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乳腺癌治疗后医院随访与电话随访的比较:随机等效性试验

Comparing hospital and telephone follow-up after treatment for breast cancer: randomised equivalence trial.

作者信息

Beaver Kinta, Tysver-Robinson Debbie, Campbell Malcolm, Twomey Mary, Williamson Susan, Hindley Andrew, Susnerwala Shabbir, Dunn Graham, Luker Karen

机构信息

School of Nursing, Midwifery and Social Work, University of Manchester, UK.

出版信息

BMJ. 2009 Jan 14;338:a3147. doi: 10.1136/bmj.a3147.

Abstract

OBJECTIVE

To compare traditional hospital follow-up with telephone follow-up by specialist nurses after treatment for breast cancer.

DESIGN

A two centre randomised equivalence trial in which women remained in the study for a mean of 24 months.

SETTING

Outpatient clinics in two NHS hospital trusts in the north west of England

PARTICIPANTS

374 women treated for breast cancer who were at low to moderate risk of recurrence.

INTERVENTIONS

Participants were randomised to traditional hospital follow-up (consultation, clinical examination, and mammography as per hospital policy) or telephone follow-up by specialist nurses (consultation with structured intervention and mammography according to hospital policy).

MAIN OUTCOME MEASURES

Psychological morbidity (state-trait anxiety inventory, general health questionnaire (GHQ-12)), participants' needs for information, participants' satisfaction, clinical investigations ordered, and time to detection of recurrent disease.

RESULTS

The 95% confidence interval for difference in mean state-trait scores adjusted for treatment received (-3.33 to 2.07) was within the predefined equivalence region (-3.5 to 3.5). The women in the telephone group were no more anxious as a result of foregoing clinic examinations and face-to-face consultations and reported higher levels of satisfaction than those attending hospital clinics (intention to treat P<0.001). The numbers of clinical investigations ordered did not differ between groups. Recurrences were few (4.5%), with no differences between groups for time to detection (median 60.5 (range 37-131) days in hospital group v 39.0 (10-152) days in telephone group; P=0.228).

CONCLUSIONS

Telephone follow-up was well received by participants, with no physical or psychological disadvantage. It is suitable for women at low to moderate risk of recurrence and those with long travelling distances or mobility problems and decreases the burden on busy hospital clinics.

TRIAL REGISTRATION

National Cancer Research Institute 1477.

摘要

目的

比较乳腺癌治疗后传统医院随访与专科护士电话随访的效果。

设计

一项两中心随机等效性试验,女性平均参与研究24个月。

地点

英格兰西北部两个国民保健服务医院信托机构的门诊诊所

参与者

374名接受乳腺癌治疗且复发风险低至中度的女性。

干预措施

参与者被随机分为传统医院随访组(按照医院政策进行会诊、临床检查和乳房X光检查)或专科护士电话随访组(按照医院政策进行结构化干预会诊和乳房X光检查)。

主要观察指标

心理发病率(状态-特质焦虑量表、一般健康问卷(GHQ-12))、参与者的信息需求、参与者满意度、所安排的临床检查以及复发病灶的检测时间。

结果

根据接受的治疗调整后的平均状态-特质得分差异的95%置信区间(-3.33至2.07)在预先定义的等效区域(-3.5至3.5)内。电话随访组的女性并未因放弃门诊检查和面对面会诊而更加焦虑,且报告的满意度高于前往医院门诊的女性(意向性分析P<0.001)。两组所安排的临床检查数量没有差异。复发情况较少(4.5%),两组在病灶检测时间方面没有差异(住院组中位数为60.5(范围37 - 131)天,电话随访组为39.0(10 - 152)天;P = 0.228)。

结论

参与者对电话随访接受度良好,没有身体或心理方面的不利影响。它适用于复发风险低至中度的女性以及路途遥远或行动不便的女性,并减轻了繁忙医院门诊的负担。

试验注册号

国家癌症研究所1477

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/87e5/4787226/f363722c9370/beak584029.f1.jpg

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