Development of the initial list of markers for the SHE scale was based on previous observational, prevalence research conducted by the study team. Multiple sources were used to compile the list including:
- surveys from women with and without hormone use were used to identify differences in complaints or treatment effects
- a large, observational study in nine countries and five continents contributed to the identification of possible items (unpublished research report and 1,2)
- the Italian arm of the EURAS-OC study3 was used as a check-list for potentially beneficial treatment effects with oral contraceptives (“Benefit Questionnaire”, not validated).
- discussions with women about their experience during hormone treatment were performed as part of the EURAS-OC Italy study
- extensive literature reviews were undertaken listing positive and negative short-term effects of hormone use
- validated scales for women related to the concept and domains of the new scale (MRS 4, FSFI 5, FSDS 6, DISF 7, and 8) were assessed looking specifically at how different symptoms and complaints were phrased
The initial list of potential markers was reviewed by a panel of experts leading to a reduction in the list from 80 items to approximately 40. The latter were put into the raw scale. As part of the translation of the scale into Italian, the raw scale was subjected to cognitive debriefing (10 women), which was then officially piloted by TNS Infratest (Milan, Italy). Twenty women completed the questionnaire and made remarks about clarity of items, introduction, response categories of the Likert scale and the type of presentation of the questionnaire in general, followed by some minor revisions.
Choice of data collection
The scale was designed as paper-based, self-administrable PRO scale. There is no evidence available yet how an electronic or web-based administration would influence the results, although a major effect is considered unlikely.
Choice of recall period
The goal is the assessment of hormonal short-term effects. Therefore, the focus of interest was defined as the recent period (limited to the recent 6 months). It can be assumed, that the experience gathered in the most recent month will dominate patients’ responses.
A Likert scale was used to document the response. The patient has to check for each of the items if the symptoms/complaints apply for her, and if so, how severe/intense or strong it was perceived. The appropriate box has to be marked.
1. Heinemann L. Female hormone therapy. Multinational survey on desires, attitudes, and acceptability of different forms of hormone therapy. Unpublished research report. ZEG, Berlin 2002.
2. Heinemann, K, Rübig A, Strothmann A, Nahum GG, Heinemann LAJ. Prevalence and opinions of hormone therapy prior to the Women’s Health Initiative: A multinational Survey in four continents. J Women’s Health 2008;17:1-16.
3. Heinemann l. Analyses of subjective effects of hormone therapy. A long-term active surveillance study I Italy (EURAS-Italy). Unpublished research report. ZEG, Berlin 2007.
4. Heinemann LAJ, Potthoff P, Schneider HPG. International versions of the Menopause Rating Scale (MRS). Health and Quality of Life Outcomes 2003;1:28 (30 July 2003).
5. Rosen R, Brown C, Heiman J et al. The female Sexual Function Index (FSFI): A multidimensional self-report instrument for the assessment of female sexual function. J Sex Mar Ther 2000; 26:191-208.
6. Derogatis LR. The Derogates Interview for Sexual Functioning (DISF)/DISF-R): an introductory report. J Sex Mar Ther 1997;23:291-6.
7. Derogates LR, Burnett A, Heiman J, Leiblum S, Rosen R. Development and continuing validation of the Female Sexual Distress Scale (FSDS). Presented at the 4th Annual Female Sexual Function Forum, Boston, MA (October 29,2001).
8. Heinemann LAJ, Potthoff P, Heinemann K, Pauls A, Ahlers CJ, Saad F. Scale for Quality of Sexual Function (QSF) as an outcome measure for both genders? J Sexual Med 2005;2:82-95.