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CytoAccess, a relational laboratory information management system for a clinical cytogenetics laboratory.

We developed a CytoAccess laboratory management system based on the widely used Microsoft Access software to facilitate data processing, result reporting, and quality management for a full-service cytogenetics laboratory. The CytoAccess system consists of four functional modules. The data entry module is for logging in patient information. The result entry module is used to generate chromosome, fluorescent in situ hybridization (FISH), and array comparative genomic hybridization (aCGH) reports. The administrative module enables periodic monitoring of quality control and quality improvement (QA/QI) parameters and produces billing forms. The maintenance module allows users to update clinical demographics, report templates, code tables, and to refresh data links. We have integrated into this system over 15,000 chromosome and FISH results from prenatal, postnatal, and cancer cases for the past six years. This system is cost-effective, user-friendly, flexible in updating, and potentially adaptable for data mining.

Journal Article↗

Prevalence, incidence, predictors and outcome of type 2 diabetes in Turkey.

OBJECTIVES: To investigate prospectively the incidence, certain predictors and outcomes of type 2 diabetes (DM), as well as to determine its prevalence cross-sectionally, in a representative sample of Turkish men and women. METHODS: Prospective evaluation of 3401 male and female participants (aged 48.2 +/-12 years). Follow-up constituted 19,050 person-years. Individuals with DM were diagnosed with criteria of the American Diabetes Association. Fatal and nonfatal coronary heart disease (CHD) was identified by clinical findings and Minnesota coding of resting electrocardiograms. Cut-points of > or = 95 cm in males and > or = 91 cm in females were selected for abdominal obesity. For prospective evaluations, cases with DM or CHD were excluded. RESULTS: Prevalence of DM in Turkish adults was estimated as 2.89 million (11.0% of the population aged > or = 35 years). Over a mean follow-up of 5.9 years, incident DM developed in 223 subjects, yielding an incidence per 1000 person-years of 11.0 in women and 12.4 in men. This corresponded to a 300,000 annual incidence. Following risk parameter levels but not HDL-cholesterol were significantly elevated at baseline in subjects developing DM compared to those without: age (5 years), waist girth (7 cm), blood pressure (12/6 mmHg), apolipoprotein B (7 mg/dl), total cholesterol (14 mg/dl), and fasting triglycerides (only in women, 52 mg/dl). Abdominal obesity (RR 2.61 [95%CI 1.87; 3.63]) and age in both genders, hypertension (RR 1.81 [95%CI 1.10; 2.98]) and low HDL-cholesterol in men alone were significant independent predictors of DM. Diabetes mellitus was a significant and independent predictor of fatal and nonfatal CHD, with a RR of 1.81 (95%CI 1.19; 2.75), after adjustment for sex, age, hypertension, waist circumference, serum total cholesterol and smoking status. CONCLUSIONS: The annual incidence of DM in Turkey rises very rapidly, currently stands at 300,000, and, hence, its prevalence also rises correspondingly. Insulin resistance appears to be a weak determinant of DM in Turkish women while abdominal obesity is the main determinant. Multivariately adjusted DM is a significant independent predictor of fatal and nonfatal CHD. These observations emphasize that measures to reverse or stop the "epidemic" of abdominal obesity are severely required.

Adult↗

Some ethical considerations in clinical trials.

The ethical norms established in various codes and regulations are inadequate to resolve some of the ethical problems presented by clinical trials. They are stated too vaguely to provide unequivocal answers to many specific questions. In order to remedy this situation, many commentators have proposed the development of more specific and complex regulations. We propose that a more fruitful approach would be to examine the ethical principles underlying the norms and to apply these principles to the specific problems. We apply this approach to two questions: (1) Is it ethical to select subjects for a randomized clinical trial (RCT) exclusively from Veterans Administration (VA) hospitals? (2) In the conduct of a RCT is it necessary to disclose the fact that therapy will be determined by chance? We conclude that problems of justice arise not only because of the vulnerability of patients in VA hospitals but also because of the loss of the physician-patient relationship in an RCT. However, the use of patients in a VA hospital is not always unjust; in most cases such use can be made more just through various modifications in design. We also conclude that the fact of randomization should be disclosed in any situation in which it might materially affect the prospective subject's decision, and that the values and preferences of the subjects should be taken into account in determining what information might be material. This work is only a preliminary step toward analyzing ethical issues in clinical trials. While some would challenge our conclusions, we hope that our methods will facilitate clarity about the locus of disagreement in current controversies and about the value questions that must be answered in order to set an ethical context for the conduct of clinical trials.

Clinical Trials as Topic↗

Primum utilis esse: the primacy of usefulness in medicine.

The famous and oft-quoted maxim "Do no harm" should not be thought of as the first principle of medical ethics. The documents of the Hippocratic tradition and clinical experience indicate that a more appropriate and helpful first principle would be "Above all, be useful." The concept of usefulness implicitly rests at the very heart of medicine itself and the physician-patient relationship. The failure to adhere to this concept undermines the physician-patient relationship, dissolves the distinction between quacks and physicians, and destroys the integrity of the medical profession. The determination of useful medical treatment belongs to both physicians and patients. Any decision to initiate, continue, or discontinue diagnostic or therapeutic action has both a medical and a personal value component; the former properly belongs to physicians and the latter to patients. Practicing medicine with the intent of producing benefit and being useful to the patient is far more fundamental than practicing medicine to avoid harm.

Clinical Competence↗

A conceptual model for clinical radiology reports.

The structural and informational content of clinical radiology reports was examined to develop a comprehensive representational schema of the concepts in the domain. The model involves several different conceptual levels, ranging from the high level description of the report to the lower level description of the clinical concepts contained in the reports and the specification of the terms used to express the concepts. The design of an adequate structured representation for the domain has important implications for the design of the electronic patient record, for the unification of different controlled vocabularies by enabling them to be mapped to one common representation, and for the facilitation of natural language processing of clinical reports so that coded data may be obtained.

Humans↗

[Laparoscopic ligation of spermatic vessels in varicocele].

Open surgical procedures and percutaneous transvenous radiological techniques are available for the treatment of varicoceles. With the advent of laparoscopic surgery another minimally invasive procedure has become available. In 39 patients with left unilateral and 1 with bilateral, clinically evident, varicocele laparoscopic ligation of the spermatic vessels was performed. In 17 cases both the spermatic veins and the artery were cut, whereas in 24 cases it was possible to spare the spermatic artery. In more than 90% of these cases the artery could be identified as a pulsatile vessel. No serious complications were encountered. All patients were discharged from the hospital on postoperative day 1 or 2. Out of 26 patients who could be followed clinically and by colour coded Duplex sonography, 1 showed signs of persistent and 1 of recurrent varicocele. The quick convalescence of the mostly young patients, the excellent identification of the anatomic structures, and the minimal surgical trauma are advantages of laparoscopic varicocelectomy.

Adolescent↗

[Criminal law problems in forensic medicine].

This paper first goes into cases of medical malpractice proceeding from the definition of the subject (forensic medicine). Among the material examined by the author lapses were to be assumed in 6.9% of the cases. A forensic autopsy can, however, also be of significance in countering false accusations. Forensic autopsies are regulated by Sect. 87 of the German Code of Criminal Procedure. Clinical autopsies are performed in Berlin in conformity with the Autopsy Act of 1996. Therapeutic removal of tissue is, moreover, also regulated by the Autopsy Act. Last year's Grafting Act, on the other hand, is Federal Law. Another act promulgated in 1997 has likewise provoked considerable controversial debate: viz. the Criminal Proceedings Amendment Act--keyword: DNA analysis/genetic fingerprint. And, finally, the paper also goes somewhat deeper into the introduction of breath-alcohol tests as evidence admitted in court. Further points discussed: reports prepared in connection with trials involving shootings along the Berlin wall, reports drawn up in connection with matters involving the abuse of anabolic substances by competitive athletes in the German Democratic Republic, reports on former GDR functionaries pertaining to their fitness to plead in court or to undergo detention. To conclude with, the question, whether evidence obtained by coerced vomiting can be used in court, is also discussed (drug couriers).

Autopsy↗

Representation of ophthalmology concepts by electronic systems: intercoder agreement among physicians using controlled terminologies.

OBJECTIVE: To assess intercoder agreement for ophthalmology concepts by 3 physician coders using 5 controlled terminologies (International Classification of Diseases 9, Clinical Modification [ICD9CM]; Current Procedural Terminology, fourth edition; Logical Observation Identifiers, Names, and Codes [LOINC]; Systematized Nomenclature of Medicine, Clinical Terms [SNOMED-CT]; and Medical Entities Dictionary). DESIGN: Noncomparative case series. PARTICIPANTS: Five complete ophthalmology case presentations selected from a publicly available journal. METHODS: Each case was parsed into discrete concepts. Electronic or paper browsers were used independently by 3 physician coders to assign a code for every concept in each terminology. A match score representing adequacy of assignment for each concept was assigned on a 3-point scale (0, no match; 1, partial match; 2, complete match). For every concept, the level of intercoder agreement was determined by 2 methods: (1) based on exact code matching with assignment of complete agreement when all coders assigned the same code, partial agreement when 2 coders assigned the same code, and no agreement when all coders assigned different codes, and (2) based on manual review for semantic equivalence of all assigned codes by an independent ophthalmologist to classify intercoder agreement for each concept as complete agreement, partial agreement, or no agreement. Subsequently, intercoder agreement was calculated in the same manner for the subset of concepts judged to have adequate coverage by each terminology, based on receiving a match score of 2 by at least 2 of the 3 coders. MAIN OUTCOME MEASURES: Intercoder agreement in each controlled terminology: complete, partial, or none. RESULTS: Cases were parsed into 242 unique concepts. When all concepts were analyzed by manual review, the proportion of complete intercoder agreement ranged from 12% (LOINC) to 44% (SNOMED-CT), and the difference in intercoder agreement between LOINC and all other terminologies was statistically significant (P<0.004). When only concepts with adequate terminology were analyzed by manual review, the proportion of complete intercoder agreement ranged from 33% (LOINC) to 64% (ICD9CM), and there were no statistically significant differences in intercoder agreement among any pairs of terminologies. CONCLUSIONS: The level of intercoder agreement for ophthalmic concepts in existing controlled medical terminologies is imperfect. Intercoder reproducibility is essential for accurate and consistent electronic representation of medical data.

Decision Support Systems, Clinical↗

Computer-prompted diagnostic codes.

BACKGROUND: The purpose of this study was to develop and evaluate a computer system that would translate patient diagnoses noted by a physician into appropriate International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes and maintain a patient-specific up-to-date problem list. METHODS: The intervention consisted of a computerized list (dictionary) of diagnoses, including practice-specific synonyms and abbreviations, linked to their corresponding ICD-9-CM codes. To record the diagnoses for the office visit before the intervention, physicians used International Classification of Health Problems in Primary Care (ICHPPC-2) codes. After the intervention, physicians used their own words or checked previously identified diagnoses on the computer-generated problem list. The computer then identified the correct ICD-9-CM code. Accuracy of coding was compared before and after the new computerized system was implemented. RESULTS: Visits in which all diagnoses matched increased from 58% to 76% (P < .001) with use of the computer system. Visits in which no computer diagnoses matched the chart decreased from 22% to 8% (P < .001). Errors of omission declined from 38% to 18% (P < .001). Errors of commission decreased from 19% to 11% (P = .006). Overall accuracy increased from 62% to 82% (P < .001). CONCLUSIONS: Outpatient medical diagnosis coding can be simplified and accuracy improved by using a computerized dictionary of practice-specific diagnoses and synonyms linked to appropriate ICD-9-CM codes. Such a system provides a computer-generated problem list that accurately reflects the chart and assists with prompted coding on subsequent visits.

Abstracting and Indexing↗

Long term prognosis in yersinia arthritis: clinical and serological findings.

Twenty two patients were followed up for a mean of 10.7 years after acute yersinia arthritis. Their clinical course, agglutination antibodies, antibodies against plasmid coded yersinia proteins, and laboratory parameters of inflammation were analysed. The clinical findings were unremarkable. Serum agglutinating antibodies against Yersinia enterocolitica were not found in any patient. Ten patients had no antibodies against plasmid coded bacterial proteins. Five patients showed IgG antibodies, one patient had an IgA and IgG result of questionable significance, and six patients had IgA and IgG antibodies in the immunoblot reaction. No evidence of systemic inflammation was found. The persistence of IgA or IgG antibodies, or both, did not have a discernible influence on the clinical course. The development of erosive changes in the sacroiliac joints occurred independently of yersinia infection.

Adult↗

Perceptions of psychosocial adjustment to acquired communication disorders: applications of the Code-Müller Protocols.

The 'Code-Müller protocols' (CMP) were introduced in 1983 and originally aimed to compare perceptions of psychosocial adjustment to aphasia and related disorders from the separate perspectives of patients, relatives and speech and language therapists as a basis for counselling. In later studies the items of the CMP were also used to examine perceptions of their importance as possible therapy targets in the rehabilitation of people with communication disorders. This paper describes the development of the CMP and presents an overview of their application in aphasia, laryngectomy and acquired deafness and discusses some clinical implications. Studies published in the past 15 years show that aphasic people and their relatives or significant others are significantly more optimistic concerning psychosocial adjustment than their therapists. Furthermore, optimism changes during the course of illness. The relative weightings given for therapy or rehabilitation targets significantly differ between different professional groups concerned with aphasia rehabilitation (speech and language therapists/pathologists, physiotherapists, occupational therapists, psychologists and physicians) and are influenced by clinical experience.

Clinical Protocols↗

Data structure and computer program for fast interactive searches of clinical diagnoses.

Since 1987 the IDC codes of all diagnoses of patients treated in our hospital are stored in a patient-oriented (upright) database. In order to facilitate interactive searches for specific diagnoses and their combinations this database has been inverted into a data structure sorted by diagnoses. The report presented describes the data structure and the functionality of a computer program that allows very fast searches for complex combinations of diagnoses.

Clinical Medicine↗

Morphology of non A-non B hepatitis (HNANB). A study of 104 cases.

A series of 104 liver biopsies from patients with clinical HNANB were classified under code into established histologic groups. Activity and basic features were semiquantitatively assessed using a score system. In 23/104 cases non viral lesions were diagnosed. After breaking the code the remaining 81 hepatic biopsies were ranged into three groups: post-transfusional cases (PT) (n. 20), sporadic cases with clinically documented initial "acute hepatitis" (SP1) (n. 44), sporadic cases without determined onset of disease (SP2) (n. 17). There were no statistically significant features discriminating histologically PT group from SP 1 + 2 group. However, aggressive forms of hepatitis (acute hepatitis with piecemeal necrosis [AVH+PMN] and chronic aggressive hepatitis [CAH]) were more frequent in PT group (11/20 = 55% in PT versus 28/61 = 45.9% in SP 1+2 groups). No statistical significant differences were detected for the scored basic pattern (i.e. acidophilic body type, mononucleosis-like bead file pattern, etc.). Bile duct lesions were observed approximately with the same frequency in PT and SP1 groups. Prevalence of fatty change was striking: 55% in PT group and 54.1% in SP1 group.

Biopsy↗