HIPAA 时代下受试者招募策略的成本效益分析：一项结直肠癌筛查依从性试验的结果。

A cost-effectiveness analysis of subject recruitment strategies in the HIPAA era: results from a colorectal cancer screening adherence trial.

机构信息

Department of Medicine, Boston University School of Medicine, Boston, MA 02118, USA.

出版信息

Clin Trials. 2009 Dec;6(6):597-609. doi: 10.1177/1740774509346703. Epub 2009 Nov 23.

DOI:10.1177/1740774509346703

PMID:19933718

Abstract

BACKGROUND

Changes in regulatory standards that restrict use of identifiable health information can reduce patient recruitment to clinical trials and increase recruitment costs.

PURPOSE

To compare subject accrual rates and costs of three recruitment strategies that comply with new regulatory standards within the context of a clinical trial evaluating the impact of shared decision-making on colorectal cancer screening adherence.

METHODS

Sequential cohorts of English-speaking, average-risk patients due for colorectal cancer screening were allocated to one of three recruitment strategies: (1) a provider-initiated electronic 'opt-in' referral (Click) method; (2) a provider-mediated 'opt-in' referral letter (Letter) method; and (3) an investigator-initiated direct contact 'opt-out' (Call) method.

RESULTS

During distinct 6-month recruitment periods between March 2005 and April 2006, 100 potential subjects were identified using the Click method, 847 by the Letter method, and 758 by the Call method. After excluding ineligible prescreened patients, accrual rates were higher for the Call method (188 of 531 [35.4%]) than either the Click (12 of 72 [16.7%]; p = 0.002) or Letter (17 of 816 [2.1%]; p < 0.001) methods. The average cost per patient enrolled for the Call ($156) method was competitive with the Click ($129) and substantially lower than the Letter ($1967) methods; the Call method was least expensive if combined with automated patient identification ($99). Data extrapolation suggest it would take 2.4 years at an overall cost of $138,518 to recruit a target sample of 900 patients by the Call method, 40.5 years at $62,419 for the Click method and 27.9 years at $1,737,757 for the Letter method.

LIMITATIONS

The study was nonrandomized and findings may not be generalizable to other research settings.

CONCLUSION

The investigator-initiated direct contact 'opt-out' strategy is significantly more cost-effective and feasible than provider-initiated and provider-mediated 'opt-in' strategies for patient recruitment to clinical trials.

摘要

背景

限制可识别健康信息使用的监管标准的变化可能会减少临床试验的患者招募，并增加招募成本。

目的

在评估共享决策对结直肠癌筛查依从性影响的临床试验中，比较三种符合新监管标准的招募策略的受试者入组率和成本，这三种策略都符合新监管标准。

方法

按顺序将即将接受结直肠癌筛查的英语母语、平均风险患者分配到以下三种招募策略之一：（1）提供者发起的电子“选择加入”推荐（Click）方法；（2）提供者介导的“选择加入”推荐信（Letter）方法；（3）调查员发起的直接联系“选择退出”（Call）方法。

结果

在 2005 年 3 月至 2006 年 4 月期间进行的三个为期 6 个月的独立招募期间，通过 Click 方法识别了 100 名潜在患者，通过 Letter 方法识别了 847 名患者，通过 Call 方法识别了 758 名患者。排除不合格的预筛选患者后，Call 方法的入组率更高（531 名中的 188 名，35.4%），而 Click 方法（72 名中的 12 名，16.7%；p=0.002）或 Letter 方法（816 名中的 17 名，2.1%；p<0.001）的入组率较低。通过 Call 方法（$156）招募每位患者的平均成本与 Click 方法（$129）相当，且显著低于 Letter 方法（$1967）；如果结合自动化患者识别，Call 方法最便宜（$99）。数据推断表明，通过 Call 方法招募 900 名目标患者需要 2.4 年，总成本为 138518 美元；通过 Click 方法需要 40.5 年，总成本为 62419 美元；通过 Letter 方法需要 27.9 年，总成本为 1737757 美元。