Rates per woman versus rates per cycle: The importance of relevant outcome measures in subfertility.

Article type
Authors
Wilson M, Lethaby A
Abstract
Background: Pregnancy rate is the most basic outcome measure in subfertility research yet its reporting remains controversial. Pregnancy is commonly reported as rate per treatment cycle, however the statistical guidelines of the Menstrual Disorders and Subfertility Group (published August 1998) recommend the use of pregnancy rate per woman or couple. The justifications for this are 1) repeated cycles in the same woman are not statistical independent and using them invalidates standard analyses, 2) rates per woman are more likely to be relevant and meaningful to the users of the review.

Objectives: To examine the most appropriate/useful way of reporting pregnancy as an outcome measure in subfertility reviews.

Methods: Having already decided, as a group, that rates per women should be reported we will: a. Examine why this is the group's directive - both from a consumer point of view and from a statistical point of view. All reviews that report both rates per cycle and rates per woman will be identified and the summary statistics will be compared to assess differences in results. b. Investigate if the publication of statistical guidelines has had an impact on the use of rates per woman in subfertility reviews. Review all subfertility systematic reviews and protocols, with pregnancy as an outcome measure, produced by the MDSG and published in Issue 1, 2000 of the Cochrane Library. Categorise the reviews and protocols by pregnancy outcome and year published.

Results: a. Discussion and results will be reported at Colloquium b. This table will presented and discussed Number of published reviews and protocols Prior to Guidelines Post Guidelines Reviews Protocols Reviews Protocols Intended outcome measures Rate per woman only 2 0 2 1 Rate per cycle only 1 3 1 0 Rate per woman and per cycle 1 0 3 3 Not specified 11 3 4 0 Total 15 6 10 4 Outcome measure included data Rate per woman only 8 3 Rate per cycle only 3 2 Rate per woman and per cycle 3 2 Unclear/no data 1 1 Total 15 10

Conclusions: To be reported at the Colloquium