Time for a New Era in Outcomes Reporting for Breast Reconstruction

JNCI: Journal of the National Cancer Institute, Jan 2011

Morrow, Monica, Pusic, Andrea L.

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Time for a New Era in Outcomes Reporting for Breast Reconstruction

? please? e-mail:? . 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 - 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)


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Morrow, Monica, Pusic, Andrea L.. Time for a New Era in Outcomes Reporting for Breast Reconstruction, JNCI: Journal of the National Cancer Institute, 2011, pp. 5-7, Volume 103, Issue 1, DOI: 10.1093/jnci/djq471