PMID- 14596626
OWN - NLM
STAT- MEDLINE
DCOM- 20031204
LR  - 20191210
IS  - 1170-7690 (Print)
IS  - 1170-7690 (Linking)
VI  - 21
IP  - 15
DP  - 2003
TI  - Evaluating minimal clinically important differences for the acne-specific quality 
      of life questionnaire.
PG  - 1069-79
AB  - BACKGROUND: The Acne-Specific Quality of Life Questionnaire (Acne-QoL) is a 
      responsive, reliable and valid instrument developed to measure the impact of 
      facial acne across four dimensions of patient QOL. Score changes on this 
      instrument have been used to report statistically significant treatment 
      advantages for a low-dose oral contraceptive (Estrostep, containing 
      norethisterone (norethindrone) acetate (NA) 1mg and ethinylestradiol (EE) [20, 
      30, 35 mg] as compared with placebo in women with moderate acne vulgaris. 
      However, the question remained if these statistically significant results were 
      also clinically meaningful. OBJECTIVES: To evaluate the statistically significant 
      Acne-QoL benefits observed with NA/EE in terms of their clinical significance, 
      and to compare the three different approaches for defining a minimal clinically 
      important difference (MCID) for the Acne-QoL instrument. METHODS: Since the 
      optimum method for estimating MCIDs has yet to be established, three different 
      published approaches for determining MCIDs were applied and compared using data 
      from two randomised, double-blind, placebo- controlled studies of the efficacy of 
      NA/EE in the treatment of facial acne. RESULTS: Although the approaches differed 
      substantially, the resulting MCID estimates were comparable. Specifically, the 
      MCID estimates ranged from 0.50-10.3 mean change per item, depending on the 
      domain. The results showed that the statistically significant treatment 
      advantages for NA/EE were also clinically significant. CONCLUSION: When applied 
      to the change scores present, the results showed that the statistically 
      significant treatment advantages for NA/EE were also clinically significant.
FAU - McLeod, Lori D
AU  - McLeod LD
AD  - RTI Health Solutions, Research Triangle Institute, North Carolina 27709-2194, 
      USA. lmcleod@rti.org
FAU - Fehnel, Sheri E
AU  - Fehnel SE
FAU - Brandman, Jane
AU  - Brandman J
FAU - Symonds, Tara
AU  - Symonds T
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Pharmacoeconomics
JT  - PharmacoEconomics
JID - 9212404
RN  - 0 (Contraceptives, Oral, Combined)
RN  - 0 (Drug Combinations)
RN  - 37270-71-6 (norethindrone acetate, ethinyl estradiol, ferrous fumarate drug 
      combination)
RN  - 423D2T571U (Ethinyl Estradiol)
RN  - T18F433X4S (Norethindrone)
MH  - Acne Vulgaris/*drug therapy/*psychology
MH  - Adolescent
MH  - Adult
MH  - Contraceptives, Oral, Combined/*therapeutic use
MH  - Drug Combinations
MH  - Ethinyl Estradiol/*therapeutic use
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Norethindrone/*therapeutic use
MH  - Psychometrics
MH  - Quality of Life/*psychology
MH  - Self Concept
MH  - *Sickness Impact Profile
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
EDAT- 2003/11/05 05:00
MHDA- 2003/12/05 05:00
CRDT- 2003/11/05 05:00
PHST- 2003/11/05 05:00 [pubmed]
PHST- 2003/12/05 05:00 [medline]
PHST- 2003/11/05 05:00 [entrez]
AID - 21151 [pii]
AID - 10.2165/00019053-200321150-00001 [doi]
PST - ppublish
SO  - Pharmacoeconomics. 2003;21(15):1069-79. doi: 10.2165/00019053-200321150-00001.