Checklists for Writing a Scientific Manuscript
14- 5
How to Write the Methods Section: Retrospective Clinical Studies
One way to write the Methods section of a retrospective clinical study is to address each topic below that applies to your study. The following order works well in many papers.
▪ Subjects: Source of the study subjects (for example, chart review, database, patients in a previously reported prospective clinical study). ▪ Selection criteria: Criteria for selection of the overall study population (inclusion and exclusion criteria, including dates).
▪ Data reviewed: Types of data reviewed or extracted from patient records.
▪ Subgroups: How the study subgroups were defined.
▪ Numbers of patients: Numbers of patients ultimately included in the study and in each subgroup. (Included in most but not all papers. When this information is not reported in the Methods section, it should be reported at the beginning of the Results section.) ▪ Approval of the study by an institutional review board and the use of an informed consent process for subjects (or the board’s waiver of this process). ▪ Evaluations and interventions: Pretreatment evaluations, treatments and interventions, and follow-up evaluations for patients in the study. Provide general information only. If the evaluations or treatments (for example, chemotherapy regimens, drug doses, radiotherapy techniques) differed from patient to patient and the study was designed to show the effect of those differences on outcome, report the numbers of patients who got each type of evaluation or treatment at the point in the Results section where you report the outcomes. ▪ Outcome measures: Outcome measures and minimum differences that were considered clinically important.
▪ Statistical methods: Methods of statistical analysis, described in sufficient detail to permit replication.
Made with FlippingBook Digital Publishing Software