Hot-Melt Extrusion: from Theory to Application in Pharmaceutical Formulation-Where Are We Now?

Hot-melt extrusion (HME) is a globally recognized, robust, effective technology that enhances the bioavailability of poorly soluble active pharmaceutical ingredients and offers an efficient continuous manufacturing process. The twin-screw extruder (TSE) offers an extremely resourceful customizable mixer that is used for continuous compounding and granulation by using different combinations of conveying elements, kneading elements (forward and reverse configuration), and distributive mixing elements. TSE is thus efficiently utilized for dry, wet, or melt granulation not only to manufacture dosage forms such as tablets, capsules, or granule-filled sachets, but also for designing novel formulations such as dry powder inhalers, drying units for granules, nanoextrusion, 3D printing, complexation, and amorphous solid dispersions. Over the past decades, combined academic and pharmaceutical industry collaborations have driven novel innovations for HME technology, which has resulted in a substantial increase in published articles and patents. This article summarizes the challenges and models for executing HME scale-up. Additionally, it covers the benefits of continuous manufacturing, process analytical technology (PAT) considerations, and regulatory requirements. In summary, this well-designed review builds upon our earlier publication, probing deeper into the potential of twin-screw extruders (TSE) for various new applications.

Electroencephalographic assessment of infant spinal anesthesia: A pilot prospective observational study.

INTRODUCTION: Spinal anesthesia is utilized as an alternative to general anesthesia in infants for some surgeries. After spinal anesthesia, infants often become less conscious without administration of sedative medications. The aim of this study was to assess electroencephalographic (EEG) correlates after spinal anesthesia in a cohort of infants. PATIENTS AND METHODS: This pilot study included 12 infants who underwent spinal anesthesia. Unprocessed electroencephalography was recorded. The electroencephalogram was interpreted by four neurologists. Processed analyses compared electroencephalogram changes 30 min after spinal anesthesia to baseline. RESULTS: Following spinal anesthesia, all 12 infants became sedated. Electroencephalography in all 12 demonstrated Stage 2 sleep with the appearance of sleep spindles (12-14 Hz) in the frontal and central leads in 8/12 (67%) of subjects. The median time to onset of sleep spindles was 24.7 interquartile range (21.2, 29.9) min. The duration of sleep spindles was 25.1 interquartile range (5.8, 99.8) min. Voltage attenuation and background slowing were the most common initial changes. Compared to baseline, the electroencephalogram 30 min after spinal anesthesia showed significantly increased absolute delta power (p = 0.02) and gamma power (p < 0.0001); decreases in beta (p = 0.0006) and higher beta (p < 0.0001) were also observed. The Fast Fourier Transform power ratio difference for delta/beta was increased (p = 0.03). Increased coherence was noted in the delta (p = 0.02) and theta (p = 0.04) bandwidths. DISCUSSION: Spinal anesthesia in infants is associated with increased electroencephalographic slow wave activity and decreased beta activity compared to the awake state, with appearance of sleep spindles suggestive of normal sleep. The etiology and significance of the observed voltage attenuation and background slowing remains unclear. CONCLUSIONS: The EEG signature of infant spinal anesthesia is distinct from that seen with general anesthesia and is consistent with normal sleep. Further investigation is required to better understand the etiology of these findings. Our preliminary findings contribute to the understanding of the brain effects of spinal anesthesia in early development.

The Conceptual Framework of Harmful Gambling: A revised framework for understanding gambling harm.

BACKGROUND AND AIMS: The Conceptual Framework of Harmful Gambling moves beyond a symptoms-based view of harm and addresses a broad set of factors related to the risks and effects of gambling harmfully at the individual, family, and community levels. Coauthored by international research experts and informed by multiple stakeholders, Gambling Research Exchange (GREO) facilitated the framework development in 2013 and retains responsibility for regular updates and mobilization. This review article presents information about the revised version of the Conceptual Framework of Harmful Gambling completed in late 2018. METHODS: We describe eight interrelated factors depicted in the framework that represent major themes in gambling ranging from the specific (gambling environment, exposure, gambling types, and treatment resources) to the general (cultural, social, psychological, and biological influences). After outlining the framework development and collaborative process, we highlight new topics for the recent update that reflect changes in the gambling landscape and prominent discourses in the scientific community. Some of these topics include social and economic impacts of gambling, and a new model of understanding gambling related harm. DISCUSSION AND CONCLUSIONS: We address the relevance of the CFHG to the gambling and behavioral addictions research community. Harm-based frameworks have been undertaken in other areas of addiction that can both inform and be informed by a model dedicated to harmful gambling. Further, the framework brings a multi-disciplinary perspective to bear on antecedents and factors that co-occur with harmful gambling.

Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer-the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT).

INTRODUCTION: Surgery (oesophagectomy), with neoadjuvant chemo(radio)therapy, is the main curative treatment for patients with oesophageal cancer. Several surgical approaches can be used to remove an oesophageal tumour. The Ivor Lewis (two-phase procedure) is usually used in the UK. This can be performed as an open oesophagectomy (OO), a laparoscopically assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO). All three are performed in the National Health Service, with LAO and OO the most common. However, there is limited evidence about which surgical approach is best for patients in terms of survival and postoperative health-related quality of life. METHODS AND ANALYSIS: We will undertake a UK multicentre randomised controlled trial to compare LAO with OO in adult patients with oesophageal cancer. The primary outcome is patient-reported physical function at 3 and 6 weeks postoperatively and 3 months after randomisation. Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures. A cost-effectiveness analysis will be performed comparing LAO with OO. We will embed a randomised substudy to evaluate the safety and evolution of the TMIO procedure and a qualitative recruitment intervention to optimise patient recruitment. We will analyse the primary outcome using a multi-level regression model. Patients will be monitored for up to 3 years after their surgery. ETHICS AND DISSEMINATION: This study received ethical approval from the South-West Franchay Research Ethics Committee. We will submit the results for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN10386621.

Analysis of Protein Glycation Using Phenylboronate Acrylamide Gel Electrophoresis.

Carbohydrate modification of proteins adds complexity and diversity to the proteome. However, undesired carbohydrate modifications also occur in the form of glycation, which have been implicated in diseases such as diabetes, Alzheimer's disease, autoimmune diseases, and cancer. The analysis of glycated proteins is challenging due to their complexity and variability. Numerous analytical techniques have been developed that require expensive specialized equipment and complex data analysis. In this chapter, we describe two easy-to-use electrophoresis-based methods that will enable researchers to detect, identify, and analyze these posttranslational modifications. This new cost-effective methodology will aid the detection of unwanted glycation products in processed foods and may lead to new diagnostics and therapeutics for age-related chronic diseases.

Benchmarking the Energy Intensity of Small Water Resource Recovery Facilities.

To enable small communities to benchmark the energy efficiency of their water resource recovery facilities (also known as wastewater treatment facilities), multiple linear regression models of electric and overall energy intensity (kWh/m3) were created using data from Nebraska and Pennsylvania. Key variables found to be significant include: facility type, supplemental energy usage for sludge treatment, average flow, percent design flow, climate controlled floor area, effluent NH3-N, and influent CBOD5. The results show that energy use models for small systems differ from those for large facilities and that regulatory changes can affect energy usage. Step changes in the data for facilities that changed operators highlight the importance of operational decisions on energy efficiency for small facilities serving fewer than 10,000 people. Differences were observed between the models of data from specific states. Although these models may not include all factors that account for variability in energy use, they can provide a reference benchmark for small WRRFs.

Racial/Gender Biases in Student Clinical Decision-Making: a Mixed-Method Study of Medical School Attributes Associated with Lower Incidence of Biases.

BACKGROUND: Accumulating evidence suggests that clinician racial/gender decision-making biases in some instances contribute to health disparities. Previous work has produced evidence of such biases in medical students. OBJECTIVE: To identify contextual attributes in medical schools associated on average with low levels of racial/gender clinical decision-making biases. DESIGN: A mixed-method design using comparison case studies of 15 medical schools selected based on results of a previous survey of student decision-making bias: 7 schools whose students collectively had, and 8 schools whose students had not shown evidence of such biases. PARTICIPANTS: Purposively sampled faculty, staff, underrepresented minority medical students, and clinical-level medical students at each school. MAIN MEASURES: Quantitative descriptive data and qualitative interview and focus group data assessing 32 school attributes theorized in the literature to be associated with formation of decision-making and biases. We used a mixed-method analytic design with standard qualitative analysis and fuzzy set qualitative comparative analysis. KEY RESULTS: Across the 15 schools, a total of 104 faculty, administrators and staff and 21 students participated in individual interviews, and 196 students participated in 29 focus groups. While no single attribute or group of attributes distinguished the two clusters of schools, analysis showed some contextual attributes were seen more commonly in schools whose students had not demonstrated biases: longitudinal reflective small group sessions; non-accusatory approach to training in diversity; longitudinal, integrated diversity curriculum; admissions priorities and action steps toward a diverse student body; and school service orientation to the community. CONCLUSIONS: We identified several potentially modifiable elements of the training environment that are more common in schools whose students do not show evidence of racial and gender biases.

Assessment of Perioperative Variables That Predict the Need for Surgical Drains Following Robotic Partial Nephrectomy Utilizing Quantitative Drain Creatinine Analysis.

OBJECTIVE: To utilize body fluid creatinine analysis to determine which patients will require a surgical drain following robotic-assisted partial nephrectomy (RAPN). MATERIALS AND METHODS: One hundred fifty consecutive RAPN performed by a single surgeon were reviewed. Postoperative day (POD) 1 drain creatinine was compared to serum creatinine to calculate the drain to serum creatinine ratio (D/S ratio). Elevated D/S ratio was defined as any value >1.2. RESULTS: From February 2008 to April 2015, 140 patients underwent RAPN and had a drain placed (124 had D/S ratio available on POD 1). In the 103 patients with a D/S ratio of <1.2 and the 21 with D/S ratio of >1.2, the mean tumor size was 3.0 and 3.9 cm (P = .001) and mean RENAL score was 7.6 and 8.1 (P = .270), respectively. Collecting system entry occurred in 68.2% of patients with a D/S ratio of <1.2 and 71.4% of patients with a D/S ratio of >1.2. Mean drain time was 2.4 and 4.2 days (P = .001), hospital stay was 2.7 and 3.3 days (P = .036) for the D/S ratio <1.2 and D/S ratio >1.2 groups, respectively. Those with renal mass size of 4-7 cm had increased likelihood of D/S ratio >1.2 (OR 2.78; P = .041). CONCLUSIONS: Most RAPN do not require a surgical drain. A POD 1 elevated D/S ratio is more likely to occur with larger masses (those approaching or greater than 4 cm) and can be associated with prolonged drain time and hospital stay.

The conceptual and empirical relationship between gambling, investing, and speculation.

Background and aims To review the conceptual and empirical relationship between gambling, investing, and speculation. Methods An analysis of the attributes differentiating these constructs as well as identification of all articles speaking to their empirical relationship. Results Gambling differs from investment on many different attributes and should be seen as conceptually distinct. On the other hand, speculation is conceptually intermediate between gambling and investment, with a few of its attributes being investment-like, some of its attributes being gambling-like, and several of its attributes being neither clearly gambling or investment-like. Empirically, gamblers, investors, and speculators have similar cognitive, motivational, and personality attributes, with this relationship being particularly strong for gambling and speculation. Population levels of gambling activity also tend to be correlated with population level of financial speculation. At an individual level, speculation has a particularly strong empirical relationship to gambling, as speculators appear to be heavily involved in traditional forms of gambling and problematic speculation is strongly correlated with problematic gambling. Discussion and conclusions Investment is distinct from gambling, but speculation and gambling have conceptual overlap and a strong empirical relationship. It is recommended that financial speculation be routinely included when assessing gambling involvement, and there needs to be greater recognition and study of financial speculation as both a contributor to problem gambling as well as an additional form of behavioral addiction in its own right.

Adverse Events and Resource Utilization After Spinal and General Anesthesia in Infants Undergoing Pyloromyotomy.

BACKGROUND AND OBJECTIVES: Interest in spinal anesthesia (SA) is increasing because of concern about the long-term effects of intravenous (IV) and inhaled anesthetics in young children. This study compared SA versus general anesthesia (GA) in infants undergoing pyloromyotomy. METHODS: Between 2000 to 2013, the University of Vermont Medical Center almost exclusively used SA for infant pyloromyotomy surgery, whereas Columbia University Medical Center relied on GA. Outcomes included adverse events (AEs) within 48 hours of surgery, operating room (OR) time, and postoperative length of stay (LOS). Regression was used to evaluate the association between anesthesia technique and outcomes, accounting for demographic and clinical covariates. RESULTS: We studied 218 infants with SA at the University of Vermont Medical Center and 206 infants with GA at Columbia University Medical Center. In the SA group, 96.3% of infants had adequate initial analgesic levels, but 35.8% required supplemental IV or inhaled anesthetic agents. Compared with GA, the risk of AEs in SA (adjusted odds ratio, 0.60; 95% confidence interval [CI], 0.27-1.36) did not significantly differ, but SA was associated with shorter OR times (17.5 minutes faster; 95% CI, 13.5-21.4 minutes) and shorter postoperative LOS (GA is 1.19 times longer; 95% CI, 1.01-1.40). CONCLUSIONS: Infants undergoing pyloromyotomy with SA had shorter OR times and postoperative LOS, no significant differences in AE rates, and decreased exposure to IV and inhaled anesthetics, although SA infants often still required supplemental anesthetics. Whether these differences result in any long-term benefit is unclear; further studies are needed to determine the risk of rare AEs, such as aspiration.

Preventable drug waste among anesthesia providers: opportunities for efficiency.

BACKGROUND: Health care service bundling experiments at the state and regional levels have showed reduced costs by providing a single lump-sum reimbursement for anesthesia services, surgery, and postoperative care. Potential for cost savings related to the provision of anesthesia care has the potential to significantly impact sustainability. This study defines and quantifies routine and preventable anesthetic drug waste and the patient, procedure, and anesthesia provider characteristics associated with increased waste. METHODS: Over a 12-month period, the type and quantity of clean drugs prepared by the anesthesia team for the first case of the day were recorded. The amount of each drug administered was obtained from the computerized anesthesia record, and data were analyzed to determine the incidence and cost of routine and preventable drug waste. The monthly and yearly cost of preventable waste, including the cost of pharmacy tech labor and materials where applicable, was estimated based on surgical case volume at the study institution. All analyses were performed using SAS software v9.2. RESULTS: Anesthetic drugs prepared for 543 separate surgical cases were observed. Less than 20% of cases generated routine waste. Preventable waste was generated most frequently for ephedrine (59.5% of cases), succinylcholine (33.7%), and lidocaine (25.1%), and least frequently for ondansetron (1.3%), phenylephrine (2.6%), and dexamethasone (2.8%). The estimated yearly cost of preventable anesthetic drug waste was $185,250. CONCLUSIONS: Significant potential savings with little impact on clinically significant availability may be achieved through the use of prefilled syringes for some commonly used anesthetic drugs. An intelligently implemented switch to prefilled syringes for select drugs is a potential cost saving measure, but savings might be diminished by disposal of prefilled syringes when they expire, hidden costs in the hospital pharmacy, and inability to supply some medications in prefilled syringes due to stability or manufacturing issues.

Assessment of the emissions and air quality impacts of biomass and biogas use in California.

UNLABELLED: It is estimated that there is sufficient in-state "technically" recoverable biomass to support nearly 4000 MW of bioelectricity generation capacity. This study assesses the emissions of greenhouse gases and air pollutants and resulting air quality impacts of new and existing bioenergy capacity throughout the state of California, focusing on feedstocks and advanced technologies utilizing biomass resources predominant in each region. The options for bioresources include the production of bioelectricity and renewable natural gas (NG). Emissions of criteria pollutants and greenhouse gases are quantified for a set of scenarios that span the emission factors for power generation and the use of renewable natural gas for vehicle fueling. Emissions are input to the Community Multiscale Air Quality (CMAQ) model to predict regional and statewide temporal air quality impacts from the biopower scenarios. With current technology and at the emission levels of current installations, maximum bioelectricity production could increase nitrogen oxide (NOx) emissions by 10% in 2020, which would cause increases in ozone and particulate matter concentrations in large areas of California. Technology upgrades would achieve the lowest criteria pollutant emissions. Conversion of biomass to compressed NG (CNG) for vehicles would achieve comparable emission reductions of criteria pollutants and minimize emissions of greenhouse gases (GHG). Air quality modeling of biomass scenarios suggest that applying technological changes and emission controls would minimize the air quality impacts of bioelectricity generation. And a shift from bioelectricity production to CNG production for vehicles would reduce air quality impacts further. From a co-benefits standpoint, CNG production for vehicles appears to provide the best benefits in terms of GHG emissions and air quality. IMPLICATIONS: This investigation provides a consistent analysis of air quality impacts and greenhouse gas emissions for scenarios examining increased biomass use. Further work involving economic assessment, seasonal or annual emissions and air quality modeling, and potential exposure analysis would help inform policy makers and industry with respect to further development and direction of biomass policy and bioenergy technology alternatives needed to meet energy and environmental goals in California.

Costs and inconsistencies in US IRB review of low-risk medical education research.

CONTEXT: Advances in communication technologies over the last two decades have transformed the way medical education research is conducted, creating opportunities for multi-institution national and international studies. Although these studies enable researchers to gain broader understandings of educational processes across institutions, they increase the need for multiple institutional review board (IRB) reviews to ensure the protection of human subjects. OBJECTIVES: This study describes the process of obtaining multiple IRB approvals of the same protocol for a multi-site, low-risk, medical education research project in the USA. The burden of obtaining those reviews and their consistency are assessed. The associated time and costs, and implications for the research process are detailed. METHODS: Following review by the investigators' parent institution IRB, the project team circulated a uniform protocol for conduct of a low-risk, medical education survey to the IRBs of 89 US medical schools for review. The processes and time required to obtain approvals were recorded to estimate associated research team personnel costs. RESULTS: Approval could not be obtained from five IRBs as a result of insurmountable procedural barriers. A total of 67 IRBs eventually deferred to the parent IRB determination. The remaining IRBs required a variety of additional procedural processes before ultimately agreeing with the original determination. The personnel costs associated with obtaining the 84 approvals amounted to US$121,344. CONCLUSIONS: Considering the value of multi-site designs to address a range of research questions, enhance participant diversity and develop representative findings, solutions must be found to counter inefficiencies of current IRB review processes for low-risk research, such as that usually conducted in medical education. Although we acknowledge that local review is an essential protective measure for research involving identifiable communities that are uniquely susceptible to social or economic harm, this report suggests that proposals to modernise and streamline IRB review processes for low-risk research are timely and relevant.

Racial, gender, and socioeconomic status bias in senior medical student clinical decision-making: a national survey.

BACKGROUND: Research suggests stereotyping by clinicians as one contributor to racial and gender-based health disparities. It is necessary to understand the origins of such biases before interventions can be developed to eliminate them. As a first step toward this understanding, we tested for the presence of bias in senior medical students. OBJECTIVE: The purpose of the study was to determine whether bias based on race, gender, or socioeconomic status influenced clinical decision-making among medical students. DESIGN: We surveyed seniors at 84 medical schools, who were required to choose between two clinically equivalent management options for a set of cardiac patient vignettes. We examined variations in student recommendations based on patient race, gender, and socioeconomic status. PARTICIPANTS: The study included senior medical students. MAIN MEASURES: We investigated the percentage of students selecting cardiac procedural options for vignette patients, analyzed by patient race, gender, and socioeconomic status. KEY RESULTS: Among 4,603 returned surveys, we found no evidence in the overall sample supporting racial or gender bias in student clinical decision-making. Students were slightly more likely to recommend cardiac procedural options for black (43.9 %) vs. white (42 %, p = .03) patients; there was no difference by patient gender. Patient socioeconomic status was the strongest predictor of student recommendations, with patients described as having the highest socioeconomic status most likely to receive procedural care recommendations (50.3 % vs. 43.2 % for those in the lowest socioeconomic status group, p < .001). Analysis by subgroup, however, showed significant regional geographic variation in the influence of patient race and gender on decision-making. Multilevel analysis showed that white female patients were least likely to receive procedural recommendations. CONCLUSIONS: In the sample as a whole, we found no evidence of racial or gender bias in student clinical decision-making. However, we did find evidence of bias with regard to the influence of patient socioeconomic status, geographic variations, and the influence of interactions between patient race and gender on student recommendations.

Reliability and Validity of Three Instruments (DSM-IV, CPGI, and PPGM) in the Assessment of Problem Gambling in South Korea.

Most research on the assessment, epidemiology, and treatment of problem gambling has occurred in Western jurisdictions. This potentially limits the cross-cultural validity of problem gambling assessment instruments as well as etiological models of problem gambling. The primary objective of the present research was to investigate the reliability and validity of three problem gambling assessment instruments within a South Korean context. A total of 4,330 South Korean adults participated in a comprehensive assessment of their gambling behavior that included the administration of the DSM-IV criteria for pathological gambling (NODS), the Canadian Problem Gambling Index (CPGI), and the Problem and Pathological Gambling Measure (PPGM). Cronbach alpha showed that all three instruments had good internal consistency. Concurrent validity was established by the significant associations observed between scores on the instruments and measures of gambling involvement (number of gambling formats engaged in; frequency of gambling; and gambling expenditure). Most importantly, kappa statistics showed that all instruments have satisfactory classification accuracy against clinical assessment of problem gambling conducted by South Korean clinicians (NODS κ = .66; PPGM κ = .62; CPGI κ = .51). These results confirm that Western-derived operationalizations of problem gambling have applicability in a South Korean setting.

MyPreventiveCare: implementation and dissemination of an interactive preventive health record in three practice-based research networks serving disadvantaged patients--a randomized cluster trial.

BACKGROUND: Evidence-based preventive services for early detection of cancer and other health conditions offer profound health benefits, yet Americans receive only half of indicated services. Policy initiatives promote the adoption of information technologies to engage patients in care. We developed a theory-driven interactive preventive health record (IPHR) to engage patients in health promotion. The model defines five levels of functionality: (1) collecting patient information, (2) integrating with electronic health records (EHRs), (3) translating information into lay language, (4) providing individualized, guideline-based clinical recommendations, and (5) facilitating patient action. It is hypothesized that personal health records (PHRs) with these higher levels of functionality will inform and activate patients in ways that simpler PHRs cannot. However, realizing this vision requires both technological advances and effective implementation based upon clinician and practice engagement. METHODS/DESIGN: We are starting a two-phase, mixed-method trial to evaluate whether the IPHR is scalable across a large number of practices and how its uptake differs for minority and disadvantaged patients. In phase 1, 40 practices from three practice-based research networks will be randomized to add IPHR functionality to their PHR versus continue to use their existing PHR. Throughout the study, we will engage intervention practices to locally tailor IPHR content and learn how to integrate new functions into their practice workflow. In phase 2, the IPHR to all nonintervention practices to observe whether the IPHR can be implemented more broadly (Scalability). Phase 1 will feature an implementation assessment in intervention practices, based on the RE-AIM model, to measure Reach (creation of IPHR accounts by patients), Adoption (practice decision to use the IPHR), Implementation (consistency, fidelity, barriers, and facilitators of use), and Maintenance (sustained use). The incremental effect of the IPHR on receipt of cancer screening tests and shared decision-making compared to traditional PHRs will assess Effectiveness. In phase 2, we will assess similar outcomes as phase 1 except for effectiveness. DISCUSSION: This study will yield information about the effectiveness of new health information technologies designed to actively engage patients in their care as well as information about how to effectively implement and disseminate PHRs by engaging clinicians. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02138448.

Telemedicine and telesurgery in cancer care: inaugural conference at MD Anderson Cancer Center.

BACKGROUND: Despite the growing incidence of cancer worldwide, there are an insufficient number of primary care physicians, community oncologists, and surgeons to meet the demand for cancer care, especially in rural and other medically underserved areas. Teleoncology, including diagnostics, treatment, and supportive care, has the potential to enhance access to cancer care and to improve clinician education and training. OBJECTIVES: Major cancer centers such as The University of Texas MD Anderson Cancer Center must determine how teleoncology will be used as part of strategic planning for the future. The Telemedicine and Telesurgery in Cancer Care (TTCC) conference was convened to determine technologically based strategies for addressing global access to essential cancer care services. RESULTS: The TTCC conference brought policy makers together with physicians, legal and regulatory experts to define strategies to optimize available resources, including teleoncology, to advance global cancer care. CONCLUSIONS: The TTCC conference discourse provided insight into the present state of access to care, expertise, training, technology and other interventions, including teleoncology, currently available through MD Anderson, as well as a vision of what might be achievable in the future, and proposals for moving forward with a comprehensive strategy.

Cognitive outcome after spinal anesthesia and surgery during infancy.

BACKGROUND: Observational studies on pediatric anesthesia neurotoxicity have been unable to distinguish long-term effects of general anesthesia (GA) from factors associated with the need for surgery. A recent study on elementary school children who had received a single GA during the first year of life demonstrated an association in otherwise healthy children between the duration of anesthesia and diminished test scores and also revealed a subgroup of children with "very poor academic achievement" (VPAA), scoring below the fifth percentile on standardized testing. Analysis of postoperative cognitive function in a similar cohort of children anesthetized with an alternative to GA may help to begin to separate the effects of anesthesia from other confounders. METHODS: We used a novel methodology to construct a combined medical and educational database to search for these effects in a similar cohort of children receiving spinal anesthesia (SA) for the same procedures. We compared former patients with a control population of students matched by grade, gender, year of testing, and socioeconomic status. RESULTS: Vermont Department of Education records were analyzed for 265 students who had a single exposure to SA during infancy for circumcision, pyloromyotomy, or inguinal hernia repair. Exposure to SA and surgery had no significant effect on the odds of children having VPAA. (mathematics: P = 0.18; odds ratio 1.50, confidence interval (CI), 0.83-2.68; reading: P = 0.55; odds ratio = 1.19, CI, 0.67-2.1). There was no relationship between duration of exposure to SA and surgery and performance on mathematics (P = 0.73) or reading (P = 0.57) standardized testing. There was a small but statistically significant decrease in reading and math scores in the exposed group (mathematics: P = 0.03; reading: P = 0.02). CONCLUSIONS: We found no link between duration of surgery with infant SA and scores on academic achievement testing in elementary school. We also found no relationship between infant SA and surgery with VPAA on elementary school testing, although the CIs were wide.

Student specialty plans, clinical decision making, and health care reform.

BACKGROUND AND OBJECTIVES: Health care reform aims to increase evidence-based, cost-conscious, and patient-centered care. Family medicine is seen as central to these aims in part due to evidence of lower cost and comparable quality care compared with other specialties. We sought evidence that senior medical students planning family medicine residency differ from peers entering other fields in decision-making patterns relevant to these health care reform aims. METHODS: We conducted a national, anonymous, internet-based survey of senior medical students. Students chose one of two equivalent management options for a set of patient vignettes based on preventive care, medication selection, or initial chronic disease management scenarios, representing in turn evidence-based care, cost-conscious care, and patient-centered care. We examined differences in student recommendations, comparing those planning to enter family medicine with all others using bivariate and weighted, multilevel, multivariable analyses. RESULTS: Among 4,656 surveys received from seniors at 84 participating medical schools, students entering family medicine were significantly more likely to recommend patient management options that were more cost conscious and more patient centered. We did not find a significant difference between the student groups in recommendations for evidence-based care vignettes. CONCLUSIONS: This study provides preliminary evidence suggesting that students planning to enter family medicine may already have clinical decision-making patterns that support health care reform goals to a greater extent than their peers. If confirmed by additional studies, this could have implications for medical school admission and training processes.

Cultivating a cycle of trust with diverse communities in practice-based research: a report from PRIME Net.

PURPOSE: Practice-based research networks (PBRNs) are increasingly seen as important vehicles to translate research into practice, although less is known about the process of engaging diverse communities in PBRN research. The objective of this study was to identify strategies for successfully recruiting and retaining diverse racial/ethnic communities into PBRN research studies. METHODS: This collaborative, multisite study engaged 5 of the 8 networks of the PRImary care MultiEthnic Network (PRIME Net) consortium that conducts research with traditionally underrepresented/underserved populations. We used a sequential, qualitative research design. We first conducted 1 key informant interview with each of 24 researchers experienced in recruiting research participants from 5 racial/ethnic communities (African American, Arab/Chaldean, Chinese, Hispanic, and Native American). Subsequently, we conducted 18 focus groups with 172 persons from these communities. RESULTS: Participants' comments indicated that successful recruitment and retention of underrepresented populations in PBRN studies is linked to the overall research process. This process, which we termed the cycle of trust, entailed developing and sustaining relationships of trust during 4 interrelated stages: before the study, during study recruitment, throughout study conduct, and after study completion. Participants identified a set of flexible strategies within each stage and called for close engagement with clinic and community partners. CONCLUSIONS: Our participants suggest that approaches to research that lay a foundation of trust, demonstrate respect for community members, and extend beyond the enrollment and data collection phases are essential to enhance the participation of diverse populations in PBRN research. These findings offer the PBRN community a guide toward achieving this important goal.