Measuring quality of life in secure care: comparison of mentally ill and personality disordered patients

Improving quality of life for patients is emerging as a legitimate goal for UK inpatient forensic mental health services. The Lancashire Quality of Life Profile (LQOLP), which has been used widely to measure well-being in community settings, was trialed on an inpatient population being cared for under conditions of high security. Two groups of male patients, drawn from within the same institution but with markedly different clinical conditions, i.e. schizophrenia (N = 47) and personality disorder (N = 48), were interviewed using the LQOLP. Although both groups had been cared for under largely similar environmental conditions over similar lengths of time (9.5 years), the subjective global well-being of the two groups differed systematically as did other objective and subjective well-being measures. However, analysis found that the variations in global well-being could not be attributed readily to factors covered by the interview, including either current mood or personality. Possible reasons for these findings and implications for the use of the LQOLP under conditions of high security are discussed.     

Unusual fractures and dislocations of the axis vertebra

Seven percent of 400 patients with cervical spine fractures and/or dislocations had unusual lesions of the axis. The authors have analyzed axis injuries by review of radiographs and clinical data and have derived a classification of traumatic conditions. Uncommon traumatic axis abnormalities are discussed with reference to incidence, causes, clinical findings, mechanism of injury, and roentgen characteristics.Picker Scholar, James Picker Foundation     

Aging model for unexposed human dermis.

Young human dermis is charterized by the presence of many fibroblasts with distended endoplasmic reticulum, extensive Golgi bodies, and orderly and "clean"-appearing groundwork. Older dermis contains inactive fibrocytes with lipofuscin-like granules, macrophages with dense granules, and extracellular spaces with evidence of degeneration. We have found the sex skin of cycling pigtail macaques (Macaca nemestrina) a predictable model for studies on aging changes in human dermis. Swollen sex skin has many biochemical and ultrastructural properties that are similar to those of young dermis, and deflated sex skin resembles older human skin. Sex skin, however, is unique in that it becomes "rejuvenated" with each succeeding ovarian cycle. This animal model may prove useful to researchers attempting to increase their understanding of aging in connective tissue.     

Associations between both genetic and environmental biomarkers and lung cancer: evidence of a greater risk of lung cancer in women smokers

This molecular epidemiologic case-control study of lung cancer incorporated three complementary biomarkers: the glutathione S- transferase M1 (GSTM1) null genotype, a potential marker of susceptibility, and polycyclic aromatic hydrocarbon-DNA adducts (PAH- DNA) and sister chromatid exchanges (SCE), both indicators of environmentally induced genetic damage. Associations between biomarkers and lung cancer were investigated, as were possible gene-environment interactions between the GSTM1 null genotype and tobacco smoke exposure. Subjects included 136 primary non-small cell lung cancer surgical patients and 115 controls at the Columbia Presbyterian Medical Center. Questionnaire and Tumor Registry data, pre-treatment blood samples and biomarker measurements on blood were obtained. Overall, GSTM1 null genotype was significantly associated with lung cancer [odds ratio (OR) = 2.04, 95% confidence interval (CI) = 1.13-3.68]. ORs for GSTM1 and lung cancer were significant in females (2.50, 1.09-5.72) and smokers (2.25, 1.11-4.54) and not significant in males (1.4, 0.58-3.38) and non-smokers (0.88, 0.18-4.33). However, ORs for males versus females and smokers versus non-smokers did not differ significantly. The OR for GSTM1 and lung cancer in female smokers was 3.03 (1.09- 8.40), compared with 1.42 (0.53-4.06) in male smokers. In contrast to PAH-DNA adducts in leukocytes, SCE did not differ between cases and controls. Neither biomarker differed significantly between the two GSTM1 genotypes. The combined effect of elevated PAH-DNA adducts and GSTM1 genotype on case-control status (16.19, 1.2-115) appeared multiplicative. Results suggest that the effect of the GSTM1 null genotype is greatest in female smokers, which is consistent with other evidence that indicates that women are at higher risk of lung cancer than males, given equal smoking. Persons with both the GSTM1 deletion and elevated PAH-DNA adducts may represent a sensitive subpopulation with respect to carcinogens in tobacco smoke and other environmental media.      

Radiologically placed temporary hepatic artery catheter for treatment of liver cancer

Hepatic artery infusion (HAI) chemotherapy is associated with higher response rates compared to systemic chemotherapy in those patients with unresectable liver malignancies. Operative hepatic artery catheter (HAC) insertion has significant morbidity and mortality, especially in patients with high‐volume disease, some of whom may not respond to HAI chemotherapy. We report our experience in 45 patients with high‐volume liver disease who were initially treated with HAI chemotherapy via a radiologically placed temporary HAC to try to select the responders who then went on to have an operative HAC. In these 45 patients who had 62 radiologically placed HAC, we found very few major complications, and certainly no complications such as cholecystitis, vascular or malperfusion problems.     

Connecting food,well-being and environmental sustainability: towards an integrative public health nutrition

Modern society has no shortage of human nutrition science, nor interventions designed to improve the way we eat. Yet nutrition science, and the models, approaches and interventions derived from this, is apparently delivering diminishing returns in terms of population weight gain, unhealthy eating patterns and the obesity ‘epidemic’. We draw on a range of literature(s) to argue that public health nutritionists in affluent societies face an ingenuity gap – a series of complex and inter-connected challenges which are neither fully recognised nor easily amenable to resolution through conventional thinking and practice. Four such challenges are: nutritionism; economism; consumerism and individualism. We use an integrative framework to explain their significance for public health nutrition, where they exert a combined and compounding influence. In addition to these problems, insights from other disciplines show that ‘modern’ society and some of its key characteristics are linked to increasing environmental threats. The latter undermine food security and the sustainability of society itself, and possess global impact. For public health nutrition to be situated in and responsive to this broader context, the discipline will need a better understanding of the relationship between modern society, food choice and environmental sustainability. As ‘healthy eating’ may not be an achievable goal within the present social, economic and cultural system, public health nutrition has a unique and vital role to play in shaping change for the future.     

Late,never or non-existent: the inaccessibility of preclinical evidence for new drugs

Background and Purpose

Animal studies establish much of the evidence used to support clinical development of new drugs. Recent studies suggest that many preclinical investigations are withheld from publication, leading to exaggerated estimates of clinical utility. We sought to estimate the volume and properties of all published animal efficacy studies for a cohort of novel drugs.

Experimental Approach

We searched biomedical databases to identify 47 novel drugs whose first trials were reported between 2000 and 2003, inclusive. Next, we searched for all published animal studies testing the same drug, regardless of publication date. We then extracted items from titles and abstracts of eligible studies.

Key Results

We identified 2462 efficacy studies, representing an average of 52 studies per drug. No published efficacy studies were available for three drugs in our sample. The volume of efficacy studies was related to how far the drug had progressed in clinical development (Spearman''s correlation coefficient = 0.66, P < 0.0001). Most (87%) accessible animal efficacy studies were reported after publication of the first trial, and for 17% of the drugs in our sample, no efficacy studies were published before the first trial report. Disease indications used in trials often did not match those modelled in efficacy studies; for 35% of indications tested in trials, we were unable to identify any published efficacy studies in models of the same indication.

Conclusions and Implications

The volume of published efficacy studies is large, although numerous gaps reflect non-publication, publication delay or non-performance of efficacy studies supporting trials.     

The diagnostic value of the fibrinogen/fibrin fragment E antigen assay in clinically suspected deep vein thrombosis

We have evaluated the fibrinogen/fibrin fragment E antigen assay as a diagnostic test in patients with clinically suspected venous thrombosis by comparing the results of this assay with venography in 272 patients. The result of the fragment E antigen assay was elevated in 79 of 80 patients with positive venograms for recent venous thrombosis (sensitivity 99%) and within the normal range in 161 of 192 patients with normal venograms (specificity 84%). The fragment E assay was also evaluated in 130 medical and surgical controls without evidence of venous thrombosis by leg scanning and the test was found to be relatively nonspecific. However, in the patient group under study, a correct clinical diagnosis of no thrombosis, based on a normal fragment E result, was made in 161 of 162 cases (negative predictive value of 99%). Therefore, a normal test result effectively excludes a diagnosis of venous thrombosis in clinically symptomatic patients. The assay, as currently performed, is technically demanding and takes 24 hr to complete. Therefore, it will have to be simplified before it can be applied to clinical practice.