PMID- 32460882
OWN - NLM
STAT- MEDLINE
DCOM- 20200924
LR  - 20200924
IS  - 1477-7525 (Electronic)
IS  - 1477-7525 (Linking)
VI  - 18
IP  - 1
DP  - 2020 May 27
TI  - Practical issues encountered while determining Minimal Clinically Important 
      Difference in Patient-Reported Outcomes.
PG  - 156
LID - 10.1186/s12955-020-01398-w [doi]
LID - 156
AB  - BACKGROUND: Using a real dataset, we highlighted several major methodological 
      issues raised by the estimation of the Minimal Clinically Important Difference 
      (MCID) of a Patient-Reported Outcomes instrument. We especially considered the 
      management of missing data and the use of more than two times of measurement. 
      While inappropriate missing data management and inappropriate use of multiple 
      time points can lead to loss of precision and/or bias in MCID estimation, these 
      issues are almost never dealt with and require cautious considerations in the 
      context of MCID estimation. METHODS: We used the LIGALONGO study (French 
      Randomized Controlled Trial). We estimated MCID on the SF-36 General Health score 
      by comparing many methods (distribution or anchor-based). Different techniques 
      for imputation of missing data were performed (simple and multiple imputations). 
      We also consider all measurement occasions by longitudinal modeling, and the 
      dependence of the score difference on baseline. RESULTS: Three hundred 
      ninety-three patients were studied. With distribution-based methods, a great 
      variability in MCID was observed (from 3 to 26 points for improvement). Only 0.2 
      SD and 1/3 SD distribution methods gave MCID values consistent with anchor-based 
      methods (from 4 to 7 points for improvement). The choice of missing data 
      imputation technique clearly had an impact on MCID estimates. Simple imputation 
      by mean score seemed to lead to out-of-range estimate, but as missing not at 
      random mechanism can be hypothesized, even multiple imputations techniques can 
      have led to an slight underestimation of MCID. Using 3 measurement occasions for 
      improvement led to an increase in precision but lowered estimates. CONCLUSION: 
      This practical example illustrates the substantial impact of some methodological 
      issues that are usually never dealt with for MCID estimation. Simulation studies 
      are needed to investigate those issues. TRIAL REGISTRATION: NCT01240772 
      (ClinicalTrials.gov) registered on November 15, 2010.
FAU - Woaye-Hune, Pascal
AU  - Woaye-Hune P
AD  - Inserm, Universite Bretagne-Loire - Universite de Nantes - Universite de Tours, 
      UMR U1246 SPHERE "Methods in patient-centered outcomes and health research", 
      Nantes, France.
AD  - Internal Medicine Department, University Hospital of Nantes, Nantes, France.
FAU - Hardouin, Jean-Benoit
AU  - Hardouin JB
AD  - Inserm, Universite Bretagne-Loire - Universite de Nantes - Universite de Tours, 
      UMR U1246 SPHERE "Methods in patient-centered outcomes and health research", 
      Nantes, France.
AD  - Unit of Methodology and Biostatistics, University Hospital of Nantes, Nantes, 
      France.
FAU - Lehur, Paul-Antoine
AU  - Lehur PA
AD  - Digestive Surgery Department, University Hospital of Nantes, Nantes, France.
FAU - Meurette, Guillaume
AU  - Meurette G
AD  - Digestive Surgery Department, University Hospital of Nantes, Nantes, France.
FAU - Vanier, Antoine
AU  - Vanier A
AUID- ORCID: 0000-0001-6033-9282
AD  - Inserm, Universite Bretagne-Loire - Universite de Nantes - Universite de Tours, 
      UMR U1246 SPHERE "Methods in patient-centered outcomes and health research", 
      Nantes, France. antoine.vanier@univ-nantes.fr.
LA  - eng
SI  - ClinicalTrials.gov/NCT01240772
GR  - Jeunes Chercheurs 2016-2020 N degrees  ANR-15-CE36-0003-01/Agence Nationale de la 
      Recherche (FR)/
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20200527
PL  - England
TA  - Health Qual Life Outcomes
JT  - Health and quality of life outcomes
JID - 101153626
SB  - IM
MH  - Data Management/*organization & administration
MH  - Datasets as Topic
MH  - Humans
MH  - *Minimal Clinically Important Difference
MH  - *Patient Reported Outcome Measures
MH  - Quality of Life
PMC - PMC7251729
OTO - NOTNLM
OT  - Longitudinal modeling
OT  - Methodology
OT  - Minimal clinically important difference
OT  - Minimal important difference
OT  - Missing data
OT  - Patient-reported outcomes
COIS- The authors declare that they have no competing interests.
EDAT- 2020/05/29 06:00
MHDA- 2020/09/25 06:00
PMCR- 2020/05/27
CRDT- 2020/05/29 06:00
PHST- 2019/03/26 00:00 [received]
PHST- 2020/05/07 00:00 [accepted]
PHST- 2020/05/29 06:00 [entrez]
PHST- 2020/05/29 06:00 [pubmed]
PHST- 2020/09/25 06:00 [medline]
PHST- 2020/05/27 00:00 [pmc-release]
AID - 10.1186/s12955-020-01398-w [pii]
AID - 1398 [pii]
AID - 10.1186/s12955-020-01398-w [doi]
PST - epublish
SO  - Health Qual Life Outcomes. 2020 May 27;18(1):156. doi: 
      10.1186/s12955-020-01398-w.