Intervertebral Disc Displacement, Spinal Stenosis Lumbar, Lumbar Disc Herniation, Lumbar Spine Degeneration
Conditions
Keywords
artificial intelligence, decision support, surgery selection
Brief summary
Background One third of patients operated for lumbar disc herniation (LDH) or spinal stenosis (LSS) do not achieve substantial improvement. Studies indicate that well informed shared decision making (SDM) can improve the selection to surgery, and thus the outcomes. Numerous algorithms for outcome prediction have therefore been developed, and some use artificial intelligence (AI). Most are trained on small datasets, few are accurate, all are stand-alone or web-based applications not integrated in the electronic health record (EHR), and none are implemented in routine clinical practice. The Norwegian registry for spine surgery (NORspine) comprises a cohort of more than 69,000 cases. The investigators have used AI to analyze the dataset and predict the outcome, and developed a decision support tool (DST) which is seamlessly integrated in the EHR DIPS Arena®. The investigators intend to use the tool to inform the SDM between surgeons and patients about the indication for surgery (yes or no), to increase the proportion with a successful outcome. The aim of the study is to assess the safety and feasibility of the DST for use in a subsequent pilot study. The device The DST (the device) is an integrate compound of software-solutions. Baseline data are registered by patients and surgeons on questionnaires integrated in DIPS Arena®, and transferred to NORspine. The data are also transferred (de-identified) to the AI-enabled prediction algorithm which operates in a cloud-based model hosting service. The algorithm has been trained and validated on a dataset from NORspine. The area under the curve for prediction of the main outcome (Oswestry disability index after12 months) in receiver operating characteristic analysis is very high (0.85) for LDH and moderate (0.72) for LSS. The model host also calculates outcomes (proportions with substantial, slight, or no improvement, and worsening) for the 50 cases with baseline variables most similar to the present case (patients-like-me). Finally, the individual prediction and the outcomes for the patients-like-me are transferred back and displayed in the regular user interface of DIPS Arena® for use in the SDM. Clinical investigations For this feasibility study, the investigators will use convergent qualitative and quantitative mixed methods. The comparator is decision making in routine clinical practice, without use of the DST. The study will include 20 patients with magnetic resonance imaging confirmed LDH or LSS referred for evaluation of the indication for surgery, and six surgeons who do the evaluations. The study will iteratively redesign the user interface of the DST until it is considered safe and feasible for use in a following pilot study.
Interventions
DEVICEDecision support
Patients will digitally fill out forms, which will go into the decision support tool integrated in the electronic health record journal, which predicts outcome of surgery for the patient, to inform shared decision making.
Sponsors
University Hospital of North Norway
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Feasibility of software (medical device integrated in electronic health record) and following changed workflow in outpatient clinic (20 patient, 6 surgeons)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients with MRI-confirmed LDH or LSS referred to University hospital of North Norway Tromsø for assessment of indication for surgery * Specialists and physicians in training (for two years or more) in neurosurgery or orthopedic surgery who evaluate such patients at the neurosurgical outpatient clinic at University hospital of North Norway Tromsø
Exclusion criteria
* Patients unable to consent because of * Age \< 18 years * Serious drug abuse of severe psychiatric disorders * Language barriers (patients who cannot speak or read Norwegian) * Patients with a baseline ODI ≤14 (LDH) or ≤22 (LSS) * Patients undergoing non-elective/emergency operations * Patients with degenerative conditions other that LDH and LSS, fractures, primary infections, or malignant conditions of the spine * Physicians in training with less than two years' experience with spine surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgeons' acceptability | Acceptability will be assessed continuously, but finally evaluated towards the end of the study, after iterative redesign of the DST and the related workflow according to requirements identified with qualitative methods at up to 70 weeks. | Surgeons' acceptability of the decision support for a following clinical pilot study (yes/no) |
| Patients' acceptability | Acceptability will be assessed continuously, but finally evaluated towards the end of the study, after iterative redesign of the DST and the related workflow according to requirements identified with qualitative methods at up to 70 weeks. | Patients' acceptability of the decision support for a clinical pilot study (yes/no) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeons' compliance rate | The rates and the duration will be calculated as averages for the study period, and towards the end of the study, after iterative redesign according to requirements identified with the qualitative methods at up to 70 weeks. | The proportion of consultations in which the surgeon uses the decision support as intended |
| Patients' compliance rate | The rates and the duration will be calculated as averages for the study period, and towards the end of the study, after iterative redesign according to requirements identified with the qualitative methods at up to 70 weeks. | The proportion of patients who complete the online questionnaire with the required information before the outpatient clinic visit |
| Time | The rates and the duration will be calculated as averages for the study period, and towards the end of the study, after iterative redesign according to requirements identified with the qualitative methods at up to 70 weeks. | Duration of the consultation (minutes) |
Countries
Norway
Contacts
Primary ContactTor Ingebrigtsen, Professor and consultant neurosurgeon
Backup ContactTore Solberg, Professor and consultant neurosurgeon
Outcome results
None listed