Validation of Scales in Reconstructive Breast Surgery

Study Overview
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Brief Summary
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The main purpose of the project is to validate patient reported outcomes measures (PROMs) in reconstructive breast surgery. BREAST-Q will be evaluated for Swedish and Sweden.Hospital Anxiety and Depression Scale (HADS), EuroQol 5D (EQ5D), and SF-36 will be validated for reconstructive breast surgery. In addition, the complication classification system according to Clavien-Dindo will be validated for reconstructive breast surgery.

Official Title
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Validation of Scales in Reconstructive Breast Surgery

Conditions
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Breast Cancer, Breast Hypertrophy

Intervention / Treatment
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* Procedure: Breast reconstruction
* Procedure: Breast reduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who have had or will have reconstructive breast surgery in Sahlgrenska university hospital. Exclusion Criteria: Do not understand Swedish.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast reconstruction after breast cancer<br>Women who have had/have breast cancer and will have/have had a breast reconstruction. | Procedure: Breast reconstruction<br>* Breast reconstruction after breast cancer.<br>|
| Breast reduction<br>Women who have had/will have a breast reduction due to breast hypertrophy. | Procedure: Breast reduction<br>* Breast reduction due to breast hypertrophy.<br>* Other names: mammoplasty reduction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation and reliability of BREAST-Q for Sweden | Breast-Q measures breast related quality of life on a scale 1-100. A higher score indicates a higher quality of life. | Pre-operatively | 
| Validation and reliability of BREAST-Q for Sweden | Breast-Q measures breast related quality of life on a scale 1-100. A higher score indicates a higher quality of life. | 5 years postoperatively | 
| Validation and reliability of EuroQol-5 dimensions, 3 levels for reconstructive breast surgery | 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. | Pre-operatively | 
| Validation and reliability of EuroQol-5 dimensions, 3 levels for reconstructive breast surgery | 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 years postoperatively | 
| Validation and reliability of Hospital Anxiety and Depression scale (HADS) for Reconstructive breast surgery | 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). | Pre-operatively | 
| Validation and reliability of Hospital Anxiety and Depression scale (HADS) for Reconstructive breast surgery | 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). | 5 years postoperatively | 
| Validation and reliability of RAND-36 for reconstructive breast surgery | 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. | Pre-operatively | 
| Validation and reliability of RAND-36 for reconstructive breast surgery | 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. | 5 years postoperatively | 
| Validation of Clavion-Dindo classification for reconstructive breast surgery | 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. | 5 years postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plastic surgery, breast reconstruction, patient reported outcome, complication