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Administrative practices and procedures; internal agency review of decisions; companion document to direct final rule; correction--FDA. Proposed rule; correction.

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of June 16, 1998 (63 FR 32772). The document proposed to amend the FDA regulations governing the review of agency decisions by inserting a statement that sponsors, applicants, or manufacturers of drugs (including biologics) or devices may request review of a scientific controversy by an appropriate scientific advisory panel, or an advisory committee. The document was published with an error. This document corrects that error.

Decision Making, Organizational↗

A flowsheet for documenting independent nursing visits after breast surgery.

PURPOSE/OBJECTIVES: To redesign a postoperative flowsheet already used in clinical practice with patients who have undergone breast surgery to reflect documentation of assessments and interventions noted on each nursing visit. DATA SOURCES: Memorial Sloan-Kettering Cancer Center Standards of Practice for Ambulatory Care, clinical experience, and published articles. DATA SYNTHESIS: A comprehensive flowsheet was redesigned to provide consistency in documentation and reflect current needs of patients who have undergone breast surgery who are in ambulatory care. CONCLUSIONS: Implementation of the new flowsheet has decreased staff documentation time during busy office practices and accurately reflects the nursing care provided to patients after breast surgery. IMPLICATIONS FOR NURSING PRACTICE: Consistency in patient care can be maintained and efficiency can be increased with use of a comprehensive flowsheet.

Ambulatory Care↗

Examination for sexual assault: is the documentation of physical injury associated with the laying of charges? A retrospective cohort study.

BACKGROUND: Few studies have examined whether there is an association between individual medical findings and legal outcome in cases of sexual assault. This study was undertaken to determine the relation between the extent of documented physical injury and a positive legal outcome in cases of sexual assault and to determine other factors associated with the laying of charges in such cases. METHODS: In this retrospective cohort study, the authors reviewed the charts and medicolegal reports for all cases of sexual assault that were handled by the BC Women's Sexual Assault Service in 1992 for which a police report had been filed. Information on patients' characteristics, the nature of the assault and the extent of injury was extracted from these records. A system for scoring clinical injury was developed by 4 of the physicians at the Sexual Assault Service, and a clinical injury score was assigned for each case by one physician. The relation between the outcome (in terms of whether charges were laid) and the circumstances of the case was examined by logistic regression. RESULTS: A total of 95 cases with complete medical records and information about legal outcome were identified during the 1992 calendar year. After adjustment for income level and the patient's knowledge of the assailant (either as an acquaintance or as his or her partner), the odds ratio (OR) for charge-laying in a sexual assault case with documented moderate to severe injury was 3.33 (95% confidence interval [CI] 1.06-10.42). Socioeconomic status above the group median (defined as annual income greater than $21,893) (OR 3.26, 95% CI 1.09-9.71) and knowledge of the assailant (OR 4.58, 95% CI 1.52-13.79) were also associated with charge-laying. Presence of genital injury per se, age of the patient and detection of sperm by microscopy at the time of examination were not associated with the laying of charges. INTERPRETATION: The results of this study show that the extent of documented injury is associated with the laying of charges in cases of sexual assault. However, many questions remain about the effectiveness of the medical component of gathering such evidence.

Adolescent↗

More space, more speed. Scanning technology and COLD help improve document imaging.

UNLABELLED: Children's Hospital Medical Center, Akron, Ohio PROBLEM: The 100-year-old-plus medical center needed a reliable, economical and easy-to-use document storage method that provided a long and secure archival life. SOLUTION: Children's adopted Hewlett-Packard magneto-optical jukeboxes and Optika software. RESULTS: Since the jukeboxes became operational in January 1998, Children's has maintained "24 x 7 availability" of its stored documents for up to 150 concurrent users without any downtime. KEYS TO SUCCESS: "We started implementation in the accounting department with patient billing, hospital general ledger, accounts payable and employee payroll, and the document imaging system has quickly gained acceptance in other departments as well."

Hospital Information Systems↗

Effectiveness of a writing improvement intervention program on the readability of the research informed consent document.

BACKGROUND: Problems with the comprehensibility of human research informed consent have been documented since the 1970s, and efforts aimed at rewriting consents have not been successful in consistently producing more readable consents. This study employed researched principles of reading comprehension research to create writing intervention program designed to help the research writer produce more comprehensible informed consent documents. The purpose of this study was to determine if this intervention program was effective. METHOD: The key component of the writing improvement intervention packet was a newly formatted consent form that contained annotated instructions for researchers on how to write each section for optimum comprehension. The resulting consent forms were evaluated using a Readability and Processability Form (RPF). The RPF is based on reading research and includes the Fry Scale, which yields an approximate grade reading level. The RPF assigned points to each of the 20 areas of comprehension analysis according to strict scoring criteria, and target scores were established by the authors in consultation with the hospital institutional review board. RESULTS: We evaluated 66 post-intervention informed consents. The mean readability and processability score was 62, resulting in the RPF classification of "good." The established readability and processability target range was good to excellent or 61-100 points; 66% of the forms scored in this range. In our 1995 pre-intervention study, the corresponding score was 12%. The target range for grade reading level was 8th grade: 53% scored in that range as compared with 4% in 1995. A question-by-question analysis of each of the 20 checklist items on the RPF identified important aspects of the consent writing that improved and others that were still weak and needed improvement. CONCLUSIONS: The Hartford Hospital writing improvement intervention program was associated with the production of more comprehensible informed consent documents. Using the intervention materials, investigators from a variety of departments could function independently to produce readable consent forms. This program may help others who wish to assist their research departments in creating consents that are written for optimal reading comprehension.

Cognition↗

[X-ray documentation of the anamnesis and physical data in patients with rheumatism within the scope of the medical information system WAMIS].

A computerized on-line system of evaluating of symptoms and physical data in rheumatology is presented. Case history, previous treatment, and physical examination are documented. The documentation of the latter may be performed in two ways: one records only joint symptoms, the other includes joint measurements. In comparison to the former off-line method, all data are much better available. Moreover, we believe it to be considerably timesaving. This system should also allow an electronic differential diagnosis of rheumatic diseases, after completing laboratry and X-ray documentation.

Austria↗

Resource document on mandatory outpatient treatment.

Mandatory outpatient treatment, or outpatient commitment, refers to court-ordered treatment for patients who suffer from severe mental illness and who are unlikely to be compliant with such treatment without a court order. Many states already have commitment statutes that permit mandatory outpatient treatment, and others are considering enacting new legislation or amending existing statutes. This Resource Document was prepared under the auspices of the American Psychiatric Association's Council on Psychiatry and Law to provide information to those who are drafting mandatory outpatient treatment legislation. It begins with a review of the history of mandatory outpatient treatment and recent empirical findings, followed by a detailed discussion of the salient issues in mandatory outpatient treatment. The document concludes with a statement of recommendations concerning key provisions in statutory schemes of mandatory outpatient treatment programs. This Resource Document endorses the view that mandatory outpatient treatment can be a useful intervention for a small subset of noncompliant patients with severe and chronic mental illness who go in and out of psychiatric hospitals through the so-called "revolving door."

Chronic Disease↗

[Microbial infection documented on admission to the intensive care unit for post-chemotherapy neutropenia after empiric antibiotic therapy].

OBJECTIVE: The purpose of this study was to determine whether a systematic strategy of multiple microbiological samples for all adult patients with neutropenia admitted to an intensive care unit could document sepsis despite prior empiric antibiotic therapy. PATIENTS AND METHODS: All adults admitted to the intensive care unit with chemotherapy-induced neutropenia (WBC < 500/mm3) were included in the study. Microbiological samples were systematically obtained in all patients: 6 blood, 1 stool, 1 urine, 1 nasal swab. Data were analyzed for 54 consecutive patients: 22 men, 32 women, 42 with hematology diseases and 12 with solid tumors, mean age 46.6 +/- 14.4 years. Assessment of disease severity showed: simplified gravity index = 256 +/- 17; organ system failure score on day 1 = 2.42 +/- 1.1; 26 cases of septic shock among 47 cases of sepsis. Mortality was 50%. Within 48 h, bronchioalveolar lavage samples were obtained in 48 patients, and there were 12 spinal taps, 3 laparotomies, 3 skin biopsies and 6 sinus punctures. RESULTS: A microorganism was isolated in 39 patients (70%): 12 Gram negative, 12 Gram positive, 11 mycoses, 3 cases of herpes. Positive cultures were found for 31 blood, 1 bronchioalveolar lavage, 2 surgical, 5 serous and 22 oral or digestive tract samples. Documented microbial infection did not have prognostic value. Septic shock at admission was predictive of poor outcome. DISCUSSION: Despite prior antibiotic therapy in 46 patients, with a theoretically active drug in 37 cases, a systematic strategy of multiple deep samples increased the number of documented cases of infection in neutropenic patients. Oral and digestive tract infections predominated despite selective decontamination of the digestive tract.

Adult↗

Documenting pediatric lens problems with the MTI polaroid photoscreener.

PURPOSE: To evaluate the use of the MTI photoscreener (Medical Technology Inc, Iowa City, Iowa) in assessing and documenting lens abnormalities in the pediatric ophthalmology clinic. METHODS: MTI photoscreener photographs of pediatric patients with lens abnormalities were taken to assess and document lens opacities and subluxation, to assist with explanations to parents, and to monitor progression of abnormalities. Postoperative photographs were taken to assess opacification of the posterior capsule and contact lens fit. RESULTS: Nineteen children with lens abnormalities were examined. Twelve patients underwent surgery and 9 patients had postoperative photoscreener pictures. Illustrative cases are reported. CONCLUSION: The MTI photoscreener is a useful adjunct to clinical examination in the assessment and documentation of pediatric lens abnormalities.

Aphakia, Postcataract↗

Making High-level Queries on Diverse Genome Data: A Structured Genome Document Database System Based on GXML and GQL.

Complete DNA sequences (genomes) and associated data are being made available worldwide at an astonishing rate. Through computer analysis of such data, molecular biologists hope to gain an overall understanding of the genome, such as by predicting large-scale gene networks. However, this is difficult because diverse genome data are scattered across many highly heterogeneous databases, and because existing database systems lack the facilities to expose and analyze functional relationships among the data. To address these problems, we propose a new type of genome database system. Since a genome can be thought of intuitively as a kind of 'document', our system uses a structured document language based on XML to effectively represent genomes and associated data. The information-rich structures of the genome documents help cope with data diversity and heterogeneity. A powerful query language is introduced that exposes important biological relationships among the genome data. We have obtained favorable results from several experiments, demonstrating the usefulness of our method in building a top-down view of genome functionality.

Journal Article↗

An update on HL7's XML-based document representation standards.

Many people know of HL7 as an organization that creates healthcare messaging standards. But HL7 is also developing standards for the representation of clinical documents (such as discharge summaries and consultation notes). These document standards comprise the HL7 Clinical Document Architecture (CDA). Last year we presented a high-level conceptual overview of the CDA. Since that time, CDA has entered HL7's formal ballot process (which when successful will make the CDA an ANSI-approved HL7 standard). This article delves into the technical details of the current CDA proposal. Note that due to space limitations, only a subset of CDA details can be described. Also, because the ballot process elicits considerable feedback, it is likely that the material presented here will undergo evolution prior to becoming a final standard. The most up-to-date information is available on HL7's web site (www.hl7.org).

Medical Records Systems, Computerized↗

[Evaluation of thoroughness and legibility of informed consent documents in pediatric surgery].

BACKGROUND: The written information that is provided to the patient must gather a series of characteristics, quantitative and qualitative, so that fulfill the ethical criteria that govern the theory of the Informed Consent. AIMS: To evaluated the degree of exhaustivity and readability of a series of Informed Consents forms in Pediatric Surgery units. MATERIAL AND METHODS: 1. Forms: We evaluated 118 consent forms submitted by 17 pediatric surgery units. 2. Exhaustivity: The studied variables have been: name of the hospital, name of the patient, name of the physician, date, description of the procedure, objectives, risks mention, personalized risks, possibility of recovery, benefits of the procedure, alternatives, possibility from withdrawing the assent, arrangement to widen the information, comprehension of the document, express assent and signatures. All the variables are dichotomics, being collected your presence or absence. 3. Readability: Each document has been introduced in the program "Corel Word Perfect". It was applied to the usefulness "Grammatik" and were collected: number of words, number of phrases, Flesch/Kincaid index, Orational Complexity index and LEGIN index. RESULTS: 1. Exhaustivity: The paragraphs presence in the different forms by order of frequency were: physician signature (100%), express assent (100%), signatures (100%), date (98%), name of the patient (97%), comprehension of the forms (97%), name of the physician (94%), risks mention (92%), name of the hospital (85%), description of the procedure (78%), possibility from withdrawing the assent (70%), personalized risks (67%), arrangement to widen information (43%), to explain alternatives (41%), objectives of the procedure (36%), benefits (36%), and possibility of the recovery (16%). 2. Readability: 11.1% of the forms fulfills the Flesch index, 27.9% the Orational Complexity index, and 22.1% LEGIN index. CONCLUSIONS: Most of the documents offer sufficient quantity of information with respect to the formal aspect and the risks an less with respect to the benefits. This seems to indicate your defensive character. Equally, they are difficult to reading and by difficult to understanding.

Child↗

XML and the VITAL standard: the document-oriented approach for open telemedicine applications.

This paper describes an effort to create a common, document-oriented architecture for the interchange of medical data in healthcare telemedicine applications. Key components are: The VITAL standard specifying a common (medical device independent) representation of Vital Signs Information and the Extensible Markup Language (XML) specifying the document specifications form, an architecture that, in aggregate, define the semantics and structural constraints necessary for the exchange of vital signs and related medical data. The modelling and design technique for the described application has been the Unified Modelling Language (UML). The XMI (XML Metadata Interchange Format) of the Object Management Group (OMG) provided the meta-model for this application, for sharing objects using XML, via the transfer of the application's UML model to XML documents and DTDs.

Humans↗

Closing the loop in ICU decision support: physiologic event detection, alerts, and documentation.

Automated physiologic event detection and alerting is a challenging task in the ICU. Ideally care providers should be alerted only when events are clinically significant and there is opportunity for corrective action. However, the concepts of clinical significance and opportunity are difficult to define in automated systems, and effectiveness of alerting algorithms is difficult to measure. This paper describes recent efforts on the Simon project to capture information from ICU care providers about patient state and therapy in response to alerts, in order to assess the value of event definitions and progressively refine alerting algorithms. Event definitions for intracranial pressure and cerebral perfusion pressure were studied by implementing a reliable system to automatically deliver alerts to clinical users alphanumeric pagers, and to capture associated documentation about patient state and therapy when the alerts occurred. During a 6-month test period in the trauma ICU at Vanderbilt University Medical Center, 530 alerts were detected in 2280 hours of data spanning 14 patients. Clinical users electronically documented 81% of these alerts as they occurred. Retrospectively classifying documentation based on therapeutic actions taken, or reasons why actions were not taken, provided useful information about ways to potentially improve event definitions and enhance system utility.

Decision Support Systems, Clinical↗

An electronic documentation system increases diagnostic code capture for very low birth weight infants.

INTRODUCTION: Information describing medical interventions and patient outcome of very low birth weight (VLBW; BW <1500 grams) infants who receive neonatal intensive care is necessary to evaluate the quality of health care. We developed an electronic patient documentation system (EDS) called PCode to identify and select patient diagnostic (DX) codes and compared EDS to the previous paper-based documentation system (PDS). Our hypothesis was that EDS would capture more patient diagnostic codes than PDS. METHODS: PDS was originally developed as a two page 'code sheet' which listed all 275 neonatal diagnoses/management options and corresponding 3-4 character diagnostic (DX) codes, organized by organ system. PDS code sheets were manually completed by one of three trained 'coders' for every neonatal patient. EDS was developed as a Java application with the 'coder' selecting DX codes from drop lists also categorized by organ system. The study intervention was patient code selection using either the PDS or the EDS system. Both systems produced a paper DX code summary. PDS data capture occurred from 11/1997-3/1999 followed by EDS data capture until 8/2000. The primary outcome variable was DX codes captured per patient. Data were analyzed using independent t-test and linear regression. RESULTS: The number of diagnoses increased with decreasing birth weight. After linear regression was applied to control for birth weight, the number of DX codes was 31% greater in the EDS group, 7.2 +/- 2.9 DX codes/patient, p=0.008. There was a trend towards fewer erroneous DX codes in the EDS group. The most common DX codes were hyaline membrane disease, sepsis evaluation and hyperbilirubinemia, as expected for this patient population. CONCLUSIONS: EDS captured more VLBW infant DX codes compared to PDS. These results support the transition toward electronic data documentation for the neonatal clinical environment. Electronically linking PCode to the patient database has been initiated and should reduce manual coding errors.

Diagnosis↗

Electronic document management systems: an overview.

For over a decade, most health care information technology (IT) professionals erroneously learned that document imaging, which is one of the many component technologies of an electronic document management system (EDMS), is the only technology of an EDMS. In addition, many health care IT professionals erroneously believed that EDMSs have either a limited role or no place in IT environments. As a result, most health care IT professionals do not understand documents and unstructured data and their value as structured data partners in most aspects of transaction and information processing systems.

Analog-Digital Conversion↗

Free-text medical document retrieval via phrase-based vector space model.

Many information retrieval systems are based on vector space model (VSM) that represents a document as a vector of index terms. Concepts have been proposed to replace word stems as the index terms to improve retrieval accuracy. However, past research revealed that such systems did not outperform the traditional stem-based systems. Incorporating conceptual similarity derived from knowledge sources should have the potential to improve retrieval accuracy. Yet the incompleteness of the knowledge source precludes significant improvement. To remedy this problem, we propose to represent documents using phrases. A phrase consists of multiple concepts and word stems. The similarity between two phrases is jointly determined by their conceptual similarity and their common word stems. The document similarity can in turn be derived from phrase similarities. Using OHSUMED as a test collection and UMLS as the knowledge source, our experiment results reveal that phrase-based VSM yields a 16% increase of retrieval accuracy compared to the stem-based model.

Abstracting and Indexing↗

IBM correcting selectric typewriter: an analysis of the use of the correctable film ribbon in altering typewritten documents.

From the point of view of a document examiner, the advent of the Correcting Selectric typewriter has not changed any of the procedures ordinarily used in the examination of altered typewritten material. The same precautions should be observed in conducting examinations of such material as would be observed in making examinations for any other type of possible alteration on negotiable instruments. The security question raised with the Correcting Selectric is no different than the questions raised when an eraser was put on a pencil or a chemical bleach was found to remove ink on paper. The Correcting Selectric might even be compared to the introduction of ball-point pens on the market in the late 1940s. At that time, financial publications were suggesting that ball-point pens should not be used on any negotiable or valuable document as the ink was considered to be too readily transferable, and it was thought that they left little in the way of individual writing characteristics. However, it was not long before financial institutions were supplying such pens on their counters. Because of the complexities involved in using the Correcting Selectric to alter a document, it is felt that such problems will prove to be less prevalent than those involving other means of alterations.

Criminology↗