An opportunity to emphasize the relevance of laboratory medicine.

Objectives: Clinical practice guidelines (CPGs) are recommendations based on a systematic review of scientific evidence that are intended to help healthcare professionals and patients make the best clinical decisions. CPGs must be evidence-based and are designed by multidisciplinary teams. The purpose of this study is to assess the topics related to the clinical laboratory addressed in CPGs and evaluate the involvement of laboratory professionals in the CPG development process. Methods: A total of 16 CPGs recommended by the Spanish Society of Laboratory Medicine and/or retrieved from PubMed-Medline were included. A review of the information provided in CPGs about 80 topics related to the clinical laboratory was performed. The authorship of laboratory professionals was assessed. Results: On average, the 16 CPGs addressed 49% (standard deviation [SD]: 11%) of the topics evaluated in relation to the clinical laboratory. By order of frequency, CPGs contained information about 69% of postanalytical variables (SD: 20%); 52% of preanalytical variables (SD: 11%); and 43% of the analytical variables studied (SD: 18%). Finally, half the CPGs included a laboratory professional among its authors. Conclusions: CPGs frequently failed to provide relevant laboratory-related information. Laboratory professionals were co-authors in only half the CPGs. There is scope for improvement, and laboratory professionals should be included in multidisciplinary teams involved in the development of CPGs.

Serum CA 19.9 Levels in Patients With Benign and Malignant Disease: Correlation With the Serum Protein Electrophoretic Pattern.

AIM: To confirm that the carbohydrate antigen 19.9 (CA 19.9) protein can be evaluated by determining changes in the ß2 zone in protein electrophoresis. MATERIALS AND METHODS: A total of 75 patients (64 with cancer, 11 with benign diseases) with abnormal serum CA 19.9 level were included. RESULTS: Patients with cancer had significantly higher serum CA 19.9 concentrations than those with benign diseases (p<0.001). Similar CA 19.9 levels were observed in patients with normal (median 1129 U/ml), weakly positive (median 699 U/ml) and positive (2333 U/ml) ß2 fraction in protein electrophoresis. In contrast, changes in the protein pattern of the ß2 fraction were related to an inflammatory pattern with significantly higher C-reactive protein concentration (p<0.0001), independently of serum CA 19.9 level. CONCLUSION: The intensity of the ß2 fraction in protein electrophoresis is related to inflammation and not to CA 19.9 in patients with cancer or other diseases.

Relationship Between CA 19.9 and the Lewis Phenotype: Options to Improve Diagnostic Efficiency.

BACKGROUND/AIM: Approximately 10% of patients are unable to synthesize CA 19.9 (Lewis-negative), and these results are erroneously considered false-negatives. The aim of this study was to confirm that CA 19.9 cannot be detected by immunoassays in Lewis-negative patients. MATERIALS AND METHODS: CA 19.9 levels were measured by immunological assays and Lewis phenotype was determined by the haemagglutination reaction. RESULTS: Patients with Lewis phenotype (a+b-) or (a-b+) had significantly higher CA 19.9 levels than Lewis-negative patients with active cancer (p<0.001), no-evidence of disease (NED) patients (p<0.001) or patients with benign disease (p<0.001). Ninenty-four percent of patients (33/35) with undetectable CA 19.9 had a Lewis-negative phenotype. Additionally, 94.7% (34/36) of patients with Lewis-negative phenotypes had undetectable CA 19.9 serum levels. CONCLUSION: Patients with undetectable CA 19.9 serum levels tend to be Lewis-negative, and CA 19.9 is not useful in diagnosis or follow-up.

Incidence, prevalence and clinical course of primary biliary cirrhosis in a Spanish community.

BACKGROUND AND AIMS: Primary biliary cirrhosis (PBC) is characterized by the autoimmune inflammatory response of small intrahepatic bile ducts. Prevalence in Spain is estimated as 61.9 cases per million inhabitants, whereas Northern Europe rates over 200 cases/million. Our objective was to determine the incidence and prevalence of PBC in our health area. MATERIAL AND METHODS: PBC was defined by the presence of abnormal liver tests (dissociated cholestasis) with positive antimitochondrial antibodies and/or compatible liver histology. Medical records from patients diagnosed between 1990 and 2002 were reviewed retrospectively. The following data were collected: diagnostic data, demographic and analytic data, liver histology and stage and treatment and disease outcome. RESULTS: In a population of 389 758 inhabitants, 87 patients were diagnosed with PBC. Mean age at diagnosis was 63.9+/-12.6 years. Eighty-four (96.6%) were women. Mean annual incidence was 17.2 per 10 inhabitants and the prevalence at the end of study was 195 per 10. Biopsy was performed in 71 (81.6%) patients, 61 of whom (86%) did not have fibrosis. Time of follow-up was 63.6+/-43.2 (2.28-153.9) months. CONCLUSION: Incidence and prevalence in our reference area are higher than in some Spanish areas, as per the results previously published; however, they are comparable with those obtained in Northern Europe and the US.

The persistent exclusion of older patients from ongoing clinical trials regarding heart failure.

BACKGROUND: Much clinical research of relevance to elderly patients examines individuals who are younger than those who have the disease in question. A good example is heart failure. Therefore, we investigated the extent of exclusion of older individuals in ongoing clinical trials regarding heart failure. METHODS: In the context of the Increasing the PaRticipation of the ElDerly in Clinical Trials (PREDICT) study, data from ongoing clinical trials regarding heart failure were extracted from the World Health Organization Clinical Trials Registry Platform on December 1, 2008. Main outcome measures were the proportion of trials excluding patients by an arbitrary upper age limit or by other exclusion criteria that might indirectly cause limited recruitment of older individuals. We classified exclusion criteria into 2 categories: justified or poorly justified. RESULTS: Among 251 trials investigating treatments for heart failure, 64 (25.5%) excluded patients by an arbitrary upper age limit. Such exclusion was significantly more common in trials conducted in the European Union than in the United States (31/96 [32.3%] vs 17/105 [16.2%]; P = .007) and in drug trials sponsored by public institutions vs those by private entities (21/59 [35.6%] vs 5/36 [13.9%]; P = .02). Overall, 109 trials (43.4%) on heart failure had 1 or more poorly justified exclusion criteria that could limit the inclusion of older individuals. A similar proportion of clinical trials with poorly justified exclusion criteria was found in pharmacologic and nonpharmacologic trials. CONCLUSION: Despite the recommendations of national and international regulatory agencies, exclusion of older individuals from ongoing trials regarding heart failure continues to be widespread.