Absent: Jeremy Anderson, Kay Dickersin, Peter Gotzsche.

In Attendance: Lisa Bero, Ian Fullerton Smith.

Meeting opened: 08.00hrs


Preamble Issue 1 When do we elect the new Chair.

Issue 2 Executive officer, to be dealt with before the Extraordinary General Meeting, straight after Lisa Bero

Issue 3 Lisa Bero 1.30 to talk about Peer Review and Quality Control

1. Appointment of new chair.

Deferred to later in the day.

2. Approval of previous minutes.

At this point clarification was sought as to who should receive reimbursement for attending the meeting. The principle agreed was, that anyone travelling to any Steering Group Meeting, Annual General Meeting or Extraordinary General Meeting which is not part of their normal duties should be reimbursed. This information to be included as part of electoral process.

Action: 2.1 Ian Fullerton Smith.

Approval of the Steering Group minutes of 4 October 1995.

Item 2. Subscriptions, it was noted that the Steering Group had not arrived at an agreement to charge a subscription.

Action: 2.2 Ian Fullerton Smith to amend the item.

The minutes were accepted as amended.

Approval of the Steering Group minutes of 9 October 1995.

The minutes were accepted as a true and correct record.

3. Matters arising.

It was agreed that only the matters arising in subsection C of item 3 on today's agenda should be discussed under new business.

Subsection C. New Business.

Item 1 (04/10/95) Annual Report.

Ian Fullerton Smith reported that no further progress had been made. It was agreed that the term Annual Report should only be used to describe the document that the Cochrane Collaboration is legally bound to produce for the Charity Commissioners and Companies House. The report of the activities of the registered entities will in future be known as the Progress Report. Andy Oxman and Alessandro Liberati were asked to devise a form of reporting to enable entities to contribute to the progress report. Iain Chalmers suggested using the Entity Module as a basis for gathering information.

Action: 3.1 Alessandro Liberati, Andy Oxman.

Item 4 (04/10/95) Royalties.

Ian Fullerton Smith described the present royalty arrangements to the Steering Group.

Item 11 (04/10/95) Ethical Guidelines.

Chris Silagy explained that he was developing a paper on ethical guidelines. This would cover areas, such as funding from industry in general, guidance for Cochrane Entities making direct approaches to industry, and the use of the Cochrane logo for personal gain.

3.2 Chris Silagy, Lisa Bero to prepare a discussion paper.

Item 13 (04/10/95) Consumer Network.

Hilda Bastian addressed the issue of Network terminology, explaining the history of this item, especially the use of term Network for unregistered groups. It was agreed to discuss this item at the Steering Group meeting scheduled for 27 February 1996.

Action: 3.3 New Steering Group

Item 14 (04/10/95) Review of Steering Group procedures

It was agreed that this item should be discussed under item 4, on today's agenda.

Item 30 (04/10/95) Tom Chalmers prize

Chris Silagy and Cindy Mulrow were asked to prepare criteria to define the scope of the prize, it was reported that there had been little progress to date. It was agreed the report should cover all matters associated with the prize, e.g. content, presentation, prize money, etc.

Action: 3.4 Chris Silagy, Cindy Mulrow

Item 31 (04/10/95) Archie Cochrane Trust

Iain Chalmers stated that he was satisfied with the suggestions for the trust. It was agreed that this item should be discussed at the Steering Group meeting scheduled for 27 February 1996.

Action: 3.5 New Steering Group.

Item 1 (09/10/95) How Many Cochrane Centres?

It was agreed that this item would be fully discussed under item 4.

Item 9 (09/10/95) Training.

It was agreed that this item would be fully discussed under item 4.

Item 4 Part II (09/10/95) Synapse Contract.

Ian Fullerton Smith gave an update of the progress to date.

Item 6 Part II (09/10/96) Steering group Election.

Ian Fullerton Smith reported that this had been carried out efficiently and effectively and that he wished to have minuted his appreciation of the help he had received from all the entities.

Item 5 Part II (09/10/95) Future Colloquia.

It was reported that Jos Kleijnen had offered to organise the 1997 Colloquium in Amsterdam, and that Kay Dickersin had offered to host the 1998 Colloquium in Baltimore.

ADDITIONAL ITEM.

International Trials Register.

It was agreed that the members of the new Steering Group should read item 6 from the minutes of 9 October 1995 as background to this item. It was further agreed that this item should be discussed at the Steering Group meeting scheduled for 27 February 1996.

Action: 3.6 New Steering Group

4. Composite item dealing with Review Groups, Fields Methods Groups and the Centre Moratorium.

Discussion Paper:

Operating Guidelines for Cochrane Review Groups.

It was proposed that Carl Counsell should take the Steering Group through the main items of his paper, that deals with operating guidelines for Review Groups (see appendix 1). The key areas are personnel, the specialised register and the production of reviews. Each group must have an editorial board, a journal search co-ordinator is also desirable. Maintaining internationality is essential, though this may be difficult to achieve at the time of registration. Brian Haynes asked if the guidelines applied to all sizes of review groups. Carl Counsell replied, that it would be difficult to apply these across the board.

Discussion Paper:

Support for CRGs - Administrators' Perspective

Beverly Shea acknowledged Ruth Jepson and Jini Hetherington for their efforts in producing this paper (see appendix 2). Beverley Shea outlined the background of the paper. Administrators appear to facilitate reviews without always possessing the relevant experience. Editorial support is variable in terms of time allocation. Computer support is needed for most groups. A Glossary of Cochrane Terminology has been produced by Ruth Jepson and Jini Hetherington (see appendix 3). Beverley Shea asked all members of the Steering Group to feed back comments to her and she would circulate these to all the Administrators.

Action: 4.1 Steering Group to provide feedback

Action: 4.2 Beverley Shea to circulate comments to CRG Administrators

Dave Sackett introduced a letter from Jini Hetherington (see appendix 4) in response to the paper 'Support for CRGs - Administrators' Perspective'. Chris Silagy commented that the Centre Directors rated this very highly.

Discussion paper:

Registration and Responsibilities of CRGs, Fields, Methods Groups and Centres

Iain Chalmers opened this discussion by outlining a problem which had been highlighted in papers previously sent to members of the CCSG both by him (in June 1995) and Hilda Bastian (in November 1995). The essence of both these papers was that the Collaboration does not yet have a transparent mechanism for deciding whether or not to encourage or discourage one or more individuals who have expressed an interest in the possibility of working towards the creation of a new Cochrane entity.

The proposed transfer to the Australasian Cochrane Centre of responsibility for amending and updating the Entities Directory might improve the Collaboration's handling of this process. Staff at the Australasian Centre, with input from other Centre Directors, could decide when it was appropriate to register possible/probable new Entities on the Entities Directory. A sub group of Centre Directors would be established to develop guidelines for this process.

Action: 4.3 Centre Directors.

Responsibilities and performance of registered entities. It was agreed that each entity should set their own targets and be measured by them.

There followed a discussion about funding of prospective entities. It was suggested that many entities found it difficult to raise funding without official support from the Collaboration.

Dave Sackett thanked the presenters of the papers and enquired of the Group what they now wished to achieve. Andy Oxman suggested that it would be beneficial if the Steering Group discussed the previous papers in terms of policy rather than operational detail. This was agreed and that three specific areas should be examined:

1. Registration. 2. Accountability, performance. 3. Embryonic groups.

Chris Silagy informed the meeting that the Centre Directors had offered to form a subgroup to address items 1 & 2 . Alessandro Liberati praised Carl Counsell's paper, and asked for real life examples to be included to illustrate the problems. The question was raised, 'do we need evidence of funding as part of an application or do we accept a statement of intent'. Iain Chalmers gave some examples of how funding had been achieved.

In 1993 the Stroke Group was formed with international representation. They then approached Chief Scientist (Scotland) and approval for funding was given in light of the international support already pledged. The Peripheral Vascular Disease Group application was denied support until after it had received endorsement at an exploratory meeting. Cindy Farquhar illustrated her own experience, demonstrating that it can be possible for a group to form without definite funding. Dave Sackett suggested that the Collaboration should gap-fund, grant or loan seed money to prospective groups. Action: 4.4 New Steering Group

Registration

Chris Silagy described registration as a two part process. Centre Directors assist prospective groups to prepare an application and then the Steering Group judges the application on its merits. A policy was suggested, whereby the Steering Group should have input into defining groups rather than having the present unstructured situation. A discussion about this issue took place, and it was agreed that the new Steering Group would investigate this further. Hilda Bastian indicated there was a fear of the Steering Group in the wider Collaboration. She suggested that earlier contact between the Steering Group and prospective entities may remove possible tensions. Andy Oxman suggested that when a registration checklist was prepared, this would aid the Steering Group when reviewing an application and make the process transparent. There should be an early screening process to enable all Centres and Groups to be involved in the application process.

It was suggested that the Steering Group should produce an overview of possible groups and their potential locations. This could help to identify opportunities and or any possible redundancy. Alessandro Liberati recommended that Centre Directors should identify groups that have resources (such as personal enthusiasm) other than money. Many people have support in kind that is not quantifiable. Monica Fischer suggested a standard format for applications. Dave Sackett suggested that an advisory time line for registration would evolve along with the development of an application checklist.

It was agreed that checklists to aid applications to register should be compiled by the relevant interest group. Working groups to progress these were discussed and it was agreed that a Steering Group member should lead each group.

Action: 4.5 Prepare application checklists by 31 March 1996.

Cochrane Review Groups: Responsible Person Peter Langhorne. Team member Carl Counsell. Centre Director Iain Chalmers.

Methods Groups: Responsible Person Andy Oxman. Team member Lesley Stewart. Team member Mike Clarke.

Fields: Responsible Person Chris Silagy. Centre Director Iain Chalmers.

Cochrane Centres: Responsible Person Peter Gotzsche.

Performance measures.

Chris Silagy opened the discussion about performance measures. Andy Oxman suggested that performance measures could be included in the checklists. Iain Chalmers suggested that performance should be measured starting at the exploratory meeting stage. Ian Fullerton Smith suggested that the annual progress report be the basis for measuring performance. Discussions followed and a consensus was reached that removal from CDSR would be the ultimate sanction for non performance. Ian Fullerton Smith suggested that performance measures were to be used to identify entities that may be experiencing difficulty, and that help has to be given, rather than just removing the struggling group.

Action: 4.6 Monica Fischer to produce data to illustrate the time period between registration and the first completed review.

International Register of Trials.

Iain introduced his response to Kay Dickersin's concerns about the future of the international register of trials, by taking the Steering Group through the history and development of the register of trials. Iain Chalmers referred to the minute of 9/10/95, pointing out that the Steering Group had approved the exploration of an alternative. Update Software offered to distribute a bibliography of records with CDSR. Mark Starr had written to Dave Sackett and Iain Chalmers who replied with letters of support for this development. It was stated that the UK Cochrane Centre will work to ensure their trials are loaded onto the new register.

Brian Haynes reported that he had spoken with Kay Dickersin, and hr enquired who would be responsible for the development of this database. He indicated that Kay would like to be involved in designing the database, and asked how the indexing would be done. Andy Oxman stated that Kay had raised other issues, such as, what are the implications for the relationships with the NLM and the Baltimore Cochrane Center and importantly where are records of trials to be sent. Hilda Bastian expressed concern about sending data to two places. Carl Counsell explained the process of sending data to the NLM via Baltimore. Carl explained that preparing 2000 trials in the Baltimore format had taken 3 months, whereas transferring the same files to Update Software would take little more than 10 minutes. Brian Haynes raised concerns about the quality of indexing and who would control the assembly of the database. Chris Silagy stated that the Collaboration should retain the control of the register. Carl Counsell suggested that a single database should be set up in Baltimore, this would automatically filter out the Medline indexed journals. Andy Oxman suggested a group consisting of Kay Dickersin, Bill Hersh, Mark Starr and others could investigate this further. Hilda Bastian requested that given the role played by administrators in this process, an administrator should be involved in the group. Dave Sackett enquired if the trials register was a short term measure until Medline is properly tagged. Carl Counsell asked for definite guidance as to where entities are to send their trials. Chris Silagy agreed to take the lead with this and to form a group to work this through, and stated that above all there were 3 main needs:

1. The need to produce trial references. 2. The need to influence third parties. 3. The need to involve the Baltimore Cochrane Center.

Action: 4.7 Chris Silagy.

Discussion Paper:

Peer Review and Quality Control.

Lisa Bero explained that her purpose in attending the meeting was to describe the work that she and Drummond Rennie had prepared on the subject of peer review. She stated that 3 items needed to be resolved at today's meeting, these are:

1. Approval to go forward with the peer review process 2. Feedback from the Steering Group about the proposals. 3. With whom will the San Francisco Cochrane Center liaise?

Lisa walked the Steering Group through the paper. For the pre-publication issues, the San Francisco Cochrane Center would like to send the information to the Review Group Administrators for distribution. Andy Oxman requested that the pre-publication issues section should be included in the handbook.

Post-publication issues. Lisa Bero and Drummond Rennie are being encouraged by the NLM to approach them for funding. This grant application is for an on line system of peer review. Lisa asked the members to examine the flow chart that was attached to the paper, and she then explained the process.

Lisa needs to identify a contact person within the Steering Group. A discussion took place to examine if there was any value in having anonymous contributions. The meeting agreed that ideally those offering criticism or feedback identify themselves to a criticism editor rather than the reviewer. The criticism field would be displayed on screen and there would be a list of all those who have contributed, without singling out a specific person thereby providing a degree of anonymity. Andy Oxman suggested that the Consumer Network examine this proposal and develop a methodology. Carl Counsell asked if this system of Peer Review would be applied to protocols, this has yet to be fully explored. Andy Oxman enquired how criticism could be encouraged without the criticism editors being inundated. It was commented that to date very little criticism had been received on any of the published reviews. Andy Oxman encouraged the San Francisco Center to go forward with the process. It was agreed that the contact points for the San Francisco Center would be:

Monica Fischer for the Software Development Group. Mark Starr for Update Software. Andrew Penn for Synapse Publishing.

It was agreed that San Francisco Cochrane Center should submit a grant application to the NLM.


5. The role of the Executive Officer.

Ian Fullerton Smith was asked to leave the meeting at this point. A discussion about the role of the Executive Officer and the terms and conditions of payment for the post.

Ian Fullerton Smith rejoined the meeting and the detailed job description he had prepared was discussed and modifications suggested. The final form will be agreed between Chris Silagy and Ian Fullerton Smith.

Action: 5.1 Chris Silagy and Ian Fullerton Smith.

6. Confirmation of meeting arrangements.

It was agreed that the new Steering Group would commence at 08.00hrs.

Expression of thanks.

The Members of the new Steering group expressed gratitude for the work carried out by the old Steering Group.

There being no more business the meeting closed at 15.40hrs

STEERING GROUP MINUTES MONDAY 26 FEBRUARY 1996 GALLERIA PARK HOTEL SAN FRANCISCO


Present: Chris Silagy (Chair), Hilda Bastian, Iain Chalmers, Cindy Farquhar, Monica Fischer, Jean Jones, Peter Langhorne, Andy Oxman, Beverley Shea

Absent: Jeremy Anderson, Peter Gotzsche

In Attendance: Ian Fullerton Smith

Meeting opened: 16.00


This part of the meeting began without a formal agenda, the first item of business being the election of the Chair of the Steering Group.

1. Ian Fullerton Smith was invited to chair the meeting at this time to facilitate the election of the Chair. Ian reported that he had received 1 nomination for the position of Chair of the Steering group, Chris Silagy. Ian Fullerton Smith called for any further candidates to come forward. There being none, it was proposed that Chris Silagy be elected. The proposal was accepted unanimously by those present.

2. Chris Silagy requested that the next item of business should be to set the agenda for the meeting to be held on 27 February 1996. It was agreed that there were three main subject areas:

To agree the agenda To agree timings for tomorrow To review the processes of the Steering Group.

PROVISIONAL AGENDA

1. Clarify the role and business responsibilities of being a Director of a charity

2. Process of the Steering Committee

The role of the Executive Officer The role of the Chair

The purpose of the Executive Committee The purpose of a sub committee structure Communications Co-opting additional members Fields

3. Carried over items from 26 February 1996

Annual report Progress report Entities Non CRG Modules Complimentary copies of CDSR Ethical guidelines Networks Moratorium on Cochrane Centres Methods Groups

4. New business

Paper on Software development Peter Gotzsche, funding of an information technology post Cochrane Centre Directors issues Paper on support for Administrators Funding & Subscriptions Applications to register, outstanding & new

5. Strategic Planning

6. Dates for future meetings

The provisional agenda was agreed and Chris Silagy proposed that the Steering Group should take a short break and then be prepared to work into the evening. This was agreed.

Meeting Closed: 16.45


STEERING GROUP MINUTES MONDAY 26 FEBRUARY 1996 GALLERIA PARK HOTEL SAN FRANCISCO


Present: Chris Silagy (Chair), Hilda Bastian, Iain Chalmers, Cindy Farquhar, Monica Fischer, Jean Jones, Peter Langhorne, Andy Oxman, Beverley Shea

Absent: Jeremy Anderson, Peter Gotzsche

In Attendance: Ian Fullerton Smith

Meeting opened: 17.00


This short working meeting focused on the agenda item headed as Process of the Steering group

1. The Cochrane Fields have recently held a meeting in London and are seeking Steering Group guidance on certain matters. Firstly, a request was made for an indication of which Fields are likely to be registered with the Collaboration by 1 April 1996. This information was sought as the Fields are anxious to elect a representative to the Steering group. After discussion the Steering Group agreed to provide the information. Secondly, the fields stated that they reserved the right to send an alternative person if their elected member could not attend a Steering group meeting. The Steering group discussed the matter and refused the request as it had been agreed that there would be no alternate delegates for any Steering group member.

Action: Ian Fullerton Smith to communicate these decisions to the Fields.

2. A discussion centred around the vacant position for a policy maker on the Steering group, (at this time a non-electable post, as no Policy Maker entity exists). The group concluded that if any body of persons wished to form a Policy Maker entity, that any such group would be subject to the normal registration process. It was proposed that this vacancy could be filled, using the Steering Group power to co-opt such persons as may be required. Suggestions were made to addressthe perceived imbalance or lack of skills within the new Steering group.

- PR Person/Liaison/Fundraising

- A representative from the USA

- A Non Anglo-Saxon/European

- A representative from the developing countries

- A representative from the trials registry

- A representative with information technology skills

It was agreed that the most needed skills were for US representation, ideally someone with a PR/Liaison/fundraising background.

Iain Chalmers proposed that the Cochrane Centres in the United States should nominate a person to act as their representative and possibly raise funds. The Steering Group considered this and agreed to invite the US Centres to provide a Candidate by 31 March 1996.

Action: Ian Fullerton Smith to write to the US Cochrane Centres and inform them of the Steering group decision, requesting that the action point be completed within the timescale.

The discussion then focused on the need for certain core functions to be accountable and report directly to the Steering group. This discussion was to help to clarify who, if anyone should be co-opted. After further discussion it was agreed that the following core functions would be accountable directly to the Steering group:

- The Handbook

- The Trials Registers Development Group

- The Software Development Group

- The Colloquium

Those functions listed above are deemed essential elements that should provide input to the Steering group either through reports or by a representative attending meetings when requested. Ian Fullerton Smith suggested that members of the Steering group should take a "Director" role and assume responsibility for specific functions. Chris Silagy proposed that Kay Dickersin be invited to become an ex-officio advisor to the Steering group, If she agrees to take responsibility for the Trials register Development Group.

Action: Ian Fullerton Smith to write to Kay Dickersin inviting her to coordinate the Trials Register Development Group


Meeting Closed: 17.45

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