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Regulatory and Medical Writing, A Consultant’s Perspective – Part 4 - Narratives

Narratives can be most strongly influenced by the skilled medical writer. Different sections of our writing have very clear needs and require specific approaches.


Typing on keyboard

The introductory paragraphs should answer the following:


  • What is the problem?

  • Why is it important?

  • What solution do you propose?


Introductions should describe the problem or the disease or the symptom that is being investigated, providing context to the study through summary of important relevant research or definition of key terms.  They should move from general to specific so there is a clear link between the ‘real world’ problem, and the research to be described.


Introductions should provide a rationale for the research – is there an unanswered question, an untested population, an untried method.  Engage the reader where possible by answering questions like “Why should I care?”  Introductions should set the stage for further discussion through the clear statement of a hypothesis, a question, or a justification.


Always try not to get lost in reviewing background information.  The introduction is meant to introduce the reader to your research and not to summarize and evaluate all past research on the subject.  Many references you may be tempted to include in your introduction are better saved for the discussion where they can become a powerful tool for comparing and interpreting your results.  Include only enough background information to allow your reader to understand why you are asking the questions you are and why your hypotheses are reasonable.


Descriptions of methods and materials are typically overwritten unless you are specifically documenting a single experiment.  In summaries of several studies or a research program, many of us fall prey to that format we became familiar with in school wherein long lists of apparatus and experimental steps serve only to pad a report while providing little of relevant interest to the reader.  These sections are not meant for the reader to repeat that full experiment but rather they can consider the key aspects of the study.  Consider the following sentences:


First, the frog muscle was removed and then Ringer’s solution was poured on it.  Next the immersed frog muscle was attached to a kymograph.


Or


The frog muscle was removed and Ringer’s solution was added to prevent it from drying out.  The muscle was attached to a kymograph in order to determine the minimum voltage required for contraction.


Not only have the methods and materials been described but their ultimate purpose in answering the overall question has been presented.


Another example would be descriptions of inclusion and exclusion criteria in a clinical study.  Apart from a set study report which requires full detail, a summary of its results would focus on the objectives or end points of the study itself.  If a study were assessing the effects of a drug on blood pressure, then a summary of the population’s age, weight, prior study participation, etc. does not add to the reader’s knowledge.  The patient’s cardiac history or cholesterol levels would provide a much clearer picture.  In other words, do not focus on the common but rather the uncommon.


Results and discussion are the most important parts of any report or summary.  Clearly, medical research produces mountains of data much of which may not add to a reader’s overall interpretation of the results.  The data should be digested and condensed with important trends described.  The results should present the knowledge that is being contributed to the world.


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Betty Cory

Author: Betty Cory, President

Regxia Inc.

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