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ITA-ROM: Rome Contributor from the MPC: Simona Giampaoli and Cinzia Lo Noce

© National Institute for Health and Welfare and the MORGAM Project investigators Last updated: 12 October 2007 For more information, please contact Kari Kuulasmaa (firstname.lastname@thl.fi)

Contents

• Cohort identification
• Cohort recruitment and the baseline examination
• End-points followed up
• End of follow-up period
• Follow-up procedures
• Diagnostic procedures
  • at baseline
  • during follow-up
• References
• Updates

Cohort identification

• Country: Italy
• MPC: 31 - Rome
  • Italian National Coordinator
    • Administrative centre: MORGAM Dipartimento di Scienze Cliniche e Biologiche. Università degli Studi dell'Insubria, Varese
    • Key personnel: M Ferrario (Principal Investigator), P Chiodini, S Sarman
  • MATISS and MONICA Latina
    • Administrative centre: Cardio-Cerebrovascular Epidemiology Unit, National Center of Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy
    • Key personnel: S Giampaoli, L Palmieri, F Dima, C Lo Noce, C Donfrancesco
• RUs:
  • 02 Latina/Other districts. Six municipalities (Gaeta, Campodimele, Cori, Albano, Anzio, Nettuno and Lenola) within the provinces of Latina and Rome.
  • 03 Latina - MATISS. Four municipalities (Priverno, Sezze, Bassiano and Roccagorga) of the Region of Latina.
• RUAs:
  • ITA-ROMa - consisting of RUs 02 and 03
  • ITA-ROMb - consisting of RU 02
  • ITA-ROMc - consisting of RU 03
• Cohorts:
  • 01 - Respondents from representative samples of 25-64 years old men and women of RU 02. The baseline survey was carried out in 1983-87.
  • 21 - Respondents from representative samples of 20-69 years old men and women of RU 03. The baseline survey was carried out in 1983-84.
  • 22 - Respondents from representative samples of 20-69 years old men and women of RU 03. The baseline survey was carried out in 1986-87.
  • 23 - Respondents from representative samples of 20-70 years old men and women of RU 03. The baseline survey was carried out in 1993-95.
  • 24 - Respondents of re-examination of Cohorts 21 and 22. The re-examination, which is the baseline for this cohort, was carried out in 1993-96 when the persons were 26-81 years old.

Cohort recruitment and the baseline examination:

Cohorts 01, 21, 22 and 23 consist of respondents to representative sample surveys of the RUs. Electoral rolls were used as sampling frames in the single stage sampling, which was stratified by municipality, sex and 5-year age group. Cohort 24 consists of respondents (corresponding to 39% of the respondents of Cohorts 21 and 22) of a re-examination of Cohorts 21 and 22. The baseline examination of Cohort 01 was carried out as part of the WHO MONICA Project, where it was identified with code ITA-LAT. The baseline examinations of cohorts 21, 22, 23 and 24 were carried out as part of the so called MATISS (Malattie cardiovascolari ATerosclerotiche, Istituto Superiore di Sanità) Project [1, 2, 3] using the WHO MONICA methods.

The size of the cohorts are:

DNA is available for Cohorts 23 and 24.

End-points followed up:

• Deaths: yes
• Non-fatal acute MI: yes
• Unstable angina pectoris: no
• Silent MI: yes, for Cohorts 21 and 22 only.
• Cardiac revascularization: yes
• Stable angina pectoris: no
• Non-fatal stroke events: yes
• Thrombo-embolic events: no

End of follow-up period:

• Fatal events: 31 December 2002
• Non-fatal events: 31 December 2002

Follow-up procedures

Sources of data

• Municipalities: Municipalities maintain the information about vital status, emigration (data and place) and present residency. The municipalities also provided death certificates up to December 1995.
• Death Registry of the National Health Service: This provides death certificates from January 1996 onwards.
• Coronary and Cerebrovascular Event Register: During 1983-85 the MONICA-Latina coronary and cerebrovascular event register was operating in the Province of Latina and in part of the Province of Rome. The upper age limit of registration was 74 years.
• Hospital Discharge Records: During 1990-93, hospital discharge records from Sezze and Priverno hospitals were collected and coded manually. At that time these two hospitals served the population enrolled in the MATISS Project. During 1995-2002, the computerized hospital discharge register of the Lazio region was used.
• Person himself/Re-examination: Cohort 21 (baseline 1983-84) was re-examined twice, in 1887 and in 1993-96 (which was the baseline for Cohort 24). Cohort 22 (baseline 1986-87) was re-examined once in 1993-96 (which was the baseline for Cohort 24).
• Person himself, family and general practitioner.

Procedures

From the first screening (1983) to the last screening (1996), municipalities were contacted every five years for information about vital status, emigration and residency; from 1996 onwards municipalities were contacted every year. The follow-up procedure covers the Lazio Region. If a person moved out of the Lazio Region, then he/she was lost to follow-up since the date of emigration.

Three sources were used to identify suspected non-fatal coronary and stroke events. Record linkage was performed using person's first name, last name, date of birth and sex.

1. Record linkage was performed using the files of the Coronary and Cerebrovascular Event Register, which operated in Area Latina during 1983-85.
2. Record linkage using the files of the Hospital Discharge Records, manually in 1990-93 and by automatic procedures from 1995 onwards.
3. Re-examinations of Cohorts 21 and 22 in 1993-96 (which was the baseline for Cohort 24).
4. In case of non-response to the re-examination, persons were first contacted by mail and asked to return a standardized questionnaire containing information on their health conditions and hospitalizations. Non-respondents or their family were contacted by telephone and asked to fill in the same questionnaire. Further information from non-respondents was collected from the general practitioner.

The coverage of follow-up for non-fatal events is likely to be lower in 1985-89 than in other periods because it was only based on the re-examinations of the cohorts. Suspected events were validated later.

Diagnostic procedures

At baseline:

• History of MI:
  • Documented: data not available
  • Self-reported: For Cohorts 21, 22, 23 and 24, clinical judgement of heart disease and myocardial infarction was based on history and any of the following Minnesota codes: 1-1, 1-2, 1-3, 5-1, 5-2, 6-1, 6-2, 7-1, 7-2, 7-4, or 8-3. This was not available for Cohort 01 [3, 4, 5].
  • ECG: data not available
  • Rose questionnaire: As specified in item HISMI4 of MORGAM Form 21. This was available for Cohorts 23 and 24 only.
• History of cardiac revascularization:
  • Documented: data not available
  • Self-reported: An affirmative answer to either or both of the questions Have you ever had a coronary artery by-pass graft surgery? or Have you ever had an angioplasty? was considered as self-reported history of cardiac revascularization. This was available for Cohorts 23 and 24 only.
• History of angina pectoris:
  • Documented: data not available
  • Rose questionnaire: This was available for Cohorts 23 and 24 only. The coding was as specified in item HISAP2 of MORGAM Form 21.
  • Self-reported: An affirmative answer to the option Angina pectoris under the question Have you ever had or are still having or were treated for one of the following diseases? was considered as self-reported history of angina pectoris. This was available for Cohorts 21 and 22.
• History of coronary heart disease, type unspecified: not relevant because type-specific information was available.
• History of stroke:
  • Documented: data not available
  • Self-reported: For Cohorts 21, 22, 23 and 24, an affirmative answer to the question Have you ever had a diagnosis of cerebral haemorrhage, thrombosis, ischaemia and paralysis? was considered as self-reported history of stroke. This was not available for cohort 01.
• History of Diabetes: For Cohorts 21 and 22, an affirmative answer to the option Diabetes under the question Have you ever had or are still having or were treated for one of the following diseases? was considered as self-reported history of diabetes. For Cohorts 23 and 24, an affirmative answer to any of the questions Have you ever had a diagnosis of diabetes by a doctor or other health worker?, Have you ever had fasting blood glucose levels higher than 140 mg/dl at least twice? or Are you under anti-diabetic treatment at present? was considered as self-reported history of diabetes. This was not available for Cohort 01.

During follow-up:

• Deaths: The MPC received a copy of death certificate, from the Municipality up to year 1995 and from the Death Registry of the National Health Service after 1995. Death certificates were coded according to ICD-9 by only one person (FD) of the MPC.
• CHD events: For events found in the Coronary and Cerebrovascular Event Register, the MONICA diagnosis was used [3, 5, 6, 7].

  Otherwise, events were selected for further validation if:

  • Death certificates presented:
    • ischemic heart disease (ICD-9 codes 410-414) as the underlying cause of death;
    • sudden death (ICD-9 code 798 and 799);
    • diabetes as the underlying cause of death (ICD-9 code 250) or arterial hypertension (ICD-9 codes 401-405) or other form of heart disease (ICD-codes 420-429), associated with ischemic heart disease (ICD-9 codes 410-414) as a secondary cause of death [1, 2, 3, 4];
  • Hospital Discharges Records revealed a hospitalization with ICD-9 code 410, 411 or 412;
  • Re-examinations revealed either one of the following findings of self-reported clinical history and Minnesota codes of ECG:
    • presence of new (compared with the baseline examination) major Q wave (1-1); OR
    • history of a strong chest pain lasting at least half an hour followed by a hospital admission, and any of the following non-specific findings in the re-examination ECG: lesser or minor Q wave (1-2 or 1-3), major T-wave finding (5-1 or 5-2), or arrhythmias (6-1, 6-2, 7-1, 7-2, 7-4, or 8-3).

  For all cases selected for further validation, the clinical records were searched and:

  • if clinical documentation was found, the event was validated using the MONICA procedure.
  • if clinical documentation was not found, but the person participated in the re-examination, the event was validated using the principles adopted in the Seven Countries Study [4]. The diagnostic category was based on information collected from postal questionnaire, ECG at re-examination, records of later hospitalizations, interviews with next to kin, witnesses, and attending physicians, or information reported in the death certificate:
    • Fatal events:

      Definition:	MORGAM DGNCAT
      Supplementary information indicates death with possible MI	2
      Supplementary information indicates CHD death	3
      Supplementary information indicates sudden and unexpected death with accompanying anginal pain or without accompanying anginal pain but characteristics of cardiac mechanism	5
      Supplementary information indicates other cardiac death or non-cardiac death	7

    • Non-fatal events:

      Definition:	MORGAM DGNCAT
      No documents found but history of a strong chest pain lasting at least half an hour followed by a hospital admission with any of the following findings in the re-examination ECG compared to the baseline ECG: lesser or minor Q wave (1-2 or 1-3), major T-wave finding (5-1 or 5-2), or arrhythmias (6-1, 6-2, 7-1, 7-2, 7-4, or 8-3). NB: It means non-fatal coronary event not classifiable as definite or possible MI.	5
      No documents found but compared with the baseline ECG a new major Q wave (Minnesota code 1-1) in re-examination ECG with or without history of symptoms of myocardial infarction. The date of event is the self-reported date of symptoms or if no symptoms the date of ECG recording.	6

  • if clinical documentation was not found, and the person did not participate in the re-examination, the general practitioner was asked for information and on the basis of his/her patient description the diagnostic category was assigned. The source of validation for these is coded as "clinical or death certificate diagnosis" (i.e. DROUR5=1).

  Hospital discharges with an ICD-9-CM code 36.0-36.9 were recorded as cardiac revascularizations.

• Stroke events: For events found in the Coronary and Cerebrovascular Event Register, the MONICA diagnosis was used [8].

  Otherwise, events were selected for further validation if:

  • Deaths certificates presented:
    • cerebrovascular disease (ICD-9 codes 430-438) as the underlying cause of death; or
    • diabetes (ICD-9 code 250, hypertension (ICD-9 codes 401-405) or atherosclerosis (ICD-9 code 440) as the underlying cause associated with codes 430-438 as secondary cause of death [1, 3];
  • Hospital Discharge Records, revealed a hospitalization with ICD-9 code 430-432, 434, 436 or ICD-9-CM code 38.12; or
  • Re-examinations revealed a history of cerebrovascular accident with hospitalization.

  For all cases selected for further validation, the clinical records were searched and:

  • if clinical documentation was found, the event was validated using the MONICA procedure.
  • if clinical documentation did not include information on presenting clinical signs and symptoms but a brain lesion was visualised by magnetic resonance imaging or CT scan, the diagnosis was coded as "unclassifiable" (i.e. DGNCAT=9), and the source of diagnosis as "other systematic review" (i.e. DGSOUR2=1). This was available since about 1998.
  • if clinical documentation was not found, the event validation was based on the death certificate or in the hospital discharge form only or on a questionnaire to the general practitioner. If these indicated a stroke, the diagnosis was coded as "unclassifiable" (i.e. DGNCAT=9) and the source of diagnosis as "clinical or death certificate diagnosis" (i.e. DGSOUR5=1).

References

1. Giampaoli S, Poce A, Sciarra F, Lo Noce C, Dima F, Minoprio A, Santaquilani A, Caiola de Sanctis P, Volpe R, Menditto A, Menotti A, Urbinati GC. Change in cardiovascular risk factors during a 10-year community intervention program. Acta Cardiol. 1997;52(5):411-22.
2. Seccareccia F, Pannozzo F, Dima F, Minoprio A, Menditto A, Lo Noce C, Giampaoli S. Heart Rate as a Predictor of Mortality: MATISS Project. Am J Public Health. 2001;91:1258-63.
3. Giampaoli S, Vescio MF, Dima F, Poce A, De Sanctis Caiola P, Sciarra F, Menotti A. Incidence of major coronary heart disease events: the experience of the Project "Community Control of Chronic Diseases". G Ital Cardiol. 1997;27(7): 669-673.
4. Keys A. Coronary heart disease in Seven Countries. III. Classification-Codes and Cohorts. Circulation. 1970;41(Suppl 1):14I-19I.
5. Il Progetto Cuore - Studi Longitudinali. The Italian Heart Project - Longitudinal Studies. Ital Heart J. 2004;5(Suppl 3):94S-101S.
6. Palmieri L, Donfrancesco C, Giampaoli S, Trojani M, Panico S, Vanuzzo D, Pilotto L, Cesana G, Ferrario M, Chiodini P, Sega R, and Stamler J. Favorable cardiovascular risk profile and 10-year coronary heart disease incidence in women and men: results from the Progetto CUORE. European Journal of Cardiovascular Prevention and Rehabilitation, 2006; 13: 562–570.
7. Ferrario M, Chiodini P, Chambless LE, Cesana GC, Vanuzzo D, Panico S, Sega R, Pilotto L, Palmieri L, Giampaoli S for the CUORE Project Research Group. Prediction of coronary events in a low incidence population. Assessing accuracy of the CUORE Cohort Study prediction equation. Int J Epidemiol. 2005; 34: 413-421.
8. Giampaoli S, Palmieri L, Panico S, Vanuzzo D, Ferrario M, Chiodini P, Pilotto L, Donfrancesco C, Cesana G, Sega R and Stamler J. Favorable cardiovascular risk profile (low risk) and 10-year stroke incidence in women and men: findings on twelve Italian population samples. American Journal of Epidemiology, 2006; 163: 893-902.

Updates to this document

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