<ul><li>Documenting Outcomes with  </li></ul><ul><li>Patient-Reported Questionnaires   </li></ul>Mark S. Litwin, MD, MPH P...
Outcomes  of  care <ul><li>Mortality </li></ul><ul><li>Morbidity  and  complications </li></ul><ul><li>“ Objective”  clini...
Health - related  quality  of  life <ul><li>WHO  definition  of  health  (1948) </li></ul><ul><li>Health  is  not  merely ...
Purposes of Prostate Cancer Treatment <ul><li>Maximize  </li></ul><ul><li>Quantity  of  life “length” </li></ul><ul><li>Qu...
Outcomes  Research  Objectives <ul><li>To assess treatment efficacy </li></ul><ul><li>To help determine whether goals of t...
Outcomes  Measurement <ul><li>Surveys Instruments </li></ul><ul><li>Questions Items </li></ul><ul><li>Scales Domains </li>...
Outcomes  Measurement <ul><li>Psychometric  properties </li></ul><ul><ul><li>Reliability </li></ul></ul><ul><ul><li>Validi...
Quality of Life   the defining issue in prostate cancer <ul><li>General  domains </li></ul><ul><ul><li>Physical  function ...
QOL  Instruments  for  Prostate  Cancer <ul><li>General  domains </li></ul><ul><li>RAND  SF-36   (scored  0 - 100) </li></...
QOL  Instruments  for  Prostate  Cancer <ul><li>Prostate  Cancer  Domains </li></ul><ul><li>UCLA  Prostate  Cancer  Index ...
Prostate cancer QOL instruments <ul><li>UCLA Prostate Cancer Index </li></ul><ul><li>Self – administered,  written </li></...
Doctor  or  patient  perspective Physician   vs  Patient   perception  of  QOL  impairment Sonn, J Urol 2009 n = 1,366
Doctor  or  patient  perspective Physician   vs  Patient   perception  of  QOL  impairment Sonn, J Urol 2009 n = 1,366
National  longitudinal  QOL  Cohort Sanda, NEJM 2008 n = 1,201
UCLA  longitudinal  QOL  cohort  SF-36  Physical Composite Litwin, Cancer 2007 n = 580
UCLA  longitudinal  QOL  cohort PCI Sexual Function % Return to baseline Litwin, Cancer 2007 n = 580
Documenting outcomes with  patient-reported questionnaires <ul><ul><li>Principles </li></ul></ul><ul><ul><li>Use  validate...
Websites for further information on patient-reported outcomes proqolid.org outcomes.cancer.gov sf-36.org
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NY Prostate Cancer Conference - M. Litwin - Session 6: Documenting outcomes with patient reported questionnaires

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  • Again, the SF-36 scales run from 0-100 with higher scores representing better outcomes. Physical function was similar between groups.
  • Men undergoing brachytherapy had substantially worse AUASI scores that persisted, even a year after treatment.
  • NY Prostate Cancer Conference - M. Litwin - Session 6: Documenting outcomes with patient reported questionnaires

    1. 1. <ul><li>Documenting Outcomes with </li></ul><ul><li>Patient-Reported Questionnaires </li></ul>Mark S. Litwin, MD, MPH Professor of Urology and Public Health
    2. 2. Outcomes of care <ul><li>Mortality </li></ul><ul><li>Morbidity and complications </li></ul><ul><li>“ Objective” clinical variables (PSA) </li></ul><ul><li>Patient - centered outcomes </li></ul><ul><ul><li>Health - related quality of life (HRQOL ) </li></ul></ul><ul><ul><li>Patient satisfaction </li></ul></ul><ul><ul><li>Costs and resource utilization </li></ul></ul>
    3. 3. Health - related quality of life <ul><li>WHO definition of health (1948) </li></ul><ul><li>Health is not merely the absence of disease, but a state of complete physical, emotional, and social well-being </li></ul>
    4. 4. Purposes of Prostate Cancer Treatment <ul><li>Maximize </li></ul><ul><li>Quantity of life “length” </li></ul><ul><li>Quality of Life “breadth” </li></ul>
    5. 5. Outcomes Research Objectives <ul><li>To assess treatment efficacy </li></ul><ul><li>To help determine whether goals of treatment have been met </li></ul><ul><li>To inform medical decision making </li></ul><ul><li>To provide the defining issue if treatments are otherwise equivalent </li></ul>
    6. 6. Outcomes Measurement <ul><li>Surveys Instruments </li></ul><ul><li>Questions Items </li></ul><ul><li>Scales Domains </li></ul><ul><li>Scoring 0 - 100 </li></ul>
    7. 7. Outcomes Measurement <ul><li>Psychometric properties </li></ul><ul><ul><li>Reliability </li></ul></ul><ul><ul><li>Validity </li></ul></ul><ul><ul><li>Responsiveness </li></ul></ul>
    8. 8. Quality of Life the defining issue in prostate cancer <ul><li>General domains </li></ul><ul><ul><li>Physical function </li></ul></ul><ul><ul><li>Mental health </li></ul></ul><ul><ul><li>Social interactions </li></ul></ul><ul><ul><li>Role performance </li></ul></ul><ul><li>Disease - specific domains </li></ul><ul><ul><li>Worry about recurrence </li></ul></ul><ul><ul><li>Appetite, Weight loss, etc </li></ul></ul><ul><ul><li>Fatigue </li></ul></ul><ul><ul><li>Urinary, Sexual, Bowel </li></ul></ul>FUNCTION vs BOTHER
    9. 9. QOL Instruments for Prostate Cancer <ul><li>General domains </li></ul><ul><li>RAND SF-36 (scored 0 - 100) </li></ul><ul><li> Physical Mental </li></ul><ul><ul><li>Pain Social </li></ul></ul><ul><ul><li>General Vitality / Fatigue </li></ul></ul><ul><li>EORTC QLQ - C30 </li></ul><ul><li> Physical, Emotional, Cancer Domains </li></ul><ul><li>FACT General </li></ul><ul><li>Physical, Emotional, Cancer Domains </li></ul><ul><li>Others </li></ul>
    10. 10. QOL Instruments for Prostate Cancer <ul><li>Prostate Cancer Domains </li></ul><ul><li>UCLA Prostate Cancer Index (PCI) </li></ul><ul><ul><li>Litwin et al, JAMA 1995 </li></ul></ul><ul><li>Expanded Prostate Cancer Index Composite (EPIC) </li></ul><ul><ul><li>Sanda et al, Urology 2000 </li></ul></ul><ul><li>EORTC QLQ - C30 Prostate Module </li></ul><ul><li> Borghede et al, Qual Life Res 1996 </li></ul><ul><li>FACT - P </li></ul><ul><ul><li>Esper et al, Urology 1997 </li></ul></ul><ul><li>Others </li></ul>
    11. 11. Prostate cancer QOL instruments <ul><li>UCLA Prostate Cancer Index </li></ul><ul><li>Self – administered, written </li></ul><ul><li>20 items </li></ul><ul><li>6 Scales (scored 0 - 100) </li></ul><ul><ul><li>Urinary function and bother </li></ul></ul><ul><ul><li>Sexual function and bother </li></ul></ul><ul><ul><li>Bowel function and bother </li></ul></ul><ul><li>Used with SF – 36 </li></ul><ul><li>15-item short form </li></ul><ul><li>EPIC </li></ul><ul><li>Self – administered, written </li></ul><ul><li>50 items </li></ul><ul><li>6 Scales (scored 0 - 100) </li></ul><ul><ul><li>Urinary function and bother </li></ul></ul><ul><ul><li>Sexual function and bother </li></ul></ul><ul><ul><li>Bowel function and bother </li></ul></ul><ul><ul><li>Hormonal </li></ul></ul><ul><li>Used with SF – 36 </li></ul><ul><li>26-item short form </li></ul>
    12. 12. Doctor or patient perspective Physician vs Patient perception of QOL impairment Sonn, J Urol 2009 n = 1,366
    13. 13. Doctor or patient perspective Physician vs Patient perception of QOL impairment Sonn, J Urol 2009 n = 1,366
    14. 14. National longitudinal QOL Cohort Sanda, NEJM 2008 n = 1,201
    15. 15. UCLA longitudinal QOL cohort SF-36 Physical Composite Litwin, Cancer 2007 n = 580
    16. 16. UCLA longitudinal QOL cohort PCI Sexual Function % Return to baseline Litwin, Cancer 2007 n = 580
    17. 17. Documenting outcomes with patient-reported questionnaires <ul><ul><li>Principles </li></ul></ul><ul><ul><li>Use validated instruments </li></ul></ul><ul><ul><li>Rely on patient self assessment </li></ul></ul><ul><ul><li>Track outcomes longitudinally </li></ul></ul><ul><ul><li>Use general & disease – specific measures </li></ul></ul><ul><ul><li>Interpret outcomes in context of patient’s own baseline </li></ul></ul>
    18. 18. Websites for further information on patient-reported outcomes proqolid.org outcomes.cancer.gov sf-36.org

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