Transcript Chronic anxiety in ICD patients: A multi

CoRPS
Center of Research
on Psychology
in Somatic diseases
Quality of life. How to evaluate?
Susanne S. Pedersen, Professor of Cardiac Psychology
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Affiliations
Prof.dr. Susanne S. Pedersen
• CoRPS - Center of Research on
Psychology in Somatic diseases, Tilburg
University, The Netherlands
• Thoraxcenter, Erasmus Medical Center,
Rotterdam, The Netherlands
• Department of Cardiology, Odense
University Hospital, Denmark
Phone: + 31 (0) 13 466 2503
E-mail: [email protected]
www.tilburguniversity.nl/corps
CoRPS
Overview
• Definition of quality of life
• Why is quality of life assessment important?
• How to select a quality of life measure
• Available quality of life instruments in AF
• Conclusions and practice tips
CoRPS
Overview
• Definition of quality of life
• Why is quality of life assessment important?
• How to select a quality of life measure
• Available quality of life instruments in AF
• Conclusions and practice tips
Definition
of
quality
of
life
(QoL)
and
related
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concepts
• Functional status: Physical functioning
• Health status: The influence of disease on
patients’ physical, social, and psychological
functioning
• Health-related QoL: Patients’ evaluation of
his/her physical, psychological, and social
functioning
• QoL: Patients’ evaluation of his/her functioning in
more than the three domains
CoRPS
Overview
• Definition of quality of life
• Why is quality of life assessment important?
• How to select a quality of life measure
• Available quality of life instruments
• Conclusions and practice tips
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QoL: Subjective versus objective dimensions
or both?
Heart disease
Pain
Fatigue
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Where is the patient?
“…the important core issues
regarding device reliability
remain unsolved and
longstanding issues
regarding patient
information and patient well
being are even more acute.”
Cannom & Fisher. Pacing Clin Electrophysiol 2008;31:1233-5
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Why do we need the patient perspective
when we have physician-rated scales?
E.g. CCS angina severity and NYHA functional class….
NYHA functional class:
• Poor inter-observer agreement (e.g. 56% between two
physicians)  little better than chance
• Lack of consistency in classification between clinicians 
classification depends on clinician’s interpretation of
‘ordinary physical activity’ and ‘slight’ and ‘marked’
limitations
Spertus. Circulation 2008;118:2103-10
Raphael et al. Heart 2006;93:476-82
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• Discrepancy between physician-rated and patient-rated
health status
• Physicians tend to underestimate functional disabilities
of patients
Ask the patient!
Calkins et al. Ann Intern Med 1991;114:451-4
Lieberman et al. J Bone Joint Surg Am 1996;78:835-8
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Improvement in NYHA functional class and
health status in CHF: Who knows best?
Physician
NYHA class
or
Patient ?
Health status/QoL
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Improvement in NYHA functional class and
health status in CHF: Who knows best?
• 41.6% (42/100) improved by ≥1 NYHA class the first 2
months post CRT implantation
• Of the 59 patients whose NYHA functional class
remained stable, 61% reported clinically relevant
improvements in health status, while only 45% of the
patients reporting better health status also improved
in NYHA functional class
• Logistic regression results (ps≥.05) and c-statistics
(range 0.53-0.61) confirmed that improvement in
NYHA functional class was not associated with
improvement in health status
Versteeg, Meine, Pedersen et al. Submitted
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Percentage of patients improving in health status,
stratified by stable vs. improved NYHA functional class
61%
Versteeg, Meine, Pedersen et al. Submitted
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Applicability of QoL assessments
• Improvement physician-patient communication
• Enhancement patient satisfaction with treatment
• Performance measure to evaluate the standard of care
• Endpoint (e.g. for examining effect of intervention)
• Predictor (e.g. of morbidity and mortality)
• Tool in clinical-decision making
Represents what is
important to patients !!!
Spertus. Circulation 2008;118:2103-10
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Health status as a tool in clinical decisionmaking
Angina frequency (SAQ) - subanalysis of 68 patients
on medical therapy crossing over to PCI in first 3
months:
• Cross-over PCI: 55 ± 28 vs. OMT: 69 ± 26; p < 0.001)
Lower score on SAQ
Stable CAD: N = 2887
PCI + optimal medical therapy
vs. optimal medical therapy
(COURAGE trial)
Health status measure to identify patients in
need of revascularization
Weintraub et al. N Engl J Med 2008;359:677-87
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Incorporation of QoL measure in clinical
practice as a performance measure
• RCT cross-over design; 10 physicians (min. 10 patients); 214 patients
palliative chemotherapy
• Patients completed QoL measure at each follow-up  computer scored
profile given to patients and physicians prior to consultation
Detmar et al. JAMA 2002;288:3027-34.
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• QoL issues discussed more frequently in the intervention
• Physician identification of ↑ % patients with moderateto-severe health problems in several QoL domains in the
intervention
• All physicians and 87% of patients believed the
intervention facilitated communication  interested in
continued use
• No extra burden to physicians in terms of time spent on
consultation
Detmar et al. JAMA 2002;288:3027-34.
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QoL as a predictor of mortality in 870 PCI
patients (adjusted results)
HR: 2.12 [95% CI:1.18-3.83]
HR: 2.98 [95% CI: 1.45-6.13]
HR: 1.52 [95% CI: 0.86-2.69]
HR: 0.90 [95% CI: 0.50-1.59]
HR: 0.95 [95% CI: 0.49-1.83]
HR: 2.78 [95% CI: 1.54-5.02]
Pedersen et al. Qual Life Res 2011;20:559–67
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QoL and distress scores in AF patients...
Lone AF: N = 70
NS
↓
Lane et al. J Psychosom Res 2009;203-10
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Depression and AF recurrence
Lange et al. J Psychosom Res 2007;63:509-13
Cardiovascular death-free survival stratified by
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depression symptoms and rhythm- versus rate-control
N=947 comorbid AF-CHF
Atrial Fibrillation and Congestive
Heart Failure trial
• Rate-control (i.e., betablockers and digoxin) versus
rhythm-control (i.e.,
antiarrhythmic medications
and electrical cardioversion)
• 32% had BDI-II scores 14 (mild
to moderate symptoms of
depression)
Frasure-Smith et al. Circulation 2009;120:134-40
Distress
in
AF
patients
compared
to
other
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cardiac populations
Redhead et al. J Psychosom Res 2010;69:555-63
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Emotional distress in AF
2/3 of patients experience
significant symptoms:
Tachycardia-related
(sympathetic):
Reporting of symptoms often not in
palpitations, exercise intolerance
Suggests that thiswith
is not objective
only an electrophysiological
concordance
presence of
Congestion-related:
shortness
of breath,
disorder,
but that other factors,
like emotional
distress,
AF
rhythm
of energy
might affectfatigue/lack
symptom perception,
and maybe also
recurrence of AF episodes
CoRPS
Overview
• Definition of quality of life
• Why is quality of life assessment important?
• How to select a quality of life measure
• Available quality of life instruments in AF
• Conclusions and practice tips
CoRPS
Generic QoL measures
• Broad multidimensional measures
• Designed to measure QoL in diverse patient and age
groups, and sometimes also in healthy persons
• Used to compare outcomes across different populations
and interventions


Do not tap issues pertinent to patients with a specific disease
Not sensitive to tap treatment-related changes
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Disease-specific QoL measures
• Developed to measure QoL in specific diagnostic groups
or patient populations
• Focus on problems that are specific to the disease in
question and areas of function


Do tap issues pertinent to patients with a specific disease
Are sensitive to tap treatment-related changes
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Key psychometric properties of a health
status instrument
Spertus. Circulation 2008;118:2103-10
CoRPS
Selection of QoL questionnaire (1)
• Dependent on study design, choose for a disease-specific
or a generic measure or both
• Read the relevant literature to check for availability of
measures
• Find out about availability of language version(s) you
need
• Evaluate the psychometric properties of the measure
• If used as study outcome measure, check its sensitivity to
to tap treatment-related changes
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Selection of QoL questionnaire (2)
If a translation does not exist
in the language you need,
follow the general strict
procedures when translating
 consult an expert!!!
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Selection of QoL questionnaire (3)
• If no questionnaire is available, develop one:
o
o
o
o
o
o
o
Definition topic
Opinion (experts, lay persons)
Operationalization
Make questions
Pilot version
Final version
Check scale’s psychometrics
CoRPS
Overview
• Definition of quality of life
• Why is quality of life assessment important?
• How to select a quality of life measure
• Available quality of life instruments in AF
• Conclusions and practice tips
CoRPS
Disease-specific QoL measures
Measure
Acronym
Origin
Items Domains
Atrial Fibrillation Effect on QualiTy-of-Life
AFEQT
USA
20
(i) Symptoms
(ii) Daily Activities
(iii) Treatment Concern
(iv) Treatment Satisfaction
Atrial Fibrillation Quality of Life
questionnaire
AF-QoL
Spain
18
(i) Psychological activity
(ii) Physical activity
(iii) Sexual activity
AFSS
Canada
14
Subjective and objective
ratings of AF disease
burden:
(i) Frequency
(ii) Duration
(iii) Severity of episodes
Toronto AF Severity Scale
There are many more...
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???????
CoRPS
???????
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Generic QoL measures
Measure
Acronym
Short Form
Health Survey
SF-12 / SF-36
USA
12 / 36
(i) Physical functioning
(ii) Role limitations physical functioning
(iii) Role limitations emotional functioning
(iv) Mental health
(v) Vitality
(vi) Bodily Pain
(vii) Social functioning
(viii) General Health
EQ-5D
Euroqol
group
5 + VAS
(i) Mobility
(ii) Self-care
(iii) Usual activities
(iv) Pain/discomfort
(v) Anxiety/depression
EuroQol-5D
Origin
Items
Domains
There are many more...
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EQ-5D
By placing a tick in one box in each group below, please indicate which statements
best describe your own health state today.
Mobility
I have no problems in walking about
I have some problems in walking about
I am confined to bed
Self-Care
I have no problems with self-care
I have some problems washing or dressing myself
I am unable to wash or dress myself



Pain/Discomfort
I have no pain or discomfort
I have moderate pain or discomfort
I have extreme pain or discomfort






Anxiety/Depression
I am not anxious or depressed
I am moderately anxious or depressed
I am extremely anxious or depressed



Usual Activities (e.g. work, study, housework, family or
leisure activities)
I have no problems with performing my usual activities

I have some problems with performing my usual activities 
I am unable to perform my usual activities

+ VAS scale/thermometer 0-100 (100 best
possible health state)
© 1990 EuroQol Group EQ-5D™ is a trade mark of the EuroQol Group
CoRPS
Overview
• Definition of quality of life
• Why is quality of life assessment important?
• How to select a quality of life measure
• Available quality of life instruments in AF
• Conclusions and practice tips
CoRPS
Conclusions (1)
• QoL provides unique (predictive) information that is not
available from patient medical records
• When choosing QoL measure, consider the study
objective and know the psychometric properties of the
instrument  consult an expert
• Preference for disease-specific measure
• Check for copyright!
• Only if no good instrument available, develop own
questionnaire  consult an expert
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Conclusions (2)
• Adopt a QoL tracking method (response rate)
• Consider using other dimensions, e.g.
anxiety/depression
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ICD patients - anxious Type D patients and
ventricular arrhythmias
N = 391
van den Broek, Denollet et al. J Am Coll Cardiol 2009;54:531-7
N = 371
HR: 3.65; 95%CI: 1.57-8.45; p = .003
2-year mortality (%)
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ICD patients - Type D personality and preimplantation ICD concerns and mortality
20
18
16
14
12
10
8
6
18.2%
5.2%
4
2
0
Type D and concerns
Pedersen, Theuns, Jordaens et al. Europace 2010;12:1446-52
None or one risk marker
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Recommenations: QoL/health status
assessment
Mommersteeg, Spertus, Pedersen et al. Am Heart J 2009;157:208-18
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Recommended reading
• Krumholz HM et al. Report of the National Heart, Lung, and Blood
Institute working group on outcomes research in cardiovascular
disease. Circulation 2005;111:3158-66
• Raphael C et al. Limitations of the New York Heart Association
functional classification system and self-reported walking distances
in chronic heart failure. Heart 2006;93:476-82
• Spertus JA. Evolving applications for patient-centered health status
measures. Circulation 2008;118:2103-10
• Weintraub WS et al. Effect of PCI on quality of life in patients with
stable coronary disease. NEJM 2008;359:677-87
• Mommersteeg PMC et al. Health status as a risk factor in
cardiovascular disease: A systematic review of current evidence.
Am Heart J 2009;157:208-18
CoRPS
Device Conference, 3-4 November 2011,
Tilburg, the Netherlands
Living in a Device World: Focus on Recent Challenges and Tools to Improve
Clinical Care for Patients with an Implantable Cardioverter Defibrillator
Themes
Selection of invited faculty
• OVERCOMING THE SHOCK OF THE ICD
• Nico Blom (MD, PhD), Leiden University Medical Center, NL
• Matthew Burg (PhD), Yale School of Medicine, USA
More information available
on:
• Viviane Conraads (MD, PhD), University Hospital Antwerpen, BE
• www.tilburguniversity.edu/device2011
DEACTIVATION OF THE ICD AND END OF LIFE
• Dorothy Frizelle (PhD), University of Hull, UK
ISSUES
• ICD REGISTRIES AND THE INCLUSION OF THE
PATIENT PERSPECTIVE
• NEGLECTED SUBGROUPS
• CRT SELECTION AND RESPONSE
• THE DO’S AND DON’TS OF PATIENT
COMMUNICATION
• Jens Brock Johansen, (MD, PhD), Odense University Hospital, DK
• Karl-Heinz Ladwig (MD, PhD), Helmholtz Institute, Munich, GE
• Mathias Meine (MD, PhD), University Medical Center Utrecht, NL
• Susanne S. Pedersen (PhD), CoRPS, Tilburg University, NL
• SEXUALITY IN ICD PATIENTS
• Samuel Sears (PhD), East Carolina University, USA
• BEHAVIORAL INTERVENTIONS
• Steen Pehrson (MD, PhD), Copenhagen University Hospital, DK
• LOOKING INTO THE FUTURE
• Dominic Theuns (PhD), Erasmus Medical Center Rotterdam, NL