Musculoskeletal Pain, Self-reported Physical Function, and Quality of Life in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Cohort.

IMPORTANCE: Obesity is associated with chronic musculoskeletal pain and is a risk factor for disability and osteoarthritis. OBJECTIVES: To describe the prevalence, sites, and intensity of musculoskeletal pain in adolescents with severe obesity; to evaluate associations between musculoskeletal pain and self-reported physical function as well as weight-related quality of life; and to evaluate the association between musculoskeletal pain and high-sensitivity C-reactive protein level. DESIGN, SETTING, AND PARTICIPANTS: Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) is a prospective, observational study that collects standardized data on adolescents undergoing weight loss surgery at 5 US centers. We examined baseline data from this cohort between February 28, 2007, and December 30, 2011. We excluded adolescents with Blount disease and slipped capital femoral epiphyses. A total of 233 participants were included in these analyses. MAIN OUTCOMES AND MEASURES: We assessed musculoskeletal pain and pain intensity of the lower back, hips, knees, and ankles/feet using the visual analog scale, categorizing musculoskeletal pain into lower back pain, lower extremity (hips, knees, and feet/ankles combined) pain, and no pain. We assessed self-reported physical function status with the Health Assessment Questionnaire Disability Index and assessed weight-related quality of life with the Impact of Weight on Quality of Life-Kids measure. We adjusted for sex, race, age at surgery, body mass index (BMI; calculated as weight in kilograms divided by height in meters squared), and clinical depressive symptoms in regression analyses. RESULTS: Among the 233 participants, the mean (SD) age at surgery was 17.1 (1.56) years and the median BMI was 50.4. Participants were predominantly female (77%), white (73%), and non-Hispanic (93%). Among the participants, 49% had poor functional status and 76% had musculoskeletal pain. Lower back pain was prevalent (63%), followed by ankle/foot (53%), knee (49%), and hip (31%) pain; 26% had pain at all 4 sites. In adjusted analyses, compared with pain-free participants, those reporting lower extremity pain had greater odds of having poor physical function according to scores on the Health Assessment Questionnaire Disability Index (odds ratio = 2.82; 95% CI, 1.35 to 5.88; P < .01). Compared with pain-free participants, those reporting lower extremity pain had significantly lower Impact of Weight on Quality of Life-Kids total scores (ß = -9.42; 95% CI, -14.15 to -4.69; P < .01) and physical comfort scores (ß = -17.29; 95% CI, -23.32 to -11.25; P < .01). After adjustment, no significant relationship was observed between musculoskeletal pain and high-sensitivity C-reactive protein level. CONCLUSIONS AND RELEVANCE: Adolescents with severe obesity have musculoskeletal pain that limits their physical function and quality of life. Longitudinal follow-up will reveal whether weight loss surgery reverses pain and physical functional limitations and improves quality of life.

Cardiovascular Risk Factors in Severely Obese Adolescents: The Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Study.

IMPORTANCE: Severe obesity is increasingly common in the adolescent population but, as of yet, very little information exists regarding cardiovascular disease (CVD) risks in this group. OBJECTIVE: To assess the baseline prevalence and predictors of CVD risks among severely obese adolescents undergoing weight-loss surgery. DESIGN, SETTING, AND PARTICIPANTS: A prospective cohort study was conducted from February 28, 2007, to December 30, 2011, at the following 5 adolescent weight-loss surgery centers in the United States: Nationwide Children's Hospital in Columbus, Ohio; Cincinnati Children's Hospital Medical Center in Cincinnati, Ohio; Texas Children's Hospital in Houston; University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania; and Children's Hospital of Alabama in Birmingham. Consecutive patients aged 19 years or younger were offered enrollment in a long-term outcome study; the final analysis cohort consisted of 242 participants. MAIN OUTCOMES AND MEASURES: This report examined the preoperative prevalence of CVD risk factors (ie, fasting hyperinsulinemia, elevated high-sensitivity C-reactive protein levels, impaired fasting glucose levels, dyslipidemia, elevated blood pressure, and diabetes mellitus) and associations between risk factors and body mass index (calculated as weight in kilograms divided by height in meters squared), age, sex, and race/ethnicity. Preoperative data were collected within 30 days preceding bariatric surgery. RESULTS: The mean (SD) age was 17 (1.6) years and median body mass index was 50.5. Cardiovascular disease risk factor prevalence was fasting hyperinsulinemia (74%), elevated high-sensitivity C-reactive protein levels (75%), dyslipidemia (50%), elevated blood pressure (49%), impaired fasting glucose levels (26%), and diabetes mellitus (14%). The risk of impaired fasting glucose levels, elevated blood pressure, and elevated high-sensitivity C-reactive protein levels increased by 15%, 10%, and 6%, respectively, per 5-unit increase in body mass index (P < .01). Dyslipidemia (adjusted relative risk = 1.60 [95% CI, 1.26-2.03]; P < .01) and elevated blood pressure (adjusted relative risk = 1.48 [95% CI, 1.16-1.89]; P < .01) were more likely in adolescent boys compared with adolescent girls. White individuals were at greater risk of having elevated triglyceride levels (adjusted relative risk = 1.76 [95% CI, 1.14-2.72]; P = .01) but were less likely to have impaired fasting glucose levels (adjusted relative risk = 0.58 [95% CI, 0.38-0.89]; P = .01). CONCLUSIONS AND RELEVANCE: Numerous CVD risk factors are apparent in adolescents undergoing weight-loss surgery. Increasing body mass index and male sex increase the relative risk of specific CVD risk factors. These data suggest that even among severely obese adolescents, recognition and treatment of CVD risk factors is important to help limit further progression of disease.

Severe obesity and comorbid condition impact on the weight-related quality of life of the adolescent patient.

OBJECTIVES: To assess links between comorbid health status, severe excess weight, and weight-related quality of life (WRQOL) in adolescents with severe obesity and undergoing weight-loss surgery (WLS) to inform clinical care. STUDY DESIGN: Baseline (preoperative) data from Teen Longitudinal Assessment of Bariatric Surgery, a prospective multicenter observational study of 242 adolescents with severe obesity (MedianBMI = 50.5 kg/m(2); Meanage = 17.1; 75.6% female; 71.9% white) undergoing WLS, were used to examine the impact of demographics, body mass index (BMI), presence/absence of 16 comorbid conditions, and a cumulative comorbidity load (CLoad) index on WRQOL scores (Impact of Weight on Quality of Life-Kids). RESULTS: WRQOL was significantly lower than reference samples of healthy weight, overweight, and obese samples. Of 16 comorbid conditions, the most prevalent were dyslipidemia (74.4%), chronic pain (58.3%), and obstructive sleep apnea (56.6%). Male subjects had a greater CLoad (P = .01) and BMI (P = .01), yet less impairment in total WRQOL (P < .01) than females. CLoad was a significant predictor of male WRQOL. For females, psychosocial (vs physical) comorbidities, BMI, and white race were significant predictors of WRQOL impairment. Less prevalent conditions (eg, stress urinary incontinence) also emerged as contributors to lower WRQOL. CONCLUSIONS: WRQOL impairment is substantial for adolescents with severe obesity undergoing WLS, with predictors varying by sex. These patient-data highlight targets for education, support, and adjunctive care referrals before WLS. Furthermore, they provide a comprehensive empirical base for understanding heterogeneity in adolescent WRQOL outcomes after WLS, as weight and comorbidity profiles change over time.

Adolescent bariatric surgery program characteristics: the Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study experience.

The number of adolescents undergoing weight loss surgery (WLS) has increased in response to the increasing prevalence of severe childhood obesity. Adolescents undergoing WLS require unique support, which may differ from adult programs. The aim of this study was to describe institutional and programmatic characteristics of centers participating in Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS), a prospective study investigating safety and efficacy of adolescent WLS. Data were obtained from the Teen-LABS database, and site survey completed by Teen-LABS investigators. The survey queried (1) institutional characteristics, (2) multidisciplinary team composition, (3) clinical program characteristics, and (4) clinical research infrastructure. All centers had extensive multidisciplinary involvement in the assessment, pre-operative education, and post-operative management of adolescents undergoing WLS. Eligibility criteria and pre-operative clinical and diagnostic evaluations were similar between programs. All programs have well-developed clinical research infrastructure, use adolescent-specific educational resources, and maintain specialty equipment, including high weight capacity diagnostic imaging equipment. The composition of clinical team and institutional resources is consistent with current clinical practice guidelines. These characteristics, coupled with dedicated research staff, have facilitated enrollment of 242 participants into Teen-LABS.

Perioperative outcomes of adolescents undergoing bariatric surgery: the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study.

IMPORTANCE: Severe obesity in childhood is a major health problem with few effective treatments. Weight-loss surgery (WLS) is being used to treat severely obese adolescents, although with very limited data regarding surgical safety for currently used, minimally invasive procedures. OBJECTIVE: To assess the preoperative clinical characteristics and perioperative safety outcomes of severely obese adolescents undergoing WLS. DESIGN, SETTING, AND PARTICIPANTS: This prospective, multisite observational study enrolled patients from February 28, 2007, through December 30, 2011. Consecutive patients aged 19 years or younger who were approved to undergo WLS (n = 277) were offered enrollment into the study at 5 academic referral centers in the United States; 13 declined participation and 22 did not undergo surgery after enrollment, thus the final analysis cohort consisted of 242 individuals. There were no withdrawals. MAIN OUTCOMES AND MEASURES: This analysis examined preoperative anthropometrics, comorbid conditions, and major and minor complications occurring within 30 days of operation. All data were collected in a standardized fashion. Reoperations and hospital readmissions were adjudicated by independent reviewers to assess relatedness to the WLS procedure. RESULTS: The mean (SD) age of participants was 17.1 (1.6) years and the median body mass index (calculated as weight in kilograms divided by height in meters squared) was 50.5. Fifty-one percent demonstrated 4 or more major comorbid conditions. Laparoscopic Roux-en-Y gastric bypass, vertical sleeve gastrectomy, and adjustable gastric banding were performed in 66%, 28%, and 6% of patients, respectively. There were no deaths during the initial hospitalization or within 30 days of operation; major complications (eg, reoperation) were seen in 19 patients (8%). Minor complications (eg, readmission for dehydration) were noted in 36 patients (15%). All reoperations and 85% of readmissions were related to WLS. CONCLUSIONS AND RELEVANCE: In this series, adolescents with severe obesity presented with abundant comorbid conditions. We observed a favorable short-term complication profile, supporting the early postoperative safety of WLS in select adolescents. Further longitudinal study of this cohort will permit accurate assessment of long-term outcomes for adolescents undergoing bariatric surgery. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00474318.

Randomized trial to assess the efficacy of intraoperative steroid use in decreasing acute urinary retention after transperineal radioactive iodine-125 implantation for prostate cancer.

BACKGROUND: Acute urinary retention is a potential complication of brachytherapy, with the literature estimating that 5% to 22% of patients require catheterization within 48 hours after implantation. In theory, postimplantation edema could be reduced by using intraoperative steroids. A prospective trial was conducted randomizing patients to a single intraoperative dose of dexamethasone versus no steroid use. METHODS: In all, 196 evaluable patients who received iodine-125 (I(125)) interstitial brachytherapy alone as definitive treatment for low-to-intermediate risk prostate cancer were randomized to receive either dexamethasone at a dose of 6 mg administered intravenously intraoperatively (Arm A) or no steroids (Arm B). All patients completed the International Prostate Symptom Score before treatment. Patients were contacted by telephone 72 to 96 hours after treatment and the need for catheterization was reported. RESULTS: Between 2003 and 2005, 99 patients received steroids on treatment Arm A and 97 patients were treated according to control Arm B. Treatment arms were balanced with respect to pretreatment characteristics. A total of 3 patients required catheterization (2 in Arm A and 1 in Arm B). The overall rate of catheterization was 1.5%, with no statistically significant difference noted between treatment arms. The 3 patients requiring catheterization had no statistical differences from other patients with respect to pretreatment characteristics, number of seeds/needles used, or postimplantation computed tomography volume of the prostate. CONCLUSIONS: There was no statistically significant difference noted between treatment arms in the current study, leading the authors to conclude that intraoperative dexamethasone did not decrease the rate of catheterization required after brachytherapy. The overall rate of postimplantation catheterization in the current study was 1.5%, which is lower than reported elsewhere in the literature and in a retrospective review from the study institution.

Phase I clinical trial of concurrent paclitaxel, carboplatin, and external beam chest irradiation with glutamine in patients with locally advanced non-small cell lung cancer.

Esophagitis is a dose-limiting toxicity of combined chemoradiation therapy in patients with locally advanced lung cancer. Our study aimed at minimizing this complication by using glutamine in an attempt to escalate the dose of chemotherapy. This was a Phase I trial of escalating the dose of weekly paclitaxel and carboplatin with concurrent radiation therapy. Fifteen patients were enrolled, with median age 62 years (58-78), 13 males and 12 Caucasians. Due to multiple severe toxicities including hematological toxicities and esophagitis, the combination was deemed not feasible. In conclusion, the addition of glutamine does not prevent serious toxities of this concurrent chemoradiotherapy regimen.

Adenotonsillectomy for obstructive sleep apnea syndrome in young children: prevalence of pulmonary complications.

OBJECTIVE: To determine, in a series of children younger than 6 years undergoing adenotonsillectomy for treatment of clinical obstructive sleep apnea syndrome (OSAS), the effect of age on prevalence of postoperative respiratory complications. The primary objective was to define a practice standard for postoperative hospital admission. DESIGN: Retrospective analysis. SETTING: Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. PATIENTS: All children younger than 6 years who underwent adenotonsillectomy to treat OSAS from June 1, 1999, to May 31, 2001. MAIN OUTCOME MEASURES: The percentage of children younger than 3 years undergoing adenotonsillectomy to treat OSAS who experience a postoperative respiratory complication. RESULTS: Of 2315 patients younger than 6 years undergoing an adenotonsillectomy for treatment of OSAS, 149 (6.4%) developed a postoperative respiratory complication. Even though there was a lower incidence of comorbid medical conditions in this cohort, children younger than 3 years were at a greater risk for developing a postoperative respiratory complication compared with those aged 3 to 5 years (9.8% vs 4.9%, P<.001). Logistic regression analysis revealed that children younger than 3 years had a nearly 2-fold increased risk for respiratory complications postoperatively (odds ratio, 1.98; 95% confidence interval, 1.41-2.77) when controlling for race and sex. CONCLUSIONS: Adenotonsillectomy to treat OSAS is associated with a significantly higher rate of postoperative respiratory complication in children younger than 3 years compared with children aged 3 to 5 years. Our results support hospital admission for all patients younger than 3 years undergoing adenotonsillectomy for treatment of OSAS.

Asthma as a risk factor for respiratory complications after adenotonsillectomy in children with obstructive breathing during sleep.

BACKGROUND: Children with asthma are at increased risk for obstructive breathing during sleep. Adenotonsillectomy, the treatment of choice for obstructive breathing during sleep, is associated with significant postoperative respiratory morbidity. OBJECTIVE: To determine whether asthma is a risk factor for respiratory complications after adenotonsillectomy in children with obstructive breathing during sleep. METHODS: This case-control study compared 115 children aged 3 to 18 years with respiratory complications after adenotonsillectomy (study group) with 115 children without respiratory complications after adenotonsillectomy (control group). RESULTS: The postoperative respiratory complications ranged from oxygen desaturation to respiratory failure that required mechanical ventilation. The study group had a higher proportion of children with asthma (P < .01). Logistic regression analysis showed that asthma increases the odds of postoperative respiratory complications to 4.4 (95% confidence interval, 2.13-9.0), after controlling for age, weight greater than the 97th percentile for age, sex, race, and medical conditions other than asthma. CONCLUSIONS: In children with obstructive breathing during sleep, the presence of asthma is associated with an increased risk of respiratory complications after adenotonsillectomy.

National evaluation of the US Department of Housing and Urban Development Lead-Based Paint Hazard Control Grant Program: study methods.

The US Department of Housing and Urban Development (HUD) undertook an evaluation of its Lead Hazard Control Grant Program between 1994 and 1999. The Evaluation is the largest study ever done on the effectiveness of lead hazard controls implemented in residential dwellings. The Evaluation had several major objectives: determining the effectiveness of various lead hazard controls in reducing residential dust lead levels and children's blood lead levels, establishing the costs of doing lead hazard control work and factors that influence those costs, determining the rate of clearance testing failures and their causes, and identifying possible negative effects of lead hazard control work on children's blood lead levels. This paper reports the overall research design and data collection methods of the Evaluation. The large number of dwelling units enrolled in the Evaluation was possible only by the innovative partnership among HUD, the Evaluators, and the grantees. HUD and the Evaluators relied on the grantees for essentially all of the data collection. The 14 participating HUD Lead Hazard Control Grantees were responsible for implementing the lead hazard control programs in their communities and collecting the study data. This paper describes the methods for recruiting and enrolling dwellings and families, collecting environmental and housing data, interviewing participating families, and collecting data on lead hazard control work performed and its costs. The paper also describes the basic quality control and quality assurance procedures used. The principal outcome measures were lead in dust collected using wipes from floors, window sills, and window troughs and lead in blood collected from children who were 6 years old or younger at enrollment. Data collection was conducted before intervention, immediately postintervention, and 6 and 12 months postintervention. For a subset of dwellings undergoing an extended follow-up data were also collected at 24 and 36 months postintervention. This paper provides the context for subsequent reports that will describe such findings as the influence of lead hazard control work on serial dust lead levels, the influence of lead hazard control work on serial blood lead levels in children, the nature and costs of the lead hazard control work done at the dwellings, and the experience of the grantees in meeting clearance testing requirements.

Prevalence and location of teeth marks observed on painted surfaces in an evaluation of the HUD lead hazard control grant program.

Data from an evaluation of the HUD Lead Hazard Control Grant Program were used to evaluate the prevalence and location of teeth marks on painted surfaces in residential housing. The results of these analyses will be useful in the development of more effective pediatric lead poisoning prevention programs. These programs have historically placed considerable emphasis on surfaces accessible to children for mouthing activities. This study analyzes the largest set of data ever assembled on the prevalence of teeth marks in housing. Data from 308,851 observations in 3,454 housing units were analyzed to determine the prevalence of teeth mark observations per surface, dwelling unit, and building component, and by housing age, inspector, and grantee. An average of 4.0 teeth marks per 10,000 surfaces with paint-lead greater than or equal to 1.0 mg/cm2 were observed. For surfaces with less than 1.0 mg/cm2 lead the rate was 1.5 teeth marks/10,000 surfaces. The number of teeth marks per 10,000 surfaces increased with age of housing for surfaces with 1.0 mg/cm2 or higher lead but not for surfaces with less than 1.0 mg/cm2 lead. Teeth mark observation rates were 36 times higher for windowsills than for other components and ranged up to 11 per 10,000 surfaces and 9 dwellings per 100 dwelling units for 2 grantees with the highest rates. Blood lead levels in children exhibiting moderate to high mouthing behavior were higher than in children without such behavior, especially in housing where teeth marks were observed. Special priority should be given to windowsills when making decisions on lead hazard control for "accessible," "chewable," or "mouthable" surfaces.