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Is it research or quality improvement?
JULY 1998, VOL 68. NO I RESEARCH CORNER
Is it research or quality improvement?
w
hen faced with a problem, it is not uncommon to think of research as the method to find an answer. Not all problems, however, are amenable to research. This is particularly true in clinical practice. Although there are many clinical practice problems that do lend themselves to research, there are just as many that do not. In fact, many patient care issues are better addressed through continuous quality improvement efforts. Research and quality improvement have many similarities, but they vary in purpose and process. It is important to make the distinction between research and quality improvement before you embark on a project. Doing so will avoid complications and ensure success. Continuous quality improvement activities are developed and implemented to study clinical processes and outcomes. Generally, the activities are either concurrent (ie, at the same time) or retrospective (ie, looking to the past) to the problem being studied. In a quality improvement model, personnel in a clinical setting identify a clinical problem or issue and then use specific indicators to evaluate the clinical practice. Performance is measured using predetermined clinical indicators. When the indicators are identified and defined, clinical data are collected and analyzed. The analysis and synthesis of the data should provide clinicians with the necessary information to develop and implement an action plan specifi-
cally designed to correct the identified problem or improve the clinical process. Continuous quality improvement is thus the process by which ongoing monitoring and resultant change occurs. Research, on the other hand, is a process that generates new scientific knowledge. Research investigations are designed and implemented to answer a question or test a hypothesis. A formal proposal that outlines the scientific protocol is a necessary element of any research project. If human subjects are involved in the research, some form of review by the institutional review board (IRB) will be necessary.' Each step of the research process must adhere to strict, scientific standards, such as establishing the reliability and validity of instruments used in the study and determining the appropriate sample size for the proposed data collection and analysis strategies. When faced with a clinical problem, your first step is to consider the type of project that would be appropriate to find a solution. To determine whether it is a research or quality improvement project, ask yourself the following questions. Will this project generate new knowledge? Will this project evaluate an existing practice? How will the results of the project be used? Who will see the results? Is review by the IRB necessary? To answer these questions 117 AORN JOURNAL
accurately, consider the following guidelines (Table 1) and examples. They should assist you as you think through the clinical problem. CLARIFY PROJECT'S PURPOSE First, determine the exact problem or issue and then clarify the purpose of the project. Keep in mind that some clinical issues and questions are simply not amenable to research. For example, perhaps several ambulatory surgical patients and their family members have complained recently about the admission process. They tell you it takes too long and they have to go to too many different places in the hospital to be admitted. With your staff members, you decide to implement a project designed to look systematically at the admission process to find ways to streamline and simplify it. Clearly, this is an internal issue and a process question that lends itself to a quality improvement project. As the admission process generally involves a variety of people engaged in different activities, it would be difficult to design a sound research study to address this problem. Further, given that it is an internal problem, it is likely that new knowledge would not be generated from the results, which further supports that this problem is not a research issue. During the course of the quality improvement project, you become interested in how patients are transported into the OR. Your institution has a policy to wheel
JULY 1998, VOL 68, N O 1
Table 1 patients into the room, but several people ask you why it is done this way. A literature search reveals very little information on this topic, so you begin to develop a study that will look at patient satisfaction and anxiety, comparing wheeling patients into the OR versus letting them walk into the OR. Your goal is to present the results at Congress and publish your findings in the Journal. To implement this project, which is clearly research, you will need to write a proposal that would specifically describe all aspects of the study. This proposal would need to be reviewed by the IRB before beginning the study. This is an example of how the initial quality improvement effort led to a research project. HOW TO USE RESULTS Second, think about the purpose of the project and how you intend to use the results. The primary goal of a quality improvement project is to improve care in a specific clinical situation. Quality improvement projects are appropriate when the need is to examine specific patterns and tsends for groups of patients in a unique setting. The results are used to improve or eliminate problematic processes within that clinical setting. It is not realistic to consider generaIizing the results from a quality improvement project in a rural hospital in northern New England to a large, inner-city hospital in the Southeast. The true purpose of quality improvement is to improve internal processes and not change or correct other clinical units or agencies. It is very important to clarify who will see the results of the project. If the data and results are shared only with those involved in
RESEARCH VERSUS QUALITY IMPROVEMENT
Component
Research
Quality
improvement Examines internal processes and guides actions toward improvement
Generates new knowledge
Scope
Examines internal institution/process-specific issues
May be generalizable to other patients, situations, and seftings
Informed consent
Generally not required
Must be obtained if human subjects are involved
Design
Focuses on processes
Scientific framework
Purpose
Tests hypotheses
Well-controlled Subject selection
Available patients or subpopulationof patients
Based on research purpose, study design, power analysis, and statistical models
Results
Used by the specific
Presented and available to others
institutionlorganization the clinical process, it meets one of the criteria for quality improvement. If the results are going to be shared with others outside of the facility, however, then you should consult with your IRB about the need for review. Even if the results are only going to be used internally but individual patients could possibly be identified from the data collected, then consultation with the IRB might be a prudent course of action. Protection of the rights of patients, whether they are subjects in a research study or a source of data in a quality improvement project, must always be in the forefront of your thoughts. Consider the following fictitious example. Suppose you are involved in an ongoing quality 118 AORN JOURNAL
improvement project regarding the development of pressure ulcers in the OR. In addition, you are taking a nursing course that requires you to complete a clinical project that is scientific in nature. You consult with the course professor, who agrees that you can submit the results of the quality improvement project as your course project. The professor reads the paper and is now informed about the decubitus ulcer rate in the ORs at your institution. In addition to the written paper, you give an oral presentation to your class in which you discuss your summary data. You mention that the project began when a 74year-old diabetic female developed a Stage JII decubitus ulcer after 12 hours of surgery. The members of
JULY 1998, VOL 68, NO I
your class who are members of your community are now informed about the types and numbers of patients who have skin breakdown at your institution. In fact, one member of your class works for the local newspaper and publishes an article based on your presentation and includes your data. The next morning, the patient reads the paper and recognizes herself from the data presented in the paper. The information was published without her permission. So, very quickly, what was intended as an internal process to examine a problem is now public information. This is a worst case scenario, but you must always consider who will have access to the information and whether confidential patient information could become public. Any information that leaves the hospital must pass the confidentiality test, or what is sometimes called the “front page” test. Addressing the issues of anonymity and confidentiality before embarking on any project is crucial to protecting the rights of human subjects. You should also be familiar with your organization’s guidelines for confidentiality and adhere to them before you release any patient-related information. How could this situation have
been modified to prevent the unfortunate, worst case outcome? Instead of adopting the entire quality improvement project as your class project, it might be possible to select one component and pursue that. For example, you might decide to focus specifically on identifying those factors that contributed to skin breakdown in the OR. From there, you could complete a literature review and develop a proposal. addressing the methods you would use to implement your study. Although the data that you collect might be similar to that collected in the quality improvement initiative, there are important differences in other aspects of the project. Knowing that the information will be shared more broadly, you consult with the IRB about the project. The chair of the IRB helps you develop an informed consent, and the project is reviewed by the committee. You talk with each person from whom you hope to collect data and ask him or her to participate in the study. Each person would thus be fully informed about the study, would know how the results would be used and disseminated, and would know how confidentiality and anonymity would be
NOTE 1. L H Nicoll, S C Beyea. “The ethical conduct of
maintained. Mast importantly, every potential subject would have the right not to enroll in the study, to withdraw at any time, and to ask questions at any time. This process protects the individuals in the study and you as the researcher. This is important if you decide to present the information at a conference or to publish an article when the project is complete.
CONCLUSION Both research and quality improvement topics emerge from clinical issues or internal problems related to care processes. To determine whether a project is research or quality improvement, ask yourself the questions posed earlier. If you have trouble answering any of them, seek consultation. As nurses, it is essential that we protect our patients’ rights in every aspect of our work. Both research and quality improvement can do much to improve the care we provide, but it should not be at the expense of those we care for. SUZANNE C. BEYEA RN, CS, PHD LESLIE H. NICOLL RN, MBA, PHD CODIRECTORS, PERIOPERATIVE NURSING RESEARCH
research,” (Research Comer)AORN Journal 67 (June 1998) 1237-1243.
119 AORN JOURNAL
Is it research or quality improvement?
w
hen faced with a problem, it is not uncommon to think of research as the method to find an answer. Not all problems, however, are amenable to research. This is particularly true in clinical practice. Although there are many clinical practice problems that do lend themselves to research, there are just as many that do not. In fact, many patient care issues are better addressed through continuous quality improvement efforts. Research and quality improvement have many similarities, but they vary in purpose and process. It is important to make the distinction between research and quality improvement before you embark on a project. Doing so will avoid complications and ensure success. Continuous quality improvement activities are developed and implemented to study clinical processes and outcomes. Generally, the activities are either concurrent (ie, at the same time) or retrospective (ie, looking to the past) to the problem being studied. In a quality improvement model, personnel in a clinical setting identify a clinical problem or issue and then use specific indicators to evaluate the clinical practice. Performance is measured using predetermined clinical indicators. When the indicators are identified and defined, clinical data are collected and analyzed. The analysis and synthesis of the data should provide clinicians with the necessary information to develop and implement an action plan specifi-
cally designed to correct the identified problem or improve the clinical process. Continuous quality improvement is thus the process by which ongoing monitoring and resultant change occurs. Research, on the other hand, is a process that generates new scientific knowledge. Research investigations are designed and implemented to answer a question or test a hypothesis. A formal proposal that outlines the scientific protocol is a necessary element of any research project. If human subjects are involved in the research, some form of review by the institutional review board (IRB) will be necessary.' Each step of the research process must adhere to strict, scientific standards, such as establishing the reliability and validity of instruments used in the study and determining the appropriate sample size for the proposed data collection and analysis strategies. When faced with a clinical problem, your first step is to consider the type of project that would be appropriate to find a solution. To determine whether it is a research or quality improvement project, ask yourself the following questions. Will this project generate new knowledge? Will this project evaluate an existing practice? How will the results of the project be used? Who will see the results? Is review by the IRB necessary? To answer these questions 117 AORN JOURNAL
accurately, consider the following guidelines (Table 1) and examples. They should assist you as you think through the clinical problem. CLARIFY PROJECT'S PURPOSE First, determine the exact problem or issue and then clarify the purpose of the project. Keep in mind that some clinical issues and questions are simply not amenable to research. For example, perhaps several ambulatory surgical patients and their family members have complained recently about the admission process. They tell you it takes too long and they have to go to too many different places in the hospital to be admitted. With your staff members, you decide to implement a project designed to look systematically at the admission process to find ways to streamline and simplify it. Clearly, this is an internal issue and a process question that lends itself to a quality improvement project. As the admission process generally involves a variety of people engaged in different activities, it would be difficult to design a sound research study to address this problem. Further, given that it is an internal problem, it is likely that new knowledge would not be generated from the results, which further supports that this problem is not a research issue. During the course of the quality improvement project, you become interested in how patients are transported into the OR. Your institution has a policy to wheel
JULY 1998, VOL 68, N O 1
Table 1 patients into the room, but several people ask you why it is done this way. A literature search reveals very little information on this topic, so you begin to develop a study that will look at patient satisfaction and anxiety, comparing wheeling patients into the OR versus letting them walk into the OR. Your goal is to present the results at Congress and publish your findings in the Journal. To implement this project, which is clearly research, you will need to write a proposal that would specifically describe all aspects of the study. This proposal would need to be reviewed by the IRB before beginning the study. This is an example of how the initial quality improvement effort led to a research project. HOW TO USE RESULTS Second, think about the purpose of the project and how you intend to use the results. The primary goal of a quality improvement project is to improve care in a specific clinical situation. Quality improvement projects are appropriate when the need is to examine specific patterns and tsends for groups of patients in a unique setting. The results are used to improve or eliminate problematic processes within that clinical setting. It is not realistic to consider generaIizing the results from a quality improvement project in a rural hospital in northern New England to a large, inner-city hospital in the Southeast. The true purpose of quality improvement is to improve internal processes and not change or correct other clinical units or agencies. It is very important to clarify who will see the results of the project. If the data and results are shared only with those involved in
RESEARCH VERSUS QUALITY IMPROVEMENT
Component
Research
Quality
improvement Examines internal processes and guides actions toward improvement
Generates new knowledge
Scope
Examines internal institution/process-specific issues
May be generalizable to other patients, situations, and seftings
Informed consent
Generally not required
Must be obtained if human subjects are involved
Design
Focuses on processes
Scientific framework
Purpose
Tests hypotheses
Well-controlled Subject selection
Available patients or subpopulationof patients
Based on research purpose, study design, power analysis, and statistical models
Results
Used by the specific
Presented and available to others
institutionlorganization the clinical process, it meets one of the criteria for quality improvement. If the results are going to be shared with others outside of the facility, however, then you should consult with your IRB about the need for review. Even if the results are only going to be used internally but individual patients could possibly be identified from the data collected, then consultation with the IRB might be a prudent course of action. Protection of the rights of patients, whether they are subjects in a research study or a source of data in a quality improvement project, must always be in the forefront of your thoughts. Consider the following fictitious example. Suppose you are involved in an ongoing quality 118 AORN JOURNAL
improvement project regarding the development of pressure ulcers in the OR. In addition, you are taking a nursing course that requires you to complete a clinical project that is scientific in nature. You consult with the course professor, who agrees that you can submit the results of the quality improvement project as your course project. The professor reads the paper and is now informed about the decubitus ulcer rate in the ORs at your institution. In addition to the written paper, you give an oral presentation to your class in which you discuss your summary data. You mention that the project began when a 74year-old diabetic female developed a Stage JII decubitus ulcer after 12 hours of surgery. The members of
JULY 1998, VOL 68, NO I
your class who are members of your community are now informed about the types and numbers of patients who have skin breakdown at your institution. In fact, one member of your class works for the local newspaper and publishes an article based on your presentation and includes your data. The next morning, the patient reads the paper and recognizes herself from the data presented in the paper. The information was published without her permission. So, very quickly, what was intended as an internal process to examine a problem is now public information. This is a worst case scenario, but you must always consider who will have access to the information and whether confidential patient information could become public. Any information that leaves the hospital must pass the confidentiality test, or what is sometimes called the “front page” test. Addressing the issues of anonymity and confidentiality before embarking on any project is crucial to protecting the rights of human subjects. You should also be familiar with your organization’s guidelines for confidentiality and adhere to them before you release any patient-related information. How could this situation have
been modified to prevent the unfortunate, worst case outcome? Instead of adopting the entire quality improvement project as your class project, it might be possible to select one component and pursue that. For example, you might decide to focus specifically on identifying those factors that contributed to skin breakdown in the OR. From there, you could complete a literature review and develop a proposal. addressing the methods you would use to implement your study. Although the data that you collect might be similar to that collected in the quality improvement initiative, there are important differences in other aspects of the project. Knowing that the information will be shared more broadly, you consult with the IRB about the project. The chair of the IRB helps you develop an informed consent, and the project is reviewed by the committee. You talk with each person from whom you hope to collect data and ask him or her to participate in the study. Each person would thus be fully informed about the study, would know how the results would be used and disseminated, and would know how confidentiality and anonymity would be
NOTE 1. L H Nicoll, S C Beyea. “The ethical conduct of
maintained. Mast importantly, every potential subject would have the right not to enroll in the study, to withdraw at any time, and to ask questions at any time. This process protects the individuals in the study and you as the researcher. This is important if you decide to present the information at a conference or to publish an article when the project is complete.
CONCLUSION Both research and quality improvement topics emerge from clinical issues or internal problems related to care processes. To determine whether a project is research or quality improvement, ask yourself the questions posed earlier. If you have trouble answering any of them, seek consultation. As nurses, it is essential that we protect our patients’ rights in every aspect of our work. Both research and quality improvement can do much to improve the care we provide, but it should not be at the expense of those we care for. SUZANNE C. BEYEA RN, CS, PHD LESLIE H. NICOLL RN, MBA, PHD CODIRECTORS, PERIOPERATIVE NURSING RESEARCH
research,” (Research Comer)AORN Journal 67 (June 1998) 1237-1243.
119 AORN JOURNAL