Abstract Objective To refine the previously developed scleroderma (systemic sclerosis [SSc]) gastrointestinal tract (GIT) instrument (SSC-GIT 1.0). Methods We administered the SSC-GIT 1.0 and the Short Form 36 to 152 patients with SSc; 1 item was added to the SSC-GIT 1.0 to assess rectal incontinence. In addition, subjects completed a rating of the severity of their GIT involvement (from very mild to very severe). Evaluation of psychometric properties included internal consistency reliability, test-retest reliability (mean time interval 1.1 weeks), and multitrait scaling analysis. Results Study participants were mostly women (84%) and white (81%); 55% had diffuse SSc. Self-rated severity of GIT involvement ranged from no symptoms to very mild (39%), mild (21%), moderate (31%), and severe/very severe (9%). Of an initial 53 items in the SSC-GIT 1.0, 19 items were excluded, leaving a 34-item revised instrument (the University of California, Los Angeles Scleroderma Clinical Trial Consortium GIT 2.0 [UCLA SCTC GIT 2.0]). Analyses supported 7 multi-item scales: reflux, distention/bloating, diarrhea, fecal soilage, constipation, emotional well-being, and social functioning. Test-retest reliability estimates were 0.68 and coefficient alphas were 0.67. Participants who rated their GIT disease as mild had lower scores on a 0-3 scale on all 7 scales. Symptom scales were also able to discriminate subjects with corresponding clinical GIT diagnoses. The Total GIT Score, developed by averaging 6 of 7 scales (excluding constipation), was reliable and provided greater discrimination between mild, moderate, and severe self-rated GIT involvement than individual scales. Conclusion This study provides support for the reliability and validity of the UCLA SCTC GIT 2.0, an improvement over the SSC-GIT 1.0, and supports a Total GIT Score in SSc patients with GIT.

Objectives. To assess the extent of discrepancies between different vascular registries, at various levels of validation, and to investigate whether such differences might alter the morbidity and mortality rates obtained from the gold standard dataset for carotid endarterectomy (CEA). Methods. All CEA operations in Helsinki University Central Hospital from 2000e2005 were retrieved from the local vascular registry (HUSVASC) and the Hospital Discharge Registry (HILMO). Both registries were validated at different levels to form the final dataset. Total and indication-specific perioperative morbidity and mortality rates were estimated from each level of validation and compared with those from the final dataset and with pooled rates from systematic reviews. Results. Initial search provided 675 and 681 CEAs from HUSVASC and HILMO, respectively, decreasing to 636 (94%) and 614 (90%) when using the specific operative codes for thrombendarterectomy and patch angioplasty. Manual verification of initial HUSVASC results proved that 655 (97%) operations were true CEAs. 18 further proven CEAs, registered only in HILMO, were added to form the final CEA dataset (n ¼ 673). The peri-operative morbidity and combined morbidity and mortality rates were 2.23% and 2.67%, respectively. Comparable rates were obtained from both registries, irrespective the level of verification. Conclusion. Registry data do not appear to be biased by random loss of some operations and thus they are reliable for decision-making. However, further research is still needed to estimate the permissible volume of omissions in a registry for the data-base to remain trustworthy.  2007 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.