Sharing of personal health records(PHR)in cloud computing is an essential functionality in the healthcare system.However,how to securely,efficiently and flexibly share PHRs data of the patient in a multi-receiver sett...Sharing of personal health records(PHR)in cloud computing is an essential functionality in the healthcare system.However,how to securely,efficiently and flexibly share PHRs data of the patient in a multi-receiver setting has not been well addressed.For instance,since the trust domain of the cloud server is not identical to the data owner or data user,the semi-trust cloud service provider may intentionally destroy or tamper shared PHRs data of user or only transform partial ciphertext of the shared PHRs or even return wrong computation results to save its storage and computation resource,to pursue maximum economic interest or other malicious purposes.Thus,the PHRs data storing or sharing via the cloud server should be performed with consistency and integrity verification.Fortunately,the emergence of blockchain technology provides new ideas and prospects for ensuring the consistency and integrity of shared PHRs data.To this end,in this work,we leverage the consortiumblockchain technology to enhance the trustworthiness of each participant and propose a blockchain-based patient-centric data sharing scheme for PHRs in cloud computing(BC-PC-Share).Different from the state-of-art schemes,our proposal can achieve the following desired properties:(1)Realizing patient-centric PHRs sharing with a public verification function,i.e.,which can ensure that the returned shared data is consistent with the requested shared data and the integrity of the shared data is not compromised.(2)Supporting scalable and fine-grained access control and sharing of PHRs data with multiple domain users,such as hospitals,medical research institutes,and medical insurance companies.(3)Achieving efficient user decryption by leveraging the transformation key technique and efficient user revocation by introducing time-controlled access.The security analysis and simulation experiment demonstrate that the proposed BC-PC-Share scheme is a feasible and promising solution for PHRs data sharing via consortium blockchain.展开更多
Patient-centred medicine is being adopted as national policies in many countries, encouraged by positive outcomes of the practice at clinical and organisational levels. This study examines the patient-centred health c...Patient-centred medicine is being adopted as national policies in many countries, encouraged by positive outcomes of the practice at clinical and organisational levels. This study examines the patient-centred health care reform in China, which has adopted the approach as a national policy for two decades but has yet to achieve the intended goals. Focusing on conflicting interpretations of the nature of patients at national, organisational, and individual levels, this article argues that such conflicts lead to clashes between the political agenda of the state, priorities of health organisations, professional choices of individual practitioners, and expectations of patients in the process of implementing, practicing, and receiving patient-centred health care in China. It reveals that the national health authority has intended patient-centredness as a universal, anti-market, people-centred approach, based on the health ideology of serving the people. But hospitals, compelled by financial restraints, have implemented it as a market approach centring on patients as consumers. Medical professionals and patients also possess contradictory views towards whether a patient should be perceived as a consumer. The discordance in the interpretation of the patient identity has caused great confusion in the implementation and provision of patient-centred health care. The study points out that the success of patient-centredness as national policy cannot be assumed on the basis of its success at clinical and organisational levels. More efforts are needed to coordinate the fundamental understanding of patient-centredness by different actors.展开更多
Until recently, older adults with a cognitive impairment (CI) who experienced a hip fracture were filtered from being admitted into active rehabilitation units. The increased complexity of care required for older adul...Until recently, older adults with a cognitive impairment (CI) who experienced a hip fracture were filtered from being admitted into active rehabilitation units. The increased complexity of care required for older adults with a CI may negatively influence the attitudes and job satisfaction of healthcare practitioners working with this population. The current study is a part of a larger intervention study allowing patients with CI following a hip fracture access to rehabilitation care and implementing a patient-centred model to facilitate caring for this new population. This new model required a substantial change in the skillset and knowledge of healthcare practitioners. The focus of this study was to explore the impact on the healthcare practitioners of adopting this new model for providing care to older adults with a CI following a hip fracture. The attitudes, dementia knowledge, job satisfaction, and work stress of healthcare practitioners were the focus of evaluation. Key study findings showed that stress due to relationships with coworkers, workloads and scheduling, and the physical design and conditions at work were moderated post-intervention. Staff responses also improved for job satisfaction, biomedical knowledge of dementia, and degree of hopefulness about dementia. Although we cannot state conclusively that the our model was solely responsible for all the staff improvements observed post-intervention, our findings provide further support to the argument that patients with CI should be allowed access to rehabilitation care. Rehabilitation units need to provide education that utilizes a person-centred approach accepting of patients with CI, and focuses on areas that can bolster staff’s positive, dementia-sensitive attitudes. Ultimately, the aim is to create a culture that provides the highest standard of care for all patients, reduces work-related stress, increases job satisfaction, and leads to the highest quality of life for patients during and after rehabilitation.展开更多
Objective:This study aimed to explore the strategies used by acute care hospitals in implementing a national standard for comprehensive care.Methods:A qualitative descriptive study was conducted with 28 care professio...Objective:This study aimed to explore the strategies used by acute care hospitals in implementing a national standard for comprehensive care.Methods:A qualitative descriptive study was conducted with 28 care professionals(20 nurses,two doctors,and six allied health professionals)recruited from a broad range of Australian acute care hospitals.Data were collected using semi-structured interviews from March to August 2023.The interviews were audio-recorded,transcribed,and thematically analyzed.Results:Strategies for implementing the Comprehensive Care Standard(CCS)vary,even within a health service organization.We identifiedstrategies hospitals used regarding the implementation team and plan,communication,education and training,documentation system,patient care plan,networking,incentives and pressure,feedback,and reflectingand evaluating.Conclusions:This interview study sheds light on the various strategies adopted by hospitals in implementing the CCS,providing a practical foundation to inform implementation efforts both within Australia and internationally.展开更多
Chronic diseases are a growing concern worldwide,with nearly 25% of adults suffering from one or more chronic health conditions,thus placing a heavy burden on individuals,families,and healthcare systems.With the adven...Chronic diseases are a growing concern worldwide,with nearly 25% of adults suffering from one or more chronic health conditions,thus placing a heavy burden on individuals,families,and healthcare systems.With the advent of the“Smart Healthcare”era,a series of cutting-edge technologies has brought new experiences to the management of chronic diseases.Among them,smart wearable technology not only helps people pursue a healthier lifestyle but also provides a continuous flow of healthcare data for disease diagnosis and treatment by actively recording physiological parameters and tracking the metabolic state.However,how to organize and analyze the data to achieve the ultimate goal of improving chronic disease management,in terms of quality of life,patient outcomes,and privacy protection,is an urgent issue that needs to be addressed.Artificial intelligence(AI)can provide intelligent suggestions by analyzing a patient’s physiological data from wearable devices for the diagnosis and treatment of diseases.In addition,blockchain can improve healthcare services by authorizing decentralized data sharing,protecting the privacy of users,providing data empowerment,and ensuring the reliability of data management.Integrating AI,blockchain,and wearable technology could optimize the existing chronic disease management models,with a shift from a hospital-centered model to a patient-centered one.In this paper,we conceptually demonstrate a patient-centric technical framework based on AI,blockchain,and wearable technology and further explore the application of these integrated technologies in chronic disease management.Finally,the shortcomings of this new paradigm and future research directions are also discussed.展开更多
Prosthodontics,deals in the restoration and replacement of missing and structurally compromised teeth,this field has been remarkably transformed in the last two decades.Through the integration of digital imaging and t...Prosthodontics,deals in the restoration and replacement of missing and structurally compromised teeth,this field has been remarkably transformed in the last two decades.Through the integration of digital imaging and threedimensional printing,prosthodontics has evolved to provide more durable,precise,and patient-centric outcome.However,as we stand at the convergence of technology and healthcare,a new era is emerging,one that holds immense promise for the field and that is artificial intelligence(AI).In this paper,we explored the fascinating challenges and prospects associated with the future of prosthodontics in the era of AI.展开更多
Weani ng from mechanical ventilation in the in tensive care unit (ICU) is a complex clinical problem and relevant for future organ engineering. Prolonged mechanical ventilation (MV) leads to a range of medical complic...Weani ng from mechanical ventilation in the in tensive care unit (ICU) is a complex clinical problem and relevant for future organ engineering. Prolonged mechanical ventilation (MV) leads to a range of medical complications that increases length of stay and costs as well as contributes to morbidity and even mortality and long-term quality of life. The need to reduce MV is both clinical and economical. Artificial intelligence or machine learning (ML) methods are promising opportunities to positively influence patient outcomes. ML methods have been proposed to enhance clinical decisions processes by using the large amount of digital information generated in the ICU setting. There is a particular interest in empirical methods (such as ML) to improve management of "difficult-to-wean" patients, due to the associated costs and adverse events associated with this population. A systematic literature search was performed using the OVID, IEEEXplore, PubMed, and Web of Science databases. All publications that included (1) the application of ML to weaning from MV in the ICU and (2) a clinical outcome measurement were reviewed. A checklist to assess the study quality of medical ML publications was modified to suit the critical assessment of ML in MV weaning literature. The systematic search identified nine studies that used ML for weaning management from MV in critical care. The weaning management application areas included (1) prediction of successful spontaneous breathing trials (SBTs),(2) prediction of successful extubation,(3) prediction of arterial blood gases, and (4) ventilator setting and oxygenation-adjustment advisory systems. Seven of the nine studies scored seven out of eight on the quality index. The remaining two of the nine studies scored one out of eight on the quality index. This scoring may, in part, be explained by the publications' focus on technical novelty, and therefore focusing on issues most important to a technical audience, instead of issues most important for a systematic medical review. This review showed that only a limited number of studies have started to assess the efficacy and effectiveness of ML for MV in the ICU. However, ML has the potential to be applied to the prediction of SBT failure, extubation failure, and blood gases, and also the adjustment of ventilator and oxygenation settings. The available databases for the development of ML in this clinical area may still be inadequate. None of the reviewed studies reported on the procedure, treatment, or sedation strategy undergone by patients. Such information is unlikely to be required in a technical publication but is potentially vital to the development ML techniques that are sufficiently robust to meet the needs of the"difficult-to-wean"patient population.展开更多
The concepts of patient and public involvement (PPI) have been recognized and linked with quality in health services internationally and in Europe. In England, for more than a decade, NHS policies have increasingly qu...The concepts of patient and public involvement (PPI) have been recognized and linked with quality in health services internationally and in Europe. In England, for more than a decade, NHS policies have increasingly quoted patient-centred services. Limited evidence exists about the implementation of PPI policies and strategies within organisations;three studies only have explored health professionals’ perceptions of PPI. Although nurses’ positive support for patient and public involvement has been noted, comparatively little is known about senior nurses’ experiences of embedding PPI. A national consultation utilising three focus groups aimed to explore senior nurses’ perceptions of challenges and facilitators for PPI implementation. Four Strategic Health Authorities (SHAs) and eleven Primary Care Trusts (PCTs) in England, with fifteen senior nurses with leadership roles and direct PPI experience, participated. Nurses’ perceptions on patient and public involvement, challenges and facilitators for its implementation were discussed. Focus groups were digitally recorded and transcribed verbatim;anonymised transcripts were validated by participants and analysed with thematic analysis. Limited resources, patient representation and recruitment, complexities of implementing PPI and national policy changes were challenging. Commissioning limitations, lack of feedback on patient experience, limited staff awareness, negative attitudes, management of patients and public expectations constituted further challenges. Nursing role characteristics and informal involvement activities, PPI policy and cultural change, commissioning PPI competencies, related service frameworks, providing feedback on patient experiences to staff and recognition of involvement benefits were recognised as facilitators. Findings provided new insights into senior nurses’ experiences and evidence that progress towards meaningful, effective PPI remains slow. However, recognition of existing nursing role characteristics and potential delivery problems created by expanded nursing roles, informal PPI practice and internal organisational sharing of patient feedback may bring an “emerging productive partnership” with nurses enabling and contributing to effective PPI.展开更多
当前“以患者为中心”的药物研发(patient focused drug development,PFDD)理念被制药行业和各国监管机构广泛接纳并应用到临床研发的各个阶段,且逐渐扩展到药学研发中。在此基础上,“以患者为中心的质量标准”(patient-centric specifi...当前“以患者为中心”的药物研发(patient focused drug development,PFDD)理念被制药行业和各国监管机构广泛接纳并应用到临床研发的各个阶段,且逐渐扩展到药学研发中。在此基础上,“以患者为中心的质量标准”(patient-centric specifications,PCS)应运而生。PCS是一种基于科学和风险的质量标准制定办法,侧重于质量属性对患者安全性和有效性影响的风险评估,确定与临床相关的可接受范围,从而为患者提供符合预期的药品,尽可能提高患者的临床获益。PCS建立在大量的知识经验积累和全生命周期管理基础之上。本文将围绕对质量标准的理解,探讨PCS在治疗类生物制品中的应用。展开更多
Patient and public involvement (PPI) has been recognized internationally. In England, NHS policies have increasingly emphasized the importance of patient-centered services, but limited evidence exists about the implem...Patient and public involvement (PPI) has been recognized internationally. In England, NHS policies have increasingly emphasized the importance of patient-centered services, but limited evidence exists about the implementation of PPI policies and strategies within organizations. Few studies have explored health professionals’ perceptions of PPI and comparatively little is known about the experience of senior nurses. A national consultation utilising three focus groups aimed to explore senior nurses’ PPI experience. Four Strategic Health Authorities (SHAs) and eleven Primary Care Trusts (PCTs) in England, with fifteen senior nurses with leadership roles and direct PPI experience, participated. Focus groups were digitally recorded and transcribed verbatim;anonymised transcripts were validated by participants and analysed with thematic analysis. Sixteen categories emerged within five sub-themes of PPI experience: provision of information and raising awareness (1 category), informal generic PPI-activities not perceived as PPI (3 categories), formal generic PPI (3 categories), involvement of specific groups (5 categories) and PPI in commissioning and strategy (4 categories). Findings provided new insights into senior nurses’ experiences and evidence that progress towards meaningful, effective PPI remains slow. Nurses performed PPI in a pragmatic sense, by virtue of the nature of nursing, but they did not recognise or label these activities as such. However, a plethora and variety of innovative activities formally recognised as patient and public involvement were undertaken, together with specific networks and groups’ involvement, and involvement linked to commissioning and strategy. Enhancing awareness of nurses through education, together with monitoring and feedback mechanisms could support the PPI implementation and effectiveness at organisations.展开更多
基金supported by the Youth Doctoral Foundation of Gansu Education Committee under Grant No.2022QB-176.
文摘Sharing of personal health records(PHR)in cloud computing is an essential functionality in the healthcare system.However,how to securely,efficiently and flexibly share PHRs data of the patient in a multi-receiver setting has not been well addressed.For instance,since the trust domain of the cloud server is not identical to the data owner or data user,the semi-trust cloud service provider may intentionally destroy or tamper shared PHRs data of user or only transform partial ciphertext of the shared PHRs or even return wrong computation results to save its storage and computation resource,to pursue maximum economic interest or other malicious purposes.Thus,the PHRs data storing or sharing via the cloud server should be performed with consistency and integrity verification.Fortunately,the emergence of blockchain technology provides new ideas and prospects for ensuring the consistency and integrity of shared PHRs data.To this end,in this work,we leverage the consortiumblockchain technology to enhance the trustworthiness of each participant and propose a blockchain-based patient-centric data sharing scheme for PHRs in cloud computing(BC-PC-Share).Different from the state-of-art schemes,our proposal can achieve the following desired properties:(1)Realizing patient-centric PHRs sharing with a public verification function,i.e.,which can ensure that the returned shared data is consistent with the requested shared data and the integrity of the shared data is not compromised.(2)Supporting scalable and fine-grained access control and sharing of PHRs data with multiple domain users,such as hospitals,medical research institutes,and medical insurance companies.(3)Achieving efficient user decryption by leveraging the transformation key technique and efficient user revocation by introducing time-controlled access.The security analysis and simulation experiment demonstrate that the proposed BC-PC-Share scheme is a feasible and promising solution for PHRs data sharing via consortium blockchain.
文摘Patient-centred medicine is being adopted as national policies in many countries, encouraged by positive outcomes of the practice at clinical and organisational levels. This study examines the patient-centred health care reform in China, which has adopted the approach as a national policy for two decades but has yet to achieve the intended goals. Focusing on conflicting interpretations of the nature of patients at national, organisational, and individual levels, this article argues that such conflicts lead to clashes between the political agenda of the state, priorities of health organisations, professional choices of individual practitioners, and expectations of patients in the process of implementing, practicing, and receiving patient-centred health care in China. It reveals that the national health authority has intended patient-centredness as a universal, anti-market, people-centred approach, based on the health ideology of serving the people. But hospitals, compelled by financial restraints, have implemented it as a market approach centring on patients as consumers. Medical professionals and patients also possess contradictory views towards whether a patient should be perceived as a consumer. The discordance in the interpretation of the patient identity has caused great confusion in the implementation and provision of patient-centred health care. The study points out that the success of patient-centredness as national policy cannot be assumed on the basis of its success at clinical and organisational levels. More efforts are needed to coordinate the fundamental understanding of patient-centredness by different actors.
文摘Until recently, older adults with a cognitive impairment (CI) who experienced a hip fracture were filtered from being admitted into active rehabilitation units. The increased complexity of care required for older adults with a CI may negatively influence the attitudes and job satisfaction of healthcare practitioners working with this population. The current study is a part of a larger intervention study allowing patients with CI following a hip fracture access to rehabilitation care and implementing a patient-centred model to facilitate caring for this new population. This new model required a substantial change in the skillset and knowledge of healthcare practitioners. The focus of this study was to explore the impact on the healthcare practitioners of adopting this new model for providing care to older adults with a CI following a hip fracture. The attitudes, dementia knowledge, job satisfaction, and work stress of healthcare practitioners were the focus of evaluation. Key study findings showed that stress due to relationships with coworkers, workloads and scheduling, and the physical design and conditions at work were moderated post-intervention. Staff responses also improved for job satisfaction, biomedical knowledge of dementia, and degree of hopefulness about dementia. Although we cannot state conclusively that the our model was solely responsible for all the staff improvements observed post-intervention, our findings provide further support to the argument that patients with CI should be allowed access to rehabilitation care. Rehabilitation units need to provide education that utilizes a person-centred approach accepting of patients with CI, and focuses on areas that can bolster staff’s positive, dementia-sensitive attitudes. Ultimately, the aim is to create a culture that provides the highest standard of care for all patients, reduces work-related stress, increases job satisfaction, and leads to the highest quality of life for patients during and after rehabilitation.
基金supported by an Australian Government Research Training Program Scholarshippart of the project“Improving quality of care for people with dementia in the acute care setting(eQC)”which is funded by the National Health and Medical Research Council of the Australian Government(No.APP1140459)。
文摘Objective:This study aimed to explore the strategies used by acute care hospitals in implementing a national standard for comprehensive care.Methods:A qualitative descriptive study was conducted with 28 care professionals(20 nurses,two doctors,and six allied health professionals)recruited from a broad range of Australian acute care hospitals.Data were collected using semi-structured interviews from March to August 2023.The interviews were audio-recorded,transcribed,and thematically analyzed.Results:Strategies for implementing the Comprehensive Care Standard(CCS)vary,even within a health service organization.We identifiedstrategies hospitals used regarding the implementation team and plan,communication,education and training,documentation system,patient care plan,networking,incentives and pressure,feedback,and reflectingand evaluating.Conclusions:This interview study sheds light on the various strategies adopted by hospitals in implementing the CCS,providing a practical foundation to inform implementation efforts both within Australia and internationally.
基金supported by the National Natural Science Foundation of China(No.81974355 and No.82172525)the National Intelligence Medical Clinical Research Center(No.2020021105012440)the Hubei Province Technology Innovation Major Special Project(No.2018AAA067).
文摘Chronic diseases are a growing concern worldwide,with nearly 25% of adults suffering from one or more chronic health conditions,thus placing a heavy burden on individuals,families,and healthcare systems.With the advent of the“Smart Healthcare”era,a series of cutting-edge technologies has brought new experiences to the management of chronic diseases.Among them,smart wearable technology not only helps people pursue a healthier lifestyle but also provides a continuous flow of healthcare data for disease diagnosis and treatment by actively recording physiological parameters and tracking the metabolic state.However,how to organize and analyze the data to achieve the ultimate goal of improving chronic disease management,in terms of quality of life,patient outcomes,and privacy protection,is an urgent issue that needs to be addressed.Artificial intelligence(AI)can provide intelligent suggestions by analyzing a patient’s physiological data from wearable devices for the diagnosis and treatment of diseases.In addition,blockchain can improve healthcare services by authorizing decentralized data sharing,protecting the privacy of users,providing data empowerment,and ensuring the reliability of data management.Integrating AI,blockchain,and wearable technology could optimize the existing chronic disease management models,with a shift from a hospital-centered model to a patient-centered one.In this paper,we conceptually demonstrate a patient-centric technical framework based on AI,blockchain,and wearable technology and further explore the application of these integrated technologies in chronic disease management.Finally,the shortcomings of this new paradigm and future research directions are also discussed.
文摘Prosthodontics,deals in the restoration and replacement of missing and structurally compromised teeth,this field has been remarkably transformed in the last two decades.Through the integration of digital imaging and threedimensional printing,prosthodontics has evolved to provide more durable,precise,and patient-centric outcome.However,as we stand at the convergence of technology and healthcare,a new era is emerging,one that holds immense promise for the field and that is artificial intelligence(AI).In this paper,we explored the fascinating challenges and prospects associated with the future of prosthodontics in the era of AI.
文摘Weani ng from mechanical ventilation in the in tensive care unit (ICU) is a complex clinical problem and relevant for future organ engineering. Prolonged mechanical ventilation (MV) leads to a range of medical complications that increases length of stay and costs as well as contributes to morbidity and even mortality and long-term quality of life. The need to reduce MV is both clinical and economical. Artificial intelligence or machine learning (ML) methods are promising opportunities to positively influence patient outcomes. ML methods have been proposed to enhance clinical decisions processes by using the large amount of digital information generated in the ICU setting. There is a particular interest in empirical methods (such as ML) to improve management of "difficult-to-wean" patients, due to the associated costs and adverse events associated with this population. A systematic literature search was performed using the OVID, IEEEXplore, PubMed, and Web of Science databases. All publications that included (1) the application of ML to weaning from MV in the ICU and (2) a clinical outcome measurement were reviewed. A checklist to assess the study quality of medical ML publications was modified to suit the critical assessment of ML in MV weaning literature. The systematic search identified nine studies that used ML for weaning management from MV in critical care. The weaning management application areas included (1) prediction of successful spontaneous breathing trials (SBTs),(2) prediction of successful extubation,(3) prediction of arterial blood gases, and (4) ventilator setting and oxygenation-adjustment advisory systems. Seven of the nine studies scored seven out of eight on the quality index. The remaining two of the nine studies scored one out of eight on the quality index. This scoring may, in part, be explained by the publications' focus on technical novelty, and therefore focusing on issues most important to a technical audience, instead of issues most important for a systematic medical review. This review showed that only a limited number of studies have started to assess the efficacy and effectiveness of ML for MV in the ICU. However, ML has the potential to be applied to the prediction of SBT failure, extubation failure, and blood gases, and also the adjustment of ventilator and oxygenation settings. The available databases for the development of ML in this clinical area may still be inadequate. None of the reviewed studies reported on the procedure, treatment, or sedation strategy undergone by patients. Such information is unlikely to be required in a technical publication but is potentially vital to the development ML techniques that are sufficiently robust to meet the needs of the"difficult-to-wean"patient population.
文摘The concepts of patient and public involvement (PPI) have been recognized and linked with quality in health services internationally and in Europe. In England, for more than a decade, NHS policies have increasingly quoted patient-centred services. Limited evidence exists about the implementation of PPI policies and strategies within organisations;three studies only have explored health professionals’ perceptions of PPI. Although nurses’ positive support for patient and public involvement has been noted, comparatively little is known about senior nurses’ experiences of embedding PPI. A national consultation utilising three focus groups aimed to explore senior nurses’ perceptions of challenges and facilitators for PPI implementation. Four Strategic Health Authorities (SHAs) and eleven Primary Care Trusts (PCTs) in England, with fifteen senior nurses with leadership roles and direct PPI experience, participated. Nurses’ perceptions on patient and public involvement, challenges and facilitators for its implementation were discussed. Focus groups were digitally recorded and transcribed verbatim;anonymised transcripts were validated by participants and analysed with thematic analysis. Limited resources, patient representation and recruitment, complexities of implementing PPI and national policy changes were challenging. Commissioning limitations, lack of feedback on patient experience, limited staff awareness, negative attitudes, management of patients and public expectations constituted further challenges. Nursing role characteristics and informal involvement activities, PPI policy and cultural change, commissioning PPI competencies, related service frameworks, providing feedback on patient experiences to staff and recognition of involvement benefits were recognised as facilitators. Findings provided new insights into senior nurses’ experiences and evidence that progress towards meaningful, effective PPI remains slow. However, recognition of existing nursing role characteristics and potential delivery problems created by expanded nursing roles, informal PPI practice and internal organisational sharing of patient feedback may bring an “emerging productive partnership” with nurses enabling and contributing to effective PPI.
文摘当前“以患者为中心”的药物研发(patient focused drug development,PFDD)理念被制药行业和各国监管机构广泛接纳并应用到临床研发的各个阶段,且逐渐扩展到药学研发中。在此基础上,“以患者为中心的质量标准”(patient-centric specifications,PCS)应运而生。PCS是一种基于科学和风险的质量标准制定办法,侧重于质量属性对患者安全性和有效性影响的风险评估,确定与临床相关的可接受范围,从而为患者提供符合预期的药品,尽可能提高患者的临床获益。PCS建立在大量的知识经验积累和全生命周期管理基础之上。本文将围绕对质量标准的理解,探讨PCS在治疗类生物制品中的应用。
文摘Patient and public involvement (PPI) has been recognized internationally. In England, NHS policies have increasingly emphasized the importance of patient-centered services, but limited evidence exists about the implementation of PPI policies and strategies within organizations. Few studies have explored health professionals’ perceptions of PPI and comparatively little is known about the experience of senior nurses. A national consultation utilising three focus groups aimed to explore senior nurses’ PPI experience. Four Strategic Health Authorities (SHAs) and eleven Primary Care Trusts (PCTs) in England, with fifteen senior nurses with leadership roles and direct PPI experience, participated. Focus groups were digitally recorded and transcribed verbatim;anonymised transcripts were validated by participants and analysed with thematic analysis. Sixteen categories emerged within five sub-themes of PPI experience: provision of information and raising awareness (1 category), informal generic PPI-activities not perceived as PPI (3 categories), formal generic PPI (3 categories), involvement of specific groups (5 categories) and PPI in commissioning and strategy (4 categories). Findings provided new insights into senior nurses’ experiences and evidence that progress towards meaningful, effective PPI remains slow. Nurses performed PPI in a pragmatic sense, by virtue of the nature of nursing, but they did not recognise or label these activities as such. However, a plethora and variety of innovative activities formally recognised as patient and public involvement were undertaken, together with specific networks and groups’ involvement, and involvement linked to commissioning and strategy. Enhancing awareness of nurses through education, together with monitoring and feedback mechanisms could support the PPI implementation and effectiveness at organisations.
