It is difficult to generalize health technology assessment in the field of traditional Chinese medicine (TCM). The lack of an outcomes evaluation system based on TCM theory is one of the important reasons. Studies conducted in menstruating women have shown that the prevalence of primary dysmenorrhea varies from 45 to 95 percent. As a debilitating condition for many women, dysmenorrhea is one of the leading causes of absenteeism from school or work, which has a negative effect on quality of life (QoL). TCM has obvious advantages in treating dysmenorrhea. This study aimed to develop a dysmenorrhea QoL scale based on TCM theory.

We conducted focus group discussions and in-depth interviews with TCM gynecologists and patients, and adapted items from previously published scales. We generated an initial pool of forty-one items with eight domains. The Delphi method was used for preliminary item selection. Then, we administered the items to a sample of adolescent girls (n = 200). The distribution of survey items, discrete trend, factor analysis, correlation coefficient, and Cronbach's α coefficient were used to select items.

After two rounds of expert consultation, a total of thirty items were included in the dysmenorrhea QoL scale. And after sample analysis, four items' frequency distribution was skewed, five items' standard deviation (SD) was <0.8, four items' factor loading was <0.4, five items' score correlation coefficient with a related domain was <0.4, and three items’ deletion would cause their domain's Cronbach's α coefficient increased. The items were deleted when they met more than two above standards.

A total of twenty items with eight domains were included in the dysmenorrhea QoL scale. The methods to select the dysmenorrhea QoL scale items based on TCM theory were preferable. Given the paucity of research in this area, this new dysmenorrhea QoL scale may provide opportunities for patient-reported outcome evaluation in the field of TCM.