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Biomedical subjects

D E Shapiro

Publications and source records attributed to D E Shapiro.

33 records · Page 2Linked to original sources

Smooth non-parametric receiver operating characteristic (ROC) curves for continuous diagnostic tests.

Receiver operating characteristic (ROC) curves have seen increasing use to assess the accuracy of diagnostic tests that yield continuous test results. We can calculate a fully non-parametric ROC curve from the empirical false positive rate (FPR) and true positive rate (TPR) at each possible decision threshold, but it may be quite jagged. We can obtain a smooth ROC curve by directly fitting a parameteric model, for example, binormal or bilogistic, to the actual test results, but substantial lack-of-fit may result if the distributional assumptions are not valid. A recently proposed alternative algorithm 'LABROC4' is insensitive to such departures, but is not fully flexible in that the form of the resulting ROC curve is restricted to be binormal. We propose a smooth non-parametric ROC curve derived from kernel density estimates of the two test result distributions. We obtain pointwise standard errors for the estimated TPR at each FPR and use them to construct pointwise confidence intervals for the ROC curve, using a logit transformation. We also obtain standard errors for the estimated TPR and FPR at given thresholds and use them to construct confidence rectangles in (FPR, TPR)-space that correspond to a specific threshold. We adapt existing methods for the unsmoothed non-parametric ROC curve to obtain the area under the ROC curve and its standard error; we also give partial areas and corresponding standard errors. We have created a FORTRAN algorithm 'ROC-&-ROL', available upon request. We compare ROC curves and areas obtained by applying our methods and its competitors to two data sets, one of which is fit well by parametric methods and LABROC4, the other of which is not.

Algorithms↗

Stage II breast cancer: differences between four coping patterns in side effects during adjuvant chemotherapy.

Fifty-six women with stage II breast cancer receiving adjuvant chemotherapy were recruited for a study evaluating and comparing coping patterns for differences in physical and psychological side effects during treatment with adjuvant chemotherapy. Cluster analyses were used to split women into confrontive, avoidant-confrontive, avoidant-resigned, and resigned coping clusters. Side-effect measurements were taken on the day of adjuvant chemotherapy infusion and 3 and 7 days later. Repeated measures ANCOVAs indicated that coping clusters predicted significant variance in physical, psychological, and total side effects when variance in covariates was held constant. Confrontive subjects reported significantly fewer psychological and physical symptoms than avoidant-confrontive and avoidant-resigned copers. Confrontive copers also reported fewer side effects than resigned copers, but this difference was not significant when differences in covariate distributions were controlled. Particularly robust differences were noted when confrontive copers were compared with avoidant-confrontive copers. Results suggest that a critical component in optimal coping may be a willingness to discuss and think about illness.

Adaptation, Psychological↗

Analysis of the maternal components of the AIDS clinical trial group 076 zidovudine regimen in the prevention of mother-to-infant transmission of human immunodeficiency virus type 1.

To gain insight into the protective effects of the three components of the zidovudine regimen used in AIDS Clinical Trial Group (ACTG) 076 on mother-to-infant transmission of human immunodeficiency virus (HIV) type 1, 188 zidovudine-treated women and their untreated infants from five HIV-1 obstetric centers were retrospectively studied. The overall rate of mother-to-infant transmission was 12.3% (95% confidence interval [CI], 7.9%-18.0%). When the 38 women with <200 CD4 cells/microL were excluded, the mother-to-infant transmission rate was 8.8% (95% CI, 4.6%-14.8%). This rate compares favorably with the 8.3% transmission in the zidovudine arm of the ACTG 076 study. Apart from low (<200/microL) maternal CD4 cells (P = .016), no factors, including the duration of zidovudine therapy during gestation and intravenous administration of zidovudine during labor, affected the rate of mother-to-infant transmission. These findings suggest that antenatal oral zidovudine may be as effective as antenatal oral plus intravenous zidovudine during labor and the three-component ACTG 076 regimen in decreasing mother-to-infant HIV-1 transmission.

Acquired Immunodeficiency Syndrome↗

Diagnosis of vascular catheter-related bloodstream infection: a meta-analysis.

Catheter-related bloodstream infections increased in incidence during the past decade, causing significant morbidity, mortality, and excess hospital costs. Absence of inflammation at the catheter site in most cases makes clinical diagnosis uncertain. The relative accuracy and cost-effectiveness of different microbiologic tests for confirming that bloodstream infection is catheter related have remained unclear. A meta-analysis of published studies was conducted regarding the accuracy of diagnostic test methods using pooled sensitivity and specificity and summary receiver operating characteristic (ROC) curve analysis. The cost for each test was estimated by methods published by the College of American Pathologists. Costs of catheter replacement and antibiotic therapy for false positive results were included in the cost per accurate test result. Twenty-two studies evaluating six test methods met inclusion criteria for the meta-analysis. Accuracy increased in ROC analysis for catheter segment cultures with increasing quantitation (P = 0.03) (i.e., quantitative > semiquantitative > qualitative) largely due to an increase in specificity. The highest Youden index (mean = 0.85) was observed with quantitative catheter segment culture, the only method with pooled sensitivity and specificity above 90%. For blood culture methods, there was no statistically significant trend toward increased accuracy. The unpaired quantitative catheter blood culture offered the lowest cost per accurate test result but was only 78% sensitive. In conclusion, quantitative culture was the most accurate method for catheter segment culture, and unpaired quantitative catheter blood culture was the single most cost-effective test, especially for long-term catheters.

Bacteremia↗

Maternal viral load, zidovudine treatment, and the risk of transmission of human immunodeficiency virus type 1 from mother to infant. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group.

BACKGROUND AND METHODS: A placebo-controlled trial has shown that treatment with zidovudine reduces the rate at which human immunodeficiency virus type 1 (HIV-1) is transmitted from mother to infant. We present data from that trial showing the number of infected infants at 18 months of age and the relation between the maternal viral load, the risk of HIV-1 transmission, and the efficacy of zidovudine treatment. Viral cultures were obtained, and HIV-1 RNA was measured by two assays in samples of maternal blood obtained at study entry and at delivery. RESULTS: In 402 mother-infant pairs, the rate of transmission of HIV-1 was 7.6 percent (95 percent confidence interval, 4.3 to 12.3 percent) with zidovudine treatment and 22.6 percent (95 percent confidence interval, 17.0 to 29.0 percent) with placebo (P<0.001). In the placebo group, a large viral burden at entry or delivery or a positive culture was associated with an increased risk of transmission (the transmission rate was greater than 40 percent in the highest quartile of the RNA level). In both groups, transmission occurred at a wide range of maternal plasma HIV-1 RNA levels. Zidovudine reduced plasma RNA levels somewhat (median reduction, 0.24 log). Zidovudine was effective regardless of the HIV-1 RNA level or the CD4+ count at entry. In the zidovudine group, however, after we adjusted for the base-line HIV-1 RNA level and CD4+ count, the reduction in viral RNA from base line to delivery was not significantly associated with the risk of transmission of HIV-1. CONCLUSIONS: A high maternal plasma concentration of virus is a risk factor for the transmission of HIV-1 from an untreated mother to her infant. The reduction in such transmission after zidovudine treatment is only partly explained by the reduction in plasma levels of viral RNA. To prevent HIV-1 transmission, initiating maternal treatment with zidovudine is recommended regardless of the plasma level of HIV-1 RNA or the CD4+ count.

Anti-HIV Agents↗

Do consensus conferences influence their participants?

OBJECTIVE: To determine whether participation in a consensus conference on the assessment of dementia would influence conference participants with respect to their recommendations to primary care physicians for the assessment of dementia. DESIGN: Questionnaire before and after the conference. SETTING: Canadian Consensus Conference on the Assessment of Dementia, held in Montreal, Oct. 5 and 6, 1989. PARTICIPANTS: All 38 experts representing relevant health disciplines who participated in the consensus conference; 36 completed both questionnaires. OUTCOME MEASURES: Participants' opinion before and after the conference as to how frequently each of 28 manoeuvres (12 blood tests, 4 neurologic imaging procedures, 4 types of consultation and 8 "other" tests) should be ordered by primary care physicians as part of an assessment of a patient with dementia suspected in clinical grounds. RESULTS: For 18 (64%) of the 28 manoeuvres (10 of the 12 blood tests, 3 of the 4 neurologic imaging procedures and 5 of the 8 "other" tests), there was a shift in opinion after the conference toward recommending that primary care physicians order them less often; for 10 of these 18 (5 blood tests and 5 "other" tests) the shift was statistically significant. For the remaining 10 manoeuvres (36%) the shift in opinion was toward a recommendation that primary care physicians order them more often; the shift was not statistically significant for any of these 10 manoeuvres. CONCLUSION: Expert members of a consensus conference are influenced by the process of having participated in such a conference and are capable and willing to chance their initial recommendations when confronted with relevant data.

Clinical Laboratory Techniques↗

Cluster analysis of the medical coping modes questionnaire: evidence for coping with cancer styles?

A number of researchers have attempted to understand how individuals cope with having cancer. Unfortunately, this voluminous literature has suffered from a number of problems common to other pre-paridigmic disciples. Studies are generally isolated and fail to build upon other research in the literature. In addition, no guiding theory or conceptualization exists that helps to explain and describe the richness and complexity of observed clinical phenomena. With the understanding that coping with cancer is multidimensional, some researchers have attempted to group coping responses into dominant styles. In an effort to better understand the results of this approach, we performed a cluster analysis on 117 responses to a three scale questionnaire, the Medical Coping Modes Questionnaire. Results indicated that subjects can be grouped into one of four coping categories: confrontive, avoidant, resigned, or with a nondominant style. Future research is needed to explore how these styles influence quality of life during and following treatment.

Adaptation, Psychological↗

A controlled clinical trial with a specifically configured RNA drug, poly(I).poly(C12U), in chronic fatigue syndrome.

Chronic fatigue syndrome (CFS) is a physically debilitating illness associated with immunologic abnormalities, viral reactivation, and impairment of cognition. In a randomized, multicenter, placebo-controlled, double-blind study of 92 patients meeting the CFS case definition of the Centers for Disease Control and Prevention, the response of several laboratory and clinical variables to an antiviral and immunomodulatory drug, poly(I).poly(C12U), was determined. Measures of clinical response included Karnofsky performance score, a cognition scale derived from a self-administered instrument assessing symptomatology (SCL-90-R), an activities of daily living scale, and exercise treadmill performance. After 24 weeks, patients receiving poly(I).poly(C12U) had higher scores for both global performance and perceived cognition than did patients receiving placebo. In particular, patients given poly(I).poly(C12U) had increased Karnofsky performance scores (P < .03), exhibited a greater ability to do work during exercise treadmill testing (P = .01), displayed an enhanced capacity to perform the activities of daily living (P < .04), had a reduced cognitive deficit (P = .05), and required less use of other medications (P < .05).

Activities of Daily Living↗

The use of dermatomal evoked responses during surgical procedures that use intrapedicular fixation of the lumbosacral spine.

Monitoring of electrophysiologic function during intrapedicular fixation of the lumbosacral spine can be useful because this fixation technique has been associated with a significant number of postoperative radicular complications. Somatosensory evoked potentials (SEPs) traditionally have been used to monitor neurologic function during spinal instrumentation procedures. A case is presented of an intrapedicular fixation procedure that was monitored with SEPs and that resulted in false-negative SEP findings. This result suggests that SEPs may not be a sensitive enough monitoring tool for detecting compromise of single root function, and as a result, other monitoring techniques should be used. Dermatomal somatosensory evoked potentials (DSEPs) have been reported to be useful in this regard. To test their usefulness, 81 lumbosacral intrapedicular fixation procedures were monitored with DSEPs. Repeatable responses were obtained from all but one of the patients. The responses were sensitive to the compromise of root function. Predictions of postoperative outcome were dependent only on the responses at closing and not on changes that occurred during surgery.

Adult↗

The effect of varied physician affect on recall, anxiety, and perceptions in women at risk for breast cancer: an analogue study.

Evaluated the effect of varied physician affect on subject recall, anxiety, and perceptions in a simulated tense and ambiguous medical situation. Forty women at risk for breast cancer viewed videotapes of an oncologist presenting--with either worried or nonworried affect--mammogram results. Although the mammogram results and the oncologist were the same in both presentation, analyses indicated that, compared to the women receiving the results from a nonworried physician, the women receiving the results from a worried physician recalled significantly less information, perceived the clinical situation as significantly more severe, reported significantly higher levels of state anxiety, and had significantly higher pulse rates. These results suggest that physician affect plays a critical role in patient reaction to medical information. Implications for compliance research, patient satisfaction, and physician training are discussed.

Adult↗

The frequency of selective IgA deficiency in myasthenia gravis.

The frequency of selective IgA deficiency is unknown in myasthenia gravis. We screened a series of 333 consecutive adult myasthenic patients for selective IgA deficiency and found only one patient with a selective IgA deficiency, which is not significantly different from the normal population. Organ-specific autoimmune diseases may differ from systemic autoimmune diseases concerning their frequency of association with selective IgA deficiency.

Adult↗

Mismatched double-stranded RNA, Ampligen (poly(I): poly(C12U), demonstrates antiviral and immunostimulatory activities in HIV disease.

Mismatched double-stranded RNA (Ampligen) has broad spectrum antiviral and immunomodulatory activities. These activities generate stabilization or improvement in three important surrogate markers of HIV disease progression. Patients with HIV disease treated with Ampligen do not become positive for p24 antigen, in contrast to patients treated with AZT or placebo. Viral burden can also be decreased in patients receiving Ampligen/AZT therapy. In vitro studies indicate that both AZT sensitive and AZT resistant viruses can be inhibited by Ampligen alone and are synergistically inhibited by Ampligen in combination with AZT. The immunomodulatory effects of Ampligen are manifested as a stabilization of CD4 counts. When Ampligen is combined with AZT, an increase in CD4 count is seen. Furthermore, a return or increase in delayed type hypersensitivity to mumps, Candida, and trichophyton was seen in approximately 70% of patients treated with Ampligen. The activity of Ampligen in HIV disease is due to its multifunctional activity as an antiviral and immune stimulating agent. The antiviral effect directly inhibits HIV-infection and other viruses which have been implicated in HIV disease acceleration and progression. The immunomodulatory activity can stabilize, increase, or restore immune function. This enhanced immune function can also lead to the further inhibition of additional infections associated with disease progression. Thus, Ampligen has multiple mechanisms of action against HIV disease.

Adjuvants, Immunologic↗

The development of low-back pain after excision of a lumbar disc.

One hundred and twenty consecutive patients who had primary excision of a lumbar disc at a single level for predominantly radicular symptoms were studied. Of these patients, eighty-seven (72 per cent) were available for comprehensive review. The duration of follow-up ranged from twenty-four to eighty-seven months (average, thirty-eight months). Radiculopathy was initially relieved in eighty-six (99 per cent) of the patients, although six patients (7 per cent) had recurrent herniation, which was successfully treated by reoperation. In an additional twelve patients (14 per cent), the operation was deemed a failure due to subsequent disabling low-back pain. Narrowing of the disc space was present radiographically in 98 per cent of the patients, but the amount of narrowing did not correlate with the degree of low-back pain, the age of the patient, or the length of time after operation. Factors predisposing to failure of the operation due to disabling low-back pain included coverage under Workmen's Compensation (p less than 0.00001), a history of more than fifteen pack-years of cigarette-smoking (average, one pack a day for fifteen years) (p less than 0.01), and an age of more than forty years (p less than 0.05).

Adolescent↗

Pervasive emotion recognition deficit common to alexithymia and the repressive coping style.

OBJECTIVE: Previous research has demonstrated a deficit in the ability to recognize emotions in alexithymic individuals. The repressive coping style is thought to preferentially impair the detection of unpleasant compared with pleasant emotions, and the degree of deficit is typically thought to be less severe than in alexithymia. We compared emotion recognition ability in both individuals with alexithymia and those with the repressive coping style. METHODS: Three hundred seventy-nine subjects completed the 20-item Toronto Alexithymia Scale, the Levels of Emotional Awareness Scale, the Marlowe-Crowne Scale (a measure of repressive defensiveness), the Bendig Short Form of the Taylor Manifest Anxiety Scale, and the Perception of Affect Task. The Perception of Affect Task consists of four 35-item emotion recognition subtasks: matching sentences and words, faces and words, sentences and faces, and faces and photographs of scenes. The stimuli in each subtask consist of seven emotions (happiness, sadness, anger, fear, disgust, surprise, and neutral) depicted five times each. Recognition accuracy results were collapsed across subtasks within each emotion category. RESULTS: Highly alexithymic subjects (for all, p<.01) and those with low emotional awareness (for all, p<.001) were consistently less accurate in emotion recognition in all seven categories. Highly defensive subjects (including repressors) were less accurate in the detection of anger, sadness, fear, and happiness (for all, p<.05). Furthermore, scores on the Levels of Emotional Awareness Scale accounted for significantly more variance in performance on the Perception of Affect Task than scores on the Marlowe-Crowne Scale (p<.01). CONCLUSIONS: The results indicate that alexithymia and the repressive coping style are each associated with impairments in the recognition of both pleasant and unpleasant emotions and that the two styles of emotional self-regulation differ more in the magnitude than in the quality of these impairments.

Adaptation, Psychological↗