Long-term oncological outcomes of endoscopic full-thickness resection after previous incomplete resection of low-risk T1 CRC (LOCAL-study): study protocol of a national prospective cohort study.

BACKGROUND: T1 colorectal cancer (CRC) without histological high-risk factors for lymph node metastasis (LNM) can potentially be cured by endoscopic resection, which is associated with significantly lower morbidity, mortality and costs compared to radical surgery. An important prerequisite for endoscopic resection as definite treatment is the histological confirmation of tumour-free resection margins. Incomplete resection with involved (R1) or indeterminate (Rx) margins is considered a strong risk factor for residual disease and local recurrence. Therefore, international guidelines recommend additional surgery in case of R1/Rx resection, even in absence of high-risk factors for LNM. Endoscopic full-thickness resection (eFTR) is a relatively new technique that allows transmural resection of colorectal lesions. Local scar excision after prior R1/Rx resection of low-risk T1 CRC could offer an attractive minimal invasive strategy to achieve confirmation about radicality of the previous resection or a second attempt for radical resection of residual luminal cancer. However, oncologic safety has not been established and long-term data are lacking. Besides, surveillance varies widely and requires standardization. METHODS/DESIGN: In this nationwide, multicenter, prospective cohort study we aim to assess feasibility and oncological safety of completion eFTR following incomplete resection of low-risk T1 CRC. The primary endpoint is to assess the 2 and 5 year luminal local tumor recurrence rate. Secondary study endpoints are to assess feasibility, percentage of curative eFTR-resections, presence of scar tissue and/or complete scar excision at histopathology, safety of eFTR compared to surgery, 2 and 5 year nodal and/or distant tumor recurrence rate and 5-year disease-specific and overall-survival rate. DISCUSSION: Since the implementation of CRC screening programs, the diagnostic rate of T1 CRC is steadily increasing. A significant proportion is not recognized as cancer before endoscopic resection and is therefore resected through conventional techniques primarily reserved for benign polyps. As such, precise histological assessment is often hampered due to cauterization and fragmentation and frequently leads to treatment dilemmas. This first prospective trial will potentially demonstrate the effectiveness and oncological safety of completion eFTR for patients who have undergone a previous incomplete T1 CRC resection. Hereby, substantial surgical overtreatment may be avoided, leading to treatment optimization and organ preservation. Trial registration Nederlands Trial Register, NL 7879, 16 July 2019 ( https://trialregister.nl/trial/7879 ).

How the concept of biochemical response influenced the management of primary biliary cholangitis over time.

BACKGROUND: Criteria assessing biochemical response to ursodeoxycholic acid (UDCA) are established risk stratification tools in primary biliary cholangitis (PBC). We aimed to evaluate to what extent liver tests influenced patient management during a three decade period, and whether this changed over time. METHODS: 851 Dutch PBC patients diagnosed between 1988 and 2012 were reviewed to assess patient management in relation to liver test results during UDCA treatment. To do so, biochemical response at one year was analysed retrospectively according to Paris-1 criteria. RESULTS: Response was assessable for 687/851 (81%) patients; 157/687 non-responders. During a follow-up of 8.8 years (IQR 4.8-13.9), 141 died and 30 underwent liver transplantation. Transplant-free survival of non-responders (60%) was significantly worse compared with responders (87%) (p < 0.0001). Management was modified in 46/157 (29%) non-responders. The most frequent change observed, noted in 26/46 patients, was an increase in UDCA dosage. Subsequently, 9/26 (35%) non-responders became responders within the next two years. Steroid treatment was started in one patient; 19 patients were referred to a tertiary centre. No trend towards more frequent changes in management over time was observed (p = 0.10). CONCLUSION: Changes in medical management occurred in a minority of non-responders. This can largely be explained by the lack of accepted response criteria and of established second-line treatments for PBC. Nevertheless, the observation that response-guided management did not increase over time suggests that awareness of the concept of biochemical response requires further attention,particularly since new treatment options for PBC will soon become available.

Teaching evidence-based practice (EBP) to speech-language therapy students: are students competent and confident EBP users?

BACKGROUND: The importance and value of the principles of evidence-based practice (EBP) in the decision-making process is recognized by speech-language therapists (SLTs) worldwide and as a result curricula for speech-language therapy students incorporated EBP principles. However, the willingness actually to use EBP principles in their future profession not only depends on EBP knowledge and skills, but also on self-efficacy and task value students perceive towards EBP. AIMS: To investigate the relation between EBP knowledge and skills, and EBP self-efficacy and task value in different year groups of Dutch SLT students. METHODS & PROCEDURES: Students from three year groups filled in a tool that measured EBP knowledge and skills: the Dutch Modified Fresno (DMF). EBP self-efficacy and task value were assessed by using a 20-item questionnaire. Both tools were validated for this population. Mean scores for the three year groups were calculated and tested for group differences using a one-way analysis of variance (ANOVA) with a post-hoc Games-Howell procedure. With a multiple linear regression technique it was assessed whether EBP self-efficacy and task value predict learning achievement scores on the DMF. Other possible predictors included in the model were: level of prior education, standard of English, having had mathematics in prior education and the SLT study year. OUTCOME & RESULTS: A total of 149 students filled in both measurement tools. Mean scores on EBP knowledge and skills were significantly different for the three year groups, with students who were further along their studies scoring higher on the DMF. Mean scores on the EBP self-efficacy and task value questionnaire were the same for the three year groups: all students valued EBP positive but self-efficacy was low in all groups. Of the possible predictors, only the year in which students study and EBP self-efficacy were significant predictors for learning achievements in EBP. CONCLUSIONS & IMPLICATIONS: Despite a significant increase in EBP knowledge and skills over the years as assessed by the DMF, the integrated EBP curriculum did not raise levels of EBP self-efficacy and task value. This lack of feeling competent might have an impact on students' willingness actually to use EBP. In curricula, therefore, there should be a focus on how to raise EBP self-efficacy in SLT students. This goes even beyond the educational department because a professional culture in which professionals are competent and confident EBP users would have a positive effect on EBP self-efficacy in students.

Competent in evidence-based practice (EBP): validation of a measurement tool that measures EBP self-efficacy and task value in speech-language therapy students.

BACKGROUND: Worldwide speech-language therapy (SLT) students are educated in evidence-based practice (EBP). For students to use EBP in their future day-to-day clinical practice, they must value EBP as positive and must feel confident in using it. For curricula developers it is therefore important to know the impact their teaching has on these aspects of students' motivational beliefs. AIMS: To develop and validate a measurement tool to assess EBP task value and self-efficacy in SLT students. METHODS & PROCEDURES: A 20-item questionnaire was developed based on a review of the literature and an additional group interview with speech-language therapists. Face validity of the questionnaire was established using a Delphi panel consisting of six EBP lecturers. Dutch bachelor SLT students (n = 149) with a different level of EBP knowledge and skills filled in the newly developed questionnaire. Reliability (internal consistency) was assessed using Cronbach's alpha and internal validity using a principal component analysis (PCA). Construct validity was assessed by comparing the bachelor SLT student scores with a group of m students (n = 15) who were highly experienced in EBP. OUTCOMES & RESULTS: The PCA showed that the questionnaire consists of two components, representing EBP task value and self-efficacy, both with good reliability (Cronbach's α = 0.83 and 0.79, respectively). The hypothesis that master's students would score significantly higher on both components than bachelor SLT students was met. CONCLUSIONS & IMPLICATIONS: The study provides evidence on the internal consistency and construct validity of this questionnaire to evaluate EBP task value and self-efficacy in SLT students. As is common with new measures, more research is needed to evaluate further its psychometric properties.

The 2012 revised Dutch national guidelines for the treatment of chronic hepatitis B virus infection.

In 2008, the Netherlands Association of Gastroenterologists and Hepatologists (Nederlands Vereniging van Maag-Darm-Leverartsen) published the Dutch national guidelines for the treatment of chronic hepatitis B virus infection. New insights into the treatment of chronic hepatitis B with relevance for clinical practice have been adopted in these concise, revised guidelines. The most important changes include the choice of initial antiviral therapy, licensing of tenofovir for the treatment of chronic hepatitis B and the management of antiviral resistance.