What is the protocol for conducting a case series study?

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Last updated: May 16, 2025View editorial policy

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From the Guidelines

To conduct a case series, it is essential to start by identifying a specific clinical condition or treatment outcome and defining clear inclusion criteria for patient selection, as outlined in the study by 1. When conducting a case series, the following steps should be taken:

  • Identify a specific clinical condition or treatment outcome to study, as recommended by 1.
  • Define clear inclusion criteria for patient selection, ensuring that the cases are similar and relevant to the study, as suggested by 1.
  • Collect comprehensive data from medical records, including patient demographics, medical history, treatments received, and outcomes, while ensuring proper ethical approval and patient consent, as emphasized by 1.
  • Aim for at least 3-10 cases that demonstrate a pattern or notable clinical feature, as illustrated in the study by 1.
  • Organize findings systematically, looking for common characteristics, treatment responses, or unusual presentations across cases, and consider using a checklist, such as the one provided by 1, to ensure that all necessary information is included.
  • When writing the report, include detailed case descriptions, highlight patterns or unique features, discuss implications for clinical practice, and acknowledge limitations, such as selection bias and lack of a control group, as noted by 1.
  • The study by 1 provides a comprehensive checklist for reporting tumor pathology research, which can be adapted for use in case series studies, and it is recommended to follow this checklist to ensure that all necessary information is included. Key considerations when conducting a case series include:
  • Ensuring proper ethical approval and patient consent, as emphasized by 1.
  • Using a study protocol, as recommended by 1, to outline the plans and methods for the study.
  • Piloting the study to identify any potential issues or oversights, as suggested by 1.
  • Considering the use of a checklist, such as the one provided by 1, to ensure that all necessary information is included.
  • Being aware of the limitations of case series studies, including selection bias and lack of a control group, as noted by 1.

From the Research

Conducting a Case Series

To conduct a case series, several key principles should be considered:

  • A case series is a descriptive study that follows a group of patients with a similar diagnosis or undergoing the same procedure over time 2, 3
  • The study should have a clearly defined study question, a well-described study population, and a well-described intervention 3
  • Validated outcome measures should be used, and appropriate statistical analyses should be performed 3
  • The results should be well-described, and the discussion and conclusions should be supported by the data presented 3

Design and Analysis

When designing and analyzing a case series:

  • The study should be representative of a common clinical population, as surgeons and patients decide on treatment allocation 2
  • The study can generate hypotheses for further studies, including randomized controlled trials, but no causal inferences should be made regarding treatment efficacy 2
  • A case series should have more than four patients, while four patients or less should be reported individually as case reports 4

Reporting and Quality

To ensure high-quality case series reports:

  • Authors and journal editors should address draft characteristics such as a clearly defined study question, a well-described study population, and well-described intervention 3
  • Funding sources should be acknowledged, and the discussion and conclusions should be supported by the data presented 3
  • The quality of the research literature can be improved by critically examining study designs and providing guidance to investigators and authors 3

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

How to design a good case series.

The Journal of bone and joint surgery. American volume, 2009

Research

Clinical "case series": a concept analysis.

African health sciences, 2012

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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