Katie Biggs

All publications

Journal articles

• Bageta ML, López-Balboa P, Dimairo M, Glover R, Hutchence K, Papaioannou D, Cooper C, Biggs K, Tappenden P, Ennis K , Ogboli M et al (2025) Mesenchymal intravenous stromal cell infusions in children with recessive dystrophic epidermolysis bullosa: MissionEB protocol for a randomised, double-blinded, placebo-controlled, two-centre, crossover trial with an internal phase I dose de-escalation phase and open-label extension. BMJ Open, 15(5). View this article in WRRO
• Biggs K, Hullock K, Dix C, Lane JA, Green H, Treweek S, Shiely F, Shepherd V, Willis A, Isaacs T & Cooper C (2024) Time to STEP UP: methods and findings from the development of guidance to help researchers design inclusive clinical trials. BMC Medical Research Methodology, 24(1), 227.
• Hawksworth O, Chatters R, Julious S, Cook A, Biggs K, Solaiman K, Quah MCH & Cheong SC (2024) A methodological review of randomised n-of-1 trials. Trials, 25(1). View this article in WRRO
• Biggs K, Dix C, Shiely F, Treweek S, Shepherd V, Lane A, Green H, Isaacs T, Willis A & Cooper C (2024) Effective interventions to increase representation of under-served groups in randomised trials in UK and Ireland: a scoping literature review. NIHR Open Research, 4(12). View this article in WRRO
• Chatters R, Dimairo M, Cooper C, Ditta S, Woodward J, Biggs K, Ogunleye D, Thistlethwaite F, Yap C & Rothman A (2024) Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives. BMJ Open, 14(3). View this article in WRRO
• Kingsley E, Biggs K, Solaiman K, Packham A, Nekooi R, Bursnall M, McKendrick K, Cooper CL & Wright B (2024) Implementation successes and lessons learnt from a randomised controlled trial of a complex school-based intervention. Research Methods in Medicine & Health Sciences. View this article in WRRO
• Bolt R, Hyslop MC, Herbert E, Papaioannou DE, Totton N, Wilson MJ, Clarkson J, Evans C, Ireland N, Kettle J , Marshman Z et al (2023) The MAGIC trial: a pragmatic, multicentre, parallel, noninferiority, randomised trial of melatonin versus midazolam in the premedication of anxious children attending for elective surgery under general anaesthesia. British Journal of Anaesthesia. View this article in WRRO
• Wright B, Kingsley E, Cooper C, Biggs K, Bursnall M, Wang H-I, Chater T, Coates E, Teare MD, McKendrick K , Gomez de la Cuesta G et al (2023) Play brick therapy to aid the social skills of children and young people with autism spectrum disorder: the I-SOCIALISE cluster RCT. Public Health Research, 11(12). View this article in WRRO
• Totton N, Julious SA, Coates E, Hughes DA, Cook JA, Biggs K, Hewitt C, Day S & Cook A (2023) Appropriate design and reporting of superiority, equivalence and non-inferiority clinical trials incorporating a benefit–risk assessment: the BRAINS study including expert workshop. Health Technology Assessment, 27(20). View this article in WRRO
• Bageta ML, Balboa PL, Glover R, Cooper C, Papaioannou DE, Julious S, Dimairo M, Biggs K, Petrof G & Martinez AE (2023) O08 Mesenchymal stromal cells infusions in children with recessive dystrophic epidermolysis bullosa (MissionEB): a randomized controlled trial. British Journal of Dermatology, 189(3), e42-e43.
• Tindall L, Scott AJ, Biggs K, Hayward E, Wilson J, Cooper C, Hargate R, Wright B & Gega L (2022) The alleviating specific phobias in children trial: challenges and solutions to implementing a randomized controlled trial in clinical services. Frontiers in Child and Adolescent Psychiatry, 1. View this article in WRRO
• Love SB, Yorke-Edwards V, Ward E, Haydock R, Keen K, Biggs K, Gopalakrishnan G, Marsh L, O’Sullivan L, Fox L , Payerne E et al (2022) What is the purpose of clinical trial monitoring?. Trials, 23(1). View this article in WRRO
• Wright B, Tindall L, Scott AJ, Lee E, Biggs K, Cooper C, Bee P, Wang H-I, Gega L, Hayward E , Solaiman K et al (2022) One-session treatment compared with multisession CBT in children aged 7–16 years with specific phobias: the ASPECT non-inferiority RCT. Health Technology Assessment, 26(42).
• Hayward E, Solaiman K, Bee P, Barr A, Edwards H, Lomas J, Tindall L, Scott AJ, Biggs K & Wright B (2022) One-session treatment for specific phobias: barriers, facilitators and acceptability as perceived by children & young people, parents, and clinicians. PLOS ONE, 17(9), e0274424-e0274424. View this article in WRRO
• Hasan M, Bath PA, Marincowitz C, Sutton L, Pilbery R, Hopfgartner F, Mazumdar S, Campbell R, Stone T, Thomas B , Bell F et al (2022) Pre-hospital prediction of adverse outcomes in patients with suspected COVID-19 : development, application and comparison of machine learning and deep learning methods. Computers in Biology and Medicine, 151, Part A. View this article in WRRO
• Dawson S, Banister K, Biggs K, Cotton S, Devane D, Gardner H, Gillies K, Gopalakrishnan G, Isaacs T, Khunti K , Nichol A et al (2022) Trial Forge Guidance 3 : randomised trials and how to recruit and retain individuals from ethnic minority groups—practical guidance to support better practice. Trials, 23(1). View this article in WRRO
• Wason JMS, Dimairo M, Biggs K, Bowden S, Brown J, Flight L, Hall J, Jaki T, Lowe R, Pallmann P , Pilling MA et al (2022) Practical guidance for planning resources required to support publicly-funded adaptive clinical trials. BMC Medicine, 20(1). View this article in WRRO
• Wright B, Tindall L, Scott AJ, Lee E, Cooper C, Biggs K, Bee P, Wang H, Gega L, Hayward E , Solaiman K et al (2022) One session treatment (OST) is equivalent to multi‐session cognitive behavioral therapy (CBT) in children with specific phobias (ASPECT) : results from a national non‐inferiority randomized controlled trial. Journal of Child Psychology and Psychiatry. View this article in WRRO
• Marincowitz C, Stone T, Hasan M, Campbell R, Bath PA, Turner J, Pilbery R, Thomas BD, Sutton L, Bell F , Biggs K et al (2022) Accuracy of emergency medical service telephone triage of need for an ambulance response in suspected COVID-19 : an observational cohort study. BMJ Open, 12(5). View this article in WRRO
• Barr A, Coates E, Kingsley E, Cuesta GG, Biggs K, Le Couteur A & Wright B (2022) A mixed methods evaluation of the acceptability of therapy using LEGO® bricks (LEGO® based therapy) in mainstream primary and secondary education. Autism Research. View this article in WRRO
• Marincowitz C, Stone T, Bath P, Campbell R, Turner JK, Hasan M, Pilbery R, Thomas BD, Sutton L, Bell F , Biggs K et al (2022) Accuracy of telephone triage for predicting adverse outcomes in suspected COVID-19: an observational cohort study. BMJ Quality and Safety. View this article in WRRO
• Marincowitz C, Sutton L, Stone T, Pilbery R, Campbell R, Thomas B, Turner J, Bath PA, Bell F, Biggs K , Hasan M et al (2022) Prognostic accuracy of triage tools for adults with suspected COVID-19 in a prehospital setting : an observational cohort study. Emergency Medicine Journal. View this article in WRRO
• Wang H-I, Wright BD, Bursnall M, Cooper C, Kingsley E, Le Couteur A, Teare D, Biggs K, McKendrick K, de la Cuesta GG , Chater T et al (2022) Cost-utility analysis of LEGO based therapy for school children and young people with autism spectrum disorder: results from a randomised controlled trial.. BMJ Open, 12(1). View this article in WRRO
• Wilson N, Biggs K, Bowden S, Brown J, Dimairo M, Flight L, Hall J, Hockaday A, Jaki T, Lowe R , Murphy C et al (2021) Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project. BMC Medicine, 19(1). View this article in WRRO
• Marincowitz C, Sutton L, Stone T, Pilbery R, Campbell R, Thomas B, Turner J, Bath PA, Bell F, Biggs K , Hasan M et al (2021) Prognostic accuracy of triage tools for adults with suspected COVID-19 in a pre-hospital setting: an observational cohort study. View this article in WRRO
• Goodacre S, Thomas B, Sutton L, Burnsall M, Lee E, Bradburn M, Loban A, Waterhouse S, Simmonds R, Biggs K , Marincowitz C et al (2021) Derivation and validation of a clinical severity score for acutely ill adults with suspected COVID-19: The PRIEST observational cohort study. PLoS ONE, 16(1). View this article in WRRO
• Totton N, Julious S, Hughes D, Cook J, Biggs K, Coates L, Cook A, Hewitt C & Day S (2021) Utilising benefit-risk assessments within clinical trials—a protocol for the BRAINS project. Trials, 22. View this article in WRRO
• Goodacre S, Thomas B, Lee E, Sutton L, Loban A, Waterhouse S, Simmonds R, Biggs K, Marincowitz C, Schutter J , Connelly S et al (2020) Post-exertion oxygen saturation as a prognostic factor for adverse outcome in patients attending the emergency department with suspected COVID-19: a substudy of the PRIEST observational cohort study. Emergency Medicine Journal. View this article in WRRO
• Goodacre S, Thomas B, Lee E, Sutton L, Loban A, Waterhouse S, Simmonds R, Biggs K, Marincowitz C, Schutter J , Connelly S et al (2020) Characterisation of 22445 patients attending UK emergency departments with suspected COVID-19 infection : observational cohort study. PLoS ONE, 15(11), ---. View this article in WRRO
• Goodacre S, Thomas B, Lee E, Sutton L, Loban A, Waterhouse S, Simmonds R, Biggs K, Marincowitz C, Schutter J , Connelly S et al (2020) Characterisation of 22446 patients attending UK emergency departments with suspected COVID-19 infection: Observational cohort study. View this article in WRRO
• Peasgood T, Bhardwaj A, Brazier JE, Biggs K, Coghill D, Daley D, Cooper CL, De Silva C, Harpin V, Hodgkins P , Nadkarni A et al (2020) What Is the health and well-being burden for parents living with a child with ADHD in the United Kingdom?. Journal of Attention Disorders. View this article in WRRO
• Dimairo M, Pallmann P, Wason J, Todd S, Jaki T, Julious SA, Mander AP, Weir CJ, Koenig F, Walton MK , Nicholl JP et al (2020) The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. Trials, 21(1). View this article in WRRO
• Dimairo M, Pallmann P, Wason J, Todd S, Jaki T, Julious SA, Mander AP, Weir CJ, Koenig F, Walton MK , Nicholl JP et al (2020) The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. BMJ, 369. View this article in WRRO
• Biggs K, Hind D, Gossage-Worrall R, Sprange K, White D, Wright J, Chatters R, Berry K, Papaioannou D, Bradburn M , Walters SJ et al (2020) Challenges in the design, planning and implementation of trials evaluating group interventions. Trials, 21. View this article in WRRO
• Biggs K, Hind D, Bradburn M, Swaby L & Brown S (2019) Design, planning and implementation lessons learnt from a surgical multi-centre randomised controlled trial. Trials, 20(1). View this article in WRRO
• Varley D, Wright B, Cooper C, Marshall D, Biggs K, Ali S, Chater T, Coates E, Gilbody S, de la Cuesta GG , Kingsley E et al (2019) Investigating SOcial Competence and Isolation in children with Autism taking part in LEGO-based therapy clubs In School Environments (I-SOCIALISE) : study protocol. BMJ Open, 9(5). View this article in WRRO
• Dimairo M, Coates E, Pallmann P, Todd S, Julious SA, Jaki T, Wason J, Mander AP, Weir CJ, Koenig F , Walton MK et al (2018) Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design. BMC Medicine, 16. View this article in WRRO
• Wright BD, Cooper C, Scott AJ, Tindall L, Ali S, Bee P, Biggs K, Breckman T, Davis TE, Gega L , Hargate RJ et al (2018) Clinical and cost-effectiveness of one-session treatment (OST) versus multisession cognitive-behavioural therapy (CBT) for specific phobias in children: Protocol for a non-inferiority randomised controlled trial. BMJ Open, 8(8). View this article in WRRO
• Alshreef A, Wailoo AJ, Brown SR, Tiernan JP, Watson AJM, Biggs CE, Bradburn M & Hind D (2017) Cost-Effectiveness of Haemorrhoidal Artery Ligation versus Rubber Band Ligation for the Treatment of Grade II–III Haemorrhoids: Analysis Using Evidence from the HubBLe Trial. PharmacoEconomics Open. View this article in WRRO
• Brown S, Tiernan J, Biggs K, Hind D, Shephard N, Bradburn M, Wailoo A, Alshreef A, Swaby L, Watson A , Radley S et al (2016) The HubBle trial: Haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for symptomatic second- and third-degree haemorrhoids: A multicentre randomized controlled trial and health-economic evaluation. Health Technology Assessment, 20(88), 1-180. View this article in WRRO
• Peasgood T, Bhardwaj A, Biggs K, Brazier JE, Coghill D, Cooper CL, Daley D, De Silva C, Harpin V, Hodgkins P , Nadkarni A et al (2016) The impact of ADHD on the health and well-being of ADHD children and their siblings. European Child & Adolescent Psychiatry, 25(11), 1217-1231. View this article in WRRO
• Brown SR, Tiernan JP, Watson AJM, Biggs K, Shephard N, Wailoo AJ, Bradburn M, Alshreef A & Hind D (2016) Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial. The Lancet, 388(10042), 356-364. View this article in WRRO
• Campbell F, Biggs K, Aldiss SK, O'Neill PM, Clowes M, McDonagh J, While A & Gibson F (2016) Transition of care for adolescents from paediatric services to adult health services. Cochrane Database of Systematic Reviews, 2016(4). View this article in WRRO
• Biggs K & Cooper C (2015) Use of home visits increases data completion and retention in studies involving family members. Trials, 16(S2).
• Tiernan J, Hind D, Watson A, Wailoo AJ, Bradburn M, Shephard N, Biggs K & Brown S (2012) The HubBLe trial: haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for haemorrhoids. BMC Gastroenterology, 12(1). View this article in WRRO
• Wright B, Kingsley E, Cooper C, Biggs K, Bursnall M, Wang H-I, Chater T, Coates E, Teare MD, McKendrick K , Gomez de la Cuesta G et al () I-SOCIALISE: Results from a cluster randomised controlled trial investigating the social competence and isolation of children with autism taking part in LEGO® based therapy (‘Play Brick Therapy’) clubs in school environments. Autism. View this article in WRRO
• Dawson S, Banister K, Biggs K, Cotton S, Devane D, Gardner H, Gillies K, Gopalakrishnan G, Isaacs T, Khunti K , Nichol A et al () Correction: Trial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups—practical guidance to support better practice. Trials, 23(1).
• Wang H-I, Wright B, Tindall L, Cooper C, Biggs K, Lee E, Teare MD, Gega L, Scott AJ, Hayward E , Solaiman K et al () Cost and effectiveness of one session treatment (OST) for children and young people with specific phobias compared to multi-session cognitive behavioural therapy (CBT): results from a randomised controlled trial. BMC Psychiatry, 22(1). View this article in WRRO
• Thomas B, Goodacre S, Lee E, Sutton L, Bursnall M, Loban A, Waterhouse S, Simmonds R, Biggs K, Marincowitz C , Schutter J et al () Prognostic accuracy of emergency department triage tools for adults with suspected COVID-19: the PRIEST observational cohort study. Emergency Medicine Journal.
• Cox M, O’Connor C, Biggs K, Hind D, Bortolami O, Franklin M, Collins B, Walters S, Wailoo A, Channell J , Albert P et al () The feasibility of early pulmonary rehabilitation and activity after COPD exacerbations: external pilot randomised controlled trial, qualitative case study and exploratory economic evaluation. Health Technology Assessment, 22(11), 1-204. View this article in WRRO

Chapters

• Campbell F, Aldiss S & Biggs K (2020) Transition of Care for Adolescents from Child to Adult Health Services: A Systematic Review, Transition from Pediatric to Adult Healthcare Services for Adolescents and Young Adults with Long-term Conditions (pp. 147-169). Springer International Publishing

Conference proceedings papers

• Dimairo M, Pallmann P, Wason J, Todd S, Jaki T, Julious SA, Mander AP, Weir CJ, Koenig F, Walton MK , Nicholl JP et al (2019) Introducing the adaptive designs CONSORT extension (ACE) statement to improve reporting of randomised trials that use an adaptive design. Trials, Vol. 20(Supplement 1) (pp 2-3). Brighton, UK, 6 October 2019 - 9 October 2019. View this article in WRRO

Posters

• Biggs K, Hind D, Gossage-Worrall R, Sprange K, White D, Wright J, Chatters R, Berry K, Papaioannou D, Bradburn M , Walters SJ et al (2019) Challenges in the design, planning and implementation of trials evaluating group interventions. View this article in WRRO
• Biggs K, Hind D, Bradburn M, Swaby L & Brown S (2019) Lessons learnt from a multi-centre Type 3 surgical trial. View this article in WRRO
• Cox M, hind D, biggs C, O'Connor C, Channell J, Hughes R & Albert P (2016) The PRACTICE trial: Pulmonary Rehabilitation and ACTIvity after COPD Exacerbations. COPD10.

Other

• McDonagh JE, Farre A, Aldiss S, Biggs K & Campbell F () Adding to the transitional care evidence base for future national guidance. BMJ, i3710-i3710.

Preprints

• Hawksworth O, Chatters R, Julious SA, Cook A, Biggs K & Solaiman K (2023) A Methodological Review of Randomised n-of-1 Trials., Research Square Platform LLC.
• Love SB, Yorke-Edwards V, Ward E, Haydock R, Keen K, Biggs K, Gopalakrishnan G, Marsh L, O'Sullivan L, Fox L , Payerne E et al (2022) What is the purpose of Clinical Trial Monitoring?, Research Square Platform LLC.
• Dawson S, Banister K, Biggs K, Cotton S, Devane D, Gardner H, Gillies K, Gopalakrishnan G, Isaacs T, Khunti K , Nichol A et al (2022) Trial Forge Guidance 3: Randomised trials and how to recruit and retain individuals from ethnic minority groups– practical guidance to support better practice, Center for Open Science.
• Marincowitz C, Stone T, Hasan M, Campbell R, Bath PA, Turner J, Pilbery R, Thomas B, Sutton L, Bell F , Biggs K et al (2021) Accuracy of emergency medical service telephone triage of need for an ambulance response in suspected COVID-19: An observational cohort study, Cold Spring Harbor Laboratory.
• Marincowitz C, Stone T, Bath P, Campbell R, Turner J, Hussein M, Pilbery R, Thomas B, Sutton L, Bell F , Biggs K et al (2021) Accuracy of telephone triage for predicting adverse outcome in suspected COVID-19: An observational cohort study, Cold Spring Harbor Laboratory.
• Totton N, Julious S, Hughes D, Cook J, Biggs K, Coates L, Cook A, Hewitt C & Day S (2020) Utilising Benefit-Risk Assessments within Clinical Trials – A Protocol for the BRAINS project, Research Square Platform LLC.
• Goodacre S, Thomas B, Sutton L, Bursnall M, Lee E, Bradburn M, Loban A, Waterhouse S, Simmonds R, Biggs K , Marincowitz C et al (2020) Derivation and validation of a clinical severity score for acutely ill adults with suspected COVID-19: The PRIEST observational cohort study, Cold Spring Harbor Laboratory.
• Dimairo M, Pallmann P, Wason J, Todd S, Jaki T, Julious S, Mander A, Weir C, Koenig F, Walton M , Nicholl J et al (2019) The Adaptive designs CONSORT Extension (ACE) Statement: A checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design, Research Square.
• Hasan M, Bath P, Marincowitz C, Sutton L, Pilbery R, Hopfgartner F, Mazumdar S, Campbell R, Stone T, Benjamin T , Bell F et al () Pre-Hospital Prediction of Adverse Outcomes in Patients with Suspected COVID-19: Development, Application and Comparison of Machine Learning and Deep Learning Methods. View this article in WRRO
• Totton N, Julious S, Hughes D, Cook J, Biggs K, Coates L, Cook A, Hewitt C & Day S () Utilising Benefit-Risk Assessments within Clinical Trials – A Protocol for the BRAINS project, Research Square Platform LLC.
• Thomas B, Goodacre S, Lee E, Sutton L, Loban A, Waterhouse S, Simmonds R, Biggs K, Marincowitz C, Schutter J , Connelly S et al () Prognostic accuracy of emergency department triage tools for adults with suspected COVID-19: The PRIEST observational cohort study, Cold Spring Harbor Laboratory.
• Biggs K, Thomas B, Goodacre S, Lee E, Sutton L, Bursnall M, Loban A, Waterhouse S, Simmonds R, Marincowitz C , Schutter J et al () Prognostic accuracy of emergency department triage tools for children with suspected COVID-19: The PRIEST observational cohort study, Cold Spring Harbor Laboratory.
• Totton N, Julious S, Hughes D, Cook J, Biggs K, Coates L, Cook A, Hewitt C & Day S () Utilising Benefit-Risk Assessments within Clinical Trials – A Protocol for the BRAINS project, Research Square Platform LLC.