Non-pharmacological interventions for sleep promotion in hospitalized children.

BACKGROUND: Healthy sleep is an important component of childhood development. Changes in sleep architecture, including sleep stage composition, quantity, and quality from infancy to adolescence are a reflection of neurologic maturation. Hospital admission for acute illness introduces modifiable risk factors for sleep disruption that may negatively affect active brain development during a period of illness and recovery. Thus, it is important to examine non-pharmacologic interventions for sleep promotion in the pediatric inpatient setting. OBJECTIVES: To evaluate the effect of non-pharmacological sleep promotion interventions in hospitalized children and adolescents on sleep quality and sleep duration, child or parent satisfaction, cost-effectiveness, delirium incidence, length of mechanical ventilation, length of stay, and mortality. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL, three other databases, and three trials registers to December 2021. We searched Google Scholar, and two websites, handsearched conference abstracts, and checked reference lists of included studies. SELECTION CRITERIA: Randomized controlled trials (RCTs) or quasi-RCTs, including cross-over trials, investigating the effects of any non-pharmacological sleep promotion intervention on the sleep quality or sleep duration (or both) of children aged 1 month to 18 years in the pediatric inpatient setting (intensive care unit [ICU] or general ward setting). DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial eligibility, evaluated risk of bias, extracted and synthesized data, and used the GRADE approach to assess certainty of evidence. The primary outcomes were changes in both objective and subjective validated measures of sleep in children; secondary outcomes were child and parent satisfaction, cost-effectiveness ratios, delirium incidence or delirium-free days at time of hospital discharge, duration of mechanical ventilation, length of hospital stay, and mortality. MAIN RESULTS: We included 10 trials (528 participants; aged 3 to 22 years) in inpatient pediatric settings. Seven studies were conducted in the USA, two in Canada, and one in Brazil. Eight studies were funded by government, charity, or foundation grants. Two provided no information on funding. Eight studies investigated behavioral interventions (massage, touch therapy, and bedtime stories); two investigated physical activity interventions. Duration and timing of interventions varied widely. All studies were at high risk of performance bias due to the nature of the intervention, as participants, parents, and staff could not be masked to group assignment. We were unable to perform a quantitative synthesis due to substantial clinical heterogeneity. Behavioral interventions versus usual care Five studies (145 participants) provided low-certainty evidence of no clear difference between multicomponent relaxation interventions and usual care on objective sleep measures. Overall, evidence from single studies found no clear differences in daytime or nighttime sleep measures (33 participants); any sleep parameter (48 participants); or daytime or nighttime sleep or nighttime arousals (20 participants). One study (34 participants) reported no effect of massage on nighttime sleep, sleep efficiency (SE), wake after sleep onset (WASO), or total sleep time (TST) in adolescents with cancer. Evidence from a cross-over study in 10 children with burns suggested touch therapy may increase TST (391 minutes, interquartile range [IQR] 251 to 467 versus 331 minutes, IQR 268 to 373; P = 0.02); SE (76, IQR 53 to 90 versus 66, IQR 55 to 78; P = 0.04); and the number of rapid eye movement (REM) periods (4.5, IQR 2 to 5 versus 3.5, IQR 2 to 4; P = 0.03); but not WASO, sleep latency (SL), total duration of REM, or per cent of slow wave sleep. Four studies (232 participants) provided very low-certainty evidence on subjective measures of sleep. Evidence from single studies found that sleep efficiency may increase, and the percentage of nighttime wakefulness may decrease more over a five-day period following a massage than usual care (72 participants). One study (48 participants) reported an improvement in Children's Sleep Habits Questionnaire scores after discharge in children who received a multicomponent relaxation intervention compared to usual care. In another study, mean sleep duration per sleep episode was longer (23 minutes versus 15 minutes), and time to fall asleep was shorter (22 minutes versus 27 minutes) following a bedtime story versus no story (18 participants); and children listening to a parent-recorded story had longer SL than when a parent was present (mean 57.5 versus 43.5 minutes); both groups reported longer SL than groups who had a stranger-recorded story, and those who had no story and absent parents (94 participants; P < 0.001). In one study (34 participants), 87% (13/15) of participants felt they slept better following massage, with most parents (92%; 11/12) reporting they wanted their child to receive a massage again. Another study (20 participants) reported that parents thought the music, touch, and reading components of the intervention were acceptable, feasible, and had positive effects on their children (very low-certainty evidence). Physical activity interventions versus usual care One study (29 participants) found that an enhanced physical activity intervention may result in little or no improvement in TST or SE compared to usual care (low-certainty evidence). Another study (139 participants), comparing play versus no play found inconsistent results on subjective measures of sleep across different ages (TST was 49% higher for the no play groups in 4- to 7-year olds, 10% higher in 7- to 11-year olds, and 22% higher in 11- to 14-year olds). This study also found inconsistent results between boys and girls (girls in the first two age groups in the play group slept more than the no play group). No study evaluated child or parent satisfaction for behavioral interventions, or cost-effectiveness, delirium incidence or delirium-free days at hospital discharge, length of mechanical ventilation, length of hospital stay, or mortality for either behavioral or physical activity intervention. AUTHORS' CONCLUSIONS: The included studies were heterogeneous, so we could not quantitatively synthesize the results. Our narrative summary found inconsistent, low to very low-certainty evidence. Therefore, we are unable to determine how non-pharmacologic sleep promotion interventions affect sleep quality or sleep duration compared with usual care or other interventions. The evidence base should be strengthened through design and conduct of randomized trials, which use validated and highly reliable sleep assessment tools, including objective measures, such as polysomnography and actigraphy.

Melatonin Use in Hospitalized Children for Non-Anesthetic Indications: A Systematic Review.

Melatonin, a potent free radical scavenger, plays an important role in homeostasis of cell and organ physiology. The increased demand and synthesis from the pineal gland during times of oxidative stress suggests a potential benefit of melatonin supplementation during hospitalization for acute illness. Yet, the paucity of clinical studies for non-anesthetic-associated indications in pediatric populations hampers the safe, effective, and consistent use of melatonin. The objective of this study was to systematically review published studies of melatonin use for non-sedative and non-analgesic indications in hospitalized pediatric patients. We conducted a search of PubMed, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Web of Science, and Scopus databases for articles on the use of melatonin for pediatric patients in a hospital setting. Thirteen eligible studies, all in neonates, were identified. Data elements extracted included study design, number of study subjects, indication for melatonin therapy, and melatonin regimen (formulation, dosage, and duration). Because study methodologies were very heterogeneous, a quantitative synthesis of the published findings was not possible. The identified studies were therefore categorized by the indication of melatonin (adjuvant-antioxidant or anti-inflammatory therapy) in the following specific disease states: (i) acute infections, (ii) respiratory distress syndrome, (iii) neurologic injury, and (iv) jaundice. The current data suggest that melatonin is safe for use in hospitalized neonates. Melatonin may be beneficial for reducing inflammatory markers in neonatal patients with disease states and clinical sequelae that are associated with increased inflammation and oxidative stress. Melatonin, in conjunction with phototherapy, is not superior to use of vitamin D with phototherapy for treatment of neonatal jaundice. However, studies in other pediatric populations are needed given widespread use across clinical inpatient settings.

Implementation strategies to reduce surgical site infections: A systematic review.

BACKGROUND: Surgical site infections (SSIs) portend high patient morbidity and mortality. Although evidence-based clinical interventions can reduce SSIs, they are not reliably delivered in practice, and data are limited on the best approach to improve adherence. OBJECTIVE: To summarize implementation strategies aimed at improving adherence to evidence-based interventions that reduce SSIs. DESIGN: Systematic reviewMethods:We searched PubMed, Embase, CINAHL, the Cochrane Library, the WHO Regional databases, AFROLIB, and Africa-Wide for studies published between January 1990 and December 2015. The Effective Practice and Organization Care (EPOC) criteria were used to identify an acceptable-quality study design. We used structured forms to extract data on implementation strategies and grouped them into an implementation model called the "Four Es" framework (ie, engage, educate, execute, and evaluate). RESULTS: In total, 125 studies met our inclusion criteria, but only 8 studies met the EPOC criteria, which limited our ability to identify best practices. Most studies used multifaceted strategies to improve adherence with evidence-based interventions. Engagement strategies included multidisciplinary work and strong leadership involvement. Education strategies included various approaches to introduce evidence-based practices to clinicians and patients. Execution strategies standardized the interventions into simple tasks to facilitate uptake. Evaluation strategies assessed adherence with evidence-based interventions and patient outcomes, providing feedback of performance to providers. CONCLUSIONS: Multifaceted implementation strategies represent the most common approach to facilitating the adoption of evidence-based practices. We believe that this summary of implementation strategies complements existing clinical guidelines and may accelerate efforts to reduce SSIs.

The Pediatric Critical Care Transfusion and Anemia Expertise Initiative Consensus Conference Methodology.

OBJECTIVES: This article describes the methodology used for Pediatric Critical Care Transfusion and Anemia Expertise Initiative Consensus Conference. DESIGN: Consensus conference of international experts in pediatric critical care and transfusion medicine, following standards set by the Institute of Medicine, using the Research and Development/UCLA Appropriateness Method, modeled after the Pediatric Acute Lung Injury Consensus Conference. Topics related to RBC transfusion in children with or at risk for critical illness were divided into nine subgroups with a systematic review of the literature. METHODS: The panel of 38 content and four methodology experts met three times over the course of 2 years and collaborated to develop evidence-based and, when evidence was lacking, expert-based clinical recommendations as well as research priorities for RBC transfusions in critically ill children or those at risk for critical illness. Electronic searches were conducted using PubMed, Embase, and Cochrane Library databases from 1980 to May 2017. Agreement was obtained using the Research and Development/UCLA Appropriateness Method. We used a standardized data extraction form to construct evidence tables and graded the evidence using the Grading of Recommendations Assessment, Development, and Evaluation system. MAIN RESULTS: The consensus conference resulted in 102 recommendation statements, of which 57 were clinical (20 evidence based and 37 based on expert consensus) and 45 detailed recommendations for future research. Dissemination was done via decision tree, a primary publication listing all statements, and separate publications for each subtopic that include supporting arguments for each recommendation. CONCLUSIONS: A consensus conference of experts from around the world developed recommendations for RBC transfusions in critically ill children or children at risk for critical illness, the identification of current research gaps, and future research priorities.

Risks, Benefits, and Recommendations for Pastoral Care on Inpatient Psychiatric Units: A Systematic Review.

OBJECTIVE: A systematic review was conducted of the biomedical literature regarding pastoral care (PaC) providers on inpatient psychiatric units with the aim of answering 3 questions: (1) What are the risks and benefits of PaC providers' presence on inpatient psychiatric units? (2) What are current recommendations for integration of PaC providers into a psychiatric team? and (3) What gaps exist in the literature? METHODS: PubMed, PsycInfo, Embase, CINAHL, and Scopus were searched from the start of each database to July 9, 2014 using terms related to PaC providers and inpatient psychiatry. Two independent reviewers performed full-text reviews of each article identified by independent review of all titles/abstracts from the electronic search and by a hand search of articles included in reference lists. Inclusion criteria were: English-language article, published in a peer-reviewed journal, and focus on a PaC provider working in a psychiatric hospital setting. One author performed data extraction. RESULTS: Forty-nine articles were identified by electronic (84%) and hand search (16%), 18 of which were evaluative studies: 5 qualitative and 13 quantitative. Most of the literature viewed integration of PaC providers in inpatient treatment teams as beneficial. Potential harms were noted and mitigation strategies suggested, including providing training to PaC providers concerning psychiatric illness, clearly defining roles, and enhancing team integration. None of the articles reported outcomes data. CONCLUSIONS: Psychiatric inpatients often have unmet spiritual needs. Although the literature suggests potential benefits of PaC providers for psychiatric inpatients, more rigorous studies are needed to establish these benefits as efficacious. The authors of this review recommend the cautious integration of PaC providers into the psychiatric inpatient care team.

The Decade in Clinical Thyroid Disease: An Analysis of Published Literature.

BACKGROUND: The purpose of this study was to assess the current status of the clinical thyroidology literature using bibliographic analysis. METHODS: The subject "clinical thyroidology" was divided into six broad topics: iodine deficiency/iodine nutrition, hypothyroidism, hyperthyroidism/thyrotoxicosis, thyroiditis/autoimmune thyroid disease, thyroid nodules/multinodular goiter, and thyroid cancer. Using Scopus, an online bibliographic searching tool, this study sought to examine the trends in the publication of clinical thyroid disease-related research articles over the decade from 2006 through the end of 2015. Citation counts were also retrieved for individual research papers in order to find papers that might have had a bigger impact on clinical practice. Review articles, guidelines, and editorials were excluded. RESULTS: A total of 19,055 articles were published in the broad area of clinical thyroid disease. The largest proportion was in the topic of thyroid cancer, accounting for >30% of the total. The numbers of papers published annually on thyroid nodules and thyroid cancer increased progressively over the decade. The largest proportion of clinical thyroid publications emanated from the United States, and the majority of papers were published in subspecialty journals. Within each clinical thyroid topic, the most highly cited papers published from 2006 to 2015 were identified, and outliers-that is, papers that had been cited far more often that others in the topic-were also identified. The most highly cited paper in all of clinical thyroidology was a 2006 study describing the increase in thyroid cancer incidence in the United States (JAMA 295:2164-2167). Most of the highly cited clinical papers were case series or cohort studies, rather than randomized controlled trials. CONCLUSIONS: The number of papers in clinical thyroid disease is expanding rapidly, with >1000 papers published annually over the last decade. Research papers on thyroid nodules and cancer accounted for 51% of all clinical thyroid disease-related papers. More randomized controlled trials have been published in the last few years, portending a bright future for clinical thyroidology.

Social Media Use in Psychiatric Graduate Medical Education: Where We Are and the Places We Could Go.

This commentary discusses the use of social media in psychiatric graduate medical education (GME) based on a systematic search of the literature. The authors conclude that research on social media use in psychiatric GME is in its infancy. For the most part, the few articles that have been published on this topic caution against the use of social media in psychiatric training. However, reports from other specialties, in which social media use in medical education has been more extensively studied, suggest that there may be significant benefits to incorporating social media into medical education. Although additional challenges may exist in implementing these tools in psychiatric education, the authors suggest that this is an emerging field of scholarship that merits further investigation.

Promoting perioperative advance care planning: a systematic review of advance care planning decision aids.

This systematic review identifies possible decision aids that promote perioperative advance care planning (ACP) and synthesizes the available evidence regarding their use. Using PubMed, EMBASE, Cochrane, SCOPUS, Web of Science, CINAHL, PsycINFO and Sociological Abstracts, researchers identified and screened articles for eligibility. Data were abstracted and risk of bias assessed for included articles. Thirty-nine of 5327 articles satisfied the eligibility criteria. Primarily completed in outpatient ambulatory populations, studies evaluated a variety of ACP decision aids. None were evaluated in a perioperative population. Fifty unique outcomes were reported with no head-to-head comparisons conducted. Findings are likely generalizable to a perioperative population and can inform development of a perioperative ACP decision aid. Future studies should compare the effectiveness of ACP decision aids.

Neuromonitoring During Extracorporeal Membrane Oxygenation: A Systematic Review of the Literature.

OBJECTIVE: Neurologic injury remains a significant morbidity and risk factor for mortality in critically ill patients undergoing extracorporeal membrane oxygenation. Our goal was to systematically review the literature on the use of neuromonitoring methods during extracorporeal membrane oxygenation. DATA SOURCES: Electronic searches of PubMed, CINAHL, EMBASE, Web of Science, Cochrane, and Scopus were conducted in March 2014, using a combination of medical subject heading terms and text words to define concepts of extracorporeal life support, neurologic monitoring techniques, evaluation, and outcomes. STUDY SELECTION: Studies were selected based on inclusion and exclusion criteria defined a priori. DATA EXTRACTION: Two authors reviewed all citations independently. A standardized data extraction form was used to construct evidence tables by neuromonitoring method. Evidence was graded using the Oxford Evidence-Based Medicine scoring system. DATA SYNTHESIS: Of 3,459 unique citations, 39 studies met the inclusion criteria. Study designs were retrospective observational cohort studies (n = 20), prospective observational studies (n = 17), case-control studies (n = 2), and no interventional studies. Most studies evaluated newborns (n = 30). Extracorporeal membrane oxygenation neuromonitoring methods included neuroimaging (head ultrasound) (n = 12); intermittent, conventional, multichannel electroencephalography (n = 5); 1- to 2-channel amplitude-integrated electroencephalography (n = 2); Doppler ultrasound (n = 7); cerebral oximetry (n = 6); plasma brain injury biomarkers (n = 4); and other (n = 3). All evidence was graded 2B-4, with the majority of studies graded 3B (20/39 studies) and 4 (10/39 studies). Due to the heterogeneity of the studies included, aggregate analysis was not possible. CONCLUSIONS: Data supporting the use and effectiveness of current neuromonitoring methods are limited. Most studies have modest sample sizes, are observational in nature, and include patient populations that are of different ages and pathologies, with very limited data for pediatric and adult ages. Well-designed studies with adequate power and standardized short- and long-term outcomes are needed to develop guidelines for neuromonitoring and ultimately neuroprotection in patients on extracorporeal membrane oxygenation.

The persistence of clinical questions across shifts on an intensive care unit: an observational pilot study.

How do clinical questions emerge and move toward resolution in the intensive care setting over the course of 24 hours? In a 20-bed surgical intensive care unit in a large, tertiary-care teaching hospital, informationists shadowed clinicians for 2 48-hour periods to record questions, noting when they were asked and whether they were answered. Thirty-eight percent of 112 recorded questions remained unanswered. Some unanswered questions persisted across shifts, and clinicians' information-seeking behaviors changed over time. Clinical information services can be improved and integrated more fully into clinical workflows based on a fuller understanding of the life cycle of clinical inquiry.

Transfusion-associated hyperkalemic cardiac arrest in pediatric patients receiving massive transfusion.

BACKGROUND: Hyperkalemic cardiac arrest is a potential complication of massive transfusion in children. Our objective was to identify risk factors and potential preventive measures by reviewing the literature on transfusion-associated hyperkalemic cardiac arrest (TAHCA) in the pediatric population. STUDY DESIGN AND METHODS: Literature searches were performed in MEDLINE and the Cochrane Database of Systematic Reviews. RESULTS: We identified nine case reports of pediatric patients who had experienced cardiac arrest during massive transfusion. Serum potassium concentration was reported in eight of those reports; the mean was 9.2 ± 1.8 mmol/L. Risk factors for TAHCA noted in the case reports included infancy (n = 6); age of red blood cells (RBCs; n = 5); site of transfusion (n = 5); and the presence of comorbidities such as hyperkalemia, hypocalcemia, acidemia, and hypotension (n = 9). We also identified 13 clinical studies that examined potassium levels associated with transfusion. Of those 13, five studied routine transfusion, two were registries, and six examined massive transfusion. CONCLUSIONS: Key points identified from this literature search are as follows: 1) Case reports are skewed toward infants and neonates in particular and 2) the rate of blood transfusion, more so than total volume, cardiac output, and the site of infusion, are key factors in the development of TAHCA. Measures to reduce the risk of TAHCA in young children include anticipating and replacing blood loss before significant hemodynamic compromise occurs, using larger-bore (>23-gauge) peripheral intravenous catheters rather than central venous access, checking and correcting electrolyte abnormalities frequently, and using fresher RBCs for massive transfusion.

Quality and safety in pediatric anesthesia.

Health care quality and value are leading issues in medicine today for patients, health care professionals, and policy makers. Outcome, safety, and service-the components of quality-have been used to define value when placed in the context of cost. Health care organizations and professionals are faced with the challenge of improving quality while reducing health care related costs to improve value. Measurement of quality is essential for assessing what is effective and what is not when working toward improving quality and value. However, there are few tools currently for assessing quality of care, and clinicians often lack the resources and skills required to conduct quality improvement work. In this article, we provide a brief review of quality improvement as a discipline and describe these efforts within pediatric anesthesiology.

Teaching empathy to medical students: an updated, systematic review.

PURPOSE: Some research shows that empathy declines during medical school. The authors conducted an updated, systematic review of the literature on empathy-enhancing educational interventions in undergraduate medical education. METHOD: The authors searched PubMed, EMBASE, PsycINFO, CINAHL, Scopus, and Web of Science (January 1, 2004 through March 19, 2012) using key words related to undergraduate medical education and empathy. They independently selected and reviewed all English-language articles that described an educational intervention designed to promote empathy in medical students, assessing the quality of the quantitative studies using the Medical Education Research Study Quality Instrument (MERSQI). RESULTS: The authors identified and reviewed the full texts of 18 articles (15 quantitative and 3 qualitative studies). Included interventions used one or more of the following-patient narrative and creative arts (n=7), writing (n=3), drama (n=1), communication skills training (n=4), problem-based learning (n=1), interprofessional skills training (n=1), patient interviews (n=4), experiential learning (n=2), and empathy-focused training (n=1). Fifteen articles reported significant increases in empathy. Mean effect size was 0.23. Mean MERSQI score was 10.13 (range 6.5-14). CONCLUSIONS: These findings suggest that educational interventions can be effective in maintaining and enhancing empathy in undergraduate medical students. In addition, they highlight the need for multicenter, randomized controlled trials, reporting long-term data to evaluate the longevity of intervention effects. Defining empathy remains problematic, and the authors call for conceptual clarity to aid future research.

Health disparities in endocrine disorders: biological, clinical, and nonclinical factors--an Endocrine Society scientific statement.

OBJECTIVE: The aim was to provide a scholarly review of the published literature on biological, clinical, and nonclinical contributors to race/ethnic and sex disparities in endocrine disorders and to identify current gaps in knowledge as a focus for future research needs. PARTICIPANTS IN DEVELOPMENT OF SCIENTIFIC STATEMENT: The Endocrine Society's Scientific Statement Task Force (SSTF) selected the leader of the statement development group (S.H.G.). She selected an eight-member writing group with expertise in endocrinology and health disparities, which was approved by the Society. All discussions regarding the scientific statement content occurred via teleconference or written correspondence. No funding was provided to any expert or peer reviewer, and all participants volunteered their time to prepare this Scientific Statement. EVIDENCE: The primary sources of data on global disease prevalence are from the World Health Organization. A comprehensive literature search of PubMed identified U.S. population-based studies. Search strategies combining Medical Subject Headings terms and keyword terms and phrases defined two concepts: 1) racial, ethnic, and sex differences including specific populations; and 2) the specific endocrine disorder or condition. The search identified systematic reviews, meta-analyses, large cohort and population-based studies, and original studies focusing on the prevalence and determinants of disparities in endocrine disorders. consensus process: The writing group focused on population differences in the highly prevalent endocrine diseases of type 2 diabetes mellitus and related conditions (prediabetes and diabetic complications), gestational diabetes, metabolic syndrome with a focus on obesity and dyslipidemia, thyroid disorders, osteoporosis, and vitamin D deficiency. Authors reviewed and synthesized evidence in their areas of expertise. The final statement incorporated responses to several levels of review: 1) comments of the SSTF and the Advocacy and Public Outreach Core Committee; and 2) suggestions offered by the Council and members of The Endocrine Society. CONCLUSIONS: Several themes emerged in the statement, including a need for basic science, population-based, translational and health services studies to explore underlying mechanisms contributing to endocrine health disparities. Compared to non-Hispanic whites, non-Hispanic blacks have worse outcomes and higher mortality from certain disorders despite having a lower (e.g. macrovascular complications of diabetes mellitus and osteoporotic fractures) or similar (e.g. thyroid cancer) incidence of these disorders. Obesity is an important contributor to diabetes risk in minority populations and to sex disparities in thyroid cancer, suggesting that population interventions targeting weight loss may favorably impact a number of endocrine disorders. There are important implications regarding the definition of obesity in different race/ethnic groups, including potential underestimation of disease risk in Asian-Americans and overestimation in non-Hispanic black women. Ethnic-specific cut-points for central obesity should be determined so that clinicians can adequately assess metabolic risk. There is little evidence that genetic differences contribute significantly to race/ethnic disparities in the endocrine disorders examined. Multilevel interventions have reduced disparities in diabetes care, and these successes can be modeled to design similar interventions for other endocrine diseases.

Cost-effectiveness of a novel molecular test for cytologically indeterminate thyroid nodules.

CONTEXT: Determining which patients with thyroid nodules require surgery is limited by cytologically indeterminate findings. A new approach for preoperative molecular classification of cytologically indeterminate thyroid nodules has a reported sensitivity of 91% and specificity of 75%; however, its cost-effectiveness has yet to be assessed. OBJECTIVE: Our objective was to evaluate the 5-yr cost-effectiveness of routine use of a molecular test in adult patients with indeterminate fine-needle aspiration biopsy results from a societal perspective. DESIGN: A 16-state Markov decision model was developed. Probabilities, costs, and quality-adjusted life years (QALY) were estimated from literature review, U.S. Department of Health and Human Services data, Medicare reimbursement schedules, and expert opinion. SETTING AND SUBJECTS: Decision analysis of a hypothetical group of adult patients with cytologically indeterminate thyroid nodules was conducted. MAIN OUTCOME MEASURES: Incremental cost-effectiveness ratio was calculated as incremental cost (measured in U.S. dollars) divided by incremental effectiveness (measured in QALY). RESULTS: Modifying current practice with use of the molecular test resulted in 74% fewer surgeries for benign nodules with no greater number of untreated cancers. Over 5 yr, mean discounted cost estimates were $12,172 for current practice and $10,719 with the molecular test. Current practice and molecular test use produced 4.50 and 4.57 QALY, respectively. CONCLUSIONS: Use of this novel molecular test for differential diagnosis of cytologically indeterminate thyroid nodules can potentially avoid almost three fourths of currently performed surgeries in patients with benign nodules. Compared with current practice based on cytological findings alone, use of this test may result in lower overall costs and modestly improved quality of life for patients with indeterminate thyroid nodules.

Food and Drug Administration approval for medications used in the pediatric intensive care unit: a continuing conundrum.

OBJECTIVES: Many drugs used in the pediatric intensive care unit are administered "off label," i.e., they have been neither thoroughly tested for efficacy and safety nor approved for use in children. The U.S. Congress has enacted legislation to promote standards and requirements for Food and Drug Administration labeling for drugs used in pediatrics. Nevertheless, we hypothesized that most medications used in our pediatric intensive care unit were not Food and Drug Administration approved for use in pediatric patients. DESIGN: A list of medications dispensed in the pediatric intensive care unit from January through February 2008 was obtained from our pharmacy database. We then determined whether each medication had been granted Food and Drug Administration approval for use in children. Medications were divided into the following categories: not approved for use in any pediatric age group, approved for use in limited age groups only, and approved for use in all pediatric age groups. SETTING: A pediatric intensive care unit at a tertiary care hospital with 26 beds and 1,500 admissions per year. MEASUREMENTS AND MAIN RESULTS: In the 2-month period, 248 different medications were dispensed with a total of 49,707 medication orders. Sixty (24.2%) of the medications dispensed were not Food and Drug Administration approved for use in any pediatric age group, 106 (42.7%) were approved for use in limited age groups, and 82 (33%) were approved for use in all pediatric age groups. Eleven of the 25 most frequently dispensed medications were approved for use in limited age groups, but none of them was used for the indication or age group for which they were approved. CONCLUSIONS: Despite the efforts of Congress, 67% of medications prescribed and administered in the pediatric intensive care unit did not have Food and Drug Administration approval or had only limited approval, underscoring the need for the medical community to demand oversight and research to improve drug labeling for our patient population.

Clinical review: Prevalence and incidence of endocrine and metabolic disorders in the United States: a comprehensive review.

CONTEXT: There has not been a comprehensive compilation of data regarding the epidemiology of all endocrine and metabolic disorders in the United States. EVIDENCE ACQUISITION: We included 54 disorders with clinical and public health significance. We identified population-based studies that provided U.S. prevalence and/or incidence data by searching PubMed in December 2007 for English-language reports, hand-searching reference lists of six textbooks of endocrinology, obtaining additional resources from identified experts in each subspecialty, and searching epidemiological databases and web sites of relevant organizations. When available, we selected articles with data from 1998 or later. Otherwise, we selected the article with the most recent data, broadest geographical coverage, and most stratifications by sex, ethnicity, and/or age. Ultimately, we abstracted data from 70 articles and 40 cohorts. EVIDENCE SYNTHESIS: Endocrine disorders with U.S. prevalence estimates of at least 5% in adults included diabetes mellitus, impaired fasting glucose, impaired glucose tolerance, obesity, metabolic syndrome, osteoporosis, osteopenia, mild-moderate hypovitaminosis D, erectile dysfunction, dyslipidemia, and thyroiditis. Erectile dysfunction and osteopenia/osteoporosis had the highest incidence in males and females, respectively. The least prevalent conditions, affecting less than 1% of the U.S. population, were diabetes mellitus in children and pituitary adenoma. Conditions with the lowest incidence were adrenocortical carcinoma, pheochromocytoma, and pituitary adenomas. Certain disorders, such as hyperparathyroidism and thyroid disorders, were more common in females. As expected, the prevalence of diabetes mellitus was highest among ethnic minorities. Sparse data were available on pituitary, adrenal, and gonadal disorders. CONCLUSIONS: The current review shows high prevalence and incidence of common endocrine and metabolic disorders. Defining the epidemiology of these conditions will provide clues to risk factors and identify areas to allocate public health and research resources.