PMID- 24383418
OWN - NLM
STAT- MEDLINE
DCOM- 20140404
LR  - 20220409
IS  - 1535-4970 (Electronic)
IS  - 1073-449X (Linking)
VI  - 189
IP  - 3
DP  - 2014 Feb 1
TI  - Minimal clinically important differences in pharmacological trials.
PG  - 250-5
LID - 10.1164/rccm.201310-1863PP [doi]
AB  - The concept of a minimal clinically important difference (MCID) is well 
      established. Here, we review the evidence base and methods used to define MCIDs 
      as well as their strengths and limitations. Most MCIDs in chronic obstructive 
      pulmonary disease (COPD) are empirically derived estimates applying to 
      populations of patients. Validated MCIDs are available for many commonly used 
      outcomes in COPD, including lung function (100 ml for trough FEV1), dyspnea 
      (improvement of >/= 1 unit in the Transition Dyspnea Index total score or 5 units 
      in the University of California, San Diego Shortness of Breath Questionnaire), 
      health status (reduction of 4 units in the St George's Respiratory Questionnaire 
      total score), and exercise capacity (47.5 m for the incremental shuttle walking 
      test, 45-85 s for the endurance shuttle walking test, and 46-105 s for 
      constant-load cycling endurance tests), but there is currently no validated MCID 
      for exacerbations. In a clinical trial setting, many factors, including study 
      duration, withdrawal rate, baseline severity, and Hawthorne effects, can 
      influence the measured treatment effect and determine whether it reaches the 
      MCID. We also address recent challenges presented by clinical trials that compare 
      active treatments and suggest that MCIDs should be used to identify the 
      additional proportion of patients who benefit, for example, when one drug is 
      replaced by another or when a second drug is added to a first. We propose the 
      term "minimum worthwhile incremental advantage" to describe this parameter.
FAU - Jones, Paul W
AU  - Jones PW
AD  - 1 Division of Clinical Science, St George's University of London, London, United 
      Kingdom.
FAU - Beeh, Kai M
AU  - Beeh KM
FAU - Chapman, Kenneth R
AU  - Chapman KR
FAU - Decramer, Marc
AU  - Decramer M
FAU - Mahler, Donald A
AU  - Mahler DA
FAU - Wedzicha, Jadwiga A
AU  - Wedzicha JA
LA  - eng
GR  - RP-PG-0109-10056/DH_/Department of Health/United Kingdom
PT  - Journal Article
PT  - Review
PL  - United States
TA  - Am J Respir Crit Care Med
JT  - American journal of respiratory and critical care medicine
JID - 9421642
RN  - 0 (Bronchodilator Agents)
SB  - IM
CIN - Am J Respir Crit Care Med. 2014 May 15;189(10):1286-7. PMID: 24832751
MH  - Bronchodilator Agents/*therapeutic use
MH  - Clinical Trials as Topic/*methods
MH  - Data Interpretation, Statistical
MH  - Disease Progression
MH  - Drug Therapy, Combination
MH  - Dyspnea/diagnosis/drug therapy/etiology
MH  - Exercise Tolerance
MH  - Forced Expiratory Volume
MH  - Health Status Indicators
MH  - Humans
MH  - Pulmonary Disease, Chronic Obstructive/complications/*drug therapy
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
EDAT- 2014/01/05 06:00
MHDA- 2014/04/05 06:00
CRDT- 2014/01/04 06:00
PHST- 2014/01/04 06:00 [entrez]
PHST- 2014/01/05 06:00 [pubmed]
PHST- 2014/04/05 06:00 [medline]
AID - 10.1164/rccm.201310-1863PP [doi]
PST - ppublish
SO  - Am J Respir Crit Care Med. 2014 Feb 1;189(3):250-5. doi: 
      10.1164/rccm.201310-1863PP.