What are the Top Research Priorities in Surgical Simulation and How Can They Be Best Addressed? Results From a Multidisciplinary Consensus Conference.

OBJECTIVES: To define the top priorities in simulation-based surgical education where additional research would have the highest potential to advance the field and develop proposals that would address the identified research priorities. SUMMARY AND BACKGROUND DATA: Simulation has become integral part of surgical training but there are a number of outstanding questions that have slowed advances in this field. METHODS: The Delphi methodology was used to define the top priorities in simulation-based surgical education. A research summit was held with multiple stakeholders under the auspices of the American College of Surgeons Division of Education to develop proposals to address these priorities. RESULTS: Consensus was achieved after the first round of voting on the following 3 most important topics: (1) impact of simulation training on patient safety and outcomes, (2) the value proposition of simulation, and (3) the use of simulation for physician certification and credentialing. Knowledge gaps, challenges and opportunities, and research questions to address these topics were defined by summit participants. CONCLUSIONS: The top 3 priorities in surgical simulation research were defined and project outlines were developed for impactful projects on these topics. Successful completion of such projects is expected to advance the field of simulation-based surgical education.

Airborne Exposures to Polycyclic Aromatic Compounds Among Workers in Asphalt Roofing Manufacturing Facilities.

We studied exposure of 151 workers to polycyclic aromatic compounds and asphalt emissions during the manufacturing of asphalt roofing products-including 64 workers from 10 asphalt plants producing oxidized, straight-run, cutback, and wax- or polymer-modified asphalts, and 87 workers from 11 roofing plants producing asphalt shingles and granulated roll roofing. The facilities were located throughout the United States and used asphalt from many refiners and crude oils. This article helps fill a gap in exposure data for asphalt roofing manufacturing workers by using a fluorescence technique that targets biologically active 4-6 ring polycyclic aromatic compounds and is strongly correlated with carcinogenic activity in animal studies. Worker exposures to polycyclic aromatic compounds were compared between manufacturing plants, at different temperatures and using different raw materials, and to important external benchmarks. High levels of fine limestone particulate in the plant air during roofing manufacturing increased polycyclic aromatic compound exposure, resulting in the hypothesis that the particulate brought adsorbed polycyclic aromatic compounds to the worker breathing zone. Elevated asphalt temperatures increased exposures during the pouring of asphalt. Co-exposures in these workplaces which act as confounders for both the measurement of total organic matter and fluorescence were detected and their influence discussed. Exposures to polycyclic aromatic compounds in asphalt roofing manufacturing facilities were lower than or similar to those reported in hot-mix paving application studies, and much below those reported in studies of hot application of built-up roofing asphalt. These relatively low exposures in manufacturing are primarily attributed to air emission controls in the facilities, and the relatively moderate temperatures, compared to built-up roofing, used in these facilities for oxidized asphalt. The exposure to polycyclic aromatic compounds was a very small part of the overall worker exposure to asphalt fume, on average less than 0.07% of the benzene-soluble fraction. Measurements of benzene-soluble fraction were uniformly below the American Conference of Governmental Industrial Hygienists' Threshold Limit Value for asphalt fume.

Comparative effectiveness of statin plus fibrate combination therapy and statin monotherapy in patients with type 2 diabetes: use of propensity-score and instrumental variable methods to adjust for treatment-selection bias.

PURPOSE: Type 2 diabetes is associated with increased cardiovascular risk. The comparative effectiveness of statin plus fibrate combination therapy and statin monotherapy in reducing risk of cardiovascular disease in real-world settings is unknown. METHODS: A retrospective database analysis was performed using a large managed care claims database of patients identified with type 2 diabetes based on diagnosis codes from January 2002 through December 2003 and continuously enrolled for the entire study period, 5.5 years. A statin plus fibrate combination therapy group (patients who used statins less than 6 months and augmented with fibrates for more than 6 months) and a statin monotherapy group (patients who used statins persistently) among patients with type 2 diabetes were followed for 3 years to examine the relationship between the intervention and cardiovascular events using a multivariable logistic regression model, propensity score method, and instrumental variable approach. RESULTS: The statin plus fibrate combination therapy group of 318 and the statin monotherapy group of 9928 were identified from 75,515 diabetics. After adjusting for factors that can impact cardiovascular outcomes, the combination therapy group did not significantly experience a reduction in cardiovascular disease, as compared with the statin monotherapy group (OR = 0.77; p = 0.083). The statin plus fibrate combination therapy group was significantly associated with a reduction in cardiovascular events after propensity matching (OR = 0.53; p = 0.002). Using the physician prescribing preference instrument to adjust for unmeasured confounding, we did not find evidence that subjects in the statin plus fibrate combination therapy group versus stain monotherapy group experienced a significant reduction in cardiovascular events (p = 0.124). CONCLUSIONS: We did not find a difference in effectiveness regarding cardiovascular outcomes between the statin plus fibrate combination therapy and the statin monotherapy after controlling for hidden bias.

Positioning and integrating medication therapy management.

OBJECTIVES: To summarize findings from medication therapy management (MTM) "environmental scans" conducted from 2007 through 2010, interpret findings from the environmental scans using insights gained from the Future of MTM Roundtable convened in October 2010, and propose ideas for future positioning and integrating of MTM programs in the U.S. health care system. METHODS: Data for the environmental scans were collected from purposive samples of MTM pharmacist providers and MTM payers throughout the United States using self-administered online surveys in 2007, 2008, 2009, and 2010. RESULTS: Based on the findings, it appears that MTM is becoming more developed and that some aspects of MTM have become established within the organizations that are providing and paying for these programs. However, the findings also revealed that a need exists to better integrate MTM between organizations and patients serviced (business-to-consumer relationships), between partnering organizations (business-to-business relationships), and between collaborating practitioners (peer-to-peer relationships). CONCLUSION: The findings suggest that a "channel of distribution" is emerging in which organizational relationships and cost efficiencies will be important considerations in the near term. We propose that applying (1) customer portfolio management and (2) transaction cost economics would help improve positioning and integrating MTM into the U.S. health care system.

Impact of the COVID-19 pandemic on American College of Surgeons-Accredited Education Institutes & American Society of Anesthesiologists-Simulation Education Network: Opportunities for interdisciplinary collaboration.

BACKGROUND: The COVID-19 pandemic presented challenges for simulation programs including American College of Surgeons Accredited Education Institutes and American Society of Anesthesiologists Simulation Education Network. American College of Surgeons Accredited Education Institutes and American Society of Anesthesiologists Simulation Education Network leadership were surveyed to identify opportunities to enhance patient safety through simulation. METHODS: Between January and June 2021, surveys consisting of 3 targeted domains: (I) Changing practice; (II) Contributions and recognition; and (III) Moving ahead were distributed to 100 American College of Surgeons Accredited Education Institutes and 54 American Society of Anesthesiologists Simulation Education Network centers. Responses were combined and percent frequencies reported. RESULTS: Ninety-six respondents, representing 51 (51%) American College of Surgeons Accredited Education Institutes, 17 (31.5%) American Society of Anesthesiologists Simulation Education Network, and 28 dually accredited centers, completed the survey. Change of practice. Although 20.3% of centers stayed fully operational at the COVID-19 onset, 82% of all centers closed: 32% were closed less than 3 months, 28% were closed 3 to 6 months, 8% were closed 7 to 9 months, and 32% remained closed as of June 6, 2021. Most impacted activities were large-group instruction and team training. Sixty-nine percent of programs converted in-person to virtual programs. Contributions. The top reported innovative contributions included policies (80%), curricula (80%), and scholarly work (74%), Moving ahead. The respondents' top concerns were returning to high-quality training to best address learners' deficiencies and re-engagement of re-directed training programs. When asked "How the American College of Surgeons/American Society of Anesthesiologists Programs could best assist your simulation center goals?" the top responses were "facilitate collaboration" and "publish best practices from this work." CONCLUSION: The Pandemic presented multiple challenges and opportunities for simulation centers. Opportunities included collaboration between American College of Surgeons Accredited Education Institutes and the American Society of Anesthesiologists Simulation Education Network to identify best practices and resources needed to enhance patient safety through simulation.

Quantitative exposure matrix for asphalt fume, total particulate matter, and respirable crystalline silica among roofing and asphalt manufacturing workers.

This paper summarizes available data on worker exposures to asphalt fume (soluble fraction), total particulate matter, and respirable crystalline silica (quartz) [hereinafter RCS] over a 30-year period in Owens Corning's asphalt production and roofing manufacturing plants. For the period 1977 through 2006, the air-monitoring database contains more than 1,400 personal samples for asphalt fume (soluble fraction), 2,400 personal samples for total particulate, and 1,300 personal samples for RCS. Unique process-job categories were identified for the asphalt production and roofing shingle manufacturing plants. Quantitative exposures were tabulated by agent, process-job, and calendar period to form an exposure matrix for use in subsequent epidemiologic studies of the respiratory health of these workers. Analysis of time trends in exposure data shows substantial and statistically significant exposure reductions for asphalt fume (soluble fraction), total particulate matter, and respirable crystalline silica at Owens Corning plants. Cumulative distribution plots for the most recent sampling period (2001-2006) show that 95% of the asphalt fume (soluble fraction) measurements were less than 0.25 mg/m3; 95% of the total particulate measurements were less than 2.2 mg/m3; and 95% of the RCS measurements were less than 0.05 mg/m3. Several recommendations are offered to improve the design of future monitoring efforts.

The impact of clinical pharmacy services integrated into medical homes on diabetes-related clinical outcomes.

BACKGROUND: Pharmacist services have expanded in the US health-care system from traditional roles to include comprehensive clinical services, but many studies lack comparison groups to evaluate outcomes of these clinical services. OBJECTIVE: To evaluate the clinical outcomes of uninsured or underinsured patients with type 2 diabetes who received care from pharmacists in local "safety net" clinic medical homes compared to outcomes of patients from clinics receiving usual care without the services of clinical pharmacists. METHODS: Pharmacists provided comprehensive pharmacy services in safety net clinic medical homes for uninsured patients in a major urban city. Referred patients had poor diabetes control (hemoglobin A(1c) [A1C] >9%). Pharmacists conducted comprehensive evaluations of medications, made adjustments, monitored adherence, and provided education and follow-up. Intervention patients were compared to similar patients who were receiving usual care but were not seen by a pharmacist. Outcomes evaluated were the change in A1C levels and achievement of treatment goals. Data were derived from chart reviews retrospectively. Multivariate least-squares and logistic regression models were used to estimate the impact of the intervention. RESULTS: Two hundred twenty-two intervention and 262 control patients were evaluated. Patients receiving care from pharmacists had adjusted A1C levels reduced by 1.38% relative to usual care, increasing the likelihood of achieving an A1C <7% by 3-fold (p < 0.001 for both estimates). CONCLUSIONS: The integration of clinical pharmacy services into safety net medical homes was associated with improvement in clinical outcomes of patients with diabetes.

The critical role of accreditation in establishing the ACS Education Institutes to advance patient safety through simulation.

This paper reviews the rationale for the development of an accreditation program for Educational Institutes by the American College of Surgeons. It discusses the reasons why such accreditation program is beneficial to the institutes themselves as well as to the organizations that sponsor the institute. It analyzes the evolution of the accreditation program since its inception, and it provides advice as to how to start the accreditation process.

Pharmacist-provided medication therapy management (part 2): Payer perspectives in 2007.

OBJECTIVES: To collect and describe payer perspectives regarding (1) implementation strategies used for providing medication therapy management (MTM) services to patients/clients; (2) specific measures, if any, used to quantify the costs and benefits of MTM; (3) how the value of MTM services was tracked during 2007; and (4) barriers to offering MTM services to patients/clients. DESIGN: Descriptive, nonexperimental, cross-sectional study. SETTING: United States during 2007. PARTICIPANTS: Of the 1,898 payers who presumably received an e-mail invitation to participate in the survey, 132 (7%) responded. In addition to the online survey, 20 individuals who reported that they developed or used MTM for their organization participated in a telephone interview consisting of open-ended questions. INTERVENTIONS: Self-administered online survey and telephone interview. MAIN OUTCOME MEASURES: Implementation and monitoring of MTM. RESULTS: The results showed that 20% (n = 26) of the e-mail survey respondents offered MTM services to their members as described in the consensus definition of MTM. Payers for MTM services varied widely on how they implemented and monitored their organization's MTM programs. For 2008, MTM payer organizations plan to expand their use of face-to-face pharmacist-patient interaction. CONCLUSION: During 2008, plans may have greater opportunity to measure outcomes in a longitudinal fashion and make adjustments to MTM provision strategies. Some evidence for this was suggested in respondent comments to our survey, but future validation is needed before reaching a firm conclusion.

Pharmacist-provided medication therapy management (part 1): provider perspectives in 2007.

OBJECTIVES: To collect and describe information from providers of medication therapy management (MTM) services regarding (1) implementation strategies used for providing MTM services to patients/clients; (2) specific measures, if any, used to quantify the costs and benefits of MTM; (3) how the value of MTM services was tracked during 2007; and (4) barriers to offering MTM services to patients/clients. DESIGN: Descriptive, nonexperimental, cross-sectional study. SETTING: United States during 2007. PARTICIPANTS: Of the 6,873 providers who presumably received an e-mail invitation to participate in the survey, 687 (10%) responded and were included for analysis. INTERVENTIONS: Self-administered online survey. MAIN OUTCOME MEASURES: Implementation and monitoring of MTM. RESULTS: 65% of survey respondents were involved in providing MTM services as defined in the consensus definition used. Of these, 47% reported that they were contracted with programs to provide MTM services. Of respondents, 35% indicated that these contracts provided a positive return on investment (ROI), 31% reported that they did not provide a positive ROI, and 34% reported that they did not know. Providers varied widely on how they implemented MTM service offerings and typically did not use specific measures to quantify the costs and benefits of MTM. In addition, they did not use systematic methods for assessing value from providing MTM services to their patients. CONCLUSION: This descriptive environmental scan can serve as a baseline measure and be used for future comparisons.

Costs and utilization of triptan users who receive drug prophylaxis for migraine versus triptan users who do not receive drug prophylaxis.

OBJECTIVES: The objectives were 2-fold: (1) to describe the utilization patterns of new users of triptan therapy and (2) to measure the direct (pharmacy and medical) costs of migraine-related health care services in moderate-to-severe migraine patients treated with drug prophylaxis compared with migraine patients who are not treated with drug prophylaxis. METHODS: A retrospective administrative database study was conducted from the perspective of a managed care health plan. Patients initiating triptan therapy were identified, and utilization in the 12 months following initiation of drug therapy was determined. In addition, moderate-to-severe migraine patients were identified based on the quantity of triptan medication dispensed. Patients were classified as utilizing or not utilizing migraine prophylaxis. Migraine-specific health services costs in the 12 months following identification were determined. A multivariate ordinary least squares regression model was constructed to determine the impact of the use of drug prophylaxis on total cost. Utilizing the model, the difference in health services costs was predicted for each subject and the average treatment effect was computed. RESULTS: Thirty-nine percent of new triptan users received only 1 triptan claim during the 12-month follow-up period, accounting for 11.5% of the total triptan cost incurred by the health plan for this cohort. For new triptan users, triptan use in the first or second quarter was correlated with triptan use in the entire 12-month follow-up period (r = 0.187 and 0.279, respectively). The mean migrainerelated pharmacy cost per patient during the follow-up was $871; however, continuous users had mean costs ($1,505) nearly 3 times the mean costs for new users ($506, P<0.05). The average treatment effect of drug prophylaxis in moderate-to-severe migraine patients was a decrease of $560 ($514-$607) per patient per year in 1998-2001 dollars. CONCLUSION: High utilizers of migraine therapy can be identified early in treatment. Drug prophylaxis for migraine is cost saving, and an intervention program that increases the use of migraine prophylaxis in potential candidates could be cost beneficial.

Burden of illness: direct and indirect costs among persons with hemophilia A in the United States.

OBJECTIVE: To examine the direct and indirect costs of hemophilia care among persons with hemophilia A in the US. METHODS: Observational data were obtained from HUGS-Va, a multi-center study from six federally supported hemophilia treatment centers (HTCs). Eligible individuals completed a standardized initial questionnaire and were followed regularly for 2 years to obtain information on work or school absenteeism, time spent arranging hemophilia care, and unpaid hemophilia-related support from caregivers. Data from 1-year healthcare utilization records and 2-year clotting factor dispensing records measured direct medical costs. Indirect costs were imputed using the human capital approach, which uses wages as a proxy measure of work time output. RESULTS: A total of 222 patients with complete data were included in the analysis. Two-thirds had severe hemophilia and the mean age was 21.1 years. The use of prophylaxis in severe hemophilia patients is associated with statistically significant reduction in the numbers of emergency department (ED) visits and bleeding episodes compared with those who were treated episodically. From the societal perspective, mild hemophilia costs $59,101 (median: $7519) annually per person, $84,363 (median: $61,837) for moderate hemophilia, $201,471 (median: $143,431) for severe hemophilia using episodic treatment, and $301,392 (median: $286,198) for severe hemophilia receiving prophylaxis. Clotting factor contributed from 54% of total costs in mild hemophilia to a maximum of 94% for patients with severe hemophilia receiving prophylaxis. CONCLUSION: Hemophilia is a costly disorder not only because of its high medical expenses, but also due to the high indirect costs incurred.

Purification of dodecanethiol derivatised gold nanoparticles.

Monolayer protected gold nanoparticles synthesised by a two-phase method contain a significant amount of tetraoctylammonium bromide (TOABr), the quaternary ammonium salt used as the phase transfer reagent, as a persistently retained impurity. A simple purification protocol is described.

Pharmacist time requirements for counseling in an outpatient pharmacy.

The correlation between the pharmacist time required for counseling patients and the characteristics of the services provided was studied. Data from the Kaiser Permanente/USC Patient Consultation Study were used to examine the relationship between pharmacist time and potential problems, actions to resolve the problems, and disposition of prescriptions. A regression model was estimated with pharmacist time as the dependent variable. An encounter consisting of patient contact to monitor adverse effects, duplicate therapy, or compliance took an estimated three minutes on average. Problems related to appropriateness of therapy or drug interactions required an additional 1.8 and 0.5 minutes, respectively. Four additional minutes were required for provider contact unless the contact involved a simple clarification (an additional 2.6 minutes). Patient referrals required an additional 2.5 minutes. The time requirements related to the problem addressed and action taken were not additive. The incremental time requirements across alternative problem-action clusters ranged from 2.9 to 9 minutes. A fee-for-service payment system appears to be feasible for pharmacist counseling services.

Costs of care in hemophilia and possible implications of health care reform.

Economic evaluation in health care is increasingly used to assist policy makers in their difficult task of allocating limited resources. The high cost of care, including that for clotting factor concentrates, makes hemophilia a potential target for cost-cutting efforts by health care payers. Although the appropriate management of hemophilia is key to minimizing and preventing long-term morbidity, comparative effectiveness studies regarding the relative benefit of different treatment options are lacking. Cost-of-illness (COI) analysis, which includes direct and indirect costs from a societal perspective, can provide information to be used in cost-effectiveness and other economic analyses. Quality-of-life assessment provides another methodology with which to measure outcomes and benefits of appropriate disease management. Health care reform has implications for individuals with hemophilia and their families through changes in payment, insurance coverage expansion, and health care delivery system changes that reward quality and stimulate cooperative, team-based care. Providers will benefit from the expansion of insurance coverage and some financial benefits in rural areas, and from the expansion of coverage for preventive services. Accountable care organizations will potentially change the way providers are paid and financial incentives under reform will reward high quality of care.

Self-reported barriers to hemophilia care in people with factor VIII deficiency.

BACKGROUND: In 1975, a national network of hemophilia treatment centers (HTCs) was created to increase access to healthcare services for individuals with hemophilia. Studies demonstrate that care in HTCs improves outcomes and reduces costs. PURPOSE: The objective of the study was to assess the association of demographic, insurance, and clinical characteristics with self-reported barriers to HTC utilization. METHODS: Data were collected from six HTCs from 2005 through 2007. Adult participants and parents of children aged <18 years were interviewed. Barriers were assessed by asking whether it was difficult to obtain care in the past 12 months. Chi-square test and logistic regression were used to assess factors associated with self-reported barriers to care. All analyses were performed in 2010-2011. RESULTS: Data for 327 participants (50% adult, 64% severe hemophilia) were analyzed in 2010-2011. Most participants/parents did not report barriers to HTC utilization. However, 46 participants/parents (14%) reported one to six barriers, and 23 reported one barrier. Most frequently reported barriers were "distance to the clinic" for children (44%) and "insurance coverage" for adults (40%). Factors significantly associated with self-reported barriers were: lower income (<$20,000; OR=3.11, 95% CI=1.14-8.45), difficulty finding insurance or obtaining full-year coverage (OR=5.71, 95% CI=2.63-12.41), and decreased state Medicaid coverage for low-income, non-elderly individuals (OR=0.93, 95% CI=0.89-0.98). CONCLUSIONS: This study indicates that, although few people with hemophilia have barriers to care at HTCs, those with lower income, difficulty finding or maintaining adequate insurance coverage, or living in states with lower Medicaid generosity are more likely to report barriers. Identifying and resolving such barriers may improve care access and patient-reported outcomes.

Support for simulation-based surgical education through American College of Surgeons--accredited education institutes.

The American College of Surgeons (ACS) recently launched a new program to provide regional support for simulation-based surgical education through the establishment of a consortium of accredited education institutes. The goals of the program are to enhance surgical patient safety, support efforts of surgeons to meet the requirements for Maintenance of Certification, address the core competencies that all surgeons and surgical residents need to achieve and demonstrate, and enhance access to contemporary surgical education. The ACS-accredited institutes will comprehensively address the needs of a broad spectrum of learners and advance the science of simulation-based surgical education. Accreditation is being offered at two levels--Level I (Comprehensive) and Level II (Basic)--based on three standards that focus on the learners served, the curricula offered, and the technological support and resources available. Initial plans of the consortium of ACS-accredited Education Institutes include development and dissemination of innovative curricula, peer review of new educational programs and products, sharing of limited educational resources, and pursuit of collaborative research and development. This program should be of great value in supporting the professional activities of surgeons, surgical residents, medical students, and members of the surgical team, and in delivering surgical care of the highest quality.

In situ crystallization of low-melting ionic liquids.

Single crystals of five very low-melting ionic liquids, [emim]BF4 (mp -1.3 degrees C), [bmim]PF6 (+1.9 degrees C), [bmim]OTf (+6.7 degrees C), [hexpy]NTf2 (-3.6 degrees C), and [bmpyr]NTf2 (-10.8 degrees C), have been grown using a combined calorimetric and zone-melting approach and their crystal structures determined by X-ray diffraction.