Development of a Patient Decision Aid for Women Considering Breast Reconstruction

The statistician will calculate how many women to whom the research assistant was able to deliver the video/workbook or educational materials (i.e., by sending them the URL link or scheduling time to show them the video/workbook or educational materials on an iPad at the clinic), out of the total n = 130 eligible women. The statistician will also calculate the rates of women who prefer to view the video and workbook at home or at the clinic; and of women who re-visit the video and workbook after the consultation.

This questionnaire includes 10 true/false items assessing participants' knowledge of breast reconstruction. Items are scored such that 0% correct responses equals no knowledge and 100% correct responses equals perfect knowledge.

This questionnaire includes 11 multiple choice items assessing how well-prepared participants feel they are for making this shared medical decision with their doctors. Participants rate each item on 5-point Likert scale from 1 (Not at all) to 5 (a great deal). To calculate a total score, responses are summed and multiplied by 2 to yield the total score. Total scores range from 0 (Poorly prepared) to 100 (Excellently prepared). Alpha coefficients observed between 0.92 to 0.96. This scale discriminates between people who do/do not find the decision aid helpful (p < 0.0001). For this study, a threshold of 75 out of 100 will be considered acceptable.

This scale includes 16 question-items assessing participants' level of decisional conflict, defined as anxiety that blocks taking action. Participants rate each item on a Likert Scale with 5 responses from 0 (Not at All) to 4 (Extremely). Scores are summed, divided by 16, and multiplied by 25 to yield a total score of 0 (Less conflicted) to 100 (Highly conflicted). Total scores above 37.5 out of 100 are associated with delaying decisions and uncertainty about implementing their preferred treatment option; scores below 25 out of 100 are associated with making decisions and successfully implementing their preferred treatment option.

The BREAST-Q assesses women's self-reported ratings of their satisfaction with their breasts and associated quality of life in terms of psychosocial, sexual, and physical well-being. Participants rate 64 items from 1 (Very Dissatisfied) to 4 (Very Satisfied). Psychometric properties include a person separation index of 0.76 to 0.95, Cronbach's alphas of 0.81 to 0.96, and test-retest reproducibility of 0.73 to 0.96 Before surgery, after surgery

The study coordinator will abstract the type(s) of reconstructive surgery completed, including immediate versus delayed reconstruction, autologous versus implant-based reconstruction, nipple reconstruction, contralateral balancing surgery, oncoplastic tissue rearrangement, and/or no reconstruction. This questionnaire is not a validated scale and thus no scoring or psychometric properties are appropriate. Responses will be used to model potential covariate relationships with the primary and other secondary outcome measures.