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1. Getting Evidence into Practice:
Pragmatic Trials and
Implementation Research
Krysia Dziedzic
Arthritis Research UK Professor
of Musculoskeletal Therapies
NIHR Knowledge Mobilisation Research Fellow
2. Declarations of interest
• National Institute of Health and Care Excellence Fellow 2013-2016
• NICE Guideline Development Group for Osteoarthritis 2008 & 2014
• NICE Quality Standards Group for Osteoarthritis 2014-2015
• NIHR Knowledge Mobilisation Research Fellow 2015-2018
• EIT-Health JIGSAW-E 2016-2019
3. NHS &
1st RCT
Evidence Based
Medicine
Cochrane
Collaboration
Osteoarthritis
Guidelines
OARSI
EULAR
NICE
Quality Indicators
of Care
eumusc.net
NICE Quality
Standards
OARSI
International
Inventory of OA
programmes
OAMPA
6. NHS &
1st RCT
Evidence Based
Medicine
Cochrane
Collaboration
Osteoarthritis
Guidelines
OARSI
EULAR
NICE
Quality Indicators
of Care
eumusc.net
NICE Quality
Standards
OARSI
International
Inventory of OA
programmes
OAMPA
Funnel depicts loss in the pipeline from research to practice.
Brownson, Colditz & Proctor, 2012; From Green et al, 2009
7. NHS &
1st RCT
Evidence Based
Medicine
Cochrane
Collaboration
Osteoarthritis
Guidelines
OARSI
EULAR
NICE
Quality Indicators
of Care
eumusc.net
NICE Quality
Standards
OARSI
International
Inventory of OA
programmes
OAMPA
Blue Highways on the NIH Roadmap. Colditz, 2012; in Brownson, Colditz & Proctor 2012
8. -
Lau R, Stevenson F, Ong BN, Dziedzic K, et al. Achieving change in primary care-causes of the
evidence to practice gap: systematic reviews of reviews. Implement Sci. 2016 Mar 22;11(1):40.
10. ‘If we want more evidence-based practice we
need more practice-based evidence’
Lawrence W. Green
Increasing external validity
11. Trial design
Patient and Public Involvement
Clinical champions (national & local)
Communities of practice e.g. Clinical Advisory
Groups to underpin research decisions building
relationships, trust, partnership, MDT
Large, heterogeneous populations e.g. joint pain
12. Trial intervention
Can be tailored
Reflects clinical pathways
Can be replicated in real world
Usual care is clearly defined & audited
Aligns with (inter)national and local policy
Consensus exercises to determine usual care
Can easily be integrated into existing services
Theory to underpin intervention development
13. Intervention delivery
Whole system perspective
Training can be delivered at scale, feasible
Articulate time, tools, resources, expertise
Maximise outreach visits (intervention & control)
16. MOSAICS
Dziedzic KS, Healey EL, Porcheret Met al. Implementing the NICE osteoarthritis guidelines: a mixed
methods study and cluster randomised trial of a model osteoarthritis consultation in primary care--the
Management of OsteoArthritis In Consultations (MOSAICS) study protocol. Implement Sci. 2014 27;9:95.
17. • To determine the effect of a model
OA consultation, informed by NICE
OA recommendations, to support
self-management in adults aged 45
years and over with peripheral joint
pain
• Uptake of core NICE
recommendations
Implementing osteoarthritis
guidelines in UK primary care:
MOSAICS cluster randomised controlled trial
18. Evaluation
• Clinical effectiveness
o SF-12 (PCS) Physical Health
o OMERACT/OARSI responder criteria, joint pain intensity, pain self-
efficacy, patient enablement
• Uptake of core clinical recommendations
o Self-reported Quality Indicators of OA care (PPI*)
o Electronic medical record review of Quality Indicators of OA care
• Cost-consequences and cost-utility
o EQ-5D
19. MOSAICS CLUSTER TRIAL
8 General
Practices
• Six month consultation survey
• Clinical & cost effectiveness
• Electronic medical record review
Intervention
practices
• Interviews and observations (Morden et al, 2014; Ong et al, 2014)
• How acceptable is the new model?
• What does it mean for patients and health care professionals?
Control
practices
• Training at the end of the study
20. OA Template
0%
20%
40%
60%
80%
100%
% of times indicator entered when template used (n=828)
Edwards JJ, Khanna M, Jordan KP, Jordan JL, Bedson J, Dziedzic KS.
Quality indicators for the primary care of osteoarthritis: a systematic review. Ann Rheum
Dis. 2015 Mar;74(3):490-8.
21. OA Template
Effects on prescribing
Quality Indicator
achievement via an OA e-
template in primary care
Edwards JJ, et al. Quality of care for OA:
the effect of a point-of-care consultation
recording template. Rheumatology 2014
Edwards JJ, Jordan KP, Peat G, Bedson J, Croft PR, Hay EM, Dziedzic KS.
Quality of care for OA: the effect of a point-of-care consultation recording template.
Rheumatology (Oxford). 2015 May;54(5):844-53.
22. MOSAICS
8 General
Practices
• North West Midlands and South Cheshire
• NIHR CRN Primary Care West Midlands, Keele CTU
• OA Research Users Group [PPI]
Population
survey
• N=30,000 45 years and over
• Consent to follow up
• Permission for medical record review
Self reported
joint pain
• Hip, Knee, Hand, Foot
• Consultation for joint pain (OA or at risk of OA)
• Uptake of core NICE recommendations
23. Intervention practices
GP and Nurse Training Model OA consultation
Patient presenting
with joint pain
MOAC-1 first
consultation with
a GP
MOAC-2 follow up
consultation(s)
with a practice
nurse
OA Guidebook
24. Patient presenting with
joint pain 45 years and
over
GP makes, gives,
explains diagnosis,
analgesia, promotes self-
management, gives
guidebook, refers to
nurse
Practice Nurse supports
self-management;
guidebook; goal setting,
exercise, weight loss,
pain control
Model OA Consultation
Porcheret M, et al. Developing a model osteoarthritis consultation: a Delphi consensus exercise. BMC Musculoskelet Disord.
2013 Jan 16;14:25.
Finney A, et al. Defining the content of an opportunistic osteoarthritis consultation with primary health care professionals: a
Delphi consensus study. Arthritis Care Res. 2013 Jun; 65(6): 962-8.
Porcheret M, Main C, Croft P, McKinley R, Hassell A, Dziedzic K. Development of a behaviour change intervention: a case study
on the practical application of theory. Implement Sci. 2014 Apr 3;9(1):42.
25. Development of concrete
proposal for change
Analysis of performance: target
group and setting
Development/selection of
strategies and measures to
change practice / behaviour
Development testing and
execution of implementation
plan
Evaluate and if needed adapt
Porcheret M, Main C, Croft P, McKinley R, Hassell A, Dziedzic K. Development of a behaviour change intervention: a case study on
the practical application of theory. Implement Sci. 2014 Apr 3;9(1):42.
26. GP Training
• 4 practice-based sessions
• Practice mapping
• OA Update
• New approach
• Skills training x2
• Consultation aide-memoire
• Simulated consultations
27. OA Guidebook
Self management happens outside of primary care
consultations
Own experiences and lay networks are equally valid
Knowledge embedded in the clinical experience
Morden A, Jinks C, Bie Nio Ong. Lay models of self-management: how do people manage knee osteoarthritis in context? Chronic
Illn. 2011 Sep;7(3):185-200.
Grime J, Dudley B. Developing written information on osteoarthritis for patients: facilitating user involvement by exposure to
qualitative research. Health Expect. 2014 Apr;17(2):164-73.
28. OA Guidebook
‘to actually give them that [core
treatment] backed up with written
information I really think that makes a
difference to the impact’ (GP)
‘they’d read a little bit about what we were
going to do prior to coming to see me so all
I did was sort of reinforce the information
so that was good’ (Practice Nurse)
Morden A, Jinks C, Ong BN, et al. Acceptability of a 'guidebook' for the management of
Osteoarthritis: a qualitative study of patient and clinician's perspectives. BMC
Musculoskelet Disord. 2014 Dec 13;15:427.
29. Results
Control
0 months: n=237
3 months: n=210 (88.6%)
6 months: n=185 (78.1%)
12 months: n=172 (72.6%)
Intervention
0 months: n=288
3 months: n=260 (90.3%)
6 months: n=239 (83.0%)
12 months: n=212 (73.6%)
• N=525 consulters over 6 months
• Mean age 67.3 (10.5) years
• 59.6% Female
30. Intervention Control
Mean Mean Mean*
difference
95% CI p-value
SF-12 PCS
Post-consultation 36.49 36.48 - - -
3 months 38.03 38.12 -0.31 -1.87, 1.25 0.698
6 months 38.98 38.89 -0.38 -2.31, 1.54 0.696
12 months 38.78 39.22 -0.89 -3.33, 1.55 0.476
N=61 (21%) saw practice nurse
*(Intervention – Control) adjusted for age, gender, practice size and corresponding
baseline measures) (“Clustering” accounted for in the mixed model)
Primary and secondary outcomes
31. Treatment offered
WITHIN the first 6m of consultation
Intervention
n=288
Control
n=237
n (%) n (%) *Difference p value
OA quality indicators
Support self-manage joint problem 173(70.0) 125(62.5) 12.1 (0.9,20.8) 0.036
Info/advice on exercises, muscle
strengthening or physical activities 220(83.3) 138(67.9) 14.9 (5.1,21.7) 0.005
**Referral to services for losing weight 32(23.0) 15(12.8) 19.1 (5.1,37.4) 0.003
Information about drug effects provided 185(69.8) 162(74.7) -11.2 (-23.2,-0.2) 0.045
*(Intervention - Control) adjusted for age, sex and practice size
**applicable to participants who are overweight or obese
(“Clustering” accounted for in the mixed model)
32. Intervention
n=288
Control
n=237
n (%) n (%) *Difference p value
KNEST: Medication/Treatment prescribed/used
Anti-inflammatory tablets e.g. oral NSAIDS 168 (64.1) 162 (73.3) -14 (-26.5,-2.6) 0.015
Walking aids 113 (44.1) 114 (53.0) -15.6 (-26.5,-2.9) 0.015
Community Pharmacy 64 (25.6) 29 (14.7) 12.2 (2.1,25.1) 0.012
Muscle strengthening exercises 167 (64.9) 101 (48.3) 16.4 (4.8,26.5) 0.006
‡Education, advice and access to information 168 (65.6) 104 (50.5) 22.8 (11.7,31.7) <0.001
*(Intervention - Control) adjusted for age, sex and practice size
‡ comprises written or verbal information about joint problem, information about
treatments and advice on self-management of joint problem
(“Clustering” accounted for in the mixed model)
Treatment used
WITHIN the first 6m of consultation
33. Cost effectiveness
Model OA Usual care Difference 95% CI
NHS costs £227.72 £236.45 -8.73 -73.13, 57.66
Productivity
loss
£151.43 £187.77 -36.34 -234.33, 161.65
QALYs 0.631 0.634 -0.003 -0.03, 0.02
Visits to the orthopaedic surgeon were lower in the intervention arm
% participants who took time off work and the associated productivity cost
was lower in the intervention arm
Costs, QALYs and Productivity costs (Mean) over 12 months
34. Medical Records
WITHIN the first 6m of consultation
Intervention arm 4 practices = Control arm 4 practices =
6.0 (6.1) GPs 5.2 (6.1) GPs
Pts 45 yrs+ 10,240 (9174.8) Pts 45 yrs+ 6,983 (2060.7)
1118 patients in the intervention 842 patients in the control
Written Information
Intervention arm practices 1-4% to 15-28% Control arm practices 1-3% to 1-3%
written information on OA 4% to 28%
written exercise advice 4% to 22%
written weight loss advice 1% to 15%
35. Summary
• Model OA consultation
– improves Quality Indicators of OA care
– implements guidelines in primary care
• reduces NSAIDS and orthopaedic visits
– no additional cost
• Integrated GP and practice nurse consultation
– support for self-management
36. • 40 members of the MOSAICS team
• 8 practices
• 70+ practice visits
• 100+ hours of GP and nurse training
• 65 Health Care Professionals attended training sessions
• 11 317 consented to be contacted if they consulted
• 525 recruited to consultation survey over 6m
• 9 million consultation variables downloaded at baseline
• 8 individual consultation interviews
• 27 practice nurse consultations observations
MOSAICS Conference
37. I think it also gives you a few
more strings to your bow,
really, in terms of what you
can tell a patient, what you
can inform them, what we'd
be able to offer …….
Ong BN, Morden A, Brooks L, Porcheret M, Edwards JJ, Sanders T, Jinks
C, Dziedzic K. Changing policy and practice: Making sense of national
guidelines for osteoarthritis. Soc Sci Med. 2014 Apr;106:101-9.
….she asked me about some nodes on her
hand and it was, you know, the shape of her
hand and arthritic pain and you could see
that it was arthritis. So I was able to tell her
a bit about it and even give her a couple of
exercises to do.
38. 80 year old lady
‘She said her husband wouldn’t let her do anything. If the
doorbell rang .. ‘sit there you mustn’t move you’ve got
osteoarthritis’. When she came to me and I said I want to
get you moving she was over the moon it was like a new
lease of life..’
‘She’d got her guidebook - she used it quite a lot’
‘At her final consultation she virtually skipped into the
room. It was just brilliant to see her because she’d done
so well.’
Julie Broad, Nurse Practitioner, Autumn Conference 2013
39. 80 year old lady
‘She said her husband wouldn’t let her do anything. If the
doorbell rang .. ‘sit there you mustn’t move you’ve got
osteoarthritis’. When she came to me and I said I want to
get you moving she was over the moon it was like a new
lease of life..’
‘She’d got her guidebook - she used it quite a lot’
‘At her final consultation she virtually skipped into the
room. It was just brilliant to see her because she’d done
so well.’
Julie Broad, Nurse Practitioner, Autumn Conference 2013
41. Shropshire CCG
‘The MOSAICS study generated grass roots interest and support,
with GPs and practice nurses reporting greater confidence in
managing OA and patients feeling that their joint problems are
taken seriously.’
‘In addition, the health professionals realised that the core
management principles for OA are the same as those for other
long-term conditions (LTCs) and that the knowledge and skills
they developed were transferable across a range of LTCs.’
NHS England: OA Regional Innovation Fund
JIGSAW – Regional Innovation Fund
Joint Implementation of Guidelines for oSteoArthritis in the West Midlands
43. • Statement 1. Adults aged 45 or over are diagnosed with OA
clinically without investigations if they have activity-related
joint pain and any morning joint stiffness lasts no longer than
30 minutes.
• Statement 2. Adults newly diagnosed with OA have an
assessment that includes pain, impact on daily activities and
quality of life.
• Statement 3. Adults with OA participate in developing a
self-management plan that directs them to any support they
may need.
• Statement 4. Adults with OA are advised to participate in
muscle strengthening and aerobic exercise.
• Statement 5. Adults with OA who are overweight or obese
are offered support to lose weight.
• Statement 6. Adults with OA discuss and agree the timing of
their next review with their primary healthcare team.
• Statement 7. Adults with OA are supported with non-surgical
core treatments for at least 3 months before any referral for
consideration of joint surgery.
• Statement 8. Healthcare professionals do not use scoring
tools to identify which adults with OA are eligible for referral
for consideration of joint surgery
Quality Standard [QS87]
June 2015
44. JIGSAW-E will support primary care in five
European countries to address the unmet
needs of adults consulting for OA.
This will be achieved through the systematic
implementation of previously piloted
innovations in the West Midlands
JIGSAW-E ORGANIZATION NAME
Tony Davis, Rhian Hughes CI;
Professor Krysia Dziedzic PI
WM-AHSN, UK
Professor Sita Bierma-Zeinstra Department of General Practice Department of Orthopedics
University Medical Centre Rotterdam, Erasmus MC (EMC)
Professor Thea Vilet Vlieland Leiden University Medical Center (LUMC), The Netherlands
Richard Stone Medilink
Professor Kåre Birger Hagen/ Dr Nina
Østerås
Diakonhjemmet Hospital (DH), Oslo, Norway
Professor Ewa M Roos/ Dr Søren Skou University of Southern Denmark (DK)
Professor Sandra Pais/ Dr Clara
Cordeiro
University of Algarve, Portugal (UA)
45. This presentation presents independent research funded by the National Institute for Health Research
(NIHR) under its Programme Grants for Applied Research Programme (Grant Reference Number: RP-PG-
0407-10386.) The views expressed are those of the author(s) and not necessarily those of the NHS, the
NIHR or the Department of Health. KD is part funded by the National Institute for Health Research (NIHR)
Collaborations for Leadership in Applied Research and Care West Midlands and by a Knowledge
Mobilisation Research Fellowship (KMRF-2014-03-002) from the NIHR.
Acknowledgements: NIHR CRN Primary Care West Midlands, Arthritis Research UK, Arthritis Care,
Primary Care Consortium Board, the OA Research Users Group, the network, nursing, health informatics
and administrative staff at the Arthritis Research UK Primary Care Centre, the participating general
practices and NHS managers, the MOSAICS & JIGSAW teams and funders, our European collaborators
CLAHRC
West Midlands
Acknowledgements
Regional Innovation Fund
NHS England
Shropshire CCG
