Welcome to the Centre for Biostatistics...
Transcript of Welcome to the Centre for Biostatistics...
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Welcome to the Centre for Biostatistics Showcase
Weds 3rd May 2017
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Programme
13:40 Prof Richard Emsley “The Clinical Trials Unit”
13:50 Dr Jamie Sergeant “The Manchester Musculoskeletal Biomedical Research Unit”
14:00 Dr Sarah Cotterill “Working with the NIHR CLAHRC Greater Manchester”
14:10 “What we do” Session 1:
Matthew Gittins, Liz Howarth, Jack Wilkinson, Calvin Heal
14:30 Tea and Coffee
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Programme
14:50 Prof Andy Vail “The Biostatistics Collaboration Unit”
15:00 Dr David Reeves “The National School of Primary Care Research”
15:10 Prof Carlo Berzuini “Causal inference and its use in biomedical research”
15:20 Dr Matthias Pierce “The North West Hub for Trials Methodology Research”
15:30 Sarah Rhodes “The Research Design Service”
15:40 “What we do” Session 2:
Antonia Marsden, Fiona Holland, Stephen Pye, Hui Guo
16:00 End
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Manchester Academic Health Science
Centre Trials Co-ordination Unit (CTU)
Professor Richard Emsley Deputy Director, MAHSC CTU Centre for Biostatistics, School of Health Sciences
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What is the MAHSC CTU?
• Hosted by Christie NHS Trust since 2000
– Relocating to University by end 2017
• Funding from:
– MAHSC partners
– National Institute for Health Research CTU Support Funding
– University of Manchester (£1.2m)
– Health Innovation Manchester (£370k)
• New management team and structure
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UK Clinical Trials Units
• Specialist units with a specific remit to design, conduct, analyse and publish clinical trials & other well-designed studies
• Currently 50 registered CTUs (46 Full/4 provisional)
www.ukcrc-ctu.org.uk
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Pre Trial
• Statistics & Methodology
• Feasibility
• Budget
• Timely submission to Fun and constitution of IDSMC & TSC
• Liaison with Sponsor
• Trial supplies
Set-up
• Protocol development
• Coordinate meetings of oversight committees
• Liaise with sponsor
• Management of trial supplies
• CRF and database development
• Trial approval – ethical, institutional
• Establish/maintain Essential Documents centrally
• Site initiation and ongoing communication
Recruitment and follow-up • Primary contact
• Safety monitoring/ reporting
• Progress reports, amendment notification
• Monitor accrual
• Database support, data query resolution
• Interim and final analysis
• Reports for oversight committees
• Notification of the end of the trial
• Archiving arrangements
What does a CTU do?
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Biostatistics input into CTU
• Trial design options
• Sample size/power
• Statistical analysis plans
• Statistical analysis
• Report during the trial
• Our model is to cost a senior and junior
statistician in each proposal
• Contact us as early as possible!
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Areas of statistical expertise
1. Early phase oncology trials
– New Senior Lecturer in Clinical Trial Statistics
2. Efficacy and mechanisms evaluation
– Causal inference methods
– Precision medicine
3. Health Technology Assessment
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Find out more at:
http://www.mahsc.ac.uk/
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The NIHR Manchester Musculoskeletal
Biomedical Research Unit (BRU)
…and other stories
Jamie Sergeant
Lecturer in Biostatistics
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Contents
• About me
• NIHR Manchester Musculoskeletal Biomedical
Research Unit (BRU)
• NIHR Manchester Biomedical Research Centre
(BRC)
• Biostatistics teaching and learning
…all with a focus on collaboration
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About me
• Training in Maths and Statistics
• Qualified teacher
• Experience in risk prediction:
– breast cancer
– musculoskeletal diseases
• Interest in statistics:
– teaching and learning
– communication
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NIHR Manchester Musculoskeletal
Biomedical Research Unit (BRU)
• 2012-2017
• £4.9m NIHR funding
• “Treating arthritis: right first time”
• Understanding why some patients
respond to certain treatments and
do not
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BRU example: Predicting non-response to
methotrexate in rheumatoid arthritis
• Methotrexate is cheap and
effective for many…but not all
• Idea: predict who is unlikely to
respond to methotrexate
– earlier access to alternative drugs
– prevent disease progression
• Data: Rheumatoid Arthritis
Medication Study (RAMS)
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BRU example: Predicting non-response to
methotrexate in rheumatoid arthritis
• Methods: multivariable
regression prediction model
• Results:
– easily-measurable predictors used
to predict non-response
– patient anxiety of particular interest
• Next: additional genetic and
biological predictors
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NIHR Manchester Biomedical Research
Centre (BRC)
• 2017-2022
• £28.5m NIHR funding
• 7 themes
• 3 cross cutting themes
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BRC themes
• Advanced radiotherapy
• Cancer precision medicine
• Cancer prevention and early detection
• Dermatology
• Hearing health
• Musculoskeletal diseases
• Respiratory diseases
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BRC cross cutting themes
• Rapid translational incubator
• Biomarker platforms
• Informatics and data sciences
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Biostatistics teaching and learning
• Context:
– Students have statistics learning needs
– Staff have statistics teaching needs
• Actions:
– Training course aimed at non-statisticians teaching
statistics: “Strategies for teaching statistics”
– Pilot of “Stats Buddy” offering specialist support to
non-specialist staff
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…and clinical training for non-clinicians
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CLAHRC Greater Manchester 23
NIHR CLAHRC Greater
Manchester Sarah Cotterill
Sarah Rhodes
Eva Batistatou
Nia Coupe
Centre for Biostatistics Showcase – 3 May 2017
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CLAHRC Greater Manchester 25 CLAHRC Greater Manchester 25
OSCARSS
• Organising Support for CARers of Stroke Survivors
• Cluster randomised controlled trial (RCT)
• Partnership Between CLAHRC GM and Stroke Association
• Statistician - Sarah Rhodes:
–Design of cluster RCT
–Trial Management
–CLAHRC Workshop on design of
implementation research
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CLAHRC Greater Manchester 26 CLAHRC Greater Manchester 26
Wound Audit
• Audit of prevalence of complex wounds and their
treatment
• Partnership between GM CLAHRC and 5 NHS Primary
Care Trusts
• Statistician - Sarah Rhodes:
–Analysis of large data set
–Dissemination to NHS Trusts
–Paper on ‘Better Value Wound Care’
–Using results to plan future work
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CLAHRC Greater Manchester 27 CLAHRC Greater Manchester 27
End of Life: Carer Survey
• The contributions of family care-giving at end of life: A national post-
bereavement census survey of cancer carers
• Partnership between CLAHRC GM and Dimbleby Cancer Care
• Statistician – Eva Batistatou
- Analysis of the census survey of cancer carers
- Dissemination of results
- Plan of future work
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CLAHRC Greater Manchester 28 CLAHRC Greater Manchester 28
Type 2 Diabetes Prevention
• Evaluation of NHS Diabetes Prevention Programme
– Salford pathfinder.
• Partnership between CLAHRC GM and Salford
health trusts, local authority and voluntary sector.
Funded by Public Health England.
• Mixed methods study: literature review, analysis of
routine data and qualitative interviews.
• Principal Investigator – Sarah Cotterill
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CLAHRC Greater Manchester 29 CLAHRC Greater Manchester 29
Diabetic neuropathy screening
• Corneal confocal microscopy (CCM) for screening and early
assessment of diabetic neuropathy
• Partnership between CLAHRC GM and Heidelberg Engineering.
• Feasibility study in 4 opticians (400 patients)
• Statistician – Sarah Cotterill
– Research design
– Project management team
– Contribution to analysis
– Reports, papers
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CLAHRC Greater Manchester 30 CLAHRC Greater Manchester 30
CLAHRC PhD: Nia Coupe
• SMART-C: commitments to promote behaviour change in people who
are overweight or obese
• Supervisors
– Sarah Peters
– Sarah Cotterill
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CLAHRC Greater Manchester 31 CLAHRC Greater Manchester 31
• ‘TIDieR or Messier? Exploring the utility of TIDieR beyond trials’
• TIDieR template used in 6 CLAHRC GM projects
• Findings:
–We found the TIDieR tool to be a useful tool for applied research
outside the context of clinical trials and we have identified four
amendments to enhance its utility
• Authors: Sarah Cotterill, Sarah Knowles, Anne-Marie Martindale,
Rebecca Elvey, Nia Coupe, Susan Howard, Paul Wilson, Michael
Spence.
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CLAHRC Greater Manchester 32 CLAHRC Greater Manchester 32
NIHR CLAHRC GM
Project reports and papers:
http://clahrc-gm.nihr.ac.uk/our-work/
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PhD – Environmental Epidemiology
Manchester Guardian, 8 December 1952 Wilkins ET. Air Pollution and the London Fog of December, 1952. Ama Archives of Industrial Hygiene and Occupational Medicine. 1954;9(3):247-248.
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Recent/Current Work
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OPRA 1996-2012 - 'Core' reporters only
• STRATEGIC - HTA clinical trial aiming to improve the uptake of cervical screening particularly in non-responders at first call.
• SSNAPIEST – Observational study describing and investigating factors that impact on stroke therapy received and the effect on health outcomes.
• THOR - Surveillance scheme monitoring occupational ill-health in the UK particularly attempting to account for excess zeros due to reporter fatigue.
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Comparing missing data techniques
for intention-to-treat analyses
Liz Howarth
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Missing data is a problem
• RCTs best method to compare treatments
– Complicated by non-compliance & missing data
• Non-compliance not necessarily a problem
– Pragmatic ‘ITT’ analysis ignores compliance
• Missing data IS a problem
– biased estimates, faulty inference
• Can we exploit links between compliance & missingness?
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Compliance & missingness
• Some missing data techniques use auxiliary models
– Multiple Imputation
– Inverse Probability Weighting
• Does use of compliance in auxiliary models improve resulting ITT analysis?
Incomplete data ITT analysis Auxiliary model
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Simulation study
• Generate data
– outcome & missingness both depend on compliance
• Compare different methods
– With and without compliance in auxiliary model
– ITT analysis on full data used as benchmark
• Bias and variability used as performance measures
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PhD Aim: Develop statistical
methodology for the analysis of
complex multistage treatment
data.
Jack Wilkinson. Centre for Biostatistics Showcase 2017
Funder: NIHR
Supervisors: Steve Roberts, Andy Vail
PhD overview
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IVF success rates
• 33 different ways of reporting pregnancy rates.
• 9 different ways of reporting live birth rates. Only 51% of websites reported live birth at all, 42% per cycle started – one to HFEA standard.
• 72% presented results without sample sizes, 26% without patient ages, 23% without specifying period. 80% did not report selection criteria.
Chemical Pregnancy 19% of clinics: -per cycle started -per egg recovery -per frozen cycle -per insemination -per transfer -unspecified denominator
Clinical Pregnancy 81% of clinics: -per cycle started -per egg recovery -per frozen cycle -per insemination -per transfer -per cycle -per first cycle -per treatment -unspecified -unspecified (cumulative) -per course of inseminations -per egg recovery (cumulative) -per three cycles -per blastocyst stage achieved -per embryo transferred
Pregnancy (undefined) 21% of clinics: -per cycle started -per frozen cycle -per insemination -per transfer -per cycle -per patient (cumulative) -per three cycles -unspecified denominator -per blastocyst stage achieved
Singleton Pregnancy 2% of clinics: -unspecified denominator
Continuing Pregnancy 2% of clinics: -per cycle started -per frozen cycle
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OVERVIEW • Primarily applied statistician. • Cautiously skeptical re: much methodology research. • Given that most research is bad, how can statisticians be
more effective? • Teaching: statistics as reasoning and arguing with data –
not as a maths problem.
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Calvin Heal. Centre for Biostatistics Showcase 2017
The effects of arthritis gloves on people with
Rheumatoid Arthritis or Inflammatory Arthritis with
hand pain: a multi-centre randomised controlled trial.
Pressure &
Warmth Warmth
or
For reducing hand pain during day activity.
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Calvin Heal. Centre for Biostatistics Showcase 2017
Non-pharmacological interventions for spatial neglect due to
stroke and other non-progressive acquired brain injury in adults
Spatial neglect
• Lack of awareness of objects or people to the left
• Serious symptoms
• Often a result of injury to right cerebral hemisphere
Treatment / Rehabilitation
• Prismatic adaptation
• Transcranial direct-current stimulation
• Video feedback training
• Most treatments relatively new and have
limited evidence
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Calvin Heal. Centre for Biostatistics Showcase 2017
A single-blind randomised controlled trial with a four
month and 12 month follow up comparing
Group-Metacognitive Therapy plus usual cardiac
rehabilitation (intervention group) with
usual CR alone (control group).
Background
• Heart attack/failure -> Cardiac rehabilitation
• 69000 patients annually (37% significant anxiety/depressive symptoms)
• Current treatment options have limited benefit
Metacognitive therapy