PMID- 36811558
OWN - NLM
STAT- MEDLINE
DCOM- 20230320
LR  - 20231107
IS  - 1552-3365 (Electronic)
IS  - 0363-5465 (Print)
IS  - 0363-5465 (Linking)
VI  - 51
IP  - 4
DP  - 2023 Mar
TI  - The Minimal Clinically Important Difference Changes Greatly Based on the 
      Different Calculation Methods.
PG  - 1067-1073
LID - 10.1177/03635465231152484 [doi]
AB  - BACKGROUND: The minimal clinically important difference (MCID) for 
      patient-reported outcome measures (PROMs) expresses both the extent of the 
      improvement and the value that patients place on it. MCID use is becoming 
      increasingly widespread to understand the clinical efficacy of a given treatment, 
      define guidelines for clinical practice, and properly interpret trial results. 
      However, there is still large heterogeneity in the different calculation methods. 
      PURPOSE: To calculate and compare the MCID threshold values of a PROM by applying 
      various methods and analyzing their effect on the study results interpretation. 
      STUDY DESIGN: Cohort study (Diagnosis); Level of evidence, 3. METHODS: The data 
      set used to investigate the different MCID calculation approaches was based on a 
      database of 312 patients affected by knee osteoarthritis and treated with 
      intra-articular platelet-rich plasma. MCID values were calculated on the 
      International Knee Documentation Committee (IKDC) subjective score at 6 months 
      using 2 approaches: 9 methodologies referred to an anchor-based approach and 8 
      methodologies to a distribution-based approach. The obtained threshold values 
      were applied to the same series of patients to understand the effect of using 
      different MCID methods in evaluating patient response to treatment. RESULTS: The 
      different methods employed led to MCID values ranging from 1.8 to 25.9 points. 
      The anchor-based methods ranged from 6.3 to 25.9, while the distribution-based 
      ones were from 1.8 to 13.8 points, showing a 4.1x variation of the MCID values 
      within the anchor-based methods and a 7.6x variation within the 
      distribution-based methods. The percentage of patients who reached the MCID for 
      the IKDC subjective score changed based on the specific calculation method used. 
      Among the anchor-based methods, this value varied from 24.0% to 66.0%, while 
      among the distribution-based methods, the percentage of patients reaching the 
      MCID varied from 44.6% to 75.9%. CONCLUSION: This study proved that different 
      MCID calculation methods lead to highly heterogeneous values, which significantly 
      affect the percentage of patients achieving the MCID in a given population. The 
      wide-ranging thresholds obtained with the different methodologies make it 
      difficult to evaluate the real effectiveness of a given treatment questioning the 
      usefulness of MCID, as currently available, in the clinical research.
FAU - Franceschini, Marco
AU  - Franceschini M
AD  - Clinica Ortopedica e Traumatologica 2, IRCCS Istituto Ortopedico Rizzoli, 
      Bologna, Italy.
FAU - Boffa, Angelo
AU  - Boffa A
AUID- ORCID: 0000-0002-1523-6900
AD  - Clinica Ortopedica e Traumatologica 2, IRCCS Istituto Ortopedico Rizzoli, 
      Bologna, Italy.
FAU - Pignotti, Elettra
AU  - Pignotti E
AD  - Applied and Translational Research (ATR) Center, IRCCS Istituto Ortopedico 
      Rizzoli, Bologna, Italy.
FAU - Andriolo, Luca
AU  - Andriolo L
AUID- ORCID: 0000-0001-6352-9671
AD  - Clinica Ortopedica e Traumatologica 2, IRCCS Istituto Ortopedico Rizzoli, 
      Bologna, Italy.
FAU - Zaffagnini, Stefano
AU  - Zaffagnini S
AD  - Clinica Ortopedica e Traumatologica 2, IRCCS Istituto Ortopedico Rizzoli, 
      Bologna, Italy.
FAU - Filardo, Giuseppe
AU  - Filardo G
AD  - Applied and Translational Research (ATR) Center, IRCCS Istituto Ortopedico 
      Rizzoli, Bologna, Italy.
LA  - eng
PT  - Journal Article
DEP - 20230222
PL  - United States
TA  - Am J Sports Med
JT  - The American journal of sports medicine
JID - 7609541
SB  - IM
CIN - Am J Sports Med. 2023 Nov;51(13):NP54-NP55. PMID: 37917813
CIN - Am J Sports Med. 2023 Nov;51(13):NP52-NP53. PMID: 37917815
CIN - Am J Sports Med. 2023 Nov;51(13):NP52. PMID: 37917816
CIN - Am J Sports Med. 2023 Nov;51(13):NP51-NP52. PMID: 37917817
CIN - Am J Sports Med. 2023 Nov;51(13):NP55-NP56. PMID: 37917819
MH  - Humans
MH  - *Minimal Clinically Important Difference
MH  - Cohort Studies
MH  - Treatment Outcome
MH  - Knee Joint
MH  - *Osteoarthritis, Knee/diagnosis/therapy
PMC - PMC10026158
OTO - NOTNLM
OT  - International Knee Documentation Committee (IKDC)
OT  - knee
OT  - minimal clinically important difference (MCID)
OT  - osteoarthritis
OT  - patient-reported outcome measure (PROM)
OT  - platelet-rich plasma (PRP)
COIS- One or more of the authors has declared the following potential conflict of 
      interest or source of funding: S.Z. reports personal fees from I + SRL and grants 
      from FidiaFarmaceutici SPA, Cartiheal Ltd, IGEA clinical biophysics, BIOMET, and 
      Kensey Nash. These funders had no role in the design of the study; in the 
      collection, analyses, or interpretation of data; in the writing of the 
      manuscript; or in the decision to publish the results. AOSSM checks author 
      disclosures against the Open Payments Database (OPD). AOSSM has not conducted an 
      independent investigation on the OPD and disclaims any liability or 
      responsibility relating thereto.
EDAT- 2023/02/23 06:00
MHDA- 2023/03/21 06:00
PMCR- 2023/03/20
CRDT- 2023/02/22 15:46
PHST- 2023/02/23 06:00 [pubmed]
PHST- 2023/03/21 06:00 [medline]
PHST- 2023/02/22 15:46 [entrez]
PHST- 2023/03/20 00:00 [pmc-release]
AID - 10.1177_03635465231152484 [pii]
AID - 10.1177/03635465231152484 [doi]
PST - ppublish
SO  - Am J Sports Med. 2023 Mar;51(4):1067-1073. doi: 10.1177/03635465231152484. Epub 
      2023 Feb 22.