Assessing and reporting outcomes that are important to patients in trials and reviews

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Donald Patrick speaking at plenary session 2 at the XV Cochrane Colloquium in Sao Paulo, Brasil

Saúde e medicina Negócios

Assessing and reporting outcomes important to patients in clinical trials and Cochrane reviews XV Cochrane Collaboration 25 October 2007 09:00 am -10:30am Donald L. Patrick University of Washington Co-Convenor, Patient Reported Outcomes Methods Group

The Patient and Consumer Voice ,[object Object],[object Object],[object Object],[object Object]

After this session, you will be able to: ,[object Object],[object Object],[object Object],[object Object]

Patient-Important Outcomes Patient - Reported Survival For example, Symptoms Function Feelings For example, Mortality Years of Life Lost 5-Year Survival Caregiver - Reported For example, Caregiver burden Morbidlinical Events For example, Stroke Myocardial Infarction Disease Recurrence Hospitalization

What is a Patient-Reported Outcome (PRO)? ,[object Object],[object Object],[object Object],[object Object]

Why PROs ? ,[object Object],[object Object],[object Object],[object Object],[object Object]

Relationship between Airway Obstruction and Respiratory Symptoms Teeter J. Chest 1998; 113:272-77 r = 0.143 (p N.S.)

“ Objective” “ Subjective” Exercise test versus physical functioning, r = 0.40 Wiklund I et al. Clin Cardiol 1991;14

I´m worried and concerned GI symptoms bother me! I can not bend over or exercise My whole life is affected Heartburn disturbs my sleep I can not eat and drink whatever I like

PROs communicate value of a treatment to … ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

A little help from US drug regulators Published Feb 2, 2006 www. fda .gov/cder/ guidance /5460dft.pdf

EMEA … from European Drug Regulators Took effect: January 2006

Outcomes measured with PROs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

PRO Methods Group Finding PRO studies for Reviews ,[object Object],[object Object],[object Object],[object Object]

Common Terms ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Identifying Concepts in Existing PROs ,[object Object],[object Object],[object Object],[object Object],[object Object]

PROs in Cochrane Reviews: Cognitive Behavioural Therapy in Tinnitus ,[object Object],[object Object],[object Object],[object Object],[object Object]

Cognitive Behavioural Therapy in Tinnitus ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Cognitive Behavioural Therapy versus control (waiting list): Quality of Life Martinez DP, Waddell A, Perera R, Theodoulou M. Cognitive behavioural therapy for tinnitus. Cochrane Database of Systematic Reviews 2007, Issue 1.

Cognitive Behavioural Therapy versus control (other intervention): Quality of Life Martinez DP, Waddell A, Perera R, Theodoulou M. Cognitive behavioural therapy for tinnitus. Cochrane Database of Systematic Reviews 2007, Issue 1.

Many practical and methodological issues ,[object Object],[object Object],[object Object],[object Object]

Interpretation of Treatment Effects ,[object Object],[object Object],[object Object],[object Object]

Quote from J. Tukey ,[object Object]

Measuring the “right thing”? ,[object Object],[object Object]

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Assessing and reporting outcomes that are important to patients in trials and reviews

1. Assessing and reporting outcomes important to patients in clinical trials and Cochrane reviews XV Cochrane Collaboration 25 October 2007 09:00 am -10:30am Donald L. Patrick University of Washington Co-Convenor, Patient Reported Outcomes Methods Group

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7. Patient-Important Outcomes Patient - Reported Survival For example, Symptoms Function Feelings For example, Mortality Years of Life Lost 5-Year Survival Caregiver - Reported For example, Caregiver burden Morbidlinical Events For example, Stroke Myocardial Infarction Disease Recurrence Hospitalization

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11. Relationship between Airway Obstruction and Respiratory Symptoms Teeter J. Chest 1998; 113:272-77 r = 0.143 (p N.S.)

12. “ Objective” “ Subjective” Exercise test versus physical functioning, r = 0.40 Wiklund I et al. Clin Cardiol 1991;14

13. I´m worried and concerned GI symptoms bother me! I can not bend over or exercise My whole life is affected Heartburn disturbs my sleep I can not eat and drink whatever I like

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15. A little help from US drug regulators Published Feb 2, 2006 www. fda .gov/cder/ guidance /5460dft.pdf

16. EMEA … from European Drug Regulators Took effect: January 2006

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23. Cognitive Behavioural Therapy versus control (waiting list): Quality of Life Martinez DP, Waddell A, Perera R, Theodoulou M. Cognitive behavioural therapy for tinnitus. Cochrane Database of Systematic Reviews 2007, Issue 1.

24. Cognitive Behavioural Therapy versus control (other intervention): Quality of Life Martinez DP, Waddell A, Perera R, Theodoulou M. Cognitive behavioural therapy for tinnitus. Cochrane Database of Systematic Reviews 2007, Issue 1.

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