Background: Clinical practice guidelines are an important basis for clinical decision making, but the sources of their evidence dominated by randomized controlled trials (RCTs) have poor external validity, which often hinders their implementation. Real world study (RWS) emphasizing external validity is increasing.
Objectives: We aim to discuss how RWS can be used to improve the guidelines.
Methods: We searched relevant literature and made a review.
Results: RWS can enhance the external validity of guidelines by providing evidence of efficacy and safety of interventions in a wider population; RWS can provide localized evidence to solve regional applicability differences for guidance; RWS based on health insurance databases can provide evidence on cost-effectiveness to complement the Evidence to Decision process; Well-integrated real world data is dynamically updated and facilitates timely access to new evidence and helps ensure the timeliness of updating guidelines. In addition, RWS can monitor the implementation of guidelines, so that the guidelines’ developers are in a continuous feedback loop. However, there are still some problems to be solved in including real world evidence (RWE) as sources of evidence for guidelines, such as how to evaluate the quality of RWE, how to classify its evidence level, and how to deal with the inconsistency between conclusions drawn from RWE and those drawn from RCTs.
Conclusions: With the continuous improvement of the quantity and quality of RWS, how to make full use of RWS to improve and promote the development, implementation, and evaluation of guidelines will be a continuous topic.
Relevance and importance to patients: We summarized the roles of RWS in the optimization process of the development, audit and implementation of guidelines, which is helpful for patients in a wider range of patients and regions to obtain more personalized recommendations from the optimized guidelines.
Patients involvement：no.