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?