Implementation of blinded outcome assessment in the Effective Verruca Treatments trial (EverT) – lessons learned

Trials using inadequate levels of blinding may report larger effect sizes than blinded studies. It has been suggested that blinded outcome assessment in open trials may in some cases be undertaken by assessments of photographs. The aim of this paper is to explore the effect of using different methods to assess the primary outcome in the EVerT (Effective Verruca Treatments) trial. It also aims to give an overview of the experiences of using digital photographs within the trial. Methods We undertook a secondary analysis to explore the effect of using three different methods to assess the primary outcome in the EVerT trial: assessment of digital photographs by blinded healthcare professionals; blinded healthcare professional assessment at the recruiting site and patient self-report. The verruca clearance rates were calculated using the three different methods of assessment. A Cohen’s kappa measure of inter-rater agreement was used to assess the agreement between the methods. We also investigated the experiences of healthcare professionals using digital photographs within the trial. Results Digital photographs for 189 out of 240 (79 %) patients in the trial were received for outcome assessment. Of the 189 photographs, 30 (16 %) were uninterpretable. The overall verruca clearance rates were 21 % (43/202,) using the unblinded patient self-reported outcome, 6 % (9/159,) using blinded assessment of digital photographs and 14 % (30/210,) using blinded outcome assessment at the site. Conclusions Despite differences in the clearance rates found using different methods of outcome assessment, this did not change the original conclusion of the trial, that there is no evidence of a difference in effectiveness between cryotherapy and salicylic acid. Future trials using digital photographs should consider individual training needs at sites and have a backup method of assessment agreed a priori

A survey to investigate the association of pain, foot disability and quality of life with corns

Background Corns are a common foot problem affecting a large proportion of the population. This study describes the characteristics of corns experienced by 201 participants taking part in a randomised controlled trial to investigate associations between demographic and corn parameters on pain, foot related disability and quality of life (QoL). Methods Pain from the main (index) corn was measured using a visual analogue scale (VAS); foot related disability was assessed with the Foot Disability Questionnaire (now known as the Manchester Foot Pain and Disability Index) and quality of life was recorded with the EQ-5D questionnaire. The effect of demographic and corn parameters on the pain and quality of life outcomes was assessed with analysis of variance (ANOVA) methods. The effect of the same factors on a linear combination of the foot-related disability outcome measures was assessed using multivariate ANOVA methods. Pain was also tested for its mediating properties on the causal pathway between the independent variables and quality of life. Results The mean pain score was 5.29 points on a 10 cm VAS, with females reporting substantively higher pain levels than males. Age affected foot-related disability, with lower levels on all domains of the MFPDI reported in older participants; each year of advancing age was associated with falls of: 0.009 points on the Concern about Appearance (CA) domain; 0.047 points on the Functional Limitation (FL) domain and 0.048 points on the Pain Intensity (PI) domain. Sex and corn type also affected disability, with higher scores reported by females and participants with plantar corns. Conclusions The effect of pain was shown to mediate the relationship between sex and foot-related disability. The presence of plantar corns has a more detrimental effect on QoL than dorsal/inter-digital corns

Involving Latina/o parents in patient-centered outcomes research: Contributions to research study design, implementation and outcomes

BACKGROUND: Comparative effectiveness research (CER) is supported by policymakers as a way to provide service providers and patients with evidence-based information to make better health-care decisions and ultimately improve services for patients. However, Latina/o patients are rarely involved as study advisors, and there is a lack of documentation on how their voices contribute to the research process when they are included as collaborators. OBJECTIVES: The purpose of this article was to contribute to the literature by presenting concrete contributions of Latina/o parent involvement to study design, implementation and outcomes in the context of a CER study called Padres Efectivos (Parent Activation). METHODS: Researchers facilitated a collaborative relationship with parents by establishing a mentor parent group. The contributions of parent involvement in the following stages of the research process are described: (i) proposal development, (ii) implementation of protocols, (iii) analysis plan and (iv) dissemination of results. RESULTS: Mentor parents' contributions helped tailor the content of the intervention to their needs during proposal, increased recruitment, validated the main outcome measure and added two important outcome measures, emphasized the importance of controlling for novice treatment status and developed innovative dissemination strategies. CONCLUSIONS: Mentor parents' guidance to the researchers has contributed to reaching recruitment goals, strengthened the study protocol, expanded findings, supported broad ownership of study implications and enriched the overall study data collection efforts. These findings can inform future research efforts seeking an active Latino parent collaboration and the timely incorporation of parent voices in each phase of the research process

Nature vs. nurture in the low-density environment: structure and evolution of early-type dwarf galaxies in poor groups

We present the stellar population properties of 13 dwarf galaxies residing in poor groups (low-density environment, LDE) observed with VIMOS@VLT. Ages, metallicities, and [alpha/Fe] ratios were derived from the Lick indices Hbeta, Mgb, Fe5270 and Fe5335 through comparison with our simple stellar population (SSP) models accounting for variable [alpha/Fe] ratios. For a fiducial subsample of 10 early-type dwarfs we derive median values and scatters around the medians of 5.7 \pm 4.4 Gyr, -0.26 \pm 0.28, and -0.04 \pm 0.33 for age, log Z/Zsun, and [alpha/Fe], respectively. For a selection of bright early-type galaxies (ETGs) from the Annibali et al.2007 sample residing in comparable environment we derive median values of 9.8 \pm 4.1 Gyr, 0.06 \pm 0.16, and 0.18 \pm 0.13 for the same stellar population parameters. It follows that dwarfs are on average younger, less metal rich, and less enhanced in the alpha-elements than giants, in agreement with the extrapolation to the low mass regime of the scaling relations derived for giant ETGs. From the total (dwarf + giant) sample we derive that age \propto sigma^{0.39 \pm 0.22}, Z \propto sigma^{0.80 \pm 0.16}, and alpha/Fe \propto sigma^{0.42 \pm 0.22}. We also find correlations with morphology, in the sense that the metallicity and the [alpha/Fe] ratio increase with the Sersic index n or with the bulge-to-total light fraction B/T. The presence of a strong morphology-[alpha/Fe] relation appears to be in contradiction to the possible evolution along the Hubble sequence from low B/T (low n) to high B/T (high n) galaxies. We also investigate the role played by environment comparing the properties of our LDE dwarfs with those of Coma red passive dwarfs from the literature. We find possible evidence that LDE dwarfs experienced more prolonged star formations than Coma dwarfs, however larger data samples are needed to draw more firm conclusions.Comment: Accepted for publication on A&

Stellar populations of early-type galaxies in different environments I. Line-strength indices

Aims: This paper commences a series devoted to the study of the stellar content of early-type galaxies. The goal of the series is to set constraints on the evolutionary status of these objects. Methods: In this paper we describe the details of the galaxy sample, the observations, and the data reduction. Line-strength indices and velocity dispersions sigma are measured in 98 early-type galaxies drawn from different environments, and the relation of the indices with the velocity dispersion analysed in detail. Results: The present sample indicates that some of the index-sigma relations depend on galaxy environment. In particular, the slope of the relation between Balmer lines and sigma is steeper for galaxies in the Virgo cluster, small groups, and in the field than for galaxies in the Coma cluster. In several indices there is also a significant offset in the zero point between the relations defined by the different subsamples. The slopes of the index-sigma relation for the Virgo and low-density environment galaxies are explained by a variation of both age and metallicity with velocity dispersion, as previously noted in other studies. For the galaxies in the Coma cluster, however, the relation of the indices with sigma only requires a variation of the abundance along the sigma sequence. In agreement with other studies we find that the models that better reproduce the slopes are those in which the alpha elements vary more than the Fe-peak elements along the sigma sequence, while, at a given sigma, older galaxies show an higher alpha/Fe ratio. Conclusions: The results can be explained assuming that galaxies in the Coma cluster have experienced a truncated star formation and chemical enrichment history compared to a more continuous time-extended history for their counterparts in lower density environments.Comment: accepted for publication in A&

Protocol for the development of guidance for stakeholder engagement in health and healthcare guideline development and implementation

Stakeholder engagement has become widely accepted as a necessary component of guideline development and implementation. While frameworks for developing guidelines express the need for those potentially affected by guideline recommendations to be involved in their development, there is a lack of consensus on how this should be done in practice. Further, there is a lack of guidance on how to equitably and meaningfully engage multiple stakeholders. We aim to develop guidance for the meaningful and equitable engagement of multiple stakeholders in guideline development and implementation. METHODS: This will be a multi-stage project. The first stage is to conduct a series of four systematic reviews. These will (1) describe existing guidance and methods for stakeholder engagement in guideline development and implementation, (2) characterize barriers and facilitators to stakeholder engagement in guideline development and implementation, (3) explore the impact of stakeholder engagement on guideline development and implementation, and (4) identify issues related to conflicts of interest when engaging multiple stakeholders in guideline development and implementation. DISCUSSION: We will collaborate with our multiple and diverse stakeholders to develop guidance for multi-stakeholder engagement in guideline development and implementation. We will use the results of the systematic reviews to develop a candidate list of draft guidance recommendations and will seek broad feedback on the draft guidance via an online survey of guideline developers and external stakeholders. An invited group of representatives from all stakeholder groups will discuss the results of the survey at a consensus meeting which will inform the development of the final guidance papers. Our overall goal is to improve the development of guidelines through meaningful and equitable multi-stakeholder engagement, and subsequently to improve health outcomes and reduce inequities in health

What's in a Name? Classification of Diabetes Mellitus in Veterinary Medicine and Why It Matters

Diabetes Mellitus (DM) is a syndrome caused by various etiologies. The clinical manifestations of DM are not indicative of the cause of the disease, but might be indicative of the stage and severity of the disease process. Accurately diagnosing and classifying diabetic dogs and cats by the underlying disease process is essential for current and future studies on early detection, prevention, and treatment of underlying disease. Here, we review the current etiology‐based classification of DM and definitions of DM types in human medicine and discuss key points on the pathogenesis of each DM type and prediabetes. We then review current evidence for application of this etiology‐based classification scheme in dogs and cats. In dogs, we emphasize the lack of consistent evidence for autoimmune DM (Type 1) and the possible importance of other DM types such as DM associated with exocrine pancreatic disease. While most dogs are first examined because of DM in an insulin‐dependent state, early and accurate diagnosis of the underlying disease process could change the long‐term outcome and allow some degree of insulin independence. In cats, we review the appropriateness of using the umbrella term of Type 2 DM and differentiating it from DM secondary to other endocrine disease like hypersomatotropism. This differentiation could have crucial implications on treatment and prognosis. We also discuss the challenges in defining and diagnosing prediabetes in cats