An Overview of Data Management in Human Subjects Research.

Research studies generate data in various forms. Data can be quantitative or qualitative. Research involving human subjects requires protection of data to ensure privacy. Various regulations and local policies need to be followed to ensure data security. Data management plans are critical for effective data stewardship and include details plan on data collection, management, storage, and formatting. This paper will review data collection tools, data security strategies, file management, data storage, government regulations, prepping data for analysis, reference management, and file management.

Spectroscopic Characterisation of the Naphthalene Dioxygenase from Rhodococcus sp. Strain NCIMB12038.

Polycyclic aromatic hydrocarbons (PAHs), such as naphthalene, are potential health risks due to their carcinogenic and mutagenic effects. Bacteria from the genus Rhodococcus are able to metabolise a wide variety of pollutants such as alkanes, aromatic compounds and halogenated hydrocarbons. A naphthalene dioxygenase from Rhodococcus sp. strain NCIMB12038 has been characterised for the first time, using electron paramagnetic resonance (EPR) spectroscopy and UV-Vis spectrophotometry. In the native state, the EPR spectrum of naphthalene 1,2-dioxygenase (NDO) is formed of the mononuclear high spin Fe(III) state contribution and the oxidised Rieske cluster is not visible as EPR-silent. In the presence of the reducing agent dithionite a signal derived from the reduction of the [2Fe-2S] unit is visible. The oxidation of the reduced NDO in the presence of O2-saturated naphthalene increased the intensity of the mononuclear contribution. A study of the "peroxide shunt", an alternative mechanism for the oxidation of substrate in the presence of H2O2, showed catalysis via the oxidation of mononuclear centre while the Rieske-type cluster is not involved in the process. Therefore, the ability of these enzymes to degrade recalcitrant aromatic compounds makes them suitable for bioremediative applications and synthetic purposes.

Psychological and quality of life changes in patients using GLP-1 analogues.

AIMS: Using psychological and quality of life assessment tools, we prospectively studied changes in health-related quality of life and emotional well-being in patients who had commenced GLP-1 analogue therapy (exenatide) and compared them with new insulin starters. METHODS: Two matched groups of patients with type 2 diabetes who had suboptimal glycaemic control on oral medication were assessed using a battery of well-validated psychological and quality of life tests at baseline, prior to commencement of treatment and then again after 6 months of continuous therapy, along with body mass index (BMI) and hemoglobin A1c (HbA1c) measurements. RESULTS: In the exenatide-treated patient group (n=71), treatment satisfaction was greater (P<.05), as was the well-being score, at 6 months (P<.05), and the Hospital Anxiety and Depression Scale scores were significantly reduced (P<.05) when compared with the insulin-treated group (n=67). This was also found to be independent of changes in BMI in an analysis of covariance calculation. The effect size (using Cohen's d) of these changes was however relatively small. CONCLUSIONS: Although exenatide and insulin appear to have similar efficacy for the treatment of type 2 diabetes mellitus, there are several differences between them that could influence outcomes from a patient's perspective. Exenatide affects both physiological and psychological parameters. 'Well-being' generally tends to improve in exenatide-treated patients and could be used as an adjunctive therapy for depression in the context of diabetes. A larger study is required to confirm these interesting findings.

Primary amenorrhoea due to ovarian dysgenesis: a previously undescribed chromosome 12 abnormality.

This case describes for the first time a de novo chromosomal abnormality (46, XX, inv dup del(12)(qter-p13.3::p13.3-p12.3:)dn.ish inv dup del(12)(TEL-ETV6++) which produced the phenotype of a female with primary ovarian failure and subsequent osteopenia in early adult life. This warranted treatment with oestrogen replacement therapy and close supportive monitoring.

How often do we ask about pregnancy in the diabetes review clinic?

BACKGROUND: Sub-optimal control of diabetes is a significant cause of complications during pregnancy. One of the aims of diabetes management should be to ensure that all women of child-bearing age with diabetes should be regularly screened with regard to their plans for pregnancy to ensure that their overall diabetic control and fitness for pregnancy can be maximized. METHODS: We analysed the electronic patient records of a target population of young women of child-bearing age (16-45) with both type 1 and type 2 diabetes who were attending the diabetes review clinic over a period of three years from 2007 to 2010. The Diabeta 3 software program which is commonly used has a query builder function which allows immediate recall and analysis of data. RESULTS: Of 1808 patients within the fertile range, only a small number appeared to have had information accurately documented with regard to any of the following: pregnancy plans, preconception counselling, contraception and also the recording of whether patients with diabetes were pregnant or not and enrolled in the ante-natal diabetes clinic. CONCLUSIONS: The main inference from the data is its paucity and inaccuracy. It would appear that we are failing to enquire and/or record the fertility intentions of young female patients with diabetes. This is important because it means that we subsequently then miss those patients who need to be targeted for preconception counselling/optimization, which has implications for the morbidity and mortality associated with diabetes in pregnancy.

Emphysematous Pyelonephritis in a non-diabetic post-operative Transsexual patient.

We describe the rare condition of emphysematous pyelonephritis (EPN) in a non-diabetic patient who had previously undergone gender reassignment surgery. The report discusses the acute management and treatment and then provides background to the aetiology and historical aspects of the condition.

21st century endocrinology.

Recent developments in the field of diabetes and endocrinology have led to greater understanding of the body's complex hormonal axes. This article reviews the latest significant treatments which have the potential to impact greatly on a wide variety of disease states in the not too distant future.

How often do we ask about erectile dysfunction in the diabetes review clinic? Development of a neuropathy screening tool.

Diabetic neuropathy is a significant complication of chronic diabetes. We wished to discover whether we were successfully identifying patients who had developed neuropathic problems. Specifically, Diabetologists are traditionally poor at asking about erectile dysfunction (ED) and patients themselves are not always forthcoming as it an embarrassing medical problem. We targeted all patients attending diabetes review clinics over a 4-month period in two hospitals and asked them to complete an anonymous, self-reported questionnaire after their consultation with the diabetologist or diabetes specialist nurse. Whilst most aspects of diabetic neuropathy are routinely screened for in the diabetes clinic we found that the neuropathic symptoms of both ED and gastroparesis were not commonly enquired about, and that erectile failure was found to be more prevalent than previously. Diabetologists need to be more thorough in their assessment of diabetic neuropathy. This is especially of import with regards to ED because we often shy away from enquiring into such a personal area and male patients rarely highlight the issue due to embarrassment. Our post consultation questionnaire has now been modified to form a useful preconsultation neuropathy screening tool and this is undergoing validation.

Structure and increased thermostability of Rhodococcus sp. naphthalene 1,2-dioxygenase.

Rieske nonheme iron oxygenases form a large class of aromatic ring-hydroxylating dioxygenases found in microorganisms. These enzymes enable microorganisms to tolerate and even exclusively utilize aromatic compounds for growth, making them good candidates for use in synthesis of chiral intermediates and bioremediation. Studies of the chemical stability and thermostability of these enzymes thus become important. We report here the structure of free and substrate (indole)-bound forms of naphthalene dioxygenase from Rhodococcus sp. strain NCIMB12038. The structure of the Rhodococcus enzyme reveals that, despite a approximately 30% sequence identity between these naphthalene dioxygenases, their overall structures superpose very well with a root mean square deviation of less than 1.6 A. The differences in the active site of the two enzymes are pronounced near the entrance; however, indole binds to the Rhodococcus enzyme in the same orientation as in the Pseudomonas enzyme. Circular dichroism spectroscopy experiments show that the Rhodococcus enzyme has higher thermostability than the naphthalene dioxygenase from Pseudomonas species. The Pseudomonas enzyme has an apparent melting temperature of 55 degrees C while the Rhodococcus enzyme does not completely unfold even at 95 degrees C. Both enzymes, however, show similar unfolding behavior in urea, and the Rhodococcus enzyme is only slightly more tolerant to unfolding by guanidine hydrochloride. Structure analysis suggests that the higher thermostability of the Rhodococcus enzyme may be attributed to a larger buried surface area and extra salt bridge networks between the alpha and beta subunits in the Rhodococcus enzyme.

Crystallization and preliminary X-ray diffraction analysis of naphthalene dioxygenase from Rhodococcus sp. strain NCIMB 12038.

The three-component naphthalene dioxygenase (NDO) enzyme system carries out the first step in the aerobic degradation of naphthalene to (+)-cis-(1R,2S)-dihydroxy-1,2-dihydronaphthalene by Rhodococcus sp. strain NCIMB 12038. The terminal oxygenase component (naphthalene 1,2-dioxygenase) that catalyzes this reaction belongs to the aromatic ring hydroxylating dioxygenase family and has been crystallized. These enzymes utilize a mononuclear non-heme iron centre to catalyze the addition of dioxygen to their respective substrates. In this reaction, two electrons, two protons and a dioxygen molecule are consumed. The Rhodococcus enzyme has only 33 and 29% sequence identity to the corresponding alpha- and beta-subunits of the NDO system of Pseudomonas putida NCIMB 9816-4, for which the tertiary structure has been reported. In order to determine the three-dimensional structure of the Rhodococcus NDO, diffraction-quality crystals have been prepared by the hanging-drop method. The crystals belongs to space group P2(1)2(1)2(1), with unit-cell parameters a = 87.5, b = 144, c = 185.6 A, alpha = beta = gamma = 90 degrees, and diffract to 2.3 A resolution.

Investigation of a human case of rabies in the United Kingdom.

In May of 2001 a Nigerian woman visiting the United Kingdom presented with fever, headache and difficulty swallowing. Within 24 h she showed a marked deterioration and died shortly afterwards. Autopsy samples from a range of tissues were analysed to confirm a clinical diagnosis of rabies. Phylogenetic analysis of the viral nucleoprotein gene confirmed that this was an infection with a genotype 1 virus (classical rabies) belonging to the Africa 2 group, which is endemic in Northern Africa. Comparison of both the nucleoprotein and glycoprotein coding sequences of this isolate with an imported case of human rabies from 1996, also from Nigeria, showed that the two viruses were 99% homologous.