- RESEARCH DESIGN AND STATS
Introduction to Evidence-based Practice
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.
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
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
*Search secondary databases and the primary literature for
*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
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.
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
*Conduct an effective search of the research literature
*Select the most relevant studies, consider in patient-specific
*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.
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.
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.
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
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
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.
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
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
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
What are the results?
Within the body of literature, there are many studies reporting
statistically significant, but clinically irrelevant results.
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
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
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
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
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 health
care 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.
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.
Suggestions for Further Reading:
Center for Health Evidence:
(Power Point) http://hsc.usf.edu/CLASS/Gene/Presentation/sld001.htm
Netting the Evidence:
SUNY Downstate Medical Center Evidence Based Medicine Course:
University of Illinois at Chicago:
University of Missouri-Kansas City:
The Wisdom Centre: