More Realistic Spine Patients: assessing the Effect of Dialogue Support Tool

In Norway, data from the Norwegian Registry for Spine Surgery (NORspine) indicate thatthe proportion of patients reporting improvement 12 months after lumbar spinal surgery("success rate") ranges from 63% to 67%. This suggests that a considerable proportion ofpatients remain dissatisfied, and that spinal surgery carries an inherent risk of symptomdeterioration.Studies have shown that patients frequently hold high preoperative expectations, yet onlyapproximately 30% ultimately achieve their anticipated clinical outcome. Likewise,surgeons may overestimate the potential benefits of surgery while underestimating thelikelihood of unfavourable outcomes.The overall costs associated with spine surgery are substantial, and unsuccessfulprocedures have significant consequences for patients' health‐related quality of life andimpose a considerable economic burden on society. The advisory board of NORspine hastherefore recommended that Norwegian hospitals promote studies to improve surgicaloutcomes.Tools that improve surgeon‐patient communication and facilitate patients' understandingof the medical information provided may be a useful strategy for reducing unfavourableoutcomes. With the rapid advancement of digital technology and artificial intelligence,healthcare systems should consider implementing validated prognostic tools to supportinformed decision‐making. However, these tools must undergo rigorous evaluation to ensurereal‐world applicability and to assess their impact on the healthcare system.One such tool is the Dialogue Support (DS) application, an online platform based on theSwedish national quality register for spine patients (Swespine), designed to predictoutcomes one year after surgery for degenerative spinal disorders. The DS application hasbeen publicly available since October 2020 through a collaboration between the Eurospinesteering board and the Swedish Society of Spinal Surgeons. The predicted outcomes arepresented both numerically and graphically via a pie chart, thereby facilitatingpatients' comprehension of potential outcomes, including the possibility of symptomdeterioration in the worst‐case scenario. Additionally, second‐opinion consultations mayserve as a safeguard by providing patients scheduled for surgery or conservativetreatment with repeated information.This project will investigate the use of the DS application as a supplementaryinformation and communication tool for patients with degenerative spinal disorders. Theoverarching aim is to improve patient treatment and specialised care through clinicalresearch.A multicenter superiority randomised controlled trial (RCT) will be conducted, in whichthe intervention consists of one additional study visit using the DS tool, referred to asthe interventional arm. The RCT design ensures equal study groups and allows forcomparison of groups treated during the same period, by the same surgeons, and underidentical clinical guidelines, thereby effectively eliminating confounders and reducingbias.All patients aged 18 years or older who are scheduled to undergo lumbar spinal surgeryfor disc herniation, spinal stenosis, or degenerative disc disease will be eligible forinclusion. Patients who do not understand spoken or written Norwegian will be excluded,as language barriers may interfere with the intervention study visit, comprehension ofthe information provided, and completion of study questionnaires. Additional exclusioncriteria include patients with spondylolysis or lytic spondylolisthesis, as well as thosealready participating in other clinical studies.Eligible patients will receive verbal and written information about the study and willsign an informed consent form if willing to participate. Randomisation will assigneligible patients to one of two arms: either one additional study visit prior to plannedsurgery without using the DS tool or one additional study visit using the DS tool.Blinding of patients and surgeons will not be feasible. To account for an anticipateddropout rate of 25%, a total of 440 patients will be included for analysis of the primaryoutcome. REDCap will be used for stratified block randomisation, with stratificationbased on diagnosis‐disc herniation, spinal stenosis, or degenerative disc disease‐toensure balanced allocation across subgroups. Variable block sizes will be used to reducethe predictability of allocation sequences. Randomisation will be performed separatelywithin each participating hospital to ensure balance between intervention and controlgroups and to minimise centre‐related confounding.All participants in both study arms will attend an additional outpatient clinic studyvisit scheduled about 2 to 6 weeks before surgery. This study visit will last 30 to 40minutes and will be conducted either in person or via video consultation, according topatient's preference. Before the study visit, patients in both groups will complete aquestionnaire to collect baseline data, as well as the Oswestry Disability Index (ODI)and EuroQol 5‐Dimension 5‐Level (EQ‐5D‐5L), in paper or electronic format.The additional study visit will follow an identical framework in both study arms. In theintervention arm, the DS tool will be utilised, and these results, as well as theprognostic uncertainty, will be presented and explained to the patient. In the controlarm, the DS tool will not be employed.In both groups, patients will have the opportunity to ask questions about the surgicalprocedure, potential complications, hospitalisation, discharge, and the anticipatedrecovery period. The primary objective of the additional study visit is to improvepatients' understanding of the surgical procedure and expected outcomes. This study visitis not intended to reassess or revisit the surgical indication.Follow‐up will be conducted at 3 and 12 months, in line with the Norwegian spineregistry, and will include the same Patient‐Reported Outcome Measures (PROMs) as theregistry (ODI, NRS back and leg pain, GPE translation scale). This approach willfacilitate collaboration with the Norwegian Spine Registry and minimise the number offollow‐up forms for patients. Radiological examinations will not be performed as part ofthis study.Four studies will be derived from this project. ‐ The first study will establish external validation of the DS tool using Norwegianregistry data and assess inter‐rater reliability. To the best of our knowledge, thisis the first systematic assessment of DS interpretations among surgeons. ‐ The second study will provide new insights into how DS may influence patients'expectations. ‐ The third study will evaluate whether the use of DS improves surgical outcomes byproviding better patient information. Ongoing studies on DS tools compare resultsfrom the DS tool with either historical data or results from other regions that donot use the DS tool. This RCT will compare patients from the same region and timeperiod, ensuring equal surgical techniques and mindsets. ‐ The fourth study will assess whether the use of DS can reduce surgery cancellationsand thereby contribute new data to health services research on efficiency,cost‐effectiveness, and resource allocation in surgical care.The primary outcome measure is the difference in mean ODI between the groups. We havedeliberately chosen a target value of 5 points. Many studies are powered to detectdifferences of around 10 points, which is a relatively large difference; detecting orrefuting it requires far fewer participants. In the present context, the study groupconsidered a target value of 5 points a more appropriate aim for determining whether theintervention with an additional DS study visit would justify the use of resources and itsimplementation in clinical practice.The primary analysis will be based on the intention‐to‐treat principle, whereby allrandomised patients will be analysed according to the study arm to which they wereoriginally assigned, regardless of protocol deviations. Patients who discontinueparticipation or are lost to follow‐up will remain included in the intention‐to‐treatpopulation. Additionally, a per‐protocol analysis, including only patients who strictlyadhere to the study protocol, will be performed and reported. Subgroup analysis will beconducted according to diagnosis category: disc herniation, spinal stenosis, anddegenerative disc disease.A statistician blinded to treatment allocation will analyse the primary and secondaryoutcome measures using masked group labels. Data will be analysed using standard methods,with descriptive statistics including means and 95% confidence intervals (CIs) forcontinuous variables and numbers with proportions for categorical variables. The mainanalyses comparing the two study groups will be based on Student's t‐tests forindependent groups (continuous outcomes) and chi‐square tests (categorical outcomes).Where appropriate, mixed‐effects models will be used to account for missing data. Thestudy database will be locked before the final statistical analyses are initiated, afterwhich no further data entry or modification will be permitted. A separate StatisticalAnalysis Plan (SAP) will provide detailed specifications for the planned analyses,including handling of missing data. The SAP will be finalised, dated, and signed beforedatabase lock and made publicly available through ClinicalTrials.gov. A study groupmeeting will be organised when 220 patients have completed the 3‐month follow‐up toreview recruitment and response rates. Strategies to address non‐response will beconsidered as needed.The validation study will be an observational cohort study based on prospectivelycollected data from the Norwegian Spine Registry, including 1500 patients, with 500 ineach of the diagnosis subgroups (disc herniation, spinal stenosis, or degenerative discdisease).