Outcomes research and the neuroscience nurse: what's in it for clinical practice?
Outcomes research has been in the forefront of both clinical and public news since the late 1980s, alternately hailed as a panacea for reforming health care delivery and just another passing fad. (10) It may seem somehow important but mysterious and forbidding to both clinicians and to clinical researchers, but it need not be. This research brief is intended to clarify both the scope and limits of outcome research and to convey how it can be meaningful for individual clinical practice.
Outcomes Research: What Is It?
In the final analysis, outcomes research is no different from any other research except that the dependent variables are always specified as some outcome of care. Outcomes research is basically asking the question: how are long-term or intermediate patient outcomes related to an individual or system level intervention? (27) Kane sums up the basic components of the outcomes model in the following formula: (p.7) (17)
* Outcomes = f (baseline, patient clinical characteristics, patient demographic/psychosocial characteristics, treatment, setting)
In other words, the outcomes of a given treatment or care system are a function of the patient's baseline functioning, clinical characteristics, demographic and psychosocial characteristics, in addition to the characteristics of the treatment and the care setting in which it is delivered. This approach contrasts with typical clinical intervention research, in which the experimental design attempts to carefully control or exclude the variation in patient and context characteristics. Research in which the variations in patient characteristics or treatment setting are randomly allocated or otherwise controlled are called efficacy studies--outcome under the best possible conditions. Outcomes research is a form of effectiveness study, in which the effect of the intervention is examined in the context of usual clinical care (p.8). (12) Variations in patient and system characteristics are adjusted or accounted for statistically, by virtue of large samples for comparison.
Clinical research has often been focused on determining the impact of clinical interventions on both physiologic and functional outcomes, but without consideration for the context of those interventions. Relatively recent concern with the variations in common treatment practices (34) as well as spiraling costs of medical and overall health care have stimulated the widespread movement to examine the outcomes of treatment and interventions. (31) Insurance companies and other payers increasingly want to know that treatments are effective in ordinary practice if they are expected to pay for them. Hence, the more narrow perspective on outcomes research has been an attempt to determine the effectiveness of interventions: ie, systematically linking specific interventions to positive or negative outcomes. For example, one approach to linking an intervention to outcomes is to conduct a meta-analysis of many separate studies. The technique of meta-analysis allows one to essentially pool the results of many small studies to estimate an overall effect of the treatment. An example of this approach to outcomes research is a meta-analyses that found no advantage for surgical over conservative treatment of back pain in terms of of symptom relief, complications and costs. (7) In contrast, a meta-analysis of functional outcomes after stroke found a better effect in those patients treated with more intensive rehabilitation, even after accounting for differences in institutional setting and patient characteristics. (18)
More recently, outcomes research has broadened to compare the outcomes of type and quality of care delivered by multiple providers or organizations. Examples of this type of outcomes research would be a comparison of the satisfaction of patients who receive care through managed care groups versus traditional fee-for-service, (32) asthma control of patients cared for by practitioners of differing specialties, (9) functional and physical outcome of stroke patients managed by neurologists versus internists, (20) differing outcomes in stroke patients treated in HMO's versus fee for service, (29) or rehospitalization, costs and infant health promotion in early discharged patients managed by nurse specialists contrasted with no specialist care. (5)
The growth of the outcomes movement is evident in searching computerized literature databases using just the term "outcomes research." HealthStar, a National Library of Medicine database showed only 12 citations between 1979 and 1989, while there were 475 since 1990. Similarly, Medline had only 6 citations between 1985 and 1989, and 372 since 1990. CINAHL (Cumulative Index to Nursing and Allied Health Literature) had no citations prior to 1991, and 372 since then. It is also evident from the literature that an outcomes movement is evolving, with the advent of a variety of outcomes initiatives, including but not limited to outcomes research. It is therefore important to differentiate outcomes research from outcomes assessment and management. Outcomes research is aimed toward developing new and generalizable knowledge, using time-honored research techniques for specifying and testing hypotheses about the relationships of care delivery, interventions and patient outcomes. Most commonly, outcomes research requires large samples, across institutions, in order to adjust adequately for variations in practices and in patient characteristics. Outcomes researchers have attempted to use large existing databases to gather information in a timely manner. While in some cases this has allowed pooling of reliable data from large populations, in other cases the poor quality of data in administrative or non-clinical databases has precluded reasonable interpretation of the results. (7,17)
Outcomes assessment and management refer to systematic techniques to gather and interpret operational data within a single unit, agency or institution in order to understand and improve the quality of care for that defined population. The Joint Commission on Healthcare Organizations has recommended the term operations management for this type of outcomes analysis. (15) While systematic data collection and display are an integral part of outcomes assessment and management, the primary goal is ongoing quality improvement for the specific agency, not necessarily contribution to overall knowledge development. (16) For example, evaluation of a critical pathway for acute stroke management in a given hospital would use systematic data collection and analysis of the presenting features and outcomes of the people with acute stroke who came to that hospital. There might be very specific features of resources available to that hospital, such as a well-trained community emergency response team, or public education about the urgency of stroke symptoms, that would not allow one to generalize the stroke outcomes to other communities or regions.
Outcomes Research and Management: What's In it for My Clinical Practice?
Outcomes research and clinical efficacy studies are crucial to inform clinicians regarding the directions for effective practice. Outcomes assessment and interdisciplinary outcomes management are the tools for identifying and incorporating "best practices" into our everyday work. (35) Increasingly, advanced practice nurses in neuroscience and other specialty areas are being called on to contribute to outcomes assessment and management activities in their institutions. Outcomes research may inform the questions asked and the data collected for outcomes assessment and management, so it is useful for clinicians in all disciplines to understand what they entail.
One might think of the three approaches to outcomes analyses in the following way. Outcomes assessment examines the effectiveness of care within the context of structures and processes. Outcomes assessment is descriptive, asking the question: what are the outcomes and what are the structures and processes we have in place? Outcomes management takes the data available from outcomes assessment and goes one step further, attempting to improve outcomes by changing process variations. Outcomes research contributes to suggesting the best treatment options and expands the available evidence by comparing, across many settings, which treatments or types of care produce best outcomes.
A concrete example related to stroke care can illustrate the overlapping and distinct features of these three approaches to outcomes analysis. Recent clinical trials have demonstrated that rapid treatment of evolving ischemic stroke with thrombolytics markedly reduces the subsequent disability of patients. (23) The clinical trials that established the effect of this treatment are efficacy studies, randomized controlled trials that demonstrate the positive outcome under the best possible circumstances. Outcomes analyses are then needed as effectiveness studies-determining how effective thrombolytic therapy is under ordinary clinical circumstances. Outcomes research studies would compare the effectiveness of thrombolytic therapy in a variety of institutions and communities, attempting to tease out the conditions in which it is more and less effective. For example, one might hypothesize that communities with an aggressive public education program regarding the urgency of "brain attack" might have better outcomes and greater use of thrombolytics than communities where the public and providers continue to believe that little can be done for stroke once it is underway. Individual hospitals, HMOs and provider groups might use outcomes assessment and management to design and improve their own system for rapid delivery of this therapy, including public education and pre-hospital emergency systems.
Further along the continuum of stroke care, outcomes research, assessment and management are being reported indicating that multidisciplinary stroke teams reduce complications of immobility and reduce the time spent in acute care hospitals. (33,35) The best of these assessments would use not only the patient's neurologic function, but patient and family perception of quality of life and function. The outcomes movement has begun to shift from examining only the "five Ds:" death, disease, disability, discomfort and dissatisfaction, (19) to a wider range of outcomes that reflect patient preference, functioning, quality of life, as well as clinical factors. (16,21,22)
The evidence-based practice movement outcomes initiatives, and the use of "report cards" for comparing the performance of hospitals, managed care groups and the like are converging and are having profound impact on the individual clinician in all disciplines. First, evidence-based practice is creating a new approach to research utilization in practice. (4,24) Rather than expecting each clinician to digest and review the body of research relevant to particular practices and interventions, numerous aids are now available. These include the Agency for Health Care Policy and Research (AHCPR) clinical guidelines that incorporate explicit notation regarding the type and strength of evidence available, review and systematic review of databases such as the Cochrane Collaboration, (30) and a series of new journals that contain critical reviews. Among these are Evidence-based Nursing (RCN Publishing Company, Harrow, England) and Evidence-based Health Policy and Management (Churchill-Livingstone, London). Published guidelines most relevant to neuroscience nurses include AHCPR guidelines, #2 Urinary Incontinence in Adults, # 3 Pressure Ulcers in Adults, #15 Pressure Ulcer Treatment, #19 Recognition and Initial Assessment of Alzheimer's Disease and Related Dementias, and # 16 Post-stroke Rehabilitation. These guidelines are available at no cost via the World Wide Web: (http://www.ahcpr.gov.clinic/) or can be ordered for a fee from AHCPR. (1) (Toll free 1-800-358-9295 or write: AHCPR Publications Clearinghouse, P.O. Box 8547, Silver Springs, MD 20907.)
The American Association of Neurological Surgeons' guideline on severe head injury is highly relevant and is readily accessible in a journal synopsis (11) or can be ordered via their World Wide Web page (http://www.neurosurgery.org). The American Association of Neuroscience Nurses has developed intracranial pressure monitoring and seizure assessment guidelines, and is planning a guideline on nursing care of the head-injured patient),2 In addition, a series of articles about how to read research regarding interventions, diagnostic tests and the like, although written for medicine, can be quite useful in guiding one's own review of nursing research. (6,25)
Second, the outcomes movement most commonly uses multidisciplinary process and intermediate outcome guides called critical pathways, clinical pathways and Caremaps, among others. (8,26) These are in-house guidelines based on outcomes assessment of the particular population in that institution, and benchmarked against the available research literature (outcomes and clinical research), and "best" practices identified in formal and informal surveys of like providers. Wojner and Houston each provide excellent reviews of outcome assessment and management, how to translate these into working tools for continuous care improvement for defined populations and how to incorporate and contribute to outcomes research. (13,35) Implicit in outcomes assessment and management is the availability of data throughout the process of care, not gathered long after the patient is discharged. The increasing computerization of clinical as well as administrative records is facilitating the availability of data, but we are far from having such data at our fingertips. Advanced practice nurses are increasingly being called on to develop, maintain and use such databases to create the information needed for improvement of clinical processes and outcomes. (28,35)
Finally, the growing "report card" movement is promoting the incorporation of some common outcome measures into institutional and health plan databases. Although relatively few of these at this time are particularly sensitive to the influence of nursing care, there is growing development of such measures and report cards. (3,14,16) Thus, it will be possible in the near future to compare the impact of a variety of ways to organize nursing care on patient outcomes within defined patient populations.
Although there is a great deal of outcomes research and growing reported outcomes assessment, relatively little is in the area of neuroscience clinical care. As noted earlier, only five of the 19 AHCPR guidelines are directly relevant to the care problems of patients seen by neuroscience nurses and physicians. Condition-specific outcomes studies and guidelines developed by medical specialty organizations rarely address the components of care delivered by anyone other than physicians. The AHCPR guidelines are notable exceptions, and explicitly incorporated the views of multiple disciplines.
Although relatively little has been published in the research and outcomes management literature with respect to clinical neuroscience care, a great deal is going on in individual institutions with respect to managing outcomes for patients with spinal cord injury, stroke, subarachnoid hemorrhage, carotid endarterectomy and the like. Advanced practice neuroscience nurses are commonly leading multidisciplinary teams to develop the critical paths, outcome assessments and management guidelines for these patients. Publication of the evaluation of those pathways and changing practices would go a long way to improving outcomes management of neuroscience patients and contributing to the literature needed by outcomes researchers for comparative evaluation of current "best" practices. The challenge is there and neuroscience nurses are up to it.
(1.) American Association of Neuroscience Nurses: Clinical Guideline Series: Seizure Assessment. American Association of Neuroscience Nurses, 1997. http://www.AANN.org
(2.) American Association of Neuroscience Nurses: Clinical Guidelines Series: Intracranial Pressure Monitoring. American Association of Neuroscience Nurses, 1997. http://www.AANN.org
(3.) American Nurses Association: Nursing's Report Card for Acute Care Settings. American Nurses Association, 1995.
(4.) Barnsteiner JH: Research-based practice. Nurs Admin Q 1996; 20(4): 52-58.
(5.) Brooten, D, Naylor MD: Nurses' effect on changing patient outcomes. Image 1995; 27(2): 95-99.
(6.) Cook DJ, Meade MO, Fink MP: How to keep up with the critical care literature and avoid being buried alive. Crit Care Med 1996; 24(10):144-147.
(7.) Deyo RA: Promises and limitations of the Patient Outcome Research Teams: The low-back pain example. Proceedings of the Association of American Physicians/1995; 107(3): 324-328.
(8.) Dykes PC, Wheeler K, eds. Page 162 in: Planning, Implementing and Evaluating Critical Pathways. Springer, 1997.
(9.) Fitzgerald, J et al.: Influence of organizational components on delivery of asthma care. Med Care 1993; 31(Supplement): MS61-MS73.
(10.) Guadagnoli E, McNeil, BJ: Outcomes research: Hope for the future or latest fad? Inquiry 1994; 31: 14-24.
(11.) Head Injury Guidelines Task Force: Severe head injury guidelines. J Neurotrauma 1996; 13(11): 641-734.
(12.) Heitkoff KA, Lohr KN: Effectiveness and outcomes in health care: Proceedings of an invitational conference by the Institute of Medicine. National Academy Press, 1990.
(13.) Houston S: Getting started in outcomes research. AACN Clinical Issues 1996; 7(1):146-152.
(14.) Iowa Intervention Project: Proposal to bring nursing into the information age. Image 1997; 29(3):275-281.
(15.) Joint Commission for Accreditation of Healthcare Organizations: A Guide to Establishing Programs for Assessing Outcomes in Clinical Settings. Joint Commission for Accreditation of Healthcare Organizations, 1994.
(16.) Jones KR et al: Policy issues associated with analyzing outcomes of care. Image 1997; 29(3):261-267.
(17.) Kane RL: Understanding Health Care Outcomes Research. Aspen, 1997.
(18.) Kwakkel G et al: Effects of intensity of rehabilitation after stroke. A research synthesis. Stroke 1997; 28(8):1550-1556.
(19.) Lohr KN: Outcome measurements: Concepts and questions. Inquiry 1988; 25(1):37-50.
(20.) Mitchell JB et al: What role do neurologists play in determining the costs and outcomes of stroke patients? Stroke 1997; 27(11):1937-1943.
(21.) Mitchell PH: Perspectives on outcome-oriented care systems. Nurs Admin Q 1993; 17(3):1-7.
(22.) Mitchell PH. et al: Measurement into practice. Med Care 1997; 35(11):NS 124-NS 127.
(23.) National Institute of Neurological Disorders and Stroke rt-PA Study Group: Tissue plasminogen activator for acute ischemic stroke. N Engl J Med 1995; 333(24):1581-1587.
(24.) Olson EA: Evidence-based practice: a new approach to teaching the integration of research and practice in gerontology. Ed Ger 1996; 22:523-537.
(25.) Oxman A, Sackett DL, Guyatt GH: Users' guides to the medical literature. I. How to get started. JAMA 1993; 270(17): 2093-2095.
(26.) Pearson SD, Goulart-Fisher D, Lee TH: Critical pathways as a strategy for improving care: Problems and potential. Ann Int Med 1995; 123(12):941-948.
(27.) Perrin EJ Mitchell PH: Data, information and knowledge: theoretical and methodological issues in linking outcomes and organizational variables. Med Care 1997; 35(11):NS 84-NS 86.
(28.) Petryshen P, O'Brian-Pallas LL, Shamian, J: Outcomes monitoring: Adjusting for risk factors, severity of illness, and complexity of care. JAMA 1995; 2:243-249.
(29.) Retchin SM et al: Outcomes of stroke patients in Medicare fee for service and managed care. JAMA 1997; 278(2):119-124.
(30.) Robinson A: Research, practice and the Cochrane Collaboration. Canad Med Assoc J 1995; 152(6):883-889.
(31.) Robinson ML: HHS boosts funds for outcomes research. Hospitals 1989; 63(8):20-21.
(32.) Rubin, HR et al: Patients' ratings of outpatient visits in different practice settings. Results from the Medical Outcomes Study. JAMA 1993; 270(7):835-840.
(33.) Webb DJ et al: Effects of a specialized team on stroke care. The first two years of the Yale Stroke Program. Stroke 1995; 26(8):1353-1357.
(34.) Wennberg JE: Dealing with medical practice variation: A proposal for action. Health Affairs 1984; 3(2):6-32.
(35.) Wojner AW: Outcomes management: An interdisciplinary search for best practice. AACN Clinical Issues 1996; 7(1):133-145.
Questions or comments about this article may be directed to: Pamela H. Mitchell, PhD, FAAN, RN, CNRN, University of Washington School of Nursing, Box 357266, Seattle, Washington 98195.
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|Title Annotation:||Research Corner|
|Author:||Mitchell, Pamela H.|
|Publication:||Journal of Neuroscience Nursing|
|Date:||Oct 1, 1998|
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