Impact of Improper Storage of ChAdOx1-S (AstraZeneca) Vaccine on Its Efficacy and Safety.

Background: In May 2021, there was an incident regarding giving patients AstraZeneca vaccines stored improperly. They were stored at room temperature (21 degrees centigrade) for 18 h, 12 h longer than the producer recommends. Aim of the study: The paper aims to contribute to the body of knowledge concerning the efficacy and safety of the ChAdOx1-S (AstraZeneca) vaccine concerning the requirements for cold supply chain specification. Patients and methods: Improperly stored vaccines were given to 44 patients, and 39 of them decided to take part in the study. The Control group consisted of 56 people vaccinated on the same days by the same medical teams, using properly stored medicines. Results: The concentration of anti-S1 SARS-CoV-2 Spike protein IgG antibodies did not differ significantly between the groups. Examined group median 70 kU/L (20;100). Control group median 66 kU/L (32.75;100), p = 0.751. We did not observe any COVID-19 infections in either the control or examined group for half a year after the incident. People from each group reported that local and systemic adverse events occurred directly after the first and second doses. In the control group, one case of spontaneously subsiding face edema and joint pain was observed. There were no severe or fatal adverse events. There were no significant differences between the groups, besides the fatigue, after the second dose. Conclusion: AstraZeneca vaccine ChAdOx1-S stored at 21 degrees centigrade for 18 h before vaccination has the same safety profile (p < 0.05) and the same efficacy (p < 0.05) as the vaccines stored in conditions recommended by the producer.

Restoring patient trust in healthcare: medical information impact case study in Poland.

BACKGROUND: This study empirically evaluates the influence of medical information on patient trust at the physician level, the medical profession, hospitals, and with the payer. Restoring patient trust in a medical setting in Poland appears to be significantly affected due to the COVID-19 pandemic. Patient trust improves results from medical treatment, raises perception of healthcare performance, and smoothens the overall functionality of healthcare systems. METHODS: In order to study trust volatility, patients took part in a three-stage experiment designed via: (1) measured level of trust, (2) randomly dividing participants into two groups-control (i.e., re-examination of level of trust) and experimental (i.e., being exposed to a piece of certain manipulative information), and (3) checking whether observational changes were permanent. RESULTS: Results indicate that in the experimental group the increase of trust was noticed in the payer (27.7%, p < 0.001), hospitals (10.9%, p = 0.011), and physicians (decrease of 9.2%, p = 0.036). CONCLUSION: The study indicated that in Poland medical information is likely to influence patient trust in healthcare while interpersonal and social trust levels may be related to increases of trust in hospitals and in the payer versus decreases in physicians.

Testing cost containment of future healthcare with maintained or improved quality-The COSTCARES project.

BACKGROUND: Increasing healthcare costs need to be contained in order to maintain equality of access to care for all EU citizens. A cross-disciplinary consortium of experts was supported by the EU FP7 research programme, to produce a roadmap on cost containment, while maintaining or improving the quality of healthcare. The roadmap comprises two drivers: person-centred care and health promotion; five critical enablers also need to be addressed: information technology, quality measures, infrastructure, incentive systems, and contracting strategies. METHOD: In order to develop and test the roadmap, a COST Action project was initiated: COST-CARES, with 28 participating countries. This paper provides an overview of evidence about the effects of each of the identified enablers. Intersections between the drivers and the enablers are identified as critical for the success of future cost containment, in tandem with maintained or improved quality in healthcare. This will require further exploration through testing. CONCLUSION: Cost containment of future healthcare, with maintained or improved quality, needs to be addressed through a concerted approach of testing key factors. We propose a framework for test lab design based on these drivers and enablers in different European countries.

Implementation of Person-Centered Care: A Feasibility Study Using the WE-CARE Roadmap.

BACKGROUND: Person-Centered Care (PCC) is a promising approach towards improved quality of care and cost containment within health systems. It has been evaluated in Sweden and England. This feasibility study examines initial PCC implementation in a rehabilitation hospital for children in Poland. METHODS: The WE-CARE Roadmap of enablers was used to guide implementation of PCC for patients with moderate scoliosis. A multi-disciplinary team of professionals were trained in the PCC approach and the hospital Information Technology (IT) system was modified to enhance PCC data capture. Semi-structured interviews were conducted with the nine health care professionals involved in the pilot study and three patients/parents receiving care. Transcribed data were analyzed via content analysis. RESULTS: 51 patients and their families were treated via a PCC approach. High proportions of new PCC data fields were completed by the professionals. The professionals were able to implement the three core PCC routines and perceived benefits using the PCC approach. Patients and their families also perceived improved quality care. The WE-CARE framework enablers facilitated PCC implementation in this setting. CONCLUSIONS: This feasibility pilot study indicates that the Gothenburg PCC approach can be successfully transferred to a rehabilitation hospital in Poland with favorable perceptions of implementation by both professionals and patients/their families.

Motivators for medical staff with a high gap in healthcare efficiency: Comparative research from Poland and Ukraine.

INTRODUCTION: This article examines different motivators for medical staff in countries with a high gap in healthcare efficiency by comparing them in two healthcare systems-Polish (ie efficient) and Ukrainian (ie inefficient). METHOD: This survey-based study applies a six-stage conceptual framework to two Polish and two Ukrainian hospitals as well as medical faculties of one university from each country. Following ethical approval, data were collected in the first quarter of 2019, using the 'Evaluation of motivators questionnaire for medical staff'. FINDINGS: Medical staff perceived their working conditions in the inefficient healthcare system much worse than in the efficient system; however, they generally had a more optimistic outlook. Medical staff in efficient and inefficient healthcare systems has different motivational targets, including sizable differences from profession, gender, and age. These factors play an important role in developing a high-performance healthcare system. Results are illustrated in terms of motivators for medical staff. CONCLUSION: Optimising a healthcare system requires useful reform of enablers, especially in countries with inefficient systems, including policymaking and regulatory action. Best practices must incorporate all stakeholders interested in high healthcare performance-usage of suitable practices from abroad can act as an important resource.

Model Driven Approach for Development of Person-Centred Care in Stroke Rehabilitation.

Person-centred care is known as a novel approach which contributes to wellbeing, prevention, care and support of patients. There is little evidence about practising PCC in stroke rehabilitation. In this paper, we develop a novel framework for creation of person-centred services for stroke rehabilitation which supports service configuration adapted to the requirements of each patient. The framework is elaborated over evidence from neurology department of Clinical Centre in Montenegro.

Supporting Innovative Person-Centred Care in Financially Constrained Environments: The WE CARE Exploratory Health Laboratory Evaluation Strategy.

The COST CARES project aims to support healthcare cost containment and improve healthcare quality across Europe by developing the research and development necessary for person-centred care (PCC) and health promotion. This paper presents an overview evaluation strategy for testing 'Exploratory Health Laboratories' to deliver these aims. Our strategy is theory driven and evidence based, and developed through a multi-disciplinary and European-wide team. Specifically, we define the key approach and essential criteria necessary to evaluate initial testing, and on-going large-scale implementation with a core set of accompanying methods (metrics, models, and measurements). This paper also outlines the enabling mechanisms that support the development of the "Health Labs" towards innovative models of ethically grounded and evidenced-based PCC.

Connected Health Services: Framework for an Impact Assessment.

BACKGROUND: Connected health (CH), as a new paradigm, manages individual and community health in a holistic manner by leveraging a variety of technologies and has the potential for the incorporation of telehealth and integrated care services, covering the whole spectrum of health-related services addressing healthy subjects and chronic patients. The reorganization of services around the person or citizen has been expected to bring high impact in the health care domain. There are a series of concerns (eg, contextual factors influencing the impact of care models, the cost savings associated with CH solutions, and the sustainability of the CH ecosystem) that should be better addressed for CH technologies to reach stakeholders more successfully. Overall, there is a need to effectively establish an understanding of the concepts of CH impact. As services based on CH technologies go beyond standard clinical interventions and assessments of medical devices or medical treatments, the need for standardization and for new ways of measurements and assessments emerges when studying CH impact. OBJECTIVE: This study aimed to introduce the CH impact framework (CHIF) that serves as an approach to assess the impact of CH services. METHODS: This study focused on the subset of CH comprising services that directly address patients and citizens on the management of disease or health and wellness. The CHIF was developed through a multistep procedure and various activities. These included, as initial steps, a literature review and workshop focusing on knowledge elicitation around CH concepts. Then followed the development of the initial version of the framework, refining of the framework with the experts as a result of the second workshop, and, finally, composition and deployment of a questionnaire for preliminary feedback from early-stage researchers in the relevant domains. RESULTS: The framework contributes to a better understanding of what is CH impact and analyzes the factors toward achieving it. CHIF elaborates on how to assess impact in CH services. These aspects can contribute to an impact-aware design of CH services. It can also contribute to a comparison of CH services and further knowledge of the domain. The CHIF is based on 4 concepts, including CH system and service outline, CH system end users, CH outcomes, and factors toward achieving CH impact. The framework is visualized as an ontological model. CONCLUSIONS: The CHIF is an initial step toward identifying methodologies to objectively measure CH impact while recognizing its multiple dimensions and scales.

Early detection of idiopathic scoliosis - analysis of three screening models.

INTRODUCTION: The prevalence of lateral curvatures of the spine ranges from 0.3% to 15.3% in the general population. The aim of the study was to develop and compare three different screening tests for idiopathic scoliosis (IS) with respect to their effectiveness and costs. MATERIAL AND METHODS: The Delphi method was used to assess the efficacy of each screening algorithm in detecting IS in the population. An economic analysis was also performed. RESULTS: Diagnostic Algorithm 1 for IS comprised a screening examination performed by nurses and a general practitioner (GP) with verification by specialists. The unit cost of carrying out diagnostic work-up for IS in Algorithm 1 was €94 per child. The second algorithm involved the use of the moiré computer method, followed by verification by a specialist. The lower unit cost of €86 per child of diagnostic work-up according to Algorithm 2 was due to fewer stages compared to Algorithm 1. The highest effectiveness with the highest costs were found for the third algorithm, with only one stage, a specialist's consultation (cost €153 per child). CONCLUSIONS: The number of stages in an algorithm does not correlate positively with its efficacy or cost. The recommended scheme is Algorithm 3, where children are examined by rehabilitation specialists or a physiotherapist using a scoliometer and an inclinometer. The use of the apparently most expensive scheme (Algorithm 3) should result in lowering the costs of treatment of established idiopathic scoliosis and, in the long term, prove to be the most cost-effective solution for the health care system.

"A manager in the minds of doctors:" a comparison of new modes of control in European hospitals.

BACKGROUND: Hospital governance increasingly combines management and professional self-governance. This article maps the new emergent modes of control in a comparative perspective and aims to better understand the relationship between medicine and management as hybrid and context-dependent. Theoretically, we critically review approaches into the managerialism-professionalism relationship; methodologically, we expand cross-country comparison towards the meso-level of organisations; and empirically, the focus is on processes and actors in a range of European hospitals. METHODS: The research is explorative and was carried out as part of the FP7 COST action IS0903 Medicine and Management, Working Group 2. Comprising seven European countries, the focus is on doctors and public hospitals. We use a comparative case study design that primarily draws on expert information and document analysis as well as other secondary sources. RESULTS: The findings reveal that managerial control is not simply an external force but increasingly integrated in medical professionalism. These processes of change are relevant in all countries but shaped by organisational settings, and therefore create different patterns of control: (1) 'integrated' control with high levels of coordination and coherent patterns for cost and quality controls; (2) 'partly integrated' control with diversity of coordination on hospital and department level and between cost and quality controls; and (3) 'fragmented' control with limited coordination and gaps between quality control more strongly dominated by medicine, and cost control by management. CONCLUSIONS: Our comparison highlights how organisations matter and brings the crucial relevance of 'coordination' of medicine and management across the levels (hospital/department) and the substance (cost/quality-safety) of control into perspective. Consequently, coordination may serve as a taxonomy of emergent modes of control, thus bringing new directions for cost-efficient and quality-effective hospital governance into perspective.

Cytological examination of pleural cavity lavage accompanied by the study of gene promoter hypermethylation of p16 and O6-methylguanine-DNA-methyltransferase genes in diagnostics of non-small cell lung cancer metastatic changes into pleura.

AIM OF THE STUDY: Metastases of non-small cell lung cancer (NSCLC) into pleura disqualify a patient from surgery and present a bad prognostic index. The aim of the study was to find out whether washing out the pleural cavity in such cases and examining obtained washings for presence of cancer cells will help to detect early NSCLC metastases into pleura, and also whether negative results of the cytology determine whether hypermethylation of these genes will increase the sensitivity of this examination. MATERIAL AND METHODS: The study consisted of the examination of 76 patients, including 59 operated on for NSCLC and 17 operated on for other reasons. Pleural washing fluid collected during the surgery was subjected to cytological examination as well as examined to determine the presence of promoter region hypermethylation of p16 and MGMT genes. RESULTS: Positive cytological results of pleural lavage were confirmed in 4 persons (7%) with NSCLC. The presence of promoter region hypermethylation of one or both examined genes was found in 3 patients (18%) in the control group and in 47 (80%) in the study group. Sex, occupational exposure, smoking cigarettes, and NSCLC histological type did not have an influence on the presence of cancer cells or hypermethylation in the pleural lavage fluid. Positive cytology results were more frequent at the T4 stage of NSCLC. Hypermethylation was more frequent in the research group (p < 0.01). Cancer cells and hypermethylation did not occur more frequently in pleural lavage fluid of patients with metastases into pleura. CONCLUSIONS: The cytological examination and promoter region hypermethylation assessment of the p16 gene and MGMT gene in pleural lavage cells do not allow one to detect early metastasis of NSCLC into pleura.