Health-related quality of life by type of breast surgery in women with primary breast cancer: prospective longitudinal cohort study.

BACKGROUND: Health-related quality of life and patient-related outcome measures for patients with cancer have gained increased interest over the last decade. However, few prospective studies with longitudinal data evaluated health-related quality of life in patients with breast cancer. This study aimed to investigate how health-related quality of life changed from the time of diagnosis to 1 year after breast cancer surgery for the main surgical techniques. METHODS: This prospective longitudinal single-centre study included patients with primary breast cancer diagnosed in 2019-2020 who underwent surgery. Patients completed a health-related quality of life questionnaire (Breast-Q) at baseline. One year after surgery, they completed the Breast-Q a second time, the EORTC (European Organization for Research and Treatment of Cancer) quality of life questionnaire-C30 and the quality of life questionnaire-BR23. Analysis of variance and Kruskal-Wallis tests were used to evaluate the differences in health-related quality of life between surgical groups. Analysis of covariance with robust standard errors was used to adjust for confounders. RESULTS: In total, 340 patients were included in the study; 160 patients received oncoplastic partial mastectomy, 112 received partial mastectomy, 42 received mastectomy and 26 had mastectomy with immediate reconstruction. Patients that had partial mastectomy or oncoplastic partial mastectomy were more satisfied with their breasts (P < 0.001), had a better body image (P = 0.006) and higher sexual functioning scores (P = 0.027) than patients who had a mastectomy with/without reconstruction. The oncoplastic and mastectomy with reconstruction groups had more breast symptoms than other groups (P < 0.001), and the mastectomy group had the least symptoms from the chest area. CONCLUSION: Partial mastectomy and oncoplastic partial mastectomy have the best outcomes in terms of breast satisfaction, body image and sexual functioning. This highlights the importance of preserving the breast when feasible and underscores that breast reconstruction is not equal to breast conservation. Registration number: NCT04227613 (http://www.clinicaltrials.gov).

Retrospective validation study of an artificial neural network-based preoperative decision-support tool for noninvasive lymph node staging (NILS) in women with primary breast cancer (ISRCTN14341750).

BACKGROUND: Surgical sentinel lymph node biopsy (SLNB) is routinely used to reliably stage axillary lymph nodes in early breast cancer (BC). However, SLNB may be associated with postoperative arm morbidities. For most patients with BC undergoing SLNB, the findings are benign, and the procedure is currently questioned. A decision-support tool for the prediction of benign sentinel lymph nodes based on preoperatively available data has been developed using artificial neural network modelling. METHODS: This was a retrospective geographical and temporal validation study of the noninvasive lymph node staging (NILS) model, based on preoperatively available data from 586 women consecutively diagnosed with primary BC at two sites. Ten preoperative clinicopathological characteristics from each patient were entered into the web-based calculator, and the probability of benign lymph nodes was predicted. The performance of the NILS model was assessed in terms of discrimination with the area under the receiver operating characteristic curve (AUC) and calibration, that is, comparison of the observed and predicted event rates of benign axillary nodal status (N0) using calibration slope and intercept. The primary endpoint was axillary nodal status (discrimination, benign [N0] vs. metastatic axillary nodal status [N+]) determined by the NILS model compared to nodal status by definitive pathology. RESULTS: The mean age of the women in the cohort was 65 years, and most of them (93%) had luminal cancers. Approximately three-fourths of the patients had no metastases in SLNB (N0 74% and 73%, respectively). The AUC for the predicted probabilities for the whole cohort was 0.6741 (95% confidence interval: 0.6255-0.7227). More than one in four patients (n = 151, 26%) were identified as candidates for SLNB omission when applying the predefined cut-off for lymph node-negative status from the development cohort. The NILS model showed the best calibration in patients with a predicted high probability of healthy axilla. CONCLUSION: The performance of the NILS model was satisfactory. In approximately every fourth patient, SLNB could potentially be omitted. Considering the shift from postoperatively to preoperatively available predictors in this validation study, we have demonstrated the robustness of the NILS model. The clinical usability of the web interface will be evaluated before its clinical implementation. TRIAL REGISTRATION: Registered in the ISRCTN registry with study ID ISRCTN14341750. Date of registration 23/11/2018.

Noninvasive Staging of Lymph Node Status in Breast Cancer Using Machine Learning: External Validation and Further Model Development.

BACKGROUND: Most patients diagnosed with breast cancer present with a node-negative disease. Sentinel lymph node biopsy (SLNB) is routinely used for axillary staging, leaving patients with healthy axillary lymph nodes without therapeutic effects but at risk of morbidities from the intervention. Numerous studies have developed nodal status prediction models for noninvasive axillary staging using postoperative data or imaging features that are not part of the diagnostic workup. Lymphovascular invasion (LVI) is a top-ranked predictor of nodal metastasis; however, its preoperative assessment is challenging. OBJECTIVE: This paper aimed to externally validate a multilayer perceptron (MLP) model for noninvasive lymph node staging (NILS) in a large population-based cohort (n=18,633) and develop a new MLP in the same cohort. Data were extracted from the Swedish National Quality Register for Breast Cancer (NKBC, 2014-2017), comprising only routinely and preoperatively available documented clinicopathological variables. A secondary aim was to develop and validate an LVI MLP for imputation of missing LVI status to increase the preoperative feasibility of the original NILS model. METHODS: Three nonoverlapping cohorts were used for model development and validation. A total of 4 MLPs for nodal status and 1 LVI MLP were developed using 11 to 12 routinely available predictors. Three nodal status models were used to account for the different availabilities of LVI status in the cohorts and external validation in NKBC. The fourth nodal status model was developed for 80% (14,906/18,663) of NKBC cases and validated in the remaining 20% (3727/18,663). Three alternatives for imputation of LVI status were compared. The discriminatory capacity was evaluated using the validation area under the receiver operating characteristics curve (AUC) in 3 of the nodal status models. The clinical feasibility of the models was evaluated using calibration and decision curve analyses. RESULTS: External validation of the original NILS model was performed in NKBC (AUC 0.699, 95% CI 0.690-0.708) with good calibration and the potential of sparing 16% of patients with node-negative disease from SLNB. The LVI model was externally validated (AUC 0.747, 95% CI 0.694-0.799) with good calibration but did not improve the discriminatory performance of the nodal status models. A new nodal status model was developed in NKBC without information on LVI (AUC 0.709, 95% CI: 0.688-0.729), with excellent calibration in the holdout internal validation cohort, resulting in the potential omission of 24% of patients from unnecessary SLNBs. CONCLUSIONS: The NILS model was externally validated in NKBC, where the imputation of LVI status did not improve the model's discriminatory performance. A new nodal status model demonstrated the feasibility of using register data comprising only the variables available in the preoperative setting for NILS using machine learning. Future steps include ongoing preoperative validation of the NILS model and extending the model with, for example, mammography images.

The NILS Study Protocol: A Retrospective Validation Study of an Artificial Neural Network Based Preoperative Decision-Making Tool for Noninvasive Lymph Node Staging in Women with Primary Breast Cancer (ISRCTN14341750).

Newly diagnosed breast cancer (BC) patients with clinical T1-T2 N0 disease undergo sentinel-lymph-node (SLN) biopsy, although most of them have a benign SLN. The pilot noninvasive lymph node staging (NILS) artificial neural network (ANN) model to predict nodal status was published in 2019, showing the potential to identify patients with a low risk of SLN metastasis. The aim of this study is to assess the performance measures of the model after a web-based implementation for the prediction of a healthy SLN in clinically N0 BC patients. This retrospective study was designed to validate the NILS prediction model for SLN status using preoperatively available clinicopathological and radiological data. The model results in an estimated probability of a healthy SLN for each study participant. Our primary endpoint is to report on the performance of the NILS prediction model to distinguish between healthy and metastatic SLNs (N0 vs. N+) and compare the observed and predicted event rates of benign SLNs. After validation, the prediction model may assist medical professionals and BC patients in shared decision making on omitting SLN biopsies in patients predicted to be node-negative by the NILS model. This study was prospectively registered in the ISRCTN registry (identification number: 14341750).

Adjacent Primary Care May Reduce Less Urgent Pediatric Emergency Department Visits.

Aims: Pediatric emergency department (ED) overcrowding is a challenge. This study was designed to evaluate if a hospital-integrated primary care unit (HPCU) reduces less urgent visits at a pediatric ED. Methods: This retrospective cross-sectional study was carried out at a university hospital in Sweden, where the HPCU, open outside office hours, had been integrated next to the ED. Children seeking ED care during 4-week high- and low-load study periods before (2012) and after (2015) implementation of the HPCU were included. Information on patient characteristics, ED management, and length of ED stay was obtained from hospital data registers. Results: In total, 3216 and 3074 ED patient visits were recorded in 2012 and 2015, respectively. During opening hours of the HPCU, the proportions of pediatric ED visits (28% lower; P < .001), visits in the lowest triage group (36% lower; P < .001), patients presenting with fever (P = .001) or ear pain (P < .001), and nonadmitted ED patients (P = .033), were significantly lower in 2015 than in 2012, whereas the proportion of infants ≤3 months was higher in 2015 (P < .001). Conclusions: By enabling adjacent management of less urgent pediatric patients at adequate lower levels of medical care, implementation of a HPCU outside office hours may contribute to fewer and more appropriate pediatric ED visits.

Influence of social characteristics on use of paediatric emergency care in Sweden - a questionnaire based study.

BACKGROUND: Parental social characteristics influence the use of emergency departments (ED) in the USA, but less is known about paediatric ED care-seeking in countries with national health insurance. This prospective study was designed to evaluate associations between parental care-seeking and social characteristics, with emphasis on impact of non-native origin, at a paediatric ED in Sweden, a European country providing paediatric healthcare free of charge. METHODS: Parents attending a paediatric ED at a large urban university hospital filled out a questionnaire on social characteristics and reasons for care-seeking. Information on patient characteristics and initial management was obtained from ED registers and patient records. Paediatric ED physicians assessed the medical appropriateness of each patient visit triaged for ED care. RESULTS: In total, 962 patient visits were included. Telephone healthline service before the paediatric ED visit was less often used by non-native parents (63/345 vs. 249/544, p < 0.001). Low-aquity visits, triaged away from the ED, were more common among non-native parents (80/368 vs. 67/555, OR = 1.66; p = 0.018), and among those reporting lower abilities in the Swedish language (23/82 vs. 120/837, OR = 2.66; p = 0.003). Children of non-native parents were more often assessed by physicians not to require ED care (122/335 vs. 261/512, OR = 0.70; p = 0.028). CONCLUSIONS: This study confirms more direct and less urgent use of paediatric ED care by parents of non-native origin or with limited abilities in the Swedish language, proposing that parental social characteristics influence paediatric ED care-seeking, also in a country with healthcare free of charge, and that specific needs of these groups should be better met by prehospital medical services.

Influence of awareness and availability of medical alternatives on parents seeking paediatric emergency care.

AIMS: Direct seeking of care at paediatric emergency departments may result from an inadequate awareness or a short supply of medical alternatives. We therefore evaluated the care-seeking patterns, availability of medical options and initial medical assessments - with overall reference to socioeconomic status - of parents at an urban paediatric emergency department in a Scandinavian country providing free paediatric healthcare. METHODS: The parents of children assessed by paediatric emergency department physicians at a Swedish university hospital over a 25-day winter period completed a questionnaire on recent medical contacts and their reasons for attendance. Additional information was obtained from ledgers, patient records and population demographics. RESULTS: In total, 657 of 713 eligible patients (92%) were included. Seventy-nine per cent of their parents either failed to or managed to establish medical contact before the emergency department visit, whereas 21% sought care with no attempt at recent medical contact. Visits with a failed telephone or primary care contact (18%) were more common outside office hours ( p=0.014) and were scored as less urgent ( p=0.014). A perceived emergency was the main reason for no attempt at medical contact before the visit. Direct emergency department care-seeking was more common from the city district with the lowest socioeconomic status ( p=0.027). CONCLUSIONS: Although most parents in this Swedish study tried to seek medical advice before attending a paediatric emergency department, perceived emergency, a short supply of telephone health line or primary care facilities and lower socioeconomic status contributed to direct care-seeking by almost 40% of parents. Pre-hospital awareness and the availability of medical alternatives with an emphasis on major differences in socioeconomic status should therefore be considered to further optimize care-seeking in paediatric emergency departments.

Pediatric emergency department management benefits from appropriate early redirection of nonurgent visits.

AIMS: Overcrowding at pediatric emergency departments (EDs) may result in delayed clinical management and higher risks of medical error. This study was designed to prospectively evaluate what parents of sick children seek emergency care for and how these patients are being assessed and managed. METHODS: Patients aged 0 to 17 years seeking ED care at an urban Swedish university hospital, from 8 AM to 9 PM on 25 consecutive days, were included. Clinical urgency and further level of medical care were determined by experienced nurses based on individual clinical signs and vital parameters. Information on presenting problem, medical priority, gender, age, waiting time, day of week, time of day, and further management was recorded. RESULTS: Among 1057 included children, two thirds were assessed by physicians, whereas one third were referred directly by nurses for other ED (n = 54) or primary care (n = 114), or sent home with medical advice (n = 176), more often during evenings and weekends. Of primarily referred patients, 7.6% returned within 72 hours, and three of them were admitted. Young infants, patients with respiratory or neurological problems, and sicker patients with fever or infections were mainly assessed by physicians, within desired priority time. DISCUSSION: More than one fourth of pediatric ED patients might rapidly, appropriately, and safely be referred for primary care or sent home by experienced pediatric nurses soon after arrival, thereby facilitating management of urgent and more appropriate patients. Evaluations by physicians were primarily required in young infants and for urgent medical conditions demanding qualified pediatric skills.