type of project the team is conducting. Table 2 outlines the distinctions between research and QI and are important for teams to understand so that they can be sure to conduct their project in accordance with all regulatory guidelines. The IRB or research compliance office within many institutions has implemented a QI checklist that can help teams navigate this process. If you are planning to conduct a project and unsure whether or not it qualifies as research or QI, contact the IRB and ask for guidance in making this decision.
CONCLUSION Both research and QI have an important place in delivering evidence-based practice and ensuring ongoing improvement of patient care outcomes. There is over-
102
www.jpnnjournal.com
lap in the definitions of research and QI, but some clear differences exist. It is important for team leaders and those engaged in research and QI to understand these differences and ensure that they follow all regulatory guidelines within their institution. —Katherine E. Gregory, PhD, RN Senior Nurse Scientist Department of Pediatric Newborn Medicine Department of Nursing Brigham and Women’s Hospital Boston, Massachusetts
References 1. National Institutes of Health. Glossary & acronym list. http:// grants.nih.gov/grants/glossary.htm. Published 2015. Accessed February 20, 2015. 2. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press; 2002. 3. Baily MA, Bottrell M, Lynn J, Jennings B, Hastings C. The ethics of using QI methods to improve health care quality and safety. Hastings Cent Rep. 2006;36(4):S1–S40. 4. Shirey MR, Hauck SL, Embree JL, et al. Showcasing differences between quality improvement, evidence-based practice, and research. J Contin Educ Nurs. 2011;42(2):57–68; quiz 69–70. 5. Institute for Healthcare Improvement. Plan-Do-StudyAct worksheet. http://www.ihi.org/resources/Pages/Tools/ PlanDoStudyActWorksheet.aspx. Published 2015. Accessed February 25, 2015. 6. Arndt JV, Netsch DS. Research study or QI project. J Wound Ostomy Cont Nurs. 2012;39(4):371–375.
April/June 2015
Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
