title: Methods to determine the minimum important difference for a sexual event diary used by postmenopausal women with hypoactive sexual desire disorder.
abstract: BACKGROUND
  Recently, there has been much discussion in the literature about how to determine the meaningfulness of results generated from a patient-reported outcome measure. A number of reviews have shown that there are two main approaches: anchor- and distribution-based approaches for determining the minimum important difference (MID) for a new measure. There are issues with calculating an MID using each method: Will the two approaches give the same estimate? If the estimates differ, how do you decide on one estimate? Would asking patients directly be more beneficial?
  
  
  OBJECTIVE
  A case study was presented to address these issues based on a newly developed diary assessing number of satisfactory sexual events (SSEs) per week in women with hypoactive sexual desire disorder (HSDD).
  
  
  METHODS
  Anchor- and distribution-based estimates were generated from data gathered in two double-blind, placebo-controlled, parallel group trials for the treatment of HSDD (N = 788). A novel interview study was used to ask women directly about an MID for SSEs (N = 77).
  
  
  METHODS
  Defining the MID for an SSE diary in women with HSDD.
  
  
  RESULTS
  The estimates varied, producing a range of mean MID estimates between 0.04 and 0.46 SSEs per week.
  
  
  CONCLUSIONS
  We recommend that rather than defining the MID, a range should be selected from the set of estimates formed by the limits of the 95% confidence intervals.
authors.affiliation: Pfizer Ltd., Kent, UK. tara.symonda@pfizer.com
authors.forename: Tara
authors.initials: T
authors.lastname: Symonds
authors.forename: Cathie
authors.initials: C
authors.lastname: Spino
authors.forename: Melanie
authors.initials: M
authors.lastname: Sisson
authors.forename: Paresh
authors.initials: P
authors.lastname: Soni
authors.forename: Mona
authors.initials: M
authors.lastname: Martin
authors.forename: Lacey
authors.initials: L
authors.lastname: Gunter
authors.forename: Donald L
authors.initials: DL
authors.lastname: Patrick
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D007989:Libido; D008875:Middle Aged; D010555:Personality Inventory; D017698:Postmenopause; D011594:Psychometrics / Q000295:instrumentation; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D012735:Sexual Dysfunction, Physiological / Q000175:diagnosis*; D020018:Sexual Dysfunctions, Psychological / Q000175:diagnosis*; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D016387:Women's Health