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SGRQ

SGRQ. 3 Domains: Symptoms: cough, sputum production, wheeze, breathlessness, duration and frequency of attacks of breathlessness Activity: physical activities that either cause or are limited by breathlessness

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SGRQ

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  1. SGRQ • 3 Domains: • Symptoms: cough, sputum production, wheeze, breathlessness, duration and frequency of attacks of breathlessness • Activity: physical activities that either cause or are limited by breathlessness • Impacts: employment, being in control of health, panic, stigmatization, need for medication, side effects of medication, expectations for health, disturbance of daily life

  2. SGRQ • Included at baseline and at the following visits: • 114/115: Weeks 7, 13, 25, 37, 49 • 122A/122B: Weeks 7, 13, 26, 39, 52 • 130/137: Weeks 8, 16, and 24 • Total Score: Tiotropium statistically and clinically ( 4 units) superior to comparator: • 114/115: 2/10 • 122A/122B: 1/10 • 130/137: 0/6

  3. SGRQ: Activity Score Tiotropium was statistically superior to comparator: • Study 114: 2/5 • Study 115: 4/5 • Study 122A: 0/5 • Study 122B: 1/5 • Study 130: 0/3 • Study 137: 1/3

  4. SGRQ: Symptoms Tiotropium was statistically superior to comparator: • Study 114: 2/5 • Study 115: 0/5 • Study 122A: 0/5 • Study 122B: 0/5 • Study 130: 3/3 • Study 137: 0/3

  5. BDI/TDI • Interviewer asks open-ended questions. Interviewer interprets responses and selects a score. • The majority of other dyspnea indices are completed by the patient.

  6. Dyspnea Indices • BDI/TDI [Interviewer] • Medical Research Council Breathlessness Scale [Patient] • American Thoracic Society Dyspnea Scale [Patient] • Chronic Respiratory Questionnaire (Dyspnea component) [Patient] • UCSD Shortness of Breath Questionnaire [Patient] • Modified Borg Dyspnea Scale [Patient] • Shortness of Breath Questionnaire (Archibald, 1987) [Patient] • Dyspnea Index (Lareau, 1994) [Patient] • Oxygen-cost diagram (visual analog) [Patient] • Visual Analog Scale [Patient]

  7. “Reliability and Validity of Dyspnea Measures in Patients with Obstructive Lung Disease” • BDI • “In our experience, to use this instrument reliably, it was necessary for our four raters to discuss and standardize questions and to come to some consensus as to how ratings should be made on each one of the three scales. Ongoing assessment of inter-rater reliability to check for tendencies of each rater to stray from initial standardization was also needed.” [Eakin EG, et al. International Journal of Behavioral Medicine, 1995]

  8. “Reliability and Validity of Dyspnea Measures in Patients with Obstructive Lung Disease” • TDI • “may be affected by bias on the part of the patient and interviewer because it asks both individuals to make judgements about improvement versus deterioration in the patient’s status since baseline. Like the BDI, the TDI lacks standardized questions for raters.” [Eakin EG, et al. International Journal of Behavioral Medicine, 1995]

  9. Mean Trough FEV1, by TDI Response(Study 137, at 6 months) • TDI “non-responders” TiotropiumPlaceboSalmeterol Trough FEV1: 0.029L -0.056L 0.038L • TDI “responders” TiotropiumPlaceboSalmeterol Trough FEV1: 0.107L 0.032L 0.087L

  10. FEV1 Response* by TDI Response(Study 130, at 6 months) *defined as improvement 12% in trough FEV1, compared to baseline

  11. FEV1 Response* by TDI Response(Study 130, at 6 months) *defined as improvement 12% in trough FEV1, compared to baseline

  12. FEV1 Response* by TDI Response(Study 137, at 6 months) *defined as improvement 12% in trough FEV1, compared to baseline

  13. FEV1 Response* by TDI Response(Study 137, at 6 months) *defined as improvement 12% in trough FEV1, compared to baseline

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