This is the first blogpost in a series to illustrate the value of high-quality RWE, utilizing examples from the Swedish Fracture Registry.
The foundation for high-quality RWE is the ability to define the right variables, the ability to collect and finally the ability to transparently report the quality of the data. The ability to succeed with this very much depend on the purpose and consequent interest that is possible to create among the users.
The Swedish fracture registry defines their purpose as:
“The Fracture Register was launched in 2011 and provides the opportunity to register fractures and fracture treatment. We want to contribute nationally and internationally to increasing knowledge about treatment outcomes after fracture. In the years from 2016, nearly 50 scientific publications have been published with fracture registry data. This provides a valuable contribution as we seek to improve the quality of fracture care. Our collected data will also have an international impact as there is still no other functioning fracture registry in the world.”1
The registry includes a list of 262 variables defined by clinicians to ensure that the right information is captured to ensure the continuous improvement work and research question. A full list of the variables is available on the website of the registry.2
In the recent publication by Bergdahl et al., Completeness in the Swedish Fracture Register and the Swedish National Patient Register’ they found that “The NPR had a completeness of 97% and a positive predictive value (PPV) of 70% (95% CI: 68–72) for acute humeral fractures.”3
Even though this may seem discouraging, it is rather an indicator of the complexity to establish high quality RWE. The registry is actively working to improve the quality of the data.4
In addition to the study about the completeness, there are several sub-studies about the validity of the data:
- Albrektsson, Madelene, Olof Wolf, Anders Enocson, and Mikael Sundfeldt. ‘Validation of the Classification of Surgically Treated Acetabular Fractures in the Swedish Fracture Register’. Injury 53, no. 6 (1 June 2022): 2145–49. https://doi.org/10.1016/j.injury.2022.03.002.
- Bergvall, Malena, Carl Bergdahl, Carl Ekholm, and David Wennergren. ‘Validity of Classification of Distal Radial Fractures in the Swedish Fracture Register’. BMC Musculoskeletal Disorders 22, no. 1 (26 June 2021): 587. https://doi.org/10.1186/s12891-021-04473-5.
- Juto, Hans, Michael Möller, David Wennergren, Klas Edin, Ida Apelqvist, and Per Morberg. ‘Substantial Accuracy of Fracture Classification in the Swedish Fracture Register: Evaluation of AO/OTA-Classification in 152 Ankle Fractures’. Injury 47, no. 11 (1 November 2016): 2579–83. https://doi.org/10.1016/j.injury.2016.05.028.
- Morgonsköld, David, Victoria Warkander, Panayiotis Savvides, Axel Wihlborg, Mathilde Bouzereau, Hans Möller, and Paul Gerdhem. ‘Inter- and Intra-Rater Reliability of Vertebral Fracture Classifications in the Swedish Fracture Register’. World Journal of Orthopedics 10, no. 1 (18 January 2019): 14–22. https://doi.org/10.5312/wjo.v10.i1.14.
- Wennergren, David, Carl Ekholm, Mikael Sundfeldt, Jón Karlsson, Mohit Bhandari, and Michael Möller. ‘High Reliability in Classification of Tibia Fractures in the Swedish Fracture Register’. Injury 47, no. 2 (1 February 2016): 478–82. https://doi.org/10.1016/j.injury.2015.11.002.
- Wennergren, David, Stina Stjernström, Michael Möller, Mikael Sundfeldt, and Carl Ekholm. ‘Validity of Humerus Fracture Classification in the Swedish Fracture Register’. BMC Musculoskeletal Disorders 18, no. 1 (10 June 2017): 251. https://doi.org/10.1186/s12891-017-1612-3.
In spite of these limitations in the completeness and validity of variables, this is probably one of the best datasets in the world to carry out research about fractures.
What is known about the quality and scope of the other datasets that are available for research?
- Bergdahl, Carl, Filip Nilsson, David Wennergren, Carl Ekholm, and Michael Möller. ‘Completeness in the Swedish Fracture Register and the Swedish National Patient Register: An Assessment of Humeral Fracture Registrations</P>’. Clinical Epidemiology 13 (21 May 2021): 325–33. https://doi.org/10.2147/CLEP.S307762.