Subsequent Time Periods Research Articles

Temperament and character as predictors of recurrence in remitted patients with major depression: A 4-year prospective follow-up study

The aim of the present study was to examine whether the specific personality traits, Harm-Avoidance (HA) and Self-Directedness (SD) as measured by the Temperament and Character Inventory (TCI), were predictive for subsequent depressive episodes in remitted patients with major depressive disorders (MDDs) over a 4-year follow-up. A total of 109 inpatients with MDD participated in this study. The subjects completed the TCI when they were assessed to be in remission. They were divided into high or low HA groups and high or low SD groups, as discriminated by the quartile value. A total of 69 patients were followed-up over a 4-year period or until recurrence. Both Kaplan–Meier analysis and Cox׳s proportional hazards regression analysis indicated that patients with a low SD score had a significantly shorter time to recurrence from remission than patients with a high SD score even when some prognostic predictors were controlled for. In contrast, HA was not found to be a predictor of recurrence for future depressive episodes. A part of MDD patients with low scores in Self-Directedness are likely to develop depression over a subsequent period of time. Interventions that improve SD may help to delay recurrence of depression in MDD patients.

Traumatic lower limb injury and microsurgical free flap reconstruction with the use of negative pressure wound therapy: is timing crucial?

The timing of microsurgical free flap reconstruction for traumatic lower limb injury has been described as being optimal if conducted within the early period following injury, as higher rates of infection and flap loss were reported in the subsequent time period. However, for various reasons, reconstruction of these defects may be delayed. The aim of this article is to show that adequate debridement, negative pressure wound dressing, and sound reconstructive principles has led to increased free flap success rates regardless of the period between injury and reconstruction. A 10-year retrospective single-center analysis of 50 traumatic lower limb cases from 2002 to 2012 was conducted. All patients had microsurgical free flap reconstruction after a period of negative pressure wound therapy (NPWT). Patient factors and reconstructive methods were analyzed and outcomes were compared. Mean interval between admission and free flap coverage was 17.5 days, and patients underwent NPWT for an average of 12 days (range, 1-35). Approximately 8% of patients had postoperative infections. Overall free flap success rate was 96%. Approximately 90% of patients were able to return to their premorbid footwear, with 96% able to mobilize independently approaching the end of their follow-up period. Our study shows that traumatic lower limb reconstruction in the delayed period is no longer associated with high rates of flap failure. Improvements in microsurgery and the advent of NPWT have made timing no longer crucial in free flap coverage of traumatic lower limb injuries.

Modeling the response of shoreface-connected sand ridges to sand extraction on an inner shelf

Shoreface-connected sand ridges are rhythmic bedforms that occur on many storm-dominated inner shelves. The ridges span several kilometers, are a few meters high, and they evolve on a timescale of centuries. A process-based model is used to gain a fundamental insight into the response of these ridges to extraction of sand. Different scenarios of sand extraction (depth, location, and geometry of the extraction area; multiple sand extractions) are imposed. For each scenario, the response timescale as well as the characteristics of the new equilibrium state are determined. Results show that ridges partially restore after extraction, i.e., the disturbed bathymetry recovers on decadal timescales. However, in the end, the ridge original sand volume is not recovered. Initially, most sand that accomplishes the infill of the pit originates from the area upstream of the extraction, as well as from the areas surrounding the pit. The contribution of the latter strongly decreases in the subsequent time period. Depending on the location of the pit, additional sand sources contribute: First, if the pit is located close to the downstream trough, the pit gains sand by reduction of sand transport from the ridge to this trough. Second, if the pit is located close to the adjacent outer shelf, the ridge recovery is stronger due to an import of sand from that area. Furthermore, pits that are located close to the nearshore zone have a weak recovery, deeper pits have longer recovery timescales, wide and shallow pits recover most sand, while multiple sand pits slow down the recovery process.

The Financial Crisis of Banks (Before, During and After): An Intellectual Capital Perspective

The purpose of this paper is to evaluate the link between intellectual capital components and financial performance across three temporal periods on either side of a financial crisis.The study offers a longitudinal approach, combining two data collecting methods. A survey on intellectual capital components was administered during the initial period followed by objective performance ratios in subsequent time periods (covering pre, during and post‐financial crisis analysis). Regarding the three periods in the study, evidence seems to support the argument that intellectual capital scores are good predictors of future banking performance. One bank in particular that was ranked very low in 2005 intellectual capital scores eventually failed to survive autonomously. By 2012, it was forced to be rescued by governmental aid using public funds. Generally speaking, we can argue that intellectual capital average scores are good predictors of future banking performance.The study's generalizability is limited to the Portuguese banking industry. This is the first academic research study to evaluate the link between intellectual capital and the financial performance of banks across three temporal periods: 2005–2006 (pre‐crisis), 2007–2008 (during crisis), and 2009–10 (post‐crisis). Copyright © 2014 John Wiley & Sons, Ltd.

A Spatial Stochastic Programming Model for Timber and Core Area Management Under Risk of Fires

Previous stochastic models in harvest scheduling seldom address explicit spatial management concerns under the influence of natural disturbances. We employ multistage stochastic programming models to explore the challenges and advantages of building spatial optimization models that account for the influences of random stand-replacing fires. Our exploratory test models simultaneously consider timber harvest and mature forest core area objectives. Random fire samples are built into the model, creating a sample average approximation (SAA) formulation of our stochastic programming problem. Each model run reports first-period harvesting decisions along with recourse decisions for subsequent time periods reflecting the influence of stochastic fires. In each test, we solve 30 independent, identically distributed (i.i.d.) replicate models and calculate the persistence of period one solutions. Harvest decisions with the highest persistence are selected as the solution for each stand in a given test case. We explore various sample sizes in our SAA models. Monte Carlo simulations of these solutions are then run by fixing first-period solutions and solving new i.i.d. replicates. Multiple comparison tests identify the best first-period solution. Results indicate that integrating the occurrence of stand-replacing fire into forest harvest scheduling models can improve the quality of long-term spatially explicit forest plans.

Loneliness and attention to social threat in young adults: Findings from an eye tracker study

Cacioppo and Hawkley (2009) have hypothesized that lonely people are hyper-vigilant to social threat, with earlier work (Jones & Carver, 1991) linking this bias specifically to threats of social rejection or social exclusion. The current study examined this hypothesis in eighty-five young adults (mean age=18.22; SD=0.46; 17–19years in age) using eye-tracking methodology, which entailed recording their visual attention to social rejecting information. We found a quadratic relation between the participants’ loneliness, as assessed by the revised UCLA loneliness scale, and their visual attention to social threat immediately after presentation (2s). In support of Cacioppo and Hawkley’s (2009) hypothesis, it was found that young adults in the upper quartile range of loneliness exhibited visual vigilance of socially threatening stimuli compared to other participants. There was no relation between loneliness and visual attention to socially threatening stimuli across an extended subsequent period of time. Implications for intervention are considered.

Assessing deforestation and fragmentation in a tropical moist forest over 68 years; the impact of roads and legal protection in the Cockpit Country, Jamaica

Historical data on landuse changes are important for interpreting the current status of natural systems such as forests. Analyses of road network dynamics can be particularly useful as network expansion is often a precursor to and an indicator of increased human activity. Legal protection is often seen as the most viable option available for protecting natural forests; but over the past decade, its effectiveness has been questioned. We assessed the impact of roads and the designation of a forest reserve on deforestation and forest fragmentation in a tropical moist forest, Cockpit Country, Jamaica, from 1942 to 2010. Specifically, we classified multi-temporal images (black and white aerial photographs, IKONOS and GeoEye images) using an object based image analysis and we included a vector of digitized roads for each year of assessment during the classification process. We then conducted a fragmentation analysis of the classified images and assessed the relationship between road density and several fragmentation metrics over time, and the spatial influence of the reserves (presence/absence) and roads (Euclidean distance from roads) on deforestation and several fragmentation metrics using generalized linear models.Between 1942 and 2010, road density nearly doubled (from 0.67km/km2 to 1.22km/km2), with significant increases occurring within forest reserves, and was significantly related to the area-weighted mean shape index of the forest (forest patches became more regularly shaped and linear). Initially, relatively high deforestation rates and high levels of fragmentation between 1942 and 1961 were likely related to the large increase in road density. Deforestation and forest fragmentation were more likely to occur closer to roads over all time periods, and the magnitude/significance of this relationship peaked in subsequent time periods after road density doubled; but in the final time period, its influence declined. Legal protection afforded to the forest in the 1950s and 1960s coincided with an increase in total and core forest area and a reduction in deforestation rate, and deforestation and forest fragmentation were significantly lower inside the reserve. Therefore, the Forest Reserves were initially effective; however, their effectiveness waned after 1980. Increased deforestation and fragmentation in the 1980s and the 2000s indicate a more complex pattern of human encroachment, as these changes do not appear to have been influenced by changes to the road network, or by the presence of the Forest Reserves. Further research into the factors influencing human use of these forested areas is needed for effective management of the area.

Pancreaticoduodenectomy (PD) for periampullary tumors: Results from Tata Memorial Centre (TMC) over two decades.

366 Background: There is scarcity of short and long term data regarding results of pancreaticoduodenectomy done for periampullary tumours. Contrary to the western data, ampulla of Vater is the commonest site of involvement in Indian patients. Methods: A retrospective analysis PD was done for periampullary tumors from 1991 to July 2013 at TMC. The time period was divided into 4 spans A (1991 to 2001), B (2003 to July 2009), C (Aug 2009 to Dec 2012) and D (Jan 2013 to July 2013) based on the increasing surgical volumes and changing practice trends. Survival outcomes were analysed. Data was prospectively maintained from 2006 onwards. Results: 626 pts underwent PD for periampullary tumors over this time period. 144, 206, 150 and 126 pts were operated during span A, B, C and D respectively. Sites involved were ampulla (67.5%), head of pancreas (16.6%), duodenum (9.9%) and bile duct (6.9%). Adenocarcinoma was the most common histology (81.5%). The morbidity and mortality was 31.7% and 4.3%. Postoperative pancreatic fistula, delayed gastric emptying (DGE), post-pancreatectomy haemorrhage (PPH) and bile leaks were 12.4%, 2.8%, 4.8% and 2.7% respectively for the whole group. Morbidity, mortality, DGE, PPH and bile leak rates have declined over subsequent time periods. Majority of pts in span C and D received adjuvant chemotherapy with gemcitabine 1000mg/m2 on day 1,8 and 15 of a 28 day cycle. 2 year disease free survival (DFS) for periampullary adenocarcinoma-ampulla, bile duct & pancreas from April 2006 for 294 pts was 79.3%, 68.6% and 41.8% respectively. Overall 2 year DFS was 74%. Conclusions: These data represent the largest single centre experience with PD from Indian subcontinent. The improvement of results over the 2 decades can be due to increasing volume of pts, standardisation of surgical technique and gradually increasing experience of the operating team. The impressive 2 year DFS can be attributed to a large number of good prognosis ampullary tumors.

Cost-effectiveness of cryoballoon ablation for the management of paroxysmal atrial fibrillation

Cryoballoon ablation is an established treatment option for the management of patients with atrial fibrillation. We sought to evaluate the cost-effectiveness of cryoablation, compared with second-line anti-arrhythmic drug (AAD) therapy in patients with paroxysmal atrial fibrillation (PAF), from a UK payer perspective. We developed a state-transition (Markov) model to calculate the total costs and quality-adjusted life-years (QALYs) associated with cryoablation and AAD therapy in patients with PAF. A 5-year horizon was used for the base-case. Data from a recent study of cryoballoon ablation in patients with PAF were used to model short-term health outcomes and costs, together with longer term external evidence to populate subsequent time periods. Total discounted costs were £21 162 and £17 627 for the cryoballoon ablation and AAD arms, respectively. Total QALYs of 3.565 and 3.404 therefore led to an incremental cost-effectiveness ratio of £21 957 per QALY gained. Sensitivity analysis suggested that the key drivers of the results were the model time horizon, the costs of follow-up care in patients with recurrent AF, and the costs of the ablation procedure. Cryoballoon ablation provides increased quality-adjusted life expectancy compared with AAD at reasonable additional cost, representing good value for money in patients with PAF.

Survival In Adult Acute Lymphoblastic Leukemia Survival By Age, Gender and Ethnicity

BackgroundStudies have shown improvement in survival in adult acute lymphoblastic leukemia (ALL) with the use of risk-directed therapy pediatric-inspired regimens. We analyzed US Surveillance, Epidemiology and End Results (SEER) cancer registry database to evaluate whether survival of adult ALL patients has improved in general population. MethodsWe analyzed US Surveillance, Epidemiology and End Results (SEER) 18 registries using survival session to calculate relative survival rates (RS) during 1973-1989, 1990-1999 and 2000-2009 among adult (≥20 years) ALL patients. We used Z-test in the SEER*Stat software to compare the relative survival rates in several cohorts categorized by race, gender, and age groups (20-39, ≥ 40 years). ResultsThere were 7,435 adult ALL patients reported in SEER 18 registries during 1973-2009. The majority of patients were Caucasian (85%) and Male (57%).The relative survival rates for adult ALL patients between 1973-2009 were 55.8±0.6% and 25.0±0.5% at 1 year and 5 years respectively. The relative survival rates improved significantly for each successive time periods, with an improvement from 45.4%, to 51.6%, to 60.6% at 1 year and, from 15.3%, to 23.7%, to 29.0% at 5 years for time periods 1973-1989, 1990-1999 and 2000-2009 respectively. For younger patients (age 20-39 years), 1- and 5-year RS rates improved from 1973-1989 to 1990-1999 but not from 1990-1999 to 2000-2009. For older patients (age ≥40 years) RS improved for each successive time periods.The 1- and 5- year relative survival rates improved significantly for both male and female patients during successive time periods. Interestingly, although there was significant improvement in survival rates at 1- and 5- years for Caucasians, improvement was not seen for AA adult ALL patients during subsequent time periods examined. ConclusionsAlthough adult ALL survival rates have improved for most cohorts examined, the survival of African American patients has not improved. Similarly, survival rates of younger patients (20-39 years) has not improved from 1990-1999 to 2000-2009. Disclosures:No relevant conflicts of interest to declare.

Artistic Influences Analysis of Iraqi National Costumes

There were signs of the first civilization known to humanity for more than 6000 years BC in the north of Iraq have disappeared this civilization to appear after 500 years in southern Iraq, the Sumerian civilization, which was considered as the opinion of scientists or civilizations, exceeds the impact to Asia and the countries that had been in contact (Sumerians) and see them today in other towns and villages. In subsequent periods of time appeared distinct personalities to their nature, religious, social, special clothing with clothes seem especially long. And usually dress is made from raw wool material making them in the Sumerian era. Put the garment on the body and leaves the top of the right shoulder with the survival of an open hand. There are of special clothing used by the clergy in the exercise of religious mourning rituals .There are traditional clothes to the clergy of other faiths. The clothing we see in the beginning of the third millennium BC has gained status in society in general, and was also the head cover. The animals have for centuries symbolized the signs of a divinity that we see hanging on the walls of some temples in northern Iraq. Centuries have been mentioned in the history of the Arabian were animal horns in Sumerian times to symbolize the moon in the Sumerian language .

Robust Multi-period Fleet Allocation Models for Bike-Sharing Systems

This paper presents mathematical programming models that generate optimal daily allocation of bicycles to the stations of a bike-sharing system. First, a time-space network is constructed to describe time-dependent bike flows in the system. Next, a bike fleet allocation model that considers average historical demand and fixed fleet size is established based on the time-space network. In addition to fleet allocation in multiple periods, this model generates least cost empty bicycle redistribution plans to meet demand in subsequent time periods. The model aims to correct demand asymmetry in bike-sharing systems, where flow from one station to another is seldom equal to the flow in the opposing direction. An extension of the model that relaxes the fleet size constraint to determine optimal fleet size in supporting planning stage decisions is also presented in the paper. Moreover, we describe uncertain bike demands using some prescribed uncertainty sets and develop robust bike fleet allocation models that minimize total system cost in the worst-case or maximum demand scenarios derived from the uncertainty sets. Numerical experiments were conducted based on the New Taipei City’s public bike system to demonstrate the applicability and performance of the proposed models. In addition, this research considers two performance measures, robust price and hedge value, in order to investigate the tradeoff between robustness and optimality, as well as the benefit of applying robust solutions relative to nominal optimal solutions in uncertain demand situations.

Robust Portfolio Control with Stochastic Factor Dynamics

Portfolio selection is vulnerable to the error-amplifying effects of combining optimization with statistical estimation and model error. For dynamic portfolio control, sources of model error include the evolution of market factors and the influence of these factors on asset returns. We develop portfolio control rules that are robust to this type of uncertainty, applying a stochastic notion of robustness to uncertainty in model dynamics. In this stochastic formulation, robustness reflects uncertainty about the probability law generating market data, and not just uncertainty about model parameters. We analyze both finite- and infinite-horizon problems in a model in which returns are driven by factors that evolve stochastically. The model incorporates transaction costs and leads to simple and tractable optimal robust controls for multiple assets. We illustrate the performance of the controls on historical data. As one would expect, in-sample tests show no evidence of improved performance through robustness—evaluating performance on the same data used to estimate a model leaves no room to capture model uncertainty. However, robustness does improve performance in out-of-sample tests in which the model is estimated on a rolling window of data and then applied over a subsequent time period. By acknowledging uncertainty in the estimated model, the robust rules lead to less aggressive trading and are less sensitive to sharp moves in underlying prices.

Temporal Uncertainty in a Small Area Open Geodemographic Classification

AbstractThe 2001 Output Area Classification (2001 OAC) is an open source geodemographic classification of the UK built exclusively from 2001 UK Census data. There has been considerable user interest in its applicability to subsequent time periods, particularly given the potential propensity of characteristics and attributes in some areas to change during inter‐censual periods. Users often purchase commercial geodemographic classification products in the belief that purely census‐based classifications such as the 2001 OAC are uniformly unreliable because there is no temporal updating of input data. Yet there is evidence to suggest that whilst some UK neighborhoods are prone to sudden changes, many others change very little over protracted time periods. Using measures that are available at the small area level, temporal uncertainty indicators can be constructed to identify those areas that are less stable. Using mid‐year population estimates and dwelling stock data, this article develops three temporal uncertainty indicators. These provide a reliable means of gauging the stability or otherwise of neighborhood conditions. The conclusion from this is that while a large number of small areas in the UK do experience change over time, this change is not uniform in either degree or distribution, or by geodemographic type.

Parental Role Portrayals in Twentieth Century Children’s Picture Books: More Egalitarian or Ongoing Stereotyping?

Gender role stereotyping continues to dominate within many media forms. This research examined the portrayals of mothers and fathers as companions, disciplinarians, caregivers, nurturers, and providers in 300 twentieth century children’s picture books randomly selected from the Children’s Catalog (H.W. Wilson Company, 2001). The books were published in the United States between the years of 1902 and 2000. The list of texts was stratified by time periods before sampling. The impact of time of publication upon each of the five parental role constructs was assessed using cross-tabulations. Previous analyses suggest traditional parental role portrayals are commonplace, but by employing time of publication as an independent variable, the researchers questioned whether an evolvement of roles would be noted. By examining the father and mother role performances independently over time it was expected that some progression toward egalitarianism would be noted. Overall, mothers did outperform fathers in nurturing and caregiving, and fathers outperformed mothers in companion and providing behaviors. However, when these behaviors were cross-tabulated with time of publication, no significant role evolvement was found. For example, while not statistically significant, father characters were most likely to nurture, provide care, and act as a child’s companion in books published in the 1970s, but these behaviors declined in subsequent time periods. The role evolvement of mother characters also lacked statistical significance, suggesting that the traditional male breadwinner-female homemaker model has been consistently portrayed in children’s picture books.

Biomechanics of adjacent segments after a multilevel cervical corpectomy using anterior, posterior, and combined anterior-posterior instrumentation techniques: a finite element model study

Background contextAdjacent segment degeneration (ASD) after cervical fusion is a clinical concern. Despite previous studies documenting the biomechanical effects of multilevel cervical fusion on segments immediately superior and inferior to the operative segments, the pathogenesis of the initiation of degeneration progression in neighboring segments is still poorly understood. PurposeTo test the hypothesis that changes in range of motion, disc stresses, and facet loads would be highest at the superior adjacent segment (C3–C4) after anterior C4–C7 corpectomy and fusion and that these changes would be the least in anterior fixation and the greatest in posterior or combined anterior-posterior instrumentation techniques. Study designA finite element (FE) analysis of adjacent vertebral segment biomechanics after a two-level corpectomy fusion with three different fixation techniques (anterior, posterior, and combined anterior-posterior). MethodsA previously validated three-dimensional FE model of an intact C3–T1 segment was used. From this intact model, three additional instrumentation models were constructed using anterior (rigid screw-plate), posterior (rigid screw-rod), and combined anterior-posterior fixation techniques after a C4–C7 corpectomy and fusion. Motion patterns, disc stresses, and posterior facet loads at the levels cephalad and caudal to the fusion were assessed. ResultsRange of motion, disc stresses, and posterior facet loads increased at the adjacent segments. Use of posterior fixation, whether alone or in combination with anterior fixation, infers higher changes in segmental motion, disc stresses, and posterior facet loads at adjacent segments compared with the use of anterior fixation alone. The superior C3–C4 motion was most affected during lateral bending and the inferior C7–T1 motion was most affected during flexion, whereas both superior C3–C4 and inferior C7–T1 motions were least affected during extension. However, disc stresses and facet loads were most affected during extension. Hence, it is speculated that the most remodeling changes in discs and facets might be related to the least changes in extension motion. ConclusionsBiomechanical factors such as increased mechanical demand and motion that have been associated with the development of ASD progression are highest in the segment immediately superior to the fusion. These changes are even more pronounced when the fixation technique involves the addition of posterior instrumentation, thereby supporting the hypothesis of the present study. Increased degrees of stiffening of the fused segments not only may lead to degenerative changes in the disc but may also predispose the segments to premature facet degeneration. Over subsequent time period, any remaining construct micro-motion is further eliminated with fusion of the posterior facet joints and the remaining regions in the disc space also filled in with bone, which eventually results in a circumferential type of fusion. After a circumferential fusion, authors, however, speculate that the role of instrumentation in ASD progression might not be significant. In fact, sufficient evidence to support this speculation is still lacking in the literature.

Climate change and faunal turnover: testing the mechanics of the turnover-pulse hypothesis with South African fossil data

The turnover-pulse hypothesis (TPH) makes explicit predictions concerning the potential responses of species to climate change, which is considered to be a major cause of faunal turnover (extinction, speciation, and migration). Previous studies have tested the TPH primarily by examining temporal correlations between turnover pulses and climatic events. It is rarely possible to dissect such correlations and observe turnover as it is occurring or to predict how different lineages will respond to climate change. Thus, whether climate change drives faunal turnover in the manner predicted by the TPH remains unclear. In this study, we test the underlying mechanics of the TPH using well-dated Quaternary ungulate records from southern Africa's Cape Floristic Region (CFR). Changes in sea level, vegetation, and topographic barriers across glacial-interglacial transitions in southern Africa caused shifts in habitat size and configuration, allowing us to generate specific predictions concerning the responses of ungulates characterized by different feeding habits and habitat preferences. Examples from the CFR show how climatically forced vegetation change and allopatry can drive turnover resulting from extinction and migration. Evidence for speciation is lacking, suggesting either that climate change does not cause speciation in these circumstances or that the evolutionary outcome of turnover is contingent on the nature and rate of climate change. Migrations and extinctions are observed in the CFR fossil record over geologically short time intervals, on the order of Milankovitch-scale climate oscillations. We propose that such climate oscillations could drive a steady and moderate level of faunal turnover over 104-year time scales, which would not be resolved in paleontological records spanning 105years and longer. A turnover pulse, which is a marked increase in turnover relative to previous and subsequent time periods, requires additional, temporally constrained climatic forcing or other processes that could accelerate evolutionary change, perhaps mediated through biotic interactions.

Falling Further Behind? Child Support Arrears and Fathers’ Labor Force Participation

This study examines how child support arrears affect fathers' labor force participation. It relies on longitudinal data from the Fragile Families and Child Well-Being Study. Findings from analyses of these data suggest that child support arrears result in declines in average weeks worked in the formal labor market in subsequent time periods. These findings are driven by the behaviors of fathers who had relatively high amounts of arrears and no income in the previous year and are mostly robust to tests for selection into no work or low levels of work by fathers. Findings also suggest that arrears obligations that are low relative to income result in increases in the probability that fathers engage in any formal work. Arrears are not statistically significantly related to informal labor force participation. This study highlights both intended and unintended consequences of the growth in arrears under current child support enforcement policies.

Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS)

The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) is a North American national registry for mechanical circulatory support devices (MCSDs) that are used to treat advanced heart failure. Durable MCSDs that have been approved by the US Food and Drug Administration (FDA) are included in this registry; however, MCSDs that remain in FDA trials pending initial approval (ie, investigational device exemption [IDE] trials) and devices intended for short-term use (eg, Abiomed BVS 5000 ventricular assist device [Abiomed, Danvers, MA]) are not included. The purposes of this article are to present a developmental history of INTERMACS, to outline the collaboration of INTERMACS with various constituencies (eg, FDA, National Institutes of Health, Center for Medicare & Medicaid Services, industry, and physicians), to present a summary of information generated to date by INTERMACS, and to describe the future directions of INTERMACS. The concept of using mechanical circulatory assistance for more than a brief time after a cardiac operation dates to the early 1960s with the development of MCSDs that fit the definitions of counterpulsation devices (eg, the intra-aortic balloon pump), ventricular assist devices (VADs), and total artificial hearts.1–5 The development and initial clinical evaluation of these devices were regulated by individual academic medical center review groups that evolved into institutional review boards. The FDA entered this arena in 1976 with the advent of the FDA section for device regulation based on passage of the 1976 Medical Device Amendments.6 By 1991, groups including the Institute of Medicine foresaw the need for a detailed longitudinal database for patients receiving MCSDs, stating in an Institute of Medicine report that “patients should be followed through a registry for the remainder of their lives….”7 The committee further recommended that the National Heart, Lung, and Blood Institute support long-term follow-up studies. Eventually, a …

Safety of Zostavax™—A cohort study in a managed care organization

BackgroundZostavax™ is a live, attenuated varicella-zoster virus vaccine indicated for the prevention of herpes zoster (shingles). An observational post-licensure (Phase IV) study was conducted at Kaiser Permanente Northern California (KPNC), a US managed care organization, to assess the safety of zoster vaccine in people 60 years of age or older, vaccinated in routine medical care. MethodsWe performed a cohort study, comparing rates of clinical events resulting in hospitalizations or emergency department visits in a 42-day risk time period immediately following vaccination with rates in the same cohort in a subsequent comparison time period. The study data were reviewed and interpreted by an external safety review committee of 3 independent experts. ResultsApproximately 29,000 people≥60 years of age were vaccinated with zoster vaccine from July 2006 to November 2007. Of the 386 comparisons performed for the main analysis, 4 had an increased relative risk with a nominal p-value≤0.05. After medical records review, the timing of these conditions and procedures was found to be often prior to vaccination, and no clear increase in health events was observed in the risk period following vaccination compared to later. Persons receiving zoster vaccine appeared to be in their optimal health at the time of vaccination, which led to an apparent protective effect of the vaccine for some health outcomes, due to the study design. ConclusionsThere was no evidence of a safety concern for zoster vaccine.