Issue Special Issue 1/2013
2nd Clinical Trials Methodology Conference: Methodology Matters
Content (271 Articles)
The UK Medical Research Council and clinical trials, 1934-1960
Iain Chalmers
Removing unnecessary obstacles to randomised trials
Rory Collins
Data monitoring committees: history and their future
David L DeMets
Using evidence from observational healthcare data to inform a trial design
Christian Holm Hansen, Gordon Murray, Michael Sharpe
Impact of lack-of-benefit stopping rules on treatment effect estimates of two-arm multi-stage (TAMS) trials with time to event outcome
Babak Choodari-Oskooei, Max KB Parmar, Patrick Royston, Jack Bowden
The need for a cultural shift from two-arm to multi-arm RCTS
Matthew R Sydes, Mahesh KB Parmar
Treatment selection in multi-arm, multi-stage clinical trials
Thomas Jaki, Dominic Magirr, Nigel Stallard
Efficient design of a phase III trial of competing tests for personalised cancer treatment in the absence of gold standard outcome data: challenges and potential solutions
Peter Hall, Christopher McCabe, Claire Hulme, Richard Edlin, Janet Dunn, David Cameron, Rob Stein
Evidence synthesis in trial design: an example from the neurosciences
Kieren Egan, Hanna Vesterinen, Emily Sena, Malcolm Macleod
When is a randomised controlled trial required: the theoretical domains framework approach
Marion Campbell, Jill Francis, Eilidh Duncan, Graeme MacLennan, Brian Cuthbertson
A series of decision-theoretic phase II trials of related treatments
Siew Wan Hee, Nicholas Parsons, Matthew Costa, Nigel Stallard
The risks and benefits of RTPA in acute ischemic stroke for patients at high risk of intracranial haemorrhage and poor functional outcome: a secondary analysis of the IST-3 trial and systematic review of prediction models
Douglas Thompson, Gordon Murray, William Whiteley
Who do treatments work for and why? Understanding treatment-effect mechanisms in stratified medicine
Richard Emsley, Hanhua Liu, Sabine Landau, Graham Dunn
Adaptive enrichment in biomarker-stratified clinical trial design
Deepak Parashar, Jack Bowden, Colin Starr, Lorenz Wernisch, Adrian Mander
Using adaptive designs for decision making within the optima trial: optimal personalized treatment of early breast cancer using multi-parameter tests
Janet Dunn, Andrea Marshall, Amy Campbell, Nigel Stallard, Claire Hulme, Peter Hall, Helen Higgins, John Bartlett, Adrienne Morgan, Jenny Donovan, Andreas Makris, Luke Hughes-Davies, Rob Stein
Experiences of perceived vs actual time required for data management on electronic data capture clinical trials in a non commercial setting
Nancy Tappenden, Lindsey Masters
Clinical trials registries: is it viable for the inclusion of conduct, performance, analyses and cost of trials?
Amanda Young, James Raftery, Louise Stanton, Andrew Cook, Peter Davidson, Ruairidh Milne, David Turner
Incorporation of text recognition into trial it systems to safeguard against enrolment of ineligible patients or inappropriate reporting of adverse events
Martin Dennis, Rustam Salman, Gillian Mead, Connor McGill, David Perry
Using linked healthcare data to create a randomised controlled trial: the rapid trial (reducing antibiotic prescribing in dentistry)
Paula Elouafkaoui, Andrew Elders, Jan Clarkson, Eilidh Duncan, Maria Prior, Craig Ramsay, Linda Young
Optimising the design and evaluation of pilot work to inform the main trial: a review of current evidence and consideration of future practices
Elaine O'Connell Francischetto, Kerry Avery, Chris Metcalfe, Paula Williamson, Carrol Gamble, Jane Blazeby
Definition and reporting of pilot and feasibility studies
Sandra Eldridge, Christine Bond, Mike Campbell, Gill Lancaster, Lehana Thabane, Sally Hopwell
ADePT (algorithm for decision-making after pilot and feasibility trials): a decision aid for progression from feasibility study to main trial
Carol Bugge, Brian Williams, Suzanne Hagen
Designing and analysing feasibility studies of complex interventions: challenges related to assessing stop/go criteria
Michelle Collinson, Shamaila Anwar, Liz Graham, Kayleigh Burton, Tamar Pincus, David Owens, Amanda Farrin
Sample size requirements for pilot randomised controlled trials with binary outcomes: a simulation study
Dawn Teare, Munya Dimairo, Alexandra Hayman, Neil Shephard, Amy Whitehead, Stephen Walters
Review of the use of resource use instruments based on patient recall in relation to other methods of resource use estimation
Colin Ridyard, Dyfrig Hughes
A non-linear beta-binomial regression model for mapping qlqc-30 to the eq-5d in lung cancer patients: a comparison with existing approaches
Iftekhar Khan, Shah-Jalal Sarker, Steven Morris
Developing a lifetime disease model from RCT data using parametric models with time-updated covariates
Iryna Schlackow, Borislava Mihaylova
Fast efficient computation of expected value of sample information from a probabilistic sensitivity analysis sample: a non-parametric regression approach
Mark Strong, Alan Brennan, Jeremy Oakley
A comparison of four different approaches to measuring health utility in depressed patients
Nicholas Turner, John Campbell, Tim Peters, Nicola Wiles, Sandra Hollinghurst
The completeness of intervention descriptions in published NIHR HTA funded trials: a cross sectional study
Lisa Douet, Ruairidh Milne, Sydney Anstee, Fay Habens, Amanda Young, David Wright
PRECIS-2: a tool to improve the applicability of randomised controlled trials
Kirsty Loudon, Merrick Zwarenstein, Frank Sullivan, Peter Donnan, Shaun Treweek
Remits, roles and working models for trial steering committees and data monitoring committees in studies evaluating diagnostic tests: a survey of current practice
Lavinia Ferrante di Ruffano, Jac Dinnes, Jane Daniels, Richard Riley, Nick Hicks, Richard Kaplan, Jon Deeks
Evaluation of a site selection questionnaire for the recruitment of trial sites into multi-centre trials: experiences from the nottingham clinical trials unit
Diane Whitham, Lelia Duley
A research methodology study to map the process of initiating and operating a randomised controlled trial of podoconiosis treatment in Northern Ethiopia
Trudie Lang, Mike Clarke, Melanie Newport, Fikre Enquoselassie, Francois van Loggerenberg, Sam Franzen, Tamzin Furtado, Patricia Njuguna, Greg Fegan, Gail Davey
Feeding back the results of trials to the families of participants who have died: methodological considerations from the bracelet study (bereavement and randomised controlled trials)
Claire Snowdon, Peter Brocklehurst, Robert Tasker, Martin Ward Platt, Diana Elbourne
Using discrete choice experiments to define patient preferences for outcomes in trials
Emily Fargher, Dyfrig Hughes, Adele Ring, Ann Jacoby, Margaret Rawnsley, Anthony Marson
Evidence base for patient and public involvement in clinical trials (EPIC)
Carrol Gamble, Louise Dudley, Jennifer Newman
Service user groups as co-applicants on a platform study for a trial
Heather Morgan, Pat Hoddinott, Gill Thomson, Nicola Crossland, Fiona Dykes, Sharon McCann, Marion Campbell
Patient involvement in clinical research: a qualitative evaluation of impact
Rachael Gooberman-Hill, Amanda Burston, Erik Lenguerrand, Emma Clark, Emma Johnson
Adjusting for treatment changes in epilepsy: causal analysis of randomised controlled trial survival outcomes in the presence of departure from randomised treatment
Susanna Dodd, Paula Williamson, Ruwanthi Kolamunnage Dona, Marta Van der Hoek, Ian White
Analysis of survival data from trials with non-proportional hazards: an empirical comparison of methods
Patrick Royston, Yinghui Wei, Jayne Tierney, Mahesh Parmar
Modelling of longitudinal outcomes with highly skewed distributions: applications in the IVAN trial
R Nash, L Scott, U Chakravarthy, SP Harding, BC Reeves, CA Rogers
Rasch analysis of the PedsQL 3.0 diabetes module
Tim Pickles, Rebecca Playle, Kerenza Hood, Jonathan Gillard, Michael Robling
The implications of differential clustering for analysis of binary outcomes
Chris Roberts, Steve Roberts, Eva Batistatou
Bridging the gap: a review of dose-investigation studies in paediatric investigation plans
Lisa Hampson, Martin Posch, Julia Saperia, Anne Whitehead
Methodological considerations for neonatal trials involving multiples: lessons from the bracelet study (bereavement and randomised controlled trials)
Claire Snowdon, Peter Brocklehurst, Robert Tasker, Martin Ward Platt, Diana Elbourne
The reform study: a cohort multiple randomised controlled trial
Sarah Cockayne, Joy Adamson, Catherine Hewitt, Robin Hull, Anne-Maree Keenan, Antony Redmond, Sallie Lamb, Caroline McIntosh, Hylton Menz, Wesley Vernon, Judith Watson, David Torgerson
Comparative study of new imaging technologies for the diagnosis of glaucoma: design and conduct of a multi-centre diagnostic accuracy study
Katie Banister, Jonathan Cook, Craig Ramsay, Jennifer Burr, Rodolfo Hernández, Kirsty McCormack, Rupert Bourne, Mark Batterbury, David Garway-Heath, Augusto Azuara-Blanco
Comparative evaluation of the stepped wedge design efficiency
Gianluca Baio, Rumana Omar, Gareth Ambler
A win ratio approach to comparing ordinal or non-normal outcomes in clinical trials
Duolao Wang, Stuart Pocock
A novel measure of treatment benefit for an ordinal scale: a case study of the IST-1 and the IST-3 stroke trials
Douglas Thompson, William Whiteley, Gordon Murray
Behavioural recovery following treatments for varicose veins: developing a measure of outcome and process
Seonaidh Cotton, Jill Francis, Denise Bolsover, Maria Prior, Graeme MacLennan, Julie Brittenden
Comparing sensitivity to change of two patient-reported outcome measures in a randomised trial of patients referred for physiotherapy services
Selman Mirza, Chris Salisbury, Cherida Hopper, Nadine Foster, Alan Montgomery
Minimal important change or difference for the oxford hip and knee scores following joint replacement surgery
Kristina Harris, Andrew Price, Jill Dawson, Helen Doll, David Murray, Andrew Carr, David Beard
What can qualitative research do for randomised controlled trials? A systematic mapping review
Alicia O'Cathain, Kate Thomas, Sarah Drabble, Anne Rudolph, Jenny Hewison
‘Keep an open mind’: using qualitative research to make recruitment easier in the by-band randomised controlled trial
Sangeetha Paramasivan, Chris Rogers, Graziella Mazza, Jane Blazeby, Jenny Donovan
Intervention vignettes as a qualitative tool to refine complex intervention design
Pat Hoddinott, Heather Morgan, Gill Thomson, Nicola Crossland, Leone Craig, Jane Britten, Shelley Farrar, Rumana Newlands, Kirsty Kiezebrink, Joanne Coyle
Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists
Derek Kyte, Jonathan Ives, Heather Draper, Thomas Keeley, Melanie Calvert
Designing the CORONIS trial. Why a non-regular fractional factorial design?
Pollyanna Hardy, Ed Juszczak, Barbara Farrell
Using a Bayesian approach with reverse philosophy to design clinical trials in rare diseases
Lucinda Billingham, Emma Hall, Clare Cruickshank, Jim Barber, Steve Nicholson
Opening research sites in multicentre clinical trials within the UK: a detailed analysis of delays
Paula Williamson, Carrol Gamble, Anna Kearney, Helen Hickey
A survey of facilitators and barriers to recruitment to the magnetic trial
Geetinder Kaur, Rosalind Smyth, Colin Powell, Paula Williamson
Systematic techniques for assisting recruitment to trials (START): developing the science of recruitment
Jo Rick, Peter Bower, David Collier, Sandra Eldridge, Jonathan Graffy, Anne Kennedy, Peter Knapp, Adwoa Hughes-Morley, Chris Salisbury, Nicola Small, David Torgerson, Shaun Treweek, Paul Wallace
A simple technique to identify key recruitment issues in randomised controlled trials: Q-QAT - quanti-qualitative appointment timing
Sangeetha Paramasivan, Sean Strong, Caroline Wilson, Jane Blazeby, Jenny Donovan
Recruiters to randomised trials can be trained to facilitate recruitment and informed consent by exploring patients’ treatment preferences
Nicola Mills, Jane Blazeby, Freddie Hamdy, David Neal, Bruce Campbell, Jenny Donovan
Determining items for inclusion in a decision support intervention for clinical trial participation: a modified Delphi approach
Katie Gillies, Zoe Skea, Sara MacLennan, Craig Ramsay, Marion Campbell
Has the rheumatoid arthritis (RA) core outcome set influenced the selection of study outcome measures?
Jamie Kirkham, Maarten Boers, Peter Tugwell, Mike Clarke, Paula Williamson
Collating the knowledge base for the COMET (core outcome measures in effectiveness trials) initiative - a systematic review
Elizabeth Gargon, Binu Gurung, Paula Williamson
Design considerations in the development of a core outcome set
Nicola Harman, Iain Bruce, Peter Callery, Stephanie Tierney, Kevin O'Brien, Paula Williamson
Recruitment to trials: insights from a meta-ethnography of qualitative studies
Sharon McCann, Marion Campbell, Vikki Entwistle
Evaluating best practice in informed consent discussions: a new method of evaluating information provision and patient understanding during trial recruitment consultations
Julia Wade, Jenny Donovan, Sangeetha Paramasivan, Athene Lane, David Neal, Freddie Hamdy
Involving patients in optimising RCT participant information sheets and exploring patient acceptability of clinical trials
Alba Realpe, Peter Wall, Damian Griffin, Rachel Hobson, Jenny Donovan, Ann Adams
What are parents’ priorities when being invited to enter their child into a clinical trial and how far do they voice their priorities?
Bridget Young, Kerry Woolfall, Paula Williamson
A multi-arm multi-stage design for binary outcomes and application to tuberculosis
Daniel Bratton, Patrick Phillips, Mahesh Parmar
An integrated approach to the development of a Bayesian response-adaptive dose-finding study using sas and winbugs
Christian Holm Hansen, Christopher Weir, Pamela Warner, Hilary Critchley
Implementation of adaptive dose-finding designs in two early phase haematological trials: clinical, operational, and methodological challenges
Christina Yap, Charlie Craddock, Graham Collins, Josephine Khan, Shamyla Siddique, Lucinda Billingham
Prediction of recurrent stroke and myocardial infarction after stroke: a systematic review of clinical prediction models
Douglas Thompson, Gordon Murray, William Whiteley
A novel adaptive trial design: randomised evaluation of molecular guided therapy for diffuse large b-cell lymphoma with bortezomib (REMODL-B) with two interim analyses to explore safety and efficacy
Tom Maishman, Louise Stanton, Andy Davies, Sharon Barrans, Lisa Worrillow, Christoph Mamot, Matt Care, Tikki Immins, Debbie Hamid, Andrew McMillan, Paul Fields, Andrew Jack, Peter Johnson
Adaptive dose-finding designs to identify multiple doses that achieve multiple response targets
Simon Bond, Adrian Mander, John Todd, Linda Wicker, Frank Waldron-Lynch
An ethnographic study of group decision making to understand and improve how trial steering committees contribute to trial conduct
Anne Daykin, Ali Heawood, Athene Lane, Rhiannon Macefield, Carrol Gamble, Sharon McCann, Gillian Shorter, Matthew R Sydes
Evaluation of source data verification in a multicentre cancer trial (PROTECT)
J Athene Lane, Michael Davis, Elizabeth Down, Rhiannon Macefield, David Neal, Freddie Hamdy, Jenny Donovan, Hilary Taylor
Should involvement in a trial be discussed at a bereavement follow up visit? Views of clinicians and bereaved parents from the bracelet study (bereavement and randomised controlled trials)
Claire Snowdon, Peter Brocklehurst, Robert Tasker, Martin Ward Platt, Diana Elbourne
Issues in the design and conduct of a multicentre trial in UK ambulance services
Simon Gates, Jessica Horton, Susie Hennings, Gavin Perkins
Ensuring a high response rate to patient reported outcomes in surgical trials using incentives - a trial manager perspective
Hanne Bruhn, Alison McDonald, Angus Watson, John Norrie
Long-term post-trial follow-up of participants in randomised trials: lessons learned from the mrc / bhf heart protection study (HPS)
Theingi Aung, Richard Bulbulia, Louise Bowman, Jane Armitage
Tailoring study design to each stage of surgical innovation: the ideal recommendations
Allison Hirst, Jonathan A Cook, Peter McCulloch, Douglas G Altman, Carl Heneghan, Markus K Diener, Patrick L Ergina, Jeffrey S Barkun, Jane M Blazeby, David J Beard, Danica Marinac-Dabic, Art Sedrakyan
Accounting for intervention complexity in rcts in surgery: new approaches for intervention definition and methods for monitoring fidelity
Natalie Blencowe, Alex Boddy, Alexander Harris, Tom Hanna, Penny Whiting, Jonathan Cook, Jane Blazeby
Pro’s and con’s of the stepped wedge design in cluster randomised trials of quality improvement interventions: two current examples
Tobias Dreischulte, Aileen Grant, Peter Donnan, Bruce Guthrie
Parallel process evaluation using a proposed framework for the design and reporting of process evaluations for cluster-randomised trials of complex interventions
Aileen Grant, Tobias Dreischulte, Bruce Guthrie
Estimating effect of intervention delivery in the evaluation of complex intervention with various levels of compliance
Baptiste Leurent, Mike Crawford, Kalaitzaki Eleftheria, Irwin Nazareth
Icons: identifying continence options after stroke trial: utility of a logic model in the design and implementation of a process evaluation
Lois Thomas, Christopher Burton, Beverley French, Michael Leathley, Denise Forshaw, Christopher Sutton, Brenda Roe, Brigit Chesworth, Caroline Watkins
Guidance to detect, evaluate and prevent the problem of selective reporting in trial publications
Kerry Dwan, Paula R Williamson, Carrol Gamble, Julian Higgins, Jonathan Sterne, Douglas G Altman, Mike Clarke, Jamie J Kirkham
The use of systematic reviews in the planning, design and conduct of randomised trials: a retrospective cohort of NIHR HTA funded trials
Ashley Jones, Elizabeth Conroy, Paula Williamson, Mike Clarke, Carrol Gamble
Assessing and improving the reliability of meta-analyses of hazard ratios derived from published time-to-event data
Jayne Tierney, David Fisher, Sarah Burdett, Lesley Stewart, Mahesh Parmar
How systematic reviews and meta-analyses based on individual participant data can inform trial design and conduct
Jayne Tierney, Claire Vale, Jean-Pierre Pignon, Francois Gueffyier, Lisa Askie, Mike Clarke
Randomised trial reports continue to be islands of evidence, with few continents in sight
Michael Clarke, Sally Hopewell
Assessing the presence of selection bias in meta-analyses of randomised trials using baseline heterogeneity
Laura Clark, Caroline Fairhurst, Catherine Hewitt, Yvonne Birks, Sally Brabyn, Sarah Cockayne, Sara Rodgers, Katherine Hicks, Robert Hodgson, Elizabeth Littlewood, David Torgerson
Sensitivity analyses for trials with missing data, assuming missing not at random mechanisms
Baptiste Leurent, Mike Crawford, Hazel Gilbert, Richard Morris, Mike Sweeting, Irwin Nazareth
A comparison of multiple imputation methods for bivariate hierarchical data: an application to cost-effectiveness analyse
K Diaz-Ordaz, M Gomes, R Grieve, MG Kenward
Simplification or simulation: some unclear issues in sample size calculation
Chao Huang
A framework to assess the impact of applying formal criteria to check clinical relevance on top of statistical significance
Werner Vach, Beryl Primrose Gladstone
Statistical analysis plans (SAPS) for academic clinical trials at the edinburgh clinical trials unit: what should they contain?
Aryelly Rodriguez, Steff Lewis, Gordon Murray, Ashma Krishan, Isabella Butcher, Christopher Weir
An adaptive biomarker strategy clinical trial design
James Wason, Nigel Stallard, Janet Dunn, Rob Stein
Risk stratification in clinical trials: a subgroup to be encouraged
Tim Clayton, Stuart Pocock
Level of evidence for promising subgroup findings in a negative trial
Julien Tanniou, Ingeborg van der Tweel, Kit Roes
Simulation modelling to identify optimal monitoring strategies: the use of the elf biomarker in liver disease monitoring
Alice Sitch, Jac Dinnes, Julie Parkes, Walter Gregory, Jenny Hewison, Doug Altman, Jon Deeks
Follow up after sample size re-estimation in a breast cancer trial for time to recurrence
Erinn Hade, Gregory Young, David Jarjoura, Richard Love
Sample size formula for joint modelling of longitudinal and time-to-event data in clinical trials
Matthew Powney, Paula Williamson, Ruwanthi Kolamunnage-Dona
A nested randomised controlled trial of a leaflet, containing information on research, to increase the recruitment rate of reform (reducing falls with orthoses and a multifaceted podiatry) trial participants
Catherine Arundel, David Torgerson, Laura Jefferson, Sarah Cockayne
Trainee led research networks in the implementation and delivery of multicentre randomised trials: a model from the west midlands research collaborative
Aneel Bhangu, Thomas Pinkney, Laura Magill, Dion Morton
Approaches to participant recruitment and predictors of retention in a large community based public health trial: findings from the building blocks trial
Eleri Owen-Jones, Mike Robling, Julia Sanders, Rebecca Cannings-John, Gwenllian Moody
Comparison of recruitment yield in prevention and therapy trials
Cindy Cooper, Adjoa Asante, Danny Hind, Stephen Walyers
Recruitment and retention in internet based randomised trials
Gillian W Shorter, Finola Ferry
Can we recruit to expertise trials? Experience from the total or partial knee arthroplasty trial (TOPKAT)
Loretta Davies, Cushla Cooper, David Beard
Covariance modelling for randomised controlled trials
Gilbert MacKenzie
Using continuous data on tumour measurements to improve inference in phase II cancer studies
James Wason, Shaun Seaman
Comparing active treatments at phase II: using multiple criteria to find the optimal treatment to take forward to phase III
Michael Sweeting, Martin Law
Using meta-analysis of Phase II trials to predict Phase III trial results
Danielle Burke, Lucinda Billingham, Alan Girling, Richard Riley
Trichotomous prognosis-based outcome analysis: an efficient and clinically relevant method for analysis of acute stroke trials
David Barer, Eivind Berge, Else Charlotte Sandset
Modelling residual disease volume and re-growth rates from response durations to aid in cancer trial design, interpretation and analysis, with a particular focus on breast cancer
Walter Gregory, Helen Marshall, David Cameron, Christopher Twelves, Richard Bell, Robert Coleman
Trial forge: a systematic approach to making trials more efficient
Shaun Treweek
A systematic review of methods for specifying the target difference in randomised controlled trials (delta review)
Jonathan Cook, Jenni Hislop, Temitope Adewuyi, Kirsten Harrild, Cynthia Fraser, Doug Altman, Craig Ramsay, Peter Fraser, Andrew Briggs, John Norrie, Ian Harvey, Brian Buckley, Luke Vale
Design, analysis and reporting of active-control randomised trials: a systematic review
Lang'o Odondi, Chris Metcalfe, Jonathan Sterne
Methodological, planning and implementation challenges for rcts evaluating group interventions
Daniel Hind, Chris Roberts, Kirsty Sprange, Rebecca Gossage-Worrall, Cindy Cooper, Stephen Walters
Methodological challenges designing pragmatic, multi-centre randomised controlled trials in critical care
Graeme MacLennan, Marion Campbell, John Norrie
Measuring the impact of methodological research at the medical research council clinical trials unit hub for trials methodology research
Valerie Brueton, Claire Vale, Rachel Jinks, Babak Oskooei, Jayne Tierney
Simulation as a practical and versatile tool for sample size calculation
Richard Hooper
Is innovation in surgery less than ideal? A case study of acellular dermal matrix assisted prosthetic breast reconstruction
Shelley Potter, Danielle Browning, Jelena Savovic, Rob Warr, Simon Cawthorn, Jane Blazeby
Time to be brave: is educating surgeons the key to unlocking the potential of randomized clinical trials in surgery? A qualitative study
Shelley Potter, Nicola Mills, Simon Cawthorn, Jane Blazeby
Understanding the complexity of surgical interventions in rcts: the role of process evaluation in the operating theatre
Natalie Blencowe, Nicola Mills, Jenny Donovan, Jane Blazeby
Assessing fidelity to complex interventions: the icons experience
Brigit Chesworth, Michael Leathley, Lois Thomas, Denise Forshaw, Chris Sutton, Bev French, Chris Burton, David Britt, Brenda Roe, Francine Cheater, Caroline Watkins
Multi-level case studies in development of complex interventions: an example of the good goals intervention
Niina Kolehmainen, Graeme MacLennan, Laura Ternent, Edward AS Duncan, Eilidh M Duncan, Stephen B Ryan, Lorna McKee, Jill Francis
Causal inference techniques for trials of complex interventions
Sabine Landau
Defining ‘usual care' in trials of complex interventions
Julia Sanders, Marie-Jet Bekkers, Rebecca Cannings-John, Sue Channon, Mike Robling
Developing an intervention to support lung cancer patients and their clinicians when considering systemic anti-cancer therapy: pact study
Annmarie Nelson, Stephanie Sivell, Simon Noble, Anthony Byrne, Jason Lester
‘Once I knew there was a choice, I wanted to exercise that choice': using qualitative methods to understand why patients decline surgical trials
Emily Harrop, John Kelly, David Neal, Prokar Dasgupta, Gillian Basnett, Robert Huddart, Allan Barham, Colin Thompson, Angela Casbard, Hala Jundi, Gareth Griffiths, Annmarie Nelson
Effects of an optimised POCT guided diagnostic and treatment strategy for symptoms of uncomplicated UTI on use of appropriate antibiotics and uptake into primary care practice
Janine Bates, Emma Thomas-Jones, Nigel Kirby, Tim Pickles, Rhys Thomas, Emily Bongard, Micaela Gal, Paul Little, Theo Verheij, Carlos Llor, David Cohen, Nick Francis, Kerry Hood, Christopher Butler
Accounting for the placebo effect of surgery in surgical trials?
David Beard, Cushla Cooper, Ines Rombach, Jon Rees, Karolina Wartolowska, Naomi Cummings, Andrew Carr
Potential role of “the compensating benefit” in claiming non-inferiority
Primrose Beryl, Werner Vach
The process of stopping recruitment and trial treatment in a trial of a psychological therapy for people with personality disorder following a safety alert
Florence Day, Mary McMurran, Lelia Duley
How well documented are testing strategies and outcome measurement methods in trials of tests? A comparison of reporting quality in test-treatment and monitoring RCTS
Jac Dinnes, Lavinia Ferrante di Ruffano, Alice Sitch, Julie Parkes, Jenny Hewison, Doug Altman, Jon Deeks
Stepped-wedge cluster randomised controlled trials: some variations on the common design
Karla Hemming, Alan Girling
The dog-leg design that can give clinical trials more power to their elbow
Richard Hooper, Liam Bourke
Preventing and lessening exacerbations of asthma in school age children associated with a new term: pleasant
Steven Julious, Michelle Horspool
Seal or varnish? Overcoming the challenges of conducting a CTIMP in a research naive, primary-school based environment through a risk-adapted approach
Simon Hutchings, Ivor Chestnutt, Barbara Chadwick, Jacqui Nuttall, Rebecca Playle, Kerenza Hood
A pragmatic cluster randomised controlled trial of an oral health intervention for people with serious mental illness (three shires early intervention dental trial)
Hannah Jones, Clive Adams, Andrew Clifton, Patrick Callaghan, Peter Liddle, Heather Buchanan, Vishal Aggarwal
Practical implementation of an adaptive phase I/II design in chronic myeloid leukaemia: evaluating both efficacy and toxicity using the EffTox design
Josephine Khan, Christina Yap, Richard Clark, Nicola Fenwick, David Marin
A multi-centre randomised Phase III trial of radioembolisation (RE) combined with oxmdg compared with oxmdg alone as first-line therapy for unresectable liver-only or liver-dominant metastatic colorectal cancer (CRC)
Nicola Maycock, Susan Dutton, Ricky Sharma
Development of double blind gluten & casein free (GFCF) test foods for autism trial
Elaine McColl, Sandra Adams, Nicola Burton, Anna Cutress, Ashley Adamson, Gillian Baird, Anne O'Hare, Ann Le Couteur
Parents' and child health professionals' attitudes to dietary interventions in autism spectrum disorder (ASD): findings from a UK survey
Elaine McColl, Ann Le Couteur, Sandra Adams, Helen McConachie, Paul Gringras, Gillian Baird, Anne O'Hare, David Wilson, Jeremy Parr, Elizabeth Winburn, Jenna Charlton
Flexible trial design in a rare condition
Veronica Moroz, Keith Wheatley, Martin McCabe
Modifying the multi-arm multi-stage (MAMS) design for use in a phase II tuberculosis trial in sub-Saharan Africa with a time-to-event primary outcome
Patrick Phillips, Michael Hoelscher, Daniel Bratton, Sunita Rehal, Norbert Heinrich, Georgette Plemper van Balen, Andrew Nunn, Rob Aarnoutse, Sonja Henne, Stephen Gillespie, Martin Boeree
Recruitment challenges in surgical trials: lessons from the crisp trial
K Pike, GD Angelini, BC Reeves, DP Taggart, CA Rogers
Overcoming the challenge of conducting a pragmatic randomised trial in premises licensed for the on-site sale and consumption of alcohol
Rebecca Playle, Simon Moore, Simon Murphy, Laurence Moore, Kerry Hood, Jonathan Shepherd
Clinical development of nitisinone for alkaptonuria (developakure) - a rare disease clinical trials design
Eftychia Eirini Psarelli, Trevor Cox, Lakshminarayan Ranganath
Methodological issues in the development of a prediction model for pre-eclampsia complications
Ewelina Rogozinska, Fiona Fong, Shakila Thangaratinam, John Allotey, Julie Dodds, Sally Kerry, Nadine Marlin, Khalid Khan
Challenges in the design and analysis of surgical trials
Ines Rombach, David Beard, Andrew Carr, Jonathan Rees, Cushla Cooper, Naomi Cummings
A framework to assess the added value of subgroup analyses when the overall treatment effect (TE) was significant
Hong Sun, Werner Vach
Do participants in major, practice-changing breast cancer trials reflect the breast cancer patient population?
Shaun Treweek, Ruth Dryden, Colin McCowan, Alison Harrow, Alastair Thompson
Clinical trials in rare diseases: a review of practice
Stuart Bell, Paula Williamson, Simon Day, Keith Wheatley, John Whitehead, Catrin Tudur Smith
Introducing 'global health methodology research' a knowledge sharing platform open to all
Francois van Loggerenberg, Mike Clarke, Tamzin Furtado, Liam Boggs, Nicola McHugh, Samuel Franzen, Trudie Lang
Revisiting the multi-armed bandit model for the optimal design of clinical trials: benefits and drawbacks
Sofia S Villar, Jack Bowden, James Wason
Recruitment to diagnosis of urinary tract infections in young children (DUTY) study: an evaluation of the successful methods used in a primary care, prospective cohort study
Cherry-Ann Waldron, Emma Thomas-Jones, Timothy Pickles, Kerry Hood, Kim Harman, Harriet Downing, Kate Martinson, Marilyn Peters, Alastair D Hay, Christopher C Butler
The use of placebo in randomised surgical clinical trials
Karolina Wartolowska, Andrew Judge, Benjamin Dean, Ines Rombach, Julian Savulescu, David Beard, Andrew Carr
Benefits and harms of placebo in surgical randomised clinical trials: a systematic review
Karolina Wartolowska, Andrew Judge, Benjamin Dean, Ines Rombach, Julian Savulescu, David Beard, Andrew Carr
A comparison of bayesian adaptive randomization and multi-stage designs for multi-arm clinical trials
James Wason, Lorenzo Trippa
A novel Bayesian method for dual-agent Phase I dose-escalation studies using penalized D-optimality
Graham Wheeler
Randomised trials during a public health crisis, such as pandemic flu: a case study for a model of ‘off the shelf' ready-to-go trials
Diane Whitham, Clare Brittain, Lelia Duley, Wei-Shen Lim
External validation of a prognostic index
Laura Bonnett, Anthony Marson, Tony Johnson, Lois Kim, Ley Sander, Nicholas Lawn, Ettore Beghi, Maurizio Leone, Catrin Tudur Smith
Short- versus long-term outcomes after treatment for tuberculosis
Laura Bonnett, Gerry Davies
Biochemical efficacy and safety trial of vitamin D (BEST-D): finding an appropriate dose to test in a large randomized trial
Jane Armitage, Harold Hin, Joseph Tomson, Mike Lay, Mike Hill, Robert Clarke
Sample size requirements for pilot randomised controlled trials with continuous outcomes: a simulation study
Marion Teare, Alexandra Hayman, Munya Dimairo, Neil Shephard, Amy Whitehead, Stephen Walters
Eligibility for randomized trials of treatments specifically for intracerebral hemorrhage: community-based study
Arthur Fonville, Neshika Samarasekera, Yvo Roos, Rustam Al-Shahi Salman
Formal consensus method for the development of a primary outcome measure to assess the clinical and cost-effectiveness of cardiac magnetic resonance imaging after primary percutaneous coronary intervention pathway activation (PIPA feasibility study)
Maria Pufulete, Chiara Bucciarelli-Ducci, Rachel Brierley, Chris Rogers, Jessica Harris, Barney Reeves
Sample size in a prognostic study: prep (prediction of risks in early onset pre-eclampsia)
John Allotey, Julie Dodds, Sally Kerry, Shakila Thangaratinam
Development of maternal and neonatal composite outcomes for trials evaluating timing of delivery in women with pre-eclampsia
Fiona Fong, Ewelina Rogozinska, John Allotey, Steve Kempley, Divyen Shah, Shakila Thangaratinam
Expected value of information in the case of mixed strategies
Gianluca Baio
Research into biomarkers to facilitate the early identification of Parkinson's disease: a decision analytic model to determine the feasibility and value
Rachael Hunter, Gordon Proctor, Alastair Noyce, Anette Schrag, Elaine Ward, John Galloway
The use of historical priors to improve the efficiency of phase II clinical trials with time-to-event endpoints
Richard Jackson, Trevor Cox, Catrin Tudur-Smith
Designing clinical research into the treatment of breast cancer in the elderly - the advantages and challenges of a value of information approach
Paul Richards, Alan Brennan
Empirical evidence for the validity and reliability of resource-use measures based on patient recall: a systematic review
Joanna Thorn, Sian Noble, Theresa Moore, William Hollingworth
Utilising fax to PDF technology to increase security, confidentiality, protocol adherence, follow-up and ease of monitoring in multicentre randomised trials
Martin Dennis, Rustam Al-Shahi Salman, Gillian Mead, Christopher Matthews, Jonathan Drever, David Perry
On-line training and testing of knowledge of trial protocols to facilitate centre start-up and reduce protocol deviations
Martin Dennis, Rustam Al Shahi Salman, Gillian Mead, David Perry
Developing easy access patient information booklets and consent forms for use in multicentre stroke trials
Gillian Mead, Martin Dennis, Marian Brady
Database development to maximise recruitment in a busy cardiac surgery department
Lucy Dreyer, Katie Pike, Neil Smith, Lucy Culliford
Minimising paper: electronic data capture methods in the 3c study
Richard Haynes
Clinical trials software: commercial system or build your own?
Gladys McPherson, Mark Forrest, Sazid Mohammed
KCTU randomisation and IMP management system
Caroline Murphy, Joanna Kelly, John Hodsoll, Andrew Pickles, Evangelos Georgiou, PL Morgan
Use of an online e-learning module to standardise the assessment and reporting of a subjective endpoint in a multicentre rct
Thomas Pinkney, David Bartlett, Adrian Gheorghe, George Dowswell, Dion Morton, Melanie Calvert
Comparing the use of traditional and agile development methodologies in a clinical trials environment
Mary Rauchenberger, Emma Little, Carlos Diaz Montana
Development of the "GeneSYS" database system to support trial data capture and conduct
D Hutton, N Smith, H Cappel-Porter, C Saw, CA Rogers
Integrating qualitative research in a multi-centre trial - the clinical trials unit perspective
CA Rogers, G Mazza, S Paramasivan, N Smith, R Nash, JM Blazeby, J Donovan
Pressure relieving support surfaces: a randomised evaluation 2 (PRESSURE 2)
Sarah Brown, Isabelle Smith, Julia Brown, Claire Hulme, Jane Nixon
Time to publication for NIHR HTA programme-funded studies
Fay Chinnery, Amanda Young, Jennie Goodman, Ruairidh Milne, Martin Ashton-Key
A discussion of an issue relating to sample sizes of exact phase II trial designs
Andrew Howman
A framework for the development and appraisal of diet and eating behaviour outcome measures
Dianne Ward, Maria Bryant, Claudia Gorecki, Amber Vaughn, Rachel Tabak, June Stevens, Jane Nixon, Susan Jebb, Kath Roberts, Judy Wright, Julia Brown
The application of standardised diagnostic criteria in RCTS in depression
Finola Ferry, Gillian Shorter, Mike Clarke
Statistical evaluation of surrogate endpoints: a systematic review
Hannah Ensor, Robert Lee, Cathie Sudlow, Christopher J Weir
An exploratory and confirmatory analysis of the oxford hip score: generation of subscales assessing self-reported function and pain
Kristina Harris, David Beard, Jill Dawson, Andrew Price
The challenges of using radiological ‘tumour response' as an outcome: lessons learned from neo-tango and artemis, two neo-adjuvant chemotherapy breast cancer trials
Louise Hiller, Janet Dunn, Anne-Laure Vallier, Clare Blenkinsop, Louise Grybowicz, Helen Higgins, Helena Earl
Overview of clinical outcome measures used in glaucoma randomised controlled trials (RCTS)
Rehab Ismail, Augusto Azuara-Blanco, Craig Ramsay
Core outcome set development: the effect of Delphi panel composition and feedback on prioritisation of outcomes
Rhiannon Macefield, Natalie Blencowe, Sara Brookes, Marc Jacobs, Mirjam Sprangers, Paula Williamson, Jane Blazeby
The consensus studysquamous cell carcinoma of the oropharynx: late phase clinical trials; core outcomes
Aoife Waters, Catrin Tudur-Smith, Bridget Young, Terry M Jones
Telephone calls to boost response rates in the collection of outcome data
Suzanne Breeman, Seonaidh Cotton, Alison McDonald, Gladys McPherson, Graeme MacLennan, Hanne Bruhn
What influences surgeons’ experience of surgical research?
Cushla Cooper, David Beard, Andrew Carr
We did it their way, flexible and robust patient recruitment to the IQuaD trial
Anne Duncan, Thomas Lamont, Jan Clarkson, Craig Ramsay
Factors affecting recruitment into depression trials: systematic review and meta-synthesis of qualitative evidence
Adwoa Hughes-Morley, Bridget Young, Peter Bower
Systematic review of interventions to increase recruitment and retention of black, minority and ethnic patients into randomised controlled trials
Gulnaz Iqbal, Janet Dunn, Margaret Thorogood
A review of recruitment of children to randomised clinical trials in the NIHR clinical research network portfolio
Geetinder Kaur, Rosalind Smyth, Paula Williamson
Survey of challenges and best practice strategies for participant recruitment to research projects in northern ireland
Lisa Maguire, Mike Clarke
It's all in whom you know (as well as what you know). Using network analysis and health professionals own knowledge for recruitment
Charlene McShane, Olinda Santin, Helen McAneney, Michael Donnelly, Jackie Quinn, Oonagh Sheehy, Liam Murray, Lesley Anderson
Challenges of recruiting elderly patients undergoing cardiac surgery - our experience of recruiting 2500 participants in just 30 months at a single centre
Zoe Plummer, Emma Hopkins, Lucy Culliford, Chris Rogers, Barnaby Reeves, Gavin Murphy, Veerle Verheyden, Andrew Mumford
Building the empire: a multi specialist, multi centre pragmatic trial
Rachel Rikunenko, Julie Dodds, Shakila Thangaratinam
Factors affecting the understanding and retention of the informed consent among participants at an antiretroviral clinical trial in a resource limited setting
Donald Salami
A multimedia intervention to enhance recruitment to clinical trials in primary care and community settings: process of development and evaluation
Peter Bower, David Collier, Sandra Eldridge, Jonathan Graffy, Anne Kennedy, Peter Knapp, Adwoa Hughes-Morley, Jo Rick, Chris Salisbury, Nicola Small, David Torgerson, Shaun Treweek, Peter Wallace
Do NIHR health technology assessment randomised clinical trials perform as well as expected?
Amanda Young, James Raftery, Louise Stanton, Andrew Cook
A mapping and gapping analysis of patient and public involvement in a clinical trials unit
Heather Bagley, Paula Williamson, Carrol Gamble
‘Things often get worse before they get better’: participants’ responses to the cessation of recruitment and trial treatment in a trial of a psychological therapy for people with personality disorder following a safety alert. (A missed opportunity for collaboration?)
Florence Day, Mary McMurran, Lelia Duley
Avoiding waste of research resource: cohort study of publication rate for funded studies from a major UK research funder
Sheila Turner, David Wright, Rebecca Maeso, Andrew Cook, Ruairidh Milne
Mixed methods in evaluating acupuncture and standard care for pregnant women with back pain: ease back
Bernadette Bartlam, Annette Bishop, Melanie Holden, Ismail Khaled, Christine Kettle, Nadine Foster
Qualitative enquiry supporting trials: the 'quest' to integrate qualitative methods in clinical trials
Clare Clement, Frances Rapport
Qualitative research within trials: developing a standard operating procedure for a clinical trials unit
Frances Rapport, Clare Clement
The role of clinical trials units in maximising qualitative research with RCTS
Cindy Cooper, Alicia O'Cathain, Danny Hind, Joy Adamson, Julia Lawton
A surgical feasibility trial from the surgeon's perspective: a qualitative study
Sharon McCann, Jonathan Cook
Using qualitative research within complex interventions: lessons from the podosa (prevention of diabetes and obesity in South Asians) trial
Zoe Morrison, Anne Douglas, Raj Bhopal, Aziz Sheikh
ELCID: early lung cancer identification and diagnosis - an embedded interview study to explore patient participation and recruitment
Hayley Prout, Richard Neal, Kirsty Roberts, Chris Hurt, Trevor Rogers, Willie Hamilton, Rhiannon Tudor Edwards, Angela Todd, David Parker, Emma Thomas Jones, Kerenza Hood, Gareth Griffiths, Allan Barham, Jim Fitzgibbon, Annmarie Nelson
Treatment for femoroacetabular impingement: a qualitative method for exploring equipoise amongst hip arthroscopy surgeons
Peter Wall, Alba Realpe, Damian Griffin, Rachel Hobson, Ann Adams
Practitioner views and experiences of deferred consent in paediatric and neonatal emergency care trials: the connect study
Kerry Woolfall, Lucy Frith, Carrol Gamble, Bridget Young
Analysis of longitudinal oncology quality of life (QoL) data - are we getting it right?
Kim Cocks, Puvan Tharmanathan, Adam Smith
Testing the equivalence of survival distributions using PP- and PPP-plots
Trevor Cox
A new approach to dealing with the analysis of cutpoints in time to event analyses, designed to correct for the over-inflation both of significance levels and of survival differences
Walter Gregory, Susan Burchill
Can follow-up reminders from postal questionnaires help determine the mechanism of missing data in trials?
Ivana Holloway, Amanda Farrin, Anne Forster
Adjusting for informative missing outcome data in clinical trials with longitudinal study designs
Ruwanthi Kolamunnage-Dona, Colin Powel, Paula Williamson
Evaluation of bias and precision in methods of analysis for pragmatic trials with missing outcome data: a simulation study
Royes Joseph, Julius Sim, Reuben Ogollah, Martyn Lewis
Information-theoretic model averaging: a useful method for modelling exploratory secondary endpoints in clinical trials
Daniel Lythgoe
Mediated effect of cognitive behavioural therapy on depression outcomes
Lang'o Odondi, Glyn Lewis, Willem Kuyken, Chris Metcalfe, Nicola Wiles
Applying missing data methods to routine data: a prospective, population-based register of people with diabetes
Stephanie Read, Sarah Wild, Steff Lewis
Does stimulus predict the best candidates for deep brain stimulation for PD?
Caroline Rick, Smitaa Patel, Natalie Ives, Francis Dowling, Jane Daniels, Steven Gill, Crispin Jenkinson, Rosalind Mitchell, Hardev Pall, Niall Quinn, Carl Clarke, TRK Varma, Keith Wheatley, Adrian Williams
Challenges in the development of prognostic models utilising clinical trials data
Kym Snell, Lucinda Billingham, Deborah Stocken, Richard Riley
Statistical modelling of biomarkers incorporating non-proportional effects for survival data
Jacqueline Stephen, Gordon Murray, John Bartlett, David Cameron
Predicting risks and benefits of treatment with aspirin in the acute stage of ischaemic stroke: an analysis of 3 large randomised controlled trials
Douglas Thompson, Gordon Murray, William Whiteley
Clinical course of untreated cerebral cavernous malformations: individual patient data meta-analysis
Margaret Horne, Kelly Flemming, I-Chang Su, Christian Stapf, Robert Brown Jr, Teresa Christianson, Ronit Agid, Karel terBrugge, Robert Willinsky, Susanne Maxwell, Gordon Murray, Rustam Al-Shahi Salman
A mixed treatment comparison of Erlotinib vs. placebo and Erlotinib vs. Geftinib using Bayesian approaches
Iftekhar Khan, Gianluca Baio, Saira Ahmed
Practical methods for ordinal data meta-analysis in stroke
Ashma Krishan, James Weir, Gordon Murray, Brenda Thomas, Peter Sandercock, Steff Lewis
Compliance of randomised controlled trials in trauma surgery with the consort statement: a systematic review
Seon-Young Lee, Penelope Teoh, Christian Camm, Riaz Agha
Inadequate reporting of sample size calculations in cluster randomised trials: a review
Clare Rutterford, Monica Taljaard, Stephanie Dixon, Andrew Copas, Sandra Eldridge
Measuring impact of systematic reviews using individual participant data: evidence from clinical guidelines
Claire Vale, Larysa Rydzewska, Lesley Stewart, Maroeska Rovers, Jonathan Emberson, François Gueyffier
Development of a method for adjusting trial results for biases in meta-analysis
Rebecca Turner, Jelena Savovic, Hayley Jones, Jonathan Sterne, Nicky Welton, Julian Higgins
Meta-analysis of mean differences from randomized trials with nested clustering
Rebecca Walwyn
Using systematic reviews to identify research gaps - a case study: mIBG for the treatment of neuroblastoma in children
Jayne Wilson, Jenny Gains, Veronica Moroz, Mark Gaze, Keith Wheatley
'No collaboration, no trial; why collaborator opinion matters'
Claire Cochran
Trial steering committees for randomised controlled trials: updating and redeveloping guidance and terms of reference informed by current practice and experience
EJ Conroy, S Lewis, A Lane, MR Sydes, J Norrie, G Murray, NL Harman, C Gamble
Developing effective and efficient study specific training to enable rapid study start up
Lynda Constable, Alison McDonald, Cathryn Glazener
The need for speed? Examples from a randomised controlled trial in the emergency setting
Seonaidh Cotton, Tracey Davidson, Nishat Siddiqi, Michael Frenneaux
Minimising bias in an un-masked, pragmatic rct comparing two treatment pathways for glaucoma by the use of decision support software - the light trial experience
Gus Gazzard, Haogang Zhu, Amanda Lewis, Neil Nathwani
Rapid set up of research centres in a trial in an evolving research governance world
Sharon Ruddock, Bipin Bhakta, Amanda Lilley-Kelly, Suzanne Hartley, Lorna Barnard
File notes and breach reports: when are they appropriate?
Alison McDonald, Seonaidh Cotton, John Norrie
Impact of training for site staff recruiting into trials of rare skin diseases: experiences from stop gap and blister
Eleanor Mitchell, Lelia Duley, Hywel Williams, Diane Whitham
Reporting adverse events in a large community-based public health trial (building blocks): what gets reported and how does it vary?
Gwenllian Moody, Eleri Owen-Jones, Rebecca Cannings-John, Carolyn Wallace, Mike Robling, Julia Sanders
Using routinely collected data to enhance long term follow up data: an example from the building blocks trial
Rebecca Cannings-John, Michael Robling
Update on the temper study: targeted monitoring, prospective evaluation and refinement
Sally Stenning, Nicola Joffe, Priyanka Batra, Catrin Jones, Carlos Diaz Montana, Nancy Tappenden, Sarah Meredith
Central statistical monitoring in multicentre clinical trials: developing statistical approaches for analysing key risk indicators
Elsa Valdes-Marquez, Jemma C Hopewell, Jane Armitage, Martin Landray
Streamlining the study start up process
Samantha Wileman, John Norrie
Trial data management: lessons from a large orthopedic trial
Erik Lenguerrand, Vikki Wylde, Rachael Gooberman-Hill, Sian Noble, Elsa Marques, Paul Dieppe, Ashley Blom
The thistle study: a stepped-wedge clustered trial of an intrapartum emergencies training package in Scottish maternity units
Erik Lenguerrand, Graeme MacLennan, Dimitrios Siassakos, Timothy Draycott, Siladitya Bhattacharya, John Norrie
Statistical methodology for recurrent events, with application to major trials in heart failure
Jennifer Rogers, Stuart Pocock