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Archives of orthopaedic and trauma surgery
May, 2024;144 (5): 2257-2266.

Patient reported outcome measures (PROMs) as primary and secondary outcomes in total hip and knee arthroplasty randomized controlled trials: a systematic review.

Charles R Reiter, Vivek M Abraham, Daniel L Riddle, Nirav K Patel, Ashton H Goldman
Author Information
  1. Charles R Reiter: Department of Orthopaedic Surgery, Virginia Commonwealth University, Richmond, VA, USA.
  2. Vivek M Abraham: Department of Orthopaedics, Naval Medical Center Portsmouth, 620 John Paul Jones Circle, Portsmouth, VA, 23708, USA.
  3. Daniel L Riddle: Department of Orthopaedic Surgery, Virginia Commonwealth University, Richmond, VA, USA.
  4. Nirav K Patel: Department of Orthopaedic Surgery, Virginia Commonwealth University, Richmond, VA, USA.
  5. Ashton H Goldman: Department of Orthopaedics, Naval Medical Center Portsmouth, 620 John Paul Jones Circle, Portsmouth, VA, 23708, USA. ashton.goldman@gmail.com. ORCID
PMID: 38561507 DOI: 10.1007/s00402-024-05242-4

Abstract

BACKGROUND: Significant heterogeneity exists regarding patient reported outcome measures (PROMs) used in total hip (THA) and knee (TKA) arthroplasty randomized controlled trials (RCTs). This study investigates the PROMs used as primary and secondary outcomes in contemporary arthroplasty RCTs.
METHODS: A literature search identified THA and TKA RCTs that were published in top ten impact factor orthopaedic journals from 2017 to 2021. Screening identified 241 trials: 76 THA, 157 TKA, and eight combined. Data were extracted to identify PROMs utilized as either primary or secondary outcomes and the time period of measurement.
RESULTS: Visual Analog Scale (VAS) pain was the most reported primary PROM in THA (9.2%) and TKA (22.9%) trials. This was followed by Numeric Rating Scale (NRS) pain (7.9%) and the Harris hip score (6.6%) in THA trials and NRS pain (4.5%) and the Knee Society score (4.5%) in TKA trials. Many THA (37.0%) and TKA (52.1%) trials did not clearly specify primary outcome time points. Only pain scales were reported at time points less than one week, while various joint-specific functional outcomes were reported at later time points. As secondary outcomes, the Harris hip score (28.9%) was most common in THA trials and the Knee Society score (26.1%) was most common in TKA trials. Indeterminate primary or secondary outcomes were reported in 18.2% of studies.
CONCLUSIONS: Contemporary THA and TKA trials exhibit heterogeneity of PROMs as study outcomes after the first postoperative week. Our findings highlight the need for consensus in PROM reporting and better methodological reporting to improve the interpretability of RCT outcomes.
PROSPERO REGISTRATION NUMBER: CRD42022337255.

Keywords

Patient reported outcome measure Randomized controlled trial Total hip arthroplasty Total knee arthroplasty

References

  1. Alghadir AH, Anwer S, Iqbal A, Iqbal ZA (2018) Test-retest reliability, validity, and minimum detectable change of visual analog, numerical rating, and verbal rating scales for measurement of osteoarthritic knee pain. J Pain Res 11:851���856 [DOI: 10.2147/JPR.S158847]
  2. Behrend H, Giesinger K, Giesinger JM, Kuster MS (2012) The ���forgotten joint��� as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty 27(3):430-436.e431 [DOI: 10.1016/j.arth.2011.06.035]
  3. Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW (1988) Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 15(12):1833���1840 [PMID: 3068365]
  4. Blasco JM, Acosta-Ballester Y, Igual-Camacho C et al (2020) Preferred outcome measures used in randomized clinical trials of total knee replacement rehabilitation: a systematic review. PM R 12(7):706���713 [DOI: 10.1002/pmrj.12312]
  5. Browne JP, Bastaki H, Dawson J (2013) What is the optimal time point to assess patient-reported recovery after hip and knee replacement? A systematic review and analysis of routinely reported outcome data from the English patient-reported outcome measures programme. Health Qual Life Outcomes 11(1):128 [DOI: 10.1186/1477-7525-11-128]
  6. Cuellar Do NPC (2015) Evaluating pain in orthopedic patients: can the visual analog scale be used as a long-term outcome instrument? J Pain Relief. https://doi.org/10.4172/2167-0846.1000182 [DOI: 10.4172/2167-0846.1000182]
  7. de Nies F, Fidler MW (1997) Visual analog scale for the assessment of total hip arthroplasty. J Arthroplasty 12(4):416���419 [DOI: 10.1016/S0883-5403(97)90197-2]
  8. Deckey DG, Verhey JT, Christopher ZK et al (2023) Discordance abounds in minimum clinically important differences in THA: a systematic review. Clin Orthop Relat Res 481(4):702���714 [DOI: 10.1097/CORR.0000000000002434]
  9. Deckey DG, Verhey JT, Gerhart CRB et al (2023) There are considerable inconsistencies among minimum clinically important differences in TKA: a systematic review. Clin Orthop Relat Res 481(1):63���80 [DOI: 10.1097/CORR.0000000000002440]
  10. Eckhard L, Munir S, Wood D et al (2021) The ceiling effects of patient reported outcome measures for total knee arthroplasty. Orthop Traumatol Surg Res 107(3):102758 [DOI: 10.1016/j.otsr.2020.102758]
  11. EuroQol G (1990) EuroQol���a new facility for the measurement of health-related quality of life. Health Policy 16(3):199���208 [DOI: 10.1016/0168-8510(90)90421-9]
  12. Fidai MS, Saltzman BM, Meta F et al (2018) Patient-reported outcomes measurement information system and legacy patient-reported outcome measures in the field of orthopaedics: a systematic review. Arthroscopy 34(2):605���614 [DOI: 10.1016/j.arthro.2017.07.030]
  13. Finch DJ, Martin BI, Franklin PD, Magder LS, Pellegrini VD (2020) Patient-reported outcomes following total hip arthroplasty: a multicenter comparison based on surgical approaches. J Arthroplasty 35(4):1029-1035.e1023 [DOI: 10.1016/j.arth.2019.10.017]
  14. Gagnier JJ, Huang H, Mullins M et al (2018) Measurement properties of patient-reported outcome measures used in patients undergoing total hip arthroplasty: a systematic review. JBJS Rev 6(1):e2 [DOI: 10.2106/JBJS.RVW.17.00038]
  15. Gagnier JJ, Mullins M, Huang H et al (2017) A systematic review of measurement properties of patient-reported outcome measures used in patients undergoing total knee arthroplasty. J Arthroplasty 32(5):1688-1697.e1687 [DOI: 10.1016/j.arth.2016.12.052]
  16. Harris WH (1969) Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Jt Surg Am 51(4):737���755 [DOI: 10.2106/00004623-196951040-00012]
  17. Hjermstad MJ, Fayers PM, Haugen DF et al (2011) Studies comparing numerical rating scales, verbal rating scales, and visual analogue scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manag 41(6):1073���1093 [DOI: 10.1016/j.jpainsymman.2010.08.016]
  18. Hoeffel DP, Daly PJ, Kelly BJ, Giveans MR (2019) Outcomes of the first 1,000 total hip and total knee arthroplasties at a same-day surgery center using a rapid-recovery protocol. J Am Acad Orthop Surg Glob Res Rev 3(3):e022 [PMID: 31157316]
  19. Huddleston III JI (2023) Patient-reported outcome measures in total hip and knee arthroplasty are here to stay. AAOS Now
  20. Khalil LS, Darrith B, Franovic S, Davis JJ, Weir RM, Banka TR (2020) Patient-reported outcomes measurement information system (PROMIS) global health short forms demonstrate responsiveness in patients undergoing knee arthroplasty. J Arthroplasty 35(6):1540���1544 [DOI: 10.1016/j.arth.2020.01.032]
  21. Lim CR, Harris K, Dawson J, Beard DJ, Fitzpatrick R, Price AJ (2015) Floor and ceiling effects in the OHS: an analysis of the NHS PROMs data set. BMJ Open 5(7):e007765 [DOI: 10.1136/bmjopen-2015-007765]
  22. Maratt JD, Lee YY, Lyman S, Westrich GH (2015) Predictors of satisfaction following total knee arthroplasty. J Arthroplasty 30(7):1142���1145 [DOI: 10.1016/j.arth.2015.01.039]
  23. Moher D, Hopewell S, Schulz KF et al (2012) CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg 10(1):28���55 [DOI: 10.1016/j.ijsu.2011.10.001]
  24. Mohtadi NG, Pedersen ME, Chan D (2011) CHAPTER 8���assessing outcomes after hip surgery. In: Sekiya JK, Safran MR, Ranawat AS, Leunig M (eds) Techniques in hip arthroscopy and joint preservation surgery. W. B. Saunders, Philadelphia, pp 74���85 [DOI: 10.1016/B978-1-4160-5642-3.00008-6]
  25. Nilsdotter A, Bremander A (2011) Measures of hip function and symptoms: Harris Hip Score (HHS), Hip Disability and Osteoarthritis Outcome Score (HOOS), Oxford Hip Score (OHS), Lequesne Index of Severity for Osteoarthritis of the Hip (LISOH), and American Academy of Orthopedic Surgeons (AAOS) Hip and Knee Questionnaire. Arthritis Care Res (Hoboken) 63(Suppl 11):S200-207 [PMID: 22588745]
  26. Nilsdotter AK, Lohmander LS, Klassbo M, Roos EM (2003) Hip disability and osteoarthritis outcome score (HOOS)���validity and responsiveness in total hip replacement. BMC Musculoskelet Disord 4:10 [DOI: 10.1186/1471-2474-4-10]
  27. Ogon M, Krismer M, Sollner W, Kantner-Rumplmair W, Lampe A (1996) Chronic low back pain measurement with visual analogue scales in different settings. Pain 64(3):425���428 [DOI: 10.1016/0304-3959(95)00208-1]
  28. Page MJ, McKenzie JE, Bossuyt PM et al (2021) The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 372:n71 [DOI: 10.1136/bmj.n71]
  29. Richards BL, Wall PDH, Sprowson AP, Singh JA, Buchbinder R (2017) Outcome measures used in arthroplasty trials: systematic review of the 2008 and 2013 literature. J Rheumatol 44(8):1277���1287 [DOI: 10.3899/jrheum.161477]
  30. Riddle DL, Goldman AH, Tarver T, Patel NK (2022) Examination of randomized trials and corresponding trial registry entries: registration timing and primary outcome analysis in the journal of arthroplasty. J Arthroplasty 37(8):1645-1649.e1647 [DOI: 10.1016/j.arth.2022.02.105]
  31. Riddle DL, Stratford PW, Bowman DH (2008) Findings of extensive variation in the types of outcome measures used in hip and knee replacement clinical trials: a systematic review. Arthritis Rheum 59(6):876���883 [DOI: 10.1002/art.23706]
  32. Rolfson O, Bohm E, Franklin P et al (2016) Patient-reported outcome measures in arthroplasty registries Report of the Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty Registries Part II. Recommendations for selection, administration, and analysis. Acta Orthop 87(Suppl 1):9���23 [DOI: 10.1080/17453674.2016.1181816]
  33. Roos EM, Lohmander LS (2003) The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes 1:64 [DOI: 10.1186/1477-7525-1-64]
  34. Soderman P, Malchau H (2001) Is the Harris hip score system useful to study the outcome of total hip replacement? Clin Orthop Relat Res 384:189���197 [DOI: 10.1097/00003086-200103000-00022]
  35. Stephan A, Stadelmann VA, Leunig M, Impellizzeri FM (2021) Measurement properties of PROMIS short forms for pain and function in total hip arthroplasty patients. J Patient-Report Outcomes 5(1):1���7 [DOI: 10.1186/s41687-021-00313-1]
  36. Theodoulou A, Bramwell DC, Spiteri AC, Kim SW, Krishnan J (2016) The use of scoring systems in knee arthroplasty: a systematic review of the literature. J Arthroplasty 31(10):2364-2370.e2368 [DOI: 10.1016/j.arth.2016.05.055]
  37. Vajapey SP, Morris J, Spitzer AI, Glassman AH, Greco NJ, Li M (2020) Outcome reporting patterns in total knee arthroplasty: a systematic review. J Clin Orthop Trauma 11(Suppl 4):S464���S471 [DOI: 10.1016/j.jcot.2020.05.014]
  38. Wang Y, Yin M, Zhu S, Chen X, Zhou H, Qian W (2021) Patient-reported outcome measures used in patients undergoing total knee arthroplasty. Bone Jt Res 10(3):203���217 [DOI: 10.1302/2046-3758.103.BJR-2020-0268.R1]
  39. Ware JE Jr, Sherbourne CD (1992) The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 30(6):473���483 [DOI: 10.1097/00005650-199206000-00002]
  40. Williamson A, Hoggart B (2005) Pain: a review of three commonly used pain rating scales. J Clin Nurs 14(7):798���804 [DOI: 10.1111/j.1365-2702.2005.01121.x]
  41. Zhang J, Chen X, Zhu Q, Cui J, Cao L, Su J (2016) Methodological reporting quality of randomized controlled trials: a survey of seven core journals of orthopaedics from Mainland China over 5 years following the CONSORT statement. Orthop Traumatol Surg Res 102(7):933���938 [DOI: 10.1016/j.otsr.2016.05.018]

MeSH Term

Humans
Arthroplasty, Replacement, Knee
Patient Reported Outcome Measures
Arthroplasty, Replacement, Hip
Randomized Controlled Trials as Topic
Pain Measurement
Journal Article Systematic Review

Word Cloud

Created with Highcharts 10.0.0THATKAtrialsoutcomesreportedprimaryPROMsarthroplastysecondaryoutcometimescorehipkneecontrolledRCTsPain9%pointsheterogeneitymeasuresusedtotalrandomizedstudyidentifiedtrials:ScalePROM2%NRSHarrisHip45%KneeSociety1%weekcommonreportingPatientTotalBACKGROUND:SignificantexistsregardingpatientinvestigatescontemporaryMETHODS:literaturesearchpublishedtoptenimpactfactororthopaedicjournals20172021Screening24176157eightcombinedDataextractedidentifyutilizedeitherperiodmeasurementRESULTS:VisualAnalogVAS922followedNumericRating766%Many370%52clearlyspecifypainscaleslessonevariousjoint-specificfunctionallater2826Indeterminate18studiesCONCLUSIONS:ContemporaryexhibitfirstpostoperativefindingshighlightneedconsensusbettermethodologicalimproveinterpretabilityRCTPROSPEROREGISTRATIONNUMBER:CRD42022337255systematicreviewmeasureRandomizedtrial

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