Skip to main content

Advertisement

SpringerLink
Log in

The quality of measurement properties of neurocognitive assessment in brain tumor clinical trials over the last 30 years: a COSMIN checklist-based approach

  • Review Article
  • Published:
Neurological Sciences Aims and scope Submit manuscript

Abstract

Purpose

To provide an exhaustive review of the neuropsychological examination as conducted in brain tumor clinical trials over the last 30 years and to provide objective ratings about the reliability and suitability of such tests in neurooncological research and clinical practice.

Methods

Methodologies and tools provided by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) were exploited in order to assess the measurement properties of questionnaires and performance-based instruments used to evaluate cognitive functioning in brain tumor clinical trials from 1997 to 2017.

Results

Twenty-six brain tumor clinical trials were analyzed and an overall set of 10 neuropsychological tests was identified. A list of 24 studies concerning the reliability of such tests was analyzed. Reliability and level of evidence scores for each study and for each test were obtained. The results revealed relevant faults about the quality of measurements and the suitability of the neurocognitive assessment batteries most commonly used in brain tumor clinical trials.

Conclusion

Our findings suggest that the cognitive assessment in brain tumor clinical trials should be implemented according to specific endpoints and should be addressed to investigate all the cognitive domains known to be affected by brain tumor and treatment.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

Notes

  1. In spite of the fact that the present paper is focused on the measurement properties of cognitive tests used in brain tumor neuropsychological assessment, no brain tumor studies addressing this issue were found.

References

  1. van Loon EM, Heijenbrok-Kal MH, van Loon WS, van den Bent MJ, Vincent AJ, de Koning I, Ribbers GM (2015) Assessment methods and prevalence of cognitive dysfunction in patients with low-grade glioma: a systematic review. J Rehabil Med 47(6):481–488

    Article  PubMed  Google Scholar 

  2. Meyers CA, Brown PD (2006) Role and relevance of neurocognitive assessment in clinical trials of patients with CNS tumors. J Clin Oncol 24(8):1305–1309

    Article  PubMed  Google Scholar 

  3. Tucha O, Smely C, Preier M, Lange KW (2000) Cognitive deficits before treatment among patients with brain tumors. Neurosurgery 47(2):324–334

    Article  CAS  PubMed  Google Scholar 

  4. Keime-Guibert F, Napolitano M, Delattre JY (1998) Neurological complications of radiotherapy and chemotherapy. J Neurol 245(11):695–708

    Article  CAS  PubMed  Google Scholar 

  5. Saad S, Wang TJ (2015) Neurocognitive deficits after radiation therapy for brain malignancies. Am J Clin Oncol 38(6):634–640

    Article  PubMed  Google Scholar 

  6. Douw L, Klein M, Fagel SS, van den Heuvel J, Taphoorn MJ, Aaronson NK et al (2009) Cognitive and radiological effects of radiotherapy in patients with low-grade glioma: long-term follow-up. Lancet Neurol 8(9):810–818

    Article  PubMed  Google Scholar 

  7. Helfer JL, Wen PY, Blakeley J, Gilbert MR, Armstrong TS (2016) Report of the Jumpstarting Brain Tumor Drug Development Coalition and FDA clinical trials clinical outcome assessment endpoints workshop (October 15, 2014, Bethesda MD). Neuro-oncology 18(suppl_2):ii26–ii36

    Article  PubMed  PubMed Central  Google Scholar 

  8. Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL et al (2012) COSMIN checklist manual. University Medical Center, Amsterdam

    Google Scholar 

  9. Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, de Vet HCW (2010) The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res 19(4):539–549

    Article  PubMed  PubMed Central  Google Scholar 

  10. Folstein MF, Folstein SE, McHugh PR (1975) “Mini-mental state”: a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 12(3):189–198

    Article  CAS  PubMed  Google Scholar 

  11. Mattis, S. (1988). Dementia rating scale: DRS: Professional manual. PAR.

    Google Scholar 

  12. Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J (1994) The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology 44(12):2308–2314

    Article  CAS  PubMed  Google Scholar 

  13. Cummings JL (1997) The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology 48(5 Suppl 6):10S–16S

    Article  Google Scholar 

  14. Johnson DR, Sawyer AM, Meyers CA, O'Neill BP, Wefel JS (2012) Early measures of cognitive function predict survival in patients with newly diagnosed glioblastoma. Neuro-oncology 14(6):808–816

    Article  PubMed  PubMed Central  Google Scholar 

  15. Benedict RH, Schretlen D, Groninger L, Brandt J (1998) Hopkins Verbal Learning Test–Revised: normative data and analysis of inter-form and test-retest reliability. Clin Neuropsychol 12(1):43–55

    Article  Google Scholar 

  16. Reitan RM, Wolfson D (1986) 3/The Halstead-Reitan neuropsychological test battery and aging. Clin Gerontol 5(1-2):39–61

    Article  Google Scholar 

  17. Benton AL, Hamsher K, Sivan AB (1976) Multilingual Aphasia Examination. University of Iowa, Iowa City

    Google Scholar 

  18. Benton AL, Hamsher KD, Sivan AB (1994) Controlled oral word association test, multilingual aphasia examination. AJA Associates, Iowa City, IA

    Google Scholar 

  19. Wefel JS, Vardy J, Ahles T, Schagen SB (2011) International Cognition and Cancer Task Force recommendations to harmonise studies of cognitive function in patients with cancer. Lancet Oncol 12(7):703–708

    Article  PubMed  Google Scholar 

  20. Wechsler D (1940) The measurement of adult intelligence. J Nerv Ment Dis 91(4):548

    Article  Google Scholar 

  21. Bornstein RA (1985) Normative data on selected neuropsychological measures from a nonclinical sample. J Clin Psychol 41(5):651–659

    Article  Google Scholar 

  22. Lezak MD, Howieson DB, Loring DW, Fischer JS (2004) Neuropsychological assessment. Oxford University Press, USA

    Google Scholar 

  23. Terwee CB, De Vet HCW, Prinsen CAC, Mokkink LB (2011) Protocol for systematic reviews of measurement properties. Knowledge center Measurement Instruments, COSMIN

    Google Scholar 

  24. Schellingerhout JM, Heymans MW, Verhagen AP, de Vet HC, Koes BW, Terwee CB (2011) Measurement properties of translated versions of neck-specific questionnaires: a systematic review. BMC Med Res Methodol 11(1):87

    Article  PubMed  PubMed Central  Google Scholar 

  25. Kabátová O, Puteková S, Martinková J, Súkenníková M (2016) Analysis of psychometric features of the Mini-Mental State Examination and the Montreal Cognitive Assessment methods. Clinical Social Work 62

  26. Jorm AF, Korten AE (1988) Assessment of cognitive decline in the elderly by informant interview. Br J Psychiatry 152(2):209–213

    Article  CAS  PubMed  Google Scholar 

  27. Dick JP, Guiloff RJ, Stewart A, Blackstock J, Bielawska C, Paul EA, Marsden CD (1984) Mini-mental state examination in neurological patients. J Neurol Neurosurg Psychiatry 47(5):496–499

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  28. Olin JT, Zelinski EM (1991) The 12-month reliability of the mini-mental state examination. J Consult Clin Psychol 3(3):427–432

  29. Binetti G, Mega MS, Magni E, Padovani A, Rozzini L, Bianchetti A, Trabucchi M, Cummings JL (1998) Behavioral disorders in Alzheimer disease: a transcultural perspective. Arch Neurol 55(4):539–544

    Article  CAS  PubMed  Google Scholar 

  30. Kilmer RP, Demakis GJ, Hammond FM, Grattan KE, Cook JR, Kornev AA (2006) Use of the Neuropsychiatric Inventory in traumatic brain injury: a pilot investigation. Rehabil Psychol 51(3):232–238

    Article  Google Scholar 

  31. Tombaugh TN, Kozak J, Rees L (1999) Normative data stratified by age and education for two measures of verbal fluency: FAS and animal naming. Arch Clin Neuropsychol 14(2):167–177

    CAS  PubMed  Google Scholar 

  32. Ruff RM, Light RH, Parker SB, Levin HS (1996) Benton controlled oral word association test: reliability and updated norms. Arch Clin Neuropsychol 11(4):329–338

    Article  CAS  PubMed  Google Scholar 

  33. Ross TP (2003) The reliability of cluster and switch scores for the Controlled Oral Word Association Test. Arch Clin Neuropsychol 18(2):153–164

    Article  PubMed  Google Scholar 

  34. Basso MR, Bornstein RA, Lang JM (1999) Practice effects on commonly used measures of executive function across twelve months. Clin Neuropsychol 13(3):283–292

    Article  CAS  PubMed  Google Scholar 

  35. Levine AJ, Miller EN, Becker JT, Selnes OA, Cohen BA (2004) Normative data for determining significance of test–retest differences on eight common neuropsychological instruments. Clin Neuropsychol 18(3):373–384

    Article  PubMed  Google Scholar 

  36. Rasmusson DX, Bylsma FW, Brandt J (1995) Stability of performance on the Hopkins verbal learning test. Arch Clin Neuropsychol 10(1):21–26

    Article  CAS  PubMed  Google Scholar 

  37. O’Neil-Pirozzi TM, Goldstein R, Strangman GE, Glenn MB (2012) Test–re-test reliability of the Hopkins Verbal Learning Test-Revised in individuals with traumatic brain injury. Brain Inj 26(12):1425–1430

    Article  PubMed  Google Scholar 

  38. Dikmen SS, Heaton RK, Grant I, Temkin NR (1999) Test–retest reliability and practice effects of expanded Halstead–Reitan neuropsychological test battery. J Int Neuropsychol Soc 5(4):346–356

    Article  CAS  PubMed  Google Scholar 

  39. Giovagnoli AR, Del Pesce M, Mascheroni S, Simoncelli M, Laiacona M, Capitani E (1996) Trail making test: normative values from 287 normal adult controls. Ital J Neurol Sci 17(4):305–309

    Article  CAS  PubMed  Google Scholar 

  40. Morrison GE, Simone CM, Ng NF, Hardy JL (2015) Reliability and validity of the NeuroCognitive Performance Test, a web-based neuropsychological assessment. Front Psychol 6:1652

    Article  PubMed  PubMed Central  Google Scholar 

  41. Woods SP, Childers M, Ellis RJ, Guaman S, Grant I, Heaton RK, HIV Neurobehavioral Research Center (HNRC) Group 1 (2006) A battery approach for measuring neuropsychological change. Arch Clin Neuropsychol 21(1):83–89

    Article  PubMed  Google Scholar 

  42. Ruff RM, Parker SB (1993) Gender-and age-specific changes in motor speed and eye-hand coordination in adults: normative values for the Finger Tapping and Grooved Pegboard Tests. Percept Mot Skills 76(3_suppl):1219–1230

    Article  CAS  PubMed  Google Scholar 

  43. Wang YC, Magasi SR, Bohannon RW, Reuben DB, McCreath HE, Bubela DJ, Gershon RC, Rymer WZ (2011) Assessing dexterity function: a comparison of two alternatives for the NIH Toolbox. J Hand Ther 24(4):313–321

    Article  PubMed  PubMed Central  Google Scholar 

  44. Bohannon RW (1986) Test-retest reliability of hand-held dynamometry during a single session of strength assessment. Phys Ther 66(2):206–209

    Article  CAS  PubMed  Google Scholar 

  45. Morris SL, Dodd KJ, Morris ME (2008) Reliability of dynamometry to quantify isometric strength following traumatic brain injury. Brain Inj 22(13-14):1030–1037

    Article  PubMed  Google Scholar 

  46. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E et al (1998) The Mini-International Neuropsychiatric Interview (MINI): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiat 59(20):22–57

    Google Scholar 

  47. Castellanos-Pinedo F, Hernández-Pérez JM, Zurdo M, Rodríguez-Fúnez B, Hernández-Bayo JM, García-Fernández C, Cueli-Rincón B, Castro-Posada JA (2011) Influence of premorbid psychopathology and lesion location on affective and behavioral disorders after ischemic stroke. J Neuropsychiatr Clin Neurosci 23(3):340–347

    Article  Google Scholar 

  48. Giovagnoli AR, Boiardi A (1994) Cognitive impairment and quality of life in long-term survivors of malignant brain tumors. Ital J Neurol Sci 15(9):481–488

    Article  CAS  PubMed  Google Scholar 

  49. Meyers CA, Geara F, Wong PF, Morrison WH (2000) Neurocognitive effects of therapeutic irradiation for base of skull tumors. Int J Radiat Oncol Biol Phys 46(1):51–55

    Article  CAS  PubMed  Google Scholar 

  50. Meyers CA, Smith JA, Bezjak A, Mehta MP, Liebmann J, Illidge T et al (2004) Neurocognitive function and progression in patients with brain metastases treated with whole-brain radiation and motexafin gadolinium: results of a randomized phase III trial. J Clin Oncol 22(1):157–165

    Article  CAS  PubMed  Google Scholar 

  51. Correa DD (2010) Neurocognitive function in brain tumors. Curr Neurol Neurosci Rep 10(3):232–239

    Article  PubMed  Google Scholar 

  52. Gregor A, Cull A, Traynor E, Stewart M, Lander F, Love S (1996) Neuropsychometric evaluation of long-term survivors of adult brain tumours: relationship with tumour and treatment parameters. Radiother Oncol 41(1):55–59

    Article  CAS  PubMed  Google Scholar 

  53. Scheibel RS, Meyers CA, Levin VA (1996) Cognitive dysfunction following surgery for intracerebral glioma: influence of histopathology, lesion location, and treatment. J Neuro-Oncol 30(1):61–69

    Article  CAS  Google Scholar 

  54. Duffau H, Lopes M, Arthuis F, Bitar A, Sichez JP, Van Effenterre R, Capelle L (2005) Contribution of intraoperative electrical stimulations in surgery of low grade gliomas: a comparative study between two series without (1985–96) and with (1996–2003) functional mapping in the same institution. J Neurol Neurosurg Psychiatry 76(6):845–851

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  55. Talacchi A, Santini B, Savazzi S, Gerosa M (2011) Cognitive effects of tumour and surgical treatment in glioma patients. J Neuro-Oncol 103(3):541–549

    Article  Google Scholar 

  56. Meyers CA, Rock EP, Fine HA (2012) Refining endpoints in brain tumor clinical trials. J Neuro-Oncol 108(2):227–230

    Article  Google Scholar 

  57. Platta CS, Khuntia D, Mehta MP, Suh JH (2010) Current treatment strategies for brain metastasis and complications from therapeutic techniques: a review of current literature. Am J Clin Oncol 33(4):398–407

    Article  PubMed  Google Scholar 

  58. Taphoorn MJ, Klein M (2004) Cognitive deficits in adult patients with brain tumours. Lancet Neurol 3(3):159–168

    Article  PubMed  Google Scholar 

  59. Klein M, Heimans JJ, Aaronson NK, Postma TJ, Muller M, Taphoorn MJ (2004) Impaired cognitive functioning in low-grade glioma patients: relationship to tumor localisation, radiotherapy and the use of anticonvulsants. Ned Tijdschr Geneeskd 148(44):2175–2180

    CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Political and Communication Sciences, University of Salerno, Via Giovanni Paolo II, 132, (SA), 84084, Fisciano, Italy

    Maria De Martino

  2. Section of Neurosurgery, Department of Neuroscience, Biomedicine and Movement, University of Verona, Piazzale Stefani, 1, 37126, Verona, Italy

    Barbara Santini, Giovanna Cappelletti, Annapina Mazzotta, Matteo Rasi, Giorgia Bulgarelli, Luciano Annicchiarico & Andrea Talacchi

  3. Unit of Othorinolaringology, Merano Hospital, Via Rossini, 5, 39012, Merano (BZ), Italy

    Alessandro Marcocci

Authors
  1. Maria De Martino
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Barbara Santini
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Giovanna Cappelletti
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Annapina Mazzotta
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Matteo Rasi
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Giorgia Bulgarelli
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Luciano Annicchiarico
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Alessandro Marcocci
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Andrea Talacchi
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Maria De Martino.

Ethics declarations

Conflict of interest

None

Ethical approval

None

Additional information

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic supplementary material

ESM 1

(DOCX 19.6 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

De Martino, M., Santini, B., Cappelletti, G. et al. The quality of measurement properties of neurocognitive assessment in brain tumor clinical trials over the last 30 years: a COSMIN checklist-based approach. Neurol Sci 41, 3105–3121 (2020). https://doi.org/10.1007/s10072-020-04477-4

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10072-020-04477-4

Keywords

Search

Navigation