ObjectiveA shared decision-making (SDM) approach is recommended for prenatal decisions at the limit of viability, with a guiding role for parental values. People born extremely premature experience... Show moreObjectiveA shared decision-making (SDM) approach is recommended for prenatal decisions at the limit of viability, with a guiding role for parental values. People born extremely premature experience the consequences of the decision made, but information about their perspectives on prenatal decisions is lacking. Therefore, this study aims to describe their perspectives on what is important in decision-making at the limit of viability.DesignSemi-structured focus group discussions were conducted, recorded and transcribed verbatim. The data were independently analysed by two researchers in Atlas.ti.ResultsFour focus groups were conducted in the Netherlands, with five to six participants each, born between 240/7 and 300/7 weeks gestation in the period between 1965 and 2002. Considering their personal life experiences and how their extremely premature birth affected their families, the participants reflected on decision-making at the limit of viability. Various considerations were discussed and summarised into the following themes: anticipated parental regret, the wish to look at the baby directly after birth, to give the infant a chance at survival, quality of life, long-term outcomes for the infant and the family, and religious or spiritual considerations.ConclusionsInsights into the perspectives of adults born extremely premature deepened our understanding of values considered in decision-making at the limit of viability. Results point out the need for a more individualised prediction of the prognosis and more extensive information on the lifelong impact of an extremely premature birth on both the infant and the family. This could help future parents and healthcare professionals in value-laden decision-making. Show less
Hendriks, A.C.; Sombroek-van Doorm, M.; Vries, M. de 2023
Background: Implementation of an LHS in cardiology departments presents itself with ethical challenges, including ethical review and informed consent. In this qualitative study, we investigated... Show moreBackground: Implementation of an LHS in cardiology departments presents itself with ethical challenges, including ethical review and informed consent. In this qualitative study, we investigated stakeholders' attitudes toward ethical issues regarding the implementation of an LHS in the cardiology department.Methods: We conducted a qualitative study using 35 semi-structured interviews and 5 focus group interviews with 34 individuals. We interviewed cardiologists, research nurses, cardiovascular patients, ethicists, health lawyers, epidemiologists/statisticians and insurance spokespersons.Results: Respondents identified different ethical obstacles for the implementation of an LHS within the cardiology department. These obstacles were mainly on ethical oversight in LHSs; in particular, informed con sent and data ownership were discussed. In addition, respondents reported on the role of patients in LHS. Respondents described the LHS as a possibility for patients to engage in both research and care. While the LHS can promote patient engagement, patients might also be reduced to their data and are therefore at risk, according to respondents.Conclusions: Views on the ethical dilemmas of a LHSs within cardiology are diverse. Similar to the literary debate on oversight, there are different views on how ethical oversight should be regulated. This study adds to the literary debate on oversight by highlighting that patients wish to be informed about the learning activities within the LHS they participate in, and that they wish to actively contribute by sharing their data and identifying learning goals, provided that informed consent is obtained. Show less
Background. Involved lateral lymph nodes (LLNs) have been associated with increased local recurrence (LR) and ipsi-lateral LR (LLR) rates. However, consensus regarding the indication and type of... Show moreBackground. Involved lateral lymph nodes (LLNs) have been associated with increased local recurrence (LR) and ipsi-lateral LR (LLR) rates. However, consensus regarding the indication and type of surgical treatment for suspicious LLNs is lacking. This study evaluated the surgical treatment of LLNs in an untrained setting at a national level.Methods. Patients who underwent additional LLN surgery were selected from a national cross-sectional cohort study regarding patients undergoing rectal cancer surgery in 69 Dutch hospitals in 2016. LLN surgery consisted of either 'node-picking' (the removal of an individual LLN) or 'partial regional node dissection' (PRND; an incomplete resection of the LLN area). For all patients with primarily enlarged (=7 mm) LLNs, those undergoing rectal surgery with an additional LLN procedure were compared to those undergoing only rectal resection.Results. Out of 3057 patients, 64 underwent additional LLN surgery, with 4-year LR and LLR rates of 26% and 15%, respectively. Forty-eight patients (75%) had enlarged LLNs, with corresponding recurrence rates of 26% and 19%, respectively. Node-picking (n = 40) resulted in a 20% 4-year LLR, and a 14% LLR after PRND (n = 8; p = 0.677). Multivariable analysis of 158 patients with enlarged LLNs undergoing additional LLN surgery (n = 48) or rectal resection alone (n = 110) showed no significant association of LLN surgery with 4-year LR or LLR, but suggested higher recurrence risks after LLN surgery (LR: hazard ratio [HR] 1.5, 95% confidence interval [CI] 0.7-3.2, p = 0.264; LLR: HR 1.9, 95% CI 0.2-2.5, p = 0.874).Conclusion. Evaluation of Dutch practice in 2016 revealed that approximately one-third of patients with primarily enlarged LLNs underwent surgical treatment, mostly consisting of node-picking. Recurrence rates were not significantly affected by LLN surgery, but did suggest worse outcomes. Outcomes of LLN surgery after adequate training requires further research. Show less
Vries, M. de; Mantz, A.B.; Allen, S.W.; Morris, R.G.; Zhuravleva, I.; Canning, R.E.A.; ... ; Werner, N. 2023
Purpose Financial resources for health care are limited, so assessment of intervention effectiveness in terms of health in relation to its costs is important. Measuring health outcomes in cost... Show morePurpose Financial resources for health care are limited, so assessment of intervention effectiveness in terms of health in relation to its costs is important. Measuring health outcomes in cost-effectiveness analyses is usually done by health-related quality of life measures, like the EQ-5D. However, over the past decade, innovations on the conceptual level of health have evolved and novel approaches are rising such as the capability approach, subjective wellbeing, and Positive Health. This study assesses the psychometric properties of the subjective wellbeing-5 dimension (SWB-5D) outcome measure. Methods A quantitative, cross-sectional study design was used to determine the concurrent and construct (convergent and known group) validity for the SWB-5D. Concurrent and convergent validity were estimated as correlations between the SWB-5D and the Dutch version of the EQ-5D, ICECAP-A, and PH-17. Assessment of known-groups validity was based on the variables illness, education, and the overall happiness (Cantril Ladder) and overall health scale (EQ-5D VAS). Results A representative sample of 1016 respondents of the Dutch population completed an online questionnaire. The SWB-5D showed reasonable concurrent validity and showed good convergent and known-group validity. The SWB-5D had a lower ceiling effect compared to the EQ-5D and ICECAP-A. Conclusion Compared to traditional health measurement approaches, novel approaches are more focused on the mental and social pillars of health. The SWB-5D shows psychometric feasibility of comprehensive measurement of health, as indicated by a range of validity measures in a large representative sample of the Dutch population. Show less
Mekelenkamp, H.; Smiers, F.; Camp, N.; Stubenrouch, F.; Lankester, A.; Vries, M. de 2022
Hematopoietic stem cell transplantation decision-making for hemoglobinopathy patients is a complex process, and it remains difficult for health care professionals to decide whether and when a... Show moreHematopoietic stem cell transplantation decision-making for hemoglobinopathy patients is a complex process, and it remains difficult for health care professionals to decide whether and when a hematopoietic stem cell transplantation should be offered. Gaining insight into health care professionals' considerations is required to understand and optimize this decision-making process. A qualitative interview study using semi-structured interviews with eighteen health care professionals. Data were thematically analyzed. Two main themes emerged from the data: (1) Experiencing the influence of a frame of reference and (2) Feeling responsible for a guided decision-making. The frame of reference, meaning the health care professionals' knowledge and experiences regarding hematopoietic stem cell transplantation, influenced the guided decision-making process. Subsequently, three subthemes evolved from the second theme: (a) weighing up disease severity against possible complications, (b) making an effort to inform, and (c) supporting the best fitting decision for the individual patient. The health care professionals' frame of reference determined the hematopoietic stem cell transplantation decision-making process. This demands reflection on the health care professionals' own frame of reference and its influence on decision-making. Furthermore, reflection on the frame of reference is needed by exchange of knowledge and experiences between referring and referred-to healthcare professionals in an open and two-way direction. The transplantation teams have a responsibility of keeping the frame of reference of their referring colleagues up to date and referring health care professionals should share their feelings regarding hematopoietic stem cell transplantation. To guide patients, a shared decision-making approach is supportive, in which eliciting the patients' preferences is highly important. Health care professionals can refine the decision-making process by guiding patients in eliciting their preferences and including these in the decision. Show less
Lambregts, M.; Rump, B.; Ropers, F.; Sijbom, M.; Petrignani, M.; Visser, L.; ... ; Boer, M. de 2021
Introduction: Guidelines on antimicrobial therapy are subject to periodic revision to anticipate changes in the epidemiology of antimicrobial resistance and new scientific knowledge. Changing a... Show moreIntroduction: Guidelines on antimicrobial therapy are subject to periodic revision to anticipate changes in the epidemiology of antimicrobial resistance and new scientific knowledge. Changing a policy to a broader spectrum has important consequences on both the individual patient level (e.g. effectiveness, toxicity) and population level (e.g. emerging resistance, costs). By combining both clinical data evaluation and an ethical analysis, we aim to propose a comprehensive framework to guide antibiotic policy dilemmas.Methods: A preliminary framework for decision-making on antimicrobial policy was constructed based on existing literature and panel discussions. Antibiotic policy themes were translated into specific elements that were fitted into this framework. The adapted framework was evaluated in two moral deliberation groups. The moral deliberation sessions were analysed using ATLAS.ti statistical software to categorize arguments and evaluate completeness of the final framework.Results: The final framework outlines the process of data evaluation, ethical deliberation and decision-making. The first phase is a factual data exploration. In the second phase, perspectives are weighed and the policy of moral preference is formulated. Judgments are made on three levels: the individual patient, the patient population and society. In the final phase, feasibility, implementation and re-evaluation are addressed.Conclusions: The proposed framework facilitates decision-making on antibiotic policy by structuring existing data, identifying knowledge gaps, explicating ethical considerations and balancing interests of the individual and current and future generations. Show less
Meijer, C.R.; Akker, M.E. van den; Bodegom, L. van; Escher, J.C.; Geloven, N. van; Overveld, F. van; ... ; Mearin, M.L. 2021
Introduction Coeliac disease (CD) occurs in 1% of the population, develops early in life and is severely underdiagnosed. Undiagnosed and untreated disease is associated with short-term and long... Show moreIntroduction Coeliac disease (CD) occurs in 1% of the population, develops early in life and is severely underdiagnosed. Undiagnosed and untreated disease is associated with short-term and long-term complications. The current healthcare approach is unable to solve the underdiagnosis of CD and timely diagnosis and treatment is only achieved by active case finding. Aim: to perform a case finding project to detect CD children who visit the Youth Health Care Centres (YHCCs) in a well-described region in the Netherlands to evaluate whether it is feasible, cost-effective and well accepted by the population.Methods/analysis Prospective intervention cohort study. Parents of all children aged 12 months and 4 years attending the YHCCs for a regular visit are asked whether their child has one or more CD-related symptoms from a standardised list. If so, they will be invited to participate in the case finding study. After informed consent, a point of care test (POCT) to assess CD-specific antibodies against tissue transglutaminase (TG2A) is performed onsite the YHCCs. If the POCT is positive, CD is highly suspected and the child will be referred to hospital for definitive diagnosis according to the Guideline Coeliac Disease of the European Society for Pediatric Gastroenterology, Hepatology and Nutrition guideline.Main outcomes1. Incidence rate of new CD diagnoses in the study region in comparison to the one in the same age diagnosed by standard of care in the rest of the Netherlands.2. Feasibility and cost-effectiveness of active CD case finding at the YHCCs. All costs of active case finding, diagnostics and treatment of CD and the potential short-term and long-term consequences of the disease will be calculated for the setting with and without case finding.1. Ethical acceptability: by questionnaires on parental and healthcare professionals' satisfaction.A statistical analysis plan was prepared and is published on the GLUTENSCREEN website () and added as annex 1).Ethics and disseminationThe Medical Ethics Committee Leiden approved this study. If we prove that case finding at the YHCC is feasible, cost-effective and well accepted by the population, implementation is recommended. Show less
Stahle, M.; Silvola, J.M.U.; Hellberg, S.; Vries, M. de; Quax, P.H.A.; Kroon, J.; ... ; Saraste, A. 2020
This study showed that treatment with a therapeutic monoclonal immunoglobutin-G1 antibody against phosphorylcholine on oxidized phospholipids preserves coronary flow reserve and attenuates... Show moreThis study showed that treatment with a therapeutic monoclonal immunoglobutin-G1 antibody against phosphorylcholine on oxidized phospholipids preserves coronary flow reserve and attenuates atherosclerotic inflammation as determined by the uptake of F-18-fluorodeoxyglucose in atherosclerotic mice. The noninvasive imaging techniques represent translational tools to assess the efficacy of phosphorylcholine-targeted therapy on coronary artery function and atherosclerosis in clinical studies. (C) 2020 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. Show less
Background: eHealth promises to increase self-management and personalised medicine and improve cost-effectiveness in primary care. Paired with these promises are ethical implications, as eHealth... Show moreBackground: eHealth promises to increase self-management and personalised medicine and improve cost-effectiveness in primary care. Paired with these promises are ethical implications, as eHealth will affect patients’ and primary care professionals’ (PCPs) experiences, values, norms, and relationships.Objectives: We argue what ethical implications related to the impact of eHealth on four vital aspects of primary care could (and should) be anticipated.Discussion: (1) EHealth influences dealing with predictive and diagnostic uncertainty. Machine-learning based clinical decision support systems offer (seemingly) objective, quantified, and personalised outcomes. However, they also introduce new loci of uncertainty and subjectivity. The decision-making process becomes opaque, and algorithms can be invalid, biased, or even discriminatory. This has implications for professional responsibilities and judgments, justice, autonomy, and trust. (2) EHealth affects the roles and responsibilities of patients because it can stimulate self-management and autonomy. However, autonomy can also be compromised, e.g. in cases of persuasive technologies and eHealth can increase existing health disparities. (3) The delegation of tasks to a network of technologies and stakeholders requires attention for responsibility gaps and new responsibilities. (4) The triangulate relationship: patient–eHealth–PCP requires a reconsideration of the role of human interaction and ‘humanness’ in primary care as well as of shaping Shared Decision Making.Conclusion: Our analysis is an essential first step towards setting up a dedicated ethics research agenda that should be examined in parallel to the development and implementation of eHealth. The ultimate goal is to inspire the development of practice-specific ethical recommendations. Show less
The aim of this thesis is to shed light on the biological background of progression of sporadic vestibular schwannomas. The results of our studies indicate that, in different ways, intratumoral... Show moreThe aim of this thesis is to shed light on the biological background of progression of sporadic vestibular schwannomas. The results of our studies indicate that, in different ways, intratumoral inflammation seems to be important in the clinical progression of these tumors. By stimulating angiogenesis and through inhibition of antitumor immune responses tumor associated macrophages may allow some tumors to progress faster and reach a larger volume.M-CSF and IL-34 may play a regulatory role when it comes to macrophage activity within vestibular schwannomas, thereby potentially making them targets for therapy. These outcomes must be interpreted with caution. It is important to note that the results of the comparisons we made are observations of association. There is always the possibility that these findings are epiphenomena of a larger biological growth process and therefore not directly related to one another.In the search for new drugs capable of targeting tumor biological factors involved in the progression of vestibular schwannomas it is important to realize that our findings also indicate that these tumors may be protected by barrier proteins such as BCRP. Show less
Bruintjes, M.H.D.; Helden, E.V. van; Vries, M. de; Wirken, L.; Evers, A.W.M.; Middendorp, H. van; ... ; Warlé, M.C. 2019
Chronic postsurgical pain (CPSP) following laparoscopic donor nephrectomy (LDN) is a disregarded topic. In this cross‐sectional study, all consecutive patients who under‐went an LDN at the Radboud... Show moreChronic postsurgical pain (CPSP) following laparoscopic donor nephrectomy (LDN) is a disregarded topic. In this cross‐sectional study, all consecutive patients who under‐went an LDN at the Radboud University Medical Center (Radboudumc; 2003‐2016) were approached for participation. Five hundred twelve living kidney donors were included and asked to complete two questionnaires, including the McGill Pain Questionnaire and the RAND Short Form‐36 Health Status Inventory (RAND SF‐36) regarding their health‐related quality of life (HRQoL). The mean prevalence of CPSP following LDN was 5.7%, with a mean follow‐up time of 6 years. Possible predictors of CPSP following LDN are severe early postoperative pain, previous abdominal sur‐gery, and preexisting backache. The RAND SF‐36 revealed an impaired HRQoL in patients with CPSP when compared to patients without CPSP. In conclusion, this study revealed that the prevalence of CPSP following LDN is substantial. Given the possible association between the presence of CPSP and impaired HRQoL scores, liv‐ing kidney donors should be well informed in the preoperative phase about the risk of CPSP. Show less
Coskun, B.; Kuijpers, A.J.; Rooij, E. van; Dam, M.; Fokkens-Bruinsma, M.; Goedhart, M.; ... ; Vries, M. de 2019
