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1.
Ann Surg ; 2024 Jun 07.
Article in English | MEDLINE | ID: mdl-38847099

ABSTRACT

OBJECTIVE: To systematically review technologies that objectively measure CWL in surgery, assessing their psychometric and methodological characteristics. SUMMARY BACKGROUND DATA: Surgical tasks involving concurrent clinical decision-making and the safe application of technical and non-technical skills require a substantial cognitive demand and resource utilization. Cognitive overload leads to impaired clinical decision-making and performance decline. Assessing cognitive workload (CWL) could enable interventions to alleviate burden and improve patient safety. METHODS: Ovid MEDLINE, OVID Embase, the Cochrane Library and IEEE Xplore databases were searched from inception to August 2023. Full-text, peer-reviewed original studies in a population of surgeons, anesthesiologists or interventional radiologists were considered, with no publication date constraints. Study population, task paradigm, stressor, Cognitive Load Theory (CLT) domain, objective and subjective parameters, statistical analysis and results were extracted. Studies were assessed for a) definition of CWL, b) details of the clinical task paradigm, and c) objective CWL assessment tool. Assessment tools were evaluated using psychometric and methodological characteristics. RESULTS: 10790 studies were identified; 9004 were screened; 269 full studies were assessed for eligibility, of which 67 met inclusion criteria. The most widely used assessment modalities were autonomic (32 eye studies and 24 cardiac). Intrinsic workload (e.g. task complexity) and germane workload (effect of training or expertize) were the most prevalent designs investigated. CWL was not defined in 30 of 67 studies (44.8%). Sensitivity was greatest for neurophysiological instruments (100% EEG, 80% fNIRS); and across modalities accuracy increased with multi-sensor recordings. Specificity was limited to cardiac and ocular metrics, and was found to be sub-optimal (50% and 66.67%). Cardiac sensors were the least intrusive, with 54.2% of studies conducted in naturalistic clinical environments (higher ecological validity). CONCLUSION: Physiological metrics provide an accessible, objective assessment of CWL, but dependence on autonomic function negates selectivity and diagnosticity. Neurophysiological measures demonstrate favorable sensitivity, directly measuring brain activation as a correlate of cognitive state. Lacking an objective gold standard at present, we recommend the concurrent use of multimodal objective sensors and subjective tools for cross-validation. A theoretical and technical framework for objective assessment of CWL is required to overcome the heterogeneity of methodological reporting, data processing, and analysis.

2.
J Biomed Opt ; 29(3): 030901, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38440101

ABSTRACT

Significance: Breast-conserving surgery (BCS) is limited by high rates of positive margins and re-operative interventions. Fluorescence-guided surgery seeks to detect the entire lesion in real time, thus guiding the surgeons to remove all the tumor at the index procedure. Aim: Our aim was to identify the optimal combination of a camera system and fluorophore for fluorescence-guided BCS. Approach: A systematic review of medical databases using the terms "fluorescence," "breast cancer," "surgery," and "fluorescence imaging" was performed. Cameras were compared using the ratio between the fluorescent signal from the tumor compared to background fluorescence, as well as diagnostic accuracy measures, such as sensitivity, specificity, and positive predictive value. Results: Twenty-one studies identified 14 camera systems using nine different fluorophores. Twelve cameras worked in the infrared spectrum. Ten studies reported on the difference in strength of the fluorescence signal between cancer and normal tissue, with results ranging from 1.72 to 4.7. In addition, nine studies reported on whether any tumor remained in the resection cavity (5.4% to 32.5%). To date, only three studies used the fluorescent signal for guidance during real BCS. Diagnostic accuracy ranged from 63% to 98% sensitivity, 32% to 97% specificity, and 75% to 100% positive predictive value. Conclusion: In this systematic review, all the studies reported a clinically significant difference in signal between the tumor and normal tissue using various camera/fluorophore combinations. However, given the heterogeneity in protocols, including camera setup, fluorophore studied, data acquisition, and reporting structure, it was impossible to determine the optimal camera and fluorophore combination for use in BCS. It would be beneficial to develop a standardized reporting structure using similar metrics to provide necessary data for a comparison between camera systems.


Subject(s)
Breast Neoplasms , Humans , Fluorescent Dyes , Light , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/surgery
5.
Ann Surg Oncol ; 30(12): 7036-7045, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37507555

ABSTRACT

BACKGROUND: We suspect that morbidity from both sentinel lymph node biopsy (SLNB) and axillary lymph node dissection (ALND) has been inadequately evaluated to date. Current methodologies are subjective and susceptible to bias. Objective assessment using wearable activity monitors (WAMs) would allow quantitative analysis of recovery by measuring physical activity (PA) and could provide evidence for axillary de-escalation. PATIENTS AND METHODS: A prospective, single center, observational study was conducted from February 2020 to May 2022. Consecutive patients undergoing breast and/or reconstructive surgery and axillary surgeries were identified from the operating schedules. Patients wore WAMs for an average of 3 days prior to surgery and up to 2 weeks following surgery. In total, 56 patients with breast cancer were recruited, of whom 35 underwent SLNB and 21 ALND. RESULTS: Patients who underwent ALND experienced significantly worse PA compared with those who underwent SLNB in week 2 (median 66.4% versus 72.7%, p = 0.015). Subgroup analysis revealed significantly lower PA in simple mastectomy (Mx)-ALND versus Mx-SLNB (median 90.3% versus 70.5%, p = 0.015) in week 2. The PA for SLNB did not return to baseline at 2 weeks after surgery. CONCLUSIONS: Compared with SLNB, ALND results in a lower PA level in week 2. The findings also indicate that SLNB has a protracted effect on PA levels, which extend to 2 weeks postoperatively. Monitoring recovery objectively following breast cancer surgery provides patients and surgeons with more information regarding the predicted outcomes of their surgery, which can drive the development of a personalized rehabilitation program.


Subject(s)
Breast Neoplasms , Sentinel Lymph Node , Wearable Electronic Devices , Humans , Female , Sentinel Lymph Node Biopsy/methods , Breast Neoplasms/surgery , Breast Neoplasms/pathology , Prospective Studies , Mastectomy , Lymphatic Metastasis , Lymph Node Excision/methods , Axilla/pathology , Sentinel Lymph Node/pathology
6.
Cancers (Basel) ; 15(11)2023 May 23.
Article in English | MEDLINE | ID: mdl-37296847

ABSTRACT

Up to 19% of patients require re-excision surgery due to positive margins in breast-conserving surgery (BCS). Intraoperative margin assessment tools (IMAs) that incorporate tissue optical measurements could help reduce re-excision rates. This review focuses on methods that use and assess spectrally resolved diffusely reflected light for breast cancer detection in the intraoperative setting. Following PROSPERO registration (CRD42022356216), an electronic search was performed. The modalities searched for were diffuse reflectance spectroscopy (DRS), multispectral imaging (MSI), hyperspectral imaging (HSI), and spatial frequency domain imaging (SFDI). The inclusion criteria encompassed studies of human in vivo or ex vivo breast tissues, which presented data on accuracy. The exclusion criteria were contrast use, frozen samples, and other imaging adjuncts. 19 studies were selected following PRISMA guidelines. Studies were divided into point-based (spectroscopy) or whole field-of-view (imaging) techniques. A fixed-or random-effects model analysis generated pooled sensitivity/specificity for the different modalities, following heterogeneity calculations using the Q statistic. Overall, imaging-based techniques had better pooled sensitivity/specificity (0.90 (CI 0.76-1.03)/0.92 (CI 0.78-1.06)) compared with probe-based techniques (0.84 (CI 0.78-0.89)/0.85 (CI 0.79-0.91)). The use of spectrally resolved diffusely reflected light is a rapid, non-contact technique that confers accuracy in discriminating between normal and malignant breast tissue, and it constitutes a potential IMA tool.

7.
Breast Cancer Res Treat ; 199(2): 265-279, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37010651

ABSTRACT

PURPOSE: The B-MaP-C study investigated changes to breast cancer care that were necessitated by the COVID-19 pandemic. Here we present a follow-up analysis of those patients commenced on bridging endocrine therapy (BrET), whilst they were awaiting surgery due to reprioritisation of resources. METHODS: This multicentre, multinational cohort study recruited 6045 patients from the UK, Spain and Portugal during the peak pandemic period (Feb-July 2020). Patients on BrET were followed up to investigate the duration of, and response to, BrET. This included changes in tumour size to reflect downstaging potential, and changes in cellular proliferation (Ki67), as a marker of prognosis. RESULTS: 1094 patients were prescribed BrET, over a median period of 53 days (IQR 32-81 days). The majority of patients (95.6%) had strong ER expression (Allred score 7-8/8). Very few patients required expedited surgery, due to lack of response (1.2%) or due to lack of tolerance/compliance (0.8%). There were small reductions in median tumour size after 3 months' treatment duration; median of 4 mm [IQR - 20, 4]. In a small subset of patients (n = 47), a drop in cellular proliferation (Ki67) occurred in 26 patients (55%), from high (Ki67 ≥ 10%) to low (< 10%), with at least one month's duration of BrET. DISCUSSION: This study describes real-world usage of pre-operative endocrine therapy as necessitated by the pandemic. BrET was found to be tolerable and safe. The data support short-term (≤ 3 months) usage of pre-operative endocrine therapy. Longer-term use should be investigated in future trials.


Subject(s)
Breast Neoplasms , COVID-19 , Humans , Female , Breast Neoplasms/drug therapy , Breast Neoplasms/surgery , Pandemics , Ki-67 Antigen/metabolism , Cohort Studies , Prognosis , Neoadjuvant Therapy
8.
J Plast Reconstr Aesthet Surg ; 78: 19-28, 2023 03.
Article in English | MEDLINE | ID: mdl-36764040

ABSTRACT

INTRODUCTION: The optimal combination of radiotherapy and breast reconstruction has not yet been defined. Post-mastectomy radiotherapy (PMRT) has deleterious effects on breast reconstruction, leading to caution amongst surgeons. Pre-operative radiotherapy (PRT) is a growing area of interest, is demonstrated to be safe, and spares autologous flaps from radiotherapy. This study evaluates the aesthetic outcome of PRT and deep inferior epigastric artery perforator (DIEP) flap reconstruction within the Pre-operative Radiotherapy And Deep Inferior Epigastric artery Perforator (DIEP) flAp (PRADA) cohort. METHODS: PRADA was an observational cohort study designed to evaluate the feasibility and safety of PRT for women undergoing neoadjuvant chemotherapy and DIEP reconstruction. Panel evaluation of 3D surface images (3D-SIs) and patient-reported outcome measures (BREAST-Q) for a subset of women in the study were compared with those of a DIEP-PMRT cohort who had undergone DIEP reconstruction and PMRT. RESULTS: Seventeen out of 33 women from the PRADA study participated in this planned substudy. Twenty-eight women formed the DIEP-PMRT cohort (median follow-up 23 months). The median (inter-quartile range [IQR]) 'satisfaction with breasts' score at 12 months for the PRADA cohort was significantly better than the DIEP-PMRT cohort (77 [72-87] versus 64 [54-71], respectively), p=0.01). Median [IQR] panel evaluation (5-point scale) was also significantly better for the PRADA cohort than for the DIEP-PMRT cohort (4.3 [3.9-4.6] versus 3.6 [2.8-4] p=0.003). CONCLUSIONS: Aesthetic outcome for the PRADA cohort was reported to be 'good' or 'excellent' in 93% of cases using a bespoke panel assessment with robust methodology. Patient satisfaction at one year is encouraging and superior to DIEP-PMRT at 23 months. Switching surgery-radiotherapy sequencing leads to similar breast aesthetic outcomes and warrants further large-scale, multi-centre evaluation in a randomised trial.


Subject(s)
Breast Neoplasms , Mammaplasty , Perforator Flap , Female , Humans , Patient Satisfaction , Mastectomy/methods , Epigastric Arteries/surgery , Breast Neoplasms/radiotherapy , Breast Neoplasms/surgery , Perforator Flap/blood supply , Mammaplasty/methods , Esthetics , Retrospective Studies
10.
Ann Surg ; 277(4): 572-580, 2023 04 01.
Article in English | MEDLINE | ID: mdl-35946806

ABSTRACT

OBJECTIVE: To evaluate the impact of axillary lymph node dissection (ALND) and sentinel lymph node biopsy (SLNB) on upper limb (UL) morbidity in breast cancer patients. BACKGROUND: Axillary de-escalation is motivated by a desire to reduce harm of ALND. Understanding the impact of axillary surgery and disparities in operative procedures on postoperative arm morbidity would better direct resources to the point of need and cement the need for de-escalation strategies. METHODS: Embase, MEDLINE, CINAHL, and PsychINFO were searched from 1990 until March 2020. Included studies were randomized-controlled and observational studies focusing on UL morbidities, in breast surgery patients. The study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The prevalence of UL morbidity comparing SLNB and ALND at <12 months, 12 to 24 months, and beyond 24 months were analyzed. RESULTS: Sixty-seven studies were included. All studies reported a higher rate of lymphedema and pain after ALND compared with SLNB. The difference in lymphedema and pain prevalence between SLNB and ALND was 13.7% (95% confidence interval: 10.5-16.8, P <0.005) and 24.2% (95% confidence interval: 12.1-36.3, P <0.005), respectively. Pooled estimates for prevalence of reduced strength and range of motion after SLNB and ALND were 15.2% versus 30.9% and 17.1% versus 29.8%, respectively. Type of axillary surgery, greater body mass index, and radiotherapy were some of the predictors for UL morbidities. CONCLUSIONS: Prevalence of lymphedema after ALND was higher than previously estimated. ALND patients experienced greater rates of lymphedema, pain, reduced strength, and range of motion compared with SLNB. The findings support the continued drive to de-escalate axillary surgery.


Subject(s)
Breast Neoplasms , Lymphedema , Sentinel Lymph Node , Humans , Female , Sentinel Lymph Node Biopsy/adverse effects , Sentinel Lymph Node Biopsy/methods , Breast Neoplasms/surgery , Breast Neoplasms/pathology , Lymph Node Excision/adverse effects , Lymph Node Excision/methods , Morbidity , Lymphedema/epidemiology , Lymphedema/etiology , Axilla , Pain , Lymph Nodes/pathology , Sentinel Lymph Node/pathology , Randomized Controlled Trials as Topic
11.
Front Neurogenom ; 4: 1142182, 2023.
Article in English | MEDLINE | ID: mdl-38234498

ABSTRACT

Introduction: Functional near-infrared spectroscopy (fNIRS) is a non-invasive optical neuroimaging technique used to assess surgeons' brain function. The aim of this narrative review is to outline the effect of expertise, stress, surgical technology, and neurostimulation on surgeons' neural activation patterns, and highlight key progress areas required in surgical neuroergonomics to modulate training and performance. Methods: A literature search of PubMed and Embase was conducted to identify neuroimaging studies using fNIRS and neurostimulation in surgeons performing simulated tasks. Results: Novice surgeons exhibit greater haemodynamic responses across the pre-frontal cortex than experts during simple surgical tasks, whilst expert surgical performance is characterized by relative prefrontal attenuation and upregulation of activation foci across other regions such as the supplementary motor area. The association between PFC activation and mental workload follows an inverted-U shaped curve, activation increasing then attenuating past a critical inflection point at which demands outstrip cognitive capacity Neuroimages are sensitive to the impact of laparoscopic and robotic tools on cognitive workload, helping inform the development of training programs which target neural learning curves. FNIRS differs in comparison to current tools to assess proficiency by depicting a cognitive state during surgery, enabling the development of cognitive benchmarks of expertise. Finally, neurostimulation using transcranial direct-current-stimulation may accelerate skill acquisition and enhance technical performance. Conclusion: FNIRS can inform the development of surgical training programs which modulate stress responses, cognitive learning curves, and motor skill performance. Improved data processing with machine learning offers the possibility of live feedback regarding surgeons' cognitive states during operative procedures.

12.
BJS Open ; 6(3)2022 05 02.
Article in English | MEDLINE | ID: mdl-35674701

ABSTRACT

BACKGROUND: Following therapeutic mammoplasty (TM), the contralateral breast may require a later balancing procedure to optimize shape and symmetry. The alternative is to offer patients simultaneous TM with immediate contralateral symmetrization via a dual-surgeon approach, with the goal of reducing costs and minimizing the number of subsequent hospital appointments in an era of COVID-19 surges. The aim of this cost-consequence analysis is to characterize the cost-benefit of immediate bilateral symmetrization dual-operator mammoplasty versus staged unilateral single operator for breast cancer surgery. METHOD: A prospective single-centre observational study was conducted at an academic teaching centre for breast cancer surgery in the UK. Pseudonymized data for clinicopathological variables and procedural care information, including the type of initial breast-conserving surgery and subsequent reoperation(s), were extracted from the electronic patient record. Financial data were retrieved using the Patient-Level Information and Costing Systems. RESULTS: Between April 2014 and March 2020, 232 women received either immediate bilateral (n = 44), staged unilateral (n = 57) for breast cancer, or unilateral mammoplasty alone (n = 131). The median (interquartile range (i.q.r.)) additional cost of unilateral mammoplasty with staged versus immediate bilateral mammoplasty was €5500 (€4330 to €6570) per patient (P < 0.001), which represents a total supplementary financial burden of €313 462 to the study institution. There was no significant difference between groups in age, Charlson comorbidity index, operating minutes, time to adjuvant radiotherapy in months, or duration of hospital stay. CONCLUSION: Synchronous dual-surgeon immediate bilateral TM can deliver safe immediate symmetrization and is financially beneficial, without delay to receipt of adjuvant therapy, or additional postoperative morbidity.


Subject(s)
Breast Neoplasms , COVID-19 , Mammaplasty , Breast Neoplasms/pathology , Female , Humans , Mammaplasty/methods , Mastectomy, Segmental/methods , Prospective Studies , Treatment Outcome
13.
Sci Rep ; 12(1): 8607, 2022 05 21.
Article in English | MEDLINE | ID: mdl-35597783

ABSTRACT

Re-operation due to disease being inadvertently close to the resection margin is a major challenge in breast conserving surgery (BCS). Indocyanine green (ICG) fluorescence imaging could be used to visualize the tumor boundaries and help surgeons resect disease more efficiently. In this work, ICG fluorescence and color images were acquired with a custom-built camera system from 40 patients treated with BCS. Images were acquired from the tumor in-situ, surgical cavity post-excision, freshly excised tumor and histopathology tumour grossing. Fluorescence image intensity and texture were used as individual or combined predictors in both logistic regression (LR) and support vector machine models to predict the tumor extent. ICG fluorescence spectra in formalin-fixed histopathology grossing tumor were acquired and analyzed. Our results showed that ICG remains in the tissue after formalin fixation. Therefore, tissue imaging could be validated in freshly excised and in formalin-fixed grossing tumor. The trained LR model with combined fluorescence intensity (pixel values) and texture (slope of power spectral density curve) identified the tumor's extent in the grossing images with pixel-level resolution and sensitivity, specificity of 0.75 ± 0.3, 0.89 ± 0.2.This model was applied on tumor in-situ and surgical cavity (post-excision) images to predict tumor presence.


Subject(s)
Breast Neoplasms , Indocyanine Green , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/surgery , Female , Fluorescence , Formaldehyde , Humans , Margins of Excision , Mastectomy, Segmental/methods , Optical Imaging/methods
14.
Lancet Oncol ; 23(5): 682-690, 2022 05.
Article in English | MEDLINE | ID: mdl-35397804

ABSTRACT

BACKGROUND: Radiotherapy before mastectomy and autologous free-flap breast reconstruction can avoid adverse radiation effects on healthy donor tissues and delays to adjuvant radiotherapy. However, evidence for this treatment sequence is sparse. We aimed to explore the feasibility of preoperative radiotherapy followed by skin-sparing mastectomy and deep inferior epigastric perforator (DIEP) flap reconstruction in patients with breast cancer requiring mastectomy. METHODS: We conducted a prospective, non-randomised, feasibility study at two National Health Service trusts in the UK. Eligible patients were women aged older than 18 years with a laboratory diagnosis of primary breast cancer requiring mastectomy and post-mastectomy radiotherapy, who were suitable for DIEP flap reconstruction. Preoperative radiotherapy started 3-4 weeks after neoadjuvant chemotherapy and was delivered to the breast, plus regional nodes as required, at 40 Gy in 15 fractions (over 3 weeks) or 42·72 Gy in 16 fractions (over 3·2 weeks). Adverse skin radiation toxicity was assessed preoperatively using the Radiation Therapy Oncology Group toxicity grading system. Skin-sparing mastectomy and DIEP flap reconstruction were planned for 2-6 weeks after completion of preoperative radiotherapy. The primary endpoint was the proportion of open breast wounds greater than 1 cm width requiring a dressing at 4 weeks after surgery, assessed in all participants. This study is registered with ClinicalTrials.gov, NCT02771938, and is closed to recruitment. FINDINGS: Between Jan 25, 2016, and Dec 11, 2017, 33 patients were enrolled. At 4 weeks after surgery, four (12·1%, 95% CI 3·4-28·2) of 33 patients had an open breast wound greater than 1 cm. One (3%) patient had confluent moist desquamation (grade 3). There were no serious treatment-related adverse events and no treatment-related deaths. INTERPRETATION: Preoperative radiotherapy followed by skin-sparing mastectomy and immediate DIEP flap reconstruction is feasible and technically safe, with rates of breast open wounds similar to those reported with post-mastectomy radiotherapy. A randomised trial comparing preoperative radiotherapy with post-mastectomy radiotherapy is required to precisely determine and compare surgical, oncological, and breast reconstruction outcomes, including quality of life. FUNDING: Cancer Research UK, National Institute for Health Research.


Subject(s)
Breast Neoplasms , Mammaplasty , Perforator Flap , Breast Neoplasms/radiotherapy , Breast Neoplasms/surgery , Feasibility Studies , Female , Humans , Male , Mammaplasty/adverse effects , Mastectomy/adverse effects , Perforator Flap/surgery , Prospective Studies , Quality of Life , State Medicine
16.
Ann Surg ; 275(3): e568-e574, 2022 03 01.
Article in English | MEDLINE | ID: mdl-32590540

ABSTRACT

OBJECTIVE: A simulator to enable safe practice and assessment of ALND has been designed, and face, content and construct validity has been investigated. SUMMARY AND BACKGROUND DATA: The reduction in the number of ALNDs conducted has led to decreased resident exposure and confidence. METHODS: A cross-sectional multicenter observational study was carried out between July 2017 and August 2018. Following model development, 30 surgeons of varying experience (n = "experts," n = 11 "senior residents," and n = 10 "junior residents") were asked to perform a simulated ALND. Face and content validity questionnaires were administered immediately after ALND. All ALND procedures were retrospectively assessed by 2 attending breast surgeons, blinded to operator identity, using a video-based assessment tool, and an end product assessment tool. RESULTS: Statistically significant differences between groups were observed across all operative subphases on the axillary clearance assessment tool (P < 0.001). Significant differences between groups were observed for overall procedure quality (P < 0.05) and total number of lymph nodes harvested (P < 0.001). However, operator grade could not be distinguished across other end product variables such as axillary vein damage (P = 0.864) and long thoracic nerve injury (P = 0.094). Overall, participants indicated that the simulator has good anatomical (median score >7) and procedural realism (median score >7). CONCLUSIONS: Video-based analysis demonstrates construct validity for ALND assessment. Given reduced ALND exposure, this simulation is a useful adjunct for both technical skills training and formative Deanery or Faculty administered assessments.


Subject(s)
Clinical Competence , Lymph Node Excision/standards , Axilla , Cross-Sectional Studies , Humans , Retrospective Studies
18.
Med Image Anal ; 76: 102306, 2022 02.
Article in English | MEDLINE | ID: mdl-34879287

ABSTRACT

Recent developments in data science in general and machine learning in particular have transformed the way experts envision the future of surgery. Surgical Data Science (SDS) is a new research field that aims to improve the quality of interventional healthcare through the capture, organization, analysis and modeling of data. While an increasing number of data-driven approaches and clinical applications have been studied in the fields of radiological and clinical data science, translational success stories are still lacking in surgery. In this publication, we shed light on the underlying reasons and provide a roadmap for future advances in the field. Based on an international workshop involving leading researchers in the field of SDS, we review current practice, key achievements and initiatives as well as available standards and tools for a number of topics relevant to the field, namely (1) infrastructure for data acquisition, storage and access in the presence of regulatory constraints, (2) data annotation and sharing and (3) data analytics. We further complement this technical perspective with (4) a review of currently available SDS products and the translational progress from academia and (5) a roadmap for faster clinical translation and exploitation of the full potential of SDS, based on an international multi-round Delphi process.


Subject(s)
Data Science , Machine Learning , Humans
19.
BJS Open ; 5(6)2021 11 09.
Article in English | MEDLINE | ID: mdl-34894122

ABSTRACT

BACKGROUND: Therapeutic mammaplasty (TM) is an oncological procedure which combines tumour resection with breast reduction and mastopexy techniques. Previous systematic reviews have demonstrated the oncological safety of TM but reporting of critically important outcomes, such as quality of life, aesthetic and functional outcomes, are limited, piecemeal or inconsistent. This systematic review aimed to identify all outcomes reported in clinical studies of TM to facilitate development of a core outcome set. METHODS: Medline, EMBASE, CINAHL and Web of Science were searched from inception to 5 August 2020. Included studies reported clinical outcomes following TM for adult women. Two authors screened articles independently for eligibility. Data were extracted regarding the outcome definition and classification type (for example, oncological, quality of life, etc.), time of outcome reporting and measurement tools. RESULTS: Of 5709 de-duplicated records, 148 were included in the narrative synthesis. The majority of studies (n = 102, 68.9 per cent) reported measures of survival and/or recurrence; approximately three-quarters (n = 75, 73.5 per cent) had less than 5 years follow-up. Aesthetic outcome was reported in half of studies (n = 75, 50.7 per cent) using mainly subjective, non-validated measurement tools. The time point at which aesthetic assessment was conducted was highly variable, and only defined in 48 (64.0 per cent) studies and none included a preoperative baseline for comparison. Few studies reported quality of life (n = 30, 20.3 per cent), functional outcomes (n = 5, 3.4 per cent) or resource use (n = 28, 18.9 per cent). CONCLUSION: Given the oncological equivalence of TM and mastectomy, treatment decisions are often driven by aesthetic and functional outcomes, which are infrequently and inconsistently reported with non-validated measurement tools.


Subject(s)
Breast Neoplasms , Mammaplasty , Adult , Breast Neoplasms/surgery , Esthetics , Female , Humans , Mastectomy , Quality of Life
20.
Ann Surg Oncol ; 28(10): 5617-5625, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34347221

ABSTRACT

BACKGROUND: On average, 21% of women in the USA treated with Breast Conserving Surgery (BCS) undergo a second operation because of close positive margins. Tumor identification with fluorescence imaging could improve positive margin rates through demarcating location, size, and invasiveness of tumors. We investigated the technique's diagnostic accuracy in detecting tumors during BCS using intravenous indocyanine green (ICG) and a custom-built fluorescence camera system. METHODS: In this single-center prospective clinical study, 40 recruited BCS patients were sub-categorized into two cohorts. In the first 'enhanced permeability and retention' (EPR) cohort, 0.25 mg/kg ICG was injected ~ 25 min prior to tumor excision, and in the second 'angiography' cohort, ~ 5 min prior to tumor excision. Subsequently, an in-house imaging system was used to image the tumor in situ prior to resection, ex vivo following resection, the resection bed, and during grossing in the histopathology laboratory to compare the technique's diagnostic accuracy between the cohorts. RESULTS: The two cohorts were matched in patient and tumor characteristics. The majority of patients had invasive ductal carcinoma with concomitant ductal carcinoma in situ. Tumor-to-background ratio (TBR) in the angiography cohort was superior to the EPR cohort (TBR = 3.18 ± 1.74 vs 2.10 ± 0.92 respectively, p = 0.023). Tumor detection reached sensitivity and specificity scores of 0.82 and 0.93 for the angiography cohort and 0.66 and 0.90 for the EPR cohort, respectively (p = 0.1051 and p = 0.9099). DISCUSSION: ICG administration timing during the angiography phase compared with the EPR phase improved TBR and diagnostic accuracy. Future work will focus on image pattern analysis and adaptation of the camera system to targeting fluorophores specific to breast cancer.


Subject(s)
Breast Neoplasms , Indocyanine Green , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/surgery , Female , Humans , Margins of Excision , Mastectomy, Segmental , Prospective Studies
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