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Rhodri Saunders,1 Jason A Davis,1 Peter Kranke,2 Rachel Weissbrod,3 David K Whitaker,4 Jenifer R Lightdale5 1Coreva Scientific GmbH & Co KG, Freiburg, Germany; 2Department of Anaesthesia and Critical Care, University of Würzburg, Würzburg, Germany; 3Medical Affairs, Medtronic, Jerusalem, Israel; 4Department of Anaesthesia, Manchester Royal Infirmary, Manchester, UK; 5Pediatric Gastroenterology, Hepatology and Nutrition, University of Massachusetts, Worcester, MA, USA Background: Studies have reported on the incidence of sedation-related adverse events (AEs), but little is known about their impact on health care costs and resource use.Methods: Health care providers and payers in five countries were recruited for an online survey by independent administrators to ensure that investigators and respondents were blinded to each other. Surveys were conducted in the local language and began with a “screener” to ensure that respondents had relevant expertise and experience. Responses were analyzed using Excel and R, with the Dixon’s Q statistic used to identify and remove outliers. Global and country-specific average treatment patterns were calculated via bootstrapping; costs were mean values. The sum product of costs and intervention probability gave a cost per AE.Results: Responses were received from 101 providers and 26 payers, the majority having >5 years of experience. At a minimum, the respondents performed a total of 3,430 procedural sedations per month. All AEs detailed occurred in clinical practice in the last year and were reported to cause procedural delays and cancellations in some patients. Standard procedural sedation costs ranged from €74 (Germany) to $2,300 (US). Respondents estimated that AEs would increase costs by between 16% (Italy) and 179% (US). Hypotension was reported as the most commonly observed AE with an associated global mean cost (interquartile range) of $43 ($27–$68). Other frequent AEs, including mild hypotension, bradycardia, tachycardia, mild oxygen desaturation, hypertension, and brief apnea, were estimated to increase health care spending on procedural sedation by $2.2 billion annually in the US.Conclusion: All sedation-related AEs can increase health care costs and result in substantial delays or cancellations of subsequent procedures. The prevention of even minor AEs during procedural sedation may be crucial to ensuring its value as a health care service. Keywords: costs, complications, moderate sedation, questionnaire, survey, health care payers

Objective evaluations comparing different techniques and approaches to pediatric procedural sedation studies have been limited by a lack of consistency among the outcome measures used in assessment. This study reviewed those existing measures, which have undergone psychometric analysis in a pediatric procedural sedation setting, to determine to what extent and in what circumstances their use is justified across the spectrum of procedures, age groups, and techniques. The results of our study suggest that a wide range of measures has been used to assess the efficacy and effectiveness of pediatric procedural sedation. Most lack the evidence of validity and reliability that is necessary to facilitate rigorous clinical trial design, as well as the evaluation of new drugs and devices. A set of core pediatric sedation outcome domains and outcome measures can be developed on the basis of our findings. We believe that consensus among all stakeholders regarding appropriate domains and measures to evaluate pediatric procedural sedation is possible and that widespread implementation of such recommendations should be pursued.

Triple immunosuppressive therapy using mycophenolate mofetil (MMF), microemulsion cyclosporine (me-CsA), and prednisone offers the potential for potent immunosuppression without intravenous drug therapy or anti-T-cell antibody induction therapy. This report describes the application of an immunosuppressive protocol (CNp) using MMF, me-CsA, and prednisone as primary immunosuppression for pediatric liver transplant recipients at the University of California at San Francisco. From August 1995 through December 1996, 26 children (17 boys, 9 girls) aged 1 month to 16 years (mean +/- standard deviation, 58 +/- 62 months; median, 31 months) underwent liver transplantation at our institution, receiving CNp as primary immunosuppression. Posttransplantation renal function, incidence of leukopenia, and drug tolerance within the group receiving CNp as primary immunosuppression were compared with those of 19 children who received primary immunosuppression consisting of azathioprine, oil-based gel-encapsulated cyclosporine, and prednisone with anti-T-cell antibody induction therapy at the same institution from October 1993 through July 1995. No significant difference was observed between immunosuppressive protocols in serum creatinine level or incidence of leukopenia requiring medical therapy during the first year posttransplantation. Whereas gastrointestinal symptoms were observed in approximately 30% of CNp recipients during initial immunotherapy, tolerance of CNp primary immunotherapy was routinely achieved by the dose reduction of MMF. At 1 year posttransplantation, 20 children (77%) remained on CNp primary immunotherapy, 5 children (19%) were receiving tacrolimus-based immunotherapy secondary to rejection, and 1 patient (4%) converted to tacrolimus-based immunotherapy secondary to persistent gastrointestinal intolerance. In conclusion, CNp provides an alternative immunosuppressive protocol that eliminates the necessity of intravenous and induction immunosuppressive therapy with no increased incidence of posttransplantation renal dysfunction or leukopenia and is well tolerated in children.

Objective: To examine the role of pediatricians in posttransplantation care of pediatric liver transplant recipients., Design: Written survey of parents and pediatricians of children enrolled in a pediatric liver transplant program., Setting: Questionnaires were mailed from a liver transplant center (LTC), set in a university-affiliated, tertiary-care medical center, to the homes of families and the offices of pediatricians in a variety of urban, suburban, and rural locales worldwide., Study Population: Eighty-four percent of families and 81% of pediatricians who met study criteria participated., Results: Only 8.9% of all pediatricians reported feeling comfortable providing all care for their liver transplant patients, while 82.2% were most comfortable sharing responsibility for care with the LTC. The remaining 8.9% of pediatricians were most comfortable with the LTC providing care. The more comfort pediatricians reported in providing care, the more likely parents were to report contacting pediatricians for medical problems. The more comfort pediatricians reported, the more parents perceived that (1) pediatricians and the LTC work well together (P<.03); (2) the LTC is informed about their child (P<.001); and (3) pediatricians are similarly up-to-date (P<.001). Furthermore, the more comfort pediatricians felt, the more parents believed that the liver transplant improved their child's health (P<.03) and that their child enjoys school (P=.08). Of the pediatricians, 15.6% who reported attending a continuing medical education course were significantly more comfortable (P=.05). The 18.9% of participating pediatricians who reported receiving some training in pediatric gastroenterology were also significantly more comfortable caring for children with liver transplants (P<.05)., Conclusion: Increasing pediatrician comfort levels in providing posttransplantation care for children with liver transplants is critical to the continuing success of pediatric liver transplantation.

Northern Plains Indians (N = 200) completed the Indian Specific Health Risk Appraisal and measures assessing beliefs about risk factors and personal risk. Participants rated personal risk optimistically, judged their risk factor standing as superior to that of their peers, and neglected to consider risk factor standing when appraising personal risk. Moreover, participants were often not improving their standing on risk factors they considered relevant to their health. Such biases in health beliefs may prevent health interventions from being successful.

American Indians, especially those residing in the Northern Plains, experience considerable preventable morbidity and mortality from alcohol-related motor vehicle events. Research focusing on unintentional injuries associated with drinking drivers has disregarded the epidemiology of their passengers, who are equally at risk. The purpose of this investigation was to define the prevalence of motor vehicle passengers riding with drivers who have been drinking on a Northern Plains Reservation. We surveyed a sample of 151 Northern Plains Indians about their experiences riding with drinking drivers. Associated behavioral and demographic risk factors were also examined to identify possible predictor variables. The majority (54%) of respondents reported riding with a driver who had been drinking at least once during the previous three months. Most often, passengers ride with a friend who has been drinking, on a weekend night. Injury risk may be compounded because few respondents reported regular seat-belt use. The results off our study suggest the need for immediate comprehensive prevention efforts focusing on motor vehicle passengers.