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

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

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

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?

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

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. 2012 JBJS Br

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

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

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WOMAC Function Scale (0-100; worst to best) Median score was 88 BUT 16% had severe disability severe disability Unpublished data from Avon Orthopaedic Centre

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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