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Biomedical subjects

L E Braitman

Publications and source records attributed to L E Braitman.

At least 19 recordsLinked to original sources

Cocaine-exposed children: follow-up through 30 months.

This prospective, blinded study evaluates the effect of in utero cocaine exposure on outcome of nonasphyxiated, term and near-term children born to women of low socioeconomic status. Two hundred nineteen children (101 cocaine-exposed and 118 control) with extensive natal evaluations are evaluated at 6-month intervals. We report here growth, performance on the Bayley Scales of Infant Development (BSID) through 30 months of age, and tone and reflexes at 6 and 12 months. To date, subjects have had 816 follow-up visits, with subject retention greater than or equal to 73%. Cocaine-exposed children showed statistically lower mean weights and smaller mean head circumferences than control children over the 30-month follow-up period (p < or = .011). The percentage of children with abnormal tone and reflexes, however, was similar in the two groups at 6 and 12 months (p > or = .34). Mean BSID Mental Development Index (MDI) and Psychomotor Development Index scores did not differ between the two groups (p > or = .16), although both groups' scores decreased over time (p < .001). Of concern, both cocaine-exposed and control groups had lower mean MDI scores than those published for a group of children of higher socioeconomic status. We conclude that, in our cohort of children, low socioeconomic or minority status may have had a substantial influence on BSID scores whereas in utero drug exposure did not.

Adult

Diagnostic accuracy of an intrathecal test dose in epidural analgesia.

The authors evaluated the accuracy of an intrathecal test dose (TD) to rule out unintentional subarachnoid injection in a prospective and double-blind study. Twenty-nine unmedicated patients scheduled to receive continuous spinal analgesia for their surgical procedures entered the study. After placement of non-invasive monitoring (ECG, BP and SpO2), an intrathecal catheter was placed in the lumbar area. In the supine position 15 patients in the study group received lidocaine 45 mg + epinephrine 15 mg and 14 patients in the control group received normal saline 3 ml intrathecally. After the injection, a blinded observer assessed the presence of the following signs at one minute intervals for five minutes: sensory loss by pin-prick (P) over the lumbar and sacral dermatomes, ability to raise legs (R), and subjective feeling of warmth (W) and heaviness (H) over the lower limbs. For each sign the sensitivity (SN), specificity (SP), and negative (-) and positive (+) predictive value (PV) were calculated. At four minutes SN reached 100% (CI 78-100%) for R and H, while only R obtained a SP of 93% (CI 66-100%). Using R as detector of intrathecal injection the -PV was 100% and the +PV 25% (assuming a 2% prevalence of unintentional spinal). We conclude that, with our test dose; (a) four minutes are needed to recognize signs of intrathecal injection; (b) leg-raising is a reliable sign; and (c) inquiring about other signs may only decrease the diagnostic accuracy of this test.

Aged

Epidural test dose: lidocaine 100 mg, not chloroprocaine, is a symptomatic marker of i.v. injection in labouring parturients.

The authors studied the sensitivity (SN) and specificity (SP) of an epidural test dose containing either lidocaine 100 mg or 2-chloroprocaine 100 mg as symptomatic markers of intravascular injection in labouring parturients. In a prospective, double-blind and randomized fashion 48 unmedicated and labouring parturients were equally divided into three groups. After placement of a lumbar epidural catheter the normal saline group (NS) received 5 ml normal saline i.v., the lidocaine group (LD) received lidocaine 100 mg i.v., and the 2-chloroprocaine group (CH) received 2-chloroprocaine 100 mg i.v. All injections were given during uterine diastole. Within the next one to two minutes a blinded observer recorded the patient's perception of the presence of metallic or funny taste, dizziness, and tinnitus. We then calculated SN and SP of each symptom (alone and in combination) along with their positive (+) and negative (-) predictive value (PV). In both groups no symptom alone reached clinically acceptable levels of SN (< 87%). Only in the LD group, tinnitus+taste and dizziness+taste reached a SN of 100% with a SP of 81% and 69% respectively. While the -PV was 100% for both groups of symptoms, the +PV reached 42% for tinnitus+taste and 30% for dizziness+taste. We conclude that lidocaine 100 mg is a sensitive marker of intravascular injection in labouring parturients, and that tinnitus+taste is the most reliable indicator of intravenous injection.

Anesthesia, Epidural

Plasma concentration of endothelin-1 in women with cocaine-associated pregnancy complications.

OBJECTIVE: The purpose of this study was to determine if the plasma concentration of endothelin-1 is elevated in pregnant women abusing cocaine and to determine how these levels differ from those in patients with preeclampsia and in women with uncomplicated pregnancies. STUDY DESIGN: Plasma endothelin-1 levels were measured in 30 women with acute cocaine intoxication, 32 women with preeclampsia, 14 pregnant women with chronic hypertension, 26 women with uncomplicated pregnancies, and 16 nonpregnant individuals. Serial samples after delivery were obtained in 12 women with preeclampsia, 10 with cocaine abuse, 4 with chronic hypertension, and 7 with uncomplicated pregnancies. RESULTS: The mean endothelin-1 concentration in those with cocaine abuse was 18.2 +/- 8.1 pg/ml (95% confidence interval 15.2 to 21.2). This was similar to that in women with preeclampsia (21.1 +/- 5.9 pg/ml, 95% confidence interval 19 to 23.3) (p = 0.2) but significantly different from that in women with chronic hypertension (11.5 +/- 3.6 pg/ml, 95% confidence interval 9.4 to 13.6) (p < 0.001) and women with uncomplicated pregnancies (6.7 +/- 3.9 pg/ml, 95% confidence interval 5.1 to 8.2) (p < 0.001). CONCLUSIONS: Endothelin-1 levels in women abusing cocaine are comparable to those in women with preeclampsia and are significantly higher than those in gravid women with chronic hypertension and women with uncomplicated pregnancies. Elevated levels of endothelin-1 may contribute to some of the pregnancy-related complications in women abusing cocaine.

Adult

Endotracheal tube selection in children: a comparison of four methods.

STUDY OBJECTIVE: To determine the accuracy of four methods of endotracheal tube size selection in the pediatric population. STUDY DESIGN: Prospective, blinded comparison. SETTING: The Children's Hospital of Philadelphia. PARTICIPANTS: Two hundred thirty-seven children aged 1 month to 9 years old undergoing elective surgery requiring endotracheal intubation. SELECTION PROCEDURES: Consecutive sample. INTERVENTIONS: Four methods of determining proper endotracheal tube size in children were compared. These methods included direct comparison with the width of the fifth finger, direct comparison with the diameter of the fifth finger using a ring-sizing device, direct comparison with the width of the fifth fingernail, and estimation using a formula ([age in years + 16]/4). In infants, a 3.0-mm (internal diameter) endotracheal tube was predicted for those 3 months of age and younger, and a 3.5-mm endotracheal tube was predicted for those from 3 to 9 months of age. The size of the endotracheal tube used in the operating room was recorded, as was the "air leak" around the tube. An appropriately sized endotracheal tube was determined by an air leak with ventilation pressures between 5 and 40 cm of water. MAIN RESULTS: Direct comparison using the width and the diameter of the fifth finger predicted an endotracheal tube between 1 mm smaller and 0.5 mm larger than that used by the anesthesiologists in 11% and 14% of patients, respectively. The age-based formula predicted an endotracheal tube size in this range in 97.5% of patients, and direct comparison with the width of the fifth fingernail predicted an endotracheal tube in this same range in 91% of patients. These findings were consistent within all age groups studied. CONCLUSION: Neither fifth finger width nor fifth finger diameter accurately predicts proper endotracheal tube size in most children. A more accurate estimation can be made using the age-based formula, but when the child's age is unknown or when calculation is awkward or impossible, an accurate estimate can be made using the width of the fifth fingernail.

Child

Statistical estimates and clinical trials.

Statistical estimates and significance tests address distinct (but related) questions using the same data. Point estimates and confidence intervals of differences are statistical estimates that address: "How LARGE is the difference in the population of interest?" A significance test addresses the question: "How LIKELY was the difference to have occurred by chance?" Because p-values deal with the existence of a real nonzero difference between treatments but not the size of that treatment difference, they cannot be used to assess clinical (practical) significance. A confidence interval is a range of values used to infer both the size of a difference and the uncertainty of the estimate. Examples illustrate how confidence intervals help us assess both the clinical significance and the statistical significance of an observed difference. The point estimate is the outcome difference actually observed in the study sample; it is also the best single-number estimate of the unknown difference in the sampled population. Point estimates, confidence intervals, and p-values extract complementary information from study data and should all be reported for major results.

Clinical Trials as Topic

Magnetization transfer of hepatic lesions: evaluation of a novel contrast technique in the abdomen.

The authors evaluated the technique of magnetization transfer to determine if it could enable distinction of benign from malignant liver lesions. Thirteen patients with 27 hemangiomas or cysts and 13 patients with 31 malignant liver lesions underwent magnetic resonance imaging. Hepatic malignancies demonstrated magnetization transfer similar to that of the liver. However, hemangiomas and cysts showed significantly less magnetization transfer than malignant liver lesions. Gradient-recalled-echo imaging with the off-resonance saturation pulse showed increased lesion contrast compared with the liver for hemangiomas and cysts but not for malignancies. On the basis of signal intensity measurements alone (ie, ignoring morphologic criteria), the magnetization transfer studies showed an area under the receiver operating characteristic curve of 0.96 for distinguishing benign from malignant liver lesions. Though the separation of these two groups was imperfect, it was comparable with that achieved with qualitative analysis of signal intensity ratios at spin-echo imaging.

Cysts

Epidural test dose and intravascular injection in obstetrics: sensitivity, specificity, and lowest effective dose.

The authors studied the sensitivity and specificity of several epidural test doses as markers of intravascular injection in laboring patients in a prospective double-blind, randomized study. Fifty-nine parturients were assigned randomly to receive an intravenous injection of either normal saline solution (3 mL, NS group) or 1.5% lidocaine with epinephrine 1:200,000 (1 mL, EPI-5 group; 2 mL, EPI-10 group; or 3 mL, EPI-15 group). The EPI-5 and EPI-10 doses were diluted to 3 mL volume with normal saline solution. All injections were given during uterine diastole. Maternal heart rate was monitored with a pulse oximeter. An observer who was unaware of the study treatment recorded the baseline and the peak maternal heart rate within the first minute after the injection and questioned the patient about tinnitus, dizziness, metallic taste, and palpitations. He then recorded his opinion as to whether the patient had received the saline or the test solution. Analysis of the maternal heart rate showed an average increase (baseline-to-peak criterion) of 8 +/- 10 beats/min (mean +/- SD) in the NS group. In the other groups, the increase was 21 +/- 8 (EPI-5 group), 31.5 +/- 13 (EPI-10 group), and 29 +/- 9 beats/min (EPI-15 group). A baseline-to-peak criterion of greater than 10 beats/min identified all intravascular injections in the EPI-15 (by design) and EPI-10 groups (15 of 15 and 14 of 14, respectively) with a sensitivity of 100%. Specificity was 73% (11 of 15 true negatives).(ABSTRACT TRUNCATED AT 250 WORDS)

Analgesia, Epidural

Treatment of advanced and recurrent endometrial cancer with cisplatin, doxorubicin, and cyclophosphamide.

Twenty-five patients with recurrent or advanced-stage endometrial cancer were treated with cisplatin, doxorubicin, and cyclophosphamide (PAC) from May 1982 to November 1987. A retrospective chart analysis was performed to evaluate the effect of treatment on survival and progression-free interval. Toxicity was moderate. Neutropenia was the most common side effect. Age, performance status, and tumor cytoreduction were statistically significant predictors of survival time (P less than 0.03). In the 17 evaluable patients, the response rate was 47%. PAC is an active regimen in the treatment of endometrial cancer. Larger prospective studies are needed to evaluate whether tumor cytoreduction is important in the treatment of this disease.

Adult

Estimation of the risk of thrombocytopenia in the offspring of pregnant women with presumed immune thrombocytopenic purpura.

BACKGROUND AND METHODS: The optimal management of immune thrombocytopenic purpura during pregnancy remains controversial because the risk of severe neonatal thrombocytopenia remains uncertain. We studied the outcome of the index pregnancy in 162 women with a presumptive diagnosis of immune thrombocytopenic purpura to determine the frequency of neonatal thrombocytopenia and to determine whether neonatal risk could be predicted antenatally by history or platelet-antibody testing. RESULTS: Two maternal characteristics were identified as predicting a low risk of severe neonatal thrombocytopenia: the absence of a history of immune thrombocytopenic purpura before pregnancy, and the absence of circulating platelet antibodies in the women who did have a history of the condition. Eighteen of 88 neonates (20 percent; 95 percent confidence interval, 13 to 30 percent) born to women with a history of immune thrombocytopenic purpura had severe thrombocytopenia (platelet count less than 50 x 10(9) per liter at birth), as compared with 0 of 74 (0 percent; 95 percent confidence interval, 0 to 5 percent) born to women first noted to have thrombocytopenia during pregnancy (P less than 0.0001). Among the women with a history of immune thrombocytopenic purpura, 18 of 70 neonates (26 percent; 95 percent confidence interval, 16 to 38 percent) born to those with circulating platelet antibodies had severe thrombocytopenia, as compared with 0 of 18 infants (0 percent; 95 percent confidence interval, 0 to 18.5 percent) born to those without circulating antibodies (P less than 0.02). Thus, the risk of severe neonatal thrombocytopenia in the offspring of women without a history of immune thrombocytopenic purpura before pregnancy and of women with a history of the condition in whom circulating platelet antibodies are not detected was 0 percent (95 percent confidence intervals, 0 to 5 and 0 to 18.5 percent, respectively). CONCLUSIONS: The absence of a history of immune thrombocytopenic purpura or the presence of negative results on circulating-antibody testing in pregnant women indicates a minimal risk of severe neonatal thrombocytopenia in their offspring.

Autoantibodies

Posterior airway changes associated with mandibular advancement surgery: implications for patients with obstructive sleep apnea.

Obstructive sleep apnea syndrome is caused by loss of tone in the pharyngeal muscles. Bilateral sagittal ramus osteotomy has occasionally been used to treat this syndrome. To determine if postsurgical changes in posterior airway space are predictable, the posterior airway space in 25 patients who did not have obstructive sleep apnea was measured before and after surgery. Analysis revealed that the posterior airway space usually increased after advancement of the mandible, but the changes were varied. Therefore, the procedure may be helpful in some patients with obstructive sleep apnea syndrome and may obviate the need for tracheostomy, but success cannot be guaranteed.

Adolescent

Model predicting survival in stage I melanoma based on tumor progression.

We used the lesional steps in tumor progression and multivariable logistic regression to develop a prognostic model for primary, clinical stage I cutaneous melanoma. This model is 89% accurate in predicting survival. Using histologic criteria, we assigned melanomas to tumor progression steps by ascertaining their particular growth phase. These phases were the in situ and invasive radial growth phase and the vertical growth phase (the focal formation of a dermal tumor nodule or dermal tumor plaque within the radial growth phase or such dermal growth without an evident radial growth phase). After a minimum follow-up of 100.6 months and a median follow-up of 150.2 months, 122 invasive radial-growth-phase tumors were found to be without metastases. Eight-year survival among the 264 patients whose tumors had entered the vertical growth phase was 71.2%. Survival prediction in these patients was enhanced by the use of a multivariable logistic regression model. Twenty-three attributes were tested for entry into this model. Six had independently predictive prognostic information: (a) mitotic rate per square millimeter, (b) tumor-infiltrating lymphocytes, (c) tumor thickness, (d) anatomic site of primary melanoma, (e) sex of the patient, and (f) histologic regression. When mitotic rate per square millimeter, tumor-infiltrating lymphocytes, primary site, sex, and histologic regression are added to a logistic regression model containing tumor thickness alone, they are independent predictors of 8-year survival (P less than .0005).

Female

Obesity and caloric intake: the National Health and Nutrition Examination Survey of 1971-1975 (HANES I).

Most published studies have failed to show a greater food intake in obese subjects than in nonobese. However, the sample sizes in most of these studies are small and the methodologies open to question. HANES I is based on a probability sample of 20,749 people, representative of the civilian noninstitutional population of the U.S. We analyzed a subsample of 6219 nonpregnant adults whose diet was not influenced by illness or drugs and who stated that their intake, estimated by dietary interview, represented their usual pattern. Neither the caloric intake nor the caloric intake adjusted for physical activity level and age was higher in the obese subjects. This suggests that, unless estimates of food intake differ in accuracy between obese and nonobese subjects, factors other than overeating should be given increased consideration in the etiology of obesity.

Adult

Chronic thyroiditis and mitral valve prolapse.

Mitral valve prolapse is more prevalent in patients with autoimmune diffuse toxic goiter, suggesting a possible etiologic association. The prevalence of mitral valve prolapse was determined in 75 patients with chronic lymphocytic thyroiditis, another autoimmune thyroid disorder, and in 50 healthy control subjects. Mitral valve prolapse was found in 31 of 75 (41%) patients with chronic lymphocytic thyroiditis and in 4 of 50 (8%) controls (odds ratio, 8.10; 95% confidence interval, 2.64 to 24.83; p less than 0.0005). The age-race adjusted odds ratio was 9.26 (95% confidence interval, 2.83 to 30.26; p less than 0.0005). No correlation between the prevalence of mitral valve prolapse and the presence of hypothyroidism, serum antithyroid antibodies, or the duration of chronic lymphocytic thyroiditis was found. The prevalence of mitral valve prolapse is substantially increased in patients with the autoimmune thyroid disorders.

Adult