Lisdexamfetamine Pharmacokinetic Comparison Between Patients Who Underwent Roux-en-Y Gastric Bypass and Nonsurgical Controls.

INTRODUCTION/PURPOSE: The objective of this research was to characterize the impact of Roux-en-Y gastric bypass (RYGB) on the pharmacokinetic properties of the pro-drug lisdexamfetamine and its active metabolite, d-amphetamine. MATERIALS AND METHODS: A case-control design was used where patients who had undergone RYGB 9-24 months prior were matched on sex, age, and body mass index (BMI) to nonsurgical controls who had no history of weight loss surgery. Each participant received a single 50 mg dose of lisdexamfetamine, and plasma samples were collected over a 24-h period following dosing. Noncompartmental analyses were used to compare pharmacokinetic measures between groups. RESULTS: There were no significant differences between the RYGB (n = 10) and NSC groups (n = 10) on sex (70% female), age (40.9 ± 9.6 vs. 41.3 ± 8.9 years), BMI (30.3 ± 5.2 vs. 31 ± 5.9 kg/m2), or ethnicity (100% vs. 80% White). The pharmacokinetic parameters between the RYGB and NCS groups were found to be equivalent for lisdexamfetamine and d-amphetamine, including maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), and area under the plasma concentration-time curve (AUC(0-∞)). CONCLUSION: These data suggest that there is no need to routinely adjust lisdexamfetamine dosing following RYGB. However, given the potential for inter-individual differences, patients who undergo RYGB should be clinically monitored and individualized dosing strategies should be considered for concerns surrounding efficacy or toxicity.

Real-time Feedback in Pay-for-Performance: Does More Information Lead to Improvement?

BACKGROUND: Pay-for-performance (P4P) has been used expansively to improve quality of care delivered by physicians. However, to what extent P4P works through the provision of information versus financial incentives is poorly understood. OBJECTIVE: To determine whether an increase in information feedback without changes to financial incentives resulted in improved physician performance within an existing P4P program. INTERVENTION/EXPOSURE: Implementation of a new registry enabling real-time feedback to physicians on quality measure performance. DESIGN: Observational, predictive piecewise model at the physician-measure level to examine whether registry introduction associated with performance changes. We used detailed physician quality measure data 3 years prior to registry implementation (2010-2012) and 2 years after implementation (2014-2015). We also linked physician-level data including age, gender, and board certification; group-level data including registry click rates; and patient panel data including chronic conditions. PARTICIPANTS: Four hundred thirty-four physicians continuously affiliated with Advocate from 2010 to 2015. MAIN MEASURES: Physician performance on ten quality metrics. KEY RESULTS: We found no consistent pattern of improvement associated with the availability of real-time information across ten measures. Relative to predicted performance without the registry, average performance increased for two measures (childhood immunization status-rotavirus (p < 0.001) and diabetes care-medical attention for nephropathy (p = 0.024)) and decreased for three measures (childhood immunization status-influenza (p < 0.001) and diabetes care-HbA1c testing (p < 0.001) and poor HbA1c control (p < 0.001)). Results were consistent for subgroup analysis on those most able to improve, i.e., physicians in the bottom tertile of performance prior to registry introduction. Physicians who improved most were in groups that accessed the registry more than those who improved least (8.0 vs 10.0 times per week, p = 0.010). CONCLUSIONS: More frequent provision of information, provided in real-time, was insufficient to improve physician performance in an existing P4P program with high baseline performance. Results suggest that electronic registries may not themselves drive performance improvement. Future work should consider testing information feedback enhancements with financial incentives.

Effect of Financial Bonus Size, Loss Aversion, and Increased Social Pressure on Physician Pay-for-Performance: A Randomized Clinical Trial and Cohort Study.

Importance: Despite limited effectiveness of pay-for-performance (P4P), payers continue to expand P4P nationally. Objective: To test whether increasing bonus size or adding the behavioral economic principles of increased social pressure (ISP) or loss aversion (LA) improves the effectiveness of P4P. Design, Setting, and Participants: Parallel studies conducted from January 1 to December 31, 2016, consisted of a randomized clinical trial with patients cluster-randomized by practice site to an active control group (larger bonus size [LBS] only) or to groups with 1 of 2 behavioral economic interventions added and a cohort study comparing changes in outcomes among patients of physicians receiving an LBS with outcomes in propensity-matched physicians not receiving an LBS. A total of 8118 patients attributed to 66 physicians with 1 of 5 chronic conditions were treated at Advocate HealthCare, an integrated health system in Illinois. Data were analyzed using intention to treat and multiple imputation from February 1, 2017, through May 31, 2018. Interventions: Physician participants received an LBS increased by a mean of $3355 per physician (LBS-only group); prefunded incentives to elicit LA and an LBS; or increasing proportion of a P4P bonus determined by group performance from 30% to 50% (ISP) and an LBS. Main Outcomes and Measures: The proportion of 20 evidence-based quality measures achieved at the patient level. Results: A total of 86 physicians were eligible for the randomized trial. Of these, 32 were excluded because they did not have unique attributed patients. Fifty-four physicians were randomly assigned to 1 of 3 groups, and 33 physicians (54.5% male; mean [SD] age, 57 [10] years) and 3747 patients (63.6% female; mean [SD] age, 64 [18] years) were included in the final analysis. Nine physicians and 864 patients were randomized to the LBS-only group, 13 physicians and 1496 patients to the LBS plus ISP group, and 11 physicians and 1387 patients to the LBS plus LA group. Physician characteristics did not differ significantly by arm, such as mean (SD) physician age ranging from 56 (9) to 59 (9) years, and sex (6 [46.2%] to 6 [66.7%] male). No differences were found between the LBS-only and the intervention groups (adjusted odds ratio [aOR] for LBS plus LA vs LBS-only, 0.86 [95% CI, 0.65-1.15; P = .31]; aOR for LBS plus ISP vs LBS-only, 0.95 [95% CI, 0.64-1.42; P = .81]; and aOR for LBS plus ISP vs LBS plus LA, 1.10 [95% CI, 0.75-1.61; P = .62]). Increased bonus size was associated with a greater increase in evidence-based care relative to the comparison group (risk-standardized absolute difference-in-differences, 3.2 percentage points; 95% CI, 1.9-4.5 percentage points; P < .001). Conclusions and Relevance: Increased bonus size was associated with significantly improved quality of care relative to a comparison group. Adding ISP and opportunities for LA did not improve quality. Trial Registration: ClinicalTrials.gov Identifier: NCT02634879.

Clinical practice guideline for the diagnosis and management of acute bacterial sinusitis in children aged 1 to 18 years.

OBJECTIVE: To update the American Academy of Pediatrics clinical practice guideline regarding the diagnosis and management of acute bacterial sinusitis in children and adolescents. METHODS: Analysis of the medical literature published since the last version of the guideline (2001). RESULTS: The diagnosis of acute bacterial sinusitis is made when a child with an acute upper respiratory tract infection (URI) presents with (1) persistent illness (nasal discharge [of any quality] or daytime cough or both lasting more than 10 days without improvement), (2) a worsening course (worsening or new onset of nasal discharge, daytime cough, or fever after initial improvement), or (3) severe onset (concurrent fever[temperature ≥39°C/102.2°F] and purulent nasal discharge for at least 3 consecutive days). Clinicians should not obtain imaging studies of any kind to distinguish acute bacterial sinusitis from viral URI, because they do not contribute to the diagnosis; however, a contrast-enhanced computed tomography scan of the paranasal sinuses should be obtained whenever a child is suspected of having orbital or central nervous system complications. The clinician should prescribe antibiotic therapy for acute bacterial sinusitis in children with severe onset or worsening course. The clinician should either prescribe antibiotic therapy or offer additional observation for 3 days to children with persistent illness. Amoxicillin with or without clavulanate is the firstline treatment of acute bacterial sinusitis. Clinicians should reassess initial management if there is either a caregiver report of worsening(progression of initial signs/symptoms or appearance of new signs/symptoms) or failure to improve within 72 hours of initial management.If the diagnosis of acute bacterial sinusitis is confirmed in a child with worsening symptoms or failure to improve, then clinicians may change the antibiotic therapy for the child initially managed with antibiotic or initiate antibiotic treatment of the child initially managed with observation. CONCLUSIONS: Changes in this revision include the addition of a clinical presentation designated as "worsening course," an option to treat immediately or observe children with persistent symptoms for 3 days before treating, and a review of evidence indicating that imaging is not necessary in children with uncomplicated acute bacterial sinusitis.

Clinical inquiries. What does the evidence tell us about treating very-high-risk patients to an LDL <70 mg/dL?

No studies directly compare low-density lipoprotein (LDL) levels <70 mg/dL to levels of 71 to 100 mg/dL in very-high-risk patients. However, no evidence suggests a "floor" for LDL cholesterol levels beyond which further reductions of heart disease risk cannot be achieved. The target LDL cholesterol of <70 mg/dL is based on data extrapolated from RCTs. Comparing larger (80 mg) with smaller doses of atorvastatin shows that larger doses reduce LDL and major cardiac events more than smaller doses. No studies report patient-oriented outcomes of treatments for patients who fail to reach target LDL levels <100 mg/dL.

Clinical practice guideline: cerumen impaction.

OBJECTIVE: This guideline provides evidence-based recommendations on managing cerumen impaction, defined as an accumulation of cerumen that causes symptoms, prevents assessment of the ear, or both. We recognize that the term "impaction" suggests that the ear canal is completely obstructed with cerumen and that our definition of cerumen impaction does not require a complete obstruction. However, cerumen impaction is the preferred term since it is consistently used in clinical practice and in the published literature to describe symptomatic cerumen or cerumen that prevents assessment of the ear. This guideline is intended for all clinicians who are likely to diagnose and manage patients with cerumen impaction. PURPOSE: The primary purpose of this guideline is to improve diagnostic accuracy for cerumen impaction, promote appropriate intervention in patients with cerumen impaction, highlight the need for evaluation and intervention in special populations, promote appropriate therapeutic options with outcomes assessment, and improve counseling and education for prevention of cerumen impaction. In creating this guideline the American Academy of Otolaryngology-Head and Neck Surgery Foundation selected a panel representing the fields of audiology, family medicine, geriatrics, internal medicine, nursing, otolaryngology-head and neck surgery, and pediatrics. RESULTS: The panel made a strong recommendation that 1) clinicians should treat cerumen impaction that causes symptoms expressed by the patient or prevents clinical examination when warranted. The panel made recommendations that 1) clinicians should diagnose cerumen impaction when an accumulation of cerumen is associated with symptoms, or prevents needed assessment of the ear (the external auditory canal or tympanic membrane), or both; 2) clinicians should assess the patient with cerumen impaction by history and/or physical examination for factors that modify management, such as one or more of the following: nonintact tympanic membrane, ear canal stenosis, exostoses, diabetes mellitus, immunocompromised state, or anticoagulant therapy; 3) the clinician should examine patients with hearing aids for the presence of cerumen impaction during a healthcare encounter (examination more frequently than every three months, however, is not deemed necessary); 4) clinicians should treat the patient with cerumen impaction with an appropriate intervention, which may include one or more of the following: cerumenolytic agents, irrigation, or manual removal other than irrigation; and 5) clinicians should assess patients at the conclusion of in-office treatment of cerumen impaction and document the resolution of impaction. If the impaction is not resolved, the clinician should prescribe additional treatment. If full or partial symptoms persist despite resolution of impaction, alternative diagnoses should be considered. The panel offered as an option that 1) clinicians may observe patients with nonimpacted cerumen that is asymptomatic and does not prevent the clinician from adequately assessing the patient when an evaluation is needed; 2) clinicians may distinguish and promptly evaluate the need for intervention in the patient who may not be able to express symptoms but presents with cerumen obstructing the ear canal; 3) the clinician may treat the patient with cerumen impaction with cerumenolytic agents, irrigation, or manual removal other than irrigation; and 4) clinicians may educate/counsel patients with cerumen impaction/excessive cerumen regarding control measures. DISCLAIMER: This clinical practice guideline is not intended as a sole source of guidance in managing cerumen impaction. Rather, it is designed to assist clinicians by providing an evidence-based framework for decision-making strategies. It is not intended to replace clinical judgment or establish a protocol for all individuals with this condition, and may not provide the only appropriate approach to diagnosing and managing this problem.

The False Claims Act: the courts move toward a rule of reason.

Physicians have been concerned that the False Claims Act may be invoked recklessly, and that they are at the mercy of whistleblowers in their own midst or from the outside who may act in revenge or pique. This article discusses the evolution of case law involving medical practices and reimbursement issues that deal with government payment regulations. It indicates the limitations that are imposed on prosecutors, as well as the liability that providers do incur under current statues.