br The European Organisation for Research and Treatment
The European Organisation for Research and Treatment of Cancer Breast Reconstruction Questionnaire (EORTC QLQ-BRR26) assesses satisfaction with the results after breast reconstruction. The questionnaire was validated/tested for reliability in a set of breast cancer patients after breast reconstruction [19,20]. It consists of 26 items constituting three scales with scores ranging from 1 (‘Not at all’) to 4 (‘A lot’). The Swedish version has been formally translated, and was a part of the development of this questionnaire [19,20].
The Body Image Scale (BIS) is a 10-item scale measuring the impact of surgery on self-consciousness, physical/sexual attrac-tiveness, femininity, satisfaction with body/scars, body integrity, and avoidance behaviour after surgery for cancer patients . The development of the scale did not rely on a particular theoretical model, as there was no consensus on the definition of body image disturbance in 1997, when the first study was carried out. Scores per item ranges from 0 (‘Not at all’) to 3 (‘Very much’), creating a total score of 0e30/patient. A higher total score translates to more problems. The Swedish version was translated at Karolinska Uni-versity Hospital in 1997. It has not been formally validated/ reliability-tested, but the Cronbach a coefficient for the study sample at the six-month assessment was 0.85 .
The Sexuality Activity Questionnaire (SAQ) consists of a 10-item scale assessing sexual activity: ‘Pleasure’ (desire, enjoyment, and satisfaction; higher scores indicate more pleasure (range 0e18)), ‘Discomfort’ (dryness and pain; higher scores indicate more discomfort (range 0e6)), and ‘Sexual habit’ (<0.33 indicate less frequent than usual (range 0e3)) . The Swedish T16Ainh-A01 has not been formally validated, but the English version was shown to be valid/reliable as a measure of women's sexual functioning .
The Hospital Anxiety and Depression (HAD) scale assesses anxi-ety/depressive symptoms . It consists of 14 items (seven items assessing ‘Anxiety’ and ‘Depressive symptoms’ each), scored 0 to 3, yielding a summated score per scale between 0 and 21. Cut-offs for clinically relevant anxiety/depressive symptoms have been estab-lished . Less than 8 points indicate normal levels of problems, 8e10 points indicate possible clinical cases, and 11 points indicate clinical cases. The Swedish version has been validated against di-aries in a sample of breast cancer patients .
The Swedish Short Term-36 Health Survey (SF-36) measures HRQoL . It covers eight-domains by 36 items. For each domain, mean scores were transformed to a 0 to 100 scale, where a higher number represents higher functioning.
2.3. Statistical analysis
Differences in scores between the one-year and long-term as-sessments were investigated using paired t-tests. Mean paired differences are presented together with 95% confidence intervals. Unpaired comparisons between women with or without previous breast cancer were performed by linear regression models. Factors included in the adjusted models were: scores one year post-RRM, time since RRM, age at long-term follow-up, mutation-status, bilateral prophylactic salpingo-oophorectomy, and body mass in-dex (BMI; kg/m2). Results from these models are presented as mean differences with 95% confidence intervals. For SF-36, clinically meaningful differences were determined according to Osoba . A difference of 5e9 points was considered as ‘small’ (S), 10e19 as ‘moderate’ (M), and 20 as ‘large’ (L). Reported p-values are two-sided and refer to Wald tests. The statistical significance level was set to 0.05. All analyses were performed using STATA/IC 14.2 for Mac, StataCorp, TX, USA.
The Consort diagram (Fig. 1) presents the 148 (74%) women Single-strand assimilation returned the envelopes, of whom 146 (73%) (99 without previous breast cancer; 47 with previous breast cancer) completed the questionnaires. Demographic/clinical data for 136 (68%) women who consented to data collection from medical records are pre-sented in Table 1. For the women who completed the question-naires without giving permission to extract data from their medical records, some missing data were replaced using the research
Women going through risk-reducing mastectomy at Karolinska University Hospital 1997–2010 n=298
Women responding to at least one previous short-term assessment n=246
Eligible women for the long-term follow-up n=200 (136 without previous breast cancer; 64 with previous breast cancer)
Women responding to the invitation n=148 (100 without previous breast cancer, mean age at follow-up 52.8 years; 48 with previous breast cancer,