Is there a problem with the status quo? Debating the need for standalone ethical guidelines for research with people who use alcohol and other drugs

In 2011, the Australian National Health and Medical Research Council (NHMRC) initiated an inquiry to determine whether there is a need for expanded ethical guidance in the form of a discrete guidance document for alcohol and other drug (AOD) research. An issues paper was developed to frame the inquiry. AOD researchers, Human Research Ethics Committees and others were invited to discuss whether there are distinctive ethical issues facing researchers and Human Research Ethics Committees in the AOD setting. Based on the public submissions, the NHMRC recommended that no AOD research‐specific guidance is required. The inquiry and the NHMRC decision were not widely publicized, and we feel there is a need for further discussion. In order to do so, we have analysed the public inquiry submissions and described the central themes. Few submissions in the inquiry explicitly agreed AOD research warrants a specific guidance framework. Most were concerned that the NHMRC issues paper unfairly targeted people who use drugs as complex research participants. The inquiry highlights tensions around research governance and ethics review boards dealing with illicit and stigmatised behaviours. While we agree that a specific guidance framework for AOD research is not needed and could potentially be harmful and restrictive, we are concerned that the wholesale rejection of a guidance framework has closed the door to much needed debate. There remains, we argue, a need for alternative strategies and tools to support ethical research, inform and streamline institutional ethics approval, and engage and protect participants. [Olsen A, Mooney‐Somers J. Is there a problem with the status quo? Debating the need for standalone ethical guidelines for research with people who use AODs. Drug Alcohol Rev 2014;33:637‐642]     

中成药在流行性感冒治疗中的临床地位

流行性感冒简称流感,是一种由流感病毒引起的急性呼吸道传染病。21世纪以来,全球已发生3次流感大流行,每次均波及我国。我国卫生系统每次都对流感流行作出积极应对,逐渐积累了对流感的防控经验,并将我国的传统医药--中医药用于抗流感治疗,取得了较好的疗效。同时,还带动了我国抗流感中成药的研究,奠定了中成药在流感治疗中的临床地位。     

小儿支气管哮喘中药新药临床试验设计与评价技术指南

《儿科常见疾病中药新药临床试验设计与评价技术指南》是中华中医药学会儿科分会临床评价学组制定的、指导儿科中药Ⅱ期、Ⅲ期临床试验和上市后有效性再评价方案设计的、具有病种特色的系列临床评价技术指南, 旨在推动儿科中药临床试验设计与评价水平的提高, 并为临床提供安全有效的儿童用药。采用世界卫生组织(WHO)推荐的“共识会议法”和美国国立卫生研究院(NIH)发展共识方案(GPP)有关原则, 国内全部18个国家药物临床试验机构中医儿科专业的临床儿科专家以及国内相关临床评价专家参加了急性上呼吸道感染、急性支气管炎、支气管哮喘、反复呼吸道感染、厌食、轮状病毒性肠炎、注意缺陷-多动障碍、抽动障碍、遗尿症、手足口病、湿疹11个儿科常见病种指南的起草或多次提出修改建议, 历经3年反复完善, 最终形成共识, 并由中华中医药学会儿科分会于2013年10月发布。本指南从研究背景、研究目标、总体设计、诊断标准、受试者的选择、给药方案、安全性评价、有效性评价、试验流程、数据管理与统计分析、质量保证、相关伦理学要求、试验结束后的医疗措施、资料保存等方面阐述了小儿支气管哮喘中药新药临床试验的设计与评价技术要点, 期望能为申办者与研究者在临床试验方案设计中提供指导。     

68Ga-DOTA-生长抑素受体PET/CT神经内分泌肿瘤显像操作指南

本指南针对神经内分泌肿瘤患者提出⁶⁸Ga-DOTA-生长抑素受体PET/CT检查的临床适应证、核医学医务人员岗位要求、检查操作规范、报告处理、质量控制及显像过程中的辐射安全问题,为临床进行⁶⁸Ga-DOTA-生长抑素受体PET/CT检查提供相应操作规范,为各种影像学表现提供合理解释和标准的诊断报告。     

Challenges in Statewide Implementation of a Prehospital Evidence-Based Guideline: An Assessment of Barriers and Enablers in Five States

Background: Individual states, regions, and local emergency medical service (EMS) agencies are responsible for the development and implementation of prehospital patient care protocols. Many states lack model prehospital guidelines for managing common conditions. Recently developed national evidence-based guidelines (EBGs) may address this gap. Barriers to statewide dissemination and implementation of model guidelines have not been studied. The objective of this study was to examine barriers and enablers to dissemination and implementation of an evidence-based guideline for traumatic pain management across 5 states. Methods: This study used mixed methods to evaluate the statewide dissemination and implementation of a prehospital EBG. The guideline provided pain assessment tools, recommended opiate medication dosing, and indications and contraindications for analgesia. Participating states were provided an implementation toolkit, standardized training materials, and a state-specific implementation plan. Outcomes were assessed via an electronic self-assessment tool in which states reported barriers and enablers to dissemination and implementation and information about changes in pain management practices in their states after implementation of the EBG. Results: Of the 5 participating states, 3 reported dissemination of the guideline, one through a state model guideline process and 2 through regional EMS systems. Two states did not disseminate or implement the guideline. Of these, one state chose to utilize a locally developed guideline, and the other state did not perform guideline dissemination at the state level. Barriers to state implementation were the lack of authority at the state level to mandate protocols, technical challenges with learning management systems, and inability to track and monitor training and implementation at the agency level. Enablers included having a state/regional EMS office champion and the availability of an implementation toolkit. No participating states demonstrated an increase in opioid delivery to patients during the study period. Conclusion: Statewide dissemination and implementation of an EBG is complex with many challenges. Future efforts should consider the advantages of having statewide model or mandatory guidelines and the value of local champions and be aware of the challenges of a statewide learning management system and of tracking the success of implementation efforts.