Long-term outcomes, quality of life, and costs of treatment modalities for T1-T2 lip carcinomas.

PURPOSE: Early stage lip squamous cell carcinoma (lip SCC) can be treated with conventional excision, Mohs micrographic surgery (MMS), or brachytherapy. The aim of this retrospective study was to describe the medical outcomes, patient-reported outcomes, and costs of these treatments. METHODS: A retrospective cohort study of T1-T2 lip SSCs treated between 1996 and 2019. Medical outcomes, recurrences, and survival were retrieved from medical records. Facial appearance, facial function, and Quality of Life (QoL) were measured with the Face-Q H&N and EQ-5D-5L questionnaires. Costs were also calculated. RESULTS: Of the 336 lip SCCs, 122 were treated with excision, 139 with MMS, and 75 with brachytherapy. Locally, the recurrence rate was 2.7% and regionally 4.8%. There were 2% disease-related deaths. T2-stage and poor tumor differentiation were associated with recurrences. Posttreatment QoL, facial function, and appearance were rated as good. Brachytherapy was the most expensive treatment modality. CONCLUSION: Early-stage lip SCC has a good prognosis, with a disease-specific survival of 98.2% after a median follow-up of 36 months, there was a high QoL and satisfaction at long-term follow-up. Based on the costs and the risk of locoregional recurrences, we believe that, for most noncomplex lip SCCs, MMS would be the most logical treatment option.

Comparing costs of standard Breast-Conserving Surgery to Oncoplastic Breast-Conserving Surgery and Mastectomy with Immediate two-stage Implant-Based Breast Reconstruction.

BACKGROUND: Conventional breast-conserving surgery (C-BCS) has equal oncological outcomes and superior cosmetic and patient-reported outcomes compared to mastectomy with immediate two-stage implant-based breast reconstruction (M-IBR). Oncoplastic breast-conserving surgery (OP-BCS) is increasingly being used, as it often has better cosmetic results and it enables larger tumour resection. However, OP-BCS and M-IBR compared to C-BCS lengthens operative time and might lead to more complications and consequently to additional costs. Therefore, this study aimed to compare costs and complication rates of C-BCS, OP-BCS and M-IBR. METHODS: This single-centre, retrospective cohort study, calculated costs for all patients who had undergone breast cancer surgery between January 2014 and December 2016. Patient-, tumour- and surgery-related data of C-BCS, OP-BCS and M-IBR patients were retrieved by medical record review. Treatment costs were calculated using hospital financial data. Differences in costs and complications were analysed. RESULTS: A total of 220 patients were included: 74 patients in the C-BCS, 78 in the OP-BCS and 68 in the M-IBR group. From most expensive to least expensive, differences in total costs were found between C-BCS vs. OP-BCS and C-BCS vs. M-IBR (p=<0.01 and p=0.04, respectively). Costs of OP-BCS and M-IBR were comparable. Complication rates were 5.5% for C-BCS, followed by 17% for OP-BCS, and 34% for M-IBR (p<0.01). CONCLUSION: Considering total treatment costs, OP-BCS was financially non-inferior to M-IBR, whereas complication rates were higher following M-IBR. Therefore, when considering other benefits of OP-BCS, such as higher patient-reported outcomes and similar oncological outcomes, a shift from M-IBR to BCS using oncoplastic techniques seems justified.

Cost-utility analysis of four common surgical treatment pathways for breast cancer.

BACKGROUND: The aim was to evaluate the cost-utility of four common surgical treatment pathways for breast cancer: mastectomy, breast-conserving therapy (BCT), implant breast reconstruction (BR) and autologous-BR. METHODS: Patient-level healthcare consumption data and results of a large quality of life (QoL) study from five Dutch hospitals were combined. The cost-effectiveness was assessed in terms of incremental costs and quality adjusted life years (QALYs) over a 10-year follow-up period. Costs were assessed from a healthcare provider perspective. RESULTS: BCT resulted in comparable QoL with lower costs compared to implant-BR and autologous-BR and showed better QoL with higher costs than mastectomy (€17,246/QALY). QoL outcomes and costs of especially autologous-BR were affected by the relatively high occurrence of complications. If reconstruction following mastectomy was performed, implant-BR was more cost-effective than autologous-BR. CONCLUSION: The occurrence of complications had a substantial effect on costs and QoL outcomes of different surgical pathways for breast cancer. When this was taken into account, BCT was most the cost-effective treatment. Even with higher costs and a higher risk of complications, implant-BR and autologous-BR remained cost-effective over mastectomy. This pleas for adapting surgical pathways to individual patient preferences in the trade-off between the risks of complications and expected outcomes.

Beauty Is in the Eye of the Beholder: Esthetic Outcome Assessment in Smile Reanimation Surgery in Patients With Facial Palsy.

ABSTRACT: Layperson assessments are becoming increasingly important in the evaluation of surgical procedures of the face, including smile reanimation. In this study, the authors set out to answer 3 questions: (1) are esthetic scores more dependent on the assessor or the person that is being assessed, (2) how does smile reanimation change esthetic scores, (3) do sex and age of the patient and assessor explain some of the esthetic outcomes?Thirty-five assessors scored pre and postoperative photographs of 21 facial palsy patients undergoing smile reanimation. Linear mixed-effect models were used to investigate the effects of assessor and patient factors on esthetic outcome assessments, to examine changes after smile reanimation, and to determine whether sex and age explained part of the esthetic outcomes.Fifty-eight percent of variation in the esthetic scores can be explained by some assessors being more positive in their esthetic scoring compared to other assessors. Twenty-nine percent was attributed to patient baseline esthetic scores. Overall esthetic scores improved after smile reanimation. Sex and age of the patient and assessor could not explain variation in the esthetic scores.Esthetic appearance highly depends on "who is looking." These findings are important for preoperative counseling, and for those treating and educating patients with facial palsy.

Regional incidence of and reconstructive management patterns in melanoma and nonmelanoma skin cancer of the head and neck: A 3-year analysis in the inpatient setting.

INTRODUCTION: Currently, there is limited literature on reconstructive trends for inpatient head and neck skin cancer. Rather, studies have focused primarily on patients treated on an outpatient basis. To gain a better understanding of the effect that reconstructive correction of complex skin cancer defects has on the healthcare system, we examined the existing incidence and reconstructive trends of head and neck melanoma and nonmelanoma skin cancer (NMSC) in the inpatient setting. METHOD: We performed the analysis of the Healthcare Cost and Utilization Project Nationwide Inpatient Sample Database (NIS) for the years 2012-2014 of the United States (US). Adults diagnosed with melanoma skin cancer or NMSC of the head and neck region were included. Patient characteristics, reconstructive modality, surgical specifics, and outcomes were retrieved. Trends with time for reconstruction techniques were analyzed. RESULTS: In total, 41,185 patients with a diagnosis of skin malignancy were identified, of whom 5,480 (13.3%) underwent reconstruction. Most patients were white (90.0%), male (71.6%), and had a diagnosis of NMSC (79.2%). An increase in flap reconstruction (p < 0.001) was observed. After population adjustment, the highest incidence of skin malignancy was found in the Northeast. CONCLUSION: There has been a trending increase in inpatient NMSC and melanoma skin cancer of the head and neck region, correlating to an increase in the reconstructive procedures performed, and greater cost burden. Resources may be allocated toward early identification and treatment for skin cancer to help control the current rise in complex skin cancer cases necessitating inpatient admission.

"The validity of the EQ-5D-5L in measuring quality of life benefits of breast reconstruction".

BACKGROUND: The EuroQol EQ-5D-5L instrument is the most widely used quality of life (QoL) measure in health economic evaluations. It is unclear whether such a generic instrument is valid enough to estimate the benefits of breast reconstruction (BR), given the specific changes observed in QoL after BR. Hence, we aimed to evaluate the validity of the EQ-5D-5L in patients who had undergone postmastectomy BR. METHODS: In a 10-year cross-sectional cohort study, 463 mastectomy patients completed an online survey: 202 patients with autologous-BR (A-BR), 103 with implant-based-BR (I-BR), and 158 without BR (MAS). The results were used to evaluate the psychometric performance of the EQ-5D-5L with respect to the ceiling effect and to known-group, convergent, and discriminant validity, by comparing it with the Breast-Q, the cancer-specific (EORTC-QLQ-C30), and breast cancer-specific (EORTC-QLQ-BR23) questionnaires. RESULTS: The EQ-5D-5L was able to discriminate between patients with and without complications, MAS with or without BR and MAS versus the general population. It was, however, not able to discriminate between A-BR vs. I-BR as well as BR vs. general population. It is not clear whether this was due to the insensitivity of the instrument, insufficient sample sizes, or because there were no actual differences in QoL between these groups. Good convergent and discriminant validity of both the EQ-5D-5L and its individual dimensions were demonstrated. Additional support for the instrument's validity was revealed by moderate correlations between the generic EQ-5D-5L and specific QoL aspects of BR such as sexuality and body image. CONCLUSIONS: The results of this study support the validity of the EQ-5D-5L as an outcome measure in health economic evaluations of BR.

High risk device registries: Global value, costs, and sustainable funding.

BACKGROUND: Well-designed implant registries have been shown to be a worthwhile investment, from both a health and economic perspective. However, many registries do not attain desirable capture rates or lack sufficient funding, potentially leading to premature termination. This study aims to provide information about rarely discussed, yet pivotal topics regarding the long-term survival of implant registries, focusing on costs, funding models, and the role of stakeholders. METHODS: Worldwide, relatively recently developed breast device (BD) registries were compared to long-standing, orthopaedic (OD) and cardiovascular device (CD) registries. A standardised questionnaire was sent to the registries' designated representatives with key positions, discussing start-up costs, costs of maintenance, value of investment, governance, stakeholders, funding, and sustainability. RESULTS: Thirteen registries were included, originating from nine countries (seven BD registries, five OD registries, one CD registry). In general, start-up costs were comparable, and younger registries were more expensive to maintain. Numerous stakeholders showed interest in registry outcomes. However, only 50% of the registries reported a sustainable funding structure. CONCLUSION: This study provides a global perspective on implantable device registries. All registries provided important information, serving three unique purposes by evaluating the quality of healthcare provided, the quality of all registered devices, and processing recall information. Yet, only half of the registries were certain of sustainable funding, and thus their future existence. It is of utmost importance to bring this to the attention of all parties involved.

Burden of Keloid Disease: A Cross-sectional Health-related Quality of Life Assessment.

Keloid scars may be painful, itch severely and be cosmetically disturbing. The burden of keloid disease, however, has not yet been determined. This study evaluated the association of keloid disease with health-related quality of life (HRQL) and identified indicators of burden using a cross-sectional survey study, with one disease-specific HRQL measure (Skindex-29) and 2 generic HRQL measures (SF-36 and EQ-5D-5L). A total of 106 keloid patients with no other skin diseases participated in the study. Having keloid disease was associated with a considerable impairment of emotional wellbeing, with most impairment on the emotional and mental HRQL. Pain and itch were the strongest indicators of HRQL impairment in keloid patients. Having painful or itchy keloids was related to low mental and emotional HRQL, implying that patients with keloids require access to effective treatment aimed at alleviating physical symptoms.

A Standard Set of Value-Based Patient-Centered Outcomes for Breast Cancer: The International Consortium for Health Outcomes Measurement (ICHOM) Initiative.

A major challenge in value-based health care is the lack of standardized health outcomes measurements, hindering optimal monitoring and comparison of the quality of health care across different settings globally. The International Consortium for Health Outcomes Measurement (ICHOM) assembled a multidisciplinary international working group, comprised of 26 health care providers and patient advocates, to develop a standard set of value-based patient-centered outcomes for breast cancer (BC). The working group convened via 8 teleconferences and completed a follow-up survey after each meeting. A modified 2-round Delphi method was used to achieve consensus on the outcomes and case-mix variables to be included. Patient focus group meetings (8 early or metastatic BC patients) and online anonymized surveys of 1225 multinational BC patients and survivors were also conducted to obtain patients' input. The standard set encompasses survival and cancer control, and disutility of care (eg, acute treatment complications) outcomes, to be collected through administrative data and/or clinical records. A combination of multiple patient-reported outcomes measurement (PROM) tools is recommended to capture long-term degree of health outcomes. Selected case-mix factors were recommended to be collected at baseline. The ICHOM will endeavor to achieve wide buy-in of this set and facilitate its implementation in routine clinical practice in various settings and institutions worldwide.

Nipple-areolar Complex Reconstruction following Postmastectomy Breast Reconstruction: A Comparative Utility Assessment Study.

BACKGROUND: Nipple-areola complex (NAC) reconstruction occurs toward the final stage of breast reconstruction; however, not all women follow through with these procedures. The goal of this study was to determine the impact of the health state burden of living with a reconstructed breast before NAC reconstruction. METHODS: A sample of the population and medical students at McGill University were recruited to establish the utility scores [visual analog scale (VAS), time trade-off (TTO), and standard gamble (SG)] of living with an NAC deformity. Utility scores for monocular and binocular blindness were determined for validation and comparison. Linear regression and Student's t test were used for statistical analysis, and significance was set at P < 0.05. RESULTS: There were 103 prospective volunteers included. Utility scores (VAS, TTO, and SG) for NAC deformity were 0.84 ± 0.18, 0.92 ± 0.11, and 0.92 ± 0.11, respectively. Age, gender, and ethnicity were not statistically significant independent predictors of utility scores. Income thresholds of <$10,000 and >$10,000 revealed a statistically significant difference for VAS (P = 0.049) and SG (P = 0.015). Linear regression analysis showed that medical education was directly proportional to the SG and TTO scores (P < 0.05). CONCLUSIONS: The absence of NAC in a reconstructed breast can be objectively assessed using utility scores (VAS, 0.84 ± 0.18; TTO, 0.92 ± 0.11; SG, 0.92 ± 0.11). In comparison to prior reported conditions, the quality of life in patients choosing to undergo NAC reconstruction is similar to that of persons living with a nasal deformity or an aging neck requiring rejuvenation.

High satisfaction rates in women after DIEP flap breast reconstruction.

BACKGROUND: Breast reconstruction (BR) is aimed at improving quality of life (QoL) after mastectomy. Patient satisfaction is an important indicator to evaluate the success of BR. This study explored patient satisfaction and its determinants in women undergoing deep inferior epigastric artery perforator (DIEP) flap BR as well as the impact of the procedure on body image, sexuality and QoL. METHODS: Patient satisfaction and QoL were studied in 72 women who underwent DIEP flap BR using a study-specific questionnaire as well as the Short Form-36 (SF-36). RESULTS: Patient satisfaction was very high. Approximately 90% of the patients reported that they had been sufficiently informed about the procedure and its consequences, that their preoperative expectations had been met, that the reconstructed breast felt like their own and that they would choose the same procedure again and would recommend this procedure to a friend. Patient satisfaction was positively and significantly related to the reconstructed breast(s) feeling like their own. Women with secondary reconstructions were more positive about changes in sexuality and femininity than women with primary BRs. There were no clinically relevant differences in QoL between our study population and a random sample of Dutch females. CONCLUSIONS: Women with DIEP flap BRs reported high satisfaction rates. However, to compare these satisfaction rates with other forms of BR, prospective studies in comparable groups are necessary.

Interstitial radiation therapy for early-stage nasal vestibule cancer: a continuing quest for optimal tumor control and cosmesis.

INTRODUCTION: This article reports on the effectiveness, cosmetic outcome, and costs of interstitial high-dose-rate (HDR) brachytherapy for early-stage cancer of the nasal vestibule (NV) proper and/or columella high-dose-rate (HDR). METHODS AND MATERIALS: Tumor control, survival, cosmetic outcome, functional results, and costs were established in 64 T1/T2N0 nasal vestibule cancers treated from 1991-2005 by fractionated interstitial radiation therapy (IRT) only. Total dose is 44 Gy: 2 fractions of 3 Gy per day, 6-hour interval, first and last fraction 4 Gy. Cosmesis is noted in the chart by the medical doctor during follow-up, by the patient (visual analog scale), and by a panel. Finally, full hospital costs are computed. RESULTS: A local relapse-free survival rate of 92% at 5 years was obtained. Four local failures were observed; all four patients were salvaged. The neck was not treated electively; no neck recurrence in follow-up was seen. Excellent cosmetic and functional results were observed. With 10 days admission for full treatment, hospital costs amounted to euro5772 (7044 US dollars). CONCLUSION: Excellent tumor control, cosmesis, and function of nasal airway passage can be achieved when HDR-IRT for T1/T2N0 NV cancers is used. For the more advanced cancers (Wang classification: T3 tumor stage), we elect to treat by local excision followed by a reconstructive procedure. The costs, admission to hospital inclusive, for treatment by HDR-IRT amounts to euro5772 (7044 US dollars). This contrasts substantially with the full hospital costs when NV cancers are treated by plastic reconstructive surgery, being on average threefold as expensive.