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 .
Short-term opioids for breathlessness in stable chronic heart failure: a randomized controlled trial.
AIMS To assess the effect of oral opioids vs. placebo on breathlessness in patients with chronic heart failure ( CHF ) . METHODS AND RESULTS Oral morphine ( Oramorph ) , oral oxycodone ( Oxynorm ) , and placebo were studied in an outpatient setting . Once r and omized , participants received all three interventions in a controlled double-blind crossover trial for 4 days each , with a 3-day washout between interventions . Patients known to the Hull and East Yorkshire Academic Cardiology department with CHF ( New York Heart Association Grade III-IV ) were invited to participate . Participants were eligible if they were on st and ard medical therapy with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers , and diuretics .  Participant-rated change in 11-point numerical rating scale ( NRS ) ( average over previous 24 h ) breathlessness severity score from baseline ( Day 1 ) to Day 4 of treatment was the primary outcome measure . The study was powered to detect a one-point change in severity . Thirty-nine patients were r and omized and 35 completed all three study arms . Breathlessness severity was reduced from baseline with all three interventions . There was no statistically significant difference between active intervention and placebo or between the two types of opioid for the primary endpoint [ -1.37 in NRS score for placebo group vs. -0.41 in morphine group ( P = 0.13 ) and -1.29 for oxycodone group ( P = 0.90 ) ] . The response to treatment was not affected by aetiology , severity of CHF , or concurrent drug therapy . Opioid administration did not cause detrimental changes in clinical observations and was well tolerated . CONCLUSION We demonstrated no benefit over placebo for the relief of breathlessness with short-term low-dose oral opioids for CHF patients . Trial registered prior to the recruitment of the first participant with Current Controlled Trials ( www.controlled-trials.com ; Trial number IS RCT N 85268059 )
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 .