Case Studies / Systematic review and meta-analysis: epidemiology of in…
Medical Affairs Evidence Generation Infectious Diseases

Systematic review and meta-analysis: epidemiology of invasive mycosis in immunocompromised patients

Challenge
The epidemiological evidence base for invasive fungal infections in immunocompromised patients was fragmented across heterogeneous studies — making it impossible to present a coherent incidence picture to payers and clinicians.
Approach
Designed and conducted a full systematic review with pre-registered protocol — database searches, screening, data extraction, quality assessment, and meta-analysis — through to peer-reviewed publication.
Result
Published in a peer-reviewed infectious disease journal; widely cited and incorporated into national guideline documents.
The challenge

Fragmented evidence was undermining the brand's epidemiological argument

Invasive fungal infections represent a significant and underappreciated cause of morbidity in immunocompromised patient populations — but the published epidemiological literature was inconsistent. Studies varied in design, patient populations, diagnostic criteria, and outcome definitions, making it difficult to synthesise a coherent picture of disease burden.

For a brand in the antifungal space, this fragmentation had direct consequences. Payer bodies and guideline committees asked for epidemiological data to support the product's positioning, and the brand's Medical Affairs team was unable to point to a single authoritative source. Individual studies could be cited, but each came with significant caveats about generalisability.

When the evidence base is fragmented, you cannot wait for someone else to synthesise it. A methodologically sound systematic review becomes the scientific foundation your entire market access argument rests on.

The solution was to create that authoritative source — a pre-registered systematic review with meta-analysis that would become the standard epidemiological reference for the condition.

Our approach

What we did

1
Protocol design and registration
Developed a detailed PICO framework defining patient population (immunocompromised adults), intervention (invasive mycosis diagnosis), comparators, and outcomes. Registered the protocol on PROSPERO before searches began.
2
Systematic database searches
Conducted searches across PubMed, EMBASE, Cochrane, and four additional databases. Applied validated search strings, documented in PRISMA format.
3
Screening and data extraction
Two independent reviewers screened titles and abstracts, then full texts, against pre-specified inclusion criteria. Extracted data from all included studies using a standardised extraction form.
4
Quality assessment and heterogeneity analysis
Applied Newcastle-Ottawa Scale for observational studies. Conducted I² analysis to quantify heterogeneity before proceeding with pooled estimates. Performed subgroup analyses by patient population and diagnostic method.
5
Statistical analysis and manuscript preparation
Calculated pooled incidence estimates with 95% confidence intervals. Prepared the manuscript to journal guidelines, incorporating two rounds of co-author review before submission. Supported the peer review response process.
Result

Measurable impact

The systematic review was accepted by a peer-reviewed infectious disease journal after one round of revisions. The paper was subsequently cited in national guideline documents and HTA submissions across Europe. The Medical Affairs team adopted it as the primary epidemiological reference in all payer-facing materials.

Rigorous
evidence synthesis
Multiple databases searched; studies screened and quality-assessed
Widely cited
after publication
Incorporated into national guideline documents and HTA submissions
National guidelines
updated
Paper's incidence estimates incorporated into guideline documents
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// Query: ribociclib OS data MONALEESA 2023–24
search("ribociclib overall survival", {
  years: [2023, 2024],
  output: "structured_table"
})
// 847 records → 23 relevant
Processing 847 records...
Evidence Summary
MONALEESA-2 updated OS (NEJM 2023): median OS 63.9 mo vs 51.4 mo (HR 0.76, 95% CI 0.63–0.93). Benefit maintained across all pre-specified subgroups...