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:
- What is the difference between a clinical study and a case report?
- Who can observe and document the results of a clinical study?
- 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.
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.
The process of writing a case study. The structure of the paper.
People who work in business, marketing, social sciences, legal, medical, engineering, academic, and many other fields quite often need to submit reports about a person, a group of people, or a situation that they have been studying over a certain period of time. Such a published report is called case study, and in order to write good case studies one should follow specific guidelines because they have a particular style and format.
Is There Any Difference between Essay and Case Study?
You might be already familiar with essay writing. Essays differ from case studies because they answer a certain question based on research through the author’s own evaluation. Reports, in turn, present and analyze findings from practical research. While reports are usually descriptive and describe sequential events such as experiments or results from surveys, essay can be descriptive, evaluative, and discursive. The type of the essay depends on the given questions.
Because case studies are educational for readers, they have to provide information as clear as possible. The structure of this writing should be as follows:
The title should give a very accurate description of a study. It has to be very effective because its function is to let readers know what the main focus of the study is.
Since it is not a scientific paper, the abstract in this writing does not have a structure, i.e. no subheadings of methodology, conclusions, etc. You need to give a background which has to outline, for instance, the clinical condition of the study under analysis. Then you need to provide relevant details and results of the study and give an overall conclusion. The final step is to give five key words.
In this section you need to provide a brief review of the published literature relevant to your subject. The best kind of articles to use here are other review articles and the first case that was described in the literature.
If you are working in the field of medicine, for example, in this part you write about your patient’s health issues, treatment, and laboratory results. All the data has to be presented in chronological order and in figures or tables. Research ethics is crucial: your patient cannot be identified anywhere in the study. If a photo is necessary, your patient has to sign a written consent. To publish your writing you have to contact the primary care physician and come to an agreement.
In this section one presents the case and the laboratory findings. An author’s job is to relate his/her findings to the previous studies and, in case they differ, make it clear what is the reason of this difference and what your scientific opinion is. The question you should answer here is why your paper is unique.
Make a summary of what you have learnt from your study. Do not repeat the case history; just give short and informative conclusions.
If there are people who have assisted you in your study but are not co-authors, make sure to acknowledge them.
You can use only reliable sources in this section such as peer-reviewed scholarly articles. Make sure that the entire reference is accurate according to the style – MLA, APA, etc.
Tables and Figures
If you have a lot of data that you cannot mention in the discussion section, put it to tables and figures and locate them in this section of your writing. Adding tables and photographs is a great strategic decision because it makes the writing more informative and comprehensible.
Are People Taught Case Study Writing?
This type of writing is rather popular in education system and quite often happens to be a student assignment. This project is very helpful in school/university because it allows students to apply their knowledge in practice. For example, students who take courses in psychotherapy or physiology can put themselves in the role of professionals and examine how certain method can be applied to the person in the story and how your case management and counseling skills can help the client.
Not only can students pay more attention to the development of their technical writing skills, but also they can demonstrate their individual approach to a specific issue. Although teaching how to write a case study requires a lot of time, students need training in this field because the process of the case study writing is complex. A good guide will help them learn how to use their analytical skills to make a better work. Besides, you can always mention this skill during the interview with the company you want to work for.
What Is the Case Study Method?
If you are a student in a law school or are planning to get your MBA, Harvard University has prepared a lot of extremely helpful tips on case study writing for current and prospective students. For instance, Harvard Law School presents the difference between case study method and case method. While the first method uses a narrative of a legal dilemma to showcase the principles of law, the second one uses a court decision for the same purpose. The case study method requires teamwork and discussion between the participants whereas the case method uses the discussion between professor and student. Finally, the case study method analyzes the dilemma in its developments while the second method analyzes it after it has been resolved.
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