An empirical study of how the Dutch healthcare regulator first formulates the concept of trust and then puts it into practice.

BACKGROUND: Responsive regulation assumes that the parties being regulated are trustworthy and motivated by social responsibility. This assumes that regulation based upon trust will improve the regulated organization more effectively than other regulation models. The purpose of our qualitative study was to unravel the most important elements of trust in the inspectee which can support the inspector's work and to develop a model and a framework of trust that can be used by the inspectors to legitimize their trust in the inspectee. METHODS: We conducted an empirical study on trust regarding the regulation of care services to reveal how trust in the inspectee is conceptualized and assessed. Based on literature and empirical research, we synthesized the concept of trust into six elements, five regarding behavior, and a sixth looking at information about its context. We developed a practical framework for the concept to reduce the conceptual ambiguity, strengthen regulatory assessment, and support appropriate tailoring of the regulatory response. RESULTS: Six elements with respect to trust emerged from the data: showing integrity; transparency; ability to learn; accepting feedback; showing actual change in behavior; context information. These five behavioral elements, plus the context information were merged into a Framework of Trust and designed into an interactive PDF document. CONCLUSIONS: This study has sought to address a gap in the empirical knowledge regarding the assessment of trust in the inspectee. The results aim to inform and clarify the regulatory conceptualization and understanding of trust in the inspectee. Other inspectorates may learn from these results for their own practice and explore whether operational deployment of our Framework of Trust effects their assessment and enforcement strategies.

A cross-sectional study into medical students' perceptions of healthcare regulation and self-reported compliance: a study conducted in the City of Al Ain, United Arab Emirates, 2016.

BACKGROUND: Although healthcare regulation is commonplace, there is limited evidence of its impact. Making sure that healthcare professionals comply with the regulatory requirements is a prerequisite to achieving effective regulation. Therefore, investigating factors that influence compliance may provide better insights into how regulators can be more effective. This study aimed to find out if medical students' perceptions of regulation in the United Arab Emirates are associated with self-reported regulatory compliance. METHODS: In the cross-sectional study, we administered a structured questionnaire to students of medicine with different statements concerning their perceptions of healthcare regulation and self-reported compliance. The statements included statement regarding the legitimacy, fairness and regulatory performance, as well as the risk to getting caught and being punished. The association between perceptions and self-reported compliance was analyzed using multiple regression models. RESULTS: One hundred and six Year 3 and 4 pre-clinical medicine students (56.4% response rate) completed the survey. Almost 40% of the students rated their level of awareness and understanding of regulation as Good or Very Good., despite their lack of direct contact with the regulatory authorities (less than 10% reported monthly or more frequent contact). Self-reported compliance was high with almost 85% of the students either agreeing or strongly agreeing with the four compliance statements (mean score 4.1 out of 5). The findings suggest that positive perceptions of the regulator's performance (ß 0.27; 95% CI 0.13-0.41), fairness of the regulatory processes (ß 0.25; 95% CI 0.11-0.38) and its legitimacy (ß 0.23; 95% CI 0.05-0.41), are stronger associated with compliance than the perceived risks of getting caught and being punished (ß 0.10; 95% CI -0.04 - 0.23). CONCLUSIONS: To improve compliant behavior, healthcare regulators should pay more attention to their own perceived performance, as well as the perceived fairness and legitimacy of their regulatory processes rather than focusing on more traditional methods of deterrence, such as perceived risk of getting caught and being published.

Surveillance cues do not enhance altruistic behavior among anonymous strangers in the field.

The degree of altruistic behavior among strangers is an evolutionary puzzle. A prominent explanation is the evolutionary legacy hypothesis according to which an evolved reciprocity-based psychology affects behavior even when reciprocity is impossible, i.e., altruistic behavior in such instances is maladaptive. Empirical support for this explanation comes from laboratory experiments showing that surveillance cues, e.g., photographs of watching eyes, increase altruistic behavior. A competing interpretation for this evidence, however, is that the cues signal the experimenter's expectations and participants, aware of being monitored, intentionally behave more altruistically to boost their reputation. Here we report the first results from a field experiment on the topic in which participants are unaware they are being monitored and reciprocity is precluded. The experiment investigates the impact of surveillance cues on a textbook example of altruistic behavior-hand hygiene prior to treating a 'patient'. We find no evidence surveillance cues affect hand hygiene, despite using different measures of hand-hygiene quality and cues that have been previously shown to be effective. We argue that surveillance cues may have an effect only when participants have reasons to believe they are actually monitored. Thus they cannot support claims altruistic behavior between strangers is maladaptive.

Government supervision on quality of smoking-cessation counselling in midwifery practices: a qualitative exploration.

BACKGROUND: The Dutch Healthcare Inspectorate supervises care providers in order to improve quality of care. Recently the inspectorate assessed and promoted the use of a guideline on smoking-cessation counselling in midwifery practices. The supervision programme consisted of an announcement of the enforcement deadline for the guideline and site visits. The purpose of our qualitative study was to identify factors related to guideline adherence after the supervision programme, and investigate whether the programme had helped improve adherence. METHODS: We conducted semi-structured interviews with inspected and non-inspected midwives. Additionally, we studied documents and observed the inspection process. The sampled midwives all work in primary care midwifery practices providing care to pregnant smokers. The questions included the current provision of smoking-cessation counselling, support to the midwife in counselling, recent changes in provision of counselling, reasons for recent changes, knowledge about the supervision programme, and experiences with supervision by the inspectorate. RESULTS: Our results show that guideline adherence depends on several factors. Awareness and familiarity with the guideline are important, as is outcome expectancy. Additionally, motivation, guideline factors and environment factors were mentioned. Besides these previously documented factors, we found that professional collaboration also determined guideline adherence. Increased collaboration in counselling is associated with greater adherence to the guideline, such as provision of counselling and taking required training. The supervision programme helped improve stop-smoking counselling, by making midwives aware of the counselling and giving them an extrinsic motivation to provide counselling. CONCLUSION: Motivation and environmental aspects were the most important factors related to guideline adherence, and professional environment was added as significant factor. The improved guideline adherence is partly attributable to the supervision programme.

[Effects of government supervision on quality of integrated diabetes care: a cluster randomized controlled trial]. / Effecten van overheidstoezicht op kwaliteit van diabetesketenzorg: een clustergerandomiseerde gecontroleerde trial.

OBJECTIVES: The quality of integrated diabetes care is important for reducing the burden of diabetes. Therefore, we have evaluated the effect of a supervision program on the quality of integrated diabetes care in the Netherlands in the 2011-2012 period. METHODS: In this cluster RCT, the supervision program was assigned to randomly selected care groups providing care to diabetes patients. The supervision program included announcements of inspections, site visits, and sending individualized reports. Indicators of effectiveness were derived from the structures, processes, and outcomes of care. These indicators were collected from patients' files, before and after the supervision program. Hierarchical linear and logistic regression models were used to analyze data from 356 patients of 10 intervention and 8 control care groups. RESULTS: Structures and processes of care did not improve more in the intervention groups than in the control care groups. Moreover, health outcomes did not improve more in the intervention groups than in the control care groups. Although structures of care improved over time in the total population of intervention and control care groups, there were no changes in process of care or health outcomes. CONCLUSIONS: In this cluster RCT, we could not demonstrate improvements in quality of integrated diabetes care resulting from the supervision program. Although structures of care did improve over time, other quality-improvement initiatives are necessary to substantially strengthen integrated care for diabetes patients.

The disciplined healthcare professional: a qualitative interview study on the impact of the disciplinary process and imposed measures in the Netherlands.

OBJECTIVE: It is known that doctors who receive complaints may have feelings of anger, guilt, shame and depression, both in the short and in the long term. This might lead to functional impairment. Less is known about the impact of the disciplinary process and imposed measures. Previous studies of disciplinary proceedings have mainly focused on identifying characteristics of disciplined doctors and on sentencing policies. Therefore, the aim of this study is to explore what impact the disciplinary process and imposed measures have on healthcare professionals. DESIGN: Semistructured interview study, with purposive sampling and inductive qualitative content analysis. PARTICIPANTS: 16 healthcare professionals (9 medical specialists, 3 general practitioners, 2 physiotherapists and 2 psychologists) that were sanctioned by the disciplinary tribunal. SETTING: The Netherlands. RESULTS: Professionals described feelings of misery and insecurity both during the process as in its aftermath. Furthermore, they reported to fear receiving new complaints and provide care more cautiously after the imposed measure. Factors that may enhance psychological and professional impact are the publication of measures online and in newspapers, media coverage, the feeling of treated as guilty before any verdict has been reached, and the long duration of the process. CONCLUSIONS: This study shows that the disciplinary process and imposed measures can have a profound psychological and professional impact on healthcare professionals. Although a disciplinary measure is meant to have a corrective effect, our results suggest that the impact that is experienced by professionals might hamper optimal rehabilitation afterwards. Therefore, organising emotional support should be considered during the disciplinary process and in the period after the verdict.

Effects of Government Supervision on Quality of Integrated Diabetes Care: A Cluster Randomized Controlled Trial.

OBJECTIVES: The quality of integrated diabetes care is important for reducing the burden of diabetes. Therefore, we have evaluated the effect of a supervision program on the quality of integrated diabetes care in the Netherlands in the 2011-2012 period. METHODS: In this cluster RCT, the supervision program was assigned to randomly selected care groups providing care to diabetes patients. The supervision program included announcements of inspections, site visits, and sending individualized reports. Indicators of effectiveness were derived from the structures, processes, and outcomes of care. These indicators were collected from patients' files, before and after the supervision program. Hierarchical linear and logistic regression models were used to analyze data from 356 patients of 10 intervention and 8 control care groups. RESULTS: Structures and processes of care did not improve more in the intervention groups than in the control care groups. Moreover, health outcomes did not improve more in the intervention groups than in the control care groups. Although structures of care improved over time in the total population of intervention and control care groups, there were no changes in process of care or health outcomes. CONCLUSIONS: In this cluster RCT, we could not demonstrate improvements in quality of integrated diabetes care resulting from the supervision program. Although structures of care did improve over time, other quality-improvement initiatives are necessary to substantially strengthen integrated care for diabetes patients.

Provision and effect of quit-smoking counselling by primary care midwives.

OBJECTIVE: we aimed to evaluate the provision of quit-smoking counselling by midwives in the Netherlands and its effect on smoking behaviour and birth weight. DESIGN: quasi-experimental study in which we collected information from pregnant women who smoke throughout their pregnancy by extracting data from electronic patient files. SETTING: primary care midwifery practices. PARTICIPANTS: 851 pregnant women who smoke, treated between 2011 and 2014. INTERVENTION: quit-smoking counselling. MEASUREMENTS AND FINDINGS: the midwives decided to provide quit-smoking counselling to the participant or not. Non-counselled women were used as the control group. The primary outcome parameter was quit smoking, defined as 'quit smoking by end of pregnancy'. At intake, 67% of the women smoked 1-9 cigarettes a day, 23% smoked 10-20 cigarettes a day and 4% more than 20 cigarettes a day. The midwives began counselling with 42% of the participants, but seldom completed all the counselling steps. The average quit rate was 10% and average birth weight of the babies was 3200g. We found no difference in quit rate or birth weight between counselled women and those who were not. However, the data suggested that counselling is more effective when more steps of counselling are completed. KEY CONCLUSIONS: no effect was found of quit-smoking counselling on quit-smoking rate or birth weight. Possibly, counselling is effective when provided extensively throughout pregnancy. IMPLICATIONS FOR PRACTICE: our study shows that provision of counselling can be improved.

Guideline adherence and health outcomes in diabetes mellitus type 2 patients: a cross-sectional study.

BACKGROUND: The complex disease of diabetes mellitus type 2 (T2DM) requires a high standard of quality of care. Clinical practice guidelines define norms for diabetes care that ensure regular monitoring of T2DM patients, including annual diagnostic tests. This study aims to quantify guideline adherence in Dutch general practices providing care to T2DM patients and explores the association between guideline adherence and patients' health outcomes. METHODS: In this cross-sectional study, we studied 363 T2DM patients in 32 general practices in 2011 and 2012. Guideline adherence was measured by comparing structure and process indicators of care with recommendations in the national diabetes care guideline. Health outcomes included biomedical measures and health behaviours. Data was extracted from medical records. The association between guideline adherence and health outcomes was analysed using hierarchical linear and logistic regression models. RESULTS: Guideline adherence varied between different recommendations. For example 53% of the practices had a system for collecting patient experience feedback, while 97% had a policy for no-show patients. With regard to process indicators of care, guideline adherence was below 50% for foot, eye and urine albumin examination and high (>85%) for blood pressure, HbA1c and smoking behaviour assessment. Although guideline adherence varied considerably between practices, after adjusting for patient characteristics we found guideline adherence not to be associated with patients' health outcomes. CONCLUSIONS: Guideline adherence in Dutch general practices offering diabetes care was not optimal. Despite considerable variations between general practices, we found no clear relationship between guideline adherence and health outcomes. More research is needed to better understand the relationship between guideline adherence and health outcomes, specifically for guidelines that are based on limited scientific evidence.

Does government supervision improve stop-smoking counseling in midwifery practices?

INTRODUCTION: Smoking-cessation counseling during pregnancy is important to prevent smoking-related harm in pregnant smokers and their children. Therefore we evaluated the effects of an Inspectorate's supervision programme on the provision of smoking-cessation counseling by midwifery practices in the Netherlands. The supervision programme consisted of 3 elements: A) A deadline was announced by which all practices should comply with professional norms on such counseling (2011); B) A set of randomly selected practices were assessed using a questionnaire and a personal feedback report (2010); C) Another set of randomly selected practices were assessed through a site visit and a personal feedback report (2012). METHODS: Programme A was evaluated in a before-after study, Programmes B and C were evaluated in a randomized controlled trial (RCT) with only a post-intervention measurement. Primary outcome was provision of smoking-cessation counseling through a minimal-intervention strategy (V-MIS). Linear and logistic regression models were used to analyze data from 233 primary-care midwifery practices. RESULTS: A) After announcement of the deadline, Dutch midwifery practices reported significantly more provision of smoking-cessation counseling. For example, the use of V-MIS increased substantially from 28% to 80%; B) In practices that were assessed with a questionnaire, the provision of counseling improved partially compared to controls; C) The provision of counseling did not differ between practices that were visited and their controls. While the training participation rate in counseling by midwifery practices did not differ between the intervention and control groups, the rate increased significantly in all practices after the start of the supervision programme. CONCLUSIONS: The provision of smoking-cessation counseling improved spectacularly in Dutch midwifery practices. Despite some limitations of our study, the Inspectorate's supervision programme is likely to have contributed to the improvements in provision of counseling.

Unannounced, compared with announced inspections: a systematic review and exploratory study in nursing homes.

Politicians and regulators have high expectations of unannounced inspections. Unannounced inspections, unlike announced ones, would, they believe, lead to a clearer insight into the risks and a reduction of the regulatory burden. In order to verify these assumptions, a systematic review of the scientific literature and an exploratory study were conducted. In the systematic review only three relevant articles were found concerned with research into the difference between unannounced and announced inspections. In the exploratory study, Dutch nursing homes were inspected, unannounced, and later announced, in order to compare the risks detected during the inspections. It is concluded that unannounced inspections did not reveal more or different risks, but provided a better insight into the quality of care delivered. Announced inspections are the best option for the assessment both of the organization and of its preconditions for good care. Evidence was found that an unannounced inspection leads to a reduction of the regulatory burden.

[Transparency: can the effect of governmental surveillance be quantified?]. / Transparantie: is het effect van toezicht te meten?

OBJECTIVE: To explore the feasibility of using existing data to measure the impact of surveillance by the Health Care Inspectorate (IGZ) on public health. DESIGN: Retrospective, descriptive. METHOD: We examined the magnitude of the health problems of suicide, pressure ulcers and medication errors before and after surveillance by the IGZ. To do this, we used data from the IGZ, external data files and data from the literature. In addition, we assessed definitions and possible underreporting and overreporting of the results. We then determined whether an estimate could be made of the effect of the surveillance on the magnitude of the health problem using a time series design. RESULTS: Medication errors were not sufficiently defined to measure an effect of surveillance. The prevalence of pressure ulcers and the incidence of suicide could be quantified reliably using data from the Inspectorate. A time series design showed that both health problems declined after surveillance by the Inspectorate. However, these trends could not be attributed to the surveillance since there was no insight into the external factors that might have played a role. CONCLUSION: In case of clearly defined health problems, the extent of the problem can be defined using IGZ data and trends can be observed using a time series design. However, establishing a causal relationship between supervision and observed trends requires an experimental research design, such as a prospective randomized study or a stepped wedge design.

Mental health reforms in Europe: further evaluation of the Dutch supervision system for suicides of mental health care users.

Until recently, suicides of mental health care users in the Netherlands had to be reported to the Health Care Inspectorate by treating clinicians and medical directors. Interview data from 38 clinicians who reported a suicide and directors of the 28 facilities where they worked indicated ambivalence about the procedure's usefulness, especially about the blame implied by the required reporting procedure. No interviewee reported that a suicide could have been prevented. In May 2011 the national policy was changed so that most suicides can be reported in a blame-free manner within the facility and fewer suicides must be reported to the inspectorate.

Health system reform in the Emirate of Abu Dhabi, United Arab Emirates.

The desire to achieve the best outcomes in the provision of healthcare has driven health system reforms in many countries across the globe, including the Emirate of Abu Dhabi, United Arab Emirates. As a young state (the United Arab Emirates was founded as an independent state in 1971) with a diverse (with 78% expatriates) and young population (40.23% of the national Emirati population is under 15 years of age), the government of the Emirate of Abu Dhabi has embarked on a journey to reform their healthcare system. This reform focuses on the redesign, financing, regulation and provision of healthcare with the aim of delivering accessible, affordable and high quality health care. We will describe and review the health system reform in Abu Dhabi to date: its background, history and characteristics. The review looks at whether the main components of the reform (mandatory health insurance; enhanced competition and a centralized regulatory system) have had the desired effects in terms of improving quality, enhancing access and ensuring affordability. Looking toward the future for the health system in Abu Dhabi we conclude that it is too early to tell whether the reform programme is having the desired effects in terms of achieving its goals of quality, access and affordability.

The development of quality indicators in mental healthcare: a discrete choice experiment.

BACKGROUND: Health care regulatory agencies perform audits or inspections to judge the quality and safety of health care. This judgment is based on the assessment of a large set of health care indicators as accepted by the profession. However, there is a lack of knowledge about the influence of these indicators and whether a smaller number would be sufficient for a quality assessment or audit procedure. METHODS: A discrete choice experiment (DCE) was performed for the assessment of quality of care regarding the management of patients with schizophrenia and drug dependency in psychiatric institutes. Based on multidisciplinary guidelines for the treatment of schizophrenia and a visit of (co)inspectors of the Dutch Healthcare Inspectorate at all 33 integrated mental hospitals a set of 51 indicators were assessed in a subsequent interview. With the analysis of the results, 6 attributes were selected for the DCE as quality indicators. RESULTS: Seventy-six percent of all health services (co)inspectors (n = 33) involved in the inspection of mental health services, participated in the experiment. Respondents considered an operational elaborate treatment plan the most important indicator for the assessment of quality of care in a psychiatric institute, followed by a general care program, treatment outcome measurement, and involvement in treatment of patients and relatives. Pharmacotherapy and governance responsibility were valued as less important indicators. CONCLUSIONS: The results of this DCE show that there is a prioritisation in the six selected quality indicators. This might help health services (co) inspectors to enhance the efficiency and transparency of the quality of care assessment for patients with schizophrenia and/or drug dependency in psychiatric institutes.

Suicides in users of mental health care services: treatment characteristics and hindsight reflections.

The current study aims to describe the patient and treatment characteristics of a sample of 505 suicides by mental health care patients, and to determine how clinicians view the care provided and what they learned. The results indicate that the quality of mental health care for suicidal patients could be improved by focusing on communication among clinicians, continuity of care, suicide risk assessment procedures, and the involvement of relatives.

Evaluating instruments for regulation of health care in the Netherlands.

OBJECTIVES: Reliable and valid judgments are necessary for regulatory authorities to merit confidence from care institutions and society and preserve authority. Moreover, limited reliability and validity of regulatory judgments increase the risk of limited improvement of the quality of health care. The goal of the study is to obtain insight in (dis) advantages of different regulatory instruments for regulation of health care. METHOD: In this study, the reliability and validity of judgments generated by a lightly structured and highly structured regulatory instrument used by the Dutch Health Care Inspectorate are compared. RESULTS: Results indicate that the lightly structured instrument causes a large variety in discussed topics in regulatory visits: indicators pointing out potential risks in care are not always part of these discussions, by which incentives to improve care remain unjustly undone. Both types of instruments show variations in the meaning of judgments, indicating validity problems. CONCLUSION: The results of our study suggest that regulation of health care requires thorough appraisal of instruments. Several requirements are identified: first, an instrument that justifies the complexity of care with an accompanying explicit set of standards is necessary. Second, commitment of inspectors to the instrument is essential. And third, training of inspectors is indispensable.

An examination of the Dutch Health Care Inspectorate's supervision system for suicides of mental health care users.

OBJECTIVE: This study examined characteristics of suicides among mental health care users reported between 1996 and 2006 to the Dutch Health Care Inspectorate and the inspectorate's follow-up responses. The aims were to determine whether follow-up was associated with particular characteristics and whether the responses could be improved in accordance with guidelines for treatment of suicidal patients. METHODS: Information about patient and treatment characteristics was collected from a sample of 505 of the 5,483 suicide notifications between 1996 and 2006. The 1996-2005 sample included an equal number of cases to which the inspectorate did and did not respond. The 2006 sample included the first 205 notifications in that year. RESULTS: For 2006 notifications the response rate was 37%. The responses most frequently addressed how and whether the suicide was evaluated and the adequacy of treatment for the psychiatric disorder. A follow-up response was more likely when the suicide involved a young patient or a patient treated in a mental health care setting for less than a year or when the notification was accompanied by the mental health institution's plans for improving its policies. A response was less likely when the patient was discharged from inpatient care in the three months before the suicide. Since 2002 responses have more frequently emphasized the importance of suicide risk assessment, in accordance with guidelines. CONCLUSIONS: The inspectorate might improve its supervision system by placing greater emphasis on addressing suicidal impulses and treating older and chronically suicidal patients and patients soon after inpatient discharge.