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Added: October 24, 2022
Updated: June 26, 2023
The Government’s Research and Development Roadmap sets out a commitment to “require that research outputs funded by the UK government are freely available to the taxpayer who funds research”. In Autumn of 2020, the Department of Health and Social Care (DHSC) ran a consultation to inform the review of the National Institute for Health Research (NIHR) OA Policy. The consultation gathered views from a wide range of stakeholders, including members of the public. A survey focussed on opportunities and barriers of OA, and gathered specific views on the existing NIHR OA policy and on proposed policy options. In addition, DHSC was particularly interested in capturing a diversity of public views to understand how research can be better accessed to maximise its reach, value and impact. Thus, a workshop to capture public perspectives on the OA policy (including research contributors and participants, evidence users and beneficiaries) was also conducted. Findings of the consultation are summarised in a report available in the NIHR official website and the NIHR Open Research platform (see: https://www.nihr.ac.uk/documents/knowledge-is-power-public-perspectives-on-open-access-publishing/28787).
Added: September 29, 2022
Updated: January 31, 2024
Background: Social media has potential to facilitate research dissemination to busy practitioners, such as nurses to enhance, evidence-based care
Aims: To explore the effectiveness of social media for disseminating research evidence to practitioners and explore how nurses use social media to access research evidence.
Methods: This multi-methods study included a systematic review (PROSPERO 2022 CRD42022378793, doi: 10.2196/45684) and qualitative interview study.
Six databases were searched from January 2010 to January 2023. Randomised and non-randomised trials, pre/post designs and case studies were included. Independent reviewers conducted screening, data extraction and quality assessment (Cochrane tool for assessing risk of bias and the Newcastle-Ottawa Scale). Outcomes were grouped into four domains (reach, engagement, direct dissemination, impact). Twenty-one nurses from a range of practice settings were interviewed. Verbatim transcripts were anonymised and analysed thematically.
Results: Fifty mixed quality articles were included (9 randomised controlled trials). Social media was effective for dissemination (article download) compared to no social media and somewhat effective for reach, engagement and impact. Nurses used open and closed social media platforms professionally, although seldom within working hours due to lack of access and time. Open platforms were valued as they raised awareness of diverse research evidence. Closed social media groups provided an extended professional network and community of practice around specialist areas. Authenticity of research evidence shared via social media was rarely questioned and interviewees tended to assess the credibility of the originator of the social media information (i.e., credible organisations) rather than critically appraise research evidence being shared. Participants reported that they lacked training to use social media.
Conclusion: Social media is an effective means of disseminating research evidence and offers the opportunity to expand professional networks and awareness of research evidence. Judicious use and a critical approach to research evidence shared on social media is required to minimise the risk of misinformation.
Added: September 29, 2022
Updated: September 29, 2022
The study explored whether a narrative CV is an efficient and effective mechanism for the NIHR to collect information about applicants and/or teams as part of the NIHR research application and assessment process. The study involved two stages. The first consisted in secondary analysis of data collected by the Royal Society from their work on research culture and the subsequent development of the Résumé for Researchers. The second stage consisted of thematic analysis of focus groups and interviews with NIHR stakeholders: (1) early career successful and unsuccessful applicants; (2) mid/senior career successful and unsuccessful applicants; (3) NIHR funding committee programme directors, chairs, and deans; (4) NIHR committee members/interview panellists; (5) external reviewers and (6) NIHR Coordinating Centre staff involved in research and training programmes. This study was part of a wider programme of work to explore the use of narrative CVs within the NIHR. The study was given ethics approval from the Faculty of Medicine, University of Southampton (id: 66298). Following analysis, the study made thirty-seven recommendations across six areas: Broad considerations for implementation; Training and guidelines for content; Reviewing current practices to embed narrative principles; NIHR role in wider adoption of narrative CV principles; Monitoring, evaluation, and learning; Purpose: What a narrative CV is and why NIHR is implementing it. These recommendations informed discussions regarding the policy and practice of using narrative CV by the NIHR, and emphasise the need to consider the recommendations and complete piloting and evaluation before a decision on implementation is made. This work was part of a wider programme in the NIHR related to the use of narrative CVs.
Added: September 15, 2022
Updated: May 11, 2023
Reporting is a mechanism for funding organisations to monitor and manage the progress, outputs, outcomes and impacts of the research they fund. Inconsistent approaches to reporting and post-award management, and a growing demand for research information, can lead to perception of unnecessary administrative effort that impacts on decision-making and research activity. Identifying this effort, and what stakeholders see as unmet need for improvement, is crucial if funders and Higher Education Institutions (HEIs) are to streamline their practices and provide better support with reporting activities. In this review, we summarise the processes in post-award management, compare current practices, and explore the purpose of collecting information on funded research. We also identify areas where unnecessary effort is perceived and improvement is needed, using previously reported solutions to inform recommendations for funders and HEIs.
Methods: We conducted a scoping review of the relevant research and grey literature. Electronic searches of databases, and manual searches of journals and funder websites, resulted in inclusion of 52 records and 11 websites. Information on HEI and funder post-award management processes was extracted, catalogued, and summarised to inform discussion.
Results: Post-award management is a complex process that serves many purposes but requires considerable effort, particularly in the set up and reporting of research. Perceptions of unnecessary effort stem from inefficiencies in compliance, data management and reporting approaches, and there is evidence of needed improvement in mechanisms of administrative support, research impact assessment, monitoring, and evaluation. Solutions should focus on integrating digital systems to reduce duplication, streamlining reporting methods, and improving administrative
resources in HEIs.
Conclusions: Funders and HEIs should work together to support a more efficient post-award management process. The value of research information, and how it is collected and used, can be improved by aligning practices and addressing the specific issues highlighted in this review.
Added: August 15, 2022
Updated: September 14, 2022
Background: Recruitment is the Achilles heel of clinical trials. Failure to recruit the sample size jeopardises the reliability of results and wastes a significant amount of time and resources. Site feasibility assessments are a common tool employed by sponsors to assess a site’s recruitment potential and ability to undertake the clinical trial protocol. The purpose of this study is to evaluate site feasibility procedures as a tool for predicting recruitment potential.
Methods: We conducted site feasibility with thirty-nine sites across the UK. Twenty-seven were selected to participate in the CapaCiTY (01/02/03) program; three randomised controlled trials aiming to develop an evidence based chronic constipation (CC) treatment pathway for adults. We compared site feasibilities predicted recruitment rates with actual recruitment rates and conducted a telephone survey to understand the barriers to recruitment.
Results: Sites did not accurately predict their recruitment potential during site feasibility. Conducting site feasibility did not result in the trials reaching the required sample size. At the time of survey, 17% of sites in CapaCiTY01 were meeting recruitment targets, 83% were recruiting half or less than half their target. Of these, 17% recruited no participants. In CapaCiTY02, 13% of sites were recruiting to target, 87% were recruiting half or less than half, of these, 25% recruited no participants. In CapaCiTY03, 14% of sites were recruiting to target, 86% recruited half or less than half the target, of these 43% recruited none. The main barriers to recruitment were lack of resources and study design not being compatible with routine care.
Conclusions Improving the reliability of site feasibility assessment could potentially save hundreds of millions of pounds each year in failed investments and speed up the time to delivery of new treatments for patients. We recommend 1) conducting site feasibility assessment at the pre-award stage. 2) investment in training researchers in conducting and completing site feasibility. 3) sample size feasibility assessment based on country-specific disease prevalence and epidemiology data 4) funders to include clinical trial feasibility specialists on peer review and grants panels 5) development of a national database of sites previous trial recruitment performance.
Added: April 14, 2022
Updated: April 14, 2022
The results of trials will not have their full impact if part of the population is ignored or forgotten. Unfortunately, this is often the case for ethnic minority groups. We have recently developed a tool called the INCLUDE Ethnicity Framework (https://www.trialforge.org/trial-forge-centre/include/), which helps trial teams to think about how their design decisions might make it easy or difficult for participants from some ethnic groups to take part. Feedback so far has been very positive, and organisations that fund trials such as the National Institute for Health Research and the Wellcome Trust, now include it in their guidance for researchers.
We now want to go further. Firstly, we want to help trial teams using the Framework to identify the proportion of people from different ethnic groups needed for the trial to be truly representative. This will drive their recruitment targets and plans. Secondly, we want to give them evidence-based strategies to help them achieve these proportions. Doing this will reduce inequality and increase confidence that the results of an expensive trial will help all those who could benefit, including people from ethnic minority groups.
This project is funded by the Chief Scientist Office of the Scottish Government’s Health and Social Care Department and led by Prof Shaun Treweek at the University of Aberdeen.
Added: April 11, 2022
Updated: April 11, 2022
Background
At the 2015 REWARD/EQUATOR conference on research waste, the late Doug Altman revealed that his only regret about his 1994 BMJ paper ‘The scandal of poor medical research’ was that he used the word ‘poor’ rather than ‘bad’. But how much research is bad? And what would improve things?
Main text
We focus on randomised trials and look at scale, participants and cost. We randomly selected up to two quantitative intervention reviews published by all clinical Cochrane Review Groups between May 2020 and April 2021. Data including risk of bias, number of participants, intervention type and country were extracted for all trials included in selected reviews. High risk of bias trials were classed as bad. The cost of high risk of bias trials was estimated using published estimates of trial cost per-participant.
We identified 96 reviews authored by 546 reviewers from 49 clinical Cochrane Review Groups that included 1,659 trials done in 84 countries. Of the 1,640 trials providing risk of bias information, 1,013 (62%) were high risk of bias (bad), 494 (30%) unclear and 133 (8%) low risk of bias. Bad trials were spread across all clinical areas and all countries. Well over 220,000 participants (or 56% of all participants) were in bad trials. The low estimate of the cost of bad trials was £726 million; our high estimate was over £8 billion.
We have five recommendations: trials should be neither funded (1) or given ethical approval (2) unless they have a statistician and methodologist; trialists should use a risk of bias tool at design (3); more statisticians and methodologists should be trained and supported (4); there should be more funding into applied methodology research and infrastructure (5).
Conclusions
Most randomised trials are bad and most trial participants will be in one. The research community has tolerated this for decades. This has to stop: we need to put rigour and methodology where it belongs– at the centre of our science.
Added: April 9, 2022
Updated: September 14, 2023
Academic research is having little influence on the commissioning and design of health care services, and stakeholders (including patients) are currently not consulted sufficiently for research to be genuinely informed by their experiences. This systematic review aimed to assess the effectiveness of knowledge sharing techniques and mechanisms on knowledge sharing between researchers and stakeholders in NIHR funded health research. Electronic database searches and manual searches of reference lists of included studies were conducted to identify articles that reported healthcare knowledge sharing between academics or researchers and non-academic stakeholders (e.g., clinicians, health service managers, policy makers, hospital managers or patients/public contributors) through any medium (e.g., email, telephone). 8,890 records were identified. Following de-duplication and independent screening, 19 articles were included. Four articles were co-production studies, 3 reports described priority setting partnerships, 5 studies reported using intermediaries, 5 studies used collaborative or consultative events and 2 articles reported systematic reviews of interventions. Quality appraisal, data extraction and synthesis is ongoing.
Added: April 9, 2022
Updated: January 31, 2024
Members of the public want to access and use research evidence to help them make health and treatment decisions. While efforts have been made by researchers, funders and governmental bodies to make health research transparent and accessible, some members of the public face challenges and barriers that hinder access to health research.
This two phase study described (i) the extent and nature of the published evidence on the ways that members of the public access health research and (ii) how people from ethnically diverse communities (Black and South Asian communities) access and use health research.
For the first phase, a scoping review was conducted informed by the the Joanna Briggs Institute guidance for conducting scoping reviews (https://osf.io/rxp39). The second phase included 30 individual semi-structured interviews with members of the Black or south Asian community and two ethnographic observational visits to community meetings organized by the Mosaic Community Trust, a registered charity working to promote community cohesion and raise awareness about health and well-being in its communities in North Westminster.
Added: February 8, 2022
Updated: February 8, 2022
A criticism of some orthopaedic surgical trials has been that the screening, choice, and application of eligibility criteria to select patients for a study means that many are excluded from the target population. This has been interpreted as limiting the applicability of the findings which may impact on implementation to clinical practice. For orthopaedic surgical trials, the focus has been on how to improve their internal validity. When RCTs are judged for their quality, this does not adequately address external validity. It is orthopaedic research that are published in high impact medical journals that may have the highest visibility and the largest potential for influencing key stake-holders and consequently clinical practice. To address these concerns, and in the context of the wider agenda to improve the under-representation of patients in research, we will conduct a review of orthopaedic surgical RCTs published in high impact journals to examine the selection of patients for recruitment into the trial.