Writing and Publishing Scientific Articles
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How to Write the Methods Section: Prospective Clinical Studies
One way to write the Methods section of a prospective clinical study is to address each topic below that applies to your study. The following list is from the CONSORT statement, which provides recommendations for reporting the results of prospective randomized clinical trials. ▪ Participants: Eligibility criteria for participants and the settings and locations where the data were collected. ▪ Interventions: Precise details of the interventions intended for each group and how and when they were actually administered. ▪ Outcome measures: Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors). ▪ Sample size: How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules. ▪ Randomization — sequence generation: Method used to generate the random allocation sequence, including details of any restriction (e.g., blocking, stratification). ▪ Randomization — allocation concealment: Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned. ▪ Randomization — implementation: Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups. ▪ Blinding (masking): Whether or not participants, those administering the interventions, and those assessing the outcome were blinded to group assignment. If done, how the success of blinding was evaluated. ▪ Statistical methods: Statistical methods used to compare groups for primary outcome(s); methods for additional analyses, such as subgroup analyses and adjusted analyses. In addition to the items above, from the CONSORT statement, describe the procedures used to ensure ethical conduct of the study, such as approval of the study by an institutional review board and the use of an informed consent process for participants.
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