Empowering medicine residents to order labs mindfully to improve patient-centered care.

BACKGROUND: Unnecessary laboratory testing of hospitalized patients is prevalent. OBJECTIVE: We conducted a study focused on "mindful ordering" to decrease unnecessary laboratory ordering within an Internal Medicine residency program. DESIGNS, SETTINGS AND PARTICIPANTS: We collected survey data on resident/faculty perceptions of laboratory ordering as well as order information from the electronic medical record (EMR). INTERVENTION: Interventions focused on resident-identified barriers such as knowledge, EMR, habit and faculty expectations. Interventions were cumulative and included resident/faculty education and EMR optimization. MAIN OUTCOMES AND MEASURES: We assessed basic and complete metabolic panels (BMP, CMP) and complete blood counts with and without differential (CBC w/diff, w/o diff). Primary outcomes included: total labs ordered per week, lab and frequency, and resident perception of ordering practices. Secondary outcomes included: length-of stay (LOS) and venipuncture utilization. RESULTS: Survey data demonstrated increased resident perception of both mindful ordering and team discussion. Total labs ordered per week decreased 20% in the first year (1944 to 1500 labs/week). Residents' use of the "one-time draw" option increased; use of "daily" frequency decreased. Trends showed an increase in BMP relative to CMP, and an increase in CBC w/o diff relative to CBC w/diff. These changes were sustained through 127 weeks. There was an approximately 10% decrease in monthly average of patients undergoing venipuncture each day (86.7% to 74.2%). The shifts in laboratory ordering in conjunction with increased discussion about labs suggest a sustained change in resident lab ordering behavior. This study shows the impact of focusing interventions on resident-identified barriers to mindful ordering to create a sustained decrease laboratory orders.

Phase I dose-escalation study of cabazitaxel administered in combination with cisplatin in patients with advanced solid tumors.

INTRODUCTION: Cabazitaxel is a second-generation taxane with in vivo activity against taxane-sensitive and -resistant tumor cell lines and tumor xenografts. Cabazitaxel/cisplatin have therapeutic synergism in tumor-bearing mice, providing a rationale for assessing this combination in patients with solid tumors. METHODS: The primary objectives of this study were to determine dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of a cabazitaxel/cisplatin combined regimen (Part 1) and to assess antitumor activity at the MTD (Part 2). Safety and pharmacokinetics (PK) were also examined. RESULTS: Twenty-five patients with advanced solid tumors were enrolled (10 in Part 1; 15 in Part 2). In Part 1, two dose levels were evaluated; the MTD for cabazitaxel/cisplatin (given Q3W) was 15/75 mg/m(2). DLTs occurring during Cycle 1 at the maximum administered dose (20/75 mg/m(2); acute renal failure and febrile neutropenia) and the MTD (febrile neutropenia and hypersensitivity despite pre-medication) were as expected for taxane/platinum combinations. For the 18 patients treated at the MTD, the most frequent possibly related non-hematologic treatment-emergent adverse events (Grade ≥ 3) were nausea (16.7%), fatigue, acute renal failure and decreased appetite (each 11.1%). Neutropenia was the most frequent treatment-emergent Grade ≥ 3 hematologic laboratory abnormality at the MTD (77.8%). The best overall response at the MTD was stable disease, observed in 66.7% of patients. PK results of the combination did not appear to differ from single-agent administration for each agent. CONCLUSION: Combination treatment with cabazitaxel/cisplatin had a manageable safety profile; no PK interactions were evident. The recommended Phase II dose for this combination is cabazitaxel/cisplatin 15/75 mg/m(2) administered every 3 weeks. Antitumor activity findings suggest that further evaluation of this combination in disease-specific trials is warranted.

Review of ongoing clinical trials in non-small-cell lung cancer: a status report for 2012 from the ClinicalTrials.gov Web site.

INTRODUCTION: Clinical research in non-small-cell lung cancer (NSCLC) is a rapidly evolving field. In an effort to identify the current trends in lung cancer clinical research, we reviewed ongoing clinical trials in NSCLC listed in the ClinicalTrials.gov registry in 2012, and we also compared this data to a similar survey conducted by us in 2009. METHODS: The Web site's advanced search function was used to search for the term "non-small cell lung cancer." The search was further refined by using the following options from the search page drop-down menu, "open studies" and "interventional." Studies with non-NSCLC tumor histologies and pediatric studies were excluded. RESULTS: Of the 477 trials included in the analysis, 105 (22.0%) were phase I, 223 phase II (46.8%), and 63 phase III trials (13.2%). When compared with data from 2009, university-sponsored trials decreased in number (45.4%-34.2%; p < 0.001) whereas industry-sponsored trials remained almost the same. There was a significant increase in trials conducted exclusively outside of the United States (35.9%-48.8%; p = 0.001). The number of studies with locations in China (61, 12.8%) was second only to that in the United States (244, 51.2%). Studies reporting biomarker analysis increased significantly from 37.5% to 49.1% in 2012 (p < 0.001). Biomarker-based patient selection also increased significantly from 7.9% to 25.8% (p < 0.001). Targeted therapies were evaluated in 70.6% of phase I/II and II trials, and the most common class of targeted agent studied was epidermal growth factor receptor tyrosine kinase inhibitors (38.0%). Prespecified accrual times were observed to increase when compared with data reported in 2009, especially among industry-sponsored studies. CONCLUSIONS: Our survey identified major changes in lung cancer clinical research since 2009. Almost half of all studies registered at the ClinicalTrials.gov Web site are being conducted outside the United States, and several novel molecularly targeted agents are being evaluated in the treatment of patients with NSCLC. More importantly, we identified a threefold increase in the number of studies that perform biomarker testing to determine patient selection over the last 3 years.

Pilot Study of Caffeine Abstinence for Control of Chronic Glucose in Type 2 Diabetes.

BACKGROUND: A growing body of evidence suggests that caffeinated beverages may impair chronic glucose control in type 2 diabetes. This pilot study tested the chronic effects of caffeine abstinence on glucose control in type 2 diabetic patients who were daily coffee drinkers. METHODS: Twelve coffee drinkers (six males) with established type 2 diabetes participated. Seven (five males) completed 3 months of total caffeine abstinence. Measures of chronic glucose control, long-term (hemoglobin A1c [HbA1c]) and short-term (1,5-anhydroglucitol [1,5-AG]), were collected at baseline and during follow-up. Abstinence was established by diaries confirmed by saliva caffeine assays. RESULTS: Abstinence produced significant decreases in HbA1c and increases in 1,5-AG, both indicating improvements in chronic glucose control. Fasting glucose and insulin did not change, nor were changes in body weight observed. CONCLUSIONS: Although preliminary, these results suggest that caffeine abstinence may be beneficial for patients with type 2 diabetes. This hypothesis should be confirmed in larger controlled clinical trials.