Guideline Alignment and Medication Concordance in COPD.

BACKGROUND: Provider adherence to clinical treatment guidelines in COPD is low. However, for patients to receive guideline-aligned care, providers not only must prescribe guideline-aligned care, but also must communicate that regimen successfully to patients to ensure medication concordance. The rate of medication concordance between patients and providers and its impact on clinical management is unknown in COPD. RESEARCH QUESTION: To examine rates of guideline alignment and medication concordance and to identify patient-level factors that place patients at risk for these types of poor disease management outcomes. STUDY DESIGN AND METHODS: This study was a secondary data analysis of the Medication Adherence Research in COPD study (2017-2023). Participants were categorized into 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage. Medication regimens were classified as aligned or nonaligned with 2017 GOLD guidelines. Nonaligned regimens were stratified further into overuse and underuse categories. Medication concordance between provider-reported and participant-reported regimens was determined. Factors associated with guideline alignment and medication concordance were evaluated using logistic regression. RESULTS: Of 191 participants, 51% of provider-reported regimens were guideline aligned, with 86% of nonaligned regimens reflecting overuse with an inhaled corticosteroid (ICS). Thirty-eight percent of participants reported different regimens than their providers, of which > 80% reflected participants not reporting medications their providers reported prescribing. Participants did not report long-acting muscarinic antagonists and long-acting beta-agonists at similar rates as ICSs. Greater symptom burden and absence of a pulmonologist on the care team were associated with both guideline misalignment and medication discordance. Cognitive impairment and Black race additionally were associated with medication discordance. INTERPRETATION: Guideline misalignment and medication discordance were common and were driven by overuse of ICSs and unreported medications, respectively. The patient-level factors associated with medication discordance highlight the importance of improving patient-provider communication to improve clinical management in COPD.

Up-to-date guidance towards improving medication adherence in patients with chronic obstructive pulmonary disease.

INTRODUCTION: Despite efficacious treatment for chronic obstructive pulmonary disease (COPD), medication adherence remains quite poor, with most estimates based on electronic monitoring devices ranging from 20-30%. This degree of nonadherence represents a significant missed opportunity to realize the benefits of treatment of this disease. AREAS COVERED: In this article, we review research on the prevalence of nonadherence among patients with COPD, the association of nonadherence with health outcomes, barriers to adherence in this patient population, and potential interventions. EXPERT OPINION: Integrating research into practice involves assessing patients' adherence, identifying modifiable barriers to adherence, open discussion of these barriers with patients, and tailored interventions to address them. These interventions may include treatment of previously unrecognized comorbid disease, providing educational or behavioral interventions, optimizing prescribing strategies, use of adherence aids, or addressing cost and other access barriers. Electronic inhaler monitors are promising interventions for both monitoring and improving adherence. However, remaining concerns about integration into patient care, data management, cost, acceptability, and ethical and privacy issues must be overcome prior to their implementation in clinical practice.

Powering Bias and Clinically Important Treatment Effects in Randomized Trials of Critical Illness.

OBJECTIVES: Recurring issues in clinical trial design may bias results toward the null, yielding findings inconclusive for treatment effects. This study evaluated for powering bias among high-impact critical care trials and the associated risk of masking clinically important treatment effects. DESIGN, SETTING, AND PATIENTS: Secondary analysis of multicenter randomized trials of critically ill adults in which mortality was the main endpoint. Trials were eligible for inclusion if published between 2008 and 2018 in leading journals. Analyses evaluated for accuracy of estimated control group mortality, adaptive sample size strategy, plausibility of predicted treatment effect, and results relative to the minimal clinically important difference. The main outcome was the mortality risk difference at the study-specific follow-up interval. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Of 101 included trials, 12 met statistical significance for their main endpoint, five for increased intervention-associated mortality. Most trials (77.3%) overestimated control group mortality in power calculations (observed minus predicted difference, -6.7% ± 9.8%; p < 0.01). Due to this misestimation of control group mortality, in 14 trials, the intervention would have had to prevent at least half of all deaths to achieve the hypothesized treatment effect. Seven trials prespecified adaptive sample size strategies that might have mitigated this issue. The observed risk difference for mortality fell within 5% of predicted in 20 trials, of which 16 did not reach statistical significance. Half of trials (47.0%) were powered for an absolute risk reduction greater than or equal to 10%, but this effect size was observed in only three trials with a statistically significant treatment benefit. Most trials (67.3%) could not exclude clinically important treatment benefit or harm. CONCLUSIONS: The design of most high-impact critical care trials biased results toward the null by overestimating control group mortality and powering for unrealistic treatment effects. Clinically important treatment effects often cannot be excluded.

Pediatric Emergency Department Return: A Literature Review of Risk Factors and Interventions.

BACKGROUND AND OBJECTIVE: Children discharged from emergency departments (EDs) are often at risk for ED return. The objective was to identify risk factors and interventions to mitigate or prevent ED return among this patient population. METHODS: Structured literature review of PubMed and clinicaltrials.gov was conducted to identify relevant studies. Inclusion criteria were studies evaluating ED returns by identifying risk factors and interventions in the pediatric population. Emergency department return was defined as returning to the ED within 1 year after initial visit. Abstract and full text articles were reviewed, and data were abstracted by 2 independent authors. RESULTS: A total of 963 articles were screened and yielded 42 potential relevant articles involving pediatric population. After full text review, a total of 12 articles were included in the final analysis (6 on risk factors and 6 on interventions). Risk factors for pediatric ED return included behavioral/psychiatric problems, younger age, acuity of illness, medical history of asthma, and social factors. Interventions included computer-generated instructions, postdischarge telephone coaching, ED-made appointments, case management, and home environment intervention. Emergency department-made appointments and postdischarge telephone coaching plus monetary incentive improved outpatient follow-up rate but not ED return. Home environment assessment coupled with case management reduced ED returns specifically among asthma patients. CONCLUSIONS: Several patient and visit characteristics can help predict children at risk for ED return. Although some interventions are successful at improving postdischarge follow-up, most did not reduce ED returns.