Ayurveda-specific case reporting guidelines - Need of the hour
Year: 2025
Type: article
Abstract: The understanding of the diverse application of evidence across different population settings, along with knowledge of their benefits and limitations, with an objective to support and advance the goals of health promotion and public health has gained momentum in the past decades. The public health community has made significant progress in narrowing the gap between certainty and uncertainty by organizing evidence from a wide range of sources, even though definitive evidence about the causal links between risk factors and disease or interventions and outcomes may still be elusive in many areas of research on human population health.[1] There is a growing focus on generating evidence from community trials and practice-based experience rather than solely relying on data from highly controlled, investigator-initiated experimental trials.[1] Practice-based evidence is necessary in the era of evidence-based practice, as the data generated is based on patient-specific real-time details, not on the controlled clinical trial approaches. Evidence-based practice focuses on implementation of the interventions to study the impact on a primary outcome measure, and in such settings, internal validity is prioritized over external validity. The evidence-based approach has a primary goal of obtaining evidence of impact, rather than promoting implementation at the practice level, whereas the practice-based evidence acknowledges the efficacy or effectiveness of an intervention to impact public health at large.[2] This concept of practice-based evidence has a long history of origin in the indigenous community, and these practices have an evidence base but lack research background as per contemporary science. Practice-based evidence is a real-world practice, with uncontrollable variables, where the impact is measured and recorded as it happens, thus necessitating the adoption of “evidence-based clinical practice” with close integration of best research evidence with clinical expertise and patient values.[3] Hence, it is deemed necessary to foster partnerships among researchers and practitioners through efficient, scalable mechanisms for the exchange of knowledge so that the objective of wider adaptation of effective interventions at a broader scale and larger public health platforms can be attained. It is the necessity of the hour to generate practice-based evidence in the form of meticulously documented case reports supported by standard biomedical investigation tools. Such practice-based information, valuable evidence derived from clinical practices, and observations in the form of case reports can be promising candidates for the best and most reliable sources of practice-based evidence. Case reports, or case series, are the types of descriptive studies in real-world clinical settings which highlight new, uncommon, or atypical traits observed in individual patients or a group of patients during clinical practice, having the potential to generate new research questions. These case reports deal with the cases having the following features (1) an unanticipated correlation between illnesses or symptoms; (2) an unforeseen incident that occurred while a patient was being observed or treated; (3) discoveries that provide fresh insight into the pathogenesis of the disease; (4) unique or rare characteristics of disease; (5) diverse anatomical structures; distinct therapeutic techniques.[4] The case reports highlight the best practices adopted in clinical settings, which ultimately help in improving the global healthcare situation. They can serve as a source of generating new hypotheses for clinical research, along with updating the researchers and clinicians with the concept of individualization and personalization of therapies in clinical practice. There are over 606 guidelines according to various types of trials and protocols such as PRISMA, PRISMA-P (for protocol) for the systematic review of Randomized Controlled Trials (RCTs), Meta-analysis of Observational Studies in Epidemiology for a systematic review of observational studies, CONSORT, SPIRIT (for protocol) for RCTs, STROBE for observational studies, STARD, TRIPOD (for protocol) for diagnostic/prognostic studies, ARRIVE for preclinical studies. Furthermore, with the determination of a group of 27 participants through a three-phase consensus process a 13-item checklist – a reporting guideline for case reports (CARE guidelines) has been developed and presented at the International Congress on Peer Review and Scientific Publication in 2013.[5,6] The guidelines consists of a title, keywords, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent. Anticipating the role of case reports in clinical research and Clinical Practice Guidelines, CARE guidelines offer a framework for systematic reporting standards and ensure that the significance and impact of case reports are not only limited to the patient’s care or the healthcare provider but to the broader medical and scientific community.[7] The CARE guidelines provide a structure to meet the requirements for accuracy, comprehensiveness, and transparency in communicating the information received from patient interactions, to disseminate, and utilize such information-based “evidence” into high-quality data for making a significant impact in the healthcare sector of society. Ayurveda, being the traditional system of medicine, considers the development of imbalances in Doshas (~regulatory functional factors of the body) and other systems of the body, as deviation from health. Ayurveda offers complex and holistic treatment modalities such as combinations of different medicines, along with specific advice on nutrition and lifestyle modifications (~Pathya-apathya ahara-vihara) including yoga practices and several bio-cleansing procedures (~Panchakarma therapy), which are customized according to the Prakriti (~somatic constitution) of the patient, to achieve a homeostatic or physiological equilibrium state.[8] Thus, there is a dire need to create a standard format to report the results of Ayurveda interventions with multiple components of diagnosis and therapies, with specified endpoints through publishing case reports to provide evidence of clinical practices in Ayurveda. It has been observed that there are discrepancies in the reporting of Ayurvedic treatments due to the inadequacies of standard reporting guidelines and Ayurveda-specific trial designs, necessitating efforts to develop exclusive multi-component, individualized and holistic guidelines for reporting of cases and clinical trials so that higher credibility for clinical studies of the Ayurveda system of medicine can be generated. There are currently no such reporting guidelines or any extension of preexisting standard reporting guidelines available for Ayurveda. In the present scenario, Ayurveda case reporting, even following the existing CARE Guideline, which is not exclusively developed for recording the Ayurveda components of clinical practice, is incapable of capturing basic Ayurveda parameters, which creates confusion and unclarity to the therapeutic principles adopted for the management of the case. It becomes difficult for the authors to uniformly convey the case report dealing with the Ayurveda principle of management prepared by following the existing “CARE guideline” which is specific for modern or conventional case reports. Concerning such discrepancies in reporting cases, a few recommendations and guidelines to comprehensively document a homeopathy case report have been developed for the homeopathic system of medicines. Reporting criteria that support the scientific value of a case report and enhance the quality of reporting include the WissHom Documentation Standard, HOM-CASE (Homeopathic Clinical Case Reports), and CARE (Case Report), along with documentation and evaluation of case using a few additional scientific instruments such as cognition-based medicine, prognostic factor research, prospective outcome assessment, and the Modified Naranjo Criteria for Homeopathy score have been developed to improve the quality of reporting and strengthen the scientific value of a case report.[9] Similarly, domain-specific guidelines, “SCARE (Surgical CAse REport) guidelines,” were first published in the year 2016, as a significant tool for surgeons to document and report their surgical cases in a standardized and comprehensive manner. The guidelines were recently revised and updated as SCARE 2023 guidelines through a Delphi consensus exercise to provide surgeons with a comprehensive and up-to-date tool for documenting and reporting their surgical cases, along with highlighting the importance of patient-centered care.[10] Previously, a paper on creating Ayurvedic-Specific Extension Guidelines (AYUR-CASE) for case reporting has been published, where the two key aspects of case reporting, namely diagnosis and therapeutics, are given prime importance and were suggested to consider for developing AYUR-CASE.[11] The paper opines to consider and enlist important Ayurveda diagnostic aspects such as Panchalakshana nidana (~Five factors of identification of diseases), Ashtasthana pariksha (~eight-fold examination of patient), and Dashvidh pariksha (~ten-fold examination of patient) under the diagnostic assessment section of CARE guidelines. Similarly, under the therapeutics intervention section, the parameters for such line of treatment planned based on the Samprapti (~pathogenesis) of the disease, the rationality of therapeutic administration based on the Avastha (~stage) of the disease, Antarparimarjana (~internal therapies), Bahirparimarjana (~external therapies), Shastrapranidhana (~surgical procedures), Shodhana (~bio-cleansing therapy), Shamana (~palliative procedures), Rasayana (~rejuvenation and revitalization therapy), Daivavyapashraya (~spiritual therapy), Yuktivyapashraya (~logic-based treatment), Sattvavajaya (subjugation of mind/counseling), and Pathyapathya (~wholesome-unwholesome dietary regimens) can be included.[11] Here, it is worth mentioning that the suggestion of including treatment planned based on the Samprapti and the rationality of therapeutic administration can be discussed and elaborated under the discussion section. Furthermore, the bifurcation of the therapeutic intervention section should be as per the Ayurveda classification of Chikitsa (~treatment), namely Trividha chikitsa consisting of Daivavyapashraya, Yuktivyapashraya, and Sattvavajaya chikitsa, with appropriate sub-domains and subcategories. Similarly, a specified section for dietary and lifestyle modifications, including yoga practices, needs to be developed in the Ayurveda-specific Case Reporting (AyuCaRe) guidelines, as the wholesomeness and the unwholesomeness (~Pathya-apathya) of diet and lifestyle are given utmost importance in Ayurveda in the management of the diseased condition. Apart from these aspects, the prognostic aspects and mortality indicators (~Arishta lakshanas) have been documented in Ayurveda texts. In the conventional system of medicine, a considerable amount of effort has been made in the section of prognosis research to identify patient prognosis along with determining the outcome based on the interaction between disease and nondisease factors such as social, psychological, and behavioral characteristics.[12] Diagnosis, treatment, and prognosis are the core clinical skills fundamental to good clinical practice, and there is a need to develop guidelines that also consider prognosis-focused treatment approaches. It has been observed that there are instances where physicians have success stories for certain conditions, and at the same time, certain clinical situations which are presented unusually are not somehow communicated to scientific society. Thus, proper dissemination of such clinical practices to help shape a more efficient and holistic system of health care is needed. Therefore, it is essential to prioritize the task of developing new Ayurveda-specific Case Reporting (AyuCaRe) guidelines or an extension of the existing CARE guideline following the standard methodology for the development of the same through a consensus-based process. The All India Institute of Ayurveda, which considers the clinical case report as an integral component for the advancement of medical science, specifically Ayurveda medical science, releases its quarterly peer-reviewed Journal of Ayurveda Case Reports (JACR) as a special platform for sharing the clinical experiences among the stakeholders from Ayurveda as well as other medical disciplines. The journal provides an opportunity to communicate key Ayurvedic practices adopted across the globe to further enhance global health and increase clinical understanding of case reports from the Ayurveda perspective. JACR serves as a dedicated platform for the exchange of Ayurveda-specific clinical knowledge and experiences, providing a scientific rationale to Ayurveda science, and transforming the clinical practice of Ayurveda from practice-based evidence to evidence-based clinical practice.
Source: Journal of Ayurveda Case Reports
Author: Sujata D. Kadam
Institution: All India Institute of Ayurveda, New Delhi
Language: English
Subfield: Complementary and alternative medicine
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4411154145