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药剂师参与腰痛临床试验的受试者招募工作。

Participation of pharmacists in clinical trial recruitment for low back pain.

作者信息

Abdel Shaheed Christina, Maher Christopher G, Williams Kylie A, McLachlan Andrew J

机构信息

Faculty of Pharmacy, University of Sydney, Pharmacy Building A15, Sydney, NSW, 2006, Australia.

出版信息

Int J Clin Pharm. 2014 Oct;36(5):986-94. doi: 10.1007/s11096-014-9985-y. Epub 2014 Aug 8.

Abstract

INTRODUCTION

Clinician involvement in clinical trials research represents a significant contribution to addressing important research questions in primary care.

AIM

This study aimed to explore the experiences of pharmacists recruiting patients to a low back pain (LBP) clinical trial conducted in Australia, the challenges they experienced and screening and management of people with acute LBP.

ETHICAL APPROVAL

This study received ethical approval (No. 13799) through the University of Sydney Human Research Ethics Committee.

METHODS

A convenience sample of 15 pharmacists who successfully recruited people to the clinical trial and 15 pharmacists who collaborated on the trial but did not recruit any participants were invited to complete an open ended questionnaire. The questionnaire consisted of six items framed to evaluate pharmacists' views on participation in the LBP clinical trial, ideas for addressing the challenges they experienced and screening and management of people with LBP who present to the pharmacy.

RESULTS

A total of 30 pharmacists completed the questionnaire. Pharmacists identified lack of time and patient reluctance to participate as the major challenges to recruiting participants to the LBP clinical trial. Greater patient incentives and a more efficient paperwork system have been recommended as strategies to overcome these challenges. The recruiters and non-recruiters held similar views on pharmacological management of acute LBP and complied with guideline recommended care; although their views on the non-pharmacological management of acute LBP were less consistent with the guidelines.

DISCUSSION

The experiences of pharmacists evaluated in this study has broadened the understanding around challenges to recruitment for a placebo controlled trial and identified gaps which can be addressed in future training and education of pharmacists.

CONCLUSION

This study has identified time pressure as the major barrier to recruitment of participants to the LBP clinical trial. Education of pharmacists on the appropriate non-pharmacological management of people with LBP and screening for possible red flag conditions is required.

摘要

引言

临床医生参与临床试验研究对解决初级保健中的重要研究问题具有重大贡献。

目的

本研究旨在探讨药剂师在澳大利亚进行的一项腰痛(LBP)临床试验中招募患者的经历、他们所面临的挑战以及急性LBP患者的筛查和管理。

伦理批准

本研究通过悉尼大学人类研究伦理委员会获得伦理批准(编号13799)。

方法

邀请15名成功招募患者参加临床试验的药剂师和15名参与试验但未招募到任何参与者的药剂师组成的便利样本,完成一份开放式问卷。该问卷由六个项目组成,旨在评估药剂师对参与LBP临床试验的看法、应对他们所经历挑战的想法以及对到药房就诊的LBP患者的筛查和管理。

结果

共有30名药剂师完成了问卷。药剂师认为时间不足和患者不愿参与是招募LBP临床试验参与者的主要挑战。建议提供更大的患者激励措施和更高效的文书工作系统作为克服这些挑战的策略。招募者和未招募者对急性LBP的药物管理持有相似观点,并遵循指南推荐的护理;尽管他们对急性LBP的非药物管理观点与指南不太一致。

讨论

本研究中评估的药剂师的经历拓宽了对安慰剂对照试验招募挑战的理解,并确定了在未来药剂师培训和教育中可以解决的差距。

结论

本研究确定时间压力是招募LBP临床试验参与者的主要障碍。需要对药剂师进行关于LBP患者适当非药物管理以及筛查可能的警示情况的教育。

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