Why don't women participate? A qualitative study on non-participation in a surgical randomised controlled trial.

INTRODUCTION AND HYPOTHESIS: The objective of the study was to identify reasons why women declined participation in a pilot randomised controlled trial (RCT) comparing tension-free vaginal tape (TVT) under general anaesthetic (GA) with single incision sling (SIS) under local anaesthetic (LA). These data would inform the design of a larger trial to improve patient recruitment. METHODS: This was a qualitative interview study on women eligible to have a TVT for stress urinary incontinence in a tertiary referral hospital in the UK. Women were counselled in a standardised manner. They were informed that the short-term success rates were similar for both operations. Women who declined to take part in the RCT were interviewed using a topic guide. Themes and sub-themes on non-participation were identified by two independent observers using a constant comparison method. RESULTS: Twenty-three non-participants of the RCT were interviewed. Common themes for non-participation were a preference for TVT and request for GA. Sub-themes showed that the TVT was preferred due to its perceived better efficacy as well as a minimal benefit from a SIS and also an unwillingness to take unknown risks. GA was favoured due to fear of local awareness, past negative experiences and embarrassment. Additional tests and follow-up visits were not cited as a reason for non-participation. CONCLUSIONS: The study found that non-participants are not research averse in general but they had strong preferences about specific aspects of treatment. Risk propensity and personality may also influence this behaviour. The study also demonstrates how a qualitative pilot study may improve trial design.

Vitamin D status among long-term survivors of hematopoietic cell transplantation.

Little is known about serum vitamin D levels following hematopoietic cell transplantation (HCT). Patients are instructed to avoid sun exposure because of an increased risk of skin cancers. Altered gastrointestinal absorptive capacity as a result of GVHD, bile acid or pancreatic enzyme insufficiency or bacterial overgrowth may lead to difficulty in absorbing the fat-soluble vitamin D. This study was undertaken to determine the prevalence of serum 25-hydroxyvitamin D (25(OH)D) deficiency, and factors associated with 25(OH)D deficiency, among children and adults who were at least 1 year following HCT. A total of 95 participants (54 males and 41 females) completed a questionnaire on usual diet and lifestyle, and provided a blood sample for 25(OH)D determinations between November 2008 and July 2009. The majority of participants had serum 25(OH)D levels ≥75 nmol/L (n=62, 65%), 23 had insufficient levels (50-75 nmol/L) and 10 participants were deficient (<50 nmol/L). The majority of participants reported regular use of vitamin D supplements (n=58, 61%). Prednisone use was significantly inversely associated with serum 25(OH)D concentrations. Total vitamin D intake was the strongest single predictor of 25(OH)D concentrations. These findings suggest that 400-600 IU vitamin D per day appears to be required to achieve optimal serum 25(OH)D concentrations following HCT.

A 2-year observational study to determine the efficacy of a novel single incision sling procedure (Minitape) for female stress urinary incontinence.

OBJECTIVE: Assessment of the 2 year outcome of the Minitape procedure. DESIGN: A prospective observational study of women undergoing the Minitape procedure for urodynamic stress incontinence. Setting Two tertiary referral urogynaecology units in the north of England. POPULATION: Sixty women between November 2002 and March 2006. METHODS: Women attended a research clinic where they completed a standardised 1 hour pad test and were examined. Women were assessed preoperatively and postoperatively at 6 months, 1 year and 2 years. MAIN OUTCOME MEASURES: Success was determined by a negative 1 hour pad test (gain of <1 g) and no desire for further treatment for stress urinary incontinence. RESULTS: All procedures were completed with local anaesthesia, with no additional sedation in 82% of cases. Intra-operative and immediate postoperative complications were rare. Twelve women (20%) experienced mesh complications, half of which were considered to be serious adverse events requiring exit from the study. At 2 years following Minitape insertion, six women (10%) were defined as cured. CONCLUSIONS: Although feasible to perform, this procedure is associated with a substantially lower cure rate than that published previously for other procedures. Cure rates decline over the 2 year follow-up period, especially during the first 6 months.

Evidence for an extraterrestrial impact 12,900 years ago that contributed to the megafaunal extinctions and the Younger Dryas cooling.

A carbon-rich black layer, dating to approximately 12.9 ka, has been previously identified at approximately 50 Clovis-age sites across North America and appears contemporaneous with the abrupt onset of Younger Dryas (YD) cooling. The in situ bones of extinct Pleistocene megafauna, along with Clovis tool assemblages, occur below this black layer but not within or above it. Causes for the extinctions, YD cooling, and termination of Clovis culture have long been controversial. In this paper, we provide evidence for an extraterrestrial (ET) impact event at approximately equal 12.9 ka, which we hypothesize caused abrupt environmental changes that contributed to YD cooling, major ecological reorganization, broad-scale extinctions, and rapid human behavioral shifts at the end of the Clovis Period. Clovis-age sites in North American are overlain by a thin, discrete layer with varying peak abundances of (i) magnetic grains with iridium, (ii) magnetic microspherules, (iii) charcoal, (iv) soot, (v) carbon spherules, (vi) glass-like carbon containing nanodiamonds, and (vii) fullerenes with ET helium, all of which are evidence for an ET impact and associated biomass burning at approximately 12.9 ka. This layer also extends throughout at least 15 Carolina Bays, which are unique, elliptical depressions, oriented to the northwest across the Atlantic Coastal Plain. We propose that one or more large, low-density ET objects exploded over northern North America, partially destabilizing the Laurentide Ice Sheet and triggering YD cooling. The shock wave, thermal pulse, and event-related environmental effects (e.g., extensive biomass burning and food limitations) contributed to end-Pleistocene megafaunal extinctions and adaptive shifts among PaleoAmericans in North America.

Lipoic acid as a potential therapy for chronic diseases associated with oxidative stress.

alpha-Lipoic acid (LA), a naturally occurring dithiol compound, has long been known as an essential cofactor for mitochondrial bioenergetic enzymes. Aside from its enzymatic role, in vitro and in vivo studies suggest that LA also acts as a powerful micronutrient with diverse pharmacologic and antioxidant properties. Pharmacologically, LA improves glycemic control, polyneuropathies associated with diabetes mellitus, and effectively mitigates toxicities associated with heavy metal poisoning. As an antioxidant, LA directly terminates free radicals, chelates transition metal ions (e.g. iron and copper), increases cytosolic glutathione and vitamin C levels and prevents toxicities associated with their loss. These diverse actions suggest that LA acts by multiple mechanisms both physiologically and pharmacologically, many of which are only now being explored. Herein, we review the known biochemical properties of LA with particular reference to how LA may be an effective agent to ameliorate certain pathophysiologies of many chronic diseases.

Horsetails and ferns are a monophyletic group and the closest living relatives to seed plants.

Most of the 470-million-year history of plants on land belongs to bryophytes, pteridophytes and gymnosperms, which eventually yielded to the ecological dominance by angiosperms 90 Myr ago. Our knowledge of angiosperm phylogeny, particularly the branching order of the earliest lineages, has recently been increased by the concurrence of multigene sequence analyses. However, reconstructing relationships for all the main lineages of vascular plants that diverged since the Devonian period has remained a challenge. Here we report phylogenetic analyses of combined data--from morphology and from four genes--for 35 representatives from all the main lineages of land plants. We show that there are three monophyletic groups of extant vascular plants: (1) lycophytes, (2) seed plants and (3) a clade including equisetophytes (horsetails), psilotophytes (whisk ferns) and all eusporangiate and leptosporangiate ferns. Our maximum-likelihood analysis shows unambiguously that horsetails and ferns together are the closest relatives to seed plants. This refutes the prevailing view that horsetails and ferns are transitional evolutionary grades between bryophytes and seed plants, and has important implications for our understanding of the development and evolution of plants.

A geochemical assessment of terrestrial gamma-ray absorbed dose rates.

A survey of the geochemical literature and unpublished data has resulted in the classification of the concentrations of the naturally occurring radioelements U, Th, and K by their associated rock types. A data base of over 2500 entries has been compiled, permitting calculation of terrestrial gamma-ray absorbed dose rates. The general lithology of terrains may be distinguished by their radioelement ratios, relative abundances, and total gamma radioactivities. The gamma-ray absorbed dose rates in air above igneous rocks generally vary with their silica contents, and with the exception of shale, sedimentary rocks have lower K:U and K:Th ratios than most igneous rocks. The appreciable difference between the overall mean terrestrial gamma-ray dose rate for rock of the continental surface (approximately 7 X 10(-8) Gy h-1) and the mean dose rate from field measurements over soil (approximately 5 X 10(-8) Gy h-1) is explained by the substantial differences between radioelement concentrations of soil and rock, differences that may vary markedly with rock type.

Effect of pinealectomy, gonadectomy, pCPA and pineal extracts on the rat parvocellular neurosecretory hypothalamic system; a fluorescence histochemical investigation.

Using the fluorescence histochemical technique, yellow autofluorescent granules were observed in neurones of the arcuate and ventromedial hypothalamic nuclei of the rat (type I cells). In the same nuclei, neurones could be demonstrated showing a formaldehyde-induced yellow fluorescence (type II cells). Microelectrophoresis and special staining methods applied to the pineal gland revealed the autofluorescent compound to be a protein containing a relatively high content of tryptophan. It is probable that the formaldehyde-induced yellow fluorescence is due to the presence of serotonin. In view of investigating a possible functional relationship between the pineal gland and the parvocellular hypothalamic nuclei mentioned, hypothalamic type I and type II cells, as well as autofluorescent and serotonin-containing pinealocytes, if present, were quantified under the following experimental conditions: (1) p-chlorophenylalanine (pCPA) administration, (2) castration, (3) pinealectomy, and (4) pinealectomy followed by substitution using rat and sheep pineal extract. Administration of pCPA caused a decrease in the number of type II and an increase in the number of type I cells, both in the pineal gland and the hypothalamic nuclei. Castration, in contrast, was followed by an increase in the number of autofluorescent pinealocytes, but a decrease of autofluorescent neurones in the hypothalamic nuclei (type I cells) while the number of serotonin-containing pinealocytes increased; decreasing in both hypothalamic nuclei. After pinealectomy the hypothalamic nuclei showed an increase of type I neurones, but a decrease of type II nerve cells. Pinealectomy followed by substitution using pineal extracts restored the number of type I and type II neurones to that normally found in the arcuate and ventromedial hypothalamic nuclei of control animals. The present investigation brings histological evidence of an influence exerted by the rat pineal gland on nuclei forming part of the hypothalamic hypophyseotropic area. The data obtained and some of the literature strongly suggest that the type II neurones, which probably contain serotonin, inhibit, in the same hypothalamic nuclei, the production of luteinizing hormone-releasing factor (LH-RF). As yet, the function of the autofluorescent compound present in the type I neurones is not known.