Impact of Axillary Lymph Node Dissection and Sentinel Lymph Node Biopsy on Upper Limb Morbidity in Breast Cancer Patients: A Systematic Review and Meta-Analysis.

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.

The Use of Wearable Activity Monitors to Measure Upper Limb Physical Activity After Axillary Lymph Node Dissection and Sentinel Lymph Node Biopsy.

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.

IDEAL-D Framework for Device Innovation: A Consensus Statement on the Preclinical Stage.

OBJECTIVE: To extend the IDEAL framework for device innovation, IDEAL-D, to include the preclinical stage of development (stage 0). BACKGROUND: In previous work, the IDEAL collaboration has proposed frameworks for new surgical techniques and complex therapeutic technologies, the central tenet being that development and evaluation can and should proceed together in an ordered and logical manner that balances innovation and safety. METHODS: Following agreement at the IDEAL Collaboration Council, a multidisciplinary working group was formed comprising 12 representatives from healthcare, academia, industry, and a patient advocate. The group conducted a series of discussions following the principles used in the development of the original IDEAL framework. Importantly, IDEAL aims for maximal transparency, optimal validity in the evaluation of primary effects, and minimization of potential risk to patients or others. The proposals were subjected to further review and editing by members of the IDEAL Council before a final consensus version was adopted. RESULTS: In considering which studies are required before a first-in-human study, we have: (1) classified devices according to what they do and the risks they carry, (2) classified studies according to what they show about the device, and (3) made recommendations based on the principle that the more invasive and high risk a device is, the greater proof required of their safety and effectiveness before progression to clinical studies (stage 1). CONCLUSIONS: The proposed recommendations for preclinical evaluation of medical devices represent a proportionate and pragmatic approach that balances the de-risking of first-in-human translational studies against the benefits of rapid translation of new devices into clinical practice.

Objective Assessment of Postoperative Morbidity After Breast Cancer Treatments with Wearable Activity Monitors: The "BRACELET" Study.

BACKGROUND: Current validated tools to measure upper limb dysfunction after breast cancer treatment, such as questionnaires, are prone to recall bias and do not enable comparisons between patients. This study aimed to test the feasibility of wearable activity monitors (WAMs) for achieving a continuous, objective assessment of functional recovery by measuring peri-operative physical activity (PA). METHODS: A prospective, single-center, non-randomized, observational study was conducted. Patients undergoing breast and axillary surgery were invited to wear WAMs on both wrists in the peri-operative period and then complete upper limb function (DASH) and quality-of-life (EQ-5D-5L) questionnaires. Statistical analyses were performed to determine the construct validity and concurrent validity of WAMs. RESULTS: The analysis included 39 patients with a mean age of 55 ± 13.2 years. Regain of function on the surgically treated side was observed to be an increase of arm activity as a percentage of preoperative levels, with the greatest increase observed between the postoperative days 1 and 2. The PA was significantly greater on the side not treated by surgery than on the surgically treated side after week 1 (mean PA, 75.8% vs. 62.3%; p < 0.0005) and week 2 (mean PA, 91.6% vs. 77.4%; p < 0.005). Subgroup analyses showed differences in recovery trends between different surgical procedures. Concurrent validity was demonstrated by a significant negative moderate correlation between the PA and DASH questionnaires (R = -0.506; p < 0.05). CONCLUSION: This study demonstrated the feasibility and validity of WAMs to objectively measure postoperative recovery of upper limb function after breast surgery, providing a starting point for personalized rehabilitation through early detection of upper limb physical morbidity.

Wearable Sensor Technology Efficacy in Peripheral Vascular Disease (wSTEP): A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect of using wearable activity monitors (WAMs) in patients with intermittent claudication (IC) within a single-center randomized controlled trial. BACKGROUND: WAMs allow users to set daily activity targets and monitor their progress. They may offer an alternative treatment to supervised exercise programs (SEPs) for patients with IC. METHODS: Thirty-seven patients with IC were recruited and randomized into intervention or control group. The intervention consisted of a feedback-enabled, wrist-worn activity monitor (WAM) in addition to access to SEP. The control group was given access to SEP only. The outcome measures were maximum walking distance (MWD), claudication distance (CD), and quality of life as measured by the VascuQol questionnaire. Participants were assessed upon recruitment, and at 3, 6, and 12 months. RESULTS: Patients in the WAM group showed significant improvement in MWD at 3 and 6 months (80-112 m, to 178 m; P < 0.001), which was sustained at 12 months. The WAM group also increased CD (40 vs 110 m; P < 0.001) and VascuQol score (4.7 vs 5.8; P = 0.004). The control group saw a temporary increase in VascuQol score at 6 months (4.5 vs 4.7; P = 0.028), but no other improvements in MWD or CD were observed. Significantly higher improvements in MWD were seen in the WAM group compared with that in the control group at 6 months (82 vs -5 m; P = 0.009, r = 0.47) and 12 months (69 vs 7.5 m; P = 0.011, r = 0.52). CONCLUSIONS: The study demonstrates the significant, sustained benefit of WAM-led technologies for patients with IC. This potentially resource-sparing intervention is likely to provide a valuable adjunct or alternative to SEP.

The Effect of Electronic Cigarettes on Hand Microcirculation.

PURPOSE: Smoking conventional cigarettes reduces peripheral microcirculation leading to worse outcomes after hand surgery. Patients are increasingly using electronic cigarettes (eCigarettes); however, there is no published research investigating the effects of eCigarettes on hand microcirculation. METHODS: Fifteen healthy subjects with a median age of 26 years were recruited: 7 smokers and 8 nonsmokers. A noninvasive O2C laser Doppler probe measured a baseline control reading at deep (7-mm) and superficial (3-mm) levels. Participants commenced a 5-minute smoking protocol of nonnicotine (0-mg) eCigarettes with continuous microcirculation measurements during smoking and for 20 minutes afterward. This was repeated with nicotine (24-mg) eCigarettes. Readings were averaged over 5-minute periods and standardized as a percentage of baseline. A linear mixed-effects model with an unstructured covariance structure was used to analyze the data. RESULTS: Smokers had a statistically significant reduction in hand microcirculation during and up to 20 minutes after smoking a 24-mg eCigarette. There was a maximum reduction of 77% in superficial flow and 29% in deep flow. After smoking a 0-mg eCigarette, smokers demonstrated an increase in superficial flow of up to 70% with no change in deep flow. Nonsmokers had no statistically significant change in superficial or deep flow after smoking either eCigarette. CONCLUSIONS: A 24-mg eCigarette significantly reduced smokers' hand microcirculation during and after smoking. Microcirculation increased in smokers after inhalation of a 0-mg eCigarette. CLINICAL RELEVANCE: We advise smokers undergoing hand surgery to avoid high-dose eCigarettes and, if necessary, to use 0-mg eCigarettes as an alternative.

A pilot study to determine whether using a lightweight, wearable micro-camera improves dietary assessment accuracy and offers information on macronutrients and eating rate.

A major limitation in nutritional science is the lack of understanding of the nutritional intake of free-living people. There is an inverse relationship between accuracy of reporting of energy intake by all current nutritional methodologies and body weight. In this pilot study we aim to explore whether using a novel lightweight, wearable micro-camera improves the accuracy of dietary intake assessment. Doubly labelled water (DLW) was used to estimate energy expenditure and intake over a 14-d period, over which time participants (n 6) completed a food diary and wore a micro-camera on 2 of the days. Comparisons were made between the estimated energy intake from the reported food diary alone and together with the images from the micro-camera recordings. There was an average daily deficit of 3912 kJ using food diaries to estimate energy intake compared with estimated energy expenditure from DLW (P=0·0118), representing an under-reporting rate of 34 %. Analysis of food diaries alone showed a significant deficit in estimated daily energy intake compared with estimated intake from food diary analysis with images from the micro-camera recordings (405 kJ). Use of the micro-camera images in conjunction with food diaries improves the accuracy of dietary assessment and provides valuable information on macronutrient intake and eating rate. There is a need to develop this recording technique to remove user and assessor bias.

Assessing functional mobility after lower limb reconstruction: a psychometric evaluation of a sensor-based mobility score.

OBJECTIVE: To develop and validate a robust, objective mobility assessment tool, Hamlyn Mobility Score (HMS), using a wearable motion sensor. BACKGROUND: Advances in reconstructive techniques allow more limbs to be salvaged. However, evidence demonstrating superior long-term outcomes compared with amputation is unavailable. Lack of access to quality regular functional mobility status may be preventing patients and health care staff from optimizing rehabilitation programs and evaluating the reconstructive services. METHODS: In this prospective cohort study, 20 patients undergoing lower limb reconstruction and 10 age-matched controls were recruited. All subjects completed the HMS activity protocol twice under different instructors at 3 months postoperatively, and again at 6 months, while wearing an ear-worn accelerometer. Demographic and clinical data were also collected including a short-form health survey (SF-36). HMS parameters included standard test metrics and additional kinematic features extracted from accelerometer data. A psychometric evaluation was conducted to ascertain reliability and validity. RESULTS: The HMS demonstrated excellent reliability (intraclass correlation coefficient >0.90, P < 0.001) and internal consistency (Cronbach α = 0.897). Concurrent validity was demonstrated by correlation between HMS and SF-36 scores (Spearman ρ = 0.666, P = 0.005). Significant HMS differences between healthy subjects and patients, stratified according to fracture severity, were shown (Kruskal-Wallis nonparametric 1-way analysis of variance, χ = 21.5, P < 0.001). The HMS was 50% more responsive to change than SF-36 (effect size: 1.49 vs 0.99). CONCLUSIONS: The HMS shows satisfactory reliability and validity and may provide a platform to support adaptable, personalized rehabilitation and enhanced service evaluation to facilitate optimal patient outcomes.

A Randomized Controlled Study to Evaluate the Impact of Instrument and Laparoscope Length on Performance and Learning Curve in Single-Incision Laparoscopic Surgery.

INTRODUCTION: The proximity of instrumentation in single-incision laparoscopic surgery (SILS) creates ergonomic challenges. An innovative method to reduce external collisions between instruments and handles is to use instruments of different lengths. This study evaluated the impact of instrument and laparoscope length on simulated SILS performance. METHODS: Performance was assessed using peg transfer (PEG) and pattern cutting (CUT) tasks from the Fundamentals of Laparoscopic Surgery (FLS) curriculum. Following baseline testing, surgeons were randomized into 3 trial arms: Control--standard length instruments and standard length laparoscope; group 1--one long instrument, one standard length instrument and standard length laparoscope; and group 2--standard length instruments and long laparoscope. Two phases were undertaken using a validated SILS-modified FLS box trainer: phase 1--25 repetitions of PEG and phase 2--5 repetitions of CUT. FLS scoring parameters measured performance and the Imperial College Surgical Assessment Device (ICSAD) captured motion analysis of hands. RESULTS: Twenty-three surgeons were recruited--control (n = 7), group 1 (n = 9), and group 2 (n = 7). No significant differences were observed in operative experience or baseline skills performance. Phase 1: Peak FLS score was significantly higher in group 1 compared with control (P = .009). Comparison of learning curves revealed learning plateau was significantly higher in group 1 compared with control (P = .010). Phase 2: Group 1 revealed a trend toward higher peak FLS scores over the control (P = .067). No significant differences in motion analysis of hands were demonstrated using ICSAD. CONCLUSIONS: This study demonstrates that using instruments of different lengths can improve simulated SILS performance.

An evaluation of the management of severe open tibial fractures in the United Kingdom's major trauma centres.

AIM: To evaluate the management of patients with severe open tibial fractures at major trauma centres (MTCs) in the UK with respect to BOAST 4 guidelines. METHODS: Data collected by the Trauma and Audit Research Network (TARN) for all severe open tibial fractures treated at the 23 adult MTCs were evaluated. Key performance indicators (KPIs) included MTC admission under orthoplastics, administration of antibiotics within three hours of injury, initial debridement within 24 h and definitive fixation and soft tissue coverage within 72 h. Outcomes included 30-day infection rate, amputation rate and mortality rate. A score was calculated according to overall attainment of KPIs, and correlated to outcomes. RESULTS: From 2014 to 2020, 3359 adults with Gustilo-Anderson (GA) IIIB and/or IIIC fractures were admitted to MTCs. Male to female ratio was 2:1 with a mean age of 43 and 65 years respectively. There was a negative correlation between KPI score and mortality rate (r=-0.4929, p = 0.0169). Direct admission to an MTC was positively correlated with receipt of antibiotics within three hours (r = 0.5452, p = 0.0070). Joint orthoplastic plans were documented in 89 % of patients (MTC range 30-95 %). Soft tissue cover was achieved within 72 h for 48 % (MTC range 5.23-89.39 %). Patients over 65 were significantly more likely to have a delay to MTC admission and prophylactic antibiotic administration. Mortality rate in this group was 6% vs 2 % in those under 65. The older cohort were twice as likely to require an amputation. CONCLUSION: This is the largest cohort of open tibial injuries managed in the UK with wide variation in practice between centres demonstrated and better adherence to BOAST guidelines linked to reduced mortality in those aged 65 and over. The older cohort of patients also had higher rates of infection and amputation. It is unclear whether these poor outcomes are due to the pre-morbid physiological status of the patient or non-compliance to Standards. We present these data to highlight the need for improved adherence to Standards - the adoption of a scoring system provides a simple way to evidence this.

Identifying variation in the cost of abdominally based breast reconstruction in the UK.

AIMS: To understand variation in the cost of autologous breast reconstruction in the UK, including identifying key areas of cost variability, differences between and within units and the impact of enhanced recovery protocols (ERAS). METHODS: A micro-costing study was designed based on the responses to a national survey of clinical preferences completed by the majority of plastic surgeons and anaesthetists involved in the UK. Detailed costs were estimated from macro elements such as ward and theatre running costs, down to that of surgical meshes, anaesthetic drugs and flap monitoring devices. RESULTS: The largest variation in cost arose from postoperative location and length of stay, preoperative imaging and flap monitoring strategies. Plastic surgeon costs varied from £1282 to £3141, whereas anaesthetic costs were between £32 and £151 (not including salary). Estimated cost variation within units was up to £893 per case. Units with ERAS had significantly lower total costs than those without (p < 0.05). CONCLUSION: This study reveals significant cost variation in breast reconstruction in the UK based on clinician preferences. Many areas of practice driving this variation lack strong evidence of any clinical advantage. The total cost of a deep inferior epigastric perforator in the majority, if not all units, likely surpasses the national tariff for reimbursement, particularly when considering additional resource demand for immediate and bilateral breast reconstruction, as well as future symmetrisation procedures. Whilst units should look to streamline costs through ERAS, there should also be a realistic tariff that promotes excellent care.

Quantifying postoperative recovery using wearable activity monitors following abdominal wall surgery: The AbTech trial.

PURPOSE: This work aimed to investigate the validity of wearable activity monitors (WAMs) as an objective tool to measure the return toward normal functional mobility following abdominal wall surgery. This was achieved by quantifying and comparing pre- and postoperative physical activity (PA). METHODS: A multicenter, prospective, observational cohort study was designed. Patients undergoing abdominal wall surgery were assessed for eligibility and consent for study participation was obtained. Participants were asked to wear a WAM (AX3, Axivity) on the wrist of their dominant hand at least 48 hours pre-operatively, for up to 2 weeks postop, and again after 6 months postop for 48 hours. RESULTS: A cohort of 20 patients were recruited in this validation study with a mean age of 47.3 ± 13.0 years. Postoperation, the percentage median PA (±IQR) dropped to 32.6% (20.1), whereas on day 14, PA had reached 64.6% (22.7) of the preoperative value providing construct validity. Activity levels at >6 months postop increased by 16.4% on an average when compared to baseline preoperative PA (p = 0.046). CONCLUSION: This study demonstrates that WAMs are valid markers of postoperative recovery following abdominal wall surgery. This was achieved by quantifying the reduction in PA postoperation, which has not been previously shown. In addition, this study suggests that abdominal wall surgery may improve the patient's quality of life via increased functional mobility at 6 months postop. In the future, this technology could be used to identify the patient and surgical factors that are predictors of outcome following abdominal wall surgery.

Dynamic assessment of the upper extremity: a review of available and emerging technologies.

The purpose of this review article is to provide an update on the realm of emerging technology available for the assessment of dynamic functional movement of the hand and upper limb. A critical overview of the literature and a conceptual framework for use of such technologies is proposed. The framework explores three broad purpose categories including customization of care, functional surveillance and interventions through biofeedback strategies. State-of-the-art technologies are described, from basic activity monitors to feedback-enabled robotic gloves, along with exemplar trials and clinical applications. The future of technologies innovation in hand pathology is proposed in the context of the current obstacles and opportunities for hand surgeons and therapists.

Does previous laparoscopic experience improve ability to perform single-incision laparoscopic surgery?

BACKGROUND: Single-site laparoscopic surgery (SSLS) has been suggested as a safe and less invasive alternative to standard laparoscopic surgery (LAP). It is not clear whether previous laparoscopic experience influences the ability to perform SSLS. This study aimed to assess the impact of laparoscopic experience on the performance of SSLS. METHODS: For this study, 18 surgeons were recruited including 12 novice surgeons, four experienced laparoscopic surgeons (intermediate) and two experienced SSLS surgeons (expert). All these subjects completed four tasks from the validated Fundamentals of laparoscopic surgery (FLS) curriculum. The tasks were performed using both a LAP and an SSLS approach with a randomized crossover design. Assessment of the tasks was performed with standardized FLS metrics and dexterity analysis using the Imperial college surgical assessment device. RESULTS: The novice group performed two tasks (precision cutting and intracorporeal suture) significantly better with a LAP approach than with an SSLS approach in all parameters (P < 0.05). The two other tasks (peg transfer and endoloop) were performed significantly better with LAP than with SSLS in terms of time and dexterity only (P < 0.05) but not in terms of error score. The intermediate and expert groups demonstrated no significant difference between their LAP and SSLS performances for any of the tasks in any parameter. Intergroup analysis of performance demonstrated construct validity of the SSLS tasks, with significant differences between novice and intermediate performances for three tasks (peg transfer, endoloop, and intracorporeal suture) (P < 0.05) and between novice and expert performances for three tasks (peg transfer, precision cutting, and intracorporeal suture) (P < 0.05). CONCLUSIONS: This study demonstrated that previous laparoscopic experience improves ability to perform SSLS tasks. Some SSLS tasks do not show construct validity due to the complexity of the SSLS technique. It also is implied that current LAP technical skills training curricula are insufficient for teaching SSLS.

Pulse oximetry for the diagnosis of vascular injury following limb trauma.

Prompt diagnosis and intervention are essential for acute limb ischaemia after trauma. Guidelines for diagnosis are changing with new evidence. Pulse oximetry may be a useful adjunct. We aim to assess the value of pulse oximetry and other common tests for diagnosing vascular injury. Electronic medical records of patients with limb injuries were identified. Patient demographics, the mechanism of injury, comorbidities, the results of diagnostic tests or examinations, and the end outcome were extracted. Receiver Operator Characteristics (ROC) curves were used to calculate cut-offs with optimum sensitivity and specificity for pulse oximetry. Performance characteristics to predict vascular injury for all documented tests were calculated and compared. SpO2 values were significantly different in the group with and without vascular disruption (p = 0.034). Using a cut-off of 96% calculated from ROC curve analysis, SpO2 had a sensitivity of 78% and a specificity of 90%. For the other techniques, abnormal pulse oximetry waveform, absent distal pulses, and capillary refill over 2 s were significantly different between the two groups. Abnormal pulse oximetry waveform had the highest specificity (100%) while SpO2 was the most sensitive (78%). We suggest that pulse oximetry is a useful adjunct for patients with limb trauma, an abnormal waveform or SpO2 value below 96% suggests vascular disruption is present. Capillary refill over 2 s and absent distal pulses can also be used; if either are positive, this suggests vascular disruption. No test or examination was shown to be able to exclude vascular injury.

Emati: a recommender system for biomedical literature based on supervised learning.

The scientific literature continues to grow at an ever-increasing rate. Considering that thousands of new articles are published every week, it is obvious how challenging it is to keep up with newly published literature on a regular basis. Using a recommender system that improves the user experience in the online environment can be a solution to this problem. In the present study, we aimed to develop a web-based article recommender service, called Emati. Since the data are text-based by nature and we wanted our system to be independent of the number of users, a content-based approach has been adopted in this study. A supervised machine learning model has been proposed to generate article recommendations. Two different supervised learning approaches, namely the naïve Bayes model with Term Frequency-Inverse Document Frequency (TF-IDF) vectorizer and the state-of-the-art language model bidirectional encoder representations from transformers (BERT), have been implemented. In the first one, a list of documents is converted into TF-IDF-weighted features and fed into a classifier to distinguish relevant articles from irrelevant ones. Multinomial naïve Bayes algorithm is used as a classifier since, along with the class label, it also gives the probability that the input belongs to this class. The second approach is based on fine-tuning the pretrained state-of-the-art language model BERT for the text classification task. Emati provides a weekly updated list of article recommendations and presents it to the user, sorted by probability scores. New article recommendations are also sent to users' email addresses on a weekly basis. Additionally, Emati has a personalized search feature to search online services' (such as PubMed and arXiv) content and have the results sorted by the user's classifier. Database URL: https://emati.biotec.tu-dresden.de.