Defining what a document is for
A document’s purpose is the outcome it should achieve, the contribution it makes and the essential information its readers need to reach the intended decision.
The intended outcome
Sound science and polished language do not guarantee successful communication: a document should convey the intended messages to its target audience and achieve the desired outcome. Before drafting, the writer should establish why the document is needed beyond the fact that it has been requested and what needs to be said.
The document’s nature and purpose determine how writing proceeds. Medical and drug-development documents include investigational new drug applications, investigational medicinal product dossiers, investigator’s brochures, study protocols, study reports, the Common Technical Document and journal publications.
The required outcome determines a document’s content and format. Examples include regulatory approval of a marketing submission, journal acceptance of a paper and an investigator’s brochure that supports the conduct of a good clinical study by the investigator and staff.
Significance and relevance
For a publication, significance concerns whether the work says something new that has not already been said, perhaps better. Relevance concerns the professionals and patients who might benefit from it. Both the writer’s time and the audience’s reading time make the contribution worth establishing before committing to a project.
A routine report of 100 appendicitis cases may add little, whereas a new technique for acute retrocecal appendicitis offers a more distinctive contribution. Similarly, reporting the diagnoses of the next 1,000 patients seen in a practice may offer little, while following 1,000 patients presenting with pelvic pain to their definitive diagnoses could interest generalists and gynaecologists.
An observed dislike of milk among patients with peptic ulcer disease interested one physician, but colleagues’ indifference led him to abandon a proposed study of it.
The essential message
The key messages should convey the essential information needed to convince the responsible people to make a decision consistent with the intended outcome. Key data may determine the messages, and the arguments need supporting messages that carry what must be said.