developing a programme grant: the importance of feasibility work to inform design and conduct dr...

Developing a programme grant: the importance of feasibility work to

inform design and conduct

Dr Rachel TaylorResearch Associate

University College London & London South Bank University

Why the Essence of Care study?

• Teenage and Young Adult (TYA) cancer care experience relatively unknown

• Poorer outcomes in 15 – 24 year olds compared to children

• Increased interest in specialist TYA cancer care NICE Children & Young people’s Improving

Outcome Guidance Internationally

• Critically asking for evidence of outcomes associated with TYA care

Aim

• To determine whether specialist TYA cancer care in England, for young people aged 13 – 24 years, is associated with improved outcomes during and after treatment

• BUT…

Challenges• What study design?

Ideally randomised controlled trial, BUT• Services are already in place • Unethical to randomise to specialist care vs. not• Variation in services across country

• What sample? Too much variability to be single centre National cohort, BUT

• How do you identify ALL young people?• How do you recruit ALL young people?

• What outcomes?

Solution

Feasibility studies

MRC framework for evaluating complex interventions

Implementation Dissemination

Surveillance and monitoring Long term follow up

Development Identifying the evidence base Identifying/developing theory

Modelling processes and outcomes

Evaluation Assessing effectiveness

Understanding change processes Assessing cost effectiveness

Feasibility/ piloting: Testing procedures

Estimating recruitment/ retention

Determining sample size

Essence of Care: Phase I

Phase 1Commenced J une 2009

Understanding TYA cancer services

Methodological issues related to Phase 2

Review of longitudinal & panel surveys

in England

Management & Organisation of Phase 2

Interviews with

commissioners & documentary

analysis

Non-participant observation & interviews

with TYA & HP

Workshops with

YP & HP

Literature reviews of TYA cancer

services, outcomes & measures

Interviews with

young people

Evaluation of NHS datasets

& registries

Phase 1Commenced J une 2009

Understanding TYA cancer services

Methodological issues related to Phase 2

Review of longitudinal & panel surveys

in England

Management & Organisation of Phase 2

Interviews with

commissioners & documentary

analysis

Non-participant observation & interviews

with TYA & HP

Workshops with

YP & HP

Literature reviews of TYA cancer

services, outcomes & measures

Interviews with

young people

Evaluation of NHS datasets

& registries

Study 1: Current & future policy underpinning TYA cancer

• Semi-structured interviews with four commissioners of TYA cancer services

• Documentary analysis of implementation plans Progress reports from Sept ‘08 to Nov ‘09

What this informed…

• Aspects of study design:

Multi-centre, national

Study 2: Nature of TYA cancer care

• Non-participant observation Single principle treatment centre Observation over 2 weeks All areas providing TYA cancer care

• Semi-structured interviews Three health care professionals Three young people


• Observation schedule for a multiple case study using non-participant observation

• Guided the sampling strategy for a multiple case study

Studies 3 - 5

• Study 3: Towards a definition of TYA cancer care unit• Study 4: Identifying the professional competencies

for TYA cancer care• Study 5: Young people’s experiences of cancer care

Workshops with young people and health professionals

Workshop participants

Young people• n = 11 (4 CCG)• Age at diagnosis:

13 – 25 years• Current age:

16 – 29 years• All off treatment

Health Care Professionals• Two workshops• n = 22• Clinical leads = 5• Doctors = 2• Nurses = 9• Other = 6

Study 3: Towards a definition of TYA cancer care unit

• Included in both young person and health professional workshop + ‘Find Your Sense of Tumour’ 2010 conference

• ‘Pyramid of importance’ Key features of a TYA cancer unit (identified from

literature) + blank cards Rank according to importance on a pyramid Features given a rank score according to placement in

pyramid


• Importance of involving young people if researching ‘experience’ Involve young people in study design Involve young people in study conduct

Study 4: Identifying the professional competencies for TYA cancer care

• Included in the health professional workshop• Diamond ranking

61 key skills, knowledge, attitudes (identified from a review of the literature) + blank cards

Rank on a diamond Focus on the top half of the pyramid


• Highlighted the pattern of communication in TYA healthcare

• Initial survey for an international Delphi survey

Study 5: Young people’s experiences of cancer care

• Included in the workshop with young people• Peer interviews

Conducted by the CCG (young person user group) Concluded with a newspaper headline

• Spider diagram Expansion of headlines through group discussion

• Group analysis with the CCG using thematic analysis of headlines & transcripts


• Quality of life as important as survival Implication for primary outcome

• Basic framework for the Essence of Care Survey

Study 6: Self-reported outcome after treatment for cancer

• Literature review Search terms related to outcome, i.e., quality of

life Cochrane + 4 databases Young people aged 13 – 45 years with cancer (US

definition of ‘young adult’) Any study design Study quality assessed with

Cesario/CONSORT/STROBE guidelines


• Identify significant non-medical outcomes• Understand young people’s experiences of

cancer [care] Underpin content of the Essence of Care Survey

Study 7: Outcome measures validated for young people aged 13 – 24 years

• Literature review Search terms related to outcome, i.e., quality of

life Cochrane + 4 databases Participants <16 years and ≥19 years Only quantitative designs Instrument quality assessed with McMaster

Outcome Measure Rating Form


• Identify outcome measures that can be used in the Essence of Care study

• Develop a toolkit of outcome measures used in TYA, with a validity & reliability profile, for use in future research

Study 8: Evaluation of NHS datasets

• Aims Identify young people within 90 days of diagnosis To provide clinical data

• Review national datasets• Criteria:

Population based Minimum data: NHS number, name, gender, age,

address, diagnosis & place of care

Results: identification of a dataset


• Cancer Waiting Time dataset had overall completeness of 99% Young people can be identified within 90 days

• Only suspected therefore needs confirmation• Additional data in other datasets

Clinical data available without relying on medical notes• Quality of data is not confirmed• Missing data• Lack of reliable death data

Study 9: Young people’s preference for participation in a longitudinal study

• Recruitment in two principal treatment centres

• Six young people aged 17 – 21 years• Complete outcome measures

PedsQL, INPATSAT, HUI2, EQ5D• Semi-structured interviews


• Primary and secondary outcome measures• Study design issues• Importance of involving young people in study

design

Study 10: Framework for the Essence of Care study

• Challenges for Phase II Can we identify all newly diagnosed young people

in England in 2012? How can they be recruited?????? How can data be collected??????

Yes

Solutions

• NIHR funded project = access to NCRN nurses Will they recruit young people?

• Search existing national cohort studies (e.g. Millennium Cohort Study)

• How do they data collect? Commercial research companies Is this economically feasible?

Yes

Yes

The 2012 TYA Cancer Cohort Study

UCLH:• Dr Jeremy Whelan (CI)• Susie Pearce• Martin LernerUCL:• Dr Julie Barber • Professor Steve Morris• Professor Rosalind Raine• Dr Rachel TaylorUniversity of Leeds:• Dr Richard FeltbowerSt James’ University Hospital• Dr Dan Stark

Cancer Research UK• Dr Lorna Fern GOSH/LSBU• Professor Faith Gibson NCAT• Louise HookerNWCIS• Dr Tony Moran• Dr Catherine O’HaraNCRI CSG TYA CCG:• Hannah Millington

Workstream 1: the description of specialist TYA cancer care

• Explore the culture of care through non-participant observation, interviews and documents analysis

• Identify the specialist competencies and added value of specialist health professionals through a Delphi survey

• Validate a bespoke scale to categorise 3 levels of TYA care (TYA Cancer Specialism Scale)

Workstream 2: cohort study of all TYA diagnosed during an 18 month period

• Accrual within 3 months of diagnosis and follow-up will continue for 3 years

• Relate the level of specialist care received to: Patient reported outcome Clinical processes and outcomes Experience of cancer care Achieving social and educational milestones Geographic and socio-demographic inequalities

Workstream 3: health economics

• Compare costs to the NHS and personal social services between TYA receiving different levels of specialist care

• Estimate the cost to TYA and families of specialist care

• Calculate the cost effectiveness of different levels of TYA care

• Workstream 4: intervention development & service evaluation

Summary

• Complex evaluation of health care need complex study designs

• MRC framework for evaluating complex interventions Importance of feasibility & pilot studies

• NIHR recognition Programme development grant

Conclusion

• So how did we do? Stage 1 submission: March 2010 Reviewer feedback: May 2010 Stage 2 submission: October 2010 Sub-panel comments: March 2011 Amended submission: May 2011

• Outcome?

• Dr Lorna Fern• Professor Faith Gibson• Dr Catherine O’Hara• Susie Pearce• Dr Rachel Taylor• Dr Jeremy Whelan

Research team: Phase I

• NCRI Clinical Studies Group Teenage & Young Adult Core Consumer Group James Ashton Katie Brooman Tom Grew Hannah Millington Carol Starkey

Acknowledgements

• Teenage Cancer Trust for funding the ‘Essence of Care’ project

• Carol Irving & David Wright for their support with the CCG

• Professor Ian Lewis, Dr David Hobin & members of TYAC for permission to work with their data

• Participants & Steering Committee of ‘Find Your Sense of Tumour’

developing a programme grant: the importance of feasibility work to inform design and conduct dr...

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