Procedural sedation competencies: a review and multidisciplinary international consensus statement on knowledge, skills, training, and credentialing.

Procedural sedation is practised by a heterogeneous group of practitioners working in a wide array of settings. However, there are currently no accepted standards for the competencies a sedation practitioner should have, the content of sedation training programmes, and guidelines for credentialing. The multidisciplinary International Committee for the Advancement of Procedural Sedation sought to develop a consensus statement on the following: which competencies should medical or dental practitioners have for procedural sedation and how are they obtained, assessed, maintained, and privileged. Using the framework of Competency-Based Medical Education, the practice of procedural sedation was defined as a complex professional task requiring demonstrable integration of different competencies. For each question, the results of a literature review were synthetised into preliminary statements. Following an iterative Delphi review method, final consensus was reached. Using multispeciality consensus, we defined procedural sedation competence by identifying a set of core competencies in the domains of knowledge, skills, and attitudes across physical safety, effectiveness, psychological safety, and deliberate practice. In addition, we present a standardised framework for competency-based training and credentialing of procedural sedation practitioners.

Efficacy Outcome Measures for Pediatric Procedural Sedation Clinical Trials: An ACTTION Systematic Review.

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.

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 2 Safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations.

The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, a public-private partnership with the US Food and Drug Administration, convened a second meeting of sedation experts from a variety of clinical specialties and research backgrounds to develop recommendations for procedural sedation research. The previous meeting addressed efficacy and patient- and/or family-centered outcomes. This meeting addressed issues of safety, which was defined as "the avoidance of physical or psychological harm." A literature review identified 133 articles addressing safety measures in procedural sedation clinical trials. After basic reporting of vital signs, the most commonly measured safety parameter was oxygen saturation. Adverse events were inconsistently defined throughout the studies. Only 6 of the 133 studies used a previously validated measure of safety. The meeting identified methodological problems associated with measuring infrequent adverse events. With a consensus discussion, a set of core and supplemental measures were recommended to code for safety in future procedural clinical trials. When adopted, these measures should improve the integration of safety data across studies and facilitate comparisons in systematic reviews and meta-analyses.

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 1 Efficacy: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations.

The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks public-private partnership with the US Food and Drug Administration, convened a meeting of sedation experts from a variety of clinical specialties and research backgrounds with the objective of developing recommendations for procedural sedation research. Four core outcome domains were recommended for consideration in sedation clinical trials: (1) safety, (2) efficacy, (3) patient-centered and/or family-centered outcomes, and (4) efficiency. This meeting identified core outcome measures within the efficacy and patient-centered and/or family-centered domains. Safety will be addressed in a subsequent meeting, and efficiency will not be addressed at this time. These measures encompass depth and levels of sedation, proceduralist and patient satisfaction, patient recall, and degree of pain experienced. Consistent use of the recommended outcome measures will facilitate the comprehensive reporting across sedation trials, along with meaningful comparisons among studies and interventions in systematic reviews and meta-analyses.

Update on pharmacological management of procedural sedation for children.

PURPOSE OF REVIEW: The review provides an update on pharmacological techniques for procedural sedation for children outside the operating room. RECENT FINDINGS: An increasing number of studies of propofol, ketamine, nitrous oxide, dexmedetomidine, and intranasal administration of drugs for procedural sedation of children continue to be reported. SUMMARY: Propofol and ketamine are commonly used for procedural sedation in children and the use of dexmedetomidine and nitrous oxide is increasing. Although the intravenous route remains the mainstay; intranasal drug administration is increasingly used for anxiolysis and moderate sedation.

Evaluation of an Extended-Release, Abuse-Deterrent, Microsphere-in-Capsule Analgesic for the Management of Patients with Chronic Pain With Dysphagia (CPD).

BACKGROUND: Patients who have chronic pain with dysphagia (difficulty swallowing) (CPD) often have difficulty taking oral medication and, as such, alter their medications by crushing or chewing in an attempt to make it easier to swallow. Such manipulation of currently marketed, extended-release (ER) opioid analgesics can significantly alter the pharmacokinetic (PK) properties of the formulations, resulting in poor treatment outcome or serious adverse events. There is an unmet medical need for oral ER opioid formulations suitable for patients with CPD. OBJECTIVE: The primary objectives of this study were to conduct in vitro studies to evaluate alternate means of administration of a new, extended-release (ER), abuse-deterrent, microsphere-in-capsule formulation of oxycodone for patients with CPD. Specifically, these studies investigated the in vitro equivalence of drug release rates from Oxycodone DETERx® ER intact capsules (control condition) and administration via alternate modes-opening the capsule and sprinkling the microspheres onto soft foods or administration through enteral tubes. Secondary objectives were to compare alternate modes of administration of Oxycodone DETERx® to a commercially available ER-morphine product. METHODS: Soft food study: Oxycodone DETERx® microspheres were sprinkled onto and mixed with several soft foods (ie, applesauce, vanilla pudding, strawberry jam, yogurt, and vanilla ice cream); the effect of drug contact time (0, 30, and 60 minutes) on drug release was studied. Enteral tube study: Oxycodone DETERx® microspheres were administered through varying sizes of nasogastric (10 and 12 Fr.) tubes and a 16 Fr. gastrostomy tube using 5 different delivery vehicles (ie, water, liquid nutritional feeds [Jevity®, Ensure®], and milk [whole milk and 2% milk]). Drug release rate was characterized using a standard in vitro dissolution methodology; dissolution of intact Oxycodone DETERx® capsules served as the control for both the soft food and enteral tube studies. Oxycodone concentration was measured using a standardized high-performance liquid chromatography (HPLC) assay. Similarity factor (f2) analysis was used to compare similarity of the dissolution profiles of test and control conditions. RESULTS: The mean dissolution profile of Oxycodone DETERx® microspheres sprinkled onto and mixed with each of the soft foods were similar (f2 > 50) to that of the control. Study drug-food contact time did not impact dissolution profiles. The dissolution data obtained from Oxycodone DETERx® microspheres passed through enteral feeding tubes of varying sizes were similar (f2 > 50) to that of the control. Unlike a marketed morphine sulfate ER pellet formulation, Oxycodone DETERx® did not clog any of the studied enteral tubes. CONCLUSION: A new ER, abuse-deterrent, microsphere-in-capsule formulation of oxycodone can be administered by sprinkling onto soft food without affecting the drug release profile of the formulation. The formulation can also be administered directly via enteral tubes without affecting drug release and without clogging enteral tubes. Oxycodone DETERx® may offer physicians and patients with CPD an alternate treatment option, especially in those patients who have dysphagia or an aversion to swallowing monolithic tablet/capsule formulations and for whom analgesic patches or other opioid formulations are not a viable therapeutic option.

Procedural sedation for diagnostic imaging in children by pediatric hospitalists using propofol: analysis of the nature, frequency, and predictors of adverse events and interventions.

OBJECTIVE: To evaluate the nature, frequency, and predictors of adverse events during the use of propofol by pediatric hospitalists. STUDY DESIGN: We reviewed 1649 charts of patients sedated with propofol by pediatric hospitalists at St Louis Children's Hospital between January 2005 and September 2009. RESULTS: Hospitalists were able to complete 1633 of the 1649 sedations reviewed (99%). Major complications included 2 patients with aspiration and 1 patient intubated to complete the study. We observed a 74% reduction in the number of patients with respiratory events and airway interventions from 2005 to 2009. Predictors of respiratory events were history of snoring (OR, 2.40; 95% CI, 1.52-3.80), American Society of Anesthesiologists (ASA) physical status classification of ASA 3 (OR, 2.30; 95% CI, 1.22-4.33), age >12 years (OR, 4.01; 95% CI, 2.02-7.98), premedication with midazolam (OR, 1.85; 95% CI, 1.15-2.98), and use of adjuvant glycopyrrolate (OR, 4.70; 95% CI, 2.35-9.40). All except ASA 3 status were also predictors for airway intervention. There was a decline in the prevalence of all of these predictors over the study years (P < .05) except for use of glycopyrrolate. CONCLUSION: Our pediatric hospitalists implemented a successful propofol sedation program that realized a 74% reduction in respiratory events and airway interventions between 2005 and 2009. Decreased prevalence of the predictors of adverse events that we identified likely contributed to this reduction.

Hurricane Preparedness and Response Along Florida's Central-East Coast: Indian River Mosquito Control District's Experiences Over the Years.

The hurricane is no stranger to longtime residents of Florida's east coast. In 1979, after about 15 years of local inactivity, Hurricane David made landfall in West Palm Beach. Thirteen years later and 100 miles south, category 5 Hurricane Andrew caused catastrophic damage when it hit the city of Homestead in the Miami-Dade area. In 2004, the counties along the east coast of central Florida were hit by 2 devastating hurricanes, Frances and Jeanne, that made landfall at Sewall's Point just 20 days apart. The very next year, Hurricane Wilma made landfall near Everglades City as a Category 3 storm. After a decade of relief, a glancing blow from Hurricane Matthew struck in 2016, only to be followed by the extremely devastating Hurricane Irma just 1 year later. Each of these hurricanes caused significant property damage and mosquito problems for the Florida residents affected by these storms. In 1997, the Indian River Mosquito Control District (IRMCD) developed a hurricane preparedness plan outlining the appropriate action to be taken depending on the severity of the approaching storm. The IRMCD has also learned to negotiate the intricacies of the Federal Emergency Management Agency's reimbursement program, thus reducing the financial impact to the District. This paper provides an overview of how IRMCD has prepared, reacted, and followed-up with the seemingly constant parade of hurricanes that have threatened and affected the east coast over time.

Developing Content for Pediatric Hospital Medicine Certification Examination Using Practice Analysis.

OBJECTIVES: The American Board of Pediatrics (ABP) and the Pediatric Hospital Medicine (PHM) subboard developed a content outline to serve as a blueprint for the inaugural certification examination through practice analysis. The systematic approach of practice analyses process is described in the study. METHODS: A diverse, representative panel of 12 pediatric hospitalists developed the draft content outline using multiple resources (publications, textbooks, PHM Core Competencies, PHM fellow's curriculum, etc). The panel categorized practice knowledge into 13 domains and 202 subdomains. By using the ABP database self-defined practicing pediatric hospitalists were identified. Participants rated the frequency and criticality of content domains and subdomains along with providing open-ended comments. RESULTS: In total, 1449 (12.1%) generalists in the ABP database self-identified as pediatric hospitalists, and 800 full-time pediatric hospitalists responded. The content domains that were rated as highly critical and frequently required in practice were weighted more heavily (ie, the percentage of examination questions associated with a domain) than the less critical and less frequently rated. Both community and noncommunity pediatric hospitalists rated domains similarly (P = .943). Subdomain and preliminary weights were rated with similar means and SDs in the majority of topics. CONCLUSIONS: There was concordance in the rating of domain and universal tasks among both community and noncommunity hospitalists. The areas of significant differences, although minor, could be explained by difference in practice settings. The practice analysis approach was structured, engaged the PHM community, reflected the breadth and depth of knowledge required for PHM practice, and used an iterative process to refine the final product.

Mosquito Control and Coastal Development: How they Have Coexisted and Matured in Florida and Australia.

The aims of this review were to compare planning for both mosquito control and land use in east-central Florida, USA, and in New South Wales, Queensland, and the Northern Territory, Australia. Saltwater mosquito production in mangroves and salt marsh is the predominant mosquito control concern in all the areas. Urban encroachment towards saltwater mosquito habitats is a problem in both Florida and Australia. In east-central Florida and the Northern Territory, mosquito control is supported by comprehensive source reduction programs, whereas in Queensland and New South Wales, larviciding is the main method of control. The long-term control by source reduction programs reduces vulnerability to mosquito issues as population encroaches towards wetlands, whereas larviciding programs have to respond repeatedly as problems arise. Problems from urban encroachment are exacerbated if mosquito control and land-use planning are not integrated. Further, urban planning that is not informed by mosquito management can lead to increased mosquito problems by inadvertent design or allowing residential development close to mosquito habitats. This increases the need for mosquito control and related resourcing. At the regional level of governance, Florida and the Northern Territory generally have greater integration between planning for development and mosquito control than at the local government level in New South Wales and Queensland, where there is a lack of integration between mosquito agencies and planners. It is concluded that coordination of planning and mosquito control is more effective at higher government levels than at local levels, which have less connectivity between management areas and/or insufficient resources. The lesson is that collaboration can assist in avoiding or resolving conflicts.

Four degrees of latitude: mosquito control on the "right" coasts of Australia and Florida, USA.

This study compares mosquito control within similar environments between 26 and 30 degrees of latitude on the east central coasts of Florida and of Australia. It describes and compares the relevant mosquito-producing environments, the development of mosquito control, legislative framework, funding arrangements, and organizational differences between the areas, including the international interactions that have facilitated good practices. The article identifies some strengths and weaknesses of the programs in each area. Significant strengths include some aspects of funding and administration; collaborations with other organizations; the roles of national and state organizations, including research agencies; and commitment of individuals. Potential weaknesses in programs that are part of larger organizations include their relatively low position in the organizational hierarchy and the need to compete for resources. Programs that are independent districts may lack opportunity to interact with other land management units. Other weaknesses include the relatively high turnover of staff in state environmental resource agencies and the potential loss of institutional memory when long-term mosquito control staff members leave. The case comparison highlights similarities in product use at the individual program level (Indian River Mosquito Control District and Gold Coast Pest Management Unit) and differences in practices including aerial adulticiding being used in Florida but not in Australia.

Storm-damaged saline-contaminated boreholes as a means of aquifer contamination.

Saline water from a storm surge can flow down storm-damaged submerged water supply wells and contaminate boreholes and surrounding aquifers. Using data from conventional purging techniques, aquifer test response analysis, chemical analysis, and regression analysis of chloride/silica (Cl/Si) ratio, equations were derived to estimate the volume of saline water intrusion into a well and a porous media aquifer, the volume of water needed to purge a well shortly following an intrusion event, and the volume of water needed after delay of several or more months, when the saline plume has expanded. Purging time required is a function of volume of water and pumping rate. The study site well is located within a shoreline community of Lake Pontchartrain, St. Tammany Parish, in southeastern Louisiana, United States, which was impacted by two hurricane storm surges and had neither been rehabilitated nor chlorinated prior to our study. Chemical analysis of water samples in fall 2005 and purging of well and aquifer in June 6, 2006, indicated saline water had intruded the well in 2005 and the well and aquifer in 2006. The volume of water needed to purge the study well was approximately 200 casing volumes, which is significantly greater than conventionally used during collection of water samples for water quality analyses.

Source reduction in Florida's salt marshes: management to reduce pesticide use and enhance the resource.

Source reduction as part of an integrated pest management program is a cornerstone of the American Mosquito Control Association's Pesticide Environmental Stewardship Program Strategy Document to reduce pesticide risk. Since the early 1980s, Florida has made important strides in implementing environmentally sound source reduction strategies in salt marshes while managing them for both mosquito control and natural resource enhancement. The political mechanism for this progress has been interagency cooperation through the Florida Coordinating Council on Mosquito Control and its Subcommittee on Managed Marshes. Challenges in accomplishing source reduction continue because both public and private lands are involved. Public lands include those owned by federal (e.g., U.S. Fish and Wildlife Service, National Park Service), state (Florida Department of Environmental Protection), and local governments, and they have a diversity of management objectives. This diversity adds to the challenge facing mosquito control agencies in providing mosquito control services while protecting and enhancing the environment.

Graduate Medical Education Specialty Mix and Geographic Residency Program Maldistribution: Is There a Role for the ACGME?

As we've stated, GME is the final common pathway toward clinical medical practice in the US. It makes sense, then, that national physician workforce policy aimed at meeting future public health demands should be directed at this phase of medical education. It would also make sense that ACGME, as the single accreditor of all residency programs in the US, should be engaged in physician workforce policymaking on behalf of the public. We identified three issues that must be addressed in order for the ACGME to assume this role: First, there must be a national agreed-upon and long-term plan for the design and implementation of the health care delivery system. Second, there must be a nationally coordinated strategy for identifying long-term physician workforce needs and funding mechanisms to physician and other health care professional developments. Third, in order to execute these roles, the ACGME must receive support from the profession and national and state-level statutory protection from enforcement of state and federal antitrust law.

The use of high-dose epinephrine for patients with out-of-hospital cardiopulmonary arrest refractory to prehospital interventions.

OBJECTIVE: To determine if high-dose epinephrine (HDE) used during out-of-hospital cardiopulmonary arrest refractory to prehospital interventions improves return of spontaneous circulation, 24-hour survival, discharge survival, and neurological outcomes. METHODS: A multicenter randomized controlled trial was conducted between May 1991 and October 1996 to compare the effectiveness of HDE versus standard-dose epinephrine (SDE) in patients having out-of-hospital cardiopulmonary arrest refractory to prehospital resuscitation efforts. Cardiopulmonary arrest was classified as "medical" or "traumatic." Two hundred thirty patients were enrolled in 7 pediatric emergency departments. Ages ranged from newborn to 22 years. Seventeen patients met exclusion criteria. Patients were assigned to receive HDE (0.1 mg/kg for the initial dose and 0.2 mg/kg for subsequent doses) or SDE (0.01 mg/kg). The main end points evaluated were return of spontaneous circulation, 24-hour survival, discharge survival, and neurological outcome. RESULTS: One hundred twenty-seven patients received HDE (32 trauma patients), and 86 patients received SDE (27 trauma patients). Among medical patients, 24 (25%) of 95 experienced return of spontaneous circulation in the HDE group as compared with 9 (15%) of 59 in the SDE group (P = 0.14, chi2 = 2.17, relative risk = 1.66 [0.83-3.31]). Sixteen (17%) of 95 HDE patients and 5 (8%) of 59 SDE patients survived at least 24 hours (P = 0.14, chi2 = 2.16, relative risk = 1.99 [0.77-5.14]). Nine survivors to discharge received HDE, and 2 received SDE (P = 0.21, Fisher exact test, relative risk = 2.75 [0.61-12.28]). There were no long-term survivors among the trauma patients. Eight of 11 long-term survivors had severe neurological outcomes defined by the Glasgow Outcome Scale (2/2 SDE, 6/9 HDE; P = 0.51, Fisher exact test). CONCLUSION: HDE does not improve or diminish return of spontaneous circulation, 24-hour survival, long-term survival, or neurological outcome compared with SDE in out-of-hospital cardiopulmonary arrest.

Variation in Procedural Sedation Practices Among Children's Hospitals.

BACKGROUND AND OBJECTIVE: Children often need procedural sedation for painful procedures. There are few data on type of provider, site of sedation, and agents used for procedural sedation in hospitals across the nation. The objective was to determine procedural sedation practices for hospitalized children outside the PICU and emergency department. METHODS: Surveys were sent to 89 pediatric hospitalist (PH) leaders in hospitals belonging to the Child Health Corporation of America or the National Association of Children's Hospitals and Related Institutions. RESULTS: We received responses from 56 PHs (63%), of whom 49 (55%) completed the survey. PHs provided sedation in 18 hospitals. Provider, setting, and agents used for procedural sedation varied. The primary providers of procedural sedation for abscess incision and drainage, renal biopsy, joint aspiration, computed tomography, and MRI were anesthesiologists. A significantly greater percentage of hospitals where PHs did not provide procedural sedation used the operating room for abscess incision and drainage compared with hospitals where PHs provided procedural sedation (63% vs 28%, respectively). Postoperative/abscess dressing change, vesicocystourethrogram, and ≥1 painful procedure were performed without sedation in significantly greater percentage of hospitals where PHs did not provide procedural sedation compared with hospitals where PHs provided procedural sedation. CONCLUSIONS: There is variability in sedation practices in hospitals across the nation, which affects patient care and use of resources such as the operating room. In hospitals where PHs provide procedural sedation, there is less operating room use and fewer painful procedures for which no sedation is provided.

Pediatric hospitalists fill varied roles in the care of newborns.

The use of hospitalists in the care of newborns appears to be increasing and may be advantageous for several reasons, including decreased cost, decreased length of stay, increased patient survival, increased availability, and greater experience among hospitalists. Research specific to the use of hospitalists in newborn medicine needs to be done to support this hypothesis. Non-clinical activities such as teaching, developing clinical guidelines, and taking an active role in hospital and academic leadership also may improve education and patient care. It is essential that hospitalists who provide care in nurseries work to smooth the transition to a PCP and not act as a barrier. Relatively speaking, the care provided by hospitalists is most often short-term, and the relationship between infants and their parents with the PCP should begin as soon as possible.

Pediatric sedation.

Pediatric sedation is an evolving field performed by an extensive list of specialties. Well-defined sedation systems within pediatric facilities are paramount to providing consistent, safe sedation. Pediatric sedation providers should be trained in the principles and practice of sedation, which include patient selection, pre-sedation assessment to determine risks during sedation, selection of optimal sedation medication, monitoring requirements, and post-sedation care. Training, credentialing, and continuing sedation education must be incorporated into sedation systems to verify and monitor the practice of safe sedation. Pediatric hospitalists represent a group of providers with extensive pediatric knowledge and skills who can safely provide pediatric sedation.

Challenges of treating patients with chronic pain with dysphagia (CPD): physician and patient perspectives.

OBJECTIVE: Dysphagia--difficulty eating and swallowing--can significantly impair a patient's ability to maintain adequate nutritional and medication intake. There are a large number of patients with chronic pain, including pediatric, geriatric, and palliative care patients, who suffer from dysphagia and, therefore, have difficulty achieving optimal pain management with solid, oral formulations. The objective of this study was to survey physicians and patients in the US to understand their knowledge, attitudes, and clinical management/analgesic usage patterns in the treatment of patients with chronic pain with dysphagia (CPD). RESEARCH DESIGN AND METHODS: Two separate surveys were administered to physicians and patients. The physician survey design was qualitative; physicians participated in a semi-structured phone interview. The patient survey design was quantitative; patients participated in a structured online survey. Purposive sampling was used to recruit participants into both studies. Physician participants were identified based on their specialty, prescribing practices, and geographic location. Patient participants were recruited through a consumer panel of pre-identified individuals who, for 3 months or longer, had chronic pain and were taking opioids. RESULTS: Thirty-four physicians and 1021 patients were surveyed. Physicians indicated that 5-20% of their patients had difficulty swallowing. Treatment for CPD consisted of the fentanyl patch, immediate-release opioids, methadone liquid, or extended-release morphine products. Physicians were not satisfied with currently available treatment options. Twenty-nine per cent of patients surveyed had trouble swallowing or disliked swallowing pills. Eighty per cent of patients were not asked about their ability to swallow solid, oral dosage forms by their physician. To circumvent swallowing difficulties, some patients (16%) cut/crush/grind their medication to facilitate swallowing. Most of these patients (65%) did not know that altering tablets could potentially change the drug release (pharmacokinetic) characteristics of the tablet and lead to serious adverse events. LIMITATIONS: Qualitative survey research can be influenced by responder bias as well as selection bias. The number of survey participants for both the physician and patient surveys was small, thus responses may not reflect those in the general population. CONCLUSION: A proportion of patients with chronic pain have dysphagia and cannot swallow solid, oral dosage forms, which creates a serious treatment challenge for pain specialists and other healthcare providers. Currently available treatment options have limitations; new treatment options would be welcomed by both physicians and patients. Physician and patient education should be enhanced in order to promote awareness of the deleterious consequences associated with altering currently available analgesic formulations. Facilitating patient-physician communication on this topic may help to improve treatment outcomes.