Despite widespread enthusiasm about the potential impact of new investments in comparative effectiveness research, recent history suggests that scientific evidence may be slow to change clinical practice. Reflecting on studies conducted over the past decade, we identify five causes that underlie the failure of many comparative effectiveness studies to alter patient care. These are financial incentives, such as fee-for-service payment, that may militate against the adoption of new clinical practices; ambiguity of study results that hamper decision making; cognitive biases in the interpretation of new information; failure of the research to address the needs of end users; and limited use of decision support by patients and clinicians. Policies that encourage the development of consensus objectives, methods, and evidentiary standards before studies get under way and that provide strong incentives for patients and providers to use resources efficiently may help overcome at least some of these barriers and enable comparative effectiveness results to alter medical practice more quickly.

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Background:Despite increased cases published on breast implant–associated anaplastic large cell lymphoma (BIA-ALCL), important clinical issues remain unanswered. We conducted a second structured expert consultation process to rate statements related to the diagnosis, management, and surveillance of this disease, based on their interpretation of published evidence.Methods:A multidisciplinary panel of 12 experts was selected based on nominations from national specialty societies, academic department heads, and recognized researchers in the United States.Results:Panelists agreed that (1) this disease should be called “BIA-ALCL”; (2) late seromas occurring >1 year after breast implantation should be evaluated via ultrasound, and if a seroma is present, the fluid should be aspirated and sent for culture, cytology, flow cytometry, and cell block to an experienced hematopathologist; (3) surgical removal of the affected implant and capsule (as completely as possible) should occur, which is sufficient to eradicate capsule-confined BIA-ALCL; (4) surveillance should consist of clinical follow-up at least every 6 months for at least 5 years and breast ultrasound yearly for at least 2 years; and (5) BIA-ALCL is generally a biologically indolent disease with a good prognosis, unless it extends beyond the capsule and/or presents as a mass. They firmly disagreed with statements that chemotherapy and radiation therapy should be given to all patients with BIA-ALCL.Conclusions:Our assessment yielded consistent results on a number of key, incompletely addressed issues regarding BIA-ALCL, but additional research is needed to support these statement ratings and enhance our understanding of the biology, treatment, and outcomes associated with this disease.

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