The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials. Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.

https://www.bmj.com/content/bmj/355/bmj.i5239.full.pdf

CONSORT 2010 statement: extension to randomised pilot and feasibility trials.

In recent years, Carbon Capture and Storage (Sequestration) (CCS) has been proposed as a potential method to allow the continued use of fossil-fuelled power stations whilst preventing emissions of CO2 from reaching the atmosphere. Gas, coal (and biomass)-fired power stations can respond to changes in demand more readily than many other sources of electricity production, hence the importance of retaining them as an option in the energy mix. Here, we review the leading CO2 capture technologies, available in the short and long term, and their technological maturity, before discussing CO2 transport and storage. Current pilot plants and demonstrations are highlighted, as is the importance of optimising the CCS system as a whole. Other topics briefly discussed include the viability of both the capture of CO2 from the air and CO2 reutilisation as climate change mitigation strategies. Finally, we discuss the economic and legal aspects of CCS.

Carbon capture and storage update

https://repository.tudelft.nl/islandora/object/uuid%3A7bdae86a-0209-4e53-83d0-c531dd3465ec/datastream/OBJ/download

Artificial Intelligence (AI) : Multidisciplinary perspectives on emerging challenges, opportunities, and agenda for research, practice and policy

on behalf of the PAFS consensus group authors (listed alphabetically): Doug Altman (address 1), Frank Bretz (2), Marion Campbell (3), Erik Cobo (4), Peter Craig (5), Peter Davidson (6), Trish Groves (7), Freedom Gumedze (8), Jenny Hewison (9), Allison Hirst (10), Pat Hoddinott (11), Sarah E Lamb (12), Tom Lang (13), Elaine McColl (14), Alicia O’Cathain (15), Daniel R Shanahan (16), Chris Sutton (17), Peter Tugwell (18)

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CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Patient Health Questionnaire

The relationship between disciplines is strongly influenced by national funding agencies and a great deal of tacit knowledge about the management of interdisciplinary research programmes and projects is held by such bodies. Funders' support is critical to achieving the potential value-added of interdisciplinarity and these agencies have key roles to play, especially in shaping large-scale interdisciplinary initiatives. This paper reports on an empirical study and offers some lessons for public policy aimed at promoting learning and generating benefits that are broadly applicable across future efforts to tackle complex, multi-dimensional research challenges. There are key practical organisational steps that could be taken to promote and support collaborative working and integration for large-scale interdisciplinary research initiatives. Awareness of these critical processes can benefit funders as well as practitioners if interdisciplinary research is to achieve its full potential. Copyright The Author 2013. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com, Oxford University Press.

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The role of funding agencies in creating interdisciplinary knowledge

Objectives To conduct a pilot trial of a primary care Symptoms Clinic for patients with medically unexplained symptoms and evaluate recruitment and retention, and acceptability of the intervention and to estimate potential treatment effects for a full trial. Trial design Randomised parallel group pilot trial. Setting Primary care in one locality. Participants Primary care database and postal questionnaire were used to identify patients with multiple specialist referrals and multiple physical symptoms unlikely to be explained by disease. Interventions General practitioner (GP) with special interest ‘Symptoms Clinic’ + usual care versus usual care alone. The Symptoms Clinic comprised one long (1 h) and three short (20 min) appointments. Outcomes Number of patients identified and recruited; acceptability of the intervention (items from Client Satisfaction Questionnaire and interview); Medical Outcomes Survey Short Form 12 (SF-12) physical component summary. Randomisation Automated blocked randomisation accessed by telephone. Blinding None. Numbers randomized 16 to intervention and 16 to usual care alone. Recruitment 72 patients, from seven GP practices, had repeated specialist referrals and a Patient Health Questionnaire (PHQ)-15 score of ≥10 indicating a high probability of medically unexplained symptoms. 15 were ineligible and 25 declined to participate. Numbers analysed 26 patients; two patients randomised to the intervention group were incorrectly included, three patients in the intervention group and one control did not complete outcome measures. Outcome Most patients randomised to the Symptoms Clinic found the intervention acceptable: eight out of 11 reported the intervention helped them to deal with their problems. The mean difference between groups in SF-12 physical component summary, adjusted for baseline, was 3.8 points (SD 6). Harms No observed harms. Conclusions Patients with multiple medically unexplained symptoms can be systematically identified in primary care; a randomised trial comparing the Symptoms Clinic with usual care is feasible and has the potential to show clinically meaningful benefit. Trial registration ISRCTN63083469.

https://bmjopen.bmj.com/content/bmjopen/2/1/e000513.full.pdf

A primary care Symptoms Clinic for patients with medically unexplained symptoms: pilot randomised trial

Carbon capture and storage: realising the potential? is the culmination of a two-year project funded by UKERC and led by Professor Jim Watson, Director of the Sussex Energy Group .
 
The project is an independent, inter-disciplinary assessment of the viability of CCS technologies from now to 2030. Although these technologies could be a crucial component of global climate change mitigation strategies, there are significant uncertainties about their technical, economic and financial viability.
 
The report draws lessons from history, and concludes that previous technologies have faced similar challenges to those affecting CCS technologies today. In the past, such uncertainties have been resolved sufficiently for these technologies to succeed. While care is needed when learning from history, the findings offer some optimism that, given the right actions by government and industry, the uncertainties surrounding CCS can also be dealt with.

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Carbon Capture and Storage Realising the potential

Innovations in scientific and medical technologies, such as xenotransplantation and admixed embryos, invariably become the target of regulatory agencies and often demand new regulatory frameworks. In making decisions associated with these innovations, it is sometimes necessary for regulators to adopt certain positions about the status and significance of the human–animal embryo or body. In the UK, the regulatory and advisory bodies involved in the sphere of human/non-human transfer and exchange of material are: (1) the Human Fertilisation and Embryology Authority (HFEA); (2) the (defunct) UK Xenotransplantation Interm Regulatory Authority; and (3) the Home Office's Animal Procedures Committee (APC). In this article, we critically examine the reasons for the HFEA's involvement in regulating and advising in research which uses admixed embryos, given that the HFEA's remit is the government's fertility watchdog regulating in the area of human embryos. This expansion, we argue, was partly due to pressure from ...

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Wendy Marsden

Papers

The role of funding agencies in creating interdisciplinary knowledge

A primary care Symptoms Clinic for patients with medically unexplained symptoms: pilot randomised trial

Carbon Capture and Storage Realising the potential

Not “human” enough to be human but not “animal” enough to be animal – the case of the HFEA, cybrids and xenotransplantation in the UK

Identifying key success factors in the quest for interdisciplinary knowledge