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Vijayasingam A, Shah A, Simmonds NJ, et al., 2018, INTERIM RESULTS FROM A PROSPECTIVE STUDY OF TABLET AND WEB-BASED AUDIOMETRY TO DETECT OTOTOXICITY IN ADULTS WITH CYSTIC FIBROSIS, THORAX, Vol: 73, Pages: A87-A88, ISSN: 0040-6376
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Vijayasingam A, Shah A, Simmonds NJ, et al., 2018, S140 Interim results from a prospective study of tablet and web- based audiometry to detect ototoxicity in adults with cystic fibrosis, British Thoracic Society Winter Meeting 2018, QEII Centre, Broad Sanctuary, Westminster, London SW1P 3EE, 5 to 7 December 2018, Programme and Abstracts, Publisher: BMJ Publishing Group Ltd and British Thoracic Society
Roberts HW, Wagh VK, Mullens IJM, et al., 2018, Evaluation of a hub-and-spoke model for the delivery of femtosecond laser-assisted cataract surgery within the context of a large randomised controlled trial, British Journal of Ophthalmology, Vol: 102, Pages: 1556-1563, ISSN: 0007-1161
AIMS: To test a hypothesis that cataract operating room (OR) productivity can be improved with a femtosecond laser (FL) using a hub-and-spoke model and whether any increase in productivity can offset additional costs relating to the FL. METHODS: 400 eyes of 400 patients were enrolled in a randomised-controlled trial comparing FL-assisted cataract surgery (FLACS) with conventional phacoemulsification surgery (CPS). 299 of 400 operations were performed on designated high-volume theatre lists (FLACS=134, CPS=165), where a hub-and-spoke FLACS model (1×FL, 2×ORs=2:1) was compared with independent CPS theatre lists. Details of operative timings and OR utilisation were recorded. Differences in productivity between hub-and-spoke FLACS and CPS sessions were compared using an economic model including testing hypothetical 3:1 and 4:1 models. RESULTS: The duration of the operation itself was 12.04±4.89 min for FLACS compared with CPS of 14.54±6.1 min (P<0.001). Total patient time in the OR was reduced from 23.39±6.89 min with CPS to 20.34±5.82 min with FLACS (P<0.001)(reduction of 3.05 min per case). There was no difference in OR turnaround time between the models. Average number of patients treated per theatre list was 9 for FLACS and 8 for CPS. OR utilisation was 92.08% for FLACS and 95.83% for CPS (P<0.001). Using a previously established economic model, the FLACS service cost £144.60 more than CPS per case. This difference would be £131 and £125 for 3:1 and 4:1 models, respectively. CONCLUSION: The FLACS hub-and-spoke model was significantly faster than CPS, with patients spending less time in the OR. This enabled an improvement in productivity, but insufficient to meaningfully offset the additional costs relating to FLACS.
Roberts HW, Myerscough J, Borsci S, et al., 2018, Time and motion studies of National Health Service cataract theatre lists to determine strategies to improve efficiency, British Journal of Ophthalmology, Vol: 102, Pages: 1259-1267, ISSN: 0007-1161
Aim To provide a quantitative assessment of cataract theatre lists focusing on productivity and staffing levels/tasks using time and motion studies.Methods National Health Service (NHS) cataract theatre lists were prospectively observed in five different institutions (four NHS hospitals and one private hospital). Individual tasks and their timings of every member of staff were recorded. Multiple linear regression analyses were performed to investigate possible associations between individual timings and tasks.Results 140 operations were studied over 18 theatre sessions. The median number of scheduled cataract operations was 7 (range: 5–14). The average duration of an operation was 10.3 min±(SD 4.11 min). The average time to complete one case including patient turnaround was 19.97 min (SD 8.77 min). The proportion of the surgeons’ time occupied on total duties or operating ranged from 65.2% to 76.1% and from 42.4% to 56.7%, respectively. The correlations of the surgical time to patient time in theatre was R2=0.95. A multiple linear regression model found a significant association (F(3,111)=32.86, P<0.001) with R2=0.47 between the duration of one operation and the number of allied healthcare professionals (AHPs), the number of AHP key tasks and the time taken to perform these key tasks by the AHPs.Conclusions Significant variability in the number of cases performed and the efficiency of patient flow were found between different institutions. Time and motion studies identified requirements for high-volume models and factors relating to performance. Supporting the surgeon with sufficient AHPs and tasks performed by AHPs could improve surgical efficiency up to approximately double productivity over conventional theatre models.
Borsci S, Uchegbu I, Buckle P, et al., 2017, Designing medical technology for resilience: Integrating health economics and human factors approaches, Expert Review of Medical Devices, Vol: 15, Pages: 15-26, ISSN: 1743-4440
INTRODUCTION: The slow adoption of innovation into healthcare calls into question the manner of evidence generation for medical technology. This paper identifies potential reasons for this including a lack of attention to human factors, poor evaluation of economic benefits, lack of understanding of the existing healthcare system and a failure to recognise the need to generate resilient products. Areas covered. Recognising a cross-disciplinary need to enhance evidence generation early in a technology's life cycle, the present paper proposes a new approach that integrates human factors and health economic evaluation as part of a wider systems approach to the design of technology. This approach (Human and Economic Resilience Design for Medical Technology or HERD MedTech) supports early stages of product development and is based on the recent experiences of the National Institute for Health Research London Diagnostic Evidence Co-operative in the UK. Expert commentary. HERD MedTech i) proposes a shift from design for usability to design for resilience, ii) aspires to reduce the need for service adaptation to technological constraints iii) ensures value of innovation at the time of product development, and iv) aims to stimulate discussion around the integration of pre- and post-market methods of assessment of medical technology.
Shah A, Abdolrasouli A, Schelenz S, et al., 2017, Latent class modelling for pulmonary aspergillosis diagnosis in lung transplant recipients, Winter Meeting of the British-Thoracic-Society, Publisher: BMJ PUBLISHING GROUP, Pages: A13-A14, ISSN: 0040-6376
Rationale Timely, accurate diagnosis of invasive aspergillosis (IA) is key to enable initiation of antifungal therapy in lung transplantation. Despite promising novel fungal biomarkers, the lack of a diagnostic gold-standard creates difficulty in determining utility.Objectives This study aimed to use latent class modelling of fungal diagnostics to classify lung transplant recipients (LTR) with IA in a large single centre.Methods Regression models were used to compare composite biomarker testing of bronchoalveolar lavage to clinical and EORTC-MSG guideline-based diagnosis of IA with mortality used as a surrogate primary outcome measure. Bootstrap analysis identified radiological features associated with IA. Bayesian latent class modelling was used to define IA.Measurements and Main Results A clinical diagnosis of fungal infection (P =<0.001) and composite biomarker positive Results (P =<0.001) had significantly increased 12 month mortality. There was poor correlation between clinical diagnosis, EORTC-based IA diagnosis and composite biomarker positivity. Tracheobronchitis was positively predictive of a clinical and composite biomarker positive diagnosis of IA (p=0.004;95% CI–1.79–21.28 and p=0.03;95% CI–0.85–15.62 respectively). Latent class modelling resulted in the formation of 3 groups: Class 1: likely fungal infection; Class 2: unlikely fungal infection; Class 3: unclassifiable. A. fumigatus PCR was positive in ∼90% of class 1 LTRs compared to only 1% in class 2. Analysis of mortality showed a trend towards significance comparing class 1 with class 2 (p=0.06;HR–4.7;95% CI(0.91–24)) (figure 1).
Borsci S, Buckle P, Huddy J, et al., 2017, Usability study of pH strips for nasogastric tube placement, PLoS ONE, Vol: 12, Pages: 1-14, ISSN: 1932-6203
Aims(1) To model the process of use and usability of pH strips (2) to identify, through simulation studies, the likelihood of misreading pH strips, and to assess professional’s acceptance, trust and perceived usability of pH strips.MethodsThis study was undertaken in four phases and used a mixed method approach (an audit, a semi-structured interview, a survey and simulation study). The three months audit was of 24 patients, the semi-structured interview was performed with 19 health professionals and informed the process of use of pH strips. A survey of 134 professionals and novices explored the likelihood of misinterpreting pH strips. Standardised questionnaires were used to assess professionals perceived usability, trust and acceptance of pH strip use in a simulated study.ResultsThe audit found that in 45.7% of the cases aspiration could not be achieved, and that 54% of the NG-tube insertions required x-ray confirmation. None of those interviewed had received formal training on pH strips use. In the simulated study, participants made up to 11.15% errors in reading the strips with important implications for decision making regarding NG tube placement. No difference was identified between professionals and novices in their likelihood of misinterpreting the pH value of the strips. Whilst the overall experience of usage is poor (47.3%), health professionals gave a positive level of trust in both the interview (62.6%) and the survey (68.7%) and acceptance (interview group 65.1%, survey group 74.7%). They also reported anxiety in the use of strips (interview group 29.7%, survey group 49.7%).ConclusionsSignificant errors occur when using pH strips in a simulated study. Manufacturers should consider developing new pH strips, specifically designed for bedside use, that are more usable and less likely to be misread.
Ni MZ, Huddy JR, Priest OH, et al., 2017, Selecting pH cut-offs for the safe verification of nasogastric feeding tube placement: a decision analytical modelling approach., BMJ Open, Vol: 7, ISSN: 2044-6055
OBJECTIVES: The existing British National Patient Safety Agency (NPSA) safety guideline recommends testing the pH of nasogastric (NG) tube aspirates. Feeding is considered safe if a pH of 5.5 or lower has been observed; otherwise chest X-rays are recommended. Our previous research found that at 5.5, the pH test lacks sensitivity towards oesophageal placements, a major risk identified by feeding experts. The aim of this research is to use a decision analytic modelling approach to systematically assess the safety of the pH test under cut-offs 1-9. MATERIALS AND METHODS: We mapped out the care pathway according to the existing safety guideline where the pH test is used as a first-line test, followed by chest x-rays. Decision outcomes were scored on a 0-100 scale in terms of safety. Sensitivities and specificities of the pH test at each cut-off were extracted from our previous research. Aggregating outcome scores and probabilities resulted in weighted scores which enabled an analysis of the relative safety of the checking procedure under various pH cut-offs. RESULTS: The pH test was the safest under cut-off 5 when there was ≥30% of NG tube misplacements. Under cut-off 5, respiratory feeding was excluded; oesophageal feeding was kept to a minimum to balance the need of chest X-rays for patients with a pH higher than 5. Routine chest X-rays were less safe than the pH test while to feed all without safety checks was the most risky. DISCUSSION: The safety of the current checking procedure is sensitive to the choice of pH cut-offs, the impact of feeding delays, the accuracy of the pH in the oesophagus, as well as the extent of tube misplacements. CONCLUSIONS: The pH test with 5 as the cut-off was the safest overall. It is important to understand the local clinical environment so that appropriate choice of pH cut-offs can be made to maximise safety and to minimise the use of chest X-rays. TRIAL REGISTRATION NUMBER: ISRCTN11170249; Pre-results.
Markar S, Mackenzie H, Ni Z, et al., 2017, The influence of procedural volume and proficiency gain on mortality from upper GI endoscopic mucosal resection, Gut, Vol: 67, Pages: 79-85, ISSN: 1468-3288
ObjectiveEndoscopic mucosal resection (EMR) is established for the management of benign and early malignant upper gastrointestinal disease. The aim of this observational study was to establish the effect of endoscopist procedural volume on mortality.DesignPatients undergoing upper gastrointestinal 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 reintervention. 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 RA-CUSUM curve.Results11,051 patients underwent upper gastrointestinal EMR. Endoscopist procedure volume was an independent predictor of 30-day mortality. Fifty-eight percent of EMR procedures were performed by endoscopists with annual volume of 2 cases or less, and had a higher 30- and 90-day mortality rate for cancer patients, 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 cancer patients, the RA-CUSUM curve change-point for 30-day mortality and elective re-intervention was 4 and 43 cases respectively.ConclusionEMR 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.
El-Osta A, Woringer M, Pizzo E, et al., 2017, Does use of point of care testing improve cost effectiveness of the NHS Health Checks programme in the primary care setting? A cost minimisation analysis, BMJ Open, Vol: 7, ISSN: 2044-6055
Objective: To determine if use of Point of Care Testing (POCT) is less costly than laboratory testing to the NHS in delivering the NHS Heath Check (NHSHC) programme in the primary care setting Design: Observational study and theoretical mathematical model with micro-costing approachSetting: We collected data on NHSHC delivered at 9 general practices (7 using POCT; 2 not using POCT). Participants: We recruited 9 general practices offering NHSHC, and a Pathology Services Laboratory in the same area. Methods: We conducted mathematical modelling with permutations in the following fields: provider type (HCA or nurse), type of test performed (total cholesterol with either lab fasting glucose or HbA1c), consumables costs and variable uptake rates including rate of non-response to invite letter and rate of missed (DNA) appointments. We calculated Total Expected Cost (TEC) per 100 invites, number of NHSHC conducted per 100 invites and costs for completed NHSHC for laboratory and POCT-based pathways. A univariate and probabilistic sensitivity analysis was conducted to account for uncertainty in the input parameters. Main outcome measures: We collected data on cost, volume and type of pathology services performed at seven general practices using POCT and a Pathology Services Laboratory. We collected data on response to the NHSHC invitation letter and DNA rates from two general practices. Results: TEC of using POCT to deliver a routine NHSHC is lower than the laboratory-led pathway with savings of £29 per 100 invited patients up the point of CVD risk-score presentation. Use of POCT can deliver NHSHC in one sitting, whereas the laboratory pathway offers patients several opportunities to DNA appointment. Conclusions: TEC of using POCT to deliver an NHSHC in the primary care setting is lower than the laboratory-led pat
Borsci S, Buckle P, Uchegbu I, et al., 2017, Integrating human factors and health economics to inform the design of medical device: a conceptual framework, EMBEC & NBC 2017: Joint Conference of the European Medical and Biological Engineering Conference (EMBEC) and the Nordic-Baltic Conference on Biomedical Engineering and Medical Physics (NBC)
Gopalakrishna G, Langendam M, Scholten R, et al., 2017, Erratum to: Methods for evaluating medical tests and biomarkers, Diagnostic and Prognostic Research, Vol: 1, Pages: 11-11, ISSN: 2397-7523
[This corrects the article DOI: 10.1186/s41512-016-0001-y.].
Roberts HW, Ni MZ, O'Brart DPS, 2017, Financial modelling of femtosecond laser-assisted cataract surgery within the National Health Service using a 'hub and spoke' model for the delivery of high-volume cataract surgery, BMJ Open, Vol: 7, ISSN: 2044-6055
Aims To develop financial models which offset additional costs associated with femtosecond laser (FL)-assisted cataract surgery (FLACS) against improvements in productivity and to determine important factors relating to its implementation into the National Health Service (NHS).Methods FL platforms are expensive, in initial purchase and running costs. The additional costs associated with FL technology might be offset by an increase in surgical efficiency. Using a ‘hub and spoke’ model to provide high-volume cataract surgery, we designed a financial model, comparing FLACS against conventional phacoemulsification surgery (CPS). The model was populated with averaged financial data from 4 NHS foundation trusts and 4 commercial organisations manufacturing FL platforms. We tested our model with sensitivity and threshold analyses to allow for variations or uncertainties.Results The averaged weekly workload for cataract surgery using our hub and spoke model required either 8 or 5.4 theatre sessions with CPS or FLACS, respectively. Despite reduced theatre utilisation, CPS (average £433/case) was still found to be 8.7% cheaper than FLACS (average £502/case). The greatest associated cost of FLACS was the patient interface (PI) (average £135/case). Sensitivity analyses demonstrated that FLACS could be less expensive than CPS, but only if increased efficiency, in terms of cataract procedures per theatre list, increased by over 100%, or if the cost of the PI was reduced by almost 70%.Conclusions The financial viability of FLACS within the NHS is currently precluded by the cost of the PI and the lack of knowledge regarding any gains in operational efficiency.
Roberts HW, Ni MZ, O'Brart DPS, 2017, Financial modelling of femtosecond laser-assisted cataract surgery within the National Health Service using a `hub and spoke' model for the delivery of high-volume cataract surgery, BMJ Open, Vol: 7, ISSN: 2044-6055
Aims To develop financial models which offset additional costs associated with femtosecond laser (FL)-assisted cataract surgery (FLACS) against improvements in productivity and to determine important factors relating to its implementation into the National Health Service (NHS).Methods FL platforms are expensive, in initial purchase and running costs. The additional costs associated with FL technology might be offset by an increase in surgical efficiency. Using a ‘hub and spoke’ model to provide high-volume cataract surgery, we designed a financial model, comparing FLACS against conventional phacoemulsification surgery (CPS). The model was populated with averaged financial data from 4 NHS foundation trusts and 4 commercial organisations manufacturing FL platforms. We tested our model with sensitivity and threshold analyses to allow for variations or uncertainties.Results The averaged weekly workload for cataract surgery using our hub and spoke model required either 8 or 5.4 theatre sessions with CPS or FLACS, respectively. Despite reduced theatre utilisation, CPS (average £433/case) was still found to be 8.7% cheaper than FLACS (average £502/case). The greatest associated cost of FLACS was the patient interface (PI) (average £135/case). Sensitivity analyses demonstrated that FLACS could be less expensive than CPS, but only if increased efficiency, in terms of cataract procedures per theatre list, increased by over 100%, or if the cost of the PI was reduced by almost 70%.Conclusions The financial viability of FLACS within the NHS is currently precluded by the cost of the PI and the lack of knowledge regarding any gains in operational efficiency.
Acharya A, Markar S, Matar M, et al., 2016, Use of tumour markers in gastrointestinal cancers: surgeon perceptions and cost-benefit trade-off analysis, Annals of Surgical Oncology, Vol: 24, Pages: 1-9, ISSN: 1534-4681
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.
Acharya A, Markar SR, Matar M, et al., 2016, Use of Tumor Markers in Gastrointestinal Cancers: Surgeon Perceptions and Cost-Benefit Trade-Off Analysis, ANNALS OF SURGICAL ONCOLOGY, Vol: 24, Pages: 1165-1173, ISSN: 1068-9265
Markar SR, Noordman BJ, Mackenzie H, et al., 2016, Multimodality treatment for esophageal adenocaricnoma: multi-center propensity-score matched study., Annals of Oncology, Vol: 28, Pages: 519-527, ISSN: 1569-8041
BACKGROUND: The primary aim of this study was to compare survival from neoadjuvant chemoradiotherapy plus surgery (NCRS) versus neoadjuvant chemotherapy plus surgery (NCS) for the treatment of esophageal or junctional adenocarcinoma. The secondary aims were to compare pathological effects, short-term mortality and morbidity, and to evaluate the effect of lymph node harvest upon survival in both treatment groups. METHODS: Data were collected from 10 European centers from 2001 to 2012. Six hundred and eight patients with stage II or III oesophageal or oesophago-gastric junctional adenocarcinoma were included; 301 in the NCRS group and 307 in the NCS group. Propensity score matching and Cox regression analyses were used to compensate for differences in baseline characteristics. RESULTS: NCRS resulted in significant pathological benefits with more ypT0 (26.7% versus 5%; P < 0.001), more ypN0 (63.3% versus 32.1%; P < 0.001), and reduced R1/2 resection margins (7.7% versus 21.8%; P < 0.001). Analysis of short-term outcomes showed no statistically significant differences in 30-day or 90-day mortality, but increased incidence of anastomotic leak (23.1% versus 6.8%; P < 0.001) in NCRS patients.There were no statistically significant differences between the groups in 3-year overall survival (57.9% versus 53.4%; Hazard Ratio (HR)= 0.89, 95%C.I. 0.67-1.17, P = 0.391) nor disease-free survival (52.9% versus 48.9%; HR = 0.90, 95%C.I. 0.69-1.18, P = 0.443). The pattern of recurrence was also similar (P = 0.660). There was a higher lymph node harvest in the NCS group (27 versus 14; P < 0.001), which was significantly associated with a lower recurrence rate and improved disease free survival within the NCS group. CONCLUSION: The survival differences between NCRS and NCS maybe modest, if present at all, for the treatment of locally advanc
Markar SR, Mackenzie H, Ni M, et al., 2016, The influence of procedural volume and proficiency gain on mortality from upper GI endoscopic mucosal resection, Gut, ISSN: 0017-5749
© 2016 BMJ Publishing Group Ltd & British Society of Gastroenterology. 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 (RACUSUM) 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.
Acharya A, Markar SR, Ni M, et al., 2016, Biomarkers of acute appendicitis: systematic review and cost–benefit trade-off analysis, Surgical Endoscopy, Vol: 31, Pages: 1022-1031, ISSN: 1432-2218
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.
Huddy JR, Markar SR, Ni MZ, et al., 2016, Laparoscopic repair of hiatus hernia: does mesh type influence outcome? A meta-analysis and European survey study, Surgical Endoscopy and Other Interventional Techniques, ISSN: 1432-2218
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
Mamidanna R, Ni Z, Anderson O, et al., 2016, Surgeon Volume and Cancer Esophagectomy, Gastrectomy, and Pancreatectomy: A Population-based Study in England, Annals of Surgery, Vol: 263, Pages: 727-732, ISSN: 1528-1140
Objective: The aim of the study was to assess whether there is a proficiency curve-like relationship between surgeon volume and operative mortality and determine the minimum surgeon volume for optimum operative mortality.Background: The inverse relationship between hospital volume and operative mortality is well-established for esophageal, gastric, and pancreatic cancer. The recommended minimum surgeon volumes are however uncertain.Methods: We retrieved data on esophagectomies, gastrectomies, and pancreatectomies for cancer from the NHS Hospital Episodes Statistics database from April 2000 to March 2010. We defined mortality as in-hospital death within 30 days of surgery. We determined whether there was a proficiency curve relationship by inspecting surgeon volume-mortality graphs after adjusting for patient age, sex, socioeconomic, and comorbidity indices. We then statistically determined the minimum surgeon volume that produced a mortality rate insignificantly different from the optimum of the curve.Results: Sixteen thousand five hundred seventy-two esophagectomies, 12,622 gastrectomies, and 9116 pancreatectomies were examined. Surgeon volume ranged from 2 to 29 esophagectomies, from 1 to 14 gastrectomies, and from 2 to 31 pancreatectomies per surgeon per year. We demonstrated a proficiency relationship between surgeon volume and mortality in esophageal, gastric, and pancreatic cancer surgery. Each additional case of esophagectomy, gastrectomy, and pancreatectomy would reduce 30-day mortality odds by 3.4%, 7.2%, and 4.1%, respectively. However, as surgeon volume increased, mortality rate continued to improve. Therefore, we were unable to recommend minimum surgeon volume.Conclusions: Mortality after resections for esophageal, gastric, and pancreatic cancer falls as surgeon volume rises up to 30 cases. Within this range, we did not demonstrate any statistical threshold that could be recommended as a minimum volume target.
Wyles SM, Miskovic D, Ni Z, et al., 2016, Development and implementation of the Structured Training Trainer Assessment Report (STTAR) in the English National Training Programme for laparoscopic colorectal surgery, Surgical Endoscopy, Vol: 30, Pages: 993-1003, ISSN: 0930-2794
Background: There is a lack of educational tools available for surgical teaching critique, particularly for advanced laparoscopic surgery. The aim was to develop and implement a tool that assesses training quality and structures feedback for trainers in the English National Training Programme for laparoscopic colorectal surgery.Methods: Semi-structured interviews were performed and analysed, and items were extracted. Through the Delphi process, essential items pertaining to desirable trainer characteristics, training structure and feedback were determined. An assessment tool (Structured Training Trainer Assessment Report—STTAR) was developed and tested for feasibility, acceptability and educational impact.Results: Interview transcripts (29 surgical trainers, 10 trainees, four educationalists) were analysed, and item lists created and distributed for consensus opinion (11 trainers and seven trainees). The STTAR consisted of 64 factors, and its web-based version, the mini-STTAR, included 21 factors that were categorised into four groups (training structure, training behaviour, trainer attributes and role modelling) and structured around a training session timeline (beginning, middle and end). The STTAR (six trainers, 48 different assessments) demonstrated good internal consistency (α = 0.88) and inter-rater reliability (ICC = 0.75). The mini-STTAR demonstrated good inter-item reliability (α = 0.79) and intra-observer reliability on comparison of 85 different trainer/trainee combinations (r = 0.701, p = <0.001). Both were found to be feasible and acceptable. The educational report for trainers was found to be useful (4.4 out of 5).Conclusions: An assessment tool that evaluates training quality was developed and shown to be reliable, acceptable and of educational value. It has been successfully implemented into the English National Training Programme for laparoscopic colorectal surgery.
Ni M, Mackenzie H, Widdison A, et al., 2016, 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, SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES, Vol: 30, Pages: 1020-1027, ISSN: 0930-2794
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- Citations: 7
Huddy JR, Ni MZ, Barlow J, et al., 2016, Point-of-care C reactive protein for the diagnosis of lower respiratory tract infection in NHS primary care: a qualitative study of barriers and facilitators to adoption, BMJ Open, Vol: 6, ISSN: 2044-6055
Mackenzie H, Markar SR, Askari A, et al., 2016, National proficiency-gain curves for minimally invasive gastrointestinal cancer surgery, British Journal of Surgery, Vol: 103, Pages: 88-96, ISSN: 1365-2168
BackgroundMinimal access surgery for gastrointestinal cancer has short-term benefits but is associated with a proficiency-gain curve. The aim of this study was to define national proficiency-gain curves for minimal access colorectal and oesophagogastric surgery, and to determine the impact on clinical outcomes.MethodsAll adult patients undergoing minimal access oesophageal, colonic and rectal surgery between 2002 and 2012 were identified from the Hospital Episode Statistics database. Proficiency-gain curves were created using risk-adjusted cumulative sum analysis. Change points were identified, and bootstrapping was performed with 1000 iterations to identify a confidence level. The primary outcome was 30-day mortality; secondary outcomes were 90-day mortality, reintervention, conversion and length of hospital stay.ResultsSome 1696, 15 008 and 16 701 minimal access oesophageal, rectal and colonic cancer resections were performed during the study period. The change point in the proficiency-gain curve for 30-day mortality for oesophageal, rectal and colonic surgery was 19 (confidence level 98·4 per cent), 20 (99·2 per cent) and three (99·5 per cent) procedures; the mortality rate fell from 4·0 to 2·0 per cent (relative risk reduction (RRR) 0·50, P = 0·033), from 2·1 to 1·2 per cent (RRR 0·43, P < 0·001) and from 2·4 to 1·8 per cent (RRR 0·25, P = 0·058) respectively. The change point in the proficiency-gain curve for reintervention in oesophageal, rectal and colonic resection was 19 (98·1 per cent), 32 (99·5 per cent) and 26 (99·2 per cent) procedures respectively. There were also significant proficiency-gain curves for 90-day mortality, conversion and length of stay.ConclusionThe introduction of minimal access gastrointestinal cancer surgery has been associated with a proficiency-gain c
Huddy JR, Ni M, Mavroveli S, et al., 2015, A research protocol for developing a Point-Of-Care Key Evidence Tool 'POCKET': a checklist for multidimensional evidence reporting on point-of-care in vitro diagnostics., BMJ Open, Vol: 5, Pages: e007840-e007840, ISSN: 2044-6055
INTRODUCTION: Point-of-care in vitro diagnostics (POC-IVD) are increasingly becoming widespread as an acceptable means of providing rapid diagnostic results to facilitate decision-making in many clinical pathways. Evidence in utility, usability and cost-effectiveness is currently provided in a fragmented and detached manner that is fraught with methodological challenges given the disruptive nature these tests have on the clinical pathway. The Point-of-care Key Evidence Tool (POCKET) checklist aims to provide an integrated evidence-based framework that incorporates all required evidence to guide the evaluation of POC-IVD to meet the needs of policy and decisionmakers in the National Health Service (NHS). METHODS AND ANALYSIS: A multimethod approach will be applied in order to develop the POCKET. A thorough literature review has formed the basis of a robust Delphi process and validation study. Semistructured interviews are being undertaken with POC-IVD stakeholders, including industry, regulators, commissioners, clinicians and patients to understand what evidence is required to facilitate decision-making. Emergent themes will be translated into a series of statements to form a survey questionnaire that aims to reach a consensus in each stakeholder group to what needs to be included in the tool. Results will be presented to a workshop to discuss the statements brought forward and the optimal format for the tool. Once assembled, the tool will be field-tested through case studies to ensure validity and usability and inform refinement, if required. The final version will be published online with a call for comments. Limitations include unpredictable sample representation, development of compromise position rather than consensus, and absence of blinding in validation exercise. ETHICS AND DISSEMINATION: The Imperial College Joint Research Compliance Office and the Imperial College Hospitals NHS Trust R&D department have approved the protocol. The checklist tool will be
Mackenzie H, Ni M, Miskovic D, et al., 2015, Clinical validity of consultant technical skills assessment in the English National Training Programme for Laparoscopic Colorectal Surgery, BRITISH JOURNAL OF SURGERY, Vol: 102, Pages: 991-997, ISSN: 0007-1323
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- Citations: 42
Huddy JR, Ni MZ, Markar SR, et al., 2015, Point-of-care testing in the diagnosis of gastrointestinal cancers: Current technology and future directions, WORLD JOURNAL OF GASTROENTEROLOGY, Vol: 21, Pages: 4111-4120, ISSN: 1007-9327
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- Citations: 18
Mackenzie H, Miskovic D, Ni M, et al., 2015, Risk prediction score in laparoscopic colorectal surgery training. Experience from the English National Training Program, Annals of Surgery, Vol: 261, Pages: 338-344, ISSN: 0003-4932
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.
Markar SR, Wiggins T, Ni M, et al., 2015, Assessment of the quality of surgery within randomised controlled trials for the treatment of gastro-oesophageal cancer: a systematic review, The Lancet Oncology, Vol: 16, Pages: E23-E31, ISSN: 1213-9432
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.
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