Healthcare Regulation and Resilience: a Norwegian Multilevel Case Study

Introduction: A new regulatory framework (the Quality Improvement Regulation) to support local, management-based quality and safety efforts in hospitals was introduced to the Norwegian healthcare system in 2017. This thesis explores healthcare regulation and resilience through the Quality Improvement Regulation, by investigating its possible links to adaptive capacity in hospital management of quality and safety enhancing activities. The literature lacks studies exploring how regulation and resilience intertwine, two concepts often considered as counterparts. Hence, there is a gap in knowledge about regulatory and supervisory impact on quality and safety, and attention to hospital managers’ competences and responsibilities as key elements to resilience in healthcare. This thesis therefore casts a new light on how regulators and inspectors may design, inspect, and enforce a regulation regime, and thereby contribute to adaptive capacity, anticipatory capacity, and learning as key elements in different hospital contexts. Overall outputs from this thesis are important to the development and implementation of future regulatory amendments. Aim: The overall aim of this thesis was to explore the rationale, expectations, implementation, and management of the Quality Improvement Regulation. The overall and leading research question was: How does a new healthcare regulation implemented across three system levels contribute to adaptive capacity in hospital management of quality and safety? Methods: The study was designed as a multilevel, single embedded case study. Data was collected by approximately 500 pages of documentary evidence, 29 individual interviews and 3 focus group interviews (10 participants): in total 39 participants. Data was analyzed by legal dogmatic and qualitative content analysis. Three levels of stakeholders were included from the Norwegian healthcare system: macro-level (three governmental regulatory bodies), meso- level (three County Governors), micro-level (three hospitals retrieved from two regional health authorities). Macro-level participants were seven strategic participants positioned at the Norwegian Ministry of Health and Care Services, the Norwegian Directorate of Health, and the Norwegian Board of Health Supervision. Meso-level participants were two chief county medical officers, three assistant chief county medical officers, and seven inspectors, recruited from three County Governors. Micro-level participants were 20 hospital managers or quality advisors selected from different levels at three hospitals. Findings: Paper I (macro-level) explored the governmental rationale for developing the Quality Improvement Regulation, expectations towards hospital management and its expected influence on resilience. Data retrieved from documentary evidence and individual interviews indicated that the rationale for the Quality Improvement Regulation’s design was to make it flexible to various hospital contexts. In turn, the macro-level expected hospital managers to anticipate local risks. However, the study found that the Government expected the generic regulatory design to come across as challenging for hospital managers and clinicians. Paper II (meso-level) investigated into changes in the supervisory approach and inspectors’ work to promote or hamper adaptive capacity and learning in hospitals. Evidence emerged from documents and focus group interviews and indicated that despite supervision being adapted to specific hospital contexts and the inspectors’ trade-offs, there was a general concern about the lack of impact of supervision on hospital performance. Paper III (micro-level) explored hospital managers’ perspectives on implementation efforts and the following work practices, to understand if, and how, the new Quality Improvement Regulation influenced quality and safety improvement activities. Across interview data, participants experienced the Quality Improvement Regulation as more suitable to variation and different contexts compared to the previous regulatory framework. However, findings revealed no change in practice related to quality and safety activities, solely due to the new regulatory framework, despite recent structural and cultural changes to quality improvement systems in hospitals. Data reported that lack of time, competence and/or motivation affected hospital implementation. Conclusions: This thesis represents a rare glimpse into regulatory implementation efforts across three system levels, set out in a resilience in healthcare perspective. This thesis revealed that regulators considered the perspective of variation, complexity, and uncertainty in hospital settings to be important when designing the Quality Improvement Regulation. The latter resonates with resilience in healthcare concepts and contradicts previous research. The Quality Improvement Regulation contributed to context adaptation, by supporting nondetailed risk based organizing and management of quality and safety. However, hospital managers’ autonomy and adaptive capacity to tailor quality improvement efforts were imperative for the regulatory requirements to have any relevant impact on hospital practice. Limited involvement of clinicians in the regulatory development process could hamper quality improvement efforts. Inspectors could nurture learning by improving their follow up, use expert inspectors, and add more hospital self- assessment activities. This thesis highlights the importance of ensuring that any macro-level quality improvement initiatives and regulatory requirements are accompanied by appropriate resourcing, support, and advanced preparation to ensure the best possible chance of getting implemented effectively.

Oral cancer patient’s profile and time to treatment initiation in the public health system in Rio de Janeiro, Brazil

BackgroundThis paper aims to describe the profile of oral cancer (OC) patients, their risk classification and identify the time between screening and treatment initiation in Rio de Janeiro Municipality.MethodData were obtained from the healthcare Regulation System (SISREG) regarding the period January 2013 to September 2015. Descriptive, bivariate and multivariate analysis were performed identifying the factors associates with a diagnosis of OC as well as the time to treatment initiation (TTI) differences between groups.ResultsFrom 3,862 individuals with a potential OC lesion, 6.9 % had OC diagnosis. OC patients were 62.3 y.o. (mean), 64.7 % male, 36.1 % were white and 62.5 % of the records received a red/yellow estimated risk classification. Being older, male, white and receiving a high-risk classification was associated with having an OC diagnosis. OC TTI was in average 59.1 days and median of 50 days significantly higher than non-OC individuals (p = 0.007). TTI was higher for individuals older than 60 years old, male, and white individuals and for risk classification red and yellow, nevertheless while in average none of these differences were statistically significant, the median of individuals classified as low risk was significantly (p = 0.044) lower than those with high risk.ConclusionsTime to treatment initiation (TTI) was higher for OC patients related to non OC. Despite OC confirmed was associated with risk at screening classified as urgent or emergent, a high percentage of OC patients had their risk classified for elective care when specialized care was requested.

Oral Cancer patient’s profile and time to treatment initiation in the public health system in Rio de Janeiro, Brazil

Background: This paper aims to describe the profile of oral cancer (OC) patients, their risk classification and identify the time between screening and treatment initiation in Rio de Janeiro Municipality.Method: Data were obtained from the healthcare Regulation System (SISREG) regarding the period January 2013 to September 2015. Descriptive, bivariate and multivariate analysis were performed identifying the factors associates with a diagnosis of OC as well as the time to treatment initiation (TTI) differences between groups.Results: From 3,862 individuals with a potential OC lesion, 6.9% had OC diagnosis. OC patients were 62.3 y.o. (mean), 64.7% male, 36.1% were white and 62.5% of the records received a red/yellow estimated risk classification. Being older, male, white and receiving a high-risk classification was associated with having an OC diagnosis. OC TTI was in average 59.1 days and median of 50 days significantly higher than non-OC individuals (p=0.007). TTI was higher for individuals older than 60 years old, male, and white individuals and for risk classification red and yellow, nevertheless while in average none of these differences were statistically significant, the median of individuals classified as low risk was significantly (p=0.044) lower than those with high risk.Conclusions: Time to treatment initiation (TTI) was higher for OC patients related to non OC. Despite OC confirmed was associated with risk at screening classified as urgent or emergent, a high percentage of OC patients had their risk classified for elective care when specialized care was requested.

From One Stress Test to Another: Lessons for Healthcare Reform from the Financial Sector

The financial crisis in 2008 and the COVID-19 pandemic today have made it clear that both financial and medical crises spread pervasively across borders. The financial crisis proved that the health of the entire European banking system stands and falls with the health of a single systemically important bank. As such, in the past decade, European Union (EU)-wide cooperation and regulation have been strengthened to ensure financial health across Europe. Today, the COVID-19 crisis reveals the de facto existence of a European healthcare system, where Member States’ medical health is interlinked and challenged. It too highlights the need for a more coordinated approach. This paper will draw lessons from European financial regulation and stress testing to make recommendations for EU-wide healthcare. The paper will show the latent benefits that a stress test might have on healthcare performance through mechanisms of governmentality. Moreover, it will pinpoint shortcomings in the financial stress test that could pose looming dangers for a European Health Union, such as a lack of de facto risk sharing. The paper concludes with pragmatic suggestions for a way forward in European healthcare regulation.

Regulation of Professionals and Facilities in the United States

This chapter covers the regulation of healthcare professionals and facilities in the United States. In the midst of an era of great policy uncertainty, the quality of healthcare in the United States is regulated by a number of different actors and rules. This chapter seeks to summarize the types of regulation that govern American healthcare professionals and institutions while providing an overview for comparison with European counterparts. After summarizing the general themes of quality regulation in the United States, the first part of the chapter covers the regulation of professionals—including the self-regulatory state-based system, the government certification regime, and the reimbursement-based voluntary system. The second part of the chapter focuses on the regulation of healthcare institutions, focused primarily on government accreditation and reimbursement-based regulation. In addition to summarizing the basic structure of healthcare regulation for professionals and institutions, new developments and challenges in American health law and policy will be highlighted throughout the chapter.

What methods are used to promote patient and family involvement in healthcare regulation? A case study across four countries

Background: In the regulation of healthcare, the subject of patient and family involvement figures increasingly prominently on the agenda. However, the literature on involving patients and families in regulation is still in its infancy. A systematic analysis of how patient and family involvement in regulation is accomplished across different health systems is lacking. We provide such an overview by mapping and classifying methods of patient and family involvement in regulatory practice in four countries; Norway, England, the Netherlands, and Australia. We thus provide a knowledge base that enables discussions about possible types of involvement, and advantages and difficulties of involvement encountered in practice. Methods: The research design was a multiple case study of patient and family involvement in regulation in four countries. The authors collected 1) academic literature if available and 2) documents of regulators that describe user involvement. Based on the data collected, the authors from each country completed a pre-agreed template to describe the involvement methods. The following information was extracted and included where available: 1) Method of involvement, 2) Type of regulatory activity, 3) Purpose of involvement, 4) Who is involved and 5) Lessons learnt.Results: Our mapping of involvement strategies showed a range of methods being used in regulation, which we classified into four categories: individual proactive, individual reactive, collective proactive, and collective reactive methods. Reported advantages included: increased quality of regulation, increased legitimacy, perceived justice for those affected, and empowerment. Difficulties were also reported concerning: how to incorporate the input of users in decisions, the fact that not all users want to be involved, time and costs required, organizational procedures standing in the way of involvement, and dealing with emotions. Conclusions: Our mapping of user involvement strategies establishes a broad variety of ways to involve patients and families. The four categories can serve as inspiration to regulators in healthcare. The paper shows that stimulating involvement in regulation is a challenging and complex task. The fact that regulators are experimenting with different methods can be viewed positively in this regard.

Resource and Infrastructure-Appropriate Management of ST-Segment Elevation Myocardial Infarction in Low- and Middle-Income Countries

The 143 low- and middle-income countries (LMICs) of the world constitute 80% of the world’s population or roughly 5.86 billion people with much variation in geography, culture, literacy, financial resources, access to health care, insurance penetration, and healthcare regulation. Unfortunately, their burden of cardiovascular disease in general and acute ST-segment–elevation myocardial infarction (STEMI) in particular is increasing at an unprecedented rate. Compounding the problem, outcomes remain suboptimal because of a lack of awareness and a severe paucity of resources. Guideline-based treatment has dramatically improved the outcomes of STEMI in high-income countries. However, no such focused recommendations exist for LMICs, and the unique challenges in LMICs make directly implementing Western guidelines unfeasible. Thus, structured solutions tailored to their individual, local needs, and resources are a vital need. With this in mind, a multicountry collaboration of investigators interested in LMIC STEMI care have tried to create a consensus document that extracts transferable elements from Western guidelines and couples them with local realities gathered from expert experience. It outlines general operating principles for LMICs focused best practices and is intended to create the broad outlines of implementable, resource-appropriate paradigms for management of STEMI in LMICs. Although this document is focused primarily on governments and organizations involved with improvement in STEMI care in LMICs, it also provides some specific targeted information for the frontline clinicians to allow standardized care pathways and improved outcomes.

What methods are used to promote patient and family involvement in healthcare regulation? A case study across four countries

Background In healthcare regulation, the subject of patient and family involvement figures increasingly prominently on the agenda. However, the literature on involving patient and families in regulation is still in its infancy. A systematic analysis of how patient and family involvement in regulation is accomplished across different health systems is lacking. We provide such an overview by mapping and classifying methods of patient and family involvement in regulatory practice in four countries; Norway, England, the Netherlands, and Australia. We thus provide a knowledge base that enables discussions about possible types of involvement, and advantages and difficulties of involvement encountered in practice.Methods The research design was a multiple case study of patient and family involvement in regulation in four countries. The authors collected 1) academic literature if available and 2) documents of regulators that describe user involvement. Based on the data collected, the authors from each country completed a pre-agreed template to describe the involvement methods. The following information was extracted and included if available: 1) Method of involvement, 2) Type of regulatory activity, 3) Purpose of involvement, 4) Who is involved and 5) Lessons learnt.Results Our mapping of involvement methods showed a range of methods being used in regulation, which we classified into four categories: individual proactive, individual reactive, collective proactive, and collective reactive methods. Reported advantages include: increased quality of regulation, increased legitimacy, perceived justice for those affected, and empowerment. Difficulties were also reported concerning: how to incorporate the input of users in decisions, the fact that not all users want to be involved, time and costs required, organizational procedures standing in the way of involvement, and dealing with emotions.Conclusions Our mapping of user involvement methods found a broad variety of involvement methods. These can serve as inspiration to regulators in healthcare. The paper shows that making involvement in regulation successful is a challenging and complex task. The fact that regulators are experimenting with different methods can be valued positively in this regard.