Creation of an institutional preoperative checklist to support clinical risk assessment in patients with ulcerative colitis (UC) considering ileoanal pouch surgery.

Background: Total proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the most established restorative operative approach for patients with ulcerative colitis. It has associated morbidity and the potential for major repercussions on quality of life. As such, patient selection is crucial to its success. The main aim of this paper is to present an institutional preoperative checklist to support clinical risk assessment and patient selection in those considering IPAA. Methods: A literature review was performed to identify the risk factors associated with surgical complications, decreased functional outcomes/quality of life, and pouch failure after IPAA. Based on this, a preliminary checklist was devised and modified through an iterative process. This was then evaluated by a consensus group comprising the pouch multidisciplinary team (MDT) core members. Results: The final preoperative checklist includes assessment for risk factors such as gender, advanced age, obesity, comorbidities, sphincteric impairment, Crohn's disease and pelvic radiation therapy. In addition, essential steps in the decision-making process, such as pouch nurse counselling and discussion regarding surgical alternatives, are also included. The last step of the checklist is discussion at a dedicated pouch-MDT. Discussion: A preoperative checklist may support clinicians with the selection of patients that are suitable for pouch surgery. It also serves as a useful tool to inform the discussion of cases at the MDT meeting.

MRI-enema for the assessment of pelvic intestinal anastomotic integrity.

AIM: Anastomotic leak causes significant morbidity for patients undergoing pelvic intestinal surgery. Fluoroscopic assessment of anastomotic integrity using water-soluble contrast enema (WSCE) is of questionable benefit over examination alone. We hypothesized that MRI-enema may be more accurate. The aim of this study was to compare MRI-enema with fluoroscopic WSCE. METHOD: Patients referred for WSCE with pelvic intestinal anastomosis and defunctioning ileostomy (including patients with suspected or known leaks) were invited to participate. WSCE and MRI-enema were undertaken within 48 h of each other. MRI sequences were performed before, during and immediately after the introduction of 400 ml of 1% gadolinium contrast solution per anus. MRI examinations were reported to protocol by two blinded gastrointestinal radiologists. A Likert-scale patient questionnaire was administered to compare patient experience. Follow-up was >12 months after ileostomy reversal. Anastomotic leak was determined by unblinded consensus of examination and radiological findings. RESULTS: Sixteen patients were recruited, with a median age of 39 years (range 22-69). Ten were men, 11 had ileoanal pouch formation and five had low anterior resection. Five patients had anastomotic leak identified by MRI and four by WSCE. The radial location of the anastomotic defect was identified in all five patients by MRI versus two on WSCE. MRI revealed additional information including contents of a widened presacral space. Patient experience was equivalent. Eleven patients eventually had ileostomy reversal without complications. CONCLUSION: MRI-enema is a feasible and tolerable alternative to WSCE and offers greater anatomical detail in the context of pelvic intestinal anastomotic leak. Larger prospective studies are required to define its potential role in the UK National Health Service.

The pouch behaving badly: management of morbidity after ileal pouch-anal anastomosis.

AIM: Ileal pouch-anal anastomosis (IPAA), or a 'pouch', allows restoration of intestinal continuity after proctocolectomy for ulcerative colitis or familial adenomatous polyposis. Most patients have a good long-term outcome after IPAA, but in a significant proportion the functional outcome and quality of life are unsatisfactory. We term this outcome 'the pouch behaving badly'. Managing this, especially one is when unfamiliar with the possible underlying pathologies, is a challenge for both patient and clinician. We aim to outline the clinical approach to the pouch behaving badly, highlighting key aspects of investigation and management. METHOD: This is a narrative review of the literature covering the investigation and management of postoperative complications and morbidity after IPAA. RESULTS: Management of the pouch behaving badly requires a careful clinical assessment. The patient may present with multiple symptoms and a clear picture of the symptomatology and past history should be constructed before thorough examination and specialist investigation. We divide the pathology that underlies this clinical scenario into surgical, inflammatory, mechanical, functional and dysplastic causes and outline the investigation and management of each one. CONCLUSION: The pouch behaving badly is a challenging problem for both patient and clinician. A detailed clinical assessment with careful specialist investigation is key to diagnosing the underlying pathology. We stress the importance of patient-centred care - the aim is to improve quality of life.

Circulating MicroRNAs in Small-bowel Neuroendocrine Tumors: A Potential Tool for Diagnosis and Assessment of Effectiveness of Surgical Resection.

OBJECTIVE: To discover serum-based microRNA (miRNA) biomarkers for small-bowel neuroendocrine tumors (SBNET) to help guide clinical decisions. BACKGROUND: MiRNAs are small noncoding RNA molecules implicated in the initiation and progression of many cancers. MiRNAs are remarkably stable in bodily fluids, and can potentially be translated into clinically useful biomarkers. Novel biomarkers are needed in SBNET to determine disease aggressiveness, select patients for treatment, detect early recurrence, and monitor response. METHODS: This study was performed in 3 stages (discovery, validation, and a prospective, longitudinal assessment). Discovery comprised of global profiling of 376 miRNA in sera from SBNET patients (n = 11) versus healthy controls (HCs; n = 3). Up-regulated miRNAs were subsequently validated in additional SBNET (n = 33) and HC sera (n = 14); and then longitudinally after SBNET resection (n = 12), with serial serum sampling (preoperatively day 0; postoperatively at 1 week, 1 month, and 12 months). RESULTS: Four serum miRNAs (miR-125b-5p, -362-5p, -425-5p and -500a-5p) were significantly up-regulated in SBNET (P < 0.05; fold-change >2) based on multiple normalization strategies, and were validated by RT-qPCR. This combination was able to differentiate SBNET from HC with an area under the curve of 0.951. Longitudinal assessment revealed that miR-125b-5p returned towards HC levels at 1 month postoperatively in patients without disease, whereas remaining up-regulated in those with residual disease (RSD). This was also true at 12 months postoperatively. In addition, miR-362-5p appeared up-regulated at 12 months in RSD and recurrent disease (RCD). CONCLUSIONS: Our study represents the largest global profiling of serum miRNAs in SBNET patients, and the first to evaluate ongoing serum miRNA expression changes after surgical resection. Serum miR-125b-5p and miR-362-5p have potential to be used to detect RSD/RCD.

Standardising assessment and documentation of pouchoscopy.

BACKGROUND/AIMS: Variation in quality of reporting on endoscopic procedures is a common clinical problem. Findings are not documented in a standardised manner and there is a tendency towards reporting abnormal findings only. This study aimed to review quality of flexible pouchoscopy reports and to develop a standardised reporting template. METHODS: Ileo-anal-pouch experts (n=5) compiled a list of items that should be documented at flexible pouchoscopy. Reports were reviewed retrospectively for their completeness compared with the template. The template was then introduced and quality of reports was analysed prospectively. RESULTS: One hundred and twenty-one reports produced between March 2015 and June 2015 were reviewed. Between August 2015 and November 2015, the template was introduced and reports were analysed. There was significant improvement in documentation of anus and perianal area (before template (B) 12% to after template (A) 51%, p<0.0001), rectal cuff (B: 55% to A: 75%, p=0.01), pouch-anal anastomosis (B: 37% to A: 67%, p=0.0002) and pouch inlet (B: 13% to A: 41%, p<0.0001). Pouch body was described in high percentage regardless of introduction of the template (B: 98% to A: 97%, p=0.61). CONCLUSIONS: Documentation of pouchoscopy findings was suboptimal and introduction of a template improved documentation of flexible pouchoscopy significantly.

Volume assessment magnetic resonance imaging technique for monitoring perianal Crohn's fistulas.

BACKGROUND: Perianal Crohn's fistula and their response to anti-tumour necrosis factor (TNF) therapies are best assessed with magnetic resonance imaging (MRI), but radiologist reporting is subjective and variable. This study investigates whether segmentation software could provide precise and reproducible objective measurements of fistula volume. METHODS: Retrospective analysis of patients with perianal Crohn's fistula at our institution between 2007 and 2013. Pre- and post-biologic MRI scans were used with varying time intervals. A total of two radiologists recorded fistula volumes, mean signal intensity and time taken to measure fistula volumes using validated Open Source segmentation software. A total of three radiologists assessed fistula response to treatment (improved, worse or unchanged) by comparing MRI scans. RESULTS: A total of 18 cases were reviewed for this pilot study. Inter-observer variability was very good for volume and mean signal intensity; intra-class correlation (ICC) 0.95 [95% confidence interval (CI) 0.91-0.98] and 0.95 (95% CI 0.90-0.97) respectively. Intra-observer variability was very good for volume and mean signal intensity; ICC 0.99 (95% CI 0.97-0.99) and 0.98 (95% CI 0.95-0.99) respectively. Average time taken to measure fistula volume was 202 s and 250 s for readers 1 and 2. Agreement between three specialist radiologists was good [kappa 0.69 (95% CI 0.49-0.90)] for the subjective assessment of fistula response. Significant association was found between objective percentage volume change and subjective consensus agreement of response (p = 0.001). Median volume change for improved, stable or worsening fistula response was -67% [interquartile range (IQR): -78, -47], 0% (IQR: -16, +17), and +487% (IQR: +217, +559) respectively. CONCLUSION: Quantification of fistula volumes and signal intensities is feasible and reliable, providing an objective measure of perianal Crohn's fistula and response to treatment.

Who requires emergency surgery for colorectal cancer and can national screening programmes reduce this need?

INTRODUCTION: Patients undergoing emergency colorectal cancer (CRC) surgery are at higher risk of poor outcome than those managed electively. The aim of this national study is to identify groups at high risk of undergoing unplanned CRC surgery and assess short and long-term outcome in this cohort subsequent morbidity and mortality as well as quantify their long-term survival. The aim of this national study is to identify groups at high risk of undergoing unplanned CRC surgery and assess short and long-term outcome, subsequent morbidity and mortality as well as quantify their long-term survival. METHODS: The Hospital Episode Statistics (HES) database between the years of 1997-2012 was used to identify all patients that had undergone surgery for colorectal cancer. Multivariable logistic regression analysis and cox regression analyses were undertaken to identify patient factors predictive of undergoing emergency and quantify their long-term survival. RESULTS: A total of 286,591 patients underwent resection for CRC between April 1997 and April 2012, of which 24.3% (69,718 patients) were admitted as emergencies and underwent emergency surgery. Independent predictors of undergoing emergency surgery were female gender (OR 1.23, CI: 1.21-1.25, p < 0.001), older age (>79 years old OR 1.55, CI: 1.50-1.60, p < 0.001), social deprivation (most deprived quintile, OR 1.64, CI: 1.50-1.80, p < 0.001) and Black African/Caribbean ethnicity (OR 1.36, CI: 1.21-1.66, p < 0.001). All cause 30- and 90-day mortality within the emergency group was significantly higher than that for the electively managed patients group (13.3% versus compared with 3.4% at 30-days) as was 90-day (20.0% versus compared with 5.8% at 90-days). Amongst patients eligible for bowel screening there was an approximate 40% significant reduction in the proportion of patients requiring emergency surgery before and after its introduction in 2006 (23.4%-14.9%, p < 0.001). This reduction in emergency surgery included both proximal and distal cancer resections. CONCLUSION: Older, socially deprived and ethnic minority patients with colorectal cancer are more likely to present as emergencies requiring CRC surgery. Public health initiatives, such as bowel cancer screening, appear to have concomitantly reduced emergency and increased elective surgical rates within the eligible cohort. This is likely to have a beneficial impact on population survival. Strategies aimed at preventing emergency presentation by identifying patients at specific risk could improve survival outcome for colorectal cancer surgery in England.

The impact of the introduction of formalised polypectomy assessment on training in the UK.

OBJECTIVE: The aim was to describe the impact on polypectomy experience by the mandatory introduction of the Directly Observed Polypectomy Skills tool (DOPyS) and electronic portfolio as part of the formal colonoscopy certification process. DESIGN: Applications for colonoscopy certification in the UK in the year prior to the introduction of DOPyS were analysed retrospectively and compared with data collected prospectively for those in the following year. SETTING: UK National Health Service. PATIENTS: None. INTERVENTIONS: None. MAIN OUTCOME MEASURES: The outcomes studied included whether evidence of exposure to polypectomy, endoscopic mucosal resection (EMR) and colonoscopy changed over the 2-year period. The nature of the polyps removed by trainees was also studied. RESULTS: Thirty two per cent of candidates in the first year had evidence of any observed polypectomy with 7% of candidates referring to training in EMR. The median number of formative colonoscopy assessments was 3 (range 0-16). All of these candidates in the second year had evidence of polypectomy assessment, with a median number of DOPyS of 7 (range 3-27). Eighty nine per cent of applicants had evidence of assessed EMR. The median number of formative colonoscopy assessments in this cohort was 32 (range 9-199). There was a significant increase in the number of logged polypectomy assessments (p<0.001), experience of EMR (p<0.001) and formative colonoscopy assessments (p<0.001). There was no significant difference in the total number of colonoscopy procedures performed. CONCLUSIONS: Structured polypectomy assessment improves trainees' documented exposure to therapeutic endoscopy as well as providing formal evidence of skills acquisition. As polypectomy plays an increasing role globally in colorectal cancer prevention, the DOPyS provides an effective means of assessing and certifying polypectomy.

Avoiding Radical Surgery in Elderly Patients With Rectal Cancer Is Cost-Effective.

BACKGROUND: Radical surgery is associated with significant perioperative mortality in elderly and comorbid populations. Emerging data suggest for patients with a clinical complete response after neoadjuvant chemoradiotherapy that a watch-and-wait approach may provide equivalent survival and oncological outcomes. OBJECTIVE: The purpose of this study was to compare the cost-effectiveness of watch and wait and radical surgery for patients with rectal cancer after a clinical complete response following chemoradiotherapy. DESIGN: Decision analytical modeling and a Markov simulation were used to model long-term costs, quality-adjusted life-years, and cost-effectiveness after watch and wait and radical surgery. Sensitivity analysis was used to investigate the effect of uncertainty in model parameters. SETTINGS: A third-party payer perspective was adopted. PATIENTS: Patients included in the study were a 60-year-old male cohort with no comorbidities, 80-year-old male cohorts with no comorbidities, and 80-year-old male cohorts with significant comorbidities. INTERVENTIONS: Radical surgery and watch-and-wait approaches were studied. MAIN OUTCOME MEASURES: Incremental cost, effectiveness, and cost-effectiveness ratio over the entire lifetime of the hypothetical patient cohorts were measured. RESULTS: Watch and wait was more effective (60-year-old male cohort with no comorbidities = 0.63 quality-adjusted life-years (95% CI, 2.48-3.65 quality-adjusted life-years); 80-year-old male cohort with no comorbidities = 0.56 quality-adjusted life-years (95% CI, 0.52-1.59 quality-adjusted life-years); 80-year-old male cohort with significant comorbidities = 0.72 quality-adjusted life-years (95% CI, 0.34-1.76 quality-adjusted life-years)) and less costly (60-year-old male cohort with no comorbidities = $11,332.35 (95% CI, $668.50-$23,970.20); 80-year-old male cohort with no comorbidities = $8783.93 (95% CI, $2504.26-$21,900.66); 80-year-old male cohort with significant comorbidities = $10,206.01 (95% CI, $2762.014-$24,135.31)) independent of patient cohort age and comorbidity. Consequently, watch and wait was more cost-effective with a high degree of certainty (range, 69.6%-89.2%) at a threshold of $50,000/quality-adjusted life-year. LIMITATIONS: Long-term outcomes were derived from modeled cohorts. Analysis was performed for a United Kingdom third-party payer perspective, limiting generalizability to other healthcare contexts. CONCLUSIONS: Watch and wait is likely to be cost-effective compared with radical surgery. These findings strongly support the discussion of organ-preserving strategies with suitable patients.

Investigating Adverse Event Free Admissions in Medicare Inpatients as a Patient Safety Indicator.

OBJECTIVE: To investigate adverse event free admissions as a potential, patient-centered indicator aligned directly with the goal of patient safety-freedom from harm. BACKGROUND: Preventable adverse event rates in healthcare could be further reduced. These are generally measured separately, one adverse event at a time. However, this does not reveal whether different patients are affected or the same patients are experiencing multiple events. METHODS: We examined Medicare inpatient hospital administrative datasets for 2009 to 2011, processed using standard criteria. Events were (i) death within 30 days, (ii) unplanned readmissions within 30 days, (iii) long length of stay, (iv) healthcare acquired infections, and (v) established patient safety indicators not present on admission. We defined adverse event free admissions as those without record of any of these events. National rates were calculated by diagnosis group. Risk-adjusted hospital-specific rates of adverse event free admissions were calculated using colorectal procedures as an example. RESULTS: There were 23,991,193 admissions after exclusions. Approximately, 64% went through the acute inpatient Medicare system without record of anything untoward. Multiple events were recorded in 22·7% admissions; 15% of these experienced more than 2 adverse events. Risk-adjusted hospital-specific rates of adverse event free admissions for colorectal procedures showed 131 out of 3786 hospitals below the 99·8% lower control limit of the national upper quartile. CONCLUSIONS: Overall, only 60% of admissions were recorded as adverse event free. Multiple adverse events were common. Even if events are under recorded, this measure could provide an easily understandable and useful baseline for clinicians and managers.

What Are the Top 10 Research Questions in the Treatment of Inflammatory Bowel Disease? A Priority Setting Partnership with the James Lind Alliance.

BACKGROUND AND AIMS: Many uncertainties remain regarding optimal therapies and strategies for the treatment of inflammatory bowel disease. Setting research priorities addressing therapies requires a partnership between health care professionals, patients and organisations supporting patients. We aimed to use the structure of the James Lind Alliance Priority Setting Partnership, which has been used in other disease areas, to identify and prioritise unanswered questions about treatments for inflammatory bowel disease. METHODS: The James Lind Priority Setting Partnership uses methods agreed and adopted in other disease areas to work with patients and clinicians: to identify uncertainties about treatments; to agree by consensus a prioritised list of uncertainties for research; then to translate these uncertainties into research questions which are amenable to hypothesis testing; and finally to take results to research commissioning bodies to be considered for funding. RESULTS: A total of 1636 uncertainties were collected in the initial survey from 531 respondents, which included 22% health care professionals and 78% patients and carers. Using the rigorously applied processes of the priority setting partnership, this list was distilled down to the top 10 research priorities for inflammatory bowel disease. The top priorities were: identifying treatment strategies to optimise efficacy, safety and cost-effectiveness; and stratifying patients with regard to their disease course and treatment response. Diet and symptom control [pain, incontinence and fatigue] were also topics which were prioritised. CONCLUSIONS: A partnership involving multidisciplinary clinicians, patients and organisations supporting patients has identified the top 10 research priorities in the treatment of patients with inflammatory bowel disease.

The HubBLe Trial: haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for symptomatic second- and third-degree haemorrhoids: a multicentre randomised controlled trial and health-economic evaluation.

BACKGROUND: Optimal surgical intervention for low-grade haemorrhoids is unknown. Rubber band ligation (RBL) is probably the most common intervention. Haemorrhoidal artery ligation (HAL) is a novel alternative that may be more efficacious. OBJECTIVE: The comparison of HAL with RBL for the treatment of grade II/III haemorrhoids. DESIGN: A multicentre, parallel-group randomised controlled trial. PERSPECTIVE: UK NHS and Personal Social Services. SETTING: 17 NHS Trusts. PARTICIPANTS: Patients aged ≥ 18 years presenting with grade II/III (second- and third-degree) haemorrhoids, including those who have undergone previous RBL. INTERVENTIONS: HAL with Doppler probe compared with RBL. OUTCOMES: Primary outcome - recurrence at 1 year post procedure; secondary outcomes - recurrence at 6 weeks; haemorrhoid severity score; European Quality of Life-5 Dimensions, 5-level version (EQ-5D-5L); Vaizey incontinence score; pain assessment; complications; and cost-effectiveness. RESULTS: A total of 370 participants entered the trial. At 1 year post procedure, 30% of the HAL group had evidence of recurrence compared with 49% after RBL [adjusted odds ratio (OR) = 2.23, 95% confidence interval (CI) 1.42 to 3.51; p = 0.0005]. The main reason for the difference was the number of extra procedures required to achieve improvement/cure. If a single HAL is compared with multiple RBLs then only 37.5% recurred in the RBL arm (adjusted OR 1.35, 95% CI 0.85 to 2.15; p = 0.20). Persistence of significant symptoms at 6 weeks was lower in both arms than at 1 year (9% HAL and 29% RBL), suggesting significant deterioration in both groups over the year. Symptom score, EQ-5D-5L and Vaizey score improved in both groups compared with baseline, but there was no difference between interventions. Pain was less severe and of shorter duration in the RBL group; most of the HAL group who had pain had mild to moderate pain, resolving by 3 weeks. Complications were low frequency and not significantly different between groups. It appeared that HAL was not cost-effective compared with RBL. In the base-case analysis, the difference in mean total costs was £1027 higher for HAL. Quality-adjusted life-years (QALYs) were higher for HAL; however, the difference was very small (0.01) resulting in an incremental cost-effectiveness ratio of £104,427 per additional QALY. CONCLUSIONS: At 1 year, although HAL resulted in fewer recurrences, recurrence was similar to repeat RBL. Symptom scores, complications, EQ-5D-5L and continence score were no different, and patients had more pain in the early postoperative period after HAL. HAL is more expensive and unlikely to be cost-effective in terms of incremental cost per QALY. LIMITATIONS: Blinding of participants and site staff was not possible. FUTURE WORK: The incidence of recurrence may continue to increase with time. Further follow-up would add to the evidence regarding long-term clinical effectiveness and cost-effectiveness. The polysymptomatic nature of haemorrhoidal disease requires a validated scoring system, and the data from this trial will allow further assessment of validity of such a system. These data add to the literature regarding treatment of grade II/III haemorrhoids. The results dovetail with results from the eTHoS study [Watson AJM, Hudson J, Wood J, Kilonzo M, Brown SR, McDonald A, et al. Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial. Lancet 2016, in press.] comparing stapled haemorrhoidectomy with excisional haemorrhoidectomy. Combined results will allow expansion of analysis, allowing surgeons to tailor their treatment options to individual patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41394716. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 88. See the NIHR Journals Library website for further project information.

Impact of laparoscopic versus open surgery on hospital costs for colon cancer: a population-based retrospective cohort study.

OBJECTIVE: Laparoscopy is increasingly being used as an alternative to open surgery in the treatment of patients with colon cancer. The study objective is to estimate the difference in hospital costs between laparoscopic and open colon cancer surgery. DESIGN: Population-based retrospective cohort study. SETTINGS: All acute hospitals of the National Health System in England. POPULATION: A total of 55 358 patients aged 30 and over with a primary diagnosis of colon cancer admitted for planned (elective) open or laparoscopic major resection between April 2006 and March 2013. PRIMARY OUTCOMES: Inpatient hospital costs during index admission and after 30 and 90 days following the index admission. RESULTS: Propensity score matching was used to create comparable exposed and control groups. The hospital cost of an index admission was estimated to be £1933 (95% CI 1834 to 2027; p<0.01) lower among patients who underwent laparoscopic resection. After including the first unplanned readmission following index admission, laparoscopy was £2107 (95% CI 2000 to 2215; p<0.01) less expensive at 30 days and £2202 (95% CI 2092 to 2316; p<0.01) less expensive at 90 days. The difference in cost was explained by shorter hospital stay and lower readmission rates in patients undergoing minimal access surgery. The use of laparoscopic colon cancer surgery increased 4-fold between 2006 and 2012 resulting in a total cost saving in excess of £29.3 million for the National Health Service (NHS). CONCLUSIONS: Laparoscopy is associated with lower hospital costs than open surgery in elective patients with colon cancer suitable for both interventions.

The potential impact of local excision for T1 colonic cancer in elderly and comorbid populations: a decision analysis.

BACKGROUND: Population-based bowel cancer screening has resulted in increasing numbers of patients with T1 colonic cancer. The need for colectomy in this group is questioned due to the low risk of lymphatic spread and increased treatment morbidity, particularly for elderly, comorbid patients. This study examined the quality-of-life benefits and risks of endoscopic resection compared with results after colectomy, for low-risk and high-risk T1 colonic cancer. METHODS: Decision analysis using a Markov simulation model was performed; patients were managed with either endoscopic resection (advanced therapeutic endoscopy) or colectomy. Lesions were considered high risk according to accepted national guidelines. Probabilities and utilities (perception of quality of life) were derived from published data. Hypothetical cohorts of 65- and 80-year-old, fit and unfit patients with low-risk or high-risk T1 colonic cancer were studied. The primary outcome was quality-adjusted life expectancy (QALE) in life-years (QALYs). RESULTS: In low-risk T1 colonic neoplasia, endoscopic resection increases QALE by 0.09 QALYS for fit 65-year-olds and by 0.67 for unfit 80-year-olds. For high-risk T1 cancers, the QALE benefit for surgical resection is 0.24 QALYs for fit 65-year-olds and the endoscopic QALE benefit is 0.47 for unfit 80-year-olds. The model findings only favored surgery with high local recurrence rates and when quality of life under surveillance was perceived poorly. CONCLUSIONS: Under broad assumptions, endoscopic resection is a reasonable treatment option for both low-risk and high-risk T1 colonic cancer, particularly in elderly, comorbid patients. Exploration of methods to facilitate endoscopic resection of T1 colonic neoplasia appears warranted.

Unemployment, public-sector healthcare expenditure and colorectal cancer mortality in the European Union: 1990-2009.

OBJECTIVES: We examined the association between unemployment and government spending on healthcare with colorectal cancer mortality. METHODS: Retrospective observational study using data from the World Bank and WHO. Multivariate regression analysis was used, controlling for country-specific differences in infrastructure and demographics. RESULTS: A 1 % increase in unemployment was associated with a significant increase in colorectal cancer mortality in both men and women [men: coefficient (R) = 0.0995, 95 % confidence interval (CI) 0.0132-0.1858, P = 0.024; women: R = 0.0742, 95 % CI 0.0160-0.1324, P = 0.013]. A 1 % increase in government spending on healthcare was associated with a statistically significant decrease in colorectal cancer mortality across both sexes (men: R = -0.4307, 95 % CI -0.6057 to -0.2557, P < 0.001; women: R = -0.2162, 95 % CI -0.3407 to -0.0917, P = 0.001). The largest changes in mortality occurred 3-4 years following changes in either economic variable. CONCLUSIONS: Unemployment rises are associated with a significant increase in colorectal cancer mortality, whilst government healthcare spending rises are associated with falling mortality. This is likely due, in part, to reduced access to healthcare services and has major implications for clinicians and policy makers alike.

Avoiding radical surgery improves early survival in elderly patients with rectal cancer, demonstrating complete clinical response after neoadjuvant therapy: results of a decision-analytic model.

BACKGROUND: In elderly and comorbid patients with rectal cancer, radical surgery is associated with significant perioperative mortality. Data suggest that a watch-and-wait approach where a complete clinical response is obtained after neoadjuvant chemoradiotherapy might be oncologically safe. OBJECTIVE: This study aimed to determine whether patient age and comorbidity should influence surgeon and patient decision making where a complete clinical response is obtained. DESIGN: Decision-analytic modeling consisting of a decision tree and Markov chain simulation was used. Modeled outcome parameters were elicited both from comprehensive literature review and from a national patient outcomes database. SETTINGS: Outcomes for 3 patient cohorts treated with neoadjuvant therapy were modeled after either surgery or watch and wait. PATIENTS: Patients included 60-year-old and 80-year-old men with mild comorbidities (Charlson score <3) and 80-year-old men with significant comorbidities (Charlson score >3). MAIN OUTCOME MEASURES: Absolute survival, disease-free survival, and quality-adjusted life years were measured. RESULTS: The model found that absolute survival was similar in 60-year-old patients but was significantly improved in fit and comorbid 80-year-old patients at 1 year after treatment where watch and wait was implemented instead of radical surgery, with a survival advantage of 10.1% (95% CI, 7.9-12.6) and 13.5% (95% CI, 10.2-16.9). At all of the other time points, absolute survival was equivalent for both techniques. There were no short- or long-term differences among any patient groups managed either by radical surgery or watch and wait in terms of either disease-free survival or quality-adjusted life years. LIMITATIONS: Oncologic data for the watch-and-wait approach used for this study is derived from only a small number of studies pertaining to a highly selected group of patients. The 90-day postoperative mortality rate derived from the United Kingdom population-based study might be lower in other countries or individual institutions. CONCLUSIONS: This study suggests competing effects of oncologic and surgical risk when using watch-and-wait management and that elderly and comorbid patients have the most to gain from this approach.

Unemployment, public-sector health-care spending and breast cancer mortality in the European Union: 1990-2009.

BACKGROUND: The global economic crisis has been associated with increased unemployment, reduced health-care spending and adverse health outcomes. Insights into the impact of economic variations on cancer mortality, however, remain limited. METHODS: We used multivariate regression analysis to assess how changes in unemployment and public-sector expenditure on health care (PSEH) varied with female breast cancer mortality in the 27 European Union member states from 1990 to 2009. We then determined how the association with unemployment was modified by PSEH. Country-specific differences in infrastructure and demographic structure were controlled for, and 1-, 3-, 5- and 10-year lag analyses were conducted. Several robustness checks were also implemented. RESULTS: Unemployment was associated with an increase in breast cancer mortality [P < 0.0001, coefficient (R) = 0.1829, 95% confidence interval (CI) 0.0978-0.2680]. Lag analysis showed a continued increase in breast cancer mortality at 1, 3, 5 and 10 years after unemployment rises (P < 0.05). Controlling for PSEH removed this association (P = 0.063, R = 0.080, 95% CI -0.004 to 0.163). PSEH increases were associated with significant decreases in breast cancer mortality (P < 0.0001, R = -1.28, 95% CI -1.67 to -0.877). The association between unemployment and breast cancer mortality remained in all robustness checks. CONCLUSION: Rises in unemployment are associated with significant short- and long-term increases in breast cancer mortality, while increases in PSEH are associated with reductions in breast cancer mortality. Initiatives that bolster employment and maintain total health-care expenditure may help minimize increases in breast cancer mortality during economic crises.

Unemployment, public-sector healthcare spending and stomach cancer mortality in the European Union, 1981-2009.

OBJECTIVES: We sought to determine the association between changes in unemployment, healthcare spending and stomach cancer mortality. METHODS: Multivariate regression analysis was used to assess how changes in unemployment and public-sector expenditure on healthcare (PSEH) varied with stomach cancer mortality in 25 member states of the European Union from 1981 to 2009. Country-specific differences in healthcare infrastructure and demographics were controlled for 1- to 5-year time-lag analyses and robustness checks were carried out. RESULTS: A 1% increase in unemployment was associated with a significant increase in stomach cancer mortality in both men and women [men: coefficient (R)=0.1080, 95% confidence interval (CI)=0.0470-0.1690, P=0.0006; women: R=0.0488, 95% CI=0.0168-0.0809, P=0.0029]. A 1% increase in PSEH was associated with a significant decrease in stomach cancer mortality (men: R=-0.0009, 95% CI=-0.0013 to -0.005, P<0.0001; women: R=-0.0004, 95% CI=-0.0007 to -0.0001, P=0.0054). The associations remained when economic factors, urbanization, nutrition and alcohol intake were controlled for, but not when healthcare resources were controlled for. Time-lag analysis showed that the largest changes in mortality occurred 3-4 years after any changes in either unemployment or PSEH. CONCLUSION: Increases in unemployment are associated with a significant increase in stomach cancer mortality. Stomach cancer mortality is also affected by public-sector healthcare spending. Initiatives that bolster employment and maintain public-sector healthcare expenditure may help to minimize increases in stomach cancer mortality during economic downturns.