ORCID Profile
0000-0001-7890-2854
Current Organisations
Plant Breeding and Acclimatization Institute - National Research Institute
,
University of Aberdeen
Does something not look right? The information on this page has been harvested from data sources that may not be up to date. We continue to work with information providers to improve coverage and quality. To report an issue, use the Feedback Form.
Publisher: Springer Science and Business Media LLC
Date: 28-02-2023
DOI: 10.1186/S13063-023-07159-6
Abstract: Informed consent is considered a fundamental requirement for participation in trials, yet obtaining consent is challenging in a number of populations and settings. This may be due to participants having communication or other disabilities, their capacity to consent fluctuates or they lack capacity, or in emergency situations where their medical condition or the urgent nature of the treatment precludes seeking consent from either the participant or a representative. These challenges, and the subsequent complexity of designing and conducting trials where alternative consent pathways are required, contribute to these populations being underserved in research. Recognising and addressing these challenges is essential to support trials involving these populations and ensure that they have an equitable opportunity to participate in, and benefit from, research. Given the complex nature of these challenges, which are encountered by both adults and children, a cross-disciplinary approach is required. A UK-wide collaboration, a sub-group of the Trial Conduct Working Group in the MRC-NIHR Trial Methodology Research Partnership, was formed to collectively address these challenges. Members are drawn from disciplines including bioethics, qualitative research, trials methodology, healthcare professions, and social sciences. This commentary draws on our collective expertise to identify key populations where particular methodological and ethical challenges around consent are encountered, articulate the specific issues arising in each population, summarise ongoing and completed research, and identify targets for future research. Key populations include people with communication or other disabilities, people whose capacity to consent fluctuates, adults who lack the capacity to consent, and adults and children in emergency and urgent care settings. Work is ongoing by the sub-group to create a database of resources, to update NIHR guidance, and to develop proposals to address identified research gaps. Collaboration across disciplines, sectors, organisations, and countries is essential if the ethical and methodological challenges surrounding trials involving complex and alternate consent pathways are to be addressed. Explicating these challenges, sharing resources, and identifying gaps for future research is an essential first step. We hope that doing so will serve as a call to action for others seeking ways to address the current consent-based exclusion of underserved populations from trials.
Publisher: Public Library of Science (PLoS)
Date: 30-03-2023
DOI: 10.1371/JOURNAL.PONE.0283000
Abstract: The introduction of robot-assisted surgery is costly and requires whole system transformation, which makes the assessment of benefits (or drawbacks) complex. To date, there has been little agreement on which outcomes should be used in this regard. The aim of the RoboCOS study was to develop a core outcome set for the evaluation of robot-assisted surgery that would account for its impact on the whole system. Identification of a long-list of potentially relevant outcomes through systematic review of trials and health technology assessments interviews with in iduals from a range of stakeholder groups (surgeons, service managers, policy makers and evaluators) and a focus group with patients and public prioritisation of outcomes via a 2-round online international Delphi survey consensus meeting. 721 outcomes were extracted from the systematic reviews, interviews and focus group which were conceptualised into 83 different outcome domains across four distinct levels (patient, surgeon, organisation and population) for inclusion in the international Delphi prioritisation survey (128 completed both rounds). The consensus meeting led to the agreement of a 10-item core outcome set including outcomes at: patient level (treatment effectiveness overall quality of life disease-specific quality of life complications (including mortality) surgeon level (precision/accuracy visualisation) organisation (equipment failure standardisation of operative quality cost-effectiveness) and population (equity of access). The RoboCOS core outcome set, which includes the outcomes of importance to all stakeholders, is recommended for use in all future evaluations of robot-assisted surgery to ensure relevant and comparable reporting of outcomes.
Publisher: Elsevier BV
Date: 02-2018
DOI: 10.1016/J.CMI.2018.08.020
Abstract: Antibiotic stewardship programmes (ASPs) are necessary in hospitals to improve the judicious use of antibiotics. While ASPs require complex change of key behaviours on in idual, team organization and policy levels, evidence from the behavioural sciences is underutilized in antibiotic stewardship studies across the world, including high-income countries (HICs). A consensus procedure was performed to propose research priority areas for optimizing effective implementation of ASPs in hospital settings using a behavioural perspective. A workgroup for behavioural approaches to ASPs was convened in response to the fourth call for leading expert network proposals by the Joint Programming Initiative on Antimicrobial Resistance (JPIAMR). Eighteen clinical and academic specialists in antibiotic stewardship, implementation science and behaviour change from four HICs with publicly funded healthcare systems (e.g. Canada, Germany, Norway and the UK) met face-to-face to agree on broad research priority areas using a structured consensus method. Question addressed and recommendations: The consensus process assessing the ten identified research priority areas resulted in recommendations that need urgent scientific interest and funding to optimize effective implementation of ASPs for hospital inpatients in HICs with publicly funded healthcare systems. We suggest and detail behavioural science evidence-guided research efforts in the following areas: (a) comprehensively identifying barriers and facilitators to implementing ASPs and clinical recommendations intended to optimize antibiotic prescribing (b) identifying actors ('who') and actions ('what needs to be done') of ASPs and clinical teams (c) synthesizing available evidence to support future research and planning for ASPs (d) specifying the activities in current ASPs with the purpose of defining a control group for comparison with new initiatives (e) defining a balanced set of outcomes and measures to evaluate the effects of interventions focused on reducing unnecessary exposure to antibiotics (f) conducting robust evaluations of ASPs with built-in process evaluations and fidelity assessments (g) defining and designing ASPs (h) establishing the evidence base for impact of ASPs on resistance (i) investigating the role and impact of government and policy contexts on ASPs and (j) understanding what matters to patients in ASPs in hospitals. Assessment, revisions and updates of our priority-setting exercise should be considered at intervals of 2 years. To propose research priority areas in low- and middle-income countries, the methodology reported here could be applied.
Publisher: Springer Science and Business Media LLC
Date: 27-03-2018
Publisher: Springer Science and Business Media LLC
Date: 28-10-2019
DOI: 10.1186/S13063-019-3704-X
Abstract: Poor recruitment to, and retention in, clinical trials is a source of research waste that could be reduced by more informed choices about participation. Barriers to effective recruitment and retention can be wide-ranging but relevance of the questions being addressed by trials and the outcomes that they are assessing are key for potential participants. Decisions about trial participation should be informed by general and trial-specific information and by considering broader assessments of ‘informedness’ and how they impact on both recruitment and retention. We suggest that more informed decisions about trial participation should encourage personally appropriate decisions, increase recruitment and retention, and reduce research waste and increase its value.
Publisher: Springer Science and Business Media LLC
Date: 09-11-2019
DOI: 10.1186/S13063-019-3710-Z
Abstract: Recruitment and retention of participants are both critical for the success of trials, yet both remain significant problems. The use of incentives to target participants and trial staff has been proposed as one solution. The effects of incentives are complex and depend upon how they are designed, but these complexities are often overlooked. In this paper, we used a scoping review to ‘map’ the literature, with two aims: to develop a checklist on the design and use of incentives to support recruitment and retention in trials and to identify key research topics for the future. The scoping review drew on the existing economic theory of incentives and a structured review of the literature on the use of incentives in three healthcare settings: trials, pay for performance, and health behaviour change. We identified the design issues that need to be considered when introducing an incentive scheme to improve recruitment and retention in trials. We then reviewed both the theoretical and empirical evidence relating to each of these design issues. We synthesised the findings into a checklist to guide the design of interventions using incentives. The issues to consider when designing an incentive system were summarised into an eight-question checklist. The checklist covers: the current incentives and barriers operating in the system who the incentive should be directed towards what the incentive should be linked to the form of incentive the incentive size the structure of the incentive system the timing and frequency of incentive payouts and the potential unintended consequences. We concluded the section on each design aspect by highlighting the gaps in the current evidence base. Our findings highlight how complex the design of incentive systems can be, and how crucial each design choice is to overall effectiveness. The most appropriate design choice will differ according to context, and we have aimed to provide context-specific advice. Whilst all design issues warrant further research, evidence is most needed on incentives directed at recruiters, optimal incentive size, and testing of different incentive structures, particularly exploring repeat arrangements with recruiters.
Publisher: SAGE Publications
Date: 10-06-2022
DOI: 10.1177/26320843221089632
Abstract: The PROMETHEUS programme (PROMoting THE USE of SWATs) was funded by the UK Medical Research Council (MRC) and Clinical Trials Unit (CTU) infrastructure funding from the National Institute for Health Research (NIHR). The purpose was to develop strategies to increase the recruitment and retention evidence base. This paper aims to present observations from this work. The PROMETHUS programme funded 42 SWATs, the average cost of each SWAT was £4007. A central coordination point enabled a concentrated effort in SWAT research activity leading to a rapid increase in the evidence base. The methodological feasibility of undertaking a coordinated SWAT design was established. The international Trial Forge SWAT Network was developed in 2021 to connect research groups in response for the need to connect teams undertaking methodological research. A SWAT reporting template and a database of researchers willing to peer review SWATs are also needed to improve the reporting of SWATs. There is a need to develop a strategy to aid teams to identify a suitable SWAT for their host trial populations and a mechanism to communicate SWAT research priorities. Work is needed to increase the awareness of the methodological importance of SWAT research with research teams and develop engagement strategies to increase SWAT activity. Continued collaboration with the HRA is necessary to refine the SWAT approvals process. The coordination PROMETHEUS provided is crucial to increasing the recruitment retention evidence base. The Trial Forge Network will be key to provide ongoing networking and dissemination opportunities.
Publisher: F1000 Research Ltd
Date: 05-02-2020
DOI: 10.12688/F1000RESEARCH.22182.1
Abstract: Background : Recruitment to trials can be challenging. Currently, non-randomised evaluations of trial recruitment interventions are rejected due to poor methodological quality, but systematic assessment of this substantial body of work may inform trialists’ decision-making about recruitment methods. Our objective was to quantify the effects of strategies to improve participant recruitment to randomised trials evaluated using non-randomised study designs. Methods : We searched relevant databases for non-randomised studies that included two or more interventions evaluating recruitment to trials. Two reviewers screened abstracts and full texts for eligible studies, then extracted data on: recruitment intervention, setting, participant characteristics, number of participants in intervention and comparator groups. The ROBINS-I tool was used to assess risk of bias. The primary outcome was the number of recruits to a trial. Results : We identified 92 studies for inclusion 90 studies aimed to improve the recruitment of participants, one aimed to improve the recruitment of GP practices, and one aimed to improve recruitment of GPs. Of the 92 included studies, 20 were at high risk of bias due to confounding the remaining 72 were at high risk of bias due to confounding and at least one other category of the ROBINS-I tool. The 20 studies at least risk of bias were synthesised narratively based on seven broad categories Face to face recruitment initiatives, postal invitations and responses, language adaptations, randomisation methods, trial awareness strategies aimed at the recruitee, trial awareness strategies aimed at the recruiter, and use of networks and databases. The utility of included studies is substantially limited due to small s le sizes, inadequate reporting, and a lack of coordination around deciding what to evaluate and how. Conclusions : Careful thought around planning, conduct, and reporting of non-randomised evaluations of recruitment interventions is required to prevent future non-randomised studies contributing to research waste. Registration : PROSPERO CRD42016037718
Publisher: Elsevier BV
Date: 03-2020
Publisher: National Institute for Health and Care Research
Date: 09-2021
DOI: 10.3310/HTA25530
Abstract: The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space. Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council–National Institute for Health Research Methodology Research programme.
Publisher: Public Library of Science (PLoS)
Date: 03-11-2022
DOI: 10.1371/JOURNAL.PGEN.1010367
Abstract: Host genetics is a key determinant of COVID-19 outcomes. Previously, the COVID-19 Host Genetics Initiative genome-wide association study used common variants to identify multiple loci associated with COVID-19 outcomes. However, variants with the largest impact on COVID-19 outcomes are expected to be rare in the population. Hence, studying rare variants may provide additional insights into disease susceptibility and pathogenesis, thereby informing therapeutics development. Here, we combined whole-exome and whole-genome sequencing from 21 cohorts across 12 countries and performed rare variant exome-wide burden analyses for COVID-19 outcomes. In an analysis of 5,085 severe disease cases and 571,737 controls, we observed that carrying a rare deleterious variant in the SARS-CoV-2 sensor toll-like receptor TLR7 (on chromosome X) was associated with a 5.3-fold increase in severe disease (95% CI: 2.75–10.05, p = 5.41x10 -7 ). This association was consistent across sexes. These results further support TLR7 as a genetic determinant of severe disease and suggest that larger studies on rare variants influencing COVID-19 outcomes could provide additional insights.
Publisher: BMJ
Date: 11-2022
DOI: 10.1136/BMJOPEN-2022-067427
Abstract: The effective implementation of a fast-changing healthcare delivery innovation, such as robotic-assisted surgery (RAS), into a healthcare system, can be affected (both positively and negatively) by external contextual factors. As part of a wider project investigating ways to optimise the implementation of RAS, this qualitative study aimed to uncover current issues of RAS and predictions about the future of robotic surgery. We refer to ‘current issues’ as the topical and salient challenges and opportunities related to the introduction of RAS in the UK healthcare system, from the perspectives of key stakeholders involved in the delivery and implementation of RAS. Semi-structured interviews and focus groups were conducted. A thematic analysis was conducted to summarise salient issues that were articulated by the participants. The interview s le (n=35) comprised surgeons, wider theatre staff and other relevant personnel involved in the introduction and delivery of RAS services across the UK, including service managers and policymakers/commissioners. Two focus groups were also conducted with surgical trainees (n=7) and members of the public (n=8), respectively. The results revealed a largely positive attitude towards the introduction of RAS technology and an expectation of continued rapid expansion. Areas perceived to be particularly pertinent and requiring ongoing attention were also highlighted, including the need to achieve improved quality control, expertise quantification and training issues and the need to educate the public. Issues of centralisation, service organisation and equity of access were also emphasised. Our study has highlighted a range of issues perceived to be particularly pertinent to the current and future provision of RAS which should be addressed. The areas outlined can enable healthcare managers and surgeons to plan for the adoption and/or expansion of RAS services.
Publisher: Public Library of Science (PLoS)
Date: 29-08-2022
DOI: 10.1371/JOURNAL.PONE.0273696
Abstract: Implementation of Robotic Assisted Surgery (RAS) is complex as it requires adjustments to associated physical infrastructure, but also changes to processes and behaviours. With the global objective of optimising and improving RAS implementation, this study aimed to: 1) Explore the barriers and enablers to RAS service adoption, incorporating an assessment of behavioural influences 2) Provide an optimised plan for effective RAS implementation, with the incorporation of theory-informed implementation strategies that have been adapted to address the barriers/enablers that affect RAS service adoption. Semi-structured interviews were conducted with RAS personnel and stakeholders, including: surgeons, theatre staff, managers, industry representatives, and policy-makers/commissioners. The Theoretical Domains Framework (TDF) and the Consolidated Framework for Implementation Research (CFIR) was used to identify barriers and enablers that represent in idual behaviours, capabilities, attitudes, beliefs, and external organisational factors that influence the implementation of RAS. Findings suggest that implementation planning has three separate phases–pre-, early, and late implementation. For pre-implementation, barriers and enablers identified included the cost of RAS equipment and issues of economic viability, weak outcome evidence for RAS, a preponderance of an eminence driven model, the clinician/manager relationship, and views around the uptake and expansion of RAS in the future. Early implementation findings revealed role changes for theatre personnel and an enhanced team approach, reliance on industry for training provision, and changes in skill sets and attentional processes. Late implementation factors included equipment maintenance costs, technological limitations, changes to cognition during RAS routine use, and benefits to institutions/healthcare professionals (such as ergonomic improvement). Together, findings suggest the factors that affect RAS implementation are multi-faceted and change across the life-cycle of intervention adoption. Theory-informed strategies are suggested which can optimise implementation of RAS. Optimisation strategies need planning from the outset.
Publisher: Oxford University Press (OUP)
Date: 04-02-2020
DOI: 10.1093/JAC/DKAA001
Abstract: Reducing unnecessary antibiotic exposure is a key strategy in reducing the development and selection of antibiotic-resistant bacteria. Hospital antimicrobial stewardship (AMS) interventions are inherently complex, often requiring multiple healthcare professionals to change multiple behaviours at multiple timepoints along the care pathway. Inaction can arise when roles and responsibilities are unclear. A behavioural perspective can offer insights to maximize the chances of successful implementation. To apply a behavioural framework [the Target Action Context Timing Actors (TACTA) framework] to existing evidence about hospital AMS interventions to specify which key behavioural aspects of interventions are detailed. Randomized controlled trials (RCTs) and interrupted time series (ITS) studies with a focus on reducing unnecessary exposure to antibiotics were identified from the most recent Cochrane review of interventions to improve hospital AMS. The TACTA framework was applied to published intervention reports to assess the extent to which key details were reported about what behaviour should be performed, who is responsible for doing it and when, where, how often and with whom it should be performed. The included studies (n = 45 31 RCTs and 14 ITS studies with 49 outcome measures) reported what should be done, where and to whom. However, key details were missing about who should act (45%) and when (22%). Specification of who should act was missing in 79% of 15 interventions to reduce duration of treatment in continuing-care wards. The lack of precise specification within AMS interventions limits the generalizability and reproducibility of evidence, h ering efforts to implement AMS interventions in practice.
Publisher: Springer Science and Business Media LLC
Date: 10-06-2023
DOI: 10.1186/S13063-023-07417-7
Abstract: The use of invasive placebo controls in surgical trials can be challenging. The ASPIRE guidance, published in the Lancet in 2020, provided advice for the design and conduct of surgical trials with an invasive placebo control. Based on a more recent international expert workshop in June 2022, we now provide further insights into this topic. These include the purpose and design of invasive placebo controls, patient information provision and how findings from these trials may be used to inform decision-making.
Publisher: Elsevier BV
Date: 09-2021
Location: Poland
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Katie Gillies.