Victor E Staartjes1, Alessandro Siccoli2, Marlies P de Wispelaere3, Marc L Schröder4. 1. Department of Neurosurgery, Bergman Clinics Amsterdam, Naarden, Rijksweg 69, 1411 GE, Naarden, The Netherlands; Faculty of Medicine, University of Zurich, Zurich, Switzerland. Electronic address: victor.staartjes@gmail.com. 2. Faculty of Medicine, University of Zurich, Zurich, Switzerland. 3. Department of Clinical Informatics, Bergman Clinics Amsterdam, Naarden, The Netherlands. 4. Department of Neurosurgery, Bergman Clinics Amsterdam, Naarden, Rijksweg 69, 1411 GE, Naarden, The Netherlands.
Abstract
BACKGROUND: In modern clinical research, the accepted minimum follow-up for patient-reported outcome measures (PROMs) after lumbar spine surgery is 24 months, particularly after fusion. Recently, this minimum requirement has been called into question. PURPOSE: We aim to quantify the concordance of 1- and 2-year PROMs to evaluate the importance of long-term follow-up after elective lumbar spine surgery. STUDY DESIGN: Retrospective analysis of data from a prospective registry. PATIENT SAMPLE: We identified all patients in our prospective institutional registry who underwent degenerative lumbar spine surgery with complete baseline, 12-month, and 24-month follow-up for ODI and numeric rating scales for back and leg pain (NRS-BP and NRS-LP). OUTCOME MEASURES: Oswestry Disability Index (ODI) and NRS-BP and NRS-LP at 1 year and at 2 years. METHODS: We evaluated concordance of 1- and 2-year change scores by means of Pearson's product-moment correlation and performed logistic regression to assess if achieving the minimum clinically important difference (MCID) at 12 months predicted 24-month MCID. Odds ratios (OR) and their 95% confidence intervals (CI), as well as model areas-under-the-curve were obtained. RESULTS: A total of 210 patients were included. We observed excellent correlation among 12- and 24-month ODI (r = 0.88), NRS-LP (r = 0.76) and NRS-BP (r = 0.72, all p <.001). Equal results were obtained when stratifying for discectomy, decompression, or fusion. Patients achieving 12-month MCID were likely to achieve 24-month MCID for ODI (OR: 3.3, 95% CI: 2.4-4.1), NRS-LP (OR: 2.99, 95% CI: 2.2-4.2) and NRS-BP (OR: 3.4, 95% CI: 2.7-4.2, all p <.001) with excellent areas-under-the-curve values of 0.81, 0.77, and 0.84, respectively. Concordance rates between MCID at both follow-ups were 87.2%, 83.8%, and 84.2%. A post-hoc power analysis demonstrated sufficient statistical power. CONCLUSIONS: Irrespective of the surgical procedure, 12-month PROMs for functional disability and pain severity accurately reflect those at 24 months. In support of previous literature, our results suggest that 12 months of follow-up may be sufficient for evaluating spinal patient care in clinical practice as well as in research.
BACKGROUND: In modern clinical research, the accepted minimum follow-up for patient-reported outcome measures (PROMs) after lumbar spine surgery is 24 months, particularly after fusion. Recently, this minimum requirement has been called into question. PURPOSE: We aim to quantify the concordance of 1- and 2-year PROMs to evaluate the importance of long-term follow-up after elective lumbar spine surgery. STUDY DESIGN: Retrospective analysis of data from a prospective registry. PATIENT SAMPLE: We identified all patients in our prospective institutional registry who underwent degenerative lumbar spine surgery with complete baseline, 12-month, and 24-month follow-up for ODI and numeric rating scales for back and leg pain (NRS-BP and NRS-LP). OUTCOME MEASURES: Oswestry Disability Index (ODI) and NRS-BP and NRS-LP at 1 year and at 2 years. METHODS: We evaluated concordance of 1- and 2-year change scores by means of Pearson's product-moment correlation and performed logistic regression to assess if achieving the minimum clinically important difference (MCID) at 12 months predicted 24-month MCID. Odds ratios (OR) and their 95% confidence intervals (CI), as well as model areas-under-the-curve were obtained. RESULTS: A total of 210 patients were included. We observed excellent correlation among 12- and 24-month ODI (r = 0.88), NRS-LP (r = 0.76) and NRS-BP (r = 0.72, all p <.001). Equal results were obtained when stratifying for discectomy, decompression, or fusion. Patients achieving 12-month MCID were likely to achieve 24-month MCID for ODI (OR: 3.3, 95% CI: 2.4-4.1), NRS-LP (OR: 2.99, 95% CI: 2.2-4.2) and NRS-BP (OR: 3.4, 95% CI: 2.7-4.2, all p <.001) with excellent areas-under-the-curve values of 0.81, 0.77, and 0.84, respectively. Concordance rates between MCID at both follow-ups were 87.2%, 83.8%, and 84.2%. A post-hoc power analysis demonstrated sufficient statistical power. CONCLUSIONS: Irrespective of the surgical procedure, 12-month PROMs for functional disability and pain severity accurately reflect those at 24 months. In support of previous literature, our results suggest that 12 months of follow-up may be sufficient for evaluating spinal patient care in clinical practice as well as in research.
Authors: Ayesha Quddusi; Hubert A J Eversdijk; Anita M Klukowska; Marlies P de Wispelaere; Julius M Kernbach; Marc L Schröder; Victor E Staartjes Journal: Eur Spine J Date: 2019-10-22 Impact factor: 3.134
Authors: I David Kaye; Terry Fang; Scott C Wagner; Joseph S Butler; Arjun Sebastian; Patrick B Morrissey; Marc J Levine; Alex R Vaccaro; Alan S Hilibrand Journal: Global Spine J Date: 2019-11-20
Authors: Moira Vieli; Victor E Staartjes; Hubert A J Eversdjik; Marlies P De Wispelaere; Jan Wolter A Oosterhuis; Marc L Schröder Journal: Cureus Date: 2019-08-07
Authors: Victor E Staartjes; Granit Molliqaj; Paulien M van Kampen; Hubert A J Eversdijk; Aymeric Amelot; Christoph Bettag; Jasper F C Wolfs; Sophie Urbanski; Farman Hedayat; Carsten G Schneekloth; Mike Abu Saris; Michel Lefranc; Johann Peltier; Duccio Boscherini; Ingo Fiss; Bawarjan Schatlo; Veit Rohde; Yu-Mi Ryang; Sandro M Krieg; Bernhard Meyer; Nikolaus Kögl; Pierre-Pascal Girod; Claudius Thomé; Jos W R Twisk; Enrico Tessitore; Marc L Schröder Journal: BMJ Open Date: 2019-09-08 Impact factor: 2.692