Abstract: The Post-Licensure Rapid Immunization Safety Monitoring (PRISM) system is a cohort-based active surveillance network initiated by the US Department of Health and Human Services to supplement preexisting and other vaccine safety monitoring systems in tracking the safety of monovalent pandemic 2009 H1N1 influenza vaccine in the United States during 2009-2010. PRISM investigators conducted retrospective analysis to determine whether 2009 H1N1 vaccination was associated with increased risk of any of 14 prespecified outcomes. Five health insurance and associated companies with 38 million members and 9 state/city immunization registries contributed records on more than 2.6 million doses of 2009 H1N1 vaccine. Data on outcomes came from insurance claims. Complementary designs (self-controlled risk interval, case-centered, and current-vs.-historical comparison) were used to optimize control for confounding and statistical power. The self-controlled risk interval analysis of chart-confirmed Guillain-Barre syndrome found an elevated but not statistically significant incidence rate ratio following receipt of inactivated 2009 H1N1 vaccine (incidence rate ratio = 2.50, 95% confidence interval: 0.42, 15.0) and no cases following live attenuated 2009 H1N1 vaccine. The study did not control for infection prior to Guillain-Barre syndrome, which may have been a confounder. The risks of other health outcomes of interest were generally not significantly elevated after 2009 H1N1 vaccination.

Abstract: Objective To evaluate whether rates of serious infection with anti–tumor necrosis factor (anti-TNF) therapy in rheumatoid arthritis (RA) patients differ in magnitude by specific drugs and patient characteristics. Methods Among new nonbiologic disease-modifying antirheumatic drug users enrolled in Medicare and Medicaid or a large US commercial health plan, we created and validated a person-specific infection risk score based on age, demographics, insurance type, glucocorticoid dose, and comorbidities to identify patients at high risk for hospitalized infections. We then applied this risk score to new users of infliximab, etanercept, and adalimumab and compared the observed 1-year rates of infection to one another and to the predicted infection risk score estimated in the absence of anti-TNF exposure. Results Among 11,657 RA patients initiating anti-TNF therapy, the observed 1-year rate of infection was 14.2 infections per 100 person-years in older patients (age ≥65 years) and 4.8 in younger patients (age <65 years). There was a relatively constant rate difference of ∼1–4 infections per 100 person-years associated with anti-TNF therapy across the range of the infection risk score. Infliximab had a significantly greater adjusted rate of infection compared to etanercept and adalimumab in both high- and lower-risk RA patients. Conclusion The rate of serious infections for anti-TNF agents was incrementally increased by a fixed absolute difference irrespective of age, comorbidities, and other factors that contributed to infections. Older patients and those with high comorbidity burdens should be reassured that the magnitude of their incremental risk with anti-TNF agents is not greater than for lower-risk patients.

Abstract: Purpose A new meningococcal conjugate vaccine (MCV4) was introduced in 2005. Shortly after, case reports of Guillain-Barre syndrome (GBS), a serious demyelinating disease, began to be reported to the Vaccine Adverse Event Reporting System. In 2006, the Centers for Disease Control and Prevention and the Food and Drug Administration requested the evaluation of GBS risk after MCV4 vaccination. We conducted a study to assess the risk of GBS after MCV4 vaccination using health plan administrative and claims data together with the review of primary medical records of potential cases. Methods Retrospective cohort study among 12.6 million 11- to 21-year-old members of five US health plans with a total membership of 50 million. Automated enrollment and medical claims data from March 2005 through August 2008 were used to identify the population, the vaccinations administered, and the medical services associated with possible GBS. Medical records were reviewed and adjudicated by a neurologist panel to confirm cases of GBS. The study used distributed data analysis methods that minimized sharing of protected health information. Results We confirmed 99 GBS cases during 18,322,800 person-years (5.4/1,000,000 person-years). More than 1.4 million MCV4 vaccinations were observed. No confirmed cases of GBS occurred within 6 weeks after vaccination. The upper 95% CI for the attributable risk of GBS associated with MCV4 is estimated as 1.5 cases per 1,000,000 doses. Conclusions Among members of five US health plans, MCV4 vaccination was not associated with increased GBS risk.

Abstract: Purpose: This project examined recently implemented shared medical appointments (SMAs) at a free clinic for patients with diabetes and/or hypertension. Changes in patients' self-managing behaviors, specifically exercise and goal-setting activity, were explored after participating in SMAs for 4 months. Data sources: The study employed a pretest-posttest quasi-experimental design. Participants completed a questionnaire of their self-managing behaviors and a behavioral action plan at each SMA. The SMAs were facilitated in English, Spanish, and bilingually (English and Spanish) with a total of 37 participants. Conclusions: Descriptive analysis showed a significant increase in exercise time with a mean increase of 86 min per week at post-SMA (p= .002, 95% confidence interval [CI]). Each participant identified a measurable goal, and 97% of participants reported achieving or almost achieving their goals. Males reported a significantly (p= .002, 95% CI) larger increase in exercise time than women. Variance of self-managing behaviors among the English, Spanish, and bilingual SMAs was statistically not significant. Implications for practice: Though much evidence exists demonstrating that SMAs provide effective quality care, literature is lacking in examining patients' self-managing behaviors after participation in language-specific SMAs. Understanding patients' response to programs that address the needs of the individual leads to more effective programs.

Abstract: Patient-centered, accountable care has garnered increased attention with the passage of the Affordable Care Act and new Medicare regulations. This case study examines a care model jointly developed by a provider and a payer that approximates an accountable care organization for a Medicare Advantage population. The collaboration between Aetna and NovaHealth, an independent physician association based in Portland, Maine, focused on shared data, financial incentives, and care management to improve health outcomes for approximately 750 Medicare Advantage members. The patient population in the pilot program had 50 percent fewer hospital days per 1,000 patients, 45 percent fewer admissions, and 56 percent fewer readmissions than statewide unmanaged Medicare populations. NovaHealth’s total per member per month costs across all cost categories for its Aetna Medicare Advantage members were 16.5 percent to 33 percent lower than costs for members not in this provider organization. Clinical quality metrics for diabet...

Abstract: A machine for wrapping a load with a film made of synthetic plastics includes a first frame suitable for supporting second frame that rotatably supports around, and slidably parallel to, a wrapping axis at least one wrapping unit including a reel of the film and a roller assembly arranged for unwinding and prestretching the film. The second frame is slidably mounted on the first frame and is movable along an advancing direction that is transverse, and in particular orthogonal, to the wrapping axis. A conveyor is provided for moving the load along the advancing direction. The conveyor and the second frame are movable in a mutually coordinated manner to wrap the load with the film also while the load is moved along the advancing direction.

Abstract: Aims: The Center for Comparative Effectiveness Research in Cancer Genomics completed a 2-year stakeholder-guided process for the prioritization of genomic tests for comparative effectiveness research studies. We sought to evaluate the effectiveness of engagement procedures in achieving project goals and to identify opportunities for future improvements. Materials & methods: The evaluation included an online questionnaire, one-on-one telephone interviews and facilitated discussion. Responses to the online questionnaire were tabulated for descriptive purposes, while transcripts from key informant interviews were analyzed using a directed content analysis approach. Results: A total of 11 out of 13 stakeholders completed both the online questionnaire and interview process, while nine participated in the facilitated discussion. Eighty-nine percent of questionnaire items received overall ratings of agree or strongly agree; 11% of responses were rated as neutral with the exception of a single rating of disagreem...

Abstract: The invention relates to a movement system that is associable with a wrapping machine (100) for wrapping a load (70) with a film (4) comprising at least one operating unit (30, 40, 50, 80) for performing operations on the load (70) and/or on said film (4); the system comprises shuttle means (11, 12, 21, 22; 32; 41, 42; 52) that is movable for supporting and moving said operating unit (30, 40, 50, 80) along a path (P) at least between an operating position (F1, F2, F3, F4, F5), in which the operating unit (30, 40, 50, 80) can perform operations on the load (70) and/or on the film (4) and/or can interact with the wrapping machine (100), and a non-operating position (N1; N2) in which the operating unit (30, 40, 50, 80) is outside a working zone (W) of the wrapping machine (100) in order not to interfere with the operation of the latter.

Abstract: An apparatus, associable to a wrapping machine (10), comprises at least one unwinding unit (50) for said wrapping machine (10) for wrapping a load (L) with a film (4), and shuttle means (11, 12; 21, 22) that are movable along a path (P) and suitable for receiving and supporting an unwinding unit (50) to be replaced and to be dismantled from said wrapping machine (10), and/or a new unwinding unit (50) to be mounted on said wrapping machine (10); the shuttle means (11, 12; 21, 22) operates along a substantially horizontal operating direction (T) so as to dismantle and receive from said wrapping machine (10) an unwinding unit (50) to be replaced and/or so as to transfer and mount on said wrapping machine (10) a new unwinding unit (50); the apparatus (1) comprises a supporting unit (60) suitable to be fixed to said wrapping machine (10) and arranged to he coupled to, and support, said unwinding unit (50), said unwinding unit (50) comprising first coupling means (58), and said supporting unit (60) comprising second coupling means (64), said first coupling means (58) and said second coupling means (68) being mutually couplable or uncouplable along said operating direction (T).

Abstract: Medical billing errors constitute a major problem in the medical payment system in the USA. Little is known about how to identify the predictors that influence the error rate in hospital billings. Health services researchers have concentrated to a large extent on applying exploratory statistical methods to identify the patterns of care and analyse the variation in health services use. Despite the importance of medical claims data for detecting billing errors or fraudulent billing practises, little is known about the extent to which variations in the frequency, types, and seriousness of deficiencies reflect differences in the quality of care or broad systemic differences in the provision and use of health services. To address that gap, we propose an evidence-based approach to mining claims data to not only identify patterns of care, but also examine how individual, organisational and contextual factors may influence a particular pattern of Medicare/Medicaid fraud or abuse.

Abstract: We applaud ASCO for undertaking this endeavor. As strong supporters of clinical research, we hope that all stakeholders take this opportunity to make improvements in oncology care that go beyond the basic requirements of the ACA. This is a tremendous opportunity to step back and realize it is a complex system that cares for a patient enrolled onto a clinical trial, not just one physician. We believe there is no such thing as a single, sacred physician-patient relationship in modern oncology. Consider the patients who need combined-modality care to have the best outcome. Several physician teams, sometimes with different opinions, must work together, each without undermining the recommendations of the others for therapy to be successful and for the patient to have faith in his treating team. The majority of oncology care consists of networks of critical, dependent relationships. No single stakeholder has a right to disregard the needs and rights of the rest of the system components. Just as payers have responsibilities, they also have rights. Clinical investigators have both rights and responsibilities, as do trial sponsors. And although we all want patients' rights to never be forsaken, they must also uphold their own responsibilities for the plan choices they make. Only when all parties can come to terms with their own responsibilities as well as respect the rights of others will we be able to function as a unified team in producing a unique and robust clinical trial process. We believe our proposal for the types of data elements that could be communicated to a payer or plan manager when a patient is considering enrolling onto a clinical trial has merit in terms of achieving the goals of better and more comprehensive communication, increased transparency, and patient protection. We look forward to future interaction and participation with the PPI as we all work together in the unique initiative to make certain we can continue to advance the treatment of cancer.

Abstract: Purpose Highly stressed employees are subject to greater health risks, costs, and productivity losses than those with normal stress levels. To address this issue, work-site stress management programs must be able to engage individuals as well as capture data on stress, health indices, work productivity, and healthcare costs. In this randomized controlled pilot, our primary objective was to evaluate the viability and proof of concept for two innovative mind-body workplace stress reduction programs, setting the stage for larger cost-effectiveness trials. A second objective was to evaluate two delivery venues of the mindfulness intervention (online versus in-person). Methods

Abstract: Approximately 200 oncologists, payers, employers, managed care executives, pharmacy benefit managers, and other healthcare stakeholders convened in Houston, TX, on March 28–31, 2012, for the Second Annual Conference of the Association for Value-Based Cancer Care (AVBCC). The mission of the conference was to align the various perspectives around the growing need of defining value in cancer care and developing strategies to enhance patient outcomes. The AVBCC conference presented a forum for the various viewpoints from all the stakeholders across the cancer care continuum, featuring more than 20 sessions and symposia led by nearly 30 oncology leaders. The discussions focused on current trends and challenges in optimizing value in oncology by reducing or controlling cost while improving care quality and patient outcomes, introducing emerging approaches to management and tools that providers and payers are using to enhance cancer care collaboratively. The AVBCC Second Annual Conference was opened by a Steering Committee discussion of 11 panel members who attempted to define value in cancer care and articulated action steps that can help to implement value into cancer care delivery. The following summary represents highlights from the Steering Committee discussion, which was moderated by Gene Beed, MD, and Gary M. Owens, MD.

Abstract: A machine for wrapping a load (100; 150, 151, 152; 200, 201, 202, 203, 204) with a film (50) made of plastics comprises first frame means (2) suitable for supporting second frame means (3) that rotatably supports around, and slidably parallel to, a wrapping axis (Z) at least one wrapping unit (4) including a reel (5) of the film (50) and roller means (6) arranged for unwinding and prestretching the film (50); the second frame means (3) is slidably mounted on the first frame means (2) and is movable along an advancing direction (X) that is transverse, and in particular orthogonal, to the wrapping axis (Z); conveying means (7; 70) is provided for moving the load (100; 150, 151, 152; 200, 201, 202, 203, 204) along the advancing direction (X); the conveying means (7; 70) and the second frame means (3) are movable in a mutually coordinated manner to wrap the load (100) with the film (50) also whilst the load (100) is moved along the advancing direction (X).

Abstract: A film unwinding apparatus for a wrapping machine (10) comprises a supporting unit (60) fixable to said wrapping machine (10), and an unwinding unit (50) provided with a reel (3) of film (4) and with roller means (55, 56, 57) for unwinding said film (4) from said reel (3) and winding it around a load (L); the unwinding unit (50) is removably couplable to said supporting unit (60) in an assembled configuration (A); the roller means (55, 56, 57) comprise a first pre-stretching roller (55) and a second pre-stretching roller (56) for unwinding and pre-stretching said film (4) and the supporting unit (60) comprises driving means (70) for rotating the pre-stretching rollers (55, 56) in said assembled configuration (A).

Abstract: Traditional drug licensing approaches are based on binary decisions. At the moment of licensing, an experimental therapy is presumptively transformed into a fully vetted, safe, efficacious therapy. By contrast, adaptive licensing (AL) approaches are based on stepwise learning under conditions of acknowledged uncertainty, with iterative phases of data gathering and regulatory evaluation. This approach allows approval to align more closely with patient needs for timely access to new technologies and for data to inform medical decisions. The concept of AL embraces a range of perspectives. Some see AL as an evolutionary step, extending elements that are now in place. Others envision a transformative framework that may require legislative action before implementation. This article summarizes recent AL proposals; discusses how proposals might be translated into practice, with illustrations in different therapeutic areas; and identifies unresolved issues to inform decisions on the design and implementation of AL.