Evaluating the self-esteem of myopic children over a three-year period: The COMET Experience.

PURPOSE: The purposes of this study were to evaluate self-esteem over 3 years in the 469 myopic children participating in the Correction of Myopia Evaluation Trial (COMET), and to examine its relationship with lens assignment (progressive addition lenses [PALs] vs. single-vision lenses [SVLs]), myopia progression, and several other ocular and demographic characteristics. METHODS: Data collection included refractive error measurements, child-reported visual symptoms, attitude toward glasses, adherence, and self-esteem as measured by the Self-Perception Profile for Children (SPPC). A two-way analysis of variance (treatment group x time) was performed to examine whether PAL and SVL wearers differed in self-esteem over time. Multiple regression analyses were used to evaluate associations between self-esteem at follow-up and relevant factors identified by univariate analyses. RESULTS: Regardless of lens assignment or myopia progression, COMET children reported moderate to high levels of self-esteem at follow-up in the areas of scholastic and athletic competence, physical appearance, social acceptance, behavioral conduct, and global self-worth. Mean scores ranged from 2.87 (+/- 0.68) on athletic competence to 3.40 (+/- 0.56) on global self-worth. Self-esteem changed significantly (p < 0.05) over 3 years in the domains of scholastic competence, social acceptance, and physical appearance. Self-esteem at follow-up was associated with visual symptoms, attitude toward glasses, age, gender, and ethnicity. CONCLUSIONS: Lens assignment and myopia progression were not associated with self-esteem in the COMET cohort. These children had high levels of self-esteem, suggesting that having myopia does not negatively impact self-esteem. Follow-up reports will monitor self-esteem and related factors in this cohort of myopic children over the course of adolescence and early adulthood.     

Prevalence of HBsAg carriers in native and immigrant pregnant female populations in Israel and passive/active vaccination against HBV of newborns at risk.

Israel has no official prevention policy at present against perinatal and horizontal transmission of hepatitis B virus (HBV) infection in newborns and children at risk. The present study was designed to assess the prevalence of HBV carrier state in a population of 11,123 pregnant women at term. Among this population (mean age 29.7 +/- 5.9), 98 women (0.88%) were found to be asymptomatic HBsAg+ carriers, and 97% of these carriers were anti-HBe+. Evidence for HBV replication, as determined by serum HBV-DNA, was established in 6.6% of the HBsAg+/anti-HBe+ population. The HBsAg carrier rate was strongly influenced by religion, continent, and country of birth of the carrier mothers. The highest relative carrier rate was found among women of Moslem origin (4.3%), as compared to Jewish women (0.67%). Most carrier women were born in Israel (56.1%) to mothers who had emigrated from regions with intermediate or high endemicity of HBV, such as North Africa or the Middle East. In these groups, the HBsAg carrier rate ranged between 1.2 and 3.0%. Ninety-three percent of newborns receiving passive/active vaccination against HBV developed protective levels of anti-HBs. Finally, evidence for horizontal transmission of HBV was found in 19.3% of 83 non-vaccinated children in families of HBsAg carriers. The present study therefore establishes HBsAg prevalence rates in specific risk groups of women at term and confirms the need for an official policy on immunization against HBV in Israel. Since over 50% of women at term belong to the defined risk groups, universal active vaccination of the entire newborn population each year is suggested as the most rational and needed policy in Israel.     

Vesicocolic fistula due to "collision" between adenocarcinoma of the colon and transitional cell carcinoma of the urinary bladder.

A patient with sigmoidocystic fistula due to "collision" between mucoid adenocarcinoma of the colon and transitional cell carcinoma of the urinary bladder is presented. A wide resection of the colonic tumor, along with the involved bladder segment, and a decompressive colostomy with bladder drainage by catheter, were performed. The clinical symptoms, diagnostic procedures, operative treatment, and prognosis are discussed. Although fistular formation is an indication of advanced carcinoma, wide resection of the tumor and the associated fistular along with the node-bearing area will result in a reasonable percentage of 5-year survivals.     

Neurophysiologic Monitoring Can Predict Iatrogenic Injury During Acetabular and Pelvic Fracture Fixation

Background:

Nerve injury during acetabular and pelvic fracture fixation can have devastating consequences for trauma patients already in a compromised situation.

Questions/Purposes:

This study aims to evaluate the efficacy of multimodality intraoperative neurophysiologic monitoring during acetabular and pelvic fracture fixation in identifying emerging iatrogenic nerve injury.

Methods:

Sixty patients were retrospectively identified after surgical fixation following acetabular or pelvic fracture. Neuromonitoring during surgery was performed using three different modalities, transcranial electric motor evoked potential (tceMEP), somatosensory evoked potential (SSEP), and electromyographic (EMG) monitoring. Each modality was evaluated for sensitivity and specificity of detecting an intraoperative nerve injury.

Results:

tceMEP monitoring was found to be 100% sensitive and 86% specific at detecting an impending nerve injury. The sensitivity and specificity of SSEP were 75% and 94%, while EMG sensitivity was unacceptably low at 20% although specificity was 93%.

Conclusions:

Multimodality neuromonitoring of transcranial electric motor and peroneal nerve somatosensory evoked potentials with or without spontaneous EMG monitoring is a safe and effective method for detecting impending nerve injury during acetabular and pelvic surgery.     

Toward more specific and transparent research and development costs: The case of seasonal influenza vaccines

Background

The ability to calculate the development costs for specific medicines and vaccines is important to inform investments in innovation. Unfortunately, the literature is predominated by non-reproducible studies only measuring aggregate level drug research and development (R&D) costs. We describe methodology that improves the transparency and reproducibility of primary indication expected R&D expenditures.

Methods

We used publically accessible clinical trial data to investigate the fate of all seasonal influenza vaccine candidates that entered clinical development post year 2000. We calculated development times and probabilities of success for these candidates through the various phases of clinical development. Clinical trial cost data obtained from university based clinical researchers were used to estimate the costs of each phase of development. The cost of preclinical development was estimated using published literature.

Results

A vaccine candidate entering pre-clinical development in 2011 would be expected to achieve licensure in 2022; all costs are reported in 2022 Canadian dollars (CAD). After applying a 9% cost of capital, the capitalized total R&D expenditure amounts to $474.88 million CAD.

Conclusion

Clinical development costs for vaccines and drugs can be estimated with increased specificity and transparency using public sources of data. The robustness of these estimates will only increase over time due to public disclosure incentives first introduced in the late 1990s. However, preclinical development costs remain difficult to estimate from public data.     

Ethnical and clinical aspects of chronic lymphocytic leukemia in Israel: a survey on 288 patients.

The ethnic distribution of 288 patients with chronic lymphocytic leukemia (CLL) from five medical centers in Israel during the decade 1960--1970 was investigated as well as other features of the disease. 80.5% of the patients were of East European descent, 14.5% originated from Asia and Africa and 5% were born in Israel. Based on the ethnic distribution of the elderly population of Israel during the above period, it is suggested that CLL occurs more frequently in European-born Jews than in Asian and African Jews. A low occurrence of Coombs positive hemolytic anemia was revealed, amounting to 7.2% of the patients. Of 68 patients who underwent serum immunoglobulin studies, up to 74% exhibited deficiency of at least one type of immunoglobulin. Low levels of IgA were encountered in 61.2%, IgM in 51.5% and IgG in 29.5% of the patients. 26 of 206 patients with CLL (12.5%), all of East European origin, had an additional primary malignant tumor, cancer of the skin and breast being the most frequent associated malignancies. In 6 patients of the 26, two additional neoplasms were diagnosed. Hypogammaglobulinemia was more frequent in patients with additional primary malignant tumors and in patients with advanced disease. The possible causes for the ethnic distribution of CLL in Israil as well as of other tumors are discussed.     

Pulmonary and systemic consequences of localized acid aspiration

Acid aspiration may recruit a generalized inflammatory reaction that can potentiate the local injury. After surgical isolation of bronchi in a group of 15 dogs, 1 milliliter per kilogram of 0.37 normal hydrochloric acid was instilled into either side. After five minutes, platelet and white blood cell counts fell to 10,000 and 1,000 per cubic millimeter (p less than 0.05). Platelet aggregates were noted in blood smears. 111Indium-platelet activity doubled over both the aspirated and nonaspirated lung (p less than 0.05). Physiologic dead space rose from 18 to 67 per cent and to 46 per cent in the aspirated and nonaspirated lung (p less than 0.05). Physiologic shunt increased from 12 to 47 per cent and to 43 per cent (p less than 0.05) on the two sides. Plasma thromboxane B2 levels at 30 minutes rose from 0.28 to 0.93 nanograms per milliliter (p less than 0.05). Edema fluid from the aspirated lung had thromboxane B2 values of 2.87 nanograms per milliliter, indicating pulmonary synthesis. Within five minutes of aspiration, systemic effects were prominent; mean arterial pressure fell from 114 to 46 milliliters of mercury (p less than 0.05), and the cardiac index fell 24 per cent from 106 to 81 milliliters per kilogram per minute (p less than 0.05) along with an 18 per cent decrease in contractility of a rat papillary muscle bathed in plasma from the aspirated dog. Mean pulmonary arterial pressure rose from 12 to 18 millimeters of mercury (p less than 0.05). Despite fluid infusion at 36 milliliters per kilogram per hour to keep wedge pressure constant at 5.5 millimeters of mercury, and sampling of one-third the blood volume, hemoglobin concentration rose 0.9 grams per cent (p less than 0.05) indicating increased microvascular permeability. At autopsy, the aspirated and nonaspirated lung were indistinguishable with congestion, interstitial hemorrhage, and white blood cell infiltrates. Systemic organs showed vascular congestion and edema. These data demonstrate that local aspiration leads to generalized inflammatory sequelae with cardiopulmonary failure.