TSH levels are associated with vitamin D status and seasonality in an adult population of euthyroid adults.

A circannual periodicity in thyrotropin (TSH) secretion has been reported but the causes of these phenomenon are still undefined. Vitamin D exerts a direct influence on pituitary axes including the hypothalamus-pituitary-thyroid axis. Aims of the present study were to investigate the presence of a seasonal variability of TSH secretion and to study the association between vitamin D status and TSH levels in a population of euthyroid adults. For this purpose, we recruited 294 euthyroid adults (M/F 133/161, 48.5 ± 12.4 years). Study participants underwent clinical examination and routine biochemistry assessment. Vitamin D deficiency was diagnosed for serum 25(OH) vitamin D <25 nmol/l. Significantly higher TSH levels were found in subjects who underwent blood sampling during the Autumn-Winter compared with individuals evaluated in Spring-Summer (2.3 ± 1.3 vs. 1.8 ± 1.1 µIU/ml, p = 0.03). Vitamin D deficiency was strongly associated with higher TSH levels (p = 0.01) after adjusting for sex, age, and sample's season. Although vitamin D deficiency was also associated with metabolic syndrome and its components, the association between TSH levels and vitamin D status persisted also considering these confounders. These data reveal the occurrence of seasonal variability of serum TSH concentration in euthyroid subjects and provide evidence for the first time that an association exists between vitamin D status and serum TSH levels.

Anorectal reconstruction by electrostimulated graciloplasty as part of abdominoperineal resection.

AIMS: To report the outcomes of anorectal reconstruction by electrostimulated graciloplasty as part of abdominoperineal resection, on data prospectively collected over 10 years. PATIENTS AND METHODS: Twenty-three abdominoperineal resections were associated to coloperineal pull through, double graciloplasty and loop abdominal stoma. Fifteen patients also received an implantable pulse generator, either for unsatisfactory result after external-source intermittent electrostimulation and biofeedback (five cases) or during graciloplasty (10 cases). Follow-up was to a maximum of 10 years. Functional outcome was followed up in sixteen patients who underwent stoma takedown. RESULTS: Mean actuarial survival at 5 years was 72.3%. Satisfactory results (score < or =8) occurred in 75% of patients (three without and 13 with stimulator) in the early stages, decreasing to 57% at 1 year and gradually increasing up to 100% at 5 years and over. CONCLUSIONS: Total anorectal reconstruction yields a good functional outcome over time. Thus, despite, and because of, a high complication rate and a great drain on resources, it should be considered a suitable procedure only for selected, strongly motivated patients.

Discriminant power and information content of Ranson's prognostic signs in acute pancreatitis: a meta-analytic study.

OBJECTIVE: To determine a meta-analytical definition of the discriminant power of Ranson's signs in the prediction of acute pancreatitis severity and outcome, and of their information content, also compared with clinical judgment. DATA SOURCES: Two hundred eleven studies since 1974, reporting any predictive system for acute pancreatitis (MEDLINE by various Medical Subject Headings in MEDLARS, Current Contents, Medscape, Virtual Hospital, and other on-line medical services). STUDY SELECTION: One hundred ten studies reporting clinical use of Ranson's signs were retained. A quality index was calculated for each study. A selection was made according to inclusion criteria, separately for prediction of severity (19 studies; group S) and prognosis (10 studies; group P). Six other studies reporting clinical judgment results were also selected (group C). DATA EXTRACTION: Sensitivity and specificity values were extracted. Effect sizes were calculated and summarized by the inverse variance-weighted method. Categorical models were studied by analysis of variance. Publication bias was sought by correlation test and analysis of variance. Summary receiver operating characteristic curves were drawn, and the corresponding false-positive rate (FPR) and true-positive rate were calculated for each group. From the total true-positive rate and FPRs, the probabilities of illness for positive and negative results were calculated, for severe pancreatitis prevalence from 0 to 1. Last, the area below the curve and the ratio between this and that of the "perfect test" were calculated as a measurement of information content. DATA SYNTHESIS: Ranson's signs demonstrated poor discriminant power in both predictions: "d" values were 1.200 (95% confidence interval, 1.083-1.318) and 1.302 (95% confidence interval, 1.046-1.559), respectively. The lack of homogeneity in group S (Q = 58.737; p = .0000032) can be explained by the presence of three outliers. The summary curves showed, for low FPRs, a higher sensitivity of clinical judgment; Ranson's signs reached useful sensitivity only for high FPRs. No differences between groups in the area below the information content curves were found. CONCLUSIONS: Ranson's signs showed a poor predictive power. The information content did not differ from that of clinical judgment.

[Method and application limitations of decision support systems in acute pancreatitis]. / Limiti metodologici e applicativi dei sistemi di supporto alle decisioni nella pancreatite acuta.

Several decision support systems (DSSs) for acute pancreatitis (AP) were analyzed with reference to development methods, procedure limits and operational performances. Almost all the DSSs have been addressed to the early definition of severity, which appears the only decisional point in the approach to the management of AP. None of the three groups of methods, multifactor, scoring and bayesian systems, provides an explicit evidence of effectiveness. The multifactor systems (Ranson and successive) show inadequacy of design and operational limits which involve poor reliability and conflicting indications from the different centers. The scoring systems (APACHE, SAPS) have been projected and developed for clinical situations quite different from the AP at the onset, and seem more properly to be applicable to the monitoring of its complications. The bayesian systems, although the models used until now present important methodological shortcomings, are those which furnished the best results but are lacking in clinical validation and present a form hardly accepted by the clinician. Despite the disappointing operative results and their limited use in the AP, the DSSs probably constitute one of the most effective tools to improve the management of the severe forms, on condition that the methodology of design enad trial is correctly adjusted.

[The prognostic evaluation of acute pancreatitis]. / Valutazione prognostica della pancreatite acuta.

Early identification of severity is one of the most important problems in acute pancreatitis, both for decision-making and classification. Predictive criteria show a wide range of accuracy: clinical examination (on admission: 76-85%); single laboratory data (PCR: 68-98%, C3-C4: 63-72%); multifactorial scoring systems (Ranson: 65-82%, Imrie: 78-95%); diagnostic peritoneal lavage (72-90%); CT features (52-81%). In 1982 we started a prospective evaluation of the prognostic performances of a bayesian statistical model for the prediction of severe vs mild pancreatis and death vs survival, which uses the outcome-related patterns of several variables, assuming their independence, analysed on a data of 44 patients. The performances have been calculated prospectively by comparing the expected vs actual results on 88 further patients (accuracy, sensitivity and specificity, respectively, in the prediction of severe pancreatitis: 92%, 92%, 93%; in the prediction of death: 95%, 97%, 87%). Moreover, the model can represent classes of risk by combining prediction of death + severe pancreatitis (DSP), survival + severe pancreatitis (SSP) and survival + mild pancreatitis (SMP) (accuracy, sensitivity and specificity, respectively, in the prediction of DSP: 97%, 83%, 100%; in the prediction of SSP: 95%, 87%, 97%; in the prediction of SMP: 95%, 97%, 90%). Our model enables clinicians dealing with other population to re-determine different variables or integrate them with new information, whenever available. It seems to be transferable and adaptable, even with a probable further increase of the performances, without compromising the objectivity of the predictive judgement and the homogeneity of the classes of risk.

[Gastric carcinoma in the elderly (clinical findings and results)]. / Il carcinoma gastrico nell'anziano (rilievi clinici e risultati).

On the basis of a series of 643 patients operated on for gastric cancer, the Authors seek to establish whether this disease presents clinical differences with advancing age of such a nature as to have a significant effect on therapeutic management. The series is divided into two groups, the first consisting of patients aged below 70 and the second of patients aged over 70. The following aspects were evaluated: sex, tumour site, oncological stage, type of surgery performed, operative mortality, postoperative survival, as assessed in overall terms and also differentiated in relation to curative or palliative surgery and oncological stage. Analysis of the data confirms that, apart from certain particular aspects, carcinoma of the stomach in the elderly benefits from the same sort of indications and techniques as those proposed for younger patients, with comparable postoperative survival rates, but with a higher operative mortality. To achieve better operative results, what is needed, in addition to correction of metabolic and functional abnormalities, is thorough assessment of risk factors. In patients with tumours at advanced stages, usually characterized by very poor postoperative results, the presence of major risk factors may raise serious doubts as to the actual advisability of the surgical indication itself.

[Clinical implications of the infiltration level of early gastric cancer]. / Implicazioni cliniche del livello di infiltrazione nell' "early" gastrico.

Sixty-nine cases of early gastric cancer (EGC) were taken into consideration, out of a series of 585 operations for gastric cancer, carried out between January 1976 and June 1988. Differences between two groups (I: EGC limited to the mucosa; II: EGC with invasion of both the mucosa and submucosa) have been assessed with reference to familiarity for gastric cancer, previous gastric and duodenal pathology, symptoms, site of the lesion, histological features, lymph node metastatic involvement and results. Despite some pathological and clinical differences, modification of current surgical treatment with endoscopic management is not justified by any features, even when dealing with intramucosal, intestinal type EGC, because of possible lymph node involvement or long-term recurrences.

Automated selection of high-risk patients with acute pancreatitis.

One hundred six early features were retrospectively collected on 44 patients with acute pancreatitis and stored in a database programmed on a microcomputer. Intraoperative/autopsy findings or clinical course categorized patients as having severe (n = 16) or mild (n = 28) pancreatitis. The frequency of 88 early available variables was analyzed. Twenty significant differences were found and used to program a Bayesian prediction of severity, assuming their independence. The computer's performance was assessed by retrospective testing of the patients, and a further 47 (14 severe, 33 mild) were studied prospectively, with a comparison carried out involving the unaided prediction of the clinicians. Finally, all 91 patients were retrospectively tested with the early predictive Ranson's signs and the results were compared with the computer's output. In the prospective evaluation, the computer's performance was 89.4% accuracy, 100% sensitivity, 84.8% specificity, while that of the physicians was 65.9%, 71.4%, 63.6%, respectively, like the performances of Ranson's criteria. Methodologic problems were: selecting patients to study, based on wide inclusion and exclusion in hindsight of the false-positives; dividing them into groups, based on both pathologic and clinical criteria; and the assumption of independence within the variables. The use of the procedure in other populations requires a specific analysis of the discriminant variables, but this study suggests a method to compare several samples of patients which allows prospective and controlled clinical trials.

[Design criteria for a computerized clinical database]. / Criteri di progettazione di un archivio clinico computerizzato.

The techniques of data management constitute a principal field in medical informatics, both for systems oriented to sole information retrieval, and basic-systems for more sophisticated applications. The operative utility of a data base depends on a careful planning based on foreseen requirements, and on the observance of some methodological rules. Such as, a precised preliminary study for the selection of clinical data to include in the data base, the choice of better tools and methodologies for the data collection and the right programming of software for the management of the archives. The knowledge of these problems allows, in many cases, the programming of computerized data base to use efficiently in the management of clinical information and in the planning of research. These problems, which do not depend on the hardware used, are commonly found in these applications. However, they have to be solved either for the use of large data base in hospital, which run on mainframe, or for the archives of the department, which can be built by every clinician on his own personal computer.

[Efficacy of a low-residue diet in the prevention of immuno-nutritional changes caused by the preparation of the colon for surgery]. / Efficacia di una dieta a basso residuo nella prevenzione delle alterazioni immunonutrizionali indotte dalla preparazione del colon.

Twenty-four patients about to undergo colorectal resection for cancer were randomly divided into two groups of 12: A and B. All had an uninterrupted colonic preparation for colonoscopy and surgery involving dietary restrictions for 4-8 days (450 calories; 25 g. proteins daily). In the group B an additional intake of 1200 Kcal. and 32 g. protein daily was given by a low-residue diet. Body weight, lymphocytes, albumin, prealbumin, C3, C4 and Complement activity (CH100) were evaluated on admission and after bowel preparation. In group A statistically significant decrease were found in all the parameters. In group B significant reduction occurred only in C4. The data confirm a relationship between immuno-nutritional state and preparation for colonic surgery, and suggest that a preoperative nutritional support may avoid or limit bio-humoral changes, indicative of an immuno-nutritional impairment.

[Systems assisting decisions in clinical medicine]. / Sistemi di aiuto alle decisioni in medicina clinica.

There are numerous systems and computerized procedures which have been developed and tested as a guide to clinical decisions. The methods used in the development of these systems can be divided into two large groups: mathematical and logical. None of these can be considered as better than the other in absolute, but the efficiency of each system depends on that problem is to be described and solved. The mathematical methods seem more suitable in the description of biological systems and for the selection of groups which have discriminant and sufficiently defined characteristics. Meanwhile the logical methods are better in the description and the formalization of more complicated clinical problems, characterized by uncertainty and availability of more or less numerous alternatives. It is foreseen that in the next years the systems for aided decision making will be programmed making use of methods belonging to both categories, and particularly, the expert systems will be planned using both artificial intelligence techniques and mathematical and statistical methods. The increasing frequency in the use of such systems in clinical practice will cause a reevaluation and a checking of most aspects of medical proceedings, as seen by the new methodologies or the traditional methods whose use could be driven by computer.

[Research on correlations between immuno-nutritional parameters and oncologic stage in patients operated on for cancer of the stomach]. / Ricerca di correlazione tra parametri immunonutrizionali e stadio oncologico in soggetti operati per cancro dello stomaco.

A correlation was sought, in 40 patients operated on for gastric cancer, between a number of immunological and nutritional variables and oncological stage. Prealbumin, transferrin, C3, C4, total complement (CH100), total serum lymphocytes, IgG, IgA and IgM were evaluated preoperatively prior to commencing any nutritional treatment. Statistical analysis was performed with a view to assessing whether the values of the above-mentioned parameters, taken singly or as a whole, differed in the 4 in the 4 oncological stages (UICC 1978). Analysis of individual parameter values showed a significant difference between stage I and stage IV with regard to prealbumin and between stages I and II with regard to C3 (p = 0.0165 and p = 0.0329, respectively). When evaluating the 9 parameters as a whole, no significant differences emerged, though such differences might be detected on increasing the study population and by adopting statistical procedures aimed at eliminating the least significant variables from the model.

Changes in nutritional and immunologic parameters after preparation for colonic surgery.

In 15 patients about to undergo colorectal resection for cancer (group I), body weight, lymphocytes, albumin, prealbumin, complement components C3 and C4 and total hemolytic complement activity (TC) were evaluated on admission to hospital and after preroperative preparation which involved dietary restrictions for 5-9 days (450 calories, 25 g protein daily). The same parameters were evaluated in 15 patients admitted for other major surgery not requiring colonic preparation (group II). Statistically significant reduction in prealbumin, C3, C4 and TC were found only in group I. The observations suggest a relationship between immunonutritional status and preparation for large-bowel surgery, reproducing a state of acute malnutrition.

Effect of perioperative somatostatin administration of sphincteroplasty-induced increase of amylase.

Twenty patients undergoing sphincteroplasty for cholelithiasis were randomly divided into two groups of 10. The former (T) were treated with a 4-h somatostatin intravenous drip (250 micrograms/h), started at the beginning of operation, while the latter (C) made up the control group. Serum and urine amylase, amylase creatinine clearance ratio, and liver function tests were assessed for 2 days before surgery, after the operation and for a period of 5 postoperative days. Homogeneity between the two series was verified in experimental conditions. Statistical differences occurred postoperatively in amylase creatinine clearance ratio, which proved higher in C group, and gamma-GT, which was higher in T group. Short-term somatostatin administration proved effective in reducing the postoperative amylase creatinine clearance ratio, although more evident results are reported after long-term administration. Cholestasis or any serious impairment in liver function did not occur, suggesting the suitability of somatostatin use even in patients with jaundice. Since a relationship between postoperative amylase levels and risk of pancreatitis has not yet been proved, the value of somatostatin in the prevention of postoperative pancreatitis after sphincteroplasty needs to be further verified.

Early detection of necrotizing pancreatitis by computer.

In 59 patients admitted with a clinical picture compatible with acute pancreatitis, 88 features, recorded within the first day, were retrospectively collected and stored in a database programmed on a NCR DM V personal computer. On the basis of the final diagnosis, the patients were divided into two groups, according to Becker's grading of acute pancreatitis. A third group comprised the false-positives. Using 14 significant differences (p less than 0.025) between the three groups, a Bayesian analysis was programmed for early prediction, in terms of percentage probability, of each of the three final diagnoses. A retrospective assessment of computer performance was carried out in the patients entered the initial database, and further 38 underwent a prospective test. In the detection of necrotizing pancreatitis the procedure gave 95.8% accuracy, 91.9% sensitivity and 98.3% specificity. Previous diagnosis of pancreatitis, estimate of the degree of necrosis, data to be used for the processing, are discussed. Performances, similar in retrospective and prospective series, proved higher as compared to diagnostic peritoneal lavage. Comparison with Ranson's multiple criteria or computed tomography is inappropriate. The system seems to be reliable feasible and adaptable. The choice of treatment is difficult in acute pancreatitis. A computer-aided analysis may provide a better approach, than an unaided clinical estimate, to several decisional problems in acute pancreatitis.