The incremental cost of non-alcoholic steatohepatitis and type 2 diabetes in the United States using real-world data.

BACKGROUND: Non-alcoholic steatohepatitis (NASH) and type 2 diabetes (T2D) are both linked to substantial healthcare costs and are often co-occurring. We aim to quantify the incremental cost of NASH and T2D using real-world data. METHODS: Adults (≥18 years old) with ≥2 diagnosis codes for NASH and/or ≥2 diagnosis codes for T2D between 1/1/2016 and 12/31/2021 and ≥24 months of continuous claims enrollment (study period) were identified in electronic health records or claims in the Veradigm Integrated Dataset. Patients were stratified into 3 cohorts: NASH-only, T2D-only, and NASH + T2D. We calculated annualized costs for the 24-month study period and fit a generalized linear model (excluding the most expensive 1%) that controlled for disease cohort, age, sex, and modified Charlson comorbidity index to estimate the per year all-cause healthcare costs and incremental cost of adding T2D to a NASH diagnosis (or vice versa). RESULTS: We identified 23,111 patients diagnosed with NASH-only, 3,548,786 patients with T2D-only, and 30,339 patients with NASH + T2D. The model-predicted mean costs per year were $7,668 for patients with NASH-only, $11,226 for patients with T2D-only, and $16,812 for patients with NASH + T2D. The incremental increase in costs per year of adding T2D to NASH was 63% (+$4,846), and the incremental increase in costs per year of adding NASH to T2D was 42% (+$4,692). CONCLUSIONS: Both NASH and T2D contribute to the high healthcare costs among patients with a dual diagnosis. Results from our analysis indicate that NASH comprises a high portion of total healthcare costs among patients with NASH and T2D.

Healthcare resource utilization and costs of care in the United States for patients with non-alcoholic steatohepatitis.

AIMS: This retrospective, observational cohort study aimed to determine the burden of comorbidities, hospitalization, and healthcare costs among patients with non-alcoholic steatohepatitis (NASH) in the United States stratified by fibrosis-4 (FIB-4) or body mass index (BMI). METHODS: Adults with NASH were identified in the Veradigm Health Insights Electronic Health Record Database and linked Komodo claims data. The index date was the earliest coded NASH diagnosis between 1 January 2016 and 31 December 2020 with valid FIB-4 and ≥6 months of database activity and continuous enrollment pre- and post-index. We excluded patients with viral hepatitis, alcohol-use disorder, or alcoholic liver disease. Patients were stratified by FIB-4: FIB-4 ≤ 0.95, 0.95 < FIB-4 ≤ 2.67, 2.67 < FIB-4 ≤ 4.12, FIB-4 > 4.12) or BMI (BMI <25, 25 ≤ BMI ≤30, BMI > 30). Multivariate analysis was used to assess the relationship of FIB-4 with costs and hospitalizations. RESULTS: Among 6,743 qualifying patients, index FIB-4 was ≤0.95 for 2,345 patents, 0.95-2.67 for 3,289 patients, 2.67-4.12 for 571 patients, and >4.12 for 538 patients (mean age 55.8 years; 62.9% female). Mean age, comorbidity burden, cardiovascular disease risk, and healthcare utilization increased with increasing FIB-4. Mean ± SD annual costs increased from $16,744±$53,810 to $34,667±$67,691 between the lowest and highest FIB-4 cohorts and were higher among patients with BMI <25 ($24,568±$81,250) than BMI >30 ($21,542±$61,490). A one-unit increase in FIB-4 at index was associated with a 3.4% (95%CI: 1.7%-5.2%) increase in mean total annual cost and an 11.6% (95%CI: 8.0%-15.3%) increased likelihood of hospitalization. CONCLUSIONS: A higher FIB-4 was associated with increased healthcare costs and risk of hospitalization in adults with NASH; however, even patients with FIB-4 ≤ 0.95 presented a significant burden.

Should Gene Editing Be Used to Develop Crops for Continuous-Living-Cover Agriculture? A Multi-Sector Stakeholder Assessment Using a Cooperative Governance Approach.

Continuous-living-cover (CLC) agriculture integrates multiple crops to create diversified agroecosystems in which soils are covered by living plants across time and space continuously. CLC agriculture can greatly improve production of many different ecosystem services from agroecosystems, including climate adaptation and mitigation. To go to scale, CLC agriculture requires crops that not only provide continuous living cover but are viable in economic and social terms. At present, lack of such viable crops is strongly limiting the scaling of CLC agriculture. Gene editing (GE) might provide a powerful tool for developing the crops needed to expand CLC agriculture to scale. To assess this possibility, a broad multi-sector deliberative group considered the merits of GE-relative to alternative plant-breeding methods-as means for improving crops for CLC agriculture. The group included many of the sectors whose support is necessary to scaling agricultural innovations, including actors involved in markets, finance, policy, and R&D. In this article, we report findings from interviews and deliberative workshops. Many in the group were enthusiastic about prospects for applications of GE to develop crops for CLC agriculture, relative to alternative plant-breeding options. However, the group noted many issues, risks, and contingencies, all of which are likely to require responsive and adaptive management. Conversely, if these issues, risks, and contingencies cannot be managed, it appears unlikely that a strong multi-sector base of support can be sustained for such applications, limiting their scaling. Emerging methods for responsible innovation and scaling have potential to manage these issues, risks, and contingencies; we propose that outcomes from GE crops for CLC agriculture are likely to be much improved if these emerging methods are used to govern such projects. However, both GE of CLC crops and responsible innovation and scaling are unrefined innovations. Therefore, we suggest that the best pathway for exploring GE of CLC crops is to intentionally couple implementation and refinement of both kinds of innovations. More broadly, we argue that such pilot projects are urgently needed to navigate intensifying grand challenges around food and agriculture, which are likely to create intense pressures to develop genetically-engineered agricultural products and equally intense social conflict.

Staying Connected: Alternative Transportation Use, Neighborhoods, and Social Participation Among Older Americans.

BACKGROUND AND OBJECTIVES: A wealth of empirical evidence documents improved health among older adults who participate in social activities. Alternative transportation can serve as a bridge linking older adults to social activities and improving person-environment fit. RESEARCH DESIGN AND METHODS: Using Waves 1-8 of the National Health and Aging Trends Study, this research examines whether alternative transportation use is associated with participation in diverse social activities among a sample of Medicare beneficiaries aged 65 or older. Additionally, this research explores whether the effect of transportation use varies across neighborhood environments. We analyzed individual trajectories of participation in social activities by estimating 2-level growth curve models. RESULTS: The use of public transportation, paratransit, getting a ride, or walking/using wheelchair/scooter to get places was associated with participating in more types of social activities. Respondents who used alternative transportation had less steep declines in participation. The effect of getting rides and using paratransit services was more pronounced among respondents living in disordered neighborhoods. DISCUSSION AND IMPLICATIONS: This research underscores the importance of alternative transportation use and the neighborhood context for participation among older adults. Age-friendly initiatives aimed at fostering greater community engagement should think broadly about the role of multiple forms of transportation.

Comparing patterns of care and outcomes after operative management of complications after bariatric surgery at MBSAQIP accredited bariatric centers and non-bariatric facilities.

BACKGROUND: Many operations for complications after bariatric surgery are performed by surgeons without bariatric expertise at centers without teams who routinely care for bariatric patients. This study sought to evaluate whether bariatric expertise affects patterns of care and perioperative outcomes among patients undergoing operative intervention for complications after bariatric surgery. METHODS: Administrative claims data from the Kentucky Office of Health Policy were queried for inpatients undergoing operative intervention for complications related to bariatric surgery between 2015 and 2018. Patients were stratified with respect to whether or not they underwent surgery at a Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) accredited bariatric surgery center (BCE) or not (non-BCE). Groups were compared with respect to demographic, procedural, and outcome variables. RESULTS: BCE patients were more often Caucasian than non-BCE patients (p < 0.001) and have either private insurance or Medicare coverage (p = 0.02). Regarding operative approach, operations were more likely to be performed laparoscopically in BCE (88.5% BCE vs. 80.9% non-BCE, p = 0.007). Length of stay was significantly shorter for BCE patients (median 2 days BCE vs. 3 days non-BCE, p < 0.001), and BCE patients were more likely to be discharged home (85.4% BCE vs. 78.5% non-BCE, p = 0.02). Inpatient mortality and average total charges per patient did not differ significantly between the two groups CONCLUSIONS: Surgical management of complications after bariatric surgery at BCE is associated with greater utilization of minimally invasive techniques, shorter hospital stay, and increased likelihood of routine home discharge. These findings should prompt a review and standardization of care patterns for patients with complications after bariatric surgery aimed at optimizing outcomes and improving value.

External quality assessment demonstrates that PD-L1 22C3 and SP263 assays are systematically different.

PD-L1 inhibitors are part of first line treatment options for patients with advanced non-small cell lung cancer. PD-L1 immunohistochemistry (IHC) assays act as either a companion or a complementary diagnostic. The purpose of this study is to describe the experience of external quality assurance (EQA) provider UK NEQAS ICC and ISH with the comparison of different PD-L1 assays used in daily practice. Three EQA rounds (pilot, run A and run B) were carried out using formalin fixed paraffin embedded samples with sample sets covering a range of epitope concentrations, including 'critical samples' near to clinical threshold cut-offs. An expert panel (n = 4) evaluated all returned slides simultaneously and independently on a multi-header microscope together with the participants own in-house control material. The tonsil sample was evaluated as 'acceptable' or 'unacceptable', and for the other samples the percentage of PD-L1 stained tumour cells were estimated in predetermined categories (<1%, 1 to <5%, 5 to <10%, 10 to <25%, 25 to <50%, 50 to <80%, 80 to 100%). In the pilot and the two subsequent runs the number of participating laboratories was 43, 69 and 76, respectively. The pass rate for the pilot run was 67%; this increased to 81% at run A and 82% at run B. For two 'critical samples', in runs A and B, 22C3 IHC had significantly higher PD-L1 expression than SP263 IHC (p < 0.001), whilst the PD-L1 scores for the other six samples were similar for all assays. In run A the laboratory developed tests (LDTs) using 22C3 scored lower than the commercial 22C3 tests (p = 0.01). After the initial testing, improvement in performance of PD-L1 IHC is shown for approved and LDT PD-L1 assays. Equivalency of approved PD-L1 22C3 and SP263 assays cannot be assumed as the scores cross the clinically relevant thresholds of 1% and 50% PD-L1 expression.

Energy Expenditure and Protein Requirements Following Burn Injury.

Severe burn injuries have long been known to have a profound effect on metabolic equilibrium that can persist after resolution of the cutaneous injuries. Following burn injury, metabolism is a dynamic state resulting in the need for frequent interval reassessment over the course of the care continuum. The acute phase of injury transitions to chronic alterations in macronutrient utilization characterized by futile energy cycling and disproportionate catabolism of skeletal muscle. Protein supplementation appears to be preferentially distributed to the burn wound rather than the skeletal muscle pool. Accurate assessment of caloric and protein requirements is extremely difficult in these patients but is an essential step in efforts to attenuate functional impairment. Indirect calorimetry should be utilized to determine caloric requirements, but trophic feeding strategies are preferred in the initial resuscitative phase to prevent overfeeding while maintaining enteric and immune function. Controversy persists regarding optimal protein targets, and weight-based estimates remain the norm. Exogenous protein and caloric provision performed in isolation is insufficient to optimize outcomes and should be incorporated within a multidisciplinary approach to include muscle loading and pharmaceutical adjuncts.

An international multicenter study to evaluate reproducibility of automated scoring for assessment of Ki67 in breast cancer.

The nuclear proliferation biomarker Ki67 has potential prognostic, predictive, and monitoring roles in breast cancer. Unacceptable between-laboratory variability has limited its clinical value. The International Ki67 in Breast Cancer Working Group investigated whether Ki67 immunohistochemistry can be analytically validated and standardized across laboratories using automated machine-based scoring. Sets of pre-stained core-cut biopsy sections of 30 breast tumors were circulated to 14 laboratories for scanning and automated assessment of the average and maximum percentage of tumor cells positive for Ki67. Seven unique scanners and 10 software platforms were involved in this study. Pre-specified analyses included evaluation of reproducibility between all laboratories (primary) as well as among those using scanners from a single vendor (secondary). The primary reproducibility metric was intraclass correlation coefficient between laboratories, with success considered to be intraclass correlation coefficient >0.80. Intraclass correlation coefficient for automated average scores across 16 operators was 0.83 (95% credible interval: 0.73-0.91) and intraclass correlation coefficient for maximum scores across 10 operators was 0.63 (95% credible interval: 0.44-0.80). For the laboratories using scanners from a single vendor (8 score sets), intraclass correlation coefficient for average automated scores was 0.89 (95% credible interval: 0.81-0.96), which was similar to the intraclass correlation coefficient of 0.87 (95% credible interval: 0.81-0.93) achieved using these same slides in a prior visual-reading reproducibility study. Automated machine assessment of average Ki67 has the potential to achieve between-laboratory reproducibility similar to that for a rigorously standardized pathologist-based visual assessment of Ki67. The observed intraclass correlation coefficient was worse for maximum compared to average scoring methods, suggesting that maximum score methods may be suboptimal for consistent measurement of proliferation. Automated average scoring methods show promise for assessment of Ki67 scoring, but requires further standardization and subsequent clinical validation.

Gunshot Injuries to the Extremity: Is Immediate General Surgery Presence Needed?

Gunshot wounds (GSW) are becoming increasingly prevalent in urban settings. GSW to the trunk mandate full trauma activation and immediate surgeon response because of the high likelihood of operative intervention. Extremity GSW proximal to the knee/elbow also require full trauma activation based on American College of Surgeons Committee on trauma standards. However, whether isolated extremity GSW require frequent operative intervention is unclear. We evaluated GSW at our Level I trauma center from January 2012 to December 2016. Demographic data and injury patterns were abstracted from the trauma registry and charts. The number of GSW increased yearly but the age, gender, Injury Severity Score and injury pattern did not change (P = ns, not shown). There were 504 GSW that included an extremity and 194 (38%) involved multiple body regions. There were 310 GSW (62%) isolated to an extremity and 176 were proximal to the elbow/knee. If proximal GSW had an Emergency Department systolic blood pressure <90 mm Hg, 53 per cent underwent vascular repair, 12 per cent had soft tissue repair, and 29 per cent required no operation. If proximal GSW had an Emergency Department blood pressure >90 mm Hg, 57 per cent underwent orthopedic repair, 22 per cent required no surgery, and only 13 per cent required vascular repair (P < 0.01). In the absence of other criteria for full trauma activation such as shock, the need for the immediate presence of a general surgeon to perform emergency surgery for a GSW isolated to the extremity is low.

Standing frames for children with cerebral palsy: a mixed-methods feasibility study.

BACKGROUND: Standing frames are recommended as part of postural management for young people with cerebral palsy (CP) Gross Motor Function Classification System (GMFCS) level IV or V. They may have a variety of benefits, including improving bone mineral density, gastrointestinal function and social participation. The NHS needs to know if these benefits are real, given the cost implications of use and the reported negative effects (e.g. pain). The lack of evidence for the clinical effectiveness of standing frames demonstrates the need for evaluative research. OBJECTIVE(S): The aim of the study was to explore the acceptability of a future trial to determine the clinical effectiveness of standing frames. DESIGN: A sequential mixed-methods design was used. The findings of each stage informed the next stage. We conducted surveys, focus groups and in-depth interviews. PARTICIPANTS: Professionals who work with young people who use standing frames and parents who have a child who uses a standing frame took part in a survey of current standing frame practice (n = 551), a series of focus groups (seven focus groups, 49 participants in total) and a survey of research trial acceptability and feasibility (n = 585). Twelve young people who use a standing frame were interviewed. RESULTS: Standing frames were widely used as part of postural management for young people with CP both in school and at home but more frequently in school, and particularly by young people in primary school. Achieving the prescribed use was not always possible owing to resources, environment and family factors. Participation and activity engagement were important to young people. The majority of participants believed that standing frames research is necessary. Some reported concern that stopping standing frame use for a trial would cause irreversible damage. The maximum amount of time most health professionals and parents would agree to suspend standing frame use would be 12 weeks. LIMITATIONS: Owing to the nature of recruitment, we could not calculate response rates or determine non-response bias. Therefore, participants may not be representative of all standing frame users. CONCLUSIONS: Although parents and professionals who engaged in the qualitative aspect of this research and stakeholders who took part in the design workshops appreciated the lack of clinical evidence, our surveys, qualitative information and PPI demonstrated that most people had strong beliefs regarding the clinical effectiveness of standing frames. However, with key stakeholder engagement and careful planning, a trial would be acceptable. FUTURE WORK: We recommend a carefully planned trial that includes a pilot phase. The trial should evaluate the following question: 'does using a standing frame in school improve patient-reported outcomes of participation (primary outcome), quality of life, subjective well-being, body function and body structure (secondary outcomes) in young children (aged 4-11 years) with CP GMFCS III-V?'. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Breast cancer biomarkers in clinical testing: analysis of a UK national external quality assessment scheme for immunocytochemistry and in situ hybridisation database containing results from 199 300 patients.

We describe a collated data set of results from clinical testing of breast cancers carried out between 2009 and 2016 in the United Kingdom and Republic of Ireland. More than 199 000 patient biomarker data sets, together with clinicopathological parameters were collected. Our analyses focused on human epidermal growth factor receptor-2 (HER2), oestrogen receptor (ER) and progesterone receptor (PR), with the aim of the study being to provide robust confirmatory evidence on known associations in these biomarkers and to uncover new data on previously undescribed or unconfirmed associations, thus strengthening the evidence-base in clinical breast cancer testing. Overall, 13.1% of tumours were HER2-positive; 10.6% in ER-positive tumours, and 25.5% in ER-negative tumours. Higher rates of HER2 positivity were significantly associated with patient age <56 years versus age ≥56 years, symptomatic versus screen-detected tumours, testing of involved axillary node versus primary breast cancer, invasive ductal carcinoma (not otherwise specified) versus other histological types, higher histological grade, increasing tumour size, increasing nodal involvement, ER-negative versus ER-positive tumour status, PR-negative versus PR-positive tumour status. Where ER status was known, 82.7% of tumours were ER-positive; 80.9% in women age <56 years, and 83.6% in those age ≥56 years (ER-positive cut-off ≥1.0% positive tumour cells or equivalent). Where PR status was known, 64.9% of tumours were PR-positive; 65.8% in women age <56 years, and 64.4% in women age ≥56 years (PR-positive cut off ≥10.0% or equivalent). These analyses of clinical test results provide contemporary benchmarking data for HER2, ER and PR positive rates.

Organ donation as an outcome of traumatic cardiopulmonary arrest: A cost evaluation.

BACKGROUND: Survival after traumatic cardiopulmonary arrest (TCPA) is rare and requires significant resource expenditure. Organ donation as an outcome of TCPA resuscitation has not yet been included in a cost analysis. The aims of this study were to identify variables associated with survival and organ donation after TCPA, and to estimate the cost of achieving these outcomes. We hypothesized that the inclusion of organ donation as a potential outcome would make TCPA resuscitation more cost-effective. METHODS: Adult patients who required resuscitation for TCPA at a level I trauma center were retrospectively reviewed over 36 months. Data were obtained from medical records, hospital accounting records, and the local organ procurement agency. Outcomes included survival to discharge, neurologic function, and organ donor eligibility. An individual-level state-transition cost-effectiveness model was used to evaluate the cost of TCPA resuscitation with and without organ donation included as an outcome. Incremental cost-effectiveness ratio was calculated to determine additional cost per life saved when organ donation is included. RESULTS: Over the study period, 8,932 subjects were evaluated. Traumatic cardiopulmonary arrest occurred in 237 patients (3%). The mortality rate was 97%. Variables associated with survival included emergency department disposition to the operating room (p < 0.01) and reactive pupils (p < 0.001). Of seven survivors, four were discharged neurologically intact. Of the patients with TCPA, 5% were eligible for organ donation with a procurement rate of 2%. Organ donor eligibility was associated with arrest after arrival to the emergency department (p < 0.01) and transfusion of fresh frozen plasma (p = 0.01). The cost of TCPA resuscitation per survivor was $1.8 million; cost per survivor or life saved by donation was $538,000. The incremental cost-effectiveness ratio was $76,816 per additional life saved including donation as an outcome. CONCLUSION: The decision to pursue resuscitation should continue to be based on the presence of signs of life, especially pupil reactivity and duration of arrest. If the primary objective is survival, organ procurement will be maximized without conflict of interest. Early fresh frozen plasma transfusion may increase successful organ donation. The financial burden of TCPA resuscitation can be mitigated by expanding end points to include organ donation. LEVEL OF EVIDENCE: Prognostic and epidemiologic study, level III; cost analysis, level V.

The feasibility and educational value of Hear My Voice, a chaplain-led spiritual life review process for patients with brain cancers and progressive neurologic conditions.

Research continues to establish the importance of spirituality for many persons with medical illnesses. This paper describes a pilot study titled, "Hear My Voice," designed to provide an opportunity for persons with progressive neurologic illnesses, including brain tumors and other neurodegenerative diseases, to review and discuss their spirituality with a board-certified chaplain, and to prepare a spiritual legacy document (SLD). First, we provide background information that underscores the importance of such a project for this patient population that is particularly vulnerable to cognitive impairment and communication difficulties. Second, we provide detailed methodology, including the semi-structured interview format used, the development of the SLD, and an overview of responses from participants and investigators. We also describe the quantitative and qualitative approaches to analysis taken with the aim of developing scientific validation in support of the Hear My Voice project.

The relevance of external quality assessment for molecular testing for ALK positive non-small cell lung cancer: results from two pilot rounds show room for optimization.

BACKGROUND AND PURPOSE: Molecular profiling should be performed on all advanced non-small cell lung cancer with non-squamous histology to allow treatment selection. Currently, this should include EGFR mutation testing and testing for ALK rearrangements. ROS1 is another emerging target. ALK rearrangement status is a critical biomarker to predict response to tyrosine kinase inhibitors such as crizotinib. To promote high quality testing in non-small cell lung cancer, the European Society of Pathology has introduced an external quality assessment scheme. This article summarizes the results of the first two pilot rounds organized in 2012-2013. MATERIALS AND METHODS: Tissue microarray slides consisting of cell-lines and resection specimens were distributed with the request for routine ALK testing using IHC or FISH. Participation in ALK FISH testing included the interpretation of four digital FISH images. RESULTS: Data from 173 different laboratories was obtained. Results demonstrate decreased error rates in the second round for both ALK FISH and ALK IHC, although the error rates were still high and the need for external quality assessment in laboratories performing ALK testing is evident. Error rates obtained by FISH were lower than by IHC. The lowest error rates were observed for the interpretation of digital FISH images. CONCLUSION: There was a large variety in FISH enumeration practices. Based on the results from this study, recommendations for the methodology, analysis, interpretation and result reporting were issued. External quality assessment is a crucial element to improve the quality of molecular testing.

Factors that impact patient outcome: nutrition assessment.

Defining malnutrition and nutrition risk has been a topic of many papers and discussions throughout the modern literature. Multiple definitions have been proposed, ranging from simple body weight measurements to a more all-encompassing concept looking at disease-specific inflammatory states. Biochemical markers, elements of a history examination, physical examination findings, calculations, and technical tests have all been proposed to help further characterize and delineate those who might be at risk for malnutrition, translating to an increased risk of adverse outcomes after major surgery. The purpose of this paper is to summarize some of the most utilized and most reliable ways to determine nutrition status within the scope of the North American Surgical Nutrition Summit (2012) and discuss how to incorporate these methods into the way that patients are screened preoperatively for elective surgery.

"CAN WE FEED?" A mnemonic to merge nutrition and intensive care assessment of the critically ill patient.

As care of the critically ill patient grows more complex, so does the breadth of knowledge required of the intensivist to deliver quality service. Nutrition is one area of many where the complexity of care has grown and the opportunity for improving patient outcomes has become evident. The use of mnemonics has proven successful in compartmentalizing information that must be considered in complex decision-making processes. The authors propose one such mnemonic, "CAN WE FEED?" to assist in the development and initiation of early enteral nutrition therapy in the intensive care unit (ICU). Critical illness severity (C), age (A), and nutrition risk screening (N) are considered when performing a baseline evaluation of the critically ill patient upon presentation to the ICU. Wait for resuscitation (W) is a key component in the care of most critically ill patients and is an important consideration prior to the initiation of feeding. Energy requirements (E) are determined using conventional weight-based equations, indirect calorimetry, or combinations of both techniques. The more practical aspects of support that follow include formula selection (F), enteral access (E), efficacy (E), and the determination of tolerance (D). With careful consideration of these components through the use of the mnemonic "CAN WE FEED?" the intensivist can successfully implement a nutrition plan, and the clinical nutritionist can appreciate where nutrition therapy appropriately intervenes in the initial resuscitation and management of the critically ill patient.

Comparison of in vivo clinical performance and shaft temperature and in vitro tissue temperature and transection times between new and reprocessed harmonic scalpels.

The ultrasonic harmonic scalpel (HS) uses ultrasound energy to achieve surgical dissection. To test the feasibility of limited HS reuse and to insure that reprocessed HS function in a substantially equivalent manner to their new counterparts, this study compared in vivo mesenteric vessel and liver cutting characteristics, scalpel shaft temperatures during in vivo usage and in vitro tissue temperature dissipation characteristics between new and reprocessed ACE™36 series HS. The study found that new and reprocessed ACE™-36 HS exhibit identical performance with respect to in vivo dissection characteristics and postcut shaft temperatures. The in vitro studies show tissue temperature elevations and durations adjacent to dissection sites to be substantially equivalent for reprocessed versus new devices. Finally, cut times and extended use performance for new and reprocessed devices exhibit no statistical differences. We conclude that reprocessed HS scalpels that pass acceptance tests exhibit functional and safety capabilities that are equivalent to their new counterparts.

Potential for false-positive staining with a rabbit monoclonal antibody to progesterone receptor (SP2): findings of the UK National External Quality Assessment Scheme for Immunocytochemistry and FISH highlight the need for correct validation of antibodies on introduction to the laboratory.

This study focused on recent assessment results from the United Kingdom National External Quality Assessment Scheme for Immunocytochemistry and Fluorescence In-Situ Hybridisation breast hormone receptor module in which participants were asked to demonstrate progesterone receptors (PRs). The slides consisted of 3 infiltrating ductal breast carcinomas, previously classified as a high PR expresser, a moderate to low PR expresser, and a negative tumor. During this assessment, 2 commercial rabbit monoclonal antibodies, SP2 (Lab Vision/NeoMarkers, Fremont, CA), and 1E2 (Ventana, Tucson, AZ) were used by 15% of the participants. The SP2 rabbit monoclonal antibody showed false-positive and nonspecific staining on the previously established PR-tumor. This article highlights the necessity for all clinical laboratories to validate immunohistochemical methods and protocols when using newly marketed antibodies such as SP2; use composite tissue blocks with known levels of tumor expression such as a high, mid, and negative expression; and participate in internal and external quality assessment schemes, which can highlight potential technical issues in laboratory methods.

Ecological Assessment of Substance-abuse Experiences (EASE): findings from a new instrument development pilot study.

A newly developed instrument that assesses a client's orientation to addiction or recovery communities using social context referents was pilot tested with a sample of 103 adults seeking treatment for substance abuse at outpatient and residential treatment facilities on the East Coast. Preliminary findings show promising subscale reliabilities, and suggest that drug- and recovery-related social identities are related to drug-use severity and drug-use concern; and drug-related attitudinal congruence between the treatment-seeker and family and treatment-seeker and other significant persons are related to intention to make behavioral changes in reducing substance abuse.