ORIGINAL ARTICLE

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CROSS-SECTIONAL SURVEY OF MULTI-CENTRE PATIENT REGISTRIES IN MALAYSIA

Characteristics of patient registries
Although the oldest registry has been functioning for 9 years, the majority are under 3 years of age (76%). All registries emphasize on measuring the quality of care (Table 2) and most of them (63%) were established to cover the 4 main functions of a registry. 70% of registries were designed for degenerative diseases. All pathological aspects in medicine are covered such as allergy, infections, congenital diseases, drug induced pathologies, injuries and psychopathological problems. More than half of the registries capture patient records from all age groups and all of them included both genders.

All registries receive MOH data. However, majority (62%) have more than 1 type of health sector reporting to them. 1 registry has all sectors involved; MOH, armed forces, universities, non governmental organisations and private centres. It is also one of the 2 registries with more than 50 centres as data providers, 180 in total. 50% of the registries receive first patient notification within 1 month of initiation while the rest within 12 months. Only one required 36 months from initiation for their first patient notification.

Table 2: Characteristics of patient registries

Characteristics	No. of registries (%) n=21
Objectives
To determine natural history of disease	18 (86)
To determine clinical/ cost effectiveness of health care product/services	17 (81)
To measure or monitor safety and harm	17 (81)
To measure quality of care	21 (100)
All 4 of the above	14 (67)
Pathogenesis
Allergy	1 (5)
Infections	8 (38)
Drug induced	5 (24)
Degenerative	15 (71)
Congenital/ genetic	6 (29)
Injury	4 (19)
Psychopathology	1 (5)
Age groups
Neonatal	1 (5)
Children	1 (5)
Adults	7 (33)
Older people	1 (5)
All age groups	11 (52)
Type of centres reporting
Ministry of Health	21 (100)
Armed Forces	1 (5)
University	10 (48)
NGO	1 (5)
Private	7 (33)
Number of centres reporting
< 50	19 (90)
≥ 50	2 (10)
Level of data collection
Individual	21 (100)
Aggregate / census	8 (38)
Number of patient notifications for year 2008
0 - 99	2 (10)
100 – 999	7 (33)
1000 – 9999	6 (29)
10000 and above	5 (24)
Duration from initiation of registry to 1st patient notification
Within 1 month	15 (71)
1- 12 months	5 (24)
More than 1 year	1 (5)

Security and confidentiality of data
Data capture is mainly via web application. Data storage is 100% electronic with majority (18 registries) having an off site data centre. All of them have their data backed up; 50% ensuring backup is done on a daily basis (Table 3). 67% of registries have data back up located both on site and off site.

All registries have antivirus software and firewalls installed at every workstation, server and network perimeter. The antivirus software is updated hourly. Full scans are done weekly and firewalls have an alerting mechanism for security incidents. 100% of the registries have the following security features installed in their network perimeter; gateway antivirus, intrusion prevention and web filtering. They also have policies for IT security, password protection, screen lock and patch management in place. Each registry has designated personnel in charge of IT security and a disaster recovery plan in place. Disaster recovery plan testing is conducted yearly and the network assessment 6 monthly.

Confidentiality of data stored is mainly anonymised but is reversible to become identifiable (65%). This is much higher compared to only 33% of the registries in UK.⁷ The rest have identifiable data stored on the registry databases.

All except 1 registry inform their patients about participation in the registry collectively via a public notice. However, 30% of them do not provide an option to opt out of having their details collected.

Table 3: Data capture, storage, security, and confidentiality of patient registries

Characteristics	No. of registries (%) n=20
Data capture
Paper-base (post or fax)	11 (55)
Electronic via CD/Diskette	1 (5)
Electronic via web	19 (95)
Auto download/  linked with hospital data	1 (5)
Data storage
Register book/ paper forms	6 (30)
Electronic – offsite data centre	20 (100)
Back up devices
CD Rom	1 (5)
External hard drive	2 (10)
Back up tapes	17 (85)
Same server	3 (15)
Separate server	4 (20)
Frequency of back up
Daily	10 (50)
Weekly	7 (35)
Monthly	2 (10)
Confidentiality
Anonymised (but reversible if need arose)	13 (65)
Identifiable	5 (25)
Patients informed of data collection
Collectively informed	19 (95)
Not informed	1 (5)
Patient consent for data collection
No signed consent but option to opt out	14 (70)
No signed consent or option to opt out	6 (30)

Uses of patient registries
All registries have planned outputs (Table 4). Patient registry data is used to produce journal articles, oral papers and poster conference presentations as well as reports (planned or ad hoc basis).

Most registries (65%) produced journal articles and poster presentations. Although poster presentations were a more favoured method of information dissemination, the number of oral paper presentations presented per registry reached as high as 31.

Majority of the registries (62%) produce planned annual reports covering all centres under their purview. Almost all registries make some form of information available to the public, with the majority having ‘internet downloadable’ annual reports. In terms of other reports, only 10% conducted planned analyses daily. The rest conducts them at quarterly or yearly intervals. Every single registry can perform ad hoc analysis at the central level. Only 1 registry reported that it does not cater for ad hoc analysis at the local level.

Table 4: Usage of patient registries

Uses	No. of registries (%) n=21
Planned analysis
Daily	2 (10)
Quarterly	7 (33)
Annually	12 (57)
Annual reports produced
No	3 (14)
Yes	9 (43)
In the process of 1st report	9 (43)
Reports
Centre specific	3 (14)
Multi centre	10 (48)
Centre specific and multi centre	3 (14)
Level of information sharing
Share data via hardcopy documents	5 (24)
Share contact details via web	5 (24)
Share annual reports via web	8 (38)
Share anonymised raw data via web	1 (5)
Outputs (total cumulative)
Oral Paper presentations	9 (43)
Poster presentations	13 (62)
Reports	8 (38)
Journal articles	14 (67)

Quality of data
In two thirds of registries, there were at least good evidence that the patient population was representative of the population in the country (Table 5). 70% reported at least 80% in completeness of patient recruitment. At least 60% could confirm that at least 80% of data collected was complete. All registries had explicit definitions for at least 50% of the data variables. 90% had explicit rules for how most of their variables were recorded. Of the registries that had outcome variables, at least one third had observers not independent or blinded to the outcome. Objective patient outcomes were the main outcome for only 1 registry (e.g. laboratory based results).

Data in all registries underwent either range or consistency checks or both during data validation. None had independent or external validation from other sources such as source data (original medical records) verification etc.

Table 5: Quality of data

Quality criteria	No. of registries (%) (n=20)
Patients in registry representative of the population
No evidence or unlikely	6 (30)
Some evidence	12 (60)
Good evidence	2 (10)
Total population of country included
Completeness of recruitment
Few( <80%) or unknown	6 (30)
Some (80-89%)	6 (30)
Most (90-97%)	6 (30)
All or almost all (>97%)	2 (10)
Completeness of data
Few (<50%) or unknown	1 (5)
Some (50-79%)	7 (35)
Most (80-97%)	10 (50)
All or almost all (>97%)	2 (10)
Use of explicit definitions for variables
Most (50-97%)	11 (55)
All or almost all (>97%)	9 (45)
Use of explicit rules for deciding how variables are recorded
Some (<50%)	2 (10)
Most (50-97%)	8 (40)
All or almost all (>97%)	10 (50)
Reliability of coding
Not tested	4 (20)
Fair	1 (5)
Good	15 (75)
Independence of observations to primary outcome
Outcome not included	1 (5)
Observer neither independent nor blinded	7 (35)
Independent observer not blinded	11 (55)
Independent observer is blinded or outcome is objective	1 (5)
Extent of data validation
Range or consistency	12 (60)
Range and consistency checks	8 (40)

DISCUSSION

Patient registries in Malaysia currently cover all the critical chronic medical diseases and conditions. They range from various age groups covered, number of records, patient and geographical coverage. Their potential uses also varied. Despite this variety, a few characteristics on data security and confidentiality were very similar.

Most of the registries used personal identifiers as it is required during record linkage within and between databases and to ensure completeness of recruitment. Hence, data confidentiality becomes an integral part of registries especially when it has personal identifiers. Data confidentiality ideally should be reversibly anonymised so as to minimise risk of disclosure of patient identities but maximise potential use of data.⁷ In the registries we surveyed, 65% fulfilled this criterion. This can be explained by the fact that most registries in Malaysia have requested assistance from 1 organisation i.e. Clinical Research Centre (CRC) during its set up. CRC imposes strict criteria on data confidentiality and data security. It imposes stringent information security policies and procedures in controlling access, disclosure control, monitoring access logs, physical protections and data handling. Since we do not have a Malaysian Data Protection Act yet, the security measures taken were done in compliance with the United States (US)⁸ and European Standards.^9,10 Therefore, the robust security measures found are to be expected. CRC also plays a role in providing dedicated specialised support to assist clinicians in establishing and maintaining uniform and standardised methods for patient registries. It is what has been recommended for registries in the UK.⁷ Currently, funding of all registries is mainly through a special Registry Grant generously set aside by the Deputy Director General (Research & Technical Support) MOH Malaysia. It would be ideal if more professional bodies and other sectors involve themselves in co funding of patient registries. It would lead to long term financial viability and stability.

The registry outputs found here are acceptable as more than 52% of registries are less than 2 years old. Most registries are able to produce reports only after their second year of establishment.

Limitations of study

This study used the NMRR to obtain the number of registries in the country. The NMRR was introduced in 2007 under the directive of the Director General of Health which states all research have to be registered. This may not be all encompassing because there may be independent registries that might have been started earlier on and missed registration. Some may also perceive that patient registry is not research and hence do not need NMRR registration. Also, private sector registries may not feel the need to register themselves if public sector data is not used. Thus, most of this study’s findings are limited to public sector registries. The questionnaires are self administered therefore open to possible bias in reporting from the administrators.

CONCLUSION

The quality of registries in Malaysia is of a similar standard and is mainly due to the standardized criteria they fulfil prior to the development of a registry. Despite registries amazing potential for the future of patients in the country, the benefits of many registries are still in its infancy. It is recommended that more clinicians and researchers involve themselves in patient registries to enhance and attain its full potential.

ACKNOWLEDGEMENTS

We would like to thank registry managers and administrators who responded to this survey.

REFERENCES

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