Consideration of substance use in compensation and pension examinations of veterans filing PTSD claims.

Veterans filing claims that service-induced PTSD impairs them worry that claims examiners may attribute their difficulties to conditions other than PTSD, such as substance use. Substance use commonly co-occurs with PTSD and complicates establishing a PTSD diagnosis because symptoms may be explained by PTSD alone, PTSD-induced substance use, or by a substance use condition independent of PTSD. These alternative explanations of symptoms lead to different conclusions about whether a PTSD diagnosis can be made. How substance use impacts an examiner's diagnosis of PTSD in a Veteran's service-connection claim has not been previously studied. In this study, we tested the hypothesis that mention of risky substance use in the Compensation & Pension (C&P) examination would result in a lower likelihood of service-connection award, presumably because substance use reflected an alternative explanation for symptoms. Data were analyzed from 208 Veterans' C&P examinations, medical records, and confidentially-collected research assessments. In this sample, 165/208 (79%) Veterans' claims were approved for a mental health condition; 70/83 (84%) with risky substance use mentioned and 95/125 (76%) without risky use mentioned (p = .02). Contrary to the a priori hypothesis, Veterans with risky substance use were more likely to get a service-connection award, even after controlling for baseline PTSD severity and other potential confounds. They had almost twice the odds of receiving any mental health award and 2.4 times greater odds of receiving an award for PTSD specifically. These data contradict assertions of bias against Veterans with risky substance use when their claims are reviewed. The data are more consistent with substance use often being judged as a symptom of PTSD. The more liberal granting of awards is consistent with literature concerning comorbid PTSD and substance use, and with claims procedures that make it more likely that substance use will be attributed to trauma exposure than to other causes.

Quality expectations and tolerance limits of trial master files (TMF) - Developing a risk-based approach for quality assessments of TMFs.

This article addresses the question of when a trial master file (TMF) can be considered sufficiently accurate and complete: What attributes does the TMF need to have so that a clinical trial can be adequately reconstructed from documented data and procedures? Clinical trial sponsors face significant challenges in assembling the TMF, especially when dealing with large, international, multicenter studies; despite all newly introduced archiving techniques it is becoming more and more difficult to ensure that the TMF is complete. This is directly reflected in the number of inspection findings reported and published by the EMA in 2014. Based on quality risk management principles in clinical trials the authors defined the quality expectations for the different document types in a TMF and furthermore defined tolerance limits for missing documents. This publication provides guidance on what type of documents and processes are most important, and in consequence, indicates on which documents and processes trial team staff should focus in order to achieve a high-quality TMF. The members of this working group belong to the CQAG Group (Clinical Quality Assurance Germany) and are QA (quality assurance) experts (auditors or compliance functions) with long-term experience in the practical handling of TMFs.

FCS 3.1 Implementation guidance.

The Flow Cytometry Standard (FCS) format was developed back in 1984. Since then, FCS became the standard file format supported by all flow cytometry software and hardware vendors. Over the years, updates were incorporated to adapt to technological advancements in both flow cytometry and computing technologies. However, flexibility in how data may be stored in FCS has led to implementation difficulties for instrument vendors and third party software developers. In this technical note, we are providing implementation guidance and examples related to FCS 3.1, the latest version of the standard. By publishing this text, we intend to prevent potential compatibility issues that could be faced when implementing the FCS spillover and preferred display keywords that have arisen during discussions among some implementers.

Improving medical records filing in a municipal hospital in Ghana.

BACKGROUND: Medical records are kept in the interest of both the patient and clinician. Proper filing of patient's medical records ensures easy retrieval and contributes to decreased patient waiting time at the hospital and continuity of care. This paper reports on an intervention study to address the issue of misfiling and multiple patient folders in a health facility. DESIGN: Intervention study. SETTING: Municipal Hospital, Goaso, Asunafo North District, Brong Ahafo Region, Ghana. METHODS: Methods employed for data collection were records review, direct observation and tracking of folders. Interventions instituted were staff durbars, advocacy and communication, consultations, in-service trainings, procurement and monitoring. Factors contributing to issuance of multiple folders and misfiling were determined. Proportion of multiple folders was estimated. RESULTS: Results revealed direct and indirect factors contributing to issuance of multiple patient folders and misfiling. Interventions and monitoring reduce acquisition of numerous medical folders per patient and misfiling. After the intervention, there was significant reduction in the use of multiple folders (i.e., overall 97% reduction) and a high usage of single patient medical folders (i.e., 99%). CONCLUSION: In conclusion, a defined medical records filing system with adequate training, logistics and regular monitoring and supervision minimises issuance of multiple folders and misfiling.

Evolución de la ciencia archivística / Evolution of the Archive Science

Se estudia la evolución histórica de la ciencia archivística, sus principales conceptos; así como las etapas de su desarrollo. Se examinan los paradigmas transitados por esta ciencia, a saber: paradigma clásico y paradigma social.

The historical evolution of the Archive Science, its main concepts and the stages of its development are studied. The paradigms through which this science has gone through, that is, classic paradigm and social paradigm, are examined.

Have your say on filing translations of European patents.

Comments are being sought on the future of an agreement to change the system for filing translations of European patents.

Excerpts from Maintaining Radiation Protection Records. National Council on Radiation Protection and Measurements.

This is the first of a three-part series of articles from a report by the NCRP, to be reprinted in successive issues of Radiology Management. The report offers practical recommendations for establishing a radiation safety program. Different aspects of record-keeping, an essential part of all radiation safety programs, will be highlighted in each article. The introduction and a chapter on the systematic generation of records are included in this issue.

Hospital records--asset or liability?

Health records of different sorts have been shown--in one region--to cost 13m pounds a year, and to take up 10 miles of shelving. Across one region, records would take up the length of the M4. Terry Gould and colleagues describe a project to establish some protocols for sensible record keeping.

Medical documentation and record management in Germany.

In the mid-1960s, the author was assigned the responsibility of modifying American medical record concepts, policies, procedures, and technology for a new university medical center in Berlin. Her basic design is now the law of the land in Germany. Here she describes health record information practices in Germany.

Current practices in discharge analysis and record assembly.

Are practitioners adopting the "less is best" philosophy for management of medical records? Making record abstracting less time consuming, and assembling charts to appear as they do on the patient units have been debated over recent years. This article reports on a survey of practitioners to see if newer methods are being adopted or if traditional practice prevails.

A proposed standard data file format for hyperthermia treatments.

One of the most critical areas of research essential to improve the clinical use of hyperthermia in cancer therapy is the determination and evaluation of temperature during therapy. In order to improve the dissemination of newly developed thermometry measurement and analysis programs and facilitate the transport of hyperthermia data files between computers for both intra- and inter- institutional use, we propose a standard file format, the Hyperthermia Data Standard (HDS), which can be used for all hyperthermia data. This data file consists of segments of which nine have been defined. The first is an initial /VERSION segment which identifies the file standard. This is followed by eight major segments: 2) a /IDENT segment which contains file and patient identification information; 3) a /TEXT segment containing additional miscellaneous documentation; 4) a /TUMOR segment which provides tumor and treatment site information; 5) a /HSETUP segment which contains treatment setup information; 6) a /FORMAT segment which defines the data segment structure; 7) a /DATA segment containing the actual thermometry data; 8) a /FOLLOWUP segment for documenting patient response; and 9) an /ANALYSIS segment containing summary information. All segments begin and end with a specified delimiter and, except for the first two (/VERSION and /IDENT), may be repeated more than once. For ease in debugging and verifying adherence to the standard, all information in the file is encoded in printable ASCII characters. All segments consist solely of records containing KEYWORDS and KEYWORD VALUES which identify specified information. Certain KEYWORDS are standard, i.e., having specified names and information formats as defined in this document. The /DATA segment consists of ASCII encoded chronological treatment thermometry and other data whose format and structure is identified in the /FORMAT segment. The /ANALYSIS segment provides the flexibility to store the results of any analysis program along with the actual data file for ease of data management. This thermometry data file standard is designed to provide both flexibility and extendability for all possible forms of hyperthermia treatment data. Furthermore, it is designed to provide a simple format which may be easily read by higher level languages. This document is intended for commercial manufacturers and others who are writing programs to document clinical hyperthermia treatments with the intention that they either use this format for their data storage or provide a means to convert their data into this format.(ABSTRACT TRUNCATED AT 400 WORDS)

Record keeping in Norwegian general practice.

Routines of medical record keeping were studied in a random sample of 50 out of 228 general practitioners in two counties, Möre & Romsdal and Sör-Tröndelag. One doctor refused to participate and one had retired. The 48 physicians were interviewed and a questionnaire was completed with details about their record keeping. The standard of the records was assessed according to legibility, quality of notes, past history and tidiness using a score system. All general practitioners had records for every patient, but the quality of the records varied considerably. More than 50 per cent used handwriting in progress notes, which varied from diagnostic labels to extended reports. Few records contained accessible background information about the patient concerned, and many records contained large amounts of old and irrelevant papers. The record-scores varied from 3 to maximum 10 with an average of 6.7. Higher Standards of recording in general practice are called for, since the quality of records does not only affect the individual patient, but, in the end, the quality of medical care in general.