9 February 2012 NIHR-funded Surgical Research: NIHR PGfPG Award Holder Mr Peter McCulloch.

9 February 2012

NIHR-funded Surgical Research: NIHR PGfPG Award Holder

Mr Peter McCulloch

Who are we?• Quality, Reliability, Safety & Teamwork Unit (QRSTU)• Research unit focussed on INTERVENTIONS to improve

SAFETY in SURGERY• Based in Nuffield Dept of Surgical Science, Oxford

University• Multidisciplinary team includes clinicians, ergonomists,

aviation teamwork experts, specialist in systems improvement, knowledge translation, statistics and health economics

Safer Surgical Services

• Programme of studies to evaluate INTERVENTIONS to improve safety and quality in surgery

• Looking at SYNERGY between approaches and effects of CONTEXT and CULTURE on success

• Based on a 3 dimensional model of safety (system, culture and technology)

• Uses learning from non-medical experience eg CRM, “Lean”, Ergonomics

• 3 Trusts over 3.5 years, mainly Orthopaedics

Application Process

• Dates and timelines – 2 years from start to go.• 5/9/08 Final Draft 1.3• Notes on reviews 28/11/08• Response to review 8/01/09• Response to further reviews 19/01/09• Full application 09/06/09• Resubmission 25/08/09• Final resubmission 22/09/09

• Outline, full application & revision so 3 submissions• Further revisions x3 and contract signing 1/11/09• Difficulties around NHS budget holding & sponsorship for

academic partners

Overall Impressions of Application Process

• Two stage process pointless where HEI involved, and causes delay

• Review process thorough and professional (- overly so?)• CCF staff superb• Rules a disincentive to career academics• Online forms not optimal

Pointers for Applicants• Referees showed strong focus on TEAM

and ENVIRONMENT• Strong track record with relevant pilot data

essential • Patience and flexibility required

Setting Up

• Agreeing Contract after award can take time

• Ethics – vastly improved in last 5 years

• Permissions to enter hospitals – challenging!!

Delays (n = 24)

Mean 7.8 weeks

Median 8 weeks

Range 3 – 18 weeks

Achieving permission

Issues

•Difficulty in determining what is needed – HC, OC, RP ?•Multiple steps required

• = time and money• Multiplies chance of delay

•Justification for several steps unclear

• CRB• Medical Director sign-off• Occ Health at each Trust• Clearance for Letter of

Access

Budgetary control

• Subcontracting awkward – NHS, University and NIHR accounting systems

• Generally flexible and sensible in day to day running

• Good interaction with CCF staff – availability and ability

• Interpretation of rules for funding NHS support costs seems difficult – and narrow.

Reporting

• Requirements light and not onerous• Requirement for permission to publish

irritating• No real feedback on reports

Dealing with NHS R&D Offices at Trust Level

• Urgent and serious problem which is damaging research

• Access• Ethics Amendments• Protocols• Sponsorship

• Perverse incentives• Staff justify existence by activity not results• No targets or deadlines (? Look at Ethics model)

Patient & Public Involvement

• Principle not easy to implement• PALS• Patients Association• Special interest groups

• More support needed?

SummaryThe Good

• Generous support, vitally needed and unique

• Very thorough and fair reviewing process• Superb staff interface at CCF - very helpful

prompt and professional advice• Financial and Reporting structures effective

and not onerous

SummaryThe not so good

• Two stage application process• Iterations in contract negotiation• NHS R&D Offices at Trust level a serious

problem• Dissemination and PPI obligations could do

with more help• Lack of rigorous mid-stage evaluation

Conclusions

• Vital and important funding for clinically relevant research

• Innovative on a world scale• Slow and bureaucratic selection and contracting• NHS budget holding a problem• Major problems with Trust research governance• Effective and helpful day to day management• Need to put more into PPI and reporting

Thank You NIHR!

9 February 2012

Thank you