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Maintaining Ethics in Quality Improvement
GUEST EDITORIAL
Maintaining Ethics in Quality Improvement RODNEY W. HICKS, PhD, RN, FNP-BC, FAAN, FAANP
I
mprovement science is a contemporary term that spans many activities undertaken to improve health care, such as quality improvement (QI), research, and engagement in evidence-based practice (EBP). The overall framework for improvement science allows clinicians, researchers, educators, and administrators to come together to identify a problem, develop solutions based on best evidence, and then evaluate the outcomes. A QI activity is a “systematic, data-guided activity designed to bring about immediate improvements in a local setting.”1(p669) Quality improvement efforts are not foreign to clinicians, given that clinicians are the ones most closely associated with the identified problem. Dissemination of the effectiveness of the QI activities and solutions to problems is an important contribution to patient care. As practitioners, perioperative nurses should be able to understand the commonalities and differences, as well as the ethical nature of human participation, within each of the improvement science categories (ie, QI, research, EBP). Quality improvement seeks to improve care, research seeks to generate new knowledge, and EBP allows clinicians to have the best available evidence at the point of care. Quality improvement projects, and the subsequent reporting of project effectiveness, must follow established ethical guidelines pertaining to the protection of human participants. The process of submitting QI manuscripts to the AORN Journal requires authors to affirm adherence to the ethical standards of human participant protection when applicable. Without formal author acknowledgement of human participant protection, manuscript reviewers and journal editors are left to second-guess whether such protection was afforded. One common theme recently observed in submitted manuscripts suggests that some authors may not be fully aware of the ethical nature of human participant
protection surrounding QI projects. Interpretation of the ethical guidelines that direct participant protection in QI projects is somewhat blurred2 and can result in confusion.
WHY HUMAN PARTICIPATION GUIDELINES MAY SEEM UNCLEAR Historically, QI activities were conducted at the local level, whether at the unit level, institutional level, or facility level. Quality improvement processes have been undertaken for decades, and nearly every health care organization has some mechanism in place to advance practice. Advancing practice, as opposed to generating knowledge, is clearly a QI activity.3 Quality improvement activities were often shielded by various health care laws as the findings were generally used to improve efficiency and effectiveness in individual settings. The findings of the QI activities carried legal protection. Moreover, given the retrospective nature of QI initiatives, practitioners rarely sought review of the process, and little attention was given to human participant protection beyond ensuring the confidentiality of those patient records from which data were being used, a step necessary to avoid Health Insurance Portability and Accountability Act (HIPAA) concerns. The maturation of QI has resulted in overlapping similarities with research that can lead to confusion. Today, it is common to borrow some of the language, tools, and analytical techniques from research and apply them to QI. For example, the QI process has a purpose, a scope, an established method of data acquisition, and reporting of results. What has also changed in some instances is the sophistication of obtaining data, the breadth and depth of electronic medical records,2 a greater breadth of tools and analytical techniques,2,4 and the drive to share findings external to the organization. This
http://dx.doi.org/10.1016/j.aorn.2015.12.014 ª AORN, Inc, 2016
www.aornjournal.org
AORN Journal j 139
Hicks
external sharing may lead to the perception that findings are generalizable when the findings have a local effect only. Furthermore, QI is no longer merely retrospective in nature; prospective interventions are among the advancements in the field.2 These changes position QI activities to look more like research. In some cases, a project may be considered a meaningful QI project but in actuality may be a scaled-back research project. These advancements and issues raise the question: What is appropriate oversight of QI in terms of human protection? Institutional review boards (IRBs) are in place for researchers. Researchers’ proposals have a theoretical approach, a purpose, a scope, documentation of human participant protection, sound methods (in terms of sample, intervention, instrumentation, data analysis techniques, and results), and a dissemination plan3 indicating that results could be generalizable.5 Institutional review boards review proposals to ensure that the design and methods are appropriate, people are afforded the opportunity to participate with full understanding (or to withdraw without retribution), participants’ autonomy is protected, and the investigator does everything possible to minimize risk to all involved.2 One tenet of research is the understanding that the knowledge (ie, benefit) gained from the study outweighs the risk.3 Institutional review boards provide the authoritative determination of human participant protection; they traditionally have not reviewed QI proposals, projects, or results.1 Today, some IRBs struggle to recognize the different boundaries between QI and research.1
ETHICAL CONSIDERATIONS FOR HUMAN PARTICIPANT PROTECTION IN QI Data collected from patient care records in QI efforts does represent human participation. Data collection activities may mask the identity of the patient and only report summary information to avoid HIPAA concerns and ensure the confidentiality of those whose data are being used. One ethical consideration that should occur pertains to consent. Patients routinely seek treatment and consent to that treatment; however, patients may not be aware that the medical information shared during their visit is incorporated into QI activities. Organizations should be able to document that patients are informed that such information is gathered, and consent-totreat forms should reflect such.1 Including patients in the QI process is a logical progression. Patient education materials that discuss patients’ rights should be widely available.1 Organizations should have a collaborative process in place for open dialogue with their IRBs. The opportunity for individuals 140 j AORN Journal
February 2016, Vol. 103, No. 2
working with QI activities to consult with an experienced standing committee should result in tangible guidelines that direct when IRB review is warranted,2 and this discussion should take place before initiation of the QI project. This process follows the recommendations by the Hastings Center in Garrison, New York, in that health professionals should be continually educated about the standards of ethical conduct for QI and research.1 Members of the IRB are in a position to help educate others about the need for participant protection and can offer formal and informal consultations about a QI project. Individuals working on QI projects in isolation should avoid making the determination of the need for a review. Rather, consultation with the IRB should be commonplace in the absence of policies. An additional review affords one more opportunity to address all ethical principles. Furthermore, the process allows the recognition of circumstances where a QI project may qualify as a research project.6 A number of authors4,5,7 have discussed the commonalities and differences between research and QI. Discussions like these signal the need for checklists or worksheets that offer guidance to practitioners. Collaborative teams that develop checklists might consider philosophical underpinning, purpose of the project, a determination of who benefits, funding sources, the intent of generating new knowledge (research) versus reviewing and applying existing evidence (QI), the element of risk, the target audience,3 where data will originate, and the intervention3,5,8 as starting points. Administrators, practitioners, legal counsel, IRB members, and others should review such checklists.6 These checklists should be prospectively available because an initial review process can reinforce the ethical considerations surrounding the project. Some facilities may not have IRBs in place. In these instances, a number of options are available. For example, a facility may elect to contract with a community-based IRB, the IRB of a facility in proximity, or a university or college. Some facilities, especially those that have robust research, QI, and EBP teams, may have policies and checklists in place that differentiate the three aspects of improvement science. However, the literature is fairly minimal in regard to the widespread sharing and dissemination of such checklists. There is a need to share these tools in the clinical literature to help support all clinicians. A checklist may assist the perioperative nurse in making a determination if the project is QI, EBP, or research.
CONCLUSION The protection of human participants’ rights transcends all aspects of information science, including QI. Positioning QI into the IRB-based research structure may not be the most
www.aornjournal.org
February 2016, Vol. 103, No. 2
effective approach. Rather, there is a need to develop pragmatic rules to address the issue. Such rules help not only clinicians, authors, and editors but ultimately help position valuable QI findings in the right context for inclusion in evidence appraisals; eventually, patients and health care systems should benefit from the findings. Perioperative nurses should be encouraged to participate in any aspect of information science, and nurses should be leaders in understanding and implementing the processes. Now is an exciting time for perioperative nurses to continue the momentum, because regardless of educational preparation and current role, all nurses have a professional responsibility to improve health care.
References 1. Lynn J, Baily MA, Bottrell M, et al. The ethics of using quality improvement methods in health care. Ann Intern Med. 2007; 146(9):666-673. 2. Bellin E, Dubler NN. The quality improvement-research divide and the need for external oversight. Am J Public Health. 2001;91(9): 1512-1517. 3. Reinhardt AC, Ray LN. Differentiating quality improvement from research. Appl Nurs Res. 2003;16(1):2-8.
www.aornjournal.org
Maintaining Ethics in Quality Improvement 4. Newhouse RP, Pettit JC, Poe S, Rocco L. The slippery slope: differentiating between quality improvement and research. J Nurs Adm. 2006;36(4):211-219. 5. Newhouse RP. Diffusing confusion among evidence-based practice, quality improvement, and research. J Nurs Adm. 2007;37(10):432-435. 6. Nosowsky R. Quality improvement or research? Implications of OHRP’s response to the Keystone: ICU project. Teaching Hospitals & Academic Medical Centers. 2008;6(1):5-8. http://ora.research .ucla.edu/OHRPP/documents/policy/3/P3Nosowsky-QI_v_Research .pdf. Accessed December 2, 2015. 7. Shirey MR, Hauck SL, Embree JL, et al. Showcasing differences between quality improvement, evidence-based practice, and research. J Contin Educ Nurs. 2011;42(5):57-68, quiz 69-70. 8. Kring DL. Research and quality improvement: different processes, different evidence. Medsurg Nurs. 2008;17(3):162-169, quiz 170.
Rodney W. Hicks, PhD, RN, FNP-BC, FAAN, FAANP, is an AORN Journal editorial board member and a professor in the Doctor of Nursing Practice Program at Western University of Health Sciences, Pomona, CA. Dr Hicks has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
AORN Journal j 141
Maintaining Ethics in Quality Improvement RODNEY W. HICKS, PhD, RN, FNP-BC, FAAN, FAANP
I
mprovement science is a contemporary term that spans many activities undertaken to improve health care, such as quality improvement (QI), research, and engagement in evidence-based practice (EBP). The overall framework for improvement science allows clinicians, researchers, educators, and administrators to come together to identify a problem, develop solutions based on best evidence, and then evaluate the outcomes. A QI activity is a “systematic, data-guided activity designed to bring about immediate improvements in a local setting.”1(p669) Quality improvement efforts are not foreign to clinicians, given that clinicians are the ones most closely associated with the identified problem. Dissemination of the effectiveness of the QI activities and solutions to problems is an important contribution to patient care. As practitioners, perioperative nurses should be able to understand the commonalities and differences, as well as the ethical nature of human participation, within each of the improvement science categories (ie, QI, research, EBP). Quality improvement seeks to improve care, research seeks to generate new knowledge, and EBP allows clinicians to have the best available evidence at the point of care. Quality improvement projects, and the subsequent reporting of project effectiveness, must follow established ethical guidelines pertaining to the protection of human participants. The process of submitting QI manuscripts to the AORN Journal requires authors to affirm adherence to the ethical standards of human participant protection when applicable. Without formal author acknowledgement of human participant protection, manuscript reviewers and journal editors are left to second-guess whether such protection was afforded. One common theme recently observed in submitted manuscripts suggests that some authors may not be fully aware of the ethical nature of human participant
protection surrounding QI projects. Interpretation of the ethical guidelines that direct participant protection in QI projects is somewhat blurred2 and can result in confusion.
WHY HUMAN PARTICIPATION GUIDELINES MAY SEEM UNCLEAR Historically, QI activities were conducted at the local level, whether at the unit level, institutional level, or facility level. Quality improvement processes have been undertaken for decades, and nearly every health care organization has some mechanism in place to advance practice. Advancing practice, as opposed to generating knowledge, is clearly a QI activity.3 Quality improvement activities were often shielded by various health care laws as the findings were generally used to improve efficiency and effectiveness in individual settings. The findings of the QI activities carried legal protection. Moreover, given the retrospective nature of QI initiatives, practitioners rarely sought review of the process, and little attention was given to human participant protection beyond ensuring the confidentiality of those patient records from which data were being used, a step necessary to avoid Health Insurance Portability and Accountability Act (HIPAA) concerns. The maturation of QI has resulted in overlapping similarities with research that can lead to confusion. Today, it is common to borrow some of the language, tools, and analytical techniques from research and apply them to QI. For example, the QI process has a purpose, a scope, an established method of data acquisition, and reporting of results. What has also changed in some instances is the sophistication of obtaining data, the breadth and depth of electronic medical records,2 a greater breadth of tools and analytical techniques,2,4 and the drive to share findings external to the organization. This
http://dx.doi.org/10.1016/j.aorn.2015.12.014 ª AORN, Inc, 2016
www.aornjournal.org
AORN Journal j 139
Hicks
external sharing may lead to the perception that findings are generalizable when the findings have a local effect only. Furthermore, QI is no longer merely retrospective in nature; prospective interventions are among the advancements in the field.2 These changes position QI activities to look more like research. In some cases, a project may be considered a meaningful QI project but in actuality may be a scaled-back research project. These advancements and issues raise the question: What is appropriate oversight of QI in terms of human protection? Institutional review boards (IRBs) are in place for researchers. Researchers’ proposals have a theoretical approach, a purpose, a scope, documentation of human participant protection, sound methods (in terms of sample, intervention, instrumentation, data analysis techniques, and results), and a dissemination plan3 indicating that results could be generalizable.5 Institutional review boards review proposals to ensure that the design and methods are appropriate, people are afforded the opportunity to participate with full understanding (or to withdraw without retribution), participants’ autonomy is protected, and the investigator does everything possible to minimize risk to all involved.2 One tenet of research is the understanding that the knowledge (ie, benefit) gained from the study outweighs the risk.3 Institutional review boards provide the authoritative determination of human participant protection; they traditionally have not reviewed QI proposals, projects, or results.1 Today, some IRBs struggle to recognize the different boundaries between QI and research.1
ETHICAL CONSIDERATIONS FOR HUMAN PARTICIPANT PROTECTION IN QI Data collected from patient care records in QI efforts does represent human participation. Data collection activities may mask the identity of the patient and only report summary information to avoid HIPAA concerns and ensure the confidentiality of those whose data are being used. One ethical consideration that should occur pertains to consent. Patients routinely seek treatment and consent to that treatment; however, patients may not be aware that the medical information shared during their visit is incorporated into QI activities. Organizations should be able to document that patients are informed that such information is gathered, and consent-totreat forms should reflect such.1 Including patients in the QI process is a logical progression. Patient education materials that discuss patients’ rights should be widely available.1 Organizations should have a collaborative process in place for open dialogue with their IRBs. The opportunity for individuals 140 j AORN Journal
February 2016, Vol. 103, No. 2
working with QI activities to consult with an experienced standing committee should result in tangible guidelines that direct when IRB review is warranted,2 and this discussion should take place before initiation of the QI project. This process follows the recommendations by the Hastings Center in Garrison, New York, in that health professionals should be continually educated about the standards of ethical conduct for QI and research.1 Members of the IRB are in a position to help educate others about the need for participant protection and can offer formal and informal consultations about a QI project. Individuals working on QI projects in isolation should avoid making the determination of the need for a review. Rather, consultation with the IRB should be commonplace in the absence of policies. An additional review affords one more opportunity to address all ethical principles. Furthermore, the process allows the recognition of circumstances where a QI project may qualify as a research project.6 A number of authors4,5,7 have discussed the commonalities and differences between research and QI. Discussions like these signal the need for checklists or worksheets that offer guidance to practitioners. Collaborative teams that develop checklists might consider philosophical underpinning, purpose of the project, a determination of who benefits, funding sources, the intent of generating new knowledge (research) versus reviewing and applying existing evidence (QI), the element of risk, the target audience,3 where data will originate, and the intervention3,5,8 as starting points. Administrators, practitioners, legal counsel, IRB members, and others should review such checklists.6 These checklists should be prospectively available because an initial review process can reinforce the ethical considerations surrounding the project. Some facilities may not have IRBs in place. In these instances, a number of options are available. For example, a facility may elect to contract with a community-based IRB, the IRB of a facility in proximity, or a university or college. Some facilities, especially those that have robust research, QI, and EBP teams, may have policies and checklists in place that differentiate the three aspects of improvement science. However, the literature is fairly minimal in regard to the widespread sharing and dissemination of such checklists. There is a need to share these tools in the clinical literature to help support all clinicians. A checklist may assist the perioperative nurse in making a determination if the project is QI, EBP, or research.
CONCLUSION The protection of human participants’ rights transcends all aspects of information science, including QI. Positioning QI into the IRB-based research structure may not be the most
www.aornjournal.org
February 2016, Vol. 103, No. 2
effective approach. Rather, there is a need to develop pragmatic rules to address the issue. Such rules help not only clinicians, authors, and editors but ultimately help position valuable QI findings in the right context for inclusion in evidence appraisals; eventually, patients and health care systems should benefit from the findings. Perioperative nurses should be encouraged to participate in any aspect of information science, and nurses should be leaders in understanding and implementing the processes. Now is an exciting time for perioperative nurses to continue the momentum, because regardless of educational preparation and current role, all nurses have a professional responsibility to improve health care.
References 1. Lynn J, Baily MA, Bottrell M, et al. The ethics of using quality improvement methods in health care. Ann Intern Med. 2007; 146(9):666-673. 2. Bellin E, Dubler NN. The quality improvement-research divide and the need for external oversight. Am J Public Health. 2001;91(9): 1512-1517. 3. Reinhardt AC, Ray LN. Differentiating quality improvement from research. Appl Nurs Res. 2003;16(1):2-8.
www.aornjournal.org
Maintaining Ethics in Quality Improvement 4. Newhouse RP, Pettit JC, Poe S, Rocco L. The slippery slope: differentiating between quality improvement and research. J Nurs Adm. 2006;36(4):211-219. 5. Newhouse RP. Diffusing confusion among evidence-based practice, quality improvement, and research. J Nurs Adm. 2007;37(10):432-435. 6. Nosowsky R. Quality improvement or research? Implications of OHRP’s response to the Keystone: ICU project. Teaching Hospitals & Academic Medical Centers. 2008;6(1):5-8. http://ora.research .ucla.edu/OHRPP/documents/policy/3/P3Nosowsky-QI_v_Research .pdf. Accessed December 2, 2015. 7. Shirey MR, Hauck SL, Embree JL, et al. Showcasing differences between quality improvement, evidence-based practice, and research. J Contin Educ Nurs. 2011;42(5):57-68, quiz 69-70. 8. Kring DL. Research and quality improvement: different processes, different evidence. Medsurg Nurs. 2008;17(3):162-169, quiz 170.
Rodney W. Hicks, PhD, RN, FNP-BC, FAAN, FAANP, is an AORN Journal editorial board member and a professor in the Doctor of Nursing Practice Program at Western University of Health Sciences, Pomona, CA. Dr Hicks has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
AORN Journal j 141