M. Louise Lawson

Surgical repair of pectus excavatum markedly improves body image and perceived ability for physical activity: multicenter study.

OBJECTIVE. This study evaluated changes in both physical and psychosocial quality of life reported by the parent and child after surgical repair of pectus excavatum. METHODS. As part of a multicenter study of pectus excavatum, a previously validated tool called the Pectus Excavatum Evaluation Questionnaire was administered by the research coordinator, via telephone, to parents and patients (8–21 years of age) before and 1 year after surgery. Eleven North American childrens hospitals participated. From 2001 to 2006, 264 patients and 291 parents completed the initial questionnaire, and 247 patients and 274 parents completed the postoperative questionnaire. Responses used a Likert-type scale of 1 to 4, reflecting the extent or frequency of a particular experience, with higher values conveying less-desirable experience. RESULTS. Preoperative psychosocial functioning was unrelated to objective pectus excavatum severity (computed tomographic index). Patients and their parents reported significant positive postoperative changes. Improvements occurred in both physical and psychosocial functioning, including less social self-consciousness and a more-favorable body image. For children, the body image component improved from 2.30 ± 0.62 (mean ± SD) to 1.40 ± 0.42 after surgery and the physical difficulties component improved from 2.11 ± 0.82 to 1.37 ± 0.44. For the parent questionnaire, the childs emotional difficulties improved from 1.81 ± 0.70 to 1.24 ± 0.36, social self-consciousness improved from 2.86 ± 1.03 to 1.33 ± 0.68, and physical difficulties improved from 2.14 ± 0.75 to 1.32 ± 0.39. Ninety-seven percent of patients thought that surgery improved how their chest looked. CONCLUSIONS. Surgical repair of pectus excavatum can significantly improve the body image difficulties and limitations on physical activity experienced by patients. These results should prompt physicians to consider the physiologic and psychological implications of pectus excavatum just as they would any other physical deformity known to have such consequences.

A pilot study of the impact of surgical repair on disease-specific quality of life among patients with pectus excavatum.

BACKGROUND This study was conducted to determine the ability of 2 questionnaires (ie, child and parent versions) to measure physical and psychosocial quality-of-life changes after surgical repair of pectus excavatum. METHODS The authors administered these questionnaires by telephone interviews with 22 parents and 19 children (ages 8 to 18) before surgery and 6 to 12 months after repair by the Nuss procedure. RESULTS The instruments had high test-retest reliability (Rho > 0.6 for all retained questions). Children reported significant improvements in exercise intolerance, shortness of breath, and tiredness. Of 9 questions asking the children how they feel or act about their bodies, all but one question showed significant improvement after surgery. Parents also reported significant improvements in their childs exercise tolerance, chest pain, shortness of breath, and tiredness and decreases in the frequency of the child being frustrated, sad, self-conscious, and isolated. CONCLUSIONS These questionnaires appear to be more than adequate to measure disease-specific quality-of-life changes after surgery. These data confirm for the first time that surgical repair of pectus excavatum has a positive impact on both the physical and psychosocial well-being of the child.

Surfer's ear: External auditory exostoses are more prevalent in cold water surfers

OBJECTIVE: The study goal was to demonstrate the prevalence and severity of external auditory exostoses (EAEs) in a population of surfers and to examine the relationship between these lesions and the length of time surfed as well as water temperature in which the swimmers surfed. It was hypothesized that subjects who predominantly surfed in colder waters had more frequent and more severe exostoses. METHODS: Two hundred two avid surfers (91% male and 9% female, median age 17 years) were included in the study. EAEs were graded based on the extent of external auditory canal patency; grades of normal (100% patency), mild (66% to 99% patency), and moderate-severe (<66% patency) were assigned. Otoscopic findings were correlated with data collected via questionnaires that detailed surfing habits. RESULTS: There was a 38% overall prevalence of EAEs, with 69% of lesions graded as mild and 31% graded as moderate-severe. Professional surfers (odds ratio 3.8) and those subjects who surfed predominantly in colder waters (odds ratio 5.8) were found to be at a significantly increased risk for the development of EAEs. The number of years surfed was also found to be significant, increasing ones risk for developing an exostosis by 12% per year and for developing more severe lesions by 10% per year. Individuals who had moderate-severe EAEs were significantly more likely to be willing to surf in colder waters than were those who had mild EAEs (odds ratio 4.3). CONCLUSIONS: EAEs are more prevalent in cold water surfers, and additional years surfing increase ones risk not only for developing an EAE but also for developing more severe lesions.

Local anesthetic and stylet styles: factors associated with resident lumbar puncture success.

OBJECTIVE. To assess the effects of procedural techniques, local anesthetic use, and postgraduate training level on lumbar puncture (LP) success rates. METHODS. In this prospective observational study, medical students and residents (“trainees”) reported techniques used for infant LPs in an urban teaching emergency department. Data on postgraduate year, patient position, draping, total and trainee numbers of attempts, local anesthetic use, and timing of stylet removal were collected. Logistic regression analysis was used to identify predictors of successful LP, with success defined as the trainee obtaining cerebrospinal fluid with <1000 red blood cells per mm3. RESULTS. We collected data on 428 (72%) of 594 infant LPs performed during the study period. Of 377 performed by trainees, 279 (74%) were successful. Local anesthesia was used for 280 (74%), and 225 (60%) were performed with early stylet removal. Controlling for the total number of attempts, LPs were 3 times more likely to be successful among infants >12 weeks of age than among younger infants (odds ratio [OR]: 3.1; 95% confidence interval [CI]: 1.2–8.5). Controlling for attempts and age, LPs performed with local anesthetic were twice as likely to be successful (OR: 2.2; 95% CI: 1.04–4.6). For infants ≤12 weeks of age, early stylet removal improved success rates (OR: 2.4; 95% CI: 1.1–5.2). Position, drape use, and year of training were not significant predictors of success. CONCLUSIONS. Patient age, use of local anesthetic, and trainee stylet techniques were associated with LP success rates. This offers an additional rationale for pain control. Predictors identified in this study should be considered in the training of physicians, to maximize their success with this important procedure.

Increasing severity of pectus excavatum is associated with reduced pulmonary function

OBJECTIVE To determine whether pulmonary function decreases as a function of severity of pectus excavatum, and whether reduced function is restrictive or obstructive in nature in a large multicenter study. STUDY DESIGN We evaluated preoperative spirometry data in 310 patients and lung volumes in 218 patients aged 6 to 21 years at 11 North American centers. We modeled the impact of the severity of deformity (based on the Haller index) on pulmonary function. RESULTS The percentages of patients with abnormal forced vital capacity (FVC), forced expiratory volume in 1 second (FEV(1)), forced expiratory flow from 25% exhalation to 75% exhalation, and total lung capacity findings increased with increasing Haller index score. Less than 2% of patients demonstrated an obstructive pattern (FEV(1)/FVC <67%), and 14.5% demonstrated a restrictive pattern (FVC and FEV(1) <80% predicted; FEV(1)/FVC >80%). Patients with a Haller index of 7 are >4 times more likely to have an FVC of ≤80% than those with a Haller index of 4, and are also 4 times more likely to exhibit a restrictive pulmonary pattern. CONCLUSIONS Among patients presenting for surgical repair of pectus excavatum, those with more severe deformities have a much higher likelihood of decreased pulmonary function with a restrictive pulmonary pattern.

Multicenter Study of Pectus Excavatum, Final Report: Complications, Static/Exercise Pulmonary Function, and Anatomic Outcomes

BACKGROUND A multicenter study of pectus excavatum was described previously. This report presents our final results. STUDY DESIGN Patients treated surgically at 11 centers were followed prospectively. Each underwent a preoperative evaluation with CT scan, pulmonary function tests, and body image survey. Data were collected about associated conditions, complications, and perioperative pain. One year after treatment, patients underwent repeat chest CT scan, pulmonary function tests, and body image survey. A subset of 50 underwent exercise pulmonary function testing. RESULTS Of 327 patients, 284 underwent Nuss procedure and 43 underwent open procedure without mortality. Of 182 patients with complete follow-up (56%), 18% had late complications, similarly distributed, including substernal bar displacement in 7% and wound infection in 2%. Mean initial CT scan index of 4.4 improved to 3.0 post operation (severe >3.2, normal = 2.5). Computed tomography index improved at the deepest point (xiphoid) and also upper and middle sternum. Pulmonary function tests improved (forced vital capacity from 88% to 93%, forced expiratory volume in 1 second from 87% to 90%, and total lung capacity from 94% to 100% of predicted (p < 0.001 for each). VO2 max during peak exercise increased by 10.1% (p = 0.015) and O2 pulse by 19% (p = 0.007) in 20 subjects who completed both pre- and postoperative exercise tests. CONCLUSIONS There is significant improvement in lung function at rest and in VO2 max and O2 pulse after surgical correction of pectus excavatum, with CT index >3.2. Operative correction significantly reduces CT index and markedly improves the shape of the entire chest, and can be performed safely in a variety of centers.

Reliability of a staging assessment system for recurrent respiratory papillomatosis

INTRODUCTION A staging system for the assessment of severity of disease and response to the therapy in recurrent respiratory papillomatosis (RRP) was proposed several years ago. It includes both a subjective functional assessment of clinical parameters and an anatomic assessment of disease distribution. The anatomic score can then be used in combination with the functional score to measure an individual patients clinical course and response to the therapy over time. In using this system, it would be of benefit to know what level of variability can be expected from one surgeon to another in the assessment of an RRP patient and the assignment of a score. DESIGN Ten videotaped recordings of endoscopic assessments of patients with RRP were reviewed by 15 pediatric otolaryngologists and scored based on the criteria of the staging assessment system. RESULTS Analysis was conducted for 15 raters of scoring severity over 25 sites of 10 patients. The total score is the addition of scores over the 25 sites with a score equal to or greater than 20 representing high risk. For 8/10 (80%) of the subjects, there was a complete agreement about risk categorization (low risk) and agreement by 14/15 (93%) raters for categorization of one other patient. For 9/10 (90%) of subjects, the standard errors of the mean total scores were less than 1, meaning a low variance and subsequent high reliability of the total score. CONCLUSIONS This staging system was able to achieve agreement by 15 pediatric otolaryngologists on 9 of 10 subjects in terms of degree of severity of RRP.

Higher protein intake improves length, not weight, z scores in preterm infants.

Objective: The aim of the study was to evaluate the relation between nutritional intake (kilocalories, protein) and weight and length growth in preterm infants, and to describe their metabolic tolerance with a focus on those with high protein intake (≥4.6 g · kg−1 · day−1). Methods: Secondary analysis of data from appropriate-for-gestational age preterm infants in a 28-day randomized clinical trial that evaluated growth, tolerance, and safety of a new ultraconcentrated liquid human milk fortifier (original study n = 150). This subset of 56 infants had complete growth and nutrition data and met criteria for the original studys “efficacy analysis” (eg, >80% of kilocalorie intake from study diet). Nutritional intake was estimated, not actual. Regressions were used to test cumulative kilocalories and protein as the predictors of 28-day change in weight and length z scores (growth status), and to evaluate protein tolerance. Results: Average intake was 118 ± 8 kcal · kg−1 · day−1 and 4.3 ± 0.4 g protein · kg−1 · day−1, with 16 ± 3 g · kg−1 · day−1 and 1.1 ± 0.2 cm/week growth for 28 days. Cumulative total kilocalories and protein were significant predictors of improved length z score (P = 0.0054, 0.0005) but not weight z score change. Regression models indicated that protein not kilocalories explained the improvement in length z score, with protein explaining 19% of the variability. The high protein group averaged 4.6 to 5.5 g · kg−1 · day−1 (n = 16). Protein tolerance was adequate for all of the study infants based on metabolic measures (blood urea nitrogen, serum carbon dioxide, pH). Conclusions: Higher cumulative protein intake was tolerated and overall lessened the commonly occurring decline in the length but not weight growth status in a 28-day study of preterm infants.

Concerns with the methodology, analysis and discussion of the Buzzy® and transillumination comparison article

In the article by Dr. Lima-Oliveira et al., “A new device to relieve venipuncture pain can affect haematology test results”1, prolonged application of a Buzzy®/ice pack unit with the elastic tourniquet included resulted in different laboratory values from those in free-flowing blood collected with transillumination. As the physician inventor and manufacturer of the Buzzy® device, I appreciate the opportunity to respond to the findings, clarify appropriate use of our product, and illuminate a source of bias not considered in the discussion. As laboratory analysis and procedures are an integral part of the discussion, a statistician familiar with comparative sample methodology has reviewed the work as well. Buzzy® (MMJ Labs LLC, Atlanta, GA, Unites States of America) combines high frequency vibration with an optional ice pack; the healthcare version tested in this study came with an elastic black Velcro tourniquet to attach Buzzy® to the arm. When placed immediately prior to venipuncture Buzzy® has been shown to decrease pain significantly in adults without compromising the success of venous access2. In children, Buzzy® decreased pain by half compared to that present when a cold spray was used, and increased the likelihood of obtaining blood at the first attempt3,4. In contrast to the statements made in the article, we have no data to support that the pain relief will “enhance patients’ compliance during venous blood collection”, although Buzzy® has been used to enhance compliance with burning injections5. Our instructions state that Buzzy ®should be applied “immediately before cleaning and inserting IV”. In contrast to recommending 15 to 60 seconds of direct application to relieve the pain of IM (intramuscular) injections, the package insert notes that “direct or prolonged application of ice could vasoconstrict or alter lab values”. The theoretical concerns of both vasoconstriction and triggering cold agglutinins do not support prolonged application of Buzzy®, and we are concerned that the article by Lima-Oliveira et al. supports an incorrect usage of the device. The article indicates that Buzzy® was correctly placed 5 cm above the puncture site, but does not specify how Buzzy® was held in place. An article published by the same authors 2 months earlier compares Buzzy® to the same brand of transilluminator for blood chemistry evaluation, and uses the same sentences to describe methodology, including fasting, blood draw order, sequence, needle gauge, and 2 mL wastage. It is not stated in either paper whether Buzzy® is applied with the black elastic tourniquet strap; however in the chemistry paper a picture shows the application with the black tourniquet elastic constricting a patient’s arm. It is not clear in either paper whether Buzzy® was applied first for 1 minute, then blood was drawn from the opposite side using the transilluminator, then subsequently blood was drawn from the Buzzy® side. Depending on the procedure, the total Buzzy® application time would be between 90 and 180 seconds. The methods do specify that the transilluminator device was applied without a tourniquet. It is clear that there was no randomisation between whether blood was drawn first from the right or left arm. In all cases blood was drawn from the transilluminator side first, introducing order of draw as a potential confounder. There were few significant differences between the laboratory results between the two methods, even with a highly powered paired design. The differences found echoed the differences Dr. Lima-Oliveira reported in a previous paper comparing a tourniquet vs the transilluminator device for the collection of blood. According to the 2011 tourniquet/transilluminator paper6, when a tourniquet was left in place for 90 seconds significant differences were found in red blood cell counts, haemoglobin concentration, haematocrit, as well as eosinophils and basophils. In the Buzzy/transilluminator paper, differences were found in red blood cell count, haemoglobin concentration and haematocrit. It seems logical that the major differences between Buzzy® and the transilluminator may be largely due to the black elastic tourniquet, and not to the Buzzy. The authors state that “there is a tangible risk that some physicians could make inappropriate clinical decisions, e.g. delay or avoid RBC transfusions” due to the differences in laboratory values. They base this potential clinical risk on a 2.5% difference in haemoglobin (141.4 g/L vs 137.9 g/L) or a haematocrit difference of 2.2% (41.5 vs 40.6). The Authors neglect to mention that in their own comparisons between the transilluminator device and application of a tourniquet for 90 seconds, the haemoglobin and haematocrit differences were greater than those in the Buzzy®/transilluminator comparison (2.6% and 2.9%, respectively) (Table I). Following this logic, use of the transilluminator would be even more likely to contribute to the same dire clinical results when compared to the gold standard of tourniquet use, yet the authors praise the transilluminator in their previous articles and refer to it as the “gold standard” in their Buzzy® comparison papers. Table I Comparison between values in blood collected using a transilluminator (trans) and Buzzy® left 90–180 seconds1, and a transilluminator and tourniquet left 90 seconds6, with mean difference between paired results. Items in bold are statistically ... As a clinician, the most important finding comes from comparing the two transilluminator studies. While the prolonged tourniquet application caused platelet, white blood cell and neutrophil counts to increase by 4.8%, 4.2% and 3.6%, respectively (P=NS), in the Buzzy® study they fell by 2.9%, 3.9%, and 0.8%. The fact that these differences were not statistically significant in a paired evaluation may mean the differences were not clinically relevant, but this finding is worth reporting as many paediatric clinics may use Buzzy® when determining whether a patient is neutropenic. These results would cause a clinician to err conservatively, but are worth knowing in a worst-case application scenario. Because the Buzzy®/transilluminator paper does not mention the previous tourniquet/transilluminator paper, this result is not emphasised. For their analysis, Dr. Lima-Oliveira et al. used as a standard the allowed bias for laboratory quality control, and appear to have extrapolated that these constitute clinically significant differences. In laboratory quality control, multiple analyses of the same sample are run and compared to a reference database for optimal minimum differences, which are not generally achieved in the clinical laboratory setting7. According to the authors of the reference database Lima-Oliveira cites, there is a measure appropriate for clinical differences. Specifically, “The numerical value that delineates medically significant changes between two results, classically named “critical difference”8 and today called Reference Change Value (RCV), comes from the formula: RCV=k×2×CVA2+CVI2 with k=1.65 for a one tail test and a probability risk α of 95%, and CVA and CVI the analytical and the within-subject (or intra-individual) coefficients of variation, respectively9. It is unclear why this value was not used or at least reported, as it would provide the clinician with vital information that the “desired bias” values do not. While both transilluminator papers refer to the device as the “gold standard”, traditional laboratory value textbooks presumably used tourniquet samples rather than this new transilluminator device. As such, the term “gold standard” is possibly premature. Finally, the discussion of the effect of compression by Buzzy’s elastic tourniquet is absent. Dr. Lima-Oliveira has published five papers discussing the differences between constricted blood draws and free flowing blood draws using the transilluminator device, made in Brazil near his laboratory. For this reason, omission of the discussion of the contribution of prolonged tourniquet application is perplexing, as the papers were published prior to the current Buzzy®/transilluminator article. Given the use of Buzzy® against package insert instructions, lack of full discussion of methods, the knowledge that tourniquet compression causes greater laboratory changes than those found in the Buzzy® study, and the choice of analytic methods, the conclusion that “the novel Buzzy® device should be used with caution,” seems excessive and inexplicably biased. The knowledge that few laboratory values were in any way clinically different despite the prolonged application is useful, and we appreciate the time of the author in conducting this study.

Reply to the Letter to the Editor “Accurate Direct Measures Are Required to Validate Derived Measures”

for each gestational age. Interestingly, including these outliers does not meaningfully change our charts or our conclusions (paper in progress). It is our hypothesis that most measurements are accurate and that the errors are uniform in direction: both overand underestimates of the true measurement occur with the same frequency. Others share this opinion and have discussed this issue [6]. We believe the median values we report are accurate reflections of prematurely born infants. In 2 previous publications [7, 8], we discussed the limitations of using administrative data to define what is normal. Preterm birth is not a normal event, and even when we try to create a “normal” sample of preterm infants there will be some selection bias. The authors of the INTERGROWTH21st growth charts comment on how sampling only low-risk infants results in relatively few eligible preterm infants [9]. Dr. Pereira-da-Silva and Dr. Virella also detailed the limitations of assessing growth of premature infants using cross-sectional data Dear Sir, We appreciate and agree with the concerns expressed by Dr. Pereira-da-Silva and Dr. Virella [1]. The precise method by which length was measured for each infant in the study cohort used for our growth curves [2, 3] is not reported in the Pediatrix Clinical Data Warehouse. When we surveyed our sites, almost all reported using tape measurements. We are actively involved in promoting a more accurate and uniform approach to measurements of premature infants using length boards, especially in light of newer data on the impact of linear growth on important health outcomes, e.g., neurodevelopment [4, 5]. We recognize that measurements of weight, length, and head circumference are difficult and that there were likely some errors made in making these measurements. For this reason, we excluded extreme outliers for any of the growth measures (weight, length, or head circumference), defining these as infants with values greater than 2 times the interquartile range above the 75th percentile or below the 25th percentile Received: December 12, 2017 Accepted: December 12, 2107 Published online: January 31, 2018