How to Engage Your Team to Implement Delayed Cord Clamping.

This article describes how a health care team changed practice by implementing delayed cord clamping as standard practice. After administration of a survey to assess clinicians' knowledge and to discover barriers to this proposed practice change, members of a multidisciplinary committee used the results to create a guideline for delayed cord clamping and a plan for successful implementation. Integral to embedding and sustaining changes in practice was development of the Delivery Room Brief and Debrief Tool and inclusion of the process into nursing guidelines and the electronic health record.

The Perinatal Birth Environment: Communication Strategies and Processes for Adherence to a Standardized Guideline in Women Undergoing Second-Stage Labor With Epidural Anesthesia.

Key to any perinatal safety initiative is buy-in and strong leadership from obstetric and pediatric providers, advanced practice nurses, and labor and delivery nurses in collaboration with ancillary staff. In the fall of 2007, executives of a large Midwestern hospital system created the Zero Birth Injury Initiative. This multidisciplinary group sought to eliminate birth injury using the Institute of Healthcare Improvement Perinatal Bundles.

A perinatal care quality and safety initiative: are there financial rewards for improved quality?

Background: Although costs of providing care may decrease with hospital initiatives to improve obstetric and neonatal outcomes, the accompanying reduced adverse outcomes may negatively affect hospital revenues.

Methods: In 2008 a Minnesota-based hospital system (Fairview Health Services) launched the Zero Birth Injury (ZBI) initiative, which used evidence-based care bundles to guide management of obstetric services. A pre-post analysis of financial impacts of ZBI was conducted by using hospital administrative records to measure costs and revenues associated with changes in maternal and neonatal birth injuries before (2008) and after (2009-2011) the initiative.

Phase III trials of toremifene vs tamoxifen.

Three pivotal phase III trials conducted in North America and Europe served as the basis for the application for approval of toremifene (Fareston) by the FDA. These trials demonstrated that 60 mg/d of toremifene is safe and effective in the treatment of advanced breast cancer in postmenopausal women. The studies also indicated that, on the basis of antitumor efficacy, as well as safety, toremifene is at least equivalent to tamoxifen and may have some long-term advantages.

Delayed administration of dexrazoxane provides cardioprotection for patients with advanced breast cancer treated with doxorubicin-containing therapy.

Purpose: To assess whether dexrazoxane (DZR) given after a cumulative doxorubicin dose of 300 mg/m2 confers cardioprotection in patients with advanced breast cancer treated with fluorouracil, doxorubicin, and cyclophosphamide (FAC).

Patients And Methods: In two multicenter studies (088001 and 088006), patients were randomized to receive FAC and placebo (PLA) versus FAC and DZR. After a protocol amendment, all patients received open-label DZR after they had reached a cumulative doxorubicin dose of 300 mg/m2.

Cardioprotection with dexrazoxane for doxorubicin-containing therapy in advanced breast cancer.

Purpose: To determine the cardioprotective effect of dexrazoxane (DZR) used in a doxorubicin-based combination therapy in advanced breast cancer.

Patients And Methods: Between November 1988 and January 1991, 534 patients with advanced breast cancer were randomized to two multicenter, double-blind studies (088001 and 088006). Patients received fluorouracil, doxorubicin, and cyclophosphamide (FAC) with either DZR (DZR-to-doxorubicin ratio, 10:1) or placebo (PLA) every 3 weeks and were monitored with serial multiplegated acquisition (MUGA) scans.

A phase II trial of ilmofosine in non-small cell bronchogenic carcinoma.

We have conducted a study of ilmofosine (1-hexadecylthio; 2-methoxyethyl-rac-glycero-3-phosphocholine) in non-small cell bronchogenic carcinoma, using a schedule of continuous infusion for 5 days and a dose of 300 mg/m2/day. Toxicities were gastrointestinal (nausea, vomiting, diarrhea), fatigue and liver function abnormalities. These were severe and resulted in the removal of some patients from study.

Worsening bone scan in the evaluation of antitumor response during hormonal therapy of breast cancer.

Purpose: Scintigraphic flare in association with response to therapy has been well described in the medical literature. During the course of a recent breast cancer trial, it became apparent that several patients with worsening bone scan but no other clinical evidence of disease progression might have potentially benefited from continued therapy, but had therapy discontinued. A retrospective analysis of this issue was performed to assess the magnitude and scope of this problem.

Uterine adenocarcinoma metastatic to the skin responsive to megestrol acetate.

Background: Although endometrial carcinoma is the most common gynecological cancer, it only rarely metastasizes to the skin, with a reported prevalence of 0.8%. We report a case of an elderly lady who recently developed cutaneous metastases from an endometrial primary diagnosed 7 years earlier.

Chemotherapy of intermediate- and high-grade non-Hodgkin's lymphomas with an intensive epirubicin-containing regimen.

An intensive chemotherapy regimen (EVDAC), including high-dose epirubicin, vincristine, and dexamethasone followed by cyclophosphamide and high-dose cytarabine, was administered to 54 untreated adults with intermediate or high-grade non-Hodgkin's lymphomas (NHL). The median age was 59, 61% were Ann Arbor Stage IV, 57% had "B" symptoms, 50% had serum lactate dehydrogenase greater than 250 U/L, and 48% had masses greater than 7 cm (33% > 10 cm) in diameter. Seventy-six percent of patients attained complete or probable complete remissions.

Antiestrogenic potency of toremifene and tamoxifen in postmenopausal women.

In this nonblinded, controlled multicenter trial, postmenopausal women were randomly assigned to receive graded doses of toremifene and tamoxifen or no antiestrogen to assess dose-response levels and evaluation methodology. For standardization, transdermal estradiol (Estraderm-Ciba Geigy) was applied to all women for 38 days. The antiestrogens were added on days 29-38.

Treatment of myelodysplastic syndromes with daily oral idarubicin. A phase I-II study.

Background: Idarubicin, a new anthracycline analogue, is available in an oral preparation, and responses have been observed using relatively aggressive therapy in patients with myelodysplastic syndromes (MDS). The authors studied whether a chronic low-dose schedule would be effective but less myelotoxic.

Methods: Forty-two patients with MDS received daily low-dose oral idarubicin in 5-week courses that included 3 weeks of treatment, followed by a 2-week rest period.

Multicenter phase II efficacy trial of toremifene in tamoxifen-refractory patients with advanced breast cancer.

Purpose: To explore further the efficacy of high-dose toremifene in patients with advanced breast cancer who had failed to respond to tamoxifen or whose disease had progressed on tamoxifen.

Patients And Methods: One hundred two perimenopausal or postmenopausal women with metastatic breast cancer refractory to tamoxifen were entered onto a phase II clinical trial of toremifene at a dose of 200 mg/d. The study patients consisted of 28 primarily refractory patients; 43 patients who had relapsed after a prior tamoxifen response; and 31 patients who had relapsed while receiving adjuvant tamoxifen.

Phase II study of intravenous idarubicin in unfavorable non-Hodgkin's lymphoma.

Idarubicin, a new analogue of daunorubicin, was administered intravenously at a dose of 15 mg/m2 to 31 patients with previously treated patients with unfavorable non-Hodgkin's lymphoma. Clinical characteristics included median age 69 years, performance status 1, and prior chemotherapeutic regimens 1. Twenty of the patients were relapsing after prior therapy and 11 were refractory; 29 had received prior anthracycline or anthracenedione.

Phase II study of intravenous idarubicin in unfavorable non-Hodgkin's lymphoma.

Idarubicin, a new analogue of daunorubicin, was administered i.v. at a dose of 15 mg/m2 to 31 previously treated patients with unfavorable non-Hodgkin's lymphoma.

Phase II study of oral idarubicin in favorable histology non-Hodgkin's lymphoma.

Idarubicin, a new analogue of daunorubicin, was administered p.o. for 3 consecutive days every 3 weeks at a dose of 45 mg/m2 in 46 patients (45 eligible and evaluable) with previously treated, favorable histology, non-Hodgkin's lymphoma.

Phase I-II study of epirubicin in multiple myeloma.

Forty patients with relapsed (26) or refractory (14) myeloma were treated with epirubicin of doses of 75, 90, 105, and 120 mg/m2 in groups of 6 or more patients to test for response, maximum tolerated dose, and toxicity. Thirteen patients had received prior doxorubicin and were included in the dose findings part of the study only. Staging was I (1), II (5), and III (34).

Phase I-II trial of high-dose epirubicin in patients with lymphoma.

High-dose doxorubicin has shown considerable activity in both previously treated and previously untreated patients with lymphoma. Because of the toxicities of doxorubicin at high dose, we elected to study a new anthracycline at doses comparable to doxorubicin at high dose, to assess response and toxicity. Epirubicin was administered at doses of 120 mg/m2, 150 mg/m2, and 180 mg/m2 every 3 weeks (maximum four doses) to groups of six patients with previously treated intermediate- and high-grade lymphoma.

Weekly mitoxantrone therapy of Hodgkin's disease, non-Hodgkin's lymphoma, and chronic lymphocytic leukemia. A Southeastern Cancer Study Group Trial.

A weekly schedule of mitoxantrone was evaluated in chronic lymphoproliferative disorders. One of 11 patients with Hodgkin's disease, 2 of 12 with favorable-histology non-Hodgkin's lymphoma, 4 of 27 with unfavorable-histology non-Hodgkin's lymphoma, and 1 of 11 with chronic lymphocytic leukemia showed a response. Since the use of a larger single dose every 3 weeks is well tolerated, simpler, and probably more effective, we do not recommend further evaluation of the weekly dose schedule.

Alternating sequential combination chemotherapy in the management of advanced Hodgkin's disease. A Southeastern Cancer Study Group trial.

The Southeastern Cancer Study Group has explored the use of alternating sequential combination chemotherapy in advanced Hodgkin's disease. Two hundred twelve evaluable patients were randomly assigned to treatment with the six-drug combination, BCNU, cyclophosphamide, vinblastine, procarbazine, prednisone, and bleomycin (BCVPP-Bleo) or with the same drugs alternating in monthly cycles with doxorubicin, dacarbazine, and bleomycin. Both regimens produced complete response rates of approximately 73%.