Time for a New Era in Outcomes Reporting for Breast Reconstruction
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Time for a New Era in Outcomes Reporting for Breast Reconstruction
Monica Morrow 0
Andrea L. Pusic 0
0 Affiliations of authors: Breast Service, Department of Surgery (MM) and Department of Plastic and Reconstructive Surgery, Memorial Sloan-Kettering Cancer Center , New York, NY, ALP , USA
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The local therapy of breast cancer is based on a strong foundation
of evidence derived from prospective randomized trials comparing
local recurrence and survival outcomes after breast-conserving
therapy (BCT) to those after mastectomy (
1
). Although there is no
survival advantage to mastectomy, approximately 25% of women
with ductal carcinoma in situ and stage I and II breast cancer
undergo mastectomy due to patient preference or contraindications
to BCT (
2,3
), and the use of contralateral prophylactic mastectomy
appears to be increasing (4). Together, these factors mean that a
substantial proportion of women undergoing surgical treatment for
breast cancer are candidates for unilateral or bilateral breast
reconstruction. Survey research suggests that patient knowledge of
reconstructive options statistically increases willingness to consider
mastectomy (
5
). In a study of women from the Los Angeles and
Detroit Surveillance, Epidemiology, and End Results registries
diagnosed with breast cancer between 2001 and 2003, Alderman
et al. (
5
) found that those who discussed reconstruction with their
general surgeon were four times more likely to undergo mastectomy
than those who did not (odds ratio, 4.48; 95% confidence interval,
3.31 to 6.06; P < .001) after controlling for age, race, education, and
comorbidities (
5
). The discussion about breast reconstruction
includes a description of the spectrum of reconstructive options, the
incidence and types of complications, and the long-term cosmetic
results. Unfortunately, as documented by Potter et al. in this
issue of the Journal (
6
), reliable information on these outcomes is
difficult to obtain. Of the 134 studies evaluating surgical
complications after reconstruction, only 11 (8.2%) were prospective
randomized trials, 49 (36.6%) were case series, and the remainder
cohort studies. Important discrepancies between the number of
outcomes defined and the number reported were observed for
the majority of studies, and key information such as the method of
complication assessment, duration of follow-up, and distribution
of risk factors among the patients studied was missing in many
instances. This variability in reporting makes both an assessment of
the generalizability of the findings of individual studies and
comparison among studies difficult. There is clearly an opportunity to
improve the quality of information that is available to patients faced
with a breast cancer surgery decision that includes reconstruction,
and the development of a rigorously defined set of core outcome
measures is a logical first step.
The recent UK National Mastectomy and Breast Reconstruction
Audit was an important step toward the goal of standardized
reporting of outcomes (
7
). The audit prospectively evaluated
in-hospital complications and patient-reported outcomes in a large
cohort of patients treated at over 200 surgical centers. Before the
initiative, standardized definitions of complication were
developed. This report thus provides high-quality information on the
incidence of adverse events that may directly inform and support
shared medical decision making for patients and surgeons. As an
example, the audit identified that one in six women undergoing
reconstruction required re-admission for unplanned further
treatment or surgery and that one in four required antibiotics for a
wound infection. The audit also provided concrete benchmark
data that will be useful for quality improvement efforts, and it
would be advisable for researchers and surgical societies elsewhere
in the world to strongly consider adoption of similar definitions for
standardized reporting.
Evidence suggests that patients may more sensitively discern
and reliably report adverse events than their physicians (
8
). As an
example, among patients undergoing sentinel node biopsy or
axillary dissection, there is striking discordance between the presence
of measured and patient-perceived lymphedema (
9
), suggesting
that consideration be given to standardization of patient, as well as
clinician-reported outcomes (
10
). High-quality standardized
information on patient satisfaction with various aspects of
reconstruction is also needed. Patient perceptions may differ in important
ways from those of their physicians (
10
). For example, physician
assumptions that a contralateral prophylactic mastectomy for
symmetry, with the resultant anesthetic breast, is preferable to a
mastopexy or reduction, which provides less-perfect symmetry but
maintains a sensate breast, may not reflect patient values. Three
systematic reviews have confirmed that research evaluating
patientreported outcomes in br (...truncated)