PMID- 20165594
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20110714
LR  - 20220310
IS  - 1177-889X (Electronic)
IS  - 1177-889X (Linking)
VI  - 4
DP  - 2010 Feb 4
TI  - A closer look at the baseline-observation-carried-forward (BOCF).
PG  - 11-6
AB  - PURPOSE: The baseline-observation-carried-forward (BOCF) approach is one method 
      to handle missing data from early treatment discontinuation. We examined 
      modifications of this approach, taking into consideration treatment-related and 
      nontreatment-related reasons for discontinuation. METHODS: Two duloxetine chronic 
      pain trials (placebo-controlled) were used to examine the impact of different 
      analytical methods on study outcome. Reasons for discontinuation were categorized 
      as treatment-related and nontreatment-related. Missing data in the primary 
      efficacy outcome were handled using five statistical methods: mixed-model 
      repeated measures (MMRM), last-observation-carried-forward (LOCF), BOCF, modified 
      BOCF (mBOCF, discontinuation due to treatment-related reasons, ie, adverse events 
      [AEs] or lack of efficacy), and aeBOCF (discontinuation due to AEs only). 
      RESULTS: Duloxetine was superior to placebo on mean change from baseline in Brief 
      Pain Inventory average pain rating, using MMRM (study 1, P = 0.004; study 2, P < 
      0.001), LOCF (study 1, P = 0.019; study 2, P < 0.001), BOCF (study 1, P = 0.019; 
      study 2, P = 0.013), and mBOCF (study 1, P = 0.041; study 2, P = 0.005). Using 
      aeBOCF, duloxetine was superior to placebo in study 2 (P = 0.005) and numerically 
      better in study 1 (P = 0.075). CONCLUSION: Due to the different assumptions made 
      by various methods regarding accounting for missing data, the analytical methods 
      chosen may influence the interpretation of study results. Consideration should be 
      given to the effect of actual treatment outcomes from patients. Employing 
      different statistical approaches such as sensitivity analyses may help to assess 
      the robustness of the study results and provide a more accurate reflection of the 
      treatment outcome.
FAU - Liu-Seifert, Hong
AU  - Liu-Seifert H
AD  - Lilly Research Laboratories, Indianapolis, IN, USA.
FAU - Zhang, Shuyu
AU  - Zhang S
FAU - D'Souza, Deborah
AU  - D'Souza D
FAU - Skljarevski, Vladimir
AU  - Skljarevski V
LA  - eng
PT  - Journal Article
DEP - 20100204
PL  - New Zealand
TA  - Patient Prefer Adherence
JT  - Patient preference and adherence
JID - 101475748
PMC - PMC2819899
OTO - NOTNLM
OT  - discontinuation
OT  - pain
OT  - statistical
OT  - treatment-related
EDAT- 2010/02/19 06:00
MHDA- 2010/02/19 06:01
PMCR- 2010/02/04
CRDT- 2010/02/19 06:00
PHST- 2010/01/16 00:00 [received]
PHST- 2010/02/19 06:00 [entrez]
PHST- 2010/02/19 06:00 [pubmed]
PHST- 2010/02/19 06:01 [medline]
PHST- 2010/02/04 00:00 [pmc-release]
AID - ppa-4-011 [pii]
AID - 10.2147/ppa.s8135 [doi]
PST - epublish
SO  - Patient Prefer Adherence. 2010 Feb 4;4:11-6. doi: 10.2147/ppa.s8135.