TD Tosteson 1,2, JD Lurie 2,6, K Mycek 4, D Peter 4, S Schwarz 5, W Zhao 2, K Spratt 6, EA Scherer1 1, L Pearson 2, S Mirza 3,6, J Weinstein 6

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1 The Dartmouth/Consumer Reports Treatment Outcomes Calculator for Surgical and Nonsurgical Treatment of Disc Herniation, Spinal Stenosis and Degenerative Spondylolisthesis TD Tosteson 1,2, JD Lurie 2,6, K Mycek 4, D Peter 4, S Schwarz 5, W Zhao 2, K Spratt 6, EA Scherer1 1, L Pearson 2, S Mirza 3,6, J Weinstein 6 1 Department of Biomedical Data Science, 2 The Dartmouth Institute, 3 Department of Orthopaedics, Geisel School of Medicine at Dartmouth, Lebanon NH, USA; 4 Consumer Reports, Yonkers NY, USA; 5 Research Computing, Dartmouth College, Hanover NH, USA; 6 Dartmouth-Hitchcock Medical Center, Lebanon NH, USA; COI disclosure: None noted Grants: NIH/NIAMS P60 AR062799

2 Introduction Consideration of surgical treatment for low back pain conditions is an important preference sensitive decision for patients and clinicians. A web-based personalized outcomes prediction calculator was developed for this purpose using SPORT (Spine Patient Outcomes Research Trial) data for the three major indications for lumbar spine surgery: disc herniation (IDH), spinal stenosis (SPS) and spondylolisthesis (DS). The calculator provides personalized evidence in considering treatment options, with results summarized graphically for each treatment goal. Patients and consumers participated in the design process. Web-based studies were performed to evaluate the impact of calculator usage on consumer and patient knowledge and decision quality

3 Materials and Methods: Models Predictive models were developed based on the combined randomized and observational data from the SPORT trials. Variables were selected from best-fitting models for outcomes at one year based on linear or binary regression models according to penalized variable selection methods using BIC (Bayesian) information criteria. Two-way interaction terms were included, including interactions with treatment type. The selected variables were then calibrated in longitudinal models developed for the SPORT main analyses to predict patient outcomes over 8 years. Probabilities of improving, staying the same, or getting worse for function and pain scores were calculated using prediction variances.

4 Materials and Methods: Evaluation Interviews with consumers and patients and software experts were conducted to evaluate prototype interfaces for usability and effectiveness of data presentations, and to identify which SPORT outcomes were of most importance to consumers and patients. Software was created to embed the final calculator in web-based surveys prior to and following use by consumers and patients. Decisional conflict and knowledge questions were asked before and after viewing the calculator. Knowledge questions were randomized to be asked before or after to avoid possible effects on knowledge gained. Consumers with low back pain were identified from the CR 2015 annual summer survey and 6,000 were contacted by with links to the calculator study website. The same website is being used for patients seen in surgical clinics.

5 Calculator Screens

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8 Survey Results Table 1. Study participants from Consumer Reports subscribers with IDH, SPS, or DS conditions. Survey Question Condition Participants with IDH, SPS, or DScondition (n= 2282) Participants who completed the survey (n = 1279, 56%) IDH 798 (35%) 409 (32%) Please check which condition you have. n (%) SPS 1220 (53%) 717 (56%) DS 264 (12%) 153 (12%) Table 2. Baseline demographic characteristics and health status measures for subscribers who completed surveys compared with SPORT patients. IDH SPS DS Consumers SPORT Consumers SPORT Consumer SPORT s (n=402) (n=1244) p (n=703) (n=654) p (n=151) (n=607) p Age, mean (SD), year 63.3 (10) 41.7 (11.4) < (8.2) 64.6 (11.7) < (8.8) 66.1 (10.3) 1 Female, n (%) 107 (27%) 522 (42%) < (25%) 254 (39%) < (35%) 418 (69%) <0.001 SF-36 Physical Function score, mean (SD) Sciatica/stenosis Bothersomeness Index, mean (SD) 54.4 (26.2) 37.9 (25.5) < (25.5) 34.7 (23.3) < (26.1) 34.1 (22.4) < (6.5) 15.5 (5.3) < (6.5) 14.4 (5.7) < (7) 14.7 (5.6) <0.001

9 Figure 1. Which treatment is most likely to provide faster relief from pain caused by [a herniated disc/spinal stenosis]? (N = 1279). Figure 2. Decisional conflict measures Percentage 100 * * * * p < p = Pre-Calculator Post-Calculator 40 (Correct!) 20 0 SURE about the best choice for me Know the benefits and risks of each option Clear about which benefits and risks matter most to me Have enough support and advice to make a choice

10 Conclusions Calculator generally well received by CR subscribers. (76% user satisfaction) 43% considered it very or extremely important to provide to patients. CR sample was generally older, healthier than SPORT. Knowledge & decisional conflict were somewhat improved with some notable exceptions.