Patient involvement in health research is getting more accepted over the years. Until recently scientists and medical professionals were the sole assessors of quality and relevance of research proposals. In the Nether...Patient involvement in health research is getting more accepted over the years. Until recently scientists and medical professionals were the sole assessors of quality and relevance of research proposals. In the Netherlands, as in other European and North American countries, emancipatory, political and democratic developments stimulated the emergence of patient involvement as a new “voice” in the appraisal of research. A time-series cross sectional longi-tudinal case study was used to describe and analyse a seven year period since the introduction of the patients’ perspective in the Long-fonds research cycle. Longfonds, the Lung Foundation in the Netherlands (LFN) was formerly called “Astma Fonds”. The study was conducted using an actors-interaction model against the background of the dynamics in society. The introduction of patient involvement resulted in a paradigm shift. The scientific and societal relevance of research proposals are now being reviewed by all parties in a more ef- fective and efficient way. Patients, now involved in the review procedure of research funding, are trained and equipped with an appraisal tool for societal relevance from a patients perspective. Scientific relevance and societal relevance are evaluated separately and balanced in the re- search funding application approval process. Societal relevance is being evaluated by a pa- tient advocates group. The results show how a government initiative and an approach by a patient organisation have led to more patient involvement in lung research. It requires “believers” both to initiate and continue the work and to promote the lessons learned inside and outside the patient organisation. As this depends on devoted individuals, the continuity of patient involvement remains vulnerable. This seven year study offers valuable insight in patient involvement against the background of the changeing health discourse.展开更多
A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, whi...A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine （TCM） products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.展开更多
接纳与承诺疗法(Acceptance and Commitment Therapy,ACT)于上世纪90年代初由美国治疗师Steven C.Hayes提出。作为基于正念技术的第三代行为治疗理论之一,该疗法以功能情境主义为哲学基础,立足于人类认知和语言基本性质的实证研究,旨在...接纳与承诺疗法(Acceptance and Commitment Therapy,ACT)于上世纪90年代初由美国治疗师Steven C.Hayes提出。作为基于正念技术的第三代行为治疗理论之一,该疗法以功能情境主义为哲学基础,立足于人类认知和语言基本性质的实证研究,旨在通过平衡接纳与改变来提高心理灵活性。临床研究已证明其在相当广泛的临床问题上都取得了良好效果,并在与CBT等传统疗法的对比中展现优势。ACT的临床效果和技术细节可做进一步研究,该疗法与CBT的融合及其在临床领域之外的应用也是未来的研究方向。展开更多
文摘Patient involvement in health research is getting more accepted over the years. Until recently scientists and medical professionals were the sole assessors of quality and relevance of research proposals. In the Netherlands, as in other European and North American countries, emancipatory, political and democratic developments stimulated the emergence of patient involvement as a new “voice” in the appraisal of research. A time-series cross sectional longi-tudinal case study was used to describe and analyse a seven year period since the introduction of the patients’ perspective in the Long-fonds research cycle. Longfonds, the Lung Foundation in the Netherlands (LFN) was formerly called “Astma Fonds”. The study was conducted using an actors-interaction model against the background of the dynamics in society. The introduction of patient involvement resulted in a paradigm shift. The scientific and societal relevance of research proposals are now being reviewed by all parties in a more ef- fective and efficient way. Patients, now involved in the review procedure of research funding, are trained and equipped with an appraisal tool for societal relevance from a patients perspective. Scientific relevance and societal relevance are evaluated separately and balanced in the re- search funding application approval process. Societal relevance is being evaluated by a pa- tient advocates group. The results show how a government initiative and an approach by a patient organisation have led to more patient involvement in lung research. It requires “believers” both to initiate and continue the work and to promote the lessons learned inside and outside the patient organisation. As this depends on devoted individuals, the continuity of patient involvement remains vulnerable. This seven year study offers valuable insight in patient involvement against the background of the changeing health discourse.
基金Supported by the Research on Key Techniques of Reevaluation of Post-marketing Chinese Medicine,the Ministry of Science and Technology(No.2009ZX09502-030)the Sixth-Science Foundation of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(Grant No.Z0215)the Seventh-Science Foundation of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(Grant No.Z0255)
文摘A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine （TCM） products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.
文摘接纳与承诺疗法(Acceptance and Commitment Therapy,ACT)于上世纪90年代初由美国治疗师Steven C.Hayes提出。作为基于正念技术的第三代行为治疗理论之一,该疗法以功能情境主义为哲学基础,立足于人类认知和语言基本性质的实证研究,旨在通过平衡接纳与改变来提高心理灵活性。临床研究已证明其在相当广泛的临床问题上都取得了良好效果,并在与CBT等传统疗法的对比中展现优势。ACT的临床效果和技术细节可做进一步研究,该疗法与CBT的融合及其在临床领域之外的应用也是未来的研究方向。
