PMID- 32398083 OWN - NLM STAT- MEDLINE DCOM- 20200911 LR - 20200911 IS - 1477-7525 (Electronic) IS - 1477-7525 (Linking) VI - 18 IP - 1 DP - 2020 May 12 TI - How is the minimal clinically important difference established in health-related quality of life instruments? Review of anchors and methods. PG - 136 LID - 10.1186/s12955-020-01344-w [doi] LID - 136 AB - BACKGROUND: The aim of this systematic review is to describe the different types of anchors and statistical methods used in estimating the Minimal Clinically Important Difference (MCID) for Health-Related Quality of Life (HRQoL) instruments. METHODS: PubMed and Google scholar were searched for English and French language studies published from 2010 to 2018 using selected keywords. We included original articles (reviews, meta-analysis, commentaries and research letters were not considered) that described anchors and statistical methods used to estimate the MCID in HRQoL instruments. RESULTS: Forty-seven papers satisfied the inclusion criteria. The MCID was estimated for 6 generic and 18 disease-specific instruments. Most studies in our review used anchor-based methods (n = 41), either alone or in combination with distribution-based methods. The most common applied anchors were non-clinical, from the viewpoint of patients. Different statistical methods for anchor-based methods were applied and the Change Difference (CD) was the most used one. Most distributional methods included 0.2 standard deviations (SD), 0.3 SD, 0.5 SD and 1 standard error of measurement (SEM). MCID values were very variable depending on methods applied, and also on clinical context of the study. CONCLUSION: Multiple anchors and methods were applied in the included studies, which lead to different estimations of MCID. Using several methods enables to assess the robustness of the results. This corresponds to a sensitivity analysis of the methods. Close collaboration between statisticians and clinicians is recommended to integrate an agreement regarding the appropriate method to determine MCID for a specific context. FAU - Mouelhi, Yosra AU - Mouelhi Y AD - Laboratoire de Sante Publique, Faculte de Medecine, Universite Aix-Marseille, 3279, Marseille, EA, France. FAU - Jouve, Elisabeth AU - Jouve E AD - Service d'Evaluation Medicale, Assistance Publique - Hopitaux de Marseille, Marseille, France. FAU - Castelli, Christel AU - Castelli C AD - Service Biostatistique Epidemiologie Sante Publique Innovation et Methodologie (BESPIM), CHU Nimes, Nimes, France. AD - UPRES EA 2415 Aide a la decision medicale personnalisee, Faculte de Medecine, Universite de Montpellier, Montpellier, France. FAU - Gentile, Stephanie AU - Gentile S AD - Laboratoire de Sante Publique, Faculte de Medecine, Universite Aix-Marseille, 3279, Marseille, EA, France. StephanieMarie.GENTILE@ap-hm.fr. AD - Service d'Evaluation Medicale, Assistance Publique - Hopitaux de Marseille, Marseille, France. StephanieMarie.GENTILE@ap-hm.fr. LA - eng PT - Journal Article PT - Systematic Review DEP - 20200512 PL - England TA - Health Qual Life Outcomes JT - Health and quality of life outcomes JID - 101153626 SB - IM MH - Adult MH - Aged MH - Female MH - Humans MH - Male MH - Middle Aged MH - *Minimal Clinically Important Difference MH - Psychometrics/instrumentation MH - *Quality of Life PMC - PMC7218583 OTO - NOTNLM OT - Anchors-based methods OT - Distribution-based methods OT - Health-related-quality of life OT - Minimal clinically important difference COIS- The authors declare they have no competing interest. EDAT- 2020/05/14 06:00 MHDA- 2020/09/12 06:00 PMCR- 2020/05/12 CRDT- 2020/05/14 06:00 PHST- 2019/03/27 00:00 [received] PHST- 2020/04/01 00:00 [accepted] PHST- 2020/05/14 06:00 [entrez] PHST- 2020/05/14 06:00 [pubmed] PHST- 2020/09/12 06:00 [medline] PHST- 2020/05/12 00:00 [pmc-release] AID - 10.1186/s12955-020-01344-w [pii] AID - 1344 [pii] AID - 10.1186/s12955-020-01344-w [doi] PST - epublish SO - Health Qual Life Outcomes. 2020 May 12;18(1):136. doi: 10.1186/s12955-020-01344-w.