Research Design & Stats

For more than two decades, clinical practice guidelines have been a source of interest for health insurance carriers and government providers (Medicare, Department of Veterans Affairs, etc.) seeking to reduce health care/pharmaceutical costs, improve quality assurance measures, and to reduce wide variations between clinical practice settings.

Wyer (2002) asserts that while clinical practice guidelines offer direction for practice and decrease variations between practitioners, evidence-based medicine integrates research findings and clinical evidence which ultimately supports or refutes the current principles of care.

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Definition

Sacket, Rosenberg, Gray, Haynes, and Richardson (1997) define evidence-based medicine 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 Center (New York Academy of Medicine and American College of Physicians, 2002) 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 requires the use of current best evidence in making medical decisions about individual patients. To achieve evidence-informed 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

*Access the validity and usefulness of those articles

*Judge the relevance to the individual patient

*Implement the findings in patient care.”

Evidence-based medicine is not a “new” concept in the field, but may be an effective methodology for evaluating and developing clinical practice guidelines and evaluating research literature within healthcare fields. Rather than relying solely upon one’s personal clinical experience, professionals are encouraged to consult research literature when making patient recommendations.

The evidence-based approach is consistent with the basic tenets and methodologies of life care planning which state that plan recommendations must have a basis in research literature which is relevant to the specific patient for whom the plan is developed. This approach is also consistent with other health care entities and is sometimes referred to as “evidence-based health care” or “evidence-based practice.”

O’Rourke (1997) points out that the evidence-based approach parallels clinical practice in that both:

*Are about using rather than doing research

*Aim at improving healthcare 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

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Professional Skills

Most professionals coming to the specialty of life care planning will have had experience reviewing and critiquing research articles as one component of undergraduate/graduate preparatory academic programs. Continuing education, professional development activities, and continuous research literature review are essential responsibilities of life care planners. The American Medical Association (1992) delineates the following skills as being necessary in order to fully utilize research literature. The ability to:

*Precisely define a patient problem

*Determine what information is necessary in order to resolve the problem

*Conduct an effective search of the research literature

*Select the most relevant studies, consider in patient-specific information

*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

Life care planners attend to the pathophysiology of injury as well as the cognitive, emotional, and interpersonal consequences of long-term disability. When referencing clinical practice guidelines and research literature, life care planners must also take these factors into consideration.

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Evidence-based Methodology and Life Care Planning

By applying an evidence-based approach to research involving patient-specific plan recommendations, life care planners may conduct successful literature reviews.

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Step One: Identify the Patient Problem

Patient Characteristics and Demographics

The more precisely you are able to define the patient and his/her limitations, the more productive your literature search will prove to be. Many of the data points will be identified through a review of patient records and the clinical interview and history.

Functional Limitations

In addition to the patient’s specific medical diagnoses, life care planners should assess the functional limitations (physical, emotional, cognitive, interpersonal, vocational) imposed by the disability. Both the medical diagnosis (e.g., Projected Evaluations, Therapeutic Modalities, Medications, etc.) and the functional limitations (Aids for Independent Functioning, Home Furnishings and Accessories, Recreation and Leisure, etc.) are addressed in the life care plan.

Focus of Research

The SUNY Downstate Medical Center (2000) provides an excellent online introductory course to the basic methodology of the evidenced-based approach. It is suggested that, in addition to patient-specific data, the patient’s problem should clearly defined before beginning a literature search. The following classifications were extracted from the Center’s website (http://servers.medlib.hscbklyn.edu/ebmdos/toc.html):

Therapy: Therapy problems are questions about what treatment, if any, to give a patient, and what the outcomes of different treatment options might be.

Diagnosis: Diagnosis problems are questions about the degree to which a particular test is reliable and clinically useful, generally asked in order to decide whether a patient of yours would get enough benefit from the test, on average, 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: Prognosis problems are questions about a patient’s future health, life span, and quality of life in the event that s/he chooses a particular treatment option. For instance, how do the life span 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: Harm problems are 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 life care planners would be considered to be prognosis oriented since our work focuses on the long-term needs of patients.

Be cautious, however, that you do not attempt to make recommendations which are beyond your area of licensure/certification. The purpose of performing patient-specific research is not to make an independent assessment or diagnosis of the patient’s condition, but to illustrate the basis for your recommendations. When reporting the conclusions of research, life care planners should make certain that it is presented as an educational component of the process, not as a prescription for specific medical treatments or interventions for which you are not qualified to make.

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Step Two: Begin the Literature Review

Using reliable Internet sites for statistics/data, current texts, peer-reviewed journals, and other sources, your first choice in locating articles is to find those which employ randomized, controlled (true experimental or quasi-experimental) designs which address the needs of the patient with whom you are working. Experimental research designs are preferable to others because they represent the research design types having the highest degree of control. Unfortunately, for most of the topics life care planners are interested in researching, randomized controlled trials are ruled out for ethical reasons.

When true/quasi-experimental studies not available within your particular area of interest, carefully evaluate the designs of those you chose to review. Recall that each research design type and methodology has benefits and limitations which may impact the validity of results.

Consider the Relevance of the Study

Are the participants similar to your patient? If so, to what extent?

Can the results of the study be generalized to your patient?

Is the treatment/intervention feasible and/or available to your patient?

Consider the Validity of the Study

As life care planners, we are seeking articles which provide the best possible evidence to guide our recommendations; we are seeking validity in the research design, methodology, analysis, and interpretation.

Are subjects randomly assigned to the different treatment groups?

Random assignment allows for the most stringent control of factors (i.e., age, sex, 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 body of literature, there are many studies reporting statistically significant, but clinically irrelevant results.

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Step Three: Evaluate the Research Evidence

Throughout this chapter you have been practicing strategies for evaluating the information provided in published research studies. Identifying whether a specific study is valid and practically significant is absolutely necessary, but not sufficient to determine whether it is of use to you; its relevance to the patient is paramount. Without relevance, the results of the study are meaningless to the outcomes of the patient with whom you are working.

Life care planners must make use of their knowledge of research design, methodology, data collection, analysis, and interpretation in order to answer the question: Is this study relevant to my patient?

The following questions were extracted from the SUNY Downstate Medical Center (2000) website:

Are the People in the Study Like my Patient?

You want a study in which the patients are as like your patient as possible, in terms of variables such as:

*Age, general state of health, type and severity of disease process, time in the course of the disease

You will rarely find a study with patients exactly like yours, but if they are too different you may want to spend some time looking for another study.

Did the Study Cover All Aspects of the Problem?

Most medical problems have many different aspects to consider when deciding on a treatment or course of action for a patient. Look for studies that deal with all the aspects that are of importance to your patient. For instance, a study may show that a treatment is effective for a certain condition, but it does not address the treatment’s side effects. Or a study may indicate that one treatment provides patients better pain relief than another, but may not identify which of the treatments most effectively treats the underlying condition.

In cases like these, you will want to look for other studies that answer the questions which were not addressed by the first study. If you are unable to locate such articles, be aware that you need to fill in the gaps using your own judgment or the recommendations of members of the treatment team.

Were the Groups Selected in an Impartial Way?

The paper should describe in detail how the groups were selected, and the method should be designed so that the groups are as similar as possible in every way except for the one being studied.

If this is not done, then any results of the study could just be due to the initial differences between the groups. For instance, a group of physicians studied air pollution levels and mortality in six U.S. cities (Citation: Dockery et al. 1993. An association between air pollution and mortality in six U.S. cities. New England Journal of Medicine, 329, 1753-9). They went into enormous detail on measurements of mortality and pollution levels and obtained some extremely impressive results. However, they never said anywhere in the paper how or why they selected those six cities. So for all the reader knows, they just looked through the atlas and selected only those cities that had high pollution levels and poor life expectancies, or low pollution levels and good life expectancies, and ignored the rest. The results would have been much stronger if they had studied all cities within a certain region (even in less detail) and/or explained clearly why they selected the cities they did.

Was the Follow-up of Sufficient Duration and Complete?

Conditions under study regarding “Prognosis” and “Harm” often take a long while to run their course. For example, sometimes it can take decades between initial exposure to a carcinogen and full-blown cancer. So a study whose follow-up is not long enough can underestimate risk 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. Patients 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, while others may have lost interest in the healthcare system, possibly to the point that they are no longer taking care of themselves. The study results should indicate how many patients were lost to follow-up, under what circumstances, and whether the rate of attrition could materially affect the results of the study.

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Step Four: Apply the Conclusions to Practice

Ideally, the processes of research, education, professional development and practice should be integrated.

Does it Suggest a Clear and Useful Plan of Action?

The most useful studies are those that suggest a useful plan to improve your patient’s state of health. Studies that help clarify a patient’s prognosis may also be helpful to the patient in making life decisions. Studies that don’t do either of these are of little or no interest to you. A lot of very valuable preliminary research falls into this category. It is not that the research is not good, it’s just that it hasn’t yet reached the point of being able to provide clear-cut clinical recommendations.

Cautiously Reference Clinical Practice Guidelines

Consider the discussion regarding the validity of development methodologies relied upon in creating clinical practice guidelines. Life care planners must be cautious when citing a set of clinical practice guidelines as the sole substantiation for specific plan recommendations.

In addition, consider the fact that most clinical practice guidelines do not address the effects of aging with disability or specify factors influencing long-term 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, life care planners are primarily interested in using prognosis-oriented research literature and practice guidelines to build a foundation for the projected needs of an individual patient.

The link between research literature, clinical practice guidelines, and future needs must be clearly demonstrated within the narrative report and the life care plan. Patients, family members, and other professionals should be able reach the same conclusions represented in a life care plan when given a comprehensive explanation of the methodology and resources used to develop the recommendations.