Organization - Nordsten

Overal Organisational structure of the NORDSTEN Trial

NORDSTEN is a national multicentre randomized control trial with 10 year follow-up, conducted at 18 public hospitals in Norway. The NORDSTEN national project organization was established to administer, guide, monitor and assist the surgical units and researchers. This trial received funding from the Central Norway Regional Health Authority (RHA) and Western Norway Regional Health Authority (RHA).

The Norwegian Degenerative spondylolisthesis and spinal stenosis (NORDSTEN) organization.

Members: head of the NORDSTEN study, head of scientific board, investigators for each study, head of NORDSTEN coordinating center and head of finances.
Members: all Administrative Executive Board members, principal investigators (PIs) from all four health regions in Norway, an international researcher and a patient representative.
An independent data monitoring committee at Clinical Trial Unit (CTU) at Oslo University Hospital (OUH).
Members: local PIs (surgeons) and study coordinator from each of the recruiting hospitals, and staff from the national NORDSTEN coordinating center. Responsibilities: recruit, treat and follow-up of patients in accordance with the standard procedures and guidelines developed by the Scientific Board and the Administrative Executive Board. Also, an external study monitor supervising activities according to Good Clinical Practice.
The Research and Communication Unit for Musculoskeletal Health (FORMI) at OUH is responsible for the nationwide coordination of the NORDSTEN study. Responsible for daily administration and support to the local coordinators, the randomization process and data management (collection and recording). Reports to the independent data monitoring committee at CTU/OUH.

Norwegian Degenerative spondylolisthesis and spinal stenosis (NORDSTEN) organization is structured in a way which has led to effective communication between the different groups within the NORDSTEN trial. The fundament of this project is the national working group consisting of both local PIs and CRAs to ensure quality patient care, follow up, and data quality throughout the study period. Responsibilities of the national working group involve; recruit, treat and follow up of patients in accordance with the standard operating procedures and guidelines developed by the Scientific Board and the Administrative Executive Board. Also, an external study monitors supervising activities according to Good Clinical Practice guidelines.

Furthermore, PIs from each study site and region are represented on the scientific board together with the study’s patient representative, international reviewer and national coordinating center. This board provides support and guidance for all PhD candidates while insuring guidelines and internal routines of the NORDSTEN trial are being met. Finally, the administrative executive board consisting of study arm heads, financial advisor and national coordinator lead the NORDSTEN study through the project.

NORDSTEN group

Project lead

Erland Hermansen M.D., PhD, Department of Research and Innovation, Møre and Romsdal Hospital Trust

Administrative Executive Board

Christian Hellum (Leader Scientific Steering Committee) M.D., PhD, University of Oslo Hospital
Erland Hermansen M.D., PhD, Department of Research and Innovation, Møre and Romsdal Hospital Trust
Frode Rekeland M.D., PhD Fellow, Orthopedic Department, Haukeland University Hospital
Ivar Magne Austevoll M.D., PhD, Orthopedic Department, Haukeland University Hospital
Kari Indrekvam (Administrative Leader) Prof., M.D., PhD, Hospital Manager, Head of Orthopedic Department, Haukeland University Hospital
Kjersti Storheim Prof., PhD, leader FORMI, University of Oslo Hospital

Scientific Steering Committee

Christian Hellum (Leader Scientific Steering Committee) M.D., PhD, University of Oslo Hospital
Erland Hermansen M.D., PhD, Department of Research and Innovation, Møre and Romsdal Hospital Trust
Frode Rekeland M.D., PhD Fellow, Orthopedic Department, Haukeland University Hospital
Helena Brisby M.D., PhD Professor/Chief Physician, University of Gothenberg
Inger Ljøstad, Patient Representative, Back Association of Norway
Ivar Magne Austevoll M.D., PhD, Orthopedic Department, Haukeland University Hospital
Jens Ivar Brox Prof., M.D., PhD, Oslo University Hospital
Kari Indrekvam Prof., M.D., PhD, Hospital Manager, Head of Orthopedic Department, Haukeland University Hospital
Kjersti Storheim Prof., PhD, Leader FORMI, Oslo University Hospital
Hasan Banitalebi M.D., PhD Department of Diagnostic Imaging, Akershus University Hospital
Tore Solberg M.D., PhD, University Hospital of Northern Norway

Working Group

Andreas Sørlie M.D., PI, University Hospital of Northern Norway
Arild Hjulstad M.D., PI, Levanger Hospital
Arnfinn Pedersen M.D., PI, Innland Hospital, Elverum
Benedickte Aasen, Project Administration, Oslo University Hospital
Christian Hellum M.D., PhD, PI, Oslo University Hospital
Eric Franssen M.D., PI, Stavanger University Hospital
Erland Hermansen M.D., PhD, Department of Research and Innovation, Møre and Romsdal Hospital Trust
Frode Rekeland M.D., PhD Fellow, Orthopedic Department, Haukeland University Hospital
Greger Lønne M.D., PI, Lillehammer Hospital
Håvard Furunes M.D., PI, Senior Physician, Gjøvik Hospital
Inger Ljøstad, Patient representative, Back Association of Norway
Ivar Magne Austevoll M.D., PhD, Orthopedic Department, Haukeland University Hospital
John Magne Hoseth M.D., PI, Kristiansund Hospital
Kamaran Raza M.D., PI, Sørlandet Hospital Kristiansand
Knut Jørgen Haug M.D., PI, Skien Hospital
Lars Hubshle M.D., PI, Drammen Hospital
Leif Kibsgård M.D., PI, Levanger Hospital
Nikolaos Ikonomou M.D., PI, Martina Hansens Hospital
Oliver Grundnes M.D., PI, Orthopedic Department, Akershus University Hospital
Samer Habiba, M.D., PI, Neurological Clinic, Haukeland Hospital
Vidar Opland M.D., Bærum Hospital
Yngve Sporstøl, Arendal Hospital
Øystein Nygård M.D., St. Olavs Hospital, University Hospital Trondheim

Affiliated Members

Clemens Weber M.D., PhD, Neurology Department, Stavanger University Hospital
Eric Franssen M.D., PI, Stavanger University Hospital
Jørn Aaen M.D., Orthopedic Department, Ålesund Hospital

Clinical Research Associates (CRA)

Andrea Veen RN, Stavanger Stavanger University Hospital
Anita Karin Vassbakk MSN, Ålesund Hospital
Bettina Døsvik PT, Sørlandet Hospital Kristiansand
Eira Ebbs PhD Fellow, Research Coordinator, FORMI, Oslo University Hospital
Elisabeth Lilleholt Muller PT, Sørlandet Hospital Arendal
Gjermund Skyttemyr PT, Martina Hansens Hospital
Grete Ward RN, Levanger Sykehus
Hege Andresen PT, St. Olavs Hospital, University Hospital Trondheim
Hege B Nilsen PT, Gjøvik Hospital
Hege Westgard PT, Innland Hospital Elverum
Ingrid Bånerud MSc., Research Coordinator, FORMI, Oslo University Hospital
Ingrid Edborg RN, Skien Hospital
Janne Haugland Harkestad MPT, Haukeland University Hospital
Kirstine Hansen PT, Stavanger University Hospital
Maria Rieber-Mohn MPT, Haukeland University Hospital
Marthe Stine Rustad RN, Lillehammer Hospital
Merete Finjarn PT, Bærum Hospital
Myrthle Slettvåg Hoel PT, Kristiansund Hospital
Sara Pedersen, University Hospital of Northern Norway
Sara Søreng RN, University Hospital of Northern Norway
Tone Elden, Levanger Sykehus

Data administration center

The study coordinating center (Research and Communication Unit for Musculoskeletal Health, FORMI), the Clinical Trials Unit (CTU) and the Regional Research Support at Oslo University Hospital are responsible for data collection, safety and quality. The data control plan included automatic and manual checks of data quality at defined time intervals. Plotting of primary outcome were verified for all research subjects at all follow-up intervals, all other data entered were verified for every fifth research participant number (20%).

Data Monitoring

Regional Research Support Infrastructure (Forskningstøtte) is responsible for data monitoring following GCP up to primary outcome measurements.