Shoulder belts in motor vehicle crashes: a statewide analysis of restraint efficacy.

The purpose of our study was to evaluate the impact of shoulder belt use on motor vehicle crash ejection, morbidity and mortality. We analyzed motor vehicle crash records linked to hospital inpatient data for front seat occupants of passenger cars in Utah between 1994 and 1996 (n = 103,035). Stochastic simulations were used to adjust for possible seatbelt misclassification. There were 276 (0.3%) occupants coded as using only a shoulder belt. The adjusted odds of ejection for shoulder only belted occupants was higher compared to lap-shoulder belted (odds ratio (OR) = 18.9; 95% confidence interval (CI) = 15.1, 25.1) and lap only belted occupants (OR = 4.3; 95% Cl = 2.9, 7.7). There was no difference in the odds of ejection for an occupant using a shoulder belt only and an occupant using no seatbelt (OR = 1.1; 95% CI = 1.0, 1.3). Occupants using a shoulder belt only were more likely to sustain a fatal or hospitalizing injury than lap-shoulder belted (OR = 2.3; 95% Cl = 1.9, 3.0), and lap only belted occupants (OR = 1.8; 95% CI = 1.3, 2.7), while controlling for other covariates. Occupants using only a shoulder belt had the same odds of a fatal or hospitalizing injury as unbelted occupants (OR = 1.1; 95% Cl = 0.9, 1.4). Average hospital inpatient length of stay, charges and injury severity scores were similar for all restraint types. These results stress the need for the use of a lap belt in conjunction with the shoulder belt.

Radiographic scoring method for the assessment of the severity of nutritional rickets.

Radiographic changes of rickets are well characterized, but no method of grading the severity of these changes has been in general use. Consequently, it is difficult to compare objectively or follow radiographic improvement. We prospectively evaluated the utility and reproducibility of a scoring method for measuring the severity of rickets. A 10-point score for radiographs of wrists and knees was devised to assess the degree of metaphyseal fraying and cupping and the proportion of the growth plate affected. The score progresses in half point increments from zero (normal) to 10 points (severe). Four trained physicians independently scored radiographs on two separate occasions from 67 children with active rickets. A broad representation of mean radiographic scores was moderately correlated with alkaline phosphatase (r = 0.58). Interobserver correlation of radiographic scores was 0.84 or greater for all observer pairs and intraobserver correlation was 0.89 or greater for each observer. Researchers and clinicians should find the score useful to assess objectively the severity of rickets.

A comparison of calcium, vitamin D, or both for nutritional rickets in Nigerian children.

BACKGROUND: Nutritional rickets remains prevalent in many tropical countries despite the fact that such countries have ample sunlight. Some postulate that a deficiency of dietary calcium, rather than vitamin D, is often responsible for rickets after infancy. METHODS: We enrolled 123 Nigerian children (median age, 46 months) with rickets in a randomized, double-blind, controlled trial of 24 weeks of treatment with vitamin D (600,000 U intramuscularly at enrollment and at 12 weeks), calcium (1000 mg daily), or a combination of vitamin D and calcium. We compared the calcium intake of the children at enrollment with that of control children without rickets who were matched for sex, age, and weight. We measured serum calcium and alkaline phosphatase and used a 10-point radiographic score to assess the response to treatment at 24 weeks. RESULTS: The daily dietary calcium intake was low in the children with rickets and the control children (median, 203 mg and 196 mg, respectively; P=0.64). Treatment produced a smaller increase in the mean (+/-SD) serum calcium concentration in the vitamin D group (from 7.8+/-0.8 mg per deciliter [2.0+/-0.2 mmol per liter] at base line to 8.3+/-0.7 mg per deciliter [2.1+/-0.2 mmol per liter] at 24 weeks) than in the calcium group (from 7.5+/-0.8 [1.9+/-0.2 mmol per liter] to 9.0+/-0.6 mg per deciliter [2.2+/-0.2 mmol per liter], P<0.001) or the combination-therapy group (from 7.7+/-1.0 [1.9+/-0.25 mmol per liter] to 9.1+/-0.6 mg per deciliter [2.3+/-0.2 mmol per liter], P<0.001). A greater proportion of children in the calcium and combination-therapy groups than in the vitamin D group reached the combined end point of a serum alkaline phosphatase concentration of 350 U per liter or less and radiographic evidence of nearly complete healing of rickets (61 percent, 58 percent, and 19 percent, respectively; P<0.001). CONCLUSIONS: Nigerian children with rickets have a low intake of calcium and have a better response to treatment with calcium alone or in combination with vitamin D than to treatment with vitamin D alone.

PIP: A randomized, double-blind, controlled trial was conducted to compare the efficacy of calcium, vitamin D, and a combination of both in the treatment of nutritional rickets among Nigerian children. Subjects included 123 Nigerian children with the deformity characteristics of rickets. For each child who was enrolled, a parent or guardian was asked to recruit a control child with the same sex, age, weight, and who had no clinical signs of rickets. Children with rickets were under treatment for 24 weeks with vitamin D (600,000 U intramuscularly at enrollment and at 12 weeks), calcium (1000 mg daily), or a combination of both. Then the serum calcium and alkaline phosphates were measured and a 10-point radiographic score was used to assess the response to the 24-week treatment. The results revealed a low dietary calcium intake in children with rickets and in control children. Children under vitamin D treatment appeared to have a small increase in the mean serum calcium concentration when compared to children under calcium treatment or a combination of both vitamin D and calcium. A greater proportion of children in the calcium and combination-therapy groups than in the vitamin D group reached the combined end point of a serum alkaline phosphates concentration of 350 U/liter or less and radiographic evidence of nearly complete healing of rickets. Overall, compliance ranged from 92% to 96% across the three groups. Since Nigerian children with rickets had low calcium intake, treatment should focus on dietary supplementation with calcium or a combination of calcium and vitamin D.

Open trial of thalidomide in the treatment of rheumatoid arthritis.

Reports on the use of thalidomide in the last 20 years have described favorable responses in a variety of inflammatory conditions. We have performed an open trial to begin to assess further its efficacy in rheumatoid arthritis (RA). During a 3-year-period, 31 patients with chronic active RA were enrolled into a 4-month open trial using thalidomide, to assess its efficacy and safety. Of these patients, 21 began the study taking 300 mg/day and the other 10 patients began at lesser doses that were increased gradually. Patients were evaluated at least 7 times during the 4-month study. Of the 31 patients, 17 (55%) withdrew from the study over the course of 12 weeks because of adverse events and no benefit was seen in any of these patients with a mean dose of 177 mg/day. There were 14 patients taking thalidomide for 4 months, and 4 of the 14 (29%) responded to therapy, satisfying at least 4 of the 6 Paulus criteria; 6 of 14 (43%) partially responded to therapy, satisfying 3 of the 6 Paulus criteria; and 4 of 14 (29%) did not respond, with each group taking average dosages, respectively, of 304 mg/day, 264 mg/day, and 303 mg/day. Of the 14 patients completing the 4-month study, 9 patients consented to participate in an extended trial of thalidomide treatment for at least 4 more months. Patients showing partial benefit within the first 4 months are more likely to show definite benefit later on.This study did not confirm the level of effect previously reported with thalidomide. However, some patients with previously refractory RA did improve. Although we had no comparison group, we believe that, as an investigational therapy, thalidomide should be considered in patients with RA for whom other conventional treatment approaches have failed. Thalidomide should be administered initially at 50 mg/hs for 1-2 weeks and then increased by 50 mg every 1-2 weeks as tolerated. The major obstacle to short term use of thalidomide is drowsiness and the major adverse effect to long term use is peripheral neuropathy.

Nonradiographic assessment of enteral feeding tube position.

OBJECTIVE: To determine whether a clinical, nonradiographic criterion can be used to predict when the tip of a blindly placed feeding tube is in the small intestine. DESIGN: Prospective sample. SETTING: Pediatric intensive care unit at a tertiary care children's hospital. PATIENTS: Critically ill children requiring transpyloric feeding. INTERVENTIONS: The small bowel was intubated, using a blind, bedside transpyloric feeding tube placement protocol. The feeding tube was considered to be in the small bowel when <2 mL of a 10- mL aliquot of insufflated air could be aspirated from the feeding tube. This clinical criterion was confirmed with an abdominal radiograph. MEASUREMENTS AND MAIN RESULTS: Patient age ranged from 1 month to 19 yrs (median 6 months). Weight ranged from 2.2 to 60 kg (median 4.9). Median time to feeding tube placement was 10 mins (range 5 to 60). Eighty-nine percent of the patients were mechanically ventilated, while 28% of these patients were pharmacologically paralyzed. Seventy-five feeding tubes were inserted. There were no known complications. Ninety-nine (74/75) percent of the feeding tubes were positioned in the small bowel. The inability to aspirate insufflated air correctly predicted small bowel intubation with 99% certainty (Sequential Probability Ratio Test, p = .05 and power = .80). This test incorrectly predicted the position of only one feeding tube, the 26th, which was in the stomach. Of the 74 feeding tubes positioned in the small bowel, 13 feeding tubes were in the duodenum and 61 were in the jejunum. CONCLUSIONS: The inability to aspirate insufflated air confirms the transpyloric position of a feeding tube. Other clinical criteria did not successfully predict small bowel intubation. Use of this single test may obviate confirmatory abdominal radiographs in carefully selected patients and may lead to more cost-effective and timely initiation of enteral feedings.

Serum phospholipase A2 activity in patients with rheumatoid arthritis before and after treatment with methotrexate, auranofin, or combination of the two.

OBJECTIVE: (1) To confirm a previous observation that serum phospholipase A2 (PLA2) activity correlates with disease activity in rheumatoid arthritis (RA); and (2) to determine whether serum PLA2 activity changes after treatment with methotrexate (MTX), auranofin (AF), or a combination of the 2 (COMBO). METHODS: Sera obtained at baseline and after treatment from 100 patients with RA (40 MTX, 32 AF, and 28 COMBO) who participated in a multicenter, double blind trial were tested for PLA2 activity using an assay that measures the release of radiolabeled 14C oleic acid from the cell membrane of Escherichia coli. Detailed statistical analysis was performed using previously collected clinical data to determine whether correlations exist between RA disease activity and serum PLA2 activity; whether baseline serum PLA2 activity predicted a therapeutic response in any treatment group; and whether there was a significant change in serum PLA2 activity after treatment in patients who responded to the various drugs. RESULTS: Baseline serum PLA2 activity was significantly increased in patients with RA compared to healthy controls. No correlation between serum PLA2 activity and RA disease activity was noted at baseline. Mean serum PLA2 activity did not change significantly after treatment with MTX, AF, or COMBO in either treatment responders or nonresponders. CONCLUSION: Serum PLA2 activity is increased in patients with RA compared to healthy controls, but does not correlate with disease activity in patients, nor does it predict a response to treatment with MTX, AF, or COMBO. Serum PLA2 activity also did not change significantly after treatment with any of the above agents.

Reliability and validity of the CSSRD functional assessment survey in rheumatoid arthritis. Cooperative Systematic Studies of Rheumatic Diseases.

OBJECTIVE: To demonstrate the reliability and validity characteristics of a fast, intensively focused functional assessment questionnaire that has been used in rheumatoid arthritis clinical trials by the Cooperative Systematic Studies of Rheumatic Diseases group (CSSRD). METHODS: Data from three double-blind, controlled clinical trials by CSSRD were used to examine the properties of the Functional Assessment Survey as a measure of physiologic function. RESULTS: The Functional Assessment Survey has reasonable test-retest reliability and convergent validity with the Steinbrocker et al. functional class. It demonstrated appropriate divergent validity with other clinical measures of response, as well as discriminant validity. CONCLUSIONS: The CSSRD Functional Assessment Survey is brief, intensive, and focused. Reliability and validity characteristics have been documented.

Comparison of aminobenzoate potassium and placebo in the treatment of scleroderma.

OBJECTIVE: To determine the safety and efficacy of aminobenzoate potassium (KPAB) in treating the skin manifestations of scleroderma. METHODS: Via a 48-week prospective, randomized, double blind, placebo controlled trial we compared the efficacy of KPAB 12 g/day with matching placebo. Outcome measures included skin mobility and thickening scores, patient and physician global assessments and, measurements of maximal oral aperture and hand range of motion. RESULTS: Of 146 patients who entered the study, 76 (52%) completed. Demographics of the study population included age 49 +/- 13 years, 83% women, mean (range) disease duration was 104 (7-600) months. There were no differences in the demographics of the KPAB vs placebo nor the group that completed the study compared with the withdrawal group. There were no clinical or statistically significant differences between the KPAB and the placebo treated groups in any of the outcome measures. Subgroup analyses of skin mobility and skin thickening based on age, extent of disease, severity of disease, duration of disease and involved vs uninvolved skin were performed, but no differences were noted. The overall compliance to the medical regimen was > or = 75% in 93% of patients completing the study. Eighteen patients in the KPAB group and 6 placebo patients withdrew due to adverse drug reactions (ADR). The most common withdrawals for ADR were gastrointestinal intolerance and headaches. All ADR resolved following withdrawal of medication. CONCLUSION: KPAB did not alter the skin changes of scleroderma in a group of patients with relatively longstanding stable disease. KPAB was reasonably well tolerated in this group of patients.

Radiographic assessment of disease progression in rheumatoid arthritis patients enrolled in the cooperative systematic studies of the rheumatic diseases program randomized clinical trial of methotrexate, auranofin, or a combination of the two.

OBJECTIVE: To determine the radiographic progression of disease in rheumatoid arthritis (RA) patients from the Cooperative Systematic Studies of the Rheumatic Diseases clinical trial of auranofin (AUR) versus methotrexate (MTX) versus a combination of the two. METHODS: Baseline (week-0) and study-end (week-48) hand/wrist radiographs in 200 of the 211 patients who completed this multicenter trial (95%) were scored blindly by 2 readers for the presence of erosions and joint space narrowing (JSN). Both intraobserver reliability and interobserver reliability were 0.80 for erosions (P < or = 0.001); intraobserver reliability and interobserver reliability were both 0.75 for JSN (P < or = 0.001). RESULTS: Worsening erosion and JSN scores occurred in all 3 treatment groups, but the difference from baseline reached significance only in the AUR group. CONCLUSION: Clinical improvement has been clearly documented in all 3 treatment groups in this trial. Radiographic deterioration occurs in RA even when clinical features improve, but progression of disease as determined radiographically may be slowed by treatment with MTX.

Early undifferentiated connective tissue disease: III. Outcome and prognostic indicators in early scleroderma (systemic sclerosis).

OBJECTIVE: To characterize the course of early scleroderma and to delineate prognostic factors present within 1 year of disease onset that might identify patients at high risk. DESIGN: Inception cohort study. SETTING: Ten university-based rheumatology clinics participating in the Cooperative Systematic Studies of Rheumatic Diseases Program. PATIENTS: Forty-eight patients who had had scleroderma for less than 1 year. MEASUREMENTS: Fifteen patients with early scleroderma who died were compared with those still living during the initial study period (1982 to 1992). Kaplan-Meier survival estimation and Cox proportional hazards analysis were used to analyze baseline variables for their ability to predict survival duration. RESULTS: Eight of 15 deaths were due to cardiac or pulmonary system failure. The estimated 5-year survival rate was 68%. Baseline factors that were the most predictive of a poor outcome included the presence of abnormal cardiopulmonary signs and abnormal urine sediment (pyuria, hematuria). CONCLUSION: Evidence of early cardiopulmonary disease, renal disease, inflammation, or immune activation may identify a subset of patients with scleroderma who will experience rapidly progressive disease and early death.

Outcome of treated pregnancies in women with antiphospholipid syndrome: an update of the Utah experience.

OBJECTIVE: To determine the outcome of treated pregnancies in women with well-characterized antiphospholipid syndrome. METHODS: We reviewed 82 consecutive pregnancies in 54 women with antiphospholipid syndrome who were treated during pregnancy with the following: 1) prednisone and low-dose aspirin; 2) heparin and low-dose aspirin; 3) prednisone, heparin, and low-dose aspirin; or 4) other combinations of these medications or immunoglobulin. RESULTS: The overall neonatal survival rate was 73%, excluding spontaneous abortions, but treatment failures (fetal and neonatal deaths) occurred in all treatment groups. Patients with successful treated pregnancies had fewer previous fetal deaths than those with unsuccessful treated pregnancies. There were no significant differences in outcome among the four treatment groups. Preeclampsia and fetal distress occurred in half of all pregnancies, and fetal growth impairment occurred in nearly one-third. Preterm delivery due to maternal or fetal indications was required in 37% of the pregnancies. Four pregnancies were also complicated by postpartum thrombosis during treatment. CONCLUSIONS: Pregnancy in women with antiphospholipid syndrome appears to be improved by treatment, but fetal loss may occur despite treatment. Preeclampsia, fetal distress, fetal growth impairment, and premature delivery are common. Because of the clinically significant risk of thrombotic episodes, thrombosis prophylaxis should be considered in these patients.

Teaching skills through the enhancement of natural antecedents.

The manipulation of the natural antecedents of a task offers a potentially valuable alternative to teaching strategies requiring the presentation of additional prompting stimuli, particularly in work with individuals with severe learning difficulties. The utility of procedures involving the enhancement of natural antecedents has frequently been demonstrated, but this has generally been with respect to tasks of limited ecological validity. This study reports an attempt to teach coat-buttoning skills to two women with severe learning difficulties using an antecedent enhancement procedure. Manipulation of the natural antecedents of coat buttoning produced swift acquisition of the required component responses in both subjects. Further, these skills generalized successfully across both materials (other coats) and time (6-month follow-up). Such antecedent enhancement procedures may be of particular value to the extent that they offer a consistent means of presenting subtle, interactive interventions without requiring advanced teaching skills on the part of staff.

Comparison of auranofin, methotrexate, and the combination of both in the treatment of rheumatoid arthritis. A controlled clinical trial.

OBJECTIVE: To compare the relative safety and efficacy of auranofin (AUR), methotrexate (MTX), and the combination of both in the treatment of active rheumatoid arthritis (RA). METHODS: Three hundred thirty-five patients with active RA were entered into a 48-week, prospective, controlled, double-blind, multicenter trial and were randomly assigned to 1 of 3 treatment groups. RESULTS: Two hundred eleven patients completed the trial. No remissions were seen, and there were no statistically significant differences among the treatment groups in the clinical or laboratory variables measured. Patients taking AUR alone had a slower onset of response than did patients taking MTX alone or in combination. Withdrawals because of adverse drug reactions were slightly more common for those taking combination therapy, but the differences were not statistically significant. Withdrawals because of lack of response were more common for single-drug therapy, with the difference between AUR and the combination reaching statistical significance. No unexpected adverse drug effects were identified, and all reactions resolved without sequelae. CONCLUSION: Except for fewer withdrawals because of lack of response, combination therapy did not demonstrate any advantage in efficacy over single-drug treatment within the time frame of the study.

Outcome of pregnancies experienced during residency.

To investigate potential adverse effects of residency training on pregnancy outcome, a cohort study was conducted among 45 university-affiliated residency programs. Outcomes of the first pregnancy experienced during residency were compared between 92 female residents and 144 spouses of male residents. Despite long hours, sleep deprivation, and an increase in perceived stress, the female residents were as likely to give birth to a live, full-term newborn as the spouses of male residents. For white cohort members, an increased risk of premature labor without delivery was identified (RR = 12.3, 95% confidence interval 2.4-61.6). No significant differences were found in prematurity, spontaneous and therapeutic abortions, or presence of congenital abnormalities in the infants. Method of delivery and use of anesthetics and of other medications were similar in both groups. Pregnancy outcomes between the two groups were similar; however, the increased risk for premature labor among female residents is a cause for concern and should be further investigated.

Implications of pregnancy for residents and their training programs.

This study investigated the implications of pregnancy on residents and their training programs and how programs have planned for pregnancy disruptions compared to other employers. We received questionnaires from 236 male and female residents and their families who had experienced at least one pregnancy during their training. Results for female residents were compared with working spouses of male residents. Approximately half of the female residents reported that their programs had formal leave policies compared to 70% of the working spouses. The average amount of leave taken by residents was considerably less than that taken by the spouse group. For both groups, 35% of all pregnancies were unplanned; 19% of these without benefit of birth control. Approximately 30% of both groups said they should have timed their pregnancies differently. Female residents were more likely to perceive their pregnancies as a stressful time. Despite this greater stress, female residents were equally as unlikely as spouses of male residents to miss work for pregnancy-related causes. This study supports the need for better planning for pregnancy during residency training.

Symptomatic lower extremity deep venous thrombosis: accuracy, limitations, and role of color duplex flow imaging in diagnosis.

Color duplex flow imaging (CDFI) permits pain- and risk-free direct imaging of the deep venous system of the lower extremities. To prospectively ascertain the accuracy and limitations of this technique, CDFI was performed in 75 lower limbs of 69 consecutive patients referred for venographic evaluation of clinically suspected lower extremity deep venous thrombosis (DVT). The CDFI study was obtained within 24 hours of the contrast venogram. Both studies were interpreted without knowledge of the patient's clinical findings or the results of the other test. Contrast venography was regarded as the standard for diagnosis of DVT. Accuracy was 99% for detection of DVT above the knee and 81% below the knee. Sonographic evaluation of the calf veins was technically adequate in 60% of limbs; accuracy was 98% in this group. In the 40% of limbs with technically limited CDFI studies of the calf, accuracy decreased to 57%. Although small nonocclusive thrombi occurred infrequently in this series of symptomatic patients, CDFI missed three of four such thrombi. It is concluded that CDFI, when not technically compromised, is sufficiently accurate to definitively diagnose symptomatic lower extremity DVT.

Clinical and laboratory outcomes during the treatment of rheumatoid arthritis with methotrexate.

Ten clinical and three laboratory outcomes were evaluated in 86 patients completing a double-blind placebo-controlled trial of methotrexate in rheumatoid arthritis. The improvement in all measured outcomes was statistically significantly better in patients receiving methotrexate than in patients receiving placebo. The correlations of the changes in outcome measures were calculated to determine if improvement in one parameter was associated with improvement in other clinical parameters. Associations between different clinical outcomes were often statistically significant. Associations between laboratory outcomes were also often statistically significant. However, the association between clinical outcomes and laboratory outcomes was generally poor.

Female residents not at increased risk for adverse pregnancy outcome.

A cohort study was conducted among 45 university-affiliated residency programs to investigate potential adverse effects of residency training on pregnancy outcome. Pregnancy outcomes between female residents and spouses of male residents were similar; however, the increased risk for premature labor among female residents is a cause for concern and should be further investigated.

The development and evaluation of a hydrobromic acid-coated sampling tube for measuring occupational exposures to ethylene oxide.

A new sampling method has been developed for the measurement of ethylene oxide (EtO) exposures in the workplace. This sampling method uses a hydrobromic acid-coated charcoal tube to collect EtO as its 2-bromoethanol reaction product. Because 2-bromoethanol is less volatile and less reactive than EtO, improved sampling capacity and sample stability are observed with this method over the collection of EtO on untreated charcoal. Sample analysis is performed by gas chromatography with electron capture detection (GC/ECD) following desorption with dimethylformamide (DMF) and derivatization of the 2-bromoethanol reaction product with heptafluorobutyrylimidazole (HFBI). The direct analysis of 2-bromoethanol by GC/ECD was not reproducible and this effect was attributed to the presence of excess hydrobromic acid (HBr) in the sample. This matrix effect was eliminated by the formation of the heptafluorobutyrate ester, a water-insoluble derivative of 2-bromoethanol, which was extracted into iso-octane for analysis. This analytical scheme is very sensitive and was used to monitor test atmospheres of EtO at the 0.1 ppm level. An average recovery of 96% was obtained for short-term samples (15 minutes) collected from a 5-ppm test atmosphere at 23 degrees C and 80% relative humidity. Similar high recoveries were obtained for 4-hr samples collected at a sampling rate of 0.1 L/min from test atmospheres in the concentration range of 0.1 to 16 ppm EtO at high humidity (80%) and ambient temperature (22 degrees C to 25 degrees C). Samples collected under these same conditions and stored for a minimum of 2 weeks resulted in average recoveries that ranged from 84% to 101%. Average recoveries of 97% were obtained for 2-ppm air samples collected at low humidity with no storage; however, storage of these samples at 22 degrees C to 25 degrees C resulted in an approximate loss of 5% per week. A field comparison study of samples, that was obtained from a hospital sterilization facility, used the test method and the Qazi-Ketchum sample method and resulted in a correlation for paired samples of 0.99 over a concentration range of 0.3 to 7.0 ppm EtO. These results indicate that this sampling and analytical method is a convenient, accurate and reliable means of monitoring EtO exposures in the workplace.