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BACKGROUND: Patient adherence to medications can be assessed using interactive digital health technologies such as electronic monitors (EMs). Changes in treatment regimens and deviations from EM use over time must be characterized to establish the actual level of medication adherence. OBJECTIVE: We developed the computer script CleanADHdata.R to clean raw EM adherence data, and this tutorial is a guide for users. METHODS: In addition to raw EM data, we collected adherence start and stop monitoring dates and identified the prescribed regimens, the expected number of EM openings per day based on the prescribed regimen, EM use deviations, and patients' demographic data. The script formats the data longitudinally and calculates each day's medication implementation. RESULTS: We provided a simulated data set for 10 patients, for which 15 EMs were used over a median period of 187 (IQR 135-342) days. The median patient implementation before and after EM raw data cleaning was 83.3% (IQR 71.5%-93.9%) and 97.3% (IQR 95.8%-97.6%), respectively (Δ+14%). This difference is substantial enough to consider EM data cleaning to be capable of avoiding data misinterpretation and providing a cleaned data set for the adherence analysis in terms of implementation and persistence. CONCLUSIONS: The CleanADHdata.R script is a semiautomated procedure that increases standardization and reproducibility. This script has broader applicability within the realm of digital health, as it can be used to clean adherence data collected with diverse digital technologies.
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BACKGROUND: Postbariatric hypoglycemia (PBH) is a challenging condition affecting quality of life of patients after bariatric surgery. However, its incidence and predictive factors remain debated. OBJECTIVES: To determine the incidence of PBH, identify predictors of PBH and assess its association with weight trajectory after bariatric surgery. SETTING: University Hospital. METHODS: Prospective observational cohort study including 222 nondiabetic patients who underwent Roux-en-Y gastric bypass between 2014 and 2021, had an oral glucose tolerance test (OGTT) and/or A1C (glycated hemoglobin) measurement prior to surgery and were followed for at least 12 months. Diagnosis of PBH was made when symptoms of hypoglycemia were accompanied by a postprandial plasma glucose level < 3.9 mmol/l or a glycemia < 3.9 mmol/l during continuous glucose monitoring, with resolution of symptomatology after carbohydrate consumption. Univariable and multivariable logistic regression analyses were performed to identify factors associated with PBH. RESULTS: Out of 222 patients, 71 (32%) were diagnosed with PBH. The highest incidence rate was observed at 2 years postbariatric surgery with a cumulative incidence of 26.5%. Predictive factors for higher risk of PBH were younger age at surgery (OR = .97; 95% CI: .94-.99; P = .049) and early dumping syndrome (OR = 3.05; 95% CI: 1.62-6.04; P = .0008). In multivariable logistic regression, higher glycemia at 2 hours during preoperative OGTT was associated with lower risk of PBH (OR = .8; 95% CI: .63-.98; P = .04). PBH was not associated with weight trajectory after surgery in our cohort. CONCLUSIONS: Younger age at time of surgery and lower blood glucose at 120 minute during preoperative OGTT are risk factors for PBH. Early dumping syndrome is significantly associated with PBH and could be used as a red flag to help identify patients at risk of PBH.
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BACKGROUND: Oral anticancer therapies such as protein kinase inhibitors (PKIs) are increasingly prescribed in cancer care. We aimed to evaluate the impact of a pharmacist-led interprofessional medication adherence program (IMAP) on patient implementation (dosing history), persistence (time until premature cessation of the treatment) and adherence to 27 PKIs prescribed for various solid cancers, as well as the impact on patients' beliefs about medicines (BAM) and quality of life (QoL). METHODS: Patients (n = 118) were randomized 1:1 into two arms. In the intervention arm, pharmacists supported patient adherence through monthly electronic and motivational feedback, including educational, behavioral and affective components, for 12 months. The control arm received standard care plus EM without intervention. All PKIs were delivered in electronic monitors (EMs). Medication implementation and adherence were compared between groups using generalized estimating equation models, in which relevant covariables were included; persistence was compared with KaplanâMeier curves. Information on all treatment interruptions was compiled for the analysis. Questionnaires to evaluate BAM and QoL were completed among patients who refused and those who accepted to participate at inclusion, 6 and 12 months post-inclusion or at study exit. RESULTS: Day-by-day PKI implementation was consistently higher and statistically significant in the intervention arm (n = 58) than in the control arm (n = 60), with 98.1% and 95.0% (Δ3.1%, 95% confidence interval (CI) of the difference 2.5%; 3.7%) implementation at 6 months, respectively. The probabilities of persistence and adherence were not different between groups, and no difference was found between groups for BAM and QoL scores. No difference in BAM or QoL was found among patients who refused versus those who participated. The intervention benefited mostly men (at 6 months, Δ4.7%, 95% CI 3.4%; 6.0%), those younger than 60 years (Δ4.0%, 95% CI 3.1%; 4.9%), those who had initiated PKI more than 60 days ago before inclusion (Δ4.5%, 95% CI 3.6%; 5.4%), patients without metastasis (Δ4.5%, 95% CI 3.4%; 5.7%), those who were diagnosed with metastasis more than 2 years ago (Δ5.3%, 95% CI 4.3%; 6.4%) and those who had never used any adherence tool before inclusion (Δ3.8%, 95% CI 3.1%; 4.5%). CONCLUSIONS: The IMAP, led by pharmacists in the context of an interprofessional collaborative practice, supported adherence, specifically implementation, to PKIs among patients with solid cancers. To manage adverse drug events, PKI transient interruptions are often mandated as part of a strategy for treatment and adherence optimization according to guidelines. Implementation of longer-term medication adherence interventions in the daily clinic may contribute to the improvement of progression-free survival. TRIAL REGISTRATION: ClinicalTrials.gov NCT04484064.