Real World Data Request Example 2

Example Request number 2

Neoadjuvant Systematic Anti-Cancer Treatment (SACT) for HER2+ early BC

Question

The question should ultimately describe the question you’re trying to answer and should be focused enough to give the reader a meaningful understanding of the population, intervention (+/- comparators) and outcomes of interest. These categories will then be developed further in the objectives and the PICO overview.

“What systemic anti-cancer treatment regimens are commonly used in the neoadjuvant treatment of patients with early HER2+ breast cancer?”

Objectives

This should provide a greater level of detail and context which helps the reader understand what you are hoping to get out of the research.

  • To describe the patient and disease characteristics of patients receiving neoadjuvant therapy for HER2+ early breast cancer (eBC)
  • To report the different neoadjuvant regimens administered to eligible patients receiving first treatment in the years 2015 – 2016
  • To describe the top 5 most frequently administered chemotherapy +/- targeted therapy regimens (by proportion of the total population)
  • To report the distribution of patients receiving 1-2; 3-4; 5-6; >6 cycles of systemic neoadjuvant therapy
  • To describe the proportion of patients undergoing different types of surgery for breast cancer (e.g. breast-conserving surgery; mastectomy) following neoadjuvant therapy for HER2+ eBC

PICO framework

This is where you can give in-depth details that will define the different characteristics of the analysis. The more detail, the better, as it allows you to clearly state out what characteristics the patient cohort should have, what interventions are/aren’t relevant, and what outcomes will need to be extracted in order to answer the research question.

Category (P/I/C/O) Details
Population of interest (P) –          Female or male patients

–          Diagnosis of early breast cancer (e.g. ICD10 code: C50.xxx)

–          Diagnosed within set time period (e.g. 1st Jan 2015 – 31st Dec 2016)

–          HER2+ status confirmed (includes IHC3+ and/or ISH≥2.0, if available)

–          Underwent surgery for primary breast cancer (e.g. breast-conserving surgery; mastectomy) within 9 months of diagnosis

–          No recorded diagnosis of metastatic disease between time of eBC diagnosis and time of surgery

Intervention (I) –          At least 1 recorded dose/cycle of any systemic anti-cancer therapy comprising chemotherapy, targeted therapy, or multi-drug combinations of the two
Comparator (C) Not applicable
Outcomes (O)  

Any of:

–          Patient demographics and disease characteristics (e.g. age, gender, ethnicity, hormone receptor status, TNM status/breast cancer stage, HER2 status, time from diagnosis to first anti-cancer treatment, time from diagnosis to surgery)

–          Systemic anticancer treatment regimen received

–          Duration/number of cycles of systemic anti-cancer treatment

–          Use of concomitant hormone therapy

–          Type of surgery conducted (e.g. mastectomy, breast conserving surgery).

 

Outcomes to be reported at an aggregate level using summary statistics.

 

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