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Attendee

My Journey Through the TNMGRMU AYUSH Research & Biostatistics Workshop 2025

Date:May 13 - 15, 2025
Location:Chennai, Tamil Nadu, India
Venue:The Tamil Nadu Dr. M.G.R. Medical University
Event:Research Methodology & Biostatistics for AYUSH Post Graduates Program - Homeopathy
By:Department of Epidemiology, The Tamil Nadu Dr. M.G.R. Medical University
HomoeopathyResearch MethodologyBiostatistics#TNMGRMU#AYUSH#Homoeopathy#Research Methodology#Biostatistics#Workshop#Epidemiology#Medical Education#Continuing Medical Education

A Personal Foreword

MD scholar waiting in Lecture Hall

MD scholar waiting in Lecture Hall

Embarking on postgraduate studies in Homoeopathy, the call to rigorous, evidence-based research becomes ever more pronounced. This three-day workshop by TNMGRMU's Department of Epidemiology was not just a series of lectures, but a transformative experience. It provided the crucial scaffolding—both conceptual and practical—to navigate the complexities of research. This article is my attempt to distill the essence of those invaluable sessions, sharing key learnings and personal takeaways.

Day 1: Architecting the Research Blueprint

The inaugural day masterfully laid the foundational stones, moving from the 'why' of research in AYUSH to the 'how' of formulating questions, navigating literature, designing instruments, understanding basic statistics, and upholding ethical tenets.

Introduction to Research in AYUSH: Bridging Tradition with Evidence

Speaker: Dr. N. Kabilan (Prof & HoD, DoS, TNMGRMU)

Dr. Kabilan's opening address was a powerful reminder of our responsibility as AYUSH practitioners to contribute to the scientific validation and evolution of our systems. Key highlights:

  • The "Why" of AYUSH Research : Beyond academic necessity, it's about enhancing patient care, informing policy, and ensuring AYUSH systems earn their rightful place in integrative healthcare.
  • AYUSH Systems - A Tapestry of Healing : Celebrated the unique philosophies of each system while underscoring the common thread of holistic, patient-centered care, with Homoeopathy's individualized approach as a prime example.
  • The Imperative of Interdisciplinary Synergy : Advocated for "breaking silos" – robust collaborations with conventional medicine, basic sciences, and even social sciences to tackle complex health challenges.
Dr. Kabilan's Core Message

"Research is not an esoteric pursuit but a vital tool to refine, validate, and expand the reach of AYUSH knowledge for global well-being."

From Spark to Specificity: Crafting Research Questions

Speaker: Dr. Maanasa Rajagopalan (NIE)

Dr. Maanasa brilliantly demystified the art of formulating a research question – the cornerstone of any study.

The Genesis of Inquiry:
  • The Research Cycle : From observation question hypothesis study analysis new questions.
  • FINER & PICO(T): Not just acronyms, but practical sieves to refine raw ideas into robust, answerable questions (e.g., for Homoeopathy: Patient characteristics, specific Remedy/Intervention, Comparison like placebo/other remedy, Outcome, Time).
Translating & Refining:
  • Question to Objective: The crucial step of converting the "what" (question) to "how and what will be measured" (SMART objectives).
  • Types Demystified: Descriptive (What is the profile of...), Associative (Is X related to Y?), Causal (Does X cause/improve Y?).
Key Insight: The Iterative Process

A research question isn't set in stone. It evolves with deeper literature understanding and preliminary exploration. Be prepared to refine!

Mastering the Maze: Literature Search & Organization

Speaker: Ms. Sandhya Bharathi (SRMC)

Ms. Sandhya equipped us with a veritable arsenal for conquering the literature review:

Targeted Search Strategies :
  • Database Deep Dive: Beyond PubMed, exploring Cochrane, AYUSH Portal, DHARA, Scopus. Emphasis on using MeSH terms effectively.
  • Boolean Brilliance: Practical use of AND, OR, NOT. Example: (Homoeopathy OR Homeopathy) AND "Low Back Pain" AND RCT.
  • Citation Chaining: Snowballing from key papers.
Modern Tools & Organization :
  • AI Companions: Leveraging SciSpace, Perplexity AI, Elicit for discovery and summarization (not replacement of critical reading!).
  • Reference Managers: Zotero/Mendeley are non-negotiable for sanity! Practice: APA initially, then convert.
  • Staying Updated: Using Feedly, journal alerts.
  • Systematic Review Data Sheet: The structure provided (Title, Year, Abstract, Method, Result, Aim, Database) is key for meta-analysis prep.
Enhanced Collage of Literature Search Tools, Databases, and AI Assistants

Enhanced Collage of Literature Search Tools, Databases, and AI Assistants

Pro-Tip for Literature Review

Don't just summarize; synthesize. Identify gaps, controversies, and emerging themes. This forms the strongest rationale for your study.

The Art of Asking: Crafting Effective Questionnaires

Speaker: Ms. Sivaranjani

Ms. Sivaranjani emphasized that a questionnaire is a precision instrument; its design dictates data quality.

  • Question Types : When to use open-ended (rich qualitative data) vs. closed-ended (quantifiable, easier analysis). Nuances of Likert scales, semantic differentials.
  • The "Don'ts" of Wording: Avoid jargon, ambiguity, double-barreled questions (e.g., "Is the remedy effective and safe?"), leading questions. Clarity is king!
  • Logical Flow & Aesthetics: Start broad, then specific. Group similar items. Make it visually appealing.
  • Pilot Testing - The Unskippable Step: Test on a small, similar sample to catch confusing items, estimate time, and refine.
Beware: Poor Questionnaire = Poor Data

No amount of sophisticated statistical analysis can rescue data collected from a poorly designed questionnaire. Invest time here!

The hands-on exercise of drafting a questionnaire for our own topics was particularly illuminating.

Statistics Without Tears: Concepts & Test Selection

Speaker: Dr. Vasantha (NIRT, ICMR)

Dr. Vasantha masterfully broke down foundational statistical concepts, focusing on intuition over complex formulae.

Describing vs. Inferring:
  • Descriptive Stats: Painting a picture of your sample (mean, median, mode, SD, range, frequencies).
  • Inferential Stats: Drawing conclusions about the population from your sample (hypothesis tests, CIs).
  • Data Types Rule : Nominal (categories), Ordinal (ordered), Interval (equal intervals, no true zero), Ratio (true zero) – understanding this is critical for test choice.
Hypothesis Testing Essentials:
  • Null (H0) vs. Alternative (H1): The scientific tug-of-war.
  • P-value : Probability of seeing your data (or more extreme) if H0 is true. Not the probability H0 is true!
  • Errors : Type I (α, false alarm) & Type II (β, missed detection). Power = 1-β.
  • Parametric vs. Non-Parametric: Guided by data distribution (normality tests like Shapiro-Wilk) and data type.
Statistical Mantra

"Your research question dictates your variables; your variable types and data distribution dictate your statistical test."

The Moral Compass: Ethics in Health Research

Speaker: Dr. K.S. Uma (TNMGRMU)

Dr. Uma's session was a profound exploration of the ethical bedrock upon which all credible research must stand.

  • Historical Echoes : The Tuskegee Syphilis Study wasn't just a historical event but a stark reminder of why ethical oversight (Nuremberg, Helsinki, Belmont) is paramount. Its 40-year duration for a supposed 6-month study underscores the potential for egregious breaches.
  • Pillars of Ethics: Autonomy (true informed consent), Beneficence (do good), Non-maleficence (do no harm), Justice (fairness in selection/benefits).
  • IEC/IRB – Your Ethical Partner: Not a hurdle, but a collaborative body to ensure research integrity.
  • Informed Consent Nuances: Beyond a signature – ensuring comprehension, voluntariness, especially for vulnerable groups.
  • AYUSH Ethical Considerations: Sensitive handling of traditional knowledge, placebo rationale in Homoeopathy, ensuring community benefit.
Ethics as an Ongoing Dialogue

Ethical considerations are not a one-time approval process. They are woven into every stage of research, from conception to dissemination.

Day 1 concluded with a stimulating quiz and valuable feedback, cementing the day's rich learnings. The journey had truly begun!

Day 2: Mastering Study Design & Methodological Precision

Day two ventured into the intricate world of study architecture. We explored various research designs, the meticulous craft of protocol writing, the nuances of interventional studies, and the practicalities of operational research and sample size determination.

Choosing Your Lens: An Overview of Research Designs

Speaker: Dr. A. Vigneswari (SRMC)

Dr. Vigneswari skillfully navigated the landscape of research designs, emphasizing that the choice is dictated by the research question and feasibility.

Fundamental Choices:
  • Qualitative vs. Quantitative: Exploring "why" and "how" vs. measuring "how much" or "how often." Mixed-methods offer richness.
  • Observational vs. Experimental: Observing nature vs. actively intervening. This is a critical fork in the road.
Key Design Families:
  • Descriptive: Case Reports/Series (2+ for clinical insights, >30 for statistical software often, but context matters), Cross-Sectional (snapshot for prevalence - proportion in population at particular time vs. proportion in specific group).
  • Analytical (Observational): Case-Control (retrospective, outcome exposure, Odds Ratio), Cohort (prospective/retrospective, exposure outcome, Relative Risk – remember RR interpretation inversion in vaccine efficacy).
  • Experimental: RCTs (gold standard for causality), Quasi-experimental (when full randomization isn't feasible).
Design Selection Wisdom

No single design is universally superior. The "best" design is the one that most appropriately, ethically, and feasibly answers your specific research question while minimizing bias.

The Research Roadmap: Crafting Protocols & Concept Papers

Speaker: Dr. Premalatha

Dr. Premalatha underscored the protocol as the non-negotiable blueprint for any research endeavor.

  • Protocol's Purpose : Ensures clarity, reproducibility, ethical adherence, and serves as a guide for the entire team.
  • Essential Components: Detailed breakdown of Title, Abstract, Intro/Rationale, Objectives, Methodology (Design, Population, Sampling, Sample Size, Intervention details if any, Data Collection tools & plan, Statistical Analysis plan, Timeline/Gantt Chart is vital in methodology), Ethical considerations, Budget (if applicable), Dissemination strategy.
  • Concept Paper: The "elevator pitch" – a concise summary for initial approvals or grant feelers.
  • Golden Rule of Writing: "Clarity and Simplicity." Dr. Premalatha's advice that "80 pages is enough" for a dissertation resonated, emphasizing focus over verbosity.
Enhanced Example of a Gantt Chart for Research Timeline in a Protocol

Enhanced Example of a Gantt Chart for Research Timeline in a Protocol

Protocol as a Living Document (Initially)

While the final protocol submitted for ethical approval should be adhered to, early drafts can be iterative. However, any changes post-approval often require amendments.

Deep Dive into Interventional Study Designs

Speaker: Dr. T. Prabha (Nandha College)

Dr. Prabha focused on the robust methodology of interventional studies, particularly Randomized Controlled Trials (RCTs).

  • RCT Pillars : The trifecta of Randomization (eliminating selection bias), appropriate Control group (placebo, active, usual care), and careful Intervention manipulation.
  • Randomization Techniques : From Simple to Block (e.g., for the Helonias intervention study, block randomization ensures balanced groups over time), Stratified (for known confounders), and Cluster randomization.
  • Blinding/Masking : Single, Double, Triple-blind designs to minimize performance and detection bias. Open-label for feasibility in some contexts.
  • Clinical Trial Phases (Brief): Phase I (Safety), II (Efficacy & Dosing), III (Confirmation & Comparison), IV (Post-marketing surveillance).
  • CONSORT Statement: The essential checklist for transparent and complete reporting of RCTs.
  • Homoeopathic RCTs: Addressing challenges like individualization (pragmatic trials, n-of-1), appropriate placebo design, and defining meaningful outcomes.
RCTs: The Gold Standard (When Applicable)

For questions of therapeutic efficacy, well-conducted RCTs provide the highest level of evidence. However, their feasibility and ethical appropriateness must always be considered.

Bridging the Gap: Operational & Implementation Research

Speaker: Dr. E. Rajalakshmi (TANCAM)

Dr. Rajalakshmi introduced the crucial field of research that focuses on "making things work" in real-world public health settings.

  • The "How-To" Research : Identifying and addressing bottlenecks in delivering health interventions effectively. Moving from "does it work?" (efficacy) to "how can we make it work here?" (effectiveness/implementation).
  • Key Areas for AYUSH: Improving accessibility of Homoeopathic clinics, enhancing patient adherence to treatment, ensuring quality of AYUSH services, integrating AYUSH into mainstream public health programs.
  • Methodological Toolkit: Often employs mixed-methods (surveys, interviews, focus groups, routine data analysis), participatory action research, and quality improvement cycles (PDSA - Plan-Do-Study-Act).
  • Example Cycle: Problem Identification Solution Co-design Pilot Implementation Monitoring & Evaluation Refinement & Scale-up.
Impact-Oriented Research

Operational and Implementation Research is highly practical and aims to directly improve health outcomes by optimizing service delivery.

The Numbers Game: Sample Size Determination

Speaker: Ms. Abarna

Ms. Abarna demystified the often-daunting task of sample size calculation, emphasizing its critical role in study validity.

  • Why Size Matters : Too small = risk of Type II error (missing a real effect) & low power. Too large = resource wastage & unethical exposure of participants.

  • Key Ingredients for Calculation:
    • Desired Effect Size (clinically meaningful difference).
    • Alpha (α) level (typically 0.05).
    • Power (1-β) (typically 0.80 or 0.90).
    • Variability of the outcome measure (e.g., standard deviation).
    • Study design specifics.
  • The Logical Flow: Research Question Primary Objective Study Design Key Variables & Outcome Sample Size Calculation.
  • Helpful Tools : Software like G*Power (often demonstrated), online calculators, modules in SPSS, R.
  • Practical Considerations: Always account for anticipated dropout/attrition by inflating the initial estimate. Feasibility is paramount.
  • Quick Stats Software Recap: SPSS, SAS, R, Python, WinNonlin – each with its strengths.
Garbage In, Garbage Out (GIGO)

Sample size formulas are precise, but their output is only as good as the input parameters. Careful estimation of effect size and variability is crucial.

Day 2 equipped us with the architectural tools for robust research. The focus on practical application and real-world challenges was particularly valuable.

Day 3: Critical Appraisal, Data Mastery & Impactful Dissemination

The final day was about bringing it all together: critically evaluating existing research, managing data effectively, structuring our own dissertations, understanding the unique landscape of Homoeopathic research, and navigating the challenging yet rewarding path to publication.

Reading Between the Lines: Critical Appraisal Skills

Speaker: Dr. E. Rajalakshmi (TANCAM)

Dr. Rajalakshmi empowered us to move from passive readers to active, critical evaluators of scientific literature.

  • The "Why" of Appraisal : To assess validity (truthfulness), reliability (consistency), and applicability of research findings to our practice or further research.

  • Structured Questioning (e.g., CASP Checklists):
    • Is the research question clear and focused?
    • Was the study design appropriate for the question? (e.g., RCT for intervention efficacy)
    • Were methods to minimize bias employed (randomization, blinding)?
    • Are results clearly presented? Is the P-value interpreted correctly (probability of observed difference by chance if H0 is true)?
    • What about the Confidence Interval (CI)? (A narrow CI indicates more precise results; a wide CI suggests more uncertainty/vagueness. The range of values within which the true effect likely lies).
    • Are conclusions justified by the data? Are limitations acknowledged?
  • Recognizing Biases: Selection, performance, detection, attrition, reporting – understanding how they can skew results.
Beyond the P-value

A statistically significant p-value doesn't automatically mean clinical significance or importance. Consider effect size, CIs, and the context of the research. Is the difference meaningful in practice?

Guardians of Truth: Data Collection & Management

Speaker: Dr. Prabhu

Dr. Prabhu emphasized that meticulous data collection and management are the bedrock of trustworthy research.

Data Collection Best Practices:
  • Standard Operating Procedures (SOPs): Detailed, written instructions for all data collection steps.
  • Training & Calibration: Ensuring all data collectors are consistent.
  • Case Report Forms (CRFs): Well-designed, unambiguous forms (paper or electronic).
  • Pilot Testing: Essential for refining CRFs and procedures.
  • Quality Control: Regular checks for completeness and accuracy during collection.
Robust Data Management:
  • Data Hierarchy Clarified: Bit 8 bits = Byte Field/Column Record/Row File Database.
  • Secure Data Entry: Double data entry, validated systems (e.g., EpiData, REDCap).
  • Data Cleaning: Identifying and correcting errors/inconsistencies (range checks, logic checks).
  • Storage & Security: Secure servers, regular backups, access controls, anonymization/de-identification plans.
  • Data Dictionary/Codebook: The "metadata" – defines all variables, codes, and formats. Absolutely essential!
  • Types of Statistics: Quick recap - Descriptive (summarize) vs. Analytic (test hypotheses, explore relationships).
Data Integrity is Non-Negotiable

Errors or sloppiness in data collection/management can invalidate an entire study. Plan meticulously from the start.

The Capstone: Writing a Compelling Dissertation

Speaker: Dr. E.M. Manikgantan (TNMGRMU)

Dr. Manikgantan provided a clear roadmap for structuring and writing a successful dissertation.

  • Purpose & Audience : Demonstrating research competence, contributing original knowledge, communicating effectively to peers and examiners.

  • The IMRaD Core (and beyond):
    • Title Page, Abstract, Acknowledgements, Table of Contents
    • Introduction: Background, problem statement, rationale, research question/objectives.
    • Literature Review: Critical synthesis of existing knowledge, identifying gaps.
    • Methodology: Detailed account of design, setting, participants, sampling, data collection, tools, ethical considerations, statistical plan (written in past tense after completion).
    • Results: Objective presentation of findings (text, tables, figures) without interpretation (past tense).
    • Discussion: Interpretation of results, comparison with literature, strengths, limitations, implications, future directions.
    • Conclusion: Summary of key findings and their significance.
    • References, Appendices.
  • Writing Style: Formal, objective, precise, clear, concise. Consistent terminology. Adherence to university guidelines.
  • Practical Tips: Create a detailed outline. Write regularly. Seek feedback often from your supervisor. Edit and proofread ruthlessly. ~80 pages is a good guideline for focused work.
Tell a Coherent Story

A good dissertation flows logically, with each section building upon the previous, leading the reader clearly from the research question to the conclusions.

The Unique Terrain: Navigating Research in Homoeopathy

Speaker: Dr. Ganesh Lakshmanan (Asan memorial DC)

Dr. Lakshmanan provided invaluable, Homoeopathy-specific insights into conducting meaningful research.

Dr. Lakshmanan's "10 Rules" for Homoeopathic Researchers (Conceptual):
  1. Title Precision: Be clear, concise, and accurate. Avoid vague or sensational titles (like the example cited about penis injuries). A good title reflects the study accurately.
  2. Model Mastery: Understand your chosen research model – Clinical , Fundamental/Basic Science (essential for exploring mechanisms of action), Drug Proving (Pathogenetic Trials), Survey, Animal studies. If exploring how a remedy works, lean towards fundamental research.
  3. Relevance & Feasibility First: Ensure your study addresses a significant question in Homoeopathy and is practically achievable with available resources.
  4. Logical Sample Sizing: Define your target population, inclusion/exclusion criteria with clarity. Use tools like G*Power for calculation, don't just guess.
  5. Statistical Savvy: Know your tools (SPSS, R, GraphPad Prism) and, more importantly, which statistical tests are appropriate for your data and research question.
  6. Unyielding Ethics & Plagiarism Prevention (RIPE - Research Integrity and Publications Ethics): Adhere to all ethical guidelines (Turnitin, Urkund, Viper, iThenticate for plagiarism checks). Follow CPCSEA guidelines for animal ethics. Misconduct includes Fabrication and Falsification of data.
  7. Reference Rigor: Use reference managers (RefDB, PapersOnline, RefWorks, CiteULike, Qiqqa, EndNote, Zotero, Mendeley). Master citation styles (APA often preferred, then convert to Vancouver or Chicago). Differentiate primary vs. secondary citations.
  8. Strategic Publication: Target appropriate, indexed journals. Homoeopathy-specific: Homoeopathy (Thieme), Journal of Alternative and Complementary Medicine (JACM), British Homoeopathic Journal (historical, now Homoeopathy), Indian Journal of Research in Homoeopathy (IJRH). Beware of cloned/predatory journals (check Elsevier, SciMago, Nature Index).
  9. Funding Awareness: Product-oriented research often attracts more funding. Explore government schemes (AYUSH, ICMR). Pilot study data significantly increases chances of securing larger grants.
  10. Anticipate & Plan for Challenges: Homoeopathy is a "One Health" medicine applicable to humans, animals, plants, soil, fish. However, anticipate issues like hypoglycemic rat death (plan monitoring), patient dropout (increase initial sample size). Consider all possibilities in study conduct and paper writing.
Homoeopathy Research: Adapting, Not Compromising

The challenge lies in adapting established research methodologies to suit the unique principles of Homoeopathy (like individualization, high dilutions, holistic assessment) without compromising scientific rigor.

From Manuscript to Impact: The Publication Journey

Speaker: Dr. M.S. Shreedevi (MD (Siddha), PhD)

Dr. Shreedevi demystified the often-intimidating process of getting research published.

Crafting a Publishable Manuscript:
  • IMRaD Structure: The gold standard for original research articles (Introduction, Methods, Results, and Discussion). Write in past tense for methods and results.
  • Compelling Title & Abstract: Your "shop window" – make them accurate, concise, and keyword-rich.
  • Clarity in Tables & Figures: Self-explanatory, well-labeled, and referenced in the text.
  • References: Prefer recent (past 5 years ideally) papers from indexed journals. Cite any modifications made to standard SOPs.
  • Types of Articles: Original Research, Systematic Reviews/Meta-Analyses, Case Reports, Short Communications, Letters to the Editor, Editorials, Perspective/Opinion pieces.
Navigating Submission & Ethics:
  • Journal Selection: Align scope with journal's aims. Check indexing (PubMed, Scopus, Web of Science). Impact factor is one metric, but relevance is key.
  • Author Guidelines: Follow meticulously to avoid desk rejection.
  • Professional Cover Letter: Briefly highlight significance and fit.
  • Peer Review: Understand the process. Respond constructively to reviewer comments.
  • Publication Ethics (COPE Guidelines): Committee on Publication Ethics. Avoid FFP (Fabrication, Falsification, Plagiarism). Ensure proper authorship (ICMJE criteria). Declare conflicts of interest. Avoid ghost or gift authorship.
Persistence Pays Off!

Rejection is common in academic publishing. Don't be discouraged. Learn from feedback, revise, and resubmit (to the same or another journal).

A Journey of a Thousand Miles...

This intensive three-day workshop was more than just an academic exercise; it was a catalyst. The knowledge imparted, the tools shared, and the discussions fostered have profoundly reshaped my understanding and approach to research in Homoeopathy. It has equipped me not just with methods, but with a mindset of critical inquiry, ethical responsibility, and a passion for contributing meaningfully to our field. The path of research is long, but this workshop has illuminated the way forward.

A final Post Test and Feedback session marked the formal close, but the learning and inspiration will undoubtedly continue.

Gallery

MD scholar waiting in Lecture Hall

MD scholar waiting in Lecture Hall

Entrance of the event place

Entrance of the event place

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