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Optimizing adherence in osteoarthritis rehabilitation trials
1. Optimizing adherence in
osteoarthritis rehabilitation trials
Rana Hinman BPhysio(Hons), PhD
Centre for Health, Exercise and Sports Medicine
Department of Physiotherapy
University of Melbourne
Australia
2. Disclosure information
• I have no financial relationships with
commercial interests to disclose
• My presentation does not include discussion
of off-label or investigational use.
3. What is adherence?
World Health Organization (2003)
“the extent to which a person's behaviour -
taking medication, following a diet, and/or
executing lifestyle changes- corresponds
with agreed recommendations from a
health care provider”
4. Seek healthcare
attention
Purchase exercise
equipment or
attend an exercise
facility
Perform exercises
- appropriate intensity
- repetitions/sessions
- sessions/week
Attend follow-up
appointments
Act on referrals to
exercise provider
Adjust dosage &
program
progressively
Adherence is complex….
7. Adherence in RCTs……
• Impacts trial outcomes
– Introduces variability into data, reducing power
– May lead to underestimation of treatment
efficacy
– Dismissal of a potentially useful therapy
• Influences generalizability of findings to
routine clinical practice
– Adherence in real world poorer than RCTs
9. Mean change in physical function over time.
Non-
adherent
Adherent
10. Walking distance
Highest-28.3 m more
Middle- 15.2 m more
Compared to lowest tertile at
6 months
WOMAC
Highest- 6.1 units more
Middle- 3.3 units more
15. Knowledge
Lack of
knowledge
about OA
Inadequate
instruction in
exercise
Lack of
knowledge
about exercise
benefits
Beliefs about
capabilities
Beliefs
symptom
severity
impacts
capability
Perceived
inability to
exercise due
to excess
weight &
comorbidities
Beliefs about
consequences
Belief exercise
has limited
effectiveness
for OA
Exercise will
result in
negative
consequences
(eg pain)
Environmental
context &
resources
Access to
facilities
Weather
Costs
Hills/stairs
Use of walking
aid
Transport &
parking
Intentions
Lack of
motivation
Laziness
Belief already
sufficiently
active
16. Knowledge
Education - OA, its
prognosis & core
treatments
Specific exercise
instructions
Verbal & written
resources; exercise
video clips
Counter
misconceptions
Information sharing
should be ongoing
Beliefs about
capabilities
Ask about, &
acknowledge,
patient concerns
Reassurance &
education
Tailor exercise- use
a graded approach
Physical skill
development
Goal setting &
improvements
Beliefs about
consequences
Education- benefits
& harms; relative to
other treatments
Realistic
expectations about
timeframes
Myth busting!
Patient “stories”
Environmental
context &
resources
Shared decision-
making
Where & how to
purchase
equipment; access
facilities
Home-based
programs
Environmental
restructuring
Intentions
Readiness for
change- find a
motivator!
Motivational
interviewing
Planning- when?
How to overcome
potential
obstacles?
Review &
monitoring exercise
adherence-trouble-
shooting!
17. Interventions to increase
exercise adherence?
Few interventions have been tested in RCTs:
– Motivational programs- YES (LBP)
– Behavioural counselling- NO (LBP)
– Behavioural graded activity- YES (OA)
– Goal setting- NO (OA)
– Action coping plans- NO (OA)
– Audio/video cues- NO (OA)
Nicolson et al Brit J Sports Med 2017
18. Activity monitor & feedback system
Written exercise instructions
Behavioural exercise program with booster
sessions
Goal setting
Peek et al Physiotherapy (2016)
19. Adherence strategies will differ in
explanatory vs pragmatic trials
Describe adherence strategies used
Record adherence to intervention
Consider extent to which monitoring
adherence influences behaviour
21. Physio consults
“5-10 consults over 6
months”
Mean (SD)=
6 (2) calls with physio
Online PCST
“1 module per week
for 8 weeks”
Mean (95% CI)=
6.4 (5.7 to 7.0)
completed
Footwear
“Wear at least 4
hrs/day for 6 months”
Mean (SD)=
7.5 (3.2) hrs/day
Bennell et al Ann Int
Med (2017)
Hinman et al (under
review)
Hinman et al Ann Int
Med (2016)
22. Physio consults
“5-10 consults over 6
months”
87% people adherent
(5 or more calls)
Online PCST
“1 module per week
for 8 weeks”
66% people adherent
(completed all 8
modules)
Footwear
“Wear at least 4
hrs/day for 6 months”
88% people adherent
(wore shoes for at
least 4 hrs/day)
Bennell et al Ann Int
Med (2017)
Hinman et al (under
review)
Hinman et al Ann Int
Med (2016)
23. McLean et al Rheumatol 2017
234 approaches to
measuring exercise
adherence were
identified.
49 clearly described
or named
(reproducible)
scales
10 articles providing
evidence for only 7
scales
Clear recommendations for the assessment of exercise adherence in MSK populations cannot be
made.
Evidence for the short-listed measures was mostly limited or not available.
Exercise adherence measures
24. Nicolson et al JOSPT 2018
1. Exercise diary
2. Numerical rating scale:
“Overall I have been doing my exercises exactly as I
was asked to by my physiotherapist (number of
sessions and number of exercises)”
0=Strongly disagree to 10=Strongly agree.
25. Diaries-over-estimate by 20%, questionable validity
NRS- limited validity, neared but did not meet
acceptable test-retest reliability
27. Giggins et al J NeuroEng Rehabil 2014
Inertial sensors
Accurate at
distinguishing
between correct
& incorrect
exercise
technique
28. Rathleff et al J Physiother 2016
Elastic band sensors
Riel et al BMC Musc Dis 2016
Valid & reliable for measuring
exercise quality and quantity
29. Cheung et al J PLoS One 2017
Force sensors in insoles
Used to measure
footstrike
patterns
30. Gamification
• Commercially available systems:
– Nintendo Wii with Wii Fit/Sport
games, Wii Balance Board
– Xbox Kinect
• Balance training, strength,
endurance, fitness,
proprioception
Valenzuela et al J Geriatr Phys Ther 2018
31. App-based exercise
Bennell et al Am J Phys Med Rehabil (2019)
https://www.physitrack.com
n=305 with MSK conditions
Outcome Physitrack Usual methods
Adherence to number of
exercise sessions (0-10)
7.4 (0.2) 6.4 (0.2) **
Confidence to exercise (0-10) 9.0 (0.1) 8.4 (0.2)**
32. SMS to support adherence
Hall et al Annu Rev Public Health 2015
Systematic review of systematic reviews:
- Greater weight loss
- Increase in physical activity
Limited evidence to inform effective
intervention characteristics
33. SMS to support home exercise
Nelligan et al (under review)
34. Trial design considerations
• Involving patients in design of research
• Pre-trial feasibility/pilot
• Identify & ?exclude poor adherers at outset
– “Run-in” period
– Consider stratification based on adherence
• Pre-specify post hoc analyses based on adherence
– Per protocol analyses, sub-group analyses, sensitivity
analyses modelling under scenarios of adherence
– A priori definition of adherence