“SUSTAINING AYUSH MODEL IN PUBLIC HEALTH SECTOR WITH FOCUS ON MALARIA IN TRIBAL BLOCK OF BOUDH & FILARIASIS IN BALIPATANA

BLOCK OF KHURDA, ORISSA”

Evaluation Report on Community Study prepared by Dr. Rajan R Patil 1, based on Field visit to project areas of Tapobhoomi Trust in Orissa, from May 26 to 28th 2010.

At the outset Tapobhoomi Trust needs to be congratulated for their massive efforts in attempting to provide health care to the unreached and marginalized people in some of the most under developed districts of Orissa state. Orissa is one of the most malaria endemic states in India and any efforts to mitigate the suffering of the ailing community there is praise worthy. Tapobhoomi is right in its claim of being one of the very few organizations to have attempted mass application of Ayurvedic drugs such as Ayush-64 recommended by CCRAS for Malaria and Filariasis.

The current initiative by Tapobhoomi is part of a community based integrated development and health interventional project with special focus on Malaria and Filariasis control. It has all the components of a comprehensive health and development project such as:

1. School programme on yogic practices 2. Family level training programmes to follow dinacharyas and yogasanas.3. Creating Awareness on use of clean drinking water, maintenance of hygiene,

sanitation & ongoing development activities 4. Health Committees formed by facilitating PRIs and SHGs in every revenue village

to enable them to plan and monitor the health activities5. Economic development of community by assisting them to open & operate bank

accounts and proper utilization of that fund at village level 6. Organising Arogya Mela (health fair) in Orissa and inviting Ministers,

Secretaries, Directors to visit the same along with the public7. Training of CBOs and PRIs covering other crucial inputs such as integration of

the several vertical disease control and health programmes; synergies between the health and allied sectors

8. Community Mobilization through community campaigns, village meetings, Women SHG Meetings, Youth meetings & School meetings in every nook & corner of the project area

The current health project evaluated is being undertaken using an operations research framework to assess the feasibility of operationalizing an integrated health and development initiative in the process of providing care and treatment for malaria and filariasis using Ayurvedic drugs. The ongoing project in in Boudh and Balipatna are very encouraging. It clearly demonstrates that it is possible to operationalize a health project with alternative system of medicine using Ayurvedic drugs for treatment of malaria and filariasis in endemic regions. The project has been successful in demonstrating community acceptance of Ayurvedic drugs, and also demonstrating the meticulous operational and logicstics planning required for delivery of community based public health interventions through trained community volunteers. The project has proven the operational feasibility of community based application of AYUSH interventions in tribal and underserved areas.

1 DR. RAJAN R PATIL IS AN EPIDEMIOLOGIST CURRENTLY WORKING AS ASSISTANT PROFESSOR

AT THE SCHOOL OF PUBLIC HEALTH, SRM UNIVERSITY, POTHERI-PIN-603203,CHENNAI

EMAIL: RAJANPATIL@YAHOO.COM

KEY OUTCOMES OF THE PROJECT:

No deaths due to malaria in the three Gram Panchayats (GP) of Bodh block Transmission of Microfilaria in the three GPs of Balipatna b block Swelling of foot or hand and hydroceles of Filariasis patients reduced to normalcy AYUSH-64 & Nityananda Rasa effective for community level Filariasis and Malaria

control 90% coverage for use of mosquito nets in project villages 4000+ patients benefited out of health camps 38 community activists engaged in disease surveillance benefiting 47,000 people Micro health plans prepared in 40 villages Community Sanitation and vermi-composting activities organized 18 Women SHGs promoting vermi-composting & sanitation activities

Tapobhoomi Trust is now keen on promoting this community based project experience as an intervention research project. The following are some of key issues that the Tapobhumi Trust would need to take into consideration for reformulating the project from an operations research to an intervention research framework:

Research Protocol & Ethical Clearance: Detailed Research Protocol needs to be developed which needs to be approved and monitored by a Technical Advisory Committee which can vouch for, own and defend the methodologies. An independent ethics committee should review and approve the study protocol. The study needs to be headed by technically qualified Principle Investigator and Co-investigators with demonstrable research capacities and experience. These investigators should undertake the training of the volunteers for implementation of the protocol and put in place adequate quality assurance mechanisms to ensure adherence to the protocol during implementation. Written informed consent from the study subjects / community should be taken.

Case Definitions: Operational Case definitions of Malaria and Filariasis cases to be used in the study should be clearly formulated. The criteria for clinical diagnosis and laboratory confirmation of cases should be delineated. All the volunteers should be trained on use of the case definitions and adherence should be monitored.

Control Groups: While study villages are well identified for the operations research project, identification of control villages is essential for the intervention project. Without earmarking appropriate control areas, assessing the impact of the health interventions would not be possible. Either concurrent controls or if data for at least the preceding three years is available then historical controls for the study villages can be identified.

Case Ascertainment: A large proportion of the cases were identified by organizing health camps during the operations research project. During the intervention project, selection bias through unbalanced case ascertainment between the intervention and control areas should be avoided through conducting similar health camps and other cases detection mechanisms in both areas.

Defining Interventions: During the operations research study in addition to Ayush-64, the main intervention Ayurvedic drug, it was seen that patients were administered multiple ayurvedic drugs including quinine. This is as per Ayurvedic praxis wherein the treatment regimen is tailored according to the individual’s characteristics and a standard regimen is not applied to all cases. This automatically precludes the evaluation of the outcome due to a single drug. In this scenario, it would be more practical to assess the efficacy of a set regimen rather than a single drug. Rather than using the traditional Randomized Placebo Controlled Trial design, it might be feasible only to undertake a community intervention trial of the entire clearly defined regimen using largely an observational study design. The key ensuring validity and precision in such a study design is very high quality of data as detailed below.

Data Quality: The case records for the study needs to be well crafted and uniform. Meticulous updating of the case records is essential. All instances of exceptions from the standard trial regimen should be documented in detail. All demographic and secondary data should be collected with equal rigour and thoroughness in the intervention and the control areas. Quality assurance from data collection to data analysis stages to be put in place.

Intervention Outcomes: Successful outcomes expected due to the treatment of cases with the ayurvedic drug/regimen should be clearly defined. Pre and post intervention evaluation – clinical as well as laboratory – for the achievement of defined outcomes for every case treated should be undertaken and recorded in detail. If subjective criteria based on the patient’s own assessments are to be used as outcome

measures then these should be standardized using instruments and scales that have been evaluated and tested in similar field situations. Clinical as well as laboratory evaluations / tests have to be done by technical personnel who are appropriately qualified and trained and their performance during the duration of the study needs to be regularly monitored.

CONCLUSION:

1. The operations research project completed by Tapobhumi Trust has demonstrated the effectiveness of innovative methods for the community level application of AYUSH to address the malaria and filariasis burden of tribal and underserved communities.

2. While the current project cannot clearly prove the effectiveness of specific Ayurvedic drugs such as Ayush-64 or Nityananda ras, the study base and the credibility in the community established by Tapobhoomi Trust clearly places it in a good position to carry out an intervention research study guided by and in collaboration the appropriate technical experts and institutions.

3. A well designed and executed community intervention trial using an observational epidemiological study design framework with well defined ethically cleared research protocol with clear intervention and control areas, intervention regimens, intervention outcomes, quality assured outcomes assessment and data quality is strongly recommended as the way forward for the Tapobhoomi Trust.