1. CoRPS Center of Research on Psychology in Somatic diseases Quality of life. How to evaluate? Susanne S. Pedersen, Professor of Cardiac Psychology

2. CoRPS 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: s.s.pedersen@uvt.nl www.tilburguniversity.nl/corps

3. 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

4. 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

5. CoRPS Definition of quality of life (QoL) and related 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

6. 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

7. CoRPS QoL: Subjective versus objective dimensions or both? Heart disease Fatigue Pain

8. CoRPS 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

9. CoRPS 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

10. CoRPS Discrepancy between physician-rated and patient-rated health status Physicians tend to underestimate functional disabilities of patients Calkins et al. Ann Intern Med 1991;114:451-4 Lieberman et al. J Bone Joint Surg Am 1996;78:835-8 Ask the patient!

11. CoRPS Improvement in NYHA functional class and health status in CHF: Who knows best? PhysicianorPatient ? NYHA classHealth status/QoL

12. CoRPS 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

13. CoRPS Versteeg, Meine, Pedersen et al. Submitted Percentage of patients improving in health status, stratified by stable vs. improved NYHA functional class 61%

14. CoRPS 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

15. CoRPS Health status as a tool in clinical decision- making 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) Weintraub et al. N Engl J Med 2008;359:677-87 Stable CAD: N = 2887 PCI + optimal medical therapy vs. optimal medical therapy (COURAGE trial) Lower score on SAQ Health status measure to identify patients in need of revascularization

16. CoRPS 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.

17. CoRPS QoL issues discussed more frequently in the intervention Physician identification of ↑ % patients with moderate- to-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.

18. CoRPS QoL as a predictor of mortality in 870 PCI patients (adjusted results) Pedersen et al. Qual Life Res 2011;20:559–67 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]

19. CoRPS QoL and distress scores in AF patients... Lane et al. J Psychosom Res 2009;203-10 NS ↓ Lone AF: N = 70

20. CoRPS Depression and AF recurrence Lange et al. J Psychosom Res 2007;63:509-13

21. CoRPS Cardiovascular death-free survival stratified by depression symptoms and rhythm- versus rate-control Frasure-Smith et al. Circulation 2009;120:134-40 N=947 comorbid AF-CHF Atrial Fibrillation and Congestive Heart Failure trial Rate-control (i.e., beta- blockers and digoxin) versus rhythm-control (i.e., antiarrhythmic medications and electrical cardioversion) 32% had BDI-II scores 14 (mild to moderate symptoms of depression)

22. CoRPS Distress in AF patients compared to other cardiac populations Redhead et al. J Psychosom Res 2010;69:555-63

23. CoRPS Emotional distress in AF 2/3 of patients experience significant symptoms: Tachycardia-related (sympathetic): palpitations, exercise intolerance Congestion-related: shortness of breath, fatigue/lack of energy 2/3 of patients experience significant symptoms: Tachycardia-related (sympathetic): palpitations, exercise intolerance Congestion-related: shortness of breath, fatigue/lack of energy Reporting of symptoms often not in concordance with objective presence of AF rhythm Suggests that this is not only an electrophysiological disorder, but that other factors, like emotional distress, might affect symptom perception, and maybe also recurrence of AF episodes

24. 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

25. 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

26. CoRPS 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

27. CoRPS Key psychometric properties of a health status instrument Spertus. Circulation 2008;118:2103-10

28. 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

29. CoRPS 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!!!

30. CoRPS Selection of QoL questionnaire (3) If no questionnaire is available, develop one: o Definition topic o Opinion (experts, lay persons) o Operationalization o Make questions o Pilot version o Final version o Check scale’s psychometrics

31. 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

32. CoRPS Disease-specific QoL measures MeasureAcronymOriginItemsDomains Atrial Fibrillation Effect on QualiTy-of-LifeAFEQTUSA20(i) Symptoms (ii) Daily Activities (iii) Treatment Concern (iv) Treatment Satisfaction Atrial Fibrillation Quality of Life questionnaire AF-QoLSpain18(i) Psychological activity (ii) Physical activity (iii) Sexual activity Toronto AF Severity ScaleAFSSCanada14Subjective and objective ratings of AF disease burden: (i)Frequency (ii)Duration (iii)Severity of episodes There are many more...

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35. CoRPS Generic QoL measures MeasureAcronymOriginItemsDomains Short Form Health Survey SF-12 / SF-36USA12 / 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 EuroQol-5DEQ-5DEuroqol group 5 + VAS(i) Mobility (ii) Self-care (iii) Usual activities (iv) Pain/discomfort (v) Anxiety/depression There are many more...

36. CoRPS EQ-5D 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  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  By placing a tick in one box in each group below, please indicate which statements best describe your own health state today. 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  + VAS scale/thermometer 0-100 (100 best possible health state) © 1990 EuroQol Group EQ-5D™ is a trade mark of the EuroQol Group

37. 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

38. 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

39. CoRPS Conclusions (2) Adopt a QoL tracking method (response rate) Consider using other dimensions, e.g. anxiety/depression

40. CoRPS ICD patients - anxious Type D patients and ventricular arrhythmias van den Broek, Denollet et al. J Am Coll Cardiol 2009;54:531-7 N = 391

41. CoRPS Pedersen, Theuns, Jordaens et al. Europace 2010;12:1446-52 ICD patients - Type D personality and pre- implantation ICD concerns and mortality N = 371 HR: 3.65; 95%CI: 1.57-8.45; p =.003 18.2% 5.2%

42. CoRPS Recommenations: QoL/health status assessment Mommersteeg, Spertus, Pedersen et al. Am Heart J 2009;157:208-18

43. CoRPS 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

44. CoRPS Living in a Device World: Focus on Recent Challenges and Tools to Improve Clinical Care for Patients with an Implantable Cardioverter Defibrillator Device Conference, 3-4 November 2011, Tilburg, the Netherlands Themes OVERCOMING THE SHOCK OF THE ICD ICD REGISTRIES AND THE INCLUSION OF THE PATIENT PERSPECTIVE DEACTIVATION OF THE ICD AND END OF LIFE ISSUES NEGLECTED SUBGROUPS CRT SELECTION AND RESPONSE THE DO’S AND DON’TS OF PATIENT COMMUNICATION SEXUALITY IN ICD PATIENTS BEHAVIORAL INTERVENTIONS LOOKING INTO THE FUTURE Selection of invited faculty Nico Blom (MD, PhD), Leiden University Medical Center, NL Matthew Burg (PhD), Yale School of Medicine, USA Viviane Conraads (MD, PhD), University Hospital Antwerpen, BE Dorothy Frizelle (PhD), University of Hull, UK 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 Samuel Sears (PhD), East Carolina University, USA Steen Pehrson (MD, PhD), Copenhagen University Hospital, DK Dominic Theuns (PhD), Erasmus Medical Center Rotterdam, NL More information available on: www.tilburguniversity.edu/device2011