Clinical trial metadata:Defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the National Institute for Health Research Health Technology Assessment programme

Background:  By 2011, the Health Technology Assessment (HTA) programme had published the results of over 100 trials with another 220 in progress. The aim of the project was to develop and pilot ‘metadata’ on clinical trials funded by the HTA programme.   Objectives: The aim of the project was to develop and pilot questions describing clinical trials funded by the HTA programme in terms of it meeting the needs of the NHS with scientifically robust studies. The objectives were to develop relevant classification systems and definitions for use in answering relevant questions and to assess their utility.   Data sources: Published monographs and internal HTA documents.   Review methods: A database was developed, ‘populated’ using retrospective data and used to answer questions under six prespecified themes. Questions were screened for feasibility in terms of data availability and/or ease of extraction. Answers were assessed by the authors in terms of completeness, success of the classification system used and resources required. Each question was scored to be retained, amended or dropped.    Results: One hundred and twenty-five randomised trials were included in the database from 109 monographs. Neither the International Standard Randomised Controlled Trial Number nor the term ‘randomised trial’ in the title proved a reliable way of identifying randomised trials. Only limited data were available on how the trials aimed to meet the needs of the NHS. Most trials were shown to follow their protocols but updates were often necessary as hardly any trials recruited as planned. Details were often lacking on planned statistical analyses, but we did not have access to the relevant statistical plans. Almost all the trials reported on cost-effectiveness, often in terms of both the primary outcome and quality-adjusted life-years. The cost of trials was shown to depend on the number of centres and the duration of the trial. Of the 78 questions explored, 61 were well answered, 33 fully with 28 requiring amendment were the analysis updated. The other 17 could not be answered with readily available data.   Limitations: The study was limited by being confined to 125 randomised trials by one funder.   Conclusions: Metadata on randomised controlled trials can be expanded to include aspects of design, performance, results and costs. The HTA programme should continue and extend the work reported here

Positioning creative, three dimensional design practice and understanding its role and value in university health research and development projects

The success or failure of new product innovations depend upon many, complex and often competing demands. These range from market conditions, availability of technology, psychology of consumer acceptance to the fundamental reasons for a particular product or technology existing in the first instance. The role of universities in this mix can compound success or failure issues further. Where there may be a desire and ambition to improve the quality of life of a population through new scientific or clinical discovery, often translating those discoveries to real world application is challenging. The Wilson report, commissioned by the UK Government, 'A Review of Business–University Collaboration' highlights some of the issues universities and industry face and states that “There is no simple model for interaction; the diverse business needs and diversity of supply from universities leads to complexity in relationships” (Wilson, 2012). Based on the experiences of the authors of this paper and through a number of short health research and product development case studies this paper presents and discusses a theoretical model developed to help build greater understanding and demonstrate the value of design practices value in university and industry collaborations. It identifies 3D designs value through targeted activity towards successful outcomes and discusses how those projects have run in university research setting

Empathetic design research and development in practice; co-development of an innovative head and neck support for people with Motor Neurone Disease

People with Motor Neuron Disease (MND) experience muscle weakness. The human head can weigh 5kg so when this happens in the muscles around the neck it can become very difficult to hold the head up and result in the head falling forward. The situation can lead to extreme pain, restricted movement, problems with eating, drinking, swallowing, breathing and importantly adversely affect face to face communication. Ideally, a neck collar would help alleviate these important quality of life (QoL) issues. Current neck collar provision can be of limited use for people with MND and are regularly rejected by users as often they are designed to immobilise the head and neck, and can be socially stigmatising. A fundamental reappraisal of the way these physical products are configured and used was undertaken. The project explored the use of open and empathic approaches to the co-design of solutions and further product designs role as developer and explorer of complex multidisciplinary, social and QoL issues. It demonstrates experts working openly together using a range of 'live' research practice methods to arrive at holistically considered optimum outcomes. The project was funded by the NIHR i4i program. The team consisted of clinicians, engineers and designers working with partners including people experiencing MND and their carers. Processes included a range of research through design methods at the heart of which was a series of ten, iterative, co-design workshops. The team developed mutual empathies between project participants. These played a key role in the motivation to reach appropriate solutions

Mobile Technology for Empowering Health Workers in Underserved Communities: New Approaches to Facilitate the Elimination of Neglected Tropical Diseases.

BACKGROUND As global mobile phone penetration increases, direct health information communication from hard-to-reach communities is becoming commonplace. Mobile health (mHealth) tools that enable disease control programs to benefit from this information, while simultaneously empowering community members to take control of their own health, are vital to the goal of universal health care. OBJECTIVE Our aim was to highlight the development of the Liverpool mHealth Suite (LMS), which has been designed to address this need and improve health services for neglected tropical diseases being targeted for global elimination, such as lymphatic filariasis. METHODS The LMS has two main communication approaches-short message service and mobile phone apps-to facilitate real-time mass drug administration (MDA) coverage, reporting patient numbers, managing stock levels of treatment supplies, and exchanging health information to improve the quality of care of those affected. RESULTS The LMS includes the MeasureSMS-MDA tool to improve drug supplies and MDA coverage rates in real-time (currently being trialed in urban Tanzania); the MeasureSMS-Morbidity tool to map morbidity, including lymphedema and hydrocele cases (initially piloted in rural Malawi and Ghana, then extended to Ethiopia, and scaled up to large urban areas in Bangladesh and Tanzania); the LyMSS-lymphedema management supply system app to improve distribution of treatments (trialed for 6 months in Malawi with positive impacts on health workers and patients); and the HealthFront app to improve education and training (in development with field trials planned). CONCLUSIONS The current success and scale-up of the LMS by many community health workers in rural and urban settings across Africa and Asia highlights the value of this simple and practical suite of tools that empowers local health care workers to contribute to local, national, and global elimination of disease

Lunar lander conceptual design

A conceptual design is presented of a Lunar Lander, which can be the primary vehicle to transport the equipment necessary to establish a surface lunar base, the crew that will man the base, and the raw materials which the Lunar Station will process. A Lunar Lander will be needed to operate in the regime between the lunar surface and low lunar orbit (LLO), up to 200 km. This lander is intended for the establishment and operation of a manned surface base on the moon and for the support of the Lunar Space Station. The lander will be able to fulfill the requirements of 3 basic missions: A mission dedicated to delivering maximum payload for setting up the initial lunar base; Multiple missions between LLO and lunar surface dedicated to crew rotation; and Multiple missions dedicated to cargo shipments within the regime of lunar surface and LLO. A complete set of structural specifications is given

Differences in perception of dysentery and enteric fever and willingness to receive vaccines among rural residents in China.

BACKGROUND: Enteric diseases including dysentery and enteric fever remain significant public health problems in China. While vaccines offer great potential in controlling these diseases, greater understanding of factors influencing acceptance of vaccines is needed to create effective enteric disease control programs in rural China. DESIGN: Cross-sectional quantitative study with randomly sampled households from two sites in China, one experiencing high rates of shigellosis (Zengding) and the other of typhoid/paratyphoid (Lingchuan). METHODS: Sociobehavioral survey data were collected through face-to-face interviews from 501 respondents (56% female) in Zhengding regarding dysentery and 624 in Lingchuan (51% female) regarding enteric fever. Vaccine acceptability was measured by expressed need for vaccination and willingness to pay. Comparative and associative analyses were conducted to assess disease perception, vaccination service satisfaction, likelihood of improvements in water and sanitation, and vaccine acceptability. RESULTS: Nearly all respondents in Lingchuan considered enteric fever to be prevalent in the community, while only one half of the respondents in Zhengding considered dysentery to be problematic (p < 0.01). Nevertheless, more respondents in Zhengding were fearful that a household member would acquire dysentery than were Lingchuan respondents worried that a household member would acquire enteric fever (p < 0.01). Perceived vulnerability of specific subgroups (odds ratios ranging from 1.6 to 8.1), knowing someone who died of the disease (odds ratio reached infinity) and satisfaction with past vaccination services (odds ratios reached infinity) were consistently associated with perceived need for vaccines of target populations of all age groups while the association between perception of sanitary improvement and vaccine need was limited. Perceived need for a vaccine was associated with willingness to pay for the vaccine. CONCLUSIONS: Perceptions of enhanced vulnerability of specific subgroups to a disease and satisfactory experiences with vaccination services may increase the perceived need for a vaccine, leading to increased willingness to pay for vaccine. Vaccines are not perceived as important for the elderly

Augmenting CT cardiac roadmaps with segmented streaming ultrasound

Static X-ray computed tomography (CT) volumes are often used as anatomic roadmaps during catheter-based cardiac interventions performed under X-ray fluoroscopy guidance. These CT volumes provide a high-resolution depiction of soft-tissue structures, but at only a single point within the cardiac and respiratory cycles. Augmenting these static CT roadmaps with segmented myocardial borders extracted from live ultrasound (US) provides intra-operative access to real-time dynamic information about the cardiac anatomy. In this work, using a customized segmentation method based on a 3D active mesh, endocardial borders of the left ventricle were extracted from US image streams (4D data sets) at a frame rate of approximately 5 frames per second. The coordinate systems for CT and US modalities were registered using rigid body registration based on manually selected landmarks, and the segmented endocardial surfaces were overlaid onto the CT volume. The root-mean squared fiducial registration error was 3.80 mm. The accuracy of the segmentation was quantitatively evaluated in phantom and human volunteer studies via comparison with manual tracings on 9 randomly selected frames using a finite-element model (the US image resolutions of the phantom and volunteer data were 1.3 x 1.1 x 1.3 mm and 0.70 x 0.82 x 0.77 mm, respectively). This comparison yielded 3.70±2.5 mm (approximately 3 pixels) root-mean squared error (RMSE) in a phantom study and 2.58±1.58 mm (approximately 3 pixels) RMSE in a clinical study. The combination of static anatomical roadmap volumes and dynamic intra-operative anatomic information will enable better guidance and feedback for image-guided minimally invasive cardiac interventions