Protocolization of multicenter clinical studies in the digital era. Is useful data centralization by a data-manager?

INTRODUCTION: In multicenter studies, the protocolization of data is a critical phase that can generate biases.The objective is to analyze the concordance and reliability of the data obtained in a clinical multicenter study between the protocolization in the center of origin and the centralized protocolization of the data by a data -manager. METHODS: National multicenter clinical study about an infrequent carcinoma. A double protocolization of the data is carried out: (a) center of origin; and (b) centralized by a data manager: The concordance between the data is analyzed for the global data and for the two groups of the project: (a) study group (Familiar carcinoma, 30 researchers protocolize); (b) control group (Sporadic carcinoma, 4 people protocolize). Interobserver variability is evaluated using Cohen's kappa coefficient. RESULTS: The study includes a total of 689 patients with carcinoma, 252 in the study group and 437 in the control group. Regarding the concordance analysis of the tumor stage, 2.5% of disagreements were observed and the concordance between people who protocolize was near perfect (Kappa = 0.931). Regarding the evaluation of the recurrence risk, disagreements occurred in 7% of the cases and the concordance was near perfect (Kappa = 0.819). Regarding the sonography evaluation (TIRADS), the disagreements were 6.9% and the concordance was near perfect (Kappa = 0.922). Also, 4.6% of transcription errors were detected. CONCLUSIONS: In multicenter clinical studies, the centralized data protocolization o by a data-manager seems to present similar results to the direct protocolization in the database in the center of origin.

Susceptibility Genes and Chromosomal Regions Associated With Non-Syndromic Familial Non-Medullary Thyroid Carcinoma: Some Pathogenetic and Diagnostic Keys.

Thyroid cancer is the malignant tumor that is increasing most rapidly in the world, mainly at the expense of sporadic papillary thyroid carcinoma. The somatic alterations involved in the pathogenesis of sporadic follicular cell derived tumors are well recognized, while the predisposing alterations implicated in hereditary follicular tumors are less well known. Since the genetic background of syndromic familial non-medullary carcinoma has been well established, here we review the pathogenesis of non-syndromic familial non-medullary carcinoma emphasizing those aspects that may be useful in clinical and pathological diagnosis. Non-syndromic familial non-medullary carcinoma has a complex and heterogeneous genetic basis involving several genes and loci with a monogenic or polygenic inheritance model. Most cases are papillary thyroid carcinoma (classic and follicular variant), usually accompanied by benign thyroid nodules (follicular thyroid adenoma and/or multinodular goiter). The possible diagnostic and prognostic usefulness of the changes in the expression and/or translocation of various proteins secondary to several mutations reported in this setting requires further confirmation. Given that non-syndromic familial non-medullary carcinoma and sporadic non-medullary thyroid carcinoma share the same morphology and somatic mutations, the same targeted therapies could be used at present, if necessary, until more specific targeted treatments become available.

[Role of laparoscopic surgery in the treatment of achalasia: an analysis of 50 cases]. / Papel del tratamiento quirúrgico por vía laparoscópica de la achalasia de cardias: análisis de 50 casos.

UNLABELLED: Achalasia is an uncommon oesophageal motor disorder, with a controversial therapeutic management. AIM: The aim of our study was to analyse our experience in the management of achalasia, assessing the impact of minimally invasive surgery, its complications and its outcomes in the short and medium term. METHODS: A retrospective and descriptive study was designed, including all patients operated on between 1999 and 2010 with the diagnosis of achalasia. Previous diagnostic tests, duration of symptoms, previous non-surgical treatment, surgical approach, associated antireflux intervention, surgical time and perioperative complications were analysed. RESULTS: A total of 50 patients, 24 males and 26 females, with a mean age of 47 years underwent laparoscopic surgery. The mean duration of the disease was 2 years. Eleven (22%) patients had received endoscopic treatment (1-4 sessions) prior to the surgery, with 100% of symptomatic recurrence. The surgery was accompanied by a Dor fundoplication in 48 patients, and Toupet fundoplication in the remaining two. The mean surgical time was 123 minutes. There were 9 intraoperative complications (5 gastric mucosal perforations, 2 bleeding, 1 liver injury and 1 aspiration); 4 postoperative complications (3 scapular pain and 1 sub-phrenic collection) were reported. The long-term subjective symptomatic response was excellent/good in 84% of patients, intermediate in 12% and a poor response in 4%. The mean follow-up was 28 months. CONCLUSIONS: Heller cardiomyotomy should be the treatment of choice in selected Achalasia patients, because of its short and long term outcomes, and its low morbidity.