O u t c o m e s R e s e a rc h

and the Challenge

of Evidence-Based
Surgery
Thomas B. Dodson, DMD, MPHa,b,*
KEYWORDS
 Outcomes research  Quality assurance
 Evidence-based surgical practice
 Patient-oriented research

WHAT IS OUTCOMES RESEARCH?

Almost invariably, when the author mentions
outcomes research, audiences or readers raise
their collective eyebrows quizzically as if to ask,
What does that mean? It is an excellent question. In general, outcomes research focuses on
the end products or results of health care practices, interventions, and processes.
As practiced, however, outcomes research
means different things to different people. To
some, outcomes research means developing clinical benchmarks or practice guidelines. To others,
outcomes research is used for quality assurance
and patient safety activities. To others still,
outcomes research tries to explain variability in
clinical practice or linking types of care to
outcomes. Regardless of an individuals definition
of outcomes research, outcomes research has
similar goals (eg, improve the patient care or the

health care process) and uses similar clinical

epidemiologic investigative tools.
At the Center for Applied Clinical Investigation
(CACI) based in the Department of Oral and Maxillofacial Surgery at Massachusetts General
Hospital, outcomes research is one area of focus.
Outcomes researchers at CACI measure what
happened and why it happened.
CACIs outcomes research activities are
grouped into two areas. First, researchers want
to estimate how often events of interest occur,
that is, what happened. Frequency, incidence, or
survival estimates of outcomes are measured for
patient care activities (eg, nerve repair, complications after third molar surgery, or implant
survival).15 This information is used to inform clinical care and practice.
Equally important is estimating the results of
health care processes or practices (eg, satisfaction with telephone follow-up after dentoalveolar
procedures or following nerve repair, frequency
of completed consent forms, or length of hospitalization after orthognathic surgery).68 This
information can be used for benchmarking,
patient education, or improving quality or safety
processes.

Article preparation was supported by the Massachusetts General Hospital Department of Oral and
Maxillofacial Surgerys Center for Applied Clinical Investigation and Education and Research Fund and
Massachusetts General Physician Organization.
a
Center for Applied Clinical Investigation, Department of Oral and Maxillofacial Surgery, Massachusetts
General Hospital, 55 Fruit Street, Warren Building Suite 1201, Boston, MA 02114, USA
b
Department of Oral and Maxillofacial Surgery, Harvard School of Dental Medicine, 188 Longwood Avenue,
Boston, MA 02115, USA
* Center for Applied Clinical Investigation, Department of Oral and Maxillofacial Surgery, Massachusetts
General Hospital, 55 Fruit Street, Warren Building Suite 1201, Boston, MA 02114.
E-mail address: tbdodson@partners.org
Oral Maxillofacial Surg Clin N Am 22 (2010) 14
doi:10.1016/j.coms.2009.10.004
1042-3699/10/$ see front matter 2010 Elsevier Inc. All rights reserved.

oralmaxsurgery.theclinics.com

The purposes of this article are to introduce a definition of outcomes research, to review how
outcomes research may guide evidence-based
surgical practice and health care processes, and
to review a model for outcomes research.

Dodson
The Centers second outcomes research
activity focuses on identifying factors or variables
associated with the outcome (ie, why did the event
of interest happen?). These factors can be classified as prognostic (ie, associated with a favorable
outcome or result) or risk (ie, associated with an
unfavorable outcome or result). For example, one
could look at factors associated with implant
survival (prognostic) or implant failure (risk).9 The
factors associated with an outcome of interest
are then categorized as immutable (eg, age or
sex) or potentially modifiable (eg, perioperative
antibiotic use). Immutable factors may be used
to predict prognosis or risk for outcomes of
interest. Modifiable factors may be used to
improve outcomes.

USING OUTCOMES RESEARCH TO ENHANCE

AND GUIDE EVIDENCE-BASED SURGICAL
PRACTICE AND HEALTH CARE PROCESSES
Enhancing Evidence-based Surgical Practice
Systematic collection of outcome data can inform
clinical practice. Frequency, incidence, or survival
data can be used be used to inform patients of the
likelihood of a good (or bad) result. For example,
these types of data can be used to inform the
average patient about the likelihood for postoperative infection or nerve injury after third molar
surgery or the chance that an implant will survive.
As noted above, factors associated with
outcomes are identified and grouped into two
categories: immutable (eg, age and sex) or modifiable (eg, tobacco use, implant length, timing of
implant loading, use of antibiotics). Since immutable variables cannot be changed, data regarding
these variables can be used to inform the patient
of prognosis or risk. For example, an older patient
may have an increased risk for intra- or postoperative complications associated with third molar
surgery. One cannot change the patients age,
but can use that information to help set treatment
or prognosis expectations.
In contrast, modifiable variables may be used to
enhance prognosis or decrease the risk for an
adverse outcome. Modifying tobacco use may
affect the risk of postoperative complications. As
such, the clinician may suggest that a patient stop
smoking before implant insertion to improve the
likelihood of implant survival or decrease the risk
for a postoperative inflammatory complication.
Modifiable variables can be used to generate
additional studies to test a hypothesis that
changes in the modifiable variable results in
changes the outcome. Absent additional data,
one should be quite cautious in translating the
findings from an outcomes study directly to patient

care. In most cases, outcomes studies are not designed to identify variables associated with the
outcome of interest. These findings are valuable
side-effects of the study. As such, biases in
study sample selection, incomplete data collection, subject follow-up, or variable definitions
could produce spurious associations. Instead,
new, controlled trials should be implemented,
guided by hypotheses arising from the outcomes
research, to confirm or refute the observed relationship between the factor and outcome of
interest.

Enhancing Evidence-based
Healthcare Processes
Outcomes research can improve or inform health
care processes. Outcomes research may be
used to establish benchmarks and used as
a quality assurance or safety activity. For example,
national statistics suggest that the frequency of
patients who are extremely or moderately satisfied
with their deep sedation, general anesthesia experience is 94.9%.10 Individual clinicians or practices
may survey their patients satisfaction with deep
sedation, general anesthesia and compare the
results to a prespecified target or nationally established benchmark. Adverse deviations from the
target or benchmark may prompt a review of clinical protocols, and suggest changes, implementation of a new clinical protocol, and iterative
measures of the outcome to see if the changes
result in achieving or exceeding the benchmark.
Absent a prespecified national benchmark, the
practice may survey its patients to establish its
own baseline frequency of some outcome of
interest (eg, use of two identifiers for patient identification). Once the baseline is established, the
practice may repeat the survey on a regular basis
to confirm that the baseline target is being
achieved. If the target is consistently achieved,
a new target may be specified or a different
outcome evaluated.
Outcomes research can be used for patient
education. Estimates of a practices or specialties
frequency of inferior alveolar nerve injury or
surgical site infection after third molar removal
may be valuable information because, when
conveyed to patients, it may to help them determine the best management choice for third
molars.

A MODEL FOR OUTCOMES RESEARCH

Fig. 1 summarizes CACIs outcomes research
cycle. The first step is to generate a research
question. There are two excellent sources to
generate research questions. The first is the

Challenge of Evidence-Based Surgery

Fig. 1. Models for outcomes research.

investigators clinical practice. A practical alternative source is a regulatory or licensing body.

Generically, the research question takes the
following form, Among patients with (some clinical problem of interest), what is the frequency of
(an outcome of interest) and what factors or variables are associated with (the outcome of
interest)? A specific question could be, Among
patients receiving dental implants in my practice,
what is the one-year survival rate and what prognostic factors are associated with survival?
To answer the question, the investigator will
need to determine a study design and choose
a clinically relevant sample. For many outcomes
research purposes, retrospective or crosssectional study designs work are excellent for
generating preliminary data or benchmarks. Use
of retrospective or cross-sectional data allows
the investigator to generate quickly a study sample
and a database. However, as noted previously,
because of well-known biases associated with
retrospective or cross-sectional studies, one
should exercise caution in translating these findings to patient care.
To maximize data collection efforts, the study
should be designed to address the two primary
goals of outcomes research, estimating the
frequency of outcome of interest and identifying
factors associated with the outcome. For
purposes of benchmarking activities, one may
only be interested in the frequency estimates and
use these estimate to establish targets or benchmarks as part of quality assurance exercises. For
clinical practice, the investigator will try to identify
modifiable variables associated with the outcome.
In the latter circumstance, these factors can be
converted into new clinical questions and generate
new hypothesis-driven research usually in the form
of a prospective, controlled clinical trial. The

results from well-designed, controlled clinical trials

may then feed back to improve clinical practice. A
side effect of outcomes research may be observations that generate biologic questions answered in
basic research laboratories.
Quality assurance or patient safety studies used
to generate targets or benchmarks need not be
limited to generating descriptive statistics alone.
These types of projects can be readily adapted
to become hypothesis-driven outcomes research.
One can just as easily identify factors associated
with achieving targets and then manipulate them
to enhance the likelihood of reaching future
targets.

SUMMARY
Outcomes research is a special case of patientoriented research activities. Its focus is measuring
the frequency of outcomes and identifying factors
associated with outcomes. The goals of outcomes
research are to improve clinical care and health
care processes and practices.

REFERENCES
1. Chuang SK, Perrott DH, Susarla SM, et al. Risk
factors for inflammatory complications following third
molar surgery. J Oral Maxillofac Surg 2008;66:
22138.
2. Susarla S, Kaban LB, Donoff RB, et al. Does early
repair of lingual nerve injuries improve functional
sensory recovery? J Oral Maxillofac Surg 2007;65:
10706.
3. Bui CH, Seldin EB, Dodson TB. Types, frequencies,
and risk factors for complications following third
molar extraction. J Oral Maxillofac Surg 2003;61:
137989.

Dodson
4. Chuang SK, Tian L, Wei L-J, et al. Kaplan-Meier
analysis of dental implant survival: a strategy for estimating survival with clustered observations. J Dent
Res 2001;80:201620.
5. Susarla SM, Dodson TB. How well do clinicians estimate third molar extraction difficulty? J Oral Maxillofac Surg 2005;63:1919.
6. Human ET, Juvet LM, Nastri A, et al. Changing
patterns of hospital length of stay following orthognathic surgery. J Oral Maxillofac Surg 2008;66:
4927.
7. Susarla S, Kaban LB, Donoff RB, et al. A comparison
of patient satisfaction and objective assessment of

neurosensory function after trigeminal nerve repair.

J Oral Maxillofac Surg 2005;63:1138.
8. Lam NP, Kaban LB, Donoff RB, et al. Patient satisfaction after trigeminal nerve repair. Oral Surg Oral Med
Oral Pathol 2003;95:53843.
9. Chuang SK, Wei L-J, Douglass CW, et al. Risk
factors for dental implant failure: a strategy for the
analysis of clustered failure time observations.
J Dent Res 2002;81:5727.
10. Perrott DH, Yuen J, Andresen R, et al. Office-based
ambulatory anesthesia: an overview of the clinical
practice of oral and maxillofacial surgeons in the
United States. J Oral Maxillofac Surg 2003;61:98395.