Beruflich Dokumente
Kultur Dokumente
00
From the Department of Prosthodontics, New York University College of Dentistry; and
Department of Dental Material Science, New York University Graduate School of Arts
and Sciences, New York, New York
known variables that come in to play in all studies, are equally distrib-
uted among the test groups. To ensure equal distribution, the study
population (N) must be sufficiently large. A randomized controlled trial
(RCTs) is considered the optimal research design and is the reference
standard for most clinical questions. Not all RCTs, however, are properly
planned and carried out. The reader must still examine the methodology.
Also, as Sackett concluded, ‘‘some questions about therapy do not re-
quire randomized trials (successful interventions for otherwise fatal in-
terventions) or cannot wait for the trials to be conducted. And if no
randomized trial has been carried out for our patient’s predicament, we
follow the trail to the next best external evidence and work from there.’’23
Feinstein9 has questioned the blind faith often put in randomized
trials and has suggested that prognostic stratification is critical to the
utilization of the data. He maintains that if data are to be evaluated
in prognostic subgroups, those subgroups should be identified, where
possible, before the study starts, and that subjects should be allocated to
those subgroups before they are randomly allocated to treatment.10 For
example, in a study on implants in which the site (anterior mandible
versus posterior maxilla) is a major variable, it would be sensible to
identify the site before randomizing to ensure that chance alone does
not place most of the anterior mandibles in one group and most of the
posterior maxillae in the other. Another potential confounder would be
smoking. Although it would be unwieldy, if not impossible, to identify
every possible variable, certain dominant ones known to affect the
outcome of the therapy should be identified at the start of the project.
It is critical that all patients who enter a trial are properly accounted
for at its conclusion. It is not enough to say that a certain number of
patients dropped out. One must include the dropouts in the statistical
analysis (see article by Clive on page 137 of this issue). The most
common reason patients drop out of a therapy trial is because they are
unhappy with the therapy. Some subjects die, and some move out of the
area, but the number in these categories should be relatively equal in
the control and test groups. If the drop-out rate exceeds 20%, the clini-
cian should be concerned about the external validity or generalizability
of the project.
Blinding means that someone was not aware of the treatment being
rendered. Double-blinded means that both the evaluators and the patients
4 GOLDSTEIN
remaining. If six implants were placed and three were lost, the prosthesis
might be stable, but the clinician has cause to question the data.
The critical question for clinicians is whether the results will help
them provide better care for their patients, because that question in-
volves all the others. If the methodology is good, if the statistically
significant results have clinical relevance, and if the data interpretation
is rational, one would lean towards accepting the study. If, however, the
population is not representative of a clinician’s practice or if the inclusion
and exclusion criteria do not match the practice population, clinicians
should be hesitant about applying the results to the population they are
treating.3
6 GOLDSTEIN
nies have already developed evidence based care policies that require
dentists to prove that patients need the services.3 The possibility of abuse
does not mean that dentistry should reject EBD. Indeed, dentists have
been practicing EBD, in part, for many years. When clinicians tell pa-
tients to brush and floss, they do so because the evidence supports the
efficacy of these interventions. When dentists advocate fluoride, they do
so because the evidence supports its efficacy. Although many areas of
dental practice are supported by numerous high-quality research proj-
ects, many more areas are supported only by anecdotal data. Hence, the
validity of the data and who evaluates it become critical. Aurbach4 has
questioned:
‘‘Who will be the anointed one or group that determines which evidence
is valid? Who will set the research agenda and determine where the
results will be maintained? Who will validate the research? Who will
maintain the data base to make sure that it is up to date? How will the
results be used?’’3
It is obvious that to control the data, clinicians need to own it. If
clinicians are not sophisticated enough to force good research practices
by their ability to evaluate and reject poor science, they will be at the
hands of third parties who can use dubious research as justification to
control clinicians’ practices. The sooner dentistry as a profession univer-
sally embraces EBD, the sooner the profession will command the use of
research and prevent its misuse.
Evidence based dentistry is not a veil to mask the same old, inade-
quate research. It is disturbing to see lecturers invoke EBD and present
the same anecdotal lectures they gave before, with different slide titles.
As the profession of dentistry becomes more sophisticated, researchers
and lecturers will be forced to grow also. Evidence based dentistry does
not take the clinical decisions out of clinicians hands and put them into
the hands of the literature. In fact, the opposite is true. Evidence based
dentistry gives guidelines for the clinician and relies first on clinical
expertise.
Evidence based dentistry does not mean that third parties will
control dental practices. In fact, educated dentists, understanding the
literature, will be able to prevent the misrepresention of data by commer-
cial interests.
Evidence based dentistry does not mean the clinician need not
study basic and dental material sciences. In fact, the opposite is true. To
evaluate the research presented, clinicians need a solid background on
which to base their evaluations and decisions.
Evidence based dentistry does not mean clinicians abandon every-
thing they learned in dental school. It does not force clinicians to go
backwards to justify things the profession universally accepts.
8 GOLDSTEIN
References
1. Anderson JD: Need for evidence based practice in prosthodontics. J Prosthet Dent
83:58–65, 2000
2. Anderson JD, Zarb GA: Evidence based dentistry: Prognosis. J Prosthet Dent 83:495–
500, 2000
3. Anderson V: Evidence based care, is the defense ready? Dental Economics 28–32, 2000
4. Aurbach FE: Evidence based dentistry: A practitioner’s perspective. J Am Col Dent
66:17–20, 1999
5. Carr AB, McGivney GP: Measurement in dentistry. J Prosthet Dent 83:266–271, 2000
6. Carr AB, McGivney GP: Users’ guides to the dental literature: How to get started. J
Prosthet Dent 83:13–20, 2000
7. Chambers D: Research for practitioners or research for researchers? J Am Coll Dent
65:2–4, 1998
8. Eckert SE, Goldstein GR, Koka S: How to evaluate a diagnostic test. J Prosthet Dent
83:386–391, 2000
9. Feinstein AR: An additional basic science for clinical medicine: II. The limitations of
randomized trials. Ann Intern Med 99:544–550, 1983
10. Feinstein AR: An additional basic science for clinical medicine: III. The challenges of
comparison and measurement. Ann Intern Med 99:705–712, 1983
11. Felton DA, Lang BR: The overview: An article that interrogates the literature. J Prosthet
Dent 84:17–21, 2000
12. Goldstein GR, Preston JD: How to evaluate an article about therapy. J Prosthet Dent
83:599–603, 2000
13. Guyatt GH, Sackett DL, Cook DJ: Users’ guides to the medical literature. II. How to
use an article about therapy or prevention. A. Are the results of the study valid?
Evidence-Based Medicine Working Group. JAMA 270:2598–2601, 1993
14. Guyatt GH, Sackett DL, Cook DJ: Users’ guides to the medical literature. II. How to
use an article about therapy or prevention. B. What were the results and will they
help me in caring for my patients? Evidence-Based Medicine Working Group. JAMA
271:59–63, 1994
15. Jacob RF, Carr AB: Hierarchy of research design used to categorize the ‘‘strength of
evidence’’ in answering clinical dental questions. J Prosthet Dent 83:137–152, 2000
16. Jacob RF, Lloyd PM: How to evaluate a dental article about harm. J Prosthet Dent
84:8–16, 2000
17. Jaeschke R, Guyatt G, Sackett DL: Users’ guides to the medical literature. III. How to
WHAT IS EVIDENCE BASED DENTISTRY? 9
use an article about a diagnostic test. A. Are the results of the study valid? Evidence-
Based Medicine Working Group. JAMA 271:389–391, 1994
18. Jaeschke R, Guyatt GH, Sackett DL: Users’ guides to the medical literature. III. How
to use an article about a diagnostic test. B. What are the results and will they help me
in caring for my patients? The Evidence-Based Medicine Working Group. JAMA
271:703–707, 1994
19. Laupacis A, Wells GA, Richardson S, et al: Users’ guides to the medical literature V.
How to use an article about prognosis. JAMA 272:234–237, 1994
20. Levine M, Walter S, Lee H, et al: Users’ guides to the medical literature IV. How to
use an article about harm. JAMA 271:1615–1619, 1994
21. Oxman AD, Cook DJ, Guyatt G: Users’ guides to the medical literature VI. How to
use an overview. JAMA 272:1367–1371, 1994
22. Oxman AD, Sackett DL, Guyatt GH: Users’ guides to the medical literature. I. How to
get started. The Evidence-Based Medicine Working Group. JAMA 270:2093–2095, 1993
23. Sackett D, Richardson WS, Rosenberg W, et al: Evidence based Medicine: How to
Practice and Teach EBM. New York, Churchill Livingstone, 1997
e-mail: gary.goldstein@nyu.edu
EVIDENCE BASED DENTISTRY 0011–8532/02 $15.00 .00
THE QUESTION
James D. Anderson, BSc, DDS, MScD
There are two aspects to the clinical practice of dentistry. The surgi-
cal component includes all the manipulation of hard and soft tissue that
is performed every day in dental practice. Examples are tooth prepara-
tion and restoration, scaling, orthodontics, and prosthesis fabrication.
The other element involves decision making. The diagnosis of unlocal-
ized dental pain, the prognosis for a periodontally compromised tooth,
the choice of posterior restorative materials, and the risks/benefits as-
sessment of third molar extractions are examples. Early in the career,
decision making may be the most difficult aspect of clinical practice.
There is an overwhelming array of choices with little or no structure on
which to build an approach to solving the problems. As a practitioner
gains experience, he or she acquires the advantage having seen the
results of previous decisions, good and bad, and can recall how a
problem was dealt with previously. The practitioner also develop habits
that make each task easier. Habits, too, are the result of decisions made
but not re-examined.
As a start, the thoughtful practitioner will ask first if there is a
compelling reason to intervene for a patient, and second if there is a
compelling reason to intervene at this time. The answers to these ques-
tions can be obvious or elusive. The patient who has severe, throbbing
pain and tender swelling over the apex of a heavily carious lateral
incisor with a large periapical radiolucency clearly needs treatment and
needs it promptly. On the other hand, whether or when to treat the
young patient with impacted but asymptomatic third molars is less
From the Faculty of Dentistry, University of Toronto; and the Craniofacial Prosthetic Unit,
Toronto-Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada
WHICH QUESTIONS?
WHY BOTHER?
TYPES OF QUESTIONS
Framing a Question
The clinician now wants to scan the found titles and abstracts
quickly to identify the best one or two articles that are most likely to
answer the patient’s question. Here, again, the details of the question
facilitate the process. Each title (and abstract, if necessary) is scanned,
and the content is compared with the population, maneuvers, and out-
comes articulated in the question.
Of the five titles found in the search, the first is a case series by
Leimola-Virtanen7 that followed four implants in the mandibles of 39
patients for 3 to 10 years. Implant and prosthesis success rates are
provided. This article thus seems to address the patient’s question quite
closely, except the prostheses used were denture prostheses, not fixed
prostheses. In addition, being a case series, the article offers no control
against which to compare the success rates found in the patients with
only four implants. This article therefore is not a strong piece of evidence
to use in answering the patient’s question.
The title of the next article, by Jemt and Lekholm,5 seems to deal
more with varying amounts of remaining bone. Nothing is said about
the number of implants or prosthesis type used. A quick check of the
abstract against the criteria in the question confirms that this article will
not help answer the question.
The title of the third article describes a study by Brånemark and
others2 that compares the use of four implants against six implants in
edentulous patients. By the title alone, this article seems to satisfy two
of the criteria specified in the question. A check of the abstract reveals
it to be a study that uses a cross-sectional design that provides a control
group to assess the success rates in the four-implant group against a
control group with more implants. This article thus provides much
stronger and more focused evidence of the implant and prosthesis suc-
cess rates that could be expected when only four implants are available.
The fourth article by Zarb and Schmitt10 provides a title and abstract
18 ANDERSON
that are too vague to identify the details of either the maneuvers or the
outcomes. With the relatively focused article by Brånemark et al avail-
able, there seems little value in retrieving this article and reading it
in detail.
Finally, the title of the fifth article, by Jemt and others4 suggests that
the article deals with overdentures exclusively and thus is not relevant
to the patient’s problem.
This review of the found titles has revealed an article that seems to
address the practitioner’s question directly and provides a study design
that permits useful comparisons of success rates to support an answer
to the patient. Although the evidence is not compelling (the study is not
a randomized trial), it is the best available evidence that bears directly
on the question. The patient can thus be informed that leaving his
prosthesis to function on four implants is unlikely to pose greater risk
of implant or prosthesis failure than there was when there were more
implants. The patient is thus spared the time, cost, and discomfort of
further implant surgery while avoiding any extra risk of failure.
SUMMARY
This exercise of isolating the strongest article from the found titles
should take no more than 1 to 2 minutes. Thus, the whole process of
searching for the best evidence should take no more than 5 minutes. In
medical practices where evidence based practice is done routinely, this
process can be completed in less than 1 minute.8 Obviously, the evalua-
tion could not have been made as expeditiously without the benefit of
the specific details articulated in the question. The question focused the
search terms and expedited the identification of the strongest evidence
that directly addressed the patient’s problem from among the found
titles. It provided the dentist with good (but not compelling) evidence
to support an answer to the patient. It also provided the dentist with a
new piece of information to use the next time the problem of reduced
implant support comes up. The dentist has thus enjoyed the satisfaction
of quickly identifying new knowledge and the confidence that comes
with its use. In addition, the information has provided the dentist
with a small but important block against the deterioration of clinical
judgment skills.
References
e-mail:jim.anderson@utoronto.ca
EVIDENCE BASED DENTISTRY 0011–8532/02 $15.00 .00
THERAPY
Anecdote, Experience, or Evidence?
From the Department of Prosthodontics, New York University College of Dentistry; De-
partment of Dental Material Science, New York University Graduate School of Arts
and Sciences, New York, New York (GRG); and The University of Southern California
School of Dentistry, Los Angeles, California (JDP)
not be representative of the clinicians’ patients, and the study may have
decreased validity.
For example, in a well-done study on IPS Empress inlays and
onlays, the population (N 130) consisted of 27 one-surface inlays, 38
two-surface inlays, 40 three-surface inlays,8 and 25 onlays.1 A significant
percentage of the population consisted of class I restorations; therefore,
the data may not be pertinent to a clinician who does not normally
perform class 1 restorations.
Exactly what a study is to measure must be determined in advance,
and the methods of measurement of the effects must be clearly and
specifically stated. The precision of the measurements (or the converse,
the error of the study) must be established before the study is initiated.
It is not enough to know that the microscope used had a precision of 5
m. The ability of investigators to repeat their measurement is crucial.
How many persons were involved in making the measurements? Was
their equipment calibrated to ensure that the measurements were equiva-
lent? The method by which the study is to be analyzed must also be
established a priori. Too often, investigators gather data only to find that
statistical analysis is compromised by the procedures used.
The outcome assessment must be relevant. Investigators sometimes
are encumbered by the dogma that the only legitimate way to do an
experiment is to vary one factor at a time.1 This univariate approach is
at odds with the multivariate climate in which the clinician functions.
For example, in reviewing the current literature for dental luting ce-
ments, Rosenstiel et al6 listed 10 different clinically important parame-
ters. A study that concentrates on only one factor may not supply
enough information to warrant a change in material.
Readers must be acutely aware of the structure of the study before
trying to ascertain its applicability to their patients. The design is deter-
mined by the direction of inquiry, who determines the therapy, and the
presence of a control group. Prospective studies are those in which the
therapy is initiated at the start of the study. The advantage of a prospec-
tive trial is that, theoretically, the investigator can control all aspects
of the treatment and minimize the effect of confounding variables.
Retrospective studies are those in which the therapy was initiated before
the beginning of the study. The disadvantage of this study design is the
inability of the investigator to control inadvertent confounding variables.
Studies can be further divided into comparative studies, (also called
analytical studies) that have a control group, and descriptive studies
with no control group.
The hierarchy of evidence can be listed as
1. Comparative studies
• Prospective studies
Randomized, controlled trials (RCTs) – assignment to therapy
is under the control of the investigator
Cohort study – two matched study groups (cohorts) are assem-
THERAPY: ANECDOTE, EXPERIENCE, OR EVIDENCE? 25
SUMMARY
read or see have the greatest validity possible. This validity is imperative
to achieve evidence-based dentistry that uses relevant, high-quality, clini-
cally oriented research that provides better information for the clinician
and better treatment for the patient.
References
1. Brunette DM: Critical Thinking. Understanding and Evaluating Dental Research. Chi-
cago, Quintessence Publishing Co, 1996
2. Chambers D: The big placebo. J Am Coll Dent 66:2–5, 1999
3. Goldstein GR, Preston JD: How to evaluate an article about therapy. J Prosthet Dent
83:599–603, 2000
4. Jacob RF, Lloyd PM: How to evaluate a dental article about harm. J Prosthet Dent
84:8–16, 2000
5. McCoy RB, Anderson MH, Lepe X, et al: Clinical sucess of class V composite resin
restorations without mechanical retention. J Am Dent Assoc 129:593–599, 1998
6. Rosenstiel SF, Land MF, Crispin BJ: Dental luting agents: A review of the current
literature. J Prosthet Dent 80:280–301, 1998
7. Sackett D, Richardson WS, Rosenberg W, et al: Evidence-based Medicine: How to
Practice and teach EBM. New York, Churchill Livingstone; 1997
8. Struder S, Lehner C, Brodbeck U, et al: Short-term results of IPS-Empress onlays and
inlays. Journal of Prosthodontics 5:277–287, 1996
9. Witter DJ, Creugers NHJ, Kreulen CM, et al: Occlusal stability in shortened dental
arches. J Dent Res 80:432–436, 2001
e-mail: gary.goldstein@nyu.edu
EVIDENCE BASED DENTISTRY 0011–8532/02 $15.00 .00
From the Office of Academic Affairs and Scholarship, School of Dentistry, University of
the Pacific, San Francisco, California
Principle Definition
Autonomy The right of the patient, the dentist, and any other competent
individual who is involved to determine what should be done
by and to them
Beneficence An obligation to help others, normally assumed in exchange for
privileges granted a group such as professionals
Competence The capacity to perform as one promises or as expected
Integrity Consistency throughout one’s actions and language; being
guided by core values
Justice Fairness in the distribution of rewards and obligations and in
the processes by which distribution is made; sometimes tested
by a willingness to trade places with others one deals with
Nonmaleficence Avoiding unnecessary harm to others
Veracity Telling the truth and creating environments where honest views
are expressed
Patients also realize that they are expected to be present and prompt for
appointments, to pay their bills, to answer honestly when asked about
their health, and to comply with reasonable requests for home care
and postoperative recommendations. This general therapeutic alliance is
understood by reasonable adults. It is the background for the jury
system, and it makes health care possible and efficient. No book contains
these rules, and they are normally discussed only when something
unexpected happens. Patients participating in insurance fraud or dentists
who performs unnecessary work generally understand that they are
acting outside the normal bounds of right and wrong.
In other cases, the therapeutic alliance is ambiguous. The patient
knows a damaged tooth must be fixed. But there are choices: considera-
tions of function, appearance, and cost must be understood and
weighed. Or the patient may be uncertain whether to remain with the
current dentist. The hours are inconvenient, the staff may not show
respect, and the dentist is abstemious with explanations. Again, an
understanding must be reached. These are not cases of universal expecta-
tions that form a treatment alliance. They represent alternatives in a
range of variation that contains individuality. Some dentists are known
to be expensive or to focus on esthetics. Others are known to take a
holistic approach. Some patients have personal traits that make them
difficult to deal with; others require an inordinate amount of attention.
As long as the office team and the patient can come to an understanding
about what is mutually acceptable, the treatment alliance can be pre-
served across a wide range of individual variation. Of course, there is a
limit to individual agreements that exceed public acceptability. Dentists
cannot perform medicine even if the patient agrees to medical proce-
dures, and insurance fraud is unacceptable, even with patients’ collusion.
Discursive ethicists are concerned with ethical communities and
agreements that promote civil good. Making and keeping promises is
central to a discursive view of ethics.7 A definition that is used in this
article is Ethics is the creation, adjustment, and maintenance of communities
in which participants can reach their potentials.
Several aspects of this definition go beyond the traditional concept
of ethics. First, ethics is a community activity; it concerns the relation-
ships among people. There are no private ethics. Ethics is something
people do together. Second, ethical understandings are created. This is
different from some traditional notions that there are abstract ethical
principles that must be discovered or with which all people would
agree. Discursive ethics is not ethical relativism; some actions such as
lying, murder, and seeking to avoid the penalties of violating agreements
are universally abhorred. The general treatment alliance mentioned pre-
viously contains such examples. Discursive ethics also recognizes that
there can be ethical violations within specific communities. A husband
can cheat on his wife in ways that might not bother other couples. A
dentist can violate the confidence of a patient without violating the ADA
Code or any generally accepted set of ethical rules. Third, discursive
ethics is concerned with the obligation to create ethical communities and
THE ETHICS OF EXPERIMENTING IN DENTAL PRACTICE 33
Scientific Investigation
Type Characteristics
Scientific investigation Extreme uncertainty regarding outcomes,
rigorous control, nonpractice context, purpose
to discover general principles, results in
publications
Experimental practice High probability of success, careful observation
rather than control, realistic settings, purpose
to discover more effective methods, results in
improved practice
Heroic measures High probability of failure, little control, all else
has failed
Doing nothing Unknown outcomes, no control, changes in
practice unrelated to outcomes
Experimental Practice
The patient’s interests must always be the primary concern, and the
reasons for experimentation must always be to improve patient oral
health. Placing patients at risk in hopes of finding a faster or more
profitable way of delivering care is unethical. It is true that all three
parties (dentist, profession, and patient) are at risk in most practice
experiments, but patients cannot be co-opted into endeavors in which
they bear risk for the sake of other’s potential gain. It is insufficient to
argue that patients tacitly agree to general experimentation by agreeing
to care. (Treatment in dental schools is a possible exception to the rule.)
A special challenge to the principle of patients first involves the
38 CHAMBERS
Standard of Care
Third, there must be probable reason to expect success with the new
product or procedure or patient. This baseline of probable success can
THE ETHICS OF EXPERIMENTING IN DENTAL PRACTICE 39
Systematic Approach
Heroic Experiments
Heroic experiments are high risk. Although they may be undertaken
in the patient’s best interests, they normally fail two other tests: being
within the standard of care and having evidence of probable success.
Normally, heroic efforts are considered only when there is no other valid
alternative. Professional groups and the public at large normally frown
on such interventions because they expose both the individual patient
and the system for deciding what is appropriate behavior to risk. Den-
tists who may be attracted to such interventions are well counseled to
investigate the standard of care carefully.
The fundamental justification for heroic effort is that all other con-
ventional alternatives have been exhausted and that great risks are
justified to protect the patient from grave harm. There are presumed
trade-offs between the criterion for evidence of probable success and the
criterion for improving the patient’s well being. For such trade-offs to be
considered valid, there is a greatly heightened requirement for informed
consent. The patient’s true interests must be carefully explored, and
there must be overwhelming evidence that the patient understands the
risks associated with various outcomes (including no treatment) and
that the patient has made a completely uncoerced decision. The criteria
are written in capital letters when cases of experimentation in the dental
office deviate from standard circumstances. There may also be cases in
which the patient agrees to heroic treatment that would shock the
profession or the public. A private agreement between the patient and
the dentist—for example, to practice outside legal limits—is still unethi-
cal because there are communities to consider other than the patient.
Generalizability
References
4. Chambers DW: Looking for virtue in a virtuous society – discursive ethics and dental
managed care. J Am Coll Dent 63:39–42, 1996
5. Chambers DW: The roles of evidence and the baseline in dental decision making. J
Am Coll Dent 66:60–68, 1999
6. Chambers DW: Above all, check your references. J Am Coll Dent 67:2–3, 2000
7. Chambers DW: Promises. J Am Coll Dent 67:51–55, 2000
8. Chambers DW, Abrams RG: Dental Communication. Sonoma, CA, The Ohana
Group, 1986
9. Chambers DW, Eng WRL Jr: Practice profile: The first twelve years. Journal of the
California Dental Association 12:25–32, 1994
10. Ethics of managed care. J Am Coll Dent 63: entire issue, 1996
11. Licensure Results. News & Views [the newsletter of the American College of Dentists]
26:5, 1998
12. Ozar D, Sokol D: Dental Ethics at Chairside: Professional Principles and Practical
Applications. Washington, DC, Georgetown University Press, 1999
13. Peltier B: Reflection, introspection, and communication: A psychologist’s view of
dental ethics. J Am Coll Dent 67:33–38, 2000
14. Rest JR, Narvaez D: Moral Development in the Professions: Psychology and Applied
Ethics. Hillsdale, NJ, Lawrence Erlbaum, 1994
15. Rule J, Veatch R: Ethical Questions in Dentistry. Chicago, Quintessence, 1993
16. Schon DA: The Reflective Practitioner: How Professionals Think in Action. New York,
Basic Books 1983
17. Toward responsible research conduct: The role of scientific societies. J Dent Res 75:823–
860, 1996
e-mail: dchambers@uop.edu
EVIDENCE BASED DENTISTRY 0011–8532/02 $15.00 .00
CONDUCTING A SEARCH OF
THE LITERATURE
David A. Felton, DDS, MS
Unless the clinician has access to a health sciences library, the use
of traditional source materials such as Index Medicus or the Index to
Dental Literature may be limited. Determining under which traditional
headings in the Index to Dental Literature a particular topic is listed can
also be time-consuming. Each volume of these indices generally covers
the topics published in a single year, and searching through the array of
these indices is often daunting. When reviewing these indices, the reader
is urged to begin with the most current year’s index and to work
backward in time, unless the exact publication date of an article on a
particular subject is known. The exception for this technique might be a
search for a treatment material or method that is antiquated or no longer
practiced, such as the gold foil technique or the clinical use of a particu-
lar all-ceramic crown material that is no longer manufactured. For these
historical searches, review articles might be useful initial sources for the
topic of interest.
the clinician to discard old journal issues that may be consuming valu-
able space in the office or home. The disadvantage of this search tech-
nique is that it allows a search for articles in only one particular journal,
rather than providing a more comprehensive listing of all articles pub-
lished on any given topic. This technique may prove too limiting when
treatment decisions require a more comprehensive approach. Several
journals typically underwrite dental conferences or symposia and often
provide a CD-rom or on-line review of the conference proceedings, for
an appropriate fee. This review may serve as an additional source of
information for the busy clinician. Finally, several journals provide CD-
rom disks of their published manuscripts for persons without internet
access.
ELECTRONIC DATABASES
concluded that the field of dentistry has a long way to go to provide the
clinician with an adequate amount of conclusive evidence for planning
treatment interventions in patient care.
Once the list of citations has been produced, each can be opened to
review an abstract of the article (if available) for initial review. If a useful
article is found, one can improve search results by selecting the related
articles link to find others that MEDLINE has assessed. The entire text
of the article can then be ordered through a link to the publisher (if
available), or through the Loansome Doc Document Ordering service
described previously. When the entire article has been obtained, how-
ever, it is essential that the precepts of evidence based dentistry be
accurately applied to determine whether the research methods, use of
control groups, appropriate sample size, and appropriate statistical tests
have been suitably employed so that the article provides a valid presen-
tation of data. Otherwise, to paraphrase the ancient Romans, ‘‘caveat
lector’’ or, ‘‘Let the reader beware!’’
References
1. Felton D, Lang B: The overview: An article that interrogates the literature. J Prosthet
Dent 84:17–21, 2000
2. Oxman A, Guyatt G, for The Evidence based Medicine Working Group: How to use an
overview. In Sakett DL: Evidence based Medicine: Users’ Guides to the Medical Litera-
ture. Hamilton, Canada, McMaster University Health Sciences Centre, 1993
3. Oxman A, Cook D, Guyatt G, for The Evidence based Medicine Working Group: Users’
guide to the medical literature. VI. How to use an overview. JAMA 272:1367–1371, 1994
From the Department of Oral Health Policy and Epidemiology, Harvard School of Dental
Medicine, Boston, Massachusetts
ing of the various types of research studies. Briefly, there are two broad
categories of research: basic science and clinical research. The principles
that govern the validity of scientific research are common to both
branches of scientific research. It is more challenging to ensure that a
study is free of bias with clinical research than with basic science or
laboratory research, because in the laboratory the researcher has more
control over the environment and other variables that may influence the
results of the study. This article focuses on assessing the validity of
clinical research studies.
It is important to understand the hierarchy of evidence in clinical
research. All clinical research studies are encompassed under the broad
heading of epidemiologic studies. Epidemiology is defined as the study
of the distribution and determinants of disease frequency in human
populations.2 The distribution of disease refers to who is at risk for a
particular disease. For example, older men have the highest risk for oral
cancer. The determinants of disease are the factors that affect the individu-
al’s risk of developing a disease. For example, tobacco use increases an
individual’s risk for developing oral cancer and is thus considered a risk
factor. A risk factor may increase an individual’s likelihood of devel-
oping a disease (as smoking increases the risk of lung cancer), or it may
decrease an individual’s likelihood of developing disease (as fluoride
decreases the risk of dental caries). In clinical research the aim is to
quantify risk relationships as well as benefits of specific treatments to
improve the health of the public.
Epidemiologic studies include studies that follow the natural course
of disease or treatment effects as well as studies in which the investiga-
tors intervene in assigning a treatment for a particular condition or in
using a preventive agent to decrease likelihood of disease. These studies
can be categorized into two broad categories: descriptive and analytical
studies.
Descriptive Studies
Descriptive studies describe the general characteristics of the distri-
bution of a disease, particularly in relation to person, place, and time.
EVIDENCE BASED DENTISTRY: DESIGN ARCHITECTURE 53
Analytic Studies
study that minimizes bias of the study findings. Also, the ability to
assign subjects randomly into treatment groups ensures that the only
difference between study groups is the intervention being evaluated. In
a randomized study, each subject has an equal likelihood of being
assigned to any of the study groups, thus reducing the influence of bias.
This process creates groups that are relatively similar with respect to all
variables except for treatment, thus balancing the study groups in terms
of known and unknown confounders. Randomization to create similar
study groups is possible only with clinical trials and therefore signifi-
cantly increases the validity of these studies in comparison with other
clinical research study designs. Whenever possible, a clinical research
question should be addressed with a double-blind, randomized, con-
trolled clinical trial. Such a trial is not always feasible for ethical or
logistic reasons, leading investigators to choose one of the other study
designs.
In observational studies, investigators observe the natural course of
events, noting which subjects are exposed or not exposed, which have
had a particular treatment and which have not, and which have or have
not developed the outcome. There are two subcategories of observational
studies: cohort studies and case-control studies. In a cohort study, sub-
jects are selected on the basis of presence or absence of a particular
exposure (treatment) and then followed to determine the association
between the exposure (treatment) and outcome. All subjects must be
free of the disease of interest at the time the exposure is defined. Cohort
studies are efficient for the study of rare exposures, such as occupational
exposures (e.g., to asbestos), provide the ability to examine multiple
effects of a single exposure, and provide the ability to determine the
temporal relationship between exposure and disease. Cohort studies also
have disadvantages: they are inefficient for the study of rare diseases,
they may be expensive and time consuming, and they have the potential
for loss-to-follow-up bias that may affect the validity of the study.2 An
example of a cohort study in dental research is following individual
smokers and non-smokers to determine their risk for developing peri-
odontal disease. The study subjects must be free of periodontal disease
when the study begins.
The second class of observational studies are case-control studies in
which subjects are selected on the basis of whether or not they have the
disease of interest. Case-control studies are efficient for studying rare
diseases and diseases with long latency periods and have the ability to
examine multiple causes of a single disease. The disadvantages of case-
control studies include their inefficiency for the study of rare exposures,
the difficulty in establishing a temporal relationship between exposure
and disease, and their susceptibility to selection and recall bias.2 An
example of a case-control study is a study examining the association
between oral cancer and smoking. Oral cancer cases are compared with
a similar group of individuals who do not have oral cancer to determine
the difference in smoking rates between the groups. This approach was
used when it was first discovered that smoking is a significant risk factor
EVIDENCE BASED DENTISTRY: DESIGN ARCHITECTURE 55
for lung cancer. It is important that cases and controls be selected from
the same source population to ensure that study subjects are similar
except in respect to the diagnosis of the study disease.
In summary, the study design chosen to address a specific research
question must take into account the nature of the exposure or treatment
and the nature of the outcome as well as ethical and logistic considera-
tions. For example, if one were studying the effect of two treatments on
a particular disease, to randomize subjects ethically to one treatment or
the other, there must be sufficient belief that either treatment may offer
benefits to the study participant and that neither treatment poses any
risk. This assurance is often not possible, and researchers therefore
choose one of the other analytic approaches. It is important to decide
if the disease or outcome is considered rare and thus decide which
observational design is most efficient in addressing the specific ques-
tions, keeping in mind that bias and confounding are of greater concern
in observational than in intervention studies.
STUDY SAMPLES
MEASURES OF ASSOCIATION
The relative risk of 0.71 indicates that the standard therapy, scaling
and root planing, is more beneficial in treating periodontal disease. The
classification of treatment success may be considered arbitrary, and the
investigator may wish to evaluate several outcomes, such as actual
attachment loss in millimeters.
In case-control studies, a relative risk cannot be used, because by
definition the cases in a case-control study already have disease. Instead
an odds ratio is calculated using the same 22 table format. Essentially,
the odds ratio determines the odds of being exposed among cases and
controls.
disease. The participants’ smoking status was then ascertained by self report
and validated by coltinine levels. Of the 1000 subjects with periodontal disease,
400 were smokers, compared with 200 of the controls subjects. The results are
shown in Table 3.
The interpretation of the odds ratio is the same as the relative risk.
Therefore, in this example, the conclusion is that smokers are 2.7 times
more likely to have periodontal disease than nonsmokers.
CONFIDENCE INTERVALS
The measures of association are calculated with data from the sam-
ple of individuals being studied; however, it is the population estimate
of risk that is of interest. To estimate the population value of the measure
of association, a confidence interval is calculated. A confidence interval
is one method of statistical inference that allows statements to be made
about the population using data from the sample. The most commonly
used method is that of calculating a 95% confidence interval. The meth-
ods of calculation are beyond the scope of this discussion; interested
readers are referred to a statistical text.1, 5 Briefly, the data can be used
to calculate an interval that includes lower and upper limits. For exam-
ple, in a study conducted to examine the association between diabetes
and tooth loss, the relative risk was calculated to be 1.9, and the 95%
confidence interval was calculated to be 1.2 to 2.7. That is, the data
indicate that there is approximately a twofold increase in the risk of
tooth loss among diabetics as compared with nondiabetics. It can be
concluded with 95% confidence that the true risk is between a 20%
increase and a 2.7-fold increase. Because the null value of 1.0 is not
included in this interval, this result is statistically significant.
ASSESSING VALIDITY
Disease Status
SUMMARY
References
e-mail: catherine_hayes@hms.harvard.edu
EVIDENCE BASED DENTISTRY 0011–8532/02 $15.00 .00
From the Department of Head and Neck Surgery, MD Anderson Cancer Center, Hous-
ton, Texas
CLINICAL RESEARCH
How the human population as a whole behaves under natural
conditions and how the entire population of humans responds to a
particular treatment are the ultimate health care questions for researchers
and clinicians. Because the entire human population cannot be entered
into or managed in a study, researchers and clinicians rely on the laws
of probability and inferential statistics, which allow smaller sample
populations to be studied as representatives of the population as a
whole. These studies of sample populations use a multitude of research
methods to determine the relationship between event and outcome. If
stringent research and design criteria are not maintained, the assurance
is lost that the sample population and its event-to-outcome relationship
accurately represent that relationship in the total population; the study
lacks validity.
Health care research designs are broadly described as observational
or experimental.19, 38 In observational studies, a passive investigator usu-
ally observes subjects for exposures and outcomes. In experimental
studies, an involved investigator usually prescribes an intervention to
achieve a particular outcome. It is generally accepted that, because of
the active participation of the investigator, experimental studies offer
the best opportunity to control bias and that a correctly implemented
experimental study offers the best available evidence to answer a specific
research question.
Whether an observational or experimental design is chosen to an-
swer a given health care question depends on the type of research
question being asked. For many health care questions, an experimental
research design may not be appropriate because of the constraints of
population availability, population management, cost, time, and ethics.
Various design strategies have evolved to overcome these constraints,
but some of the strategies increase the possibility of bias.
A hierarchy of research design exists, based on study validity and
the ability to control bias within certain study designs.15, 32 Clinicians
and researchers must understand that less confidence can be placed in
the research conclusions derived from some study designs, and extreme
caution must be exercised when using these study reports to influence
decisions concerning patient care.
In addition to employing the appropriate study design, certain
elementary research methods must be implemented in all studies to
control bias. These include methods regarding patient selection, exam-
iner training, intervention, data collection, and analysis. When bias is
not controlled in these areas of clinical research, conclusions are highly
suspect, no matter what the study design.
Blind Participants
SUMMARY
The first RCT was instituted in the early 1950s, evaluating strepto-
mycin and bed rest compared with bed rest alone for tuberculosis.26 This
research design has become the reference standard for comparative
evaluations of therapies because of its prospective nature and the ability
to control bias. Because it is easier to conduct observational studies, they
have often been inappropriately substituted for the better experimental
study designs. Since the 1950s, however, readers of the medical literature
have slowly come to demand quality clinical research to assist them in
caring for their patients. Dentists are somewhat behind their medical
colleagues in using the strongest research designs to answer clinical
questions. In dentistry, observational studies with convenience samples
of patients have been commonly used. It is often argued that few dental
ailments affect a person’s life as negatively as most medical maladies;
therefore, experimental rigors are not required of dental research. Al-
though most dental care does not involve life-and-death issues, dentists
are as eager as physicians to offer their patients optimal care. Optimal
care is best defined through nonbiased research strategies.
References
1. Bangsi D, Ghadirian P, Ducic S, et al: Dental amalgam and multiple sclerosis: A case-
control study in Montreal, Canada. Int J Epidemiol 27:667–671, 1998
2. Boerrigter EM, Geertman ME, van Oort RP, et al: Patient satisfaction with implant-
retained mandibular overdentues: A comparison with new complete dentures not
retained by implants—a multicentre randomized clinical trail. Br J Oral Maxillofac
Surg 33:282–288, 1995
3. Carr AB, McGivney GP: Users’ guides to the dental literature: How to get started. J
Prosthet Dent 83:13–15, 2000
4. Chalmers TC, Celano P, Sacks HS, et al: Bias in treatment assignment in controlled
clinical trials. N Engl J Med 309:1358–1361, 1983
5. Cheung GS, Dimmer A, Mellor R, et al: Gale M. A clinical evaluation of conventional
bridgework. J Oral Rehabil 17:131–136, 1990
6. Cohen J: A coefficient of agreement for nominal scales. Educational Psychology and
Measurement 20:37–46, 1960
7. Ellenberg JH: Selection bias in observational and experimental studies. Stat Med
13:557–567, 1994
8. Elmore JG, Feinstein AR: A bibliography of publications on observer variability (final
installment). J Clin Epidemiol 45;567–580, 1992
9. Feinstein AR: Clinical Epidemiology: The Architecture of Clinical Research. Philadel-
phia, WB Saunders, 1985
10. Fleiss JL: The measurement of interrater agreement. In Fleiss JL: Statistical Methods
for Rates and Proportions, ed 2. New York, John Wiley & Sons, 1981
11. Friedman GD: Primer of Epidemiology, ed 4. New York, McGraw-Hill, 1994
12. Gordis L: Epidemiology. Philadelphia, WB Saunders, 1996
13. Hulley SB, Cummings SR: Designing Clinical Research in Epidemiologic Research,
ed 2. Baltimore, Lippincott Williams & Wilkins, 2001
14. Isaac S, Michael WB: Handbook in Research and Evaluation: A Collection of Principles,
Methods, and Strategies Useful in the Planning, Design and Evaluation of Studies in
Education and the Behavioral Sciences, ed 2. San Diego, CA, Edits Publishers, 1981
15. Jacob RF, Carr AB: Hierarchy of research design used to categorize the ‘‘strength of
evidence’’ in answering clinical dental questions. J Prosthet Dent 83:137–152, 2000
16. Jacob RF: [abstracts/commentary]. Journal of Prosthodontics 6:325–327, 1997
78 JACOB
SYSTEMATIC REVIEWS OF
THE LITERATURE
The Overview and Meta-analysis
strategy was designed to identify the best evidence related to the catego-
ries of etiology, diagnosis, therapy, and prognosis in implant care. The
results for this single area of dentistry reinforced the notion of an
information explosion. The search provided an amount of clinically
relevant information regarding implants that would require a clinician
to read between one and two articles a week for 52 weeks out of the
year just to stay current with the progress in dental implants. For the
practitioner also interested in staying current in other areas, such as
prosthetic, surgical, periodontal, endodontic, and direct restorative pro-
cedures, staying current could indeed be difficult.
To determine whether this volume of literature is characteristic of
all aspects of dentistry or only of special dental subjects such as dental
implants, another study16 investigated trends in dental and medical
research publications and the proportion of high-quality clinical studies
(randomized, controlled trials [RCTs]) of relevance to general dentistry.
In this study, the authors conducted a MEDLINE search of the literature
published between 1969 and 1999 and found that clinical trials in dental
research had increased to 7% and RCTs had increased to 5% of all dental
research during this period. Although the overall number of research
publications decreased during this period, the proportion specifically
related to outcomes of patient care had increased. Thus, more of the
literature currently published focuses directly on patient care and might
be important for clinicians to read. Between 1979 to 1999, the authors
found that one of every 200 research publications was an RCT, studies
which by nature of their design have the best chance to provide valid
and reliable information. These trials were relevant to between 60% of
the dental care activities for adults and 80% of those for children.
Together these findings suggest that more high-quality information
is available to clinicians than ever before. In a professional life that
leaves little time for reviewing the increasing numbers of potentially
useful research reports, how does the conscientious clinician of today
find the highest quality and most relevant reports among the hundreds
of others.
than are nonexperts.11 More reliable are the reviews that take a systematic
approach in providing an overview of the relevant and important pri-
mary research regarding a specific clinical question. (In this context,
primary research refers to the research reports that contain the original
information on which the review is based.) Such a systematic review is
an overview of the primary research that has an explicit statement of
the objectives, materials, and methods and has been conducted following
a previously established rigorous and reproducible methodology.5 When
the systematic review includes a statistical synthesis of the numerical
results of several trials that examined the same question it is termed a
meta-analysis.
Systematic reviews are now considered the most reliable method
for summarizing large volumes of research evidence. These reviews are
less prone to subconscious and subjective forms of bias often seen in
reports by experts because they follow principles of research design
similar to those found in primary research. The fundamental difference
between the primary research study and the systematic review is the
unit of study. The scientific principles of a systematic review—docu-
mentation of methods before beginning, a comprehensive search identi-
fying all relevant studies, and the use of rigorous methods for appraisal,
collection, and synthesis of data—limit the bias in identifying and re-
jecting studies and provide more reliable and accurate conclusions. The
usefulness of overviews and meta-analyses is reflected in the increasing
numbers of review publications and in the efforts of groups, most
notably the Cochrane Collaboration, to prepare, maintain, and dissemi-
nate results of systematic reviews of health care. The Cochrane Collabo-
ration is an international initiative for systematic review management
and currently has an Oral Health Group that encourages participation
by interested individuals.
SUMMARY
References
1. Anderson JD, Zarb GA: Evidence based dentistry: Prognosis. J Prosthet Dent 83:495–
500, 2000
2. Eckert SE, Goldstein GR, Koka S: How to evaluate a diagnostic test. J Prosthet Dent
83:386–391, 2000
3. Felton DA, Lang BR: The overview: An article that interrogates the literature. J Prosthet
Dent 84:17–21, 2000
4. Goldstein GR, Preston JD: How to evaluate an article about therapy. J Prosthet Dent
83:599–603, 2000
5. Greenhalgh T: Papers that summarize other papers (systematic reviews and meta-
analyses). In: How to Read a Paper: The Basics of Evidence Based Medicine. London,
BMJ, 1997, p 111
6. Greenhalgh T: Papers that summarize other papers (systematic reviews and meta-
analyses). In: How to Read a Paper: The Basics of Evidence Based Medicine. London,
BMJ, 1997, p 113
7. Greenhalgh T: How to read a paper: The Basics of Evidence Based Medicine. London,
BMJ, 1997
8. Jacob RF, Lloyd PM: How to evaluate a dental article about harm. J Prosthet Dent
84:8–16, 2000
9. McDonagh MS, Whiting PF, Wilson PM, et al: Systematic review of water fluoridation.
BMJ 321:855–859, 2000
10. Montori VM, Smieja M, Guyatt GH: Publication bias: A brief review for clinicians.
Mayo Clin Proc 75:1284–1288, 2000
11. Oxman AD, Guyatt GH: The science of reviewing research. Ann N Y Acad Sci
703:125–131, 1993
12. Oxman AD, Guyatt GH: Guidelines for reading literature reviews. Can Med Assoc J
138:697–703, 1988
13. Oxman AD, Cook DJ, Guyatt GH for the Evidence-Based Medicine Working Group:
User’s guide to the medical literature. VI. How to use an overview. JAMA 272:1367–
1371, 1994
14. Randall RC, Wilson NH: Glass-ionomer restoratives: A systematic review of a second-
ary caries treatment effect. J Dent Res 78:628–637, 1999
86 CARR
15. Russo SP, Fiorellin JP, Weber HP, et al: Benchmarking the dental implant evidence on
MEDLINE. Int J Oral Maxillofac Implants 15:792–800, 2000
16. Sjogren P, Hallinf A: Trends in dental and medical research and relevance of random-
ized controlled trials to common activities in general dentistry. Acta Odontol Scand
58:260–264, 2000
17. Slavin RE: Best evidence synthesis: An intelligent alternative to meta-analysis. J Clin
Epidemiol 48:9–18, 1995
18. Song F, O’Meara S, Wilson P, et al: The effectiveness and cost-effectiveness of prophy-
lactic removal of wisdom teeth. Health Technol Assess (Winch Eng) 4:1–55, 2000
e-mail: Carr.alan@mayo.edu
EVIDENCE BASED DENTISTRY 0011–8532/02 $15.00 .00
‘‘If it looks like a duck, quacks and waddles like a duck . . . then it
probably is a duck!’’ and ‘‘if you hear hoof beats, think of horses not
zebras’’ (unless, of course, you are on the plains of the Serengeti). At
first glance, these adages may seem irrelevant to the diagnostic process
in clinical dental practice. These adages, however, respectively illustrate
the principle of pattern recognition and the effect of prevalence, both of
which are important aspects of the diagnostic process.
This article presents the dentist in clinical practice with an evidence-
based approach to diagnostic data and tests so that the reader can
become a more discriminating user of tests offered by the medical
profession and, increasingly, by the pharmaceutic industry for promo-
tional purposes.
This article reviews a few basic principles of biostatistics, discusses
test design and test characteristics, and demonstrates how to identify a
good test and the circumstances in which a test will be useful in the
clinical setting. For ease of discussion, this article focuses on dichoto-
mous data that are divided into mutually exclusive categories: positive
or negative. Data are presented from the dental literature, and clinical
dental examples are used. Texts providing more detailed, comprehensive
information regarding biostatistics, clinical epidemiology, and related
topics are listed with the references.4, 22, 29 Much of the following discus-
sion has been summarized from these sources.
From the Department of Oral Biological and Medical Sciences, Faculty of Dentistry,
University of British Columbia, Vancouver, British Columbia, Canada
Most dentists have had their height, weight, and blood pressure
measured in a physician’s office. They may have had blood drawn for
complete blood cell count and differential blood series or testing for
cholesterol levels, prostate surface antigen, blood glucose, or thyroid
hormone levels. They may have undergone tuberculin skin tests, mam-
mography, electrocardiograms, and cardiac stress tests or had suspicious
moles removed for histologic examination. They may even have sought
the convenience of home pregnancy tests. As dentists, clinicians have
probably prescribed dental radiographs and used explorers and peri-
odontal probes to detect caries, defective restorative margins, and peri-
odontal attachment loss. They may have applied electric pulp testers or
ice to teeth to determine their vitality. They may have used toluidine
blue dye to aid in selecting sites for biopsy of suspicious oral lesions.
They may have recorded mandibular excursions, palpated muscles of
mastication, and listened for temporomandibular (TM) joint sounds.
As consumers and providers of health care, dentists reasonably
expect that the information obtained from diagnostic investigations is
reliable and truthful. Moreover, it is generally assumed that the informa-
tion obtained from these investigations will provide a diagnosis as to
the presence or absence of an abnormality or disease and that the
diagnosis will direct a subsequent course of management or treatment.
The question remains, however: how can patients and clinicians know
if the data and subsequent diagnosis are correct?
Beck2 maintains that dentistry, in contrast to medicine, has de-
emphasized diagnostic activities and merged them with treatment-plan-
ning activities. Nevertheless, the aim of a medical or dental clinician is
to arrive at a diagnosis that may direct a subsequent course of manage-
ment. The diagnostic process is initiated by the patient history and
symptoms and is followed by the clinical examination, during which the
clinician perceives signs that are manifestations of the disorders. The
clinician may also use assays or measurements that are traditionally
referred to as diagnostic tests or tools. In reality, symptoms, signs, and
assays may all be considered diagnostic tools, because all are sources of
information used to generate a diagnosis.2
Sacket et al29 explain that patients, clinicians, and researchers gener-
ally agree that the presence of disease indicates a derangement in anat-
omy, biochemistry, physiology, or psychology. They less often agree,
however, on the exact criteria that define the condition that is the target
of the diagnostic process.
Wulff 40 distinguished two major principles of disease: (1) the nomi-
nalistic or patient-oriented principle, and (2) the essentialistic principle
that emphasizes disease as an independent entity. In the nominalistic
approach, disease does not exist as an independent entity, and disease
classification is really a classification of sick people or patients. Thus, a
particular disease is defined by a group of characteristics that occur
more often in persons with the disease than in other people. Patients
THE USE OF DIAGNOSTIC DATA IN CLINICAL DENTAL PRACTICE 89
will have a pattern of similar symptoms and signs, and their prognosis
and treatment will have some common features. The nominalistic princi-
ple does not require a definition of normality and recognizes that defini-
tions of disease may vary among different societies.40
The essentialistic view40 is closely related to a modern principle of
disease termed biochemical fundamentalism.6 This view is based on the
idea that disease can be described in terms of biochemistry and molecu-
lar biology. Diseases are assumed to follow regular patterns, and once
the underlying biochemical events are understood, the course of the
disease can theoretically be predicted. Hence, disease classification be-
comes a matter of biotechnology, and the need for defining a normal
state is avoided by relying upon statistical terms to define the disease
state. That is, disease is defined by the distribution of certain features in
a particular population and the extent to which that distribution differs
from a similar assessment of a group the investigators consider not
diseased.6, 40 This statistical approach forms the basis for using biomark-
ers as diagnostic or screening tests.
Contemporary clinical medical and dental practice is still an art and
a science. Overall, the nominalistic approach may offer a more realistic
strategy for coping successfully with the varying manifestations of con-
ditions such as coronary heart disease and temporomandibular disorders
(TMD) that can be defined in both essentialistic and nominalistic
terms.24, 29
as the test threshold and a second threshold for treatment known as the
test-treatment threshold.29 In general, these cutoff threshold probabilities
for ruling in or ruling out a disease depend on the particular disease
and the subsequent courses of action or follow-up that relate to either
ruling in or ruling out the disease. That is, the consequences of false-
positive and false-negative results must be weighed in each case. If a
test is not powerful enough to alter the pretest probabilities so that a
positive or negative test result will not alter the pretest planned course
of action, the test should not be performed.29, 31 The strategies for defining
specific test and test-treatment threshold cutoffs are discussed in greater
detail by Sacket et al.29
Three clinical decisions are depicted in Figure 1. In the first instance,
the pretest probability of a disease is below the test threshold (Zone A
in Fig. 1). The patient is unlikely to have the disease, and even a positive
test result would not alter the posttest probability to a level that would
justify treatment. Therefore, neither treatment of the disorder nor further
testing for the disorder should proceed. For example, multiple yellowish
92 OAKLEY & BRUNETTE
spots and plaques are observed bilaterally on the posterior buccal mu-
cosa of an elderly male patient. The spots and plaques cannot be re-
moved with gentle wiping of a gauze across the mucosal surface. The
clinician is confident that Fordyce granules are present and that no
pathologic condition is present. Therefore, further investigations such as
biopsy or further management or treatment are not indicated.
In similar fashion, if the pretest likelihood of disease exceeds the
test-treatment threshold (zone C in Figure 1), treatment should proceed
without further diagnostic testing. For example, soft white plaques re-
sembling milk curds are observed on the palate and buccal mucosa of
an elderly male patient. The plaques may be stripped from the tissue,
leaving an intensely erythematous surface with localized bleeding. Oral
thrush (candidiasis) is most likely present, and further investigation
such as biopsy will not alter the diagnosis or the probable management
with antifungal medications.
When the pretest probability falls in between the test and test-
treatment thresholds, however (zone B in Figure 1), testing is indicated,
and treatment should proceed on the basis of the test results. In general,
a diagnostic test is most useful when the pretest probabilities fall be-
tween roughly 30% and 70%.5, 20, 21 For example, an adherent white
plaque is observed on the anterior floor of the mouth and ventral left
lateral tongue of an elderly adult male. A pathologic condition may or
may not be present. Further investigation such as biopsy is indicated to
establish a diagnosis and to direct further management.
MEASUREMENT RELIABILITY
attempts, however, the distance between fingers and toes may decrease.
In similar fashion, clinical variables for assessment of TMD such as
muscle palpation and assessment of joint sounds may not be stable in
the short- or long-term, and they may be altered by repeated palpation
or repeated mandibular movements.39 Some phenomena such as blood
pressure will demonstrate regression towards the mean by returning to
usual levels over time.4 Therefore, evaluation of some phenomena may
require several examinations over time before a diagnosis is finalized.
Variability of Examiners
Correlation Coefficients
Correlation
Coefficient Kappa
Intraclass
Reference Inter- Intra- Correlation Inter- Intra-
Test Number observer observer Coefficient observer observer
Periodontics
Probing depth, general 5b, 10a 0.63 0.72 0.26
Plaque 6b, 11a 0.81 0.32 0.22
Temporomandibular disorders
Temporomandibular joint sounds—manual palpation
Trained examiner 8 0.68 0.62
Untrained examiner 8 0.35 0.30
Temporomandibular joint sounds—stethoscope
Trained examiner 8 0.26 0.61
Untrained examiner 8 0.32 0.35
Mandibular kinesiology
Maximal pain-free vertical opening 8, 10b
Trained examiner 0.89 0.90
Untrained examiner 8 0.72
Dental radiology
Caries, calibrated examiner 36a 0.73 0.80
Periodontal disease, calibrated examiner 36a 0.80 0.79
Degenerative temporomandibular joint changes on 5a 0.47–0.80 0.58–0.79
tomography
Disk displacement on MR imaging 24 0.70
Oral pathology
Diagnosis of dysplasia 1 0.30–0.63 0.29–0.48 0.05–0.49
Grading of oral leukoplakia from no dysplasia to carcinoma 16 0.27–0.45
in situ
THE USE OF DIAGNOSTIC DATA IN CLINICAL DENTAL PRACTICE 97
Kappa Scores
The best approach in evaluating reliability for noninterval data is
the statistic, which adjusts for the degree of agreement expected by
chance. For a perfect association, 1.0, and for no association 0.
Qualitative interpretation in relation to values vary,16, 29 but Brunette4
suggests that values below 0.4 indicate poor agreement, values of
0.4 to 0.75 are fair, and values of 0.75 to 1.0 are excellent. A rule of
thumb is that clinical studies should not proceed before investigators
have been trained and calibrated with demonstrated high scores (e.g.,
⬎ 0.6).
Table 1 lists the reliabilities of some measurements and tests used
in dentistry and illustrates the differences between correlation coeffi-
cients and scores. For example, the interexaminer correlation coeffi-
cients for probing depths and plaque assessment are 0.63 and 0.81,
respectively; in contrast, the interexaminer scores are only 0.26 and
0.22! In similar fashion, Abbey et al1 calculated correlation coefficients
and scores for six pathologists whose agreement between their original
sign-out diagnoses of dysplasia and subsequent reexaminations of the
same slides were compared. Correlation coefficients averaged 0.50; in-
traexaminer scores ranged from 0.05 to 0.49. In the same study, interex-
aminer scores for the presence or absence of dysplasia ranged from
0.29 to 0.48.
manner. Not all body sites are as readily accessible for biopsy and
histologic examination as the oral soft tissues. Therefore, surrogate pa-
rameters such as biologic assays or measurements are used as the stan-
dard for comparison. For example, in the case of bovine spongiform
encephalopathy and its human variant, Creutzfeld-Jacob disease, au-
topsy is both the reference standard and the only reliable and valid
diagnostic tool at this time. If valid and less invasive laboratory tech-
niques were available, earlier diagnosis of the disease would be possible.
The assumed benefit of earlier disease detection, such as through screen-
ing tests, must be tempered with the possibility that for some diseases
earlier detection is unlikely to improve the prognosis. The early detection
of disease is assumed to be beneficial, because treatment initiated before
the onset of symptoms is assumed to be more effective than later
treatment and thereby the development of disease may be reduced or
eliminated. For some conditions, such as Creutzfeld-Jacob disease, there
is no effective treatment at this time; hence, the earlier diagnosis of some
conditions must be weighed against the overall risks and benefits for
the individual and society.13
Widmer39 reviewed the measurement validity of TM joint imaging
techniques to anatomy. Arthrography demonstrated an 84% true correla-
tion to anatomy,37 MR imaging had a 73% to 85% true correlation,7 and
tomography had a 63% to 85% true correlation to anatomy.12 Widmer39
also reviewed the measurement validity of TM joint sounds by palpation
and stethoscope in an arthrographic examination of asymptomatic sub-
jects. Assessment for TM joint sounds by manual palpation revealed that
15% of silent joints had disk displacement.37 Joint sound assessment by
stethoscope revealed 14% of silent joints with disk displacement.32 These
results demonstrate that disk displacements may be present in the ab-
sence of joint sounds and that the presence of joint sounds may not offer
a valid assessment of disk displacements.
Biologic assays do not exist for all disorders, and for some diseases
and conditions, a real or practical reference standard does not exist. For
example, biologic assays for TMD and fibromyalgia do not exist, and
there is no reference standard for the measurement of active periodontal
disease. Instead, clinicians use measurements such as probing and at-
tachment levels, which are cumulative indices reflecting the history of
disease (in this case, attachment loss) rather than the presence of active
disease.4 In similar fashion, the diagnosis of fibromyalgia relies on the
key clinical feature of decreased pain threshold as manifested by tender-
ness at 18 specified anatomic locations.
Widmer39 distinguishes measurement validity from diagnostic valid-
ity, which is the extent to which diagnostic criteria can be used to classify
persons as to the absence or presence of a disorder in regards to the
THE USE OF DIAGNOSTIC DATA IN CLINICAL DENTAL PRACTICE 99
TEST CHARACTERISTICS
Figure 2. Contingency comparison between gold standard and new test. For example, for
the disease of caries, the gold standard is histologic examination, and a new test for
diagnosis of caries may be direct digital radiography.
100 OAKLEY & BRUNETTE
Accuracy is the overall agreement between the test and the ref-
erence gold standard. Accuracy may be calculated
from a 2 2 contingency table as shown in Figure 2
by the formula
ad
abcd
a
ac
d
bd
ac
abcd
a
ab
THE USE OF DIAGNOSTIC DATA IN CLINICAL DENTAL PRACTICE 101
c
cd
When the sensitivity, specificity, and prevalence or
pretest likelihood are known, PTL() may be calcu-
lated by the formula
P LR()
PTL()
(1.0 P) P LR()
d
cd
Caries
Clinical examination 36b 0.13 0.94 2.2 0.93
Bite-wing radiographs 21a 0.73 0.97 24.3 0.28
Periodontics
Gingival redness 11a 0.27 0.67 0.82 1.09
Plaque 11a 0.47 0.65 1.3 0.82
Bleeding on probing (2 mm, 5/6 18a 0.29 0.88 2.4 0.81
threshold)
Temporomandibular joint disorders
Temporomandibular 7a 0.43 0.75 1.7 .76
sounds—manual
palpation—single click
Disk displacement on MR imaging 0.86 0.63 2.3 .22
Degenerative changes on sagittal 36a 0.47 0.94 7.8 .56
tomography
sesnsitivity
*LR () is calculated by
1.0 specificity
1.0 sensitivity
†LR () is calculated by
specificity
palpation and the number and type of TM joint sounds will affect the
proportions of individuals diagnosed with TMD.39
Ideally, the selection of a cutoff point should be based on what is
best for the patients concerned, and the consequences of over- and
underdiagnosis must be considered. If the condition is innocuous and
neither shame nor anguish is associated with the diagnosis (for example,
the diagnoses of linea alba or the common cold), then the cutoff for
classification as diseased may be relaxed. Conversely, if there is no
advantage in early diagnosis, a positive diagnosis has the potential to
produce anxiety in the patient, and there is no effective treatment, the
cutoff for disease should be set high (ⱖ 99%) to exclude the nondis-
eased.29
The selection of the cutoff point will determine the proportion
of true-positive, false-positive, true-negative, and false-negative results,
which, in turn, will produce different estimates of the sensitivity and
specificity of the diagnostic test (see box). A perfect test will yield only
true-positive and true-negative results without any overlap or false-
positive or false-negative result (Fig. 3).
Criteria for Selection of Test Thresholds
Low Threshold
• selected if it is important that all individuals with the disease or
its progression are detected
• provides high sensitivity and high PTL()
• results in increased number of false-positive results because of the
low specificity
• is useful for screening for serious or life-threatening disease but
confirmation testing is required (e.g., dentists perform screening
examinations for high blood pressure or for oral cancer in patients
who are asymptomatic for these diseases.)
High Threshold
• limits the number of false-positive results
• is required for confirmation testing
• results in high specificity but lower sensitivity. High-specificity
values are important for diseases that are not life-threatening such
as TMD. High specificity excludes individuals without the disease
from pursuing unnecessary, irrelevant, and possibly invasive, irre-
versible, and expensive treatment.
In general, if a low threshold is selected, the sensitivity is increased,
and the specificity is decreased; a high threshold results in high specific-
ity but lower sensitivity. High sensitivity is desirable for screening tests.
High specificity is required for exclusionary tests to minimize the num-
ber of false-positive results. The highest possible sensitivity and specific-
ity are desirable for confirmatory tests to minimize both false-positive
and false-negative results. Unfortunately, high sensitivity and high speci-
ficity are rarely found in a single test.
104 OAKLEY & BRUNETTE
No. of Individuals
TNF
TPF
A Parameter
No. of Individuals
TNF
TPF
B Parameter
Figure 3. Hypothetical distribution of healthy (true positive fraction [TPF]) and diseased
(true negative fraction [TNF]) populations. Test results yield different estimates of sensitivity
and specificity A, Hypothetical perfect test with 100% sensitivity and 100% specificity. The
diseased (TPF, dashed line) and healthy (TNF, solid line) individuals are identified without
false negative (FNF) or false positive (FPF) fractions. B, Hypothetical useless test. The
diseased and healthy populations are not identified by the test.
FNF
TNF TPF
FPF
C Parameter
No. of Individuals
Cut-Off #2
FNF
TNF TPF
FPF
D Parameter
Figure 3 (Continued). C and D, Hypothetical typical test with overlap of healthy and
diseased populations. The selection of the cut-off point to distinguish between healthy and
diseased individuals affects the proportion of the FNF and FPF. Sensitivity and specificity
are affected by the selection of the cut-off point. In C, the cut-off point is located further to
the right than the cut-off point in D. Therefore, the FPF in C is smaller than the FPF in D.
Conversely, the FNF in C is larger than the FNF in D.
consequences of over- and undertreatment, and the cost and time re-
quired to perform the diagnostic test. Once test thresholds are estab-
lished, sensitivity and specificity are considered to be stable properties
of the test because they are apparently not affected by the prevalence of
the target disease. Some evidence, however, indicates that sensitivity
and specificity do change from one clinical population to another,14, 15
especially if the stage of disease varies in different groups of patients.11, 24
Figure 4. Receiver operating characteristics (ROC) curves plot the TPF (sensitivity) against
the FPF (1.0-specificity). ROC curves permit selection of the threshold or cut-off point that
provides the best combination of sensitivity and specificity scores. The most discriminating
tests cluster in the upper left-hand corner, and the most discriminating test has the greatest
area under its ROC curve. ROC curves also permit the comparison of tests without selection
of reference limits or sensitivity and specificity. For example, this figure compares the ROC
curve for conventional radiographic film evaluation of artificial cortical bone lesions, pro-
duced with a size 6 burr in dried mandibles (bulleted line) with the ROC curve for conven-
tional radiographic film evaluation of in vivo periodontal crestal alveolar bone loss (dashed
line). In this example, the area under the ROC curve for the detection of in vitro cortical
lesions is larger than the area under the ROC curve for the in vivo detection of periodontal
crestal bone loss. As expected, conventional radiographic evaluation of in vitro artificial
cortical lesions is more discriminating or a more powerful test than conventional radio-
graphic evaluation of in vivo crestal bone loss. Solid line ROC curve of noise or a
hypothetical useless test. (Dashed line, Data from Nummikoski PV, Steffensen B, Hamilton
K, et al: Clinical validation of a new subtraction radiography technique for periodontal bone
loss detection. J Periodontol 71:598–605, 2000; Bulleted line, Data from Paurazas SB,
Geist JR, Pink FE, et al: Comparison of diagnostic accuracy of digital imaging by using
CCD and CMOS-APS sensors with E-speed film in the detection of periapical bony lesions.
Oral Surg Oral Med Oral Pathol Oral Radiol Endod 89:356–363, 2000.)
negative predictive value. For a patient with a negative test result, the
clinician may need to know the probability that disease is actually
present; this probability is known as the post-test likelihood of a negative
test (PTL[]). Although a negative result will reduce the probability of
disease being present, typically it will not absolutely eliminate this
possibility.
The predictive values of a test vary widely as the prevalence of the
disease changes.11, 29 Prevalence is also known as the pretest likelihood,
and it is the overall probability or risk that disease is present before the
test is administered.
For example, toluidine blue has been advocated for the detection of
oral squamous cell carcinoma (SCC). The sensitivity of toluidine blue
ranges from 93.5% to 97.8%, and its specificity ranges from 73.3% to
92.9%.28 The predictive values of toluidine blue and the conclusions
provided by this test will vary, however, depending on the individual
patient to whom or the population in which the test is applied. The
prevalence of SCC in the general population has been estimated at 3%,25
and therefore the posttest likelihood of a positive toluidine blue test in
the general population is only 6%.10 In contrast, the prevalence of SCC,
either as primary or recurrent disease, is greater in a tertiary care center
for oral SCC, where prevalence estimates range from 26%25, 34 to 33%.10
Consequently, the posttest likelihood of a positive test in a tertiary care
center is also greater (51%).10 In the high-prevalence setting, the posttest
likelihoods of the tests are considerably higher than the pretest probabili-
ties, meaning that there is a considerably increased probability that the
disease is actually present. In contrast, the posttest likelihoods of the
same test in the general population (low-prevalence setting) are similar
to the pretest probabilities, meaning that there is only a slight increase
in the probability that the disease is actually present. Nevertheless, the
significance of each positive and negative test must be evaluated on an
individual basis by the clinician, who must then decide the subsequent
course of action.
The example with the toluidine blue test demonstrates that even a
test with high sensitivity (93.5%–97.8%) and specificity (73.3%–92.9%)27
can yield low predictive values when the prevalence (or pretest likeli-
hood) is low. Sacket et al29 further illustrate this point using a theoretical
test with 95% sensitivity and 95% specificity under conditions of variable
prevalence. For example, as the prevalence changes from 99% to 1%, the
PTL() changes from 99.99% to 16%, respectively. Thus, even a test that
has excellent specificity and sensitivity will produce a low likelihood of
disease being present if it is applied to an individual in a population in
which the initial pretest prevalence is low.
The choice of a particular test for a specific disease is determined
by the power or ability of the test to revise the pretest probabilities,
either upwards to rule in the disease, or downwards to rule out the
disease. In general, for a test with a sufficiently high sensitivity, a
negative result rules out the disease. In contrast, for a test with a
sufficiently high specificity, a positive result rules in the disease.29 In
108 OAKLEY & BRUNETTE
other words, the clinician relies on pattern recognition: ‘‘if it looks like
a duck, quacks like a duck, and waddles like a duck, it probably is
a duck.’’
Different tests for the same disease can be used in combination,
either in series, such as screening testing followed by confirmation
testing, or in parallel.
In series testing
• tests are used in succession
• if tests A and B are used in series, then either test A or test B can
be used first
• a positive result on the first test requires testing with the second
test
• is less sensitive in detecting disease than parallel testing, but series
testing has greater specificity and is more efficient at confirming
the presence of disease
• is used in confirmation testing
In parallel testing
• tests are performed concurrently
• if tests A and B are used in parallel,
a positive result requires positive results for either test A or
test B
a negative result requires that both test A and test B are negative
• is more sensitive than series testing for detecting disease but less
efficient at confirming presence of disease
At health fairs, clinician dentists may perform screening tests for
oral cancer through a careful visual inspection of the oral soft tissues or
a screening test for TMD by evaluating the patient’s range of pain-free
mandibular movements. With positive results of suspicious oral lesions
or a restricted range of jaw movements and associated discomfort, the
patients would be referred to their own dentists or to specialists for
possible oral biopsy or more detailed TMD evaluation including assess-
ment of joint sounds and TM joint and neck and masticatory muscle
tenderness.
When several tests are used in sequence, the posttest likelihood of
disease after the first test is used as the pretest likelihood for the
subsequent test. A possible problem with this approach is the propaga-
tion of errors, because each test can be considered as having some
associated error. Therefore, as more tests are performed, the precision of
the probability estimate will decline. The posttest probability of disease
may also be distorted by the end of the test sequence if the clinician
assumes that the tests are independent when the test results are actually
dependent. That is, the test result on one test or measure may affect the
characteristics of the second test, a phenomenon termed concordance or
convergence.29 Concordance occurs when patients who are positive on
one of the paired tests are likely to be positive on the other one as well,
or when patients who are negative on one test are likely to be negative
on the other one. For example, the electric pulp-stimulation test is much
THE USE OF DIAGNOSTIC DATA IN CLINICAL DENTAL PRACTICE 109
more likely to be positive when the thermal (cold) test is positive (i.e.,
the patient reports sensation upon cold stimulation of the tooth) than
when the thermal test is negative (the patient denies sensation to cold
stimuli). Conversely, teeth with negative results on one test (either the
cold or electric pulp test) are also likely to be negative on the other.
Concordance results in an overestimate of disease likelihood. Sacket et
al29 suggest that for short courses of two or three diagnostic tests,
convergence is not a serious problem but should be considered. For
example, concordance was observed between the use of toluidine blue
and visual clinical examination of patients in an oral cancer tertiary care
center by a trained and experienced clinician.10 That is, oral lesions that
were classified as suspicious or positive by one these methods were
likely to be positive on the other method as well. When the results of
both the visual clinical examination and toluidine blue were positive,
the pretest likelihood of 33% was raised to a posttest likelihood of 54%,
which is greater than the PTL() obtained by either toluidine blue
application alone (51%) or the visual clinical examination alone (44%).10
A PTL() of 54% calculated with consideration of concordance is a
lower but more realistic value than the PTL() of 62% that is calculated
if the tests are used sequentially and assumed to be independent.
ful tests for revising pretest probabilities of disease have positive likeli-
hood ratios with values greater than 10 and negative likelihood ratios
less than 0.1.
Likelihood ratios offer diagnostic advantages in that they are less
susceptible than sensitivity or specificity to changes in the prevalence or
pretest probability of the disease.29 Likelihood ratios may also be calcu-
lated for dichotomous levels of disease and for several levels of the test
result. The product of the likelihood ratio for the diagnostic test result
and the pretest odds for the target disorder yields the posttest odds for
the target disorder.29 A convenient method for rapidly calculating post-
test probability of disease is offered by the use of likelihood ratios for
the test and nomograms.
Nomograms (Fig. 5)30 offer a convenient and fast alternative to the
calculation of posttest likelihoods using the formulas shown in the box
on pages 100–101. Table 2 illustrates the sensitivities, specificities, and
likelihood ratios of some diagnostic tests used in dentistry. Figure 6
demonstrates use of the nomogram in the diagnostic decisions for three
examples of potential interproximal caries (the disease) and use of bite-
wing radiographs (the test). In each case, the clinician detects a small
area of discoloration on the distal aspect of the maxillary second bicuspid
but is not able to engage the explorer interproximally. For the disease of
caries, the clinician has assigned a test threshold of 30% and a test-
treatment threshold of 65% (Figs. 1, 6).
Patient A is an adolescent female who aspires to a career in model-
ing with an unrestored permanent dentition. Patient A practices excellent
oral hygiene and is compliant with twice-yearly prophylaxis appoint-
ments. Bitewing radiographs taken 2 years ago at the completion of
orthodontic treatment do not reveal any abnormalities. The clinician
assigns a pretest probability for caries of 1%. The clinician’s pretest
probability is located well below the test threshold of 30%, and therefore
radiographs would not be indicated. In the unlikely event that radio-
graphs (the test) were performed with a positive test result, the probabil-
ity of caries or PTL() can be calculated to be 20%. Despite this positive
test result, no further tests or restoration would be indicated, because
this probability is still less than the test threshold of 30%. If the test
results were negative, PTL() can be calculated to be 0.4%, effectively
ruling out the presence of caries.
Patient B is a young adult male with a moderately restored posterior
dentition. Patient B is a pastry chef apprentice who demonstrates poor
oral hygiene and poor compliance with recommended dental recall and
prophylaxis appointments. The patient was last seen 3 years ago when
bitewing radiographs revealed no sites of interproximal caries in the
posterior mandibular dentition. The clinician assigns a pretest probabil-
ity of 50% to the presence of caries. This pretest probability is located
between the test and test-treatment thresholds; therefore, bitewing radio-
graphs are indicated. With a positive test result, treatment is indicated,
but a negative test result rules out the disease and treatment.
Patient C is an elderly patient with a heavily restored dentition and
THE USE OF DIAGNOSTIC DATA IN CLINICAL DENTAL PRACTICE 111
Figure 5. Nomograms have converted pre- and post-test odds to their corresponding
probabilities. To use the nomogram, a straightedge is used to align the pretest probability
(left column) with the likelihood ratio (center column) of the test being used. The post-test
probability is revealed by reading across the straightedge to the right-hand column on the
nomogram. (Data from Fagan, TJ: Nomogram for Bayes’ theorem [letter]. N Engl J Med
293:257, 1975; Sacket DL, Richardson WS, Rosenberg W, et al: Evidence-Based Medicine:
How to Practice and Teach EBM. New York, Churchill Livingstone, 1997, p 127.)
112 OAKLEY & BRUNETTE
Figure 6. Diagnostic decisions for bitewing radiographs for three patients with possible
caries (the disease). Patient A, By aligning the straightedge at 1% in the pretest probability
column with 24 in the likelihood ratio column, the post-test probability of caries being
present is raised to about 20%—a value well below the test-treatment threshold of 65%
and below the test threshold of 30%. Despite a positive test result, no further tests or
restoration are indicated, and the clinician may feel confident about merely observing the
tooth. When the pretest probability of 1% is aligned with the likelihood ratio (LR) of a
negative test result (0.28), the post-test probability of disease has been further reduced to
about 0.4%, effectively ruling out the presence of caries. Patient B, The pretest probability
of 50% is located between the test and test-treatment thresholds. Radiographs are indi-
cated. Post-test likelihood of disease (PTL[]) is raised to 92% and treatment is indicated.
PTL() is reduced to 18% and treatment is not indicated. Patient C, The clinician recog-
nizes that the 95% pretest probability exceeds the established test-treatment threshold;
bitewing radiographs are not required for diagnosis and test results would not alter the
proposed management (restoration of the tooth). Even a negative test result (no radio-
graphic evidence of caries) would still result in an 80% post-test probability of caries being
present. Although 80% is a lesser probability of disease than 95%, it still exceeds the test-
treatment threshold and is probably not low enough to change the planned management.
LR() 24; LR() 0.28 (see Table 2); test threshold 30%; test-treatment threshold
65% (see Figure 1); see Figure 4 for nomogram.
THE USE OF DIAGNOSTIC DATA IN CLINICAL DENTAL PRACTICE 113
SUMMARY
This article has briefly introduced the dental clinician to the princi-
ples and practical application of diagnostic decision analysis. There are
trade-offs and uncertainties in the process of arriving at a diagnosis, but
they can be understood and controlled. First, the clinician must under-
stand the significance of disease prevalence and assign to the patient an
initial probability of disease being present. The clinician must then
determine if further diagnostic measurements or tests are warranted. If
so, the appropriate test must be selected, based on the ability of the test
to revise the initial pretest probability. When a diagnostic test is positive,
the clinician must know the probability that disease is actually present.
The clinician must also know the probability that disease is actually
present if the test result is negative. The astute clinician will calculate
the posttest probabilities before proceeding with a test and will base
treatment decisions on test results in accordance with predetermined
test and test-treatment thresholds.
ACKNOWLEDGEMENTS
The authors are grateful to David Perizzolo for formatting the digital figures, to Lesley
Weston for her careful editing, and to Dr. Babak Chehroudi for his critical review.
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31. Schechter MT, Sheps SB: Diagnostic testing revisited: Pathways through uncertainty.
J Can Med Assoc 132:755–759, 1985
32. Schiffman E, Anderson GC, Fricton J, et al: Diagnostic criteria for intraarticular TM
disorders. Community Dent Oral Epidemiol 17:252–257, 1989
33. Schwartz WB, Wolfe HJ, Pauker SG: Pathology and probabilities. A new approach to
interpreting and reporting biopsies. N Engl J Med 305:917–913, 1981
34. Silverman SJR: Oral Cancer, ed 3. Atlanta, GA, American Cancer Society, 1990
35. Streiner DL, Norman GR: Health Measurement Scales. Oxford, Oxford University
Press, 1989, pp 79–95
36. Tanimoto K, Peterson A, Rohlin M, et al: Comparison of computed with conventional
tomography in the evaluation of temporomandibular joint disease: A study of autopsy
specimens. Dentomaxillofacial Radiology 19:21–27, 1990
36a. Valachovic RW, Douglass CW, Berkey CS, et al: Examiner reliability in dental radiog-
raphy. J Dent Res 65:432–436, 1986
36b. Vendonschotsh, Bronkhurst EM, Burgersdijk RCS, et al: Performance of some diagnos-
tic systems in examinations for small occlusal caries. Caries Res 26:59–64, 1992
37. Westesson PL, Bronstein SL, Liedberg J: Temporomandibular joint: Correlation be-
tween single-contrast videoarthrography and postmortem morphology. Radiology
160:767–771, 1986
38. Westesson PL, Eriksson L, Kurita K: Reliability of a negative clinical temporomandib-
ular joint examination: Prevalence of disk displacement in asymptomatic temporo-
mandibular joints. Oral Surgery, Oral Medicine and Oral Pathology 68:551–554, 1989
39. Widmer CG: Physical characteristics associated with temporomandibular disorders.
In Sessle BJ, Bryant PS, Dionne RA (eds): Temporomandibular Disorders and Related
Pain Conditions, Progress in Pain Research and Management, vol 4. Seattle, IASP
Press, 1995, pp 161–174
40. Wulff HR: Rational Diagnosis and Treatment. Oxford, Blackwell Scientific Publica-
tions, 1976
e-mail: brunette@interchange.ubc.ca
EVIDENCE BASED DENTISTRY 0011–8532/02 $15.00 .00
From the Department of Head and Neck Surgery, MD Anderson Cancer Center, Hous-
ton, Texas
100 times, in 95% of those studies the true risk estimate would fall
somewhere between 1.3 and 4.4.7, 9, 15
Case-control Studies
compared with persons without attachment loss. The odds ratio for
persons with attachment loss of 3 mm or greater in 33% to 67% of
measurements was 2.3 (C.I. 1.2–4.4). There was no statistically significant
difference in odds ratio with attachment loss in less than 33% of mea-
surements.1 A second study of 85 persons referred to a hospital for
angiography, matched with persons without coronary heart disease se-
lected from public records, revealed no difference in the dental indices
of periapical and periodontal disease. The average age was 56 years,
and the author speculated that this group is older than those in previous
studies. There may have been an age-selection bias, such that older
patients with coronary heart disease are in better general health and
have better oral health, because the severely ill patients with coronary
heart disease have all ready died.13 Another one-point-in-time assess-
ment from chart review data and periodontal examination of a sample
of 320 Veterans Medical Association dental patients older than 60 years
of age was performed to determine dental associations with coronary
heart disease. Other risk factors were also considered from data gathered
from hospital charts and patient interviews. Use of cardiac medications
were considered to represent a diagnosis of coronary heart disease.
Multiple analyses were performed on 25 characteristics. The medically
recognized risk factors for coronary heart disease did not have significant
association in this study. The authors believed the lack of significance in
this study was probably caused by to the increased age of the subjects
and that those subjects with significant associations may have already
succumbed to coronary heart disease. In addition, subjects were being
treated for many of the other risk factors, and therefore those risk factors
were under control. Statistical associations with coronary heart disease
were found for total tooth number up to 14, low salivary levels of
Streptococcus sanguis, gingival bleeding, positive plaque scores, and a
complaint of xerostomia.12
A prospective analysis of 9760 persons concluded that persons with
periodontitis had a 25% increased risk of coronary heart disease com-
pared with those with minimal periodontal disease. Poor oral hygiene,
determined by dental debris and calculus, was also associated with an
increased incidence of coronary heart disease, which was defined as a
hospital admission or death caused by coronary heart disease. Compared
with men without periodontal disease, the highest relative risk for coro-
nary heart disease was for men with periodontitis who were younger
than 50 years old, 1.72 (C.I. 1.10–2.68). An even greater relative risk for
total mortality was found for this group; those with periodontitis had a
relative risk of 2.12 (C.I. 1.24–3.62), and the edentulous subjects had a
relative risk of 2.60 (C.I. 1.33–5.07). The authors concluded that a causal
association between periodontal disease and coronary heart disease is
unclear, and that dental health may be more an indicator of personal
hygiene and overall health care practices.4
Case-control studies that interface with the subjects at one point in
time can suggest an association between a characteristic and an outcome,
but they cannot confirm the temporal relationship that the risk factor
ASSESSMENT OF KEY ELEMENTS TO DETERMINE CAUSATION AND RISK FACTORS 123
SUMMARY
dentistry. It is the science of dentistry that will change the scope of the
profession in this millennium.
References
1. Arbes SJ Jr, Slade GD, Beck JD: Association between extent of periodontal attachment
loss and self-reported history of heart attack: An analysis of NHANES III data. J Dent
Res 78:1777–1982, 1999
2. Ast DB, Schlesinger EF: The conclusion of a 10-year study of water fluoridation. Am J
Pub Health 46:265–271, 1956
3. Brothwell DJ, Limeback H: Fluorosis risk in grade 2 students residing in a rural area
with widely varying natural fluoride. Community Dent Oral Epidemiol 27:130–136,
1999
4. DeStefano F, Anda RF, Kahn HS, et al: Dental disease and risk of coronary heart
disease and mortality. BMJ 306:688–691, 1993
5. Fletcher RH, Fletcher S, Wagner EH: Clinical Epidemiology: The Essentials, ed 3.
Baltimore, Williams & Wilkins, 1996
6. Friedman GD: Primer of Epidemiology, ed 4. New York, McGraw-Hill, 1994
7. Gordis L: Epidemiology. Philadelphia, WB Saunders, 1996
8. Hujoel PP, Drangsholt M, Spiekerman C, et al: Periodontal disease and coronary heart
disease risk. JAMA 284:1406–1410, 2000
9. Hulley SB, Cummings SR: Designing Clinical Research. An Epidemiologic Research,
ed 2. Baltimore, Lippincott Williams & Wilkins, 2001
10. Jacob RF, Carr AB: Hierarchy of research design used to categorize the ‘‘strength of
evidence’’ in answering clinical dental questions. J Prosth Dent 83:137–152, 2000
11. Lemke CW, Doherty JM, Arra MC: Controlled fluoridation: The dental effects of
discontinuation in Antigo, Wisconsin. J Am Dent Assoc. 80:782–786, 1970
12. Loesche WJW, Schork A, Terpenning MS, et al: Assessing the relationship between
dental disease and coronary heart disease in elderly U.S. Veterans. J Am Dent Assoc
129:301–311, 1998
13. Mattila KJ, Askikainen S, Wolf J, et al: Age, dental infections, and coronary heart
disease. J Dent Res 79:756–760, 2000
14. US Public Health Services, 1942, pp 1155–1179, Public Health Report 57
15. Sackett DL, Haynes RB, Guyatt GH, et al: Clinical Epidemiology. A Basic Science for
Clinical Medicine, ed 2. Boston, Little, Brown and Co, 1991
16. Scott BA, Clark GM, Hatch JP, et al: Comparing prospective and retrospective evalua-
tions of termporomandibular disorders after orthognathic surgery. J Am Dent Assoc
28:999–1003, 1997
e-mail: rjacob@mail.mdanderson.org
EVIDENCE BASED DENTISTRY 0011–8532/02 $15.00 .00
From the Department of Family Dentistry, The University of Iowa College of Dentistry,
Iowa City, Iowa
From Jacob R, Lloyd P: How to evaluate a dental article about harm. J Prosthet
Dent 84:8–16, 2000; with permission.
CLINICAL SITUATION
root fracture and recommended extraction. The patient has excellent oral
hygiene, a class I Angle’s malocclusion bilaterally, no mucogingival
defects, and an extensively restored posterior dentition (with silver amal-
gam as the predominate restorative material). Her third molars are the
only other missing teeth.
Her chief concern is whether a dental prosthesis should be fabri-
cated to replace her missing molar tooth. Her general dentist has told
her that if the edentulous space is left untreated, it will lead to future
problems, the most significant of which would be drifting and shifting
of the adjacent and opposing teeth. Such tooth movement, the dentist
said, often results in severe occlusal disharmony, limiting a patient’s
ability to eat comfortably and, because of the concomitant gingival and
periodontal complications, ultimately leading to the demise of other
teeth. At present, the patient does not find the toothless site to be an
esthetic problem. She reports having slightly modified her chewing
pattern, eating more on her right side than her left since the trauma to
tooth #19.
The prosthodontic specialist informs the patient that before treat-
ment options can be considered it is necessary to make diagnostic casts
and to test the vitality and physical condition of the teeth surrounding
the edentulous space. A relevant article reporting a study of the conse-
quences of not replacing a missing posterior tooth has been published
recently in a national dental journal. The specialist promises to share the
results presented in that article with the patient at her next visit so that
she can make an informed decision.
After spending almost an hour rummaging through a stack of
journals later that day, the practitioner finally locates the article. Its title
seems to fit the patient’s condition perfectly: ‘‘The consequences of not
replacing a missing posterior tooth,’’ by Shugars et al.6 Because the
specialist has read it once, a few months ago, he plans to review it again
in more detail before the patient’s next appointment.
Ultimately, the clinician would have definitive insight to share with the
patient and could feel secure in advising her.
This type of study would provide the information the reader de-
sired, but it is unlikely to be undertaken for many reasons. First are
considerations of cost and time. To assemble such a pool of patients
would require innumerable resources: hundreds of calibrated examiners
and clinical facilities that could accommodate tens of thousands of
subjects. Identical follow-up treatment would have to be provided to
each subject (e.g., the same period for prophylaxis, operative treatments,
and other, more complicated procedures). To assure that there were no
influences from other health conditions, it would be necessary to remove
patients from the study who developed illnesses or were prescribed
medications. Ultimately, the initial population might be reduced to too
small a group to make a conclusive assessment. Many years would be
required collect the data necessary to allow advice to be given with
confidence.
A cohort study design offers a more realistic approach for exposing
the risks associated with certain conditions. Patients in a cohort study
would have the same condition (missing a mandibular first molar) but
would be different in ways previously reported to influence the outcome
(e.g., type of malocclusion, periodontal status, other tooth loss). Subjects
would be grouped according to these prognostic factors and followed
over time. Data collected on other conditions that arise during the course
of the study would allow additional analysis to expose other factors
that contribute to the negative outcomes. Absolute risk ratios could be
calculated so that the patient could be offered probabilities on the
outcomes associated with not treating her condition.
The case-control study design is even more practical from both a
resource and a time perspective but is extremely prone to bias. In a case-
control study, subjects with the condition who have experienced the
negative outcome (periodontal destruction, additional tooth loss) are
compared with subjects who have not. Because subjects, cases, and
controls are selected after the event has or should have occurred, there
is tremendous potential bias. Investigators, because they must examine
subjects to determine their appropriateness for the study, cannot be
blinded during the selection process. The population from which sub-
jects are drawn (e.g., a convenience sample from a dental college) further
contributes to bias. Bias is compounded by the inherent shortcomings of
a retrospective study design, substantially reducing the confidence that
clinicians can realistically derive from such a study. Also, because case-
control studies do not follow subjects over time, only relative risks can
be calculated. In spite of these deficiencies, skillfully planned and tightly
monitored case-control studies can play a significant role in patient
care, especially when the outcome under consideration is infrequently
detected or the time needed to observe the outcome is excessively long.
(For example, mesial drifting of teeth posterior to the edentulous space
has been reported to take several years.)
USERS’ GUIDE TO THE DENTAL LITERATURE 131
Primary Guides
Of all the questions patients pose, none is more frequent than ‘‘How
long will it last?’’ or, in the case of predicting risk, ‘‘What are the odds
that it will happen to me?’’ To satisfy the sophisticated patient whose
decision whether to be treated may depend on the response to this
question, the practitioner should consider crafting an answer that will
address the issue even more completely than the patient expects.
One could first offer a predication based on absolute prevalence
rates—the percent of likelihood that a particular event will occur at
USERS’ GUIDE TO THE DENTAL LITERATURE 133
some time in the future. In the article by Shugars et al6, 12% of the
patients who did not receive treatment for a missing posterior tooth lost
an additional adjacent tooth. The median time was 2.5 years, with a
range of 0.9 to 6.7 years. An additional 13% experienced a tilting of the
teeth adjacent to the edentulous space by a distance greater than 2.0
mm, with a median time of 6.9 years and a range of 1.1 to 9.6 years.
A second-level response would be to advise the patient of the
relative likelihood that she will experience the outcome. This response
would involve calculating the relative risk that the event (additional
tooth loss) would occur during a specified period of time if no treatment
were rendered. In a related article on the same cohort of patients,
Shugars et al7 reported the status of teeth adjacent to a bound edentulous
space for patients who received no treatment and for patients for whom
a fixed partial denture was fabricated. There was a 13% failure rate (e.g.,
an additional tooth was lost adjacent to the edentulous space) for the
untreated group of patients and a 7% failure rate for those who received
a fixed partial denture. These rates demonstrate a relative risk of 1.86.
In other words, patients in this study were 1.86 times as likely to lose a
tooth adjacent to an edentulous space if they received no treatment than
if a fixed partial denture were constructed.
Finally, to provide the patient with a perspective on the rate at
which the event is likely to occur over time (more often than not, there
is significant variation), one could provide information gleaned from a
survival curve. These graphic representations depict what occurs over
the course of time and yield information of potentially great value to
the patient. McLaren and White, in a report on the survival rates of In-
Ceram (In-Ceram, Vident, Brea, California) crowns, used multiple survival
graphs to show the rate of failure in each successive month (Fig 1).3a
Figure 1. Reasons for loss of service of In-Ceram crowns followed for 36 months. (From
McLaren E, White S: Survival of In-Ceram crowns in a private practice: A prospective
clinical trial. J Prosthet Dent 83:216–222, 2000; with permission.)
134 LLOYD
Even with the best of intentions and systematic planning, the popu-
lation selected for study will always be a sampling of the population as
a whole. From the data collected, the relative risk for a particular event
can be calculated, but the value will be only an estimate. To show the
precision of this estimate, confidence intervals (CIs) are used. Confidence
intervals help clinicians decide the range within which they can be
confident of the relative risk estimate.2 Norderyd et al, reporting on the
risk of periodontal disease in a Swedish adult population, found that
age is correlated with severe periodontal disease progression.4 Because
this was a case-control study, their calculated risks were expressed as
odds ratios, with a value of 1.05 for the age correlation. The CI was 1.02
to 1.07, a rather tight range and one indicating that the calculated risk
is quite precise.
ACKNOWLEDGMENT
The author expresses appreciation to Anita Makuluni for her insights and editorial
comments.
References
e-mail: patrick-lloyd@viowa.edu
EVIDENCE BASED DENTISTRY 0011–8532/02 $15.00 .00
BIOSTATISTICAL CONSULTATION
FOR DENTAL RESEARCH
Jonathan Clive, PhD
The mean and standard deviation of a normal curve (or any set of
data, for that matter) are often presented in the scientific literature as
mean standard deviation. For example, an author might write that
‘‘the mean and standard deviation DMFS for the test group was 8.3
4.5, whereas for the control group the mean and standard deviation
DMFS was 11.6 5.2.’’ The symbol ‘‘’’ means plus or minus and is
technically not correctly used in this context. The standard deviation is
a positive quantity. By convention, however, the use of this notation has
been almost universally adopted.
The best interpretation of a statement of the form mean standard
deviation is that approximately 68% of all observations lie within one
standard deviation of the mean. Approximately 95% of all observations
lie within two standard deviations of the mean. (These statements apply
to observations that are well modeled by a normal distribution.) The use
of this notation does provide the reader with the notion of an interval
in which most of the data are contained. A confidence interval represents
BIOSTATISTICAL CONSULTATION FOR DENTAL RESEARCH 141
If two distributions have identical means, one can assume that the
distribution of values of the variable being measured are identical in the
two groups from which the data were drawn. If two distributions have
similar means, the distributions are similar; finally, if two distributions
have different means, the distributions are different. Statistics provides
a way of estimating how probable it is that two or more means origi-
nated from the same underlying population. This probability is called
a ‘‘P-value’’ and is the last of the routinely invoked statistical terms
considered here.
P-values arise when two means are compared statistically. Thus,
one may report that ‘‘when the two means were compared using a t-test
of independent group means, it was observed that t on 44 degrees of
freedom was 4.55, P ⬍ 0.001.’’ The interpretation of this statement is as
follows: if there is really no difference between the groups being ob-
served, then the probability of observing a mean difference as extreme
or more extreme than that observed is less than 1 in 1000.
Because the P-value in the example is less than 0.05, the difference
is said to be statistically significant. This cutoff point for statistical signifi-
cance (0.05) is rather arbitrary but has developed into a standard in the
scientific literature over time. The P-value indicates the strength of the
evidence against the hypothesis of no difference in means. (The perspec-
tive of no difference is used because doing so reflects how the theory of
statistical hypothesis testing developed.) Small P-values indicate that the
hypothesis of no difference is unlikely. Unlikely does not mean impossi-
ble, however; therefore the researcher (or reader) must choose between
rejecting the hypothesis of no difference or accepting the conclusion
142 CLIVE
two-tailed, carried out at the 0.05 level of significance. Note that is also
possible to perform a one-way analysis of variance given the tabulated
summary measures. A one-way analysis of variance permits comparison
of all three group means simultaneously, as well as the appropriate
multiple-comparison procedures to isolate group differences.
Is it reasonable to expect practitioners to be familiar with these
terms and to be able to duplicate statistical procedures of the type
discussed here in the course of evaluating a journal article? Probably
not. Any statistical background practitioners acquired in dental school
may be long forgotten, and the practitioner probably faces more pressing
concerns involving office management and patient treatment. In addi-
tion, the practical import of a study in the literature may need time to
propagate to the office of a practitioner.
Unfortunately, in the presentation of scientific studies, the situation
is often ‘‘let the reader beware.’’18 It is true that since the appearance of
the Kilburn, et al article, most journals have increased their requirements
for statistical rigor in submitted manuscripts. Many journals retain statis-
tical consultants for special reviews and will use statistically sophisti-
cated referees where necessary. Nonetheless, a practitioner may need to
know how to evaluate such issues as the suitability of the experimental
design, the appropriateness of the statistical tests used, and whether the
results of the test have been interpreted correctly.
COMPLICATING FACTORS
*The table is designed to show the number of subjects needed in each of two groups, assuming a
repeated measures design with hypothesis testing carried out at ␣ 0.05. Sample size estimates are
shown for each of two values of , and each of several effect sizes.
␣ probability of a type I error;  probability of a type II error
BIOSTATISTICAL CONSULTATION FOR DENTAL RESEARCH 151
DATA MANAGEMENT
values for further checking. This procedure should be followed for all
major study variables.
Data confidentiality is important in clinical trials involving human
subjects. Assuring confidentiality usually entails an intermediate step in
the data-entry process in which identifying information is replaced with
some numeric patient identifier. This is the responsibility of the re-
searcher, who establishes and maintains the key relating the two data
fields. Access to the key is limited by and is under the direction of the
researcher. The file supplied to the statistical consultant should contain
no unique patient data that could be used for identification or to breach
subject anonymity.
RESEARCH ADMINISTRATION
The biostatistical consultant can help the researcher with other as-
pects of the actual administration and execution of the research project.
Several such topics noted here arise in clinical trials and include the
randomization of patients, protocol deviations, and the analysis of drop-
outs and missing data.
The randomization of patients refers to the assignment of patients
to study groups, usually by some random mechanism. Randomization
is generally a straightforward task, and the method of randomization
depends largely on the study design. Both the researcher and the statisti-
cal consultant need to keep careful track of any protocol deviations.
Protocol deviations involve changes in the study design or plan once
subject intake has begun. These planning changes are sometimes un-
avoidable.
Subject dropout can be a major problem in longitudinal clinical
trials. Patients can leave for a variety of reasons. Some may decide not
to continue participating, especially if the experiment involves some
unpleasant or invasive procedures. Others may leave the area. Some
may become injured or ill. The researcher and the biostatistician will
hope fervently that such dropout is random; that is, one is not primarily
losing the treatment responders or non-responders or only the most
compliant or non-compliant participants. Random dropout implies that
subjects who leave a clinical trial before completion of the protocol do
so at random, and that the remaining subject groups are still homoge-
neous with respect to potentially confounding factors.
The term intent to treat refers to the analysis of data from all subjects,
including those who drop out. The rationale for this method of analysis
is discussed in most clinical trial guides; see, for example, Spilker’s
Guide to Clinical Trials19 and Piantadosi’s Clinical Trials: A Methodological
Perspective.15 Most researchers will also analyze those subgroups of parti-
cipants completing the protocol. A crucial phase of the analysis of data
from a clinical trial is the analysis of dropouts and their comparison
with subjects who remained.
BIOSTATISTICAL CONSULTATION FOR DENTAL RESEARCH 153
DISCUSSION
The primary theme of this article is that it is not essential that the
researcher have a strong working knowledge of elementary (or higher)
statistics to perform valid scientific research. Rather, the researcher
should be prepared to work with a biostatistical consultant on an exten-
sive and ongoing basis to plan and execute a research project carefully.
The need for this emphasis was recognized by Moses and Louis, who
suggested that effective collaboration between clinician and statistician
can help identify tractable scientific and statistical problems that need
attention and can help avoid undertaking intractable ones.13 Further-
more, they assert that the ‘‘central requirement for successful collabora-
tion is clear, broad, specific, two-way communication on both scientific
issues and research roles.’’13
The researcher will need to assist the biostatistician in estimating
sample size, in understanding the basics of the science involved, and in
relating scientific and statistical hypotheses. The biostatistician should
come to appreciate the scientific and clinical issues and underlying
principles; likewise, the researcher will come to appreciate how appro-
priately executed data analysis can extract valuable scientific knowledge
from experimental data.
Over time, the researcher will acquire the statistical knowledge
needed to interpret and present study results. The statistical understand-
ing may be focused and restricted to the methods relevant to the particu-
lar study, but it will constitute a useful body of knowledge, appropriate
for future studies or as a basis for using other statistical methods in
different studies.
Most, if not all, scientists are convinced of the utility of mathematical
models in representing and studying natural phenomena. Statistical
models are mathematical models that incorporate probabilistic measures
of uncertainty. In the study of oral health, two primary sources of
variation impart this uncertainty. The first is the natural variation among
patients in measures of oral health; the second is the variation resulting
from sampling, or selecting a subgroup of patients for study, because
the entire population of such patients is impossible to access.
The progression of data analyses intended to account for this varia-
tion, from simple independent group t-tests through complex multivari-
154 CLIVE
References
1. Armitage GC, Jeffcoat MK, Chadwick DE, et al: Longitudinal evaluation of elastase as
a marker for the progression of periodontitis. J Peridontol 65:120–128, 1994
2. Chugal N, Clive J, Spangberg L: A prognostic model for assessment of the outcome of
endodontic treatment: Effect of biologic and diagnostic variables. Oral Surg Oral Med
Oral Pathol Oral Radiol Endod, in press
3. Clive J, Woodbury MA: Continuous and discrete global models of disease. Mathemati-
cal Modeling 7:1137–1154, 1986
4. Diggle PJ, Liang K-Y, Zeger SL: The Analysis of Longitudinal Data. New York, Oxford
University Press, 1994
5. Elashoff J: nQuery Advisor Version 4.0 User’s Guide. Los Angeles, CA, 2000
6. Feinstein A: Clinical Biostatistics. Boca Raton, FL, CRC Press, 2002
7. Friedman G: Primer of Epidemiology, ed 4. New York, McGraw Hill, 1994
8. Glantz A: Primer of Biostatistics, ed 4. New York, McGraw Hill, 1997
9. Imrey PB, Chilton NW: Design and analytic concepts for periodontal clinical trials. J
Periodontol (suppl) 63:1124–1140, 1992
10. Kilburn KH, Alsmundsson T: Anteroposterior chest diameter in emphysema. Arch
Intern Med 123:379–382, 1969
11. Littell RC, Milliken GA, Stroup WW, et al: SAS System for Mixed Models. Cary, NC,
SAS Institute, 1996
12. Löe H, Anerud A, Boysen H, et al: Natural history of periodontal disease in man.
Rapid, moderate and no loss of attachment in Sri Lankan laborers 14 to 46 years of
age. J Clin Periodontol 13:431–440, 1986
13. Moses LE, Louis TA: Statistical consulting in clinical research: The two-way street. Stat
Med 3:1–5, 1984
14. Neely A: The natural history of periodontal disease in man. Risk factors for progres-
sion of attachment loss in subjects receiving no oral health care. J Periodontol
72(8):1006–1015, 2001
15. Piantadosi S: Clinical Trails: A Methodological Perspective. New York; John Wiley &
Sons, 1997
16. Riegelman RK: Studying a Study and Testing a Test, ed 4. Philadelphia, Lippincott
Williams & Wilkins, 2000
17. Sackett DL, Haynes RB, Tugwell P, et al: Clinical Epidemiology ed 2. Philadelphia,
Lippincott Williams & Wilkins, 1991
18. Sheehan TJ: The medical literature: Let the reader beware. Arch Intern Med 140:472–
474, 1980
19. Spilker B: Guide to Clinical Trials. New York, Raven Press, 1991
BIOSTATISTICAL CONSULTATION FOR DENTAL RESEARCH 155
20. Ten Have TR, Landis JR, Weaver SL: Association models for periodontal disease
progression: A comparison of methods for clustered binary data. Stat Med 14:413–
429, 1995
21. Voelkl KE, Gerber S: Using SPSS for Windows. New York, Springer-Verlag New
York, 1999
e-mail: clive@nso1.uch.edu
EVIDENCE BASED DENTISTRY 0011–8532/02 $15.00 .00
GENERAL ISSUES
From the Faculty of Dentistry, University of Toronto ; and the Craniofacial Prosthetic Unit,
Toronto-Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada
Figure 1. The steps in the model of evidence-based practice. (From Anderson JD: Need
for evidence-based practice in prosthodontics. J Prosthet Dent 83:58–65, 2000; with permis-
sion.)
0.003), meaning there was only a 0.3% chance that such a difference
could have occurred by chance. This difference seems major until one
realizes that it is only a 0.5-mm difference and therefore is unlikely to
be clinically significant. A highly significant statistical difference is there-
fore no indicator of a clinically significant difference.
Most articles that describe clinical research report their findings on
a sample of patients. Often, the sample of patients is intended to repre-
sent the whole population. The selected patients therefore should have
demographic and disease characteristics similar to those of the popula-
tion at large. The distribution of age, sex, socioeconomic status, educa-
tion, nutritional status, and occupational range all should reflect society
in general. Similarly, the prevalence, severity, and duration of disease
status should also mirror the general population. Clearly, a sample of
patients in any given study is unlikely to fulfill all these criteria. Often,
the authors do not want to reflect the whole population and limit their
sample to persons of a certain age group, or with a history of exposure
to an agent such as smoking, or with a clinical condition such as
edentulousness. In applying the findings from such studies to the indi-
vidual patient, a clinician must decide if the patient is similar enough to
the study patients for the results to be applicable. One way to do so is
to see if the clinician’s patient would have met the inclusion and exclu-
sion criteria to be included the study. Often, some differences are found
between the study sample and the present patient. These differences
may not make the article useless. A more useful approach may be to
reverse the question and ask whether the study population is so different
APPLYING EVIDENCE BASED DENTISTRY TO YOUR PATIENTS 159
from the patient that the results cannot possibly be applied. This ap-
proach makes it possible to apply some information from the article. If
the study population is divided into subgroups, it may be possible
to match the reader’s patient to one of the groups for more focused
information.
The setting in which the study was gathered can have a major
impact on the findings. The results of a new, experimental periodontal
treatment tested in a major teaching institution may not be applicable to
the patients of a general practitioner because of an effect called referral
filter bias. The major teaching institution is likely to attract patients
who have more severe periodontal problems than those seen in general
practice. Similarly, the treatment they receive at a major center may not
be feasible in general practice. The patients’ response to the new treat-
ment, therefore, may not be applicable to the patients of a general
practice. An example is the series of patients treated with severe (apical
third) periodontal bone loss who were rehabilitated with extensive fixed
bridges and aggressive oral hygiene maintenance.6 Such a report offers
little help to the general practitioner who sees less severe periodontal
destruction, is less likely to undertake such extensive reconstructions,
and may not be able to expect such a high degree of patient compliance
in oral hygiene. Therefore, if readers are seeking information to apply to
their general practice, it will be necessary to pay special attention to
how the patients were selected with respect to the severity of their
disease and the feasibility of the treatment approach. The important
question for the practitioner to ask is, ‘‘Could such circumstances be
duplicated in my office?’’
No clinical decisions are made without some element of patient
input. The patient’s preferences, priorities, and resources will therefore
affect clinical decisions. Stated another way, the social and cultural issues
that are important to the patient must be considered when deciding how
to apply the information found in a literature search related to the
patient’s problem. A new, highly effective treatment approach that takes
too long, is likely to be painful, or is too expensive is not appropriate if
it is not consistent with the patient’s wishes. Similarly, treatment solu-
tions exist for problems that are not important to some patients. The use
of effective veneering techniques makes sense only if the social and
cultural pressures on a patient exceed the risks inherent in the technique.
For many people, a less than perfect smile is simply not important. To
suggest a solution where there is no problem invites disaster. Marketing
techniques aimed at creating demand are a concern here.
SPECIFIC APPLICATIONS
Diagnostic Tests
Prognosis
Therapy
SUMMARY
References
1. Boerrigter EM, van Oort RP, Raghoebar GM, et al: A controlled clinical trial of implant-
retained mandibular overdentures: Clinical aspects. J Oral Rehabil 24:182–190, 1997
2. Bragger U: Evidence Based Outcomes of Periodontal Therapy: Clinical Decision Making
in Prosthodontics and the Impact of Implants. Bern, Switzerland, 2001
3. de Leeuw R, Boering G, Stegenga B, et al: Symptoms of temporomandibular joint
osteoarthrosis and internal derangement 30 years after non-surgical treatment. Cranio
13:81–88, 1995
4. Jeffcoat MK, Reddy MS, Wang IC, et al: The effect of systemic flurbiprofen on bone
supporting dental implants. J Am Dent Assoc 126:305–311, 1995
5. Kassirer JP, Kopelman RI: Cognitive errors in diagnosis: Instantiation, classification, and
consequences. Am J Med 86:433–441, 1989
164 ANDERSON
e-mail: jim.anderson@utoronto.ca