Thus the distribution method can only be used to calculate an absolute MCID as there is no st and ard deviation of baseline score for a relative measure .
The anchor-based method relates the change in
To the Editor : The same patient outcome data from clinical trial results , when presented as absolute or relative changes , may appear different in magnitude .
Recommendations are to report both absolute and relative , or at least baseline , data from which to calculate absolute values [ 1 , 2 ] .
To inform clinical practice , outcome improvements , whether relative or absolute , must be statistically significant and clinical ly meaningful .
A minimal clinical ly important difference ( MCID ) should inform sample size calculations for clinical trials .
Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale
& NA ;  Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies
Thus the distribution method can only be used to calculate an absolute MCID as there is no st and ard deviation of baseline score for a relative measure .
The anchor-based method relates the change in
To the Editor : The same patient outcome data from clinical trial results , when presented as absolute or relative changes , may appear different in magnitude .
Recommendations are to report both absolute and relative , or at least baseline , data from which to calculate absolute values [ 1 , 2 ] .
To inform clinical practice , outcome improvements , whether relative or absolute , must be statistically significant and clinical ly meaningful .
A minimal clinical ly important difference ( MCID ) should inform sample size calculations for clinical trials .