We undertook the investigation in several phases.
Phase 1
Obtaining information from media reports, literature searches, reports and protocols from the National System for Managed Introduction of New Health Technologies (New Methods). Published reports from other European countries’ method assessments of taTME were also reviewed. The survey in Phase 1 was the basis for assessment of the need for further investigations. Based on our findings, we wished to interview a selection of key individuals in order to shed light on the perspectives of the health authorities, the professional gastrointestinal surgical community, and patient and user organisations.
Phase 2
- In this phase, we interviewed key individuals within the professional gastrointestinal surgical community, health administration and other relevant professionals.
- We obtained information from the seven hospitals that had performed taTME.
- Information was also obtained from the Cancer Registry and the Norwegian System of Patient Injury Compensation (NPE)
Phase 3
Systematisation of key findings from our media review, literature searches, interviews and data retrieval from the seven hospital authorities, and further assessment of how this affects patient and user safety when new surgical methods are introduced.
Phase 4
Prior to the completion of the report, we reviewed the draft timeline, findings and learning points with actors relevant to this investigation, for necessary corrections and input:
- Representatives of the gastrointestinal surgery profession in all regional health authorities
- Norwegian Gastro Intestinal Cancer Group (NGICG) and Norwegian Gastro Intestinal Cancer Group – Colorectal (NGICG-CR)
- A member of the Danish Colorectal Cancer Group (DCCG)
- The Norwegian Medical Association represented by the Norwegian Association for Gastroenterological Surgery (NFGK)
- The Cancer Registry
- Centre for Clinical Documentation and Evaluation (SKDE)
- Norwegian Directorate of Health
- Shared decision making centre at the University Hospital of North Norway HF (UNN)
- Norwegian Cancer Society and NORILCO
- Norwegian National System for Managed Introduction of New Health Technologies (New Methods) represented by the Bestillerforum (Ordering Forum)
- Norwegian System of Patient Injury Compensation (NPE)
- The hospitals that performed taTME surgery
- Intervention Centre at Oslo University Hospital HF
- Probo in connection with national evaluation of New Methods,
- Reflection Panel in NHIB