Research In Clinical Samples Research Articles

Psychosocial impairment in DSM-5 intermittent explosive disorder

The purpose of this study was to document the functional severity of DSM-5 IED in a clinical research sample. IED and control groups were compared on psychosocial functioning, life satisfaction, and on a variety of cognitive and behavioral issues. IED study participants reported significantly worse psychosocial function, quality of life, and higher job dysfunction than both psychiatric and healthy control study participants. The presence of DSM-5 IED is associated with significant psychosocial and functional impairment. Early intervention may aid in minimizing the consequences of impulsive aggressive behavior, and improving psychosocial functioning and quality of life.

Design and Patient Characteristics of the Chronic Graft-versus-Host Disease Response Measures Validation Study

In 2014, the National Institutes of Health sponsored the second Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease (GVHD). The purpose was to update recommendations about key elements of chronic GVHD research, including definitions for diagnosis, severity scoring, and response measures, based on empirical data published since the first 2005 Consensus Conference. The most significant modifications were to the response assessments, based on studies demonstrating difficulty with the first consensus definitions. The Response Measures Validation Study is a multicenter, prospective cohort study of patients who are starting initial or subsequent treatments for chronic GVHD. The aim of the study is to evaluate the performance of the 2014 response measures and determine whether any other combination of assessments is superior. Clinical data, clinician assessments, patient-reported outcomes, and research samples are collected at enrollment and 3, 6, and 18 months later, and whenever another chronic GVHD systemic treatment is added. The target enrollment of 368 evaluable patients from 12 transplantation centers has been reached. This report describes the rationale, design, and methods of the Chronic GVHD Response Measures Validation Study, and invites other investigators to collaborate with the Consortium to analyze data or specimens.

Examination of factor structure of the inventory of complicated grief (ICG) in a sample of bereaved military family members with persistent and elevated grief.

Knowledge about the effect of a US service member's death on surviving family members is limited. In order to identify their grief-related health care needs, a first step is to identify the characteristics of persistent and elevated grief in a military family sample. The present study identified military family members (n=232) bereaved more than six months who endorsed an elevated level of grief. A confirmatory factor analysis and test of measurement invariance of factor structure were used to compare the factor structure of their Inventory of Complicated Grief (ICG) responses to that of a bereaved non-military-related clinical research sample with similar grief levels. Results confirmed an equivalent five-factor structure of the ICG in both the military family sample and the clinical research sample. The similarity in factor structure was present despite differences in demographic characteristics and bereavement experiences between samples. Thus, the ICG reliably measures persistent and elevated grief in military family samples and provides grief symptom profiles that facilitates better understanding of their grief-related needs.

The Situational Dysphoria Scale (SITDS): development and validation of a self-report questionnaire for assessing situational dysphoria in borderline patients

IntroductionAccording to contemporary phenomenological literature, dysphoria is the background mood characterizing patients with borderline personality disorders (BPD). In particular circumstances, it can take the form of a state of pressure, urge to act, and quasi-explosion, which is very dependent on situational triggers. There are currently no instruments able to measure this situational form of dysphoria.ObjectivesTo develop and analyze psychometric properties of the Situational Dysphoria Scale (SITDS), a self-report questionnaire that measures situational dysphoria.AimsTo validate the SITDS for a future use in routine clinical practice and, more generally, to assess different forms of dysphoria in BPD in a more precise way.MethodsThe preliminary 58-item SITDS was administered to 105 BPD patients, along with other conceptually similar (Nepean Dysphoria Scale) and conceptually distinct (Cynical Distrust Scale, Inventory of Interpersonal Problems-47, empathy quotient, and borderline personality severity Index-IV) instruments. The psychometric characteristics (reliability, internal structure, convergent and divergent validity) of the SITDS were then examined.ResultsThe final 24-item SITDS (with each item rated on three subscales: internal pressure, urge to act, and quasi-explosion) demonstrated excellent internal consistency (alpha = .91). A three-cluster solution was found, with clusters pertaining to personal events, interpersonal events, and environmental events. There were medium to strong correlations with NDS, and weaker but still significant correlations with CynDis, IIP-47, EQ, and BPDSI-IV.ConclusionsThe SITDS is a useful and easy-to-handle instrument for measuring situational dysphoria. Further research in clinical samples is needed.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Intermittent explosive disorder and eating disorders: Analysis of national comorbidity and research samples

ObjectiveClinical studies suggest comorbidity between eating disorders and aggressive behaviors. This study examined the pattern of comorbidity between intermittent explosive disorder (IED) and eating disorders (ED). MethodsData were analyzed from both the adult and adolescent samples of the National Comorbidity Survey-Replication (n = 19,430) and a clinical research sample (n = 1,642). ResultsLifetime prevalence of Any ED was elevated in IED vs. non-IED for both the community and clinical research samples. Though anorexia nervosa displayed no relationship with IED in either sample, bulimia nervosa was associated with IED in the community sample and binge eating disorder was associated with IED in both the community and clinical research samples. Onset of IED preceded onset of Any ED in at least 70% of comorbid IED/ED cases in both community and clinical research samples. Associations of IED with Any ED and bulimia nervosa in the community sample, and associations of IED with binge eating disorder in the clinical research sample, remained significant after controlling for other psychiatric disorders. ConclusionsIndividuals with IED are more likely to report lifetime prevalence of ED, particularly bulimic spectrum disorders. This finding, and the observation that the onset of IED occurs prior to the onset of ED in the majority of individuals, suggests that longitudinal studies are needed to clarify this relationship and determine whether IED is a risk factor for the development of ED. Early identification of individuals with IED or impulsive aggression may provide clinically useful information to determine most effective treatment interventions.

The predictors of persistent DSM-IV disorders in 3-year follow-ups of the British Child and Adolescent Mental Health Surveys 1999 and 2004.

The identification of the factors that influence the persistence of psychiatric disorder may assist practitioners to focus on young people who are particularly prone to poor outcomes, but population-based samples of sufficient size are rare. This secondary analysis combined data from two large, population-based cross-sectional surveys in Great Britain (1999 and 2004) and their respective follow-ups (2002 and 2007), to study homotypic persistence among the 998 school-age children with psychiatric disorder at baseline. Psychiatric disorder was measured using the Development and Well-Being Assessment applying DSM-IV criteria. Factors relating to the child, family, and the severity and type of psychopathology at baseline were analysed using logistic regression. Approximately 50% of children with at least one psychiatric disorder were assigned the same diagnostic grouping at 3-year follow-up. Persistent attention-deficit/hyperactivity disorder and anxiety were predicted by poor peer relationship scores. Persistent conduct disorder was predicted by intellectual disability, rented housing, large family size, poor family function and by severer baseline psychopathology scores. Homotypic persistence was predicted by different factors for different groups of psychiatric disorders. Experimental research in clinical samples should explore whether these factors also influence response to interventions.

"Self-Assessment of Hearing Disabilities in Cochlear Implant Users Using the SSQ and the Reduced SSQ5 Version. Otology & Neurotology 2013;34: 1622-9".

To the Editor: We thank you for giving us the opportunity to add some comments and trends raised after the publication of our article “Self-Assessment of Hearing Disabilities in Cochlear Implant Users Using the SSQ and the Reduced SSQ5 Version.” The five-item Speech Spatial and Qualities of Hearing Scale (SSQ5), introduced by Demeester et al. (1), was used as a starting point to investigate whether this questionnaire is robust to effectively measure evolutions in hearing (dis)abilities in Cochlear Implant (CI) users. Recently, Noble et al. (2) developed and evaluated a 12-item version of the Speech Spatial and Qualities of Hearing Scale (SSQ). They concluded that the SSQ12 provides similar results to SSQ49 in a large clinical research sample. To examine which reduced SSQ version had the strongest degree of agreement with the original SSQ49 in a CI population, Spearman correlations coefficients were calculated in our CI study group. Figure 1 shows that the 12-item version provides more similar results to the SSQ49 (r2 = 0.90), compared with the 5-item version (r2 = 0.62) of Demeester et al. (1).FIG. 1: Spearman correlations between (A) the SSQ49 and the SSQ12 and (B) the SSQ49 and the SSQ5 for the CI population study group (n = 54). CI indicates cochlear implant; SSQ5, five-item Speech Spatial and Qualities of Hearing Scale (SSQ5).In conclusion, the SSQ5 is a robust questionnaire to effectively measure the evolutions in hearing (dis)abilities in CI users. However, the degree of agreement between the SSQ49 and the SSQ12 turns out to be stronger, compared with the SSQ5. Therefore, routine clinical self-assessment hearing performance in the CI population in the Antwerp University Hospital (Belgium) will include the SSQ12 from now on.

Recent Advances in Developmental and Risk Factor Research on Eating Disorders.

The Diagnostic and Statistical Manual of Mental Disorders (i.e., DSM-5) currently recognizes three primary eating disorders: anorexia nervosa, bulimia nervosa, and binge eating disorder. The origins of eating disorders are complex and remain poorly understood. However, emerging research highlights a dimensional approach to understanding the multifactorial etiology of eating disorders as a means to inform assessment, prevention, and treatment efforts. Guided by research published since 2011, this review summarizes recent findings elucidating risk factors for the development of eating disorders across the lifespan in three primary domains: (1) genetic/biological, (2) psychological, and (3) socio-environmental. Prospective empirical research in clinical samples with full-syndrome eating disorders is emphasized with added support from cross-sectional studies, where relevant. The developmental stages of puberty and the transition from adolescence to young adulthood are discussed as crucial periods for the identification and prevention of eating disorders. The importance of continuing to elucidate the mechanisms underlying gene by environmental interactions in eating disorder risk is also discussed. Finally, controversial topics in the field of eating disorder research and the clinical implications of this research are summarized.

Focused Ultrasound as a Scalable and Contact-Free Method to Manufacture Protein-Loaded PLGA Nanoparticles.

Although nanomaterials are under investigation for a very broad range of medical applications, only a small fraction of these are already commercialized or in clinical development. A major challenge for the translation of nanomedicines into the clinic is the missing scalability of the available lab scale preparation methods and, ultimately, non-identical samples during early and late research. Protein-loaded PLGA nanoparticles using focused ultrasound in an emulsion solvent diffusion method were prepared in different batch sizes to evaluate achievable mean size, protein loading, and yield. Using the same equipment, nanoparticles could be prepared in batch sizes from 1 mg to 2.5 g. Size and yield were directly controllable by the amount of incident energy with good reproducibility. The nanoparticles displayed similar mean size, protein loading, and nanoparticle yield in batch sizes over three orders of magnitude. A scalable purification method based on diafiltration was established. The proposed method enables for feasibility studies during early research using just a small amount of polymer and protein, while at the same time it allows for larger scale production at later stages. As the proposed method further relies on contact-free energy transmission, it is especially suited for the preparation of clinical research samples.

Validation and application of a canine-specific automated high-sensitivity C-reactive protein assay.

Measurement of low concentrations of C-reactive protein (CRP) in dogs has previously been performed with nonautomated assays. The aim of this study was to validate an automated high-sensitivity CRP (hsCRP) assay, developed by modifying a routinely used canine-specific immunoturbidimetric CRP test (cCRP). Imprecision, linearity under dilution, limit of blank (LOB), limit of detection (LOD), and limit of quantification (LOQ) were determined for the hsCRP test, as well as the presence of prozone effect and interferences. The imprecision, measured as intra-assay variation, was ≤2.7%. The assay was acceptably linear under dilution. An analytically relevant prozone effect was present for samples with CRP concentration >150 mg/L, and there were mild interferences from hemolysis and lipemia. The LOB, LOD, and LOQ were 0.10 mg/L, 0.22 mg/L, and 0.50 mg/L, respectively. A method comparison study with a canine-specific enzyme-linked immunosorbent assay (ELISA) was performed, showing poor agreement between the hsCRP test and the ELISA. An additional aim of the study was to apply the hsCRP test to clinical research samples. Serum samples from 7 dogs undergoing ovariohysterectomy were collected pre- and postoperatively, and CRP was measured with both the cCRP and hsCRP assay. The expected postoperative increase in CRP was detected earlier with the hsCRP test, compared with the cCRP test. The hsCRP assay was further applied on samples from 6 lean and 9 overweight dogs. There was no significant difference in CRP concentration between the groups (P = 0.06). In conclusion, the hsCRP test had acceptable analytical performance, and the assay was successfully applied to clinical research samples.

Association Between Restless Legs Syndrome and Adult ADHD in a German Community-Based Sample

Objective: Previous research in clinical samples indicated a significant association between ADHD and restless legs syndrome (RLS). The present study examined the association between adult ADHD and RLS in the German population. Method: Self-rating instruments to assess RLS, childhood ADHD, and adult ADHD were administered to a community-based sample (N = 1,632). In addition, current depression and anxiety, sleep disturbances, weight, and height were assessed by self-report. Results: Adult ADHD was associated with statistically significant increases in the odds of meeting diagnostic criteria for RLS even when adjusting for potential confounding variables such as weight (odds ratio [OR] = 3.18, 95% confidence interval [CI] = [1.29, 7.63], p< .001). However, the association did not hold true after adjusting for the presence of sleep disturbances (OR = 2.02, 95% CI = [0.82, 4.96], p = .13). Conclusion: The findings suggest a strong link between RLS and adult ADHD symptoms. Clinicians should be aware of RLS among adult ADHD patients, especially as there might be a negative interactive effect.

Selective augmentation of striatal functional connectivity following NMDA receptor antagonism: implications for psychosis.

The psychotomimetic effect of the N-methyl-D-aspartate receptor (NMDAR) antagonist ketamine is thought to arise from a functional modulation of the brain's fronto-striato-thalamic (FST) circuits. Animal models suggest a pronounced effect on ventral 'limbic' FST systems, although recent work in patients with psychosis and high-risk individuals suggests specific alterations of dorsal 'associative' FST circuits. Here, we used functional magnetic resonance imaging to investigate the effects of a subanesthetic dose of ketamine on measures of functional connectivity as indexed by the temporal coherence of spontaneous neural activity in both dorsal and ventral FST circuits, as well as their symptom correlates. We adopted a placebo-controlled, double-blind, randomized, repeated-measures design in which 19 healthy participants received either an intravenous saline infusion or a racemic mixture of ketamine (100 ng/ml) separated by at least 1 week. Compared with placebo, ketamine increased functional connectivity between the dorsal caudate and both the thalamus and midbrain bilaterally. Ketamine additionally increased functional connectivity of the ventral striatum/nucleus accumbens and ventromedial prefrontal cortex. Both connectivity increases significantly correlated with the psychosis-like and dissociative symptoms under ketamine. Importantly, dorsal caudate connectivity with the ventrolateral thalamus and subthalamic nucleus showed inverse correlation with ketamine-induced symptomatology, pointing to a possible resilience role to disturbances in FST circuits. Although consistent with the role of FST in mediating psychosis, these findings contrast with previous research in clinical samples by suggesting that acute NMDAR antagonism may lead to psychosis-like experiences via a mechanism that is distinct from that implicated in frank psychotic illness.

Do Clinical Trials of Treatment of Alcohol Dependence Adequately Enroll Participants With Co-Occurring Independent Mood and Anxiety Disorders?

In the care of alcohol-dependent patients, co-occurring independent (ie, not substance-induced) mood and anxiety disorders present a significant challenge. Clinical trials of alcohol dependence treatment could help clinicians meet this challenge, but only if they enroll such complex patients. This study examined whether such individuals are likely to be included in alcohol dependence treatment trials under typical eligibility criteria. Data were derived from the 2001-2002 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a national representative sample of 43,093 adults in the United States population. Psychiatric diagnoses were made according to the DSM-IV criteria with the Alcohol Use Disorder and Associated Disabilities Interview Schedule-DSM-IV Version (AUDADIS-IV). Of 1,484 alcohol-dependent participants, 39.22% (SE = 1.67) had a co-occurring independent mood or anxiety disorder; more than 60% of these individuals would be ineligible for an alcohol dependence treatment trial under typical eligibility criteria. Alcohol-dependent individuals with current major depressive episode, mania, dysthymia, panic disorder, and generalized anxiety disorder were particularly likely to be excluded from clinical trials. In a subsample of 185 individuals who had sought alcohol treatment, 52.59% (SE = 4.42) had an independent mood or anxiety disorder. Remarkably, almost all of these individuals (96.93%, SE = 1.97) would have been ineligible for clinical trials. Independent mood and anxiety disorders are prevalent in the alcohol-dependent population but not in clinical trial research samples. For alcohol dependence treatment trials to adequately inform clinical practice, the enrollment of patients with co-occurring mood or anxiety disorders must be increased, through trials tailored to this population, a general relaxation of overly stringent eligibility criteria, or both.

EPA-0151 – Study of the relationship between attachment styles and symptoms of borderline personality disorder: study on non-clinical samples

Many psychotic and personality disorders of children are the result of deprivation of maternal care or lack of reliability of a child with the attached individual. Since attachment problems are one of the features of borderline personality disorder, this study aims at studying the relationship between attachment styles and symptoms of borderline personality disorder in non-clinical samples. The present study was conducted as a survey and it was descriptive. Therefore, a sample of 300 individuals were randomly selected and tested. Participants responded to adult attachment styles and symptoms of borderline personality questionnaire. The data were analyzed using one way analysis of variance. The results revealed that people with avoidant attachment styles compared to those with secure attachment and ambivalent insecure attachment style got the highest score in borderline personality disorder symptoms. The results obtained in this study are somewhat consistent with this idea that environmental factors such as attachment styles have an important role in the development of borderline personality disorder also these findings are in accordance with with previous research in clinical samples and in line with the theory of attachment styles in borderline personality disorder are debatable.

A sensitive HPLC–MS/MS method for the determination of dolutegravir in human plasma

A sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) assay was developed and validated to facilitate the assessment of clinical pharmacokinetics of dolutegravir (DTG) in plasma samples. This work describes an assay system requiring only a 20μL aliquot of human plasma that is subjected to a simple acetonitrile protein precipitation containing a stably labeled isotope of DTG used as an internal standard. Chromatography was performed on an XBridge C18, 2.1mm×50mm, reversed phase analytical column, using a 60:40 acetonitrile/water mobile phase containing 0.1% formic acid. Detection of the analyte and internal standard was achieved by ESI positive ionization tandem mass spectrometry. The precursor/product transitions (m/z) monitored were 420.1/136.0 and 428.1/283.1 for DTG and DTG-IS, respectively. The dynamic range of this assay extends from 5 to 10,000ng/mL, with a mean coefficient of determination (r, mean±SD) of 0.9996±0.0003. The mean precision values for calibration standards ranged from 0.7 to 4.1%, while accuracy values were 98.3 to 102.0%. Validation results demonstrated high accuracy (≤6.5% deviation) and high precision (≤9.1% CV) for the quality control samples. This assay system provides an accurate, precise, and sensitive method for DTG quantitation and was successfully applied to clinical research samples as part of a phase I/II pediatric clinical trial.

Occurrence of Listeria spp. in Retail Meat and Dairy Products in the Area of Addis Ababa, Ethiopia

Listeriosis, a bacterial disease in humans and animals, is mostly caused by ingestion of Listeria monocytogenes via contaminated food and/or water, or by a zoonotic infection. Globally, listeriosis has in general a low incidence but a high case fatality rate. The objective of this study was to investigate the occurrence, antimicrobial profiles, and genetic relatedness of L. monocytogenes from raw meat and dairy products (raw milk, cottage cheese, cream cake), collected from the capital and five neighboring towns in Ethiopia. Two hundred forty food samples were purchased from July to December 2006 from food vendors, shops, and supermarkets, using a cross-sectional study design. L. monocytogenes were isolated and subjected to molecular serotyping. The genetic relatedness and antimicrobial susceptibility patterns were investigated using pulsed-field gel electrophoresis (PFGE) and minimum inhibitory concentration determinations. Of 240 food samples tested, 66 (27.5%) were positive for Listeria species. Of 59 viable isolates, 10 (4.1%) were L. monocytogenes. Nine were serotype 4b and one was 2b. Minimum inhibitory concentration determination and PFGE of the 10 L. monocytogenes isolates showed low occurrence of antimicrobial resistance among eight different PFGE types. The findings in this study correspond to similar research undertaken in Ethiopia by detecting L. monocytogenes with similar prevalence rates. Public education is crucial as regards the nature of this organism and relevant prevention measures. Moreover, further research in clinical samples should be carried out to estimate the prevalence and carrier rate in humans, and future investigations on foodborne outbreaks must include L. monocytogenes.

A short form of the Speech, Spatial and Qualities of Hearing scale suitable for clinical use: The SSQ12

Objective: To develop and evaluate a 12-item version of the Speech, Spatial and Qualities of Hearing scale for use in clinical research and rehabilitation settings, and provide a formula for converting scores between the full (SSQ49) and abbreviated (SSQ12) versions. Design: Items were selected independently at the three centres (Eriksholm Research Centre, MRC Institute of Hearing Research, University of New England) to be representative of the complete scale. A consensus was achieved after discussion. Study sample: The data set (n = 1220) used for a factor analysis (, submitted) was re-analysed to compare original SSQ scores (SSQ49) with scores on the short version (SSQ12). Results: A scatter-plot of SSQ12 scores against SSQ49 scores showed that SSQ12 score was about 0.6 of a scale point lower than the SSQ49 (0–10 scale) in the re-analysis of the Akeroyd et al data. SSQ12 scores lay on a slightly steeper slope than scores on the SSQ49. Conclusions: The SSQ12 provides similar results to SSQ49 in a large clinical research sample. The slightly lower average SSQ12 score and the slightly steeper slope reflect the composition of this short form relative to the SSQ49.

Factor mixture model of anxiety sensitivity and anxiety psychopathology vulnerability

BackgroundThe purpose of the present study was to shed light on the latent structure and nature of individual differences in anxiety sensitivity (AS) and related risk for psychopathology. MethodsThe present study evaluated the latent structure of AS using factor mixture modeling (FMM; Lubke and Muthén, 2005) and tested the relations between the observed FMM-based model of AS and psychopathology in a large, diverse adult clinical research sample (N=481; 57.6% women; M(SD)age=36.6(15.0) years). ResultsFindings showed that a two-class three-factor partially invariant model of AS demonstrated significantly better fit than a one-class dimensional model and more complex multi-class models. As predicted, risk conferred by AS taxonicity was specific to anxiety psychopathology, and not to other forms of psychopathology. LimitationsThe sample was not epidemiologic, self-report and psychiatric interview data were used to index AS and psychopathology, and a cross-sectional design limited inference regarding the directionality of observed relations between AS and anxiety psychopathology. ConclusionsFindings are discussed with respect to the nature of AS and related anxiety psychopathology vulnerability specifically, as well as the implications of factor mixture modeling for advancing taxonomy of vulnerability and psychopathology more broadly.

Determination of nucleoside analog mono-, di-, and tri-phosphates in cellular matrix by solid phase extraction and ultra-sensitive LC–MS/MS detection

An ultra-sensitive liquid chromatography tandem mass spectrometry (LC–MS/MS) assay was developed and validated to facilitate the assessment of clinical pharmacokinetics of nucleotide analogs from lysed intracellular matrix. The method utilized a strong anion exchange isolation of mono-(MP), di-(DP), and tri-phosphates (TP) from intracellular matrix. Each fraction was then dephosphorylated to the parent moiety yielding a molar equivalent to the original nucleotide analog intracellular concentration. The analytical portion of the methodology was optimized in specific nucleoside analog centric modes (i.e. tenofovir (TFV) centric, zidovudine (ZDV) centric), which included desalting/concentration by solid phase extraction and detection by LC–MS/MS. Nucleotide analog MP-, DP-, and TP-determined on the TFV centric mode of analysis include TFV, lamivudine (3TC), and emtricitibine (FTC). The quantifiable linear range for TFV was 2.5–2000 fmol/sample, and that for 3TC/FTC was 0.1 200 pmol/sample. Nucleoside analog MP-, DP-, and TP-determined on the ZDV centric mode of analysis included 3TC and ZDV. The quantifiable linear range for 3TC was 0.1 100 pmol/sample, and 5–2000 fmol/sample for ZDV. Stable labeled isotopic internal standards facilitated accuracy and precision in alternative cell matrices, which supported the intended use of the method for MP, DP, and TP determinations in various cell types. The method was successfully applied to clinical research samples generating novel intracellular information for TFV, FTC, ZDV, and 3TC nucleotides. This document outlines method development, validation, and application to clinical research.

Risks of propofol sedation/anesthesia for imaging studies in pediatric research: eight years of experience in a clinical research center.

To quantify the incidence of adverse events associated with anesthesia given for research-driven imaging studies and to identify risk factors for those events in pediatric research subjects. Retrospective cohort study. National Institutes of Health Clinical Center. Children and adolescents enrolled in clinical research protocols who required anesthesia for research-related imaging studies from January 2000 to September 2008. Propofol sedation/anesthesia. The occurrence of respiratory, cardiovascular, and all anesthesia-related adverse events that required intervention while receiving anesthetics for research-driven imaging studies and other noninvasive procedures. We identified 607 children who received 1480 propofol anesthetic procedures for imaging studies. Seventy percent of anesthetics were given to subjects with severe diseases and significant disabilities (American Society of Anesthesiologists Physical Status [ASA] III). Anesthesia had a mean (SD) duration of 115 (55) minutes, and in 12.5% of procedures, an airway device was necessary. There were 98 notable respiratory, cardiovascular, and other events in 79 anesthetic procedures, a rate of 534 per 10 000 anesthetic procedures with 1 or more adverse events. There was no long-lasting morbidity or mortality. The ASA classification (odds ratio [OR], 2.92; 95% confidence interval [CI], 1.24-6.88), anesthetic effect duration (OR, 1.46; 95% CI, 1.25-1.70), and presence of airway abnormalities (OR, 4.41; 95% CI, 1.60-12.12) were independently associated with adverse events during anesthetic use. In our clinical research sample of high-risk children who received sedation/anesthesia by an anesthesiologist, we observed a low incidence of adverse events and no long-term complications. Risk factors for adverse events included higher ASA classification, increasing anesthetic duration, and presence of airway abnormalities.