|Year : 2021 | Volume
| Issue : 3 | Page : 77-80
Practice-based evidence to evidence-based clinical practice: Way forward
Tanuja Manoj Nesari
Director, All India Institute of Ayurveda, Sarita Vihar, New Delhi, India
|Date of Submission||07-Dec-2021|
|Date of Acceptance||09-Dec-2021|
|Date of Web Publication||14-Dec-2021|
Prof. Tanuja Manoj Nesari
All India Institute of Ayurveda, Sarita Vihar, New Delhi
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Nesari TM. Practice-based evidence to evidence-based clinical practice: Way forward. J Ayurveda Case Rep 2021;4:77-80
Herbal medicines form an important part of most traditional systems of medicine. Majority of the world's population in developing countries still relies on herbal medicines to meet their health needs. They are often used to provide first-line and basic health service to people living in remote and poor areas. Even in areas where modern medicine is available, the interest on herbal medicines has been increasing rapidly in recent years. The Honorable Prime Minister's vision for “New India” endeavoring to empower youth, women, and poor is indeed laudable. The “New India” needs to be a “Healthy India” where its own traditional systems can play a significant role. Ayurveda, Yoga, Unani, Siddha, Homeopathy (AYUSH) systems in healthcare can play an important role in realizing the dream of “New India” by providing quality healthcare and medical facilities for its citizens. Many reforms in administration, research strategies, nature of practice, and education are already underway at the Ministry of AYUSH.
India has the largest traditional healthcare, which is fully functional with a network of qualified registered practitioners, research institutions, and licensed pharmacies. Herbs as potential source of therapeutics have attained a significant role in health system all over the world not only in the diseased condition but also as a potential material for maintaining health. All such efficiencies of herbal preparations in providing long-lasting cure for specific diseases need to be compared, documented, and published in standard journals, rather than obscure journals. This is the right time to think and discuss the impact of Ayurveda practices in maintaining health and preventing chronic diseases. A suitable platform is needed to communicate all such experiences. Considering the acute need, All India Institute of Ayurveda (AIIA), New Delhi, has started Journal of Ayurveda Case Reports (AyuCaRe) for all the stakeholders of AYUSH to share their experience.
The concept of practice-based evidence (PBE) represents practices that come from the local community. PBEs are embedded in the culture, are accepted as effective by local communities, and support healing of youth and families from a cultural framework. Many of these PBEs have been in place for years and for many tribal communities, for centuries. These practices do not have a research base as we define research today; however, they do have an evidence base developed from multiple trials of experimenting with what work best. In the concept of PBE, the real, messy, complicated world is not controlled. Instead, real-world practice is documented and measured, just as it occurs, “warts” and all. It is the process of measurement and tracking that matters, not controlling how practice is delivered. Evidence-based clinical practice (EBCP) is “the integration of best research evidence with clinical expertise and patient values,” which, when applied by practitioners, ultimately lead to improved patient outcome. Clinical practice guidelines (CPGs) are tangible evidence of an environment that foster evidence-based practice. EBCP also assists decision-makers in implementing best healthcare practice while drawing roadmaps for the health system.
There are three fundamental components of EBCP.
- Best evidence which is usually found in clinically relevant research that has been conducted using sound methodology
- Clinical expertise refers to the clinician's cumulated education, experience, and clinical skills
- Patient values which are the unique preferences, concerns, and expectations each patient brings to a clinical encounter.
Over the past decade, clinical guidelines have increasingly become a familiar part of clinical practice. Every day, clinical decisions at the bedside, rules of operation at hospitals and clinics, and health spending by governments and insurers are being influenced by guidelines. As defined by the Institute of Medicine, in the USA, clinical guidelines are “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.” They may offer concise instructions on which diagnostic or screening tests to order, how to provide medical or surgical services, how long patients should stay in hospital, or other details of clinical practice. Evidence-based CPGs can identify which components of the decision-making process are objective. They can also enable the cohesive incorporation of traditional “standards” of care with scientific research paradigms.
Evidence is usually abstracted from any empirical observation. This might be in different formats and types of studies, being systematically or nonsystematically reported. However, the unsystematic ones are often limited by the small sample size and flaws in inferences affected by the illness natural history, placebo effect, clinicians' expectations, and patients' desire to please their healthcare providers.
By systematic examination and analysis of prospective, randomized, controlled trials (RCTs), other experimental studies, nonexperimental observational studies, anecdote, and consensus statements according to an a priori set of rules, the extant dynamic body of medical knowledge can be infused with new information. The strength of the RCTs is obtained from its powerful design that includes randomization. Randomization, when implemented appropriately, is the best way to achieve matching of the comparison groups for their prognostic factors.
The second fundamental principle about clinical decision-making is very important in clinical practice and is often overlooked. A healthcare professional should always keep in mind their patients' values and preferences when taking a clinical decision. Implementation of EBCP requires careful review of the patients and possibly cultural, acceptance of the diagnostic test, and/or management intervention. Clinical expertise is always needed, and therefore, EBCP should take into account an expert opinion when dealing with different clinical scenarios. In addition, healthcare providers should always be good judges when mixing both EBCP and clinical expertise along with taking into consideration the economic aspect of the test/intervention.
The production and dissemination of evidence-based CPGs has several components: First, a local group or, more often, a national body decides to develop guidelines in a clinical area in which there is a demonstrated need for such guidelines. Second, data are synthesized from research information and relevant practice patterns by searching the literature (including existing guidelines) and then weighing the strength of the evidence from the resulting trials or studies. Third, these data are further reviewed, appraised, distilled, and collated as guidelines, that is, as recommendations about strategies for investigation and management. Fourth, the sponsoring organization and other interested organizations then endorse the guidelines. Fifth, CPGs are disseminated, usually by traditional means such as mailing them to members or publishing them in recognized professional clinical journals. Sixth, various groups or individual practitioners may attempt to implement the guidelines more actively, through various, often multiple, strategies to assist, convince, or otherwise influence physicians, patients, and their caregivers. Finally, the guidelines are subjected, albeit irregularly, to reappraisal, evaluation, and reiteration of the process.,
Ayurveda is one of the traditional systems of medicine that practices holistic principles primarily focused on personalized health. Originated in India, Ayurveda is one of the ancient yet living health traditions and is the most relevant in the present era. Prolonged use of Ayurveda by people has also led to several home remedies for common ailments. Ayurvedic medicines contain sophisticated therapeutic formulations. Ayurveda is also a person-centered medicine, which deals with healthy lifestyle, health promotion and sustenance, disease prevention, diagnosis, and treatment.
Ayurveda practice is based on principles narrated by classical scriptures and tradition. Ayurvedic physician makes decision to provide the best effective treatment by considering tradition and knowledge inherited from his/her environment and upbringing. Further, he/she follows examples of peers. An Ayurvedic physician who applies the principles of Dravya (~drug), Guna (~quality), Karma (~action), and Virya (~potency) falls in place. New age Ayurvedic practitioners think that evidence should be the basis for their decision and action. A field such as the Ayurveda as a medical profession that deals with the health and wellness of individuals should ensure the utmost care in diagnosis and management. Providing incorrect treatment cannot be afforded in such holistic medicine. Hence, evidence-based Ayurveda practice is need of the hour from a clinician to student to patient and public in large. Evidence-based medical practice helps ensure that the right treatment is given to the right patient at the right time.
The aim of Ayurveda treatment is to achieve and maintain health by balance or equilibrium among three morbid factors, i.e., there Doshas namely Vata, Pitta, and Kapha – the functional component of body – and Sapta dhatu – the structural component of the body. The excretory products, i.e., Trimala, should evacuated properly and a person should be happy for achieving health in Ayurvedic sense. All diseases are manifested due to imbalance of Dosha and Dhatu by food, emotion, and environment. The Ayurvedic practice is based on certain principles narrated by classical texts and tradition. Drug therapy, Ksharasutra, and Panchakarma are the famous acceptable interventions of Ayurveda. A field such as the Ayurveda as medical profession that deals with the health and lives of individuals should ensure the utmost care in diagnosing and treating a patient. To provide incorrect treatment can be devastating. Evidence-based medical practice helps ensure that the right treatment is given to the right patient.
Experiential, observational therapeutic strength is to be highlighted. However, PBE in the form of well-documented case reports supported with biomedical tools of investigations as practiced in conventional medicine is the need of te hour. AyuCaRe is a platform that is to encourage practitioners to present their success stories in managing challenging clinical conditions with holistic Ayurveda principal in a systematic way.
As per the present regulations in India, no scientific or clinical data are required for manufacture and sale of classical Ayurvedic medicines. Technically, sound pharmacopoeia, good manufacturing practices, quality control, and pharmaceutical technologies for Ayurvedic medicine are still evolving. Issues related to appropriate research methodologies or treatment protocols for Ayurveda have also not been properly addressed. Many critiques are demanding better coordination between stakeholders, continuous dialog with scientific community, and total overhaul of the curriculum and pedagogy along with the need for cross-talks between different streams. Recent report on status of Indian medicine and folk healing indicates the need to strengthen research and use of AYUSH systems in national healthcare. The need for innovation is also urged by thought leaders in this sector. In short, the evidence base to support good clinical practice, guidelines, and documentation in Ayurvedic medicine remains scant and grossly inadequate.
Evidence based is nothing but some sort of systematic assessment of evidence that may be a single isolated instance called as case study or case report, or it may be a series of observation; then, it is case series or it can be go up to systemic evaluation by single-blind or double-blind randomized trial. The Data and Safety Monitoring Board (DSMB) should review each protocol for any major concern before implementation. During the trial, the DSMB should review cumulative study data to evaluate safety, study conduct, and scientific validity and integrity of the trial. Standard case report form should be designed in such a way that it helps the collection of consistent and valid data, ultimately resulting in submission of data to regulatory authorities and its acceptance.
Ministry of AYUSH has taken initiative to get onboard in healthcare information technology implementation projects. In this regard, Ministry of AYUSH has created AYUSH GRID to get all the information technology (IT) projects under one umbrella. It is integration of IT projects exclusively meant for improvement and facilitation of AYUSH pan India. AYUSH Hospital Management Information System is a comprehensive IT platform to effectively manage all functions of healthcare delivery systems and patient care in AYUSH facilities. Prime Minister Narendra Modi launched the Ayushman Bharat Digital Mission (ABDM) on September 27, 2021. ABDM aims to develop the backbone necessary to support the integrated digital health infrastructure of the country. It will bridge the existing gap among different stakeholders of healthcare ecosystem through digital highways. ABDM shall create a seamless online platform “through the provision of a wide range of data, information and infrastructure services, duly leveraging open, interoperable, standard-based digital systems” while ensuring the security, confidentiality, and privacy of health-related personal information.
To strengthen the evidence-based practice, massive number of articles has been published in AYUSH system of medicine. 33,325 articles are available so far on AYUSH research portal, an evidence-based research data of AYUSH systems at global level. Out of these, 6056 articles published are from clinical research, 13,384 articles are from preclinical research, 8346 articles are from drug research, and 5540 are from fundamental research area. COVID-19–related AYUSH research and development articles available on AYUSH research portal are 237.
Ayurveda, being a continuously practiced medicine, is accommodating itself in the contemporary era by providing quality services through focused approaches. AIIA, being a tertiary care center, is taking lead to generate evidence-based practices. AIIA has specialty Out Patient Departments (OPDs) that are mainly focusing on evidence-based practices. Publishing case reports to provide evidence of clinical practices in Ayurveda is also another activity. A number of projects have been initiated in association with various national and international Memorandum of Understanding (MoU) partners. Formal collaboration with London School of Hygiene and Tropical Medicine, London, UK, along with the Ministry of AYUSH, Government of India, is one such example to generate sufficient scientific evidences, which is truly needed.
We take this opportunity to appeal all researches to utilize this platform. Proper methodology for evidence-based clinical practice should be incorporated in AYUSH hospitals. Every Ayurvedic physician should contribute something to generate evidence and should practice Ayurveda backed by evidence. Evidence-based practice can also be generated in all 700 colleges to join together to create evidence-based practice in a very small period of time. We have to act local to go global.
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