1. Interim Findings: Fostering the exchange of real life data across different countries to answer primary care research questions An UNLOCK study from the IPCRG Liza Cragg
Interim findings
Of an UNLOCK study to capture learning from the 6 years of the Group’s work
Thanks to Novarits for funding of UNLOCK, co-authors, members of UNLOCK who participated in research and special thanks to Sian Williams

2. Or ‘real life challenges in real life research…’

3. Overview What is UNLOCK? About this study Findings
Who is involved and how it works
The data
Motivation for participation
Challenges and constraints
Strategies and action to overcome these
Impact of UNLOCK
Lessons for future studies and collaborations

4. About UNLOCK

6. About UNLOCK
Uncovering and Noting Long-term Outcomes in COPD and asthma to enhance Knowledge
Is an international collaboration between primary care researchers and practitioners
Set up in 2010 by members of IPCRG as part of its original ambition
Responds to the identified research need for research in primary care
Primary purpose: provide evidence to underpin the primary care approach to diagnosis, assessment and broad management strategies
By sharing primary care datasets of relevant variables to answer agreed research questions

7. This study
Authors: Liza Cragg, Siân Williams, Thys van der Molen, Mike Thomas, Jaime Correia de Sousa, Niels Chavannes
Objectives:
To describe and classify the successes and motivation of members
To describe and classify the constraints experienced and how these have been overcome
To identify methods to improve the effectiveness of future studies and research collaborations
To describe other impacts of UNLOCK

8. Study methods A review of documents related to and produced by UNLOCK
A structured on-line questionnaire for UNLOCK Group members (response rate of 77%)
Structured interviews with 12 key informants
A review of the datasets held by UNLOCK members
I should add this study is not an external evaluation – process of capturing learning of the Group by the Group. I’ve been involved as project manager for a number of years.

9. Who is involved
Initially conceived of as membership conditional on access to a dataset, in practice based on interest
27 individuals over 6 years
Most have combined research/academic and clinical role, some have a research/academic role and some have a clinical role
15 countries : Sweden, Spain, Ukraine, Canada, Greece, UK, Netherlands, Norway, Portugal, Germany, India, USA, Australia, Uganda and Chile
15 have attended five or more meetings, 21 two or more
14 have contributed data to an UNLOCK study
Although it was initially conceived of a Group with membership conditional on access to a dataset, in practice participation has been based on interest
So an active and sustained participation
Survey shows 57% have combined research/academic and clinical role, 33% have a research/academic role and 10% have a clinical role
Participation takes several forms: leading a study, contributing data, advising, inputting to meetings

10. How UNLOCK works
The Group meets in person twice yearly coinciding with other events
Participants discuss potential research questions at meetings
The question owner is the first author
Those with data & interest contribute to a study as co-authors
A small grant is paid to the institutions of 1st authors
Or they can opt to receive support from an UNLOCK researcher
Work takes place outside meetings to progress studies
Supported by the IPCRG & by 2 unrestricted grants from Novartis, totalling €200,000
The Group meets in person twice yearly coinciding with other events, addtionally 3 extended overnight meetings

11. The data available to UNLOCK
Participants in the UNLOCK Group have access to 14 datasets
One has become outdated and five have been added
From 9 countries
10 datasets have been used in at least one UNLOCK study
3.8m primary care patients, 800,000 patients with asthma and 216,000 patients with COPD
Variations in dataset size, purpose and variables included
Some common variables (demographics, diagnosis, medication, smoking status)
Routine data, cohort studies, pragmatic clinical trials
Different ownership and governance arrangements

12. Motivation to participate
Key informants said:
Improving understanding of the role primary care play & importance of real life research
There is a need to show the world how effective primary care can be in the treatment of COPD and asthma.
Learning from other countries
The social aspect – spending time with trusted colleagues
Improving patient outcomes

13. Why I like UNLOCK meetings
The online survey asked respondents to agree or disagree with a number of statements about what was useful about UNLOCK meetings. All respondents either agreed or agreed strongly that they the meetings are useful because they get to know about research colleagues are doing, The reason rated next was they get to learn about what other countries are doing, followed by improving dataset management, very few agreed that they were too bus and no one that they were not useful.

14. Challenges and constraints
Data…
Very different size of datasets (130 <1.4m)
How representative is the data
Different variables
Same variables, different coding and definitions
How accurate is the data
Internal validity of studies
Does a question need comparison or pure power
Some
research questions can be answered using our own data. This is much quicker and easier than sharing data.
The datasets are very different sizes (130 <1.4m)
How representative is the data of the population, given different purposes for which it was collected
It includes different variables
Even the same variables may have different coding and definitions
How accurate is the data
Some questions about how best to ensure the internal validity of studies
Does a question need comparison or pure power

15. Challenges and constraints
Working as group…
Different expectations and practices around processes and quality
Different languages
Different expectations of meetings
Big, fast meetings can be a barrier to quality
Different expectations and practices around processes and quality eg how worked up should a proposal for a study be before it is brought to a meeting
Different languages
Different expectations of meetings - should they be fast for decisions, should they be reflective for discussing analysis and findings
But no other meeting or fora to progress issues except the UNLOCK
This lead to some frustration that some studies weren’t progressing fast enough and when in difficulty keep coming back meetings
But no other meeting or fora to progress issues
Frustration that some studies weren’t progressing fast enough

16. Challenges and constraints
Time, or lack it!
Many demands on the time of UNLOCK participants due to their clinical and/or research priorities
Studies progress as fast as the slowest responder
Analysis, write-up and submission hugely time consuming
UNLOCK model requires too much input from very busy people
Ideas people vs doers
As a person, I am more into the development of ideas rather than putting them on paper and carrying it through.
There are many demands on the time of UNLOCK participants due to their clinical and/or research priorities
Because it is a collaboration studies progress as fast as the slowest responder
Analysis, write-up and submission hugely time consuming, as you all know
Some participants said the UNLOCK model requires too much input from very busy people
The Group has attracted more ideas people than doers
Ideas people vs doers

17. Overcoming these
A pragmatic approach to solving problems as they arise
Explored the feasibility of a mechanism to enable pooling of data
Then compared the results of data analysed separately
PhD students to progress studies
Small grants to lead authors
A private discussion space on the IPCRG web platform
A part time project manager
A Steering Committee
A part time researcher
Templates for developing studies
The Group took pragmatic approach to solving problems as they arise
It explored the feasibility of a mechanism to enable pooling of data
Then compared the results of data analysed separately by members who owned the data
In sine cases PhD students to progress studies
A system of small grants was set up to lead authors to facilitate studies
A private discussion space on the IPCRG web platform was set up
A project manager was engaged part time
A Steering Committee to oversee progress between meetings was set up
A part time researcher was recruited
Templates for developing studies were provided

18. How effective were these actions?

19. UNLOCK achievements
9 studies on the diagnosis and management of COPD, asthma and ACOS in primary care
9 publications
Many presentations at conferences
Access to data from 3.8 million PC patients across 10 countries
A sustained network of primary care researchers from 15 very different countries
UNLOCK has undertaken 9 studies on different aspects of the diagnosis and management of COPD, asthma and ACOS in primary care
9 publications either published or in press
At least 12 presentations at international and national conferences and events
Created a network with access to data from 3.8 million PC patients across 10 countries
A network of primary care researchers across 15 very different countries for 6 years

20. UNLOCK’s impact
Generated knowledge on how to develop & use primary care datasets
Acted as a catalyst for the development of new national primary care datasets
UNLOCK datasets now being used to validate 1st European COPD atlas
Raising the profile and credibility of real life research
Interformants agreed it has
generated knowledge on how to develop & use primary care datasets
Acted as a catalyst for the development of new national primary care datasets
UNLOCK datasets now being used to validate 1st European COPD atlas
Raising the profile and credibility of real life research

21. More UNLOCK impacts
Stimulated ideas and collaborations taken forward outside the Group
Contributed to the profile of IPCRG
Proved it is possible for an international collaboration to do primary care research
Impact on practice still low
Need to understand better the mechanism for impacting on practice
No-one else has done this before in this field so we are pioneers
It has
stimulated ideas and collaborations taken forward outside the Group
Contributed to the profile of IPCRG
Proved it is possible for an international collaboration to do primary care research
However, informants agreed the Impact on practice still low
However, the point was also made that we need to understand better what the mechanism should be for impacting on practice

22. So how effective were the actions?
One has to temper the enthusiasm with the knowledge it is not easy.
Partly…
Some frustration that progress wasn’t faster with more outputs
Some limitations inherent in a collaborative model relying on existing datasets
Consensus that the expectations were too high in the beginning
Going back to the earlier question about effective the actions to overcome the constraints were
Well there is consensus they were partly effective…
Some frustration that progress wasn’t faster with more outputs
Some limitations inherent in a collaborative model relying on existing datasets, eg suggestions around enforcing deadlines more strictly but this is actually very difficult to do in an entirely voluntary collaboration of busy people
Consensus that the expectations were too high in the beginning
And the learning was part of the process
The participants were learning by doing
We are more aware of the difficulties now but that is part of the development process.

23. Lessons
An interest and willingness amongst primary care researchers and clinicians
Primary care data has a unique value
There are complex issues around datasets and no easy solutions
There are complex ethical & governance issues
More complex than a single dataset study so methodological & statistical expertise is required
There is an interest and willingness amongst primary care researchers and clinicians to participate in research across countries
Primary care data has a unique value, particularly around its capitiy to capture patient reported variables including symptoms and QOL
There are complex issues around sharing priamary care datasets and there really are no easy solutions
There are complex ethical & governance issues
It is more more complex than a single dataset study so methodological & statistical expertise is required

24. More lessons
For me the first lesson is it is much harder
than I thought…
The research question needs to be right: requiring international comparison rather than pure power with a strong interest from collaborators
More work is needed on the standardisation of datasets
International collaborations require coordination
Individual relationships are a strong motivator
The research question needs to be right which means it must requiring international comparison rather than pure power and there must be a strong interest from collaborators
More work is needed on the standardisation of datasets, including dictionaries of codes and definitiions
International collaborations require coordination and the resources required for this
Individual relationships are a strong motivator
the second is that it is possible!

25. Thanks!

26. Unique challenges for primary care
Many issues shared with other medical research
But some extra ones suggested by key informants
The large number of conditions that are diagnosed and managed in primary care
Routine data may be less accurate
Particular ethical and governance issues involved in using routine data for research
Variations in primary care between countries are greater than other specialisms
Less capacity and expertise for research than in other specialisms