Predictors of undergoing multivisceral resection, margin status and survival in Dutch patients with locally advanced colorectal cancer

Background: The aim of this nationwide observational study was to evaluate factors associated with multivisceral resection (MVR), margin status and overall survival in locally advanced colorectal cancer (CRC). Material and methods: Patients with (y)pT4, cM0 CRC between 2006 and 2017 were selected from the Netherlands Cancer Registry. Cox-proportional hazards modelling was used for survival analysis, stratified for T4a and T4b. Annual hospital volume cut-off was 75 for colon and 40 for rectal resections. Results: A total of 11.930 patients were included and 2410 patients (20.2%) underwent MVR. Factors associated with MVR for colon and rectal cancer besides cT4 category were more recent diagnosis (OR 3.61, CI 95% 3.06–4.25 (colon) and OR 2.72, CI 95% 1.82–4.08 (rectum)) and high hospital volume (OR 1.20, CI 95% 1.05–1.38 (colon) and OR 2.17, CI 95% 1.55–3.04 (rectum)). Patients ≥70 year were less likely to undergo MVR for colon cancer (OR 0.80, 95% CI 0.70–0.90). Risk factors for incomplete resection were cT4 (OR 3.08, CI 95% 2.35–4.04 (colon) and OR 1.82, CI 95% 1.13–2.94 (rectum)) and poor/undifferentiated tumors (OR 1.41, CI 95% 1.14–1.72 (colon) and OR 1.69, CI 95% 1.05–2.74 (rectum)). More recent diagnosis was independently associated with less incomplete resections in colon cancer (OR 0.58, CI 95% 0.40–0.76). Independent predictors of survival were age, resection margin, nodal status and adjuvant chemotherapy, but not MVR. Conclusion: Treatment of locally advanced CRC with MVR at population level was influenced by year of diagnosis and hospital volume. Margin status in colon cancer improved substantially over time.</p

The capability set for work: Development and validation of a new questionnaire

__Objectives__ The aim of this study was to develop a questionnaire to measure work capabilities based on Amartya Sen’s capability approach and evaluate its validity. __Methods__ The development of the questionnaire was based on a combination of qualitative and quantitative methods: interviews, literature study, and an expert meeting. Additionally, in a survey, the validity was evaluated by means of hypotheses testing (using correlations and regression analyses). __Results__ The questionnaire consists of a set of seven capability aspects for work. For each aspect, it is determined whether it is part of a worker’s capability set, ie, when the aspect is considered valuable, is enabled in work, and is realized. The capability set was significantly correlated with work role functioning-flexibility demands (-0,187), work ability (-0.304), work performance (-0.282), worked hours (-0.073), sickness absence (yes/no) (0.098), and sickness absence days (0.105). The capability set and the overall capability item are significantly associated with all work outcomes (P<0.010). __Conclusions__ The new capability set for work questionnaire appears to be a valid instrument to measure work capabilities. The questionnaire is unique because the items include the valued aspects of work and incorporate whether a worker is able to achieve what (s)he values in his/her work. The questionnaire can be used to evaluate the capability set of workers in organizations to identify aspects that need to be addressed in interventions

Groepshuisvesting kan, maar niet voor iedereen

Het Praktijkonderzoek Varkenshouderij heeft vier bedrijfssystemen voor guste en drachtige zeugen vergeleken: het voerligboxsysteem, het voerligboxsysteem met uitloop, het groepshuisvestingssysteem met voerstations en het biofixsysteem. Het onderzoek betrof de periode januari 1994 tot en met maart 1996

Priority setting for universal health coverage: We need evidence-informed deliberative processes, not just more evidence on cost-effectiveness

Priority setting of health interventions is generally considered as a valuable approach to support low- and middle-income countries (LMICs) in their strive for universal health coverage (UHC). However, present initiatives on priority setting are mainly geared towards the development of more cost-effectiveness information, and this evidence does not sufficiently support countries to make optimal choices. The reason is that priority setting is in reality a value-laden political process in which multiple criteria beyond cost-effectiveness are important, and stakeholders often justifiably disagree about the relative importance of these criteria. Here, we propose the use of ‘evidence-informed deliberative processes’ as an approach that does explicitly recognise priority setting as a political process and an intrinsically complex task. In these processes, deliberation between stakeholders is crucial to identify, reflect and learn about the meaning and importance of values, informed by evidence on these values. Such processes then result in the use of a broader range of explicit criteria that can be seen as the product of both international learning (‘core’ criteria, which include eg, cost-effectiveness, priority to the worse off, and financial protection) and learning among local stakeholders (‘contextual’ criteria). We believe that, with these evidence-informed deliberative processes in place, priority setting can provide a more meaningful contribution to achieving UHC

Combined N-of-1 trials to investigate mexiletine in non-dystrophic myotonia using a Bayesian approach; study rationale and protocol

Background: To obtain evidence for the clinical and cost-effectiveness of treatments for patients with rare diseases is a challenge. Non-dystrophic myotonia (NDM) is a group of inherited, rare muscle diseases characterized by muscle stiffness. The reimbursement of mexiletine, the expert opinion drug for NDM, has been discontinued in some countries due to a lack of independent randomized controlled trials (RCTs). It remains unclear however, which concessions can be accepted towards the level 1 evidence needed for coverage decisions, in rare diseases. Considering the large number of rare diseases with a lack of treatment evidence, more experience with innovative trial designs is needed. Both NDM and mexiletine are well suited for an N-of-1 trial design. A Bayesian approach allows for the combination of N-of-1 trials, which enables the assessment of outcomes on the patient and group level simultaneously. Methods/Design: We will combine 30 individual, double-blind, randomized, placebo-controlled N-of-1 trials of mexiletine (600 mg daily) vs. placebo in genetically confirmed NDM patients using hierarchical Bayesian modeling. Our results will be compared and combined with the main results of an international cross-over RCT (mexiletine vs. placebo in NDM) published in 2012 that will be used as an informative prior. Similar criteria of eligibility, treatment regimen, end-points and measurement instruments are employed as used in the international cross-over RCT. Discussion: The treatment of patients with NDM with mexiletine offers a unique opportunity to compare outcomes and efficiency of novel N-of-1 trial-based designs and conventional approaches in producing evidence of clinical and cost-effectiveness of treatments for patients with rare diseases

Metachronous peritoneal metastases in patients with pT4b colon cancer: An international multicenter analysis of intraperitoneal versus retroperitoneal tumor invasion

It was hypothesized that colon cancer with only retroperitoneal invasion is associated with a low risk of peritoneal dissemination. This study aimed to compare the risk of metachronous peritoneal metastases (mPM) between intraperitoneal and retroperitoneal invasion

Patient and public involvement in scope development for a palliative care health technology assessment in Europe

Background Patient and Public Involvement (PPI) helps to ensure that study findings are useful to end users but is under-developed in Health Technology Assessment (HTA). "INTEGRATE-HTA, (a co-funded European Union project -grant agreement 30614) is developing new methods to assess complex health technologies and applying these in a palliative care case study. Having experienced the intended and unintended consequences of palliative care services, which vary widely across Europe, patients in six countries (England, Germany, Italy, Netherlands, Norway and Poland) provided valuable insights and advice for scope development. Aims To establish PPI in a palliative care HTA. Methods As PPI to assist early scope development in HTA is novel, each country implemented PPI methods as appropriate locally. One of two advocated methods was used, either a qualitative research approach or seeking the views of patients, relatives, carers or patient representatives as research partners. Using a qualitative approach, 21 individual, face-face patient interviews were conducted and analysed thematically. When patients were research partners, an adapted version of the EUnetHTA core model guided 30 face-face discussions. Thematic analysis and conceptual mapping identified key issues. Findings PPI in palliative care requires researchers to have cultural awareness of the acceptability of engaging in discussions around dying in each country. Ensuring positive PPI experiences and effective participation by acknowledging patient knowledge and experience whilst establishing a two-way flow of information in the HTA process is essential. Partnership working between researchers and patients, stakeholder evaluation and remuneration when involved as partners is important. Conclusions PPI was successfully implemented in each country, assisting patient-centred scope development and identification of important issues related to palliative care. Although there is much to be gained from PPI, methods of PPI engagement require further development. All PPI methods have advantages and limitations which must be considered in light of local needs, resources and culture