Association of Medication Regimen Complexity With Clinical Endpoints in Pediatric Patients With Cystic Fibrosis.
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ABSTRACT: Objective
Cystic fibrosis (CF) patients and caregivers are impacted by the number of pharmacological agents and unique administration needs; however, no data currently assesses how medication regimen complexity impacts clinical outcomes in this population. The objective of this study is to evaluate if an association exists between increased medication regimen complexity and clinical endpoints in pediatric patients with CF.Methods
This retrospective analysis included all pediatric patients with CF (ages 5-20 years) with at least 2 pharmacist encounters and acceptable pulmonary function tests at our pediatric pulmonary clinic during 2017. Each patient's medication regimen was scored using the validated Medication Regimen Complexity Index (MRCI) tool. The primary outcome was the correlation between MRCI score and lung function. Secondary endpoints included growth, number of infections requiring antibiotics, and hospitalizations.Results
MRCI scores of the 113 included patients ranged from 2 to 101 points. A negative correlation was found between initial and final MRCI score and initial and final forced expiratory volume in 1 second (FEV1; r = -0.323, p = 0.0005 and r = -0.287, p = 0.0021, respectively). MRCI scores were negatively correlated with BMI percentile for both encounters (r = -0.162 and r = -0.125) but were not significant. Higher MRCI scores were associated with increased use of oral and intravenous antibiotics and hospital admissions.Conclusions
Higher MRCI scores are correlated with a significant decrease in FEV1, increased need for antibiotic therapy, and more hospital admissions in pediatric patients with CF. Larger studies are needed to determine if a correlation exists between MRCI score and growth.
SUBMITTER: Tjugum SL
PROVIDER: S-EPMC8021245 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveTo adapt and automate the medication regimen complexity index (MRCI) within the structure of a commercial medication database in the post-acute home care setting.Materials and methodsIn phase 1, medication data from 89 645 electronic health records were abstracted to line up with the components of the MRCI: dosage form, dosing frequency, and additional administrative directions. A committee reviewed output to assign index weights and determine necessary adaptations. In phase 2 we examined the face validity of the modified MRCI through analysis of automatic tabulations and descriptive statistics.ResultsThe mean number of medications per patient record was 7.6 (SD 3.8); mean MRCI score was 16.1 (SD 9.0). The number of medications and MRCI were highly associated, but there was a wide range of MRCI scores for each number of medications. Most patients (55%) were taking only oral medications in tablet/capsule form, although 16% had regimens with three or more medications with different routes/forms. The biggest contributor to the MRCI score was dosing frequency (mean 11.9). Over 36% of patients needed to remember two or more special instructions (eg, take on alternate days, dissolve).DiscussionMedication complexity can be tabulated through an automated process with some adaptation for local organizational systems. The MRCI provides a more nuanced way of measuring and assessing complexity than a simple medication count.ConclusionsAn automated MRCI may help to identify patients who are at higher risk of adverse events, and could potentially be used in research and clinical decision support to improve medication management and patient outcomes.
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Project description:BackgroundCystic fibrosis (CF) pulmonary exacerbations can be serious respiratory events and reduction in exacerbation rate or risk are important efficacy endpoints for CF therapeutic trials. Variability in exacerbation diagnoses and treatment have led drug developers to employ "objective" exacerbation definitions combining antimicrobial treatment (AT) and the presence of ≥4 of 12 respiratory criteria (first published by Fuchs et al. [NEJM 1994;331(10):637-42]). Assumptions underlying this approach have yet to be formally evaluated.MethodsRespiratory events (RE) observed during a 48-week trial of ataluren (NCT02139306), a read-through agent for premature nonsense codons, were compared across six exacerbation definitions: any AT, intravenous AT (IVAT), ≥4 Fuchs criteria present, AT plus ≥4 Fuchs criteria, IVAT plus ≥4 Fuchs criteria, and investigator assessment. Fuchs definitions were evaluated by assessing missingness of individual criteria and associations between criteria presence and clinician exacerbation assessment.ResultsAmong 751 RE, more than one third had ≥4 Fuchs criteria present but were not assessed as exacerbations by investigators. Data for ≥1 and for 4 Fuchs criteria, respectively, were missing for ~ 90% and >30% of RE. Only 6/12 Fuchs criteria were present more often when investigators assessed RE as exacerbations than when they did not.Conclusions"Objective" definitions have shortcomings inconsistent with their purpose of optimizing exacerbation capture in clinical trials : 1) they capture events clinicians do not consider exacerbations, 2) are prone to data missingness which can bias the likelihood of meeting the definition, and 3) employ criteria that are not associated with investigator assessment of exacerbation.
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Project description:Introduction: Most type 2 diabetes mellitus (T2DM) patients with chronic conditions require multiple medications to achieve and maintain good glycemic control. Objective: This study assessed medication burden, regimen complexity, and adherence among T2DM patients and evaluate its association with glycemic control. Method: We analyzed data of 2,696 T2DM patients at public health clinics in Malaysia from January 2018 until May 2019. Medication burden was based on medication count, regimen complexity was measured using the validated Medication Regimen Complexity Index (MRCI) tool, and adherence was measured using proportion of days covered (PDC) formula. Logistic regression models were used to compute unadjusted and adjusted odds ratio (aOR) with 95% confidence interval (CI) for association between the medication parameters and glycemic control (HbA1c ≤ 7.0%) over a 90-day period. Results: The cohort mean age was 60.4 years old (±10.8) and 62.9% were female. Overall, the average medication count was 4.8 with MRCI score of 15.1. Mean adherence score (PDC) was 90%. High medication count and MRCI scores were associated with lower odds of achieving good glycemic control (aOR 0.88; 95% CI 0.82, 0.94 and aOR 0.89; 95% CI 0.87, 0.92, respectively) while inverse association was observed between adherence and HbA1c level (aOR 2.7, 95% CI 1.66, 5.19). Similar findings were observed for diabetes-specific measures. Conclusions: High medication count, high regimen complexity, and low medication adherence were associated with poor glycemic control over the 3-month follow-up period. These parameters could be used to identify patients with complex pharmacotherapy regimens so that targets for intervention can be taken to achieve optimum outcomes and ease of self-care.
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Project description:Discrepancies between the medicines consumed by patients and those documented in the medical record can affect medication safety. We aimed to characterize medication discrepancies and medication regimen complexity over time in a cohort of outpatients with decompensated cirrhosis, and evaluate the impact of pharmacist-led intervention on discrepancies and patient outcomes. In a randomized-controlled trial (n = 57 intervention and n = 57 usual care participants), medication reconciliation and patient-oriented education delivered over a six-month period was associated with a 45% reduction in the incidence rate of 'high' risk discrepancies (IRR = 0.55, 95%CI = 0.31-0.96) compared to usual care. For each additional 'high' risk discrepancy at baseline, the odds of having ≥ 1 unplanned medication-related admission during a 12-month follow-up period increased by 25% (adj-OR = 1.25, 95%CI = 0.97-1.63) independently of the Child-Pugh score and a history of variceal bleeding. Among participants with complete follow-up, intervention patients were 3-fold less likely to have an unplanned medication-related admission (adj-OR = 0.27, 95%CI = 0.07-0.97) compared to usual care. There was no association between medication discrepancies and mortality. Medication regimen complexity, frequent changes to the regimen and hepatic encephalopathy were associated with discrepancies. Medication reconciliation may improve medication safety by facilitating communication between patients and clinicians about 'current' therapies and identifying potentially inappropriate medicines that may lead to harm.
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Project description:BackgroundPulmonary exacerbations (PEx) in people with cystic fibrosis (PwCF) are associated with significant morbidity. While standard PEx treatment for PwCF with Pseudomonas aeruginosa infection includes two IV antipseudomonal antibiotics, little evidence exists to recommend this approach. This study aimed to compare clinical outcomes of single versus double antipseudomonal antibiotic use for PEx treatment.MethodsRetrospective cohort study using the linked CF Foundation Patient Registry-Pediatric Health Information System dataset. PwCF were included if hospitalized between 2007 and 2018 and 6-21 years of age. Regression modeling accounting for repeated measures was used to compare lung function outcomes between single versus double IV antipseudomonal antibiotic regimens using propensity-score weighting to adjust for relevant confounding factors.ResultsAmong 10,660 PwCF in the dataset, we analyzed 2,578 PEx from 1,080 PwCF, of which 455 and 2,123 PEx were treated with 1 versus 2 IV antipseudomonal antibiotics, respectively. We identified no significant differences between PEx treated with 1 versus 2 IV antipseudomonal antibiotics either in change between pre- and post-PEx percent predicted forced expiratory volume in one second (ppFEV1) (-0.84%, [95% CI -2.25, 0.56]; P = 0.24), odds of returning to ≥90% of baseline ppFEV1 within 3 months following PEx (Odds Ratio 0.83, [95% CI 0.61, 1.13]; P = 0.24) or time to next PEx requiring IV antibiotics (Hazard Ratio 1.04, [95% CI 0.87, 1.24]; P = 0.69).ConclusionsUse of 2 IV antipseudomonal antibiotics for PEx treatment in young PwCF was not associated with greater improvements in measured respiratory and clinical outcomes compared to treatment with 1 IV antipseudomonal antibiotic.
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Project description:BackgroundMedication Regimen Complexity (MRC) refers to the combination of medication classes, dosages, and frequencies. The objective of this study was to examine the relationship between the scores of different MRC tools and the clinical outcomes.MethodsWe conducted a retrospective cohort study at Roger William Medical Center, Providence, Rhode Island, which included 317 adult patients admitted to the intensive care unit (ICU) between 1 February 2020 and 30 August 2020. MRC was assessed using the MRC Index (MRCI) and MRC for the Intensive Care Unit (MRC-ICU). A multivariable logistic regression model was used to identify associations among MRC scores, clinical outcomes, and a logistic classifier to predict clinical outcomes.ResultsHigher MRC scores were associated with increased mortality, a longer ICU length of stay (LOS), and the need for mechanical ventilation (MV). MRC-ICU scores at 24 h were significantly (p < 0.001) associated with increased ICU mortality, LOS, and MV, with ORs of 1.12 (95% CI: 1.06-1.19), 1.17 (1.1-1.24), and 1.21 (1.14-1.29), respectively. Mortality prediction was similar using both scoring tools (AUC: 0.88 [0.75-0.97] vs. 0.88 [0.76-0.97]. The model with 15 medication classes outperformed others in predicting the ICU LOS and the need for MV with AUCs of 0.82 (0.71-0.93) and 0.87 (0.77-0.96), respectively.ConclusionOur results demonstrated that both MRC scores were associated with poorer clinical outcomes. The incorporation of MRC scores in real-time therapeutic decision making can aid clinicians to prescribe safer alternatives.
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Project description:ObjectiveAn institution's tobramycin pharmacokinetics (PK) database was reviewed to evaluate the efficacy and safety of empiric tobramycin dosing and monitoring strategies used in pediatric patients with cystic fibrosis (CF). The relationship between patient age and tobramycin dosing needed to achieve the area under the curve (AUC) goal was investigated.MethodsRetrospective chart review was performed for patients who received tobramycin during a CF exacerbation from 2009 to 2019 who received PK monitoring by pediatric pharmacists. Tobramycin dosing needed to achieve an AUC of 100 mg·hr/L was calculated for each patient. Serum creatinine and concomitant nephrotoxin use were collected as surrogate nephrotoxicity endpoints to evaluate safety.ResultsGoal AUC (100 ± 15 mg·hr/L) was achieved based on initial or repeat PK calculations in 43.5% (95% CI, 37.7-49.3) of 85 unique patients across 326 encounters. Patients with calculated recommended doses of 9.5 to 11.9 mg/kg every 24 hours empirically achieved goal AUC in 77% (78/101) of encounters. The odds of achieving goal AUC were 56% higher for children aged 10 vs 5 years (OR = 1.56; 95% CI, 1.04-2.34; p = 0.033) and 32% higher for children aged 15 vs 10 years (OR = 1.32; 95% CI, 1.07-1.61; p = 0.008). Overall rates of acute kidney injury and concomitant nephrotoxin use were 10.8% (95% CI, 6.2-15.5) and 80.7% (95% CI, 74.3-87.1), respectively.ConclusionsDesired AUC was achieved by 43.5% of pediatric patients with CF using tobramycin 10 mg/kg every 24 hours. Older patient age was associated with higher initial AUC attainment and fewer dose modifications. Younger children may require higher weight-based dosing to meet AUC goals.
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