Clinical InvestigationCongestive Heart FailureMinimally clinically important difference in chronic breathlessness: Every little helps
Section snippets
Methods
Measurements were made as part of a randomized, controlled, crossover, double-blind trial of opioids for breathlessness in CHF (International Standard Randomised Controlled Trial Number: 85268059).16 Symptomatic adults with a diagnosis of New York Heart Association III and IV CHF taking standard medical therapy were randomized to oral morphine, oral oxycodone, or placebo. Equianalgesic doses (British National Formulary) of the 2 short-acting opioids were used (morphine 5 mg 4 times per day and
Results
All 35 patients completed the 3 study arms, resulting in 105 complete data sets. The linear gradients, reciprocal linear gradients, and effect sizes (using the model described by Ries13 [2005]) are shown in the Table. The gradient of the line between the 2 estimates is equal to a 1-point change on the GC score. Both regression equation values are based on the gradient of the regression line to calculate the NRS or Borg score, and the corresponding reciprocal gradients based on the calculation
Discussion
This is the first study to demonstrate an MCID for chronic breathlessness in CHF and, to the best of our knowledge, is the first study in chronic breathlessness to assess the MCID for breathlessness as reported by the patient in any disease group. It is a vital piece of missing information for researchers designing studies using intensity of breathlessness as a primary end point. It is also important for physicians in the interpretation of clinical changes observed in their interpretation of
Conclusions
Chronic breathlessness is important to patients and their caregivers as a target for therapeutic intervention. It is important that we can measure the effects of any intervention and assess whether any effects found are clinically relevant; the results of our study suggest that even small improvements are noticeable for people trying to cope with daily breathlessness.
A 1-point change in NRS or mBorg score is a reasonable estimate of the MCID in average daily chronic breathlessness in CHF.
Disclosures
Funding source: This work was supported with a Clinical Research Fellowship for a PhD through Hull York Medical School, York, UK.
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RCT reg number 85268059.