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一项针对腰椎管狭窄症的整脊治疗随机、安慰剂对照试验的招募方法与成本:一项单中心试点研究

Recruitment methods and costs for a randomized, placebo-controlled trial of chiropractic care for lumbar spinal stenosis: a single-site pilot study.

作者信息

Cambron Jerrilyn A, Dexheimer Jennifer M, Chang Mabel, Cramer Gregory D

机构信息

Department of Research, National University of Health Sciences, Lombard, IL 60148, USA.

出版信息

J Manipulative Physiol Ther. 2010 Jan;33(1):56-61. doi: 10.1016/j.jmpt.2009.11.002.

DOI:10.1016/j.jmpt.2009.11.002
PMID:20114101
Abstract

OBJECTIVE

The purpose of this article is to describe the methods for recruitment in a clinical trial on chiropractic care for lumbar spinal stenosis.

METHODS

This randomized, placebo-controlled pilot study investigated the efficacy of different amounts of total treatment dosage over 6 weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects were recruited for this study through several media venues, focusing on successful and cost-effective strategies. Included in our efforts were radio advertising, newspaper advertising, direct mail, and various other low-cost initiatives.

RESULTS

Of the 1211 telephone screens, 60 responders (5.0%) were randomized into the study. The most successful recruitment method was radio advertising, generating more than 64% of the calls (776 subjects). Newspaper and magazine advertising generated approximately 9% of all calls (108 subjects), and direct mail generated less than 7% (79 subjects). The total direct cost for recruitment was $40 740 or $679 per randomized patient. The costs per randomization were highest for direct mail ($995 per randomization) and lowest for newspaper/magazine advertising ($558 per randomization).

CONCLUSIONS

Success of recruitment methods may vary based on target population and location. Planning of recruitment efforts is essential to the success of any clinical trial.

摘要

目的

本文旨在描述一项关于脊椎按摩疗法治疗腰椎管狭窄症的临床试验中的招募方法。

方法

这项随机、安慰剂对照的试点研究调查了60名腰椎管狭窄症志愿者在6周内不同总治疗剂量的疗效。通过多种媒体渠道招募本研究的受试者,重点关注成功且具成本效益的策略。我们的努力包括广播广告、报纸广告、直邮以及各种其他低成本举措。

结果

在1211次电话筛选中,60名应答者(5.0%)被随机纳入研究。最成功的招募方法是广播广告,产生了超过64%的电话咨询(776名受试者)。报纸和杂志广告产生了约9%的所有电话咨询(108名受试者),直邮产生的电话咨询不到7%(79名受试者)。招募的总直接成本为40740美元,即每名随机入组患者679美元。每次随机入组的成本以直邮最高(每次随机入组995美元),报纸/杂志广告最低(每次随机入组558美元)。

结论

招募方法的成功可能因目标人群和地点而异。招募工作的规划对任何临床试验取得成功至关重要。

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