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Clinical Audit and Risk Stratification in Toxic Epidermal Necrolysis (TEN)

Project type

A REDCap and R-Based Mortality Review at KNH

Date

2025

Role

Biostatistician

This project was a clinical audit conducted at Kenyatta National Hospital (KNH) to evaluate the presentation, risk profiles, management, and outcomes of patients diagnosed with Toxic Epidermal Necrolysis (TEN) in March 2025. TEN is a rare but critical dermatological emergency, commonly drug-induced, with high rates of morbidity and mortality.

Using REDCap for structured data capture and R Studio for data cleaning, visualization, and statistical analysis, this project assessed 19 confirmed TEN cases to uncover actionable insights for clinical improvement, focusing on severity scoring (SCORTEN), drug causality, complications, and outcome prediction.

Objectives:
Describe demographic and clinical patterns in TEN patients

Identify commonly implicated drugs

Evaluate outcomes based on SCORTEN scores and comorbidities

Investigate complications and interventions used

Propose data-driven recommendations for clinical protocol enhancement

Methods & Tools:
Study Design: Retrospective clinical audit

Data Source: REDCap-based collection of 19 de-identified patient records

Tools Used:

R (tidyverse, janitor, ggplot2) for cleaning, visualization, and analysis

REDCap for structured clinical data entry

Variables Analyzed: Age, sex, BSA involvement, drug exposure, comorbidities (e.g., HIV, DM), SCORTEN score, interventions, and outcome

Key Findings:
📌 Demographics & Presentation
Median age: 29 years (range: 1–44); TEN affects even young adults

Gender distribution: Balanced; no strong sex-based predisposition

Classical TEN features: Widespread erythema, blistering, mucosal involvement

📌 Causative Drugs
Most implicated: Antibiotics (sulfonamides, penicillins) and anticonvulsants (phenytoin, carbamazepine)

Minor cases involved NSAIDs and antivirals

📌 SCORTEN & Risk Stratification
Higher SCORTEN scores (>3) were strongly associated with mortality

HIV-positive patients had notably worse outcomes

SCORTEN confirmed as a valuable predictive tool for triage and ICU referral

📌 Complications
Most common: Infections (due to skin barrier loss), ocular damage, GI bleeding

Visual complications pose long-term risks

Complication rates correlated with higher SCORTEN and late presentation

📌 Management Practices
Standard supportive care included IV fluids, analgesia, wound care

IVIG and systemic corticosteroids used variably; early administration linked to better outcomes

Highlighted need for standardized TEN protocols

📌 Outcomes
Most patients survived; fatalities were tied to SCORTEN >3, HIV, and BSA >30%

Older non-survivors noted, but age alone wasn’t a dominant predictor

Mortality partly preventable with earlier escalation to ICU and aggressive care

Recommendations:
Systematic SCORTEN scoring at admission for all suspected TEN cases

Strengthen drug allergy documentation and risk screening

Standardize TEN care protocols including early use of IVIG/steroids

Enhance access to multidisciplinary teams (dermatology, ophthalmology, ICU, ID specialists)

Institutionalize regular mortality audits using tools like REDCap + R

Impact:
This audit demonstrated the value of structured clinical data collection and statistical analysis in improving care for rare, high-risk conditions. It showcases your ability to:

Design and execute a hospital-based clinical audit

Integrate REDCap and R for meaningful clinical insights

Interpret risk models (SCORTEN), visualize outcomes, and recommend systemic improvements

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