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Added: May 31, 2023
Updated: May 31, 2023
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: May 17, 2023
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 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 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.
User-focused research to identify the benefits of innovative digital recruitment and retention tools for more efficient conduct of randomised trials
Added: April 14, 2023
Updated: April 14, 2023
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: March 8, 2023
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.
Major mistakes and errors in the use of Trial Sequential Analysis in systematic reviews or meta‑analyses
Added: March 7, 2023
Updated: March 7, 2023
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.
Including people experiencing socioeconomic disadvantage in the development and evaluation of complex interventions for health – a scoping review
Added: January 17, 2023
Updated: January 17, 2023
Populations in trials and other research do not often represent the population that suffers from the condition or illness being studied, and often the people omitted from the research as those disproportionally experiencing inequalities in health and social care. Complex interventions are interventions with a number of interacting parts, and due to this, may lead to further exclusion of under-served groups. Socioeconomic disadvantage is linked to health inequalities, and also intersection with other under-served groups.
This scoping review aims to identify key concepts around including or undertaking research in complex intervention development and evaluation for socioeconomically disadvantaged groups/individuals.
Participant retention in paediatric randomised controlled trials: systematic review and meta-analysis
Added: January 1, 2023
Updated: January 1, 2023
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.
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.
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.
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.
Added: November 8, 2022
Updated: November 16, 2022
The project is investigating how to best support career development conversations in academia. The project will test tools that could support career conversations by arranging for researchers to experience two different forms of development tool / experience (such as 360-degree feedback tool and career planning tool) and then asking them to provide a pairwise comparison.
We will also explore researcher's perceptions and experience of the barriers to career development conversations.