Zahidy Misk Al, Ridgeway Jennifer L, Branda Megan E, Maldonado Kerly Guevara, Simha Sue, Herzog Alexandra, Hougen Jada, Borras-Osorio Mariana, Tran Viet-Thi, Montori Victor M
Mayo Clinic.
Res Sq. 2025 Aug 20:rs.3.rs-7265768. doi: 10.21203/rs.3.rs-7265768/v1.
Patients living with diabetes and chronic conditions may face significant burden managing their health. Many of these patients use digital medicine tools such as continuous glucose monitoring systems. Although measures exist to assess treatment burden from tasks such as managing medications and attending healthcare visits, there is no patient-reported measure that captures the burden of digital care. Therefore, the purpose of this study is to validate the Treatment Burden Questionnaire Plus Digital (TBQ + D), a patient-reported measure of treatment burden that includes using digital tools for adults with diabetes.
Adult patients with type 1 or type 2 diabetes mellitus completed the 25-item TBQ + D (scored 0 [none] to 10 [maximum] per item; total score range 0-250). We evaluated ease of administration, internal consistency, and tested hypotheses about the relationship between TBQ + D scores and treatment complexity, digital tool use intensity, social risk factors, and digital comfort to assess TBQ + D's validity.
Of 324 patients approached, 300 (93%) consented and completed the TBQ + D (mean age 57 [SD 17]; 50% female; 50% with type 2). The mean TBQ + D score was 53.7 (SD 41.6). Internal consistency was excellent (Cronbach's α = 0.94). As hypothesized, higher TBQ + D scores were reported by patients with type 1 vs. type 2 diabetes mellitus (61.7 vs. 45.7; p = .0008), maximal/moderate vs. minimal to no digital tool use (56.5/60.7 vs. 41.3; p = .001), those on intensive insulin therapy vs. other treatments (61.4 vs. 38.0; p < .0001), and those with greater social vulnerability (p < .0106). TBQ + D scores were not significantly higher in patients with HbA1c ≥ 8% (p = .055) or less comfortable with digital technology (p = .08).
TBQ + D is a novel and valid measure of treatment burden in patients living with diabetes, inclusive of digital burden, that can play a role in fostering minimally disruptive care for patients with diabetes.
患有糖尿病和慢性病的患者在管理自身健康方面可能面临巨大负担。这些患者中有许多人使用数字医疗工具，如连续血糖监测系统。尽管存在评估诸如管理药物和就医等任务的治疗负担的措施，但尚无患者报告的衡量数字护理负担的指标。因此，本研究的目的是验证治疗负担问卷升级版数字版（TBQ + D），这是一种由患者报告的治疗负担衡量指标，适用于患有糖尿病的成年人，其中包括使用数字工具的情况。
1型或2型糖尿病成年患者完成了包含25个条目的TBQ + D（每个条目得分从0[无]到10[最高]；总分范围为0 - 250）。我们评估了其施测的简易程度、内部一致性，并检验了关于TBQ + D得分与治疗复杂性、数字工具使用强度、社会风险因素和数字舒适度之间关系的假设，以评估TBQ + D的有效性。
在324名被邀请的患者中，300名（93%）同意并完成了TBQ + D（平均年龄57岁[标准差17]；50%为女性；50%患有2型糖尿病）。TBQ + D的平均得分为53.7（标准差41.6）。内部一致性极佳（克朗巴哈α系数 = 0.94）。如假设所示，1型糖尿病患者报告的TBQ + D得分高于2型糖尿病患者（61.7对45.7；p = 0.0008），数字工具使用强度为最大/中度的患者高于最低至未使用数字工具的患者（56.5/60.7对41.3；p = 0.001），接受强化胰岛素治疗的患者高于接受其他治疗的患者（61.4对38.0；p < 0.0001），以及社会脆弱性较高的患者（p < 0.0106）。糖化血红蛋白（HbA1c）≥8%的患者或对数字技术不太适应的患者的TBQ + D得分没有显著更高（p = 0.055和p = 0.08）。
TBQ + D是一种用于衡量糖尿病患者治疗负担（包括数字负担）的新颖且有效的指标，可在为糖尿病患者提供最小干扰性护理方面发挥作用。
