SGRQ

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
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6
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.

7
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

8
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
9
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 patients status
  since baseline. Like the BDI, the TDI lacks
  standardized questions for raters.

Eakin EG, et al. International Journal of
Behavioral Medicine, 1995
10
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11
Mean Trough FEV1, by TDI Response(Study 137, at
6 months)

• TDI non-responders
• Tiotropium Placebo Salmeterol
• Trough FEV1 0.029L -0.056L 0.038L
• TDI responders
• Tiotropium Placebo Salmeterol
• Trough FEV1 0.107L 0.032L 0.087L

12
FEV1 Response by TDI Response(Study 130, at 6
months)

• defined as improvement ?12 in trough FEV1,
  compared to baseline

13
FEV1 Response by TDI Response(Study 130, at 6
months)

• defined as improvement ?12 in trough FEV1,
  compared to baseline

14
FEV1 Response by TDI Response(Study 137, at 6
months)

• defined as improvement ?12 in trough FEV1,
  compared to baseline

15
FEV1 Response by TDI Response(Study 137, at 6
months)

• defined as improvement ?12 in trough FEV1,
  compared to baseline