Linked Colour imaging for the detection of polyps in patients with Lynch syndrome: a multicentre, parallel randomised controlled trial.

OBJECTIVE: Despite regular colonoscopy surveillance, colorectal cancers still occur in patients with Lynch syndrome. Thus, detection of all relevant precancerous lesions remains very important. The present study investigates Linked Colour imaging (LCI), an image-enhancing technique, as compared with high-definition white light endoscopy (HD-WLE) for the detection of polyps in this patient group. DESIGN: This prospective, randomised controlled trial was performed by 22 experienced endoscopists from eight centres in six countries. Consecutive Lynch syndrome patients ≥18 years undergoing surveillance colonoscopy were randomised (1:1) and stratified by centre for inspection with either LCI or HD-WLE. Primary outcome was the polyp detection rate (PDR). RESULTS: Between January 2018 and March 2020, 357 patients were randomised and 332 patients analysed (160 LCI, 172 HD-WLE; 6 excluded due to incomplete colonoscopies and 19 due to insufficient bowel cleanliness). No significant difference was observed in PDR with LCI (44.4%; 95% CI 36.5% to 52.4%) compared with HD-WLE (36.0%; 95% CI 28.9% to 43.7%) (p=0.12). Of the secondary outcome parameters, more adenomas were found on a patient (adenoma detection rate 36.3%; vs 25.6%; p=0.04) and a colonoscopy basis (mean adenomas per colonoscopy 0.65 vs 0.42; p=0.04). The median withdrawal time was not statistically different between LCI and HD-WLE (12 vs 11 min; p=0.16). CONCLUSION: LCI did not improve the PDR compared with HD-WLE in patients with Lynch syndrome undergoing surveillance. The relevance of findings more adenomas by LCI has to be examined further. TRIAL REGISTRATION NUMBER: NCT03344289.

Fear and forget: how anxiety impacts information recall in newly diagnosed cancer patients visiting a fast-track clinic.

INTRODUCTION: One-day fast track programs for cancer diagnostics and treatment planning are increasingly being implemented in health care. Fast-track programs are highly effective at reducing waiting times, and thus well received by patients and healthcare providers. However, these programs may also burden patients, as patients generally receive a lot of information from multiple healthcare providers within a short time span. This might increase anxiety and negatively impact recall of medical information in newly diagnosed patients. This study examines whether anxiety influences information recall at the moment of diagnosis, and whether this relation differs for younger and older patients. METHODS: Data were collected from 78 colorectal cancer patients visiting a one-day fast-track multidisciplinary outpatient clinic. All consultations that took place were recorded on a video. Anxiety was measured at baseline (T1) and immediately after consultations (T2) with the STAI-6. Information recall was assessed by telephone within 36-48 hours after patients' visit (T3) using open questions. RESULTS: After consultations (T2), 32% of patients experienced clinical anxiety levels. Patients recalled ∼60% of medical information (T3). Information recall was negatively impacted by anxiety (ß = -.28, p = .011), and negatively related to higher age (ß = -.23, p = .031), and lower education level (ß = .27, p = .013). Although older patients (M = 53.99) recalled 11% less information than younger patients (M = 64.84), age was not related to anxiety and did not moderate the anxiety-recall relationship. CONCLUSION: High levels of anxiety after receiving a cancer diagnosis negatively influence how much information patients remember after visiting a one-day fast-track clinic. This calls for interventions that may reduce patients' anxiety as much as reasonably possible and support patients' information recall. Researchers, practitioners, and hospitals are encouraged to continue exploring ways to optimize information provision to cancer patients in current modern healthcare.

Optimising eHealth tools for older patients: Collaborative redesign of a hospital website.

Most hospital websites have not been developed in collaboration with patients and, therefore, rarely take into account the preferences and abilities of older patients. This study describes the systematic redesign of an existing hospital website in a co-design process with patients and professional stakeholders (e.g. researchers, physicians, nurses, department heads, policymakers, website designers), with the aim to make it more user-friendly for older patients with colorectal cancer (CRC). The redesign process consisted of three phases, where (I) both existing content and design were evaluated among CRC patients; (II) a prototype website was developed based on these insights; which (III) was evaluated again before making final adjustments. Mixed research methods were used for the redesign process. Specifically, insights from existing literature, outcomes from qualitative and quantitative empirical studies conducted by our team, and expert knowledge from relevant stakeholders, were collected and discussed in multidisciplinary consensus meetings, and served as input for the redesigned website. While the existing website was evaluated poorly, the qualitative evaluation of the prototype website in phase 3 showed that the newly redesigned website was usable for older CRC patients. A practical roadmap on how to collaboratively redesign and optimise existing eHealth tools to make them suitable for and operational in clinical settings is provided.

Development of a tailored work-related support intervention for gastrointestinal cancer patients.

Aim is the development of a work-related support intervention, tailored to the severity of work-related problems of patients diagnosed with gastrointestinal (GI) cancer treated with curative intent. Two methods were used: (1) Work-related problems were identified from the literature and submitted to an expert panel during a modified Delphi study. Experts allocated work-related problems into degrees of severity: mild, severe or complex. In addition, experts indicated which health care professional should provide the tailored support: (2) These outcomes were combined with existing interventions to design the tailored intervention. Semi-structured interviews with experts were conducted to assess whether the intervention was comprehensive, and feasible for daily practice. A decision diagram measuring severity of work-related problems was developed based on the modified Delphi study with 44 experts, encompassing social, disease and occupational problems. Based on the degree of severity, support was provided by: an oncological nurse (mild), oncological occupational physician (severe) or multidisciplinary team (complex). The intervention encompassed three individual meetings in the clinical setting and was considered comprehensive and feasible by 12 experts. The intervention is innovative in combining oncological and occupational care in the clinic and being tailored to the needs of GI cancer patients with specific work-related problems.

The Value of Multidisciplinary Team Meetings for Patients with Gastrointestinal Malignancies: A Systematic Review.

INTRODUCTION: The incidence of gastrointestinal (GI) cancer is rising and most patients with GI malignancies are discussed by a multidisciplinary team (MDT). We performed a systematic review to assess whether MDTs for patients with GI malignancies can correctly change diagnosis, tumor stage and subsequent treatment plan, and whether the treatment plan was implemented. METHODS: We performed a systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We conducted a search of the PubMed, MEDLINE and EMBASE electronic databases, and included studies relating to adults with a GI malignancy discussed by an MDT prior to the start of treatment which described a change of initial diagnosis, stage or treatment plan. Two researchers independently evaluated all retrieved titles and abstracts from the abovementioned databases. RESULTS: Overall, 16 studies were included; the study quality was rated as fair. Four studies reported that MDTs changed the diagnoses formulated by individual physicians in 18.4-26.9% of evaluated cases; two studies reported that MDTs formulated an accurate diagnosis in 89 and 93.5% of evaluated cases, respectively; nine studies described that the treatment plan was altered in 23.0-41.7% of evaluated cases; and four studies found that MDT decisions were implemented in 90-100% of evaluated cases. The reasons for altering a treatment plan included the patient's wishes, and comorbidities. CONCLUSIONS: MDT meetings for patients with a GI malignancy are responsible for changes in diagnoses and management in a significant number of patients. Treatment plans formulated by MDTs are implemented in 90-100% of discussed patients. All patients with a GI malignancy should be discussed by an MDT.

Is there a Benefit of Multidisciplinary Cancer Team Meetings for Patients with Gastrointestinal Malignancies?

BACKGROUND: Multidisciplinary cancer team meetings are intended to optimize the diagnosis of a patient with a malignancy. The aim of this study was to assess the number of correct diagnoses formulated by the multidisciplinary team (MDT) and whether MDT decisions were implemented. METHODS: In a prospective study, data of consecutive patients discussed at gastrointestinal oncology MDT meetings were studied, and MDT diagnoses were validated with pathology or follow-up. Factors of influence on the correct diagnosis were identified by use of a Poisson regression model. Electronic patient records were used to assess whether MDT decisions were implemented, and reasons to deviate from these decisions were hand-searched within these records. RESULTS: In 74 MDT meetings, 551 patients were discussed a total of 691 times. The MDTs formulated a correct diagnosis for 515/551 patients (93.4 %), and for 120/551 (21.8 %) patients the MDT changed the referral diagnosis. Of the MDT diagnoses, 451/515 (87.6 %) were validated with pathology. Patients presented to the MDT by their treating physician were 20 % more likely to receive a correct diagnosis [relative risk (RR) 1.2, 95 % confidence interval (CI) 1.1-1.5], while the number of patients discussed or the duration of the meeting had no influence on this (RR 1.0, 95 % CI 0.99-1.0; RR 1.0, 95 % CI 0.9-1.1; resp.). MDT decisions were implemented in 94.4 % of cases. Deviations of MDT decisions occurred when a patient's wishes or physical condition were not taken into account. CONCLUSIONS: MDTs rectify 20 % of the referral diagnoses. The presence of the treating physician is the most important factor to ensure a correct diagnosis and adherence to the treatment plan.

Design of a multicentre randomized controlled trial to evaluate the effectiveness of a tailored clinical support intervention to enhance return to work for gastrointestinal cancer patients.

BACKGROUND: Gastrointestinal (GI) cancer is frequently diagnosed in people of working age, and many GI cancer patients experience work-related problems. Although these patients often experience difficulties returning to work, supportive work-related interventions are lacking. We have therefore developed a tailored work-related support intervention for GI cancer patients, and we aim to evaluate its cost-effectiveness compared with the usual care provided. If this intervention proves effective, it can be implemented in practice to support GI cancer patients after diagnosis and to help them return to work. METHODS/DESIGN: We designed a multicentre randomized controlled trial with a follow-up of twelve months. The study population (N = 310) will include individuals aged 18-63 years diagnosed with a primary GI cancer and employed at the time of diagnosis. The participants will be randomized to the intervention or to usual care. 'Usual care' is defined as psychosocial care in which work-related issues are not discussed. The intervention group will receive tailored work-related support consisting of three face-to-face meetings of approximately 30 min each. Based on the severity of their work-related problems, the intervention group will be divided into groups receiving three types of support (A, B or C). A different supportive healthcare professional will be available for each group: an oncological nurse (A), an oncological occupational physician (B) and a multidisciplinary team (C) that includes an oncological nurse, oncological occupational physician and treating oncologist/physician. The primary outcome measure is return to work (RTW), defined as the time to a partial or full RTW. The secondary outcomes are work ability, work limitations, quality of life, and direct and indirect costs. DISCUSSION: The hypothesis is that tailored work-related support for GI cancer patients is more effective than usual care in terms of the RTW. The intervention is innovative in that it combines oncological and occupational care in a clinical setting, early in the cancer treatment process. TRIAL REGISTRATION: METC protocol number NL51444.018.14/Netherlands Trial Register number NTR5022 . Registered 6 March 2015.

Incidence of colonic neoplasia in patients with serrated polyposis syndrome who undergo annual endoscopic surveillance.

BACKGROUND & AIMS: Patients with serrated polyposis syndrome (SPS) are advised to undergo endoscopic surveillance for early detection of polyps and prevention of colorectal cancer (CRC). The optimal surveillance and treatment regimen is unknown. We performed a prospective study to evaluate a standardized endoscopic treatment protocol in a large cohort of patients with SPS. METHODS: We followed a cohort of patients with SPS who received annual endoscopic surveillance at the Academic Medical Centre in Amsterdam, The Netherlands from January 2007 through December 2012. All patients underwent clearing colonoscopy with removal of all polyps ≥3 mm. After clearance, subsequent follow-up colonoscopies were scheduled annually. The primary outcomes measure was the incidence of CRC and polyps. Secondary outcomes were the incidence of complications and the rate of preventive surgery. RESULTS: Successful endoscopic clearance of all polyps ≥3 mm was achieved in 41 of 50 (82%) patients. During subsequent annual surveillance, with a median follow-up time of 3.1 years (interquartile range, 1.5-4.3 years), CRC was not detected. The cumulative risks of detecting CRC, advanced adenomas, or large (≥10 mm) serrated polyps after 3 surveillance colonoscopies were 0%, 9%, 34%, respectively. Twelve patients (24%) were referred for preventive surgery; 9 at initial colonoscopy and 3 during surveillance. Perforations or severe bleeding did not occur. CONCLUSIONS: Annual surveillance with complete removal of all polyps ≥3 mm with timely referral of selected high-risk patients for prophylactic surgery prevents development of CRC in SPS patients without significant morbidity. Considering the substantial risk of polyp recurrence, close endoscopic surveillance in SPS seems warranted. www.trialregister.nl ID NTR2757.

Narrow-band imaging for the detection of polyps in patients with serrated polyposis syndrome: a multicenter, randomized, back-to-back trial.

BACKGROUND: Serrated polyposis syndrome (SPS) is characterized by the presence of multiple serrated polyps spread throughout the colon. Patients with SPS are considered to be at risk of colorectal cancer and are advised to undergo endoscopic surveillance. Narrow-band imaging (NBI) may improve the detection of polyps during these surveillance colonoscopies. OBJECTIVE: To compare polyp miss rates between NBI and high-resolution white-light endoscopy (HR-WLE). DESIGN: Multicenter, randomized, crossover study. SETTING: Four tertiary referral institutions. PATIENTS: A total of 52 patients with SPS undergoing surveillance colonoscopy. INTERVENTION: All patients underwent back-to-back colonoscopies with HR-WLE and NBI in a randomized order. MAIN OUTCOME MEASUREMENTS: Polyp miss rates of HR-WLE and NBI. RESULTS: In the HR-WLE group, 116 polyps were detected during the first inspection. A second inspection with NBI added 47 polyps, resulting in an overall polyp miss rate of 29% with HR-WLE (95% confidence interval, 22-36). In the NBI group, a total of 128 polyps were detected during the first inspection. Subsequent inspection with HR-WLE added 32 polyps, resulting in an overall polyp miss rate of NBI of 20% (95% confidence interval, 15-27). Comparison of the overall polyp miss rates of HR-WLE and NBI showed no significant difference (P = .065). LIMITATIONS: Small sample size; second inspection was performed by the same endoscopist. CONCLUSIONS: The results of our study suggest that NBI does not reduce polyp miss rates in patients with SPS compared with HR-WLE. Further multinational studies with larger numbers of patients are warranted to verify these results. ( CLINICAL TRIAL REGISTRATION NUMBER: NTR2497.).

Automatic optical diagnosis of small colorectal lesions by laser-induced autofluorescence.

BACKGROUND AND STUDY AIMS: Endoscopic optical diagnosis can potentially replace histopathological evaluation of small colorectal lesions. The aim of this study was to evaluate diagnostic performance of WavSTAT, a novel system for automatic optical diagnosis based on laser-induced autofluorescence spectroscopy. PATIENTS AND METHODS: Consecutive patients who were scheduled for colonoscopy were included in the study. Each detected lesion with a size of ≤ 9 mm was differentiated using high resolution endoscopy (HRE) by the endoscopist, who then reported this as a low or high confidence call. Thereafter, all lesions were analyzed using WavSTAT. Histopathology was used as the reference standard. The primary outcome measures were the accuracy of WavSTAT to differentiate between adenomatous and nonadenomatous lesions, and the accuracy of an algorithm combining HRE (lesions differentiated with high confidence) and WavSTAT (all remaining lesions). The secondary outcome measure was the accuracy of on-site recommended surveillance intervals. RESULTS: At total of 87 patients with 207 small colorectal lesions were evaluated. Accuracy and negative predictive value of WavSTAT were 74.4 % and 73.5 %, respectively. The corresponding figures for the algorithm were 79.2 % and 73.9 %, respectively. Accuracy of on-site recommended surveillance interval was 73.7 % for WavSTAT alone and 77.2 % for the algorithm of HRE and WavSTAT. CONCLUSIONS: Both accuracy of WavSTAT alone and the algorithm combining HRE with WavSTAT proved to be insufficient for the in vivo differentiation of small colorectal lesions, and do not fulfill American Society for Gastrointestinal Endoscopy performance thresholds for assessment of diminutive lesions. Future studies should assess whether combining WavSTAT with more advanced imaging techniques could result in a higher accuracy.Netherlands Trial Registry (NTR 3235).

Yield of screening colonoscopy in first-degree relatives of patients with serrated polyposis syndrome.

GOALS: We aimed to evaluate the diagnostic yield of screening colonoscopies in first-degree relatives (FDRs) of patients with serrated polyposis syndrome (SPS). BACKGROUND: Patients with SPS are at an increased risk for colorectal cancer. Although inheritance patterns are unknown, FDRs of these patients have an increased risk for both colorectal cancer and SPS. Prospective studies evaluating the yield of screening colonoscopies in this group are however scarce. This information would be useful to evaluate a possible mode of inheritance and to investigate whether screening colonoscopies are justified in this group. STUDY: FDR of patients with SPS were invited to undergo colonoscopy. The diagnostic yield was expressed by the number of FDRs with at least 1 significant polyp relative to the total number of included FDRs. Significant polyps were defined adenomas, traditional serrated adenomas, sessile serrated adenoma/polyp, or proximal hyperplastic polyp. Tissue specimens were reviewed by one expert pathologist. RESULTS: Seventy-seven FDRs underwent colonoscopy (median age 52 y; interquartile range, 41 to 60). Colorectal cancer was not diagnosed. One or more significant polyps were detected in 43% of FDRs. No differences based on age, gender, or familial relationship were observed in the detection of polyps. Seven first-degree (9%) relatives had multiple polyps (≥5). Eleven (14%) FDRs fulfilled SPS WHO-criterion 2, of whom 1 sibling also met SPS WHO-criterion 3. CONCLUSIONS: The yield of a single screening colonoscopy in FDRs of patients with serrated polyposis is substantial, warranting a colonoscopy screening program for these individuals.

Endoscopic features of sessile serrated adenomas: validation by international experts using high-resolution white-light endoscopy and narrow-band imaging.

BACKGROUND: Sessile serrated adenomas/polyps (SSAs/Ps) are premalignant lesions susceptible to being easily overlooked by endoscopists. A detailed description of the endoscopic appearance of SSAs/Ps might help endoscopists to recognize these lesions to improve the effectiveness of colonoscopy. OBJECTIVE: To identify various endoscopic features of SSAs/Ps using high-resolution white-light endoscopy (HR-WLE) and narrow-band imaging (NBI). DESIGN: Retrospective image evaluation study. SETTING: Single tertiary referral center. PATIENTS: Forty-5 patients with serrated polyposis syndrome undergoing surveillance colonoscopies. INTERVENTION: HR-WLE and NBI images of 150 polyps (50 SSAs/Ps, 50 hyperplastic polyps [HPs], and 50 adenomas) were systematically assessed by 5 experts using various endoscopic descriptors. MAIN OUTCOME MEASUREMENTS: The prevalence of specific endoscopic features observed in SSAs/Ps versus HPs. RESULTS: Multivariate analysis demonstrated that indistinct borders (OR, 3.11; 95% CI, 1.57-6.15) and a cloud-like surface (OR, 2.65; 95% CI, 1.21-5.78) were associated with SSA/P histology on HR-WLE. On NBI, a cloud-like surface (OR, 4.91; 95% CI, 2.42-9.97), indistinct borders (OR, 2.38; 95% CI, 1.14-4.96), irregular shape (OR, 3.17; 95% CI, 1.59-6.29), and dark spots inside the crypts (OR, 2.05; 95% CI, 1.02-4.11) were found to be endoscopic predictors of SSA/P histology. The sensitivity, specificity, and accuracy of NBI for differentiating serrated polyps containing either none or all 4 endoscopic SSA/P features were, respectively, 89%, 96%, and 93%. LIMITATIONS: Retrospective, image evaluation analysis. CONCLUSIONS: The current study demonstrates that SSAs/Ps possess several specific endoscopic features compared with HPs. Recognition of these characteristics might assist endoscopists in the differentiation of these lesions and could possibly facilitate endoscopic detection of these rather subtle lesions.

Differences in proximal serrated polyp detection among endoscopists are associated with variability in withdrawal time.

BACKGROUND: Insufficient detection of proximal serrated polyps (PSP) might explain the occurrence of a proportion of interval carcinomas in colonoscopy surveillance programs. OBJECTIVE: To compare PSP detection among endoscopists and to identify patient-related and endoscopist-related factors associated with PSP detection. DESIGN: Prospective study in unselected patients. SETTING: Colonoscopy screening program for colorectal cancer at two academic medical centers. PATIENTS: Asymptomatic consecutive screening participants (aged 50-75 years). INTERVENTION: Colonoscopies were performed by 5 experienced endoscopists. All detected polyps were removed. Multiple colonoscopy quality indicators were prospectively recorded. MAIN OUTCOME MEASUREMENTS: We compared PSP detection among endoscopists by calculating odds ratios (OR) with logistic regression analysis. Logistic regression also was used to identify patient features and colonoscopy factors associated with PSP detection. RESULTS: A total of 1354 patients underwent a complete screening colonoscopy: 1635 polyps were detected, of which 707 (43%) were adenomas and 685 (42%) were serrated polyps, including 215 PSPs. In 167 patients (12%) 1 or more PSPs were detected. The PSP detection rate differed significantly among endoscopists, ranging from 6% to 22% (P < .001). Longer withdrawal time (OR 1.12; 95% confidence interval, 1.10-1.16) was significantly associated with better PSP detection, whereas patient age, sex, and quality of bowel preparation were not. LIMITATIONS: Limited number of highly experienced endoscopists. CONCLUSION: The PSP detection rate differs among endoscopists. Longer withdrawal times are associated with better PSP detection, but patient features are not. ( CLINICAL TRIAL REGISTRATION NUMBER: NTR1888.).

Adenoma detection with cap-assisted colonoscopy versus regular colonoscopy: a randomised controlled trial.

OBJECTIVE: Conventional colonoscopy (CC) is considered the reference standard for detection of colorectal neoplasia, but it can still miss a substantial number of adenomas. The use of a transparent plastic cap may improve colonic visualisation. Cap-assisted colonoscopy (CAC) was compared with CC for adenoma detection. Secondary outcomes were caecal intubation time, caecal intubation rate and the degree of discomfort of colonoscopy. DESIGN: This is a parallel, randomised, controlled trial at two centres. Asymptomatic participants (aged 50-75 years) in a primary colonoscopy screening programme were consecutively invited. Consenting subjects were 1:1 randomised to either CAC or CC. All colonoscopies were performed by experienced endoscopists (≥ 1000 colonoscopies) who were trained in CAC. Colonoscopy quality indicators were prospectively recorded. RESULTS: A total of 1380 participants were randomly allocated to CC (N=694) or CAC (N=686). Caecal intubation rate was comparable in the two groups (98% vs 99%; p=0.29). Caecal intubation time was significantly lower in the CAC group: 7.7 ± 5.0 min with CAC vs 8.9 ± 6.2 min with CC (p<0.001) (values mean ± SD). Adenoma detection rates of all endoscopists were ≥ 20%. The proportion of subjects with at least one adenoma was similar in the two groups (28% vs 28%; RR 0.98; 95% CI 0.82 to 1.16), as well as the mean number of adenomas per subject (0.49 ± 1.05 vs 0.50 ± 1.03; p=0.91). Detection of small size, flat and proximally located adenomas was comparable. CAC participants had lower Gloucester Comfort Scores during colonoscopy (2.2 ± 1.0 vs 2.0 ± 1.0; p=0.03). CONCLUSION: CAC does not improve adenoma detection, but does reduce caecal intubation time by more than 1 min and does lessen the degree of discomfort during colonoscopy.

[Unrecognised sexual abuse and abdominal and pelvic complaints]. / Miskend seksueel geweld bij buik- en bekkenklachten.

Sexual abuse is a risk factor for developing various abdominal and pelvic complaints. In this clinical lesson we present one case, highlighting this connection and how it can be missed by different medical professionals. Early identification of the underlying connection with sexual abuse can prevent re-traumatization by medical treatments, reduce the risk of the patient being abused again and raises the opportunity for a more appropriate treatment, such as addition or trauma therapy and/or pelvic physiotherapy.

Ferric carboxymaltose infusion versus oral iron supplementation for preoperative iron deficiency anaemia in patients with colorectal cancer (FIT): a multicentre, open-label, randomised, controlled trial.

BACKGROUND: A third of patients with colorectal cancer who are eligible for surgery in high-income countries have concomitant anaemia associated with adverse outcomes. We aimed to compare the efficacy of preoperative intravenous and oral iron supplementation in patients with colorectal cancer and iron deficiency anaemia. METHODS: In the FIT multicentre, open-label, randomised, controlled trial, adult patients (aged 18 years or older) with M0 stage colorectal cancer scheduled for elective curative resection and iron deficiency anaemia (defined as haemoglobin level of less than 7·5 mmol/L (12 g/dL) for women and less than 8 mmol/L (13 g/dL) for men, and a transferrin saturation of less than 20%) were randomly assigned to either 1-2 g of ferric carboxymaltose intravenously or three tablets of 200 mg of oral ferrous fumarate daily. The primary endpoint was the proportion of patients with normalised haemoglobin levels before surgery (≥12 g/dL for women and ≥13 g/dL for men). An intention-to-treat analysis was done for the primary analysis. Safety was analysed in all patients who received treatment. The trial was registered at ClincalTrials.gov, NCT02243735, and has completed recruitment. FINDINGS: Between Oct 31, 2014, and Feb 23, 2021, 202 patients were included and assigned to intravenous (n=96) or oral (n=106) iron treatment. Treatment began a median of 14 days (IQR 11-22) before surgery for intravenous iron and 19 days (IQR 13-27) for oral iron. Normalisation of haemoglobin at day of admission was reached in 14 (17%) of 84 patients treated intravenously and 15 (16%) of 97 patients treated orally (relative risk [RR] 1·08 [95% CI 0·55-2·10]; p=0·83), but the proportion of patients with normalised haemoglobin significantly increased for the intravenous treatment group at later timepoints (49 [60%] of 82 vs 18 [21%] of 88 at 30 days; RR 2·92 [95% CI 1·87-4·58]; p<0·0001). The most prevalent treatment-related adverse event was discoloured faeces (grade 1) after oral iron treatment (14 [13%] of 105), and no treatment-related serious adverse events or deaths were observed in either group. No differences in other safety outcomes were seen, and the most common serious adverse events were anastomotic leakage (11 [5%] of 202), aspiration pneumonia (5 [2%] of 202), and intra-abdominal abscess (5 [2%] 202). INTERPRETATION: Normalisation of haemoglobin before surgery was infrequent with both treatment regimens, but significantly improved at all other timepoints following intravenous iron treatment. Restoration of iron stores was feasible only with intravenous iron. In selected patients, surgery might be delayed to augment the effect of intravenous iron on haemoglobin normalisation. FUNDING: Vifor Pharma.

Optimising diagnostics to discriminate complicated from uncomplicated appendicitis: a prospective cohort study protocol.

INTRODUCTION: Growing evidence is showing that complicated and uncomplicated appendicitis are two different entities that may be treated differently. A correct diagnosis of the type of appendicitis is therefore essential. The Scoring system of Appendicitis Severity (SAS) combines clinical, laboratory and imaging findings. The SAS rules out complicated appendicitis in 95% (negative predictive value, NPV) and detects 95% (sensitivity) of patients with complicated appendicitis in adults suspected of acute appendicitis. However, this scoring system has not yet been validated externally. In this study, we aim to provide a prospective external validation of the SAS in a new cohort of patients with clinical suspicion of appendicitis. We will optimise the score when necessary. METHODS AND ANALYSIS: The SAS will be validated in 795 consecutive adult patients diagnosed with acute appendicitis confirmed by imaging. Data will be collected prospectively in multiple centres. The predicted diagnosis based on the SAS score will be compared with the combined surgical and histological diagnosis. Diagnostic accuracy for ruling out complicated appendicitis will be calculated. If the SAS does not reach a sensitivity and NPV of 95% in its present form, the score will be optimised. After optimisation, a second external validation will be performed in a new group of 328 patients. Furthermore, the diagnostic accuracy of the clinical perspective of the treating physician for differentiation between uncomplicated and complicated appendicitis and the patient's preferences for different treatment options will be assessed. ETHICS AND DISSEMINATION: Ethical approval was granted by the Amsterdam UMC Medical Ethics Committee (reference W19_416 # 19.483). Because of the observational nature of this study, the study does not fall under the scope of the Medical Research Involving Human Subjects Act. Results will be presented in peer-reviewed journals. This protocol is submitted for publication before analysis of the results.

Performance of EUS-FNA for mediastinal lymphadenopathy: impact on patient management and costs in low-volume EUS centers.

BACKGROUND: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of mediastinal lymphadenopathy has been shown to be a valuable diagnostic tool in high-volume EUS centers (≥ 50 mediastinal EUS-FNA/endoscopist/year). Our goal was to assess the diagnostic accuracy of EUS-FNA and its impact on clinical management and costs in low-volume EUS centers (<50 mediastinal EUS-FNA/endoscopist/year). METHODS: Consecutive patients referred to two Dutch endoscopy centers in the period 2002-2008 for EUS-FNA of mediastinal lymphadenopathy were reviewed. The gold standard for a cytological diagnosis was histological confirmation or clinical follow-up of more than 6 months with repeat imaging. The impact of EUS-FNA on clinical management was subdivided into a positive impact by providing (1) adequate cytology that influenced the decision to perform surgery or (2) a diagnosis of a benign inflammatory disorder, and a negative impact which was subdivided into (1) false-negative or inconclusive cytology or (2) an adequate cytological diagnosis that did not influence patient management. Costs of an alternative diagnostic work-up without EUS-FNA, as established by an expert panel, were compared to costs of the actual work-up. RESULTS: In total, 213 patients (71% male, median age= 61 years, range = 23-88 years) underwent EUS-FNA. Sensitivity, specificity, and negative and positive predictive values were 89%, 100%, 80%, and 100%, respectively. EUS-FNA had a positive impact on clinical management in 84% of cases by either influencing the decision to perform surgery (49%) or excluding malignant lymphadenopathy (35%), and a negative impact in 7% of cases because of inadequate (3%) or false-negative (4%) cytology. In 9% of cases, EUS-FNA was performed without an established indication. Two nonfatal perforations occurred (0.9%). Total cost reduction was €100,593, with a mean cost reduction of €472 (SD = €607) per patient. CONCLUSIONS: Mediastinal EUS-FNA can be performed in low-volume EUS centers without compromising diagnostic accuracy. Moreover, EUS-FNA plays an important role in the management of patients with mediastinal lymphadenopathy and reduces total diagnostic costs.

Process evaluation of a tailored work-related support intervention for patients diagnosed with gastrointestinal cancer.

PURPOSE: To perform a process evaluation of a tailored work-related support intervention for patients diagnosed with gastrointestinal cancer. METHODS: The intervention comprised three tailored psychosocial work-related support meetings. To outline the process evaluation of this intervention, we used six key components: recruitment, context, reach, dose delivered, dose received and fidelity. Data were collected using questionnaires, checklists and research logbooks and were analysed both quantitatively and qualitatively. RESULTS: In total, 16 hospitals, 33 nurses and 7 oncological occupational physicians (OOPs) participated. Analysis of the six key components revealed that the inclusion rate of eligible patients was 47%. Thirty-eight intervention patients were included: 35 actually had a first meeting, 32 had a second and 17 had a third. For 31 patients (89%), the first meeting was face to face, as per protocol. However, in only 32% of the cases referred to support type A (oncological nurse) and 13% of the cases referred to support type B (OOP), the first meeting was before the start of the treatment, as per protocol. The average duration of the support type A meetings was around the pre-established 30 min; for the OOPs, the average was 50 min. Protocol was easy to follow according to the healthcare professionals. Overall, the patients considered the intervention useful. CONCLUSIONS: This study has shown that the strategy of tailored work-related support is appreciated by both patients and healthcare professionals and applicable in clinical practice. IMPLICATIONS FOR CANCER SURVIVORS: The intervention was appreciated by patients; however, whether the timing of the work-related support was adequate (i.e. before treatment was started) requires further research. TRIAL REGISTRATION: NTR5022.

Is a tailored work-related support intervention feasible in everyday clinical practice? The experience of healthcare professionals and patients with cancer.

BACKGROUND: Work is valued as an important feature in life, however patients diagnosed with cancer can experience work-related problems. We developed a work-related support intervention to support those in need. OBJECTIVE: The objective of this study was to evaluate the feasibility of the performed tailored GIRONA (Gastro Intestinal cancer patients Receiving Occupational support Near and After diagnosis) intervention and to describe the experiences of those receiving the work-related support and of those providing it. METHODS: An online questionnaire was used to survey the feasibility of the intervention of the support recipients (patients diagnosed with gastrointestinal cancer) and the support providers (healthcare professionals including: oncology nurses and oncological occupational physicians). Five themes were covered: acceptability, demand, implementation, practicality and integration of Bowen's feasibility model. RESULTS: Twenty-three patients, 14 oncology nurses and 4 oncological occupational physicians, shared their experiences about the tailored work-related support intervention. This intervention was generally perceived as positive and feasible by the participants. Some patients received work-related support despite not experiencing severe problems; others mentioned that they received no such support even though they did need it. Despite positive experiences, there are some barriers to tackle, such as length of consultation, timing of the initiation of work-related support and embedding the oncological occupational physician within the clinical setting. CONCLUSION: According to the healthcare professionals involved, GIRONA is feasible, however some practical barriers were mentioned. The intervention was perceived as positive by both patients and healthcare professionals, but the tailored component could be further improved to better support those in need of work-related support.