伦理审查视角下临床研究知情同意书质量分析

目的从伦理审查的视角调查医院临床研究中知情同意书质量,分析申办者和研究者发起的临床研究中知情同意书存在的主要问题,对其要点进行评价归纳并提出建议。方法收集整理上海市某三级甲等医院伦理委员会2013年1月—2020年12月接受伦理审查的临床研究项目知情同意书共计678项,根据《药物临床试验质量管理规范》要求对知情同意书的内容和语言等要素进行统计分析。结果完全符合规范的知情同意书311份(占45.9%),存在要素和/或语言问题的知情同意书367份(占54.1%),问题主要体现在研究过程(占23.7%)、可能的风险(占15.5%)、受损害后的赔偿补偿(占15.0%)和研究相关费用的告知(占14.2%)等方面;申办者发起的临床研究的知情同意书合格率高于研究者发起的临床研究。结论合格的知情同意书文本应保证内容完整和语言规范,以达到信息完整、理解无误、自愿同意的效果,确保受试者做出符合其真实意愿的选择。对于知情同意书质量的保障,需要包括申办者、研究者和伦理委员会在内的临床研究各相关方的共同努力。     

Defining the "community" in community consultation for emergency research: findings from the community VOICES study

This article explores the application of the concept "community consultation" in the context of emergency medical research. Emergency medicine researchers are permitted, by the World Medical Association regulations and in the United States by U.S. Federal Regulations, to conduct emergency medical research on individuals with a life-threatening condition without obtaining their consent or that of their surrogates if certain conditions are met. Among these conditions is the requirement that researchers observe a number of special protections for the participants, including "community consultation and notification" prior to the initiation of such studies. The term "community" is not defined clearly and the process for conducting community consultations is not specified in these regulations. This study explores the feasibility of conducting community consultation in the context of emergency medical research by examining: research participant's definitions of community in New York, the factors that help shape their definitions of community and the people they would authorize to render participation decisions on their behalves. Findings from this study suggest that participants' definitions of community vary as a function of the purpose of the definition and the demographics of the respondents. Most significantly, this study reveals that although respondents can identify potential spokespersons for their communities, these community spokespersons were rarely identified as those who should have decision-making authority in medical emergencies. Finally, this article explores the implications of these findings for the definition of community as it applies to community consultation for emergency medical research.     

高危型人乳头瘤病毒感染相关危险因素分析

目的探讨宫颈高危人乳头瘤病毒(HPV)感染的危险因素。方法选取郑州大学第三附属医院2009年9月～2011年3月间行高危型HPV(HR-HPV)筛查的门诊或病房患者阳性病例306例,27例HPV-DNA阴性作为对照组,用杂交捕获二代法(HC2)检测HPV-DNA,所有患者均填写HPV感染相关危险因素调查表,单因素和多因素非条件Logistic回归分析的方法对调查信息进行分析。结果经单因素非条件Logistic回归分析,受教育程度,家庭人均收入,第一次结婚年龄、被动吸烟、曾经怀孕、人工流产、使用避孕套、第一次性生活年龄、性伴侣数与HPV感染存在相关性(P﹤0.05)。经多因素非条件Logistic回归分析,家庭人均收入,被动吸烟,使用避孕套,第一次性生活年龄有关(P﹤0.05)。结论被动吸烟、人工流产、性伴侣数多是HPV感染的危险因素(OR﹥1),受教育程度高、经济收入多、使用避孕套、第一次性生活年龄大是HPV感染的保护因素(OR﹤1)。因此应加强对HPV易感人群的卫生宣教与管理,从而预防宫颈癌的发生。     

Expanding the boundaries of previously obtained informed consent in research: Views from participants in the Personalised Risk-based Mammascreening study

Introduction

Understanding participants' concerns and information needs regarding broadened consent is crucial to ensure transparency and participant autonomy. Our study qualitatively examined these issues in women participating in the Personalized RISk-based MAmmascreening study (PRISMA). The original PRISMA informed consent was project-specific (i.e., breast cancer research), limiting the scope of secondary research. We explored participants' needs for broadened consent to preserve informed decision-making while maximising the potential re-use of data.

Methods

Focus groups (FGs) were performed following a semistructured discussion guide. Two independent researchers analysed the data thematically using an inductive approach.

Findings

Twenty-three asymptomatic women and 13 women diagnosed with breast cancer were randomly divided into six FGs. Four superordinate themes were identified: (1) Normalization, (2) Attitude towards the pharmaceutical industry, (3) Privacy and (4) Knowledge. Our participants viewed data sharing as an important conduit for advancing medical science. Perceived integrity was more often attributed to noncommercial than commercial parties, with a marked mistrust towards the pharmaceutical industry. Most requested information needs related to data protection. Participants' ideal consent process would confer a range of options; for example, they would be able to choose with whom data can be shared, whether data will be de-identified or anonymous, the expiration date of their consent and how, if requested, general and personal study results would be disclosed.

Conclusion

Our participants expressed clear information needs and a strong desire to be actively engaged in future data sharing decisions. Given that many researchers collaborate with commercial parties, building public confidence in these institutions would be beneficial. Illustrative examples addressing privacy concerns and clarifying difficult terms would aid consent decision-making. Although our participants displayed great altruism in sharing their data and accepted that broad consent would ultimately facilitate future research, broad consent did not reflect their ideal situation. Dynamic consent may be an option but warrants further feasibility research.

Patient and Public Contribution

Women were recruited from the general breast cancer screening population. Their perceptions and information needs, as reported in this study, will not only inform broadened consent for PRISMA but ideally guide other consent templates and decisions regarding consent processes.     

Embryo futures and stem cell research: the management of informed uncertainty

In the social worlds of assisted conception and stem cell science, uncertainties proliferate and particular framings of the future may be highly strategic. In this article we explore meanings and articulations of the future using data from our study of ethical and social issues implicated by the donation of embryos to human embryonic stem cell research in three linked assisted conception units and stem cell laboratories in the UK. Framings of the future in this field inform the professional management of uncertainty and we explore some of the tensions this involves in practice. The bifurcation of choices for donating embryos into accepting informed uncertainty or not donating at all was identified through the research process of interviews and ethics discussion groups. Professional staff accounts in this study contained moral orientations that valued ideas such as engendering patient trust by offering full information, the sense of collective ownership of the National Heath Service and publicly funded science and ideas for how donors might be able to give restricted consent as a third option.     

What Women Want From Abortion Counseling in the United States: A Qualitative Study of Abortion Patients in 2008

Abortion counseling, including informed consent laws specifying what a woman must be told to obtain an abortion, have been the subject of a great deal of social policy. Using a qualitative sample of 49 women seeking abortions in 2008, we asked women whether they had their mind made up when they called the clinic to make their appointment as well as what they wanted from abortion counseling. The majority of women contacting the abortion clinic had already made up their minds to have an abortion and were therefore not seeking options counseling. Neither were they seeking to emotionally confide in their abortion counselors: They anticipated that the counselor would try to discourage them from having an abortion, they stated that they had met their emotional needs elsewhere, and they feared that confiding in the counselor might endanger their ability to obtain an abortion. They perceived other women needed counseling, though, to help them make a responsible decision. A cafeteria-style approach to counseling that allows women to specify what their needs are would better match abortion counseling with women's stated needs. These data have the potential to inform public policy to better suit abortion-related counseling with women's needs.     

Placebo use in vaccine trials: Recommendations of a WHO expert panel

Vaccines are among the most cost-effective interventions against infectious diseases. Many candidate vaccines targeting neglected diseases in low- and middle-income countries are now progressing to large-scale clinical testing. However, controversy surrounds the appropriate design of vaccine trials and, in particular, the use of unvaccinated controls (with or without placebo) when an efficacious vaccine already exists. This paper specifies four situations in which placebo use may be acceptable, provided that the study question cannot be answered in an active-controlled trial design; the risks of delaying or foregoing an efficacious vaccine are mitigated; the risks of using a placebo control are justified by the social and public health value of the research; and the research is responsive to local health needs. The four situations are: (1) developing a locally affordable vaccine, (2) evaluating the local safety and efficacy of an existing vaccine, (3) testing a new vaccine when an existing vaccine is considered inappropriate for local use (e.g. based on epidemiologic or demographic factors), and (4) determining the local burden of disease.     

Co‐creation of information materials within the assent process: From theory to practice

IntroductionThe informed consent process is key to safeguarding the autonomy of the participant in medical research. For this process to be valid, the information presented to the potential participant should meet their needs and be understood by them. The i‐CONSENT project has developed ‘Guidelines for adapting the informed consent process in clinical trials’ which aim to improve informed consent so that they are easier to understand and better adapted to the needs and preferences of the target population. The best way to tailor information to the characteristics and preferences of the target population is to involve the community itself.MethodsFollowing guidelines developed by i‐CONSENT, assent materials were co‐created for a mock clinical trial of the human papillomavirus vaccine in adolescents. During the process, two design thinking sessions were conducted involving a total of 10 children and 5 parents. The objectives of the sessions were to find out the children''s opinion of the informed consent (assent in their case) process in clinical trials, identify the parts that were most difficult to understand and alternatives for their presentation and wording, identify the preferred formats for receiving the information and the main characteristics of these formats, design a video explaining the clinical trial and evaluate a tool for assessing comprehension.ResultsAssent materials were co‐created in three formats: a web‐based material following a layered approach; a video in story format; a pdf document with an innovative way of presenting information compared to traditional assent documents. In addition, the Comprehension of Assent Questionnaire was co‐designed, based on the Quality of Informed Consent questionnaire.ConclusionThe design thinking methodology has proven to be an easy and useful tool for involving children in designing information tailored to their needs and preferences.Patient or Public ContributionA sample of the target population participated in the design and piloting of the materials created using design thinking methodology. In addition, patient representatives participated in the design and evaluation of the guidelines developed by the i‐CONSENT project that were followed for the development of the materials in this study.     

无创性游离DNA产前诊断胎儿染色体异常的现状

唐氏综合征（DS）是导致儿童智力先天残疾的重要原因。常规的产前诊断操作如羊膜穿刺术、绒毛活检等方法存在风险较高等不足。产前无创性游离DNA（cfDNA）诊断可避免对胎儿的侵入性操作,通过孕妇外周血循环中胎儿cfDNA对唐氏综合征及其他遗传性疾病进行无创早期诊断,受到临床的广泛关注,成为产前诊断领域的研究热点。尽管近年来cfDNA诊断技术具有较大发展,但此技术在广泛应用于临床前,还面临着技术、经济、法律以及伦理学等诸多问题尚待解决。综述无创性cfDNA产前诊断胎儿染色体异常的现状。     

Testosterone and sexual risk among transmen: a mixed methods exploratory study

Abstract

Little research has explored the link between the behavioural effects of testosterone use among transmen and HIV risk. We conducted a mixed methods study to explore testosterone use among transmen and the behavioural effects on HIV risk. A sample of 122 transmen from San Francisco participated in a cross-sectional quantitative survey and 14 transmen participated in 2 focus group discussions. Most participants (81.9%) were currently taking hormones. Participants attributed testosterone use to new sexual behaviours among 69% of transmen, changes in sexual attraction (49%), and increased frequency of sexual activity (72%). Among current testosterone users, 3.3% had cisgender men as partners before starting testosterone, whereas after starting testosterone, 25.4% did. Similarly, 4.1% had a transgender woman as a sexual partner before starting testosterone and 13.9% after starting testosterone. Findings suggest that testosterone’s side effects were associated with transmen’s desires for sex with cisgender men who have sex with men. The reported increase in attraction to and sex with partners from populations with a high HIV prevalence may have important implications for HIV risk among transmen, especially as the availability of transgender health services may draw transmen to a context in which HIV prevalence is high.     

Physician payment mechanisms,hospital length of stay and risk of readmission: Evidence from a natural experiment

We provide an analysis of the effect of physician payment methods on their hospital patients’ length of stay and risk of readmission. To do so, we exploit a major reform implemented in Quebec (Canada) in 1999. The Quebec Government introduced an optional mixed compensation (MC) scheme for specialist physicians working in hospital. This scheme combines a fixed per diem with a reduced fee for services provided, as an alternative to the traditional fee-for-service system. We develop a model of a physician's decision to choose the MC scheme. We show that a physician who adopts this system will have incentives to increase his time per clinical service provided. We demonstrate that as long as this effect does not improve his patients’ health by more than a critical level, they will stay more days in hospital over the period. At the empirical level, we estimate a model of transition between spells in and out of hospital analog to a difference-in-differences approach. We find that the hospital length of stay of patients treated in departments that opted for the MC system increased on average by 4.2% (0.28 days). However, the risk of readmission to the same department with the same diagnosis does not appear to be overall affected by the reform.     

中国四座城市男男性行为人群HIV感染状况及其危险因素

目的 了解男男性行为人群(MSM)HIV感染状况,探索感染的危险因素.方法 采用同伴驱动抽样和滚雪球方法在北京市、哈尔滨市、郑州市与成都市招募MSM研究对象(1950名),以面对面问卷调查(共调查1950份,有效问卷1950份)获得相关人口学及行为学资料,抽取1950名调查对象各5 ml静脉血进行HIV抗体血清学检测(用胶体金法、乳胶层析法与双抗原夹心酶联免疫法进行初筛,用免疫印迹试验进行确证检测),描述HIV感染特征,分析其危险因素.对不同组别间的率或构成比进行x2检验,感染危险因素进行多因素logistic回归分析.结果 共调查MSM 1864名,HⅣ感染率为6.7%(125/1864).≥40岁者HIV感染率为9.5%(24/252),≤19岁者为1.9%(2/105);大学文化程度者HIV感染率为4.8%(41/858),初中及以下文化程度者为8.4%(31/371);性伴与之年龄差小于10岁者为5.0%(58/1168),性伴比之大10岁者为10.3%(35/340);无无保护被动肛交者HIV感染率为5.5%(64/1169),有无保护被动肛交者为8.9%(61/695).年龄≥40岁(OR=6.5,95% CI:1.5～28.7)、初中及以下文化程度(OR=1.8,95% CI:1.1～2.7)、拥有比自己年龄大10岁及以上性伴(OR=2.1,95% CI:1.3～3.3)、有无保护被动肛交(OR=1.6,95% CI:1.1～2.4)是HIV感染的独立危险因素.结论 MSM人群HIV感染率较高,年龄大、文化程度低、拥有较大年龄的性伴及无保护被动肛交与HIV感染相关.     

广东省中低档女性性工作者艾滋病病毒/性传播疾病感染状况及危险因素分析

目的 了解广东省某经济欠发达地区中低档女性性工作者 （FSW） 感染HIV和性传播疾病 （STD） 的状况并分析其危险因素。方法 横断面调查,通过绘制分布图,采用等比例等概率抽样方法,对抽中的中低档FSW进行调查,获取人口学特征、 性行为、 吸毒行为等信息,并抽取5 ml静脉血进行HIV、 梅毒及单纯疱疹病毒2型 （HSV-2） 检测。结果 该地区中低档FSWs的HIV感染率为0.3% （2/575）; STDs感染率32.2%（185/575）,其中梅毒感染率为4.9% （28/575）,HSV-2感染率为30.6% （176/575）。多因素非条件logistic分析结果显示使用毒品 （OR＝3.91,95%CI： 1.17～13.03） 为感染STDs的危险因素; 接受过干预服务 （OR＝0.14,95%CI： 0.04～0.52）、 教育程度高 （OR＝0.40,95%CI：0.19-0.83）、 中档 （相对于低档）（OR＝0.27,95%CI： 0.09～0.79） 为感染STD的保护性因素。结论 广东省某经济欠发达地区中低档FSW均存在不同程度HIV/STD感染及危险行为,低档FSW更为严重,需加强对该类人群的宣传干预,预防当地HIV/STD传播。     

Using a neural network for mining interpretable relationships of West Nile risk factors

The West Nile Virus (WNV) is an infectious disease spreading rapidly throughout the United States, causing illness among thousands of birds, animals, and humans. Yet, we only have a rudimentary understanding of how the mosquito-borne virus operates in complex avian-human environmental systems. The four broad categories of risk factors underlying WNV incidences are: environmental (temperature, precipitation, wetlands), socioeconomic (housing age), built-environment (catch basins, ditches), and existing mosquito abatement policies. This research first built a model incorporating the non-linear relationship between WNV incidences and hypothesized risk factors and second, identified important factor(s) whose management would result in effective disease prevention and containment. The research was conducted in the Metropolitan area of Minnesota, which had experienced significant WNV outbreaks from 2002. Computational neural network (CNN) modeling was used to understand the occurrence of WNV infected dead birds because of their ability to capture complex relationships with higher accuracy than linear models. Further a detailed interpretation technique, based on weights and biases of the network, provided a means for extracting relationships between risk factors and disease occurrence. Five risk factors: proximity to bogs, lakes, temperature, housing age, and developed medium density land cover class, were selected by the model. The detailed interpretation indicated that temperature, age of houses, and developed medium density land cover were positively related, and distance to bogs and lakes were negatively related to the incidence of WNV. This paper provides both applied and methodological contributions to the field of health geography. The relationships between the risk factors and disease occurrence could contribute to vector control strategies such as targeted insecticide spraying near bogs and lakes, mosquito control treatments for older houses, and extensive mapping, inspection, and treatments of catch basins. The proposed interpretation technique expanded the role of CNN models in health sciences as both predictive and explanatory tools.     

儿童紫癜性肾炎的危险因素研究

目的分析儿童过敏性紫癜（HSP）的肾脏受累因素。方法将2007年1月1日～12月31日入住安徽医科大学第一附属医院的212例HSP患儿,分为紫癜性肾炎（HSPN）组和非肾炎组,对性别、年龄、临床表现及实验室检验等因素进行单变量和多变量分析。结果①HSP中96例（45.28%）出现肾脏损害,92.71%HSPN患儿尿检异常发生在起病3个月内;②皮疹症状严重,皮疹3月内反复≥3次,持续性剧烈腹痛及关节受累严重与HSPN发生密切相关,Logistic回归分析具有统计学意义（P〈0.05）。结论HSP中皮疹、关节、胃肠道等肾外症状严重及皮疹短期内反复多次者,易出现肾脏受累,应严密监测并采取积极治疗措施以防止肾损害的发生和进展。     

Sedentary lifestyle as a risk factor for low back pain: a systematic review

Objectives  To review systematically studies examining the association between sedentary lifestyle and low back pain (LBP) using a comprehensive definition of sedentary behaviour including prolonged sitting both at work and during leisure time. Methods  Journal articles published between 1998 and 2006 were obtained by searching computerized bibliographical databases. Quality assessment of studies employing a cohort or case–control design was performed to assess the strength of the evidence. Results  Using pre-determined keywords, we identified 1,778 titles of which 1,391 were considered irrelevant. Then, 20 of the remaining 387 publications were scrutinized for full review after an examination of all the 387 abstracts. Finally, 15 studies (10 prospective cohorts and 5 case–controls) were included in the methodological quality assessment, of which 8 (6 cohorts and 2 case–controls; 53%) were classified as high-quality studies. One high-quality cohort study reported a positive association, between LBP and sitting at work only; all other studies reported no significant associations. Hence, there was limited evidence to demonstrate that sedentary behaviour is a risk factor for developing LBP. Conclusions  The present review confirms that sedentary lifestyle by itself is not associated with LBP.