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Added: July 6, 2023
Updated: July 6, 2023
In the context of avoiding research waste, the conduct of a feasibility study before a clinical trial should reduce the risk that further resources will be committed to a trial that is likely to ‘fail’. However, there is little evidence indicating whether feasibility studies add to or reduce waste in research. Feasibility studies funded by the National Institute for Health Research’s (NIHR) Research for Patient Benefit (RfPB) programme were examined to determine how many had published their findings, how many had applied for further funding for a full trial and the timeframe in which both of these occurred. A total of 120 feasibility studies which had closed by May 2016 were identified and each Principal Investigator (PI) was sent a questionnaire of which 89 responses were received and deemed suitable for analysis. Based on self reported answers from the PIs a total of 57 feasibility studies were judged as feasible, 20 were judged not feasible and for 12 it was judged as uncertain whether a full trial was feasible. The RfPB programme had spent approximately £19.5m on the 89 feasibility studies of which 16 further studies had been subsequently funded to a total of £16.8m. The 20 feasibility studies which were judged as not feasible potentially saved up to approximately £20m of further research funding which would likely to have not completed successfully. The average RfPB feasibility study took 31 months (range 18 to 48) to complete and cost £219,048 (range £72,031 to £326,830) and the average full trial funded from an RfPB feasibility study took 42 months (range 26 to 55) to complete and cost £1,163,996 (range £321,403 to £2,099,813). The average timeframe of feasibility study and full trial was 72 months (range 56 to 91), however in addition to this time an average of 10 months (range -7 to 29) was taken between the end of the feasibility study and the application for the full trial, and a further average of 18 months (range 13 to 28) between the application for the full trial and the start of the full trial. Approximately 58% of the 89 feasibility studies had published their findings with the majority of the remaining studies still planning to publish. Due to the long time frames involved a number of studies were still in the process of publishing the feasibility findings and/or applying for a full trial. Feasibility studies are potentially useful at avoiding waste and de-risking funding investments of more expensive full trials, however there is a clear time delay and therefore some potential waste in the existing research pathway.
Added: June 20, 2023
Updated: December 12, 2025
The pericapsular nerve group, or PENG block, has been recently described and shows promise in providing analgesia to the hip joint. However, the effect of this block on postoperative rehabilitation is uncertain. This study compares a preoperative PENG block to a placebo before total hip arthroplasty under spinal anesthesia.
Added: May 31, 2023
Updated: December 12, 2025
Background:
Non-inferiority (NI) trials aim to show a new treatment is no worse than a comparator. These trials have additional complexities in the design and analysis when compared with the more common superiority trials and these complexities can create confusion with researchers completing these trials.
Guidance is available for best practice of NI trials, however most of these focus on industry-funded trials as this is where much of the research has been to date. However, with this increase of more treatments being used in practice within the NHS, NI trials are becoming more common as the benefit of the new treatment is not always the main health outcome but instead a secondary outcome for example side effects. Research suggests there may be differences in the design of industry and publicly funded NI trials and many of the current reviews of NI trials are heavily influenced by industry-funded trials. This creates a gap in the literature to understand how publicly funded NI trials are being designed and how the guidance is translating to this different setting.
Methods: The International Standard Randomised Controlled Trial Number (ISRCTN) web registry and the National Institute for Health Research’s (NIHR) Funding and Awards Library and Journals Library were searched using the term non-inferiority and logical synonyms.
Characteristics of the design, analysis and results, as available, were recorded on a dedicated data extraction spreadsheet.
Added: May 17, 2023
Updated: December 12, 2025
Research Administration as a Profession (RAAAP) Taskforce
Research Administration as a Profession (RAAAP) is an international survey which seeks to identify the key skills, attitudes and behaviours of successful research management and administration (RMA) leaders.
The initial RAAAP survey, held in 2016, was funded by NCURA. It was led by Simon Kerridge (University of Kent, UK) and Stephanie Scott (Columbia University, USA) as Co-PIs, and supported by an international advisory group. In June 2018, the Council of the International Network of Research Management Societies (INORMS) formally endorsed the RAAAP survey as an INORMS initiative
The Taskforce
The RAAAP Taskforce was formed in October 2018 and has evolved over the years. Initially it included many members involved in the initial (2016) RAAAP exercise, and expanded to include representation from each of the INORMS Associations and also some other related associations.
The aim of the RAAAP Taskforce is to continue the work of the initial RAAAP survey, by surveying Research Managers and Administrators every three years (or thereabouts), to collect and analyse longitudinal data about the profession. The Taskforce is also responsible for revising the initial survey and editing future iterations of the survey, as required.
The Surveys
The RAAAP survey now comprises two main sections. One section of the survey is a streamlined version of the 2016 survey. This section is intended to remain the same longitudinally. The other section of the survey focuses on a specific area of interest, of particular relevance at the time – the focus of this section will change with each iteration of the survey.
RAAAP-3 (2022): The third iteration of the RAAAP survey (RAAAP-3) is now live and focusses on “How I Became a Research Manager and Administrator” (HIBARMA) looking at the myriad of ways we find ourselves in this profession.
RAAAP-2 (2019): The second iteration of the RAAAP survey (RAAAP-2) was launched on 1 October 2019. The ‘guest’ section of the survey focused on “Research Impact”.
RAAAP (2016): The first iteration of the RAAAP survey attracted responses from over 2,600 individuals from 64 countries. The survey’s findings were presented at RM and INORMS conferences between 2016 and 2018.
Added: April 14, 2023
Updated: December 12, 2025
Recruitment of participants to, and their retention in, RCTs is a key determinant of research efficiency, but is challenging (Treweek 2013). As a result, trialists and CTUs are increasingly exploring the use of digital tools to identify, recruit and retain participants.
Examples of these tools include:
• Eligibility: searches and interactive record tools to support clinicians screening participants (e.g. Koepcke et al. 2013)
• Recruitment: trial websites, social media and email campaigns to engage with the public
• Retention: Emails, websites, text messages or apps to retain patients in trials and help them meet drug, behavioural adherence or outcome assessment criteria
These tools should benefit research by reducing costs, avoiding waste and speeding delivery of results, improve recruitment reach and reduce recruitment of ineligible patients (around 6% in Koepcke’s study 2013). However, selecting appropriate digital tools is challenging because few have been evaluated rigorously. Also, different success metrics are used: for example, reduced screening time, improved coverage of recruitment or percentage of patients recruited. We need to understand which metrics are most relevant to stakeholders, to ensure wider uptake of effective tools.
We identified only one systematic review in this area, on databases to improve trial recruitment [Koepcke 2014]. The methods used were not rigorous by current standards, and it located only 9 studies using reasonably robust methods. It concluded that databases could reduce the time taken to screen participants, improve participant coverage and actual recruitment rates by between 14% and 6 times, though 4 of 5 studies used an uncontrolled before-after design and the fifth was confounded.
Our view, is that the evidence base for these tools needs to be assembled, mapped and critically appraised before synthesis, where appropriate. Only then can we confidently advise on the wider use of such tools by trialists, or on further primary research.
Added: March 8, 2023
Updated: January 16, 2025
Background: The crisis in research culture is well documented but there is still a tendency for quantity over quality, unhealthy competitive environments, and assessment based on publications, journal prestige and funding. Research institutions need to assess their own practices to promote and advocate for change in the current research ecosystem. To build an understanding of research culture and institution’s current practice, we conducted a review to address the questions ‘What does the evidence say about the ‘problem’ with ‘poor’ research culture, what are the benefits of ‘good’ research culture, and what does ‘good’ look like?
Aims: To examine the peer-reviewed and grey literature to explore the interplay between research culture, open research, career paths, recognition and rewards, and equality, diversity and inclusion, as part of a larger programme of activity at the University of Southampton.
Methods: A scoping review was undertaken. Six databases were searched along with grey literature. Eligible literature had relevance to academic research institutions, addressed research culture, and were published between January 2017 to May 2022. Evidence were mapped and themed to specific categories. The search strategy, screening and analysis took place between April-May 2022.
Results:1666 titles and abstracts, and 924 full text articles were assessed for eligibility. Of these, 254 articles met the eligibility criteria for inclusion. A purposive sampling of relevant websites was drawn from to complement the review. Key areas for consideration were identified across the four themes of job security, wellbeing and equality of opportunity, teamwork and interdisciplinary, and research quality and accountability.
Conclusions: There are opportunities for research institutions to improve their own practice, however institutional solutions cannot act in isolation. Research institutions and research funders need to work together to build a more sustainable and inclusive research culture that is diverse in nature and supports individuals’ well-being, career progression and performance.
Added: March 8, 2023
Updated: March 8, 2023
Background: The COVID-19 pandemic highlighted the potential significance of preprints in a public health emergency, and now with their continued use, preprints are considered within the context of open research. Funders and publishers are establishing their position on the use of preprints, in grant applications and publishing models. The purpose of this scoping review was to review the current evidence on the use and acceptability of preprints by publishers, funders, and the research community throughout the research pathway.
Methods: A scoping review was undertaken with no study or language limits. The search strategy was limited to the last five years (2017-2022) to capture changes influenced by the COVID-19 pandemic (e.g., accelerated use and role of preprints in research). The review included international literature, including grey literature. Two databases were searched: Scopus and Web of Science on 24 August 2022.
Results: 379 titles and abstracts and 193 full text articles were assessed for eligibility. Ninety-eight articles met eligibility criteria and were included for full extraction. For barriers and challenges, 26 statements were grouped under four main themes (e.g., volume/growth of publication, quality assurance/trustworthiness, risks associated to credibility and quality). For benefits and value, 34 statements were grouped under six themes (e.g., openness/transparency, increased visibility/credibility, open review process, open research, democratic process/systems, increased productivity/opportunities).
Conclusions: Opportunities for rapid dissemination using preprints means that best practices through policies and guidelines are required from journals, publishers, and funders, to ensure preprints become embedded into practice. Cautionary measures to maintain quality are needed, both to be transparent with the public and to maintain credibility within social media, so care is recommended when reading and digesting research from preprints. Transparent guidelines by journals and funders are required to articulate to academia the role and purpose of preprints compared to a peer reviewed journal publication.
Added: March 7, 2023
Updated: December 12, 2025
Background: Adequately conducted systematic reviews with meta-analyses are considered the highest level of evidence and thus directly defines many clinical guidelines. However, the risks of type I and II errors in meta-analyses are substantial. Trial Sequential Analysis is a method for controlling these risks. Erroneous use of the method might lead to research waste or misleading conclusions.
Methods: The current protocol describes a systematic review aimed to identify common and major mistakes and errors in the use of Trial Sequential Analysis by evaluating published systematic reviews and meta-analyses that include this method. We plan to include all studies using Trial Sequential Analysis published from January 2018 to January 2022, an estimated 400 to 600 publications. We will search Medical Literature Analysis and Retrieval System Online and the Cochrane Database of Systematic Reviews, including studies with all types of participants, interventions, and outcomes. Two independent reviewers will screen titles and abstracts, include relevant full text articles, extract data from the studies into a predefined checklist, and evaluate the methodological quality of the study using
the AMSTAR 2, assessing the methodological quality of the systematic reviews.
Discussion: This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P). The identified mistakes and errors will be published in peer reviewed articles and form the basis of a reviewed guideline for the use of Trial Sequential Analysis. Appropriately controlling for type I and II errors might reduce research waste and improve quality and precision of the evidence that clinical guidelines are based upon.
Added: February 17, 2023
Updated: February 17, 2023
Relatively little is known about the practice and implications of using standardised research measures with people living with dementia at different degrees of severity. It is crucial that we learn more about the ways that dementia symptoms and their progression can affect both the quality (reliability and validity) of quantitative data, and the experiences of research participants.
I am investigating the quantitative data collection encounter from the perspectives of participants living with dementia and research workers administering standardised measures. I will consider the impact of dementia symptoms as they change over time, combined with the interview context and questionnaire content, on the types and quality of data collected.
Added: January 1, 2023
Updated: December 12, 2025
Background
The factors which influence participant retention in paediatric randomised controlled trials are under-researched. Retention may be more challenging due to child developmental stages, involving additional participants, and proxy-reporting of outcomes. This systematic review and meta-analysis explores the factors which may influence retention in paediatric trials.
Methods
Using the MEDLINE database, paediatric randomised controlled trials published between 2015 and 2019 were identified from six general and specialist medical journals. The review outcome was participant retention for each reviewed trial’s primary outcome. Context and design factors were extracted. Retention was examined for each context and design factor in turn, with evidence for an association being determined by a univariate random-effects meta-regression analysis.
Results
Ninety-four trials were included, and median total retention was 0.92 (inter-quartile range 0.83 to 0.98). Higher estimates of retention were seen for trials with five or more follow-up assessments before the primary outcome, and those less than six-months between randomisation and primary outcome. Trials involving children aged 11 and over had the higher estimated retention compared with those involving younger children. Those trials which did not involve other participants also had higher retention, than those where they were involved. There was also evidence that a trial which used an active or placebo control treatment had higher estimated retention, than treatment-as-usual. Retention increased if at least one engagement method was used. Unlike reviews of trials including all ages of participants, we did not find any association between retention and, number of treatment groups, size of trial, or type of treatment.
Conclusions
Published paediatric RCTs rarely report the use of specific modifiable factors that improve retention. Including multiple, regular follow-ups with participants before the primary outcome may reduce attrition. Retention may be highest when the primary outcome is collected up to six-months after a participant is recruited. Our findings suggest that primary research into improving retention when trials involve multiple participants such as young people, and their caregivers or teachers would be worthwhile. Those designing paediatric trials also need to consider the use of appropriate engagement methods such as incentives or reminders.