Real-world research and the role of observational data in the field of gynaecology - a practical review.

OBJECTIVES: In the context of women's health, we examine (1) the role that observational ('real-world') studies have in overcoming limitations of randomised clinical trials, (2) the relative advantages and disadvantages of different study designs, (3) the importance of outcome data from observational studies when making health-economic or clinical decisions, and (4) provide insights into changing perceptions of observational clinical data.

METHODS: PubMed and internet searches were used to identify (i) guidance and expert commentary on designing, conducting, analysing, and reporting clinical trials or observational studies, (ii) supporting evidence of the rapid growth of observational ('real world') studies and publications since the turn of millennium in the fields of contraception, reproductive health, obstetrics or gynaecology.

RESULTS: The rapidly growing use and validation of large, computerised medical records and related databases (e.g., health insurance or national registries) have played a major part in changing perceptions of observational data among researchers and clinicians. In the past 10 years, a distinct increase in the number of observational studies published tends to confirm their growing acceptance, appreciation and use.

CONCLUSIONS: Observational studies can provide information that is impossible or infeasible to obtain otherwise (e.g., impractical, very expensive, or ethically unacceptable). Greater understanding, dissemination, uptake and use of observational data might be expected to drive ongoing evolution of research, data collection, analysis, and validation, in turn improving quality and therefore credibility, utility, and further application by clinicians.