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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: April 9, 2022
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: April 9, 2022
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.
Added: February 7, 2022
Updated: February 7, 2022
Insights from studies on how research contributes to wider benefits for society (i.e. ‘impacts’) can and should inform the operations of research funding organisations. Yet there would appear to be a gap in funding managers’ knowledge of these real-world processes, and confusion over appropriate roles when it comes to supporting activities that can help research along a pathway to impact.
The UK's National Institute for Health Research (NIHR) has set out a broad programme of work to understand, learn and improve its operations with respect to impact, as part of a 5-year ‘Impact Vision’. One of these activities focusses on how NIHR can best incorporate knowledge from studies of research impact into the guidance it provides to researchers who are applying for NIHR funding, when they are in the process of designing their research plans.
Over the past 2 years, NIHR has trialled a new initiative - impact 'strengthening workshops’ - that distils down key concepts and information derived from studies of research impact, into simple exercises to support researchers’ planning. This study evaluates applicants’ views on how useful they find these exercises and NIHR’s guidance on impact, more broadly. Findings will directly inform NIHR’s development of impact ‘practice guides’ for applicants and members of the funding committees who review NIHR funding applications. The study will also provide insights on how funders can incorporate evidence from studies of science into application processes, in a way that is amenable to researchers.
Added: February 7, 2022
Updated: February 7, 2022
Insights from studies on how research contributes to wider benefits for society (i.e. ‘impacts’) can and should inform the operations of research funding organisations. Yet there would appear to be a gap in funding managers’ knowledge of these real-world processes, and confusion over appropriate roles when it comes to supporting activities that can help research along a pathway to impact.
The UK's National Institute for Health Research (NIHR) has set out a broad programme of work to understand, learn and improve its operations with respect to impact, as part of a 5-year ‘Impact Vision’. One of these activities is a unique impact training programme, designed to incorporate expert knowledge from studies of science in a way that supports NIHR’s staff to consider how impact relates to their roles.
The impact training programme has been running for the last 4 years and it is timely to conduct an evaluation to see if and how NIHR staff knowledge has improved, and their intentions to apply learning in practice. This information will help NIHR to improve the content and structure of the programme and also inform wider activities, such as how NIHR can develop consistent guidance and information on impact across its operations. The findings from this study will offer valuable insights to the wider research community, based on the unique training programme and how it affects the operations of a national public research funding organisation.
Added: October 28, 2021
Updated: October 28, 2021
Research institutes represent a large part of the Medical Research Council (MRC) annual investment in research, which amounts to 21% of its portfolio, representing £145 Millions. Thus, on the one hand, understanding the contribution of research institutes to the MRC objectives in terms of research excellence and impact is of prime importance. On the other hand, research evaluation exercises, such as the Quinquennial Reviews that the research institutes are subjected to take significant time and resources. Thus, institute assessments should provide the best way to both ensure accountability of the institutes while limiting as much as possible the administrative burden on them.
This project aims to review the evaluation process that MRC research institutes undergo to identify the evidence crucial to the decision making and accountability purposes defined by the sponsor, including the tracking of benefits, as well as to inform future science policy. To do so the project entails two strands of research.
A first strand consists of reviewing what evidence has been submitted in the research institutes past evaluation exercises through document analysis. This will characterise the evidence submitted across a number of themes (i.e. excellence, building capacity, collaboration, translation, diversity etc.), but also what type of evidence is submitted, whether these are general narratives about what has been achieved, case studies or quantitative evidence. In order to assess the usefulness of this evidence, we will also consult with stakeholders (expert panellists, executive team of the research council, etc.).
A second strand consists of exploring how bibliometric data can be leveraged to provide systematic and easily compiled evidence to evaluation exercises, to best help evidence a range of strategic benefits of research performed at institutes, such as collaborations, translational work, disciplinary focus etc.
Overall the project aims to i) provide a framework for tracking research institute benefits that takes into account that the performance of these research organisations will reflect a variety of objectives and missions, and ii) explore how evaluation can produce the best evidence while limiting the administrative burden of compiling this evidence.
Added: October 14, 2021
Updated: February 9, 2022
Core outcome sets have the potential to reduce research waste by improving the consistency of outcomes measured in trials of the same health condition. An online resource called COMET initiative https://www.comet-initiative.org/ brings together people interested in the development and application of agreed standardised sets of outcomes, known as ‘core outcome sets’ (COS). This resource also has a searchable database of all developing or published COS.
However, this reduction in waste will only be realised through the uptake of COS by clinical trialists. Without uptake, the continued development of COS that are not implemented may add to waste in research. Funders of clinical trials have the potential to have an impact on COS uptake by recommending their use to those applying for funding. It is unclear to what extent grant applicants seeking funding for clinical trials include reference to the inclusion of a Core Outcome Set, or provide rationale for their outcome selection in Ireland. A similar study was carried out in the UK in 2019 (Hughes et al. 2019), which indicated a sub-optimal consideration for COS when submitting grant applications to the funder. Reviewing the inclusion (or consideration) of COS by trial teams at the grant application stage will help identify the extent to which more work is needed to encourage the uptake of COS resources by the funder, and also by the HRB Trials Methodology Research in Ireland.
Added: September 29, 2021
Updated: September 29, 2021
Background: Academic sabbaticals are seen as an important aspect of academic life and require considerable resources; however, little research has been done into how they are used and whether their effects can be measured. We explored these issues at the University of Cambridge.
Methods: A mixed method approach including 24 interviews with academics, 8 interviews with administrators; alongside analysis of administrative and publication data between 2010 and 2019.
Results: Academics underline the importance of sabbaticals in providing uninterrupted time for research that is used to think, explore new ideas, master new techniques, develop new collaborations, draw together previous work, set work in a wider context, and provide personal discretion in research direction. They also highlight sabbaticals’ contributions in allowing the beneficial effects of combining teaching and research while mitigating some of the disadvantages. However, it is difficult to detect the effect of sabbaticals on publications using a time series approach.
Conclusions: Sabbaticals provide manifold contributions to academic research at the University of Cambridge; however, detecting and quantifying this contribution, and extending these findings requires wider and more detailed investigation.