HEROIC Trials to Answer Pragmatic Questions for Hospitalized Children.

Although the number of randomized controlled trials (RCTs) published each year involving adult populations is steadily rising, the annual number of RCTs published involving pediatric populations has not changed since 2005. Barriers to the broader utilization of RCTs in pediatrics include a lower prevalence of disease, less available funding, and more complicated regulatory requirements. Although child health researchers have been successful in overcoming these barriers for isolated diseases such as pediatric cancer, common pediatric diseases are underrepresented in RCTs relative to their burden. This article proposes a strategy called High-Efficiency RandOmIzed Controlled (HEROIC) trials to increase RCTs focused on common diseases among hospitalized children. HEROIC trials are multicenter RCTs that pursue the rapid, low-cost accumulation of study participants with minimal burden for individual sites. Five key strategies distinguish HEROIC trials: (1) dispersed low-volume recruitment, in which a large number of sites (50-150 hospitals) enroll a small number of participants per site (2-10 participants per site), (2) incentivizing site leads with authorship, training, education credits, and modest financial support, (3) a focus on pragmatic questions that examine simple, widely used interventions, (4) the use of a single institutional review board, integrated consent, and other efficient solutions to regulatory requirements, and (5) scaling the HEROIC trial strategy to accomplish multiple trials simultaneously. HEROIC trials can boost RCT feasibility and volume to answer fundamental clinical questions and improve care for hospitalized children.

2019 Update on Medical Overuse: A Review.

IMPORTANCE: Medical overuse is an important cause of patient harm and medical waste. OBSERVATION: This structured literature review of English-language articles supplemented by examination of tables of contents of high-impact journals published in 2018 identified articles related to medical overuse. Articles were appraised for their methodologic quality, clinical relevance, and influence on patients. Of 1499 candidate articles, 839 addressed medical overuse. Of these, 117 were deemed to be most significant, with the 10 highest-ranking articles selected by author consensus. The most important articles on medical overuse identified issues with testing, including that procalcitonin does not affect antibiotic duration in patients with lower respiratory tract infection (4.2 vs 4.3 days); incidentalomas are present in 22% to 38% of common magnetic resonance imaging or computed tomography studies; 9% of women dying of stage IV cancer are still screened with mammography; and computed tomography lung cancer screening offers stable benefit and higher rates of harm for patients at lower risk. Articles related to overtreatment reported that urgent care clinics commonly overprescribe antibiotics (in 39% of all visits, patients received antibiotics) and that treatment of subclinical hypothyroidism had no effect on clinical outcomes. Three studies highlighted services that should be questioned, including using opioids for chronic noncancer pain (meta-analysis found no clinically significant benefit), stress ulcer prophylaxis for intensive care unit patients (mortality, 31.1% with pantoprazole vs 30.4% with placebo), and supplemental oxygen for patients with normal oxygen levels (mortality relative risk, 1.21; 95% CI, 1.03-1.43). A policy article found that state medical liability reform was associated with reduced invasive testing for coronary artery disease, including 24% fewer angiograms. CONCLUSIONS AND RELEVANCE: The findings suggest that many tests are overused, overtreatment is common, and unnecessary care can lead to patient harm. This review of these 2018 findings aims to inform practitioners who wish to reduce overuse and improve patient care.

2018 Update on Pediatric Medical Overuse: A Review.

Importance: Efforts to combat medical overuse have gained traction in recent years, but success has been intermittent and shortcomings have been recognized. A commitment to a strong evidence base is needed to more broadly engage clinicians and reduce overuse. Observations: A structured MEDLINE search and a manual review of tables of contents from selected high-impact journals was performed to identify original research published in 2017 relevant to pediatric overuse. Articles were scored from low to high for 3 categories: quality of methods, magnitude of potential harm, and number of patients potentially harmed. The top-scoring articles presented in this review highlight examples of safe reductions in treatment intensity, including in the setting of cancer, appendicitis, acute respiratory tract infection, and elective anesthesia. This year's articles also provide cautionary examples of rational interventions adopted without a full understanding of potential harms, including pharmacologic migraine therapies, docosahexaenoic acid supplementation for preterm neonates, tight glycemic control for individuals with critically illness, and prophylactic antibiotics for children with vesicoureteral reflux. Conclusions and Relevance: The articles represent high-quality, original research from 2017 that may help mitigate overuse. These works should be fundamental to the maturation of the pediatric overuse field.

2018 Update on Medical Overuse.

Importance: Overuse of medical care is a well-recognized problem in health care, associated with patient harm and costs. We sought to identify and highlight original research articles published in 2017 that are most relevant to understanding medical overuse. Observations: A structured review of English-language articles published in 2017 was performed, coupled with examination of tables of contents of high-impact journals to identify articles related to medical overuse in adult care. Manuscripts were appraised for their quality, clinical relevance, and impact. A total of 1446 articles were identified, 910 of which addressed medical overuse. Of these, 111 articles were deemed to be the most relevant based on originality, methodologic quality, and scope. The 10 most influential articles were selected by author consensus. Findings included that unnecessary electrocardiograms are common (performed in 22% of patients at low risk) and can lead to a cascade of services, lipid monitoring rarely affects care, patients who were overdiagnosed with cancer experienced anxiety and criticism about not seeking treatment, calcium and vitamin D supplementation does not reduce hip fracture (relative risk, 1.09; 95% CI, 0.85-1.39), and pregabalin does not improve symptoms of sciatica but frequently has adverse effects (40% of patients experienced dizziness). Antipsychotic medications increased the severity of delirium in patients receiving hospice care and were associated with an increased risk of death (hazard ratio, 1.7; P = .003), and robotic-assisted radical nephrectomy was without benefits by being slower and more costly than laparoscopic surgery. High-sensitivity troponin testing often yielded false-positive results, as 16% of patients with positive troponin results in a US hospital had a myocardial infarction. One-third of patients who received a diagnosis of asthma had no evidence of asthma. Restructuring the electronic health record was able to reduce unnecessary testing (from 31.3 to 13.9 low-value tests performed per 100 patient visits). Conclusions and Relevance: Many current practices were found to represent overuse, with no benefit and potential harms. Other services were used inappropriately. Reviewing these findings and extrapolating to their patients will enable health care professionals to improve the care they provide.

2017 Update on Medical Overuse: A Systematic Review.

Importance: Overuse of medical care is a well-recognized problem. Objective: To identify and highlight original research articles published in 2016 that are most relevant to understanding medical overuse or strategies to reduce it. Evidence Review: A structured review of English-language articles on PubMed published in 2016 coupled with examination of tables of contents of high-impact journals to identify articles related to medical overuse in adults. These articles were appraised for their importance to medicine. Findings: This study considered 2252 articles, 1224 of which addressed medical overuse. Of these, 122 were deemed most relevant based on originality, methodologic quality, and number of patients potentially affected. The 10 most influential articles were selected by author consensus. Select findings from the studies include the lack of benefit of transesophageal echocardiography in the workup of cryptogenic stroke, increasing use of computed tomography in the emergency department from 2.2% to 9.4% from 2001 to 2010, and carotid ultrasonography and revascularization being performed for uncertain or inappropriate indications with 95% frequency. Likewise, services for which harms are likely to outweigh benefits include treatment for early-stage prostate cancer, which provides no mortality benefit but increases absolute risk of erectile dysfunction by 10% to 30%, oxygen for patients with moderate chronic obstructive pulmonary disease, surgery for meniscal tear with mechanical symptoms, and nutritional interventions for inpatients with malnutrition. This review highlights 2 methods for reducing overuse: clinician audit and feedback with peer comparison for antibiotic use (reduction in inappropriate antibiotic use from 20% to 4%) and a practical and sensible shared decision-making tool for low-risk chest pain (reduction in emergency department workup from 52% to 37%). Conclusions and Relevance: The body of empirical work continues to expand related to medical services that are provided for inappropriate or uncertain indications. Engaging patients in conversations aimed at shared decision making and giving practitioners feedback about their performance relative to peers appear to be useful in reducing overuse.

Overdiagnosis: how our compulsion for diagnosis may be harming children.

Overdiagnosis occurs when a true abnormality is discovered, but detection of that abnormality does not benefit the patient. It should be distinguished from misdiagnosis, in which the diagnosis is inaccurate, and it is not synonymous with overtreatment or overuse, in which excess medication or procedures are provided to patients for both correct and incorrect diagnoses. Overdiagnosis for adult conditions has gained a great deal of recognition over the last few years, led by realizations that certain screening initiatives, such as those for breast and prostate cancer, may be harming the very people they were designed to protect. In the fall of 2014, the second international Preventing Overdiagnosis Conference will be held, and the British Medical Journal will produce an overdiagnosis-themed journal issue. However, overdiagnosis in children has been less well described. This special article seeks to raise awareness of the possibility of overdiagnosis in pediatrics, suggesting that overdiagnosis may affect commonly diagnosed conditions such as attention-deficit/hyperactivity disorder, bacteremia, food allergy, hyperbilirubinemia, obstructive sleep apnea, and urinary tract infection. Through these and other examples, we discuss why overdiagnosis occurs and how it may be harming children. Additionally, we consider research and education strategies, with the goal to better elucidate pediatric overdiagnosis and mitigate its influence.