Methodological notes
Medwave 2021;21(03):e8149 doi: 10.5867/medwave.2021.03.8149
Minimal clinically important difference: The basics
Julieta Aldana Salas Apaza, Juan Víctor Ariel Franco, Nicolás Meza, Eva Madrid, Cristobal Loézar, Luis Garegnani
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Key Words: Evidence-Based Medicine, Evidence-Based Practice, Minimal Clinically Important Difference, Patient Reported Outcome Measures, Systematic Reviews as Topic, GRADE Approach

Abstract

This article is part of a collaborative methodological series of narrative reviews on biostatistics and clinical epidemiology. This review aims to present basic concepts about the minimal clinically important difference and its use in the field of clinical research and evidence synthesis. The minimal clinically important difference is defined as the smallest difference in score in any domain or outcome of interest that patients can perceive as beneficial. It is a useful concept in several aspects since it links the magnitude of change with treatment decisions in clinical practice and emphasizes the primacy of the patient’s perception, affected by endless variables such as time, place, and current state of health, all of which can cause significant variability in results.


 

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This article is part of a collaborative methodological series of narrative reviews on biostatistics and clinical epidemiology. This review aims to present basic concepts about the minimal clinically important difference and its use in the field of clinical research and evidence synthesis. The minimal clinically important difference is defined as the smallest difference in score in any domain or outcome of interest that patients can perceive as beneficial. It is a useful concept in several aspects since it links the magnitude of change with treatment decisions in clinical practice and emphasizes the primacy of the patient’s perception, affected by endless variables such as time, place, and current state of health, all of which can cause significant variability in results.

Authors: Julieta Aldana Salas Apaza[1], Juan Víctor Ariel Franco[2], Nicolás Meza[3], Eva Madrid[3], Cristobal Loézar[3], Luis Garegnani[2]

Affiliation:
[1] Universidad Nacional de La Matanza, Buenos Aires, Argentina
[2] Instituto Universitario Hospital Italiano de Buenos Aires, Ciudad Autónoma de Buenos Aires, Argentina
[3] Centro Interdisciplinario de Estudios en Salud (CIESAL), Universidad de Valparaíso, Centro Asociado Cochrane Chile, Viña del Mar, Chile

E-mail: luisgaregnani@gmail.com

Author address:
[1] Potosí 4265, C1199
Ciudad Autónoma de Buenos Aires, Argentina

Citation: Salas Apaza JA, Franco JVA, Meza N, Madrid E, Loézar C, Garegnani L. Minimal clinically important difference: The basics. Medwave 2021;21(03):e8149 doi: 10.5867/medwave.2021.03.8149

Submission date: 30/12/2020

Acceptance date: 22/3/2021

Publication date: 7/4/2021

Origin: Not commissioned.

Type of review: Externally peer-reviewed by four reviewers, double-blind.

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  1. Angst F, Aeschlimann A, Angst J. The minimal clinically important difference raised the significance of outcome effects above the statistical level, with methodological implications for future studies. J Clin Epidemiol. 2017 Feb;82:128-136. | CrossRef | PubMed |
  2. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407-15. | CrossRef | PubMed |
  3. Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008 Feb;61(2):102-9. | CrossRef | PubMed |
  4. Mouelhi Y, Jouve E, Castelli C, Gentile S. How is the minimal clinically important difference established in health-related quality of life instruments? Review of anchors and methods. Health Qual Life Outcomes. 2020 May 12;18(1):136. | CrossRef | PubMed |
  5. Male L, Noble A, Atkinson J, Marson T. Measuring patient experience: a systematic review to evaluate psychometric properties of patient reported experience measures (PREMs) for emergency care service provision. Int J Qual Health Care. 2017 Jun 1;29(3):314-326. | CrossRef | PubMed |
  6. Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR; Clinical Significance Consensus Meeting Group. Methods to explain the clinical significance of health status measures. Mayo Clin Proc. 2002 Apr;77(4):371-83. | CrossRef | PubMed |
  7. Olsen MF, Bjerre E, Hansen MD, Hilden J, Landler NE, Tendal B, et al. Pain relief that matters to patients: systematic review of empirical studies assessing the minimum clinically important difference in acute pain. BMC Med. 2017 Feb 20;15(1):35. | CrossRef | PubMed |
  8. Devji T, Carrasco-Labra A, Qasim A, Phillips M, Johnston BC, Devasenapathy N, et al. Evaluating the credibility of anchor based estimates of minimal important differences for patient reported outcomes: instrument development and reliability study. BMJ. 2020 Jun 4;369:m1714. | CrossRef | PubMed |
  9. Draak THP, de Greef BTA, Faber CG, Merkies ISJ; PeriNomS study group. The minimum clinically important difference: which direction to take. Eur J Neurol. 2019 Jun;26(6):850-855. | CrossRef | PubMed |
  10. Bernstein JA, Mauger DT. The Minimally Clinically Important Difference (MCID): What Difference Does It Make? J Allergy Clin Immunol Pract. 2016 Jul- Aug;4(4):689-90. | CrossRef | PubMed |
  11. McGlothlin AE, Lewis RJ. Minimal clinically important difference: defining what really matters to patients. JAMA. 2014 Oct 1;312(13):1342-3. | CrossRef | PubMed |
  12. Ousmen A, Touraine C, Deliu N, Cottone F, Bonnetain F, Efficace F, et al. Distribution- and anchor-based methods to determine the minimally important difference on patient-reported outcome questionnaires in oncology: a structured review. Health Qual Life Outcomes. 2018 Dec 11;16(1):228. | CrossRef | PubMed |
  13. Cella D, Hahn EA, Dineen K. Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening. Qual Life Res. 2002 May;11(3):207-21. | CrossRef | PubMed |
  14. Engel L, Beaton DE, Touma Z. Minimal Clinically Important Difference: A Review of Outcome Measure Score Interpretation. Rheum Dis Clin North Am. 2018 May;44(2):177-188. | CrossRef | PubMed |
  15. Sedaghat AR. Understanding the Minimal Clinically Important Difference (MCID) of Patient-Reported Outcome Measures. Otolaryngol Head Neck Surg. 2019 Oct;161(4):551-560. | CrossRef | PubMed |
  16. Hultcrantz M, Rind D, Akl EA, Treweek S, Mustafa RA, Iorio A, et al. The GRADE Working Group clarifies the construct of certainty of evidence. J Clin Epidemiol. 2017 Jul;87:4-13. | CrossRef | PubMed |
  17. Santesso N, Glenton C, Dahm P, Garner P, Akl EA, Alper B, et al. GRADE guidelines 26: informative statements to communicate the findings of systematic reviews of interventions. J Clin Epidemiol. 2020 Mar;119:126-135. | CrossRef | PubMed |
  18. Guyatt GH, Oxman AD, Kunz R, Brozek J, Alonso-Coello P, Rind D, et al. GRADE guidelines 6. Rating the quality of evidence--imprecision. J Clin Epidemiol. 2011 Dec;64(12):1283-93. | CrossRef | PubMed |
  19. Zhang Y, Alonso-Coello P, Guyatt GH, Yepes-Nuñez JJ, Akl EA, Hazlewood G, et al. GRADE Guidelines: 19. Assessing the certainty of evidence in the importance of outcomes or values and preferences-Risk of bias and indirectness. J Clin Epidemiol. 2019 Jul;111:94-104. | CrossRef | PubMed |
  20. Schünemann HJ. Interpreting GRADE's levels of certainty or quality of the evidence: GRADE for statisticians, considering review information size or less emphasis on imprecision? J Clin Epidemiol. 2016 Jul;75:6-15. | CrossRef | PubMed |
Angst F, Aeschlimann A, Angst J. The minimal clinically important difference raised the significance of outcome effects above the statistical level, with methodological implications for future studies. J Clin Epidemiol. 2017 Feb;82:128-136. | CrossRef | PubMed |

Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407-15. | CrossRef | PubMed |

Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008 Feb;61(2):102-9. | CrossRef | PubMed |

Mouelhi Y, Jouve E, Castelli C, Gentile S. How is the minimal clinically important difference established in health-related quality of life instruments? Review of anchors and methods. Health Qual Life Outcomes. 2020 May 12;18(1):136. | CrossRef | PubMed |

Male L, Noble A, Atkinson J, Marson T. Measuring patient experience: a systematic review to evaluate psychometric properties of patient reported experience measures (PREMs) for emergency care service provision. Int J Qual Health Care. 2017 Jun 1;29(3):314-326. | CrossRef | PubMed |

Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR; Clinical Significance Consensus Meeting Group. Methods to explain the clinical significance of health status measures. Mayo Clin Proc. 2002 Apr;77(4):371-83. | CrossRef | PubMed |

Olsen MF, Bjerre E, Hansen MD, Hilden J, Landler NE, Tendal B, et al. Pain relief that matters to patients: systematic review of empirical studies assessing the minimum clinically important difference in acute pain. BMC Med. 2017 Feb 20;15(1):35. | CrossRef | PubMed |

Devji T, Carrasco-Labra A, Qasim A, Phillips M, Johnston BC, Devasenapathy N, et al. Evaluating the credibility of anchor based estimates of minimal important differences for patient reported outcomes: instrument development and reliability study. BMJ. 2020 Jun 4;369:m1714. | CrossRef | PubMed |

Draak THP, de Greef BTA, Faber CG, Merkies ISJ; PeriNomS study group. The minimum clinically important difference: which direction to take. Eur J Neurol. 2019 Jun;26(6):850-855. | CrossRef | PubMed |

Bernstein JA, Mauger DT. The Minimally Clinically Important Difference (MCID): What Difference Does It Make? J Allergy Clin Immunol Pract. 2016 Jul- Aug;4(4):689-90. | CrossRef | PubMed |

McGlothlin AE, Lewis RJ. Minimal clinically important difference: defining what really matters to patients. JAMA. 2014 Oct 1;312(13):1342-3. | CrossRef | PubMed |

Ousmen A, Touraine C, Deliu N, Cottone F, Bonnetain F, Efficace F, et al. Distribution- and anchor-based methods to determine the minimally important difference on patient-reported outcome questionnaires in oncology: a structured review. Health Qual Life Outcomes. 2018 Dec 11;16(1):228. | CrossRef | PubMed |

Cella D, Hahn EA, Dineen K. Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening. Qual Life Res. 2002 May;11(3):207-21. | CrossRef | PubMed |

Engel L, Beaton DE, Touma Z. Minimal Clinically Important Difference: A Review of Outcome Measure Score Interpretation. Rheum Dis Clin North Am. 2018 May;44(2):177-188. | CrossRef | PubMed |

Sedaghat AR. Understanding the Minimal Clinically Important Difference (MCID) of Patient-Reported Outcome Measures. Otolaryngol Head Neck Surg. 2019 Oct;161(4):551-560. | CrossRef | PubMed |

Hultcrantz M, Rind D, Akl EA, Treweek S, Mustafa RA, Iorio A, et al. The GRADE Working Group clarifies the construct of certainty of evidence. J Clin Epidemiol. 2017 Jul;87:4-13. | CrossRef | PubMed |

Santesso N, Glenton C, Dahm P, Garner P, Akl EA, Alper B, et al. GRADE guidelines 26: informative statements to communicate the findings of systematic reviews of interventions. J Clin Epidemiol. 2020 Mar;119:126-135. | CrossRef | PubMed |

Guyatt GH, Oxman AD, Kunz R, Brozek J, Alonso-Coello P, Rind D, et al. GRADE guidelines 6. Rating the quality of evidence--imprecision. J Clin Epidemiol. 2011 Dec;64(12):1283-93. | CrossRef | PubMed |

Zhang Y, Alonso-Coello P, Guyatt GH, Yepes-Nuñez JJ, Akl EA, Hazlewood G, et al. GRADE Guidelines: 19. Assessing the certainty of evidence in the importance of outcomes or values and preferences-Risk of bias and indirectness. J Clin Epidemiol. 2019 Jul;111:94-104. | CrossRef | PubMed |

Schünemann HJ. Interpreting GRADE's levels of certainty or quality of the evidence: GRADE for statisticians, considering review information size or less emphasis on imprecision? J Clin Epidemiol. 2016 Jul;75:6-15. | CrossRef | PubMed |