Clinical Research A Primer for Ophthalmologists

s of clinical research papers published in major ophthalmology journals are rigorously structured summaries of the important issues one needs to consider in planning and reporting a research project. In essence, the reader needs to know, and the abstract needs to tell them, what was done, why it was done, and what the clinical implications of the findings might be. The rest is “commentary”. NOTE: the examples below are entirely hypothetical! 1. Statement of the problem (and the question being addressed). The first section of an abstract generally includes two important statements (even if they are sometimes combined into a single sentence): “what is the specific question the research was meant to answer?” (e.g., the “purpose” of the study); and “why is it important?” 2. Methods. The second section briefly describes the methods used to collect the data upon which the report is based (e.g., “a randomized trial assigned 1,200 subjects to receive one drop of topical antibiotic either once or twice a day”; or, “ 650 newly diagnosed diabetics presenting to a single urban hospital underwent detailed clinical examination including fluorescene angiography”). 3. Results. The third section describes what the study revealed (e.g. “38 percent of newly diagnosed adult-onset diabetics were women aged 26 though 68 years of life. The frequency of “any retinopathy” on fluorescene angiography was 4 percent among those 25–34 years, 12 percent among those 35–49 years, and 24 percent among those 50 years and older. Males accounted for 62 percent of newly diagnosed cases, in whom the rate of retinopathy also increased with age”). 4. Conclusions. The last section briefly recapitulates the results, in relation to their clinical relevance (e.g. “The risk of retinopathy among patients referred with newly diagnosed adultonset diabetes increases with age in both sexes. It is important that all newly diagnosed type II diabetics receive a careful retinal examination, regardless of their age or sex”). B. An Expanded Description of Considerations Relevant to Human Research All the important issues relevant to the design and interpretation of a well conceived and conducted clinical research project are detailed in the main body of articles published in high quality ophthalmic journals. Reading these reports carefully will Clinical Research–A Primer for Ophthalmologists 4 provide the new researcher with important insights, and a framework for planning his or her own work. It is helpful to plan a research project with the eventual abstract, and the full report in mind. In fact, it is a useful exercise to write-up the project’s report (except for its results and conclusions) before even beginning to collect data. This is an effective way to check that your plans really do meet your needs!