ORIGINAL ARTICLE

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

S Sharmini MBBS, MPH, H Jamaiyah MD, MPH, SP Jaya Purany MD, MPH
Clinical Research Centre, Hospital Kuala Lumpur (Sharmini Selvarajah, Jamaiyah Hanif, Jaya Purany Stanley Ponniah)

Address for correspondence: Dr Sharmini Selvarajah, Clinical Epidemiology Unit, Clinical Research Centre, Level 3, Dermatology Block, Hospital Kuala Lumpur, Jalan Pahang, 50586 Kuala Lumpur. Tel: 03-4044 3060/3070, Fax: 03-4044 3080, Email: sharmini_s2000@yahoo.com

Conflict of interest: None

BACKGROUND

Patient registry is an organised system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition or exposure, and that serves a predetermined scientific, clinical or policy purpose.¹

Well-designed and well-performing patient registries can provide real-world view of clinical practice, patients’ outcomes, safety and comparative effectiveness, as well as provide evidence for clinical and healthcare decision making.

Many developed nations utilize patient registries in their health care system. For example, in England, there are 250 clearly identified registries with possibly more than 400 in existence.² As of 2005, there were 60 registries in Sweden with another 30 to 40 being planned³ and Norway has more than 60 disease registers. The first disease register came up in Europe in 1856 but the majority of today’s disease registers sprung up around the 1950’s. The development of disease registers in medical and health then were driven by an urgent need; increasing incidence of chronic disease and failure of the traditional methods of infectious disease epidemiology to provide an adequate framework for the study of chronic diseases.⁴

Irrespective of the original purposes for patient registries, currently there are 4 main reasons why they are important in clinical and health management systems.¹ They are to:

1. Describe the natural history of a disease.
2. Determine the clinical or cost effectiveness of specified health care products/services.
3. Measure or monitor safety and harm of products and services.
4. Measure quality of care.

Natural history of disease
Natural history covers the progression of characteristics, management and outcomes of disease. Patients have a variety of clinical presentations and can respond differently to treatment. This can change according to ethnicity as well as geographical location. Registries which track patients, their management and outcomes allow for documented natural history of a disease in question.

Clinical or cost effectiveness
Clinical effectiveness involves determining if the treatment provided is effective in practice. Most new therapeutic products are introduced into the market after rigorous clinical trials. However, clinical trials are done under rigid settings and do not reflect the real life conditions of all patients affected by the disease. This leads to reduced clinical effectiveness in real life. Cost effectiveness is a means to describe the comparative value of a health care product or service in terms of its ability to achieve a desired outcome for a given unit of resources.⁵

Monitoring safety and harm
Patient registry can serve as an active surveillance system for the occurrence of unexpected or harmful events for products and services.⁶

Measuring quality of care
Quality of care can be determined by assessing the differences between health care providers or patient populations based on performance measures. These performance measures compare treatments provided or outcomes achieved with ‘gold standards’ (e.g. evidence-based guidelines) or other benchmarks.¹

Based on the reasons above, the Ministry of Health (MOH) has developed many new registries in line with the desire to assess our patients’ needs and to make decisions based on evidence of our own health care situation and outcomes. These registries utilize Malaysian patient data to address the issues of:

1. Providing clinicians with accurate estimates of treatment outcomes that can be shared with patients.⁷
2. Providing information to the MOH programme planners for the planning of clinical and health services.
3. Opportunities for research and clinical audit (on quality of care rendered).

However, in the enthusiasm to set up patient registries, key factors should not be forgotten; namely patient data confidentiality, data security and quality of the registries itself. The setting up of a patient registry requires considerable sums of financial and human resources and in encouraging the development of registries, it is important that the above key aspects be covered. In the United Kingdom (UK), a survey of the registries showed that there was considerable scope for improvement in terms of data security and ensuring patient confidentiality.⁷ Aside from this, 50% of databases only produced 4 or fewer peer reviewed research articles.

With this in mind, this study was undertaken to describe the patient registries in Malaysia and to determine if they have acceptable patient data confidentiality, security and high quality outputs.

METHODS

Study design
This was a cross-sectional survey using a self administered questionnaire.

Objective
The objective of this study was to:

1. Determine the characteristics of patient registries in Malaysia.
2. Determine the security features and level of data confidentiality.
3. Determine the extent of registry data use.
4. Determine the data quality of registries registered in Malaysia.

Study population
All registries were identified via the National Medical Research Register (NMRR). The Registries which were multi-centre and functioning for at least 1 year as of 1st of May 2009 were invited to participate. This is because registry set up requires at least a 1 year time period before it can be fully functioning. Registries or databases involved in products or drug therapy and harm were excluded. The main respondents were the custodians or managers of the clinical registries and database administrators who were responsible for data security.

Study instrument
The questionnaire used was modified from the “UK Directory of Clinical Databases” data collection manual. It covered the following aspects; management team, sources of funding, geographical area, clinical speciality, duration of registry coverage, numbers of notification, linkages to other databases, data confidentiality, storage and security, use of data and data quality. The quality of data in the registries was measured using 8 criteria; representativeness of patient population, completeness of patient recruitment, completeness of data collected, use of clear definitions for variables, use of rules for recording of data, reliability of data coding, independence of observations to main outcome measures and the extent of data validation.

Ethical issue
This study did not require ethical approval because there were no patients or actual data involved and questionnaires were answered by registry managers.

Statistical analysis
This study used descriptive analysis. Statistical software used was SPSS version 15.

RESULTS

Organization and management of patient registries
Out of the 24 registry managers invited, 21 responded (88% response rate). Most of the registries covered both Peninsular and East Malaysia (16 registries) while the rest covered only Peninsular (Table 1). All except 4 are set up for continuous reporting of data. Follow up periods for individual patients ranged from every clinical visit to yearly visits. The team members involved in the day to day management of the registries are mainly doctors, nurses, project managers and information technology specialists. Those involved for each registry vary in terms of numbers and designation.

18 registries are funded solely from government grants while only 3 have more than one source of funding; industry, professional bodies and non governmental organisations. The amount required to manage a registry annually ranged from RM 100 000 to RM 400 000. There was no correlation between the funding amounts per year and numbers of data collected or the number of centre’s participating in the registry, as most of the cost incurred was for information technology (IT) infrastructure set up.

Table 1: Organisation and management of patient registries

Features	No. of registries (%) n=21
Geographical area covered:
Whole of Malaysia	16 (76)
Peninsular only	5 (24)
Time trend for data collection
One off	4 (19)
Follow up	17 (81)
Day to day management team
Doctors	19 (91)
Allied health professionals	7 (33)
Statisticians	13 (62)
General/project managers	17 (81)
Nurses	19 (91)
Epidemiologists	6 (29)
IT Specialists	18 (86)
Research assistants	3 (14)
Funding source
Government	21 (100)
Industry	1 (5)
NGO	2 (10)
Professional body	2 (10)
Funding amount per annum (RM)
100,000 – 199,999	10 (48)
200,000 – 299,999	8 (38)
300,000 – 399,999	2 (10)
≥ 400,000	1 (5)