Patient Reported Outcomes – What are they & why are they
important?Dr Keith Meadows
DHP Research & Consultancy Ltd
Overview
• The new policy context
• What are outcomes?
• How can outcomes be measured?
• What are the opportunities that PROM data presents?
• What More Needs to be done to Improve Outcome Assessment & Feedback?
The New Policy Context
“Despite a century of developments in medical technology, and vast improvements in the ability of medical science to prevent, diagnose and treat disease and ill health, attempts to measure the outputs of health care in terms of their impact on patients’ health have not progressed beyond Florence Nightingale’s time.”
Getting the most out of PROMs Kings Fund 2010
A Fundamental Shift in Focus – The Policy Context
• Darzi Review – “ High Quality for All”
• NHS White Paper - Liberating the NHS Equity and excellence: Liberating the NHS
• Appraisal of new technologies (FDA, NICE) PRO data is now common place in the evaluation of new technologies
• April 2009 - Routine measurement of PROMs pre/post elective surgery (DH PROMs Programme)
• 2010 - DH Long Term Conditions PROMs Programme - 6 LTCs in feasibility study: Asthma; COPD; Diabetes; Epilepsy; Heart Failure; Stroke
… the NHS will be the first health care system in the world to measure what it produces in terms of health, rather than in terms of the production of health care.Getting the most out of PROMs Kings Fund
What are Outcomes?
Health Outcomes – A definition
“Outcomes, by and large, remain the ultimate validation of the effectiveness and quality of medical care." Avedis Donabedian 1966
The ultimate measure by which to judge the quality of medical effort is whether it helps patients (and their families), as they see it.Berwick 1997
But!!
“Different perspectives on outcomes need to be acknowledged. For instance, patients, carers and clinical staff may have different views of what outcomes are important, how you would measure them, and even which were desirable”
Long A, Jefferson J 1999
Levels of Outcomes
• Micro – Outcomes for an individual patient
• Messo – Outcomes for groups/samples of patients
• Macro – Outcomes for the whole population
Sources of outcome
Patient Outcome Assessment
Clinician reported CaregiverPhysiological Patient reported
What are PROMs?
Definitions
• Patient reported outcomes (PROM’s) are outcomes known only to the patient
• Patient reported outcome measures (PROM’s) are tools we use to measure patient outcomes
Why consider the patient’s perspective?
If quality is to be at the heart of everything we do , it must be understood from the perspective of the patient’
‘Just as important (as clinical measures) is the effectiveness of care from the patient’s own perspective which will be measured through patient-reported outcome measures’
Next Stage Review 2008
And also…
• Patients know better – ‘We know little of the clinical outcomes of NHS services from the patient’s perspective. PROM’s fill this gap’ DH 2007
• Clinical outcomes not always related to how the patient feels
• Patients like to be asked
• NHS White Paper
Variations on a theme
• Health status
• Health-related quality of life (HRQoL)
• Well-being
• Health outcomes
• Quality of life
• Satisfaction
How can Outcomes be Measured?
Generic and condition specific - strengths and weaknesses
Generic
• Suitable for the general population
• Comparisons with other conditions/disease groups
• Content may be redundant for certain condition/illnesses
• Not sensitive to detecting disease-specific issues
Condition-specific
• Specific to disease group
• Sensitive to detecting clinically significant changes
• Content relevant to target group
• Cannot compare with general population
Index v Multidimensional
• Overall score (but can be graded)
• Less information
• ?Easier to score
• Appropriate for cost-benefit analysis
• Provides a profile
• Reflects the important/different components of the illness
• Provides more information
• Can be long
What are the opportunities that PROM data presents?
PROM Stakeholders
GovernmentCharities
Professional bodies
Providers
Patients
Commisioners
Health care professionals Pharma
PROMs
What can PROM’s tell us?
• Which is the best treatment for the condition?
• Is one subgroup of the population sicker than the others?
• Is an individual patient’s condition getting better?
After Coulter A 2008
Some specific applications
• Personalised care planning
• Self-assessment
• Annual review
• Informed decision making • Population health
General applications
• Measurement of the patient’s health status or health-related quality of life (HRQoL) at a single point in time
• PROMs are used to derive measures of the outcomes of specific interventions.
• Changes in health status or HRQoL at two different points in time (e.g. before and after an operation) can be used to derive a measure of the impact of health care interventions.
• Certain PROMs suitable for purposes of economic evaluation (e.g., estimation of quality-adjusted life years – QALYs)
Hypothetical example of benefits of treatment
25 30 45 50 55 60 65 70 75
Anxiety summary score (higher scores better health)
Pre-treatment
3 months later
People of similar age & treatment UK sample
Linking PROM Research, guidelines & Routine practice
Guidelines based on
research outcomesRoutine practice
Research using PROMs
Some Caveats
Some Practical Issues
• Resources and staff time need to be set aside for training and receiving feedback
• Resources and personnel to analyse and present outcomes, case-mix and, where available, intervention data to clinical teams
Principles in Routine Measurement of Health Outcomes
• All three dimensions (context, intervention as well as outcomes) must be measured in order to understand outcomes data
• The reliability & validity of any measure of health status must be known so that their impact on the assessment of health outcomes can be taken into account
• Data collected must be fed back to maximize data quality, reliability and validity.
What More Needs to be done to Improve Outcome
Assessment & Feedback?
What needs to be done to improve outcome assessment and feedback?
• Ensure instruments, data collection and analysis is highly credible
• Data must be relevant
• Data collection affordable and practical to collect and not affect the care process
• Instrument validity and reliability
• Feedback useful & relevant to different users and decision making
• Develop & support processes for users to act on information
Some Key Questions• How can we best embed PROMs into the decision making process?
• What are the practical issues to overcome?
• Do PROMs tell us everything we need to know?
• How can we combine PROM data with other clinical data?
• Do clinicians ‘want’ or ‘believe’ in PROMs?
• What are the most effective ways to provide feedback?
PROM Research Priorities(PROMs Identifying UK Research Priorities- MRC Workshop 2009)
• Define the most appropriate domains within PROMs
• To address gaps in the currently available PROMs
• Develop guidelines for the use of PROMs in research
• Understand the impact of changes in PROMs on health functioning
Summary
• Culture shift towards the use of PROMs
• Potential gains from PROMs can be substantial but:
- Instruments and methods of data collection must be credible
- Analysis and feedback must be relevant and specific to the different needs
- A lot of challenges remain
AddendumAn Example from Diabetes
The Diabetes Health Profile (DHP)
A diabetes specific self-completion questionnaire for measuring the psychological and behavioural impact of living with diabetes for people with diabetes 18 years and older.
Completed by nearly 8,000 patients across the UK and Europe.
What does the DHP measure?
The sub-clinical psychological and behavioural problems experienced by people who live with diabetes - which often go undetected in a clinical setting but, nevertheless can have a significant impact on wellbeing and management of the disease.
Diabetes Health Profile Conceptual Model© DHP Research & Consultancy Limited 2010© DHP Research & Consultancy Limited 2010
Impact
Management Treatment Symptoms Diet Complications
Diabetes
Emotional Behavioural
Anxiety MoodLimitations in
Social/workfunctioning
Eating behaviour
DHP
What does the DHP Measure?
Psychological distress
Barriers to
activity
Disinhibitedeating
dysphoric mood, irritability, feelings of hopelessness
anxiety, perceived impairment, restrictions in activity
Lack of eating restraint, eating in response to emotional arousal and
external food cues
Two versions of the DHP
DHP-1818-items
DHP-132-items
Type1 and insulin requiring
Type 1 & Type 2 including tablet, diet
DHP-18 Conceptual Framework
Psychological distress
Lose temper/shout
Moody due to diabetes
Lose temper over testing
Lose temper over small things
More arguments at home
Days tied to meal times
Food controls life
Difficult staying out late
Worry about colds and flu
Get edgy when nowhere to eat
Don’t go out when sugars are low
Depressed due to diabetes
Worry going into busy shops
Eat to cheer self up
Hard saying no to food
Eat extra when bored/fed up
Not so many nice things to eat
Easy to stop eating
Barriers to activity
Disinhibited eating
How is the DHP scored?
Items scored using 4-point Likert type scale (range 0-3)
Standardised subscale scores 0 (no dysfunction) thru 100 (max dysfunction)
Standardised populations means
DHP-18 - Description of very high and very low BA, PD and DE scale scores
Scale Very high Very low
PD Frequent and or substantial emotional distress including dysphoric mood, irritability and externally directed hostility
None or little experienced lowered mood or feelings of expressed hostility
BA Very significant levels of anxiety restricting behaviour and perceived limitations in social/role activities
Little or absence of restricting anxiety or perceived limitations in social/roles
DE Substantial and or frequent levels of eating in response to food cues and emotional arousal. Excessive eating.
Absence of eating in response to food cues and or emotional arousal. No excessive eating.
If you would like to discuss how DHP Research can help you to use and analyse Patient Reported Outcomes for healthcare, pharmaceutical or biotech, or would like more information on the DHP, please get in touch.
Email: [email protected]
Mobile: +44 (0) 796 022 8124
Tel: +44 (0) 208 467 3739
Website: www.dhpresearch.com
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