Documentation ; Information Services ; Periodicals as Topic

Documentation ; Data Management ; Patient Care

Oral finasteride(Propecia(R)), 1mg/day, has been widely used as an effective treatment for male androgenetic alopecia since it had been approved by the Food and Drug Administration(FDA) of U.S. in December 1997. Gynecomastia has been one of the most common adverse effects in the patients who were taking 5mg of oral finasteride(Proscar(R)). Recently, several cases of unilateral or bilateral finasteride induced gynecomastia have also been reported in 1mg of oral finasteride(Propecia(r)). We report two cases of finasteride(Propecia(R)) induced painful bilateral gynecomastia, which are the first published documentations in Korea.
Alopecia ; Documentation ; Finasteride ; Gynecomastia* ; Humans ; Korea ; Male

The management for qualification documents of medical instruments is very important work to management department of medical instruments. Because the number of qualification documents of medical instruments is very large and they have an expiry date, it is difficult to manage them. This article discussed how to manage qualification documents of medical instruments, and an information management system that has a function of traceability management has been developed. This information management system standardizes management for qualification documents of medical instruments, and ensures that qualification documents of medical instruments are available and can be traced. Besides, it can reduce the amount of work for medical instruments management.
Documentation ; standards ; Equipment and Supplies ; standards ; Information Systems

A CDASH-based CRF annotation plays an important role in database setup and data verification. The STDM-based CRF annotation is also one of the essential documents when the package of clinical trial data is submitted to the regulatory authority. This paper describes the contents, procedures and related stipulations used in the CDISC-based CRF annotation.
Clinical Trials as Topic ; Databases, Factual ; Documentation ; standards

Harmonization of clinical laboratory results means that results are comparable irrespective of the measurement procedure used and where or when a measurement was made. Harmonization of test results includes consideration of pre-analytical, analytical, and post-analytical aspects. Progress has been made in each of these aspects, but there is currently poor coordination of the effort among different professional organizations in different countries. Pre-analytical considerations include terminology for the order, instructions for preparation of the patient, collection of the samples, and handling and transportation of the samples to the laboratory. Key analytical considerations include calibration traceability to a reference system, commutability of reference materials used in a traceability scheme, and specificity of the measurement of the biomolecule of interest. International organizations addressing harmonization include the International Federation for Clinical Chemistry and Laboratory Medicine, the World Health Organization, and the recently formed International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR). The ICHCLR will provide a prioritization process for measurands and a service to coordinate global harmonization activities to avoid duplication of effort. Post-analytical considerations include nomenclature, units, significant figures, and reference intervals or decision values for results. Harmonization in all of these areas is necessary for optimal laboratory service. This review summarizes the status of harmonization in each of these areas and describes activities underway to achieve the goal of fully harmonized clinical laboratory testing.
Chemistry, Clinical ; Documentation ; Guidelines as Topic ; Laboratories/*standards ; Reference Values

Child ; Documentation ; standards ; Humans ; Pediatrics ; standards ; Practice Guidelines as Topic

This list of clincal data management documentation is to ensure standardized and adequate archival of trial documents and records in clinical data management, which is applicable to all of phase I-IV clinical trials.
Clinical Trials as Topic ; Data Collection ; standards ; Documentation ; standards

Intake and Output (I/O) records in hospitals were often found to be incomplete and illegible. The form used to record I/O is not user-friendly — i.e., they feature miniscule boxes, ‘total’ lines that do not correspond with shift changes and lack of instructions. Complaints often received from Specialists & Doctors regarding calculation errors or no totalling of I/O. Moreover, Nursing Sisters objective rounds often saw incompleteness of I/O chart. This study aims to identify the types of mistakes in recording the existing I/O chart. The second aim is to find out whether shift totalling of I/O chart helps in reducing mistakes. We try to determine whether the identified mistakes were repeated in the new I/O Chart. This study was conducted from October till December 2010 in 9 selected wards in Sibu Hospital. Data collection was divided into 3 phases. A pre-implementation audit using a checklist was carried out. The compliance rate of completeness of documentation of I/O Chart was 63%. A one month trial of new I/O chart was being done in the selected 9 wards. Post implementation audit showed a significant improvement of compliance rate (88%). Feedback from health care workers (N=110) showed that, 89% of doctors (n=17) and 60% of nurses (n=93) in the sample prefer to use the new format as more practical and relevant to the changing shift of nurses and doctors’ ward round. It is suggested to implement the new format to increase compliance rate of documentation of I/O charting. Briefing should be given to nurses periodically and the new format should be introduced to nursing students in nursing colleges.
Documentation ; Forms and Records Control ; Nursing Records ; Charts ; Medical Errors

Documentation is a professional responsibility and is a form of communication to stakeholders, demanding health professionals including occupational therapists, to provide accountable records encompassing the occupational therapy process which includes evaluation, intervention, and outcomes. However, there are no clear guidelines for occupational therapy documentation. There is a lack of uniformity of content in documentation among therapists and facilities, and the length required to create the report are pertinent problems encountered. The purpose of this article is to report on the conceptual model to guide occupational therapists in creating efficient and occupation-centered evaluation documentation. With this, the proposed Dollhouse Model aims to answer the question: “What do you prioritize when creating pediatric evaluation documentation?” Utilizing this model suggests that therapists may be able to prioritize the pertinent occupational areas to document, therefore making it more efficient and occupation-centered.
documentation ; assessment ; occupational therapists ; occupational therapy ; health professionals