## International Workshops on Myositis Outcome Measures and Clinical Trial Design Issues

*First Workshop -*

*Defining Improvement in Adult and Juvenile Myositis*

# *The International Myositis Outcome Assessment Collaborative Study Group*

The Palace Hotel, San Francisco, California, USA

November 9th-10th, 2001

### AGENDA

8:30 - 9:00 AM Registration -- Sonoma Room

#### 

####  **Joint Meeting of the Adult and Juvenile Myositis Working Groups -- Sonoma Room**

9:00 - 9:40 AM Welcome, Introduction and Overview - *Fred Miller and
Lisa Rider*

9:40 - 10:00 AM Core set measures: Physician and patient/parent global
assessments -- *Lisa Rider*

10:00 - 10:25 AM Core set measures: Manual muscle testing considerations
for myositis clinical trials -- *Michael Love*

10:25 - 10:40 AM Core set measures: Muscle strength (manual muscle
testing) -- *Lisa Rider*

10:40 - 11:00 AM Break

11:00 -- 11:20 AM Core set measures: Functional assessment
considerations for myositis clinical trials -- *Galen Joe*

11:20 -- 11:35 AM Core set measures: Functional Assessment (HAQ/CHAQ)
*-- Lisa Rider*

11:35 -- 12 noon Core set measures: Laboratory evaluation (enzymes) --
*Lisa Rider*

> 12:00 -- 12:20 PM Core set measures: Extra-muscular disease activity
> assessment -- *Lisa Rider*

12:20 -- 12:30 PM Discussion of Core Set Measures - *Participants*

> 12:30 -- 12:45 PM Background for Core Set Measure Questionnaire -- *Ed
> Giannini*

12:45 -- 1:00 PM Completion of Core Set Measure Questionnaire -
*Participants*

1:00 -- 2:30 PM Lunch - On your own

> 2:30 -- 3:00 PM Review of Results of Core Set Measure Questionnaire
> and Nominal Group Technique -- *Ed Giannini*
>
> 3:00 -- 3:10 PM Review of sample paper patient profiles - *Fred Miller
> and Lisa Rider*

#### 

####  **Separate Meetings of the Adult (Sutter Room) and Juvenile (Monterey Room)**

####  **Myositis Working Groups**

> 3:20 -- 4:10 PM Evaluation of paper patient profiles and development
> of consensus on ratings using Nominal Group Technique - *Participants*

4:10 -- 4:25 PM Break

> 4:25 -- 5:15 PM Evaluation of paper patient profiles and development
> of consensus on ratings using Nominal Group Technique - *Participants*
>
> 5:15 -- 5:25 PM Break
>
> 5:25 -- 6:15 PM Evaluation of paper patient profiles and development
> of consensus on ratings using Nominal Group Technique - *Participants*
>
> 6:15 PM Adjourn

7:30 PM Dinner for those interested at the famous *Fly Trap Restaurant*

## 

## International Workshops on Myositis Outcome Measures and Clinical Trial Design Issues

*First Workshop -*

*Defining Improvement in Adult and Juvenile Myositis*

# *The International Myositis Outcome Assessment Collaborative Study Group*

The Palace Hotel, San Francisco, California, USA

November 9th-10th, 2001

### 

### AGENDA

#### **Separate Meetings of the Adult (Sutter Room) and Juvenile (Monterey Room)** 

#### **Myositis Working Groups**

9:00 --10:15 AM Evaluation of paper patient profiles and development of
consensus on ratings using Nominal Group Technique - *Participants*

10:15 -- 10:30 AM Break

10:30 -- 12 noon Evaluation of paper patient profiles and development of
consensus on ratings using Nominal Group Technique - *Participants*

Noon -- 1:00 PM Lunch - On your own

1:00 - 2:40 PM Evaluation of paper patient profiles and development of
consensus on ratings using Nominal Group Technique - *Participants*

2:40 -- 3:00 PM Break

#### 

####  **Joint Meeting of the Adult and Juvenile Myositis Working Groups -- Sonoma Room**

3:00 -- 4:00 PM Combined group discussion of results/problem areas from
the

> workshop and future plans -- *Fred Miller, Ed Giannini and Lisa Rider*

4:00 -- 5:00 PM Core set measures: Myositis Damage Index -- *Lisa Rider*

(Required for all members of the JDM Disease Activity Collaborative
Study Group and NIH physicians who will participate in chart review for
damage assessments, but others may attend if desired)

5:00 PM Adjourn -- End of First Workshop