公共卫生干预研究知情同意书伦理审查问题分析

目的 提高公共卫生干预研究知情同意书的完整性和规范性,保障研究参与者的合法权益。方法 汇总整理本机构2016年1月—2023年8月进行初始审查的公共卫生干预研究项目的伦理委员会审议决议,根据自拟的“知情同意书审查要素表”,对相关问题进行统计分析。结果 进行初始审查的39项公共卫生干预研究项目,知情同意书存在问题的项目共有36项(占92.3%)。主要问题包括干预试验内容告知不全(占91.7%),干预试验费用承担者及补偿措施的告知模糊(占38.9%),权益和风险的告知不充分(占55.6%),个人信息和生物样本收集、使用及保护措施的告知不全(占30.6%),知情同意书语言表达不规范(占27.8%)。结论 本机构公共卫生干预研究的知情同意书撰写仍存在很多问题,干预试验的相关各方可采取多种措施以提高知情同意书的完整性和规范性。伦理委员会可以向研究者提供知情同意书撰写模板,加强审查能力,根据审查要素表编写伦理审查指引,提高审查效率和质量,保护研究参与者的合法权益。

The Challenges of Identifying and Managing Epistemic Inequalities in PHIR(Population Health Intervention Research):An Illustration in the Conception and Implementation of a TPE(Therapeutic Patient Education)Program in Oncology

Aims:The joint dynamics of knowledge(of patients,health professionals,decision-makers,researchers)and of the powers(of speech and action,asymmetries,and hierarchies established between individuals and their knowledge)of the people who carry them at the heart of the PHIR,are analyzed from the perspective of the management of epistemic inequalities.We study the nature of knowledge sharing or non-sharing between these different categories of agents involved in health interventions.Procedure:The qualitative methodology is based on 36 interviews and six years of ethnographic observations of the TPE program(design or implementation),as well as steering committees and workshops of the PHIR where researchers,decisionmakers,health professionals,and patients share their experiences and knowledge.Results:The research highlights three major theoretical and methodological issues of PHIR concerning epistemic inequalities.We argue for broadening the spectrum of health expertise(researchers,decision-makers,health professionals,patients)and for their pluralization.To account for the nature and evolution of collaborations,it is necessary to closely study the dynamics of the avenues of coordination between these fields of expertise.Finally,we call to identify the resources(knowledge,values,material elements,etc.)and strengths that enable these hybrid groups to bind(or not)and to potentially generate co-learning.Conclusion:Considering these three major issues allows PHIR to reflect and take action to reduce inequalities by linking epistemic and social issues.

A Life-skills-based HIV/AIDS Prevention Education for Rural Students of Primary Schools in China:What Changed? What Have We Learned?

Objective To evaluate a four-hour life-skills-based HIV/AIDS prevention curriculum among 5th grade students in rural primary schools of Hainan province.Methods The study included two stages.Stage one （September 2006-May 2007） was a pre-post-quasi experimental design;a total of 2 413 students aged 9 to 14 years from fifth grade classes of nine primary schools completed a baseline survey （1 720 students were in the intervention group,693 in the control group）,and over 98% of them took part in a short survey.The experimental curriculum was provided to the intervention group.At stage two （September 2008）,a cross-sectional questionnaire was administered to 6 923 students in 7th grade classes of eight middle schools in the same study sites.There were 1 437 students in the intervention group when the curriculum was conducted.Results Students tended to score higher in areas of HIV/AIDS related knowledge and attitudes,if they were younger than average,lived in the county seat,had access to the internet,and their parents had completed higher levels of education.Path analysis showed that,after controlling for characteristics such as family and community factors,the total effects of curriculum on knowledge in the short-term model increased remarkably compared with the baseline,and maintained major contributions to knowledge in the mid-term model.The positive effect of knowledge on attitudes was significantly improved in the short-term model as well.Conclusion A life-skills based curriculum can improve HIV/AIDS related knowledge and self-perceived level of life-skills among primary school students in rural areas in a short time,and these positive effects can still be observed at least 2 years post participation in the curriculum.

Effects of Nursing Intervention Based on Transtheoretical Model of Behavioral Change on Disposal of Home Medical Waste in Diabetic Patients

[Objectives]To explore the effects of nursing intervention on the disposal of home medical waste for diabetic patients.[Methods]A total of 118 diabetic patients with insulin injection at home who visited a community service center in Shiyan City during November 2020 and September 2021 were selected as the research objects to implement the intervention,and the medical waste knowledge,attitude scores and standardized medical waste disposal were compared before and after the intervention.[Results]After the intervention,the patient's medical waste knowledge score was significantly higher than that before the intervention,and the medical waste disposal attitude score was significantly higher than that before the intervention.[Conclusions]If the nursing intervention based on Transtheoretical Model(TTM)of Behavioral Change penetrates deep into patients'families and communities,it is helpful to improve the knowledge and attitude of diabetic patients on home medical waste disposal,and regulate their home medical waste disposal behavior.

Design and Production of a Patient Guide to Support Return to Work after Breast Cancer:An Application of Intervention Mapping

Aims.Return to work(RTW)after breast cancer is a complex process that questions the individual trajectories of patients and stakeholders.Program planning in this context requires relying on appropriate methods like Intervention Mapping(IM)which encompasses such complexity.The aim of the methodological study is to describe an application of IM for both the design and production of a patient guide supporting RTW after breast cancer.Procedure.According to IM,the guide was co-constructed with a Community Advisory Board(CAB)of stakeholders(patients/associations,health professionals,companies,institutions)after considering other options(interactive website,mobile application).The design was done with empirical and theoretical anchoring,guided here by an Ecosystem Process of Change model.A communication agency was chosen to produce the document.Pre-tests were conducted with a representative panel of the target audience to assess the different prototypes elaborated,using questionnaires and a focus group.Results.The final structure of the guide is presented with comments in order to concretely illustrate the management of IM steps 3 and 4.The final structure of the guide is presented,along with a description of its components that target women(according to Prochaska et Di Clemente’s stages of change)and their environment(by use of levers they may activate).The results of the pre-test led to the simplification of the guide and its structure.Conclusion.IM allows a rich integration of experiential knowledge in the planning of complex health and public health programs.The development of the guide has attempted to integrate its aspects,in particular to promote both its implementation and its effects.Reflections are brought about the realistic evaluation of such complex interventions.

Intervention research on school bullying in primary schools

Intervention research on school bullying was conducted in a primary school with an action research method.After conducting a five-week intervention program,the occurrence ratio of being bullied on the way to school and back home and the degree to which children were bullied dropped significantly,but the rate of reduction in grade three was greater than that of grade five.Moreover,pupils'sense of security in school and the teachers'awareness and problem-solving ability were also improved.