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IMPORTANCE Chemotherapy-induced alopecia is a common and distressing adverse effect. In previous studies of scalp cooling to prevent chemotherapy-induced alopecia, conclusions have been limited.OBJECTIVES To evaluate whether use of a scalp cooling system is associated with a lower amount of hair loss among women receiving specific chemotherapy regimens for early-stage breast cancer and to assess related changes in quality of life. DESIGN, SETTING, AND PARTICIPANTSA prospective cohort study conducted at 5 US medical centers of women with stage I or II breast cancer receiving adjuvant or neoadjuvant chemotherapy regimens excluding sequential or combination anthracycline and taxane (106 patients in the scalp cooling group and 16 in the control group; 14 matched by both age and chemotherapy regimen). The study was conducted between August 2013 and October 2014 with ongoing annual follow-up for 5 years.EXPOSURES Use of a scalp cooling system. Scalp cooling was initiated 30 minutes prior to each chemotherapy cycle, with scalp temperature maintained at 3°C (37°F) throughout chemotherapy and for 90 minutes to 120 minutes afterward.MAIN OUTCOMES AND MEASURES Self-estimated hair loss using the Dean scale was assessed 4 weeks after the last dose of chemotherapy by unblinded patient review of 5 photographs. A Dean scale score of 0 to 2 (Յ50% hair loss) was defined as treatment success. A positive association between scalp cooling and reduced risk of hair loss would be demonstrated if 50% or more of patients in the scalp cooling group achieved treatment success, with the lower bound of the 95% CI greater than 40% of the success proportion. Quality of life was assessed at baseline, at the start of the last chemotherapy cycle, and 1 month later. Median follow-up was 29.5 months. RESULTS Among the 122 patients in the study, the mean age was 53 years (range, 28-77 years); 77.0% were white, 9.0% were black, and 10.7% were Asian; and the mean duration of chemotherapy was 2.3 months (median, 2.1 months). No participants in the scalp cooling group received anthracyclines. Hair loss of 50% or less (Dean score of 0-2) was seen in 67 of 101 patients (66.3%; 95% CI, 56.2%-75.4%) evaluable for alopecia in the scalp cooling group vs 0 of 16 patients (0%) in the control group (P < .001). Three of 5 quality-of-life measures were significantly better 1 month after the end of chemotherapy in the scalp cooling group. Of patients who underwent scalp cooling, 27.3% (95% CI, 18.0%-36.6%) reported feeling less physically attractive compared with 56.3% (95% CI, 31.9%-80.6%) of patients in the control group (P = .02). Of the 106 patients in the scalp cooling group, 4 (3.8%) experienced the adverse event of mild headache and 3 (2.8%) discontinued scalp cooling due to feeling cold.CONCLUSIONS AND RELEVANCE Among women undergoing non-anthracycline-based adjuvant chemotherapy for early-stage breast cancer, the use of scalp cooling vs no scalp cooling was associated with less hair loss at 4 weeks after the last dose of chemotherapy. Further research is ne...

Monitoring of clinical trials includes several disciplines, stakeholders, and skill sets. The aim of the present study was to identify database changes and data entry errors to an electronic data capture (EDC) clinical trial database, and to access the impact of the changes. To accomblish the aim, Target e*CRF was used as the EDC tool for a multinational, dose-finding, multicenter, double-blind, randomized, parallel, placebo-controlled trial to investigate efficacy and safety of a new treatment in men with lower urinary tract symptoms associated with benign prostatic hyperplasia. The main errors observed were simple transcription errors from the paper source documents to the EDC database. This observation was to be expected, since every transaction has an inherant error rate. What and how to monitor must be assessed within the risk-based monitoring section of the comprehensive data monitoring plan. With the advent of direct data entry, and the elimination of the requirement to transcribe from a paper source record to an EDC system, error rates should go down dramatically. In addition, protocol violations and data outside the normal range can be identified at the time of data entry and not days, weeks, and months after the fact.

Abstract. Nitrous oxide (N 2 O) emissions from sugarcane cropped soils are usually high compared with those from other arable lands. Nitrogen-efficient management strategies are needed to mitigate N 2 O emissions from sugarcane farming whilst maintaining productivity and profitability. A year-long field experiment was conducted in wet tropical Australia to assess the efficacy of polymer-coated urea (PCU) and nitrification inhibitor (3,4-dimethylpyrazole phosphate)-coated urea (NICU). Emissions of N 2 O were measured using manual and automatic gas sampling chambers in combination. The nitrogen (N) release from PCU continued for >5-6 months, and lower soil NO 3 -contents were recorded for !3 months in the NICU treatments compared with the conventional urea treatments. The annual cumulative N 2 O emissions were high, amounting to 11.4-18.2 kg N 2 O-N ha -1 . In contrast to findings in most other cropping systems, there were no significant differences in annual N 2 O emissions between treatments with different urea formulations and application rates (0, 100 and 140 kg N ha -1 ). Daily variation in N 2 O emissions at this site was driven predominantly by rainfall. Urea formulations did not significantly affect sugarcane or sugar yield at the same N application rate. Decreasing fertiliser application rate from the recommended 140 kg N ha -1 to 100 kg N ha -1 led to a decrease in sugar yield by 1.3 t ha -1 and 2.2 t ha -1 for the conventional urea and PCU treatments, respectively, but no yield loss occurred for the NICU treatment. Crop N uptake also declined at the reduced N application rate with conventional urea, but not with the PCU and NICU. These results demonstrated that substituting NICU for conventional urea may substantially decrease fertiliser N application from the normal recommended rates whilst causing no yield loss or N deficiency to the crop. Further studies are required to investigate the optimal integrated fertiliser management strategies for sugarcane production, particularly choice of products and application time and rates, in relation to site and seasonal conditions.

This two-phase retrospective study was designed to evaluate the impact of the clinical pharmacist on prescribing practice of physicians in an internal medicine service. Streptococcal (pneumococcal) pneumonia was chosen as the model disease state. The drug of choice was used more frequently and there was a statistically significant difference in raw cost of antibiotic, total cost for antibiotic administration, daily raw cost for antibiotics; total raw cost for antibiotic administration, and patient charges when physicians were exposed to the clinical pharmacists' influence.

Taliglucerase alfa is a beta-glucocerebrosidase enzyme replacement therapy approved in the United States, Israel, and other countries for treatment of Type 1 Gaucher disease in adults, and is the first approved plant cell—expressed recombinant protein. In this report, taliglucerase alfa pharmacokinetics were assessed in adult and pediatric patients with Gaucher disease from separate multicenter trials of 30 Units/kg and 60 Units/kg doses infused every 2 weeks. Serial blood samples were obtained from adult patients following single-dose administration on day 1 (n = 26) and multiple doses at week 38 (n = 29), and from pediatric patients following administration of multiple doses of taliglucerase alfa for 10–27 months (n = 10). In both adult and pediatric patients, maximum plasma concentration (Cmax), area under the plasma concentration-time curve from time zero to last measureable concentration (AUC0-t), and from time zero to infinity (AUC0-∞) were higher after 60 Units/kg dose than 30 Units/kg dose. No tendency for accumulation or change in taliglucerase alfa pharmacokinetic parameters over time from day 1 to week 38 was observed with repeated doses of 30 or 60 Units/kg in adults. After multiple doses, mean (range) dose-normalized pharmacokinetic parameters were similar for adult versus pediatric patients receiving 60 Units/kg: Cmax expressed in ng/mL/mg was 42.4 (14.5–95.4) in adults and 46.6 (34.4–68.4) in pediatric patients, AUC0 t expressed in ng•h/mL/mg was 63.4 (26.3–156) in adults and 63.9 (39.8–85.1) in pediatric patients, t1/2 expressed in minutes was 34.8 (11.3–104) in adults and 31.5 (18.0–42.9) in pediatric patients and total body clearance expressed in L/h was 19.9 (6.25–37.9) in adults and 17.0 (11.7–24.9) in pediatric patients. These pharmacokinetic data extend the findings of taliglucerase alfa in adult and pediatric patients.Trial RegistrationClinicalTrials.gov. NCT00376168 (in adults); NCT01411228 (in children)

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