Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013.

OBJECTIVES: To analyse developments (and their causes) in the number and proportion of clinical trials that were registered in different parts of the world after the International Committee of Medical Journal Editors (ICMJE) announced in 2004 that it would require registration of clinical trials as a condition for publication. SETTING: The International Clinical Trials Registry Platform (ICTRP). DESIGN: The ICTRP database was searched for all clinical trials that were registered up to 31 December 2013. RESULTS: The ICTRP database contained data on 186,523 interventional clinical trials. The annual number of registered clinical trials increased from 3294 in 2004 to 23,384 in 2013. Relative to the number of clinical trial research publications, the global number of registered clinical trials increased fivefold between 2004 and 2013, rising particularly strongly between 2004 and 2005. In certain regions, especially Asia, the annual number of registered trials increased more gradually and continued to increase up to 2013. In India and Japan, two countries with marked but more gradual increases, these increases only happened after several local measures were implemented that encouraged and enforced registration. In most regions, there was a trend toward trials being registered at local registries. CONCLUSIONS: Clinical trial registration has greatly improved transparency in clinical trial research. However, these improvements have not taken place equally in all parts of the world. Achieving compliance with registration requires a coalescence of global and local measures, and remains a key challenge in many countries. Poor quality of registered trial data and the inaccessibility of trial protocols, results and participant-level data further undermine the potential benefits of clinical trial registration. National and regional registries and the ICTRP have played a leading role in achieving the successes of trial registration to date and should be supported in addressing these challenges in the future

Health care providers and human trafficking: what do they know, what do they need to know? Findings from the middle East, the Caribbean, and central america.

BACKGROUND: Human trafficking is a crime that commonly results in acute and chronic physical and psychological harm. To foster more informed health sector responses to human trafficking, training sessions for health care providers were developed and pilot-tested in the Middle East, Central America, and the Caribbean. This study presents the results of an investigation into what health care providers knew and needed to know about human trafficking as part of that training program. METHODS: Participants attended one of seven two-day training courses in Antigua and Barbuda, Belize, Costa Rica, Egypt, El Salvador, Guyana, and Jordan. We assessed participants' knowledge about human trafficking and opinions about appropriate responses in trafficking cases via questionnaires pre-training, and considered participant feedback about the training post-training. RESULTS: 178 participants attended the trainings. Pre-training questionnaires were completed by 165 participants (93%) and post-training questionnaires by 156 participants (88%). Pre-training knowledge about health and human trafficking appeared generally high for topics such as the international nature of trafficking and the likelihood of poor mental health outcomes among survivors. However, many participants had misconceptions about the characteristics of trafficked persons and a provider's role in responding to cases of trafficking. The most valued training components included the "Role of the Health Provider," "Basic Definitions and Concepts," and "Health Consequences of Trafficking." DISCUSSION: Training health care providers on caring for trafficked persons has the potential to improve practitioners' knowledge about human trafficking and its health consequences, and to increase safe practices when responding in cases of trafficking. This study provides lessons for the design of training programs on human trafficking that aim to help health care providers identify and refer victims, and provide care for survivors

Supporting ALL victims of violence, abuse, neglect or exploitation: guidance for health providers.

Smaller groups of victims of violence, abuse, neglect or exploitation - such as male victims of intimate partner violence (IPV), victims of elder abuse, victims of abuse by carers, victims of parent abuse, victims of human trafficking, girls and boys below 18 years engaging in sex work, victims of sexual exploitation by gangs or groups and victims of honour based violence (such as forced marriages and female genital mutilation) - are often in contact with the health care system without being identified as such and frequently do not receive appropriate treatment. To address this problem, two things need to happen: 1) that ALL groups of victims of violence, abuse, neglect or exploitation are explicitly listed in policies and protocols, and 2) that both the similarities as well as the differences between the groups with regard to identification, support and referral - described in this article - are explained, so that health providers are appropriately supported in this important function

Evidence for Elevated X-ray Emission in Local Lyman Break Galaxy Analogs

In this paper, we study the relationship between the 2-10 keV X-ray luminosity (L_X), assumed to originate from X-ray binaries (XRBs), and star formation rate (SFR) in UV-selected z<0.1 Lyman break analogs (LBAs). We present Chandra observations for four new GALEX-selected LBAs. Including previously studied LBAs, Haro 11 and VV 114, we find that LBAs demonstrate L_X/SFR ratios that are elevated by ~1.5sigma compared to local galaxies, similar to the ratios found for stacked LBGs in the early Universe (z>2). We show that these LBAs are unlikely to harbor AGN, based on their optical and X-ray spectra and the spatial distribution of the X-rays in three spatially extended cases. We expect that high-mass X-ray binaries (HMXBs) dominate the X-ray emission in these galaxies, based on their high specific SFRs (sSFRs=SFR/M* > 10^{-9}/yr), which suggest the prevalence of young stellar populations. Since both LBAs and LBGs have lower dust attenuations and metallicities compared to similar samples of more typical local galaxies, we investigate the effects of dust extinction and metallicity on the L_X/SFR for the broader population of galaxies with high sSFRs (>10^{-10}/yr). The estimated dust extinctions (corresponding to column densities of N_H<10^{22}/cm^2) are expected to have insignificant effects on observed L_X/SFR ratio for the majority of galaxy samples. We find that the observed relationship between L_X/SFR and metallicity appears consistent with theoretical expectations from X-ray binary population synthesis models. Therefore, we conclude that lower metallicities, related to more luminous HMXBs such as ultraluminous X-ray sources (ULXs), drive the elevated L_X/SFR observed in our sample of z<0.1 LBAs. The relatively metal-poor, active mode of star formation in LBAs and distant z>2 LBGs may yield higher total HMXB luminosity than found in typical galaxies in the local Universe.Comment: 11 pages, 7 figures, Submitted to ApJ (references updated in v2

Optical Characterization of a New Young Stellar Population in the Serpens Molecular Cloud

We report on the results of an optical spectroscopic survey designed to confirm the youth and determine the spectral types among a sample of young stellar object (YSO) candidates in the Serpens Molecular Cloud. We observed 150 infrared excess objects, previously discovered by the Spitzer Legacy Program "From Molecular Cores to Planet-Forming Disks" (c2d), bright enough for subsequent Spitzer/IRS spectroscopy. We obtained 78 optical spectra of sufficient S/N for analysis. Extinctions, effective temperatures and luminosities are estimated for this sample, and used to construct H-R diagrams for the population. We identified 20 background giants contaminating the sample, based on their relatively high extinction, position in the H-R diagram, the lack of Halpha emission and relatively low infrared excess. Such strong background contamination (25%) is consistent with the location of Serpens being close to the Galactic plane (5degrees Galactic latitude). The remaining 58 stars (75%) were all confirmed to be young, mostly K and M-type stars that are presumed to belong to the cloud. Individual ages and masses for the YSOs are inferred based on theoretical evolutionary models. The models indicate a spread in stellar ages from 1 to 15 Myr, peaking at 2 - 6 Myr, and a mass distribution of 0.2 to 1.2 Msun with median value around 0.8 Msun. Strong H emission lines (EW[Halpha] > 3 A) have been detected in more than half of the sample (35 stars). The mass accretion rates as derived from the H line widths span a broad distribution over 4 orders of magnitude with median accretion rate of 10^-8 Msun/yr. Our analysis shows that the majority of the infrared excess objects detected in Serpens are actively accreting, young T-Tauri stars.Comment: ApJ in pres

The Extreme Hosts of Extreme Supernovae

We use GALEX ultraviolet (UV) and optical integrated photometry of the hosts of seventeen luminous supernovae (LSNe, having peak M_V < -21) and compare them to a sample of 26,000 galaxies from a cross-match between the SDSS DR4 spectral catalog and GALEX interim release 1.1. We place the LSNe hosts on the galaxy NUV-r versus M_r color magnitude diagram (CMD) with the larger sample to illustrate how extreme they are. The LSN hosts appear to favor low-density regions of the galaxy CMD falling on the blue edge of the blue cloud toward the low luminosity end. From the UV-optical photometry, we estimate the star formation history of the LSN hosts. The hosts have moderately low star formation rates (SFRs) and low stellar masses (M_*) resulting in high specific star formation rates (sSFR). Compared with the larger sample, the LSN hosts occupy low-density regions of a diagram plotting sSFR versus M_* in the area having higher sSFR and lower M_*. This preference for low M_*, high sSFR hosts implies the LSNe are produced by an effect having to do with their local environment. The correlation of mass with metallicity suggests that perhaps wind-driven mass loss is the factor that prevents LSNe from arising in higher-mass, higher-metallicity hosts. The massive progenitors of the LSNe (>100 M_sun), by appearing in low-SFR hosts, are potential tests for theories of the initial mass function that limit the maximum mass of a star based on the SFR.Comment: 8 pages, 3 figures, 2 tables, accepted to ApJ, amended references and updated SN designation

The Young and the Dustless: Interpreting Radio Observations of UltraViolet Luminous Galaxies

Ultraviolet Luminous Galaxies (UVLGs) have been identified as intensely star-forming, nearby galaxies. A subset of these, the supercompact UVLGs, are believed to be local analogs of high redshift Lyman Break Galaxies. Here we investigate the radio continuum properties of this important population for the first time. We have observed 42 supercompact UVLGs with the VLA, all of which have extensive coverage in the UV/optical by GALEX and SDSS. Our analysis includes comparison samples of multiwavelength data from the Spitzer First Look Survey and from the SDSS-Galex matched catalogs. In addition we have Spitzer MIPS data for 24 of our galaxies and find that they fall on the radio-FIR correlation of normal star-forming galaxies. We find that our galaxies have lower radio-to-UV ratios and lower Balmer decrements than other local galaxies with similar (high) star formation rates. Optical spectra show they have lower Dn(4000) and HdeltaA indices, higher Hbeta emission-line equivalents widths, and higher [OIII]5007/Hbeta emission-line ratios than normal star forming galaxies. Comparing these results to galaxy spectral evolution models we conclude that supercompact UVLGs are distinguished from normal star forming galaxies firstly by their high specific star formation rates. Moreover, compared to other types of galaxies with similar star formation rates, they have significantly less dust attenuation. In both regards they are similar to Lyman Break Galaxies. This suggests that the process that causes star formation in the supercompact UVLGs differs from other local star forming galaxies, but may be similar to Lyman Break Galaxies.Comment: 37 pages, 13 figures, accepted and scheduled to appear in ApJS December 2007 (GALEX Special Issue

The American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale; Translation and validation of the Dutch language version for ankle fractures

Objectives The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale is among the most commonly used instruments for measuring outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It consists of a patient-reported and a physician-reported part. A validated, Dutch version of this instrument is currently not available. The aim of this study was to translate the instrument into Dutch and to determine the measurement properties of the AOFAS Ankle-Hindfoot Scale Dutch language version (DLV) in patients with a unilateral ankle fracture. Setting Multicentre (two Dutch hospitals), prospective observational study. Participants In total, 142 patients with a unilateral ankle fracture were included. Ten patients were lost to follow-up. Primary and secondary outcome measures Patients completed the subjective (patient-reported) part of the AOFAS Ankle-Hindfoot Scale-DLV. A physician or trained physician-assistant completed the physician-reported part. For comparison and evaluation of the measuring characteristics, the Foot Function Index and the Short Form-36 were completed by the patient. Descriptive statistics (including floor and ceiling effects), reliability (ie, internal consistency), construct validity, reproducibility (ie, test-retest reliability, agreement and smallest detectable change) and responsiveness were determined. Results The AOFAS-DLV and its subscales showed good internal consistency (Cronbach's α >0.90). Construct validity and longitudinal validity were proven to be adequate (76.5% of predefined hypotheses were confirmed). Floor effects were not present. Ceiling effects were present from 6 months onwards, as expected. Responsiveness was adequate, with a smallest detectable change of 12.0 points. Conclusions The AOFAS-DLV is a reliable, valid and responsive measurement instrument for evaluating functional outcome in patients with a unilateral ankle fracture. This implies that the questionnaire is suitable to compare different treatment modalities within this population or to compare outcome across hospitals. Trial registration The Netherlands Trial Register (NTR5613

Perceptions of the role of diversional therapy within nursing homes by directors of nursing

Provision of leisure and recreational services has the ability to significantly contribute to the quality of life of older adults living in residential settings including those residents living in nursing homes. Therefore diversional therapy services should be seen as a vital part of these facilities. Currently, there is a feeling within the diversional therapy profession that there is a lack of understanding ofthe true role of the diversional therapist within various health care facilities, including nursing homes. The purpose of this study is to examine the perceptions of the role of the diversional therapist within nursing homes by directors of nursing. Qualitative research methods were used with the aim of gaining the true perceptions that directors of nursing have on various areas of diversional therapy practice. Thirteen in-depth interviews were conducted with directors of nursing at various nursing homes in the Sydney area. The interview data suggests that although the directors of nursing were generally supportive of diversional therapy, there is clearly a lack of understanding on behalf of the directors of nursing on various areas of diversional therapy practice, including roles, skills, training and education of a diversional therapist. Other issues were revealed in the interviews and are also of importance in relation to the diversional therapy profession such as suitability of the name diversional therapy, employment conditions and other professional issues affecting diversional therapy practice. This study aims to increase diversional therapists knowledge in relation to the perceived roles that directors of nursing hold on the diversional therapy profession and therefore to give the diversional therapy profession some kind of base line on which to focus their educational programs on the diversional therapy profession. Also, to increase the documented research base on diversional therapy practice and associated issues

Determinants of participation in a web-based health risk assessment and consequences for health promotion programs

Background: The health risk assessment (HRA) is a type of health promotion program frequently offered at the workplace. Insight into the underlying determinants of participation is needed to evaluate and implement these interventions. Objective: To analyze whether individual characteristics including demographics, health behavior, self-rated health, and work-related factors are associated with participation and nonparticipation in a Web-based HRA. Methods: Determinants of participation and nonparticipation were investigated in a cross-sectional study among individuals employed at five Dutch organizations. Multivariate logistic regression was performed to identify determinants of participation and nonparticipation in the HRA after controlling for organization and all other variables. Results: Of the 8431 employees who were invited, 31.9% (2686/8431) enrolled in the HRA. The online questionnaire was completed by 27.2% (1564/5745) of the nonparticipants. Determinants of participation were some periods of stress at home or work in the preceding year (OR 1.62, 95% CI 1.08-2.42), a decreasing number of weekdays on which at least 30 minutes were spent on moderate to vigorous physical activity (ORdayPA0.84, 95% CI 0.79-0.90), and increasing alcohol consumption. Determinants of nonparticipation were less-than-positive self-rated health (poor/very poor vs very good, OR 0.25, 95% CI 0.08-0.81) and tobacco use (at least weekly vs none, OR 0.65, 95% CI 0.46-0.90). Conclusions: This study showed that with regard to isolated health behaviors (insufficient physical activity, excess alcohol consumption, and stress), those who could benefit most from the HRA were more likely to participate. However, tobacco users and those who rate