- Email: [email protected]
Evidence-based practice as a tool for case management
Lori Allison, MA, CLCP
F
or more than 2 decades, clinical practice guidelines (CPG) have been a source of interest for health insurance carriers and government providers, including Medicare and the Department of Veterans Affairs, seeking to lower health care and pharmaceutical costs, to improve quality assurance measures, and to reduce wide variations in clinical practice. Wyer1 asserts that, although CPGs offer direction for practice and decrease variations among practitioners, evidence-based medicine (EBM) integrates research findings and clinical evidence that ultimately support or refute the current principles of care. TCM 62
September/October 2004
Definitions Sackett et al.2 define EBM as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research.” The Evidence-Based Medicine Resource Center3 at the New York Academy of Medicine, states: “Evidence-based medicine’s ultimate application is at the level of the individual clinician’s decisions about managing patients. It is an explicit approach to problem solving and continual professional learning, which require the use of current best evidence in making medical decisions about individual patients. To achieve evidencebased decisions, the health practitioner should: • Develop a focused clinical question concerning the patient’s problem(s) • Search secondary databases and the primary literature for relevant articles
ONLINE RESOURCES Center for Health Evidence, www.cche.net/usersguides/main.asp
• Access the validity and the usefulness of those articles • Judge the relevance to the individual patient • Implement the findings in patient care”
Evidence-based Medicine, hsc.usf.edu/CLASS/Gene/ebm.htm#Sourse; Power Point, hsc.usf.edu/CLASS/Gene/Presentation/sld001.htm Netting the Evidence, www.shef.ac.uk/~scharr/ir/netting/ SUNY Downstate Medical Center Evidence-Based Medicine Course, servers.medlib.hscbklyn.edu/ebmdos/toc.html University of Illinois at Chicago, www.uic.edu/depts/lib/lhsp/resources/ebm.shtml
Evidence-based medicine is not a new concept but may be an effective method for evaluating and developing CPGs and evaluating research literature within health care fields. Rather than relying solely on clinical experience, professionals are encouraged to consult research literature when making patient recommendations. This evidence-based approach is consistent with the Standards of Practice for Case Managers, which state that plan recommendations must have a basis in research literature that is relevant to the specific client for whom the plan is developed. This approach is also consistent with other health care entities and sometimes is referred to as evidence-based health care or evidencebased practice. O’Rourke4 points out that the evidencebased approach parallels clinical practice in that both: • Are about using rather than doing research • Aim to improve health care delivery and raising standards • Consider the use of resources • Focus on the range of outcomes by insisting on explicit end points • Are tools for delivering education • Are useful for standard setting Professional Skills Case managers have had experience reviewing and critiquing research articles as one component of their undergraduate/graduate academic programs. Continuing education, professional development activities, and continuous research literature review are essential responsibilities of case managers. The American Medical Association5 delineates the following skills as being necessary to fully use research literature: • Precisely define a patient problem • Determine what information is necessary to resolve the problem
University of Missouri-Kansas City, www.umkc.edu/lib/HSL/biostats.html#web The Wisdom Centre, www.shef.ac.uk/uni/projects/wrp/seminar.html#EBP
• Conduct an effective search of the research literature • Select the most relevant studies • Evaluate the validity of research studies • Communicate the findings of research studies, strengths, and limitations, and relevance to others • Apply research data to the patient problem In addition to medical aspects, case managers also must attend to clients’ cognitive, emotional, and interpersonal status. When referencing CPGs and research literature, case managers must take these factors into consideration. By applying an evidence-based approach to research involving client-specific plan recommendations, case managers must conduct successful literature reviews. Step 1: Identify the Client’s Problem Client Characteristics and Demographics The more precisely the practitioner is able to define the client’s needs and limitations, the more productive the literature search will prove to be. A careful analysis of the information collected during the assessment process will be necessary. Functional Limitations In addition to the client’s specific medical diagnoses, case managers should assess the functional limitations (physical, emotional, cognitive, interpersonal, vocational) imposed by his or her disability or condition. Both the medical diagnosis and the functional limitations are addressed in the case management plan.
Focus of Research The SUNY Downstate Medical Center6 provides an excellent online introductory course to the basic methods of the evidence-based approach. The following classifications were taken from the center’s Web site (servers.medlib.hscbklyn. edu/ebmdos/toc.html): • Therapy: questions about what treatment, if any, to give a client, and what the outcomes of different treatment options might be • Diagnosis: questions about the degree to which a particular test is reliable and clinically useful, generally asked to decide whether a client would benefit from the test to justify having it done. Most articles on diagnosis compare the results of the diagnostic test being studied to the results of another standard test that is regarded as being definitive—a “gold standard” test. • Prognosis: questions about the client’s future health, lifespan, and quality of life in the event that he or she chooses a particular treatment option. For instance, how do the lifespan and quality of life of an elderly patient undergoing surgery for prostate cancer compare with those for a similar patient who chooses not to undergo the surgery? • Harm: questions about the relationship between a disease and a possible cause. For example, does a diet rich in saturated fats increase the risk of heart disease and if so, by how much? Most of the questions asked by case managers would be considered prognosis oriented because case managers September/October 2004
TCM 63
focus on immediate and longterm needs. Case managers must be cautious, however, to not attempt to make recommendations that are beyond their area of licensure/certification. The purpose of performing client-specific research is not to make an independent assessment of a diagnosis but to illustrate the basis for recommendations. When reporting the conclusions of research, case managers should make certain that the information is presented as an educational component of the process, not as a prescription for specific medical treatments or interventions for which they are not qualified to make. Step 2: Begin the Literature Review Reliable Internet sites for statistics/data, current texts, peer-reviewed journals, and other sources are the first choices for locating articles that discuss randomized, controlled (true experimental or quasi-experimental) designs addressing clients’ needs. Experimental research designs are preferable because they have the highest degree of control. Unfortunately, for most of the topics that case managers are interested in researching, randomized controlled trials are excluded for ethical reasons. When true/quasi-experimental studies are not available within the particular area of interest, the case manager must carefully evaluate the designs of those chosen for review. Each research design type and method has benefits and limitations that may affect the validity of results. Consider the Relevance of Study Are the participants similar to the client served? If so, to what extent? Can the results of the study be generalized to the client served? Is the treatment or intervention feasible or available to the client served? TCM 64
September/October 2004
determine whether it is of use; its relevance to the client Evidence-based is paramount. Without relmedicine is not a evance, the results of the study are meaningnew concept but less to the outcomes of may be an effective the client in question. method for A case manager must make use of her evaluating and knowledge of research developing CPGs design, methodology, and evaluating data collection, analysis, and interpretation research literature to answer the question: within health Is this study relevant to care fields. the client served? The following helpful questions were taken from the SUNY Downstate Medical Center Web site.
Consider the Validity of the Study Case managers will seek articles that provide the best possible evidence to guide plan recommendations and will seek to analyze the validity of the research design, method, analysis, and interpretation. Asking the following questions narrows the search: • Are subjects randomly assigned to the different treatment groups? Random assignment allows for the most stringent control of factors (age, gender, comorbid conditions, investigator bias, etc.), because they are theoretically equally distributed among the participants in all groups. • Do the subjects, researchers, and data analyzers know which treatment was given to a particular individual? • Were all the study subjects accounted for at the end of the study? • What are the results? Within the literature, unfortunately, many studies report statistically significant but clinically irrelevant results. Step 3: Evaluate the Research Evidence Identifying whether a specific study is valid and practically significant is absolutely necessary but not sufficient to
Are the People in the Study Like My Client? A case manager is interested in locating studies in which the individuals being described are as like his or her client as possible, particularly in terms of age, general state of health, type and severity of disease process, and place in the course of the disease. The case manager may have difficulty locating studies involving clients identical to those being served, but if they are too different, the case manager may need to look for another study. Did the Study Cover All Aspects of the Problem? Most problems have many different aspects to consider when deciding on a treatment or course of action. The case manager should look for studies that deal with all the aspects that are important to the client. For instance, a study may show that a treatment is effective for a certain condition but does not address side effects. Or a study may indicate that one treatment relieves pain better than another but may not identify which treatment most effectively solves the underlying condition. In cases like these, it will be necessary to identify other studies that answer these outstanding questions. If such articles are not available, the case manager will
need to fill in the gaps by using professional judgment or the recommendations of members of other health team. Were the Groups Selected in an Impartial Way? The article should describe in detail how the groups were selected. If this is not done, any results could be attributed to the initial differences between the groups. For instance, a group of physicians studied air pollution levels and mortality in six U.S. cities.7 The researchers went into enormous detail on measurements of mortality and pollution levels and obtained some extremely impressive results. However, they never said how or why they selected those cities. So for all the reader knows, they selected only cities that had high pollution levels and poor life expectancies or that had low pollution levels and good life expectancies, and ignored the rest. The results would have been much stronger if the physicians had studied all cities in a certain region (even in less detail) or had explained clearly why they selected the cities they did. Was the Follow-up Sufficiently Long and Complete? Conditions being studied under “prognosis” and “harms” often take a long while to run their course. For example, sometimes it can take decades between initial exposure to a carcinogen and fullblown cancer. So a study whose followup is not long enough can underestimate risks and ignore clinically important effects. On the other hand, the longer the study, the greater the number of patients who may be lost to follow-up. Participants who are lost to follow-up tend to have a different prognosis from those who stay in a study. Some may be lost because they die; others may have lost interest in the health care system, possibly to the point that they no longer take care of themselves. The study results should indicate how many participants were lost to followup, under what circumstances, and
whether the rate of attrition materially affects the results of the study. Step 4: Apply the Conclusions to Practice Ideally, the process of research, education, professional development, and practice should be integrated. The most valuable studies suggest a useful plan to improve the client’s state of health. Studies that help clarify a prognosis also may be helpful in making life decisions. Studies that do not suggest these data are of little or no interest to the case manager. A lot of very valuable
Even the most welldeveloped guidelines fall short of offering recommendations relative to the interaction of the aging process and disability management. preliminary research falls into this category. It is not that the research is not good; it is just that it has not reached the point of being able to provide clearcut clinical recommendations. Conclusion Case managers must be cautious when citing a set of CPGs as the sole substantiation for specific plan recommendations. In addition, they must consider the fact that most guidelines do not address the effects of aging with disability or specify factors influencing longterm support and care needs. Even the most well-developed guidelines fall short of offering recommendations relative to the interaction of the aging process and disability management.
As stated, case managers are primarily interested in using prognosis-oriented research literature and practice guidelines to build a foundation for the projected needs of an individual client. The link between research literature, clinical guidelines, and client needs must be clearly demonstrated with the case management plan. Clients, family members, and other professionals should be able to reach the same conclusions represented in a plan when given a comprehensive explanation of the methodology and resources used to develop the recommendations. ❑ References 1. Wyer P. Evidence-based medicine—the next step: integrating evidence with values. Or, what’s up with practice guidelines? 2002. Available from URL:http://www.jgh.ca/research/ebm/Docs/ Montreal_PG2002FridayPW.pdf 2. Sackett D, Rosenberg W. Gray J, Haynes B, Richardson S. Evidence-based medicine: what it is and what it isn’t. Br Med J 1996;312:71-2. 3. Evidence-Based Medicine Resource Center. What is evidence-based medicine? 2002. Available from: URL:http:// www.ebmny.org/thecentr2.html 4. O’Rourke A. Evidence-based practice. The Wisdom Centre. 1997. Available from URL:http://www.shef.ac.uk/uni/projects/wr p/seminar.html#EBP 5. American Medical Association. Users’ guide to evidence-based medicine. JAMA 1992;268:2420-5. 6. SUNY Downstate Medical Center. SUNY Downstate Medical Center Evidence Based Medicine Course. Medical Research Library of Brooklyn. 2000. Available from URL:http://servers.medlib.hscbklyn.edu/eb mdos/toc.html 7. Dockery DW, Pope CA, Xu X, Spengler JD, Ware JH, Fay ME, et al. An association between air pollution and mortality in six U.S. cities. N Engl J Med 1993;329:1753-9.
Lori Allison, MA, CLCP, is a case manager and life care planner with Paul Deutsch & Associates in Oviedo, Fla. Reprint orders: Elsevier Inc., 11830 Westline Industrial Dr., St. Louis, MO 63146-3318; phone (314) 579-2838; reprint no. YMCM198 doi:10.1016/j.casemgr.2004.198
September/October 2004
TCM 65
F
or more than 2 decades, clinical practice guidelines (CPG) have been a source of interest for health insurance carriers and government providers, including Medicare and the Department of Veterans Affairs, seeking to lower health care and pharmaceutical costs, to improve quality assurance measures, and to reduce wide variations in clinical practice. Wyer1 asserts that, although CPGs offer direction for practice and decrease variations among practitioners, evidence-based medicine (EBM) integrates research findings and clinical evidence that ultimately support or refute the current principles of care. TCM 62
September/October 2004
Definitions Sackett et al.2 define EBM as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research.” The Evidence-Based Medicine Resource Center3 at the New York Academy of Medicine, states: “Evidence-based medicine’s ultimate application is at the level of the individual clinician’s decisions about managing patients. It is an explicit approach to problem solving and continual professional learning, which require the use of current best evidence in making medical decisions about individual patients. To achieve evidencebased decisions, the health practitioner should: • Develop a focused clinical question concerning the patient’s problem(s) • Search secondary databases and the primary literature for relevant articles
ONLINE RESOURCES Center for Health Evidence, www.cche.net/usersguides/main.asp
• Access the validity and the usefulness of those articles • Judge the relevance to the individual patient • Implement the findings in patient care”
Evidence-based Medicine, hsc.usf.edu/CLASS/Gene/ebm.htm#Sourse; Power Point, hsc.usf.edu/CLASS/Gene/Presentation/sld001.htm Netting the Evidence, www.shef.ac.uk/~scharr/ir/netting/ SUNY Downstate Medical Center Evidence-Based Medicine Course, servers.medlib.hscbklyn.edu/ebmdos/toc.html University of Illinois at Chicago, www.uic.edu/depts/lib/lhsp/resources/ebm.shtml
Evidence-based medicine is not a new concept but may be an effective method for evaluating and developing CPGs and evaluating research literature within health care fields. Rather than relying solely on clinical experience, professionals are encouraged to consult research literature when making patient recommendations. This evidence-based approach is consistent with the Standards of Practice for Case Managers, which state that plan recommendations must have a basis in research literature that is relevant to the specific client for whom the plan is developed. This approach is also consistent with other health care entities and sometimes is referred to as evidence-based health care or evidencebased practice. O’Rourke4 points out that the evidencebased approach parallels clinical practice in that both: • Are about using rather than doing research • Aim to improve health care delivery and raising standards • Consider the use of resources • Focus on the range of outcomes by insisting on explicit end points • Are tools for delivering education • Are useful for standard setting Professional Skills Case managers have had experience reviewing and critiquing research articles as one component of their undergraduate/graduate academic programs. Continuing education, professional development activities, and continuous research literature review are essential responsibilities of case managers. The American Medical Association5 delineates the following skills as being necessary to fully use research literature: • Precisely define a patient problem • Determine what information is necessary to resolve the problem
University of Missouri-Kansas City, www.umkc.edu/lib/HSL/biostats.html#web The Wisdom Centre, www.shef.ac.uk/uni/projects/wrp/seminar.html#EBP
• Conduct an effective search of the research literature • Select the most relevant studies • Evaluate the validity of research studies • Communicate the findings of research studies, strengths, and limitations, and relevance to others • Apply research data to the patient problem In addition to medical aspects, case managers also must attend to clients’ cognitive, emotional, and interpersonal status. When referencing CPGs and research literature, case managers must take these factors into consideration. By applying an evidence-based approach to research involving client-specific plan recommendations, case managers must conduct successful literature reviews. Step 1: Identify the Client’s Problem Client Characteristics and Demographics The more precisely the practitioner is able to define the client’s needs and limitations, the more productive the literature search will prove to be. A careful analysis of the information collected during the assessment process will be necessary. Functional Limitations In addition to the client’s specific medical diagnoses, case managers should assess the functional limitations (physical, emotional, cognitive, interpersonal, vocational) imposed by his or her disability or condition. Both the medical diagnosis and the functional limitations are addressed in the case management plan.
Focus of Research The SUNY Downstate Medical Center6 provides an excellent online introductory course to the basic methods of the evidence-based approach. The following classifications were taken from the center’s Web site (servers.medlib.hscbklyn. edu/ebmdos/toc.html): • Therapy: questions about what treatment, if any, to give a client, and what the outcomes of different treatment options might be • Diagnosis: questions about the degree to which a particular test is reliable and clinically useful, generally asked to decide whether a client would benefit from the test to justify having it done. Most articles on diagnosis compare the results of the diagnostic test being studied to the results of another standard test that is regarded as being definitive—a “gold standard” test. • Prognosis: questions about the client’s future health, lifespan, and quality of life in the event that he or she chooses a particular treatment option. For instance, how do the lifespan and quality of life of an elderly patient undergoing surgery for prostate cancer compare with those for a similar patient who chooses not to undergo the surgery? • Harm: questions about the relationship between a disease and a possible cause. For example, does a diet rich in saturated fats increase the risk of heart disease and if so, by how much? Most of the questions asked by case managers would be considered prognosis oriented because case managers September/October 2004
TCM 63
focus on immediate and longterm needs. Case managers must be cautious, however, to not attempt to make recommendations that are beyond their area of licensure/certification. The purpose of performing client-specific research is not to make an independent assessment of a diagnosis but to illustrate the basis for recommendations. When reporting the conclusions of research, case managers should make certain that the information is presented as an educational component of the process, not as a prescription for specific medical treatments or interventions for which they are not qualified to make. Step 2: Begin the Literature Review Reliable Internet sites for statistics/data, current texts, peer-reviewed journals, and other sources are the first choices for locating articles that discuss randomized, controlled (true experimental or quasi-experimental) designs addressing clients’ needs. Experimental research designs are preferable because they have the highest degree of control. Unfortunately, for most of the topics that case managers are interested in researching, randomized controlled trials are excluded for ethical reasons. When true/quasi-experimental studies are not available within the particular area of interest, the case manager must carefully evaluate the designs of those chosen for review. Each research design type and method has benefits and limitations that may affect the validity of results. Consider the Relevance of Study Are the participants similar to the client served? If so, to what extent? Can the results of the study be generalized to the client served? Is the treatment or intervention feasible or available to the client served? TCM 64
September/October 2004
determine whether it is of use; its relevance to the client Evidence-based is paramount. Without relmedicine is not a evance, the results of the study are meaningnew concept but less to the outcomes of may be an effective the client in question. method for A case manager must make use of her evaluating and knowledge of research developing CPGs design, methodology, and evaluating data collection, analysis, and interpretation research literature to answer the question: within health Is this study relevant to care fields. the client served? The following helpful questions were taken from the SUNY Downstate Medical Center Web site.
Consider the Validity of the Study Case managers will seek articles that provide the best possible evidence to guide plan recommendations and will seek to analyze the validity of the research design, method, analysis, and interpretation. Asking the following questions narrows the search: • Are subjects randomly assigned to the different treatment groups? Random assignment allows for the most stringent control of factors (age, gender, comorbid conditions, investigator bias, etc.), because they are theoretically equally distributed among the participants in all groups. • Do the subjects, researchers, and data analyzers know which treatment was given to a particular individual? • Were all the study subjects accounted for at the end of the study? • What are the results? Within the literature, unfortunately, many studies report statistically significant but clinically irrelevant results. Step 3: Evaluate the Research Evidence Identifying whether a specific study is valid and practically significant is absolutely necessary but not sufficient to
Are the People in the Study Like My Client? A case manager is interested in locating studies in which the individuals being described are as like his or her client as possible, particularly in terms of age, general state of health, type and severity of disease process, and place in the course of the disease. The case manager may have difficulty locating studies involving clients identical to those being served, but if they are too different, the case manager may need to look for another study. Did the Study Cover All Aspects of the Problem? Most problems have many different aspects to consider when deciding on a treatment or course of action. The case manager should look for studies that deal with all the aspects that are important to the client. For instance, a study may show that a treatment is effective for a certain condition but does not address side effects. Or a study may indicate that one treatment relieves pain better than another but may not identify which treatment most effectively solves the underlying condition. In cases like these, it will be necessary to identify other studies that answer these outstanding questions. If such articles are not available, the case manager will
need to fill in the gaps by using professional judgment or the recommendations of members of other health team. Were the Groups Selected in an Impartial Way? The article should describe in detail how the groups were selected. If this is not done, any results could be attributed to the initial differences between the groups. For instance, a group of physicians studied air pollution levels and mortality in six U.S. cities.7 The researchers went into enormous detail on measurements of mortality and pollution levels and obtained some extremely impressive results. However, they never said how or why they selected those cities. So for all the reader knows, they selected only cities that had high pollution levels and poor life expectancies or that had low pollution levels and good life expectancies, and ignored the rest. The results would have been much stronger if the physicians had studied all cities in a certain region (even in less detail) or had explained clearly why they selected the cities they did. Was the Follow-up Sufficiently Long and Complete? Conditions being studied under “prognosis” and “harms” often take a long while to run their course. For example, sometimes it can take decades between initial exposure to a carcinogen and fullblown cancer. So a study whose followup is not long enough can underestimate risks and ignore clinically important effects. On the other hand, the longer the study, the greater the number of patients who may be lost to follow-up. Participants who are lost to follow-up tend to have a different prognosis from those who stay in a study. Some may be lost because they die; others may have lost interest in the health care system, possibly to the point that they no longer take care of themselves. The study results should indicate how many participants were lost to followup, under what circumstances, and
whether the rate of attrition materially affects the results of the study. Step 4: Apply the Conclusions to Practice Ideally, the process of research, education, professional development, and practice should be integrated. The most valuable studies suggest a useful plan to improve the client’s state of health. Studies that help clarify a prognosis also may be helpful in making life decisions. Studies that do not suggest these data are of little or no interest to the case manager. A lot of very valuable
Even the most welldeveloped guidelines fall short of offering recommendations relative to the interaction of the aging process and disability management. preliminary research falls into this category. It is not that the research is not good; it is just that it has not reached the point of being able to provide clearcut clinical recommendations. Conclusion Case managers must be cautious when citing a set of CPGs as the sole substantiation for specific plan recommendations. In addition, they must consider the fact that most guidelines do not address the effects of aging with disability or specify factors influencing longterm support and care needs. Even the most well-developed guidelines fall short of offering recommendations relative to the interaction of the aging process and disability management.
As stated, case managers are primarily interested in using prognosis-oriented research literature and practice guidelines to build a foundation for the projected needs of an individual client. The link between research literature, clinical guidelines, and client needs must be clearly demonstrated with the case management plan. Clients, family members, and other professionals should be able to reach the same conclusions represented in a plan when given a comprehensive explanation of the methodology and resources used to develop the recommendations. ❑ References 1. Wyer P. Evidence-based medicine—the next step: integrating evidence with values. Or, what’s up with practice guidelines? 2002. Available from URL:http://www.jgh.ca/research/ebm/Docs/ Montreal_PG2002FridayPW.pdf 2. Sackett D, Rosenberg W. Gray J, Haynes B, Richardson S. Evidence-based medicine: what it is and what it isn’t. Br Med J 1996;312:71-2. 3. Evidence-Based Medicine Resource Center. What is evidence-based medicine? 2002. Available from: URL:http:// www.ebmny.org/thecentr2.html 4. O’Rourke A. Evidence-based practice. The Wisdom Centre. 1997. Available from URL:http://www.shef.ac.uk/uni/projects/wr p/seminar.html#EBP 5. American Medical Association. Users’ guide to evidence-based medicine. JAMA 1992;268:2420-5. 6. SUNY Downstate Medical Center. SUNY Downstate Medical Center Evidence Based Medicine Course. Medical Research Library of Brooklyn. 2000. Available from URL:http://servers.medlib.hscbklyn.edu/eb mdos/toc.html 7. Dockery DW, Pope CA, Xu X, Spengler JD, Ware JH, Fay ME, et al. An association between air pollution and mortality in six U.S. cities. N Engl J Med 1993;329:1753-9.
Lori Allison, MA, CLCP, is a case manager and life care planner with Paul Deutsch & Associates in Oviedo, Fla. Reprint orders: Elsevier Inc., 11830 Westline Industrial Dr., St. Louis, MO 63146-3318; phone (314) 579-2838; reprint no. YMCM198 doi:10.1016/j.casemgr.2004.198
September/October 2004
TCM 65