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.

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.

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.

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.

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.

Outcome reporting in therapeutic mammaplasty: a systematic review.

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.

Quantifying the Limitations of Clinical and Technology-based Flap Monitoring Strategies using a Systematic Thematic Analysis.

BACKGROUND: Multiple techniques exist to monitor free flap viability postoperatively, varying with practical and personal preference, yet the limitations of each technique remain unquantified. This systematic review aims to identify the most commonly reported limitations of these techniques in clinical practice. METHODS: A systematic review was conducted according to PRISMA guidelines using MEDLINE, EMBASE, and Web of Science with search criteria for postoperative free flap monitoring techniques. Search results were independently screened using defined criteria by two authors and a senior clinician. Limitations of the techniques found in the discussion section of eligible articles were recorded and categorized using thematic analysis. RESULTS: A total of 4699 records were identified. In total, 2210 articles met the eligibility criteria and were subsequently reviewed, with 195 papers included in the final analysis. The most frequently reported limitations of clinical monitoring were interpretation requiring expertise (25% of related papers), unsuitability for buried flaps (21%), and lack of quantitative/objective values (19%). For noninvasive technologies, the limitations were lack of quantitative/objective values (21%), cost (16%), and interpretation requiring expertise (13%). For invasive technologies, the limitations were application requiring expertise (25%), equipment design and malfunction (13%), and cost (13%). CONCLUSIONS: This is the first systematic review to quantify the limitations of different flap monitoring techniques, as reported in the literature. This information may enhance the choice in monitoring strategy for a reconstructive service, and inform the development and refinement of new flap monitoring technologies.

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.

Outcomes and outcome measures reported in clinical studies of therapeutic mammaplasty: a systematic review protocol.

INTRODUCTION: Therapeutic mammaplasty (TM) is an oncological procedure which combines tumour resection with breast reduction and mastopexy techniques. Previous systematic reviews have demonstrated oncological safety of TM, but poor and inconsistent reporting of quality-of-life, aesthetic and functional outcomes, often with non-validated measurement tools. Moreover, there is a paucity of patient-reported outcome measures. Standardisation of outcome reporting is required to enable study results to be compared and combined, for example, through core outcome set (COS) development. This systematic review aims to comprehensively describe the outcomes reported in clinical studies of TM, their respective outcome measures and the time points at which they were evaluated. The overall objective is to facilitate the development of a COS for TM. METHODS AND ANALYSIS: A systematic review of clinical studies evaluating outcomes following TM will be completed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The following electronic databases have been searched from inception to 5 August 2020: Ovid MEDLINE, Embase, CINAHL and Web of Science. Primary outcomes will include the number of reported outcomes of various types (clinical, aesthetic, functional, quality-of-life and cost-effectiveness), whether these are patient-reported or clinician-reported, how outcomes are defined and the outcome measurement tool(s) used. The time point(s) at which outcomes were measured will be a secondary outcome. No studies will be excluded on the basis of methodological quality in order to generate a comprehensive list of reported outcomes and outcome measures; hence, risk of bias assessment is not required. The data will be described narratively. This protocol has been reported in line with PRISMA-Protocols. ETHICS AND DISSEMINATION: This study does not involve human or animal participants, hence ethical approval is not required. The findings will be published in a peer-reviewed journal and presented at relevant conferences. PROSPERO REGISTRATION NUMBER: CRD42020200365.

Investigating Lower Limb Hemodynamics during Flap Training Regimens and Patient-led Isometric Contraction Protocols.

The evidence for lower limb flap (LLF) training regimens is equivocal. The commonest cause of LLF failure is venous congestion. The aim of this study was to investigate whether venous congestion could be reduced by patient-led isometric calf contractions during flap training. A prospective clinical study was conducted using photospectroscopy and laser Doppler (Oxygen to See) to assess healthy limbs and LLF characteristics during flap training and isometric calf contractions. Tissue oxygen saturation, venous congestion, and blood flow were measured at rest, as well as during and after limb dangling and calf contraction exercises. In the acute postoperative period following LLF surgery, dependency markedly reduced superficial flow (-55.20% ± 19.17%), with a concurrent increase in venous congestion (33.80% ± 28.80%); supine isometric contractions improved superficial flow and reduced venous congestion from postoperative day 5. Contractions cause a significant increase in blood flow in the outpatient cohort (+84.40% ± 7.86%, P = 0.009), with a mean time since discharge of 14 weeks. Our data suggest patient-led isometric calf exercises are well tolerated and may reduce venous congestion in the acute phase. Progressive changes toward normal physiological function were demonstrated in the outpatient rehabilitation period. Incorporating calf exercises into LLF rehabilitation may allow longer periods of leg dependency, quicker recovery from surgery, and ultimately improve outcomes.

A lightweight sensing platform for monitoring sleep quality and posture: a simulated validation study.

BACKGROUND: The prevalence of self-reported shoulder pain in the UK has been estimated at 16%. This has been linked with significant sleep disturbance. It is possible that this relationship is bidirectional, with both symptoms capable of causing the other. Within the field of sleep monitoring, there is a requirement for a mobile and unobtrusive device capable of monitoring sleep posture and quality. This study investigates the feasibility of a wearable sleep system (WSS) in accurately detecting sleeping posture and physical activity. METHODS: Sixteen healthy subjects were recruited and fitted with three wearable inertial sensors on the trunk and forearms. Ten participants were entered into a 'Posture' protocol; assuming a series of common sleeping postures in a simulated bedroom. Five participants completed an 'Activity' protocol, in which a triphasic simulated sleep was performed including awake, sleep and REM phases. A combined sleep posture and activity protocol was then conducted as a 'Proof of Concept' model. Data were used to train a posture detection algorithm, and added to activity to predict sleep phase. Classification accuracy of the WSS was measured during the simulations. RESULTS: The WSS was found to have an overall accuracy of 99.5% in detection of four major postures, and 92.5% in the detection of eight minor postures. Prediction of sleep phase using activity measurements was accurate in 97.3% of the simulations. The ability of the system to accurately detect both posture and activity enabled the design of a conceptual layout for a user-friendly tablet application. CONCLUSIONS: The study presents a pervasive wearable sensor platform, which can accurately detect both sleeping posture and activity in non-specialised environments. The extent and accuracy of sleep metrics available advances the current state-of-the-art technology. This has potential diagnostic implications in musculoskeletal pathology and with the addition of alerts may provide therapeutic value in a range of areas including the prevention of pressure sores.

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.

The relationship between physical activity and post-operative length of hospital stay: A systematic review.

BACKGROUND: Recovery from surgery has traditionally been measured using specific outcome measures, such as length of hospital stay. However, advances in technology have enabled the measurement of continuous, objective physical activity data in the perioperative period. The aim of this systematic review was to determine the relationship between length of hospital stay and physical activity data for patients undergoing surgery. METHODS: A systematic search of EMBASE, Medline and the Cochrane Library, from inception until January 2017, was performed to identify all study designs that evaluated physical activity after surgery. Studies were included if a wearable sensor measured patient activity as an in-patient and the length of hospital stay was reported. Only English articles were included. RESULTS: Six studies with a total of 343 participants were included in this review. All the studies were prospective observational studies. Each study used a different sensor, with the commonest being a tri-axial accelerometer, and multiple different physical activity outcome measures were used, thereby prohibiting meta-analysis. Four of the studies demonstrated a relationship between physical activity levels and length of hospital stay, while two studies did not show any significant relationship. CONCLUSION: The amount of physical activity performed post-operatively negatively correlates with the length of hospital stay. This suggests that objective physical activity data collected by body worn sensors may be capable of predicting functional recovery post-operatively.

Fifty Years of Innovation in Plastic Surgery.

BACKGROUND: Innovation has molded the current landscape of plastic surgery. However, documentation of this process only exists scattered throughout the literature as individual articles. The few attempts made to profile innovation in plastic surgery have been narrative, and therefore qualitative and inherently biased. Through the implementation of a novel innovation metric, this work aims to identify and characterise the most prevalent innovations in plastic surgery over the last 50 years. METHODS: Patents and publications related to plastic surgery (1960 to 2010) were retrieved from patent and MEDLINE databases, respectively. The most active patent codes were identified and grouped into technology areas, which were subsequently plotted graphically against publication data. Expert-derived technologies outside of the top performing patents areas were additionally explored. RESULTS: Between 1960 and 2010, 4,651 patents and 43,118 publications related to plastic surgery were identified. The most active patent codes were grouped under reconstructive prostheses, implants, instruments, non-invasive techniques, and tissue engineering. Of these areas and other expert-derived technologies, those currently undergoing growth include surgical instruments, implants, non-invasive practices, transplantation and breast surgery. Innovations related to microvascular surgery, liposuction, tissue engineering, lasers and prostheses have all plateaued. CONCLUSIONS: The application of a novel metric for evaluating innovation quantitatively outlines the natural history of technologies fundamental to the evolution of plastic surgery. Analysis of current innovation trends provides some insight into which technology domains are the most active.

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.