How to write Pathology Protocol?

Introduction
A Pathology Protocol (also called a Pathology Synopsis) is a structured plan for an MD, MS, or DNB thesis that outlines your study’s objectives, scope, and methods in investigating disease processes or tissue changes. A well-crafted Pathology Protocol guides your research steps and secures institutional approval.

1. Introduction to the Topic

• Define the disease, lesion, or pathological parameter under investigation (e.g., grading of dysplasia, biomarker expression).

• Specify the clinical or academic context (surgical specimens, biopsies, autopsies).

• Use both “Pathology Protocol” and “Pathology Synopsis” to refer to your document.

2. Demographics & Prevalence

• Identify the patient population (age range, sex distribution, geographic factors) and cite recent prevalence data.

• Highlight why this pathology warrants investigation in your Pathology Protocol.

3. Gap in Existing Knowledge

• Summarize current understanding of the pathological entity and pinpoint unanswered questions (e.g., variability in marker expression).

• Explain how your Pathology Synopsis will fill these knowledge gaps.

4. Need and Rationale for Study

• Explain why this research is important for postgraduate training (MD, MS, DNB) and patient care.

• Describe limitations in current diagnostic criteria or grading systems.

• State potential impact on reporting standards, therapeutic decisions, or further research.

• Mention alignment with national or global pathology guidelines, if applicable.

5. Review of Literature

• Historical Background: trace key developments in the pathology of your topic.

• Current State of Knowledge: summarize recent peer-reviewed studies, staining techniques, and molecular assays.

• Key Findings: highlight methodologies (e.g., immunohistochemistry, PCR) and major results.

• Gaps in Literature: identify what existing Pathology Synopses have overlooked.

• Relevance: show how your Pathology Protocol builds on and extends prior work.

6. Lacunae in Literature

• List specific shortcomings or under-explored areas (e.g., lack of standardized quantification).

• Explain how your Pathology Synopsis addresses each lacuna.

7. Materials and Methods

• Source of Samples: biopsy specimens, surgical resections, autopsy tissues, cell blocks, or archives.

• Study Design: cross-sectional, case-control, retrospective, prospective—state clearly in your Pathology Protocol.

• Study Population: define inclusion and exclusion criteria (e.g., confirmed diagnosis, adequate tissue preservation).

• Study Period: precise start and end dates (mm/yyyy–mm/yyyy).

• Sample Size Calculation: present the formula, parameters (expected effect size or prevalence, α, power), and final number.

• Methodology: step-by-step description of tissue processing, staining protocols, and scoring systems.

• Statistical Analysis: specify software, statistical tests (chi-square, Kaplan–Meier survival analysis, logistic regression), and significance level (p < 0.05).

8. Ethical Considerations

• Informed Consent: procedures for obtaining written consent or waiver (for archival samples).

• Confidentiality: anonymization of patient identifiers and secure data storage.

• Risk Minimization: safety protocols for handling biohazards and chemicals.

• Ethics Committee Approval: name of the Institutional Review Board and approval ID.

9. Limitations of the Study

• Sample Constraints: limited availability of quality tissue or small case numbers.

• Technical Variability: inter-observer scoring differences and assay reproducibility.

• Selection Bias: referral patterns or retrospective design limitations.

• Generalizability: applicability of findings beyond your institution or population.

10. Annexures

• Consent Form: template documenting patient permission for use of tissue and data.

• Patient Information Sheet: clear summary of study aims, procedures, risks, and benefits for participants or their guardians.

• Data Collection Form: structured sheet for recording demographics, clinical details, gross and microscopic findings consistently.

Conclusion
A concise Pathology Protocol (Pathology Synopsis) tailored for MD, MS, and DNB postgraduate students meets academic standards and provides a clear framework for conducting and presenting your research. Cover each section above thoroughly to ensure scientific rigor, originality  and clarity.