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OBJECTIVE: The objective was to gain knowledge about how external inspections following serious incidents are played out in a Norwegian hospital context from the perspective of the inspectors, and whether stakeholders' views are involved in the inspection. METHODS: Based on a qualitative mixed methods design, 10 government bureaucrats and inspectors situated at the National Board of Health Supervision and three County Governors in Norway, were strategically recruited, and individual semi-structured interviews were conducted. Key official government documents were selected, collected, and thematically analyzed along with the interview data. RESULTS: Our findings overall demonstrate two overarching themes: Theme (1) Perspectives on different external inspection approaches of responding and involving stakeholders in external inspection following serious incidents, Theme (2) Inspectors' internal work practices versus external expectations. Documents and all participants reported a development towards new approaches in external inspection, with more policies and regulatory attention to sensible involvement of stakeholders. Involvement and interaction with patients and informal caregivers could potentially inform the case complexity and the inspector's decision-making process. However, stakeholder involvement was sometimes complex and challenging due to e.g., difficult communication and interaction with patients and/or informal caregivers, due to resource demands and/or the inspector's lack of experience and/or relevant competence, different perceptions of the principle of sound professional practice, quality, and safety. The inspectors considered balancing the formal objectives and expectations, with the expectations of the public and different stakeholders (i.e. hospitals, patients and/or informal caregivers) a challenging part of their job. This balance was seen as an important part of the continuous development of ensuring public trust and legitimacy in external inspection processes. CONCLUSIONS AND IMPLICATIONS: Our study suggests that the regulatory system of external inspection and its available approaches of responding to a serious incident in the Norwegian setting is currently not designed to accommodate the complexity of needs from stakeholders at the levels of hospital organizations, patients, and informal caregivers altogether. Further studies should direct attention to how the wider system of accountability structures may support the internal work practices in the regulatory system, to better algin its formal objectives with expectations of the public.

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External inspections constitute a key element of healthcare regulation. Improved quality of care is one of the important goals of inspections but the mechanisms of how inspections might contribute to quality improvement are poorly understood. Drawing on interviews with healthcare professionals and managers and health record data from inspected organizations, we used a realist evaluation approach to explore how twelve inspections of healthcare providers in x= Norway influenced quality improvement. We found that for inspections to contribute to quality improvement, there must be contextual structures present supporting accountability and engaging staff in improvement work. When such structures are present, inspections can contribute to improvement by creating awareness of gaps between desired and current practices, which leads to readiness for change and stimulates intra-organizational reasoning around quality improvement. We discuss our findings using the theory of de- and recoupling, noting how regulators can identify decoupling between intended goals, management systems, practices, and patient outcomes. We further argue that regulators can contribute to a recoupling between these levels by having the capacity to track the providers' clinical performance over time. This will hold the organization accountable for implementing improvement measures and evaluate the effects of the measures on quality of care.

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OBJECTIVES: To determine whether the prior performance of maternity services, as measured by Royal College of Obstetricians and Gynaecologists performance indicators, is associated with ratings by the Care Quality Commission at subsequent inspection, and whether performance changes occur after inspection. METHODS: We used hospital activity data from 176 maternity sites inspected between October 2013 and March 2016 to generate a set of performance indicators developed by the Royal College of Obstetricians and Gynaecologists. We linked these data to Care Quality Commission data on inspection dates and rating scores and used regression models, controlling for site level effects, to estimate the relationships between inspection ratings and performance indicators before and after inspections. RESULTS: Coefficients measuring the relationship between indicator performance and subsequent inspection rating score had wide confidence intervals which crossed zero suggesting no statistically significant relationship prior to inspection. The same absence of statistical significance was observed for changes in indicator performance after inspection. CONCLUSIONS: The use of routine data for performance monitoring is becoming increasingly important as regular inspection is costly and regulators require accurate and timely intelligence. However, we found no statistically significant relationships between inspection ratings and performance indicators before or after inspections in maternity services. This calls into question the validity and reliability of the performance indicators, the inspection process and ratings, or both, as measures of performance.

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BACKGROUND: There is a gap in the literature regarding what takes place between the announcement of a regulatory intervention, such as an external inspection of a health care organisation, and the inspecting body's site visit. This study aimed to explore inspecting bodies' expectations of how inspected organisations should prepare before an external inspection and to elucidate how inspected health care organisations prepare before site visits. METHODS: This qualitative study was based on data from 17 group interviews with a total of 75 participants representing inspection teams, organisation leaders and clinicians in inspected health care organisations. The data were analysed using a qualitative content analysis method. RESULTS: We identified two approaches to how the inspection teams expected that the inspected organisations should prepare before site visits. In the first approach the inspection teams did not expect any improvement activities to be initiated during this period and focused on identifying inadequacies that the inspected organisations should subsequently improve. In the second approach the inspection teams expected organisations to review their own practices and begin improvement activities if necessary. The inspected organisations responded in different ways to an upcoming site visit, and the organisations' leaders were important in determining which activities would be initiated. Organisations in which leaders involved clinicians in assessing care delivery tended to initiate action to improve and expected inspection teams to assess their ongoing improvement work and provide guidance on further improvements. Leaders who did not involve clinicians in assessing the quality of care tended to perceive the current quality of care as adequate on the basis of reviewing written guidelines. They did not initiate action to improve care delivery apart from updating written guidelines describing how care should be delivered, and they expected the inspection team to confirm that their current practices were in line with the guidelines and external standards. CONCLUSIONS: To promote anticipatory effects in inspected organisations, inspecting bodies should stress the importance of assessing clinical practice and involving frontline clinical staff and leaders in the assessment and in improvement work before the site visit.

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INTRODUCTION: Inspections are widely used in health care as a means to improve the health services delivered to patients. Despite their widespread use, there is little evidence of their effect. The mechanisms for how inspections can promote change are poorly understood. In this study, we use a national inspection campaign of sepsis detection and initial treatment in hospitals as case to: (1) Explore how inspections affect the involved organizations. (2) Evaluate what effect external inspections have on the process of delivering care to patients, measured by change in indicators reflecting how sepsis detection and treatment is carried out. (3) Evaluate whether external inspections affect patient outcomes, measured as change in the 30-day mortality rate and length of hospital stay. METHODS AND ANALYSIS: The intervention that we study is inspections of sepsis detection and treatment in hospitals. The intervention will be rolled out sequentially during 12 months to 24 hospitals. Our effect measures are change on indicators related to the detection and treatment of sepsis, the 30-day mortality rate and length of hospital stay. We collect data from patient records at baseline, before the inspections, and at 8 and 14 months after the inspections. We use logistic regression models and linear regression models to compare the various effect measurements between the intervention and control periods. All the models will include time as a covariate to adjust for potential secular changes in the effect measurements during the study period. We collect qualitative data before and after the inspections, and we will conduct a thematic content analysis to explore how inspections affect the involved organisations. ETHICS AND DISSEMINATION: The study has obtained ethical approval by the Regional Ethics Committee of Norway Nord and the Norwegian Data Protection Authority. It is registered at www.clinicaltrials.gov (Identifier: NCT02747121). Results will be reported in international peer-reviewed journals. TRIAL REGISTRATION: NCT02747121; Pre-results.

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This study was aimed to reveal the relationship of bronchioloalveolar carcinoma (BAC) syndromes and metastasis, in order to provide new scientific basis for syndrome differentiation, treatment and prognostic assessment, which proved the scientificity and feasibility of internal and external inspection. A total of 60 BAC cases were divid-ed into two groups according to the syndrome of deficiency and excess. Another 30 cases of benign pulmonary nod-ules were simultaneous collected in the physical examination as control group. The quality of life (FACT-L) was scored one day before operation for patients in each group. The thoracoscopic technique was used in the biopsy of targeted tissues, in order to reveal indicators related with metastasis. The results showed that the comparison of FACT-L score of patients from two syndromes of BAC and that of the control group indicated that the score of physi-ological state, social/family condition, emotional condition, functional situation, additional situation and total score of the previous one were obviously higher than the latter one (P < 0.01). And the score of patients in the deficiency syndrome group was higher than that of the excess group with statistical significance (P< 0.01). The comparison be-tween the tumor tissues of patients from two syndromes of BAC and the benign pulmonary nodules showed that the VEGF, MMP-2, MMP-9 of the previous one were higher than the latter one (P< 0.01). The comparison between two syndromes showed that all indexes of the deficiency syndrome were higher than the excess syndrome (P < 0.01). It was concluded that syndromes of BAC was related with metastasis.