After publication of the main results of the MONICA Project, it was decided that the MONICA Manual will no longer be revised, but any changes will be included as amendments to the Manual. To the extent of the amendments, parts of the MONICA Manual, although of historical relevance, will be superseded:
February 1999
This section of the MONICA Manual describes the organization and management of the WHO MONICA Project. It can only be altered by the MCCs at a meeting of the CPI or through a postal or other form of ballot (see Annex 1).
Proposals for changes to the Manual can be made by anyone in MONICA. The MSC will review the relevance of such proposals and, where appropriate, submit them to a ballot in which the MCCs only will be eligible to vote. Decisions on change of MONICA rules will be valid if there is a 65% majority of those voting and the total vote is 80% of MCCs eligible to vote. Eligibility of MCCs to vote will depend on their continuing involvement with the WHO MONICA Project. Those Centres which have persistently failed to respond to communications over a period of three months before the ballot and have been deemed to be non-operational for that reason by the MSC will not be counted in the MONICA denominator for ballots.
The August 1998 revision was made in recognition of the changes in governance that were likely to occur with the conclusion of data collection phase of the Project. In particular it was recognised that as future Councils of Principal Investigators were unlikely, or at best unpredictable, the previous procedures for changing the rules governing the project or electing new members to the MONICA Steering Committee, would no longer apply. There will nevertheless be an ongoing requirement to oversee the ongoing publication of results and other reports from the Project and to regulate the use of the MONICA Archive.
The current (February 1999) version differs from the August 1998 version only in Annex 1, where the rules for counting postal votes in the election of MSC members have been revised to cover all situations.
The working language is English.
There are two types of membership:
The WHO MONICA Project is a partnership between the World Health Organization and the MONICA Principal Investigators. Between the infrequent meetings of the MONICA parliament - the Council of Principal Investigators - the running of the project is carried on by designated MONICA Centres as described below.
The World Health Organization acts as project sponsor and co-ordinator, assists in acquiring funds, and executes financial and other contracts whenever necessary. The general management and coordination of the WHO MONICA Project are carried out from WHO Headquarters by the Cardiovascular Diseases Programme within the Division of Noncommunicable Diseases, the MONICA Management Centre. Responsibility for the management of the major technical aspects has been assigned to different centres with expertise in the specific fields. The area of responsibility and the terms of reference for each of the different centres are stated in the relevant sections below.
The policy making and management structure of the WHO MONICA Project, is made up of the following components:
Throughout the text only the abbreviations given above are used. An organizational chart is shown below.
Only category i) has the right to vote at CPI meetings. Each MCC has only one vote, even if it has two PIs.
Note: 1 A chief scientific officer designated by a country to coordinate activities of MONICA Collaborating Centres within that country.
The Council has the following functions:
Funding: To the extent that funds are available, the costs of participation of the Principal Investigator (or his/her nominated alternate), the Heads of the MMC, MDC, MQCs and MRCs, as well as coopted advisers will be borne by WHO. In the case of joint PIs, the WHO will cover the cost of one PI for each MCC, except where one of the PIs is head of a management body (MMC, MDC, MQCs, MRCs).
Organization: Meetings of the CPI are organized by the MMC, the MSC and, where relevant, any local co-ordinator.
The MSC is a committee of the CPI with the following constitution:
Note: 2 MONICA is partially supported under Concerted Action funding granted by the European Union for a 3-year period from 1 June 1996, and a Shared Cost Action for a 3-year period from 1 May 1998.
Prior to the CPI meeting in October 1997, elected members of the MSC served for a period of three terms, where the terms were defined as the periods between two CPI meetings. After the 1997 CPI meeting, a term is defined as an 18-month period, ending on 31 March or 30 September. In principle the longest serving elected member shall retire at the end of each term. Vacancies due to the retirement of elected members shall be filled by the CPI; should an elected PI-member of the MSC resign, the alternate elected at the previous election shall serve in his/her place.
Until October 1997 one new member of the MSC was elected at each meeting of the CPI. Thereafter the appointment of the elected members of MSC can be by postal ballot. A ballot to elect a new member will be held at the end of each term. Elections will be held in March or September of the appropriate year.
Prior to October 1997, eligibility to serve on the MSC was restricted to MCC PIs or co-PIs. Post October 1997, eligibility is defined as:
Rules for postal voting:
See Annex 1.
The Chair of the MSC shall be elected by the MSC from among the three members elected by the CPI. The Chair shall hold office for one term. The Rapporteur, who serves both the MSC and CPI, shall be appointed by WHO in consultation with the MSC for a period of 3 years, and shall be subject to re-appointment.
The PC shall be appointed by the MSC from its elected PI members. In general the PC will serve for one electoral term, and can be re-elected. The PC has the responsibility for:
A total of four, including two elected members and two ex-officio members shall form a quorum.
Each member of the MSC (except coopted advisers) shall be eligible to vote. However, the three elected members, when voting together, shall have power of veto over the ex-officio members.
PIs who are not members of the MSC may be invited to attend MSC sessions but are not entitled to vote. Technical staff of the management organizations, including the MQCs, may also be invited to participate in MSC sessions when required. Observers may be permitted at the discretion of WHO after consultation with the Chair.
CVD Programme, WHO/HQ, serves as Secretariat to the MSC.
The MSC is charged with the following responsibilities:
The Cardiovascular Diseases Programme (CVD), within the Division of Noncommunicable Diseases (NCD), WHO Headquarters, is responsible for the day-to-day management and coordination of the WHO MONICA Project in accordance with WHO policy and directives. The MMC has the following functions:
The MDC is jointly sponsored by WHO, through a technical services agreement, and by the National Public Health Institute of Finland, and is supported through a Biomed grant from the European Union. The MDC is concerned with the management and analysis of the core data of the WHO MONICA Project. Under the overall direction of the MSC and of WHO, the MDC shall:
The tasks of the MDC are defined by the MSC in accordance with the requirements of the MONICA Manual.
All MCCs and MQCs will have direct communication with the MDC regarding data flow and related technical matters.
The MDC is a separate unit within the Department of Epidemiology of the National Public Health Institute of Finland, and is not part of FINMONICA.
Centres nominated by WHO in consultation with the MSC to provide expertise on specified areas of the core project. There are four Quality Control Centres with specific tasks:
Aim: To ensure comparability of data collection in the MONICA Project by testing the performance of Centres in lipid measurements.
Terms of Reference: In close cooperation with the MSC and MMC, the Prague Centre will provide the following services:
Aim: To standardize the interpretation of ECG according to Minnesota coding in order to improve diagnostic performance in assigning MONICA ECG categories.
Terms of reference: In close cooperation with the MSC, the MMC and the MQC for Event Registration, Dundee (Dundee Centre), the MONICA Quality Control Centre for ECG Coding, Budapest (Budapest Centre) will provide the following services:
Aim: To standardize the coding and classification of coronary and stroke events according to the MONICA Protocol in order to improve comparability and stability within and between Centres, thereby maximizing the chances of detecting true time trends in event rates and minimizing the likelihood of spurious trends.
Terms of reference: In close cooperation with the MSC, the MMC and the MQC Budapest, the Dundee Centre is responsible for the following areas:
Links between the Dundee Centre and the Budapest Centre: ECG diagnoses will be agreed with the MQC for ECG Coding, Budapest, this centre taking primary responsibility for Minnesota coding and Dundee for any problems with diagnostic algorithms. Other procedures are to be agreed with the MMC and the MDC concerning distribution, analysis and commentaries.
Aim: To develop methods for the collection and quality assessment of standardised data on provision of health services and selected aspects of medical and surgical care for the management of cardiovascular disease in MONICA Collaborating Centres.
Terms of Reference: In close cooperation with the MSC, MDC, MMC and MQC for Event Registration, the Perth Centre is responsible for the following areas:
MRCs deal only with optional studies carried out within the framework of the WHO MONICA Project. They coordinate and advise on their specific areas of speciality as follows:
The following conditions form the basis for recruitment, continuing participation and quality assurance of individual Centres.
Expertise:
Population to be monitored: See Section I.1.
Local procedures:
Coordination:
Local responsibilities:
The various Centres of the MONICA Project are required to provide formal written reports regularly as follows and, in addition, whenever requested for ad hoc specific purposes:
| Centre/group | Reports to | Timing |
|---|---|---|
| MCC | MMC | Annually by 30 June |
| MSC | CPI | Every meeting |
| MMC | MSC | Every meeting |
| MDC | MMC | 30 June and 30 December |
| MSC | Every meeting | |
| MQC | MMC | 30 June and 30 December |
| MRC | MMC | 30 June and 30 December |
Reports should contain the following information:
Reports should be signed by the designated PIs or the head of the centre concerned.
Procedures to be followed by MMC, MDC and MQCs.
Procedures to be followed by MCCs:
Procedures for communication by E-mail and the WWW:
(These publication rules have been superseded by those given in Amendment 2.)
The MONICA publication policy is designed to encourage scientific publication of all types, while maintaining the high quality of these publications and ensuring the legitimate interests of all MONICA participants.
The policy refers to written or oral presentations of unpublished MONICA core data (including data accepted for publication but not yet published). No such data can be presented or published without the consent of each PI. As a general rule, consent should be received within 4 weeks; failure to reply within this time will be taken to mean consent ('The 4-week rule' starts from the date the document is e-mailed, faxed or posted).
MONICA publications are coordinated by the PC (see 3.2).
Individual MONICA Centres are encouraged to present and publish results that are based on the data from their own centre, subject to acknowledgement that they are derived from the WHO MONICA Project. Publications which refer to the WHO MONICA Project in the title must be approved by the MSC before publication.
Publications from MCCs based on mutual agreement among participating PIs are encouraged. This applies to Optional Studies.
Interested Centres can directly pool their own data.
If core data from the MDC are used for such a publication, a formal request for data release, accompanied by the approval of all MCCs concerned, must be sent to the MMC. The MSC decides on the data release.
If collaborative publications from several MCCs refer to the WHO MONICA Project in the title, or if more than six Centres are included, approval by the MSC must be obtained before the manuscript is submitted for publication. For such approval the manuscript should be sent to the MMC. Approval from the MSC must also be obtained when four or more MCCs wish to explore the interrelationships of tenyear data on trends in events, case fatality, risk factors or medical care. A paper from up to three Centres exploring these relationships must carry the statement that it cannot, for reasons of power and geographical representation, test the main MONICA hypotheses.
The authors have full responsibility for the appropriate use and accuracy of the data reported in such a publication.
Anybody can propose MONICA collaborative publications (The Proposer). The proposal, including the Publication Proposal Form (Form SA) as a cover sheet, should give purpose, outline, target journal and time schedule and be submitted to the PC (see Figure 1). Whenever possible, a proposal for authorship should be made.
The PC assesses the appropriateness, priority and proposed leadership of the publication (see 7.2.2 below) possibly with the help of reviewers of his selection and the Head of the MDC. The PC advises the MSC which decides whether the manuscript should be accepted as a MONICA collaborative 'Agreed Publication', its priority, and who should be its Leader. If the MSC does not reply within 7 days, it is assumed that the proposal of the PC is accepted. The PC informs the Proposer of the decision and the Chief of the MDC updates the MONICA Publication Plan (see 7.6) as appropriate.
The manuscript is prepared by a Manuscript Group. Anyone from a MONICA centre can volunteer to join a Manuscript Group. This group will carry out the analysis and prepare the manuscript. The Group, with its Leader should include the necessary expertise in epidemiology, statistics and programming, and whichever other skills may be required. Priority will be given to those in MONICA who have indicated their interest to work on a particular manuscript.
The Leader is crucial to the success of the MONICA Publication Plan as he or she is responsible for organising the Manuscript Group, for overseeing the preparation of the manuscript, and for ensuring that the Agreed Publication is produced to an appropriately high standard within the agreed timetable. The Leader will report to the PC on a regular basis. The essential prerequisite for becoming a Leader is an ability to meet deadlines and to motivate others to do the same. The Leader may delegate some if not all the writing of the paper to another member of the Manuscript Group but in this case the delegated person's name should appear first in the authorship statement.
Authors other than the Leader and/or the first author should be significant contributors to the design of the paper, data preparation, analysis and/or writing. They should be consulted by the Leader and/or first author at key stages in the paper's development and should have seen and approved the final draft before it is submitted to the PC. In the eyes of journal editors they are responsible and answerable for the accuracy of the data and conclusions contained in the paper. Co-authors are not necessarily those who volunteered, or were volunteered by others when the paper was first proposed - they must have contributed substantially when work on the paper was in progress. The final authorship list may therefore be different from the original manuscript group. Names of co-authors should be agreed by the Leader and first author involving the PC and the MSC if there is any difficulty or ambiguity.
The PC maintains regular contact with the Leaders of the Manuscript Groups to ensure that deadlines are met and on the basis of this keeps the Publication Plan up-to-date. If MONICA core data are used for a publication, the data must be obtained from the MDC, the analysis must be carried out under the control of the MDC, and the results must be verified by the MDC (see also 7.3.2). If and when this is no longer possible, appropriate checks will be organized by the MSC through the PC.
Such publications appear with the authorship statement as follows:
Name(s) of author(s) for the WHO MONICA Project (1),
Title:................................
Text:.................................
(1) Annex: Sites and key personnel of the WHO MONICA Project
The Annex includes:
The list is drafted by the Manuscript Group and corrected when necessary by the PIs at the same time as they approve the manuscript.
The letter to the editor on submission should include this sentence displayed prominently and the accompanying statement on a separate sheet:
"Please Note: Publication of WHO MONICA Project data is subject to WHO MONICA Project publication rules. Please see accompanying statement"
Accompanying Statement.
"WHO MONICA Project Publication Rules
Ownership of MONICA data is vested in the WHO MONICA Project Principal Investigators who have resolved that publication of results should be restricted to those journals which accept the WHO MONICA Project publication rules. These appear reasonable to us and are accepted by major scientific journals. However, we wish to draw these to your attention now to prevent delays or disputes later in the publication process. Within these constraints the author of the accompanying letter is authorized by the WHO MONICA Project to negotiate publication with you. We will presume acceptance of these rules if you acknowledge this paper and forward it for refereeing. If you do not accept these rules please return the manuscripts immediately so that it can be submitted elsewhere without further delay. Thank you for your co-operation.
The publication rules cover three specific items:
- The authorship line (as in the accompanying manuscript)
- Citation of previous MONICA publications (as in the accompanying manuscript)
- Publication of the list of MONICA sites and key personnel as an annex to the paper.
The format and print size are at the discretion of the journal."
Whenever reasonable, the paper should have "WHO MONICA Project" in the title.
The publication must have an acknowledgement paragraph in a format consistent with WHO MONICA Project policy and sources of funding. The wording of this should be obtained by the Leader of the Manuscript Group from the PC who will have agreed it with the MMC and MSC. This acknowledgement may need to be updated during the development of the paper and is subject to final revision when the paper is approved by the MSC.
The acknowledgement paragraph may have added to it the names of internal MONICA reviewers who have made what is judged to be substantial contributions in the reviewing process. This can be agreed by the lead author and the PC prior to submission to a journal.
On completion the Manuscript is sent to the PC who sends it to three reviewers, at least one of whom should be a statistician. (see Figure 2).The reviewers of MONICA manuscripts will be chosen among PIs and staff members as well as among scientists outside MCCs who have proven specific knowledge in the field. The PC also informs the MSC about the manuscript and the reviewers. The MSC may appoint additional reviewers within 7 days. The PC may ask the authors to send copies of the manuscript directly to the reviewers to speed up this process.
The reviewers consider the appropriateness of the manuscript for publication and report back to the PC within 3 weeks.
On the basis of the reviews, the PC either returns the manuscript for revision to the authors or sends it with the reviewers' reports to the MSC.
In special cases (e.g. the stroke publications which concern only a part of the MCCs) the MSC may decide on a review process different from the one described above, if it can be expected to streamline the publication process.
The MSC considers the manuscript for approval as a MONICA collaborative publication and hence for distribution to the MCCs for approval. If the manuscript is not acceptable, the MSC decides on how to proceed further. If the MSC does not reply within 7 days, it is assumed that the proposal of the PC is accepted.
The manuscript is distributed to the MCCs, relevant MQCs and the MDC by the MMC, together with the list of key personnel.
The MCCs (PIs) approve the manuscript for publication and/or send their comments to the PC or the person(s) specified in the covering letter of the manuscript. This must be forthcoming within four weeks, and if no response is obtained the publication will proceed.
Any minor modifications that may be necessary, including the list of key personnel, should be made to the manuscript, before submission. After approval the manuscript will be submitted for publication.
The leader of the manuscript group and the first author should agree between themselves as to who will be responsible for submitting the paper to the agreed journal, for dealing with reviewers/ editorial comment, for checking the proofs and for ordering reprints. The decision on responsibility should be communicated to the PC. Anything other than minor corrections arising from the editorial-review process should be discussed with other members of the Manuscript group and with the PC. Whoever is responsible for the proofs must inform the PC immediately on receipt of the proofs if there is any problem with the journal carrying out MONICA publication policy on authorship, citations or listing of sites and key personnel, so that they can agree how to take the matter up with the journal editor. Whoever is responsible for obtaining the reprints must send copies to other members of the authorship group and the remainder to the MMC for distribution. The number and funding of reprints should be discussed at the time of ordering with the PC.
The MMC is responsible for providing reprints of the published paper to the MCCs, MQCs and the MDC.
Internal documents are subject to the same review procedures as for publications and require a Publication Proposal Form (Form SA), giving purpose, outline and timetable.
Abstracts submitted for oral presentation based on unpublished MONICA collaborative data will be sent to the MMC which will distribute them to the MSC (see Figure 3). Abstracts will be approved solely by the MSC, the only exception being when mention of specific MCCs is made in the abstract, in which case, explicit permission will be sought from the MCCs concerned by the presenter and evidence of this furnished to the MMC. Failure to reply within 4 weeks by the MCCs concerned will be taken to mean consent. Approved abstracts will be circulated by the MMC to all MCCs, MQCs and MDC. On approval by the MSC the PC informs the presenter that MSC approval has been given.
In addition to the above, no person invited to speak "on behalf of the WHO MONICA Project" should do so without prior approval of the MSC. If an abstract is required, the Person Invited should follow the rules for oral presentations (see Figure 4) and give details concerning the source of the invitation. If no abstract is required, the Person Invited should send details to the MMC. If the MSC gives approval, the PC will inform the Person Invited who should then proceed with the presentation but must send a summary to the MMC for distribution to the MCCs, MQCs and MDC for information. If any proceedings are subsequently published the Rules for Agreed Publications apply (see 7.2.3).
All the above rules apply, except that only PIs from MCCs participating in stroke registration have to give their consent for publications involving stroke.
The individual data analyses for all Agreed Publications are considered for acceptance by the Chief of the MDC. Quality control analyses can be accepted by the Chief of the MDC even if they are not part of an Agreed Publication. Any statistical computing will be performed, documented and reviewed according to the MDC procedures.
In certain circumstances, approval of the analysis of collaborative data outside the MDC is permissible. If an MCC wishes to undertake analysis concerning an Agreed Publication it should, after consultation with the MDC, send an application to the MMC which will be referred to the MSC (see Figure 5). The application must give full justification for the reasons for decentralising the analysis, give a firm time-table, specify the data records and items needed, with a signed commitment by the PI of the MCC that the data will be used for the specified purpose only. If the MSC gives approval a sub-set of the MONICA core data can then be transferred from the MDC to the MCC. All MCCs and MQCs will be informed about the release of the data for such decentralised analysis by the MMC.
After the analysis has been completed, the MCC will provide the MDC with a full briefing of the analysis, including source code of the data analysis programs and output listings of the results which have been used in the manuscript for publication. For this briefing, which will include details of statistical inferences, a visit to the MDC may be necessary. All resulting publications are subject to MONICA Publication Rules. On completion of the agreed analysis, the MCC must not use the data for any purpose, unless further clearances are given by the MSC.
By definition, collaborative data are those collected using the routine procedures of the WHO MONICA Project and sent to the MDC as part of the required data transfer procedures. These data form a part of the WHO MONICA database and are owned by the MONICA Council of PIs, and the MQCs (for quality control data).
Collaborative MONICA publications must be cited in the following format in both local and collaborative MONICA publications. This format should be applied both to recent and to older papers published using earlier MONICA authorship formats. All in MONICA should encourage colleagues who quote MONICA papers to cite them in the same way when they are asked to comment on or to referee papers.
Examples of citations according to MONICA publication rules:
Pajak A, Kuulasmaa K, Tuomilehto J, Ruokokoski E for the WHO MONICA Project. Geographical variation in the major risk factors of coronary heart disease in men and women aged 3564. Wld Hlth Statist Quart 1988; 41 (3/4):115140.
Pajak A, Kuulasmaa K, Tuomilehto J, Ruokokoski E for the WHO MONICA Project (1988). Geographical variation in the major risk factors of coronary heart disease in men and women aged 3564. Wld Health Statist Quart, 41, 115140.
If the sub-editor tries to change this format in the proofs, the author should change it back and inform the journal that this is the WHO MONICA Project format.
The MONICA Publication Plan outlines all MONICA collaborative Agreed Publications and reports arising from checking, quality assessment, and analysis of the collaborative MONICA data. For each of the component data sets it describes the anticipated progression from compilation of data books to generation of quality assessment reports and the drafting of papers for publication in scientific journals. For each subject, there is, in general, a series of reports relating to baseline, mid-term and final results.
For each Agreed Publication and report, the Publication Plan identifies the Leader, other members of the Manuscript Group, target journal or a mention that it will be an internal report of the project, and the current status.
The Chief of the MDC, in consultation with the PC, has the responsibility for maintaining the Publication Plan. The Plan is available in the internal MONICA site in the World Wide Web. The MMC distributes the plan regularly to the MCCs and MQCs.
A complete list of all publications and presentations relating to the WHO MONICA Project is kept by the MMC. All MCCs, MQCs and the MDC should notify the MMC about their publications, and two copies of each publication (including an English summary and/or abstract, together with the title of the article and the journal) should be submitted together with the MCC Annual Report. A list of MONICA publications and presentations should be included as an annex to the MMC Annual Report.
Site visits are part of the quality control programme of the WHO MONICA Project and are planned to add an external point of view to local procedures which may result in higher quality data.
Purpose
Each of the following activities should be reviewed in detail:
In each data component, special attention should be paid to local quality control and to procedural changes within the study period.
Follow-up
After the visit, a report must be submitted to the MMC with a copy to the MCC concerned, within one week of the site visit. The MMC then reviews the report and prepares follow-up recommendations, in consultation with the MDC, MQCs and MCC if necessary. A copy of the recommendations is sent to all management centres, including the MSC, as well as to the MCC concerned.
Based on the review, the MSC may need to decide on what action, if any, might be needed to improve local procedures, and may also need to make a decision on the status of the MCC within the MONICA Project. If the decision of the MSC is unacceptable to the MCC, the matter should be referred to the Council of Principal Investigators.
Follow-up procedures for site-visits to the MDC, MQC and the MMC are related to their original remits.
The MSC should determine the most efficient way of conducting the ballot. The procedure for a postal ballot is described below, but at the time of writing this, the use of an electronic voting system is being explored.
Postal ballots will be conducted by the MMC:
