Clinical practice, decision-making, and use of clinical decision support systems in invasive mechanical ventilation: a narrative review.

Invasive mechanical ventilation is a key supportive therapy for patients on intensive care. There is increasing emphasis on personalised ventilation strategies. Clinical decision support systems (CDSS) have been developed to support this. We conducted a narrative review to assess evidence that could inform device implementation. A search was conducted in MEDLINE (Ovid) and EMBASE. Twenty-nine studies met the inclusion criteria. Role allocation is well described, with interprofessional collaboration dependent on culture, nurse:patient ratio, the use of protocols, and perception of responsibility. There were no descriptions of process measures, quality metrics, or clinical workflow. Nurse-led weaning is well-described, with factors grouped by patient, nurse, and system. Physician-led weaning is heterogenous, guided by subjective and objective information, and 'gestalt'. No studies explored decision-making with CDSS. Several explored facilitators and barriers to implementation, grouped by clinician (facilitators: confidence using CDSS, retaining decision-making ownership; barriers: undermining clinician's role, ambiguity moving off protocol), intervention (facilitators: user-friendly interface, ease of workflow integration, minimal training requirement; barriers: increased documentation time), and organisation (facilitators: system-level mandate; barriers: poor communication, inconsistent training, lack of technical support). One study described factors that support CDSS implementation. There are gaps in our understanding of ventilation practice. A coordinated approach grounded in implementation science is required to support CDSS implementation. Future research should describe factors that guide clinical decision-making throughout mechanical ventilation, with and without CDSS, map clinical workflow, and devise implementation toolkits. Novel research design analogous to a learning organisation, that considers the commercial aspects of device design, is required.

The Biomarker Toolkit - an evidence-based guideline to predict cancer biomarker success and guide development.

BACKGROUND: An increased number of resources are allocated on cancer biomarker discovery, but very few of these biomarkers are clinically adopted. To bridge the gap between Biomarker discovery and clinical use, we aim to generate the Biomarker Toolkit, a tool designed to identify clinically promising biomarkers and promote successful biomarker translation. METHODS: All features associated with a clinically useful biomarker were identified using mixed-methodology, including systematic literature search, semi-structured interviews, and an online two-stage Delphi-Survey. Validation of the checklist was achieved by independent systematic literature searches using keywords/subheadings related to clinically and non-clinically utilised breast and colorectal cancer biomarkers. Composite aggregated scores were generated for each selected publication based on the presence/absence of an attribute listed in the Biomarker Toolkit checklist. RESULTS: Systematic literature search identified 129 attributes associated with a clinically useful biomarker. These were grouped in four main categories including: rationale, clinical utility, analytical validity, and clinical validity. This checklist was subsequently developed using semi-structured interviews with biomarker experts (n=34); and 88.23% agreement was achieved regarding the identified attributes, via the Delphi survey (consensus level:75%, n=51). Quantitative validation was completed using clinically and non-clinically implemented breast and colorectal cancer biomarkers. Cox-regression analysis suggested that total score is a significant driver of biomarker success in both cancer types (BC: p>0.0001, 95.0% CI: 0.869-0.935, CRC: p>0.0001, 95.0% CI: 0.918-0.954). CONCLUSIONS: This novel study generated a validated checklist with literature-reported attributes linked with successful biomarker implementation. Ultimately, the application of this toolkit can be used to detect biomarkers with the highest clinical potential and shape how biomarker studies are designed/performed.

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

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.

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

OBJECTIVE: To examine the impact of The National Training Program for Lapco on the rate of laparoscopic surgery and clinical outcomes of cases performed by Lapco surgeons after completion of training. SUMMARY OF 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: One hundred eight Lapco delegates performed 4586 elective colo-rectal resections pre-Lapco and 5115 post-Lapco while non-Lapco surgeons performed 72,930 matched cases. Lapco delegates had a 37.8% increase in laparoscopic surgery which was greater than non-Lapco surgeons by 20.9% [95% confidence interval (CI), 18.5-23.3, 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.

Tablet and web-based audiometry to screen for hearing loss in adults with cystic fibrosis.

INTRODUCTION: Individuals with chronic lung disease (eg, cystic fibrosis (CF)) often receive antimicrobial therapy including aminoglycosides resulting in ototoxicity. Extended high-frequency audiometry has increased sensitivity for ototoxicity detection, but diagnostic audiometry in a sound-booth is costly, time-consuming and requires a trained audiologist. This cross-sectional study analysed tablet-based audiometry (Shoebox MD) performed by non-audiologists in an outpatient setting, alongside home web-based audiometry (3D Tune-In) to screen for hearing loss in adults with CF. METHODS: Hearing was analysed in 126 CF adults using validated questionnaires, a web self-hearing test (0.5 to 4 kHz), tablet (0.25 to 12 kHz) and sound-booth audiometry (0.25 to 12 kHz). A threshold of ≥25 dB hearing loss at ≥1 audiometric frequency was considered abnormal. Demographics and mitochondrial DNA sequencing were used to analyse risk factors, and accuracy and usability of hearing tests determined. RESULTS: Prevalence of hearing loss within any frequency band tested was 48%. Multivariate analysis showed age (OR 1.127; (95% CI: 1.07 to 1.18; p value<0.0001) per year older) and total intravenous antibiotic days over 10 years (OR 1.006; (95% CI: 1.002 to 1.010; p value=0.004) per further intravenous day) were significantly associated with increased risk of hearing loss. Tablet audiometry had good usability, was 93% sensitive, 88% specific with 94% negative predictive value to screen for hearing loss compared with web self-test audiometry and questionnaires which had poor sensitivity (17% and 13%, respectively). Intraclass correlation (ICC) of tablet versus sound-booth audiometry showed high correlation (ICC >0.9) at all frequencies ≥4 kHz. CONCLUSIONS: Adults with CF have a high prevalence of drug-related hearing loss and tablet-based audiometry can be a practical, accurate screening tool within integrated ototoxicity monitoring programmes for early detection.

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

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.

Development of the Point-of-Care Key Evidence Tool (POCKET): a checklist for multi-dimensional evidence generation in point-of-care tests.

Background This study aimed to develop the Point-of-Care Key Evidence Tool (POCKET); a multi-dimensional checklist to guide the evaluation of point-of-care tests (POCTs) incorporating validity, utility, usability, cost-effectiveness and patient experience. The motivation for this was to improve the efficiency of evidence generation in POCTs and reduce the lead-time for the adoption of novel POCTs. Methods A mixed qualitative and quantitative approach was applied. Following a literature search, a three round Delphi process was undertaken incorporating a semi-structured interview study and two questionnaire rounds. Participants included clinicians, laboratory personnel, commissioners, regulators (including members of National Institute for Health and Care Excellence [NICE] committees), patients, industry representatives and methodologists. Qualitative data were analysed based on grounded theory. The final tool was revised at an expert stakeholder workshop. Results Forty-three participants were interviewed within the semi-structured interview study, 32 participated in the questionnaire rounds and nine stakeholders attended the expert workshop. The final version of the POCKET checklist contains 65 different evidence requirements grouped into seven themes. Face validity, content validity and usability has been demonstrated. There exists a shortfall in the evidence that industry and research methodologists believe should be generated regarding POCTs and what is actually required by policy and decision makers to promote implementation into current healthcare pathways. Conclusions This study has led to the development of POCKET, a checklist for evidence generation and synthesis in POCTs. This aims to guide industry and researchers to the evidence that is required by decision makers to facilitate POCT adoption so that the benefits they can bring to patients can be effectively realised.

The influence of procedural volume and proficiency gain on mortality from upper GI endoscopic mucosal resection.

OBJECTIVE: Endoscopic mucosal resection (EMR) is established for the management of benign and early malignant upper GI disease. The aim of this observational study was to establish the effect of endoscopist procedural volume on mortality. DESIGN: Patients undergoing upper GI EMR between 1997 and 2012 were identified from the Hospital Episode Statistics database. The primary outcome was 30-day mortality and secondary outcomes were 90-day mortality, requirement for emergency intervention and elective cancer re-intervention. Risk-adjusted cumulative sum (RA-CUSUM) analysis was used to assess patient mortality risk during initial stage of endoscopist proficiency gain and the effect of endoscopist and hospital volume. Mortality was compared before and after the change point or threshold in the RA-CUSUM curve. RESULTS: 11 051 patients underwent upper GI EMR. Endoscopist procedure volume was an independent predictor of 30-day mortality. Fifty-eight per cent of EMR procedures were performed by endoscopists with annual volume of 2 cases or less, and had a higher 30-day and 90-day mortality rate for patients with cancer, 6.1% vs 0.4% (p<0.001) and 12% vs 2.1% (p<0.001), respectively. The requirement for emergency intervention after EMR for cancer was also greater with low volume endoscopists (1.8% vs 0.1%, p=0.002). In patients with cancer, the RA-CUSUM curve change points for 30-day mortality and elective re-intervention were 4 cases and 43 cases, respectively. CONCLUSIONS: EMR performed by high volume endoscopists is associated with reduced adverse outcomes. In order to reach proficiency, appropriate training and procedural volume accreditation training programmes are needed nationally.

Use of Tumor Markers in Gastrointestinal Cancers: Surgeon Perceptions and Cost-Benefit Trade-Off Analysis.

BACKGROUND: Gastrointestinal cancers constitute the third most common cancers worldwide. Tumor markers have long since been used in the postoperative surveillance of these malignancies; however, the true value in clinical practice remains undetermined. OBJECTIVE: This study aimed to evaluate the clinical utility of three tumor markers in colorectal and esophagogastric cancer. METHODS: A systematic review of the literature was undertaken to elicit the sensitivity, specificity, statistical heterogeneity and ability to predict recurrence and metastases for carcinoembryonic antigen (CEA), cancer antigen (CA) 19-9 and CA125. European surgeons were surveyed to assess their current practice and the characteristics of tumor markers they most valued. Data from the included studies and survey were combined in a cost-benefit trade-off analysis to assess which tumor markers are of most use in clinical practice. RESULTS: Diagnostic sensitivity and specificity were ranked the most desirable characteristics of a tumor marker by those surveyed. Overall, 156 studies were included to inform the cost-benefit trade-off. The cost-benefit trade-off showed that CEA outperformed both CA19-9 and CA125, with lower financial cost and a higher sensitivity, and diagnostic accuracy for metastases at presentation (area under the curve [AUC] 0.70 vs. 0.61 vs. 0.46), as well as similar diagnostic accuracy for recurrence (AUC 0.46 vs. 0.48). CONCLUSIONS: Cost-benefit trade-off analysis identified CEA to be the best performing tumor marker. Further studies should seek to evaluate new tumor markers, with investigation tailored to factors that meet the requirements of practicing clinicians.

Biomarkers of acute appendicitis: systematic review and cost-benefit trade-off analysis.

BACKGROUND: Acute appendicitis is the most common surgical emergency and can represent a challenging diagnosis, with a negative appendectomy rate as high as 20 %. This review aimed to evaluate the clinical utility of individual biomarkers in the diagnosis of appendicitis and appraise the quality of these studies. METHODS: A systematic review of the literature between January 2000 and September 2015 using of PubMed, OvidMedline, EMBASE and Google Scholar was conducted. Studies in which the diagnostic accuracy, statistical heterogeneity and predictive ability for severity of several biomarkers could be elicited were included. Information regarding costs and process times was retrieved from the regional laboratory. European surgeons blinded to these reviews were independently asked to rank which characteristics of biomarkers were most important in acute appendicitis to inform a cost-benefit trade-off. Sensitivity testing and the QUADAS-2 tool were used to assess the robustness of the analysis and study quality, respectively. RESULTS: Sixty-two studies met the inclusion criteria and were assessed. Traditional biomarkers (such as white cell count) were found to have a moderate diagnostic accuracy (0.75) but lower costs in the diagnosis of acute appendicitis. Conversely, novel markers (pro-calcitonin, IL 6 and urinary 5-HIAA) were found to have high process-related costs including analytical times, but improved diagnostic accuracy. QUADAS-2 analysis revealed significant potential biases in the literature. CONCLUSION: When assessing biomarkers, an appreciation of the trade-offs between the costs and benefits of individual biomarkers is needed. Further studies should seek to investigate new biomarkers and address concerns over bias, in order to improve the diagnosis of acute appendicitis.

What errors make a laparoscopic cancer surgery unsafe? An ad hoc analysis of competency assessment in the National Training Programme for laparoscopic colorectal surgery in England.

BACKGROUND: The National Training Programme for laparoscopic colorectal surgery in England was implemented to ensure training was supervised, structured, safe and effective. Delegates were required to pass a competency assessment (sign-off) before undertaking independent practice. This study described the types of errors identified and associated these errors with competency to progress to independent laparoscopic colorectal practice. METHODS: All sign-off submissions from the start of the process in January 2008 until July 2013 were included. Content analysis was used to categorise errors. Bayes factor (BF) was used to measure the impact of individual error on assessment outcome. A smaller BF indicates that an error has stronger associations with unsuccessful assessments. Bayesian network was employed to graphically represent the reasoning process whereby the chance of successful assessment diminished with the identification of each error. Quality of the error feedback was measured by the area under the ROC curve which linked the predictions from the Bayesian model to the expert verdict. RESULTS: Among 370 assessments analysed, 240 passed and 130 failed. On average, 2.5 different types of error were identified in each assessment. Cases that were more likely to fail had three or more different types of error (χ(2) = 72, p < 0.0001) and demonstrated poorer technical skills (CAT score <2.7, χ(2) = 164, p < 0.0001). Case complexity or right- versus left-sided resection did not have a significant impact. Errors associated with dissection (BF = 0.18), anastomosis (BF = 0.23) and oncological quality (BF = 0.19) were critical determinants of surgical competence, each reducing the odds of pass by at least fourfold. The area under the ROC curve was 0.84. CONCLUSIONS: Errors associated with dissection, anastomosis and oncological quality were critical determinants of surgical competency. The detailed error analysis reported in this study can guide the design of future surgical education and clinical training programmes.

Laparoscopic repair of hiatus hernia: Does mesh type influence outcome? A meta-analysis and European survey study.

BACKGROUND: Synthetic mesh (SM) has been used in the laparoscopic repair of hiatus hernia but remains controversial due to reports of complications, most notably esophageal erosion. Biological mesh (BM) has been proposed as an alternative to mitigate this risk. The aim of this study is to establish the incidence of complications, recurrence and revision surgery in patients following suture (SR), SM or BM repair and undertake a survey of surgeons to establish a perspective of current practice. METHODS: An electronic search of EMBASE, MEDLINE and Cochrane database was performed. Pooled odds ratios (PORs) were calculated for discrete variables. To survey current practice an online questionnaire was sent to emails registered to the European Association for Endoscopic Surgery. RESULTS: Nine studies were included, comprising 676 patients (310 with SR, 214 with SM and 152 with BM). There was no significant difference in the incidence of complications with mesh compared to SR (P = 0.993). Mesh significantly reduced overall recurrence rates compared to SR [14.5 vs. 24.5 %; POR = 0.36 (95 % CI 0.17-0.77); P = 0.009]. Overall recurrence rates were reduced in the SM compared to BM groups (12.6 vs. 17.1 %), and similarly compared to the SR group, the POR for recurrence was lower in the SM group than the BM group [0.30 (95 % CI 0.12-0.73); P = 0.008 vs. 0.69 (95 % CI 0.26-1.83); P = 0.457]. Regarding surgical technique 503 survey responses were included. Mesh reinforcement of the crura was undertaken by 67 % of surgeons in all or selected cases with 67 % of these preferring synthetic mesh to absorbable mesh. One-fifth of the respondents had encountered mesh erosion in their career. CONCLUSIONS: Both SM and BM reduce rates of recurrence compared to SR, with SM proving most effective. Surgical practice is varied, and there remains insufficient evidence regarding the optimum technique for the repair of hiatal hernia.

Assessment of the quality of surgery within randomised controlled trials for the treatment of gastro-oesophageal cancer: a systematic review.

Multicentre, randomised, controlled trials (RCTs) provide level 1 evidence for surgery in the treatment of gastro-oesophageal cancer. This systematic review investigated whether standardisation of surgical techniques in RCTs reduces the variation in lymph-node harvest, in-hospital mortality, and locoregional cancer recurrence. The range in the coefficients of variation for lymph-node harvest (0.07-0.61), proportion of patients with locoregional cancer recurrence (1.1-46.2%), and in-hospital mortality (0-10%) was wide. Credentialing of surgeons through assessment of operative reports and monitoring of their performance through data collection were important factors that reduced the variation in lymph-node harvest. Factors that reduced adjusted in-hospital mortality included credentialing surgeons through procedural volume and operative reports, and standardisation of surgical techniques. Future RCTs should include an assessment of surgical performance as an important aspect of study design to reduce variation in clinical outcomes.

Risk prediction score in laparoscopic colorectal surgery training: experience from the English National Training Program.

OBJECTIVE: The overall aim was to develop and validate a risk prediction score for laparoscopic colorectal surgery training cases. BACKGROUND: Published risk prediction scores are not transferable between hospitals because they are derived from a single institution's data and are not designed for use in training situations. METHODS: Cases from the prospectively collected database of the National Training Programme in Laparoscopic Colorectal Surgery, between July 2008 and July 2012, were analyzed. Independent risk factors for conversion were identified by the logistic regression. Converting the odds ratios into integers created a risk prediction score for conversion. The clinical impact of this score was investigated by comparing postoperative complications and the level of trainer input in high- and low-risk cases. To study whether adverse outcomes in predicted high-risk cases occur outside the National Training Programme in Laparoscopic Colorectal Surgery, 2 external data sets were examined. RESULTS: A total of 2341 cases carried out in 42 hospitals were analyzed. Significant risk factors for conversion were body mass index, American Society of Anesthesiology classification, male sex, prior abdominal surgery, and resection type. At a risk score of more than 6, complication rates increased, including mortality (2.9% vs 0.5%, P < 0.001), anastomotic leak (4.3% vs 1.4%, P = 0.002), and a higher level of trainer input (32.2% vs 19.9% of cases, P < 0.001). Analysis of 786 external cases showed that high-risk cases had higher conversion (18.8% vs 7.1%, P < 0.001), overall complication (36.4% vs 15.0%, P < 0.001), and leak rates (4.0% vs 1.3%, P = 0.015). CONCLUSIONS: A risk predication score to facilitate case selection in laparoscopic colorectal surgery training was developed and validated.

Is competency assessment at the specialist level achievable? A study for the national training programme in laparoscopic colorectal surgery in England.

OBJECTIVES: To develop, validate, and implement a competency assessment tool (CAT) for technical surgical performance in the context of a summative assessment process for the National Training Programme in Laparoscopic Colorectal Surgery (NTP). BACKGROUND: The NTP is an educational initiative by the National Cancer Action Team in England to safely increase the uptake of laparoscopic colorectal surgery. It is the first competency-based national educational initiative for specialist surgeons (consultants), and performance assessment is an integral part of the program. METHODS: Content validity was sought using expert opinion by semistructured interviews and the Delphi method. For validity and reliability studies, NTP apprentices and experts were asked to submit video-recorded cases. Construct validity was established between delegates who passed the assessment and those who failed. Concurrent validity was tested by comparing scores with error counts as identified by observational clinical human reliability analysis. A fully crossed design, using generalizability theory methods and D-studies, was used for reliability. FINDINGS: Interviews and the Delphi method revealed a list of characteristics for assessment. A hybrid structure combining task-specific and generic items was used to include important characteristics into the assessment format. Fifty-four cases were submitted. Overall reliability reached G(ACI) = 0.803 when using 2 cases and 2 assessors. Experts scored significantly better than apprentices (3.19 vs 2.60; P = 0.004), and apprentices who passed had better scores than those who failed (2.95 vs 2.28; P < 0.001). There was an inverse correlation between CAT scores and observational clinical human reliability analysis error counts (ρ = -0.520, P < 0.001). The combination of both methods reached overall sensitivity of 100%, specificity of 83.3%, a positive predictive value of 93.8%, and a negative predictive value of 100%. CONCLUSIONS: The CAT can reliably assess technical performance in laparoscopic colorectal surgery. The use of CATs to judge specialist technical performance before embarking on independent practice of new procedures is achievable on a national scale and can be adapted by other specialties.

Improving the standard of lymph node retrieval after gastric cancer surgery.

AIMS: To examine factors that influence lymph node count and to study the relationship between nodal size and metastatic involvement in gastric cancer. METHODS AND RESULTS: Observational study comparing lymph node retrieval by manual nodal dissection (MND) and systematic fat blocking (SFB) from 114 gastrectomy specimens. The influence of lymph node retrieval method, patient characteristics, oncological factors and surgical approach on lymph node count were examined using regression models. The risk-adjusted cumulative sum chart method was also used to analyse lymph node count. The lymph node count increased during the course of this study (P < 0.005). Both pathologist and lymph node retrieval method were independent predictors for lymph node count. MND yielded lower lymph node counts than SFB (58 versus 66, P < 0.05). The pathologist influenced lymph node retrieval by MND (R(2) : 0.297-0.518, P < 0.0001), but not SFB (R(2) : 0.340-0.344, P > 0.05). The percentage of positive lymph nodes below 5 mm was 24.2% and 44.1% for MND and SFB, respectively, resulting in cancer upstaging (P = 0.037). CONCLUSIONS: Systematic fat blocking is associated with a higher total and positive lymph node yield compared to MND and is independent of the pathologist. Ignoring small lymph nodes can be a major cause for missing positive nodes, leading in turn to cancer down-staging.

Clinical and educational proficiency gain of supervised laparoscopic colorectal surgical trainees.

BACKGROUND: The self-taught learning curve in laparoscopic colorectal surgery (LCS) is between 100 and 150 cases. Supervised training has been shown to shorten the proficiency gain curve of senior specialist surgeons. Little is known about the learning curve of LCS trainees undergoing mentored training. The aim of this study was to analyze the proficiency gain curve and clinical outcomes of English surgical trainees during laparoscopic colorectal surgery fellowships. METHODS: In 2010 the educational, Web-based platform from the National Training Program in Laparoscopic Colorectal Surgery in England was newly available to surgical trainees undertaking a laparoscopic colorectal fellowship. These fellows were asked to submit clinical outcomes, including patient demographics and case specifications. In addition, self-perceived performance was evaluated using a validated task-specific self-assessment form [global assessment scale (GAS) range 1-6]. Proficiency gain curves and learning rates were evaluated using risk-adjusted (RA) cumulative sum (CUSUM) curves. RESULTS: Of 654 cases 608 were included for analysis. The clinical outcomes included 9.2 % conversions, 16.9 % complications, 4 % reoperations, 2.6 % readmissions and a 0.8 % in-hospital mortality rate. RA CUSUM curves for complications and reoperation do not show a learning effect. However, the RA CUSUM curve for conversion has an inflection point at 24 cases. The GAS CUSUM curves for 'setup' and 'exposure' have inflection points at case 15 and case 29 respectively. The curves for 'mobilization of colon,' 'vascular pedicle' and 'anastomosis' plateau towards the end of the training period. 'Flexure' and 'mesorectum' do not of reach a plateau by case 40. CONCLUSIONS: Supervised fellowships provide training in LCS without compromising patient safety. Forty cases are required for the fellows to feel confident to perform the majority of tasks except dissection of the mesorectum and flexure, which will require further training.

Development and validation of Medical Device Key Evidence Tool ('MeDKET'): An evidence-based framework to explain success in selected European and US companies.

Innovating in Medical Device (MD) industry is challenging. This study aims to develop and validate an evidence-based framework that helps innovators of small and large enterprises (SEs and LEs) assess their readiness for successful MD development and deployment. We conducted a key-informant process (stage 1) where 25 international experts identified a list of emergent Health Technology Assessment (HTA) themes they believed were essential to company success. A sample of 22 European and US selected companies (13 SEs and 9 LEs) then reached a consensus on a list of key themes through a robust Delphi process (stage 2). Finally, we constructed (stage 3) and validated (stage 4) the checklist for SEs and LEs. The checklist for SEs and LEs included 21 and 15 items (i.e., fundamental Yes/No questions) with nine overlapping criteria for both SEs and LEs. In both groups, MD success was driven by three major item categories: (i) R&D assessment strategy; (ii) device-outcome measures; (iii) company profiling. Alongside the retrospective validation study, we collected 40 case studies on MDs (23 successes and 17 failures) across the selected enterprises. The retrospective validation provided the proportion of successful and failed case studies that met the 'MeDKET' criteria. We discovered that early HTA plays a pivotal role in MD industry success with different implications based on enterprise size. This study is the first of its kind to provide a holistic picture of the perceived role of early-stage HTA in MD industry success.

Pathway map development for medical device event reporting in operating theatres: a human factors approach to improving the existing system.

Objectives: This study aimed to develop the actual pathway to reporting and information transfer in operating theatres in relation to medical technology malfunction/failure. This with the aim of understanding the differences with the pathway published by NHS Improvement and identification of points for improvement. Design: This is a qualitative study involving stakeholder interviews with doctors, nurses, manufacturers, medical device safety officer and Medicines and Healthcare products Regulatory Agency. Setting: Data were collected on reporting pathway used in operating theatres. Clinical staff who took part worked in different trusts throughout UK while manufacturers provided devices in UK and EU/USA. Participants: Semistructured interviews were completed with 15 clinicians and 13 manufacturers. Surveys were completed by 38 clinicians and 5 manufacturers. Recognised methods of pathway development were used. The Lean Six Sigma principles adapted to healthcare were used to develop suggestions for improvement. Main outcome measures: To identify the differences between the set pathway to reporting and information transfer to what is occurring on a day-to-day basis as reported by staff. Identify points in the pathway where improvements could be applied. Results: The developed pathway demonstrated great complexity of the current reporting system for medical devices. It identified numerous areas that give rise to problems and multiple biases in decision making. This highlighted the core issues leading to under-reporting and lack of knowledge on device performance and patient risk. Suggestions for improvement were deduced based on end user requirements and identified problems. Conclusions: This study has provided a detailed understanding of the key problem areas that exist within the current reporting system for medical devices and technology. The developed pathway sets to address the key problems to improve reporting outcomes. The identification of pathway differences between 'work as done' and 'work as imagined' can lead to development of quality improvements that could be systematically applied.

Comparing the Effectiveness of Phacoemulsification + Endoscopic Cyclophotocoagulation Laser versus Phacoemulsification Alone for the Treatment of Primary Open Angle Glaucoma in Patients with Cataract (CONCEPT): Study Methodology.

OBJECTIVE: To describe the methodology of the Comparing the Effectiveness of Phacoemulsification + Endoscopic Cyclophotocoagulation Laser and Phacoemulsification Alone for the Treatment of Primary Open Angle Glaucoma in Patients with Cataract (CONCEPT) study, a randomized controlled trial. DESIGN: Double-masked, randomized controlled trial. SUBJECTS, PARTICIPANTS, AND/OR CONTROLS: Participants will be recruited from 5 United Kingdom-based centers. One hundred and sixty eyes with a diagnosis of primary open-angle glaucoma and visually significant cataract will be included. Eighty eyes will be randomized to undergo cataract surgery alone and eighty to undergo cataract surgery with endoscopic cyclophotocoagulation (ECP). METHODS: The baseline diurnal washout intraocular pressure (IOP) will be measured. The participants will be randomized to undergo cataract surgery alone or cataract surgery with ECP upon completion of uncomplicated cataract surgery. At the 1- and 2-year post surgery follow-up visits, the measurements of washout diurnal IOP will be repeated. MAIN OUTCOME MEASURES: Diurnal washout IOP, use of glaucoma medications, and adverse events. CONCLUSIONS: We described the methodology of the first randomized controlled trial comparing cataract surgery alone with cataract surgery combined with ECP in the context of patients with primary open-angle glaucoma and symptomatic cataract. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.