The use of electronic PROMs provides same outcomes as paper version in a spine surgery registry. Results from a prospective cohort study

European Spine Journal - Tập 30 Số 9 - Trang 2645-2653 - 2021
Francesco Langella1, Paolo Barletta1, Alice Baroncini1, Matteo Agarossi1, Laura Scaramuzzo1, Andrea De Luca1, Roberto Bassani1, G. Peretti2, Claudio Lamartina1, Jorge Hugo Villafañe3, Pedro Berjano1
1IRCCS Istituto Ortopedico Galeazzi, Milano, Italy
2Department of Biomedical Sciences for Health, University of Milan, Milan, Italy
3IRCCS Fondazione Don Carlo Gnocchi, Milano, Italy

Tóm tắt

Abstract Background and Purpose Patient-Reported Measured Outcomes (PROMs) are essential to gain a full understanding of a patient’s condition, and in spine surgery, these questionnaires are of help when tailoring a surgical strategy. Electronic registries allow for a systematic collection and storage of PROMs, making them readily available for clinical and research purposes. This study aimed to investigate the reliability between the electronic and paper form of ODI (Oswestry Disability Index), SF-36 (Short Form Health Survey 36) and COMI-back (Core Outcome Measures Index for the back) questionnaires. Methods A prospective analysis was performed of ODI, SF-36 and COMI-back questionnaires collected in paper and electronic format in two patients’ groups: Pre-Operatively (PO) or at follow-up (FU). All patients, in both groups, completed the three questionnaires in paper and electronic form. The correlation between both methods was assessed with the Intraclass Correlation Coefficients (ICC). Results The data from 100 non-consecutive, volunteer patients with a mean age of 55.6 ± 15.0 years were analysed. For all of the three PROMs, the reliability between paper and electronic questionnaires results was excellent (ICC: ODI = 0.96; COMI = 0.98; SF36-MCS = 0.98; SF36-PCS = 0.98. For all p < 0.001). Conclusions This study proved an excellent reliability between the electronic and paper versions of ODI, SF-36 and COMI-back questionnaires collected using a spine registry. This validation paves the way for stronger widespread use of electronic PROMs. They offer numerous advantages in terms of accessibility, storage, and data analysis compared to paper questionnaires.

Từ khóa


Tài liệu tham khảo

Hoy D, Brooks P, Blyth F, Buchbinder R (2010) The epidemiology of low back pain. Best Pract Res Clin Rheumatol 24:769–781. https://doi.org/10.1016/j.berh.2010.10.002

Zanirato A, Damilano M, Formica M et al (2018) Complications in adult spine deformity surgery: a systematic review of the recent literature with reporting of aggregated incidences. Eur Spine J 27:2272–2284. https://doi.org/10.1007/s00586-018-5535-y

Cortesi PA, Assietti R, Cuzzocrea F, et al (2017) Epidemiologic and economic burden attributable to first spinal fusion surgery: analysis from an Italian administrative database. spine (Phila Pa 1976). doi: https://doi.org/10.1097/BRS.0000000000002118

Finkelstein JA, Schwartz CE (2019) Patient-reported outcomes in spine surgery: past, current, and future directions. J Neurosurg Spine 31:155–164. https://doi.org/10.3171/2019.1.SPINE18770

Langella F, Villafañe JH, Damilano M, et al (2017) Predictive accuracy of surgimap surgical planning for sagittal imbalance: a cohort study. Spine (Phila Pa 1976) 42:E1297–E1304. doi: https://doi.org/10.1097/BRS.0000000000002230

Berjano P, Langella F, Ismael M-F et al (2014) Successful correction of sagittal imbalance can be calculated on the basis of pelvic incidence and age. Eur Spine J 23(Suppl 6):587–596. https://doi.org/10.1007/s00586-014-3556-8

Röder C, Müller U, Aebi M (2006) The rationale for a spine registry. Eur Spine J 15:S52–S56. https://doi.org/10.1007/s00586-005-1050-z

Azad TD, Kalani M, Wolf T et al (2016) Building an electronic health record integrated quality of life outcomes registry for spine surgery. J Neurosurg Spine 24:176–185. https://doi.org/10.3171/2015.3.SPINE141127

Park JY, Kim BS, Lee HJ et al (2019) Comparison between an electronic version of the foot and ankle outcome score and the standard paper version: a randomized multicenter study. Medicine (Baltimore) 98:e17440. https://doi.org/10.1097/MD.0000000000017440

Ismael M, Villafañe JH, Cabitza F et al (2018) Spine surgery registries: hope for evidence-based spinal care? J spine Surg (Hong Kong) 4:456–458. https://doi.org/10.21037/jss.2018.05.19

Rankin G, Stokes M (1998) Reliability of assessment tools in rehabilitation: an illustration of appropriate statistical analyses. Clin Rehabil 12:187–199. https://doi.org/10.1191/026921598672178340

Monticone M, Baiardi P, Vanti C et al (2012) Responsiveness of the oswestry disability index and the roland morris disability questionnaire in italian subjects with sub-acute and chronic low back pain. Eur Spine J 21:122–129. https://doi.org/10.1007/s00586-011-1959-3

Apolone G, Mosconi P (1998) The Italian SF-36 health survey: translation, validation and norming. J Clin Epidemiol 51:1025–1036. https://doi.org/10.1016/s0895-4356(98)00094-8

Mannion AF, Boneschi M, Teli M et al (2012) Reliability and validity of the cross-culturally adapted Italian version of the Core Outcome Measures Index. Eur Spine J 21. https://doi.org/10.1007/s00586-011-1741-6

Neukamp M, Perler G, Pigott T et al (2013) Spine Tango annual report 2012. Eur Spine J 22(Suppl 5):767–786. https://doi.org/10.1007/s00586-013-2943-x

Mannion AF, Porchet F, Kleinstück FS, et al (2009) The quality of spine surgery from the patient’s perspective: part 2. Minimal clinically important difference for improvement and deterioration as measured with the Core Outcome Measures Index. Eur Spine J 18 Suppl 3:374–9 . doi: https://doi.org/10.1007/s00586-009-0931-y

Brazier JE, Harper R, Jones NMB et al (1992) Validating the SF-36 health survey questionnaire: New outcome measure for primary care. Br Med J 305:160–164. https://doi.org/10.1136/bmj.305.6846.160

Fairbank JC, Pynsent PB (2000) The Oswestry Disability Index. Spine (Phila Pa 1976) 25:2940–52; discussion 2952. doi: https://doi.org/10.1097/00007632-200011150-00017

Landis JR, Koch GG (1977) The measurement of observer agreement for categorical data. Biometrics 33:159–174

Koo TK, Li MY (2016) A guideline of selecting and reporting intraclass correlation coefficients for reliability research. J Chiropr Med 15:155–163. https://doi.org/10.1016/j.jcm.2016.02.012

Weir JP (2005) Quantifying test-retest reliability using the intraclass correlation coefficient and the SEM. J strength Cond Res 19:231–240. https://doi.org/10.1519/15184.1

Beckerman H, Roebroeck ME, Lankhorst GJ et al (2001) Smallest real difference, a link between reproducibility and responsiveness. Qual Life Res. https://doi.org/10.1023/A:1013138911638

Bland JM, Altman DG (1986) Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1:307–310

Schröder ML, de Wispelaere MP, Staartjes VE (2019) Are patient-reported outcome measures biased by method of follow-up? Evaluating paper-based and digital follow-up after lumbar fusion surgery. Spine J 19:65–70. https://doi.org/10.1016/j.spinee.2018.05.002

Copay AG, Glassman SD, Subach BR et al (2008) Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the oswestry disability index, medical outcomes study questionnaire short form 36, and pain scales. Spine J 8:968–974. https://doi.org/10.1016/j.spinee.2007.11.006

Mayer CS, Williams N, Fung KW, Huser V (2019) Evaluation of research accessibility and data elements of HIV registries. Curr HIV Res 17:258–265. https://doi.org/10.2174/1570162X17666190924195439

Bergman D, Bethell C, Gombojav N et al (2020) Physical distancing with social connectedness. Ann Fam Med 18:272–277. https://doi.org/10.1370/afm.2538

Merkel S, Hess M (2020) The use of internet-based health and care services by elderly people in europe and the importance of the country context: multilevel study. JMIR aging 3:e15491. https://doi.org/10.2196/15491

Basch E, Bennett A, Pietanza MC (2010) Use of patient-reported outcomes to improve the predictive accuracy of clinician-reported adverse events. J Natl Cancer Inst 103:1808–1810. https://doi.org/10.1093/jnci/djr493

Stey AM, Russell MM, Ko CY et al (2015) Clinical registries and quality measurement in surgery: a systematic review. Surg (United States) 157:381–395. https://doi.org/10.1016/j.surg.2014.08.097

Irwin ZN, Hilibrand A, Gustavel M, et al (2005) Variation in surgical decision making for degenerative spinal disorders. Part I: lumbar spine. Spine (Phila Pa 1976) 30:2208–13. doi: https://doi.org/10.1097/01.brs.0000181057.60012.08

Lubelski D, Williams SK, O’Rourke C, et al (2016) Differences in the surgical treatment of lower back pain among spine surgeons in the united states. Spine (Phila Pa 1976) 41:978–86 . doi: https://doi.org/10.1097/BRS.0000000000001396

Dui LG, Cabitza F, Berjano P (2018) Minimal important difference in outcome of disc degenerative disease treatment: the patients’ perspective. Stud Health Technol Inform 247:321–325

Haefeli M, Elfering A, Aebi M et al (2008) What comprises a good outcome in spinal surgery? A preliminary survey among spine surgeons of the SSE and European spine patients. Eur Spine J 17:104–116. https://doi.org/10.1007/s00586-007-0541-5

Diebo BG, Henry J, Lafage V, Berjano P (2015) Sagittal deformities of the spine: factors influencing the outcomes and complications. Eur Spine J 24(Suppl 1):S3-15. https://doi.org/10.1007/s00586-014-3653-8

Ghogawala Z, Dunbar MR, Essa I (2019) Lumbar spondylolisthesis: modern registries and the development of artificial intelligence. J Neurosurg Spine 30:729–735. https://doi.org/10.3171/2019.2.SPINE18751

Campagner A, Berjano P, Lamartina C et al (2020) Assessment and prediction of spine surgery invasiveness with machine learning techniques. Comput Biol Med 121:103796. https://doi.org/10.1016/j.compbiomed.2020.103796

Alyass A, Turcotte M, Meyre D (2015) From big data analysis to personalized medicine for all: Challenges and opportunities. BMC Med Genomics 8:1–12. https://doi.org/10.1186/s12920-015-0108-y

O’Connell S, Palmer R, Withers K et al (2018) Requirements for the collection of electronic PROMS either “in clinic” or “at home” as part of the PROMs, PREMs and effectiveness programme (PPEP) in Wales: a feasibility study using a generic PROM tool. Pilot Feasibility Stud 4:1–13. https://doi.org/10.1186/s40814-018-0282-8

Nelson EC, Dixon-Woods M, Batalden PB et al (2016) Patient focused registries can improve health, care, and science. BMJ 354:1–6. https://doi.org/10.1136/bmj.i3319

Larsson S, Lawyer P, Garellick G et al (2012) Use of 13 disease registries in 5 countries demonstrates the potential to use outcome data to improve health care’s value. Health Aff 31:220–227. https://doi.org/10.1377/hlthaff.2011.0762

Dietz N, Sharma M, Alhourani A et al (2018) Variability in the utility of predictive models in predicting patient-reported outcomes following spine surgery for degenerative conditions: a systematic review. Neurosurg Focus 45:E10. https://doi.org/10.3171/2018.8.FOCUS18331

Fullerton M, Edbrooke-Childs J, Law D et al (2018) Using patient-reported outcome measures to improve service effectiveness for supervisors: a mixed-methods evaluation of supervisors’ attitudes and self-efficacy after training to use outcome measures in child mental health. Child Adolesc Ment Health 23:34–40. https://doi.org/10.1111/camh.12206

Thông tin
Thông tin xuất bản

European Spine Journal

Tập 30 Số 9

2645-2653

Thông tin tác giả