Good — final year, aiming for publication or presentation. That changes things meaningfully. You can be more ambitious than a basic portfolio piece, but the project still needs to be something *you* can realistically execute on a clinical attachment. Here is a scaled, publishable version: --- # Quality Improvement Project ## **Adherence to Evidence-Based Breast Tumour Marker Testing at Initial Diagnosis: A Clinical Audit in an Oncology Outpatient Setting** **Project Type:** Prospective/Retrospective Clinical Audit **Specialty:** Oncology — Breast Cancer **Setting:** Oncology outpatient clinic or breast MDT, single centre **Estimated Duration:** 6–8 weeks data collection; 2–3 months full write-up **Student Role:** Data collector, analyser, presenter, first/co-author --- ## 1. Background Breast tumour markers are essential tools in guiding treatment decisions for breast cancer. Current guidelines — including the ESMO Clinical Practice Guideline (2024) and ASCO-CAP (2023) — mandate that **all newly diagnosed breast carcinomas** should have ER, PR, HER2, and Ki-67 assessed at diagnosis before any treatment planning. These four markers collectively determine: - Eligibility for endocrine therapy (ER/PR positive) - Eligibility for anti-HER2 therapy (trastuzumab, pertuzumab, T-DXd) - Chemotherapy intensity (Ki-67 proliferation index) - Prognostic subtype (Luminal A/B, HER2-enriched, Triple Negative) Despite clear guidance, real-world studies and local experience suggest that documentation of these results in clinical notes at the time of treatment planning is inconsistent. Missing or delayed biomarker results can delay treatment initiation or lead to suboptimal therapy selection. A secondary issue is the inappropriate ordering of **serum tumour markers** (CA 15-3, CEA) for primary diagnosis or screening — a practice not supported by ASCO or ESMO guidelines, which recommend serum markers only for monitoring response in established metastatic disease. --- ## 2. Aim > *"To audit whether patients with newly diagnosed breast cancer discussed at the oncology MDT or seen in clinic have a complete, documented tissue biomarker panel (ER, PR, HER2, Ki-67) available at the time of initial treatment planning, and to identify whether serum tumour markers (CA 15-3, CEA) are being ordered appropriately."* --- ## 3. Standards (Audit Criteria) | # | Standard | Source | Target | |---|---|---|---| | 1 | ER status documented before treatment planning | ESMO 2024, ASCO-CAP 2023 | 100% | | 2 | PR status documented before treatment planning | ESMO 2024, ASCO-CAP 2023 | 100% | | 3 | HER2 status documented before treatment planning | ESMO 2024, ASCO-CAP 2023 | 100% | | 4 | Ki-67 documented before treatment planning | ESMO 2024 | 95% | | 5 | HER2 FISH/ISH performed when IHC is 2+ (equivocal) | ASCO-CAP 2023 | 100% | | 6 | CA 15-3 / CEA only requested for monitoring in metastatic disease (not for screening/primary diagnosis) | ASCO Tumour Marker Guidelines | 100% appropriate indication | --- ## 4. Method ### Data Collection - **Sample size:** 30–50 consecutive newly diagnosed breast cancer patients discussed at MDT or seen in oncology clinic during your attachment - **Data source:** Electronic patient records / MDT records / pathology system - **Design:** Retrospective case note review (no patient contact needed — this usually avoids formal ethics approval and falls under local clinical audit registration) ### Data Points to Record (per patient, anonymised) - Age, tumour stage (I–IV) - Date of pathological diagnosis - Date of MDT/first oncology clinic - ER documented: Yes / No / Date - PR documented: Yes / No / Date - HER2 IHC documented: Yes / No / Date - HER2 FISH performed (if IHC 2+): Yes / No / N/A - Ki-67 documented: Yes / No / Date - Serum CA 15-3 ordered: Yes / No → if yes, documented indication: Monitoring / Screening / Primary diagnosis / Unclear - Serum CEA ordered: Yes / No → if yes, documented indication - Interval from biopsy to full biomarker panel available (days) - Treatment decision documented: Yes / No ### Tool Design a simple **data collection proforma** (spreadsheet) — one row per patient, one column per standard. --- ## 5. Analysis This is straightforward and manageable without specialist statistics: - **Descriptive statistics:** Percentage compliance for each standard, presented as bar charts - **Turnaround time:** Mean and range of days from biopsy to complete biomarker result - **Appropriateness of serum markers:** Frequency table of indication categories - **Gap analysis:** Which standard shows the lowest compliance? Which patient subgroup is most affected? No statistical software needed beyond Excel or SPSS. For a publishable piece, a simple table + run chart showing compliance across the audit period is sufficient. --- ## 6. Expected Findings (Based on Literature) From the 2025 EQA harmonisation study (Van Rossum et al., *Clin Chem Lab Med*) and ESMO 2024: - ER/PR/HER2 documentation is generally high in well-organised centres but Ki-67 and FISH reflex rates are more variable - Serum CA 15-3 over-ordering for non-metastatic patients is a recognised problem in several audits - Turnaround time gaps are common when IHC and FISH are processed by different laboratories Whatever you find, **any deviation from 100% compliance** is a valid finding worth reporting and recommending improvement for. --- ## 7. Recommendations (to Generate from Your Findings) You will formulate these based on your results, but likely candidates include: 1. Implement a **standardised pathology request form** that automatically includes ER/PR/HER2/Ki-67 as a bundle for all breast core biopsies 2. Introduce a **MDT checklist item** — "Complete biomarker panel available? Y/N" — before treatment decisions are recorded 3. Develop a **departmental guideline** for serum marker ordering with clear indication criteria 4. Feed findings into the **oncology governance/audit meeting** as a change recommendation --- ## 8. Pathway to Publication or Presentation | Venue | Suitable For | |---|---| | **Local hospital audit day / grand round** | First step — present findings to department | | **Medical student conference** (e.g. BMJ Student, AMSA, national oncology student events) | Abstract + poster/oral presentation | | **BASO – The Association for Cancer Surgery annual meeting** | Audit/QI abstract submission | | **Clinical Oncology / EJSO / BMJ Open Quality** | Written audit report (case note audit with recommendations) | | **BMJ Open Quality** | Specifically designed for QI reports; student-led audits are regularly published here | For publication, you will need a **consultant/registrar supervisor as co-author** who can verify data access and governance registration. This is standard and expected. --- ## 9. Ethical Considerations - Register the project with the **local clinical audit department** (not formal ethics — case note review is audit, not research in most jurisdictions) - All data must be **anonymised** (use a patient ID number, never name or NHS/hospital number in your spreadsheet) - Store data on a **trust-approved, password-protected** system — not personal devices or personal email - Confirm data access permission with your clinical supervisor before starting --- ## 10. Why This Project Works for a Final-Year Student | Feature | Why it matters | |---|---| | **No patient contact required** | Simpler governance; no consent issues | | **Achievable in one placement** | 6–8 weeks is sufficient for 30–50 cases | | **Clinically meaningful** | Directly tied to treatment outcomes; supervisors take it seriously | | **Guideline-anchored** | ASCO/ESMO 2024 standards give you solid, citable benchmarks | | **Publication-ready format** | Fits BMJ Open Quality / conference abstract format exactly | | **Demonstrates QI literacy** | Shows audit cycle awareness, not just data collection | --- ## Quick Summary — What You Need to Do 1. **Week 1:** Register with local audit department; get supervisor sign-off; build your data collection spreadsheet 2. **Weeks 2–7:** Collect anonymised data from 30–50 case notes 3. **Week 8:** Analyse, produce bar charts, calculate compliance rates 4. **Week 9–10:** Write up findings + recommendations; present at local audit meeting 5. **Month 3:** Submit abstract or manuscript to a suitable journal/conference Based on this QI idea, can you make a presentation to present the idea to a supervising consultant

what is meant by MDT