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This lecture was given by Dr Marta Buszewicz, General Practitioner from North London and Senior Lecturer in Community Based Teaching & Research at UCL, to the North British Pain Association Spring Scientific Meeting in Edinburgh on Friday 18th May, 2007. Her lecture forms part of a conference "Blurring the Boundaries - Managing Pain in Primary Care and Secondary Care".
Citation preview
Does Arthritis Self-management Help?
A Randomised Controlled Trial of an Arthritis Self-
Management Programme in Primary Care
The Trial
Grant Holders:
Marta Buszewicz, Greta Rait, Mark Griffin University College London
Andy Haines London School of Hygiene & Tropical Medicine Julie Barlow University of Coventry
Project Manager: Angela Atkinson UCL
Health Economists: Jeni Beecham, Anita Patel Centre for the Economics of Mental Health
Intervention provided by Arthritis CareRCT funded by the MRC
Contents of Presentation
Background to the DASH trial
Study design
Working with the voluntary sector
Results
Discussion points
Background Osteoarthritis is a common & chronic condition,
causing: Pain & functional disability Anxiety & depression Lowered quality of life
It is associated with high direct (medical) & indirect (social & community costs Estimated total cost of £ 5.5 billion in 1999-2000
Perception that ‘medical’ treatments do not address many problems patients have
Previous results from studies examining arthritis self- management programmes
in the USA & UK
Improvements in anxiety & depression, exercise taken, sense of control over arthritis & better communication with doctors (reduced pain in some studies)
Sustained use of self-management techniques
Decrease in visits to doctors (in some studies)
Results so far with volunteer patients only
Recent systematic reviews raise some queries about methodology and effect sizes
Arthritis Self-Management Programmes (ASMPs)
Developed in the USA – started pragmatically, but theoretical basis in Bandura’s self-efficacy theory
People with arthritis are a resource – have innate problem solving skills
Effective self-management techniques are taught by trained volunteers who have arthritis
Key component is building on small experiences of mastery with peers
“Challenging Arthritis” (ASMP delivered by Arthritis Care)
Six, weekly, structured group sessions
Education about condition & its management
Help individual to develop individual behavioural and cognitive strategies
Aim to improve communication with family & health professionals
Quality assured
‘Expert Patients’ Initiative
UK government initiative to address living with chronic diseases – first introduced in 2002 Expert Patients’ Programme
Generic self-management programmes Based on Lorig’s US self management programmes
Funded initially by the government via PCTs National roll-out before pilot evaluations complete No clear evidence of cost-effectiveness Recent RCT results very similar to ours for ASMP
Study Objectives
To assess whether, for primary care patients in UK, with GP diagnosis of osteoarthritis:
participation in ‘Challenging Arthritis’ groups improves quality of life (1o outcome)
participation affects pain, function, control over symptoms, anxiety or depression (2o outcomes)
the intervention is cost-effective
(also a qualitative arm led by team in Coventry)
Study Design Randomised controlled trial
• Intervention: Challenging Arthritis course + education booklet
• Comparison: Education booklet only
Sample size• 1000 patients aimed for from power calculation• Recruited from the MRC GP Research Framework & other
primary care research networks
Selection of practices• Availability of ‘Challenging Arthritis’ nationally
Inclusion & Exclusion Criteria
Age 50 years or above
GP diagnosis of osteo-arthritis of knees and / or hips
Problems for 1 year+
Significant pain & disability in past month
Too immobile to attend course
Knee / hip pain under investigation
Referral for OA surgery
Neurological signs
Inability to complete questionnaires
Outcomes to be Measured
Measured at baseline, 4 & 12 months
10 Quality of Life (SF 36) 20
Pain, Functional Disability (WOMAC)
Control over Symptoms (arthritis self-efficacy)
Anxiety and Depression (HADS)
Cost-effectiveness (CSRI)
Health Status (Euroquol)
Patient Identification & Recruitment
Nurse computer searches Read code diagnoses Repeat prescriptions for NSAIDs & analgesics
GP identification Patients seen in surgery over 4-6 week period
Letter sent to potential participants inviting for :Research nurse interview
Eligibility checked, consent & baseline questionnaires
Followed by contact with Project Manager Telephone randomisation and course information sent
Qualitative methodology
Sample of the intervention group interviewed
Baseline, 4 & 12 months Purposively sampled for age, gender, ASE score Initially 30 patients – complete interviews on 17
Aims: To examine patients’ perceptions and attitudes towards
the ‘Challenging Arthritis’ intervention To explore how they felt about being referred to an ASMP
via their general practice
Collaboration with the Voluntary Sector
DASH was the first MRC trial working with the voluntary sector
Arthritis Care is a national voluntary organisation supporting people with arthritis – activities include -
Support, education and campaigning Delivery of ‘Challenging Arthritis’ & other courses
Arthritis Care
Structure of organisation Initially centralised & hierarchical Paid management & unpaid volunteers Funding for Challenging Arthritis courses
Aim to be self-funding, including ‘central costs’Contracts traditionally set up with HAs and other
organisationsAim to add to evidence in support of CA courses
Analysis Plan
Participants analysed in randomisation group originally assigned to (ITT), with imputation of missing data
Primary comparison evaluated the long-term effects of the intervention @ 12 months
Analysis of co-variance (ANCOVA) accounting for baseline score with multiple imputation
• Further Analyses ‘Per protocol imputation’ – accounting for compliance with
intervention (>= 4 sessions) Analysis of data on those with ‘complete’ data only
Results - recruitment
B aseline
4 m onths
12 m onths
N ot elig ib le(n = 166)
R efused(n = 1027)
N o response(n = 776)
N ot elig ible at in terv iew(n = 35)
R efused(n = 75)
R esponse ra te 72%(n = 294)
R esponse ra te 76%(n = 307)
R esponse ra te 95%(n = 386)
In te rvention(n = 406)
R esponse ra te 80%(n = 325)
R esponse ra te 84%(n = 340)
R esponse ra te 94%(n = 382)
C ontrol(n = 406)
R andom ised(n = 812)
Patients attending screening in terview(n = 922)
Patients aged > 50 approached w ith possib le O A of h ips/knees(n = 2891)
Intervention n=406
Control n=406
Age (yrs) Mean (S.D.)
68.4 (8.2) 68.7 (8.6)
Gender Female
255(62.8%)
255(62.8%)
Owner Occupier 323(82.6%)
302(78.6%)
Ethnicity White
388(99.5%)
382(99.2%)
Age left school < 16 years
249(63.8%)
259(67.6%)
Higher education
107(27.6%)
102(26.7%)
Results – baseline characteristics
Results – Challenging Arthritis course attendance
219 people in the intervention group (56 %) attended >= 4 intervention sessions
29% did not attend any of the sessions
OUTCOMES Adjusted difference in means & (95% C.I.) at 4 months
Adjusted difference in means & (95% C.I.) at 12 months
SF 36 MENTAL HEALTH Intention to Treat (ITT)Per protocol analysis
0.11 (-1.18,1.40) 0.82 (-0.94,2.57)
1.35 (-0.03, 2.74) 1.56 (- 0.28, 3.39)
SF 36 PHYSICAL HEALTH Intention to Treat (ITT)Per protocol analysis
0.22 (-1.5, 1.94) - 0.37 (-2.02,1.28)
0.33 (- 1.31, 1.98)0.24 (- 1.63, 2.11)
WOMAC PAIN Intention to Treat (ITT)Per protocol analysis
- 0.15 (- 0.57,0.28) - 0.30 (- 0.79,0.19)
- 0.33 (- 0.78, 0.13)- 0.47 (- 1.05, 0.10)
WOMAC STIFFNESS Intention to Treat (ITT)Per protocol analysis
- 0.05 (-0.28,0.17) - 0.12 (- 0.36,0.11)
- 0.17 (- 0.43, 0.09)- 0.13 (- 0.40, 0.14)
WOMAC FUNCTIONIntention to Treat (ITT)Per protocol analysis
- 1.22 (- 2.59, 0.16) - 0.80 (- 2.24, 0.63)
- 1.17 (- 2.84, 0.50)- 0.95 (- 2.63, 0.74)
HADS ANXIETY Intention to Treat (ITT)Per protocol analysis
- 0.36 (- 0.76,0.05) - 0.68 (- 1.15,- 0.20) *
- 0.62 (-1.08,- 0.16) *- 0.72 (-1.24,- 0.21) *
HADS DEPRESSION Intention to Treat (ITT)Per protocol analysis
- 0.40 (- 0.76,- 0.03) * - 0.57 (- 0.96,- 0.18) *
- 0.41 (- 0.82, 0.01)- 0.33 (- 0.76, 0.10)
ASE - PAIN Intention to Treat (ITT)Per protocol analysis
1.63 (0.83, 2.43) * 2.55 (1.56, 3.56) *
0.98 (0.07, 1.89) * 1.43 (0.37, 2.48) *
ASE - OTHER Intention to Treat (ITT)Per protocol analysis
1.83 (0.74, 2.92) * 2.81 (1.74, 3.87) *
1.58 (0.25, 2.90) * 1.54 (0.48, 2.60) *
Outcome plots - positive difference in means favours
treatment :
Adjusted Difference in Means
Adjusted Difference in Means
95% CI 95% CI
4 mth intention to treat 0.81 [-0.84, 2.46] 12 mth intention to treat 2.15 [0.15, 4.15]
-4 -2 0 2 4 Favours control
Favours treatment
Adjusted Difference in Means
Adjusted Difference in Means
95% CI 95% CI
4 mth intention to treat 0.12 [-2.05, 2.28] 12 mth intention to treat 0.53 [-1.51, 2.58]
-4 -2 0 2 4 Favours control Favours treatment
SF 36 Mental Health
SF 36 Physical Health
Outcome plots continued
ASE Pain
ASE Other
Outcome plots - negative difference in means favours
treatmentHADS Anxiety
HADS Depression
Outcome plots continued
Adjusted difference in means
Adjusted difference in means
95% CI 95% CI
4 mth intention to treat -0.34 [-0.89, 0.20]
12 mth intention to treat -0.38 [-0.89, 0.13] -1 -0.5 0 0.5 1
Favours treatment Favours control
Adjusted Differencein Means
Adjusted Differencein Means
95% CI 95% CI
4 mth intention to treat -0.15 [-0.37, 0.08]
12 mth intention to treat -0.16 [-0.40, 0.09] -1 -0.5 0 0.5 1
Favours treatment Favours control
Adjusted Difference in Means
Adjusted Differencein Means
95% CI 95% CI
4 mth intention to treat -1.28 [-2.97, 0.40]
12 mth intention totreat
-0.88 [-2.91, 1.14] -4 -2 0 2 4
Favours treatment Favours control
WOMAC Pain
WOMAC Stiffness
WOMAC Physical Functioning
12 Month Results - Summary
Small non significant change in SF-36 mental health scale
Significant differences occurred in: Reduced anxiety Improved self efficacy – pain and ‘other’
No significant change in: Function, pain, stiffness, depression (after 4 months) GP/nurse attendance & costs of medication Number of ‘clinically’ anxious participants No significant differences in other health & social care costs
Economic Evaluation
No significant differences between groups at 12 months in: Costs to statutory services (health & social care) Costs to patient, family, friends Indirect costs – time off work (patient / carer) Total costs – including & excluding ASMP cost
Cost effectiveness Acceptability Curves (CEACs) Small advantages on SF-36 translated into low incremental cost-effectiveness ratios & high probabilitiesof cost effectiveness for societal costs, but not health /social care costs
Cost-effectiveness conclusions based on QALYs incremental cost / QALY exceed range suggested by NICE
Summary / Discussion (1)
Does arthritis self-management work? Statistically significant, but small changes in anxiety and
ASE at 12 months (and mental health SF 36 on straight imputation)
Trend in all outcomes favouring the intervention What do these mean (a) clinically (b) for patients
Qualitative work suggests
? patients recruited from primary care less severely unwell & several interviewed already self-manage
Summary / Discussion (2)
How does the intervention work? How might the intervention impact on anxiety and
self-efficacy in terms of a complex intervention Is it a mental health intervention? Are there a sub-group likely to do particularly well
Economic Evaluation Should this be supplied on the NHS as it stands ?
Policy What does this mean for the Expert Patient
Initiative advocating self-management courses for a range of chronic diseases and funded by PCTs?