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
Or ‘real life challenges
in real life research…’
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
About UNLOCK
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
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
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
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
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 coauthors
• 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 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
Motivation to participate
Key informants said:
• Improving understanding
of the role primary care
play & importance of real
life research
• Learning from other countries
• The social aspect – spending
time with trusted colleagues
• Improving patient outcomes
There is a
need to show
the world
how effective
primary care
can be in the
treatment of
COPD and
asthma.
Why I like UNLOCK meetings
18
16
14
12
10
Disagree
8
Neither agree nor disagre
Agree
6
Agree strongly
4
2
0
I get to hear about I learn about how I reflect on how to
I get the
I use it to influence I am too busy to I do not find useful
the research my other countries do improve dataset
opportunity to
the design of
go
colleagues are
it
management
think about the
electronic health
doing
advantages and
records
disadvantages of
different coding
Challenges and constraints
Data…
• Very different size of datasets (130
<1.4m)
Some
• How representative is the data
research
questions can
• Different variables
be answered
• Same variables, different coding and
definitions
using our own
data. This is
• How accurate is the data
much quicker
• Internal validity of studies
• Does a question need comparison or and easier than
sharing data.
pure power
Challenges and constraints
Working as group…
• Different expectations and
Big, fast
practices around processes and
meetings can be
quality
a barrier to
• Different languages
quality
• Different expectations of
meetings
• But no other meeting or fora to progress issues
• Frustration that some studies weren’t progressing
fast enough
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.
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
How effective were these actions?
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’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
More UNLOCK impacts
• Stimulated ideas and collaborations
taken forward outside the Group
• Contributed to the profile of IPCRG No-one
else has
• Proved it is possible for an
done this
international collaboration to do
before in
this field
primary care research
so we
• Impact on practice still low
are
pioneers
• Need to understand better the
mechanism for impacting on practice
So how effective were the actions?
One has to
• Partly…
temper the
• Some frustration that progress wasn’t enthusiasm
with the
faster with more outputs
knowledge
• Some limitations inherent in a
it is not
collaborative model relying on existing
easy.
datasets
• Consensus that the expectations were
too high in the beginning
• The participants were learning by
doing
We are more aware of the difficulties now but
that is part of the development process.
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
More lessons
• 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
For me the
first lesson
is it is much
harder
than I
thought…
the second
is that it is
possible!
Thanks!
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