Case Reports Vs Clinical Studies

This post discusses questions validity if authored by an employee of the reporting company, Roho. This blog will answer these questions regarding clinical studies and clinical evidence:

  1. What is the difference between a clinical study and a case report?
  2. Who can observe and document the results of a clinical study?
  3. What circumstance would beg questioning the validity of a case report?

(Information below was take from the site clinical trials .gov a service of the National Institute of Health)

Definition of case report and clinical study

In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence.

The case report is written on one individual patient.

Clinical Study

A research study using human subjects to evaluate biomedical or health-related outcomes. Two types of clinical studies are Interventional Studies (or clinical trials) and Observational Studies. A clinical study involves multiple patients.

Observational Clinical Studies have a qualified investigator.

In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions (which can include medical products such as drugs or devices) or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial).

The Key Responsibilities of a Clinical Study Investigator:

  • Be qualified to practice medicine or psychiatry and meet the qualifications specified by applicable national regulatory requirements(s)
  • Be qualified by education, training, and experience to assume responsibility for the proper conduct of the study,
  • Be familiar with and compliant with Good Clinical Practice (GCP) ICH E6 Guideline and applicable ethical and regulatory requirements prior to commencement of work on the study.
  • Provide evidence of his/her qualification using the Abbreviated  TransCelerate Curriculum Vitae (CV) form

The internal validity of a medical device case report is questioned if bias is present. One must consider bias in a case report authored by an employee of the company that makes the device described in the report.

These are the facts on clinical studies published on the roho website. 

  • There are 15 of what roho calls clinical studies on the roho website.  Based on the above definitions, these are not clinical studies but rather case reports. 
  • Of these 15 case reports only one pertains a seat cushion improving a pressure ulcer.

This one single case report is written by Cynthia Fleck, an employee of crown therapeutics which is a division of roho

After selling 1 million cushions over the span of 45 years in business roho has exactly 1 case report which was written by an employee of roho which then begs the question of validity of this report.

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