Risk of Neutropenia-Related Hospitalization in Patients Who Received Colony-Stimulating Factors With Chemotherapy for Breast Cancer.

Purpose To describe outcomes after granulocyte colony-stimulating factor (G-CSF) prophylaxis in patients with breast cancer who received chemotherapy regimens with low-to-intermediate risk of induction of neutropenia-related hospitalization. Patients and Methods We identified 8,745 patients age ≥ 18 years from a medical and pharmacy claims database for 14 commercial US health plans. This retrospective analysis included patients with breast cancer who began first-cycle chemotherapy from 2008 to 2013 using docetaxel and cyclophosphamide (TC); docetaxel, carboplatin, and trastuzumab (TCH); or doxorubicin and cyclophosphamide (conventional-dose AC) regimens. Primary prophylaxis (PP) was defined as G-CSF administration within 5 days of beginning chemotherapy. Outcome was neutropenia, fever, or infection-related hospitalization within 21 days of initiating chemotherapy. Multivariable regressions and number-needed-to-treat analyses were used. Results A total of 4,815 patients received TC (2,849 PP; 1,966 no PP); 2,292 patients received TCH (1,444 PP; 848 no PP); and 1,638 patients received AC (857 PP; 781 no PP) regimen. PP was associated with reduced risk of neutropenia-related hospitalization for TC (2.0% PP; 7.1% no PP; adjusted odds ratio [AOR], 0.29; 95% CI, 0.22 to 0.39) and TCH (1.3% PP; 7.1% no PP; AOR, 0.19; 95% CI, 0.12 to 0.30), but not AC (4.7% PP; 3.8% no PP; AOR, 1.21; 95% CI, 0.75 to 1.93) regimens. For the TC regimen, 20 patients (95% CI, 16 to 26) would have to be treated for 21 days to avoid one neutropenia-related hospitalization; with the TCH regimen, 18 patients (95% CI, 13 to 25) would have to be treated. Conclusion Primary G-CSF prophylaxis was associated with low-to-modest benefit in lowering neutropenia-related hospitalization in patients with breast cancer who received TC and TCH regimens. Further evaluation is needed to better understand which patients benefit most from G-CSF prophylaxis in this setting.

Early Trends Among Seven Recommendations From the Choosing Wisely Campaign.

IMPORTANCE: The Choosing Wisely campaign consists of more than 70 lists produced by specialty societies of medical practices or procedures of minimal clinical benefit to patients in most situations, with recommendations regarding judicious use. OBJECTIVE: To quantify the frequency and trends of some of the earliest Choosing Wisely recommendations using nationwide commercial health plan population-level data. DESIGN, SETTING, AND PARTICIPANTS: Retrospective analysis of claims data for members of Anthem-affiliated commercial health plans. The low-value services selected were (1) imaging tests for uncomplicated headache; (2) cardiac imaging without history of cardiac conditions; (3) low back pain imaging without red-flag conditions; (4) preoperative chest x-rays with unremarkable history and physical examination results; (5) human papillomavirus testing for women younger than 30 years; (6) use of antibiotics for acute sinusitis; and (7) use of prescription nonsteroidal anti-inflammatory drugs (NSAIDs) for members with hypertension, heart failure, or chronic kidney disease. MAIN OUTCOMES AND MEASURES: The number of members with medical and/or pharmacy claims for the included low-value services was assessed quarterly over a 2- to 3-year span through 2013. Trend changes in recommendations were evaluated across all quarters using Poisson regression with denominators as offsets. RESULTS: Two services had declines: Use of imaging for headache decreased from 14.9% to 13.4% (trend estimate, 0.99 [95% CI, 0.98-0.99]; P < .001), and cardiac imaging decreased from 10.8% to 9.7% (trend estimate, 0.99 [95% CI, 0.99-0.99]; P < .001). Two services had increases: Use of NSAIDs in select conditions increased from 14.4% to 16.2% (trend estimate, 1.02 [95% CI, 1.01-1.02]; P < .001), and human papillomavirus testing in younger women increased from 4.8% to 6.0% (trend estimate, 1.01 [95% CI, 1.00-1.01]; P < .001). Use of antibiotics for sinusitis remained stable (0.8% decrease from 84.5% to 83.7%; trend estimate, 1.00 [95% CI, 1.00-1.00]; P = .16). Use of preoperative chest x-rays (0.2% decrease, ending utilization 91.5%; trend estimate, 1.00 [95% CI, 1.00-1.00]; P = .70) and imaging for low back pain (53.7% utilization throughout study; P = .71) remained high with no statistically significant changes. CONCLUSIONS AND RELEVANCE: For this population-level analysis of 7 low-value services analyzed, changes were modest but showed a desirable decrease for 2 recommendations (imaging for headache, cardiac imaging for low-risk patients). The effect sizes were marginal, however, and although 4 of the 7 lists had statistically significant changes-unsurprising given the large sample size-the clinical significance is uncertain. These results suggest that additional interventions are necessary for wider implementation of Choosing Wisely recommendations.

Evaluation of practice patterns in the treatment of atrial fibrillation among the commercially insured.

OBJECTIVE: The management of atrial fibrillation (AF) involves two choices: (1) rate control versus rhythm control, and (2) anticoagulation treatment based upon risk of stroke. The objective of the study was to describe practice patterns in both of these treatment areas in patients with newly diagnosed AF among a commercially insured population. METHODS: This retrospective administrative claims analysis included patients with ≥2 AF claims between 1 January 2008 and 30 September 2010. Patients with AF claims within a year prior to the index date (i.e., the first AF diagnosis date) were excluded. The primary outcome was the proportion of patients treated with rate control (i.e., beta blockers, calcium channel blockers, digoxin) versus rhythm control (i.e., electrical cardioversion, left atrial catheter ablation [LACA], and/or surgical ablation) and the use of anticoagulants stratified by risk of stroke based on CHADS2 score. RESULTS: Of 48,814 patients with a diagnosis of AF, 38,502 (78.9%) received treatment. Of those treated, the majority received only pharmacologic treatment (73.4%), of which beta blockers were predominantly used in the initial regimen (66.7%). Antiarrhythmic drugs were used in 23.9% of patients, but within the initial regimen in only 11.7% of patients. Direct current cardioversion occurred in 18.2% of patients, with the majority being either first-line (8.5%) or second-line (9.1%) therapy. LACA was used in only 5.2% of patients and was typically reserved for use after pharmacologic treatment or direct current cardioversion. Of 1924 patients who received LACA, 14.6% received a repeat procedure and 53.4% of the repeat procedures occurred within 6 months of the initial one. A little more than half of all patients (57.0%) received anticoagulant therapy (predominantly warfarin); of those at high risk for stroke, 63.8% with a CHADS2 score ≥2 received anticoagulants. KEY LIMITATIONS: It is a retrospective analysis using administrative claims data from a commercially insured population only. Identification of the first episode of AF may be inaccurate, and we cannot differentiate between paroxysmal and persistent AF. CONCLUSIONS: Debate continues regarding whether the preferred management of most patients with AF is through rate control or restoration of normal sinus rhythm. Our retrospective study found that treatments to restore normal heart rhythm, including LACA, which could be considered aggressive initial treatment, were typically reserved as second- or third-line alternatives. Initial standard of care for the majority patients was beta blockers. Though use of anticoagulation may be higher than other observational studies, opportunities exist to increase treatment in high risk patients.

Opioid use among adolescent patients treated for headache.

PURPOSE: To determine the pervasiveness of opioid prescribing for adolescents with headache and patient and provider characteristics associated with likelihood of opioid prescribing. METHODS: This observational cohort analysis used commercial medical and pharmacy claims between January 1, 2007 and December 31, 2008. Included were adolescents (13-17 years of age) with newly diagnosed headache, ≥2 distinct claims for headache, and ≥12 months health plan eligibility preindex and postindex. Adolescents with a trauma diagnosis at any point were excluded. The primary outcome was current practice patterns, measured by a number of opioid claims, a percentage of patients prescribed opioids, a number of opioid prescriptions per year, a length of opioid therapy, and a frequency of specific comorbidities. A secondary outcome characterized providers and practice settings, comparing patients who received opioids with those who did not. RESULTS AND CONCLUSIONS: Of 8,373 adolescents with headache, 46% (3,859 patients) received an opioid prescription. Nearly half (48%) received one opioid prescription during follow-up; 29% received ≥3 opioid prescriptions. Of those with opioid prescriptions, 25% (977 patients) had a migraine diagnosis at index date. Among adolescents who received opioids, 28% (1,076 adolescents) had an emergency department (ED) visit for headache during follow-up versus 14% (608 adolescents) who did not receive opioids (p < .01). ED visits with a headache diagnosis during follow-up were strongly correlated with opioid use after adjusting for other covariates (odds ratio, 2.02; 95% confidence interval, 1.79-2.29). Despite the treatment guidelines recommending against their use, a large proportion of adolescents with headache were prescribed opioids. ED visits were strongly correlated with opioid prescriptions.

CT scan utilization patterns in pediatric patients with recurrent headache.

UNLABELLED: Although unnecessary for children with headache and normal history, computed tomography (CT) scans are widely used. This study sought to determine current practice patterns of neuroimaging to diagnose pediatric headache in a variety of treatment settings and to identify factors associated with increased use of neuroimaging. METHODS: This retrospective claims analysis included children (aged 3­17 years) with ≥2 medical claims for headache. The primary outcome was CT scan utilization on or after first presentation with headache in a physician's office or emergency department (ED). RESULTS: Of 15 836 patients, 26% (4034 patients; mean age: 11.8 years) had ≥1 CT scan, 74% within 1 month of index diagnosis. Patients with ED visits were 4 times more likely to undergo a CT scan versus those without ED visits (P < .001 [95% confidence interval: 3.9­4.8]). However, even outside the ED, use of CT scans remained widespread. Two-thirds of patients with CT scans had no ED use.Among patients with no ED utilization, >20% received a CT scan during the study period. Evaluation by a neurologist was strongly associated with a lower likelihood of CT scan compared with other provider specialties (odds ratio: 0.37; P < .01 [95% confidence interval: 0.30­0.46]). CONCLUSIONS: Use of CT scans to diagnose pediatric headache remains high despite existing guidelines, low diagnostic yield, and high potential risk. Implementing quality improvement initiatives to ensure that CT scans in children are performed only when truly indicated will reduce unnecessary exposure to ionizing radiation and associated cancer risks.

Assessment of sample collection and storage methods for multicenter immunologic research in children.

Multicenter studies involving both large and small centers separated by significant distances pose unique challenges to biological sample collection. The objective of this study was to evaluate protocols for determining inflammatory biomarkers that are cost and manpower efficient for handling blood destined for a sample repository. Tempus (Applied Biosystems) and Paxgene (Qiagen) blood collection systems were evaluated for RNA isolation. P100 tubes (BD), containing propriety stabilizers for preservation of plasma proteins, were evaluated for protein content and compared with plasma collected in conventional tubes. Blood for plasma separation was spiked with recombinant TNF-alpha and IL-2 prior to being processed and stored under various conditions. The Tempus RNA system produced a significantly greater yield of RNA at comparable quality when stored at 4 degrees C and shipped at ambient temperature than any other condition tested. The Tempus system was 20% less expensive and required approximately 40% less processing time thereby reducing costs. The P100 system preserved recombinant TNF-alpha in blood shipped at ambient temperature significantly better than conventionally collected plasma that was shipped on dry ice. There was no significant difference in IL-2 levels between the two collection methods and shipping temperatures. The Tempus RNA blood collection tubes and the P100 protein stabilization system provide the opportunity for reliable collection and ambient temperature transport of samples in multicenter studies. This cost-effective, standardized protocol for a large multicenter trial ensures the integrity of biological samples and maximizes study participation by both large and small centers.

Capillary blood sampling as an alternative to venipuncture in the assessment of serum 25 hydroxyvitamin D levels.

This study compared 25-hydroxyvitamin D [25(OH)D] measurements in capillary and venous blood samples collected, respectively by fingerprick and venipuncture. Capillary blood for measuring 25(OH)D has potential advantages by reducing blood volume required (2mL versus 0.3mL for venipuncture and capillary sampling, respectively), facilitating blood collection for those populations in whom venipuncture is difficult (e.g. infants and children), improving patient convenience and reducing costs associated with phlebotomy. The results demonstrated a highly significant relationship between 25(OH)D levels in serum derived from venous and capillary blood samples (r(2)=0.901). Despite statistically higher 25(OH)D levels in fingerprick samples (108+/-9nmol/L) compared with venipuncture samples (90+/-7nmol/L), the correlation between venous and capillary samples provides support for this approach as a practical alternative to venipuncture for vitamin D determination. However, clinical application may require the incorporation of a correction factor for the assessment of insufficiency, and research studies should avoid using the two methods interchangeably. Studying vitamin D's role in health and disease requires collection techniques and measurement methods that are reliable, reproducible, easily accessible, inexpensive and minimally burdensome to the patient. The option to collect patient samples by fingerprick may facilitate the collection process.