Arya Vaidya Pharmacy, India

AVTAR has initiated the RUDRA (Random Uninterrupted Documentation for Retrospective Analysis) Program to generate practice based evidence in the field of Ayurvedic clinical practice. There is an urgent need to initiate systematic practice based evidence (PBE) in the field of traditional medicine (TM). In the case of conventional medicine, researched knowledge gets translated into practice as a rule whereas in the context of traditional medicine, a tradition of clinical practice that has a continuity of several thousand years is already existent. This tradition of clinical practice is a heterogeneous mixture of partly verified clinical knowledge and partly innovative clinical experimentation. The challenge is to generate reliable knowledge through research on ongoing clinical practice in traditional medicine. In other words, there is a need to promote PBE in TM.

Evidence based medicine or EBM as it is called has become the corner stone of clinical practice in conventional medicine. EBM insists that clinical practice be based on research generated evidence. In this model, the flow of knowledge is from the research laboratory to the clinic. However, it is being increasingly realized that the clinical scenario cannot be completely controlled by EBM. New knowledge is discovered in the context of clinical practice that has not been previously discovered by research. In other words, EBM has to be supplemented with inputs from PBR even in the case of conventional medicine.

TM has a rich resource base of clinical expertise but not an equally rigorous body of researched knowledge to back up the clinical practice that has been in vogue for thousands of years.

Continuity of use cannot by itself be the criteria to establish safety and efficacy of TM. The expressions of clinical practice in TM are so rich and diverse that it would be a Herculean task to conduct prospective clinical studies to build up an evidence base to substantiate them. Without preliminary clinical documentation, it would be impossible to even identify the most potential areas in the TM practices for more rigorous clinical research.

Scattered and isolated attempts at PBE by a few clinical centers or hospitals in TM will not be able to meet the challenge of creating a comprehensive evidence base that can address safety and efficacy concerns in the wake of globalization of TM. Therefore, there is a need to create a network of PBE based clinics in TM. Centres of excellence in TM practice should be identified and networked to implement a uniform protocol based clinical documentation program with a view to generate epidemiological data and evidence of safety and efficacy.

The RUDRA PROGRAM

The PBE program for TM is called RUDRA, which is an acronym for Random Uninterrupted Documentation for Retrospective Analysis. RUDRA is based on the concept of randomly (all clinical encounters included) and uninterruptedly (goes hand in hand with clinical practice) documenting all encounters between patients and physicians in the field of TM in a systematic manner with a view to generate epidemiological data and evidence of safety and efficacy of TM practices. Metaphorically, RUDRA is the fiery form of Lord Shiva with his third eye opened. In the context of the PBE program in TM, it represents the introduction of the third dimension of the researcher‚Äö gaze on continuing clinical practice, over and above that of the patient and physician. The third eye represents the objectivity that burns biased, opinionated views and projects facts. The central theme of RUDRA therefore, is the investigation of ongoing clinical practice in TM by a team of well-trained researchers.

The basic operation plan of the RUDRA program is to divert patients to a research documentation cell before they enter the consultation chamber of a physician. Through effective planning and management of the patient registration process, the clinical documentation is done by utilizing the time that a patient has to wait before being called for consultation. It thus becomes a value addition to the typical clinical encounter in TM practices by making productive use of the extra time which patients have to spend to consult a practitioner.

RUDRA has twelve components that address quality, security, flexibility and reach of the program. A judicious blend of clinical research, information technology, personnel management applications as well as intellectual property rights laws contribute to make up the backbone of the RUDRA program. The various components are listed and reviewed below.

1. Documentation Protocol, 2. Qualified Personnel, 3. Training Program, 4. Infrastructure, 5. Equipment, 6. Software Solutions, 7. Quality Assurance, 8. Certification, 9. Data Security, 10. Networking, 11. Publication and 12. Up gradation.

1. Documentation Protocol: A modulated documentation protocol is designed to cover the complete cycle of a clinical encounter including booking, registration, documentation, investigations, consultation, medicine dispensation and therapy scheduling in the case of Out Patient Department with admission, progress monitoring, diet section and discharge being the additional modules in the In Patient Department. Generating a one time unique registration ID for every patient is the key data management logic. The data entry forms are customized according to gender, patient population, disease categories, first visit and follow up visits and there are specific forms for the different documentation modules mentioned. These forms are coded and assigned version numbers that indicate revisions done periodically. The documentation forms are designed to gather epidemiological, safety and efficacy data in a comprehensive way. A unique feature of the documentation protocol is the ICD (International Classification of Diseases) - ACD (Ayurvedic Classification of Diseases) Interface, which will greatly facilitate presentation of efficacy data in a scientific language for global acceptance. Manual documentation is envisaged only in the phase of training and is replaced by software modules when the program becomes fully functional.

2. Qualified Personnel: For the sake of objectivity, RUDRA program requires recruitment of qualified personnel to form a team of researchers who will engage in the clinical documentation. Ideally, a combination of TM physicians, Allopathic physicians, Social Scientists, Statisticians and Data Managers can create a good blend of the diverse skills required for successful implementation of the program. Alternatively, TM physicians could take up the diverse roles after proper training and certification.

3. Training Programs: Specific skills are required to participate in the RUDRA documentation program. Hence a variety of training modules have been developed to ensure that the recruited personnel will be able to efficiently execute the documentation protocol. Training includes Ethics in Research, Clinical Skills, Diagnostic Procedures, Technical Terminology, Good Clinical Practice Guidelines, Computer Literacy and Data Management. Computer Based Training modules facilitates self learning.

4. Infrastructure: Minimal infrastructure requirements are to be met by creating a documentation cell and data archive cell. Provision should also be made for an in house clinical laboratory.

5. Equipment: The major equipments required are computers and networking solutions, which could optionally be wireless. Computers would be a combination of high configuration servers, low and high configuration PCs, data back up devices and the like. The specific requirements would vary from hospital to hospital.

6. Software Solutions: Software modules have been designed to minimize manual work and data entry time, while at the same time enhancing capabilities for data analysis and report generation. The modules have inbuilt features that will generate alerts to prevent wrong entries and ensure that all the data fields are completed. The software also has inbuilt training modules, which have to be completed successfully to generate a certificate and system assigned user id and password, without which the data entry modules cannot be accessed. This ensures that only skilled and authorized personnel can operate the software. The software also has administrative capabilities to track bookings, generate prescriptions, track medicine dispensation, schedule therapies etc. The software solution works on the general principle of converting data into information, information into knowledge and to convert knowledge into informed decisions.

7. Quality Assurance: Quality assurance in ensured through a process of external auditing. Quality of the personnel, data, equipment and medications is checked periodically by auditors appointed for the purpose. A full time Quality Control Manager at the documentation site will be responsible for day to day enforcement of quality parameters and will report to the auditors when external audit is conducted. Quality of the RUDRA program is thus achieved by the two pronged strategy of appointing neutral researchers for clinical documentation and then scrutinizing the process through external audit.

8. Certification: Based on the external audit, institutions, equipment, physicians, researchers, laboratory and pharmacy will be certified for quality from time to time. It is hoped that this certification program will play a crucial role in authenticating evidence oriented clinical practice in TM.

9. Data Security: The designed software operates in a highly secure environment and will allow only authorized personnel to access the data. However, higher levels of security in the light of IPR laws and patent system have also been envisaged. Every institutional participant will have the choice of depositing the clinical data generated through the documentation program in a national registry preferably regulated and controlled by Government authorities. This registry could be made available to patent offices to prevent misappropriation of knowledge.

10. Networking: It is imperative that an efficient network of the centers of excellence in traditional medicine be associated to form a practice based research network (PBRN) in TM. In the initial stages it may be feasible to implement the RUDRA program only in selected major hospitals and clinical centers of TM in the country. In the long run, it could be extended to cover a wider extent of the clinical resource base in TM. Networking will facilitate queries on safety and efficacy issues of specific TM interventions across the networked centers. It will also help to easily identify areas of strength in TM in clinical centers across the length and breadth of the country. For example, if there is a public debate on the safety issue of a particular medicine, a network query can be raised to find out whether any clinical center in the PBR Network has reported similar concerns. Through the ICD-ACD Interface discussed earlier, ICD nomenclature could be used to search for areas of strength in TM clinical practice across the networked centers. However, each center will have the freedom to withhold data on grounds of security and/or concerns of misappropriation.

11. Publications: The software is designed to generate annual/periodical state of the art reports on epidemiological aspects of TM practice with carefully analyzed data on safety and efficacy issues. By organizing the documented data into a national registry, regulated patent filing systems could be enforced.

12. Up gradation: The documentation protocol will be revised and updated from time to time based on advancements in the field of medical sciences, information technology and the like. Documentation protocols may be suitably altered, hardware may be updated and new software versions created.

Epidemiology, Safety and Efficacy Data

The central theme of the RUDRA program is to generate epidemiology, safety and efficacy data from ongoing clinical practice of TM.

Epidemiological data deals with distribution of patient population, diseases, disease categories and the like.

Safety data will throw light on adverse events, serious adverse events and adverse drug reactions associated with Ayurvedic interventions.

The principles of pharmaco vigilance will be applied to monitor safety of Ayurvedic medicines and treatments. Research personnel will be rigorously trained to document safety data in a meticulous manner.

Efficacy data will be generated by documentation of symptomatology, clinical examination and lab investigations. Treatment outcomes will be evaluated by comparing baseline mid point and end point observations. All claims of efficacy will be evaluated against the natural course of a disease to determine the exact role of the TM intervention symptom management, arresting disease, preserving function, disease modifying effect, remission or resolution.

The RUDRA Program is currently implemented in various stages at Arya Vaidya Chikitsalayam, Coimbatore, National Institute of Ayurveda, Jaipur and Central Research Institute for Ayurveda, New Delhi.