Sep 26-2013-webinar-diabetes-final-a
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Transcript of Sep 26-2013-webinar-diabetes-final-a
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19 Sep 2013 Patient Reported Outcome
(PRO) Measures in Diabetes
Clinical Trials
© Copyright 2013 CRF Health
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Paul O’DonohoeDirector, Health Outcomes – CRF Health
—Paul O’Donohoe is Director of Health Outcomes at CRF Health and is based in their London office. He is responsible for developing the company’s internal scientific expertise and supporting the scientific consulting being offered to clients.
Previously Paul worked as a research psychologist at a child and adolescent mental health clinic based in Dublin, Ireland. He moved into the health consulting field with United BioSource Corporation where he worked across the health outcomes, health economics and health data capture groups.
Today’s Presenters
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Dr. Keith Meadows PhDPhD – DHP Research
—Keith is a Health Psychologist with over 25 years of research experience and has held a number of senior academic and UK NHS research positions.
Prior to setting up DHP Research & Consultancy, Keith was Associate Director of the North East London Consortium for Research & Development (NELCRAD). Keith's specialist areas include, the psychological impact of living with diabetes and patient reported outcome measurement.
Keith has published widely, and presented papers at major conferences.
Today’s Presenters
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• The psychological impact on adherence and control
• PROs in real world data collection
• Disease-specific versus generic -- making the choice
• The Diabetes Health Profile (DHP) and what it measures
Learning Objectives
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Global Diabetes impact
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Half of the people withdiabetes don’t know they have it
Global Diabetes facts
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Diabetes in the UKUK Diagnosed
2.9 million diagnosed with diabetes by 2011
Diabetes type
10% of people with diabetes have
Type 1
90% of people with diabetes have
Type 2
Financial costs
£192 million a week spent by the NHS
The impact
Deaths due cardiovascular disease
Type 1 Deaths due to kidney disease
Of people die within 5 years of an amputation
52%
21%
70%
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Diabetes in the UK
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The Psychological Impact of Living with Diabetes
The facts
“Yet there is little routine psychological
support for people with diabetes.”
Diabetes UK
of the population in Britain have depression at any one
time
10%
However,
…and the risk is higher for women than for men
according to Diabetes UK, people with
diabetes are twice as likely to
experience depression…
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ANXIETY
aggression
Denial
Eating problems
disruption to social and professional life
POOR QUALITY OF LIFE
Therapy non adherence
The Psychological Impact of Living with Diabetes
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PROs in a Real World Setting Need for real world data driven by changing regulatory environment,
drug safety and efficacy
Provides greater external validity
Identification of factors leading to treatment non-adherence and drug ineffectiveness
Evaluate adherence to treatment guidelines
Enables clinicians to tailor treatment regimens based on patient needs
Increase treatment adherence as part of patient support programmes
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A PRO Measurement Strategy
Identify primary and secondary outcomes relevant to treatment or intervention
Identify key treatment effects and outcomes
Develop endpoint model
Select appropriate Patient reported outcome (PRO) measure
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Often based on previous use in other studies
Name of PRO appears to be appropriate
PRO (health status, QoL, HRQoL, well-being) concepts used interchangeably
Common Practice Health status = quality of
health e.g. functional impairment (SF-36)
QoL = individual’s subjective evaluation of psychological, physical & social aspects of their life
HRQoL = treatment and illness perceived as impacting on areas of life considered important
PRO Measurement concepts
Selecting the appropriate PRO
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Generic and Condition-specific: Making the Choice
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
Generic Specific to disease group
Sensitive to detecting clinically significant changes
Content relevant to target group
Cannot compare with general population
Condition-specific
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The Wilson-Clearly Conceptual model of HRQoL
Characteristics of the individual
Biological & psychological
status
Symptom status
General health
perceptions
Functional status
Overall quality of life (QoL)
Characteristics of the environment
Wilson IB and Cleary PD, Linking clinical variables with health-related quality of life. JAMA 273: pp59-65. 1995
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A Simplified PRO Conceptual Framework
Item 1Item 2Item 3Item 4Item 5
Item 6Item 7Item 8Item 9
Item 10Item 11Item 12
Domain Ascore
Domain Bscore
Domain Cscore
Also known as a content map/ measurement model
Specifies how items fit together in a PRO to produce a domain score
Developed during development of PRO – focus groups/literature review, patient interviews
Validated through a process of psychometric validation
FDA requirements specify that labelling of a domain has to be meaningful with respect to all the items in the domain
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Simplified Endpoint Model for Reducing Hypoglycemia
Desired claims:
1. Reduction in symptoms
2. Improvement in HRQoL
Reduction in hypoglycaemia
Improved HRQoL
• Sweating• Fatigue• Trembling• Dizziness
• Lowered anxiety• Improved mood• Increased social
activity
MeasurePRO Measure
MeasureSymptom checklist
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Interrelationship
EndpointModel
Clinical Endpoints
PRO Endpoints
PRO Conceptual
Framework(s)
ConceptualModel
Label/value claim
between PRO Conceptual Framework, Endpoint Model and Label/Value Claim
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The Diabetes Health Profile (DHP)
Representing research spanning over 20 years, the Diabetes Health Profile (DHP) is a diabetes-specific patient reported outcome measure (PROM) developed in accordance with FDA Guidelines and available in 29 languages.
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The Diabetes Health ProfileThe conceptual model
diabetes
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Conceptual Framework for the DHP-1 and DHP-18
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The Diabetes Health Profile (DHP-18)
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The Diabetes Health Profile (DHP-18)
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Previous and Current Users of the DHP
10,000Type 1 & Type 2
RespondentsHave completed the
DHP-1 / DHP-18
More than
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Living with diabetesInterpreting the DIABETES HEALTH PROFILE (DHP)
91% Type 2 and 9% Type 1 patients completed the
questionnaire.
55% 45%
77%Of patients experiencing three severe hypoglycaemic episodes reported their days are tied to meal times.
59%Of patients experiencing one severe hypoglycaemic episode reported their days are tied to meal times.
Oral
Insulin
44 46 48 50 52 54 56
Disinhibeted eatingPsycholigical distressBarriers to ac-tivity
Score 0=No dysfunctioning p<0.05
DHP domain scores by treatment modality
63.9 years
Mean age
Patients (mean) scores on the Disinhibited eating domain by BMI
BMI<25
BMI25-34
BMI>35
47.849.2
52.435-44 45-54 55-64 65-74 >75
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Patients re-porting severe hypoglycaemic
episodes
Barriers to activity domain scores
3173
Score 0=No dysfunctioning p<0.05 Score 0=No dysfunctioning
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Getting an in-depth look at diabetes with the DHP-18
Psychological distress
Barriers to activity
Disinhibited eating
MOST AT RISK
MOST AT RISK
MOST AT RISK
• Comorbidity
• Severe hypoglycaemia
• Female
• > Age
• Visit to the psychiatrist
• Younger women
• Forgetting to take insulin
• Unaware of HbA1 level
• Visit to the psychiatrist
• Severe hypoglycaemia
• Other health issues
• Visit to the psychiatrist
Frequent and or substantial emotional stress including: dysphoric mood, irritability and externally directed hostility.
Very significant levels of anxiety restricting behaviour and perceived limitations in social/role activities
Substantial and or frequent levels of eating in response to food cues and emotional arousal.
Hard saying no to food you like
Eat to cheer self up
Depressed due to
diabetes
Food controls life
Represents high scores
Yes53%
Yes50%
Yes 69%
Yes69%
PD BA DE
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Interpreting the Diabetes Health Profile
The minimally important difference (MID) is the smallest score difference on the Diabetes Health Profile that represents the minimal clinically significant difference.
The required MID change in score for the DHP-18 domains
Psychological distress
7 – 11
Barriers to activity
Disinhibited eating
6.5 – 9.9
7.5 – 11.4
Investigating the minimally important difference of the Diabetes Health Profile (DHP-18) and the EQ-5D and SF-6D in a UK diabetes mellitus population. Mulhern B and Meadows K. Health 5: 1045-1054,2013
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Current Developments
First stage in the development of DHP-18 results dashboard
Mapping the Diabetes Health Profile (DHP-18) onto the EQ-5D and SF-6D generic preference based measures of health
Integration of DHP-18 into holistic assessment of needs programme for Type 1 and Type 2 patients
Continuing subgroup and predictive analysis to support individualised care (tailored therapeutics)
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Submit a question by phone:
– Dial 1 then 4 from your touchtone phone
Or Contact the Presenters:
Paul O’DonohoeDirector, Health Outcomes, CRF [email protected]
Keith Meadows, PhD
Q & A
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Your presenters
Dr. Keith MeadowsDHP Research
Paul O’DonohoeDirector of Health Outcomes
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