Analysis of trials, meta-analyses and observational studies

Lead Research Organisation: University College London

Abstract

We cover issues such as survival analysis methods that allow for non-proportional hazards in both trials and IPD meta-analyses, modelling of prognostic and predictive factors, and analysis of longitudinal and clustered data. On the application of causal models, CTU trials are a rich resource for evaluating aspects of patient management other than the randomised comparison, such as the impact of second-line or concomitant treatments. Although often left to clinician discretion, the trial will usually collect information on the basis for these decisions. Exploiting such data in a major causal analysis of the DART trial in HIV, we showed that 24-weekly and 12 weekly CD4 monitoring give similar results, and that a single CD4 count at 48 weeks leads to better survival than no CD4 monitoring. Finally, on missing data, even modest amounts of missing data can lead to bias and make study conclusions unreliable and/or imprecise. Some methods to deal with it can lead to further bias or imprecision, yet prevail in many disease areas, and are recommended by some regulators. In collaboration with the London School of Hygiene and Tropical Medicine (LSHTM), we have proposed a new framework for the analysis of clinical trials with missing data, which has been adopted by a Drug Information Association working group and for a pharmaceutical company regulatory submission.

Technical Summary

Appropriate analysis of trials is vital to obtain a full return on the investment made through efficient design and excellent conduct. However, this is often far from straightforward. We are focusing on those which arise directly from our clinical studies. Thus we are investigating how to analyse multi-arm multi-stage (MAMS) trials, and how best to analyses time-to-event outcomes and recurrent events within trials, as well as using causal models to answer questions not addressed by randomisation. We are also examining the analysis, validation and handling of missing data in multivariable prognostic models; and one versus two-stage and network meta-analysis approaches using individual participant data. Clustered data often arise in trials and observational studies so another focus is the Appropriate analysis of longitudinal and clustered data.

Publications

10 25 50

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Atkinson A (2019) Reference-based sensitivity analysis for time-to-event data. in Pharmaceutical statistics

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Atkinson A (2021) Withholding Primary Pneumocystis Pneumonia Prophylaxis in Virologically Suppressed Patients With Human Immunodeficiency Virus: An Emulation of a Pragmatic Trial in COHERE. in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

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Austin PC (2020) Missing Data in Clinical Research: A Tutorial on Multiple Imputation. in The Canadian journal of cardiology

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Bartlett JW (2020) The Hazards of Period Specific and Weighted Hazard Ratios. in Statistics in biopharmaceutical research

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Bazo-Alvarez JC (2020) Effects of long-term antipsychotics treatment on body weight: A population-based cohort study. in Journal of psychopharmacology (Oxford, England)

 
Description Advised Stata Corp
Geographic Reach North America 
Policy Influence Type Participation in a advisory committee
 
Description IW on AGS trial DMC
Geographic Reach National 
Policy Influence Type Participation in a advisory committee
 
Description IW on MHCOVID steering committee
Geographic Reach Multiple continents/international 
Policy Influence Type Membership of a guideline committee
URL https://mhcovid.ispm.unibe.ch/
 
Description Missing data course
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Missing data course (Philadelphia)
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Missing data course: LSHTM
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Missing data course: Swiss Winter Epidemiology School
Geographic Reach Europe 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Missing data course: focus on electronic health record data
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Cost-effectiveness analysis with informative missing data: tools and strategies
Amount £283,777 (GBP)
Funding ID DRF-2015-08-047 
Organisation National Institute for Health Research 
Department NIHR Fellowship Programme
Sector Public
Country United Kingdom
Start 10/2015 
End 09/2018
 
Description Cross-Unit Appointment: Using causal analyses to add value to large RCTs
Amount £185,000 (GBP)
Organisation Medical Research Council (MRC) 
Department MRC Population Health Sciences Research Network (PHSRN)
Sector Academic/University
Country United Kingdom
Start 04/2014 
End 03/2018
 
Description MRC Methodology Research Panel
Amount £495,140 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 10/2018 
End 10/2021
 
Description MRC Methodology Research Panel: Missing data in propensity score analyses of Electronic Health Records Data
Amount £400,000 (GBP)
Funding ID MR/M013278/1 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 09/2015 
End 09/2018
 
Description MRC Methodology Research Panel: Multiple imputation by chained equations for data that are missing not at random
Amount £164,000 (GBP)
Funding ID MR/M025012/1 
Organisation Medical Research Council (MRC) 
Department MRC/NIHR Methodology Research Programme
Sector Charity/Non Profit
Country United Kingdom
Start 02/2016 
End 01/2019
 
Description NIHR Development and Skills Enhancement Award
Amount £35,175 (GBP)
Funding ID NIHR301653 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 04/2021 
End 03/2022
 
Description Alan Turing Institute and AI 
Organisation Alan Turing Institute
Country United Kingdom 
Sector Academic/University 
PI Contribution Developed project idea which will be taken into Alan Turing Institute Hackathon week
Collaborator Contribution ATI will provide funding for project work for the week
Impact (none yet)
Start Year 2019
 
Description Alan Turing Institute and AI 
Organisation Health Data Research UK
Country United Kingdom 
Sector Private 
PI Contribution Developed project idea which will be taken into Alan Turing Institute Hackathon week
Collaborator Contribution ATI will provide funding for project work for the week
Impact (none yet)
Start Year 2019
 
Description Collaborative research with MRC BSU 
Organisation University of Cambridge
Department MRC Biostatistics Unit
Country United Kingdom 
Sector Academic/University 
PI Contribution Joint collaborative research in design and analysis of clinical trials
Collaborator Contribution Joint collaborative research in design and analysis of clinical trials
Impact Several papers including PUBMED id: 19153970; 19452569; 21225900
 
Description Collaborative research with the University of Freiburg 
Organisation Albert Ludwig University of Freiburg
Department Centre for Medical Biometry and Medical Informatics
Country Germany 
Sector Academic/University 
PI Contribution Joint collaborative research on the analysis of clinical trials
Collaborator Contribution Joint collaborative research on the analysis of clinical trials
Impact Several papers including PUBMED ID 20191601
 
Description Collaborative research with the University of Leicester 
Organisation University of Leicester
Department Department of Health Sciences
Country United Kingdom 
Sector Academic/University 
PI Contribution Joint collaborative research on analysis of clinical trials and meta-analysis and simulation studies
Collaborator Contribution Joint collaborative research on analysis of clinical trials and meta-analysis and simulation studies
Impact Several papers including in the STATA journal and PUBMED ID 20213719
Start Year 2016
 
Description IW - GSK/Royes 
Organisation GlaxoSmithKline (GSK)
Country Global 
Sector Private 
PI Contribution Supervising post-doc then collaborating in onging project
Collaborator Contribution Supervising post-doc and providing clinical trial data for methodological re-analysis, then collaborating in onging project
Impact Multi-disciplinary - biostatistics and clinical trials/drug development. This project tackles multiple imputation of data after treatment discontinuation. Presentation to GSK's annual UK biostatistics meeting about the results. Paper: Ian R. White, Royes Joseph, Nicky Best. A causal modelling framework for reference-based imputation and tipping point analysis in clinical trials with quantitative outcome. Journal of Biopharmaceutical Statistics 2020:30;334-350. Ongoing work to code the methods in R.
Start Year 2015
 
Description IW advisor to Daisy Gaunt 
Organisation University of Bristol
Country United Kingdom 
Sector Academic/University 
PI Contribution Advised on preparation of a successful NIHR doctoral fellwoship application
Collaborator Contribution Submitted the successful NIHR doctoral fellwoship application
Impact none at present
Start Year 2017
 
Description IW advisor to Kara-Louise Royle 
Organisation University of Leeds
Country United Kingdom 
Sector Academic/University 
PI Contribution Advised on developing and submitting a NIHR doctoral fellowship proposal
Collaborator Contribution Developed and submitted a NIHR doctoral fellowship proposal
Impact None at present
Start Year 2020
 
Description IW advisor to Orestis Efthimiou grant 
Organisation University of Bern
Country Switzerland 
Sector Academic/University 
PI Contribution Advised on development and submission of successful research grant proposal to Swiss National Science Foundation (SNSF). Collaborated on two papers.
Collaborator Contribution Developed and submitted successful research grant proposal to Swiss National Science Foundation (SNSF). Collaborated on two papers.
Impact Two papers published so far.
Start Year 2017
 
Description IW advisor to Suzie Cro 
Organisation Imperial College London
Department Imperial Clinical Trials Unit (ICTU)
Country United Kingdom 
Sector Academic/University 
PI Contribution Advised on development and submission of a successful NIHR Advanced Fellowship application
Collaborator Contribution Developed and submitted the successful NIHR Advanced Fellowship application
Impact Work has started but nothing is published as yet
Start Year 2019
 
Description IW collaborator on SNSF grant, PI Georgia Salanti 
Organisation University of Bern
Country Switzerland 
Sector Academic/University 
PI Contribution Advised on development and submission of successful grant application to SNF. Collaborating on papers.
Collaborator Contribution Developed and submitted successful grant application to SNF. Collaborating on papers.
Impact Initial publication under review.
Start Year 2017
 
Description IW in ROBIS-NMA group 
Organisation University of Bristol
Country United Kingdom 
Sector Academic/University 
PI Contribution Contributed expertise in network meta-analysis
Collaborator Contribution Contributed expertise in systematic review and network meta-analysis
Impact none yet
Start Year 2020
 
Description IW in ROBIS-NMA group 
Organisation University of Toronto
Country Canada 
Sector Academic/University 
PI Contribution Contributed expertise in network meta-analysis
Collaborator Contribution Contributed expertise in systematic review and network meta-analysis
Impact none yet
Start Year 2020
 
Description Methodology Research Collaboration with industry 
Organisation Amgen Inc
Country United States 
Sector Private 
PI Contribution Commitment to developing research activity in to design, conduct or analysis methodology in areas of mutual interest. Detailed discussions ongoing
Collaborator Contribution Commitment to developing research activity in to design, conduct or analysis methodology in areas of mutual interest. Detailed discussions ongoing
Impact None yet
Start Year 2014
 
Description Methodology Research Collaboration with industry 
Organisation AstraZeneca
Country United Kingdom 
Sector Private 
PI Contribution Commitment to developing research activity in to design, conduct or analysis methodology in areas of mutual interest. Detailed discussions ongoing
Collaborator Contribution Commitment to developing research activity in to design, conduct or analysis methodology in areas of mutual interest. Detailed discussions ongoing
Impact None yet
Start Year 2014
 
Description Methodology Research Collaboration with industry 
Organisation GlaxoSmithKline (GSK)
Country Global 
Sector Private 
PI Contribution Commitment to developing research activity in to design, conduct or analysis methodology in areas of mutual interest. Detailed discussions ongoing
Collaborator Contribution Commitment to developing research activity in to design, conduct or analysis methodology in areas of mutual interest. Detailed discussions ongoing
Impact None yet
Start Year 2014
 
Description Methods for multiple imputation with multiple rating scales 
Organisation Bangor University
Department Institute of Medical and Social Care Research
Country United Kingdom 
Sector Academic/University 
PI Contribution Expertise and intellectual input
Collaborator Contribution Expertise and intellectual input
Impact Paper published in 2016
Start Year 2014
 
Description Multiple imputation using multilevel models 
Organisation National Institute of Health and Medical Research (INSERM)
Country France 
Sector Academic/University 
PI Contribution Expertise and intellectual input
Collaborator Contribution Expertise and intellectual input
Impact One publication so far; a second in planning (March 2020)
Start Year 2014
 
Description NIHR & MRC Trials Methodology Research Parternship Executive Group 
Organisation Association of the British Pharmaceutical Industry
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Intellectual input and plans for further collaboration on future projects Member of Executive Group (Coordinated from University of Liverpool) Co-chair of Health Informatics Working Group (Co-chaired from University of Leeds) Co-chair of Statistical Analysis Working Group (Co-chaired from Kings College London)
Collaborator Contribution 25 partner organisations around UK (not all listed at this stage) Intellectual input and plans for further collaboration on future projects
Impact (None yet)
Start Year 2019
 
Description NIHR & MRC Trials Methodology Research Parternship Executive Group 
Organisation King's College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Intellectual input and plans for further collaboration on future projects Member of Executive Group (Coordinated from University of Liverpool) Co-chair of Health Informatics Working Group (Co-chaired from University of Leeds) Co-chair of Statistical Analysis Working Group (Co-chaired from Kings College London)
Collaborator Contribution 25 partner organisations around UK (not all listed at this stage) Intellectual input and plans for further collaboration on future projects
Impact (None yet)
Start Year 2019
 
Description NIHR & MRC Trials Methodology Research Parternship Executive Group 
Organisation Medical Research Council (MRC)
Country United Kingdom 
Sector Public 
PI Contribution Intellectual input and plans for further collaboration on future projects Member of Executive Group (Coordinated from University of Liverpool) Co-chair of Health Informatics Working Group (Co-chaired from University of Leeds) Co-chair of Statistical Analysis Working Group (Co-chaired from Kings College London)
Collaborator Contribution 25 partner organisations around UK (not all listed at this stage) Intellectual input and plans for further collaboration on future projects
Impact (None yet)
Start Year 2019
 
Description NIHR & MRC Trials Methodology Research Parternship Executive Group 
Organisation National Institute for Health Research
Country United Kingdom 
Sector Public 
PI Contribution Intellectual input and plans for further collaboration on future projects Member of Executive Group (Coordinated from University of Liverpool) Co-chair of Health Informatics Working Group (Co-chaired from University of Leeds) Co-chair of Statistical Analysis Working Group (Co-chaired from Kings College London)
Collaborator Contribution 25 partner organisations around UK (not all listed at this stage) Intellectual input and plans for further collaboration on future projects
Impact (None yet)
Start Year 2019
 
Description NIHR & MRC Trials Methodology Research Parternship Executive Group 
Organisation University of Leeds
Country United Kingdom 
Sector Academic/University 
PI Contribution Intellectual input and plans for further collaboration on future projects Member of Executive Group (Coordinated from University of Liverpool) Co-chair of Health Informatics Working Group (Co-chaired from University of Leeds) Co-chair of Statistical Analysis Working Group (Co-chaired from Kings College London)
Collaborator Contribution 25 partner organisations around UK (not all listed at this stage) Intellectual input and plans for further collaboration on future projects
Impact (None yet)
Start Year 2019
 
Description NIHR & MRC Trials Methodology Research Parternship Executive Group 
Organisation University of Liverpool
Country United Kingdom 
Sector Academic/University 
PI Contribution Intellectual input and plans for further collaboration on future projects Member of Executive Group (Coordinated from University of Liverpool) Co-chair of Health Informatics Working Group (Co-chaired from University of Leeds) Co-chair of Statistical Analysis Working Group (Co-chaired from Kings College London)
Collaborator Contribution 25 partner organisations around UK (not all listed at this stage) Intellectual input and plans for further collaboration on future projects
Impact (None yet)
Start Year 2019
 
Description NIHR & MRC Trials Methodology Research Parternship Executive Group 
Organisation University of Oxford
Country United Kingdom 
Sector Academic/University 
PI Contribution Intellectual input and plans for further collaboration on future projects Member of Executive Group (Coordinated from University of Liverpool) Co-chair of Health Informatics Working Group (Co-chaired from University of Leeds) Co-chair of Statistical Analysis Working Group (Co-chaired from Kings College London)
Collaborator Contribution 25 partner organisations around UK (not all listed at this stage) Intellectual input and plans for further collaboration on future projects
Impact (None yet)
Start Year 2019
 
Description Re-randomisation of patients within a trial 
Organisation Monash University
Country Australia 
Sector Academic/University 
PI Contribution Intellectual input to original design and resulting paper; currently working on follow up projects to demonstrate strengths and weaknesses and to understand practicalities of the design.
Collaborator Contribution Intellectual input to original design and resulting paper; currently working on follow up projects to demonstrate strengths and weaknesses and to understand practicalities of the design.
Impact Several invited seminars (Leeds, Leicester, LSHTM), conference papers, one published article.
Start Year 2014
 
Description Re-randomisation of patients within a trial 
Organisation Queen Mary University of London
Country United Kingdom 
Sector Academic/University 
PI Contribution Intellectual input to original design and resulting paper; currently working on follow up projects to demonstrate strengths and weaknesses and to understand practicalities of the design.
Collaborator Contribution Intellectual input to original design and resulting paper; currently working on follow up projects to demonstrate strengths and weaknesses and to understand practicalities of the design.
Impact Several invited seminars (Leeds, Leicester, LSHTM), conference papers, one published article.
Start Year 2014
 
Description Strengthening the Analytical Thinking for Observational Studies: STRATOS initiative 
Organisation Albert Ludwig University of Freiburg
Department Centre for Medical Biometry and Medical Informatics
Country Germany 
Sector Academic/University 
PI Contribution Member of the steering committee (James Carpenter) and co-author of the paper in Statistics in Medicine which introduced this initiative Dr Tim Morris is a member of the simulation panel and the visualisation panel.
Collaborator Contribution Besides steering group membership, James Carpenter is chair of the Topic Group on missing data, responsible for leading the activities of this group
Impact One paper has been published
Start Year 2014
 
Description Using causal analyses to add value to large RCTs 
Organisation University of Bristol
Department MRC Centre for Causal Analyses in Translational Epidemiology
Country United Kingdom 
Sector Academic/University 
PI Contribution To help develop "best practice" examples to guide statisticians working in clinical academia in the use of causal methods To help systematically survey the clinical literature, and to conduct a scoping exercise to identify types of questions which causal models have most potential to answer in RCTs To help apply causal inference methods to use RCT data to answer two new clinical questions of different types To help disseminate best practice through workshops etc
Collaborator Contribution To help develop "best practice" examples to guide statisticians working in clinical academia in the use of causal methods To help systematically survey the clinical literature, and to conduct a scoping exercise to identify types of questions which causal models have most potential to answer in RCTs To help apply causal inference methods to use RCT data to answer two new clinical questions of different types To help disseminate best practice through workshops etc
Impact Funding from the MRC Population and Health Sciences Network (to fund a cross-unit appointment for a joint appointment between CTU and CaiTE) commenced in April 2014 (until 2017)
Start Year 2012
 
Title 'metan': module for fixed and random effects meta-analysis 
Description The routines in this package provide facilities to conduct meta-analyses of binary (event) or continuous data from two groups, or intervention effect estimates with corresponding standard errors or confidence intervals. This is an updated version of metan as published in Stata Journal Issue 8, and prior to that in STB-44, authored by Michael J Bradburn, Jonathan J Deeks and Douglas G Altman. Updates include a wide range of random-effects models; cumulative and influence analysis; meta-analysis of proportions; and better handling of heterogeneity, continuity correction and returned values. The routine for constructing forest plots has been separated off ('forestplot' command) and hugely extended; extremely flexible and generalised forest plots may now be produced. 
Type Of Technology Software 
Year Produced 2020 
Impact The 'metan' package was originally developed by a group of prominent meta-analysis researchers including Profs. Jonathan Sterne, Jonathan Deeks and Douglas Altman; and was for many years the only meta-analysis package available for Stata. However, for a decade the package has not been maintained due to lack of resources, whilst the meta-analysis field has continued to evolve. The latest version of Stata 16 now has an official meta-analysis suite, but this is not available to users of older versions and is limited in scope. The update to the 'metan' package described in this Record, with vastly increased functionality, has the full blessing of the original authors; and therefore represents a comprehensive, peer-reviewed and validated update to a package which continues to be downloaded an order of magnitude greater than any other user-written meta-analysis package, and which is used in multiple courses and textbooks. 
URL https://www.statalist.org/forums/forum/general-stata-discussion/general/1585265-metan-a-comprehensiv...
 
Title Jomo 
Description R package for multilevel joint modelling imputation 
Type Of Technology Software 
Year Produced 2016 
Open Source License? Yes  
Impact Use of the jomo method by applied researchers 
URL https://cran.r-project.org/web/packages/jomo/jomo.pdf
 
Title R package for multiple imputation of missing data in IPD meta-analysis 
Description This is a software package developed in R that enables multiple imputation of missing data in IPD meta-analysis 
Type Of Technology Software 
Year Produced 2015 
Impact No impacts as yet 
 
Title Software for substantive model compatible multiple imputation 
Description Statistical software for performing multiple imputation, consistent with the assumptions made by the substantive statistical analysis model. 
Type Of Technology Software 
Year Produced 2015 
Open Source License? Yes  
Impact None so far. 
URL http://www.missingdata.org.uk
 
Title Stata package for reference based sensitvity analysis for longitudinal trials with protocol deviation via multiple imputation 
Description This software implements, in the statistical software package Stata, Reference Based Sensitivity Analysis for missing outcome data in clinical trials. Within Stata, simply type ssc install mimix to install the software 
Type Of Technology Software 
Year Produced 2016 
Impact None yet 
 
Title fp_select: model selection for univariable fractional polynomials 
Description The fp_select routine to perform model selection for univariable fractional polynomial models 
Type Of Technology Software 
Year Produced 2017 
Impact None yet - just released 
 
Title mfpa: extension of mfp using the acd covariate transformation for enhanced parametric multivariable modelling 
Description An extension of mfp using the acd covariate transformation for enhanced parametric multivariable modelling 
Type Of Technology Software 
Year Produced 2016 
Impact Use of this software 
URL http://www.homepages.ucl.ac.uk/~ucakjpr/stata
 
Title network software for Stata 
Description The -network- module for the statistical package Stata is an easy-to-use package to handle data for network meta-analysis and to fit consistency and inconsistency models (via calls to the -mvmeta- module). 
Type Of Technology Software 
Year Produced 2014 
Open Source License? Yes  
Impact Widely used, as judged from - large number of emails received about it. - has featured in various publications including two in Chinese: http://www.cjebm.org.cn/Upload/PaperUpLoad/b24bfc39-bb0d-41b9-9f0f-93c3ba90353b.pdf and http://www.cjebm.org.cn/oa/DArticle.aspx?type=view&id=20150818. - used in ~40% of network meta-analyses published in major medical journals: I estimate it has been used in 100-200 published works - often used without explicit citation. 
URL http://www.stata-journal.com/article.html?article=st0410
 
Description Cochrane SMG 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Invited to present recent research at a meeting of the Cochrane Collaboration's Statistical Mrthods Group.
Year(s) Of Engagement Activity 2018
 
Description EME workshop 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact 30 professionals attended a training course on efficacy and mechanisms evaluation with relevance to the MRC board of the same name.
Year(s) Of Engagement Activity 2017,2018,2019
 
Description IW - Bern causal inference course 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The Swiss network of trial statisticians invited me to give a course on causal inference in RCTs. ~20 people attended and reported learning about new methods of anlaysis.
Year(s) Of Engagement Activity 2020
 
Description Marie Curie workshop 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact 40 people from a range of backgrounds attended a workshop "Missing Data in Palliative Care Studies" at which Ian White spoke. This led to a draft document for use by the Marie Curie charity and others.
Year(s) Of Engagement Activity 2017
 
Description Member of trial steering committee, POSNOC trial 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Appointed member of trial steering committee, POSNOC trial (2014-2024): POSNOC - A randomised trial of armpit (axilla) treatment for women with early stage breast cancer.

The POSNOC trial will provide evidence relevant to patients and to the NHS. The protocol has been designed to integrate into current NHS
practice.
The hypothesis of the POSNOC trial is that low axillary tumour burden patients (clinically and ultrasound negative) with macrometastases in 1 or 2 SNs, receiving systemic therapy, would have non-inferior outcomes whether they are randomised to adjuvant therapy alone or adjuvant therapy plusaxillary treatment (ANC or ART)
Year(s) Of Engagement Activity 2014,2015,2016,2017,2018,2019,2020,2021
URL http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0004/111469/PRO-12-35-17.pdf
 
Description Multiple Imputation Course 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Each course is a 2 day course for 30 scientists needing to tackle missing data in their research. Feedback has always been excellent. Many of the attendees have gone on to use multiple imputation.

We haved gone on to write two methodological papers with people who have attended the course (doi 10.1186/s13104-016-1853-5; 2nd accepted but not yet published).

We have also written a highly cited tutorial paper (>1000 citations at March 2016) based in the material in the course and our experiences of teaching the course.

Course has now been repeated successfully 9 times in Cambridge and once (as a 1-day course) in Birmingham.
Year(s) Of Engagement Activity 2008,2009,2010,2011,2012,2013,2014,2015,2016,2017,2018,2019,2020
URL https://www.ucl.ac.uk/clinical-trials-and-methodology/education/short-courses/missing-data
 
Description PSI course 2019 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact 50 members of PSI (European Statistical Organisation focussing on pharmaceutical industry) attended a pre-confernece course on "Demystifying causal inference"
Year(s) Of Engagement Activity 2018
 
Description Paris NMA course 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact 25 professionals attended a 3-day course on network meta-analysis methods given by experts from UK, France and Germany.
Year(s) Of Engagement Activity 2019
URL http://livenetworkmetaanalysis.com/nma-training/
 
Description Simulations course 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact We gave a one-day course on "Using simulation studies to evaluate statistical methods". The audience were researchers either using or planning to use simulation studies in order to develop or evaluate statistical methods. Feedback indicated that the audience felt empowered to start or improve their use of simulation studies. We repeated the course in subsequent years as a 2-day course and also online.
Year(s) Of Engagement Activity 2015,2016,2017,2018,2019,2020,2021
URL https://sites.google.com/site/simulationstudies/home
 
Description UMIT course 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact A series of lectures and practicals on Treatment Switching in Randomised Trials was given in Hall, Austria as part of a 4-day course on Causal Inference Methods. Repeated annually including online in 2021.
Year(s) Of Engagement Activity 2016,2017,2018,2019,2020,2021
URL https://www.umit.at/page.cfm?vpath=departments/public_health/htads-continuing-education-program/caus...