I started at the University of Stirling working in NMAHP RU (Nursing Midwifery and Allied Health Professionals Research Unit) as an impact research fellow on 1st October 2015. I am particularly interested in ensuring trial and study designs answer health research questions that meet the needs of patients, healthcare professionals and policymakers in the “real world”.
Following a degree in nursing from Glasgow, I moved to live in Atlanta, USA (2 years) studying for a MPH at Emory University and then lived in Oslo, Norway. I have more than 15 years research experience working with the Cochrane Collaboration at the Norwegian Branch of the Nordic Cochrane Collaboration focussing on the Methodology of undertaking Cochrane systematic reviews of interventions, then working on the methodology for updating Cochrane reviews at the UK Cochrane Centre for 2 years. My varied experience within trial and health research lead to a successful application in October 2011 at the University of Dundee, to work on an MRC funded doctoral research project “Making trials matter: providing an empirical basis for the selection of pragmatic design choices in clinical trials”.
Event / Presentation
Designing randomised trials in primary care that are relevant to practice – the views of those that will use the results towards a trial design tool, PRECIS-2. Society for Academic Primary Care conference 2016
https://sapc.ac.uk/conference/2016 Designing randomised trials in primary care that are relevant to practice - the views of those that will use the results towards a trial design tool, PRECIS-2
Gordon Forbes1, Kirsty Loudon2, Megan Clinch1, Stephanie JC Taylor1, Shaun Treweek3, Sandra Eldridge1 1Queen Mary, University of London 2University of Stirling 3University of Aberdeen
407 words (word limit 450)
Randomised trials are difficult and costly. Like most things that are hard, the effort expended is only worth it because we hope to make a difference. Sadly, the benefit to potential users such as patients, healthcare professionals and policy makers is often smaller than it should be because trial design decisions reduce the relevance of the trial to users. To maximize the relevance of trial results to users it is recommended that researchers design pragmatic trials, testing their intervention under conditions similar to those found in the real world. PRECIS-2 is a trial design tool which encourages trialists to consider how pragmatic their trial is across nine different domains covering the population in the trial, how the intervention is delivered and the outcomes measured. The tool aims to help ensure researchers match their design decisions to the information needs of those they hope will use the trial results. This research explores the views of those using the results of randomised trials to find out their attitudes towards the different PRECIS-2 domains, pragmatic approaches to clinical trial design and what makes research relevant to primary care. The aim of the study is to improve the design of randomised trials in primary care so they produce results are more relevant to practice.
We carried out semi structured interviews with individuals or small groups of people involved in implementing research in primary care. We interviewed people involved with journals, guideline development, research charities, research funders, primary care educators, clinical commissioning groups, GPs and clinical effectiveness research. A thematic analysis of the data from the interviews was carried out using the framework approach.
We conducted 12 interviews across the target groups. We found differences between the way participants used evidence from trials with those involved in synthesizing evidence for guidelines or reviews encountering different challenges to clinicians applying evidence to practice. Important aspects of trial design included that the populations in trials matched those seen in practice and that trials aiming to inform primary care practice are carried out in primary care settings. PRECIS-2 covers many the design issues raises by our participants as being important to ensure trial results are relevant to primary care. There were differing views on whether a more or less pragmatic approach is required for some PRECIS-2 domains particularly whether trials should restrict the flexibility of how an intervention is delivered beyond what would occur in practice.
This work provides insights into how to design randomised trials in primary care so that their results are relevant to practice. The findings are relevant to those designing trials as well as those involved in funding decisions or using the results of randomised trials.
Applying PRECIS-2 to primary care Trials (APT) – the views of knowledge brokers. International Institute for Qualitative Methodology - Qualitative Methods Conference
http://www.cvent.com/…6f317da0da6.aspx Randomised trials are difficult and costly. Like most things that are hard, the effort expended is only worth it because we hope to make a difference. Sadly, the benefit to potential users such as patients, healthcare professionals and policy makers is often smaller than it should be because trial design decisions reduced the relevance of the trial to users.
PRECIS-2 is a tool designed to help trialists match their design decisions to the information needs of those they hope will use the trial results. PRECIS-2 has a highly visual wheel format with nine design domains including Eligibility, Recruitment, Setting, Organisation and Primary outcome which are scored on a Likert scale from "1" very explanatory - ideal world to "5" very pragmatic just like usual care.
We were keen to discuss with those synthesizing research evidence and those using it to determine how evidence is used and what aspects of trial design are important when deciding whether research is relevant to practice. Qualitative research was undertaken using semi-structured interviews of academic GPs, funders and policymakers. The interviews included questions on attitudes to the nine different PRECIS-2 domains as a tool to judge if a trial's results would be useful.
Framework analysis was used to pull out four key themes: aspects of trial results that are important when assessing evidence; how evidence is used; pragmatic and explanatory attitudes; and using the nine domains of PRECIS-2. These themes will be presented to assist future work to design trials that are fit for purpose.
Matching trial design decisions to the needs of those you hope will use the results: the PRECIS-2 tool. Ideal collaboration 2016 - Evaluating innovation in surgery and therapeutic technology: the IDEAL approach
http://www.ideal-collaboration.net/…-ideal-approach/ Matching trial design decisions to the needs of those you hope will use the results: the PRECIS-2 tool
Kirsty Loudon, Merrick Zwarenstein, Frank Sullivan, Peter Donnan and Shaun Treweek
Randomised trials are difficult and costly. Like most things that are hard, the effort expended is only worth it because we hope to make a difference. Sadly, the benefit to potential users such as patients, healthcare professionals and policy makers is often smaller than it should be because trial design decisions reduced the relevance of the trial to users.
PRECIS-2 is a tool designed to help trialists match their design decisions to the information needs of those they hope will use the trial results. PRECIS-2 was developed in collaboration with over 80 international trialists, methodologists and others to produce a tool that supports improved design insight for trialists.
PRECIS-2 has a wheel format with nine design domains including Eligibility, Recruitment, Setting and Primary outcome. One domain - Organisation - is explicitly aimed at making trialists consider the resource requirements their intervention will place on health care systems if it were to be rolled out into routine care, the intention being to think about implementation at the design stage. The highly visual presentation makes inconsistent decision-making immediately obvious; it also highlights differences of opinion between trial team members.
The IDEAL framework was created to improve the quality of research in surgery. It is proposed that PRECIS-2 could be part of this framework to design these complex intervention trials. We will present the tool, explain how to use it and show examples of how it has been used already. This work is part of the Trial Forge initiative to improve trial efficiency.
PRECIS-2 . British Council workshop – Uruguay 22-25 February 2016
http://www.ukctas.net Presentation as part of workshop on smoking cessation and alcohol reduction during pregnancy
Validity and Reliability of PRECIS-2 – a tool designed to help trialists match their trial design decisions to the needs of those they hope will use the results. Society of Clinical Trials 37th Annual Meeting
http://www.sctweb.org/public/home.cfm Kirsty Loudon, Merrick Zwarenstein, Frank Sullivan, Peter Donnan and Shaun Treweek
PRECIS-2 was developed in collaboration with over 80 international trialists, methodologists, clinicians and policymakers to produce a tool that could improve design insight for trialists. PRECIS-2 has a wheel format with nine design domains. The highly visual presentation increases transparency for the consequences of design decisions.
The original PRECIS tool did not have its validity and reliability formally measured. Rather it was conceptual. We did, however, do this for PRECIS-2. The input of so many individuals to create PRECIS-2 helped ensure face and content validity of the tool. The inter-rater reliability of PRECIS-2 was measured using 19 raters (international trialists from seven countries) who used PRECIS-2 to score a varied sample of 15 RCT protocols. Trials were purposefully selected so that they varied between pragmatic and explanatory approaches, including both drug and non-drug trials. Inter-rater reliability was generally good, with seven of nine domains having an ICC over 0.65. Flexibility (Adherence) and Recruitment had wide confidence intervals but raters found these difficult to rate and wanted more information.
Discriminant validity was tested with two raters using a binary system to independently determine if the trial protocols were more pragmatic or more explanatory. Scores from the 19 raters for the 15 trials were then used as predictors of pragmatism. The results reasonable with better than chance discrimination for all domains although confidence intervals were again wide. Primary outcome was the domain most likely to predict if a trial takes a pragmatic approach with an AUROC of 0.75.
We have succeeded in testing the validity and reliability of PRECIS-2. An elaboration paper and website provide guidance that should make it easier for future users of the tool. PRECIS-2 continues to be tested by trial teams, funders and has potential impact in retrospective and prospective use in health care evaluations.
Applying the PRECIS-2 tool to hypertension trials: using clinical experience in primary care to create a guideline for rating randomised controlled trials. Department of family and community medicine research day - 2016 DFCM Conference and Walter Rosser Day “Advancing Family Medicine”
Matching trial design decisions to the needs of those you hope will use the results: the PRECIS-2 tool. Research Waste/EQUATOR -Increasing value and reducing waste in biomedical research conference
My methodological expertise includes qualitative and quantitative research methods including surveys, focus groups, Delphi process and systemat reviewing. During my PhD I collaborated with over 80 researchers to create a tool to help trialists design trials taking an explanatory approach (ideal conditions) or pragmatic (usual care) - PRECIS-2. This involved improving the original PRECIS (2009) tool and validating the new improved PRECIS-2. I am working with the IDEAL Collaboration to update their framework for designing trials using the PRECIS-2 tool and in discussion with the EU funded GetReal team about pragmatic trial design. Research applying PRECIS-2 to Primary Care Trials (APT) has been undertaken at the Pragmatic Clinical Trials Unit. Work is also underway with researchers at the researchers in Canada to investigate if pragmatic trials sacrifice internal validity for external validity and to compare effect sizes of pragmatic and explanatory trials. PRECIS-2 is part of ongoing research within Trial Forge. I am particularly interested in the utilising the PRECIS-2 tool in projects led by NMAHP RU and researchers at the University of Stirling.
I have also been actively involved in the EU 7th Framework DECIDE project, Work package 3 creating patent versions of clinical guidelines.
We Can Quit 2 PI: Professor Linda Bauld Funded by: Health Research Board –
Santesso N, Morgano GP, Jack SA, Haynes RB, Hill S, Treweek S, Schunemann H, Callaghan M, Graham K, Harbour R, Kunnamo I, Liira H, Loudon K, McFarlane E, Ritchie K, Service D & Thornton J (2016) Dissemination of clinical practice guidelines: A content analysis of patient versions , Medical Decision Making, 36 (6), pp. 692-702.
Forbes G, Loudon K, Treweek S, Taylor S & Eldridge S (2015) How best to design a clinical trial that is relevant to practice? Applying PRECIS-2, a trial design tool, to primary care trials (Meeting Abstract).