McCoy, Rozalina G.

This mixed-methods study sought to identify pharmacotherapy preferences among 40 noninsulin-treated adults with type 2 diabetes receiving care at two U.S. health care systems. Participants ranked by relative importance various health outcomes and medication attributes and then contextualized their rankings. Most participants ranked blindness (63%), death (60%), heart attack (48%), and heart failure (48%) as the most important health outcomes and glucose-lowering efficacy (68%) as the most important medication attribute, followed by oral administration (45%) and lack of gastrointestinal side effects (38%).

Background: Gestational diabetes mellitus (GDM) is a common complication of pregnancy that carries lasting risks. For women who have a history of GDM, the risk of developing type 2 diabetes mellitus (T2DM) increases by 50 to 60%. To monitor and prevent the development of T2DM, guidelines suggest screening those with a history of GDM at 6-weeks and 3-years post-delivery. For patients with abnormal lab results at the 6-week mark, it is advised to complete lab work sooner, at the 1-year mark. Data suggests that these guidelines are not being followed globally, and most do not receive adequate screening for T2DM. Methods: A retroactive chart review of 203 women between 18 and 55 years old with a past medical history significant for GDM was conducted to determine if patients with GDM completed screening for T2DM at 6-week, 1-year, and 3-year timestamps post-delivery. Patient demographics (age, race, ethnicity, language), clinical characteristics (body mass index), provider gender, and whether prediabetes or T2DM developed were recorded. Patients who did not complete the required follow-up received educational materials via the online portal system, and hemoglobin A1c (HbA1c) screening tests were ordered. Results: Ninety days post-intervention, 38 patients (50%) completed the HbA1c screening test, which exceeded our goal of a 5% improvement. Age and BMI 1-year postpartum were found to be significant factors in whether a patient completed HbA1c screening, with 16/18 (89%) completing screening with a healthy BMI 1-year postpartum (18.5 ≤ BMI < 25.0) but only 11/41 (27%) completing screening for patients under 40 years with an unhealthy BMI 1-year postpartum. Of the 38 patients who completed HbA1c screening, 9 (23.7%) had abnormal screening results. Conclusion: Follow-up surveillance for T2DM among women with a history of GDM is poor. Electronic health records can be used to identify and rectify gaps in care. Dissemination of standardized educational materials and electronic order entry for patients improved screening between the handoff from obstetrics to primary care.

AbstractObjectiveTrends in use and continuity of use of diabetes‐specific and non‐diabetes weight‐reducing (WR), weight‐inducing (WI), and weight‐neutral (WN) medications were examined among US adults with diabetes and overweight/obesity.MethodsSerial cross‐sectional data from Medical Expenditure Panel Surveys (2010–2019) for adults (≥18 years) with diabetes and BMI ≥27 kg/m2 (≥25 kg/m2 for Asians) were analyzed.ResultsAmong 7402 US adults with diabetes and overweight/obesity (mean age 60.0 years [SD 13], 50% female), 64.9% of participants used any WI medications, decreasing from 68.9% (95% CI: 64.3%–73.5%) in 2010 to 58.6% (95% CI: 54.7%–62.5%) in 2019. It was estimated that 13.5% used WR medications, increasing 3.31‐fold, from 6.4% (95% CI: 4.1%–8.7%) to 21.2% (95% CI: 18.0%–24.4%) and that 73.1% used WN medications, ranging from 70.5% (95% CI: 66.5–74.6) to 75.0% (95% CI: 71.7%–78.4%). Among adults using diabetes‐specific WI (53.7%), WR (7.1%), and WN (62.4%) medications during the first year, 7.3%, 16.4%, and 9.0% discontinued it in the second year, respectively.ConclusionsOver 2010–2019, 64.9% of adults with diabetes and overweight/obesity were treated with WI medications, 13.5% with WR medications, and 73.1% with WN medications. Discontinuation of WR medications was nearly twice that of WI medications.

572 Background: The DEFeNDR (Decreasing the burden of Febrile Neutropenia through Dynamic RPM) program leverages in-home technology and centralized nurse monitoring to facilitate ambulatory management as an alternative to hospital-based care for cancer patients with neutropenic fever (NF). The objective of this study is to assess 30-day care utilization outcomes and patient satisfaction at 12 months after program implementation. Methods: Adult cancer patients hospitalized with NF were assessed daily for DEFeNDR program eligibility including MASCC score ≥21 (per ASCO guidelines) and no cellular therapy (CAR-T, BMT) in the prior 100 days. Patients agreeing to participate in the 30-day program received a cellular-enabled tablet with pre-connected devices for twice-daily vital signs and symptom assessments. Patient generated data were EHR-integrated in real-time. Embedded decision trees facilitated alerts for adverse trends. Virtual RPM nurses responded to alerts and utilized predefined care pathways. The primary endpoint was the mean proportion of evaluable days spent inpatient (mPEDI) within 30 days of eligibility comparing those who participated in the program (RPM) with those who declined (no RPM). Results: Of 85 eligible patients, 62 were offered DEFeNDR participation. Of those, 34 (54.8%) participated and 28 (45.2%) declined. Baseline characteristics and care utilization outcomes are summarized in Table 1. RPM patients experienced significantly lower mPEDI compared with unmonitored patients [5.1% (Standard Error [SE], 1.9%) vs 12.4% (SE, 2.1%); Wilcoxon Rank Sums p-value, 0.032]. RPM patients also experienced a trend toward fewer total hospital days and lower 30-day readmission rate, as well as shorter mean length of stay and lower rate of ICU utilization when readmitted. Non-visit care activities (EHR clinical communications, documentation, and patient messaging) were decreased from pre-hospital baseline for 58.8% of RPM patients versus 46.6% of those unmonitored. All RPM patients completing a patient satisfaction survey (n=9) indicated that they would recommend the program to patients with a similar condition. Conclusions: Cancer patients with NF participating in the DEFeNDR program experienced a significant reduction in mPEDI and care utilization compared with those who declined. Further studies are warranted to assess comparative effectiveness of this model vs usual care.[Table: see text]

A rigorous evaluation of the implementation of a diabetes quality measure implementation program across community healthcare clinics in Shanghai, China, where both quality measurement and primary care delivery are relatively recent but centrally supported, identified important concerns about the meaningfulness, feasibility, and accuracy of quality measures that are relevant to all quality measurement programs. These include the importance of stakeholder involvement in measure development and implementation, the need to select measures that accurately and reliably reflect care quality, the link between incentives for improved performance and data manipulation, the necessity for scientific credibility and practical feasibility of the measure, and the assurance that measure performance can be impacted by those being evaluated. In addition to elaborating on these aspects of quality measurement, we also discuss the need for quality measures that are balanced across established domains of quality, are not burdensome to participants, and are transparent, parsimonious, nimble, and oriented around continuous evaluation and improvement.

Objective To build on the recently completed GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) randomised trial examining the comparative effectiveness of second line glucose lowering drugs in achieving and maintaining glycaemic control in adults with type 2 diabetes. Design Emulation of a target trial. Setting Medical and pharmacy claims data from the OptumLabs Data Warehouse, a de-identified US national dataset of beneficiaries of commercially insured and Medicare Advantage plans, 29 March 2013 to 30 June 2021. Participants Adults (≥18 years) with type 2 diabetes who first started taking glimepiride, sitagliptin, liraglutide, insulin glargine, or canagliflozin between 29 March 2013 and 30 June 2021. Participants were treatment naive or were receiving metformin monotherapy at the time of starting the study drug. Main outcome measures The main outcomes were time to primary and secondary metabolic failure of the assigned treatment, calculated as days to haemoglobin A1c levels of ≥7.0% and >7.5%, respectively. Secondary metabolic, cardiovascular, and microvascular outcomes were analysed as specified in the GRADE statistical analysis plan. Propensity scores were estimated with the gradient boosting method, and inverse propensity score weighting was used to emulate randomisation to the treatment groups, which were then compared with Cox proportional hazards regression. (Results The study cohort included participants starting treatment with glimepiride (n=20 511), liraglutide (n=5569), sitagliptin (n=13 039), insulin glargine (n=7262), and canagliflozin (n=5290). The insulin glargine arm was excluded because of insufficient control of confounding. Median times to primary metabolic failure were 439 (95% confidence interval 400 to 489) days in the canagliflozin arm, 439 (426 to 453) days in the glimepiride arm, 624 (567 to 731) days in the liraglutide arm, and 461 (442 to 482) days in the sitagliptin arm. Median time to secondary metabolic failure was also longest in the liraglutide arm. Adults receiving liraglutide had the lowest one year cumulative incidence rate of primary metabolic failure (0.37, 95% confidence interval 0.35 to 0.40) followed by sitagliptin (0.44, 0.43 to 0.45), glimepiride (0.45, 0.44 to 0.45), and canagliflozin (0.46, 0.44 to 0.48). Similarly, the one year cumulative incidence rate of secondary metabolic failure was 0.27 (0.25 to 0.29) in the canagliflozin arm, 0.28 (0.27 to 0.29) in the glimepiride arm, 0.23 (0.21 to 0.26) in the liraglutide arm, and 0.28 (0.27 to 0.29) in the sitagliptin arm. No differences were observed between the study arms in the rates of microvascular and macrovascular complications. Conclusions In this target trial emulation of an expanded GRADE study framework, liraglutide was more effective in achieving and maintaining glycaemic control as a second line glucose lowering drug than canagliflozin, sitagliptin, or glimepiride.

This retrospective cohort study investigated the longer-term hyperglycemic effects of intra-articular corticosteroid (IACS) administration by evaluating changes in A1C after large joint IACS injection. Among 1,169 patients (mean age 66.1 ± 12.2 years, 52.8% female), 184 (15.7%) experienced a greater-than-expected rise in A1C (actual A1C ≥0.5% above predicted) after IACS. Greater-than-expected rise in A1C was associated solely with baseline A1C (odds ratio [OR] 1.84, 95% CI 1.08–3.13 for baseline A1C of 7.0–8.0% compared with &lt;7.0% and OR 4.79, 95% CI 2.83–8.14 for baseline A1C &gt;8.0% compared with &lt;7.0%). Although most patients do not experience an increase in A1C after IACS, clinicians should counsel patients with suboptimally controlled diabetes about risks of further hyperglycemia after IACS administration.

Background/aims There has been growing interest in better understanding the potential of observational research methods in medical product evaluation and regulatory decision-making. Previously, we used linked claims and electronic health record data to emulate two ongoing randomized controlled trials, characterizing the populations and results of each randomized controlled trial prior to publication of its results. Here, our objective was to compare the populations and results from the emulated trials with those of the now-published randomized controlled trials. Methods This study compared participants’ demographic and clinical characteristics and study results between the emulated trials, which used structured data from OptumLabs Data Warehouse, and the published PRONOUNCE and GRADE trials. First, we examined the feasibility of implementing the baseline participant characteristics included in the published PRONOUNCE and GRADE trials’ using real-world data and classified each variable as ascertainable, partially ascertainable, or not ascertainable. Second, we compared the emulated trials and published randomized controlled trials for baseline patient characteristics (concordance determined using standardized mean differences <0.20) and results of the primary and secondary endpoints (concordance determined by direction of effect estimates and statistical significance). Results The PRONOUNCE trial enrolled 544 participants, and the emulated trial included 2226 propensity score-matched participants. In the PRONOUNCE trial publication, one of the 32 baseline participant characteristics was listed as an exclusion criterion on ClinicalTrials.gov but was ultimately not used. Among the remaining 31 characteristics, 9 (29.0%) were ascertainable, 11 (35.5%) were partially ascertainable, and 10 (32.2%) were not ascertainable using structured data from OptumLabs. For one additional variable, the PRONOUNCE trial did not provide sufficient detail to allow its ascertainment. Of the nine variables that were ascertainable, values in the emulated trial and published randomized controlled trial were discordant for 6 (66.7%). The primary endpoint of time from randomization to the first major adverse cardiovascular event and secondary endpoints of nonfatal myocardial infarction and stroke were concordant between the emulated trial and published randomized controlled trial. The GRADE trial enrolled 5047 participants, and the emulated trial included 7540 participants. In the GRADE trial publication, 8 of 34 (23.5%) baseline participant characteristics were ascertainable, 14 (41.2%) were partially ascertainable, and 11 (32.4%) were not ascertainable using structured data from OptumLabs. For one variable, the GRADE trial did not provide sufficient detail to allow for ascertainment. Of the eight variables that were ascertainable, values in the emulated trial and published randomized controlled trial were discordant for 4 (50.0%). The primary endpoint of time to hemoglobin A1c ≥7.0% was mostly concordant between the emulated trial and the published randomized controlled trial. Conclusion Despite challenges, observational methods and real-world data can be leveraged in certain important situations for a more timely evaluation of drug effectiveness and safety in more diverse and representative patient populations.