A new approach to selection and weighting of items in evaluative composite measurement scales

Evaluative composite measurement scales (CMS) are increasingly used in medicine to measure complex constructs in the absence of a reference criterion or ‘gold standard’. However, the level of measurement provided by these instruments has usually been given little attention. This paper explores the influence of the characteristics of the item set and weighting on the level of measurment of an evaluative CMS. The approach is illustrated with an application to the scoring system of the Nottingham Health Profile. Simulations are provided to indicate when the composite score of item responses, on an ordinal or pass—fail scale, could be considered to achieve the properties of an interval scale.     

Belt device for simplified CT-guided puncture and biopsy: A technical note

A new radiolucent device for increased accuracy of CT-guided fine-needle punctures permits precise determination of the optimum angle, depth, and position of the fine needle, which can be preset from the data supplied on the CT monitor. Puncture and repeat scans for controlling the tip of the needle can be performed with the patient in a stationary position. The device is designed as a belt that holds a needle holder sheath and a goniometric scale, both of which can be moved to varying positions around the patient.     

Threshold for occluded formaldehyde patch test in formaldehyde-sensitive patients

Our purpose was to investigate the eliciting threshold concentration of formaldehyde in formaldehyde-sensitive individuals in the occluded and non-occluded patch teat and to evaluate the relationship in repeated open application test (ROAT) with a product containing a formaldehyde releaser. 20 formaldehyde-sensitive patients and a control group of 20 healthy volunteer were included in the study. Occluded and non-occluded patch tests with formaldehyde solutions form 25 to 10,000 ppm. and ROAT for I week with a leave-on cosmetic product containing on average 300 ppm formaldehyde. Were carried out simultaneously on each subject. In the occluded patch test. 1/2 of the 20 patients only reacted to 10,000 ppm formaldehyde. 9 reacted to 5,000 ppm. 3 reacted to 1.000 ppm. 2 reacted to 500 ppm and I reacted to 25 ppm. No definite positive reactions were observed in the non-occluded patch test or in the ROAT No positive reactions were observed in the control group to any of the test procedures. We concluded that the threshold concentration for occluded patch test to formaldehyde in formaldehyde-sensitive patients was 250 ppm. The threshold in occluded patch test corresponded to the degree of sensitivity Definite positive reactions in the ROAT were not seen, either indicating that they are unlikely to happen with the type of product used or that the exposure time was too short.     

A new immune-competent animal model of mucosally derived squamous cell carcinoma.

OBJECTIVES: To develop an immune-competent animal model for mucosally derived squamous cell carcinoma (SCCA). STUDY DESIGN: Fifteen Fischer 344 rats were inoculated with 1, 2, 5, 10, or 20 x 10(6) FAT7 cells in their flanks. The animals were observed for tumor growth and metastasis. RESULTS: All animals developed tumors that grew exponentially. Pulmonary metastases developed in all animals and 13% developed lymph node metastases. CONCLUSION: The FAT7 flank tumor in Fischer 344 rats is a new animal model that closely resembles the behavior of human mucosal head and neck cancer. SIGNIFICANCE: The existence of an immune-competent, mucosally derived, and reliable animal model of SCCA that somewhat resembles human head and neck SCCA gives the opportunity to perform immune-modulating experiments on head and neck cancer in these animals. EBM rating: B-3.     

Longitudinal in vivo effects of growth hormone overexpression on bone in transgenic mice.

In this study we examined the effect of systemic overexpression of GH on bone in transgenic mice longitudinally in vivo over a period of 9 months. We observed substantially increased BMC in GH transgenic mice and a significant reduction in serum osteocalcin. GH effects on bone were strongly dependent on gender and developmental stage. INTRODUCTION: State-of-the-art bone marker and microimaging technology was applied in this longitudinal study to examine bone metabolism, BMC, bone density, and cortical bone structure over the life span of growth hormone (GH) transgenic (tg) mice. MATERIALS AND METHODS: Thirty-eight mice from four genetic groups (male, female, tg, and controls) were examined with DXA, and their femur and tibia were examined with peripheral QCT (pQCT). Osteocalcin (formation) and collagen cross-links (resorption) from serum and urine were also measured at postnatal weeks 3, 6, 9, 12, 18, 26, and 38. RESULTS: GH tg mice displayed a significant increase in body weight (up to 50%) and BMC (up to 90%), but serum osteocalcin was significantly reduced compared with controls. GH tg females (but not males) displayed increased trabecular density over controls up to week 12. In contrast, male (but not female) GH tg mice displayed a higher cortical cross-sectional area than controls. Cortical density was significantly lower in both male and female GH tg mice compared with control mice. CONCLUSIONS: The increase in BMC in GH tg mice is associated with reduced serum osteocalcin levels, indicating that bone turnover may be lower than in the control mice. On a structural level, bone responds to GH excess in a gender-specific manner, with alterations varying substantially between different developmental stages.     

Efficacy and safety of xaliproden in amyotrophic lateral sclerosis: results of two phase III trials.

Amyotrophic lateral sclerosis (ALS) is a relentlessly progressive and fatal motor neuron disease. We carried out two randomized, double-blind, placebo-controlled, multi-centre, multi-national studies with xaliproden (a drug with neurotrophic effect) to assess drug efficacy and safety at two doses. Patients with clinically probable or definite ALS of more than 6 months and less than 5 years duration were randomly assigned to placebo, 1 mg or 2 mg xaliproden orally once daily as monotherapy in Study 1 (n=867); or to the same regimen with addition of riluzole 50 mg bid background therapy in Study 2 (n=1210 patients). The two primary endpoints were defined as: 1. Time to death, tracheostomy, or permanent assisted ventilation (DTP), and 2. Time to vital capacity (VC)<50% or DTP before (log-rank test) and after adjustment using a Cox proportional hazard model for prespecified prognostic factors. Secondary endpoints were rates of change of various functional measures. In Study 1, primary outcome measures did not reach statistical significance. For the 2 mg group, for time to VC<50% analysis (without DTP) a significant 30% RRR was obtained (95% confidence interval [CI]: 8.46, P=0.009). In Study 2, no significant results were obtained. However, there was a trend in favour of add-on 1 mg dose xaliproden vs. placebo (RRR 15% [-6.31, ns] for time to VC<50%; RRR 12% [CI: -6.27, ns] for time to VC<50% or DTP). Adjusted RR ratios were consistently more favourable for the xaliproden groups. Tolerability was good, and dose-dependent side effects were largely associated with the serotonergic properties of xaliproden. An effect of xaliproden on functional parameters, especially VC, was noted. Although this effect did not reach statistical significance, xaliproden had a small effect on clinically noteworthy aspects of disease progression in ALS.     

Verbal memory errors and symptoms in schizophrenia.

OBJECTIVE: To extend and test hypotheses linking positive and negative symptoms to selective aspects of verbal memory in schizophrenia. BACKGROUND: Verbal memory includes the ability to discriminate and prevent the intrusion of irrelevant information into recall and recognition. This ability has been proposed as a cognitive process that differentially mediates positive and negative symptoms. METHOD: Four error discrimination and 1 general recall memory index from the California Verbal Learning Test as well as general ability (IQ) and sex were used as predictors of symptom ratings in 55 schizophrenia patients within a regression framework. RESULTS: Intrusion errors during free recall contributed significantly to the prediction equation for negative symptoms (Brief Psychiatric Rating Scale). In contrast, positive symptoms and general psychopathology were not predicted by any of the discrimination indices. However, general recall memory (California Verbal Learning Test total words trials 1-5) contributed significantly to the prediction of general psychopathology and marginally to the prediction of negative symptoms. CONCLUSIONS: Impaired recall memory predicts levels of nonspecific psychopathology in schizophrenia. Negative symptoms associate with low intrusion error rates, but there is no evidence of an association between elevated errors and positive symptoms.