Systematic review of studies generating individual participant data on the efficacy of drugs for treating soil-transmitted helminthiases and the case for data-sharing

Preventive chemotherapy and transmission control (PCT) by mass drug administration is the cornerstone of the World Health Organization (WHO)’s policy to control soil-transmitted helminthiases (STHs) caused by Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm) and hookworm species (Necator americanus and Ancylostama duodenale) which affect over 1 billion people globally. Despite consensus that drug efficacies should be monitored for signs of decline that could jeopardise the effectiveness of PCT, systematic monitoring and evaluation is seldom implemented. Drug trials mostly report aggregate efficacies in groups of participants, but heterogeneities in design complicate classical meta-analyses of these data. Individual participant data (IPD) permit more detailed analysis of drug efficacies, offering increased sensitivity to identify atypical responses potentially caused by emerging drug resistance

Unresected screen-detected ductal carcinoma in situ: Outcomes of 311 women in the Forget-Me-Not 2 study.

BACKGROUND AND AIM: The natural history of ductal carcinoma in situ (DCIS) is poorly understood. The aim of this cohort study was to determine the outcomes of women who had no surgery for screen-detected DCIS in the 6 months following diagnosis. METHODS: English breast screening databases were retrospectively searched for women diagnosed with DCIS without invasive cancer at screening and who had no record of surgery within 6 months of diagnosis. These were cross-referenced with cancer registry data. Details of the potentially eligible women were sent to the relevant breast screening units for verification and for completion of data forms detailing clinical, radiological and pathological findings, non-surgical treatment and subsequent clinical course. RESULTS: Data for 311 eligible women (median age 62 years) were available. 60 women developed invasive cancer, 56 ipsilateral and 4 contralateral. Ipsilateral invasion risk increased approximately linearly with time for at least 10 years. The 10-year cumulative risk of ipsilateral invasion was 9% (95% CI 4-21%), 39% (24-58%) and 36% (24-50%) for low, intermediate and high grade DCIS respectively and was higher in younger women, in those with larger DCIS lesions and in those with microinvasion. Most invasive cancers that developed were grade 2 or 3. CONCLUSION: The findings suggest that active surveillance may be a reasonable alternative to surgery in patients with low grade DCIS but that women with intermediate or high grade disease should continue to be offered surgery. This highlights the importance of reproducible grading of DCIS to ensure patients receive appropriate treatment

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

Establishing a clinical phenotype for cachexia in end stage kidney disease - study protocol.

BACKGROUND: Surveys using traditional measures of nutritional status indicate that muscle wasting is common among persons with end-stage kidney disease (ESKD). Up to 75% of adults undergoing maintenance dialysis show some evidence of muscle wasting. ESKD is associated with an increase in inflammatory cytokines and can result in cachexia, with the loss of muscle and fat stores. At present, only limited data are available on the classification of wasting experienced by persons with ESKD. Individuals with ESKD often exhibit symptoms of anorexia, loss of lean muscle mass and altered energy expenditure. These symptoms are consistent with the syndrome of cachexia observed in other chronic diseases, such as cancer, heart failure, and acquired immune deficiency syndrome. While definitions of cachexia have been developed for some diseases, such as cardiac failure and cancer, no specific cachexia definition has been established for chronic kidney disease. The importance of developing a definition of cachexia in a population with ESKD is underscored by the negative impact that symptoms of cachexia have on quality of life and the association of cachexia with a substantially increased risk of premature mortality. The aim of this study is to determine the clinical phenotype of cachexia specific to individuals with ESKD. METHODS: A longitudinal study which will recruit adult patients with ESKD receiving haemodialysis attending a Regional Nephrology Unit within the United Kingdom. Patients will be followed 2 monthly over 12 months and measurements of weight; lean muscle mass (bioelectrical impedance, mid upper arm muscle circumference and tricep skin fold thickness); muscle strength (hand held dynamometer), fatigue, anorexia and quality of life collected. We will determine if they experience (and to what degree) the known characteristics associated with cachexia. DISCUSSION: Cachexia is a debilitating condition associated with an extremely poor outcome. Definitions of cachexia in chronic illnesses are required to reflect specific nuances associated with each disease. These discrete cachexia definitions help with the precision of research and the subsequent clinical interventions to improve outcomes for patients suffering from cachexia. The absence of a definition for cachexia in an ESKD population makes it particularly difficult to study the incidence of cachexia or potential treatments, as there are no standardised inclusion criteria for patients with ESKD who have cachexia. Outcomes from this study will provide much needed data to inform development and testing of potential treatment modalities, aimed at enhancing current clinical practice, policy and education

Pharmacology education for nurse prescribing students – a lesson in reusable learning objects

<p>Abstract</p> <p>Background</p> <p>The shift away from a biological science to a social science model of nursing care has resulted in a reduction in pharmacology knowledge and understanding in pre-registration nursing students. This has a significant impact on nurse prescribing training where pharmacology is a critical component of the course from a patient safety perspective.</p> <p>Methods</p> <p>Reusable learning objects (RLOs) are electronic resources based on a single learning objective which use high quality graphics and audio to help engagement with the material and to facilitate learning. This study used questionnaire data from three successive cohorts of nurse prescribing students (n = 84) to evaluate the use of RLOs focussed around pharmacology concepts to promote the understanding of these concepts in students. A small number of students (n = 10) were followed up by telephone interview one year after qualification to gain further insight into students' perceptions of the value of RLOs as an educational tool.</p> <p>Results</p> <p>Students' perceptions of their own understanding of pharmacology concepts increased substantially following the introduction of RLOs to supplement the pharmacology component of the course. Student evaluation of the RLOs themselves was extremely positive with a number of students continuing to access these tools post-qualification.</p> <p>Conclusion</p> <p>The use of RLOs to support the pharmacology component of nurse prescribing courses successfully resulted in a perceived increase in pharmacology understanding, with some students directly implicating these educational tools in developing confidence in their own prescribing abilities.</p

Pharmacology as a foreign language: A preliminary evaluation of podcasting as a supplementary learning tool for non-medical prescribing students

<p>Abstract</p> <p>Background</p> <p>Nurses and other health professionals in the U.K. can gain similar prescribing rights to doctors by undertaking a non-medical prescribing course. Non-medical prescribing students must have a thorough understanding of the pharmacology of prescribing to ensure safe practice. Pharmacology education at this level is complicated by the variation in students' prior subject knowledge of, and anxiety about, the subject. The recent advances in technology, particularly the potential for mobile learning, provide increased opportunities for students to familiarise themselves with lecture materials and hence promote understanding. The objective of this study was therefore to evaluate both the subjective (student perception) and objective (student use and exam results) usefulness of podcasts of pharmacology lectures which were provided as an extra learning tool to two cohorts (n = 69) of non-medical prescribing students.</p> <p>Methods</p> <p>The podcasts were made available to students through the virtual learning environment WebCT. Use of podcasts by two successive cohorts of nurse prescribing students (n = 69) was tracked through WebCT. Survey data, which was collected from 44 of these students, investigated patterns of/reasons for podcast use and perceived usefulness of podcasts as a learning tool. Of these 69 students, 64 completed the pharmacology exam. In order to examine any impact of podcasts on student knowledge, their exam results were compared with those of two historical cohorts who did not have access to podcasts (n = 70).</p> <p>Results</p> <p>WebCT tracking showed that 91% of students accessed at least one podcast. 93% of students used the podcasts to revisit a lecture, 85% used podcasts for revision, and 61% used the podcasts when they had a specific question. Only 22% used the podcasts because they had missed a pharmacology session. Most students (81%) generally listened to the entire podcast rather than specific sections and most (73%) used them while referring to their lecture handouts. The majority of students found the podcasts helpful as a learning tool, as a revision aid and in promoting their understanding of the subject. Evaluation of the range of marks obtained, mode mark and mean mark suggested improved knowledge in students with access to podcasts compared to historical cohorts of students who did not have access to pharmacology podcasts.</p> <p>Conclusions</p> <p>The results of this study suggest that non-medical prescribing students utilised podcasts of pharmacology lectures, and have found the availability of these podcasts helpful for their learning. Exam results indicate that the availability of podcasts was also associated with improved exam performance.</p

Statistical practices of educational researchers: An analysis of their ANOVA, MANOVA, and ANCOVA analyses

Articles published in several prominent educational journals were examined to investigate the use of data-analysis tools by researchers in four research paradigms: between-subjects univariate designs, between-subjects multivariate designs, repeated measures designs, and covariance designs. In addition to examining specific details pertaining to the research design (e.g., sample size, group size equality/inequality) and methods employed for data analysis, we also catalogued whether: (a) validity assumptions were examined, (b) effect size indices were reported, (c) sample sizes were selected based on power considerations, and (d) appropriate textbooks and/or articles were cited to communicate the nature of the analyses that were performed. Our analyses imply that researchers rarely verify that validity assumptions are satisfied and accordingly typically use analyses that are nonrobust to assumption violations. In addition, researchers rarely report effect size statistics, nor do they routinely perform power analyses to determine sample size requirements. We offer many recommendations to rectify these shortcomings.Social Sciences and Humanities Research Counci

Serum 25-Hydroxyvitamin D and the Incidence of Acute Viral Respiratory Tract Infections in Healthy Adults

Declining serum concentrations of 25-hydroxyvitamin D seen in the fall and winter as distance increases from the equator may be a factor in the seasonal increased prevalence of influenza and other viral infections. This study was done to determine if serum 25-hydroxyvitamin D concentrations correlated with the incidence of acute viral respiratory tract infections.In this prospective cohort study serial monthly concentrations of 25-hydroxyvitamin D were measured over the fall and winter 2009-2010 in 198 healthy adults, blinded to the nature of the substance being measured. The participants were evaluated for the development of any acute respiratory tract infections by investigators blinded to the 25-hydroxyvitamin D concentrations. The incidence of infection in participants with different concentrations of vitamin D was determined. One hundred ninety-five (98.5%) of the enrolled participants completed the study. Light skin pigmentation, lean body mass, and supplementation with vitamin D were found to correlate with higher concentrations of 25-hydroxyvitamin D. Concentrations of 38 ng/ml or more were associated with a significant (p<0.0001) two-fold reduction in the risk of developing acute respiratory tract infections and with a marked reduction in the percentages of days ill.Maintenance of a 25-hydroxyvitamin D serum concentration of 38 ng/ml or higher should significantly reduce the incidence of acute viral respiratory tract infections and the burden of illness caused thereby, at least during the fall and winter in temperate zones. The findings of the present study provide direction for and call for future interventional studies examining the efficacy of vitamin D supplementation in reducing the incidence and severity of specific viral infections, including influenza, in the general population and in subpopulations with lower 25-hydroxyvitamin D concentrations, such as pregnant women, dark skinned individuals, and the obese