Display options
Share it on

J Orthop Trauma. 2021 Mar 01;35:S6-S12. doi: 10.1097/BOT.0000000000002038.

Real-World Evidence: A Review of Real-World Data Sources Used in Orthopaedic Research.

Journal of orthopaedic trauma

David J Hak, John I Mackowiak, Debra E Irwin, Molly L Aldridge, Christina D Mack

Affiliations

  1. Hughston Orthopaedic Trauma Surgeons, Central Florida Regional Hospital, Sanford, FL.
  2. Center for Outcomes Research, Cedar Point NC.
  3. IBM Watson Health, Durham, NC.
  4. Aldridge Medical Writing & Consulting, Chapel Hill, NC; and.
  5. IQVIA Real-World Solutions, Durham, NC.

PMID: 33587540 DOI: 10.1097/BOT.0000000000002038

Abstract

SUMMARY: Real-world data (RWD) play an increasingly important role in orthopaedics as demonstrated by the rapidly growing number of publications using registry, administrative, and other databases. Each type of RWD source has its strengths and weaknesses, as does each specific database. Linkages between real-world data sets provide even greater utility and value for research than single data sources. The unique qualities of an RWD data source and all data linkages should be considered before use. Close attention to data quality and use of appropriate analysis methods can help alleviate concerns about validity of orthopaedic studies using RWD. This article describes the main types of RWD used in orthopaedics and provides brief descriptions and a sample listing of publications from selected, key data sources.

Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.

References

  1. Karlson NW, Nezwek TA, Menendez ME, et al. Increased utilization of American administrative databases and large-scale clinical registries in orthopaedic research, 1996 to 2016. JAAOS Glob Res Rev. 2018;2:e076. - PubMed
  2. Bedard NA, Pugely AJ, McHugh MA, et al. Big data and Tttal hip arthroplasty: how do large databases compare? J Arthroplasty. 2018;33:41–45. - PubMed
  3. Dreyer N. 2 Advancing a framework for regulatory use of real-world evidence: when real is reliable. Ther Innov Reg Sci. 2018;52:362–368. - PubMed
  4. US Food and Drug Administration (FDA). Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices [www.fda.gov]. 2017. Available at: https://www.fda.gov/media/99447/download. Accessed January 25, 2020. - PubMed
  5. Ritchey MB, Girman CJ. Evaluating the feasibility of electronic health records and claims data sources for specific research purposes. Ther Innov Regul Sci. 2020;54:1296–1302. - PubMed
  6. Martin GS. The essential nature of healthcare databases in critical care medicine. Crit Care. 2008;12:176. - PubMed
  7. Pugely AJ, Martin CT, Harwood J, et al. Database and registry research in orthopaedic surgery: Part 1: claims-based data. J Bone Joint Surg Am. 2015a;97:1278–1287. - PubMed
  8. Curtis JR, Sathitratanacheewin S, Starks H, et al. Using electronic health records for quality measurement and accountability in care of the seriously Ill: opportunities and challenges. J Palliat Med. 2018;21: S52–S60. - PubMed
  9. Callahan A, Fries JA, Ré C, et al. Medical device surveillance with electronic health records. NPJ Digit Med. 2019;2:94. - PubMed
  10. Patel AA, Singh K, Nunley RM, et al. Administrative databases in orthopaedic research: pearls and pitfalls of big data. J Am Acad Ortho Surg. 2016;24:172–179. - PubMed
  11. Mues KE, Liede A, Liu J, et al. Use of the Medicare database in epidemiologic and health services research: a valuable source of real-world evidence on the older and disabled populations in the US. Clin Epidemiol. 2017;9:267–277. - PubMed
  12. Carson JT, Shah SG, Ortega G, et al. Complications of pelvic and acetabular fractures in 1331 morbidly obese patients (BMI ≥40): a retrospective observational study from the National Trauma Data Bank. Patient Saf Surg. 2018;12:26. - PubMed
  13. Marmor M, Elson J, Mikhail C, et al. Short-term pelvic fracture outcomes in adolescents differ from children and adults in the National Trauma Data Bank. J Child Orthop. 2015;9:65–75. - PubMed
  14. Cram P, Hawker G, Matelski J, et al. Disparities in knee and hip arthroplasty outcomes: an observational analysis of the ACS-NSQIP clinical registry. J Racial Ethn Health Disparities. 2018;5:151–161. - PubMed
  15. Shillingford JN, Laratta JL, Lombardi JM, et al. Complications following single-level interbody fusion: an ACS-NSQIP study. J Spine Surg. 2018;4:17–27. - PubMed
  16. Khan M, Jehan F, O'Keeffe T, et al. Oral Xa inhibitors versus low molecular weight heparin for thromboprophylaxis after nonoperative spine trauma. J Surg Res. 2018;232:82–87. - PubMed
  17. Lamb LC, Montgomery SC, Wong Won B, et al. A multidisciplinary approach to improve the quality of care for patients with fragility fractures. J Orthop. 2017;14:247–251. - PubMed
  18. Gioe T, Sharma A, Tatman P, et al. Do “premium” joint implants add value? Analysis of high cost joint implants in a community registry. Clin Orthop Relat Res. 2011;469:48–54. - PubMed
  19. Johnson T, Tatman P, Mehle S, et al. Revision surgery for patellofemoral problems: should we always resurface? Clin Orthop Relat Res. 2012;470:211–219. - PubMed
  20. Singh JA, Kundukulam BS, Bhandari M. A systematic review of validated methods for identifying orthopedic implant removal and revision using administrative data. Pharmacoepidemiol Drug Saf. 2012;21(suppl 1):265–273. - PubMed
  21. Traven SA, Reeves RA, Althoff AD, et al. New five-factor modified frailty index predicts morbidity and mortality in geriatric hip fractures. J Orthop Trauma. 2019;33:319–323. - PubMed
  22. Liu JN, Agarwalla A, Gowd AK, et al. Reverse shoulder arthroplasty for proximal humerus fracture: a more complex episode of care than for cuff tear arthropathy. J Shoulder Elbow Surg. 2019;28:2139–2146. - PubMed
  23. Schwartz BE, Shah NR, Woon C, et al. In hospital outcomes of total hip arthroplasty in the Medicaid population. J Surg Orthop Adv. 2019;28:281–284. - PubMed
  24. Saben JL, Shelton SK, Hopkinson AJ, et al. The emergency medicine specimen bank: an innovative approach to biobanking in acute care. Acad Emerg Med. 2019;26:639–647. - PubMed
  25. Saluan P, Styron J, Ackley JF, et al. Injury types and incidence rates in precollegiate female gymnasts. Orthop J Sports Med. 2015;3:2325967115577596. - PubMed
  26. Shemory ST, Pfefferle KJ, Gradisar IM. Modifiable risk factors in patients with low back pain. Orthopedics. 2016;39:e413-416. - PubMed
  27. Wessel LE, Gu A, Richardson SS, et al. Elbow contracture following operative fixation of fractures about the elbow. JSES Open Access. 2019;3:261–265. - PubMed
  28. Dietz N, Sharma M, Alhourani A, et al. Outcomes of decompression and fusion for treatment of spinal infection. Neurosurg Focus. 2019;46:E7. - PubMed
  29. Han SS, Azad TD, Suarez PA, et al. A machine learning approach for predictive models of adverse events following spine surgery. Spine J. 2019;19:1772–1781. - PubMed
  30. Anis HK, Sodhi N, Vakharia RM, et al. Cost analysis of Medicare patients with varying complexities who underwent total knee arthroplasty. J Knee Surg. 2019. doi:10.1055/s-0039-1695716. [epub ahead of print]. - PubMed
  31. Madden MO, Palmer JR, Ameri BJ, et al. Trends in primary proximal interphalangeal joint system and revisions for osteoarthritis of the hand in the Medicare database. Hand (NY). 2020;15:818–823. - PubMed
  32. Herzog MM, Marshall SW, Lund JL, et al. Incidence of anterior cruciate ligament reconstruction among adolescent females in the United States, 2002 through 2014. JAMA Pediatr. 2017;171:808–810. - PubMed
  33. Mack C, Christian J, Brinkley E, et al. When context is hard to come by: external comparators and how to use them. Ther Innov Reg Sci. 2019a;5:2168479019878672. - PubMed
  34. Mosk CA, Mus M, Vroeman JP, et al. Dementia and delirium, the outcomes in elderly hip fracture patients. Clin Interv Aging. 2017;12:421–430. - PubMed
  35. Padmanabhan S, Carty L, Cameron E, et al. Approach to record linkage of primary care data from Clinical Practice Research Datalink to other health-related patient data: overview and implications. Eur J Epidemiol. 2019;34:91–99. - PubMed
  36. Weir S, Samnaliev M, Kuo TC, et al. The incidence and healthcare costs of persistent postoperative pain following lumbar spine surgery in the UK: a cohort study using the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES). BMJ Open. 2017;7:e017585. - PubMed
  37. Gliklich RE, Dreyer NA, Leavy MB. Registries for Evaluating Patient Outcomes: A User's Guide [Internet]. 3rd ed. Rockville, MD: Agency for Healthcare Research and Quality (US); 2014. - PubMed
  38. Pugely AJ, Martin CT, Harwood J, et al. Database and registry research in orthopaedic surgery: part 2: clinical registry data. J Bone Joint Surg Am. 2015b;97:1799–1808. - PubMed
  39. US Food and Drug Administration (FDA). Evaluation of Potential Data Sources for a National Network of Orthopedic Device Implant Registries—[Outcome Sciences, Inc., to the Food and Drug Administration—Electronic Letter]—Report [beta.regulations.gov]. 2009. Available at: https://beta.regulations.gov/document/FDA-2009-N-0192-0004. Accessed October 19, 2020. - PubMed
  40. Franklin PD, Lewallen D, Bozic K, et al. Implementation of patient-reported outcome measures in U.S. total joint replacement registries: rationale, status, and plans. J Bone Joint Surg Am. 2014;96(suppl 1):104–109. - PubMed
  41. Stea S, Comfort T, Sedrakyan A, et al. Multinational comprehensive evaluation of the fixation method used in hip replacement: interaction with age in context. J Bone Joint Surg Am. 2014;96:42–51. - PubMed
  42. Jarraya M, Guermazi A, Lorbergs AL, et al. A longitudinal study of disc height narrowing and facet joint osteoarthritis at the thoracic and lumbar spine, evaluated by computed tomography: the Framingham Study. Spine J. 2018;18:2065–2073. - PubMed
  43. Sentinel Initiative Final Assessment Report September 2017 [www.fda.gov]. 2017. Available at: https://www.fda.gov/media/107850/download. Accessed February 1, 2020. - PubMed
  44. Fleurence RL, Shuren J. Advances in the use of real-world evidence for medical devices: an update from the National Evaluation System for Health Technology. Clin Pharmacol Ther. 2019;106:30–33. - PubMed
  45. The National Evaluation System for Health Technology Coordinating Center (NESTcc) Announces New Real-World Evidence Test-Cases Solicited from across the Medical Device community [www.businesswire.com]. 2019. Available at: https://www.businesswire.com/news/home/20190604006034/en/National-Evaluation-System-health-Technology-Coordinating-Center. Accessed February 8, 2020. - PubMed
  46. Bohl DD, Singh K, Grauer JN. Nationwide databases in orthopaedic surgery research. J Am Acad Ortho Surg. 2016;24:673–682. - PubMed
  47. Memtsoudis SG, Besculides MC, Gaber L, et al. Risk factors for pulmonary embolism after hip and knee arthroplasty: a population-based study. Int Orthop. 2009;33:1739–1745. - PubMed
  48. Haüssler B, Gothe H, Göl D, et al. Epidemiology, treatment and costs of osteoporosis in Germany- the BoneEVA study. Osteoporos Int. 2007;18:77–84. - PubMed
  49. Mack CD, Meisel P, Herzog MM, et al. The establishment and refinement of the national Basketball association player injury and illness database. J Athl Train. 2019;54:466–471. - PubMed
  50. Dreyer NA, Mack CD, Anderson RB, et al. Lessons on data collection and curation from the NFL injury surveillance program. Sports Health. 2019;11:440–445. - PubMed
  51. Pratt NL, Mack CD, Meyer AM, et al. Data linkage in pharmacoepidemiology: a call for rigorous evaluation and reporting. Pharmacoepidemiol Drug Saf. 2019;1–9. - PubMed
  52. Benchimol EI, Smeeth L, Guttmann A, et al. The reporting of studies conducted using observational routinely‐collected health data (RECORD) statement. PLoS Med. 2015;12:e1001885. - PubMed
  53. Zura R, Irwin DE, Mack CD, et al. Real-world evidence: a primer. J Ortho Trauma. 2021;35(supple 1):S1–S5. - PubMed

MeSH terms

Publication Types