Clinically derived 12-factor structure and confirmatory factor analysis of the neurodevelopmental parent report for outcome monitoring.

Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by social communication and social interaction impairments accompanied by restrictive and repetitive behaviors or interests. Co-occurring conditions may greatly impact overall functioning and intervention needs, and contribute to individual variability and etiologic subtypes. Clinical care of individuals with ASD requires gathering a breadth of information across multiple domains. The neurodevelopmental parent report for outcome monitoring (ND-PROM) was developed to assess symptoms across core features of ASD as well as frequent concerns and comorbidities. The current study expands upon the initially reported psychometric properties of the ND-PROM and evaluates a proposed a clinically derived 12-factor structure of the ND-PROM. Methods and procedures: The ND-PROM was completed for 246 children with ASD ands tested using confirmatory factor analysis (CFA) and measurement invariance based on sex. Outcomes and results: A 12-factor correlated structure was found (expressive language, receptive language, nonverbal communication, social emotional understanding, social interaction, independent play, adaptive/toileting skills, restrictive and repetitive behaviors and interests, sensory processes, challenging behaviors, impulse/ADHD, and mental health), which did not vary by sex. Conclusions and implications: The ND-PROM captures a range of distinct aspects of developmental and behavioral functioning in ASD that can be used to track independent functioning across domains.

First-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility study.

Rationale Current hepatic locoregional therapies are limited in terms of effectiveness and toxicities. Given promising pre-clinical results, a first in-human trial was designed to assess the technical effectiveness and safety profile of histotripsy, a noninvasive, non-thermal, non-ionizing focused ultrasound therapy that creates precise, predictable tissue destruction, in patients with primary and secondary liver tumors.Methods A multicenter phase I trial (Theresa Study) was performed in a single country with 8 weeks of planned follow-up. Eight of fourteen recruited patients were deemed eligible and enrolled in the study. Hepatic histotripsy, was performed with a prototype system (HistoSonics, Inc., Ann Arbor, MI). Eleven tumors were targeted in the 8 patients who all had unresectable end-stage multifocal liver tumors: colorectal liver metastases (CRLM) in 5 patients (7 tumors), breast cancer metastases in 1 (1 tumor), cholangiocarcinoma metastases in 1 (2 tumors), and hepatocellular carcinoma (HCC) in 1 (1 tumor). The primary endpoint was acute technical success, defined as creating a zone of tissue destruction per planned volume assessed by MRI 1-day post-procedure. Safety (device-related adverse events) through 2 months was a secondary endpoint.Results The 8 patients had a median age of 60.4 years with an average targeted tumor diameter of 1.4 cm. The primary endpoint was achieved in all procedures. The secondary safety profile endpoint identified no device-related adverse events. Two patients experienced a continuous decline in tumor markers during the eight weeks following the procedure.Conclusions This first-in-human trial demonstrates that hepatic histotripsy effectively destroys liver tissue in a predictable manner, correlating very well with the planned histotripsy volume, and has a high safety profile without any device-related adverse events. Based on these results, the need for more definitive clinical trials is warranted. Trial Registration: Study to Evaluate VORTX Rx (Theresa). NCT03741088. https://clinicaltrials.gov/ct2/show/NCT03741088 KEY POINTSHistotripsy, a new noninvasive, non-thermal, non-ionizing focused ultrasound therapy, safely created a zone of tissue destruction in the liver that correlated very well with the pre-defined planned tissue destruction volume.In this first human trial histotripsy was well tolerated with no histotripsy device-related adverse events and its primary endpoint of acute technical success was achieved in all 8 enrolled patients with primary or secondary liver tumors.This new locoregional therapy for patients with liver tumors is safe and effective, warranting further trials.

Autism Spectrum Disorder Parent Report for Outcome Monitoring: A Preliminary Report of Development and Clinical Utility.

OBJECTIVE: Children with autism spectrum disorder (ASD) face challenges across many functional domains. A tool that gathers relevant clinical information before visits, emphasizing symptoms that are likely to change over development and inform clinical interventions, could improve health care quality, allowing for more patient-centered and efficient care. This study evaluated the clinical utility and preliminary psychometrics of the ASD Parent Report for Outcome Monitoring (ASD-PROM), a web-based measure assessing competence in core features of ASD, along with the breadth of concerns and comorbidities that frequently co-occur with ASD. METHODS: An interdisciplinary team drafted the ASD-PROM and made iterative revisions based on parent feedback. Parents of 62 children completed the ASD-PROM before their autism-specialty clinical visit, 53 completed the ASD-PROM twice, and 48 completed the Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) concurrently. Parents (n = 25) and clinicians (n = 13) completed postvisit surveys to assess utility (phase 1). The ASD-PROM was then released for general clinical use (phase 2). RESULTS: On a Likert scale (1 = very poorly, 10 = very well), parents found that ASD-PROM items described their child's abilities well (median = 8.0; interquartile range [IQR]: 7.0-9.5) and had a positive effect on care (median = 8.0; IQR: 7.0-10.0). Clinicians found the ASD-PROM effective in assessing parent-reported patient abilities (median = 9.0, IQR: 7.0-9.0) and felt the ASD-PROM helped make their care more patient-centered and efficient (both median = 8.0, IQR: 6.0-9.0). Two-week test-retest reliability was acceptable (0.95). ASD-PROM scores correlated positively with scores from similar domains on the Vineland-II (Pearson r 0.30-0.50, medium to large effects). CONCLUSION: The ASD-PROM is a freely available tool to gather information on developmental and behavioral functioning in children with ASD before autism-specialty clinical visits. Clinical utility and preliminary psychometrics are promising, although limitations (including a low response rate during clinical use and a need for additional in-depth assessments and potential resulting modifications to the tool) remain to be addressed. Ultimately, the ASD-PROM may help promote patient-centered and efficient care for children across a wide range of ages and developmental levels.

Understanding the Influence of Social and Motor Context on the Co-occurring Frequency of Restricted and Repetitive Behaviors in Autism.

The social and motor context in which restricted and repetitive behaviors (RRBs) occur in autism and their relationship to social traits are not well-understood. Participants with and without autism completed tasks that varied in social and motor engagement and RRB frequency was measured. Motor and verbal RRBs were most common, RRBs varied based on motor and social context for participants with autism, and social engagement was associated with lower motor and verbal RRBs. Significant correlations between RRBs and autism severity, social synchrony, and nonverbal mental age were also found. This research confirms the importance of context for understanding RRBs during on-going tasks and raises questions about whether the factors that elicit vocal and motor RRBs are unique for individual children.

Microwave ablation compared with radiofrequency ablation for treatment of hepatocellular carcinoma and liver metastases: a systematic review and meta-analysis.

PURPOSE: Percutaneous ablation techniques, including microwave ablation (MWA) and radiofrequency ablation (RFA), have become important minimally invasive treatment options for liver cancer. This systematic review compared MWA with RFA for treatment of liver cancer. METHODS: The systematic review and meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A systematic search of MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials was conducted for randomized and observational studies published from 2006 onwards. A random-effects model was used for meta-analyses and local tumor progression (LTP), technique efficacy, overall survival (OS), disease-free survival (DFS), intrahepatic de novo lesions (IDL), extrahepatic metastases (EHM), length of stay (LOS), and complications were analyzed. Subgroup and sensitivity analyses were also conducted. RESULTS: Of 1379 studies identified, 28 randomized and observational studies met inclusion criteria. The main analysis demonstrated that LTP was significantly reduced by 30% with MWA versus RFA (RR=0.70; P=0.02) (all studies) and by 45% with MWA versus RFA (RR=0.55; P=0.007) (randomized studies only). There were no significant differences between MWA and RFA for other efficacy and safety outcomes. Higher frequency (2450 MHz) and larger tumor size (≥2.5 cm) are amongst variables that may be associated with improved outcomes for MWA. Sensitivity analyses were generally congruent with the main results. CONCLUSION: MWA is at least as safe and effective as RFA for treating liver cancer and demonstrated significantly reduced LTP rates. Future studies should assess time and costs associated with these two treatment modalities.

Microwave ablation compared with hepatic resection for the treatment of hepatocellular carcinoma and liver metastases: a systematic review and meta-analysis.

BACKGROUND: Hepatic resection (HR) is the gold standard liver cancer treatment, but few patients are eligible due to comorbidities or tumor location. Microwave ablation (MWA) is an important complementary liver cancer treatment to HR. This systematic review compared MWA with HR for liver cancer treatment. METHODS: A systematic search of MEDLINE, EMBASE, and CENTRAL was conducted for randomized and observational studies published from 2006 onwards. The primary outcome was local tumor recurrence (LTR), and a random effects model was used for meta-analyses. RESULTS: Of the 1845 studies identified, 1 randomized and 15 observational studies met the inclusion criteria. LTR was significantly increased with MWA versus HR (risk ratio (RR) = 2.49; P = 0.016). In secondary measures, HR provided significantly higher 3- and 5-year overall survival (RR = 0.94; P = 0.03 and RR = 0.88; P = 0.01, respectively) and 3-year disease-free survival (RR = 0.78; P = 0.009). MWA exhibited significantly shorter length of stay (weighted mean difference (WMD) = - 6.16 days; P < 0.001) and operative time (WMD = - 58.69 min; P < 0.001), less intraoperative blood loss (WMD = - 189.09 mL; P = 0.006), and fewer complications than HR (RR = 0.31; P < 0.001). When MWA was combined with HR and compared with either modality alone, complications and blood loss were significantly lower with the combination treatment; however, there were no differences in other outcomes. Subgroup and sensitivity analyses were generally aligned with the main results. CONCLUSIONS: MWA can be an effective and safe alternative to HR in patients/tumors that are not amenable to resection. More randomized and economic studies should be performed that compare the two treatments, especially to determine the target population that benefits most from MWA.

Procedure costs associated with the use of Harmonic devices compared to conventional techniques in various surgeries: a systematic review and meta-analysis.

BACKGROUND: As compared to conventional techniques, recent meta-analyses have reported cost savings with Harmonic devices; however, only in thyroidectomy. Thus, the aim of this study was to evaluate the costs associated with Harmonic devices versus conventional techniques across a range of surgical procedures. METHODS: A systematic search of MEDLINE, EMBASE, and Cochrane Library was conducted from inception to October 01, 2016 without language restrictions to identify randomized controlled trials comparing Harmonic devices to conventional techniques and reporting procedure costs (operating time plus operating equipment/consumables/device costs). Costs were pooled using the ratio of geometric means, and a random effects model was applied. Sensitivity analyses varying statistical methods, number of included studies, and cost outcomes were completed to test the robustness of the results. RESULTS: Thirteen studies met the inclusion criteria. A total of 561 and 540 participants had procedures performed with Harmonic devices and conventional methods, respectively, with procedures including gastrectomy, thyroidectomy, colectomy, cholecystectomy, Nissen fundoplication, and pancreaticoduodenectomy. As compared to conventional methods, Harmonic devices reduced total procedure costs by 8.7% (p=0.029), resulting in an absolute reduction of US$227.77 from mean conventional technique costs, derived primarily from a reduction in operating time costs. When operating time costs, excluding operating equipment/consumables/device costs, were analyzed, costs were reduced by $544 per procedure with the use of Harmonic devices. The results from all sensitivity analyses demonstrated cost reductions with Harmonic devices. CONCLUSION: This systematic review and meta-analysis showed that despite a higher device cost, Harmonic devices provide a statistically significant reduction in procedure costs, derived primarily from a reduction in operating time costs, across surgical procedures. In addition to functionality benefits, Harmonic devices may represent a potentially cost saving method to reduce overall hospital resource use. Future research should focus on potential costs and benefits from use of Harmonic devices in procedures not covered here.

Performance of Harmonic devices in surgical oncology: an umbrella review of the evidence.

BACKGROUND: We performed an umbrella review of systematic reviews summarizing the evidence on the Harmonic scalpel (HS) compared with conventional techniques in surgical oncology (including lymph node dissection). METHODS: We searched MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews from inception to end of March of 2017 for meta-analyses or systematic reviews of randomized trials comparing HS to conventional techniques in surgical oncology. We assessed the quality of included systematic reviews with AMSTAR (A MeaSurement Tool to Assess systematic Reviews) and assessed the certainty in evidence for each pooled outcome using GRADE (Grading of Recommendations Assessment, Development, and Evaluation). RESULTS: We identified ten systematic reviews on breast cancer (n = 3), gastric cancers (n = 3), oral, head, and neck cancers (n = 1), and colon cancers (n = 3). Most reviews received a higher rating using AMSTAR. For operative time, systematic reviews reported a reduction of 25 to 29 min for HS compared with conventional methods across oncology types, with the exception of breast cancer where little differences were observed (very low to moderate quality of evidence (GRADE)). For blood loss and drainage volume, the majority of reviews reported statistically significant reductions with HS, and reductions ranged from 42 to 141 mL, and from 42 to 292 mL, respectively (very low to moderate quality of evidence). Hospitalization days were reported to decrease with use of HS by 0.2 to 3.2 days; however, reductions were only statistically significant for half of the included reviews (low to moderate quality of evidence). Regarding perioperative complications, two of six reviews reported a significantly reduced risk with HS use (breast cancer surgery) (moderate to high quality evidence)). CONCLUSION: Across surgical oncology types, the majority of included systematic reviews showed a statistically significant or numerical improvement in surgical outcomes with use of the HS compared with conventional methods. Well-designed randomized studies with large sample sizes will help to provide more precise estimates and reduce the risk of heterogeneity.

Innovation Best Practices in the Medical Device Industry.

Advances in patient care often germinate from keen clinical insights and a needs-based approach to innovation. Although there is an important role for incremental improvements to existing solutions, transformational innovation is what truly drives real shifts in clinical outcomes and subsequently patient satisfaction, market access, and economic value. A good example of this is the evolution of the coronary stent market. The best innovation programs are focused on unmet needs rather than solutions, call for a careful articulation of the specific problems to be solved, involve a deep dive within a clinical area, and seek to prioritize research and development investments into areas where the greatest impact can be expected. To enhance its ability to pursue breakthrough innovation, Johnson and Johnson (J&J) has organized itself along priority disease areas, created the global J&J Innovation organization to pursue external technology and know-how, and continues to partner closely with clinical practitioners. The process undertaken at J&J to acquire a microwave ablation technology and enter the interventional oncology space is a recent case study of these innovation principles and organizational focus in action.

Evaluating the importance of social motor synchronization and motor skill for understanding autism.

Impairments in social interaction and communicating with others are core features of autism spectrum disorder (ASD), but the specific processes underlying such social competence impairments are not well understood. An important key for increasing our understanding of ASD-specific social deficits may lie with the social motor synchronization that takes place when we implicitly coordinate our bodies with others. Here, we tested whether dynamical measures of synchronization differentiate children with ASD from controls and further explored the relationships between synchronization ability and motor control problems. We found (a) that children with ASD exhibited different and less stable patterns of social synchronization ability than controls; (b) children with ASD performed motor movements that were slower and more variable in both spacing and timing; and (c) some social synchronization that involved motor timing was related to motor ability but less rhythmic synchronization was not. These findings raise the possibility that objective dynamical measures of synchronization ability and motor skill could provide new insights into understanding the social deficits in ASD that could ultimately aid clinical diagnosis and prognosis. Autism Res 2017, 10: 1687-1699. © 2017 International Society for Autism Research, Wiley Periodicals, Inc.

Social Motor Synchronization: Insights for Understanding Social Behavior in Autism.

Impairments in social interaction and communication are critical features of ASD but the underlying processes are poorly understood. An under-explored area is the social motor synchronization that happens when we coordinate our bodies with others. Here, we explored the relationships between dynamical measures of social motor synchronization and assessments of ASD traits. We found (a) spontaneous social motor synchronization was associated with responding to joint attention, cooperation, and theory of mind while intentional social motor synchronization was associated with initiating joint attention and theory of mind; and (b) social motor synchronization was associated with ASD severity but not fully explained by motor problems. Findings suggest that objective measures of social motor synchronization may provide insights into understanding ASD traits.

Ascertaining educational outcomes after assessment in children with learning disorders.

OBJECTIVE: To survey educational outcomes after an interdisciplinary, neuropsychologically based team assessment for learning disorders. METHOD: Parents of 137 children who underwent a comprehensive interdisciplinary neuropsychologically based assessment for learning problems completed an online survey one to four years later. Questions pertained broadly to school outcomes: positive or negative school responses, changes in special education services, and parental perceptions about the helpfulness of those services. These outcomes were examined in relation to demographic characteristics and parent satisfaction with the evaluation. We also obtained recent performance on state-based academic testing for descriptive purposes. RESULTS: Parents reported that schools generally responded positively (78%), and 70% reported that their children had access to more or different special education services after the evaluation. Parents nearly uniformly (98%) viewed these services as helpful. Positive changes in education services were related to income (lower income received more services, p < .05) and parent satisfaction with the evaluation (p < .05). The intensity of special education services was strongly related to performance on state-based testing (p < .0001-p < .01). CONCLUSIONS: School response is a relatively objective and meaningful metric of educational outcome after neuropsychologically based evaluation for children with learning problems.

Can low-cost motion-tracking systems substitute a Polhemus system when researching social motor coordination in children?

Functionally stable and robust interpersonal motor coordination has been found to play an integral role in the effectiveness of social interactions. However, the motion-tracking equipment required to record and objectively measure the dynamic limb and body movements during social interaction has been very costly, cumbersome, and impractical within a non-clinical or non-laboratory setting. Here we examined whether three low-cost motion-tracking options (Microsoft Kinect skeletal tracking of either one limb or whole body and a video-based pixel change method) can be employed to investigate social motor coordination. Of particular interest was the degree to which these low-cost methods of motion tracking could be used to capture and index the coordination dynamics that occurred between a child and an experimenter for three simple social motor coordination tasks in comparison to a more expensive, laboratory-grade motion-tracking system (i.e., a Polhemus Latus system). Overall, the results demonstrated that these low-cost systems cannot substitute the Polhemus system in some tasks. However, the lower-cost Microsoft Kinect skeletal tracking and video pixel change methods were successfully able to index differences in social motor coordination in tasks that involved larger-scale, naturalistic whole body movements, which can be cumbersome and expensive to record with a Polhemus. However, we found the Kinect to be particularly vulnerable to occlusion and the pixel change method to movements that cross the video frame midline. Therefore, particular care needs to be taken in choosing the motion-tracking system that is best suited for the particular research.

Hospital costs associated with thyroidectomy performed with a Harmonic device compared to conventional techniques: a systematic review and meta-analysis.

OBJECTIVES: Harmonic devices have become a world-wide standard for dissection and hemostasis in thyroidectomy. Numerous systematic reviews have reported superior operating times, blood loss, post-operative pain, length of stay, and overall safety outcomes. What has not been extensively evaluated in a robust manner is their economic impact. The purpose of this study is to evaluate the hospital costs associated with open thyroidectomy using Harmonic devices compared with conventional techniques for hemostasis. METHODS: A systematic review of Medline, Scopus, and CENTRAL was performed from January 1, 2000 to May 23, 2014 without language restrictions for randomized clinical trials comparing Harmonic surgical devices to conventional methods in thyroidectomy. The main outcome measure was total reported costs. Costs were pooled using the ratio of means and a random effects model. Sensitivity analyses assessed whether differences in patient and trial characteristics, healthcare setting, or choice of statistical model affected outcomes. RESULTS: Seven studies met the inclusion criteria. A total of 476 participants had procedures performed with Harmonic devices and 478 with conventional monopolar electrosurgery and clamp, cut and tie techniques. Compared with conventional techniques, Harmonic devices reduced total reported costs by 10% (p = 0.007), resulting in a $229 US dollars (USD) absolute reduction from mean baseline costs. Results remained relatively robust to additional sensitivity analyses. CONCLUSIONS: This systematic review and meta-analysis demonstrates that the Harmonic family of surgical devices is associated with a reduction in total reported costs in thyroidectomy compared with conventional techniques. A large portion of the overall savings derives from a reduction in operative costs.

Differentiating Aging Among Adults With Down Syndrome and Comorbid Dementia or Psychopathology.

Differences were examined between three groups of adults with Down syndrome in their behavioral presentation, social life/activities, health, and support needs. We compared those with comorbid dementia, with comorbid psychopathology, and with no comorbid conditions. Adults with comorbid dementia were more likely to be older, have lower functional abilities, have worse health and more health conditions, and need more support in self-care. Adults with comorbid psychopathology were more likely to exhibit more behavior problems and to be living at home with their families. Adults with no comorbidities were most likely to be involved in community employment. Differences in behavioral presentation can help facilitate clinical diagnoses in aging in Down syndrome, and implications for differential diagnosis and service supports are discussed.

A systematic review and meta-analysis of Harmonic Focus in thyroidectomy compared to conventional techniques.

INTRODUCTION: Several meta-analyses have been performed comparing the use of a variety of ultrasonic devices in thyroidectomy to conventional procedures. These studies have shown the superiority of ultrasonic devices for most outcomes studied including faster operative time and less blood loss, and equivalent or better safety for recurrent laryngeal nerve paresis and hypocalcemia. The current work is the first to examine a single ultrasonic device specifically designed for thyroid surgery, the Harmonic Focus, in order to confirm its efficacy and safety in thyroidectomy. METHODS: A comprehensive literature search without language restrictions was performed for randomized clinical trials comparing Harmonic Focus and conventional clamp, cut and tie in thyroidectomy. Outcome measures included operating time, blood loss, post-operative pain, length of hospital stay, hypocalcemia and recurrent laryngeal nerve paresis. Risk of bias was analyzed for all studies. Meta-analysis was performed using random effects models with the inverse-variance method for mean differences of continuous variables and the Mantel-Haenszel method for risk ratios of dichotomous variables. RESULTS: A total of 14 studies met the inclusion criteria. Harmonic Focus reduced operative time by 29 min, a 31 % decrease (p < 0.001), intra-operative blood loss by 45 ml (p < 0.001), post-operative pain (p < 0.001), length of hospital stay by 0.68 days (p = 0.005), drainage volume by 29 ml (p = 0.01), and occurrence of transient hypocalcemia by 40 % (p = 0.001). There were no significant differences between Harmonic Focus and conventional procedures in rate of persistent hypocalcemia, or rates of transient and persistent recurrent laryngeal nerve paresis. CONCLUSION: This is the first meta-analysis of Harmonic Focus in thyroid surgery. In agreement with meta-analyses previously performed on ultrasonic devices, use of the Harmonic Focus has been shown to be a more effective surgical procedure compared to conventional methods in thyroidectomy. The low occurrence of hypocalcemia and recurrent laryngeal nerve paresis confirms that Harmonic Focus can improve thyroidectomy efficiency without increasing the risk of complications.

Sealing vessels up to 7 mm in diameter solely with ultrasonic technology.

INTRODUCTION: Ultrasonic energy is a mainstay in the armamentarium of surgeons, providing multifunctionality, precision, and control when dissecting and sealing vessels up to 5 mm in diameter. Historically, the inability to seal vessels in the 5-7 mm range has been perceived as an inherent limitation of ultrasonic technology. The purpose of this study was to evaluate sealing of vessels up to 7 mm in diameter with an ultrasonic device that modulates energy delivery during the sealing period. METHODS: In ex vivo benchtop and in vivo acute and survival preclinical models, a new ultrasonic device, Harmonic ACE(®)+7 Shears (Harmonic 7), was compared with advanced bipolar devices in sealing vessels 1-7 mm in diameter with respect of burst pressure, seal reliability, and seal durability. Lateral thermal damage and transection time were also evaluated. RESULTS: Ex vivo tests of Harmonic 7 demonstrated significantly greater median burst pressures than an advanced bipolar device both for vessels <5 mm in diameter (1,078 mmHg and 836 mmHg, respectively, P=0.046) and for those in the range of 5-7 mm (1,419 mmHg and 591 mmHg, P<0.001). In vivo tests in porcine and caprine models demonstrated similar rates of hemostasis between Harmonic 7 and advanced bipolar devices, with high success rates at initial transection and seal durability of 100% after a 30-day survival period. CONCLUSION: Sealing 5-7 mm vessels is not a limitation of the type of energy used but of how energy is delivered to tissue. These studies document the ability of ultrasonic energy alone to reliably seal large vessels 5-7 mm in diameter, with significantly greater burst pressure observed in in vitro studies than those observed with an advanced bipolar technology when energy delivery is modulated during the sealing cycle. Furthermore, the seals created in 5-7 mm vessels are shown to be reliable and durable in in vivo preclinical studies.

Perpendicular blood vessel seals are stronger than those made at an angle.

Vessel sealing devices effectively produce hemostatic seals with minimal thermal damage, but the strength of seals decreases as vessel diameter increases. Because vessels sealed at an angle to the vessel require a greater functional seal diameter than those sealed perpendicularly to the vessel, it was hypothesized that perpendicular seals would have comparably higher burst pressures. Ex vivo, porcine carotid arteries of nominal diameters of 5, 6, and 7 mm were sealed perpendicularly to and at a 45° angle to the longitudinal axis of the vessels, and burst pressures of the sealed vessels were measured. Overall burst pressures were 51% greater for perpendicular seals than for angled seals (P<.001). Mean burst pressures for the 5-mm angled and 7-mm perpendicular groups, which have similar seal lengths, were not significantly different (P=.959). Analysis using the functional diameter as a covariate indicated that the seal length is the primary variable in determining burst pressure, and not some other inherent characteristic of angled versus perpendicular sealing. These results suggest that at least for vessels ≥5 mm in diameter, surgeons should approach vessels perpendicularly and not at an angle, for the highest possible seal strength. The development of articulated sealing and cutting devices would provide greater seal strength, in addition to improved maneuverability, especially in laparoscopic surgery, where angles of approach may be limited by the fixed location of surface cannulas.

Effects of an integrated clinical information system on medication safety in a multi-hospital setting.

PURPOSE: The implementation of vendor-based integrated clinical information technology was studied, and its effect on medication errors throughout the medication-use process in a health care system was evaluated. METHODS: The integrated systems selected for implementation included computerized physician order entry, pharmacy and laboratory information systems, clinical decision-support systems (CDSSs), electronic drug dispensing systems (EDDSs), and a bar-code point-of-care medication administration system. The primary endpoint was the reduction in related medication errors. Secondary endpoints included the reductions in medication order turnaround time and EDDS override transactions. RESULTS: Integrated clinical information system technology was implemented in a multihospital health care system with a phased-in approach. A positive effect of this integration on medication errors throughout the medication-use process was demonstrated. Most prescribing errors decreased significantly in the selected categories monitored, specifically drug allergy detection, excessive dosing, and incomplete or unclear orders. Pharmacists were also twice as likely to identify dosages requiring adjustment for renal insufficiency when the integrated technology was in place and more than six times as likely for drug levels outside of the therapeutic range. A positive effect on medication administration safety was also demonstrated: 73 administration-related errors were intercepted through electronic bar-code scanning for every 100,000 doses charted. CONCLUSION: Integration of clinical information system technology decreased selected types of medication errors throughout the medication-use process in a health care system and improved therapeutic drug monitoring in patients with renal insufficiency and in patients receiving drugs with narrow therapeutic ranges through the use of CDSS alerts.