Counselling services

Study Planning

• Initial guidance depending on your stage of study
• Methodological advice on study design

Conducting research

• Review and advice on billing rules

Study evaluation

• Support with primary coding (e.g. using R/epicodr)
• Advice on data analysis
• Provision of analysis results (core analyses)
• Production of quality reports and indicators

Reuse

• Advice on use and access applications
• Support with feasibility enquiries
• Case number planning
• Advice on inclusion criteria and endpoints
• Support with study design
• Participation in kick-off meetings for data handover

Consultancy on the collection of patient-reported health data (PROs)

• Development of study-specific measurement protocols
• Support with study planning and the integration of PROs into clinical trials and registries, from data collection to analysis.
• Recommendation of standardised and validated instruments to ensure data quality, comparability and interoperability
• Advice on the technical implementation of PRO surveys, including electronic data capture and automated analysis
• Support with the interpretation of patient-reported outcomes to provide a sound assessment of efficacy, adverse effects and quality of life from the patient’s perspective
• Promotion of the harmonisation of PRO data through training, tutorials and methodological standards to improve data re-use and cross-site comparability within the NUM

Consultancy services on the utilisation and linkage of NUM external healthcare-related data, e.g.:

• on administrative and regulatory requirements (e.g. data from health insurance funds, cancer registries, population registers)
• on the preparation and finalisation of cooperation agreements with secondary data holders
• on the creation/development of a data flow and data protection concept for linking NUM with external data
• on the linking of data from sources outside NUM that are healthcare-related with clinical and study data
• on analysis and operationalisation options (e.g. variable selection, outcome definition, and inclusion and exclusion criteria)

Consultancy on the interpretation of results, e.g. assessment of the strengths and limitations of external data sources and validation of the results.

• Methodological advice specific to paediatrics

• Support with the planning, implementation and evaluation of paediatric studies
• Support with the selection and application of digital tools in the treatment and care of children and adolescents
• Advice on the selection, application and evaluation of screening and diagnostic tools for assessing the health and health outcomes of children and young people using the Methodology Toolbox