534 research outputs found
Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials
No full textBackground: trial execution commonly relies on experience and judgement because there is a lack of evidence to inform how best to design and deliver clinical trials. Recruitment and retention are critical determinants to trial success have been persistent challenges that impact various stakeholders including funders, researchers, and the public. Studies within a trial (SWATs) are a way to discover best practices for recruitment and retention strategies, however, the current SWAT landscape has not been formally explored to date. This study aimed to (i) identify where current activity is taking place (ii) understand if SWATs are addressing PRioRiTY questions (iii) highlight gaps in the literature for future research.Methods: in November 2020, registered SWATs in the SWAT repository store were extracted and categorised into ‘recruitment’, ‘retention’ or ‘other’ based on the primary outcome. Recruitment and retention SWATs were subsequently mapped against PRioRiTY 1 and 2 questions and descriptive statistics were used to present the findings.Results: 125 registered SWATs were extracted from the repository. 50 and 36 SWATs reported recruitment and retention as their primary outcome, respectively. A majority of recruitment SWATs investigated what and how information should be designed and delivered to potential trial participants (n = 23, 46%) and the advantages and disadvantages of using technology during the recruitment process (n = 9, 18%). Three of the Top 10 PRioRiTY 1 questions had no SWATs mapped against them. A majority of retention SWATs focused on the best ways to encourage participants to complete trial tasks (n = 24, 67%), how incentives should be implemented (n = 10, 28%) and strategies to make participants feel valued (n = 9, 25%). Five of the Top 10 PRioRiTY 2 questions had no SWATs mapped against them.Conclusions: this study identified a mismatch between registered SWAT activity and the priority questions in recruitment and retention. Trial teams should consider the PRioRiTy 1 and 2 questions for recruitment and retention, respectively, when designing a SWAT. In addition, there is a great breadth of research taking place, but replication of existing research is needed to produce confident evidence-based guidance for trialists and researchers to implement into their work
Supplemental Material - Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials
No full textSupplemental Material for Studies within a trial priorities to improve the evidence to inform recruitment and retention practice in clinical trials by Cherish Boxall, Shaun Treweek, Katie Gillies; on behalf of the Trials Methodology Research Partnership Trial Conduct Working Group in Research Methods in Medicine & Health Sciences</p
Evaluating complex interventions and health technologies using normalization process theory: development of a simplified approach and web-enabled toolkit
No full text<b>Background</b> Normalization Process Theory (NPT) can be used to explain implementation processes in health care relating to new technologies and complex interventions. This paper describes the processes by which we developed a simplified version of NPT for use by clinicians, managers, and policy makers, and which could be embedded in a web-enabled toolkit and on-line users manual.<p></p>
<b>Methods</b> Between 2006 and 2010 we undertook four tasks. (i) We presented NPT to potential and actual users in multiple workshops, seminars, and presentations. (ii) Using what we discovered from these meetings, we decided to create a simplified set of statements and explanations expressing core constructs of the theory (iii) We circulated these statements to a criterion sample of 60 researchers, clinicians and others, using SurveyMonkey to collect qualitative textual data about their criticisms of the statements. (iv) We then reconstructed the statements and explanations to meet users' criticisms, embedded them in a web-enabled toolkit, and beta tested this 'in the wild'.<p></p>
<b>Results</b> On-line data collection was effective: over a four week period 50/60 participants responded using SurveyMonkey (40/60) or direct phone and email contact (10/60). An additional nine responses were received from people who had been sent the SurveyMonkey form by other respondents. Beta testing of the web enabled toolkit produced 13 responses, from 327 visits to www.normalizationprocess.org. Qualitative analysis of both sets of responses showed a high level of support for the statements but also showed that some statements poorly expressed their underlying constructs or overlapped with others. These were rewritten to take account of users' criticisms and then embedded in a web-enabled toolkit. As a result we were able to translate the core constructs into a simplified set of statements that could be utilized by non-experts.<p></p>
<b>Conclusion</b> Normalization Process Theory has been developed through transparent procedures at each stage of its life. The theory has been shown to be sufficiently robust to merit formal testing. This project has provided a user friendly version of NPT that can be embedded in a web-enabled toolkit and used as a heuristic device to think through implementation and integration problems
NorthStar, a support tool for the design and evaluation of quality improvement interventions in healthcare
No full textBackground: The Research-Based Education and Quality Improvement (ReBEQI) European partnership aims to establish a framework and provide practical tools for the selection, implementation, and evaluation of quality improvement (QI) interventions. We describe the development and preliminary evaluation of the software tool NorthStar, a major product of the ReBEQI project. Methods: We focused the content of NorthStar on the design and evaluation of QI interventions. A lead individual from the ReBEQI group drafted each section, and at least two other group members reviewed it. The content is based on published literature, as well as material developed by the ReBEQI group. We developed the software in both a Microsoft Windows HTML help system version and a web-based version. In a preliminary evaluation, we surveyed 33 potential users about the acceptability and perceived utility of NorthStar. Results: NorthStar consists of 18 sections covering the design and evaluation of QI interventions. The major focus of the intervention design sections is on how to identify determinants of practice (factors affecting practice patterns), while the major focus of the intervention evaluation sections is on how to design a cluster randomised trial. The two versions of the software can be transferred by email or CD, and are available for download from the internet. The software offers easy navigation and various functions to access the content. Potential users (55% response rate) reported above-moderate levels of confidence in carrying out QI research related tasks if using NorthStar, particularly when developing a protocol for a cluster randomised trial Conclusion: NorthStar is an integrated, accessible, practical, and acceptable tool to assist developers and evaluators of QI interventions
Developing and evaluating interventions to reduce inappropriate prescribing by general practitioners of antibiotics for upper respiratory tract infections: a randomised controlled trial to compare paper-based and web-based modelling experiments
No full textBackground Much implementation research is focused on full-scale trials with little evidence of preceding modelling work. The Medical Research Council Framework for developing and evaluating complex interventions has argued for more and better theoretical and exploratory work prior to a trial as a means of improving intervention development. Intervention modelling experiments (IMEs) are a way of exploring and refining an intervention before moving to a full-scale trial. They do this by delivering key elements of the intervention in a simulation that approximates clinical practice by, for example, presenting general practitioners (GPs) with a clinical scenario about making a treatment decision. Methods The current proposal will run a full, web-based IME involving 250 GPs that will advance the methodology of IMEs by directly comparing results with an earlier paper-based IME. Moreover, the web-based IME will evaluate an intervention that can be put into a full-scale trial that aims to reduce antibiotic prescribing for upper respiratory tract infections in primary care. The study will also include a trial of email versus postal invitations to participate. Discussion More effective behaviour change interventions are needed and this study will develop one such intervention and a system to model and test future interventions. This system will be applicable to any situation in the National Health Service where behaviour needs to be modified, including interventions aimed directly at the public. Trial registration Current Controlled Trials NCT01206738
Supplemental Material - PROMoting the use of studies within a trial (PROMETHEUS): Results and experiences from a large programme to evaluate the routine embedding of recruitment and retention strategies within randomised controlled trials routinely
No full textSupplemental Material for PROMoting the use of studies within a trial (PROMETHEUS): Results and experiences from a large programme to evaluate the routine embedding of recruitment and retention strategies within randomised controlled trials routinely by Laura Doherty, Adwoa Parker, Catherine Arundel, Laura Clark, Elizabeth Coleman, Catherine Hewitt, David Beard, Peter Bower, Paul Brocklehurst, Cindy Cooper, Lucy Culliford, Declan Devane, Richard Emsley, Sandra Eldridge, Sandra Galvin, Katie Gillies, Alan Montgomery, Chris Sutton, Shaun Treweek, David Torgerson in Research Methods in Medicine & Health Sciences</p
796156_supp_mat – Supplemental material for Development of an online resource for recruitment research in clinical trials to organise and map current literature
No full textSupplemental material, 796156_supp_mat for Development of an online resource for
recruitment research in clinical trials to organise and map current literature
by Anna Kearney, Nicola L Harman, Anna Rosala-Hallas, Claire Beecher, Jane M
Blazeby, Peter Bower, Mike Clarke, William Cragg, Sinead Dune, Heidi Gardner,
Patricia Healy, Lisa Maguire, Nicola Mills, Leila Rooshenas, Ceri Rowlands,
Shaun Treweek, Akke Vellinga, Paula R Williamson and Carrol Gamble in Clinical
Trials</p
A review of trauma and orthopaedic randomised clinical trials published in high-impact general medical journals
No full textAcknowledgements The authors are grateful for Shaun Treweek for his expert insight into the nuances of Randomised Clinical Trial design. Funding The authors did not receive support from any organisation for the submitted work.Peer reviewe
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