Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
physician based his prognosis on limited clinical ex- go into testing only five are validated and sent on to
perience with this condition and literature that ulti- the fourth or final testing phase [4].
mately was shown to be out of date. The child, now Reports of the final testing stage can be considered
four years old, is getting ready for kindergarten and to be the point of the wedge both because of the step
is within normal limits for all measures of growth and nature of the research process and the relatively small
development. numbers of trials that are shown actually to improve
The other story involves an accusation of sexual patient care. The testing in the final stage is done in
abuse made by a family medicine resident after as- large, expensive, long-term trials with actual human
sessing what at first appeared to be diaper rash. The patients, often in real-life situations. The rest of this
resident told the parents that she was 100% certain of report will refer to this stage of testing as the clinical
her diagnosis of the lesions and their cause. It was not research stage or clinical research. For every five in-
until the parents who were well educated and trained terventions such as a new therapy or diagnostic test or
in EBP principles pushed for a second opinion that an etiological hypothesis, only one or two are proven
another diagnosis was investigated and confirmed. and become ready for governmental approval and im-
The second opinion showed that sexual abuse was not plementation into routine patient care [5].
involved and, even if the first diagnosis had been cor- Clinicians who practice traditional patient care use
rect, the skin lesions were not necessarily transmitted information from each of the four stages of the health
by genital contact. care research process. In contrast, those who practice
In both situations, the parents endured unnecessary using EBP principles rely on information from the clin-
anguish because the clinicians involved, one of whom ical research stage if available for making clinical de-
was experienced and one who was not, acted with cer- cisions. Evidence from reports in the clinical research
tainty based on an outdated or insufficient knowledge stage is not available for all situations in health care
base. The health care knowledge base, documented in but if information exists in this final testing stage, this
the health care literature, is vast and ever increasing information should be used.
and changing. Traditionally health care professionals Because clinicians who practice EBP rely more on
have acted based on their current knowledge, sought evidence found in the literature base than on clinical
answers from their colleagues, or consulted literature experience and pathophysiology alone, librarians play
that was readily available in their decision making. a key role in the advancement of EBP In fact, librarians
Clinicians who practice EBP rely heavily on the liter- are in an ideal situation to become stronger partners
ature, viewing and applying it differently than tradi- in the improvement of health care. To accomplish this,
tional practioners; this has implications for both health librarians need to learn about the kinds of studies and
care librarians and libraries. trials that comprise the clinical research. With this un-
derstanding, they can help clinicians identify and re-
THE LITERATURE WEDGE trieve this information for patient care. They can also
structure library services to improve retrieval speeds
Health care literature can be pictured as structured in and provide more full-text access.
a wedge-shaped manner consisting of reports from The clinical research stage includes both reports of
four different stages or levels of development. The original research trials and studies and secondary re-
largest stage consists of the earliest level of evaluation, ports that collect, analyze, and present findings from
comprised of reports that deal with communication of multiple studies. These secondary or compiled reports
ideas among researchers and clinicians. The reports include economic evaluations, systematic review arti-
are often letters, editorials, thought pieces, broad gen- cles, meta-analyses, and clinical practice guidelines.
eral review articles, and case reports. Upon discussion All of the material in this clinical research stage is also
and initial testing, some of these ideas are thought to divided into categories of therapy, diagnosis, etiology
be valuable and worth continued testing. These are or harm, and prognosis or natural history of disease
then tested and reported in papers that comprise the and conditions.
next stage of research. This second stage is smaller and The literature reporting clinical research is unique,
includes reports of studies and investigations done in and therefore can be differentiated from reports in the
laboratories with test tubes, cells, tissue samples, and other three stages of research because the studies have
often animals. Some of the laboratory-studied ideas been completed using methods common only to clin-
are shown to be unworthy of continued testing and ical research. Searchers can therefore use index terms
are abandoned, while others can be moved on to the and textwords based on these methods to retrieve only
third stage of evaluation. The third stage is the first clinically relevant material. The rest of this paper brief-
stage that involves humans. Very often volunteers are ly describes the methods used in each category (ther-
used and only a few persons are tested in each inves- apy, diagnosis, etiology, and prognosis) for original
tigation. Although numbers are hard to estimate, one studies, systematic reviews and meta-analyses, and
researcher approximates that for every 5,000 ideas that clinical practice guidelines.
EBP concentrates on using evidence from a very diagnosis, etiology, prognosis, economics, and quality
small portion of the health care literature for clinical improvement, Best Evidence has become a useful tool
decision making. Standard MEDLINE, EMBASE, or for clinical decision making in medicine. Evidence-Based
other systems can be searched using strategies that fil- Cardiovascular Medicine is published by Churchill Liv-
ter or retrieve citations from the clinical research stage ingston; Evidence-Based Health Policy and Management is
using methodology-based searching. This methodolo- published by the Institute of Health Sciences at Oxford
gy-filtered searching in MEDLINE has been validated University in the United Kingdom; and in 1998 Evi-
by Haynes and colleagues [6]. Search strategies were dence-Based Nursing is published by the Royal College
developed using Medical Subject Headings (MeSH), of Nursing and the BMJ Publishing Group, and Evi-
textwords, and phrases and were tested compiled in dence-Based Mental Health is published by the BMJ Pub-
single and complex strategies. The search strategies lishing Group.
were run and measured against a hand search of ten MEDLINE, EMBASE, and other large bibliographic
core medical journals for both 1986 and 1991. Similar databases are currently the main sources of clinical re-
search strategies have been developed for other sys- search information for EBP. Pubmed at www3.ncbi.nlm.
tems such as EMBASE [7] but these strategies and sys- nih.gov/PubMed/ is a very good MEDLINE searching
tems have not been tested in as rigorous a fashion as tool for clinicians because of two features. The "find re-
for MEDLINE. lated" button and the built-in clinical filters that use the
The Internet is not the best source of information for data from Haynes and colleagues [9] are both rapid tech-
EBP. The Internet currently has 150 million Web pages niques for identifying clinical research.
and is projected to have a billion by 2000 [8]. Few of the
sites however, contain health care information reports on THERAPEUTIC INTERVENTIONS
clinical research, which are best suited for EBP. Librari-
ans have produced excellent summaries of EBP for the Most of the studies in clinical research stage report on
Internet. Model examples from the United Kingdom in- trials of therapies-studies that evaluate a new drug,
clude that produced by Andrew Booth at www.shef. surgical technique, counseling program, educational
ac.uk / uni / academic / R-Z / scharr / ir / netting.html, from event, or any other intervention design to improve
the United States that produced by Jean Sullivant for the health, decrease suffering, or reduce costs or service
New York Academy of Medicine at www.nyam.org/li- use without adverse effects on outcomes. Therapeutic
brary/eblinks.html, and from Canada that produced by interventions are studied using a randomized con-
Jeanette Buckingham for the University of Alberta at trolled trials method. Researchers start with a group
www.med.ualberta.ca / ebm /. of patients, all of whom have the disease or condition
A better source of clinical research information is the of interest.
Cochrane Library produced by the Cochrane Collab- Taking the study by Mangano and colleagues [10]
oration. The collaboration is a world-wide volunteer as an example, all of the patients studied had risk fac-
organization and network of health care professionals, tors for coronary heart disease and were scheduled for
patients, and members of the public who are dedicated elective surgery. The investigators wanted to evaluate
to compiling citations to reports of clinical research for whether atenolol, a new cardiac drug, given before
therapy studies, collecting original and producing en- and just after surgery would reduce the rate of myo-
hanced abstracts to systematic reviews and meta-anal- cardial infarctions in patients during the next two
yses of therapeutic studies, and authoring and updat- years. Half of the patients were allocated to receive
ing high-quality systematic reviews in all areas of intravenous and oral atenolol and half were random-
health care. Fuller descriptions are available on the In- ized to receive a placebo. The placebo was saline so-
temet at hiru.mcmcaster.ca/ COCHRANE. lution for the intravenous atenolol and a look-alike,
Another excellent source of clinical research is a se- taste-alike pill for the oral medication. All patients
ries of evidence-based journals recently produced by were followed for the specified two years to ascertain
various publishers. Each journal has taken on the task the number of cardiac events in each group. To remove
of sifting through current journals, collecting reports or reduce biases, these cardiac outcomes were counted
of clinical research, producing structured abstracts of and assessed by the research staff without knowing
the important advances, and providing a commentary which patient received atenolol and which patient re-
on the study by a clinical expert. ACP Journal Club pro- ceived placebo. This is called blinding.
duced by the American College of Physicians was the This example by Mangano and colleagues shows
first, started in 1991 and designed for general inter- some of the features common to evaluation of thera-
nists. The second is Evidence-Based Medicine published peutic interventions:
jointly by the American College of Physicians and the * random allocation
BMJ Publishing Group. Both of these journals have * single-blind, double-blind, or triple blind method
been combined into a computerized product called * placebo
Best Evidence. With just over 1,000 articles on therapy, * clinical trial
study design is the same as for etiology studies except lected studies and analyzed the data that assessed the
that in etiology studies persons with risk factors are risks and benefits associated with hormone replace-
followed to ascertain if disease occurs and in prog- ment therapy in postmenopausal women. The data
nosis studies patients with disease are studied to as- were also analyzed by race, age, and risk factors such
certain progression. The unique aspect of testing for as family history of breast cancer and heart disease
prognosis is that the population at the start of the and bone mineral density levels. Women and their
study should all be at a uniform point of time in the physicians can use the data to assess the evidence
disease, and as close to the initial diagnosis of the dis- while deciding whether to take postmenopausal hor-
ease as possible. This is termed an inception cohort mone therapies. Terms associated with reports of sys-
study by some researchers. An example of a well-done tematic reviews and meta-analyses are: meta-analysis
cohort study on the progression of disease is one done with various spellings-metaanalysis, meta analysis,
at the Mayo Clinic that studied patients with optic meta-analyses, and meta-analytic-and review articles
neuritis [19]. Researchers postulated that individuals with the term MEDLINE in the abstract.
with optic neuritis were more likely to develop mul- Although this has not been fully tested, an effective
tiple sclerosis. Patients were studied for up to forty single-term search strategy for MEDLINE would be
years and researchers found that quite often these pa- "meta-analysis" as a MeSH heading, publication type,
tients did develop multiple sclerosis. To search for or textword. Note also that indexers at the National
prognosis studies, concepts that can be used in search Library of Medicine do not consider meta-analyses to
strategies are: be review articles in their indexing and that indexing
* cohort studies does not differentiate between traditional review arti-
* incidence which is defined as the number of new cles and systematic review articles. More complex
cases in a given period of time search strategies have been suggested, but not proven
* prevalence which is defined as the number of cur- by Hunt and McKibbon [22]. The Cochrane Library is
rent cases at a specific point in time also a good source for identifying systematic review
* follow-up studies articles especially in the systematic reviews database,
* disease progression one of the five sections of the Cochrane Library.
The most effective single-term strategy for MEDLINE
is explode cohort studies, using the MEDLINE ex- CLINICAL PRACTICE GUIDELINES
plode terminology to group like terms together for
searching. Clinical practice guidelines can also be considered to
These four categories complete the description of be secondary publications. The ideal clinical practice
original studies included in the clinical research stage guideline is evidence-based and produced for use in
as well as effective terms associated with each category specific clinical situations. For example, Grady and col-
of therapy, diagnosis, etiology, and prognosis. The leagues [23] used the evidence in their systematic re-
clinical research strategy also includes secondary stud- view as a starting point for the development of a clin-
ies that collect, summarize, and make recommenda- ical practice guideline for counseling United States
tions based on multiple original studies. A special women about hormone replacement therapy [24]. The
class of review articles has been developed in the past American College of Physicians in conjunction with
twenty years. These systematic review articles and their working committees has produced and endorsed
their subset meta-analyses have been described in a the guideline, which has been extensively used in
series in the Annals of Internal Medicine [20]. health care settings since publication in late 1992.
Systematic review articles differ from traditional re- Many clinical systematic reviews and clinical practice
view articles in that they must include the specific clin- guidelines are produced, either alone or as pairs of
ical questions they were designed to address, an ex- documents, and their rate of publication is increasing
plicit statement of the methods the authors used to dramatically. Many institutions are starting to develop
identify the studies to be combined such as search their own clinical practice guidelines and universities
strategies, databases searched, and years studied. If the are starting to offer courses in the production of sys-
combined analysis can be done using mathematical tematic reviews. MEDLINE can provide many clinical
and statistical calculations, the systematic review also practice guidelines but the HealthStar database may be
becomes a meta-analysis; if the combination of data the best database to use to search for them. HealthStar,
can only be in a narrative form because mathematical produced by the National Library of Medicine, was re-
combination is not possible for logistic or other rea- designed to collect practice guidelines and citations to
sons, the systematic review stays a systematic review studies and reports that can be used in the develop-
article. European systematic reviews are also called ment of clinical practice guidelines. Retrieval terms for
overviews. database searching include:
A good example of a systematic review is a meta- * guidelines
analysis done by Grady and colleagues [21]. They col- * practice guidelines