Validation of Scales in Reconstructive Breast Surgery

Primary outcomes

1. Validation and reliability of BREAST-Q for Sweden

   Time frame: Pre-operatively

   Breast-Q measures breast related quality of life on a scale 1-100. A higher score indicates a higher quality of life.

2. Validation and reliability of BREAST-Q for Sweden

   Time frame: 5 years postoperatively

   Breast-Q measures breast related quality of life on a scale 1-100. A higher score indicates a higher quality of life.

3. Validation and reliability of EuroQol-5 dimensions, 3 levels for reconstructive breast surgery

   Time frame: Pre-operatively

   EuroQol-5 dimensions-3 levels (EQ5D) is a generic instrument developed for health economic and clinical evaluation of healthcare. A total score between 0 and 1 is calculated. Zero equals death and 1 perfect health.

4. Validation and reliability of EuroQol-5 dimensions, 3 levels for reconstructive breast surgery

   Time frame: 5 years postoperatively

   EuroQol-5 dimensions-3 levels (EQ5D) is a generic instrument developed for health economic and clinical evaluation of healthcare. A total score between 0 and 1 is calculated. Zero equals death and 1 perfect health.

5. Validation and reliability of Hospital Anxiety and Depression scale (HADS) for Reconstructive breast surgery

   Time frame: Pre-operatively

   The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).

6. Validation and reliability of Hospital Anxiety and Depression scale (HADS) for Reconstructive breast surgery

   Time frame: 5 years postoperatively

   The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).

7. Validation and reliability of RAND-36 for reconstructive breast surgery

   Time frame: Pre-operatively

   It comprises eight subdomains: physical functioning (10 items), role limitations caused by physical health problems (4 items), role limitations caused by emotional problems (3 items), social functioning (2 items), emotional well-being (5 items), energy/fatigue (4 items), pain (2 items), and general health perceptions (5 items) where patients score their health during the last four weeks on Likert scales. Every item score is transformed linearly to the per cent of total possible score (0-100) and then averaged by the values of the scale. A subscore is calculated for each domain and in addition two summary scores, physical and mental health, are calculated.

8. Validation and reliability of RAND-36 for reconstructive breast surgery

   Time frame: 5 years postoperatively

   It comprises eight subdomains: physical functioning (10 items), role limitations caused by physical health problems (4 items), role limitations caused by emotional problems (3 items), social functioning (2 items), emotional well-being (5 items), energy/fatigue (4 items), pain (2 items), and general health perceptions (5 items) where patients score their health during the last four weeks on Likert scales. Every item score is transformed linearly to the per cent of total possible score (0-100) and then averaged by the values of the scale. A subscore is calculated for each domain and in addition two summary scores, physical and mental health, are calculated.

9. Validation of Clavion-Dindo classification for reconstructive breast surgery

   Time frame: 5 years postoperatively

   The Clavien-Dindo system is based on ranking the severity of the intervention required to treat a given complication, as follows: grade I includes deviations from the postoperative course without the need for pharmacological treatment or surgical/endoscopic/radiological intervention; grade II complications require pharmacological treatment, blood transfusion, or total parental nutrition; grade III complications require surgical/endoscopic/radiological intervention; grade IV includes life-threatening complications, including those involving the central nervous system, that require intensive care treatment; and grade V includes complications that result in death.