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PubMedDate not supplied

Paradigm shifts in clinical trials enabled by information technology.

The use of the world wide web for clinical trials changes the processes of performing clinical research in several fundamental ways. Greatly improved security, monitoring capability, and accuracy and timeliness of study conduct can be achieved while lowering cost. Data quality is enhanced while co-ordinating centre effort is reduced. The web provides a natural environment for linking the various components of clinical research, leading to new levels of simplicity and efficiency. It also enhances opportunities for recruitment of study investigators and patients. Other information technology tools and databases can be used to assist in this regard as well. Web-based trials change the relationship of the investigator site to the study and the site to the co-ordinating centre. Different roles and responsibilities lead to simplified processes and more and higher quality data. Many standard co-ordinating centre activities, such as randomization, protocol implementation and amending, document tracking, adverse event reporting, site monitoring, report generation and data analysis are all fundamentally changed in a web-based trial. Opportunities are enhanced to identify potential investigators and support their successful study conduct. As the role of investigator sites is changed in web-based research, more primary care medical providers can be attracted to research, providing more typical patients to studies than those sometimes available through more traditional research sites, especially those at academic study sites. Other activities can now be co-ordinated electronically with the advent of the web. The Institutional Review Board (IRB) can use online tools to control investigator participation, resulting in improved study efficiency and patient safety. A web-based research pharmacy provides tremendous efficiencies in managing and distributing study medications. Financial payments to the sites can be performed and recorded electronically, or even administered based on timeliness and quality of the data. Our early experience with web-based trials indicates that there can be tremendous gains in study efficiency and accuracy by restructuring processes, roles and responsibilities through a comprehensive centralized, web-based trial. The future appears bright for web-based clinical trials.

Clinical Trials as Topic↗
PubMed2001

Complying with the Health Insurance Portability and Accountability Act. Privacy standards.

The Privacy Rule: Limits the use and disclosure of PHI to purposes of treatment, payment, or routine health care operations. Requires covered entities to provide advance notice to the public of its policy governing disclosure of PHI. Requires entities covered by the Standard to secure general client consent to use and to disclose PHI for treatment, payment, or routine health care operations and to obtain specific client authorization to use or to disclose PHI for all other purposes unless the disclosure is specifically permitted without consent or authorization (e.g., a covered entity may disclose PHI to a health care oversight agency such as the Office of the Inspector General without first obtaining client authorization). In certain situations, a covered entity need only obtain client agreement to disclose PHI which may be oral or inferred from the circumstances surrounding the disclosure. For example, a covered entity could disclose PHI to a relative caring for the individual who is the subject of the health information. Expects covered entities to take measures to protect PHI from both inadvertent and deliberate misuse and disclosure. Requires, except in certain circumstances, the amount of PHI disclosed on any occasion to be limited to the minimum necessary to achieve the purpose of the disclosure. Gives individuals more control of their health information by permitting them to review and amend health information pertaining to themselves and to demand an accounting of persons to whom their health information has been disclosed. Establishes terms under which a covered entity may disclose PHI to a business associate. Permits states to maintain state laws that are more stringent than the Privacy Rule. The statute provides for significant civil and criminal penalties for failure to comply with the Standards. Violations are punishable by fines as much as $250,000 and 10 years imprisonment. The HHS, Office of Civil Rights is charged with enforcing the Standards. The HHS is expected to issue a single Enforcement Rule applicable to all three of the HIPAA Administrative Simplification Standards. Many worksite records will not be protected under the HIPAA Privacy Rule because employers are not covered entities and few occupational health professionals meet the criteria of being considered a covered entity. Nevertheless, occupational health professionals need to be knowledgeable about the application of HIPAA in the occupational health care setting. Furthermore, given that the Rule does not preempt state privacy laws that are more stringent than the Standards, occupational health professionals should monitor legislative activity related to privacy in the states in which they practice. To date, Oregon, Texas, and New Jersey have broadened HIPAA's definitions to create more covered entities and services.

Algorithms↗
PubMed1996

The use of E-mail by otolaryngologists.

Electronic mail (e-mail) is an extremely powerful form of communication and the most frequently used application on the Internet. While e-mail is not the appropriate mode of communication for every situation, there are many instances where its use is invaluable.

Communication↗
PubMedDate not supplied

Protecting confidentiality in small population health and environmental statistics.

Public policy decisions are fuelled by information. Often, this information is in the form of statistical data. Questions stemming from public health and environmental concerns often arise or are studied within small subgroups of a population. Continuing improvements in the performance and availability of computing resources, including geographic information systems, and the need to better understand environmental exposures and consequent health effects create increasing demand for small population health and environmental data. These demands are at odds with the need to preserve the privacy and data confidentiality of persons, groups or organizations covered by the data. Although confidentiality issues for demographic and economic data are well-studied and are gaining maturity for health data, these issues are only beginning to emerge for environmental data and combined environmental-health data. The aim of this paper is to provide a framework for that examination. Herein we examine confidentiality problems posed by small population health and environmental data, summarize available statistical methods, and propose avenues for the solution of new problems.

Computer Graphics↗
PubMed2001

Enhancing clinical trials on the internet: lessons from INVEST.

The INternational VErapamil SR/trandolapril STudy (INVEST) is the first long-term, large-scale clinical trial being conducted primarily using Web-based technology. The Web is a powerful tool for enhancing clinical trial management because of its ability to centralize all study information and coordinate multiple trial processes in real time at lower cost. The result is improved efficiency, accuracy, and safety in clinical trials conduct. In Web-based clinical trials, sites are able to focus primarily on medicine and science, rather than on trial administration. Site training, study documentation, subject recruitment, randomization, medication dispensing, and management procedures are simplified by using Web-based software to enhance processes. This paper summarizes the advantages achieved for INVEST investigators, sponsor representatives, monitors, and subjects resulting from the centralization and coordination of multiple tasks through Web-based technology.

Clinical Trials as Topic↗
PubMed2003

eMelanoBase: an online locus-specific variant database for familial melanoma.

A proportion of melanoma-prone individuals in both familial and non-familial contexts has been shown to carry inactivating mutations in either CDKN2A or, rarely, CDK4. CDKN2A is a complex locus that encodes two unrelated proteins from alternately spliced transcripts that are read in different frames. The alpha transcript (exons 1alpha, 2, and 3) produces the p16INK4A cyclin-dependent kinase inhibitor, while the beta transcript (exons 1beta and 2) is translated as p14ARF, a stabilizing factor of p53 levels through binding to MDM2. Mutations in exon 2 can impair both polypeptides and insertions and deletions in exons 1alpha, 1beta, and 2, which can theoretically generate p16INK4A-p14ARF fusion proteins. No online database currently takes into account all the consequences of these genotypes, a situation compounded by some problematic previous annotations of CDKN2A-related sequences and descriptions of their mutations. As an initiative of the international Melanoma Genetics Consortium, we have therefore established a database of germline variants observed in all loci implicated in familial melanoma susceptibility. Such a comprehensive, publicly accessible database is an essential foundation for research on melanoma susceptibility and its clinical application. Our database serves two types of data as defined by HUGO. The core dataset includes the nucleotide variants on the genomic and transcript levels, amino acid variants, and citation. The ancillary dataset includes keyword description of events at the transcription and translation levels and epidemiological data. The application that handles users' queries was designed in the model-view-controller architecture and was implemented in Java. The object-relational database schema was deduced using functional dependency analysis. We hereby present our first functional prototype of eMelanoBase. The service is accessible via the URL www.wmi.usyd.edu.au:8080/melanoma.html.

Computer Security↗
PubMed2007

The Italian XLMR bank: a clinical and molecular database.

Mental retardation (MR) is a nonprogressive condition characterized by a significant impairment of intellectual capabilities with deficit of cognitive and adaptive functioning and onset before 18 years. Mental retardation occurs in about 2 to 3% of the general population and it is estimated that 25 to 35% of the cases may be due to genetic causes. Among these "genetic" MR, 25 to 30% are probably due to mutations in a gene on the X chromosome (X-linked mental retardation, XLMR). Given the genetic heterogeneity of XLMR, the availability of a considerable number of patients with accurate phenotypic classification is a crucial factor for research. The X-linked Mental Retardation Italian Network, which has been active since 2003, has collected detailed clinical information and biological samples from a vast number of MR patients. Collected samples and clinical information are inserted within the XLMR bank, a comprehensive molecular and clinical web-based database available at the address http://xlmr.unisi.it. The database is organized in three distinct parts. Part I and II contain several electronic schedules to register information on the family, the phenotypic description, the photographs, and a 20 sec movie of the patient. Part III allows the registration of molecular analyses performed on each case; samples and clinical data are usable via password-restricted access. Clinical and molecular centers interested in joining the network may request a password by simply contacting the Medical Genetics of the University of Siena. The XLMR bank is an innovative biological database that allows the collection of molecular and clinical data, combines descriptive and iconographic resources, and represents a fundamental tool for researchers in the field of mental retardation.

Computer Security↗
PubMed2007

Data protection in biomaterial banks for Parkinson's disease research: the model of GEPARD (Gene Bank Parkinson's Disease Germany).

Parkinson's disease (PD) is the second most common neurodegenerative disease. Although 10 gene loci have been identified to cause a Parkinsonian syndrome, these loci account only for a minority of PD patients. Large, systematic research programs are required to collect, store, and analyze DNA samples and clinical information to support further discovery of additional genetic components of PD or other movement disorders. Such programs facilitate research into the relationship between genotype and phenotype. The German Competence Network on Parkinson's disease (CNP) initiated the Gene Bank Parkinson's Disease Germany (GEPARD), providing an administrative and scientific infrastructure for the storage of DNA and clinical data that are electronically accessible and protective of patient rights. In this article, we offer guidance on how to establish a framework for a clinical genetic data and DNA bank, and describe GEPARD as a model that may be useful to other local, national, and international research groups developing similar programs.

Computer Security↗
PubMed2005

Software for tabular data protection.

In order for national statistical offices to maintain the trust of the public to collect data and publish statistics of importance to society and decision-making, it is imperative that respondents (persons or establishments) be guaranteed privacy and confidentiality in return for providing requested confidential data. Consequently, for most survey and census data, disclosure limitation techniques must be applied before the data are ready for public release. For microdata, examples of methods that can be used to identify respondents include directly extracting identifying information from microdata files or indirectly identifying respondents by matching a given file with an external file. For tabular data, respondents may be identified directly from small cell counts or respondent contributions to heavily concentrated cells of magnitude data may be closely approximated by the cell value. Indirect disclosure is possible in tables through manipulation of additive tabular relationships between cell values and totals, e.g. manipulating rows and column totals in a two-dimensional table. Two-dimensional statistical tables are a staple of official statistics. This paper describes a desktop software system that for the first time implements within a single framework four standard disclosure limitation techniques for protecting tabular data in two-dimensional tables: complementary cell suppression, minimum-distance controlled rounding, unbiased controlled rounding, and controlled rounding subject to subtotals constraints, and a fifth, new method: controlled tabular adjustment, and summarizes the five methods.

Computer Security↗
PubMedDate not supplied

Data field standards and the Health Insurance Portability and Accountability Act.

The Administrative Simplification Title of the Health Insurance Portability and Accountability Act of 1996 addresses the creation and adoption of nationwide standards for the electronic exchange and confidentiality protection of all individually identified data used in health care administration. The U.S. Department of Health and Human Services (DHHS) is implementing standards under this law. In addition to new standards, the law mandates that the Congress pass a health information privacy bill by August 1999 or that the DHHS adopt privacy protections for health information by February 2000. Published in 2001 by John Wiley & Sons, Ltd.

Computer Communication Networks↗
PubMed1990

Medical data protection: a proposal for a deontology code.

In this paper, a proposal for a Medical Data Protection Deontology Code in Greece is presented. Undoubtedly, this code should also be of interest to other countries. The whole effort for the composition of this code is based on what holds internationally, particularly in the EC countries, on recent data acquired from Greek sources and on the experience resulting from what is acceptable in Greece. Accordingly, policies and their influence on the protection of health data, as well as main problems related to that protection, have been considered.

Codes of Ethics↗