Archives   Calendar    Coordinating Center    Multisite Activities    
Project Description  COSP References  Study Sites    Search Our Site   
Table of Contents    Upcoming Meeting Agendas

______________________________________________

Present: Tom Summerfelt (moderator), Crystal Blyler, Jean Campbell, Sally Clay, Pat Corrigan, Dianne Cote, Sita Diehl, Sarah Diwan, Zahira DuVall, Janine Elkanich, Nancy Erwin, Susan Essock, Louetta Hix, Matt Johnsen, Anika Keens-Douglas, Kathyrn Kidder, David Lambert, Daneylle Mannix, Brian McCorkle, Betsy McDonel, Carol Mussey, Ruth Ralph, Sally Rogers, Mark Salzer, Yvette Sangster, Bonnie Schell, James Scott, Steve Segal, Carol Silverman, Greg Teague, Sharon Togut, Daphne Walker-Thoth, Brian Yates

The tracking database that Tom Summerfelt demonstrated at the December face-to-face Steering Committee meeting has been distributed to several study sites. Illinois, Florida, Pennsylvania, Iowa, Tennessee, and Maine intend to use it. Connecticut is still exploring the possibility of using it, and California probably won’t use it. Tennessee was complimented on the quality of the program.

Currently, the Tennessee programmer is working on generating a report like the Coordinating Center’s quarterly report tables. Tom will re-distribute the database to the study sites once the quarterly report tables are incorporated. It was recommended that the study sites post any modifications they will be making on the data listserv so that everyone has access. A discussion about the other sites helping to share the cost with Tennessee can also take place on the data listserv.

Tom announced that the electronic version of the common protocol will be ready in about two weeks. If sites are interested, they should contact Tom.

California has submitted applications to public health and the university and should hear soon.

Connecticut has approval from Mount Sinai, the submission to the Department of Mental Health goes in tomorrow and then applications will be submitted to the local sites.

Florida has submitted to the university and is expecting approval shortly.

Illinois has full approval on the common protocol and cost study and now has to submit amendments by January 25 for some of the things that are going to be done locally.

Iowa has submitted its application and it is being reviewed today.

Maine has been waiting until all of the details are worked out, but its application is mainly an update—it has already been approved in general.

Pennsylvania has approval from the university and city IRB and tentative approval for a certificate of confidentiality for which final approval is expected within the next few weeks.

Tennessee applied in December and received full approval Monday for the common protocol, cost study and site visits.

Coordinating Center applied December 1 and found out yesterday that it did get the expedited review status, but the application got lost in the mail when the IRB sent it to the reviewer. The IRB was contacted twice to find out the status and only yesterday found out that a staff member was waiting for the reviewer to recuperate from the holidays before contacting him/her to find out the status of our application. The Coordinating Center expects to hear next week. Jean will file a letter of complaint. Since MIMH has an original letter from the IRB with general approval, this current application could be considered an update.

Jean moved that Daphne’s proposal for the allocation of teleconference funds by subcommittee/work group be approved. Tom seconded the motion. There was general agreement that the groups would abide by the budget with the understanding that the study sites will contribute $200 to $300 a piece to help cover the cost of two additional CAP calls and that the Cost Analysis Subcommittee’s teleconference will run for 1.5 hours instead of 1 hour. The Coordinating Center will report monthly on the number of calls held and amount of money left in each group’s allocation.

Daphne announced that she will probably be leaving the COSP the assume responsibilities as the principal investigator of a local church-based substance abuse prevention initiative.

Sally Rogers stated that a major question that needs to be answered is whether or not sites were going to stratify. From information collected after the December face-to-face meeting, it appears that half of the sites will stratify -- three by gender, two by race and one by level of involvement with traditional mental health services. Sally consulted with her university’s statistician who stated that this would pose no barrier to aggregating across site. Sally suggested that Joe Sonnefeld’s input also be sought.

During the listserv discussions about blocking somehow stratification got confused with some other things and people thought that by blocking we would be excluding groups of prospective participants from the study. Sally explained that stratifying by gender will not lead to the exclusion of anyone from the study. When you stratify, you take all eligible men and women who present and make sure they are equally divided among the control and experimental groups. Stratification by gender is a simple way to balance the control and experimental groups. It should be easy to implement and invisible to participants. Sites would have to create randomization schedules that block on gender. Sally said Boston University could generate the randomization schedules for those sites interested.

After a lengthy discussion, Crystal Blyler moved that the COSP block on gender across all study sites. Ruth Ralph seconded the motion. There were no objections, so consensus was reached.

There was some disagreement about whether the method for blocking needs to be consistent across all sites. Each site agreed to employ a blocking mechanism so that roughly half of men will go to one group and half of men will go to the other and roughly half of women will go to one group and half of women will go to the other. Joe and Matt Johnsen will provide technical assistance upon request from the sites and Sally will generate schedules for interested sites. Jean Campbell asked that each site let the Coordinating Center know its method for blocking.

It was agreed that blocking by race/ethnicity would not be undertaken at the multi-site level. In sites where there are diverse, mixed populations, it is not always obvious how people identify themselves and blocking would be extremely difficult.

Sally posted some possible dates for a teleconference on the listserv and asked that subcommittee members respond. One of the issues to be discussed is diagnoses. Jean suggested that we review some previous discussions about this issue prior to the call.

Steve Segal moved that study sites be allowed to insert a few (two to three) clarifying and appropriate questions to any given area of the common protocol. The maximum number of site-specific questions to added by any one site is 20. If an entire scale is to be added, it will be added at the end of the common protocol. Dianne Cote seconded the motion. The motion passed with 9 votes in favor and 8 votes against.

Prior to the vote, Jean pointed out that insertion of items could present a logistical problem in that insertion of questions could shift the page numbers so that the common protocol and Q-by-Q no longer match. Sally Rogers suggested that the questions not be inserted into the common protocol, but be printed on a separate schedule with separate Q-by-Q instructions. Carol Silverman suggested that if insertion of questions affect pagination that the site number the insert pages with the same number as the previous page followed by the letter "A." For example, 33A.

Florida – will add 5 questions to the housing section.

California – will probably add 10 questions throughout the protocol.

Connecticut – will add about 12 questions.

Iowa – will add about 20 questions throughout the protocol and add the Working Alliance Inventory.

Illinois – will put all of its added measures at the end of the protocol.

Maine – will add 1 question to housing and 1 on alternative medications.

Pennsylvania – will put all of its added measures at the end of the protocol.

Tennessee – will put all of its added measures at the end of the protocol.

Brian McCorkle collected people’s suggestions for improving the format of the baseline protocol, and the major objection was the length. It was suggested that the amount of white space be reduced in order to reduce the total number of pages. The service utilization worksheet at the beginning of the common protocol was confusing, but Sarah Diwan revised the introduction so that it could be used for more than service utilization.

Another suggestion was that there be a direct link between the common protocol and Q-by-Q either by putting the Q-by-Q page numbers in the common protocol or the other way around or to interleaf the Q-by-Q with the common protocol. It was suggested that at the top of the Q-by-Q that the section listings be printed. Jean will send Brian a copy of the Q-by-Q that is currently under revision. Tennessee will test the revised Q-by-Q in the field and Maine has been asked to review it in general.

Tom asked that suggestions from COSP members regarding formatting be sent to Brian or Ruth right away. He said in the electronic protocol, the Q-by-Q is folded into the common protocol.

Louetta submitted a suggestion for the follow-up common protocol. Daphne thought it was a formatting issue and didn’t realize it was related to the follow-up protocol. She will post it on the Steering Committee listserv.

Sally raised the question about how the diagnoses of participants will get into the data repository. Sally Clay asked how sites will know if prospective participants meet the criteria for serious mental illness stated in the GFA. Someone asked what the SAMHSA criteria are for serious mental illness and how the sites will record this information.

Betsy asked if prospective participants with anxiety disorders, eating disorders, personality disorders, etc will be accepted into the study. The federal definition is very broad and allows for any DSM-R IV diagnosis and problems functioning. This definition can be narrowed down by the multi-site study. Crystal suggested that we might focus on persistency. Matt asked how useful it would be to go beyond the broad definition, given that most COS don’t pay attention to diagnoses.

Tom said that diagnoses are unreliable to begin with and cautioned against implementing further diagnosis restrictions. Betsy recommended that the DSM-R IV be reviewed to determine which diagnoses would be included.

Tom recommended that this discussion be continued in the Logistics Subcommittee Group. The Coordinating Center will review notes for previous discussions on this issue.