The introduction of computerized physician order entry and change management in a tertiary pediatric hospital.

OBJECTIVES: The objectives of this review were to document the introduction of computerized physician order entry (CPOE)-centered changes in an academic tertiary care center and to review the CPOE-focused literature. DESIGN: We performed a systematic literature review of CPOE-related articles indexed on Medline, with particular emphasis on pediatric applications. We focused our commentary around the concepts involved in the implementation process at a tertiary pediatric hospital. RESULTS: In 2001, the Children's Hospital of Pittsburgh (CHP) embarked on the process of CPOE design and implementation. We determined that CPOE is a tool for improving pediatric care. The CPOE implementation process is more than a technologic change; it involves an organizational cultural transformation. Although the complete transition to CPOE was little more than 1 year ago, CHP has overcome the typical obstacles of CPOE implementation to begin to realize its many benefits. The early success of CHP was achieved by creating a realistic, positive, work environment, which fostered hospital-wide participation and integration. CONCLUSION: CPOE is an invaluable resource for supporting patient safety in health care settings. The successful implementation of CPOE requires a paradigm shift in hospital policies and processes.

The impact of hospitalwide computerized physician order entry on medical errors in a pediatric hospital.

PURPOSE: Medication errors contribute significantly to the morbidity and costs of pediatric health care. The authors hypothesized that hospitalwide computerized physician order entry (CPOE) in a pediatric hospital would lead to a decrease in medication errors. METHODS: The authors retrospectively evaluated and prospectively analyzed inpatient discharge and usage and adverse drug event (ADE) rate data pre- and postintroduction of a hospitalwide implementation of CPOE in a tertiary care pediatric hospital. They compared pre- and postintervention ADEs (Student's t test) and computed the number needed to treat (NNT) analog. RESULTS: Over the 9-month study period, there were 45,615 in patient days and 8619 discharges. Pre-CPOE verbal order regulatory compliance was 80%, whereas post-CPOE increased to 95%. Transcription errors were eliminated. All ADEs pre-CPOE were 0.3 +/- 0.04 per 1000 doses, whereas post-CPOE ADEs were 0.37 +/- 0.05 per 1000 doses (P = .3). Harmful ADEs pre-CPOE were 0.05 +/- 0.017 per 1000 doses, while post-CPOE ADEs were 0.03 +/- 0.003 per 1000 doses (P = .05). Our NNT data demonstrate that CPOE would prevent 1 ADE every 64 (95% CI 25-100) patient days. CONCLUSIONS: CPOE decreases harmful ADEs in a pediatric hospital, thus leading to increased patient safety. In addition, CPOE provides an automated system for monitoring and improving health care quality.

Prophylactic urokinase in the management of long-term venous access devices in children: a Children's Oncology Group study.

PURPOSE: Infection and thrombosis are serious complications of long-term vascular access devices in children undergoing chemotherapy. Since routine fibrinolytic therapy may decrease these complications, the purpose of this study was to compare the efficacy of an every-2-week administration of urokinase with standard heparin flushes in reducing the incidence of device-related infections and occlusions. MATERIALS AND METHODS: This study was a prospective, randomized phase III multicenter trial conducted by the Children's Cancer Group, in which patients with implantable ports or tunneled catheters received either urokinase or heparin every 2 weeks for 12 months. Study end points were time to first occlusion or time to first device-related infection. RESULTS: Five hundred seventy-seven patients from 29 institutions were enrolled, of whom 51% had external catheters and 49% had ports. Urokinase administration resulted in fewer occlusive events than heparin (23% v 31%; P =.02), a longer time to first occlusive event (log-rank analysis, P =.006), and a 1.6-fold difference in the rate of occlusive events (Poisson regression, P =.003). Similar results were noted when comparing ports and tunneled catheters. The urokinase group also had a 1.4-fold difference in the rate of infection (Poisson regression, P =.05) and longer time to first infection (log-rank, P =.07), but the difference was significant only in tunneled catheters. CONCLUSION: Urokinase administration every 2 weeks significantly affects the rate of occlusive events in ports and tunneled catheters and of infectious events in external catheters compared with heparin administration.

Failure pattern and factors predictive of local failure in rhabdomyosarcoma: a report of group III patients on the third Intergroup Rhabdomyosarcoma Study.

PURPOSE: To analyze patterns of failure and factors predictive of local treatment failure in children enrolled on the third Intergroup Rhabdomyosarcoma Study who had either biopsy only or subtotal resection of their primary tumor, had no distant metastases, and received radiation therapy for local control. PATIENTS AND METHODS: Treatment failure was categorized as local, regional nodal, or distant metastatic. The 5-year cumulative risk of failure was estimated for each category and factors predictive of local failure risk were determined using the Cox model and binary recursive partitioning. RESULTS: The estimated 5-year cumulative incidence rates by failure category were: total local (with or without concurrent regional or distant failure), 19%; total regional nodal, 2%; total distant, 11%; and death from toxicity or unknown recurrence type, 4%. Lymph node involvement at diagnosis was the single factor most predictive of increased total local failure risk (5-year cumulative incidence 32%) compared with children with negative nodes or unknown node status (16%). No significant effect on local failure risk was observed by total radiotherapy dose over the prescribed range of 41.4 Gy to 50.4 Gy. For all patients (N = 405), the estimated 5-year failure-free survival and overall survival were, respectively, 70% and 78%. CONCLUSION: Local failure after radiotherapy for group III rhabdomyosarcoma patients is the predominant type of relapse. Involved lymph nodes at diagnosis predict a higher risk of local and distant treatment failure compared with patients whose lymph nodes are negative.

Prognostic factors and surgical treatment guidelines for children with rhabdomyosarcoma of the perineum or anus: a report of Intergroup Rhabdomyosarcoma Studies I through IV, 1972 through 1997.

BACKGROUND/PURPOSE: Rhabdomyosarcoma (RMS) of the perineum or anus is a rare sarcoma of childhood with a poor prognosis. This study reviews the Intergroup Rhabdomyosarcoma Study Group (IRSG) studies I through IV to identify determinants of patient outcome and to refine surgical treatment guidelines. METHODS: From 1972 through 1997, 71 eligible patients were treated and studied. The median patient age was 6 years. The majority (64%) were at an advanced stage (clinical group III and IV) at initial presentation and 50% had positive regional lymph node (LN) involvement. RESULTS: The 5-year failure-free survival rate (FFS) for all patients was 45% and the overall survival rate (OS) was 49%. Characteristics that were associated with significantly improved survival rate were primary tumor size less than 5 cm, lower (less advanced) clinical group and stage, negative regional lymph node status, and age less than 10 years. When the extent of disease was controlled for in multivariate analysis, only age less than 10 predicted an improved outcome. The 5-year overall survival rate for patients less than 10 years of age was 71% versus 20% in older patients (P <.001). Histology (alveolar versus embryonal) and primary site (perineal versus anal) did not significantly affect outcome. CONCLUSIONS: Because of the high incidence of regional LN involvement in these patients, a strategy of routine surgical evaluation of ilioinguinal lymph nodes in all patients with perineal or anal RMS is recommended.

Treatment of localized nonorbital, nonparameningeal head and neck rhabdomyosarcoma: lessons learned from intergroup rhabdomyosarcoma studies III and IV.

PURPOSE: The characteristics and clinical outcomes of children and adolescents with localized nonorbital, nonparameningeal head and neck rhabdomyosarcoma (RMS) treated on national protocols from the Intergroup Rhabdomyosarcoma Group are reported. PATIENTS AND METHODS: We conducted a retrospective review of 164 children and adolescents enrolled in the third and fourth Intergroup Rhabdomyosarcoma Studies. Variables analyzed included age, sex, primary tumor site, histologic subtype, clinical group, therapy, site and rate of treatment failure, and time to initial recurrence. RESULTS: Localized nonorbital, nonparameningeal RMS accounted for 9% of all cases of RMS. The median age at diagnosis was 5 years; the median follow-up was 6.6 years. Estimated 5-year failure-free survival (FFS) and survival (S) rates were 76% (95% CI, 69% to 83%) and 83% (95% CI, 77% to 89%), respectively. In multivariate analysis, patients with clinically involved regional nodes (N1) had worse FFS (P =.02). For patients with embryonal tumors, FFS was significantly improved, especially among patients with Group I/II without nodal disease clinical Group I, II N0. For patients with alveolar/undifferentiated histology, FFS was significantly worse in children under the age of 1 year. Actuarial estimates of recurrences at 15 years were local (19%), regional (5%), and distant (9%). CONCLUSION: More than 80% of patients with RMS of the head and neck are cured of their disease using surgery and vincristine, dactinomycin +/- cyclophosphamide with or without radiotherapy. Our results indicate that early, limited exposure to cyclophosphamide might reduce recurrence in low-risk embryonal patients and that reduced dosages might achieve comparable results with improved toxicity profiles. These hypotheses will be tested in the next generation of trials from the Soft Tissue Committee of the Children's Oncology Group.

Surgical management of open versus laparoscopic adrenalectomy: outcome analysis.

PURPOSE: The authors sought to compare the outcome of children undergoing open versus laparoscopic adrenalectomy for an adrenal tumor. METHODS: Medical records of children that underwent an adrenalectomy from 1990 through 1999 were reviewed. Sixty-four adrenalectomies were performed: 27 pheochromocytomas, 36 neuroblastomas, and 1 virilizing tumor. Sixty adrenalectomies were performed open and 4 laparoscopically. The patient's age, surgical length of stay, operative charge, hospital cost, operating time, blood loss, and outcome were examined. RESULTS: Mean age for an open procedure was 8.9 +/- 0.9 years and 14 +/- 1.1 for laparoscopic (P =.019). Surgical length of stay for open was 5.4 +/-.38 days and 2.7 +/-.62 days for laparoscopic (P =.006). Patient operative charges were $12,941 +/- 676 for laparoscopic and $4,714 +/- 411 for open (P <.001). When total estimated patient cost, including hospital stay, were compared between groups there was no significant difference. Similar mean operating times and blood loss were noted. There were no deaths or complications in children with a pheochromocytoma. The mortality rate in children with neuroblastoma was 28%. CONCLUSIONS: Adrenalectomy for benign tumors can be performed safely. In selected children a laparoscopic procedure can be expected to decrease the surgical length of stay without increasing operating time or complications.

Treatment of children and adolescents with localized parameningeal sarcoma: experience of the Intergroup Rhabdomyosarcoma Study Group protocols IRS-II through -IV, 1978-1997.

BACKGROUND: We reviewed 611 patients with parameningeal sarcoma entered on Intergroup Rhabdomyosarcoma Study Group (IRSG) Protocols-II through IV (1978-1997), to delineate treatment results and evaluate prognostic factors. PROCEDURE: Primary sites were the middle ear/mastoid (N = 138), nasopharynx/nasal cavity (N = 235), paranasal sinuses (N = 132), parapharyngeal region (N = 29), and the pterygopalatine/infratemporal fossa (N = 77). Treatment was initial biopsy or surgery followed by multiagent chemotherapy and radiation therapy (XRT). Beginning in 1977, patients with cranial nerve palsy, cranial base bony erosion, and/or intracranial extension at diagnosis were considered as having meningeal involvement. They received triple intrathecal medications, whole brain XRT, and then spinal XRT. These treatments were successively eliminated from 1980 to 1991. RESULTS: The 611 patients' overall survival rate at 5 years was 73% (95% confidence interval, 70-77%). Favorable prognostic factors were: age 1-9 years at diagnosis; primary tumor in the nasopharynx/nasal cavity, middle ear/mastoid, or parapharyngeal areas; no meningeal involvement; and non-invasive tumors (T1). Thirty-five of 526 patients (6.7%) with information about presence/absence of meningeal involvement at diagnosis developed central nervous system (CNS) extension at 5-164 weeks (median, 46 weeks) after starting therapy. The estimated 5-year cumulative incidence rate of CNS extension during the study period was 5-7% (P = 0.88). CONCLUSIONS: Biopsy, XRT to the target volume, and systemic chemotherapy are successful treatments for the large majority of patients with localized parameningeal sarcoma. Carefully defining and irradiating the initial volume should reduce the risk of CNS failure. Aggressive initial surgical management of these patients is unnecessary.