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In order to better understand the coronavirus, ICMR has mooted a proposal for a Covid-19 registry. This powerful tool will analyse data of all Covid-19 patients in hospitals and should include those being home-managed.

By Dr KK Aggarwal

The Indian Council of Medical Research (ICMR) in collaboration with the health ministry and the All India Institute of Medical Sciences has plans to create a rigorous database of Covid-19 patients who are admitted in hospitals across the country. This is being done to understand how the treatment can be improved.

The project, a national clinical registry, will also serve as a crucial platform to conduct clinical trials to study the effectiveness of newer therapies for treatment of this disease. Around 15 hospitals across the country are expected to help create this network while waiting for clearances from the Common Ethics Committee of ICMR.

We are now more than six months into the pandemic and have learnt a lot about the disease, which was first detected in December 2019. The large amount of literature now available and more which is emerging every day has helped doctors better manage the patients. But the SARS-CoV-2 virus is still a mystery and there is much that is not known about it.  The virus is described as unpredictably unpredictable.

The 15 hospitals which will be selected initially will then mentor other hospitals and institutes to participate in the registry. Ethical clearance will help doctors and scientists study the effectiveness of new therapies.

Webster’s dictionary defines a registry as “an official record book” as well as “a place of registration”. A clinical registry is a record of a particular disease, medical history of the patient, risk factors, co-morbidities, patient outcomes, procedures, interventions, etc. Several databases, therefore, can be generated which serve as important sources of information about clinical and public health.

A registry can be disease-specific such as Covid-19 or a spectrum of specific diseases which could include rheumatic heart disease. For example, the Cardiological Society of India manages registries of stents, angioplasties, bypass surgeries, etc. 

Registries are observational, i.e. they are a record of the results and outcomes of the disease and experiences of patients in the real world. Clinical trials, on the other hand, are investigative and evaluate the impact of a particular treatment or diagnostic modality or a drug/device or some such intervention in patients. They have inclusion and exclusion criteria; the elderly, people with co-morbidities or certain population groups are often excluded and the trial is generally conducted on a homogenous population. A registry, on the other hand, includes patients who might be ineligible to participate in clinical trials and the results can be generalised.

A registry serves several useful functions for clinicians and researchers. The United States Agency for Healthcare Research and Quality considers registries as “powerful tools for understanding and improving quality of care”. The data therein helps in describing the natural history of a disease (different clinical presentations, risk factors, progression of the disease over course of time), its incidence and prevalence. Registries can help to retrospectively evaluate the safety and effectiveness of a treatment or intervention, disparities in treatments and outcomes, identify patients eligible for a clinical trial, assess quality of care and conduct epidemiological research. They allow comparisons across different data sets and also help in public health surveillance and disease control. And the information is not just limited to the country; it can be easily shared among countries to get a global perspective and learn from the experience of others.

As there is no previous evidence to refer to regarding Covid-19, it becomes important to form a registry. It is the need of the hour and a step in the right direction. Data of all Covid patients in the country—their clinical presentation, treatments and prognosis—should be analysed and made available for learning to different stakeholders. While this registry will include data of hospitalised patients with Covid-19, information about home-managed patients should also be included for a comprehensive database. It will help in further understanding the disease and better management for future outbreaks.

In India, 80 percent of patients are seen in the private sector and the registry will be incomplete without their involvement. The registry should include patients from all sections of society, states and districts where Covid-19 is present. Also, we need to see that the registry follows the principles of privacy and confidentiality so that sensitive health information is not leaked.

In any registry, there is always a column of “lost to follow-up”. This includes patients who have not come back to the hospital for a follow-up. But there is a loophole in this as many hospitals include out-of-hospital mortality too. These deaths in any registry may be lower than the actual.

Indian Covid-19 registries must involve The Association of Physicians of India, Indian Academy of Paediatrics, Indian Medical Association, Federation of Obstetric and Gynaecological Societies of India and other major medical bodies before the parameters for registration are decided. This is especially as the disease involves practically every system of the body.

It should also be stressed that any registry mandated by a registered society is more powerful than any directions mandated by the government. A registry also makes a particular hospital data transparent, thereby providing an opportunity to all others to compete for a benchmark and improve their services. Registries provide semi-actual data for future research patterns of recovery and mortality in different segments of society and the influence of environment on occurrence, mortality and recovery of any disease. Without a registry, it will be very difficult to enlist unusual and new manifestations which suggest a mutation or arrival of Covid-20. The registry should also collaborate with the Pharmacovigilance Programme of India so that even adverse drug reactions in the management of Covid-19 are included. Also, registries should have data of clinical features, demographic patterns, investigations profile, natural course of the disease including recovery, mortality and have at least a six-month follow-up.

If implemented correctly, it can be a boon in the treatment of Covid-19.

—The writer is President, Confederation of Medical Associations in Asia and Oceania, and former National President, IMA

Lead Picture: UNI

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