MOH/K/GIG/1.2002 (GU)

Primary Prevention and Early Detection of Oral Precancer and Cancer

Oral Health Division Ministry of Health Malaysia

October 2002

ii

This document has been published with the assistance of

the World Health Organisation.

TABLE OF CONTENTS

Primary Prevention and Early Detection of Oral Precancer and

Cancer TITLE

Page

Table of Contents

iii

Forward by the Oral Health Director, Ministry of Health Malaysia

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1. INTRODUCTION

1

2. LITERATURE REVIEW

2

3. OBJECTIVES

3

4. PROGRAMME TEAM

3

5. METHODOLOGY

4

5.1 The Target Population 4 5.2 Sampling 4 5.3 Target Population for Opportunistic Screening 5 5.4 Standardisation of Examiners 5 5.5 Screening Period 5 5.6 Management of Programme 5 5.7 Oral Health Education 6 5.8 Forms and Recording Instructions 6 6. EQUIPMENT

8

7. EXAMINATION PROCEDURES

9

8. AID FOR EXAMINERS

9

9. DATA COLLECTION, COLLATION, PROCESSING AND ANALYSIS

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9.1 Data entry diskette (Appendix 3) 9 9.2 Data entry diskette (Appendix 7) 10 9.3 Minimising data entry error 10 9.4 Data analysis 10 9.5 Data Flow from State to National Level 11 9.6 Data Collection and Flow at District Level 12 9.7 Data Collection and Flow at State Level 13

References

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Appendices 16-47

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iv

LIST OF APPENDICES TITLE

Page

Appendix 1: National Steering Committee 2002 Members of the Protocol Work Group

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Appendix 2: Flow Chart: Primary Prevention and Early Detection of Oral Precancer and Cancer

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Appendix 3: Format for Screening and Case Detection of Oral Precancer and Cancer Lesions

20

General Instructions for Appendix 3

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Appendix 4: Referral Letter

29

Appendix 5: Register for Referral Cases

30

Instructions for Filling In Appendix 5

31

Appendix 6: Flow Chart for Referral Cases

34

Appendix 7: Data for Analysis on Referral Cases

35

Instructions for Filling In Appendix 7

36

Appendix 8: Daily Record of Patients Examined

38

Instructions for Filling In Appendix 8

39

Appendix 9: General Data

40

Appendix 10: Distribution of Type of Oral Mucosal Lesions

41

Appendix 11: Distribution of Type of Risk Habits

42

Appendix 12: Equipment and Materials

43

Appendix 13: TNM Classification for Lip and Oral Cavity

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Appendix 14 Clinical Examination for Oral Mucosal Lesions

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Appendix 15:

District Codes by State

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FOREWORD BY THE DIRECTOR OF ORAL HEALTH, MINISTRY OF HEALTH MALAYSIA

In Malaysia, there are a number of unique characteristics pertaining to oral precancer and cancer. Although prevalence is low at 0.04%, oral lesions have been found to predominantly occur among some identified communities. The ethnic Indian group comprise about 8% of the population, yet about 60% of oral lesions are found among communities of ethnic Indian origin. There is also a higher prevalence of associated ‘precursor’ lesions found among Indians and the Indigenous Groups. While ethnic origin is cited, it is acknowledged that such communities practise risk habits found to be associated with oral lesions; namely quid chewing, tobacco use and alcohol consumption. Based on these factors, the Ministry of Health Malaysia has decided that a high-risk strategy aimed at members of such captive communities, augmented by opportunistic screening of patients in dental clinics, would afford the best approach towards reducing the incidence and prevalence of oral precancer and cancer in the country. It is realistic to expect that early intervention through raising awareness of such lesions coupled with concerted efforts at modifying, reducing, or at best, stopping risk habits would also lead to a reduction of the more invasive forms of the disease. On this rationale, the ‘Primary Prevention and Early Detection of Oral Precancer and Cancer Programme’ was launched and has subsequently gained support from the World Health Organisation (WHO) in 2002. The programme is a primary prevention programme aimed at captive groups. It works towards raising awareness of known risk factors to oral lesions and of the signs and symptoms of such lesions. Dental officers on visits to such communities will also conduct screening sessions for early detection of oral lesions, and are entrusted to make referrals where necessary, to oral surgeons. Referrals of cases made through the health system must be tracked and thus oral surgeons and pathologists play very important roles in management of cases. There is no magic bullet in preventing and treating cancers. Gaining the support and co-operation of estate management, village chiefs, and members of the various communities is pivotal to the success of this programme. It is with great hope that we undertake this programme and may our joint efforts demonstrate the reduction in morbidity and mortality that we envisage. On behalf of the Oral Health Division, I take this opportunity to convey our vote of thanks to the World Health Organisation (WHO) for its support of the programme. I also extend my heartfelt appreciation to all involved in the programme planning and implementation. DATIN DR. ROHANI BINTI RAMLI

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1. INTRODUCTION The definition of oral cancers in this programme is confined to cancers of the orofacial region affecting the oral mucosa including the tongue, lip, gingivae, palate and alveolus. (This does not include tumours of the salivary glands or of the oropharynx). Oral cancer is one form of malignancy that is very easily detected through an oral examination. Oral health personnel are in the best position to undertake a systematic and methodical examination of the mouth and its surrounding structures. There are well-documented risk habits associated with oral cancers world-wide, and this is true for Malaysia as well. The presence of ‘precursor’ or ‘precancerous’ lesions has also been associated with an increased risk of oral malignancies. In Malaysia, oral precancer and cancer lesions are very predominant among Malaysians of Indian origin. This is borne out by records of case series since the 1960s1-4. A more recent study5 also identified the indigenous groups of East Malaysia as having the highest proportion of those with oral precancerous lesions.

Accumulated records from the Ministry of Health seem to indicate high morbidity and mortality rates associated with lip and oral cavity cancers. In Malaysia, the characteristic features of the problem of oral cancer are : i) it is seen in disproportionately higher frequency in people of Indian

ethnic origin (60% of cases of oral cancer are seen in Indians4

though they comprise about 8% of the population6), and the other Bumiputra community in Sabah and Sarawak;

ii) it is seen in association with identifiable risk habits (tobacco, betel quid chewing and high consumption of alcohol); and

iii) cases seen often present late when the disease is well advanced (Stage 3 or 4).

In the local context, oral cancer meets criteria for priority areas for medical/health research under the category “research in non-communicable diseases for which hazardous factors are known.” The feasibility of primary prevention programme for oral cancer has been demonstrated7,8. In view of the associated risk habits as well as the preponderance of oral precancers and cancers found among identified ethnic groups, theoretically, if an individual is known to have a precancerous lesion(s), then it is possible to effect early detection of changes. In addition, it would also be possible to intervene and advise those with risk habits to modify, or at best, to stop these habits. On these grounds, a decision was made that a national programme for primary prevention and early detection of oral precancer and cancer lesions would offer a cost-effective option towards a reduction in the overall morbidity and mortality due to oral cancers in Malaysia. A combination of this high-risk strategy together with opportunistic screening at dental attendance would offer the best approach.

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2. LITERATURE REVIEW In 1998, oral cancers were found to account for 7.1% of cancer deaths in Ministry of Health facilities9. In the same year, a report on retrospective records of a large Penang public hospital showed that lip and oral cavity cancers accounted for about 3% of cancer admissions10. Each year, about 150 – 200 cases are diagnosed at the Stomatology Unit of the Institute for Medical Research within the Ministry of Health4 although it has been suggested that the numbers are probably 1.5 – 2 times higher as there are other hospitals and laboratories managing such cancers. Records from Penang found that more than 80% presented at Stage 3 and 4. With oral cancers cited at a prevalence of 0.04%5, the percentage of cancers admissions and deaths attributed to oral cancers would indicate high morbidity and mortality rates. Oral cancer is the sixth most common cancer in the world11. In Bangladesh, India, and Pakistan, oral cancer is the most common cancer12. Oral cancer is the fifth most common cancer in Malaysia13. In the United Kingdom, oral cancers account for about 1% of cancers, yet only 30 – 40% of patients survive five years. This high mortality rate is associated mainly with late detection14.

Tobacco and alcohol are well known risk factors in Western countries15. In South Asian countries, chewing of betel quid with tobacco is largely responsible for the high incidence of oral cancer16. This habit of betel quid chewing is also the common cause of oral cancer in this country17. In the survey of oral mucosal lesions of adults in Malaysia in 1993/1994, it was found that oral mucosal lesions were found more in the other Bumiputera subjects (17.0%) and Indian subjects (14.5%)5. This is further proven by surveys or screening program carried out in the states of Pahang18, Malacca19 and Sabah20 in 1995. In Pahang where Indians form 57% of the sample examined, 4.5% were found to have leukoplakia, 0.8% erythroplakia and 0.4% speckled leukoplakia. In Malacca where 76.5 % of the sample was Indians, 6.6 % of them were found to have precancerous or suspicious lesions. The study in Sabah was done among the other Bumiputera groups - the Bajaus, Kadazans and Illanuns. In this study, out of 150 Bajaus examined, 17 (11%) had precancerous lesions; out of 35 Kadazans examined, 3 (8.5%) had these lesions and out of 16 Illanuns examined, 5 (31%) had these lesions. The study by Tan BS8 in 1996 found that captive groups of Indians in estate communities have a 6 to 7-fold propensity for betel quid chewing and a 4-fold propensity for alcohol compared to the general population. The study found that primary prevention and screening has a positive influence on the 16.9% of the population examined.

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3. OBJECTIVES 3.1 General Objectives To reduce prevalence and incidence of oral precancers and cancers in

identified high-risk communities. 3.2 Specific Objectives

i) To screen adults aged 20 years and above in identified high-risk communities.

ii) To detect cases of oral precancers and cancers and to make the necessary referrals.

iii) To educate high-risk communities on the risk factors for oral cancers.

4. PROGRAMME TEAM

A National Steering Committee shall be formed for the programme to look into protocol building, training for implementation and monitoring and evaluation on a national level. The national committee shall also be responsible to source out new materials for oral health promotion for oral cancers. Members of the National Steering Committee and the Protocol Working Group are shown in Appendix 1.

State committees shall be formed for the purpose of: i) Planning outreach programmes at state and district levels. ii) Identification of, and liaison with, estates/kampung/clinics as well as

other communities exhibiting high-risk habits. iii) Monitoring and evaluation of the programme through the following:

• managing data collection through clinical examination formats; • ensuring efficient data flow for compliance of referral cases

between primary and secondary oral healthcare at state level; • monitoring management of patients found with oral lesions at

primary and secondary healthcare at state level; • producing an annual evaluation report on the programme for the

national steering committee. iv) Planning for training and standardisation of dental officers for oral

lesion identification with state oral surgeons. v) Planning for training in all other aspects deemed necessary for the

implementation of the national programme. At state level the Deputy Director of Health (Dental) will act on behalf of the Programme Director and shall form his own committee comprising the Oral Surgeon, Senior Dental Officers and other committee members. Examiners: All / selected dental officers Recorders: Dental Surgery Assistants shall assist in the

screening as well as registration of subjects and recording of findings.

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Support Staff: Include drivers, attendants and dental staff nurses, the latter being primarily involved in oral health promotive / preventive efforts on oral cancer and precancer lesions, such as talks and exhibitions to be held in conjunction with the programme.

This programme will require close co-operation between the various departments of the Ministry of Health, and strong collaboration with other related agencies; in particular, the plantation sector and other identified high-risk communities.

5. METHODOLOGY

A high-risk strategy involving screening/case detection within high-risk groups shall be employed.

5.1 The Target Population

5.1.1 Primary Prevention Oral health education shall be undertaken for all high-risk individuals, their family members and other members of the estate communities with the objective of increasing awareness 1) on the associated risks of high-risk habits as well as 2) on the signs and symptoms of oral precancer and cancer lesions.

5.1.2 Oral Examination

This will include individuals aged 20 years and above known to have high-risk habits or living in a community which is more prone to take up that habit. i). Indian community in rubber and palm oil estates in Peninsular

Malaysia ii). Other Bumiputeras in Sabah and Sarawak are among those identified

for the programme. iii). Other identified high-risk communities.

5.2 Sampling

5.2.1 Sampling frame

Identified estates and “kampungs” will form the sampling frame. This sampling frame shall be obtained from individual states.

This shall include the list of large estate holdings from the United Planters’ Association of Malaysia (UPAM), and a list of smallholders from the Human Resource Department of Local Authorities as well as other relevant information from census data from the Statistics Department.

Dental officers, especially in Sabah, Sarawak, Wilayah Persekutuan Kuala

Lumpur and Putrajaya, Kelantan and Perlis shall also obtain information on communities where there is widespread prevalence of high-risk habits or identified cancer cases.

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5.2.2 Sampling Units

Inclusion criteria

All adults aged 20 years and above, with, or without the high-risk habits, shall form the sampling units. Younger individuals known to have high-risk habits shall also be included in the programme. Exclusion criteria Non - Malaysians shall be excluded. Appendix 2 shows the Flow Chart for the Implementation of the National Programme for Primary Prevention and Early Detection of Oral Precancer and Cancer Lesion.

5.3 Target Population for Opportunistic Screening

Adults with high-risk habits attending dental clinics shall be rendered an oral examination for oral lesions.

5.4 Standardisation of Examiners

A two-tiered standardisation process is proposed. • At national level, a standardisation exercise, involving all oral

surgeons, shall be conducted using colour slides and on patients.

• At state level, oral surgeons shall conduct echo sessions for all potential examiners.

The Stomatology Unit, Institute for Medical Research (IMR) as well as the Oral Health Division of the Ministry of Health (MOH), shall provide slides for the purposes of training of examiners. The Oral Health Division shall be responsible for the national level training session.

5.5 Screening Period

This programme shall be part of the oral health community programmes and all effort shall be made to ensure its sustainability. Every estate/kampung/location in the programme shall be revisited at least once in 5 years.

5.6 Management of Programme Permission shall be sought from the management of identified

estates/kampungs/locations. A presurvey visit/liaison is recommended to establish:

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• details of the estate - location, access road, racial composition, and availability of amenities (water, electricity, etc.);

• contact / resource personnel - this is normally the estate medical assistant or supervisor who can help with organisation, publicity work and referrals;

• rapport with any visiting medical officer for purposes of referral and compliance of subjects;

• manpower and logistics details for the study team; • location for screening exercise and oral health promotion - house-to-

house visits are recommended to ensure maximum recruitment. If this is not feasible, an activity centre shall be identified and efforts made to increase uptake.

5.7 Oral Health Education

This shall be done through exhibitions, oral/poster/video presentations, etc. Material shall cover smoking, alcohol consumption, and betel quid chewing as risk habits for oral precancers and cancers. Visual presentation of common precancer and cancer lesions shall be shown. Information to subjects must emphasise that oral precancer lesions can be prevented from progressing or may even regress with cessation, reduction, and modification of habits.

The Oral Health Promotion Unit, MOH in collaboration with the Stomatology Unit, IMR shall prepare slide packages for training/calibration purposes and for oral health education activities. However, the states are encouraged to source out their own resource materials for educational purposes.

5.8 Forms and Recording Instructions

5.8.1 Clinical Format for Screening (Appendix 3). This form is designed to capture salient points on demographic particulars; type, size and site of lesions; risk habits and the commitment of subjects to quit habits; as well as family history on oral cancer.

Recording instructions for this format is shown in Appendix 3_1. An EPI INFO 6 rec.file shall be built specifically for the purpose of data entry from Appendix 3. Data entry shall be undertaken in duplicate diskettes, one to be sent annually, by 31 January the following year, to the Oral Health Division. All patients found with suspicious oral lesions shall be referred to the oral surgeon using the referral form shown in Appendix 4. 5.8.2 Register of Referral Cases (Appendix 5)

Appendix 5 is designed to capture information on cases with oral lesions referred from primary level to the oral surgeon. Information capture pertains to demographic particulars; provisional diagnoses made by dental officers

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and oral surgeons; as well as management of patients with reference to biopsies and histological findings. Instructions for filling in Appendix 5 are shown in Appendix 5_1. Note: Appendix 5 shall be managed as a manual form between primary and secondary level. However, an MSExcel file for Appendix 5 shall be provided for keeping a computerised register of referred cases at state level. The flow of data as described below between primary, secondary oral health care and between state and national levels is shown graphically in Appendix 6. • At the end of each outreach-screening visit the dental officer shall

enter, in duplicate, data on referred cases in Appendix 5 (Columns 1 – 11). One form shall be sent to the State Committee.

• State Committees shall compile all information from clinics/districts every 3 months (March, June, September and December) to be printed in 3 copies, two of which are to be sent to the Oral Surgeon.

• The Oral Surgeon completes information on patients who attend their clinics (Columns 12 – 18) for both copies of Appendix 5 received. One copy shall be sent back to the State Committee (by 2 January of the following year).

• All information on the completed Appendix 5 shall be entered into an MSExcel file designated Appendix 7 (Data for Analysis on Referral Cases).

5.8.3 Data for Analysis on Referral Cases (Appendix 7)

Appendix 7 is designed to capture essential data on referred cases that attend oral surgery clinics (compliance). It gives a profile on demographics; compliance rates within designated time frames; provisional diagnoses on lesions detected; as well as information on biopsies and histological findings.

An MSExcel file shall be used to input data for Appendix 7. Data entry shall be undertaken in duplicate diskettes. One diskette shall be sent to the Oral Health Division, to reach by 31 January the following year. Instructions for filling in Appendix 7 are shown in Appendix 7_1. 5.8.4 Daily Record of Patients Examined (Appendix 8)

Appendix 8 shall be used as a daily register for each outreach-screening visit. It is designed to capture particulars of cases screened, as well as their habit(s) and lesion(s) status. Instructions for filling in Appendix 8 are shown in Appendix 8_1.

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Note: Appendix 8 shall be kept separately for each estate/ kampung/ location. When an estate/kampung/location is revisited, information on the current Appendix 8 shall be compared to the previous Appendix 8 list to trace repeat cases. 5.8.5 Reporting Format (Appendices 9,10,11 and 12)

Appendices 9,10, and11 are reporting forms that are to be filled by the State Committee. Appendix 9 on ‘General Data’ captures data on locations visited, the number of adults aged 20 years and above traced and screened at each location, and the details on oral health education sessions held at each location. Appendices 10 and 11 are ‘dummy tables’ designed to capture data from the EPI INFO 6 rec.file for each state. These forms should be utilised by State Committees for their annual evaluation report.

National Level Reports 6-monthly Status Report

Appendix 9 shall be filled by the State Committee and sent to the Oral Health Division by 31 July each year. Management of this report at state and district levels shall be at the discretion of the State Committee.

Annual Report Appendices 9, 10 and 11 shall be filled by the State Committee and sent to the Oral Health Division annually to reach by 31 January the following year.

6. EQUIPMENT (Appendix 12) The essential equipments for examination of all subjects are

• disposable gloves • wooden spatulas • cotton • gauze • torchlight • plastic bags to hold waste.

In addition, cases with lesions may require an examination set of

• 2 mouth mirrors • probes • tweezers • stainless steel rulers for detailed documentation.

A suggested list of equipment and materials for each outreach-screening visit is in Appendix 12.

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7. EXAMINATION PROCEDURES The registration and examination of the subjects shall be carried out as a single exercise. i) A daily record of subjects screened shall be kept (Appendix 8) for

each estate/kampung/location. ii) An enquiry of the subjects’ medical / dental history and extra-oral

examination shall precede the intraoral examination. iii) Dentures shall be removed prior to clinical oral mucosal examination. iv) Subjects shall be seated upright on ordinary / dental / mobile chairs

and examined using adequate artificial light. v) Two mouth mirrors may be used for examination if necessary.

8. AID FOR EXAMINERS

The ‘TNM Classification for Lip and Oral Cavity Cancer’ is shown in Appendix 13. The steps for ‘Clinical Examination for Oral Mucosal Lesion’ are shown in Appendix 14. For ‘Diagnostic Criteria for Oral Mucosal Lesions’ as well as graphical presentation of steps for clinical examination for oral lesions, please refer to the following illustrated handbook :

Rosnah Z, Ikeda N, Reichart PA, Axell TE. Clinical Criteria for Diagnosis of Oral Mucosal Lesions. An Aid for Dental and Medical Practitioners in the Asia-Pacific Region.

Information for District Codes according to the Health Management Information System of the Ministry of Health is given in Appendix 15.

9. DATA COLLECTION, COLLATION, PROCESSING AND ANALYSIS

Annually 2 diskettes shall be sent to national level.

9.1 Data entry diskette (Appendix 3) At state level, all information from Appendix 3 (Format for Screening and Early Detection of Oral Precancer and Cancer Lesions) shall be entered into the EPI INFO 6 rec.file designed for the purpose of this programme. Data entry shall be undertaken in duplicate diskettes. One diskette shall be sent annually to the Oral Health Division, to reach by 31 January the following year.

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9.2 Data entry diskette (Appendix 7) Information from Appendix 5 (Register of Referral Cases) shall be transferred into the MSExcel file for Appendix 7 (Data for Analysis on Referral Cases) specifically designed to capture data pertaining to referral cases. Data entry shall be undertaken in duplicate diskettes. One diskette shall be sent annually to the Oral Health Division, to reach by 31 January of the subsequent year.

9.3 Minimising data entry error

For verification purposes and to minimise data entry error, data shall be entered twice on the same file either by • the same dental personnel after a break of time; or • by different dental personnel.

9.4 Data analysis Descriptive analysis of data shall be undertaken using both the Epi Info 6 Programme and the SPSS Version 10.

Each state committee shall send the following forms and two diskettes to the Oral Health Division.

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9.5 Data Flow from State to National Level

At 6 months (to reach by 31 July of each year)

Oral Health Division,

MOH

Appendix 9

Annually (to reach by 31 January the following year)

2

EPI INFO 6 rec.file for

Appendix 3

1

2

MSExcel file for Appendix 7

1

1 copy of each diskette to be sent by 31 January the

following year

Back-up to be kept at state level

Oral Health Division,

MOH

Back-up to be kept at state level

1 copy of each form to be sent

by 31 January the following year

Appendix 9 Appendix 10 Appendix 11

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9.6 Data Collection and Flow at District Level

Every Screening Visit

Every 6 months

For those with lesions, fill out Appendix 4 (referral letter to Oral Surgeon).

Manually enter data into Appendix 5 in duplicate (Register of Referral Cases) after completion of each screening visit. Information capture (Columns 1-11) from Appendix 3 + 4.

With lesions

Send 1 diskette by mid-January of following

year

Patient takes referral letter

Oral Surgeon

State Committee Send 1 copy after

each screening visit.

Send 1 copy every 6 months

Fill in Appendix 9 in duplicate (General Data) every 6 months. To reach State Committee by mid-July of each year and mid-January the following year.

Enter data into Appendix 8 (Daily Record of Patients Examined) for each location. File Appendix 8 for the next screening visit to the same location.

Fill Appendix 3 (Clinical Format for Screening) for each person examined. Enter data into EPI INFO6 rec.file in duplicate after each screening visit. An initial diskette with rec.file shall be provided.

All patients

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9.7 Data Collection and Flow at State Level

Every 3 months (end of March, June, September, December)

Send 2 copies every 3 months

Oral Surgeo

n

Compile all Appendix 5 (Register of Referral Cases) information from districts every 3 months. Print 3 copies. An MsExcel file shall be provided for Appendix 5. Register shall be updated for the year.

Returns 1 copy to State Committee after filling in Columns 12-18 – by 2 January of following year.

At 6 months

Send 1 copy (6 months’ data)

Oral Health

Division, MOH

Compile Appendix 9 (General Data) information from districts by 31 July each year. Print and send 1 copy to National Level by 15 July each year.

Annually (to reach National Level by 31 January the following year)

Merge data (Appendix 3) of EPI INFO6 rec.file from all districts in duplicate diskettes. Send 1 diskette to National Level

Compile cumulative data from Appendix 9 (General Data) from all districts in duplicate. Analyse data from merged EPI INFO6 rec.file to fill in Appendix 10 and 11. Appendices to be filled in duplicate. Send 1 copy of Appendix 9,10 and 11 to National Level. MSExcel files shall be provided for Appendices 9,10,11.

Send 1 copy of diskette

Send 1 copy of each Appendix

Send 1 copy of diskette

Oral Health

Division, MOH

Enter relevant data from annual Appendix 5 (Register of Referral Cases) into Appendix 7 (Data for Analysis of Referral Cases) in duplicate diskettes. Send 1 diskette to National Level. An MSExcel file shall also be provided for Appendix 7.

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REFERENCES 1. Hirayama T. An epidemiological study of oral and pharyngeal cancer in

Central and South-East Asia. Bulletin World Health org 1966;34:41-69

2. Chin CT. Lee KW. The effects of betel nut chewing on the buccal mucosa of 296 Indians and Malays in West Malaysia: A clinical study. Brit J Cancer 1970;XXIV:427-32

3. Ramanathan K, Ng KH. The First Report on the National Registry of Oral

Precancer Conditions. Department of Stomatology, Institute for Medical Research, Kuala Lumpur 03-19, Malaysia. 30 January 1978.

4. Ng KH, Siar CH. Oral Cancers in Malaysia. Proceedings of the 90th

Anniversary Scientific Seminar. Institute for Medical Research, Kuala Lumpur 1992;108-15.

5. Zain RM, Ikeda N, Muhammad Y. Oral Mucosal Survey of Adults in Malaysia

1993-1994 Joint Project by Ministry Of Health Malaysia, University of Malaya and Aichigakuin University of Japan.

6. Department of Statistics Malaysia. Yearbook of Statistics, Malaysia 2000.

Department of Statistics Malaysia. 7. Gupta PC, Mehta FA, Pindborg JJ, Bhonsle RB, Murti PR, Daftary DK, Aghi

MB. Primary Prevention Trial of Oral Cancer in India: a 10-year Follow-up Study. J Oral Pathol Med 1992;21(10):433-9.

8. Tan BS (1996). The Impact of Oral Cancer Screening and Primary Prevention

on the Behaviour of a High Risk Estate Community. Thesis in partial fulfilment for the degree of Master in Community Dentistry, University of Malaya, 1996.

9. Ministry of Health Malaysia. Information and Documentation Unit. Health

Management Information System Report 1998. Information on Discharges and Deaths due to Cancer by Age Group and Sex in Government Hospitals, Malaysia, 1998.

10. Hooi IN, Devaraj T. A hospital based study of cancer admissions. Med J

Malaysia 1998;53(1):22-9

11. Parkin DM, Laara E, Muir CS. Estimates of the Worldwide Frequency of Sixteen Major Cancers in 1980. Int J Cancer 1988;41:184-97.

12. World Health Organisation. Control of Oral Cancer in Developing Countries.

Bulletin WHO 1984;62:817-30.

13. Ministry of Health, Malaysia Proposal paper for Healthy Lifestyle Campaign 1995. Ministry of Health 1994.

14. Zakrzewska J. Oral Cancer. Brit Med J 1999;318:1051-4

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15. Boyle P, Macfarlane GI, Scully C. Oral Cancer: Necessity for Prevention Strategies. Lancet 1993;342:1129.

16. Gupta PC. Betel Quid and Oral Cancer: Prospects for Prevention. IARC Scientific Publication 1991;105:466 - 70.

17. Ramanathan K, Lakshimi S. Oral Carcinoma in Peninsular Malaysia : Racial

Variations in the Indians, Malays, Chinese and Caucasians. Gann Monograph on Cancer Research 1976;18:27-36.

18. Pahang Dental Department. Oral Precancer and Cancer Survey 1995. A

report by Bahagian Perkhidmatan Pergigian , Negeri Pahang.

19. Melaka Dental Department. Oral Cancer Screening and Detection Programme In Estates In Malacca 1995. A report by Bahagian Perkhidmatan Pergigian Negeri Melaka.

20. Norma AJ, Ferdinand JK, Zaiton T. Oral Precancer, Cancer Screening Project

in Kota Belud, Sabah 1995. Protocol_OCA2002

Appendix 1

NATIONAL STEERING COMMITTEE 2002

Chairman Datin Dr. Rohani binti Ramli,

Oral Health Director, Ministry of Health Malaysia.

Co-Chairman Dr. Norain binti Abu Talib Deputy Oral Health Director, Oral Health Division, Ministry of Health Malaysia.

Secretary Dr. Khairiyah Abd. Muttalib Principal Assistant Director, Oral Health Division, Ministry of Health Malaysia.

Members Dato’ Dr. Wan Mohamad Nasir bin Wan Othman Deputy Oral Health Director, Oral Health Division, Ministry of Health Malaysia.

Dr. Ng Kok Han, Dental Specialist (Oral Medicine/Oral Pathology), Stomatology Unit, Institute for Medical Research, Ministry of Health Malaysia.

Dr. Wan Mahadzir bin Wan Mustafa, Consultant Oral Surgeon, Dental Department, Hospital Kuala Lumpur.

Dr. Lau Shin Hin, Dental Specialist (Oral Medicine/Oral Pathology), Stomatology Unit, Institute for Medical Research, Ministry of Health Malaysia.

Dr. Chew Yoke Yuen Assistant Director, Oral Health Division, Ministry of Health Malaysia.

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MEMBERS OF THE PROTOCOL WORK GROUP Chairman Dr. Norain binti Abu Talib

Deputy Oral Health Director, Oral Health Division, Ministry of Health Malaysia.

Secretary Dr. Khairiyah Abd. Muttalib Principal Assistant Director, Oral Health Division, Ministry of Health Malaysia.

Programmer Dr. R. V. Varatha Raju, Senior Dental Officer, Sungai Petani Dental Clinic, Kedah.

Members Datin Dr. Nooral Zeila Junid Principal Assistant Director, Oral Health Division, Ministry of Health Malaysia.

Dr. Peace Indrani Chelvanayagam, Oral Surgeon, Hospital Tengku Ampuan Rahimah, Klang, Selangor.

Dr. Lau Shin Hin, Dental Specialist (Oral Medicine/Oral Pathology), Stomatology Unit, Institute for Medical Research, Ministry of Health Malaysia.

Dr. Habesah Sulaiman, Principal Assistant Director, Kelantan Dental Department, Kota Bharu, Kelantan.

Dr. Yaw Siew Lian, Principal Assistant Director, Sarawak Dental Department, Kuching, Sarawak.

Dr. Wardati Abdul Malek, Principal Assistant Director, Perak Dental Department, Ipoh, Perak.

Dr. Lee Keng Chin, Dental Public Health Officer, Melaka Tengah Dental Clinic, Jalan Tun Sri Lanang, Melaka.

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Dr. Selvaruby Selvadurai, Dental Public Health Officer, Seremban Dental Clinic, Negeri Sembilan.

Dr. Amdah Mat, Dental Public Health Officer, Banting Dental Clinic, Kuala Langat, Selangor.

Dr. Chew Yoke Yuen Assistant Director, Oral Health Division, Ministry of Health Malaysia.

Dr. Muz’ini Mohamad, Assistant Director, Oral Health Division, Ministry of Health Malaysia.

Appendix 2 Flow Chart:

PRIMARY PREVENTION AND EARLY DETECTION OF ORAL PRECANCER AND CANCER Training & standardisation of dental officers PRIMARY CARE LEVEL

Identification and liaison with estates/kampung/locations

Fix date and venue for screening programme

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High-risk habits?

Lesion detected

Yes

Suspicious of cancer?

Yes

Confirm diagnosis - malignant?

Yes

No

Refer to Oral Surgeon(Fill out Appendix 4 and 5)

SECONDARY CARE LEVEL

No

Yes

Take biopsy?

Send to IMR/local pathologist (at discretion of OS)

No

Follow-up on subjects’ commitment to quit.

Examination (Appendix 3)

Registration – Daily Record of Patients Examined (Appendix 8)

Oral Health Education

Yes

No No

Patient Management by OS(complete Appendix 5)

Yes

RecordData entry/ Record of compliance(update Appendix 5 and enter data into Appendix 7)

Follow-up by Dental Officer in clinic?

No

Appendix 3_1

GENERAL INSTRUCTIONS FOR APPENDIX 3 Data Management 1. EPI INFO 6 is a freeware programme that is available at no cost to the state

committee. An EPI INFO 6 rec.file has been built specifically for data entry for this programme. All data from Appendix 3 are to be entered into this EPI INFO 6 rec.file.

2. Diskettes provided by national level:

- 3 diskettes for installation of EPI INFO 6 shall be provided to each state committee.

- A diskette with the relevant EPI INFO 6 rec.file shall be provided to all state committees.

3. State committee members shall be responsible for making 2 back-up diskettes of this master rec.file. One diskette shall be stored as back-up for rec.file at state level.

Data Entry 1. At any one time, 2 diskettes shall be used for data entry. 2. Data entered shall be backed-up in the second diskette at the end of each day. Data Verification 1. For verification purposes, data entry is to be conducted twice

– either by the same personnel after a break of time, – or by different personnel on different occasions.

RECORDING INSTRUCTIONS FOR APPENDIX 3

GENERAL RECORDING INSTRUCTIONS 1. To maintain examiners’ objectivity during examination, ORAL MUCOSA

EXAMINATION (Section D) will precede the enquiry of HABITS and SUBJECTS’ COMMITMENT TO QUIT their habits (Section E) and FAMILY HISTORY (Section F).

2. ENTER ALL DATA IN CAPITAL LETTERS.

23

SPECIFIC INSTRUCTIONS

Item Name Specific Instructions

Personal ID **please see instructions under ‘Attendance” **Refer to Appendix 15 for District Codes

Enter an 8-digit number - the first 2 numbers are to be the state code - the second 2 numbers are to be the district

code - the last 4 numbers to be in the order of

examination of patient. For example, the first patient examined in Melaka (08) in the district of Melaka Tengah (05) will be 0 8 0 5 0 0 0 1

Registration Number Enter the last 4-digits of the patient’s identity card (IC) number.

Case Enter 1 = screening

(for cases seen during screening exercise held in the estates/kg/location)

2 = walk-in cases (cases seen as outpatients in dental clinics)

Attendance *Ask patient whether they have been examined before.

Enter 1 = new 2 = repeat (if patient has been examined before,

regardless of year of examination). If patient is a repeat case, the original Personal ID given at the first screening session must be used (trace from previous Appendix 8 of visits to the estate/kg/location – Daily Record of Patients Examined).

Year Enter the year of screening.

Date of Screening Enter the actual date of screening. For example: 2 5 1 1 2 0 0 2

day month year

A. SOCIO-DEMOGRAPHIC PARTICULARS

State Enter the state code 01 = WP Kuala Lumpur & Putrajaya 02 = Perlis 03 = Kedah 04 = Pulau Pinang 05 = Perak 06 = Selangor 07 = Negri Sembilan 08 = Melaka

24

09 = Johor 10 = Pahang 12 = Terengganu 13 = Kelantan 14 = Sabah 15 = Sarawak 16 = WP Labuan

District

Enter the district code. (*refer to Appendix 15)

Estate/Kampung/Location Enter the name of the estate/kampung/location.

Name Enter the name of the subject as it appears in the Identity Card.

Address Enter the full address of the subject for purposes of follow-up.

IC No. Enter the patient’s old/new identity card number (boxes are provided to accommodate new IC numbers).

Gender

Enter 1 = male 2 = female

Date of Birth

The patient’s actual date of birth is to be documented for verification purposes, for example, a person born on 1.1.1950 is to be recorded as 0 1 0 1 1 9 5 0

day month year

Age The age in years will be automatically computed on data entry.

Ethnic Group Use the following codes and enter accordingly 01 = Malays 02 = Chinese 03 = Indian/Pakistani 04 = Kadazan 05 = Murut 06 = Bajau 07 = Iban 08 = Bidayuh 09 = Melanau 10 = Other Bumiputera 11 = Others

B. MEDICAL HISTORY

Medical History Enter 0 = No 1 = Yes If yes, please specify the medical condition(s).

25

C. LYMPH NODES

Lymph Nodes Enter 0 = No 1 = Yes If yes, please specify site(s) of node(s) involved.

D. ORAL MUCOSA EXAMINATION

If “1=Yes” has been entered for ‘Any Lesion’ please ensure that all boxes are filled by entering a ‘0 = not applicable’ where relevant. Any Lesion Enter

0 = No (If No, go straight to Section E). 1 = Yes (If yes, specify TYPE, SIZE and SITE of lesion).

Type, Size and Site of Lesion

The patient may have more than 1 type of lesion. Boxes have been provided to accommodate for 1st, 2nd and 3rd Lesion and ‘Other Pathology’. For each type of lesion detected, enter: 0 = not applicable 1 = leukoplakia 2 = erythroplakia 3 = lichen planus 4 = submucous fibrosis 5 = suspicious of oral cancer Criteria for identification of lesion must be strictly adhered to. For example, an ulcer that is established because of a traumatic episode, and is not clinically suspicious, is recorded as ‘Other Pathology’ and specified as ‘traumatic ulcer’. For each of the lesion detected, specify the overall size of lesion by entering the following codes: 0 = not applicable 1 = 0 - 2 cm 2 = > 2 - 4 cm 3 = > 4 - 6 cm 4 = > 6 cm. For each of the lesion detected, enter the code(s) for site(s) of lesion according to the graphical presentation given. Boxes for four sites have been provided. If more than 4 sites are involved, record the lesion as code = 44 (‘widespread’) in boxes for ‘Site 1’. Enter Code ‘00’ for all other sites for that lesion. Enter Code ‘00’ if not applicable

26

E. HABITS If “1=Yes” has been entered for ‘Any present or past habits’ please ensure that all boxes are filled by entering a ‘0=no such habit/not applicable’ where relevant. Any present or past habit(s).

Enter 0 = No (If No, go straight to Section G). 1 = Yes (If yes, specify). Habit(s) not categorised under 1 – 10 are to be recorded as 11 = ‘Other habits’ and specified.

Habit For each of the habit specified enter: 0 = no such habit 1 = habit currently practised 2 = past habit now has stopped

Duration (in years) Enter the duration of present or past habit(s) 0 = not applicable 1 = 5 years and below 2 = > 5 years to 10 years 3 = > 10 years

Subject’s Commitment To Quit

This section records the patient’s own perception of how committed he/she is to quit the habit after having been informed of the dangers of smoking, alcohol drinking, and betel quid chewing. The subject may have different degree of commitment to quit for different habit(s). For example, he/she may feel that betel quid chewing may be given up easily and will succeed but may admit to not being able to give up smoking. As this section is very subjective, caution must be exercised so that the appropriate answer could be obtained. Use language that can be understood by the subject. Ask the following question. Now that you have been informed about the danger of your habit(s) [smoking, alcohol drinking and betel, quid chewing], what do you think you will do? or in Bahasa Melayu (Setelah anda diberitahu tentang bahaya tabiat yang anda amalkan (merokok, minum arak dan makan sireh atau songel tembakau), apakah langkah selanjutnya yang akan anda ambil ?) Read to the subject the options (1 – 4 below) and ask him/her to choose one answer that best describes what his/her next action will be.

27

28

All boxes must be filled.

0 = not applicable (no such habits) (tidak berkenaan)

1= quit with great determination, thinks will succeed (penuh keyakinan akan berhenti dan berjaya).

2 = attempt to quit, does not think will succeed (berusaha untuk berhenti, tetapi tidak yakin akan berjaya).

3 = reduce or modify habit

(akan mengurangkan atau menukar tabiat).

4 = continue and accept consequences (akan meneruskan tabiat dan bersedia menerima akibatnya).

F. FAMILY HISTORY Any family history of cancer is to be indicated

0 = No, 1 = Yes.. (If Yes, specify type of cancer). Specify the relationship of the affected person to the patient. 1 = parent 2 = sister/brother 3 = grandparent 4 = aunt/uncle 5 = cousin 6 = other relation, specify.

G. EXAMINER (Enter the name of the Dental Officer).

H. REFERRAL TO DENTAL SPECIALIST

Referral to dental specialist

0 = No 1 = Yes Enter Date Referred………………………

Appendix 3

CLINICAL FORMAT FOR SCREENING

PRIMARY PREVENTION AND EARLY DETECTION OF ORAL PRECANCER AND CANCER PROGRAMME

ORAL HEALTH DIVISION, MINISTRY OF HEALTH MALAYSIA

Personal ID: Registration Number: Case: (1=Screening, 2=Walk-in Case) Attendance: (1=New, 2=Repeat) Year: Date of Screening: Day Month Year A. SOCIO-DEMOGRAPHIC PARTICULARS:

State: District:

Estate/kampung/location: _______________________________________

Name: ___________________________________________________

Address: ___________________________________________________

___________________________________________________

IC No:

Gender: (1=Male, 2=Female)

Date of Birth: Age:

Ethnic Group: (01=Malay, 02=Chinese, 03=Indian/Pakistani, 04=Kadazan, 05=Murut, 06=Bajau, 07=Iban, 08=Bidayuh, 09=Melanau, 10=Other Bumiputra, 11=Others)

B. MEDICAL HISTORY: (0=No, 1=Yes)

If Yes, specify: ____________________________________________________

C. LYMPH NODES: (0=No, 1=Yes)

If Yes, specify: ____________________________________________________

20

D. ORAL MUCOSA EXAMINATION: Any lesion: (0=No, 1=Yes) (If NO, go straight to Section E)

If Yes, specify TYPE, SIZE and SITE of lesion:

LESION TYPE 0 = not applicable 1 = Leukoplakia 2 = Erythroplakia 3 = Lichen Planus 4 = Submucous fibrosis 5 = Suspicious of oral cancer

SIZE 0 = not applicable 1 = 0 - 2 cm 2 = > 2 - 4 cm 3 = > 4 – 6 cm 4 = > 6 cm

SITE OF LESION Use codes given below. If more than 4 sites are involved, enter 44 = WIDESPREAD in boxes marked for Site 1. Code 00 if not applicable

TYPE SIZE SITE 1 SITE 2 SITE 3 SITE 4

1. 1st lesion

2. 2nd lesion

3. 3rd lesion 4. Other pathology,

Please specify: _______________

SITE OF LESION: Please draw / indicate on diagram to facilitate identification of numbers.

00 = not applicable 01 = Right Lip commissure 02 = Right buccal mucosa 03 = Left lip commissure 04 = Left buccal mucosa 05 = Upper labial mucosa 06 = Lower labial mucosa 07 = Right upper buccal sulcus 08 = Upper labial sulcus 09 = Left upper buccal sulcus 10 = Right lower buccal sulcus 11 = Lower labial sulcus 12 = Left lower buccal sulcus 13 = Right upper buccal alveolar mucosa 14 = Labial alveolar mucosa 15 = Left upper buccal alveolar mucosa 16 = Right lower alveolar mucosa 17 = Lower labial alveolar mucosa 18 = Left lower alveolar mucosa 19 = Right upper palatal alveolar mucosa 20 = Upper palatal alveolar mucosa 21 = Left upper palatal alveolar mucosa 22 = Right lower lingual alveolar mucosa 23 = Lower lingual alveolar mucosa 24 = Left lingual alveolar mucosa 25 = Right floor of mouth 26 = Anterior floor of mouth 27 = Left floor of mouth 28 = Right ventral surface of tongue 29 = Left ventral surface of tongue 30 = Right lateral border of tongue 31 = Left lateral border of tongue 32 = Tip of tongue 33 = Right dorsal surface of tongue 34 = Left dorsal surface of tongue 35 = Posterior tongue 36 = Right palatal mucosa 37 = Left palatal mucosa 38 = Right soft palate 39 = Left soft palate 40 = Right retromolar 41 = Left retromolar 42 = External upper lip 43 = External lower lip 44 = WIDESPREAD

21

E. HABITS: Any present or past habits: (0=No, 1=Yes) (If NO, go straight to Section G)

If YES, specify: HABITS DURATION (IN YEARS) SUBJECT’S COMMITMENT TO QUIT

0 = no such habit 1 = habit currently

practiced 2 = past habit now has

stopped

22

0 = not applicable 1 = 5 years and below 2 = > 5 years to 10

years 3 = > 10 years

0 = not applicable 1 = quit with great determination,

thinks will succeed 2 = attempt to quit, does not think will

succeed 3 = reduce or modify habit 4 = continue and accept consequence

1. Betel quid (areca nut + tobacco) 2. Betel quid (tobacco only) 3. Betel quid (areca nut only) 4. Tobacco quid (no betel leaf) 5. Areca quid (no betel leaf) 6. Smoking cigarette 7. Smoking cigar/cheroot 8. Smoking bidi 9. Smoking pipe 10. Alcohol 11. Other habits:

please specify: ______________________________________

F. FAMILY HISTORY:

Has any member of family had cancer? (0=No, 1=Yes) If ‘yes’ please specify: ________________________________________ Relationship to patient 1=Parent 2=Sister/brother 3=Grandparent 4=Aunt/uncle 5=Cousin 6=Other relation, please specify: ________________________________

G. EXAMINER: _______________________________________ H. REFERRAL TO DENTAL SPECIALIST: (0=No, 1=Yes)

(Date referred:_________________________ )

Appendix 4

Kepada, Pakar / Pegawai Pergigian Klinik Pergigian _________________________________________ _________________________________________ Tuan / Puan Doktor, PROGRAM ‘PRIMARY PREVENTION AND EARLY DETECTION OF ORAL PRECANCER AND CANCER LESIONS’. Nama Pesakit: No. Kad Pengenalan: Estet/kampung/klinik: Personal ID -------------------------------------------------------------------------------------------------------- Pesakit ini telah diperiksa di klinik saringan yang dijalankan di

……………………………………………………………………………………………………………………..….

pada tarikh……………………….. dan dalam pemeriksaan tersebut didapati diagnosa

awalan adalah…………………………………………………………….………………………………………

…………………………………………………………………………………………………………………………

……………………………………………………………………………………………………. yang mungkin

memerlukan biopsi / rawatan lanjut. Diharap beliau dapat diberi rawatan yang

diperlukan.

Sekian. Terima kasih.

“BERKHIDMAT UNTUK NEGARA“

Saya yang menurut perintah,

....................................................

29

Appendix 5

This form is for use at clinic/district as well as at state level (fill in where applicable)

State………………………… District……………………………………..Estate/Kampung/Location……………………………

Ser Date referred Personal ID Name IC

State

Estate/Kg/ Location

Gend

er

Ethn

icity

Age

Prov. Diagnosis DO

Date seen by OS

Clinical Diagnosis OS

TNM Code

Biopsy done

Histo- Diagnosis

Lesion Status

Comments

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

To be filled in at Primary Oral Healthcare Level To be filled in by Oral Surgeon

REGISTER OF REFERRAL CASES Primary Prevention and Early Detection of Oral Precancer and Cancer Lesions Programme

Appendix 5_1

Instructions for Filling In Appendix 5 REGISTER OF REFERRAL CASES

1. Appendix 5 shall be managed as a manual form between primary and secondary oral healthcare level. However, an MSExcel file of Appendix 5 shall be provided for keeping a computerised register of referred cases at state level.

2. This diskette is not required at national level.

3. Appendix 5 is for use at clinic/district/state level. At state level, all information from

clinic/district (Columns 1 – 11) are compiled every quarter (Mar, Jun, Sept, Dec) and sent on to the Oral Surgeon.

4. The Oral Surgeon completes information (Columns 12 – 18) and returns 1 copy of

Appendix 5 to the State Committee by 2 January the following year. 5. If the Oral Surgeons receives a referral case from another state, columns 1 – 18

should be filled in (as many as possible) by the Oral Surgeon. These cases are to be noted at the bottom most portion of Appendix 5 at the end of the year. Inter-state liaison should be undertaken by the State Committee to alert the other state(s) concerned (check State Code).

Column No.

Column Name Definition

Columns 1 – 11 to be filled in at Primary Oral Healthcare Level

Column 1 Ser

Begin with number 1 and so on.

Column 2 Date referred Enter date of referral by dental officer to Oral Surgeon

Column 3 Personal ID Enter the Personal ID number as recorded on the examination form (Appendix 3).

Column 4

Name Enter the name of referred patient.

Column 5

IC Enter patient’s identification card no.

Column 6 State Enter the state code 01 = WP Kuala Lumpur & Putrajaya 02 = Perlis 03 = Kedah 04 = Pulau Pinang 05 = Perak 06 = Selangor 07 = Negri Sembilan 08 = Melaka 09 = Johor 10 = Pahang 12 = Terengganu 13 = Kelantan 14 = Sabah 15 = Sarawak 16 = WP Labuan

31

Column 7

Estate/Kg/Location Enter the name of estate/kampung/location

Column 8

Gender Enter 1 = male 2 = female

Column 9 Ethnicity Enter coding for ethnic group 01 = Malay 02 = Chinese 03 = Indian/Pakistani 04 = Kadazan 05 = Murut 06 = Bajau 07 = Iban 08 = Bidayuh 09 = Melanau 10 = Other Bumiputera 11 = Others

Column 10 Age Enter the age of patient (cross check with age automatically computed in EPI INFO file).

Column 11 Prov. Diagnosis DO (if there is more than one provisional diagnosis , please enter all relevant codes e.g. 1,3,4)

Enter code for the provisional diagnosis of dental officer 1 = Leukoplakia 2 = Erythroplakia 3 = Lichen Planus 4 = Submucous fibrosis 5 = Suspicious of oral cancer (potentially malignant) 9 = Other pathology

Columns 12 – 18 to be filled in by Oral Surgeon

Column 12 Date seen by OS

Enter date first seen by Oral Surgeon.

Column 13 Clinical Diagnosis OS (if there is more than one clinical diagnosis, please enter all relevant codes e.g. 1,3,4)

Enter code for the clinical diagnosis of Oral Surgeon 1 = Leukoplakia 2 = Erythroplakia 3 = Lichen Planus 4 = Submucous fibrosis 5 = Suspicious of oral cancer (potentially malignant) 9 = Other pathology

Column 14 TNM Code Enter the TNM clinically assessed by Oral Surgeon 1 = Stage 1 2 = Stage 2 3 = Stage 3 4 = Stage 4

Column 15 Biopsy

If biopsy done enter 1 = yes, otherwise insert a dash ( - ).

32

33

Column 16 Histological Diagnosis (if there is more than one histological finding , please enter all relevant codes e.g. 1,4,7)

Enter diagnosis based on histological findings 1 = Hyperkeratosis 2 = Epithelial dysplasia 3 = Carcinoma-in-situ 4 = Invasive squamous cell carcinoma 5 = Oral lichen planus 6 = Oral submucous fibrosis 7 = Other malignancies (please specify in Column

18) 8 = Benign pathologies (please specify in Column 18)

Column 17 Lesion Status *If there is more than 1 lesion, record the status of the most severe lesion.

Enter code 0 = benign, 1 = pre-malignant 2 = malignant Lesion status is based on histological diagnosis. If there is no histological diagnosis, then lesion status shall be based on clinical diagnosis.

Column 18 Comments Enter any comment(s) e.g. description of other pathology, refusal for management etc. If Column 16 for ‘Histological Diagnosis’ is coded either 7 or 8, please specify lesion here.

Appendix 6

FLOW CHART FOR REFERRAL CASES DATA ‘PRIMARY PREVENTION AND EARLY DETECTION OF ORAL PRECANCER AND CANCER’

Fill in 2 copies of Appendix 5 for cases referred to Oral Surgeon (Columns 1 – 11) - 1 to be sent to State Committee - 1 to be kept at clinic

Clinic/District

Send 1 copy of Appendix 5 to State Committee on

completion of screening

Compilation of Appendix 5 every quarter (Mar, Jun, Sept, Dec). Information to be typed into MSExcel file and printed in 3 copies - 2 to be sent to Oral Surgeon - 1 to be kept by State Committee

State Committee

Send 2 copies of Appendix 5 to Oral Surgeon

Update Appendix 5 MSExcel file annually. Information from Appendix 5 to be transferred into Appendix 7 MSExcel file (computerised register for referral cases). Appendix 7 diskettes to be in duplicate - 1 to be sent to national level - 1 to be kept at state level

Oral Surgeon to fill in additional information on Appendix 5 received (Columns 12 – 18) in duplicate - 1 to be sent back to State Committee - 1 to be kept at Oral Surgery Clinic

Oral Surgeon

Oral Surgeon to send back 1 copy of Appendix 5 annually (by 2 Jan of the following year)

State Committee

National Committee

Send 1 copy of diskette to national committee annually (by 31 Jan of the following year)

SPSS Analysis of information from Appendix 7 diskette annually

34

Appendix 7

This form is to be submitted as an MSExcel file only

State District PersonalID Compliance Gender Ethnicity PDDO 1 PDDO 2 PDDO 3 PDOS 1 PDOS 2 PDOS 3 TNM Biopsy HD1 HD2 HD2 Lesion Status

DATA FOR ANALYSIS ON REFERRAL CASES Primary Prevention and Early Detection of Oral Precancer and Cancer Lesions Programme

Appendix 7_1

Instructions for Filling In Appendix 7 DATA FOR ANALYSIS ON REFERRAL CASES

1. Information from Appendix 5 is to be transferred into an MSExcel file (Appendix

7) in duplicate diskettes. 1 diskette is to be sent to the Oral Health Division annually, to reach by 31 January the following year.

2. PDDO = Provisional Diagnosis by Dental Officer 3. PDOS = Provisional/Clinical Diagnosis by Oral Surgeon.

Columns

Information to be taken from Appendix 5

State Enter the recorded state code

District Enter the recorded district code

PersonalID Enter the recorded 8-digit personal ID

Compliance *Date seen by OS – Date referred.

Estimate period of compliance 1 = within 6 months 2 = > 6 months to 1 year 3 = > 1 to 2 years 4 = > 2 to 3 years 5 = > 3 to 5 years 9 = > 5 years

Gender Enter the recorded code for gender.

Ethnicity Enter the recorded code for ethnic group.

PDDO 1 Enter the recorded code for the first provisional diagnosis of dental officer.

PDDO 2

Should there be more than one provisional diagnosis, enter the second recorded code in Column PDDO 2.

PDDO 3

Enter the third recorded code in Column PDDO 3.

PDOS 1 Enter the recorded code for the first provisional/clinical diagnosis of Oral Surgeon.

PDOS 2

Should there be more than one clinical diagnosis, enter the second recorded code in Column PDOS 2.

PDOS 3

Enter the third recorded code in Column PDOS 3 (if any).

TNM Enter the recorded TNM code.

36

37

Biopsy Enter the number “1” where recorded. Columns left blank are to be recorded as zero “0”.

HD 1 ‘Histological Diagnosis 1’. Enter the first recorded code.

HD 2 ‘Histological Diagnosis 2’. Should there be more than one histological finding; enter the second recorded code in Column HD 2.

HD 3 ‘Histological Diagnosis 3’. Enter the third code recorded (if any).

Lesion Status Enter code “0”, “1” or “2” as recorded.

Appendix 8DAILY RECORD OF PATIENTS EXAMINED

State.......................................District................................................. Total estimated pop. Examiner....................…….......…Name of Estate/Kampung/Location..................................................................... 20 or more years (M'sian) Clinic.......................................…Date .................................... ……………………….

No. RN Name IC No. RemarksCigar- Cigar Leuko- Erythro- Lichen Sub- Suspicious Other (inc. other habits)

areca + tobacco areca tobacco areca ette (cheroot) plakia plakia Planus mucous of oral pathology

tobacco only nut only quid quid fibrosis cancer (specify)

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Lesions (1 = Yes)Habits ( 1 = Yes)

Per

sona

lID

Bid

i

Pip

e

Alc

ohol

Gen

der

Eth

nic

Gp.

Age

(in

year

s)

With betel leaf No betel leaf

Appendix 8_1

Instructions for Filling In Appendix 8 DAILY RECORD OF PATIENTS EXAMINED

Note: 1. This form is to be filled in after each screening session is completed. 2. This list is to be kept and referred to on subsequent follow-up visits to the

estate/kampung/location in order to trace ‘repeat’ cases. Column No.

Column Name

Definition

Column 1 No.

Begin with number 1 and so on.

Column 2 Personal ID Enter the personal ID recorded on Appendix 3 (Clinical Format for Screening).

Column 3 RN Enter the last 4 digits of IC Number (old or new)

Column 4 Name Enter patient’s name.

Column 5

IC No. Enter the full identification card number of patient.

Column 6

Age (in years)

Estimate the patient’s age in years by calculating Date of Screening – Date of Birth

Column 7 Gender Enter code 1 = male 2 = female

Column 8

Ethnic Gp. Enter coding for ethnic group 01 = Malay 02 = Chinese 03 = Indian/Pakistani 04 = Kadazan 05 = Murut 06 = Bajau 07 = Iban 08 = Bidayuh 09 = Melanau 10 = Other Bumiputera 11 = Others

Columns 9 - 18

Habits If habit(s) is present enter “1” for ‘Yes” where applicable, otherwise leave blank.

Columns 19 - 24 Lesions If lesion(s) is present enter “1” for ‘Yes” where applicable, otherwise leave blank.

Column 25 Remarks Enter any remarks as necessary, e.g. other habits etc

39

Appendix 9

STATE…………………………………… DISTRICT……………………………………… YEAR………………………No. of high-risk Estates/Kampungs/Locations identified in state/district…………………………………….

20-29 30-39 40-49 50-59 60-69 > 69

n exam. n exam. n exam. n exam. n exam. n exam. n exam. % examined

1 2 3 4 5 6 7 8 9 10 (Sum 4 to 9)

11 (10/3 x 100)

12 13 14

GENERAL DATA PRIMARY PREVENTION AND EARLY DETECTION OF ORAL PRECANCER AND CANCER LESIONS PROGRAMME

No. of DHE sessions

Name of estate/kg/location visitedNo.

No. of exhibitions etc

Total estimated pop. aged > 20

years (from Appendix 8)

Adults = 20 years or more Oral health promotion sessions for oral precancer and cancer (from PKP 201)

TOTAL No. of participants (if

available)

TOTAL

STATE ..............................................NAME OF ESTATE / KAMPUNG / LOCATION ..................................................................ETHNIC GROUP ................................................. Data can be obtained from merged data of Appendix 3 in EPI INFO rec.file

n % n % n % n % n % n % n %

1 2 3 4 4/3 x 100 5 6 6/5 x 100 7 7/5 x 100 8 8/5 x 100 9 9/5 x 100 10 10/5 x 100 11 11/5 x 100

M

F

Total

No. exam

N Submucous Fibrosis

Suspicious of oral cancer

Leukoplakia Erythroplakia Lichen Planus Other Pathology

Appendix 10DISTRIBUTION OF TYPE OF ORAL MUCOSAL LESIONS

No. found with lesions (% of N)

20-29

Type of Lesion (% calculated based on no. of lesions detected)Age Group Gender No. of lesions

detected

M

F

Total

M

F

Total

M

F

Total

M

F

Total

M

F

Total

M

F

40-49

GRAND TOTAL

60-69

70 or more

30-39

50-59

Total

Appendix 11

STATE.................................................NAME OF ESTATE/KAMPUNG/LOCATION............................................ETHNIC GROUP ................................................ Data can be obtained from merged data of Appendix 3 in EPI INFO rec.file

n % n % n % n % n % n % n % n % n % n % n % n %

1 2 3 4 4/3 x 100

5 6 6/5 x 100

7 7/5 x 100

8 8/5 x 100

9 9/5 x 100

10 10/5 x 100

11 11/5 x 100

12 12/5 x 100

13 13/5 x 100

14 14/5 x 100

15 15/5 x 100

16 16/5 x 100

M

F

Total

M

F

bidi pipeareca nut only

Quid (with betel leaf)

tobacco quid areca quid

Quid (no betel leaf)

cigar (cheroot)

Age Group

Gender No HabitsN (No.

exam.)

No. of habits

detected cigarettesareca + tobacco tobacco only

No. found with habits (% of N)

DISTRIBUTION OF TYPE OF RISK HABITS

Smoking Alcohol

20-29

30-39

Total

M

F

Total

M

F

Total

M

F

Total

M

F

Total

M

F

40-49

50-59

GRAND TOTAL

60-69

>69

Total

Appendix 12 EQUIPMENT AND MATERIALS 1. mouth mirrors

2. probes

3. tweezers

4. stainless steel rulers

5. disposable gloves

6. disposable masks

7. wooden spatulas

8. pre-sterilised cotton

9. pre-sterilised gauze

10. cold sterilising solution

11. torchlight / Waldmann light

12. mobile dental / household chair

13. clinical waste container/bag

14. Appendix 3 (Format for Screening and Early Detection of Oral Precancer and

Cancer Lesions)

15. Appendix 8 (Daily Record of Patients Examined)

16. Appendix 8 of previous visit(s) if available

17. Oral Health Promotion Materials

43

Appendix 13

TNM CLASSIFICATION FOR LIP AND ORAL CAVITY

T = Extent of the Primary tumour

• Includes both the clinical (T) and pathologic (pT) categories • T designation varies according to the anatomic site involved

Tx - primary tumour cannot be assessed T0 - no evidence of primary tumour Tis- carcinoma in-situ T1 - tumour 2 cm or less in greatest dimension T2 - tumour more than 2 cm but not more than 4 cm in greatest dimension T3 - tumour more than 4 cm in greatest dimension T4 - tumour invades adjacent structures (tongue, skin of neck, and through

cortical bone)

N = Absence/ presence and extent of regional lymph node metastasis

• Includes both the clinical (N) and pathologic (pN) categories

Nx - regional lymph nodes cannot be assessed N0 - no regional lymph node metastasis N1 - metastasis in a single ipsilateral lymph node, 3 cm or less in greatest

dimension N2 - metastasis in a single ipsilateral lymph node, more than 3 cm but not

more than 6 cm in greatest dimension or metastasis in multiple ipsilateral lymph nodes none more than 6 cm in greatest dimension or metastasis in bilateral or contralateral lymph nodes none more than 6 cm in greatest dimension

N3- Metastasis in a lymph node more than 6 cm in greatest dimension.

M = absence or presence of distant metastasis; includes both the clinical (M) and pathologic (pM) categories

Mx - not assessed M0 - no distant metastasis M1 - distant metastasis present

CLINICAL STAGE

STAGE I - T1N0M0 STAGE II - T2N0M0 STAGE III - T3N0M0 or T1N1M0 or T2N1M0 STAGE IV - T4N0M0 or T4N1M0;

Any T, N2 or N3, M0; Any T, any N, M1

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Appendix 14

CLINICAL EXAMINATION FOR ORAL MUCOSAL LESIONS See HANDBOOK

STEPS FOR INTRA-ORAL EXAMINATION

SITE

1. Anterior/Lower labial mucosa

Anterior lower labial mucosa, sulcus and alveolus

2. Right lower labial sulcus Right lower sulcus and alveolus

3. Right buccal mucosa

Right commissure, and right buccal mucosa

4. Right upper labial sulcus

Right upper sulcus and alveolus

5. Anterior/Upper labial mucosa

Anterior upper labial mucosa, sulcus and alveolus

6. Left upper labial sulcus

Left upper sulcus and alveolus

7. Left buccal mucosa

Left commissure, and left buccal mucosa

8. Left lower labial sulcus

Left lower sulcus and alveolus

9. Tongue - hold in protruded position with

a piece of gauze around the tip; - move it right and left - raised to touch palate

Posterior third, tonsillar region, dorsum and right and left lateral borders of the tongue Ventral surface of tongue and floor of mouth and lingual alveolar mucosa.

10. Head tilted backwards, mouth opened

Palate - hard and soft

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Appendix 15

DISTRICT CODES BY STATE STATE STATE CODE DISTRICT DISTRICT CODE WILAYAH PERSEKUTUAN KL & PUTRAJAYA

01 Cahaya Suria 01 Bangsar 02 Jinjang 03 Dato’ Keramat 04 Putrajaya 05

PERLIS 02 No division by district 02

KEDAH 03 Alor Setar / Pendang 01 Kuala Muda 02 Kubang Pasu 03 Padang Terap 04 Sik 05 Yan 06 Kulim / Bandar Baru 07 Baling 08 Langkawi 09

PULAU PINANG 04 Seberang Perai Utara 08 Seberang Perai Tengah 09 Seberang Perai Selatan 10 Timur Laut 11 Barat Daya 12

PERAK 05 Hilir Perak 15 Hulu Perak 16 Manjung 17 Kerian 18 Kuala Kangsar 19 Batang Padang 20 Larut, Matang, Selama 21 Kinta 22 Perak Tengah 23

SELANGOR 06 Gombak 08 Petaling 09 Kuala Selangor 10 Hulu Langat 11 Sepang 12 Sabak Bernam 13 Hulu Selangor 14 Klang 15 Kuala Langat 16

NEGRI SEMBILAN 07 Seremban 08 Kuala Pilah 09 Tampin 10 Port Dickson 11 Jelebu 12

MELAKA 08 Melaka Tengah 05 Alor Gajah 06 Jasin 07

46

47

STATE STATE CODE DISTRICT DISTRICT CODE

JOHOR 09 Johor Bharu 01 Muar 02 Batu Pahat 03 Kluang 04 Segamat 05 Pontian 06 Kota Tinggi 07 Mersing 08

PAHANG 10 Kuantan 11 Pekan 12 Lipis 13 Temerloh 14 Jerantut 15 Raub 16 Bentong 17 Cameron Highlands 18 Rompin 19 Maran 20

TERENGGANU 12 Kuala Terengganu 07 Hulu Terengganu 08 Besut 09 Dungun 10 Kemaman 11 Marang 12 Setiu 13

KELANTAN 13 Kota Bharu 10 Pasir Mas 11 Pasir Puteh 12 Machang 13 Bachok 14 Tanah Merah 15 Kuala Krai 16 Tumpat 17 Gua Musang 18 Jeli 19

SABAH 14 Kota Kinabalu 01 Kudat 02 Keningau 03 Beaufort 04 Tawau 05 Lahad Datu 06 Sandakan 07

SARAWAK 15 Kuching 01 Sri Aman 02 Sibu 03 Miri 04 Limbang 05 Sarikei 06 Kapit 07 Kota Samarahan 08 Bintulu 09

WP LABUAN 16 Labuan 08