We, the members of EARN confirm

  • Arthroplasty Registries and any other real world data used for research, regulatory, purchasing and other public health purposes shall o be used in transparent processes
    o take the local circumstances of the region the data are collected into consideration by involving experts from the individual register in the process of analysis and interpretation.
    o consider the multifactorial nature of these outcome data
  • Registries are data sources, no decision making entity by definition.
    No raw data or figures shall be used without proper and critical interpretation in a defined context.
  • Registers are valuable data sources to support a wide range of decision making processes related to arthroplasty. Everyone shall have the opportunity to study these outcome data and come to conclusions.
    Results shall be introduced in scientific debates and regulatory processes according to given law and common standards. They shall be subject of regular processes in research for publication and scientific debates.
  • Register and other real world data are clinical outcome data, which require know how and standards for interpretation. These requirements are different from sample based clinical studies.
  • Registries and Clinical Studies are no competitors, but augment each other with specific advantages and limitations.
    Conclusions on scientific data shall include any dataset and evidence available. They shall be done in respect to individual requirements of every dataset from methodological point of view.
  • To use the data several conditions shall be fulfilled:
    o Access to data shall be granted based on transparent processes.
    o Interpretation shall be done in respect to freedom of research
    o Conclusions shall be subject of democratic debates in respect of legal circumstances for stakeholders and processes
    o Register holders shall have the right to review conclusions and comment on that. They shall not have the right to stop publications or public discussion, if this is not consented in advance. Opinion and statement of register holders on interpretation in disagreement with the interpretation of the study team shall be mentioned in public use of data as a rule. Register holders shall provide detailed and constructive statements in case of disagreement.

o Efforts by register holders shall be granted according to defined guidelines. This includes co-authorship at scientific papers and financial compensation, if relevant support was provided

o Registries shall be organized in a multi-stakeholder approach taking individual advantages of any stakeholder as well as the legal framework into consideration. This includes for example, but not limited to:

o A well structured organization and governance structure based on transparent processes.

o Transparency concerning internal and external validity of data shall be provided to any stakeholder using the data based on a structured standard process.

o Any stakeholder shall be involved taking the applicable legal framework, it ́s specific impact on processes and individual competence in knowledge and decision making processes into consideration.

o Conclusions based on register data shall be conducted in a transparent way based on general scientific standards.

o Controversies shall be handled preferably inside the expert panels.
If it should not be possible to agree on one position transparency shall be granted to all stakeholders involved in the subject by any side in an objective and comprehensive way to allow any decision maker to do an independent appraisal.

o As a rule registries shall provide access to data according to legal requirements like protection of privacy and standard processes based on the scope of the registry and regulatory requirements in a transparent matter.

o Justified interests of involved stakeholders like publication of results by researchers and project leaders shall not be limited. Conflicting interests by other stakeholders like access to data related to regulatory purposes shall be addressed in mutual agreement in the given legal framework.