CC2023: The Minimal Clinically Important Difference: A Review of Clinical Significance (February 2023)-The Minimal Clinically Important Difference: A Review of Clinical Significance

The Minimal Clinically Important Difference: A Review of Clinical Significance

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The minimal clinically important difference (MCID) is a term used in orthopedic clinical research to represent the smallest change in a patient-reported outcome measure that is considered clinically valuable to patients. There are three main ways to determine the MCID: anchor-based analysis, distribution-based analysis, and sensitivity-and-specificity-based analysis. Each method has its own strengths and weaknesses. Anchor-based analyses are closely tied to clinical status but lack standardization. Distribution-based analyses have a strong statistical foundation but may not adequately capture clinical significance. Sensitivity and specificity analyses offer a compromise between the other methods but still rely on a somewhat arbitrarily defined global transition question.<br /><br />The MCID is important in analyzing patient-reported outcome measures (PROMs), which are commonly used in orthopedic research to quantify and compare a patient's functional status throughout treatment. PROMs provide reproducible and specific measurements, allowing for comparisons across treatments and patients. However, there are limitations to deriving the MCID. The methods for calculating the MCID vary, resulting in different values for the same PROM. The MCID is also influenced by baseline functional status and may be population-specific. Other limitations include a lack of standardization in GTQ design and evaluation, as well as the dependence on large study populations for anchor-based derivations.<br /><br />In conclusion, there is a need for better standardization in establishing MCIDs for orthopedic PROMs and developing universally accepted methodologies for deriving the MCID. Until then, studies attempting to derive the MCID should use anchor-based within-cohort designs based on recommendations from the Food and Drug Administration. It is important for future research to consider alternative threshold scores and more standardized methods of derivation. Overall, a better understanding and application of the MCID will enhance clinical research in orthopedics.

Keywords

minimal clinically important difference

MCID

patient-reported outcome measure

orthopedic clinical research

anchor-based analysis

distribution-based analysis

sensitivity-and-specificity-based analysis

PROMs

functional status

standardization