Efficacy of a decision aid in breast cancer patients considering immediate reconstruction: results of a randomized controlled trial.

PURPOSE: Breast cancer patients face complex decisions about immediate breast reconstruction (BR) after mastectomy. We evaluated the efficacy of an online decision aid in improving the decision-making process, decision quality and health outcomes in breast cancer patients considering immediate BR. METHODS: In a multicenter randomized controlled trial, patients were allocated to either the intervention group receiving care-as-usual (CAU) with access to an online decision aid, or the control group receiving CAU with an information leaflet. The primary outcome was decisional conflict. Secondary outcomes assessed the process of decision making (e.g. preparation for decision making, satisfaction with information), decision quality (decision regret, knowledge) and health outcomes (e.g. satisfaction with BR outcomes, body image). Patients completed questionnaires at baseline (T0), 1 week after consultation with a plastic surgeon (T1), 3 months (T2), and 12 months post-surgery (T3). RESULTS: We included 250 patients. Decisional conflict decreased over time in both groups, with no between group differences. Intervention participants felt better prepared for decision making than controls (P = .002). At T2, 87% of intervention participants were (very) satisfied with the information about BR, compared to 73% of control participants (P = .011). No significant between group differences were observed in any other outcome. CONCLUSION: Our online decision aid was as effective in reducing decisional conflict as an information leaflet about immediate BR after mastectomy. However, the decision aid substantially improved the decision-making process by better preparing breast cancer patients for decisions about immediate BR.

Short-Term Quality of Life after Autologous Compared with Alloplastic Breast Reconstruction: A Prospective Study.

BACKGROUND: The aim of this prospective multicenter study was to evaluate whether autologous breast reconstruction (BR) leads to lower short-term quality of life (QoL) compared with alloplastic BR, due to the more physically demanding surgery and increased risk of severe complications of autologous BR. METHODS: Changes in QoL after BR were measured in this prospective multicenter study using the BREAST-Q questionnaire, which was administered preoperatively and at 6 weeks and 6 months postoperatively. Characteristics and complications, classified according to Clavien-Dindo, were compared between alloplastic and autologous groups. Profile plots and generalized linear regression models were constructed to analyze the BREAST-Q subscales over time for both BR groups. RESULTS: Preoperatively, women undergoing autologous BR scored lower on all BREAST-Q scales compared with women undergoing alloplastic BR, regardless of whether they underwent immediate or delayed BR. Women undergoing autologous BR scored higher at 6 weeks and 6 months postoperatively on the Satisfaction with Breasts ( P = 0.001), Psychosocial Well-Being ( P = 0.024), and Sexual Well-Being ( P = 0.007) subscales. Postoperative Physical Well-Being: Chest score was similar between the groups ( P = 0.533). Clavien-Dindo grade III or higher complications occurred more often among women in the autologous group (27% versus 12%, P = 0.042). Complications were not associated with worse BREAST-Q scores on any of the subscales. CONCLUSIONS: In contrast to the authors' expectations, and despite the higher incidence of severe complications and lower preoperative breast satisfaction and QoL scores, women undergoing autologous BR had higher levels of breast satisfaction and psychosocial and sexual well-being, both at 6 weeks and 6 months after BR, compared with women undergoing alloplastic BR. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Development of a patient decision aid for patients with breast cancer who consider immediate breast reconstruction after mastectomy.

PURPOSE: The aim of this study was to develop a patient decision aid (pDA) that could support patients with breast cancer (BC) in making an informed decision about breast reconstruction (BR) after mastectomy. METHODS: The development included four stages: (i) Establishment of a multidisciplinary team; (ii) Needs assessment consisting of semi-structured interviews in patients and a survey among healthcare professionals (HCPs); (iii) Creation of content, design and technical system; and (iv) Acceptability and usability testing using a think-aloud approach in patients and interviews among HCPs and representatives of the Dutch Breast Cancer Patient Organization. RESULTS: From the needs assessment, three themes were identified: Challenging period to make a decision, Diverse motivations for a personal decision and Information needed to make a decision about BR. HCPs valued the development of a pDA, especially to prepare patients for consultation. The pDA that was developed contained three parts: first, a consultation sheet for oncological breast surgeons to introduce the choice; second, an online tool including an overview of reconstructive options, the pros and cons of each option, information on the consequences of each option for daily life, exercises to clarify personal values and patient stories; and third, a summary sheet with patients' values, preferences and questions to help inform and guide the discussion between the patient and her plastic surgeon. The pDA was perceived to be informative, helpful and easy to use by patients and HCPs. CONCLUSION: Consistent with information needs, a pDA was developed to support patients with BC who consider immediate BR in making an informed decision together with their plastic surgeon. PATIENT OR PUBLIC CONTRIBUTION: Patients participated in the needs assessment and in acceptability and usability testing.

Decisional conflict in breast cancer patients considering immediate breast reconstruction.

BACKGROUND: Breast cancer (BC) patients who are treated with mastectomy are frequently offered immediate breast reconstruction. This study aimed to assess decisional conflict in patients considering immediate breast reconstruction, and to identify factors associated with clinically significant decisional conflict (CSDC). METHODS: Baseline data of a multicenter randomized controlled trial evaluating the impact of an online decision aid for BC patients considering immediate breast reconstruction after mastectomy were analyzed. Participants completed questionnaires assessing sociodemographic and clinical characteristics, decisional conflict and other patient-reported outcomes related to decision-making such as breast reconstruction preference, knowledge, information resources used, preferred involvement in decision-making, information coping style, and anxiety. Multivariable logistic regression analysis was performed to identify factors associated with CSDC (score > 37.5 on decisional conflict). RESULTS: Of the 250 participants, 68% experienced CSDC. Patients with a slight preference for breast reconstruction (odds ratio (OR) = 6.19, p < .01), with no preference for or against breast reconstruction (OR = 11.84, p < .01), and with a strong preference for no breast reconstruction (OR = 5.20, p < .05) were more likely to experience CSDC than patients with a strong preference for breast reconstruction. Furthermore, patients with more anxiety were more likely to experience CSDC (OR = 1.03, p = .01). CONCLUSION: A majority of BC patients who consider immediate breast reconstruction after mastectomy experience clinically significant decisional conflict. The findings emphasize the need for decision support, especially for patients who do not have a strong preference for breast reconstruction.

Outcome of Quality of Life for Women Undergoing Autologous versus Alloplastic Breast Reconstruction following Mastectomy: A Systematic Review and Meta-Analysis.

BACKGROUND: This review aimed to meta-analyze the quality of life of alloplastic versus autologous breast reconstruction, when measured with the BREAST-Q. METHODS: An electronic PubMed and EMBASE search was designed to find articles that compared alloplastic versus autologous breast reconstruction using the BREAST-Q. Studies that failed to present BREAST-Q scores and studies that did not compare alloplastic versus autologous breast reconstruction were excluded. Two authors independently extracted data from the included studies. A standardized data collection form was used. Quality was assessed using the Newcastle-Ottawa Scale. The mean difference and 95 percent confidence intervals between breast reconstruction means were estimated for each BREAST-Q subscale. Forest plots and the I statistic were used to assess heterogeneity and funnel plot publication bias. The Z test was used to assess overall effects. RESULTS: Two hundred eighty abstracts were found; 10 articles were included. Autologous breast reconstruction scored significantly higher in the five subscales than alloplastic breast reconstruction. The Satisfaction with Breasts subscale indicated the greatest difference, with a mean difference of 6.41 (95 percent CI, 3.58 to 9.24; I = 70 percent). The Satisfaction with Results subscale displayed a mean difference of 5.52. The Sexual Well-Being subscale displayed a mean difference of 3.85. The Psychosocial Well-Being subscale displayed a mean difference of 2.64. The overall difference in physical well-being was significant, with high heterogeneity (mean difference, 3.33; 95 percent CI, 0.18 to 6.48; I = 85). CONCLUSION: Autologous breast reconstruction had superior outcomes compared with alloplastic breast reconstruction as measured by the BREAST-Q.

Improved upper blepharoplasty outcome using an internal intradermal suture technique: a prospective randomized study.

OBJECTIVE: To assess whether a suture technique in upper blepharoplasty may be the cause of differences in the occurrence of suture abscess formation and focal inflammation. MATERIALS AND METHODS: A Level I, randomized controlled trial. The upper blepharoplasty wound was closed with a running intradermal suture. External intradermal suturing implied that this suture was started by initially passing it through the intact skin adjacent to the wound. In contrast, internal intradermal suturing meant the intradermal suture was not started in the adjacent skin but simply within the wound itself. One week and 6 weeks after surgery, the presence of suture abscesses and focal inflammation was assessed at the entrance and exit of the sutures. RESULTS: After 1 week, 12 abscesses (40.0%) were found at the medial side of the externally sutured upper eyelids and 4 abscesses (13.3%) in the internally sutured upper eyelids (p = .02). The presence of erythema and edema after 1 week was also significantly lower in internally sutured upper eyelids (p = .02). CONCLUSION: In this series, the method of starting the suture (internal vs external) at the medial side of an upper blepharoplasty wound was associated with a statistically significant reduction in the incidence of medial wound inflammation and suture abscess formation at a 1-week follow-up.