A systematic approach for using DICOM structured reports in clinical processes: focus on breast cancer.

This paper describes a methodology for redesigning the clinical processes to manage diagnosis, follow-up, and response to treatment episodes of breast cancer. This methodology includes three fundamental elements: (1) identification of similar and contrasting cases that may be of clinical relevance based upon a target study, (2) codification of reports with standard medical terminologies, and (3) linking and indexing the structured reports obtained with different techniques in a common system. The combination of these elements should lead to improvements in the clinical management of breast cancer patients. The motivation for this work is the adaptation of the clinical processes for breast cancer created by the Valencian Community health authorities to the new techniques available for data processing. To achieve this adaptation, it was necessary to design nine Digital Imaging and Communications in Medicine (DICOM) structured report templates: six diagnosis templates and three summary templates that combine reports from clinical episodes. A prototype system is also described that links the lesion to the reports. Preliminary tests of the prototype have shown that the interoperability among the report templates allows correlating parameters from different reports. Further work is in progress to improve the methodology in order that it can be applied to clinical practice.

Multidisciplinary system for detecting medication errors in antineoplastic chemotherapy.

OBJECTIVE: To analyze medication errors (MEs) in a multidisciplinary system with a Computerized Pharmacotherapy Process (CPP) in cancer patients. DESIGN: A longitudinal, prospective 2-year (January 2003 -to December 2004) cohort study was made in adult patients administered antineoplastic treatment in Services of Oncology and Haematology. MEs were identified by double cross-validation of each stage of the pharmacotherapeutic process (prescription, preparation, dispensing, administration, and follow-up) carried out by the multidisciplinary team (physician, pharmacist, nurse) with CPP assistance. VARIABLES: Number of MEs per 1000 patient-days, percentage according to the stage of the pharmacotherapeutic process and the severity of intercepted ME (scored from 1 = no damage to the patient, to 5 = patient death). RESULTS: A total of 1311 patients were receiving treatment, and MEs were identified in 225. Out of a total of 13,158 patient-days, 276 MEs were detected, equivalent to 20.9 MEs per 1000 patient-days; of these, 16.8 MEs per 1000 patient-days (80%) were intercepted and did not affect any patient. The detected ME distribution according to pharmacotherapeutic stage was: prescription 75.7%, preparation 21.0%, dispensing 1.8%, administration 1.1%, and follow-up 0.4%. ME distribution according to severity was: grade 1 : 15.9%, grade 2 : 49.6%, grade 3 : 33.7%, grade 4 : 0.7%, and grade 5 : 0%. The system intercepted 98.9% of all MEs with severity >or=3 (MEs with a potential for causing patient damage). CONCLUSIONS: The multidisciplinary system with a well-established CPP detects 20.9 MEs per 1000 patient-days and intercepts 98.8% of all MEs with a potential for causing patient damage.

Prognostic value of the detection of lymph node micrometastases in colon cancer.

INTRODUCTION AND OBJECTIVES: A study is made of the clinical repercussions of occult metastases-micrometastases (MMs+)-or isolated tumour cells (ITCs+) in the lymph nodes of patients with stage IIA and IIB colon adenocarcinoma initially considered as corresponding to N0. MATERIAL AND METHODS: A retrospective study of 39 patients with stage IIA and IIB (T3-T4 N0 M0) colon adenocarcinoma, subjected to similar surgical and adjuvant chemotherapy treatment, with long and careful follow-up (minimum: 5 years, mean: 81.7 months) was performed on their previously resected lymph nodes, with the aid of new histological and immunohistochemical (cytokeratin) sections, in order to detect MMs or ITCs. Disease-free survival (DFS) and global survival (GS) in the two groups (patients with MMs+ or ITCs+ vs. patients without MMs or ITCs) were compared at 5 years based on the corresponding Kaplan-Meier survival curves, with the Breslow test. RESULTS: A total of 382 lymph nodes from the 39 patients (mean: 9.8; standard deviation: 6.09) were revised. MMs+ were detected in 2 cases and ITCs+ in 2 more cases on the Cytokeratin study. GS of the whole series at 5 years was 89.74% (35 patients alive) with a DFS at 5 years of 79.49% (31 patients free of disease), but the 2 cases with MMs+ were dead at 5 years, with high statistical differences between both groups (MMs+/MMs-) (p<0.0001). When comparing the group of MMs+/ITCs+ patients and the group of MM-/ITCs- patients, the DFS and GS times at 5 years were higher in the MMs-/ITCs- group (p=0.0692 and p=0.006 respectively). CONCLUSIONS: Although the incidence of MMs+ or ITCs+ in the examined lymph nodes was low, the presence of MMs is related to a dramatic reduction in GS and DFS at 5 years. We encourage a detailed histological study of lymph nodes resected in patients with deep penetrating colon tumours in order to assure a pN0 status.

Individualización de Carboplatino en el anciano con cáncer de pulmón no microcítico avanzado / Individual dosing of carboplatin in elderly patients with advanced non small cell lung cancer

El cáncer de pulmón no microcítico (CPNM) se diagnostica mayoritariamenteen pacientes mayores de 65 años. Los pacientes ancianos presentan una elevadacomorbilidad asociada al tratamiento antineoplásico que demanda la individualizaciónde las pautas posológicas. Las opciones de tratamiento son abundantes y elcarboplatino (CbPt) se encuentra entre los fármacos de primera línea. La dosis de CbPt se establece con la fórmula de Calvert (estándar) que requiere la medidaexacta de la función renal.El objetivo de este trabajo es aportar un modelo farmacocinético que permitaindividualizar las dosis de CbPt en ancianos con CPNM avanzado y evaluar suexactitud y precisión respecto al estándar.Los modelos farmacocinéticos para el CbPt no unido a las proteínas plasmáticas,obtenidos con las concentraciones plasmáticas de una población de 24 pacientesvarones con CPNM, indican que la edad es la covariable biométrica más estrechamenterelacionada con el aclaramiento plasmático de CbPt, sin dejar por ellode ser un factor de confusión. El error relativo medio (ERM) de la dosis ha sidopara los pacientes adultos (edad < 65 años) del 5% (1-9%) y para los pacientesancianos del 25% (19-30%). Por consiguiente, la dosificación de CbPt con la fórmulade Calvert conduce a una sobredosificación en los pacientes ancianos, produciendomayor exposición al fármaco de la deseada. El alcance clínico de estoshallazgos requiere su validación en una nueva población de pacientes

Non small cell lung cancer (NSCLC) is frequently diagnosed in patients olderthan age 65 years. Elderly patients often have comorbidities associated with theantineoplasic treatment that request individualization of the chemotherapy. Treatmentoptions are numerous and carboplatin (CbPt) is in the first line of treatment.Conventional doses of CbPt are individually adjusted applying the Calvert formulae(standar) that demands the accurate measure of renal function.The aim of this study is to develop a pharmacokinetic model in order to individualisethe dose of CbPt in elderly patients in advanced NSCLC, and to characterizeits bias and precision respect to the standard.The pharmacokinetic models for the unbound fraction of CpPt were obtainedfrom concentration-time data of ultrafiltrate plasma samples of twenty-four advancedNSCLC men patients enrolled in the study. Age was significantly related to thecarboplatin clearance, although is a confusion factor. The mean dose error, inpercentage, was 5% (1-9%) in adult patients (Age< 65 years) and 25% (19-30%) inelderly patients. Consequently, CbPt the dose regimen in enderly patients, establishedby means of Calvert’s formula is overestimated and the exposure to the antineoplasticis higher than desired. The clinical relevance of these results requiresthe validation of the model with a new population group

Pharmaceutical validation as a process of improving the quality of antineoplastic treatment.

OBJECTIVE: To quantify the improvement added by standardization of pharmaceutical validation (PV) of antineoplastic treatment to the processes of prescription and preparation of the pharmacotherapeutic sequence, in terms of prevention and reduction of medication errors (ME). DESIGN: Prospective cohort study during two years (from 2001-2002) for oncohaematologic patients (inpatients and outpatients) that compared the percentage of medication errors detected and resolved and the number of medication errors with potential clinical significance (severity value >or=4) intercepted during PV in both years. RESULTS: During the PV processes, 202 ME were identified and resolved, which is the equivalent of 16.88 ME/1,000 patient-days. In 2001 14.08 ME/1,000 patient-days were detected and 19.83 ME/1,000 patient-days in 2002. This means that the effectiveness of the identification method increased by 41%. The number of ME intercepted with clinical significance (severity value >or=4) increased in a statistically significant manner by 2.18 times in 2002. CONCLUSION: This study shows that the standardization of PV is an effective method of improving the quality of antineoplastic treatment use, by increasing the ability to intercept ME.