The Compatibility of Mandatory Vaccination with the European Convention on Human Rights: Implications for a National Vaccination Policy.

This contribution examines the compatibility of mandatory vaccination with the European Convention on Human Rights (ECHR) through an analysis of the relevant ECHR rights and related case law of the European Court of Human Rights (ECtHR). By focusing on Article 8 (Right to Private Life), Article 2 (Right to Life) and Article 9 (Freedom of Thought, Conscience and Religion) ECHR, we formulate conditions under which mandatory vaccination legislation is justified. With that, this analysis aims to provide national legislators with guidance on responsible legislative policy. Additionally, this article discusses the legal framework underlying the Dutch vaccination policy, including developments therein since COVID-19. Furthermore, the role of the European Union in the context of vaccination is briefly discussed. The importance of an extensive societal and parliamentary debate before implementing a mandatory vaccination policy is stressed, as is the need for proportionality in enforcement.

The Impact of Ex-Post Legislative Evaluations in Healthcare: A Mixed Methods Realist Evaluation Study Protocol for Conducting Case Studies.

Background: Recent studies on the impact of ex-post legislative evaluations show that there are different types of impact and different factors that can influence it. These include the context of a legislative evaluation, research quality, and interactions between researchers and other actors within the evaluation process. However, thorough empirical research in this area is lacking. This warrants empirical research into the factors that influence the impact of ex-post legislative evaluations, so these insights can be used to increase the likelihood of ex-post legislative evaluations having an impact. Methods and analysis: In this protocol, we report on the realist evaluation methodology that will be used to evaluate the impact of three ex-post legislative evaluations in the Dutch healthcare sector. The mixed methods realist evaluation approach will facilitate this theory-driven, qualitative research. The study will consist of the following three steps: (1) Initial programme theory development, (2) theory validation, and (3) theory refinement. Knowledge from two scoping reviews conducted previously, and two subsequent expert meetings will form the basis for developing the initial programme theory. During this study, three case studies will be conducted, in which three individual ex-post legislative evaluations will be examined. Specificmethods for data collection will include: documentary review, observation, structured questionnaires and focus group discussions with purposefully identified key stakeholders. Using the framework approach, the data will be analysed thematically in a within-case analysis followed by a cross-case analysis. Discussion: This protocol provides insight into how the study will be conducted. As this study uses multiple qualitative researchmethods to answer one question, this protocol supports refining data collection procedures. Careful consideration of the approach beforehand can minimise pitfalls, reduce publication bias and improve reproducibility. The protocol therefore specifies how the research question will be answered in detail, and this provides solid guidance for the research process.

Towards a less voluntary vaccination policy in the Netherlands? Findings from an expert interview study.

BACKGROUND: The Netherlands traditionally favours a voluntary approach to vaccination. However, during the COVID-19 pandemic multiple European countries drastically altered their vaccination policies, which fuelled societal and political debate about the need to make the Dutch vaccination policy less voluntary, particularly by utilising pressure or coercion. AIM: To provide insight in expert's views on main normative issues concerning a less voluntary vaccination policy (for adults). Our study adds to the existing debate by addressing this topic from a multidisciplinary viewpoint. METHODS: We conducted 16 semi-structured interviews with legal, medical and ethical experts on the Dutch vaccination policy, between November 2021 and January 2022. We analysed interview transcripts through inductive coding. RESULTS: Most experts believe a less voluntary vaccination policy is of added value under certain circumstances, as exemplified by the outbreak of COVID-19. For such a policy, a legislative approach might be most effective. However, different views exist on the desirability of a less voluntary approach. Main arguments in favour are based on epidemiological circumstances and a duty towards the collective health interest, whilst arguments against are based on the questionable necessity and adverse effectiveness of such policy. CONCLUSIONS: If implemented, a less voluntary vaccination policy should be context-specific and take into account proportionality and subsidiarity. It is recommendable for governments to embed such policy (a priori) in flexible legislation.

[The use of guidelines in medical disciplinary proceedings]. / Het gebruik van richtlijnen in de tuchtrechtspraak.

Guidelines of the medical profession play an important role in determining and developing the quality of care and they further define the general legal provisions in this area. This means that guidelines also have a certain legal significance. Guidelines play a role in disciplinary proceedings in various ways. The basic principle is that the disciplinary court follows a guideline, but sometimes there are reasons not to do so. In addition, disciplinary case law is sometimes a source of inspiration for new guidelines.

Hidden bedside rationing in the Netherlands: a cross-sectional survey among physicians in internal medicine.

BACKGROUND: Healthcare rationing can be defined as withholding beneficial care for cost reasons. One form in particular, hidden bedside rationing, is problematic because it may result in conflicting loyalties for physicians, unfair inequality among patients and illegitimate distribution of resources. Our aim is to establish whether bedside rationing occurs in the Netherlands, whether it qualifies as hidden and what physician characteristics are associated with its practice. METHODS: Cross-sectional online questionnaire on knowledge of -, experience with -, and opinion on rationing among physicians in internal medicine within the Dutch healthcare system. Multivariable ordinal logistic regression was used to explore relations between hidden bedside rationing and physician characteristics. RESULTS: The survey was distributed among 1139 physicians across 11 hospitals with a response rate of 18% (n = 203). Most participants (n = 129; 64%) had experience prescribing a cheaper course of treatment while a more effective but more expensive alternative was available, suggesting bedside rationing. Subsequently, 32 (24%) participants never disclosed this decision to their patient, qualifying it as hidden. The majority of participants (n = 153; 75%) rarely discussed treatment cost. Employment at an academic hospital was independently associated with more bedside rationing (OR = 17 95%CI 6.1-48). Furthermore, residents were more likely to disclose rationing to their patients than internists (OR = 3.2, 95%CI 2.1-4.7), while salaried physicians were less likely to do so than physicians in private practice (OR = 0.5, 95%CI 0.4-0.8). CONCLUSION: Hidden bedside rationing occurs in the Netherlands: patient choice is on occasion limited with costs as rationale and this is not always disclosed. To what extent distribution of healthcare should include bedside rationing in the Netherlands, or any other country, remains up for debate.

[Amendments of medical disciplinary law]. / Aanpassingen van het medisch tuchtrecht.

In the first half of 2019, the Dutch medical disciplinary law will be amended. Changes include court fees to be paid by people filing complaints, the introduction of an information officer and the possibility to order a health professional to stop his activities during disciplinary proceedings. Some of these amendments are mainly intended to prevent 'complaints of minor importance' from being filed with the disciplinary court.

Challenging the knowledge base and skillset for providing surgical consent by orthopedic and plastic surgeons in the Netherlands: an identified area of improvement in patient safety.

BACKGROUND: Successfully completing a surgical informed consent process is an important element of the preoperative consult. A previous study of Dutch general surgeons demonstrated that the implementation of SIC did not meet acceptable standards. However, the quality of the SIC process in the orthopedic surgical or plastic surgical arena is unknown. METHODS: Following ethical approval, an online survey investigating specifics of surgical informed consent was performed among members of the Dutch Scientific Association of Orthopedic Surgeons and the Dutch Society for Plastic Surgery. RESULTS: A total of 335 responses from a majority of departments of orthopedic (86 %) and plastic surgery (78 %) were eligible for analysis. Scores on knowledge were poor as only 50 % recognized the three basic elements of surgical informed consent (competence, exchange of information and consent). The orthopedic group used more tools in the surgical informed consent process, such as instruction movies and websites or specialized nursing staff, compared to plastic surgery (orthopedic: 31-50 % vs. plastic: 6-30 %, p = 0.05- < 0.001). In contrast, surgical informed consent forms were used more frequently by the plastic surgical group (orthopedic 21 % vs. plastic:42 % p < 0.001). Control of the efficacy of the surgical informed consent process was low, 36 % in both groups. One in every seven orthopedic or plastic surgeons was faced with an official surgical informed consent-related complaint in the previous five years. CONCLUSIONS: Similar to general surgeons, Dutch orthopedic and plastic surgeons demonstrate poor knowledge and skills regarding surgical informed consent. Increased awareness, better training and use of modern tools including standard forms and online software programs will improve the SIC process and will optimize patient care.

[Disclosing medical errors: the current situation]. / Openheid over medische fouten: waar staan we?

Recent broadly-supported guidelines stipulate that physicians and other care providers should be open and honest about incidents, i.e. medical errors. This standard has been reinforced by recent statements from the medical disciplinary board and is shortly expected to be incorporated into Dutch law. In daily practice many personal and institutional barriers hinder communication concerning medical errors. The implementation of an open disclosure policy, developed elsewhere, may assist in overcoming these barriers in the Netherlands.

[Preoperative medical record-keeping can be improved: new informed consent form assists both physicians and patients]. / Preoperatieve dossiervoering kan beter: nieuw informed-consentformulier helpt arts én patiënt.

Adequate record-keeping is an important part of the surgical informed consent (IC) process. Standardization can enhance the quality of this process but is incomplete and qualitatively insufficiently implemented in current surgical practice. The introduction of well-designed tools would improve daily practice. We inventoried preoperative reporting at all 91 Dutch departments of General Surgery. Thirty-nine of the 73 departments that provided information on their IC process used a standard form. Twenty-nine of these forms were sent for analysis using a checklist based on legislation, recent case law and specialist literature. The mean number of items per form was 37, but not a single form was complete. Based on these results in combination with relevant legislation, guidelines and expert opinions, an adequate, user-friendly and straightforward preoperative IC form was designed. This IC form can serve as a checklist and report for the physician and as an information leaflet for the patient.

[Position of guidelines under new law: consequences of new legislation on health care quality]. / Positie van richtlijnen onder nieuwe wet: consequenties van de nieuwe wet over het kwaliteitsinstituut.

Recent legislation in the Netherlands has led to the creation of an institute for health care quality ('Zorginstituut Nederland'). This institute maintains a public register of medical practice guidelines. The legislation does not influence the legal position of these guidelines, but may lead to problems with regard to the process of developing guidelines, and to the authority of the institute to accept guidelines without the full cooperation of the medical profession.

[Ending life at the patient's request: who sets the standards?]. / Levensbeëindiging op verzoek: wie stelt de norm?

Under the Dutch Termination of Life on Request and Assisted Suicide Act of 2002, independent review committees assess all reported cases of euthanasia and assisted suicide. These committees apply and conceptualise the criteria mentioned in the Act. Recently, the Royal Dutch Medical Association questioned a number of decisions made by the committees. This is a confusing situation for physicians: should they follow the 'jurisprudence' of the committees or the standards as defined by their professional organisation?

Informing family members of individuals with Lynch syndrome: a guideline for clinical geneticists.

The diagnosis of Lynch syndrome can lead to the prevention of colorectal cancer through periodic colonoscopies and removal of premalignant lesions in susceptible individuals. Therefore, predisposed individuals identified by mutation analysis are advised to inform their at-risk relatives about the options of predictive DNA testing and preventive measures. However, it has now been established that more than half of these relatives do not receive the necessary information. Barriers in conveying information include family communication problems and variable attitudes and practice among clinical geneticists. In this complex field, both medical, psychological, ethical and juridical aspects deserve consideration. Here we summarize the development of a revised guideline for clinical geneticists that allows a more active role of the geneticist, aimed at improving procedures to inform family members in Lynch syndrome and other hereditary and familial cancer syndromes.

A survey of the current practice of the informed consent process in general surgery in the Netherlands.

Additional non-English language abstract (in Dutch) BACKGROUND: A properly conducted surgical informed consent process (SIC) allows patients to authorize an invasive procedure with full comprehension of relevant information including involved risks. Current practice of SIC may differ from the ideal situation. The aim of this study is to evaluate whether SIC practiced by Dutch general surgeons and residents is adequate with involvement of all required elements. METHODS: All members of the Dutch Society of Surgery received an online multiple choice questionnaire evaluating various aspects of SIC. RESULTS: A total of 453 questionnaires obtained from surgeons and residents representing >95% of all Dutch hospitals were eligible for analysis (response rate 30%). Knowledge on SIC was limited as only 55% was familiar with all three basic elements ('assessment of preconditions', 'provision of information' and 'stage of consent'). Residents performance was inferior compared to surgeons regarding most aspects of daily practice of SIC. One in 6 surgeons (17%) had faced a SIC-related complaint in the previous five years possibly illustrating suboptimal SIC implementation in daily surgical practice. CONCLUSIONS: The quality of the current SIC process is far from optimal in the Netherlands. Surgical residents require training aimed at improving awareness and skills. The SIC process is ideally supported using modern tools including web-based interactive programs. Improvement of the SIC process may enhance patient satisfaction and may possibly reduce the number of complaints. ACHTERGROND: Het doel van het preoperatieve informed consent proces (surgical informed consent, SIC) is om patiënten een weloverwogen en welgeïnformeerde keuze te laten maken over hun operatieve ingreep. De hedendaagse praktijk betreffende SIC staat mogelijk ver van de ideale situatie af. Doel van deze studie is om de dagelijkse praktijk van chirurgen en chirurgen in opleiding betreffende SIC te evalueren en te zien of deze voldoet aan de daarvoor gestelde eisen. METHODE: Alle chirurgen en andere leden van de Nederlandse Vereniging voor Heelkunde ontvingen een online multiple-choice vragenlijst betreffende de belangrijkste aspecten van SIC. RESULTATEN: In totaal waren er 453 bruikbare reacties uit meer dan 95% van alle Nederlandse ziekenhuizen (respons 30%). De kennis over SIC blijkt zeer beperkt. Slechts 55% van de chirurgen bleek bekend met de drie basiselementen van SIC ('beoordelen van de competentie van een patiënt', 'verstrekken van informatie' and 'adequaat vastleggen van de toestemming van de patiënt'). De dagelijkse praktijk liet behoorlijke verschillen tussen alle respondenten zien, maar chirurgen in opleiding scoorden significant slechter vergeleken met chirurgen. 17% van alle chirurgen kreeg de afgelopen vijf jaar te maken met een klacht betreffende SIC, wat zou kunnen wijzen op een suboptimale implementatie van SIC in de dagelijkse praktijk. CONCLUSIE: De kwaliteit van het preoperatieve informed consent proces is in Nederland verre van goed. Chirurgen in opleiding scoorden minder goed dan chirurgen en dienen beter geschoold te worden. Het hele SIC proces zou geformaliseerd moeten worden in protocollen. Moderne hulpmiddelen zoals interactieve softwareprogramma's kunnen hierbij mogelijk helpen. Door het verbeteren van het SIC proces kan de patiëntentevredenheid verhoogd worden terwijl het aantal klachten mogelijk wordt verminderd.

The Dutch Euthanasia Act: recent legal developments.

The Dutch Termination of Life on Request and Assisted Suicide Act [Wet toetsing levensbeëindiging op verzoek en hulp bij zelfdoding (Wtl)] came into force in 2002. Its aim is to increase the degree of due care exercised by physicians when terminating a patient's life and to provide a legal framework within which physicians account for their actions in such cases. On the basis of the second evaluation of the Act, published in December 2012, this article provides an overview of the most recent legal developments regarding the Dutch Euthanasia Act. Special attention is given to patients with dementia, psychiatric patients and patient who are "weary of life".

[Who really 'owns' images made of patients?]. / Van wie zijn medische beelden eigenlijk?

Images made of patients as part of the delivery of care (photographs, x-rays, scans, histopathological images) are part of a patient's file. All legal rules pertaining to a medical record also apply to these types of images, including the patient's right to obtain a copy as well as the right to have the record (partially) destroyed. It is not useful to speak about images in terms of ownership. The issue actually relates to who has control over these images, not who owns them. Those who provide health care as well as the patient have combined control over the images.

The ideal application of surveillance technology in residential care for people with dementia.

BACKGROUND: As our society is ageing, nursing homes are finding it increasingly difficult to deal with an expanding population of patients with dementia and a decreasing workforce. A potential answer to this problem might lie in the use of technology. However, the use and application of surveillance technology in dementia care has led to considerable ethical debate among healthcare professionals and ethicists, with no clear consensus to date. AIM: To explore how surveillance technology is viewed by care professionals and ethicists working in the field, by investigating the ideal application of surveillance technology in the residential care of people with dementia. METHODS: Use was made of the concept mapping method, a computer-assisted procedure consisting of five steps: brainstorming, prioritizing, clustering, processing by the computer and analysis. Various participants (ranging from ethicists to physicians and nurses) were invited on the basis of their professional background. RESULTS: The views generated are grouped into six categories ranging from the need for a right balance between freedom and security, to be beneficial and tailored to the resident, and clearly defined procedures to competent and caring personnel, active monitoring and clear normative guidance. The results are presented in the form of a graphic chart. CONCLUSIONS: There appears to be an inherent duality in the views on using surveillance technology which is rooted in the moral conflict between safety and freedom. Elaboration of this ethical issue has proved to be very difficult.

How do disciplinary tribunals evaluate the "gut feelings" of doctors? An analysis of Dutch tribunal decisions, 2000-2008.

A sense of alarm, which is a form of "gut feeling" sometimes plays a part in the decisions of medical disciplinary tribunals in The Netherlands. Since these judgments are regarded as setting standards for professional attitudes in The Netherlands, the question arises how Dutch tribunals have evaluated gut feelings, and how tribunals in other European countries deal with them. An exploratory study searched two Dutch digital databases (2000-2008) and asked 26 national representatives of the European General Practice Research Network for information about the role of gut feelings in tribunals' decisions. A sense of alarm was mentioned in judgments in 34 Dutch cases. Defendants were hardly ever reproached for missing the correct diagnosis, but mostly for not acting in a professional manner. The sense of alarm was referred to as a diagnostic tool to assess a patient's situation, although the judgments indicate that it must be followed by further diagnostic steps. The role of gut feelings in decisions of disciplinary tribunals in Europe is unclear. The authors conclude that the sense of alarm as a diagnostic tool has been taken seriously by Dutch tribunals. Its timely development is considered to be an element of the professional standards for doctors.

Ethical and practical concerns of surveillance technologies in residential care for people with dementia or intellectual disabilities: an overview of the literature.

BACKGROUND: Technology has emerged as a potential solution to alleviate some of the pressures on an already overburdened care system, thereby meeting the growing needs of an expanding population of seriously cognitively impaired people. However, questions arise as to what extent technologies are already being used in residential care and how ethically and practically acceptable this use would be. METHODS: A systematic literature review was conducted to explore what is known on the moral and practical acceptability of surveillance technologies in residential care for people with dementia or intellectual disabilities, and to set forth the state of the debate. RESULTS: A total of 79 papers met the inclusion criteria. The findings show that application and use of surveillance technologies in residential care for vulnerable people generates considerable ethical debate. This ethical debate centers not so much around the effects of technology, but rather around the moral acceptability of those effects, especially when a conflict arises between the interests of the institution and the interests of the resident. However, the majority of articles lack in depth analysis. Furthermore, there are notable cultural differences between the European literature and American literature whereby in Britain there seems to be more ethical debate than in America. Overall however, there is little attention for the resident perspective. CONCLUSION: No ethical consensus has yet been reached, underlining the need for clear(er) policies. More research is thus recommended to determine ethical and practical viability of surveillance technologies whereby research should be specifically focused on the resident perspective.

[Removing a patient from the practice list]. / De arts die een patiënt de praktijk uit zet.

There are boundaries to what a physician can be expected to tolerate from a patient in terms of behaviour. If a patient approaches or oversteps these boundaries the physician is entitled to take action. Article 460 of the Dutch Medical Treatment Act states that a physician may unilaterally end an agreement to treat if there are important grounds to do so. A 2005 Royal Dutch Medical Association guideline contains concrete recommendations and suggestions for physicians who are seriously considering removing a patient from their practice list. Disease-related powerlessness or inability should not be a reason for breaking off a contract to treat a patient.

[The citizen as plaintiff in disciplinary procedures, lack of complaints possibly due to poor knowledge of the disciplinary system for health care]. / De burger als klager in het tuchtrecht voor de gezondheidszorg: weinig klachten, mogelijk door geringe kennis van tuchtrechtsysteem.

OBJECTIVE: To provide insight into the general public's knowledge of disciplinary procedures, their grounds for lodging a complaint or otherwise and their confidence in the disciplinary system. DESIGN: Descriptive. METHOD: In 2008, questionnaires were sent to all 1368 members of the Healthcare Consumer Panel of the Netherlands Institute for Health Services Research (NIVEL), to check their knowledge about the disciplinary procedures. The response was 69%. RESULTS: The majority of the respondents were not well-informed about the aims and procedures of the disciplinary system. They did not know which complaints can be brought before a disciplinary board and were of the opinion that you had to be very confident about your case to lodge a complaint. Many respondents expressed concerns about the accessibility of the disciplinary system. More than one-third of the respondents had no confidence in the independent status of the disciplinary proceedings. CONCLUSION: Efforts should be made to optimise the possibilities for members of the general public to lodge complaints. Examples are: organising a single office where complaints can be submitted, providing public information materials about the aims and procedures of the disciplinary system, and supplying concrete support to individuals who wish to lodge a complaint. For complaints that arise as a result of shortcomings in the quality of care provided, but which are not serious enough to justify the imposition of sanctions, ways should be found to provide plaintiffs with a just outcome. For example, the professionals involved should make it clear how the incident will be prevented from happening again.