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一种用于评估对治疗严重低血糖的鼻用与自动注射胰高血糖素给药装置态度的测量方法的开发。

Development of a Measure to Assess Attitudes Towards Nasal versus Autoinjector Glucagon Delivery Devices for Treatment of Severe Hypoglycemia.

作者信息

Bajpai Sanjay K, Cambron-Mellott M Janelle, Will Oliver, Poon Jiat-Ling, Wang Qianqian, Mitchell Beth D, Peck Eugenia Y, Babrowicz Jane, Raibulet Nedina K, Child Christopher J, Beusterien Kathleen

机构信息

Eli Lilly and Company, Indianapolis, IN, USA.

Cerner Enviza, New York, NY, USA.

出版信息

Diabetes Metab Syndr Obes. 2022 Nov 21;15:3601-3615. doi: 10.2147/DMSO.S367010. eCollection 2022.

Abstract

BACKGROUND

For individuals managing diabetes, the administration of glucagon for severe hypoglycemia can be lifesaving, yet, until recently, there were no easy-to-use devices for these stressful emergencies. New products have emerged to meet this need, including nasal glucagon (NG) and auto-injector glucagon (AI). This study evaluated the psychometric properties of a new measure, the Glucagon Device Attitudes Questionnaire (GDAQ), in assessing attitudes toward NG and AI from the perspectives of persons with diabetes on insulin (PWDs), caregivers, and acquaintances.

METHODS

Developed based on qualitative research, the GDAQ consists of 38 rating items for each device and 16 direct-elicitation of attitudes of device relative to each other. It was administered to participants via a cross-sectional online survey. Twenty-six rating items were included in principal component analysis and confirmatory factor analysis. Items comprising each factor were averaged to form scales. Additionally, 12 direct elicitation items were averaged to form an overall "Attitudes" scale. Reliability and validity analyses were conducted. Descriptive statistics were provided for the rating items not included in the factor analysis.

RESULTS

A total of 405 PWDs, 313 caregivers, and 305 acquaintances participated. Three factors were identified: "Prepared and Protected" (7 items), "Hesitation" (12 items), and "Device Perceptions by Others" (7 items); factor loadings ranged from 0.13 to 0.92, 0.50 to 0.89, and 0.16 to 0.92, respectively. Cronbach's alpha for the four scales ranged from 0.76 to 0.96. Correlations of the scales with their global item ranged from 0.30 to 0.90. The items outside of the factor analysis showed good distribution in responses and differentiation between the two devices.

DISCUSSION

This study supports the validity and reliability of the GDAQ, which successfully conceptualizes attitudes towards devices for administering glucagon among different respondent groups. Use of the GDAQ can help guide the development and testing of new glucagon drug/device combinations.

摘要

背景

对于糖尿病患者而言,使用胰高血糖素治疗严重低血糖可挽救生命,但直到最近,针对这些紧急情况仍没有易于使用的设备。为满足这一需求,出现了新产品,包括鼻用胰高血糖素(NG)和自动注射胰高血糖素(AI)。本研究评估了一种新的测量工具——胰高血糖素设备态度问卷(GDAQ)在从糖尿病胰岛素治疗患者(PWDs)、护理人员和熟人的角度评估对NG和AI的态度方面的心理测量特性。

方法

基于定性研究开发的GDAQ,针对每种设备包含38个评分项目以及16个关于设备相互之间态度的直接询问项目。通过横断面在线调查对参与者进行施测。26个评分项目纳入主成分分析和验证性因素分析。将构成每个因素的项目进行平均以形成量表。此外,将12个直接询问项目进行平均以形成一个总体“态度”量表。进行了信度和效度分析。对未纳入因素分析的评分项目提供了描述性统计。

结果

共有405名糖尿病胰岛素治疗患者、313名护理人员和305名熟人参与。确定了三个因素:“有备无患”(7个项目)、“犹豫”(12个项目)和“他人对设备的认知”(7个项目);因素负荷分别为0.13至0.92、0.50至0.89和0.16至0.92。四个量表的克朗巴哈系数范围为0.76至0.96。量表与其总体项目的相关性范围为0.30至0.90。因素分析之外的项目在回答中显示出良好的分布以及两种设备之间的区分度。

讨论

本研究支持了GDAQ的效度和信度,该问卷成功地概念化了不同应答组对胰高血糖素给药设备的态度。使用GDAQ有助于指导新型胰高血糖素药物/设备组合的开发和测试。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb38/9694976/781e012a8f65/DMSO-15-3601-g0001.jpg

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