26.51 Prospective observational studies

  • A prospective observational study is usually called a cohort study.
    • A group of patients is identified to receive a specific treatment and then treated, and their results are followed serially over time.
  • The essential feature of a cohort study is its prospective nature.
    • A study design is considered,and a priori power analysis is performed to determine the necessary sample size
    • The study is announced publicly (in a sense) by institutional review boards for human subjects
    • Then, the treatment is administered.
    • The outcomes of interest are followed at well-defined intervals.
    • All data are gathered up to a minimum interval (e.g., 2 years of follow-up) for analysis.

  • In practice, all cohort studies involve a control group, which consists of patients who have the same diagnosis but different treatment, such as a gold-standard treatment or conservative management.
  • Ideally, the control group is defined prospectively as well and follows an identical clinical protocol, except for the treatment.
  • In some cohort studies, matching is used to identify control patients.
  • In matching, patients who have similar demographic or clinical variables, such as gender, age, and co-morbidity, are compared.
  • Matching is a way of controlling for confounding variables in observational studies.

  • Prospective studies have the advantage of being a well-defined and principled type of observational study
  • Since there is no randomization, all the potential biases and confounders exist in this type of study.