Development and Initial Validation of the Perceptual Assessment of Memory (PASSOM): A Simulator Study.

OBJECTIVE: Performance validity tests (PVTs) are an integral component of neuropsychological assessment. There is a need for the development of more PVTs, especially those employing covert determinations. The aim of the present study was to provide initial validation of a new computerized PVT, the Perceptual Assessment of Memory (PASSOM). METHOD: Participants were 58 undergraduate students randomly assigned to a simulator (SIM) or control (CON) group. All participants were provided written instructions for their role prior to testing and were administered the PASSOM as part of a brief battery of neurocognitive tests. Indices of interest included response accuracy for Trials 1 and 2, and total errors across Trials, as well as response time (RT) for Trials 1 and 2, and total RT for both Trials. RESULTS: The SIM group produced significantly more errors than the CON group for Trials 1 and 2, and committed more total errors across trials. Significantly longer response latencies were found for the SIM group compared to the CON group for all RT indices examined. Linear regression modeling indicated excellent group classification for all indices studied, with areas under the curve ranging from 0.92 to 0.95. Sensitivity and specificity rates were good for several cut scores across all of the accuracy and RT indices, and sensitivity improved greatly by combining RT cut scores with the more traditional accuracy cut scores. CONCLUSION: Findings demonstrate the ability of the PASSOM to distinguish individuals instructed to feign cognitive impairment from those told to perform to the best of their ability.

Transfacet and Transpedicular Posterior Approaches to Thoracic Disc Herniations: Consecutive Case Series of 24 Patients.

OBJECTIVE: Various approaches are advocated for symptomatic thoracic disc herniation (TDH). The aim of this series is to demonstrate the feasibility, safety, and results of posterior transfacet or transpedicular approaches for excision of all types of extradural TDH. We report a consecutive series of patients undergoing posterior approach surgery for TDH. METHODS: Twenty-four patients (17 women, 7 men) underwent surgery at 25 disc levels. Mean age was 56.3 years (range, 23-79 years). A posterior transfacet or transpedicular approach was used. Patients presented with myelopathy (n = 21, 88%), radiculopathy (n = 8, 33%), sphincter dysfunction (n = 16, 67%), and axial back pain (n = 10, 43%). Preoperative imaging revealed 7 (30%) central, 14 (61%) calcified, and 10 (43%) large disc herniations. The mean follow-up period was 6.0 months (range, 2-36 months). RESULTS: Eighteen patients underwent unilateral approach surgery (5 transfacet and 13 transfacet plus transpedicular), and 7 patients required bilateral approach laminectomy for unilateral (n = 4) or bilateral (n = 3) discectomy. One patient required unplanned reoperation for resection of residual disc. Average operative time was 95 minutes (range, 40-175 minutes). Mean hospital stay was 4.9 days (range, 2-35 days). There were no major complications. Postoperative Frankel scores were maintained or improved in all patients at last review. CONCLUSIONS: TDH including large central calcified discs can be safely removed through posterior transfacet or transpedicular approaches with reduced morbidity in comparison with more invasive anterior approaches. Careful microsurgical technique and use of specialized instruments are important for successful excision of TDH from a posterior approach.

Large-Scale Survey Findings Inform Patients' Experiences in Using Secure Messaging to Engage in Patient-Provider Communication and Self-Care Management: A Quantitative Assessment.

BACKGROUND: Secure email messaging is part of a national transformation initiative in the United States to promote new models of care that support enhanced patient-provider communication. To date, only a limited number of large-scale studies have evaluated users' experiences in using secure email messaging. OBJECTIVE: To quantitatively assess veteran patients' experiences in using secure email messaging in a large patient sample. METHODS: A cross-sectional mail-delivered paper-and-pencil survey study was conducted with a sample of respondents identified as registered for the Veteran Health Administrations' Web-based patient portal (My HealtheVet) and opted to use secure messaging. The survey collected demographic data, assessed computer and health literacy, and secure messaging use. Analyses conducted on survey data include frequencies and proportions, chi-square tests, and one-way analysis of variance. RESULTS: The majority of respondents (N=819) reported using secure messaging 6 months or longer (n=499, 60.9%). They reported secure messaging to be helpful for completing medication refills (n=546, 66.7%), managing appointments (n=343, 41.9%), looking up test results (n=350, 42.7%), and asking health-related questions (n=340, 41.5%). Notably, some respondents reported using secure messaging to address sensitive health topics (n=67, 8.2%). Survey responses indicated that younger age (P=.039) and higher levels of education (P=.025) and income (P=.003) were associated with more frequent use of secure messaging. Females were more likely to report using secure messaging more often, compared with their male counterparts (P=.098). Minorities were more likely to report using secure messaging more often, at least once a month, compared with nonminorities (P=.086). Individuals with higher levels of health literacy reported more frequent use of secure messaging (P=.007), greater satisfaction (P=.002), and indicated that secure messaging is a useful (P=.002) and easy-to-use (P≤.001) communication tool, compared with individuals with lower reported health literacy. Many respondents (n=328, 40.0%) reported that they would like to receive education and/or felt other veterans would benefit from education on how to access and use the electronic patient portal and secure messaging (n=652, 79.6%). CONCLUSIONS: Survey findings validated qualitative findings found in previous research, such that veterans perceive secure email messaging as a useful tool for communicating with health care teams. To maximize sustained utilization of secure email messaging, marketing, education, skill building, and system modifications are needed. These findings can inform ongoing efforts to promote the sustained use of this electronic tool to support for patient-provider communication.

Association between health literacy and medical care costs in an integrated healthcare system: a regional population based study.

BACKGROUND: Low health literacy is associated with higher health care utilization and costs; however, no large-scale studies have demonstrated this in the Veterans Health Administration (VHA). This research evaluated the association between veterans' health literacy and their subsequent VHA health care costs across a three-year period. METHODS: This retrospective study used a Generalized Linear Model to estimate the relative association between a patient's health literacy and VHA medical costs, adjusting for covariates. Secondary data sources included electronic health records and administrative data in the VHA (e.g., Medical and DCG SAS Datasets and DSS-National Data Extracts). Health literacy assessments and identifiers were electronically retrieved from the originating health system. Demographic and cost data were retrieved from the VHA centralized databases for the corresponding patients who had VHA use in all three years. RESULTS: In a study of 92,749 veterans with service utilization from 2007-2009, average per patient cost for those with inadequate and marginal health literacy was significantly higher ($31,581 [95 % CI: $30,186 - $32,975]; $23,508 [95 % CI: $22,749 - $24,268]) than adequate health literacy ($17,033 [95 % CI: $16,810 - $17,255]). Estimated three-year cost associated with veterans' with marginal and inadequate health literacy was $143 million dollars more than those with adequate health literacy. CONCLUSIONS: Analyses suggest when controlling for other person-level factors within the VHA integrated healthcare system, lower health literacy is a significant independent factor associated with increased health care utilization and costs. This study confirms the association of lower health literacy with higher medical service utilization and pharmacy costs for veterans enrolled in the VHA. Confirmation of higher costs of care associated with lower health literacy suggests that interventions might be designed to remediate health literacy needs and reduce expenditures. These analyses suggest 17.2 % (inadequate & marginal) of the Veterans in this population account for almost one-quarter (24 %) of VA medical and pharmacy cost for this 3-year period. Meeting the needs of those with marginal and inadequate health literacy could produce potential economic savings of approximately 8 % of total costs for this population.

A mathematical model for maximizing the value of phase 3 drug development portfolios incorporating budget constraints and risk.

We describe a value-driven approach to optimizing pharmaceutical portfolios. Our approach incorporates inputs from research and development and commercial functions by simultaneously addressing internal and external factors. This approach differentiates itself from current practices in that it recognizes the impact of study design parameters, sample size in particular, on the portfolio value. We develop an integer programming (IP) model as the basis for Bayesian decision analysis to optimize phase 3 development portfolios using expected net present value as the criterion. We show how this framework can be used to determine optimal sample sizes and trial schedules to maximize the value of a portfolio under budget constraints. We then illustrate the remarkable flexibility of the IP model to answer a variety of 'what-if' questions that reflect situations that arise in practice. We extend the IP model to a stochastic IP model to incorporate uncertainty in the availability of drugs from earlier development phases for phase 3 development in the future. We show how to use stochastic IP to re-optimize the portfolio development strategy over time as new information accumulates and budget changes occur.

The posterior transpedicular approach for circumferential decompression and instrumented stabilization with titanium cage vertebrectomy reconstruction for spinal tumors: consecutive case series of 50 patients.

STUDY DESIGN: A retrospective case series. OBJECTIVE: To demonstrate the feasibility, safety, and results of the posterior transpedicular approach for circumferential decompression and instrumented reconstruction of thoracolumbar spinal tumors. SUMMARY OF BACKGROUND DATA: Patients presenting with spinal tumor disease requiring 3-column instrumented stabilization are typically treated with a combined anterior and posterior surgical approach. However, circumferential decompression and instrumented stabilization may also be achieved through a single-stage, midline posterior transpedicular approach. METHODS: Fifty consecutive patients (27 women and 23 men) underwent surgery between 2003 and 2010 at a single institution by the senior author. Mean age was 55.9 years (range, 25-79 yr).Single or multilevel, contiguous subtotal vertebrectomy was performed ranging from T1 to L4 (38 thoracic and 12 lumbar). Three-column spinal stabilization was achieved using posterior pedicle screw fixation and vertebral body reconstruction, with a titanium cage introduced through the posterior transpedicular route. The mean follow-up period was 17 months (range, 1-54 mo). RESULTS: The mean operating time was 4.2 hours. The mean estimated blood loss for a subgroup of 9 patients with hypervascular tumor pathology was 3933 mL (range, 2700-5800 mL). The mean blood loss in the remaining 41 patients was 1262 mL (range, 250-2500 mL).Postoperative neurological status was maintained or improved in all patients. Mean postoperative stay was 7.7 days (range, 3-12 d). At last review, 14 patients were alive, with a mean survival of 36 months (range, 13-71 mo). The mean survival for the 36 patients who died was 19 months (range, 2 weeks to 54 mo). CONCLUSION: This is the largest reported series of patients with spinal tumor disease undergoing circumferential decompression and 3-column instrumented stabilization through the posterior transpedicular approach.This surgical approach provides sufficient access for safe and effective circumferential decompression and stabilization, with reduced complications compared with costotransversectomy or combined anterior transcavitary and posterior approaches.

Racial and ethnic disparities in the incidence of invasive cervical cancer in Florida.

BACKGROUND: Although cervical cancer incidence has declined in the past decade, considerable racial and ethnic differences remain. The objective of this study was to examine differences in incidence by histology and cancer stage in Florida stratified further by race, ethnicity, and 5-year time intervals. METHODS: Women who were diagnosed with invasive cervical cancer in Florida between January 1985 and December 2004 were included in the analysis. Age-adjusted incidence rates by race and ethnicity were estimated for different histologic types and stages of cancer. The annual percentage of change in incidence also was calculated for each histologic type. Rate ratios were estimated by race and ethnicity using whites and non-Hispanics as the reference group. RESULTS: Overall, the incidence in Florida of cervical squamous cell carcinoma and transitional cell carcinoma declined significantly from 9.1 per 100,000 women in 1985 to 5.6 per 100,000 women in 2004 (P < .05), whereas the incidence of cervical adenocarcinoma remained stable (P > .05). The incidence of invasive cervical cancer was 9.6 per 100,000 women among whites and 13.13 per 100,000 women among African Americans from 2000 to 2004. African-American women were nearly 2 times more likely to be diagnosed at regional and distant cancer stages than white women for all periods examined. Furthermore, among African-American women aged >40 years, the age-specific incidence of invasive cervical cancer increased considerably, whereas the rates among other racial groups decreased. CONCLUSIONS: The increasing rate of invasive cervical cancer among African-American women aged >40 years in Florida, coupled with their diagnosis at a later stage of cancer, is of great concern. Most screening organizations recommend stopping screening at age 65 years. The observations from these analyses highlighted the need to focus prevention and screening efforts on African-American women living in Florida, and particularly on women of postreproductive age.

A prospective randomized, controlled study comparing low pressure versus high pressure pneumoperitoneum during laparoscopic cholecystectomy.

BACKGROUND: The increase in intra-abdominal pressure by insufflation of carbon dioxide during laparoscopy brings certain changes in function of organ systems and also leads to postoperative pain. Degree of intra-abdominal pressure is directly related with such change. Laparoscopic cholecystectomy can be performed at low pressure pneumoperitoneum. However, available space for dissection is less than the high pressure pneumoperitoneum. METHODS: Twenty-six patients for elective laparoscopic cholecystectomy were studied in a prospective, randomized, patient, and surgeon blinded manner. The intra-abdominal pressure was kept either in low pressure (8 mm Hg) or in high pressure (12 mm Hg). All patients underwent two dimensional echocardiography, pulmonary function test and color Doppler examination of lower limb vessels preoperatively and postoperatively. Arterial blood gas analysis and End Tidal CO2 monitored before insufflation, during surgery and after deflation. Pain score was measured by visual analog scale and surgeon's comfort level was recorded. Postoperative analgesia requirement, complications, and hospital stay were recorded. Student t test used for the statistical analysis. RESULTS: Both groups match for the demographic parameters. Four patients required conversion to high pressure. Intraoperative pO2 level, postoperative pain, analgesic requirement, pulmonary function, and hospital stay were favoring low pressure pneumoperitoneum in a statistically significant manner. There was no difference between 2 groups for duration of surgery, intraoperative, and postoperative complications. However, the technical difficulties were graded more (statistically nonsignificant) with low pressure pneumoperitoneum. CONCLUSIONS: An uncomplicated gall stone disease can be treated by low pressure laparoscopic cholecystectomy with reasonable safety by an experienced surgeon. Though surgeons experience more difficulty in dissection during low pressure pneumoperitoneum, it is significantly advantageous in terms of postoperative pain, use of analgesics, preservation of pulmonary function, and hospital stay.

Complications of PEG--prevention and management.

Per cutaneous endoscopic gastrostomy (PEG) is one of the most common procedures performed by the gastroenterologist for various indications. The procedure is associated with complications which may be minor or major; though the better part is minor yet a high incidence of morbidity is linked to them. This review article illustrates the complications associated with PEG and various methods to prevent and manage the complications.

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The anatomy facing a surgeon during cholecystectomy is challenging as it involves complex relationship between the gallbladder, hepatic artery and extra-hepatic billiary tree. We report a case of septate gall bladder which was successfully treated with laparoscopic cholecystectomy. In this paper, we also discuss the embryology and characteristics of this rare anomaly. Lack of awareness, non-specific symptoms, signs and inadequacy of imaging methods are possible reasons for the reported problem of overlooking of this entity. Complete identification and removal of gallbladder is mandatory, as a remnant may result in recurrence of symptoms or stones.

A Bayesian approach for incorporating economic factors in sample size design for clinical trials of individual drugs and portfolios of drugs.

Classical approaches to clinical trial design ignore economic factors that determine economic viability of a new drug. We address the choice of sample size in Phase III trials as a decision theory problem using a hybrid approach that takes a Bayesian view from the perspective of a drug company and a classical Neyman-Pearson view from the perspective of regulatory authorities. We incorporate relevant economic factors in the analysis to determine the optimal sample size to maximize the expected profit for the company. We extend the analysis to account for risk by using a 'satisficing' objective function that maximizes the chance of meeting a management-specified target level of profit. We extend the models for single drugs to a portfolio of clinical trials and optimize the sample sizes to maximize the expected profit subject to budget constraints. Further, we address the portfolio risk and optimize the sample sizes to maximize the probability of achieving a given target of expected profit.

Wegener's granulomatosis--an etiology of acute pancreatitis.

Wegener's granulomatosis is a systemic disease that usually involves the upper respiratory tract and kidneys. We report a 47-year-old man with Wegener's granulomatosis that presented as acute pancreatitis.

Dengue fever presenting as acute acalculus cholecystitis.

Classically dengue fever presents as fever with myalgia. A patient of dengue fever presented with classical symptoms and signs of acute acalculous cholecystitis. Serology and ultrasound examination identified dengue as the aetiology. Patient was treated successfully by conservative measures.

Adaptive, group sequential and decision theoretic approaches to sample size determination.

This paper presents two adaptive methods for sample size re-estimation within a unified group sequential framework. The conceptual and practical distinction between these adaptive modifications and more traditional sample size changes due to revised estimates of nuisance parameters is highlighted. The motivation for the adaptive designs is discussed. Having established that adaptive sample size modifications can be made without inflating the type 1 error, the paper concludes with a novel decision theoretic approach for determining the magnitude of the sample size modification.