An efficient strategy for evaluating new non-invasive screening tests for colorectal cancer: the guiding principles.

OBJECTIVE: New screening tests for colorectal cancer (CRC) are rapidly emerging. Conducting trials with mortality reduction as the end point supporting their adoption is challenging. We re-examined the principles underlying evaluation of new non-invasive tests in view of technological developments and identification of new biomarkers. DESIGN: A formal consensus approach involving a multidisciplinary expert panel revised eight previously established principles. RESULTS: Twelve newly stated principles emerged. Effectiveness of a new test can be evaluated by comparison with a proven comparator non-invasive test. The faecal immunochemical test is now considered the appropriate comparator, while colonoscopy remains the diagnostic standard. For a new test to be able to meet differing screening goals and regulatory requirements, flexibility to adjust its positivity threshold is desirable. A rigorous and efficient four-phased approach is proposed, commencing with small studies assessing the test's ability to discriminate between CRC and non-cancer states (phase I), followed by prospective estimation of accuracy across the continuum of neoplastic lesions in neoplasia-enriched populations (phase II). If these show promise, a provisional test positivity threshold is set before evaluation in typical screening populations. Phase III prospective studies determine single round intention-to-screen programme outcomes and confirm the test positivity threshold. Phase IV studies involve evaluation over repeated screening rounds with monitoring for missed lesions. Phases III and IV findings will provide the real-world data required to model test impact on CRC mortality and incidence. CONCLUSION: New non-invasive tests can be efficiently evaluated by a rigorous phased comparative approach, generating data from unbiased populations that inform predictions of their health impact.

Should we screen for colorectal cancer in people aged 75 and over? A systematic review - collaborative work of the French geriatric oncology society (SOFOG) and the French federation of digestive oncology (FFCD).

BACKGROUND: We have done a systematic literature review about CRC Screening over 75 years old in order to update knowledge and make recommendations. METHODS: PUBMED database was searched in October 2021 for articles published on CRC screening in the elderly, and generated 249 articles. Further searches were made to find articles on the acceptability, efficacy, and harms of screening in this population, together with the state of international guidelines. RESULTS: Most benefit-risk data on CRC screening in the over 75 s derived from simulation studies. Most guidelines recommend stopping cancer screening at the age of 75. In private health systems, extension of screening up to 80-85 years is, based on the life expectancy and the history of screening. Screening remains effective in populations without comorbidity given their better life-expectancy. Serious adverse events of colonoscopy increase with age and can outweigh the benefit of screening. The great majority of reviews concluded that screening between 75 and 85 years must be decided case by case. CONCLUSION: The current literature does not allow Evidence-Based Medicine propositions for mass screening above 75 years old. As some subjects over 75 years may benefit from CRC screening, we discussed ways to introduce CRC screening in France in the 75-80 age group. IRB: An institutional review board composed of members of the 2 learned societies (SOFOG and FFCD) defined the issues of interest, followed the evolution of the work and reviewed and validated the report.

Posttraumatic Stress Symptoms in Patients With Cancer During the COVID-19 Pandemic: A One-Year Longitudinal Study.

BACKGROUND: Patients with cancer may be particularly vulnerable to psychological consequences of the COVID-19 pandemic. We studied the prevalence and evolution of posttraumatic stress symptoms (PTSS) in patients with cancer during the pandemic waves, and we investigated factors associated with high symptoms. METHODS: COVIPACT is a 1-year longitudinal prospective study of French patients with solid/hematologic malignancies receiving treatment during the first nationwide lockdown. PTSS were measured every 3 months from April 2020 using the Impact of Event Scale-Revised. Patients also completed questionnaires on their quality of life, cognitive complaints, insomnia, and COVID-19 lockdown experience. RESULTS: Longitudinal analyses involved 386 patients with at least one PTSS assessment after baseline (median age, 63 years; 76% female). Among them, 21.5% had moderate/severe PTSS during the first lockdown. The rate of patients reporting PTSS decreased at lockdown release (13.6%), increased again at second lockdown (23.2%), and slightly declined from the second release period (22.7%) to the third lockdown (17.5%). Patients were grouped into 3 trajectories of evolution. Most patients had stable low symptoms throughout the period, 6% had high baseline symptoms slowly decreasing over time, and 17.6% had moderate symptoms worsening during the second lockdown. Female sex, feeling socially isolated, worrying about COVID-19 infection, and using psychotropic drugs were associated with PTSS. PTSS were associated with impaired quality of life, sleep, and cognition. CONCLUSIONS: Approximately one-fourth of patients with cancer experienced high and persistent PTSS over the first year of the COVID-19 pandemic and may benefit from psychological support. CLINICALTRIALS: gov identifier: NCT04366154.

Association Between Use of Anticancer Drugs and Cardiovascular Disease-Related Hospitalization in Metastatic Colorectal Cancer: Insights From a Population-Based Study, the Anticancer Vigilance of Cardiac Events Study.

We aimed to investigate the association between use of anticancer drugs and cardiovascular-related hospitalization (CVRH) among patients with metastatic colorectal cancer (mCRC). A cohort study, the Anticancer Vigilance of Cardiac Events (AVOCETTE) Study, was conducted using data from the digestive tumor registry of a French county, the Département du Calvados. Incident mCRC cases diagnosed between 2008 and 2014 were included. The follow-up end date was December 31, 2016. Data from the county hospital center pharmacy and medical information departments were matched with the registry data. A competing-risks approach was used. Statistical tests were 2-sided. A total of 1,116 mCRC patients were included, and they were administered 12,374 rounds of treatment; fluorouracil, oxaliplatin, irinotecan, and bevacizumab were most common drugs used. A total of 208 CVRH events occurred in 145 patients (13.0%). The International Cancer Survival Standards type 1 standardized incidence was 84.0 CVRH per 1,000 person-years (95% confidence interval: 72.6, 95.5). Anticancer drugs were not associated with a higher incidence of CVRH. Male sex, increasing age, a prior history of CVRH, and a higher Charlson comorbidity index score were associated with a higher incidence of CVRH. CVRH was significantly associated with higher all-cause mortality (multivariable hazard ratio = 1.58, 95% confidence interval: 1.28, 1.95). In this study, anticancer drugs were not associated with a higher incidence of CVRH in mCRC patients.

Post-traumatic stress symptomatology and adjustment of medical oncology practice during the COVID-19 pandemic among adult patients with cancer in a day care hospital.

BACKGROUND: The COVID-19 pandemic may induce post-traumatic stress disorder (PTSD) symptoms among patients with cancer, who also face adaptations to their treatment. The authors assessed the occurrence of PTSD symptoms, investigated pandemic-induced adjustments in medical oncology practice in patients with cancer, and explored risk factors for PTSD and the association between PTSD symptoms, insomnia, and quality of life (QoL). METHODS: This prospective French study was conducted in patients with solid/hematologic tumors who were receiving medical treatment in the day care departments of 2 cancer centers during the lockdown. Adjustments to medical oncology practice were collected from medical records. PTSD (measured using the Impact of Event Scale-Revised), insomnia (measured using the Insomnia Severity Index), QoL (measured using the Functional Assessment of Cancer Therapy-General instrument), and cognitive complaints (measured using the Functional Assessment of Cancer Therapy-Cognitive Function instrument) were collected through validated questionnaires. RESULTS: Clinical data and questionnaires were available for 734 and 576 patients, respectively. The median patient age was 64 years, and 69% of patients were women. Twenty-one percent of patients had PTSD. Twenty-seven percent (95% CI, 23%-30%) had an adjustment in their medical oncology program, including adjournments (29%), treatment interruptions (16%), modified treatment plans (27%), or adapted monitoring (27%). Women and patients experiencing an adjustment in oncology practice had a higher odds of PTSD (odds ratio= 2.10 [95% CI, 1.07-4.14] and 1.65 [95% CI, 1.03-2.63]; P < .05). PTSD symptoms were correlated with worse scores for QoL, cognition, and insomnia. CONCLUSIONS: Twenty-one percent of patients with cancer experienced PTSD symptoms associated with poor QoL during the first COVID-19-induced lockdown. Medical oncology practice was adjusted in approximately one-quarter of patients and was associated with the occurrence of PTSD symptoms. Psychosocial support should be offered in cancer centers to promote emotional resilience and avoid PTSD symptoms in patients.

Social inequalities in cervical cancer screening: a discrete choice experiment among French general practitioners and gynaecologists.

BACKGROUND: Cervical cancer screening is effective in reducing mortality due to uterine cervical cancer (UCC). However, inequalities in participation in UCC screening exist, especially according to age and social status. Considering the current situation in France regarding the ongoing organized UCC screening campaign, we aimed to assess general practitioners' (GPs) and gynaecologists' preferences for actions designed to reduce screening inequalities. METHODS: French physicians' preferences to UCC screening modalities was assessed using a discrete choice experiment. A national cross-sectional questionnaire was sent between September and October 2014 to 500 randomly selected physicians, and numerically to all targeted physicians working in the French region Midi-Pyrénées. Practitioners were offered 11 binary choices of organized screening scenarios in order to reduce inequalities in UCC screening participation. Each scenario was based on five attributes corresponding to five ways to enhance participation in UCC screening while reducing screening inequalities. RESULTS: Among the 123 respondents included, practitioners voted for additional interventions targeting non-screened women overall (p <  0.05), including centralized invitations sent from a central authority and involving the mentioned attending physician, or providing attending physicians with the lists of unscreened women among their patients. However, they rejected the specific targeting of women over 50 years old (p <  0.01) or living in deprived areas (p <  0.05). Only GPs were in favour of allowing nurses to perform Pap smears, but both GPs and gynaecologists rejected self-collected oncogenic papillomavirus testing. CONCLUSIONS: French practitioners tended to value the traditional principle of universalism. As well as rejecting self-collected oncogenic papillomavirus testing, their reluctance to support the principle of proportionate universalism relying on additional interventions addressing differences in socioeconomic status needs further evaluation. As these two concepts have already been recommended as secondary development leads for the French national organized screening campaign currently being implemented, the adherence of practitioners and the adaptation of these concepts are necessary conditions for reducing inequalities in health care.

Additional diagnostic value of new CT imaging techniques for the functional assessment of coronary artery disease: a meta-analysis.

OBJECTIVES: To determine the diagnostic performance of cardiac computed tomography (CT)-based modalities including coronary CT angiography (CTA), stress myocardial CT perfusion (stress CTP), computer simulation of fractional flow reserve by CT (FFRCT), and transluminal attenuation gradients (TAG), for the diagnosis of hemodynamic significant coronary artery disease (CAD), using invasive fractional flow reserve as the reference standard. METHODS: PubMed and Cochrane databases were searched for original articles until July 2018. Diagnostic accuracy results were pooled at per-patient and per-vessel level using random effect models. RESULTS: Fifty articles were included in the meta-analysis (3024 subjects). The per-patient analysis per imaging modality demonstrated a pooled positive likelihood ratio (PLR) of 1.78 (95% confidence interval CI 1.49-2.11), 4.58 (95% CI 3.54-5.91), and 3.45 (95% CI 2.38-5.00) for CTA, stress CTP, and FFRCT respectively. Per-patient specificity of stress CTP (82%, 95% CI 76-86) and FFRCT (72%, 95% CI 68-76) were higher than for CTA (48%, 95% CI 44-51). At the vessel level, PLR was 2.42 (95% CI 1.93-3.02), 7.72 (95% CI 5.50-10.83), 3.50 (95% CI 2.73-4.78), 1.97 (95% CI 1.32-2.93) for CTA, stress CTP, FFRCT, and TAG respectively. CONCLUSION: With improved PLR and specificity, stress CTP and FFRCT have incremental value over CTA for the detection of functionally significant CAD. KEY POINTS: • New functional CT imaging techniques, such as stress CTP and FFRCT, improve diagnostic accuracy of coronary CTA to predict hemodynamically relevant stenosis. • TAG yields poor diagnostic performance. • Combination of CTA and some functional CT techniques (stress CTP and FFRCT) might become a "must" to improve diagnostic accuracy of CAD and to reduce unnecessary invasive coronary angiography.

Cost-Effectiveness Analysis of a Mobile Mammography Unit for Breast Cancer Screening to Reduce Geographic and Social Health Inequalities.

BACKGROUND: Breast cancer is the leading cancer in terms of incidence and mortality among women in France. Effective organized screening does exist, however, the participation rate is low, and negatively associated with a low socioeconomic status and remoteness. OBJECTIVES: To determine the cost-effectiveness of a mobile mammography (MM) program to increase participation in breast cancer screening and reduce geographic and social inequalities. METHODS: A cost-effectiveness analysis from retrospective data was conducted from the payer perspective, comparing an invitation to a mobile mammography unit (MMU) or to a radiologist's office (MM or RO group) with an invitation to a radiologist's office only (RO group) (n = 37 461). Medical and nonmedical direct costs were estimated. Outcome was screening participation. The mean incremental cost and effect, the incremental cost-effectiveness ratio, and the cost-effectiveness acceptability curve were estimated. RESULTS: The mean incremental cost for invitation to MM or RO was estimated to be €23.21 (95% CI, 22.64-23.78) compared with RO only, and with a point of participation gain of 3.8% (95% CI, 2.8-4.8), resulting in an incremental cost per additional screen of €610.69 (95% CI, 492.11-821.01). The gain of participation was more important in women living in deprived areas and for distances exceeding 15 km from an RO. CONCLUSION: Screening involving a MMU can increase participation in breast cancer screening and reduce geographic and social inequalities while being more cost-effective in remote areas and in deprived areas. Because of the retrospective design, further research is needed to provide more evidence of the effectiveness and cost-effectiveness of using a MMU for organized breast cancer screening and to determine the optimal conditions for implementing it.

French Therapeutic Education Programme Aimed at Improving the Quality of Life of Laryngectomised Patients and their Close Relations: the Three Stages (Observational and Interventional Randomised) of the Study "PETAL".

The therapeutic education of patients and their close relations is, as yet, poorly developed in France in the field of oncology. Total laryngectomy is a mutilating surgical procedure having a major impact on the patient's life, due to its physical and functional sequelae. Its psychosocial consequences are also important and alter the quality of life of patients and their close relations. Currently, care for laryngectomised patients consists essentially in informing and educating them on some technical procedures during hospital admission. The intervention of a speech therapist, often serves as the link between the patient and the hospital care team. These healthcare modalities often insufficiently account for the social, environmental and personal factors that interact in health-related problems. This report presents the therapeutic education programme protocol "PETAL" for laryngectomised patients and their close relations to improve their quality of life. The trial will be conducted over three phases: (1) the "pilot" phase aims at developing knowledge on the consequences of laryngectomy on the quality of life of patients and their close relations and developed a pluridisciplinary therapeutic education program, (2) the prospective intervention "replication" phase aims at evaluating the programme's transferability in three centres and (3) the cluster-randomised multicentric comparative intervention phase, will assess the benefits of the developed programme. Phase I identified nine themes of workshops related to therapeutic education, training and coordination of care. The developed programme should reinforce town-hospital links to improve help, follow-up and support for patients and their close relations.

Cost-Effectiveness Analysis of a Navigation Program for Colorectal Cancer Screening to Reduce Social Health Inequalities: A French Cluster Randomized Controlled Trial.

BACKGROUND: Patient navigation programs to increase colorectal cancer (CRC) screening adherence have become widespread in recent years, especially among deprived populations. OBJECTIVES: To evaluate the cost-effectiveness of the first patient navigation program in France. METHODS: A total of 16,250 participants were randomized to either the usual screening group (n = 8145) or the navigation group (n = 8105). Navigation consisted of personalized support provided by social workers. A cost-effectiveness analysis of navigation versus usual screening was conducted from the payer perspective in the Picardy region of northern France. We considered nonmedical direct costs in the analysis. RESULTS: Navigation was associated with a significant increase of 3.3% (24.4% vs. 21.1%; P = 0.003) in participation. The increase in participation was higher among affluent participants (+4.1%; P = 0.01) than among deprived ones (+2.6%; P = 0.07). The cost per additional individual screened by navigation compared with usual screening (incremental cost-effectiveness ratio) was €1212 globally and €1527 among deprived participants. Results were sensitive to navigator wages and to the intervention effectiveness whose variations had the greatest impact on the incremental cost-effectiveness ratio. CONCLUSIONS: Patient navigation aiming at increasing CRC screening participation is more efficient among affluent individuals. Nevertheless, when the intervention is implemented for the entire population, social inequalities in CRC screening adherence increase. To reduce social inequalities, patient navigation should therefore be restricted to deprived populations, despite not being the most cost-effective strategy, and accepted to bear a higher extra cost per additional individual screened.

Could mobile mammography reduce social and geographic inequalities in breast cancer screening participation?

Evaluation of mobile mammography for reducing social and geographic inequalities in breast cancer screening participation. We examined the responses to first invitations to undergo breast cancer screening from 2003 to 2012 in Orne, a French department. Half of the participants could choose between screening in a radiologist's office or a mobile mammography (MM) unit. We calculated the participation rate and individual participation model according to age group, deprivation quintile and distance. Among participants receiving an MM invitation, the preference was for MM. This was especially the case in the age group >70years and increased with deprivation quintile and remoteness. There were no significant participation trends with regard to deprivation or remoteness. In the general population, the influence of deprivation and remoteness was markedly diminished. After adjustment, MM invitation was associated with a significant increase in individual participation (odds ratio=2.9). MM can target underserved and remote communities, allowing greater participation and decreasing social and geographic inequalities in the general population. Proportionate universalism is an effective principle for public health policy in reducing health inequalities.

Patient navigation to reduce social inequalities in colorectal cancer screening participation: A cluster randomized controlled trial.

Despite free colorectal cancer screening in France, participation remains low and low socioeconomic status is associated with a low participation. Our aim was to assess the effect of a screening navigation program on participation and the reduction in social inequalities in a national-level organized mass screening program for colorectal cancer by fecal-occult blood test (FOBT). A multicenter (3 French departments) cluster randomized controlled trial was conducted over two years. The cluster was a small geographical unit stratified according to a deprivation index and the place of residence. A total of 14,556 subjects (72 clusters) were included in the control arm where the FOBT program involved the usual postal reminders, and 14,373 subjects (66 clusters) were included in the intervention arm. Intervention concerned only non-attended subjects with a phone number available defined as the navigable population. A screening navigator was added to the usual screening organization to identify and eliminate barriers to CRC screening with personalized contact. The participation rate by strata increased in the intervention arm. The increase was greater in affluent strata than in deprived ones. Multivariate analyses demonstrated that the intervention mainly with phone navigation increased individual participation (OR=1.19 [1.10, 1.29]) in the navigable population. For such interventions to reduce social inequalities in a country with a national level organized mass screening program, they should first be administered to deprived populations, in accordance with the principle of proportionate universalism. ClinicalTrials.gov Identifier: NCT01555450.

Recommendations for a step-wise comparative approach to the evaluation of new screening tests for colorectal cancer.

BACKGROUND: New screening tests for colorectal cancer continue to emerge, but the evidence needed to justify their adoption in screening programs remains uncertain. METHODS: A review of the literature and a consensus approach by experts was undertaken to provide practical guidance on how to compare new screening tests with proven screening tests. RESULTS: Findings and recommendations from the review included the following: Adoption of a new screening test requires evidence of effectiveness relative to a proven comparator test. Clinical accuracy supported by programmatic population evaluation in the screening context on an intention-to-screen basis, including acceptability, is essential. Cancer-specific mortality is not essential as an endpoint provided that the mortality benefit of the comparator has been demonstrated and that the biologic basis of detection is similar. Effectiveness of the guaiac-based fecal occult blood test provides the minimum standard to be achieved by a new test. A 4-phase evaluation is recommended. An initial retrospective evaluation in cancer cases and controls (Phase 1) is followed by a prospective evaluation of performance across the continuum of neoplastic lesions (Phase 2). Phase 3 follows the demonstration of adequate accuracy in these 2 prescreening phases and addresses programmatic outcomes at 1 screening round on an intention-to-screen basis. Phase 4 involves more comprehensive evaluation of ongoing screening over multiple rounds. Key information is provided from the following parameters: the test positivity rate in a screening population, the true-positive and false-positive rates, and the number needed to colonoscope to detect a target lesion. CONCLUSIONS: New screening tests can be evaluated efficiently by this stepwise comparative approach.

Seasonal variations do not affect the superiority of fecal immunochemical tests over guaiac tests for colorectal cancer screening.

The aim of this study was to compare the seasonal variation in performance of a faecal immunochemical test for haemoglobin (FIT) and a guaiac test (gFOBT) for colorectal cancer screening. From June 2009 to May 2011, 18,290 screening participants (50-74 years old) performed OC-SENSOR quantitative FIT (1 sample) and Hemoccult II gFOBT (3 stool samples with 2 spots/sample). Referral for colonoscopy required a minimum of one positive spot (gFOBT), or a positive FIT [cut-off 150 ng haemoglobin/mL buffer (i.e. 30 µg haemoglobin/g feces)]. The performance of tests for detection of advanced neoplasia was compared according to seasons using Receiver Operating Characteristics (ROC) curves, at various FIT cut-off values. The positivity rate of FIT was significantly lower in the summer compared with other seasons (2.3% versus 3.0%, p = 0.03), whilst the positivity rate of gFOBT increased in the autumn (1.8% versus 1.5%, p = 0.11). FIT was clinically more effective than gFOBT over the four season-specific ROC curves. At the cut-off concentration used in the study, the season-specific FIT/gFOBT ratios for true positive rates were: 2.8 (Autumn), 2.5 (Winter), 3.0 (Spring), 3.7 (Summer), and for false positive rates: 1.2 (Autumn), 1.5 (Winter), 1.8 (Spring), 0.9 (Summer). Therefore, in this study with this cut-off concentration and in spite of lower positivity rate in summer, the seasonal variations of performance of OC-SENSOR FIT led to improved gain in specificity in the summer, without a decrease in gain in sensitivity compared with gFOBT.

Pancreaticogastrostomy is superior to pancreaticojejunostomy for prevention of pancreatic fistula after pancreaticoduodenectomy: an updated meta-analysis of randomized controlled trials.

OBJECTIVE: To review prospective randomized controlled trials to determine whether pancreaticogastrostomy (PG) or pancreaticojejunostomy (PJ) is associated with lower risks of mortality and pancreatic fistula after pancreaticoduodenectomy (PD). BACKGROUND: Previous studies comparing reconstruction by PG and PJ reported conflicting results regarding the relative risks of mortality and pancreatic fistula after these procedures. METHODS: MEDLINE, the Cochrane Trials Register, and EMBASE were searched for prospective randomized controlled trials comparing PG and PJ after PD, published up to November 2013. Meta-analysis was performed using Review Manager 5.0. RESULTS: Seven trials were selected, including 562 patients who underwent PG and 559 who underwent PJ. The pancreatic fistula rate was significantly lower in the PG group than in the PJ group (63/562, 11.2% vs 84/559, 18.7%; odds ratio = 0.53; 95% confidence interval, 0.38-0.75; P = 0.0003). The overall mortality rate was 3.7% (18/489) in the PG group and 3.9% (19/487) in the PJ group (P = 0.68). The biliary fistula rate was significantly lower in the PG group than in the PJ group (8/400, 2.0% vs 19/392, 4.8%; odds ratio = 0.42; 95% confidence interval, 0.18-0.93; P = 0.03). CONCLUSIONS: In PD, reconstruction by PG is associated with lower postoperative pancreatic and biliary fistula rates.

Digestive cancers and occupational asbestos exposure: incidence study in a cohort of asbestos plant workers.

OBJECTIVE: The aim of our study was to estimate the incidence of digestive cancers within a cohort of asbestos-exposed workers. METHODS: Our study was based on a cohort of 2024 participants occupationally exposed to asbestos. The incidence of digestive cancers was calculated from 1 January 1978 to 31 December 2009 and compared with levels among the local general population using Standardised Incidence Ratios (SIRs). Asbestos exposure was assessed using the company's job-exposure matrix. RESULTS: 119 cases of digestive cancer were observed within our cohort, for an expected number of 77 (SIR=1.54 (1.28 to 1.85)). A significantly elevated incidence was observed for peritoneal mesothelioma, particularly in women. Significantly elevated incidences were also observed among men for: all digestive cancers, even when excluding peritoneal mesothelioma (SIR=1.50 (1.23 to 1.82)), oesophageal cancer (SIR=1.67 (1.08 to 2.47)) and liver cancer (SIR=1.85 (1.09 to 2.92)). Concerning colorectal cancer, a significant excess of risk was observed for men with exposure duration above 25 years (SIR=1.75 (1.05 to 2.73)). CONCLUSIONS: Our results are in favour of a link between long-duration asbestos exposure and colorectal cancer in men. They also suggest a relationship between asbestos exposure and cancer of the oesophagus in men. Finally, our results suggest a possible association with small intestine and liver cancers in men.

Delayed laparoscopic cholecystectomy increases the total hospital stay compared to an early laparoscopic cholecystectomy after acute cholecystitis: an updated meta-analysis of randomized controlled trials.

BACKGROUND: The objective of this study was to review the available prospective, randomized, controlled trials to determine whether an early (ELC) or a delayed (DLC) approach to a laparoscopic cholecystectomy is associated with an increase in length of hospitalization after acute cholecystitis. METHODS: Medline, the Cochrane Trials Register and EMBASE were searched for prospective, randomized, controlled trials (RCTs) comparing ELC versus DLC, published up to May 2014. A meta-analysis was performed using Review Manager 5.0. RESULTS: Nine RCTs were included in a total of 617 who underwent ELC and 603 patients who underwent DLC after acute cholecystitis. The mean hospital stay was 5.4 days in the ELC group and 9.1 days in the DLC group. The meta-analysis showed a mean hospital stay significantly lower in the ELC group [medical doctor (MD) = 3.24, 95% confidence interval (CI) = 1.95-4.54, P < 0.001]. The major biliary duct injury rate in the ELC group was 0.8% (2/247) and 0.9% (2/223) in the DLC group. The meta-analysis showed no significant difference between the ELC and DLC groups [relative risk (RR) =0.96, 95%CI = 0.25-3.73, P = 0.950]. CONCLUSION: DLC is associated with a longer total hospital stay but equivalent morbidity as compared to ELC for patients presenting with acute cholecystitis. ELC would appear to be the treatment of choice for patients presenting with ELC.

A population-based comparison of immunochemical fecal occult blood tests for colorectal cancer screening.

BACKGROUND & AIMS: Quantitative fecal immunochemical tests (FITs) identify individuals with colorectal cancer with greater levels of accuracy than guaiac tests. We compared the performances of 2 FITs in a population undergoing screening for colorectal cancer. METHODS: We collected fecal samples from 19,797 individuals in France (age, 50-74 y) who participated in a colorectal cancer screening program, from June 2009 through May 2011. Samples were analyzed using the Magstream (Fujirebio Inc, Tokyo, Japan) and OC Sensor (Eiken Chemical Co, Tokyo, Japan) (2 samples each) FITs, as well as the Hemoccult II guaiac test (SKD, Villepinte, France) (3 samples each). Colonoscopies were performed for patients with positive results from all 3 tests. The cut-off values for levels of hemoglobin in buffer and stools were 55 ng/mL and 180 µg/g for the Magstream and 150 ng/mL and 30 µg/g for the OC Sensor, respectively. Results from the FITs were compared with those from the guaiac test for cut-off values for stool samples, positivity rates, and the receiver operating characteristic curve values. The numbers needed to screen and the numbers needed to scope to detect an advanced neoplasia (cancer, adenoma ≥10 mm, or high-grade dysplasia) were calculated. RESULTS: A positive test result was found in 1224 participants (6.2%); 1075 (87.8%) underwent a colonoscopy examination. Of these, 334 were found to have advanced neoplasia. Considering the cut-off values associated with the positivity rate of Hemoccult II (1.6%), the numbers needed to screen were 239 for Hemoccult II, 166 for a 1-sample Magstream FIT, and 129 for a 1-sample OC Sensor FIT; the numbers needed to scope were 3.3, 2.3, and 1.8, respectively. For the same false-positive rate as Hemoccult II (0.98%), the true-positive rates for Magstream and OC Sensor FITs were 0.65% and 0.90% respectively, compared with 0.42% for Hemoccult II. The OC Sensor FIT had a greater area under the receiver operating characteristic curve value than the Magstream FIT. CONCLUSIONS: Based on results from a large, population-based study, the OC Sensor FIT identifies patients with colorectal cancer with greater accuracy than the Magstream FIT. ClinicalTrials.gov number: NCT01251666.

Socioeconomic environment and cancer incidence: a French population-based study in Normandy.

BACKGROUND: The struggle against social inequalities is a priority for many international organizations. The objective of the study was to quantify the cancer burden related to social deprivation by identifying the cancer sites linked to socioeconomic status and measuring the proportion of cases associated with social deprivation. METHODS: The study population comprised 68 967 cases of cancer diagnosed between 1997 and 2009 in Normandy and collected by the local registries. The social environment was assessed at an aggregated level using the European Deprivation Index (EDI). The association between incidence and socioeconomic status was assessed by a Bayesian Poisson model and the excess of cases was calculated with the Population Attributable Fraction (PAF). RESULTS: For lung, lips-mouth-pharynx and unknown primary sites, a higher incidence in deprived was observed for both sexes. The same trend was observed in males for bladder, liver, esophagus, larynx, central nervous system and gall-bladder and in females for cervix uteri. The largest part of the incidence associated with deprivation was found for cancer of gall-bladder (30.1%), lips-mouth-pharynx (26.0%), larynx (23.2%) and esophagus (19.6%) in males and for unknown primary sites (18.0%) and lips-mouth-pharynx (12.7%) in females. For prostate cancer and melanoma in males, the sites where incidence increased with affluence, the part associated with affluence was respectively 9.6% and 14.0%. CONCLUSIONS: Beyond identifying cancer sites the most associated with social deprivation, this kind of study points to health care policies that could be undertaken to reduce social inequalities.

Early failure in patients starting peritoneal dialysis: a competing risks approach.

BACKGROUND: Technical failure is more likely to occur in the first 6 months of peritoneal dialysis (PD). This study was carried out to identify risk factors for early transfer from PD to haemodialysis (HD) in a country where assisted PD is available. METHODS: All patients from the French Language Peritoneal Dialysis Registry (RDPLF) who started PD between 1 January 2002 and 31 December 2010 were included. Time to transfer, death and transplantation during the first 6 months on PD were analysed by the multivariate Cox proportional hazard model. The Fine and Gray model was used to examine the occurrence of technical failure by considering death and transplantation as competing events. RESULTS: Of 9675 patients included, 615 (6.3%) moved to HD during the first 6 months of PD. Cumulative incidence of transfer to HD was 6.6% at 6 months. On multivariate analysis by both the Cox model and the Fine and Gray model, HD prior to PD, allograft failure and early peritonitis were associated with a higher risk of early technical failure, whereas being dialysed in a centre treating more than 20 new patients per year was associated with a lower risk of early transfer to HD. CONCLUSIONS: Patients treated by HD before PD and failed transplant patients had a higher risk of early PD failure when competing events were considered.