Breast Implant-associated Anaplastic Large Cell Lymphoma: Updated Results from a Structured Expert Consultation Process.

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.

Workplace Wellness Programs: Services Offered, Participation, and Incentives.

This article leverages existing data on wellness programs to explore patterns of wellness program availability, employers' use of incentives, and program participation and utilization among employees. Researchers used two sets of data for this project: The first included data from the 2012 RAND Employer Survey, which used a nationally representative sample of U.S. employers that had detailed information on wellness program offerings, program uptake, incentive use, and employer characteristics. These data were used to answer questions on program availability, configuration, uptake, and incentive use. The second dataset included health care claims and wellness program information for a large employer. These data were analyzed to predict program participation and changes in utilization and health. The findings underscore the increasing prevalence of worksite wellness programs. About four-fifths of all U.S. employers with more than 1,000 employees are estimated to offer such programs. For those larger employers, program offerings cover a range of screening activities, interventions to encourage healthy lifestyles, and support for employees with manifest chronic conditions. Smaller employers, especially those with fewer than 100 employees, appear more reserved in their implementation of wellness programs. The use of financial incentives appears to increase employee participation in wellness programs, but only modestly. Employee participation in lifestyle management aspects of workplace wellness programs does not reduce healthcare utilization or cost regardless of whether we focus on higher-risk employees or those who are more engaged in the program.

Breast implant-associated anaplastic large cell lymphoma: a systematic review.

BACKGROUND: There is substantial evidence that a type of anaplastic large cell lymphoma (ALCL) is associated with breast implants. However, the course in patients with breast implants seems to be unusually benign compared with other systemic ALCL. The purpose of this study was to identify and analyze recently published cases of breast implant-associated ALCL, with an emphasis on diagnosis, staging, treatment, and outcomes. METHODS: The authors conducted a systematic literature review of reported cases of ALCL in patients with breast implants. Publications were identified with a search algorithm and forward searches. Case-based data were abstracted independently and reconciled by multiple investigators. RESULTS: Of 248 identified articles, only 102 were relevant to breast implant-associated ALCL, and 27 were included in this study. Fifty-four cases of ALCL in patients with breast implants were identified. Detailed clinical information was lacking in many cases. Most presented with a seroma (76 percent), and approximately half were associated with the capsule (48 percent). Most presented as stage IE (61 percent). All but one case were ALK-negative. Most received chemotherapy (57 percent) and radiation therapy (48 percent), and 11 percent received stem cell transplants. Approximately one-quarter recurred, and 9 percent died. CONCLUSIONS: Since the publication of guidance related to breast implant-associated ALCL in 2010, a number of cases have been reported. Despite the typically benign course, many of the cases have been treated with radiation therapy and/or chemotherapy. Increasing awareness of this disease entity among clinicians would be helpful, along with standardizing an approach to diagnosis, staging, and treatment. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, V.

Factors Affecting Physician Professional Satisfaction and Their Implications for Patient Care, Health Systems, and Health Policy.

The American Medical Association asked RAND Health to characterize the factors that affect physician professional satisfaction. RAND researchers sought to identify high-priority determinants of professional satisfaction by gathering data from 30 physician practices in six states, using a combination of surveys and semistructured interviews. This article presents the results of the subsequent analysis.

Final Report: Evaluation of Tools and Metrics to Support Employer Selection of Health Plans.

The Patient Protection and Affordable Care Act (ACA) places strong emphasis on quality of care as a means to improve outcomes for Americans and promote the financial sustainability of our health care system. Included in the ACA are new disclosure requirements that require health plans to provide a summary of benefits and coverage that accurately describes the benefits under the plan or coverage. These requirements are intended to support employers' procurement of high-value health coverage for their employees. This study attempts to help employers understand the structural differences between health plans and the performance dimensions along which plans can differ, as well as to educate employers about available tools that can be used to evaluate plan options. The study also discusses the extent to which these and other tools or resources are used by employers to inform choices between health plans.

A demonstration of shared decision making in primary care highlights barriers to adoption and potential remedies.

Recent developments in health reform related to the passage of the Affordable Care Act and ensuing regulations encourage delivery systems to engage in shared decision making, in which patients and providers together make health care decisions that are informed by medical evidence and tailored to the specific characteristics and values of the patient. To better understand how delivery systems can implement shared decision making, we interviewed representatives of eight primary care sites participating in a demonstration funded and coordinated by the Informed Medical Decisions Foundation. Barriers to shared decision making included overworked physicians, insufficient provider training, and clinical information systems incapable of prompting or tracking patients through the decision-making process. Methods to improve shared decision making included using automatic triggers for the distribution of decision aids and engaging team members other than physicians in the process. We conclude that substantial investments in provider training, information systems, and process reengineering may be necessary to implement shared decision making successfully.

Dissemination and Adoption of Comparative Effectiveness Research Findings When Findings Challenge Current Practices.

Insufficient evidence regarding the effectiveness of medical treatments has been identified as a key source of inefficiency in the U.S. healthcare system. Variation in the use of diagnostic tests and treatments for patients with similar symptoms or conditions has been attributed to clinical uncertainty, since the published scientific evidence base does not provide adequate information to determine which treatments are most effective for patients with specific clinical needs. The federal government has made a dramatic investment in comparative effectiveness research (CER), with the expectation that CER will influence clinical practice and improve the efficiency of healthcare delivery. To do this, CER must provide information that supports fundamental changes in healthcare delivery and informs the choice of diagnostic and treatment strategies. This article summarizes findings from a qualitative analysis of the factors that impede the translation of CER into clinical practice and those that facilitate it. A case-study methodology is used to explore the extent to which these factors led to changes in clinical practice following five recent key CER studies. The enabling factors and barriers to translation for each study are discussed, the root causes for the failure of translation common to the studies are synthesized, and policy options that may optimize the impact of future CER-particularly CER funded through the American Recovery and Reinvestment Act of 2009-are proposed.

A Review of the U.S. Workplace Wellness Market.

This article describes the current state of workplace wellness programs in the United States, including typical program components; assesses current uptake among U.S. employers; reviews the evidence for program impact; and evaluates the current use and the impact of incentives to promote employee engagement. Wellness programs have become very common, as 92 percent of employers with 200 or more employees reported offering them in 2009. Survey data indicate that the most frequently targeted behaviors are exercise (addressed by 63 percent of employers with programs), smoking (60 percent), and weight loss (53 percent). In spite of widespread availability, the actual participation of employees in such programs remains limited. A 2010 survey suggests that typically less than 20 percent of eligible employees participate in wellness interventions. At this time, it is difficult to definitively assess the impact of workplace wellness on health outcomes and cost. While employer sponsors are mostly satisfied with the results, more than half stated in a recent survey that they did not know their program's return on investment. The peer-reviewed literature, while predominately positive, covers only a tiny percentage of the universe of programs. Evaluating such complex interventions is difficult and poses substantial methodological challenges that can invalidate findings. The use of incentives, such as cash, cash equivalents, and variances in health plan costs, to promote employee engagement, while increasingly popular, remains poorly understood. Future research should focus on finding out which wellness approaches deliver which results under which conditions to give much-needed guidance on best practices.

Workplace Wellness Programs Study: Final Report.

This article investigates the characteristics of workplace wellness programs, their prevalence, their impact on employee health and medical cost, facilitators of their success, and the role of incentives in such programs. The authors employ four data collection and analysis streams: a review of the scientific and trade literature, a national survey of employers, a longitudinal analysis of medical claims and wellness program data from a sample of employers, and five case studies of existing wellness programs in a diverse set of employers to gauge the effectiveness of wellness programs and employees' and employers' experiences.

Five reasons that many comparative effectiveness studies fail to change patient care and clinical practice.

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.

Systematic review of the impact of worksite wellness programs.

OBJECTIVES: To analyze the impact of worksite wellness programs on health and financial outcomes, and the effect of incentives on participation. METHODS: Sources were PubMed, CINAHL and EconLit, Embase, Web of Science, and Cochrane for 2000-2011. We examined articles with comparison groups that assessed health-related behaviors, physiologic markers, healthcare cost, and absenteeism. Data on intervention, outcome, size, industry, research design, and incentive use were extracted. RESULTS: A total of 33 studies evaluated 63 outcomes. Positive effects were found for threefourths of observational designs compared with half of outcomes in randomized controlled trials. A total of 8 of 13 studies found improvements in physical activity, 6 of 12 in diet, 6 of 12 in body mass index/weight, and 3 of 4 in mental health. A total of 6 of 7 studies on tobacco and 2 of 3 on alcohol use found significant reductions. All 4 studies on absenteeism and 7 of 8 on healthcare costs estimated significant decreases. Only 2 of 23 studies evaluated the impact of incentives and found positive health outcomes and decreased costs. CONCLUSIONS: The studies yielded mixed results regarding impact of wellness programs on healthrelated behaviors, substance use, physiologic markers, and cost, while the evidence for effects on absenteeism and mental health is insufficient. The validity of those findings is reduced by the lack of rigorous evaluation designs. Further, the body of publications is in stark contrast to the widespread use of such programs, and research on the effect of incentives is lacking.

Vulnerable patients' perceptions of health care quality and quality data.

BACKGROUND: Little is known about how patients served by safety-net hospitals utilize and respond to hospital quality data. OBJECTIVE: To understand how vulnerable, lower income patients make health care decisions and define quality of care and whether hospital quality data factor into such decisions and definitions. METHODS: Mixed quantitative and qualitative methods were used to gather primary data from patients at an urban, tertiary-care safety-net hospital. The study hospital is a member of the first public hospital system to voluntarily post hospital quality data online for public access. Patients were recruited from outpatient and inpatient clinics. Surveys were used to collect data on participants' sociodemographic characteristics, health literacy, health care experiences, and satisfaction variables. Focus groups were used to explore a representative sample of 24 patients' health care decision making and views of quality. Data from focus group transcripts were iteratively coded and analyzed by the authors. RESULTS: Focus group participants were similar to the broader diverse, low-income clinic. Participants reported exercising choice in making decisions about where to seek health care. Multiple sources influenced decision-making processes including participants' own beliefs and values, social influences, and prior experiences. Hospital quality data were notably absent as a source of influence in health care decision making for this population largely because participants were unaware of its existence. Participants' views of hospital quality were influenced by the quality and efficiency of services provided (with an emphasis on the doctor-patient relationship) and patient centeredness. When presented with it, patients appreciated the hospital quality data and, with guidance, were interested in incorporating it into health care decision making. CONCLUSIONS: Results suggest directions for optimizing the presentation, content, and availability of hospital quality data. Future research will explore how similar populations form and make choices based on presentation of hospital quality data.

Anaplastic large cell lymphoma and breast implants: results from a structured expert consultation process.

BACKGROUND: There are increasing concerns about a possible association between anaplastic large cell lymphoma (ALCL) and breast implants. The authors conducted a structured expert consultation process to evaluate the evidence for the association, its clinical significance, and a potential biological model based on their interpretation of the published evidence. METHODS: A multidisciplinary panel of 10 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) there is a positive association between breast implants and ALCL development but likely underrecognition of the true number of cases; (2) a recurrent, clinically evident seroma occurring 6 months or more after breast implantation should be aspirated and sent for cytologic analysis; (3) anaplastic lymphoma kinase-negative ALCL that develops around breast implants is a clinically indolent disease with a favorable prognosis that is distinct from systemic anaplastic lymphoma kinase-negative ALCL; (4) management should consist of removal of the involved implant and capsule, which is likely to prevent recurrence, and evaluation for other sites of disease; and (5) adjuvant radiation or chemotherapy should not be offered to women with capsule-confined disease. Little agreement, however, was found regarding etiologic risk factors for implant-associated ALCL. CONCLUSION: The authors' assessment yielded consistent results on a number of key issues regarding ALCL in women with breast implants, but substantial further research is needed to improve our understanding of the epidemiology, clinical aspects, and biology of this disease. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, V.

Anaplastic large cell lymphoma and breast implants: a systematic review.

BACKGROUND: In recent years, there have been growing concerns about a possible association of non-Hodgkin's lymphoma--in particular, anaplastic large cell lymphoma (ALCL)--and breast implants. The purpose of this study was to identify and analyze all reported cases of non-Hodgkin's lymphoma occurring in patients with breast implants. METHODS: The authors conducted a systematic literature review of reported cases of non-Hodgkin's lymphoma in patients with breast implants. Publications were identified with a search algorithm, forward searches, and expert nominations. After references were reviewed and assessed for inclusion or exclusion, case-based data were independently abstracted, reconciled, and adjudicated by multiple investigators. The data were then synthesized and analyzed. RESULTS: Of 884 identified articles, only 83 were relevant to non-Hodgkin's lymphoma involving the breast, and 34 were included in our study. Thirty-six cases of non-Hodgkin's lymphoma in patients with implants were found, of which 29 (81 percent) were ALCLs. Although detailed clinical information was lacking in many cases, ALCL often involved the capsule and/or presented as an unexplained seroma or mass, was negative for anaplastic lymphoma kinase (ALK) expression, and had a relatively indolent clinical course when it developed adjacent to a breast implant. CONCLUSIONS: A form of ALCL, which clinically behaves more like the less aggressive primary cutaneous form of ALK-negative ALCL rather than the more aggressive systemic form, may be associated with breast implants. Future research on the epidemiology and biology of this rare disease is clearly needed to better understand its nature.