Professor Melanie Calvert PhD

Professor Melanie Calvert

Institute of Applied Health Research
Professor of Outcomes Methodology

Contact details

Address
Primary Care Clinical Sciences
Institute of Applied Health Research
College of Medical and Dental Sciences
Murray Learning Centre
University of Birmingham
Edgbaston
Birmingham
B15 2TT
UK

Melanie Calvert, PhD, Professor of Outcomes Methodology at the University of Birmingham UK, has extensive experience in the design and analysis of clinical trials, trials methodology, systematic reviews, meta-analysis, economic evaluation and epidemiology. Her primary research interests are outcomes research, including the use of composite outcomes and best practice for patient reported outcome assessment in clinical trials and routine practice.

Prof Calvert is Director of the new Centre for PROs Research which aims to optimize the use of PROs in clinical trials and routine care, to improve service delivery, enhance patient care and outcomes and ensure that the patient perspective is at the heart of health research and NHS decision-making. She has a current total grant income in excess of £7 million and is the cross-cutting theme lead for PROs research within major NIHR infrastructure including the Biomedical Research Centre, Surgical Reconstruction and Microbiology Research Centre, Clinical Research Facility (further awards >£25 million) and the Institute for Translational Medicine.

Prof Calvert leads the Health Informatics and Patient Reported Outcomes (PROs) Research Group at the University of Birmingham, is an expert advisor to the NIHR West Midlands Research Design Service (patient reported outcomes/trials methodology), a NIHR CDRF Panellist, was a member of the International Society for Quality of Life Research (ISOQOL) Board of Directors, is co-Chair of the ISOQOL Best Practice for PROs in Clinical Trials Task force and Chairs the Applied Health Research Workstream/is a member of the Scientific Advisory Board within the Institute of Translational Medicine. She has >120 peer reviewed publications in journals including the NEJM, BMJ, JAMA and the Lancet. Her highly cited work has informed European Society of Cardiology guidelines, NICE and EMA guidance, was REF returned and the subject of an Impact Case Study. Prof Calvert works closely with a wide range of national and international collaborators to maximise the reach, influence and impact of her research. She sits on a number of international committees leading national and international strategy for PROs research/implementation.

Qualifications

  • 2006, Fellow of the Higher Education Academy
  • 2006, Postgraduate Certificate in Learning and Teaching in Higher Education, University of Birmingham
  • 2001, PhD (Wellcome Trust Prize student), University of Birmingham,
  • 1997, BSc Biochemistry, 1st class honours, University of Birmingham 

Biography

Melanie Calvert qualified with a BSc (Hons) in Biochemistry from the University of Birmingham in 1997.  She was awarded a Wellcome Trust Prize PhD studentship and graduated in 2001. Since then she has continued to work at the University with expertise in clinical trials, epidemiology, trials methodology and patient-reported outcomes. 

Her work has included the development of the CONSORT-PRO extension published JAMA 2013 (cited 307 times to-date) for which she was awarded the ISOQOL Emerging Leader Award. More recent work includes publications on the conduct of PRO assessment within trials (PLOS One), issues surrounding ‘PRO Alerts’ (JAMA viewpoint, PLOS One) and PROs in Big data (JRSM). Prof Calvert has worked on a number of clinical trials, most notably the Cardiac REychronisation in Heart Failure Trial (which demonstrated significant improvements in symptoms, quality of life and survival in patients receiving CRT). More recently she has led the statistical analysis of the HINGE trial, published in Circulation, the HYPER Trial (Eur J Cardiothorac Surg) and the ROSSINI trial (BMJ).

In addition Prof Calvert has led (as PI) a number of successful epidemiological studies assessing the management of diabetes and heart failure in primary care. The results have been published in major journals most notably work on the impact of the quality outcomes framework on the management of diabetes which was published in the BMJ in 2009, to date cited 138 times. Currently Prof Calvert is leading the development of a core outcome set within the NIHR funded PARTNERS2 programme grant, outcome selection/trials methodology within the NIHR funded Bluebelle, Pegasus and IMPRESS-AF studies, the development of the SPIRIT-PRO extension (Lancet comment/funder Macmillan) and ePRO development within routine practice (funded by Health Foundation/NIHR and charities).

Teaching

Prof Calvert was awarded a University of Birmingham Award for Excellence in Teaching & Supporting Learning in 2013 for her role as a Director of Graduate Studies for the School of Health and Population Sciences (2011-2014). She is a Fellow of the Higher Education Academy, led the MPH clinical trials module and undertakes medical education research with the aim of providing evidence to inform curriculum development and enhance student learning. She is an experienced PhD supervisor (currently supervising 6 students); supervised 7 to successful completion and provides training in trials methodology and quality of life to undergraduates, postgraduates, clinicians, policy makers and members of industry.

Teaching Programmes

  • Masters Public Health (Clinical Trials/Projects)
  • BCTU Research Methods Course (quality of life)
  • Clinical Oncology MSc/Diploma(quality of life)
  • CPD Training on PROs – please see PROlearn for latest dates

Postgraduate supervision

Professor Calvert is interested in supervising doctoral researchers on the following subjects:

  • Outcomes Research
  • Patient reported outcomes in clinical trials or routine practice.

Current students

  • Samantha Cruz-Rivera   
  • Olalekan Lee Aiyegbusi
  • Mohammad Tallouzi
  • Janet Jones
  • Rebecca Mercieca-Bebber (University of Sydney)
  • Nicola Anderson

Graduated students

  • Studentships will be advertised when available; however if you are interested in studying for a PhD focused on PROs please contact the team directly. For any general doctoral research enquiries, please email: dr@contacts.bham.ac.uk or call +44 (0)121 414 5005.

Research

Professor Calvert leads a programme of research within the Centre for PROs Research focused on:

  1. Best Practice for PROs in Trials
  2. Applied PROs Research
  3. PROs in Routine Clinical Practice.

For further information on the research programme and current projects please see the Centre website.

Other activities

  • Director of the University of Birmingham Centre for Patient-Reported Outcomes Research (CPROR) which aims to optimize the use of PROs in clinical trials and routine care, to improve service delivery, enhance patient care and outcomes and ensure that the patient perspective is at the heart of health research and NHS decision-making. The centre is a strategic partnership between the University of Birmingham, University Hospitals NHS Foundation Trust, patient advocates and comprises >60 members working in partnership with international collaborators to maximise the reach, influence and impact of the research.
  • Contributing to the leadership of major NIHR infrastructure and to Birmingham Health partners through strategic management roles including:

              - Institute of Translational Medicine (ITM) Strategic Advisory Committee

               - Applied Health Research Workstream Lead for the ITM

               - D3B ITM Management Group

               - University of Birmingham PPI Strategy Group

               - Institute of Applied Health Research (IAHR) Senior Executive Committee and Research Committee.

  •  Director International Society of Quality of Life Research (ISOQOL) Board (term 2013-2016). 
  • Chair of the Best Practice for PROs in Trials Taskforce and Chair elect ISOQOL Standards and Best Practice Committee. co-Chairs two international taskforces focused on best practice for PROs in trials and Chair elect Standards and Best Practice Committee for the Society which aims to develop international standards for PROs in research and routine clinical practice. In this role have led the development of ISOQOL Reporting Standards for PROs in Trials, the CONSORT-PRO extension and the SPIRIT-PRO extension.
  • Chair International Society of Quality of Life Research Taskforce leading the response to the European Medicines Agency Reflection Paper on the use of patient reported outcome (PRO) measures in oncology studies.   Submitted to the EMA – report available on the ISOQOL website, paper published in Quality of Life Research. Suggestions made in this response have subsequently been incorporated into the EMA guidelines on the evaluation of anticancer medicinal products, 2016.
  • Winner of two North American Primary Care Group (NAPCRG) Pearl awards in 2015 (out of 10 awarded internationally from over 350 entries) and a Distinguished Paper Award for doctoral research which I supervised (Grace Turner). NAPCRG Pearls are awarded to teams whose research is judged ‘most likely to have significant impact on clinical practice’. Grace’s work was recently published in Plos Medicine and was reported in the press including the Times and Telegraph.
  • International Consortium Member: Setting International Standards in Analyzing Quality of Life (SISAQOL) This international consortium aims to develop internationally endorsed recommendations to standardize the analysis of PRO data from cancer clinical trials to improve the quality of PRO data available to inform labelling claims, clinical practice and health policy. The consortium include: leading international PROs researchers, journal editors, regulators (MHRA, FDA, EMA) and funders and our work is described in a recent article published in Lancet Oncology. 
  • International Rare Disease Research Consortium Taskforce Member.  In this role I have contributed to a Report on Patient-Centered Outcome Measures Initiatives in the Field of Rare Diseases, Feb 2016 which aims to identify actions to accelerate the development and validation of patient centred outcome measures for rare disease.
  • Expert advisor international clinical societies. Internationally recognised as a leading expert in PRO methodology -member of the:
            • United States National Institute for Health/NIC education advisory committee on PROs Best Practices for Integrating PROs in Oncology Clinical Trials Taskforce – webinar released November 2015.
            • European Society of Cardiology working group – author of ESC position paper calling for the comprehensive integration of PROs in cardiovascular trials/ongoing collaboration (Published 2014, cited 69 times to date).
            • Advisor to the German Atrial Fibrillation Network (AFNET). Invited speaker/writing committee and workshop lead at the 5th joint consensus conference of AFNET and the European Heart Rhythm Association (EHRA) Understanding and eliminating inequalities and barriers that prevent optimal treatment of atrial fibrillation published in Europace, 2015.
  • External consultant: pharmaceutical industry I provide advice to a number of companies on their drug development programmes and have developed a new collaboration with the Association of the British Pharmaceutical Industry regarding use of PROs in the big data agenda/medicine adherence. Invited speaker European Epidemiological Forum, Berlin Oct 2015 Patient Centricity in Real-World Data.
  • Expert advisor on PROs for patient advocates. Provided training on PROs to ~60 patient advocates from across Europe at the European Federation of Neurological Associations Patient Advocates meeting 2016.  Member of steering committee for a Strategy in Patient Orientated Research Grant in Ontario advising on PRO training for patient advocates.

Publications

>120 publications in journals including NEJM, Plos Medicine, the BMJ, JAMA and the Lancet

SELECTED PUBLICATIONS

Derek Kyte, Paul Cockwell, Mauro Lencioni, Magdalena Skybrant, Maria von Hildebrand, Gary Price, Katie Squire, Shena Webb, Olivia Brooks, Hilary Fanning, Tim Jones, Melanie Calvert*. Reflections on the National Patient-Reported Outcome Measures (PROMs) Programme: where do we go from here? Journal Royal Society Medicine vol. 109, 12: pp. 441-445. First Published December 6, 2016.

Turner GM, Calvert M, Feltham MG, Ryan R, Fitzmaurice D, Cheng KK, Marshall T. Under-prescribing of Prevention Drugs and Primary Prevention of Stroke and Transient Ischaemic Attack in UK General Practice: A Retrospective Analysis. PLoS Med. 2016 Nov 15;13(11):e1002169. doi: 10.1371/journal.pmed.1002169. PubMedPMID: 27846215.

Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, Campbell A, Cleland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro J, O'Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Taphoorn MJ, Velikova G, Coens C; Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) consortium.. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards. Lancet Oncol. 2016 Nov;17(11):e510-e514. doi: 10.1016/S1470-2045(16)30510-1. Review. PubMed PMID: 27769798.

Mercieca-Bebber R, Palmer MJ, Brundage M, Calvert M, Stockler MR, King MT. Design, implementation and reporting strategies to reduce the instance and impact of missing patient-reported outcome (PRO) data: a systematic review. BMJ Open. 2016 Jun 15;6(6):e010938. doi: 10.1136/bmjopen-2015-010938. PubMed PMID: 27311907; PubMed Central PMCID: PMC4916640.

Kyte D, Ives J, Draper H, Calvert M*. Management of Patient-Reported Outcome (PRO) Alerts in Clinical Trials: A Cross Sectional Survey. PLoS One. 2016 Jan 19;11(1):e0144658.

Kyte D, Reeve BB, Efficace F, Haywood K, Mercieca-Bebber R, King MT, Norquist JM, Lenderking WR, Snyder C, Ring L, Velikova G, Calvert M*.International Society for Quality of Life Research commentary on the draft European Medicines Agency reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies. Qual Life Res. 2015 Aug 15. 

Calvert M*, Thwaites R, Kyte D, Devlin N. Putting patient-reported outcomes on the 'Big Data Road Map'. J R Soc Med. 2015 Mar 31. pii: 0141076815579896. [Epub ahead of print] PubMed PMID: 25827908.

Calvert M*, Kyte D, von Hildebrand M, King M, Moher D. Putting patients at the heart of health-care research. Lancet. 2015 Mar 21;385(9973):1073-4. doi:10.1016/S0140-6736(15)60599-2. PubMed PMID: 25797557.

Calvert M*, Kyte D, Duffy H, Gheorghe A, Mercieca-Bebber R, Ives J, Draper H, Brundage  M,  Blazeby J, King M Patient-Reported Outcome (PRO) Assessment in Clinical Trials: A Systematic Review of Guidance for Trial Protocol Writers. PLoS One. 2014 Oct 15;9(10):e110216. doi: 10.1371/journal.pone.0110216. eCollection 2014. PMID: 25333995. 

Anker SD,  Agewall S, Borggrefe M, Calvert M, Caro J, Cowie MR, Ford I, Paty JA, Riley JP, Swedberg K, Tavazzi L, Wiklund I, Kirchhof P The Importance of Patient Reported Outcomes:  A Call for Their Comprehensive Integration in Cardiovascular Clinical Trials.  Eur Heart J. 2014 Aug 7;35(30):2001-9. doi: 10.1093/eurheartj/ehu205. Epub 2014 Jun 5. Review. PubMed PMID: 24904027.

Kyte D, Draper H, Calvert M*. Patient Reported Outcome Alerts: Ethical and Logistical Considerations in Clinical Trials. JAMA. 2013 Sep 25;310(12):1229-30. doi: 10.1001/jama.2013.277222. PubMed PMID: 24065005.

Pinkney TD, Calvert M, Bartlett DC, Gheorghe A, Redman V, Dowswell G, Hawkins W, Mak T, Youssef H, Richardson C, Hornby S, Magill L, Haslop R, Wilson S, Morton D; West Midlands Research Collaborative and the ROSSINI Trial Investigators. Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial). BMJ. 2013 Jul 31;347:f4305. doi: 10.1136/bmj.f4305.

Calvert M, Blazeby J , Altman D , Revicki D , Moher D, Brundage M for the CONSORT PRO Group. Improving the Reporting of Patient Reported Outcomes in Randomised Trials: the CONSORT PRO Extension. JAMA 2013; 309 (8) 814-822

Calvert  M*, Wood J, Freemantle N. Designing Real World Trials for Health Policy and Reimbursement J Clin Epidemiol. 2011 Jul;64(7):711-7. Epub 2011 Mar 31.

Calvert MJ*, Freemantle N, Yao G, Cleland JG, Billingham L, Daubert JC, Bryan S; CARE-HF investigators.   Cost-effectiveness of cardiac resynchronization therapy: results from the CARE-HF trial. Eur Heart J. 2005 Dec;26(24):2681-8. Epub 2005 Nov 11.

Calvert MJ*, Freemantle N, Cleland JG.  The impact of chronic heart failure on health-related quality of life data acquired in the baseline phase of the CARE-HF study.  European Journal of Heart Failure. 2005 Mar 2;7(2):243-51.

Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C. Composite outcomes in randomized trials: greater precision but with greater uncertainty? Journal American Medical Association. 2003 May 21;289(19):2554-9.