REG Committee Meeting 26/09/15
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Transcript of REG Committee Meeting 26/09/15
2015 ERS EVENTS
DATE: SATURDAY SEPTEMBER 26TH
VENUE: Wyndham Apollo Hotel, AmsterdamROOM: BoardroomTIME: 19.00–20.00
CHAIR: Daryl Freeman: GP Principal Norfolk, Clinical Director NHS England- Midlands & East(East), UK
COMMITTEE MEETING:RESEARCH REVIEW; ACCREDITATION; MANUSCRIPT
Agenda
Committee members
• Accreditation: o Daryl Freeman, Alan Kaplan, Iain Small; Thys van der
Molen; Kevin Gruffydd-Jones
• Research Review: o Dermot Ryan, Ted Popov, Theresa Guilbert, Elliot
Israel
• Manuscript Review: o Daryl Freeman, Steve Turner ,Alan Kaplan, Liz Hillyer
Research Review Committee
Key Agenda items
• 2015 “Call for Research” / Prioritisation of Study ideas for REG core funding
• Evaluation criteria: o Details required; weighting of ideas; new tool
• Timelines for review of 2015 ideas• Distinction (or link) between Research Review
Committee & ADEPT
Call for research ideas 2014/15• Pin board: open call for ideas
• Anonymised ideas reviewed & prioritised by committee – criteria:o Unmet research needo Relevance at a national / global scaleo Others
• REG research priorities published in November 2014
• 4 studies to be funded as a result:o Priorities 1 & 2: full fundingo Priorities 3 & 6: data provision
Call for research ideas 2014/15
REG CORE FUNDING TO COVER TOP 2 RANKED RESEARCH STUDIES
REG CORE FUNDING TO COVER DATA EXTRACTION (ONLY) FOR
FURTHER 2 HIGHLY-RANKED STUDIES
2015/16 Process: The Era of the WG• Each working group is targeted at an
area of respiratory medicine for which real-life research methods offer particular value.
• All ideas that are currently passing through the working groups will be collated and submitted to the Research Review Committee for prioritization (circa 31 October).
• The process will generate a list of prioritized research needs, endorsed by the organization that can be targeted to (or by) external funders or prioritised for reinvestment & support of REG’s core grant funding stream.
Research Review in the “Working Group” Era
RESEARCH IDEA GENERATION
Working Groups Identify Research Priorities in their
respective fields of expertise
SECURING FUNDING
Nature of funding dictates future study course:• Single commercial funding source: an investigator
initiated study conducted external to REG• Non-product/brand specific grant(s): an REG
Collaboration carried by REG or in partnership with REG
REG Supporters
Non-supporter& wider
institutional grants
OR
REG develops idea in
collaboration with WG
& seeks dedicated research grant
REG Grants awarded
at start of FY16/17
REG Core Grants Awarded to Top Priority Ideas
(subject to available funding)
31 October Core Grant submission
deadline
Ideas prioritised by REG Research Committeeby 31 Dec 2015
If insufficient REG Funds, continue to look externally
Working Group Ideas So Far…1) UK “State of the Union” – current asthma morbidity in the UK
2) Evaluation of the association between duration of antibiotic courses (for respiratory infections) and issuance of repeat prescriptions
3) Development, Validation and Evaluation of a Short form of EXACT (Exacerbations of Chronic Pulmonary Disease Tool) Questionnaire for Clinical Use and Self-(tele) Monitoring
4) Validation of the COPD UK Risk Prediction Model and development of a claims-based algorithm
5) Comparative effectiveness of triple (ICS/LABA/LAMA) vs dual therapy (ICS/LABA) in COPD
6) Development of a Longitudinal Asthma Treatment Step Algorithm and Association with Asthma Outcomes
7) Towards Optimum Reporting of Pulmonary Effectiveness Databases and Outcomes (TORPEDO) Checklist: development of a quality checklist for respiratory research databases
8) Systematic review & meta-analyses of the effect of ICS particle size on real-life asthma outcomes
9) Metabolic and long-term implications of ICS particle size in obstructive lung disease
10) Intra and trans-database comparison of “research-ready” definitions of ACOS
11) Characterizing the primary care pathway to idiopathic pulmonary fibrosis (IPF) diagnosis – a UK database study
12) Global Characterization of ILD MDT Practice & Agreement and Accuracy of IPF diagnosis evaluation
13) Evaluating and describing current development practice of technology based solutions
14) Drawing on existing literature: how should health information be fed back to (positively) change patient behaviour
15) Optimising App interfaces for older people with chronic respiratory diseases
16) Implications of ICS cessation in COPD – a real-life study
17) Exploration of the role and associations between nasal and bronchial hyper-reactivity in allergic airways disease
18) Are COPD patients with serum eos < 2% on inhaled corticosteroids at an increased risk to develop pneumonia
19) Role of FeNO as a biomarker in COPD
20) Comparative decline in FEV1 over time in patients receiving dual vs triple therapy for COPD
Prioritizing External Grant Ideas
• External Grant Bids:o Horizon2020o PCORI
• All WG invited to submit ideas• Substantial REG time investment• “Strongest” idea must be selected from among
the group• Research Review Committee Prioritise ideas for
REG backing.
New approach to scoring
Additional fields
Comment from Jon Campbell“An area where I think REG could do more is within the realm of broadening our stakeholders and therefore, broadening our application and reach. Specifically, there are limited stakeholders within REG who are active within the payment/reimbursement side. Also, we have a select few within REG who bridge the gap between respiratory investigators and outcomes research.
Payers and health outcomes researchers are important stakeholders that increase the likelihood of REG-sponsored evidence influencing/improving respiratory clinical practice and population-level health. A REG strategic idea for 2015/2016 is as follows:• Give funding priority to pin-board research ideas that promote active
engagement from multiple stakeholders (i.e. at least two from different domains such as: clinical, outcomes research, and payer) with the end goal of generating clinical- and payer-relevant research.”
Weighting of ideas…
• Encouragement of new working groups, i.e. engaging new areas:o E.g. engaging new stakeholders, such as outcomes
researchers• Areas that receive little commercial support (e.g
paediatrics)• Areas that have substantial strategic value• Hot topics• Cost
ADEPT – move to REG• The Optimum Patient Care Research Database (OPCRD) has
ethical approval for respiratory research subject to protocols being approved by its Anonymised Data Ethics and Protocol Transparency (ADEPT) Committeeo Chairman: Daryl Freemano Group Members
– Dr Iain Small– Dr Stan Musgrave– Professor Graham Davies– Dr Jane Chatworthy– Dr Delyth James
• The committee now convenes under REG.
ADEPT – application procedures• All studies using OPC data must receive ADEPT approval before proceeding.
• Any studies which are destined for publication, or for which it is intended to communicate the results to third parties, must receive ADEPT approval before proceeding.
• Proposed studies should be presented as a protocol. o All applications should include a completed ADEPT Application Form (see below)o All applications should include a copy of the Principal Investigator’s cv (no more than 2 pages long).o Any questionnaires that investigators wish to send to GPs as part of a study must also be submitted to
ADEPT with the protocol.
• The ADEPT Research Co-ordinator distributes protocols and questionnaires to ADEPT members. Members will assess that:o Practice and patient confidentiality will be maintainedo There is a well defined hypothesis or clear question to be addressedo OPC data is suitable for the researcho The methodology is considered appropriate and robust
• Approved protocols will be assigned a number that should be quoted in subsequent publications
ADEPT – beyond OPCRD
• ADEPT will also review study protocols for use of data other than OPCRD, i.e. offering a protocol quality assurance review.
• An representative from the database proposed for use will invited to adjudicate the “appropriateness” and feasibility of use of the database for the proposed study
ADEPT vs Research Review Committee
• Differences between ADEPT & the REG Research Review Committee:o ADEPT reviews database protocols for ethical
“appropriateness”o REG’s Research Review Committee evaluates
research ideas originating from REG working groups and collaborators for strategic value / priority in line with REG’s objectives.
Manuscript Review Committee
Key Agenda items
• Review of manuscript review process• Publication activity summary in 2015• Is the process working
Manuscript pathway….
12 published/in press
12 papers in preparation
22 abstracts
20 studies completed
31 studies supported
Activity since Rotterdam• SOP posted on Website along with:
o Author guidanceo Author feedback (about publication challenges)
• UNLOCK informed of Ms Review Committee review option & necessary acknowledgement when issued OPCRD datasets (following pin board prioritisation and funding/support)o UNLOCK study data presented today to co-investigators (Sat
26th); publications to follow
• All REG original research accepted in 2015 written by:o Liz Hillyer or Steve Turner – Ms Review Committee Members
Process agreed in Rotterdam
The Committee’s role will comprise the following key steps:• REG Publications lead will share a copy of the REG Author Guidelines with the lead author of all REG abstracts
accepted for conference presentation• Authors will incorporate the recommendations within their draft manuscripts• Pre-submission drafts of research papers will be sent to the Manuscript review Committee (via the REG Publications
Lead) to allow a light-touch review (against REG author guidelines only) to be conducted (within 10 days).• Authors will be encouraged to incorporate the committee’s recommendations in their draft prior to submission• Following manuscript acceptance, paper authors will be asked to complete the short Manuscript Summary table to
enable the• Committee to capture key information about publications and the publication process.
Conference Abstract Accepted
Draft paper (in line with
REG guidelines)
Author sent:1. Author Guidelines 2. Request to send draft paper to Ms
Rev Committee pre submission for light-touch style review
No suggested
edits
Send draft paper to MS
rev committee
Submit paper o chosen journal
Complete & return ms
summary form to
Ms Rev Com
Consider incorporating
suggested editsSuggested
edits
PAPER ACCEPTED
Manuscript Review Committee Review carried out within 10 days of author submission
Activity since Rotterdam
Future Plans…?• Is the process working?• Should we integrate the REG taskforce tool to
help guide publication strength…?
Accreditation Review Committee
Key Agenda items
• Activity to date & expected future activity
• Appraisal Process
• Driver of activity
• Role of REG as an “Educator”
Accreditation work to date
• Course in Bali used as the guinea pig.o DF chair and designed SOP & accreditation formso Guinea pigs were Alan Kaplan, Iain Small & Kevin
Gryffd Jones.o Process now in place, in terms of what we expect
– From organisers– Course content & evaluation– Accreditation committee members
• We need to think about how we can provide accreditation for more educational courses?