SPECIAL COMMENTARY
Clinically Driven Health Services Research Angelo Sinopoli, MD,* Rebecca Russ-Sellers, PhD,* and Ronnie D. Horner, PhDw
There has been much hoopla of late regarding the need to conduct health services research in the “real-world” setting of medical practice. However, most—perhaps, all— of the conversation has been among health services researchers themselves; the voices of medical practitioners and health system leadership are seemingly absent from the discussion. The thrust of the conversations has largely been focused on the methods used to conduct the research. It is taken as a given that health services research if conducted in actual medical practices or health systems will have relevance and impact, that is, the findings will yield near-term changes in health care practice or policy. However, if we take the practitioners’ perspective, the fundamental issue that should be at the center of the discussion is the relevance of the research questions and not the research methods themselves. Interventions derived from studies that address research questions not founded in the realities of medical practice more often than not lack relevance or practicality (ie, the proposed “solutions” are too complex, too costly, or both). If health services researchers want to have a meaningful impact on health care practice and policy, their research needs to be clinically driven and intentional in the effort to achieve 2 primary endpoints: addressing clinical problems and improving patient outcomes.
CLINICALLY DERIVED QUESTIONS In our experience, much of the health services research being conducted today involves research questions that are not derived from the immediate problems in the delivery of care as identified by the practitioner, health system leadership, or the patient. The research projects being brought to practicing clinicians to be conducted in their clinics are typically investigator-initiated where the investigator is from academe and may or may not have full understanding of the intricacies involved in providing care in the current health care environment. Even when they are experienced providers, they usually are not seeing patients all day, every day; having one or two half-day clinics a week in an academically based practice is not the same as providing care for patients as your living. From where do the investigators’ ideas for a research project come? We would say that by and large, the research questions come from academe. In response to the protest sure to arise from health services researchers, we note that such researchers typically survey the literature to find gaps in knowledge and then design studies to address those gaps, hopefully receiving external funding to do the proposed project. Who writes the scientific health care literature? In most cases, it is not the practicing health care provider. It is the thought-leaders from health research organizations and academicians from academic health centers. In contradistinction, clinically driven research focuses on issues that arise from the patient-provider interaction in the day-to-day clinical setting. Those issues may be best identified by asking the provider, patient, and the clinic manager about From the *Care Coordination Institute, Greenville Health System, Greenville; and wDepartment of Health Services Policy and Management, Arnold School of Public Health, University of South Carolina, Columbia, SC. All authors have been involved in the concept, drafting, and editing of this commentary. Also, all have read and approved this version of the commentary. The authors declare no conflict of interest. Reprints: Ronnie D. Horner, PhD, Department of Health Services Policy and Management, Arnold School of Public Health, University of South Carolina, HESC Building, 800 Sumter Street, Columbia, SC 29208. E-mail: [email protected]. Copyright r 2013 by Lippincott Williams & Wilkins ISSN: 0025-7079/14/5203-0183
Medical Care
Volume 52, Number 3, March 2014
www.lww-medicalcare.com |
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Commentary
the problems that they are experiencing in the delivery of care. This is not to say that investigator-initiated research questions are always without merit. Rather, it is to say that such questions need to be vetted by those actually providing care (or receiving care) to ensure relevance. With the current emphasis on patient-centered outcomes and rapid dissemination of promising, actionable research findings, the engagement of providers and patients at the front-end of the research endeavor is a necessary shift to clinically proactive investigations.
SIMPLICITY OVER COMPLEXITY The design of the research project and the interpretation of the results require the consideration of those who will be impacted. Can the project be carried out within the clinic setting without disrupting the business of providing health care? Further, can the project be carried out so as not to modify the very care patterns it is studying? This requires a fundamental understanding—based on experience—of the clinical setting. Ideally, this is first-hand knowledge by the investigator as a result of observing clinical practice but, at a minimum, it could be obtained from discussion with providers or others who are in the clinic daily. Study approaches that are mindful of the challenges of health care work-flow processes are more likely to be conducted successfully because they are less disruptive of the practice and, being less disruptive, are more likely to capture the true dynamics of medical practice. Such sensitivity to the real-world context of medical practice may have an added benefit, that is, the development and validation of novel approaches to collect and analyze data that match closely with the realities of the clinical setting. Thus, the preferred study is designed to minimize the impact on the provider in providing care to the patient and on the patient who is there to receive care. Some research projects are designed to test an intervention, whereas others are designed to generate information as to an intervention (and the point at which that intervention might be applied). In either case, the insights of the provider are essential to understanding whether the intervention (tested or suggested) is feasible to implement in the clinical setting. As every clinician knows, there is the element of intensity and stress to the practice of medicine. Intensity is the essence of clinical work, involving the provider exerting physical and mental effort, clinical judgment, and technical skill in providing care to a patient; there is also stress associated with doing so. In the demanding environment of
184 | www.lww-medicalcare.com
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Volume 52, Number 3, March 2014
clinical practice, preference is given to changes that are more simplistic than complex. These are changes that can be incorporated into the routine of clinical practice without considerable mental and physical effort on the part of the provider to make the changes.
PRAGMATISM OVER IDEALISM The health care provider needs practical solutions to the issues faced daily. Cost is a major aspect of “practicality” in providing health care. Arguing for a particular intervention because it has a high return-on-investment to society does not make a compelling case to the provider who is in the business of health care. Interventions that negatively affect the provider’s bottom line cannot be sustained. Moreover, interventions must be compatible with the financial and regulatory framework of providing care. If health care delivery innovations, no matter how worthy, cannot be integrated within the framework of current national and state health care policies, including reporting and reimbursement rules and regulations, then they cannot make a sustainable impact on patient outcomes because they are not sustainable themselves. Provider-informed research can improve the integration of promising innovations by ensuring the innovations acknowledge and accommodate the matrix of elements comprising the existing local, state, and national health care environment.
CONCLUDING THOUGHTS It has been said that for a difference to be a difference it must make a difference. If health services researchers wish to make a positive difference in the delivery of health care and do so in the near-term, there needs to be a willingness to do research differently. Although conversations regarding the preferred methods for obtaining the most scientifically rigorous evidence to guide change are important, conversations regarding the research questions to be addressed are fundamental to making a change that is feasible and sustainable. Beyond the conversations about what to study and how to do so, the conversations on the choice and design of interventions also need to be driven by those who will make the changes and experience the consequences. The health care provider is a valuable partner to ensuring that the studies conducted have relevance and practicality and, in the end, will make a difference to the patients we serve.
r
2013 Lippincott Williams & Wilkins
Clinically Driven Health Services Research Angelo Sinopoli, MD,* Rebecca Russ-Sellers, PhD,* and Ronnie D. Horner, PhDw
There has been much hoopla of late regarding the need to conduct health services research in the “real-world” setting of medical practice. However, most—perhaps, all— of the conversation has been among health services researchers themselves; the voices of medical practitioners and health system leadership are seemingly absent from the discussion. The thrust of the conversations has largely been focused on the methods used to conduct the research. It is taken as a given that health services research if conducted in actual medical practices or health systems will have relevance and impact, that is, the findings will yield near-term changes in health care practice or policy. However, if we take the practitioners’ perspective, the fundamental issue that should be at the center of the discussion is the relevance of the research questions and not the research methods themselves. Interventions derived from studies that address research questions not founded in the realities of medical practice more often than not lack relevance or practicality (ie, the proposed “solutions” are too complex, too costly, or both). If health services researchers want to have a meaningful impact on health care practice and policy, their research needs to be clinically driven and intentional in the effort to achieve 2 primary endpoints: addressing clinical problems and improving patient outcomes.
CLINICALLY DERIVED QUESTIONS In our experience, much of the health services research being conducted today involves research questions that are not derived from the immediate problems in the delivery of care as identified by the practitioner, health system leadership, or the patient. The research projects being brought to practicing clinicians to be conducted in their clinics are typically investigator-initiated where the investigator is from academe and may or may not have full understanding of the intricacies involved in providing care in the current health care environment. Even when they are experienced providers, they usually are not seeing patients all day, every day; having one or two half-day clinics a week in an academically based practice is not the same as providing care for patients as your living. From where do the investigators’ ideas for a research project come? We would say that by and large, the research questions come from academe. In response to the protest sure to arise from health services researchers, we note that such researchers typically survey the literature to find gaps in knowledge and then design studies to address those gaps, hopefully receiving external funding to do the proposed project. Who writes the scientific health care literature? In most cases, it is not the practicing health care provider. It is the thought-leaders from health research organizations and academicians from academic health centers. In contradistinction, clinically driven research focuses on issues that arise from the patient-provider interaction in the day-to-day clinical setting. Those issues may be best identified by asking the provider, patient, and the clinic manager about From the *Care Coordination Institute, Greenville Health System, Greenville; and wDepartment of Health Services Policy and Management, Arnold School of Public Health, University of South Carolina, Columbia, SC. All authors have been involved in the concept, drafting, and editing of this commentary. Also, all have read and approved this version of the commentary. The authors declare no conflict of interest. Reprints: Ronnie D. Horner, PhD, Department of Health Services Policy and Management, Arnold School of Public Health, University of South Carolina, HESC Building, 800 Sumter Street, Columbia, SC 29208. E-mail: [email protected]. Copyright r 2013 by Lippincott Williams & Wilkins ISSN: 0025-7079/14/5203-0183
Medical Care
Volume 52, Number 3, March 2014
www.lww-medicalcare.com |
183
Commentary
the problems that they are experiencing in the delivery of care. This is not to say that investigator-initiated research questions are always without merit. Rather, it is to say that such questions need to be vetted by those actually providing care (or receiving care) to ensure relevance. With the current emphasis on patient-centered outcomes and rapid dissemination of promising, actionable research findings, the engagement of providers and patients at the front-end of the research endeavor is a necessary shift to clinically proactive investigations.
SIMPLICITY OVER COMPLEXITY The design of the research project and the interpretation of the results require the consideration of those who will be impacted. Can the project be carried out within the clinic setting without disrupting the business of providing health care? Further, can the project be carried out so as not to modify the very care patterns it is studying? This requires a fundamental understanding—based on experience—of the clinical setting. Ideally, this is first-hand knowledge by the investigator as a result of observing clinical practice but, at a minimum, it could be obtained from discussion with providers or others who are in the clinic daily. Study approaches that are mindful of the challenges of health care work-flow processes are more likely to be conducted successfully because they are less disruptive of the practice and, being less disruptive, are more likely to capture the true dynamics of medical practice. Such sensitivity to the real-world context of medical practice may have an added benefit, that is, the development and validation of novel approaches to collect and analyze data that match closely with the realities of the clinical setting. Thus, the preferred study is designed to minimize the impact on the provider in providing care to the patient and on the patient who is there to receive care. Some research projects are designed to test an intervention, whereas others are designed to generate information as to an intervention (and the point at which that intervention might be applied). In either case, the insights of the provider are essential to understanding whether the intervention (tested or suggested) is feasible to implement in the clinical setting. As every clinician knows, there is the element of intensity and stress to the practice of medicine. Intensity is the essence of clinical work, involving the provider exerting physical and mental effort, clinical judgment, and technical skill in providing care to a patient; there is also stress associated with doing so. In the demanding environment of
184 | www.lww-medicalcare.com
Medical Care
Volume 52, Number 3, March 2014
clinical practice, preference is given to changes that are more simplistic than complex. These are changes that can be incorporated into the routine of clinical practice without considerable mental and physical effort on the part of the provider to make the changes.
PRAGMATISM OVER IDEALISM The health care provider needs practical solutions to the issues faced daily. Cost is a major aspect of “practicality” in providing health care. Arguing for a particular intervention because it has a high return-on-investment to society does not make a compelling case to the provider who is in the business of health care. Interventions that negatively affect the provider’s bottom line cannot be sustained. Moreover, interventions must be compatible with the financial and regulatory framework of providing care. If health care delivery innovations, no matter how worthy, cannot be integrated within the framework of current national and state health care policies, including reporting and reimbursement rules and regulations, then they cannot make a sustainable impact on patient outcomes because they are not sustainable themselves. Provider-informed research can improve the integration of promising innovations by ensuring the innovations acknowledge and accommodate the matrix of elements comprising the existing local, state, and national health care environment.
CONCLUDING THOUGHTS It has been said that for a difference to be a difference it must make a difference. If health services researchers wish to make a positive difference in the delivery of health care and do so in the near-term, there needs to be a willingness to do research differently. Although conversations regarding the preferred methods for obtaining the most scientifically rigorous evidence to guide change are important, conversations regarding the research questions to be addressed are fundamental to making a change that is feasible and sustainable. Beyond the conversations about what to study and how to do so, the conversations on the choice and design of interventions also need to be driven by those who will make the changes and experience the consequences. The health care provider is a valuable partner to ensuring that the studies conducted have relevance and practicality and, in the end, will make a difference to the patients we serve.
r
2013 Lippincott Williams & Wilkins
