Publications by authors named "George B Hanna"

212 Publications

Editorial: volatile organic compound analysis to improve faecal immunochemical testing in the detection of colorectal cancer.

Aliment Pharmacol Ther 2021 Aug;54(4):504-505

Department of Surgery and Cancer, Imperial College London, London, UK.

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http://dx.doi.org/10.1111/apt.16471DOI Listing
August 2021

Virus-induced Volatile Organic Compounds are Detectable in Exhaled Breath During Pulmonary Infection.

Am J Respir Crit Care Med 2021 Jul 28. Epub 2021 Jul 28.

Imperial College London, 4615, London, United Kingdom of Great Britain and Northern Ireland;

Background: Chronic obstructive pulmonary disease (COPD) is a condition punctuated by acute exacerbations commonly triggered by viral and/or bacterial infection. Early identification of exacerbation trigger is important to guide appropriate therapy but currently available tests are slow and imprecise. Volatile organic compounds (VOCs) can be detected in exhaled breath and have the potential to be rapid tissue-specific biomarkers of infection aetiology.

Methods: We used serial sampling within in vitro and in vivo studies to elucidate the dynamic changes that occur in VOC production during acute respiratory viral infection. Highly sensitive gas-chromatography mass spectrometry (GC-MS) techniques were used to measure VOC production from infected airway epithelial cell cultures and in exhaled breath samples of healthy subjects experimentally challenged with rhinovirus A16 and COPD subjects with naturally-occurring exacerbations.

Results: We identified a novel VOC signature comprising of decane and other related long chain alkane compounds that is induced during rhinovirus infection of cultured airway epithelial cells and is also increased in the exhaled breath of healthy subjects experimentally challenged with rhinovirus and of COPD patients during naturally-occurring viral exacerbations. These compounds correlated with magnitude of anti-viral immune responses, virus burden and exacerbation severity but were not induced by bacterial infection, suggesting they represent a specific virus-inducible signature.

Conclusion: Our study highlights the potential for measurement of exhaled breath VOCs as rapid, non-invasive biomarkers of viral infection. Further studies are needed to determine whether measurement of these signatures could be used to guide more targeted therapy with antibiotic/antiviral agents for COPD exacerbations.
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http://dx.doi.org/10.1164/rccm.202103-0660OCDOI Listing
July 2021

Attitudes towards Trusting Artificial Intelligence Insights and Factors to Prevent the Passive Adherence of GPs: A Pilot Study.

J Clin Med 2021 Jul 14;10(14). Epub 2021 Jul 14.

NIHR London In-Vitro Diagnostics Cooperative, London W2 1PE, UK.

Artificial Intelligence (AI) systems could improve system efficiency by supporting clinicians in making appropriate referrals. However, they are imperfect by nature and misdiagnoses, if not correctly identified, can have consequences for patient care. In this paper, findings from an online survey are presented to understand the aptitude of GPs ( = 50) in appropriately trusting or not trusting the output of a fictitious AI-based decision support tool when assessing skin lesions, and to identify which individual characteristics could make GPs less prone to adhere to erroneous diagnostics results. The findings suggest that, when the AI was correct, the GPs' ability to correctly diagnose a skin lesion significantly improved after receiving correct AI information, from 73.6% to 86.8% (X (1, = 50) = 21.787, < 0.001), with significant effects for both the benign (X (1, = 50) = 21, < 0.001) and malignant cases (X (1, = 50) = 4.654, = 0.031). However, when the AI provided erroneous information, only 10% of the GPs were able to correctly disagree with the indication of the AI in terms of diagnosis (d-AIW M: 0.12, SD: 0.37), and only 14% of participants were able to correctly decide the management plan despite the AI insights (d-AIW M:0.12, SD: 0.32). The analysis of the difference between groups in terms of individual characteristics suggested that GPs with domain knowledge in dermatology were better at rejecting the wrong insights from AI.
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http://dx.doi.org/10.3390/jcm10143101DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8303875PMC
July 2021

Selected ion flow tube mass spectrometry for targeted analysis of volatile organic compounds in human breath.

Nat Protoc 2021 07 4;16(7):3419-3438. Epub 2021 Jun 4.

Department of Surgery and Cancer, Imperial College London, London, UK.

The analysis of volatile organic compounds (VOCs) within breath for noninvasive disease detection and monitoring is an emergent research field that has the potential to reshape current clinical practice. However, adoption of breath testing has been limited by a lack of standardization. This protocol provides a comprehensive workflow for online and offline breath analysis using selected ion flow tube mass spectrometry (SIFT-MS). Following the suggested protocol, 50 human breath samples can be analyzed and interpreted in <3 h. Key advantages of SIFT-MS are exploited, including the acquisition of real-time results and direct compound quantification without need for calibration curves. The protocol includes details of methods developed for targeted analysis of disease-specific VOCs, specifically short-chain fatty acids, aldehydes, phenols, alcohols and alkanes. A procedure to make custom breath collection bags is also described. This standardized protocol for VOC analysis using SIFT-MS is intended to provide a basis for wider application and the use of breath analysis in clinical studies.
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http://dx.doi.org/10.1038/s41596-021-00542-0DOI Listing
July 2021

Prognostic relevance of lymph node regression on survival in esophageal cancer: a systematic review and meta-analysis.

Dis Esophagus 2021 Apr 24. Epub 2021 Apr 24.

Department of Surgery and Cancer, Imperial College London, London, UK.

Introduction: The prognostic value of histomorphologic regression in primary esophageal cancer has been previously established, however the impact of lymph node (LN) response on survival still remains unclear. The aim of this review was to assess the prognostic significance of LN regression or downstaging following neoadjuvant therapy for esophageal cancer.

Methods: An electronic search was performed to identify articles evaluating LN regression or downstaging after neoadjuvant therapy. Random effects meta-analyses were performed to assess the influence of regression in the LNs and nodal downstaging on overall survival. Histomorphologic tumor regression in LNs was defined by the absence of viable cells or degree of fibrosis on histopathologic examination. Downstaged LNs were defined as pN0 nodes by the tumor, node, and metastasis classification, which were positive prior to treatment neoadjuvant.

Results: Eight articles were included, three of which assessed tumor regression (number of patients = 292) and five assessed downstaging (number of patients = 1368). Complete tumor regression (average rate of 29.1%) in the LNs was associated with improved survival, although not statistically significant (hazard ratio [HR] = 0.52, 95% confidence interval [CI] = 0.26-1.06; P = 0.17). LNs downstaging (average rate of 32.2%) was associated with improved survival compared to node positivity after neoadjuvant treatment (HR = 0.41, 95%CI = 0.22-0.77; P = 0.005).

Discussion: The findings of this meta-analysis have shown a survival benefit in patients with LN downstaging and are suggestive for considering LN downstaging to ypN0 as an additional prognostic marker in staging and in the comparative evaluation of differing neoadjuvant regimens in clinical trials. No statistically significant effect of histopathologic regression in the LNs on long-term survival was seen.
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http://dx.doi.org/10.1093/dote/doab021DOI Listing
April 2021

Feasibility and acceptability of breath research in primary care: a prospective, cross-sectional, observational study.

BMJ Open 2021 04 13;11(4):e044691. Epub 2021 Apr 13.

Department of Surgery and Cancer, Imperial College London, London, UK

Objectives: To examine the feasibility and acceptability of breath research in primary care.

Design: Non-randomised, prospective, mixed-methods cross-sectional observational study.

Setting: Twenty-six urban primary care practices.

Participants: 1002 patients aged 18-90 years with gastrointestinal symptoms.

Main Outcome Measures: During the first 6 months of the study (phase 1), feasibility of patient enrolment using face-to-face, telephone or SMS-messaging (Short Message Service) enrolment strategies, as well as processes for breath testing at local primary care practices, were evaluated. A mixed-method iterative study design was adopted and outcomes evaluated using weekly Plan-Do-Study-Act cycles, focus groups and general practitioner (GP) questionnaires.During the second 6 months of the study (phase 2), patient and GP acceptability of the breath test and testing process was assessed using questionnaires. In addition a 'single practice' recruitment model was compared with a 'hub and spoke' centralised recruitment model with regards to enrolment ability and patient acceptability.Throughout the study feasibility of the collection of a large number of breath samples by clinical staff over multiple study sites was evaluated and quantified by the analysis of these samples using mass spectrometry.

Results: 1002 patients were recruited within 192 sampling days. Both 'single practice' and 'hub and spoke' recruitment models were effective with an average of 5.3 and 4.3 patients accrued per day, respectively. The 'hub and spoke' model with SMS messaging was the most efficient combined method of patient accrual. Acceptability of the test was high among both patients and GPs. The methodology for collection, handling and analysis of breath samples was effective, with 95% of samples meeting quality criteria.

Conclusions: Large-scale breath testing in primary care was feasible and acceptable. This study provides a practical framework to guide the design of Phase III trials examining the performance of breath testing in primary care.
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http://dx.doi.org/10.1136/bmjopen-2020-044691DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8051376PMC
April 2021

Qualitative analysis of stakeholder interviews to identify the barriers and facilitators to the adoption of point-of-care diagnostic tests in the UK.

BMJ Open 2021 04 13;11(4):e042944. Epub 2021 Apr 13.

Department of Surgery and Cancer, Imperial College London, London, UK

Objectives: This study investigated the barriers and facilitators to the adoption of point-of-care tests (POCTs).

Design: Qualitative study incorporating a constant comparative analysis of stakeholder responses to a series of interviews undertaken to design the Point-of-Care Key Evidence Tool.

Setting: The study was conducted in relation to POCTs used in all aspects of healthcare.

Participants: Forty-three stakeholders were interviewed including clinicians (incorporating laboratory staff and members of trust POCT committees), commissioners, industry, regulators and patients.

Results: Thematic analysis highlighted 32 barriers in six themes and 28 facilitators in eight themes to the adoption of POCTs. Six themes were common to both barriers and facilitators (clinical, cultural, evidence, design and quality assurance, financial and organisational) and two themes contained facilitators alone (patient factors and other (non-financial) resource use).

Conclusions: Findings from this study demonstrate the complex motivations of stakeholders in the adoption of POCT. Most themes were common to both barriers and facilitators suggesting that good device design, stakeholder engagement and appropriate evidence provision can increase the likelihood of a POCT device adoption. However, it is important to realise that while the majority of identified barriers may be perceived or mitigated some may be absolute and if identified early in device development further investment should be carefully considered.
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http://dx.doi.org/10.1136/bmjopen-2020-042944DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8051412PMC
April 2021

Cross Platform Analysis of Volatile Organic Compounds Using Selected Ion Flow Tube and Proton-Transfer-Reaction Mass Spectrometry.

J Am Soc Mass Spectrom 2021 May 8;32(5):1215-1223. Epub 2021 Apr 8.

Department of Surgery and Cancer, Imperial College London, St. Mary's Hospital, London W2 1PE, United Kingdom.

Volatile breath metabolites serve as potential disease biomarkers. Online mass spectrometry (MS) presents real-time quantification of breath volatile organic compounds (VOCs). The study aims to assess the relationship between two online analytical mass spectrometry techniques in the quantification of target breath metabolites: selected ion flow tube mass spectrometry (SIFT-MS) and proton-transfer-reaction time-of-flight mass spectrometry (PTR-ToF-MS). The two following techniques were employed: (i) direct injection with bag sampling using SIFT-MS and PTR-ToF-MS and (ii) direct injection and thermal desorption (TD) tube comparison using PTR-ToF-MS. The concentration of abundant breath metabolites, acetone and isoprene, demonstrated a strong positive linear correlation between both mass spectrometry techniques ( = 0.97, = 0.89, respectively; < 0.001) and between direct injection and TD tube ( = 0.97, = 0.92, respectively; < 0.001) breath sampling techniques. This was reflected for the majority of short chain fatty acids and alcohols tested ( > 0.80, < 0.001). Analyte concentrations were notably higher with the direct injection of a sampling bag compared to the TD method. All metabolites produced a high degree of agreement in the detection range of VOCs between SIFT-MS and PTR-ToF-MS, with the majority of compounds falling within 95% of the limits of agreement with Bland-Altman analysis. The cross platform analysis of exhaled breath demonstrates strong positive correlation coefficients, linear regression, and agreement in target metabolite detection rates between both breath sampling techniques. The study demonstrates the transferability of using data outputs between SIFT-MS and PTR-ToF-MS. It supports the implementation of a TD platform in multi-site studies for breath biomarker research in order to facilitate sample transport between clinics and the laboratory.
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http://dx.doi.org/10.1021/jasms.1c00027DOI Listing
May 2021

Long-term variation in skeletal muscle and adiposity in patients undergoing esophagectomy.

Dis Esophagus 2021 Apr 5. Epub 2021 Apr 5.

Department of Thoracic Surgery and Thoracic Oncology, Virginia Mason Medical Center, Seattle, WA, USA.

This study seeks to define long-term variation in body composition in patients undergoing esophagectomy for cancer and to associate those changes with survival. Assessment of skeletal muscle, visceral (VAT) and subcutaneous adipose tissue (SAT) was performed using computed tomography (CT) images routinely acquired: at diagnosis; after neoadjuvant therapy, and; >6 months after esophagectomy. In cases where multiple CT scans were performed >6 months after surgery, all available images were assessed. Ninty-seven patients met inclusion criteria with a median of 2 (range 1-10) postoperative CT images acquired between 0.5 and 9.7 years after surgery. Following surgical treatment of esophageal cancer, patients lost on average 13.3% of their skeletal muscle, 64.5% of their VAT and 44.2% of their SAT. Sarcopenia at diagnosis was not associated with worse overall survival (66.3% vs. 68.5%; P = 0.331). Sarcopenia 1 year after esophagectomy was however associated with lower 5-year overall survival (53.8% vs. 87.5%; P = 0.019). Survival was lower in those patients who had >10% decrease in skeletal muscle index (SMI; 33.3% vs. 72.1%; P = 0.003) and >40% decrease in SAT 1 year after surgery (40.4% vs. 67.4%; P = 0.015). On multivariate analysis, a decline in SMI 1 year after surgery was predictive of worse survival (HR 0.38, 95%CI 0.20-0.73; P = 0.004). This study provides new insight relating to long-term variation in body composition in patients undergoing esophagectomy for cancer. Findings provide further evidence of the importance of body composition, in particular depletion of skeletal muscle, in predicting survival following esophagectomy.
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http://dx.doi.org/10.1093/dote/doab016DOI Listing
April 2021

Endogenous aldehyde accumulation generates genotoxicity and exhaled biomarkers in esophageal adenocarcinoma.

Nat Commun 2021 03 5;12(1):1454. Epub 2021 Mar 5.

Department of Surgery and Cancer, Imperial College London, London, UK.

Volatile aldehydes are enriched in esophageal adenocarcinoma (EAC) patients' breath and could improve early diagnosis, however the mechanisms of their production are unknown. Here, we show that weak aldehyde detoxification characterizes EAC, which is sufficient to cause endogenous aldehyde accumulation in vitro. Two aldehyde groups are significantly enriched in EAC biopsies and adjacent tissue: (i) short-chain alkanals, and (ii) medium-chain alkanals, including decanal. The short-chain alkanals form DNA-adducts, which demonstrates genotoxicity and confirms inadequate detoxification. Metformin, a putative aldehyde scavenger, reduces this toxicity. Tissue and breath concentrations of the medium-chain alkanal decanal are correlated, and increased decanal is linked to reduced ALDH3A2 expression, TP53 deletion, and adverse clinical features. Thus, we present a model for increased exhaled aldehydes based on endogenous accumulation from reduced detoxification, which also causes therapeutically actionable genotoxicity. These results support EAC early diagnosis trials using exhaled aldehyde analysis.
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http://dx.doi.org/10.1038/s41467-021-21800-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7935981PMC
March 2021

Quality of life and symptom assessment in paraesophageal hernias: a systematic literature review of reporting standards.

Dis Esophagus 2021 Jul;34(7)

Department of Surgery and Cancer, Imperial College London, London, UK.

Background: Paraesophageal hernias (PEH) present with a range of symptoms affecting physical and mental health. This systematic review aims to assess the quality of reporting standards for patients with PEH, identify the most frequently used quality of life (QOL) and symptom severity assessment tools in PEH and to ascertain additional symptoms reported by these patients not captured by these tools.

Methods: A systematic literature review according to PRISMA protocols was carried out following a literature search of MEDLINE, Embase and Cochrane databases for studies published between January 1960 and May 2020. Published abstracts from conference proceedings were included. Data on QOL tools used and reported symptoms were extracted.

Results: This review included 220 studies reporting on 28 353 patients. A total of 46 different QOL and symptom severity tools were used across all studies, and 89 different symptoms were reported. The most frequently utilized QOL tool was the Gastro-Esophageal Reflux Disease-Health related quality of life questionnaire symptom severity instrument (47.7%), 57.2% of studies utilized more than 2 QOL tools and 'dysphagia' was the most frequently reported symptom, in 55.0% of studies. Notably, respiratory and cardiovascular symptoms, although less common than GI symptoms, were reported and included 'dyspnea' reported in 35 studies (15.9%).

Conclusions: There lacks a QOL assessment tool that captures the range of symptoms associated with PEH. Reporting standards for this cohort must be improved to compare patient outcomes before and after surgery. Further investigations must seek to develop a PEH specific tool, that encompasses the relative importance of symptoms when considering surgical intervention and assessing symptomatic improvement following surgery.
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http://dx.doi.org/10.1093/dote/doaa134DOI Listing
July 2021

Urinary Volatile Organic Compound Analysis for the Diagnosis of Cancer: A Systematic Literature Review and Quality Assessment.

Metabolites 2020 Dec 29;11(1). Epub 2020 Dec 29.

Department of Surgery and Cancer, Imperial College London, St Mary's Hospital, London W2 1NY, UK.

The analysis of urinary volatile organic compounds (VOCs) is a promising field of research with the potential to discover new biomarkers for cancer early detection. This systematic review aims to summarise the published literature concerning cancer-associated urinary VOCs. A systematic online literature search was conducted to identify studies reporting urinary VOC biomarkers of cancers in accordance with the recommendations of the Cochrane Library and Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines. Thirteen studies comprising 1266 participants in total were included in the review. Studies reported urinary VOC profiles of five cancer subtypes: prostate cancer, gastrointestinal cancer, leukaemia/lymphoma, lung cancer, and bladder cancer. Forty-eight urinary VOCs belonging to eleven chemical classes were identified with high diagnostic performance. VOC profiles were distinctive for each cancer type with limited cross-over. The metabolic analysis suggested distinctive phenotypes for prostate and gastrointestinal cancers. The heterogenicity of study design, methodological and reporting quality may have contributed to inconsistencies between studies. Urinary VOC analysis has shown promising performance for non-invasive diagnosis of cancer. However, limitations in study design have resulted in inconsistencies between studies. These limitations are summarised and discussed in order to support future studies.
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http://dx.doi.org/10.3390/metabo11010017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7824454PMC
December 2020

The Impact of Prehabilitation on Post-operative Outcomes in Oesophageal Cancer Surgery: a Propensity Score Matched Comparison.

J Gastrointest Surg 2020 Dec 2. Epub 2020 Dec 2.

Department of Surgery and Cancer, Imperial College London, London, UK.

Background: Patients undergoing oesophageal cancer surgery are often frail with a high risk of post-operative complications. Prehabilitation has been shown to reduce post-operative complications in specific patient populations but evidence in oesophageal cancer patients is inconclusive.

Methods: Between January 2016 and April 2019, all patients with resectable oesophageal cancer who underwent curative treatment at a specialist tertiary centre participated in a personalised, home-based, multimodal prehabilitation programme. Post-operative complications and hospital stay in this group were compared to a control sample. Propensity score matching was used to control for differences in baseline characteristics.

Results: Seventy-two patients who completed prehabilitation and 39 control patients were studied; following propensity score matching, there were 38 subjects in each group. In comparison to matched controls, patients in the prehabilitation group had a lower incidence of post-operative pneumonia (prehabilitation = 26%; control = 66%; p = 0.001) and a shorter length of stay (prehabilitation = median 10 days, IQR 8-17 days; control = median 13 days, IQR 11-20 days; p = 0.018). On multivariate regression analysis, participation in prehabilitation was associated with a 77% lower incidence of post-operative pneumonia (OR 0.23, 95% CI 0.09 to 0.55 p = 0.001). There was no significant difference in the incidence of overall complications or severe complications.

Conclusion: Prehabilitation was associated with a lower incidence of post-operative pneumonia and shorter hospital length of stay following oesophagectomy. This model of home based, personalised, and supervised prehabilitation is effective and relevant to centralised cancer services.
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http://dx.doi.org/10.1007/s11605-020-04881-3DOI Listing
December 2020

Auto-deconvolution and molecular networking of gas chromatography-mass spectrometry data.

Nat Biotechnol 2021 02 9;39(2):169-173. Epub 2020 Nov 9.

Biological Sciences Division, Pacific Northwest National Laboratory, Richland, WA, USA.

We engineered a machine learning approach, MSHub, to enable auto-deconvolution of gas chromatography-mass spectrometry (GC-MS) data. We then designed workflows to enable the community to store, process, share, annotate, compare and perform molecular networking of GC-MS data within the Global Natural Product Social (GNPS) Molecular Networking analysis platform. MSHub/GNPS performs auto-deconvolution of compound fragmentation patterns via unsupervised non-negative matrix factorization and quantifies the reproducibility of fragmentation patterns across samples.
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http://dx.doi.org/10.1038/s41587-020-0700-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7971188PMC
February 2021

Laparoscopic Colorectal Surgery Outcomes Improved After National Training Program (LAPCO) for Specialists in England.

Ann Surg 2020 Oct 19. Epub 2020 Oct 19.

Department of Colorectal Surgery, Plymouth Hospitals NHS Trust, Plymouth.

Objective: To examine the impact of The National Training Programme for Laparoscopic Colorectal Surgery (Lapco) on the rate of laparoscopic surgery and clinical outcomes of cases performed by Lapco surgeons after completion of training.

Summery Background Data: Lapco provided competency-based supervised clinical training for specialist colorectal surgeons in England.

Methods: We compared the rate of laparoscopic surgery, mortality and morbidity for colorectal cancer resections by Lapco delegates and non-Lapco surgeons in 3-year periods preceding and following Lapco using difference in differences analysis. The changes in the rate of post-Lapco laparoscopic surgery with the Lapco sign-off competency assessment and in-training global assessment scores were examined using risk-adjusted cumulative sum to determine their predictive clinical validity with predefined competent scores of 3 and 5 respectively.

Results: 108 Lapco delegates performed 4586 elective colorectal resections pre-Lapco and 5115 post-Lapco while non-Lapco surgeons performed 72930 matched cases. Lapco delegates had a 37.8% increase in laparoscopic surgery which was greater than non-Lapco surgeons by 20.9% (95% CI, 18.5 to 23.3, p<0.001) with a relative decrease in 30-day mortality by -1.6% (95% CI, -3.4 to -0.2, p = 0.039) and 90-day mortality by -2.3% (95% CI, -4.3 to -0.4, p = 0.018). The change point of risk-adjusted cumulative sum was 3.12 for competency assessment tool and 4.74 for global assessment score whereas laparoscopic rate increased from 44% to 66% and 40% to 56% respectively.

Conclusions: Lapco increased the rate of laparoscopic colorectal cancer surgery and reduced mortality and morbidity in England. In-training competency assessment tools predicted clinical performance after training.
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http://dx.doi.org/10.1097/SLA.0000000000004584DOI Listing
October 2020

Challenges to quality assurance of surgical interventions in clinical oncology trials: A systematic review.

Eur J Surg Oncol 2021 Apr 6;47(4):748-756. Epub 2020 Oct 6.

Department of Surgery and Cancer, Imperial College London, UK.

Where surgery forms the primary curative modality in surgical oncology trials the quality of this intervention has the potential to directly influence outcomes. Many trials however lack a robust framework to ensure surgical quality. We aim to report existing published challenges to quality assurance of surgical interventions within oncological trials. A systematic on-line literature search of Embase and Medline identified 34 relevant studies, including 19 RCTs, 11 further analyses of the primary RCTs, and 4 trial protocols. Inclusion criteria: oncological RCTs with a surgical intervention and/or associated publications relevant to the research question; 'Challenges to quality assurance of surgery in clinical oncology trials'. Selected articles were assessed by two reviewers to identify reported challenges to quality assurance of surgical intervention within these trials. Reported challenges to surgical quality could be classified as those affecting credentialing, standardisation and monitoring of surgical interventions. Constraints of using case volume for credentialing surgeons; inter-centre variation in the definition and execution of interventions; insufficient training, and monitoring of surgical quality, were the most commonly encountered challenges within each of these three domains. Findings confirmed an inadequacy in the implementation and reporting of effective surgical quality assurance measures. The surgical community should enable implementation of agreed upon mitigating strategies to overcome challenges to surgical quality in oncology trials.
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http://dx.doi.org/10.1016/j.ejso.2020.10.002DOI Listing
April 2021

Definitive Chemoradiotherapy Compared to Neoadjuvant Chemoradiotherapy With Esophagectomy for Locoregional Esophageal Cancer: National Population-Based Cohort Study.

Ann Surg 2020 May 19. Epub 2020 May 19.

*Northern Oesophagogastric Unit, Royal Victoria Infirmary, Newcastle University Trust Hospitals, Newcastle-Upon-Tyne, United Kingdom †Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, Tyne and Wear, United Kingdom ‡School of Medical Education, Newcastle University, Newcastle upon Tyne, Tyne and Wear, United Kingdom §Department of Surgery & Cancer, Imperial College London, London, United Kingdom ¶Department of Thoracic Surgery, Virginia Mason Medical Center, Seattle, WA ||Department of Molecular Medicine & Surgery, Karolinska Institutet, Stockholm, Sweden.

Aim: Ongoing randomized controlled trials seek to evaluate the potential organ-preservation strategy of definitive chemoradiotherapy as a primary treatment for esophageal cancer. This population-based cohort study aimed to assess survival following definitive chemoradiotherapy (DCR) with or without salvage esophagectomy (SALV) in the treatment of esophageal cancer.

Patients And Methods: Data from the National Cancer Database (NCDB) from 2004 to 2015, was used to identify patients with nonmetastatic esophageal cancer receiving either DCR (n = 5977) or neoadjuvant chemoradiotherapy with planned esophagectomy (NCRS) (n = 13,555). Propensity score matching and multivariable analyses were used to account for treatment selection bias. Subset analyses compared patients receiving SALV after DCR with NCRS.

Results: Comparison of baseline demographics of the unmatched cohort revealed that patients receiving NCRS were younger, had a lower burden of medical comorbidities, lower proportion of squamous cell carcinoma (SCC), and more positive lymph nodes. Following matching, NCRS was associated with significantly improved survival compared with DCR [hazard ratio (HR): 0.60, 95% confidence Interval (CI): 0.57-0.63, P < 0.001], which persisted in subset analyses of patients with adenocarcinoma (HR: 0.60, 95% CI: 0.56-0.63, P < 0.001) and SCC (HR: 0.58, 95% CI: 0.53-0.63, P < 0.001). Of 829 receiving SALV after DCR, 823 patients were matched to 1643 NCRS. There was no difference in overall survival between SALV and NCRS (HR: 1.00, 95% CI: 0.90-1.11, P = 1.0).

Conclusions: Surgery remains an integral component of the management of patients with esophageal cancer. Neoadjuvant therapy followed by planned esophagectomy appears to remain the optimum curative treatment regime in patients with locoregional esophageal cancer.
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http://dx.doi.org/10.1097/SLA.0000000000003941DOI Listing
May 2020

Metabolic Biomarkers of Squamous Cell Carcinoma of the Aerodigestive Tract: A Systematic Review and Quality Assessment.

Oxid Med Cell Longev 2020 21;2020:2930347. Epub 2020 Feb 21.

Department of Surgery & Cancer, Imperial College London, London W2 1NY, UK.

Aerodigestive squamous cell carcinomas (ASCC) constitute a major source of global cancer deaths. Patients typically present with advanced, incurable disease, so new means of detecting early disease are a research priority. Metabolite quantitation is amenable to point-of-care analysis and can be performed in ASCC surrogates such as breath and saliva. The purpose of this systematic review is to summarise progress of ASCC metabolomic studies, with an emphasis on the critical appraisal of methodological quality and reporting.

Method: A systematic online literature search was performed to identify studies reporting metabolic biomarkers of ASCC. This review was conducted in accordance with the recommendations of the Cochrane Library and MOOSE guidelines.

Results: Thirty studies comprising 2117 patients were included in the review. All publications represented phase-I biomarker discovery studies, and none validated their findings in an independent cohort. There was heterogeneity in study design and methodological and reporting quality. Sensitivities and specificities were higher in oesophageal and head and neck squamous cell carcinomas compared to those in lung squamous cell carcinoma. The metabolic phenotypes of these cancers were similar, as was the kinetics of metabolite groups when comparing blood, tissue, and breath/saliva concentrations. Deregulation of amino acid metabolism was the most frequently reported theme.

Conclusion: Metabolite analysis has shown promising diagnostic performance, especially for oesophageal and head and neck ASCC subtypes, which are phenotypically similar. However, shortcomings in study design have led to inconsistencies between studies. To support future studies and ultimately clinical adoption, these limitations are discussed.
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http://dx.doi.org/10.1155/2020/2930347DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7330643PMC
May 2021

Assessment of Technical Skills in Axillary Lymph Node Dissection.

Ann Surg 2020 Jun 24. Epub 2020 Jun 24.

Department of Surgery and Cancer, Imperial College London, London, UK.

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.
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http://dx.doi.org/10.1097/SLA.0000000000003946DOI Listing
June 2020

Is Local Endoscopic Resection a Viable Therapeutic Option for Early Clinical Stage T1a and T1b Esophageal Adenocarcinoma?: A Propensity-Matched Analysis.

Ann Surg 2020 Jun 11. Epub 2020 Jun 11.

Department of Surgery & Cancer, Imperial College London, London, UK.

Objective: The aim of this study was to evaluate the outcome of endoscopic resection (ER) versus esophagectomy in node-negative cT1a and cT1b esophageal adenocarcinoma.

Summary Of Background Data: The role of ER in the management of subsets of clinical T1N0 esophageal adenocarcinoma is controversial.

Methods: Data from the National Cancer Database (2010-2015) were used to identify patients with clinical T1aN0 (n = 2545) and T1bN0 (n = 1281) esophageal adenocarcinoma that received either ER (cT1a, n = 1581; cT1b, n = 335) or esophagectomy (cT1a, n = 964; cT1b, n = 946). Propensity score matching and Cox analyses were used to account for treatment selection bias.

Results: ER for cT1a and cT1b disease was performed more commonly over time. The rates of node-positive disease in patients with cT1a and cT1b esophageal adenocarcinoma were 4% and 15%, respectively. In the matched cohort for cT1a cancers, ER had similar survival to esophagectomy [hazard ratio (HR): 0.85, 95% confidence interval (CI): 0.70-1.04, P = 0.1]. The corresponding 5-year survival for ER and esophagectomy were 70% and 74% (P = 0.1), respectively. For cT1b cancers, there was no statistically significant difference in overall survival between the treatment groups (HR: 0.87, 95% CI: 0.66-1.14, P = 0.3). The corresponding 5-year survival for ER and esophagectomy were 53% versus 61% (P = 0.3), respectively.

Conclusions: This study demonstrates ER has comparable long-term outcomes for clinical T1aN0 and T1bN0 esophageal adenocarcinoma. However, 15% of patients with cT1b esophageal cancer were found to have positive nodal disease. Future research should seek to identify the subset of T1b cancers at high risk of nodal metastasis and thus would benefit from esophagectomy with lymphadenectomy.
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http://dx.doi.org/10.1097/SLA.0000000000004038DOI Listing
June 2020

Protocol for LAsting Symptoms after Oesophageal Resectional Surgery (LASORS): multicentre validation cohort study.

BMJ Open 2020 06 3;10(6):e034897. Epub 2020 Jun 3.

Faculty of Medicine, Department of Surgery & Cancer, Imperial College, London, UK.

Introduction: Surgery is the primary curative treatment for oesophageal cancer, with considerable recent improvements in long-term survival. However, surgery has a long-lasting impact on patient's health-related quality of life (HRQOL). Through a multicentre European study, our research group was able to identify key symptoms that affect patient's HRQOL. These symptoms were combined to produce a tool to identify poor HRQOL following oesophagectomy (LAsting Symptoms after Oesophageal Resection (LASOR) tool). The objective of this multicentre study is to validate a six-symptom clinical tool to identify patients with poor HRQOL for use in everyday clinical practice.

Methods And Analysis: Included patients will: (1) be aged 18 years or older, (2) have undergone an oesophagectomy for cancer between 2015 and 2019, and (3) be at least 12 months after the completion of adjuvant oncological treatments. Patients will be given the previously created LASOR questionnaire. Each symptom from the LASOR questionnaire will be graded according to impact on quality of life and frequency of the symptom, with a composite score from 0 to 5. The previously developed LASOR symptom tool will be validated against HRQOL as measured by the European Organisation for Research and Treatment of Cancer QLQC30 and OG25.

Sample Size: With a predicted prevalence of poor HRQOL of 45%, based on the previously generated LASOR clinical symptom tool, to validate this tool with a sensitivity and specificity of 80%, respectively, a minimum of 640 patients will need to be recruited to the study.

Ethics And Dissemination: NHS Health Research Authority (North East-York Research Ethics Committee) approval was gained 8 November 2019 (REC reference 19/NE/0352). Multiple platforms will be used for the dissemination of the research data, including international clinical and patient group presentations and publication of research outputs in a high impact clinical journal.
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http://dx.doi.org/10.1136/bmjopen-2019-034897DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7279661PMC
June 2020

Implementation of Minimally Invasive Esophagectomy From a Randomized Controlled Trial Setting to National Practice.

J Clin Oncol 2020 07 18;38(19):2130-2139. Epub 2020 May 18.

Department of Surgery, Amsterdam University Medical Centers, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.

Purpose: The aim of this study was to examine the external validity of the randomized TIME trial, when minimally invasive esophagectomy (MIE) was implemented nationally in the Netherlands, using data from the Dutch Upper GI Cancer Audit (DUCA) for transthoracic esophagectomy.

Methods: Original patient data from the TIME trial were extracted along with data from the DUCA dataset (2011-2017). Multivariate analysis, with adjustment for patient factors, tumor factors, and year of surgery, was performed for the effect of MIE versus open esophagectomy on clinical outcomes.

Results: One hundred fifteen patients from the TIME trial (59 MIE 56 open) and 4,605 patients from the DUCA dataset (2,652 MIE 1,953 open) were included. In the TIME trial, univariate analysis showed that MIE reduced pulmonary complications and length of hospital stay. On the contrary, in the DUCA dataset, MIE was associated with increased total and pulmonary complications and reoperations; however, benefits included increased proportion of R0 margin and lymph nodes harvested, and reduced 30-day mortality. Multivariate analysis from the TIME trial showed that MIE reduced pulmonary complications (odds ratio [OR], 0.19; 95% CI, 0.06 to 0.61). In the DUCA dataset, MIE was associated with increased total complications (OR, 1.36; 95% CI, 1.19 to 1.57), pulmonary complications (OR, 1.50; 95% CI, 1.29 to 1.74), reoperations (OR, 1.74; 95% CI, 1.42 to 2.14), and length of hospital stay. Multivariate analysis of the combined and MIE datasets showed that inclusion in the TIME trial was associated with a reduction in reoperations, Clavien-Dindo grade > 1 complications, and length of hospital stay.

Conclusion: When adopted nationally outside the TIME trial, MIE was associated with an increase in total and pulmonary complications and reoperation rate. This may reflect nonexpert surgeons outside of high-volume centers performing this minimally invasive technique in a nonstandardized fashion outside of a controlled environment.
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http://dx.doi.org/10.1200/JCO.19.02483DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7325364PMC
July 2020

Lasting Symptoms After Esophageal Resection (LASER): European Multicenter Cross-sectional Study.

Ann Surg 2020 Nov 17. Epub 2020 Nov 17.

Department of Upper GI Surgery, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.

Objective: To identify the most prevalent symptoms and those with greatest impact upon health-related quality of life (HRQOL) among esophageal cancer survivors.

Background: Long-term symptom burden after esophagectomy, and associations with HRQOL, are poorly understood.

Patients And Methods: Between 2010 and 2016, patients from 20 European Centers who underwent esophageal cancer surgery, and were disease-free at least 1 year postoperatively were asked to complete LASER, EORTC-QLQ-C30, and QLQ-OG25 questionnaires. Specific symptom questionnaire items that were associated with poor HRQOL as identified by EORTC QLQ-C30 and QLQ-OG25 were identified by multivariable regression analysis and combined to form a tool.

Results: A total of 876 of 1081 invited patients responded to the questionnaire, giving a response rate of 81%. Of these, 66.9% stated in the last 6 months they had symptoms associated with their esophagectomy. Ongoing weight loss was reported by 10.4% of patients, and only 13.8% returned to work with the same activities.Three LASER symptoms were correlated with poor HRQOL on multivariable analysis; pain on scars on chest (odds ratio (OR) 1.27; 95% CI 0.97-1.65), low mood (OR 1.42; 95% CI 1.15-1.77) and reduced energy or activity tolerance (OR 1.37; 95% CI 1.18-1.59). The areas under the curves for the development and validation datasets were 0.81 ± 0.02 and 0.82 ± 0.09 respectively.

Conclusion: Two-thirds of patients experience significant symptoms more than 1 year after surgery. The 3 key symptoms associated with poor HRQOL identified in this study should be further validated, and could be used in clinical practice to identify patients who require increased support.
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http://dx.doi.org/10.1097/SLA.0000000000003917DOI Listing
November 2020

Association of Surgical Skill Assessment With Clinical Outcomes in Cancer Surgery.

JAMA Surg 2020 07;155(7):590-598

Department of General Surgery, Yeovil District Hospital National Health Service Foundation Trust, Yeovil, England.

Importance: Complex surgical interventions are inherently prone to variation yet they are not objectively measured. The reasons for outcome differences following cancer surgery are unclear.

Objective: To quantify surgical skill within advanced laparoscopic procedures and its association with histopathological and clinical outcomes.

Design, Setting, And Participants: This analysis of data and video from the Australasian Laparoscopic Cancer of Rectum (ALaCaRT) and 2-dimensional/3-dimensional (2D3D) multicenter randomized laparoscopic total mesorectal excision trials, which were conducted at 28 centers in Australia, the United Kingdom, and New Zealand, was performed from 2018 to 2019 and included 176 patients with clinical T1 to T3 rectal adenocarcinoma 15 cm or less from the anal verge. Case videos underwent blinded objective analysis using a bespoke performance assessment tool developed with a 62-international expert Delphi exercise and workshop, interview, and pilot phases.

Interventions: Laparoscopic total mesorectal excision undertaken with curative intent by 34 credentialed surgeons.

Main Outcomes And Measures: Histopathological (plane of mesorectal dissection, ALaCaRT composite end point success [mesorectal fascial plane, circumferential margin, ≥1 mm; distal margin, ≥1 mm]) and 30-day morbidity. End points were analyzed using surgeon quartiles defined by tool scores.

Results: The laparoscopic total mesorectal excision performance tool was produced and shown to be reliable and valid for the specialist level (intraclass correlation coefficient, 0.889; 95% CI, 0.832-0.926; P < .001). A substantial variation in tool scores was recorded (range, 25-48). Scores were associated with the number of intraoperative errors, plane of mesorectal dissection, and short-term patient morbidity, including the number and severity of complications. Upper quartile-scoring surgeons obtained excellent results compared with the lower quartile (mesorectal fascial plane: 93% vs 59%; number needed to treat [NNT], 2.9, P = .002; ALaCaRT end point success, 83% vs 58%; NNT, 4; P = .03; 30-day morbidity, 23% vs 50%; NNT, 3.7; P = .03).

Conclusions And Relevance: Intraoperative surgical skill can be objectively and reliably measured in complex cancer interventions. Substantial variation in technical performance among credentialed surgeons is seen and significantly associated with clinical and pathological outcomes.
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http://dx.doi.org/10.1001/jamasurg.2020.1004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7203671PMC
July 2020

Lipogenesis Alters the Phospholipidome of Esophageal Adenocarcinoma.

Cancer Res 2020 07 28;80(13):2764-2774. Epub 2020 Apr 28.

Department of Surgery and Cancer, Imperial College London, London, United Kingdom.

The incidence of esophageal adenocarcinoma is rising, survival remains poor, and new tools to improve early diagnosis and precise treatment are needed. Cancer phospholipidomes quantified with mass spectrometry imaging (MSI) can support objective diagnosis in minutes using a routine frozen tissue section. However, whether MSI can objectively identify primary esophageal adenocarcinoma is currently unknown and represents a significant challenge, as this microenvironment is complex with phenotypically similar tissue-types. Here, we used desorption electrospray ionization-MSI (DESI-MSI) and bespoke chemometrics to assess the phospholipidomes of esophageal adenocarcinoma and relevant control tissues. Multivariate models derived from phospholipid profiles of 117 patients were highly discriminant for esophageal adenocarcinoma both in discovery (AUC = 0.97) and validation cohorts (AUC = 1). Among many other changes, esophageal adenocarcinoma samples were markedly enriched for polyunsaturated phosphatidylglycerols with longer acyl chains, with stepwise enrichment in premalignant tissues. Expression of fatty acid and glycerophospholipid synthesis genes was significantly upregulated, and characteristics of fatty acid acyls matched glycerophospholipid acyls. Mechanistically, silencing the carbon switch in esophageal adenocarcinoma cells shortened glycerophospholipid chains, linking lipogenesis to the phospholipidome. Thus, DESI-MSI can objectively identify invasive esophageal adenocarcinoma from a number of premalignant tissues and unveils mechanisms of phospholipidomic reprogramming. SIGNIFICANCE: These results call for accelerated diagnosis studies using DESI-MSI in the upper gastrointestinal endoscopy suite, as well as functional studies to determine how polyunsaturated phosphatidylglycerols contribute to esophageal carcinogenesis.
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http://dx.doi.org/10.1158/0008-5472.CAN-19-4035DOI Listing
July 2020

The effect of time between procedures upon the proficiency gain period for minimally invasive esophagectomy.

Surg Endosc 2020 06 20;34(6):2703-2708. Epub 2020 Apr 20.

Division of Surgery, Department Surgery & Cancer, Imperial College London, 10th Floor QEQM Building, London, UK.

Background: Complex surgical procedures including minimally invasive esophagectomy (MIE) are commonly associated with a period of proficiency gain. We aim to study the effect of reduced procedural interval upon the number of cases required to gain proficiency and adverse patient outcomes during this period from MIE.

Methods: All adult patients undergoing MIE for esophageal cancer in England from 2002 to 2012 were identified from Hospital Episode Statistics database. Outcomes evaluated included conversion rate from MIE to open esophagectomy, 30-day re-intervention, 30-day and 90-day mortality. Regression models investigated relationships between procedural interval and the number of cases and clinical outcomes during proficiency gain period.

Results: The MIE dataset comprised of 1696 patents in total, with procedures carried out by 148 surgeons. Thresholds for procedural interval extracted from change-point modeling were found to be 60 days for conversion, 80 days for 30-day re-intervention, 80 days for 30-day mortality and 110 days for 90-day mortality. Procedural interval of MIEs did not influence the number of cases required for proficiency gain. However, reduced MIE procedural interval was associated with significant reductions in conversions (0.16 vs. 0.07; P < 0.001), re-interventions (0.15 vs. 0.09; P < 0.01), 30-day (0.12 vs. 0.05; P < 0.01) and 90-day (0.14 vs. 0.06; P < 0.01) mortality during the period of proficiency gain.

Conclusions: This national study has demonstrated that the introduction of MIE is associated with a period of proficiency gain and adverse patient outcomes. The absolute effect of this period of proficiency gain upon patient morbidity and mortality may be reduced by reduced procedural interval of MIE practice within specialized esophageal cancer centers.
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http://dx.doi.org/10.1007/s00464-019-06692-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7214481PMC
June 2020

Assessment of chest wall movement following thoracotomy: a systematic review.

J Thorac Dis 2020 Mar;12(3):1031-1040

Department of Surgery and Cancer, Imperial College London, London, UK.

Thoracotomy is a major cause of respiratory impairment, increasing the risk of postoperative pulmonary complications (PPC). Systems assessing ribcage kinematics may detect changes in chest expansion following thoracotomy and may thus aid in the development of patient-tailored chest physiotherapy. Hence, we aimed to identify studies assessing changes in chest wall movement following thoracotomy using objective measures. The Cochrane library, MEDLINE, EMBASE, Scopus and Web of Science databases were searched to find relevant articles providing an objective assessment of chest wall movement following thoracotomy. Methodological quality of included studies concerning chest wall movement following thoracotomy was assessed by use of QUADAS-2 tool. A total of 12 articles were included for the assessment of chest wall changes following thoracotomy using objective measures. Four studies measured changes in the cross-sectional area of the ribcage and abdomen using the respiratory inductive plethysmography (RIP), 1 study computed the chest wall compliance by monitoring the intra-pleural pressure, 3 studies measured changes in chest circumference with a simple tape measure and 4 articles performed a compartmental analysis of the chest wall volume by means of an optoelectronic plethysmography (OEP). There was no delay in the collection of data of the index test and reference standard, resulting in a low risk of bias for the flow and timing domain. Across all studies, participants underwent the same reference standard, resulting in a low risk of verification bias. Several objective measures were able to detect changes in chest wall displacement following thoracotomy and differed in the practical use and invasive nature. OEP allows a compartmental analysis of the chest wall volume. Hence, this system allows to assess chest wall movement changes following thoracotomy and the impact of different types of surgical approach. Furthermore, it could aid in the development of tailored physiotherapy.
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http://dx.doi.org/10.21037/jtd.2019.12.93DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7139064PMC
March 2020

Development of a Reliable Surgical Quality Assurance System for 2-stage Esophagectomy in Randomized Controlled Trials.

Ann Surg 2020 Mar 27. Epub 2020 Mar 27.

Department of Surgery & Cancer, Imperial College London, United Kingdom.

Objective: The aim was to develop a reliable surgical quality assurance system for 2-stage esophagectomy. This development was conducted during the pilot phase of the multicenter ROMIO trial, collaborating with international experts.

Summary Of Background Data: There is evidence that the quality of surgical performance in randomized controlled trials influences clinical outcomes, quality of lymphadenectomy and loco-regional recurrence.

Methods: Standardization of 2-stage esophagectomy was based on structured observations, semi-structured interviews, hierarchical task analysis, and a Delphi consensus process. This standardization provided the structure for the operation manual and video and photographic assessment tools. Reliability was examined using generalizability theory.

Results: Hierarchical task analysis for 2-stage esophagectomy comprised fifty-four steps. Consensus (75%) agreement was reached on thirty-nine steps, whereas fifteen steps had a majority decision. An operation manual and record were created. A thirty five-item video assessment tool was developed that assessed the process (safety and efficiency) and quality of the end product (anatomy exposed and lymphadenectomy performed) of the operation. The quality of the end product section was used as a twenty seven-item photographic assessment tool. Thirty-one videos and fifty-three photographic series were submitted from the ROMIO pilot phase for assessment. The overall G-coefficient for the video assessment tool was 0.744, and for the photographic assessment tool was 0.700.

Conclusions: A reliable surgical quality assurance system for 2-stage esophagectomy has been developed for surgical oncology randomized controlled trials.

Ethical Approval: 11/NW/0895 and confirmed locally as appropriate, 12/SW/0161, 16/SW/0098.

Trial Registration Number: ISRCTN59036820, ISRCTN10386621.
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http://dx.doi.org/10.1097/SLA.0000000000003850DOI Listing
March 2020
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