Table 6 Summary of suggested revisions to the SAT
Item | Original | Changes | Revised baseline item | Revised follow up and last visit items |
|---|---|---|---|---|
Instructions | Please mark one response for each question | Instructions to mark responses clarified. | Instructions: Please mark your response by marking one of the boxes for each question below. | Instructions: Please mark your response by marking one of the boxes for each question below. |
Item 1 | How do you assess your pain level after treatment in this study? | 1. Item developed to assess pain level at baseline | 1. Over the past 7 days, how would you rate your pain level? | 1. Over the past 7 days, how much has the study treatment improved your pain level? |
- I feel my pain is much worse (−2) | 2. Recall period changed to 7 days | - No pain at all | - Not at all | |
- I feel my pain is somewhat worse (−1) | 3. The response options were made consistent with the item stem and with other response options on the questionnaire | - Mild pain | - Slightly better | |
- I feel my pain is no better and no worse (0) | 4. Weighting numbers were removed | - Moderate pain | - Moderately better | |
- I feel my pain is somewhat better (1) | - Severe pain | - Quite a bit better | ||
- I feel my pain is much better (2) | - Very severe pain | - Very much better | ||
Item 2 | How do you assess your activity level after treatment in this study? | 1. Item developed to assess activity at baseline. | 2. Over the past 7 days, how much has pain affected your ability to do the following activities: | 2. Over the past 7 days, how has the study treatment improved your ability to do the following activities: |
- I feel much less active (−2) | 2. Recall period changed to 7 days | A. Daily self care activities, such as showering and dressing? | A. Daily self care activities, such as showering and dressing? | |
- I feel somewhat less active (−1) | 3. The item was split into several questions that are more targeted to pain relief aspects noted during the qualitative interviews | B. Daily activities, such as cleaning, fixing things around the house, grocery shopping, preparing meals, going to appointments, caring for someone else and other day to day tasks? | B. Daily activities, such as cleaning, fixing things around the house, grocery shopping, preparing meals, going to appointments, caring for someone else and other day to day tasks? | |
- I feel no more and not less active (0) | 4. The response options were made consistent with the item stem and with other response options on the questionnaire | C. Physical activities, such as walking, exercising, gardening or yard work? | C. Physical activities, such as walking, exercising, gardening or yard work? | |
- I feel somewhat more active (1) | 5. Weighting numbers were removed | Response options for A, B, and C | Response options for A, B, and C | |
- I feel much more active (−2) | - Not at all | - Not at all | ||
- Slightly | - Slightly better | |||
- Moderately | - Moderately better | |||
- Quite a bit | - Quite a bit better | |||
- Very much= | - Very much better | |||
Item 3 | How has your quality of life changed after treatment in this study? | 1. Item developed to assess quality of life at baseline. | 3. Over the past 7 days, how much has pain affected the following aspects of your life: | 3. Over the past 7 days, how much has the study treatment improved the following aspects of your life: |
- I feel my quality of life is much worse (−2) | 2. Recall period changed to 7 days | A. Emotional wellbeing such as mood, temperament or outlook on life? | A. Emotional wellbeing such as mood, temperament or outlook on life | |
- I feel my quality of life is somewhat worse (−1) | 3. The item was split into several questions that are more targeted to QOL aspects noted during the qualitative interviews | B. Ability to sleep? | B. Ability to sleep? | |
- I feel my quality of life is no better and no worse (0) | 4. The response options were made consistent with the item stem and with other response options on the questionnaire | C. Social functioning, such as participating in activities or relationships with friends and family? | C. Social functioning, such as participating in activities or relationships with friends and family? | |
- I feel my quality of life is somewhat better (1) | 5. Weighting numbers were removed | Response options for A, B, and C | Response options for A, B, and C | |
- I feel my quality of life is much better (2) | - Not at all | - Not at all | ||
- Slightly | - Slightly better | |||
- Moderately | - Moderately better | |||
- Quite a bit | - Quite a bit better | |||
- Very much | - Very much better | |||
Item 4 | Would you undergo this treatment again? | 1. This item now does not ask if the participant “would undergo” [treatment] as in the original question | 4. Based on your experience with the study treatment, would you like to receive this treatment again? | |
- No, definitely not (−2) | 2. Weighting numbers were removed | - No, definitely not | ||
- No, probably not (−1) | - No, probably not | |||
- Unsure (0) | - Unsure | |||
- Yes, probably (1) | - Yes, probably | |||
- Yes, definitely (2) | - Yes, definitely | |||
Item 5 | How do you compare the treatment in this study to previous medication or therapies for your pain? | 1. The item was rephrased to clarify the intended meaning of the question | 5. Based on your experience with the study treatment, overall, how does this treatment compare to other treatments you have received for your pain? | |
- Very much prefer previous (−2) | 2. The response options were revised to fit the item stem. | - Very much worse | ||
- Somewhat prefer previous (−1) | 3. Weighting numbers were removed | - Somewhat worse | ||
- No preference (0) | - No better no worse | |||
- Somewhat prefer this treatment (1) | - Somewhat better | |||
- Very much prefer this treatment (2) | - Very much better |