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Scoring Procedures for the Overactive Bladder Treatment Satisfaction Questionnaire (OAB-S)

Version 1.0

January 13th, 2005

Development and Validation of the OAB-S

Table of Contents

1. CONTENT SUMMARY .......................................................................................................................... 2

2. SCORING PROCEDURES .................................................................................................................... 3 2.1. OAB Control Expectations Scale .................................................................................................. 4 2.2. OAB Control Scale ....................................................................................................................... 4 2.3. Satisfaction with OAB Control Scale ............................................................................................ 5 2.4. Impact on Daily Living with OAB scale ......................................................................................... 5 2.5. OAB Medication Tolerability Scale ............................................................................................... 6 2.6. Fulfilment of OAB Control Expectations Item ............................................................................... 6 2.7. Interruption of Day-to-day Life due to OAB Item .......................................................................... 6 2.8. Overall Satisfaction with OAB Medication Item ............................................................................ 7 2.9. Willingness to Continue OAB Medication Item ............................................................................. 7 2.10. Improved Life with OAB Medication Item ..................................................................................... 7

APPENDIX: OAB-S PRE-MEDICATION MODULE ........................................................................................ 1

APPENDIX: OAB-S MEDICATION MODULE ................................................................................................. 1

OAB-S Scoring Algorithm—v1.0 13 Jan 06

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1. Content Summary

The Overactive Bladder Treatment Satisfaction Questionnaire (OAB-S) consists of two modules: the Pre-

medication module and the Medication module:

• The 21-item Pre-medication module is designed to be completed by the patient at the start of

a study (i.e. before study medication is started) and aims at documenting the patient’s

expectations with medication (i.e., OAB Medication Expectation scale) and the impact of the overactive bladed on patient’s day-to-day life (i.e., Impact on Daily Living scale). One global assessment, i.e., Impact on Daily Living, is also evaluated.

• The 40-item Medication module is designed to be completed at follow-up study visits (i.e.

after patients have experiences with study medication). This module consists of four scales

(i.e., OAB Control, Impact on Daily Living, OAB Medication Tolerability and Satisfaction with OAB Control) and five global assessments evaluating fulfillment of OAB medication

expectations, the overall interruption of patient’s day-to-day life due to OAB, the overall

patient’s satisfaction with OAB medication, the patient’s willingness to continue the OAB medication and patient’s perceived life improvement due to OAB medication.

The content of the OAB-S is detailed in Table 1.

Table 1: Summary of the content of the OAB-S

Scale No. of items

Pre-medication form item numbers

Medication form item numbers

Suggested Variable Names Initial response values

OAB Control Expectations

10

1, 2a, 2b, 2c, 2d, 3a, 3b, 4a, 4b, 4c

Not included

EXP1…EXP10 A lot (1) to Not at all (5)

All of the time (1) to None of the time (5)

Impact on Daily Living with OAB 10 5a, 5b, 5c, 5d, 5e,

5f, 5g, 5h, 5i, 5j 6a, 6b, 6c, 6d, 6e,

6f, 6g, 6h, 6i, 6j IDL1…IDL10 Very satisfied (1) to Very dissatisfied (5)

OAB Control

10

Not included

1, 2a, 2b, 2c, 2d, 3a, 3b, 4a, 4b, 4c

CON1…CON10 A lot (1) to Not at all (5) All of the time (1) to None of the time (5)

OAB Medication Tolerability

6

Not included

8a, 8b, 8c, 8d, 8e, 8f

TOL1…TOL6 I did not have this side effect (0)/ It bothered me a lot (1) to It did not bother me at all (5)

Satisfaction with OAB Control

10

Not included

9, 10a, 10b, 10c,

10d, 11a, 11b, 12a, 12b, 12c

SAT1…SAT10

Very satisfied (1) to Very dissatisfied (5)


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Overall assessment item

No. of items

Pre-medication form item number

Medication form item number

Standard Variable Name Initial response values

Fulfillment of OAB Medication Expectations

1

Not included

5

FULFILL

Greatly exceeds expectation (1) to Does not meet my expectations at all (5)

Interruption of Day-to-day Life due to OAB

1

6

7

INTERRUPT

A lot (1) to Not at all (5)

Overall Satisfaction with OAB Medication

1

Not included

13

OVSAT Very satisfied (1) to Very

dissatisfied (5)

Willingness to Continue OAB Medication

1

Not included

14

CONTINUE Definitely yes (1) to Definitely

not (5)

Improved Life with OAB medication 1 Not included 15 IMPLIFE A lot (1) to Not at all (5)

2. Scoring Procedures

The proportion of completed items required in order to score each OAB-S scale varies depending on

the internal consistency reliability of each scale.

For the OAB Control, OAB Satisfaction with Control and Impact on Daily Living with OAB scales, at

least five out of the ten items (50%) in each scale must be completed in order to compute a scale

score. These three scales have very good internal consistency reliability; in the original validation

study, at the first administration of each scale, Cronbach’s alpha was 0.83 for OAB Control (baseline),

0.94 for OAB Satisfaction (baseline) and 0.96 for Impact on Daily Living with OAB (enrollment). The

50% complete rule is a common standard [for example, this is the same standard used when scoring

the Medical Outcomes Study 36-item Short Form (SF-36)].

For the OAB Medication Expectations scale, at least eight out of the ten items (80%) in the scale must

be completed in order to calculate a score, and for the OAB Medication Tolerability scale, at least five

out of the six items (83.3%) in the scale must be completed to calculate a scale score. The reason for

requiring higher proportions of completed items for these two scales is that while the internal

consistency reliability for these scales met the commonly-accepted minimum standard of 0.70 for

multi-item scales intended for making group-level comparisons, the reliability coefficients were

somewhat lower than the other three scales. In the original validation study at the first administration

of each scale Cronbach’s alpha was 0.75 for OAB Medication Expectations (enrollment) and 0.76 for

OAB Medication Tolerability (baseline). Thus it was deemed advisable to require more stringent data-

completion standards for these two scales.


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In sections below, “initial response value” refers to the raw numeric response value listed on the form

next to each response choice and entered into the database (these are the values summarized in the

last column of Table 1). If in a given study the initial response values used on the CRF and entered

into the database differ from those summarized in Table 1 and shown on the forms in the Appendix,

then extra programming may be necessary to recode the initial response values so that they match

the values in Table 1 and on the forms in the Appendix. The scoring instructions below assume that

the initial response values match the values shown in Table 1 and on the forms in the Appendix.

“Final response value” refers to the numeric response value for each item after any necessary

reverse-coding or re-coding has been performed (see each section below for detailed instructions).

2.1. OAB Control Expectations Scale

First the coding of eight of the items (EXP1 to EXP7 and EXP10; Pre-Medication form items 1, 2a, 2b,

2c, 2d, 3a, 3b and 4c) must be reversed by subtracting the initial response value of each item from 6

(i.e. 6 – initial response value) so that a higher final response value is associated with expectations of

better OAB control while on medication for all items in the scale. Items EXP8 and EXP9 (Pre-

Medication form items 4a and 4b) do not require reverse coding; the final response values for those

two items are the same as the initial response values.

If fewer than eight of the ten items are completed, then do not score this scale (i.e. set the score to

missing).

If eight or more items are completed, then compute the scale score using the formula:

[(Sum of final response values for completed items / Number of completed items) - 1] X 25.

This is a simple linear transformation which results in a scale score ranging from 0 to 100, with a

higher score representing expectations of better OAB control while on medication.

2.2. OAB Control Scale

First the coding of eight of the items (CON1 to CON7 and CON10; Medication form items 1, 2a, 2b,

2c, 2d, 3a, 3b, and 4c) must be reversed by subtracting the initial response value of each item from 6

(i.e. 6 – initial response value) so that a higher final response value is associated with better OAB

control for all items in the scale. Items CON8 and CON9 (Medication form items 4a and 4b) do not

require reverse coding; the final response values for those two items are the same as the initial

response values.


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If fewer than five of the ten items are completed, then do not score this scale (i.e. set the score to

missing).

If five or more items are completed, then compute the scale score using the formula:

[(Sum of final response values for completed items / Number of completed items) - 1] X 25


higher score representing better OAB control.

2.3. Satisfaction with OAB Control Scale

First the coding of all ten items (SAT1 to SAT10; Medication form items 9, 10a, 10b, 10c, 10d, 11a,

11b, 12a, 12b, and 12c) must be reversed by subtracting the initial response value of each item from

6 (i.e. 6 – initial response value) so that a higher final response value is associated with better

satisfaction with OAB control for all items in the scale.


missing).

If 5 or more items are completed, then compute the scale score using the formula:



higher score representing better satisfaction with OAB control.

2.4. Impact on Daily Living with OAB scale

First the coding of all ten items (IDL1 to IDL10; Pre-Medication form items 5a, 5b, 5c, 5d, 5e, 5f, 5g,

5h, 5i, and 5j; Medication form items 6a, 6b, 6c, 6d, 6e, 6f, 6g, 6h, 6i, and 6j) must be reversed by

subtracting the initial response value of each item from 6 (i.e. 6 – initial response value) so that a

higher final response value is associated with better satisfaction with ability to perform daily activities

for all items in the scale.


missing).




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higher score representing better satisfaction with ability to perform daily activities.

2.5. OAB Medication Tolerability Scale

First the coding of the response “I did not have this side effect” must be changed from an initial

response value of 0 to a final response value of six for all six items (TOL1 to TOL6; Medication form

items 8a, 8b, 8c, 8d, 8e, and 8f) so that a higher final response value is associated with better

medication tolerability (less bothered by side effects, with the highest value given to “I did not have

this side effect”) for all items in the scale. Note that the final response values associated with the

other five response choices for each item do not change from their initial values.

If fewer than five of the six items are completed, then do not score this scale (i.e. set the score to

missing).




higher score representing better medication tolerability.

2.6. Fulfilment of OAB Control Expectations Item

To get the final item score, the coding of this item must be reversed by subtracting the initial response

value from 6 (i.e. 6 – initial response value) so that the final item score ranges from one to five with a

higher score associated with better fulfillment of OAB medication expectations.

2.7. Interruption of Day-to-day Life due to OAB Item

The final item score is the same as the initial response value (no coding changes necessary). The

final item score ranges from one to five with a higher score associated with less interruption in day-to-

day life due to OAB symptoms.


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2.8. Overall Satisfaction with OAB Medication Item


value from 6 (i.e. 6 – initial response value) so that the final item score ranges from one to five with a

higher score associated with better satisfaction with OAB medication.

2.9. Willingness to Continue OAB Medication Item


value from 6 (i.e. 6 – response value) so that the final item score ranges from one to five with a higher

score associated with greater desire/willingness to continue using the current OAB medication.

2.10. Improved Life with OAB Medication Item


value from 6 (i.e. 6 – response value) so that the final item score ranges from one to five with a higher

score associated with greater improvement in day-to-day life due to the current OAB medication.


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Appendix: OAB-S Pre-Medication Module

OAB Control Expectations

The following questions will help us understand what you expect from your OAB medication. For each question, mark an in the one box that best describes your answer.

EXP1 1. On your way to the bathroom, you expect your OAB medication to keep you from having urine loss:

All of the time you go to the bathroom

Most of the time you go to the

bathroom

Some of the time you go to the

bathroom

A little of the time you go to the

bathroom

None of the time you go to the

bathroom

1 2 3 4 5

2. You expect your OAB medication to decrease the number of times:

A lot

Moderately

Somewhat

A little Not at

all

EXP2 2a.

You have a sudden urgency to urinate

1

2

3

4

5

EXP3 2b.

You have urine loss due to an urgency to urinate

1

2

3

4

5

EXP4 2c.

You wake up during the night to urinate

1

2

3

4

5

EXP5 2d.

You have to urinate during the day 1 2 3 4 5

3. You expect your OAB medication:

A lot

Moderately

Somewhat

A little Not at

all

EXP6 3a.

To improve your control of your urine loss

1

2

3

4

5

EXP7 3b.

To improve your control of your need to urinate

1

2

3

4

5

OAB-S Scoring Algorithm—v1.0 13 Jan 06 Page 8 of 19


4. While on your OAB medication, you expect to:

All of the time

Most of the time

Some of the time

A little of the time

None of the time

EXP8 4a.

Wear pads

EXP9 4b.

Wear dark and/or baggy clothes 1 2 3 4 5

EXP10 4c.

Be comfortable being away from a bathroom 1 2 3 4 5

OAB Control Expectations (cont’d) The following questions will help us understand what you expect your day to day life to be like while on your OAB medication. For each question, mark an in the one box that best describes your answer.

1 2 3 4 5



5. Keeping in mind how your OAB symptoms may interrupt your activities, how satisfied are you with your ability:

Very satisfied

Somewhat satisfied

Neither

dissatisfied nor satisfied

Somewhat dissatisfied

Very dissatisfied

IDL1 5a.

To perform physical activities lasting 30 minutes or less (for example, going for a walk)

1

2

3

4

5

IDL2 5b.

To perform physical activities lasting more than one hour (for example, shopping or exercising)

1

2

3

4

5

IDL3 5c.

To participate in activities with others lasting 30 minutes or less (for example, talking on the telephone)

1

2

3

4

5

IDL4 5d.

To participate in activities with others lasting more than one hour (for example, sitting in a movie theater or going out to dinner)

IDL5 5e.

To travel for 30 minutes or less (for example, commuting)

1

2

3

4

5

IDL6 5f.

To travel for more than one hour (for example, going on a car trip)

1

2

3

4

5

IDL7 5g.

To complete work and/or household duties lasting 30 minutes or less

1

2

3

4

5

IDL8 5h.

To complete work and/or household duties lasting more than one hour

1

2

3

4

5

IDL9 5i.

To focus on work and/or household duties 1 2 3 4 5

IDL10 5j.

To sleep through the night without having to go to the bathroom

1

2

3

4

5

Impact on Daily Living with OAB

The following questions will help us understand how satisfied you are with your day to day life with your OAB. For each question, mark an in the one box that best describes your answer.

1 2 3 4 5



Impact on Daily Living with OAB (con’t)

INTERRUPT 6. How much do your OAB symptoms interrupt your day to day life? A lot Moderately Somewhat A little Not at all

1 2 3 4 5



Appendix: OAB-S Medication Module

OAB Control

The following questions will help us understand the effects your OAB medication has on your OAB symptoms. For each question, mark an in the one box that best describes your answer.

CON1 1. Your OAB medication enables you to reach the bathroom without urine loss:

All of the time you go to the bathroom

Most of the time you go to the

bathroom

Some of the time you go to the

bathroom

A little of the time you go to the

bathroom

None of the time you go to the

bathroom

1 2 3 4 5

2. Your OAB medication decreases the number of times:

A lot

Moderately

Somewhat

A little Not at

all

CON2 2a.


1

2

3

4

5

CON3 2b.


1

2

3

4

5

CON4 2c.


1

2

3

4

5

CON5 2d.


3. Your OAB medication:

A lot

Moderately

Somewhat

A little Not at

all

CON6 3a.

Improves your control of your urine loss

1

2

3

4

5

CON7 3b.

Improves your control of your need to urinate

1

2

3

4

5


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4. While on your OAB medication, you:

All of the time

Most of the time

Some of the time

A little of the time

None of the time

CON8 4a.

Wear pads

CON9 4b.

Wear dark and/or baggy clothes 1 2 3 4 5

CON10 4c.

Are comfortable being away from a bathroom 1 2 3 4 5

OAB Control (cont’d)

The following questions will help us understand the effect your OAB medication has on your day to day life. For each question, mark an in the one box that best describes your answer.

1 2 3 4 5

FULFILL 5. To what degree does your OAB medication meet your expectations?

Greatly exceeds my expectations

Somewhat exceeds my expectations

Meets my

expectations

Does not quite meet my

expectations

Does not meet my expectations

at all

1 2 3 4 5


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Impact on Daily Living with OAB

6. Keeping in mind how your OAB symptoms may interrupt your activities, how satisfied are you with your ability:

Very satisfied

Somewhat satisfied

Neither

dissatisfied nor satisfied


Very dissatisfied

IDL1 6a.

To perform physical activities lasting 30 minutes or less (for example, going for a walk)

1

2

3

4

5

IDL2 6b.

To perform physical activities lasting more than one hour (for example, shopping or exercising)

1

2

3

4

5

IDL3 6c.

To participate in activities with others lasting 30 minutes or less (for example, talking on the telephone)

IDL4 6d.

To participate in activities with others lasting more than one hour (for example, sitting in a movie theater or going out to dinner)

1

2

3

4

5

IDL5 6e.

To travel for 30 minutes or less (for example, commuting)

1

2

3

4

5

IDL6 6f.

To travel for more than one hour (for example, going on a car trip)

1

2

3

4

5

IDL7 6g.

To complete work and/or household duties lasting 30 minutes or less

1

2

3

4

5

IDL8 6h.

To complete work and/or household duties lasting more than one hour

1

2

3

4

5

IDL9 6i.

To focus on work and/or household duties 1 2 3 4 5

IDL10 6j.

To sleep through the night without having to go to the bathroom

1

2

3

4

5

The following questions will help us understand how satisfied you are with your day to day life with your OAB. For each question, mark an in the one box that best describes your answer.

1 2 3 4 5


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Impact on Daily Living with OAB (con’t)

INTERRUPT 7. How much do your OAB symptoms interrupt your day to day life? A lot Moderately Somewhat A little Not at all

1 2 3 4 5


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OAB Medication Tolerability

8. Since you started your medication, how much have you been bothered by each of the following side effects?

I did not have this

side effect

I had this side effect and:

It bothered

me a lot

It bothered me

moderately

It bothered me

somewhat

It bothered me a little

It did not bother me

at all

TOL1 8a.

Constipation

TOL2 8b.

Dry mouth

TOL3 8c.

Drowsiness

TOL4 8d.

Headache

TOL5 8e.

Nausea

TOL6 8f.

Blurred vision 0 1 2 3 4 5

The following questions will help us understand how bothered you are by the side effects of your OAB medication. For each question, mark an in the one box that best describes your answer.

0 1 2 3 4 5

0 1 2 3 4 5

0 1 2 3 4 5

0 1 2 3 4 5

0 1 2 3 4 5


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Satisfaction with OAB Control

The following questions will help us understand how satisfied you are with your OAB medication’s ability to treat your OAB symptoms. For each question, mark an in the one box that best describes your answer.

SAT1 9. Overall, how satisfied are you with your OAB medication’s ability to allow you to reach the bathroom without urine loss:

Very satisfied Somewhat satisfied Neither dissatisfied nor satisfied

Somewhat dissatisfied Very dissatisfied

1 2 3 4 5

10. Overall, how satisfied are you with your OAB medication’s ability to decrease the number of times:

Very

satisfied

Somewhat satisfied

Neither dissatisfied

nor satisfied


Very

dissatisfied

SAT2 10a.


1

2

3

4

5

SAT3 10b.


1

2

3

4

5

SAT4 10c.


1

2

3

4

5

SAT5 10d.


11.

Overall, how satisfied are you with your OAB medication’s ability

Very

satisfied

Somewhat satisfied

Neither dissatisfied nor satisfied


Very

dissatisfied

SAT6 11a.

To improve your control of your urine loss 1 2 3 4 5

SAT7 11b.

To improve your control of your need to urinate 1 2 3 4 5


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12. Overall, how satisfied are you with your OAB medication’s ability:

Very

satisfied

Somewhat satisfied

Neither dissatisfied nor satisfied


Very

dissatisfied

SAT8 12a.

To decrease the need to wear any pads at all

1

2

3

4

5

SAT9 12b.

To decrease the need to wear dark and/or baggy clothes

SAT10 12c.

To allow you to be away from a bathroom

1

2

3

4

5

Satisfaction with OAB Control (cont’d)

The following questions will help us understand how satisfied you are with the effect your OAB medication has on your day to day life. For each question, mark an in the one box that best describes your answer.

1 2 3 4 5

The following questions will help us understand your overall satisfaction with your OAB medication. For each question, mark an in the one box that best describes your answer.

OVSAT 13. Overall, how satisfied are you with your OAB medication?

Very satisfied Somewhat satisfied

Neither dissatisfied nor

satisfied


Very dissatisfied

1 2 3 4 5

CONTINUE 14. Based on your experience with your current OAB medication, would you like to continue using this OAB medication?

Definitely yes Probably yes Do not know Probably not Definitely not

1 2 3 4 5

IMPLIFE 15. How much has your OAB medication improved your day to day life?

A lot Moderately Somewhat A little Not at all

1 2 3 4 5

Thank you for your time.

OAB-S Scoring Algorithm Page 18 of 19 v1.0 13 Jan 06

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