Does sponsorship improve outcomes above Alcoholics Anonymous attendance? A latent class growth curve analysis

Aims To construct Alcoholics Anonymous (AA) attendance, sponsorship and abstinence latent class trajectories to test the added benefit of having a sponsor above the benefits of attendance in predicting abstinence over time. Design Prospective with 1‐, 3‐, 5‐ and 7‐year follow‐ups. Setting and participants Alcoholic‐dependent individuals from two probability samples, one from representative public and private treatment programs and another from the general population (n = 495). Findings Individuals in the low attendance class (four classes identified) were less likely than those in the high, descending and medium attendance classes to be in high (versus low) abstinence class (three classes identified). No differences were found between the other attendance classes as related to abstinence class membership. Overall, being in the high sponsor class (three classes identified) predicted better abstinence outcomes than being in either of two other classes (descending and low), independent of attendance class effects. Although declining sponsor involvement was associated with greater likelihood of high abstinence than low sponsor involvement, being in the descending sponsor class also increased the odds of being in the descending abstinence class. Conclusions Any pattern of Alcoholics Anonymous attendance, even if it declines or is never high for a particular 12‐month period, is better than little or no attendance in terms of abstinence. Greater initial attendance carries added value. There is a benefit for maintaining a sponsor over time above that found for attendance.     

Differing attitudes of industry and academia towards controlled clinical trials

A consensus conference was held in 1984 on controversial issues concerning controlled clinical trials. Thirty-six individuals working in academic institutions, forty-six in industry and twelve in regulatory authorities participated. Academics accepted and industrial representatives rejected the following: existing regulations cannot cope with the rate at which new treatments develop; drug companies may be reluctant to undertake surveillance programmes because sales will fall if adverse reactions are detected; novel remedies should not be promoted before extensive post-marketing surveillance; third parties should finance trials promising to reduce the costs of illness and trialists should be separated from sponsors in data analysis and interpretation, the investigator owning the data unless stated otherwise. Industrial representatives supported and academics rejected the following: government price control inhibits drug development and a multicentre trial can be justified simply by the wish to speed drug registration.     

公立医院高层次人才培养途径实践与思考——公派留学现况调查分析

目的:了解南京医科大学第一附属医院公派留学现况,为公派留学管理工作的科学化和精益化提供依据。方法:对已回院工作的公派留学人员进行自填式问卷的横断面调查,获有效问卷195份,采用SPSS 17.0软件进行频数分布分析。结果:公派留学对个人、学科和医院的影响中,除增加个人经济收益以外的其他选项,调查对象选择影响很大和较大的百分比范围为80.5%～99.5%。存在主要问题有效益评估体系没有建立、绩效考核机制不完善、学用不一致、在外期间管理力度不够以及没有建立有效的沟通渠道,其百分比分别为44.6%、38.5%、31.3%、26.2%和22.6%。结论:医院公派留学工作取得成效的同时也存在着问题。建议医院公派留学应学以致用,不断提高临床观摩比例;完善规章制度,进行全程动态跟踪和反馈;完善绩效考核机制,建立效益评估体系。     

An Exploratory Investigation of Important Qualities and Characteristics of Alcoholics Anonymous Sponsors

Alcoholics Anonymous recommends members to have sponsors, especially those early in their recovery, yet little research has been done on the qualities of an effective sponsor. Two hundred forty-five adults (117 females, 128 males) currently in substance use disorder recovery participated. Two hundred thirty-one of these individuals had experience as a sponsor, sponsee, or both (109 had experience as a sponsor). Qualitative results suggest effective sponsors are currently engaged in the program on a personal level, are trustworthy, and are available although a wide variety of attributes were cited. In a choice and ranking exercise, 12-Step engagement and qualities of character were also most often ranked highly. No significant differences were found between genders or sponsor/sponsee roles. Implications based on breadth of responses and dominant themes are discussed as well as the need for further research on sponsor/sponsee characteristics, satisfaction, and recovery outcomes.     

Improving the quality of drug research or simply increasing its cost? An evidence-based study of the cost for data monitoring in clinical trials

AIM

Procedures for verification of data from clinical studies are intended to maintain reliability for clinical trial results. Guidelines or legislations relating to clinical data management are of limited value and no study has yet demonstrated its effectiveness.

METHOD

Sponsor queries and dual entry procedures from one CRO on three different phase I trials are analysed on content, impact and cost.

RESULT

In this study, sponsor queries and dual entry procedures proved time and cost inefficient in detecting data discrepancies.

CONCLUSION

We advocate a more evidence-based approach for enhancing data integrity throughout the process of clinical data management.     

Utilizing Peer Mentorship to Engage High Recidivism Substance-Abusing Patients in Treatment

Background: Often high recidivism substance-using patients have difficulty connecting to outpatient treatment contributing to greater functioning disturbances. Approaches to address this problem frequently are staff extensive. Objective: This study evaluates the impact of peer mentorship and/or enhanced dual recovery treatment (DRT) on individuals who are inpatients, substance abusing, and have a history of high recidivism. The primary outcome is post-discharge treatment attendance. Methods: In an inpatient Veterans Administration hospital setting, 96 patients with a history of high recidivism and current and/or past diagnosis of substance use disorders were randomized to either (i) Treatment As Usual (TAU), (ii) TAU + DRT + Mentorship for Addictions Problems to Enhance Engagement to Treatment (MAP-Engage), or (iii) TAU + MAP-Engage. Results: Overall MAP-Engage was found to be comparable to the DRT + MAP-Engage and both of these conditions were significantly better than TAU alone at increasing adherence to post-discharge substance abuse, medical, and mental health outpatient appointments. Conclusion/Scientific Significance: MAP-Engage offers an alternative approach to address lack of attendance to outpatient treatment appointments post discharge that is relatively low in staff reliance.     

Participation in Alcoholics Anonymous and post-treatment abstinence from alcohol and other drugs

Background

This study examined associations between two types of AA participation (i.e., meeting attendance, having a sponsor) and two types of post-treatment abstinence (i.e., abstinence from alcohol, abstinence from drugs).

Method

Respondents completed measures that assessed their demographic characteristics, the severity of their substance use, and their motivation to change when they enrolled in treatment (T1). They completed measures of AA participation at T1 and a 3 month follow-up assessment (T2), and measures of recent abstinence at T1 and a 6 month follow-up assessment (T3).

Results

T2 sponsor was associated prospectively with T3 abstinence from alcohol.

Conclusions

Having a sponsor served as a marker for subsequent abstinence. Future research can examine factors that may mediate or moderate the associations between having a sponsor and subsequent abstinence.     

新药临床试验中GCP实施的问题与对策

现阶段“药品临床试验管理规范”(GCP)的实施中存在诸多问题，笔者通过对新版GCP的学习，分析目前临床研究中存在的问题，并探讨相应的对策。且响应国际新形势下对GCP的要求，深切感受到现阶段我国药品临床研究中实施GCP的必要性和重要性。