在随机对照试验环境下比较糖尿病患者和胰岛素泵治疗（INPUT）教育计划的疗效，以及在常规护理环境下的效果：一项比较有效性研究的结果。

Comparison of the efficacy of an education program for people with diabetes and insulin pump treatment (INPUT) in a randomized controlled trial setting and the effectiveness in a routine care setting: Results of a comparative effectiveness study.

机构信息

Division of Endocrinology & Diabetes, Department of Internal Medicine 1, Goethe-University Hospital, 60590, Frankfurt am Main, Germany.

Research Institute of the Diabetes Academy Mergentheim (FIDAM), 97980, Bad Mergentheim, Germany; Otto-Friedrich-University of Bamberg, Department of Clinical Psychology and Psychotherapy, Bamberg, Germany.

出版信息

Patient Educ Couns. 2019 Oct;102(10):1868-1874. doi: 10.1016/j.pec.2019.04.021. Epub 2019 Apr 18.

DOI:10.1016/j.pec.2019.04.021

PMID:31031097

Abstract

OBJECTIVE

To compare the efficacy of an education program for people with diabetes and insulin pump treatment (INPUT) in a randomized controlled trial (RCT) to the effectiveness in an implementation trial (IT).

METHODS

135 people with diabetes on insulin pump treatment (CSII) underwent structured education with INPUT under RCT-conditions, 191 people with diabetes on CSII underwent structured education with INPUT under IT-conditions. Baseline characteristics and treatment outcomes at the 6-month follow-up were compared.

RESULTS

At baseline, RCT-participants were younger (42.7 ± 14.2 vs. 47.2 ± 14.1 years, p = 0.005), had higher HbA1c-values (8.3 ± 0.8% vs. 7.8 ± 1.2%, p = 0.001) and had more diabetes-related distress (27.8 ± 16.4 vs 22.4 ± 14.4, p = 0.002). At follow-up, INPUT results were comparable under the RCT and IT settings. After adjustment for baseline HbA1c, reduction of HbA1c in the IT was significantly greater than in the RCT (Δ0.17%; 95% CI 0.023-0.319%, p = 0.024). Participants with higher HbA1c-levels, more diabetes-related distress and more hypoglycemia problems were most likely to benefit from INPUT regardless of the trial setting.

CONCLUSIONS

Efficacy of the INPUT program for people with CSII was demonstrated under RCT- and routine care conditions.

PRACTICE IMPLICATIONS

Education with the INPUT program is effective not only under standardized RCT conditions but also under conditions of routine care.

摘要

目的

比较糖尿病患者和胰岛素泵治疗（CSII）的教育计划（INPUT）在随机对照试验（RCT）中的疗效与实施试验（IT）中的有效性。

方法

135 名接受 CSII 治疗的糖尿病患者接受 INPUT 下的结构化教育，在 RCT 条件下，191 名接受 CSII 治疗的糖尿病患者在 IT 条件下接受 INPUT 下的结构化教育。比较基线特征和 6 个月随访时的治疗结果。

结果

在基线时，RCT 参与者年龄较小（42.7±14.2 岁 vs. 47.2±14.1 岁，p=0.005），HbA1c 值较高（8.3±0.8% vs. 7.8±1.2%，p=0.001），糖尿病相关痛苦程度较高（27.8±16.4 vs 22.4±14.4，p=0.002）。随访时，RCT 和 IT 环境下的 INPUT 结果相当。在调整基线 HbA1c 后，IT 中的 HbA1c 降低幅度明显大于 RCT（Δ0.17%；95%CI 0.023-0.319%，p=0.024）。无论试验设置如何，HbA1c 水平较高、糖尿病相关痛苦程度较高和低血糖问题较多的参与者最有可能从 INPUT 中受益。