PMID- 19432721
OWN - NLM
STAT- MEDLINE
DCOM- 20090602
LR  - 20191210
IS  - 1445-2197 (Electronic)
IS  - 1445-1433 (Linking)
VI  - 79
IP  - 4
DP  - 2009 Apr
TI  - Reporting of minimum clinically important differences in surgical trials.
PG  - 301-4
LID - 10.1111/j.1445-2197.2009.04865.x [doi]
AB  - BACKGROUND: The minimum clinically important difference (MCID) is the smallest 
      difference in outcome between the groups that would be of clinical interest. It 
      influences the estimates that are made to determine the required sample side. The 
      aim of this study was to explore the reporting of the MCID in surgical trials. 
      METHOD: Surgical trials that were published between January 1981 and December 
      2006 in five prestigious surgical journals were evaluated. Selected for study 
      were trials that studied two groups and reported the main outcome event as a 
      proportion. RESULTS: Only 21% (100/486) of the admissible surgical trials 
      mentioned a value for the MCID when estimating the sample size. There was a 
      trend, however, for compliance with these factors to increase during the study 
      period. The present post-hoc calculations of the required sample size, which were 
      based on the observed differences between the groups at the end of the study, 
      suggested that one-third of the trials should have accrued at least fivefold the 
      number of patients. Although reporting an estimate of the sample size was 
      associated with the study of more patients (median sample size 145 vs 100), it 
      was not associated with the reporting of more positive results, that is, 61% 
      (95/155) versus 65% (214/331). CONCLUSION: There has been an improvement in the 
      proportion of surgical trials reporting formal estimates of sample size during 
      the last three decades. But the construct of these estimates is often suspect 
      because of a failure to provide realistic values for the MCID.
FAU - Kashani, Irwin
AU  - Kashani I
AD  - Department of Surgery, Royal Perth Hospital, University of Western Australia, 
      Perth, Western Australia, Australia.
FAU - Hall, Jane L
AU  - Hall JL
FAU - Hall, John C
AU  - Hall JC
LA  - eng
PT  - Journal Article
PL  - Australia
TA  - ANZ J Surg
JT  - ANZ journal of surgery
JID - 101086634
SB  - IM
MH  - *Clinical Trials as Topic
MH  - Humans
MH  - Outcome Assessment, Health Care
MH  - Research Design
MH  - Sample Size
EDAT- 2009/05/13 09:00
MHDA- 2009/06/03 09:00
CRDT- 2009/05/13 09:00
PHST- 2009/05/13 09:00 [entrez]
PHST- 2009/05/13 09:00 [pubmed]
PHST- 2009/06/03 09:00 [medline]
AID - ANS4865 [pii]
AID - 10.1111/j.1445-2197.2009.04865.x [doi]
PST - ppublish
SO  - ANZ J Surg. 2009 Apr;79(4):301-4. doi: 10.1111/j.1445-2197.2009.04865.x.