1. COMPARING NEW QUESTIONNAIRES TO ASSESS PAIN, FUNCTION AND SATISFACTION
NICK HOWELLS
HONORARY LECTURER IN ORTHOPAEDIC SURGERY
MUSCULOSKELETAL RESEARCH UNIT
UNIVERSITY OF BRISTOL
UNITED KINGDOM

2. Introduction Evolution of Outcome Assessment Adverse Events reporting
Clinician Administered outcome assessment
Patient Reported outcome assessment
Disease Specific
General Health
Which Domains?
How Best to measure them
Objective Functional assessment

3. Hot Topic
Increased recent interest in outcomes assessment. IORS/EFORT/AAOS
OARSI/OMERACT Group recommendations
Pain Severity
Disability
Quality of Life
Validated, Standardised, Self-Assessment Questionnaires

4. Patient Reported Outcomes
Health Status Assessment
‘Patient-related-outcomes’ (PROMS) generally means self-assessment of health status
In musculoskeletal diseases this has led to extensive use of self-assessment measures of pain and function
Is this sufficient?

5. New Roles for PROMS New Roles for PROMS Established PROMS Use
Monitor Changes in joint Symptoms
Referral for Joint Surgery Assessment
Patient Decision for Surgery
Joint Replacement Surgery
6 month outcome of surgery
Long Term Surveillance of Failure

6. PROMS as predictors? 1523 THR, 1784 TKR OHS and OKS
No role in prediction of Patient Satisfaction
No role in Patient Selection
Judge et al JBJS Br

7. Hot Topic Huge variety in measures used
Lack of current consensus
Low-modest correlations
Combination of measures is good
Too many is not
Patient Burden
Time
Administration and Processing Burden
Riddle DL. Arth. Rheum 2008

8. Patient Reported Outcomes
Pain and function are often combined in ‘algo-functional’ measures
Makes some sense: Pain and function are inextricably linked in musculoskeletal disorders,
But
‘Function’ is complex
‘Weighting’ of domains is a problem

9. Patient Reported Outcomes
Reporting medians masks the poor outcomes
2085 TJR patients at 3-4 years post-operative1
Complete WOMAC Function Scale (0-100; worst to best)
Median score was 88 BUT 16% had severe disability
severe disability
Unpublished data from Avon Orthopaedic Centre

10. Problem Which PROMS to use? Which Domains to Measure?
Are newer PROMS any better than old PROMS?
Can a Consensus be reached?

11. Pain Assessment
Pain often considered the most important aspect of outcome but difficult to measure
Pain site, pain severity, pain distress, and the quality of pain can all be self-assessed by questionnaires
In orthopaedics we tend to concentrate on site and severity alone

12. Pain Assessment Pain and function are inextricably linked
Pain intermittent and variable
Pain elsewhere affects the perception of pain in ‘index’ joint
Pain distress not the same as pain severity
Adaptation and avoidance strategies affect pain
Gooberman-Hill et al Arth Rheum. 2007

13. Pain Assessment Sensitisation of pain pathways:
Local, spinal and cortical levels
Alterations in quality, severity and impact of pain
Severe sensitisation causes neuropathic- type pain
Neuropathic- type pain can be assessed with specific questionnaires – PainDETECT

14. PainDETECT Questionnaire
9 point Questionnaire
Scored -1 to 38
Score >19 neuropathic is likely
Developed in German, validated in English
Validated for use in Back Pain, Hip and Knee Osteoarthritis and following TKR
Freynagen. Curr Med Res Opinion 2006

15. ICOAP Questionnaire Intermittent and Constant Osteoarthritis Pain
OARSI initiative
Specifically designed to measure pain in patients with Hip and Knee OA
Measures constant and intermittent pain symptoms separately
Hawker et al. Osteoarthritis and Cartilage 2008

16. Research Pain Assessment
Domain Specific Pain Questionnaires
Quantitative Sensory Testing
Semi-objective measures of pain thresholds and pain sensitisation

17. Clinical Pain Assessment
We need simple ways of recording if pain is severe, how much it matters to the patient, and if it is getting better or worse, for use in clinical practice

18. Functional Assessment
International Classification of Functioning, Health and Disability (ICF) Framework
3 domains
Impairment
Activity Limitations
Participation Restriction
World Health Organisation, Geneva 2001

19. ICF Example- Using a Step
IMPAIRMENTS
Joint Movement
Pain
Muscle Weakness
ACTIVITY LIMITATIONS
Stairs
Getting on a bus
PARTICIPATION RESTRICTIONS
Inability to get to shops
Inability to visit grandchildren
World Health Organisation, Geneva 2001

20. Function Self-Assessment
Poor Correlation between self-report of function and objective tests
Prince et al. 2008
Poor Correlation between self-report of function and qualitative interviews
Campbell et al BMJ 2003
Poor Correlation between self-report of walking ability and timed walking test
Awaiting Publication. Bristol. ADAPT Study

21. Function Self-Assessment
Self Perceptions of functioning change with time and adapt to reduced ability
Response Shift
We like to please the person asking the questions
Floor/Ceiling effects

22. Function Self Assessment
Importantly These instruments do not assess what matters most to our patients

23. Participation in Society
New measures of participation, based on the ICF classification of disability are being developed (e.g. the Aberdeen measure)
Sense of being valued
New measures of what is of most value to people, such as the ICECAP, are being developed

24. Aberdeen Measure Ab-IAP
Aberdeen Impairment, Activity Limitation and Participation Restriction Measure (Ab-IAP)
35 item
Disease Specific
Uses ICF Framework to produce scores for Impairment, Activity Limitation and Participation Restriction
Pollard B et al. Health Qual. Life Outcomes 2009

25. HOOS/ KOOS OA-specific Extension of WOMAC with 5 subscales Pain
Other symptoms (e.g. stiffness, clicking)
Function in activities of daily living
Function in sports and recreation
Joint-related quality of life
Roos J Orthop Sports Phys Ther 1998
Nilsdotter BMC Musculoskelet Disord 2003

26. HOOS/ KOOS Assesses disability in higher function activities
Considers impact on quality of life
Improved responsiveness and less ceiling effect in comparison to WOMAC
Davis et al. Osteoarthritis and Cartilage 2009
Salvati et al Osteoarthritis and Cartilage 2011

27. Old KSS components poor reliability and responsiveness
2011 Knee Society Score
Old KSS components poor reliability and responsiveness
Shift in proportion of younger more active patients undergoing TKA
New Score
Objective and Subjective Score
Subjective Score has function, expectation and satisfaction domains- all patient reported
Noble, Scuderi et al. CORR 2012

28. 2011 Knee Society Score
Function inventory based on the Total Knee Function Questionnaire
Focus on activities including high-demand
Patient attributed importance and frequency of participation
International applicability?
Weiss, Noble et al. CORR 2002

29. Measure Yourself MYMOP
Measure Yourself Medical Outcome Profile 2
Patient generated. They rate:
2 symptoms concerning them
1 important activity restricted by the symptoms
+ General wellbeing, symptom duration and associated medication usage
Paterson C. BMJ 1996

30. Problem Which PROMS to use? Which Domains to Measure?
Are newer PROMS any better than old PROMS?
Can a Consensus be reached?

31. Thoughts Tools for researchers vs. Tools for clinicians Researchers
Disease and domain specific PROM questionnaires with consensus. Additional role Motion Analysis, QST
Clinicians
Needs and Values of the individual patient
What matters most to them e.g. MYMOP
In practice OA populations have varied range of other, often age related problems

32. Consensus
The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)
Core outcomes to assess Pain
The COMET (Core Outcome Measures in Effectiveness Trials)
Core outcome sets as minimum outcomes that should be measured and reported in research