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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast reconstruction after breast cancer | Women who have had/have breast cancer and will have/have had a breast reconstruction. |
| |
| Breast reduction | Women who have had/will have a breast reduction due to breast hypertrophy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast reconstruction | Procedure | Breast reconstruction after breast cancer. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Women who are biological women and identify as cis-women.
Women who will have or have had reconstructive breast surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emma Hansson, MD, PhD | Contact | +46313421000 | emma.em.hansson@vgregion.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska university hospital | Recruiting | Gothenburg | 413 45 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34929423 | Result | Weick L, Brorson F, Jepsen C, Liden M, Jensen EW, Hansson E. Giving meaning to patient reported outcomes in breast reconstruction after mastectomy - A systematic review of available scores and suggestions for further research. Breast. 2022 Feb;61:91-97. doi: 10.1016/j.breast.2021.11.008. Epub 2021 Nov 25. | |
| 34217326 | Result |
| Label | URL |
|---|---|
| Full text article | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| C536821 | Gigantomastia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D016462 | Mammaplasty |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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| Breast reduction | Procedure | Breast reduction due to breast hypertrophy. |
|
|
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 |
| Kamya L, Hansson E, Weick L, Hansson E. Validation and reliability testing of the Breast-Q latissimus dorsi questionnaire: cross-cultural adaptation and psychometric properties in a Swedish population. Health Qual Life Outcomes. 2021 Jul 3;19(1):174. doi: 10.1186/s12955-021-01812-x. |
| 35533094 | Result | Weick L, Grimby-Ekman A, Lunde C, Hansson E. Validation and reliability testing of the BREAST-Q expectations questionnaire in Swedish. J Plast Surg Hand Surg. 2023 Feb-Dec;57(1-6):315-323. doi: 10.1080/2000656X.2022.2070180. Epub 2022 May 9. |
| 41139858 | Derived | Jepsen C, Paganini A, Hansson E. Validation and reliability testing of the Swedish version of the BREAST-Q reconstruction. Scand J Surg. 2026 Mar;115(1):88-96. doi: 10.1177/14574969251387498. Epub 2025 Oct 26. |
| Full text article | View source |
| Full text article | View source |
| D017437 |
| Skin and Connective Tissue Diseases |