PMID- 26948292
OWN - NLM
STAT- MEDLINE
DCOM- 20180212
LR  - 20191210
IS  - 1365-2982 (Electronic)
IS  - 1350-1925 (Print)
IS  - 1350-1925 (Linking)
VI  - 28
IP  - 8
DP  - 2016 Aug
TI  - Validating endpoints for therapeutic trials in fecal incontinence.
PG  - 1148-56
LID - 10.1111/nmo.12809 [doi]
AB  - BACKGROUND: A 50% or greater reduction in the frequency of fecal incontinence 
      (FI) recorded with daily bowel diaries is the primary endpoint in clinical trials 
      of FI. Whether this difference is clinically important is unknown. The 
      relationship between FI symptoms recorded with daily and weekly instruments is 
      unknown. The contribution of psychological factors to quality of life (QOL) in FI 
      is unclear. METHODS: Fecal incontinence severity was assessed with daily bowel 
      diaries and periodic questionnaires (fecal incontinence severity score [FISS], 
      FIQOL, 36-Item Short Form Health Survey [SF-36], and hospital anxiety and 
      depression scales) for 4 weeks before and during double-blind randomization to 
      placebo or clonidine in 44 women with FI. The reduction in FI frequency was 
      compared to the minimal clinically important difference (MCID) computed from the 
      FISS. Endpoints of FI were compared between daily and weekly diaries. KEY 
      RESULTS: The FISS exceeded the MCID in 75% and 83% of patients in whom the FI 
      frequency declined by 50-74% and >/=75% respectively. Parameters of FI measured 
      with daily and weekly instruments were significantly correlated. The daily 
      parameters explained 71% of the inter-patient variation in the FISS. The SF-36 
      health scores, rather than the FISS rating, explained a majority of the 
      inter-subject variation in FIQOL. CONCLUSIONS & INFERENCES: Most patients who 
      report a >/=50% reduction in FI frequency experience a clinically important 
      improvement. Weekly questionnaires accurately assess the severity of FI. 
      Self-reported physical and mental health explained a greater proportion of the 
      variance in FIQOL than FI symptom severity.
CI  - (c) 2016 John Wiley & Sons Ltd.
FAU - Noelting, J
AU  - Noelting J
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Mayo Clinic, Rochester, MN, USA.
FAU - Zinsmeister, A R
AU  - Zinsmeister AR
AD  - Division of Biomedical Statistics and Informatics, Department of Health Sciences 
      Research, Mayo Clinic, Rochester, MN, USA.
FAU - Bharucha, A E
AU  - Bharucha AE
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Mayo Clinic, Rochester, MN, USA.
LA  - eng
GR  - R01 DK078924/DK/NIDDK NIH HHS/United States
GR  - UL1 TR000135/TR/NCATS NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Validation Study
DEP - 20160306
PL  - England
TA  - Neurogastroenterol Motil
JT  - Neurogastroenterology and motility
JID - 9432572
RN  - 0 (Sympatholytics)
RN  - MN3L5RMN02 (Clonidine)
SB  - IM
MH  - Clonidine/therapeutic use
MH  - Double-Blind Method
MH  - Fecal Incontinence/*diagnosis/*drug therapy
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - *Quality of Life
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires
MH  - Sympatholytics/therapeutic use
MH  - Treatment Outcome
PMC - PMC4956545
MID - NIHMS767104
OTO - NOTNLM
OT  - bowel diaries
OT  - endpoints
OT  - fecal incontinence
OT  - quality of life
EDAT- 2016/03/08 06:00
MHDA- 2018/02/13 06:00
PMCR- 2017/08/01
CRDT- 2016/03/08 06:00
PHST- 2015/11/19 00:00 [received]
PHST- 2016/02/01 00:00 [accepted]
PHST- 2016/03/08 06:00 [entrez]
PHST- 2016/03/08 06:00 [pubmed]
PHST- 2018/02/13 06:00 [medline]
PHST- 2017/08/01 00:00 [pmc-release]
AID - 10.1111/nmo.12809 [doi]
PST - ppublish
SO  - Neurogastroenterol Motil. 2016 Aug;28(8):1148-56. doi: 10.1111/nmo.12809. Epub 
      2016 Mar 6.