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Two routes to privacy protection: a comparison of health information legislation in Canada and the United States.

The privacy of health information is a subject of great sensitivity in both Canada and the United States. As a result of public demands for more effective protection of such information as medical records, Canada and, particularly, its provincial governments, have implemented extensive legislation. The United States, on the other hand, has largely confined its efforts to private sector initiatives that are more reflective of voluntary codes than legal statutes. Because new technologic developments facilitate data sharing in the medical field, especially in the face of a continual reduction of healthcare budgets, the concern for privacy protection in this domain has intensified. Correspondingly, there has been a gradual theoretical shift in protective health information policies on both sides of the border. As Canada pushes to extend its federal and provincial legislation to the private sector, the United States is on the brink of approving a national bill that would protect the privacy of personal medical records. It is becoming evident that efforts to secure the privacy of health information in both countries are converging.

Canada↗

Development of the Minimum Information Specification for In Situ Hybridization and Immunohistochemistry Experiments (MISFISHIE).

We describe the creation process of the Minimum Information Specification for In Situ Hybridization and Immunohistochemistry Experiments (MISFISHIE). Modeled after the existing minimum information specification for microarray data, we created a new specification for gene expression localization experiments, initially to facilitate data sharing within a consortium. After successful use within the consortium, the specification was circulated to members of the wider biomedical research community for comment and refinement. After a period of acquiring many new suggested requirements, it was necessary to enter a final phase of excluding those requirements that were deemed inappropriate as a minimum requirement for all experiments. The full specification will soon be published as a version 1.0 proposal to the community, upon which a more full discussion must take place so that the final specification may be achieved with the involvement of the whole community.

Computational Biology↗

HXMS: a standardized file format for HX-MS data.

MOTIVATION: Hydrogen/deuterium exchange-mass spectrometry (HX-MS) is a rapidly expanding technique used to investigate protein conformational ensembles. The growing popularity and utility of HX-MS has driven the development of diverse instrumentation and software, resulting in inconsistent, non-standardized data analysis and representation. Most HX-MS data formats also employ only mean deuteration representations of the data rather than full isotopic mass spectra, which reduces the information content of the data and limits downstream quantitative analysis. RESULTS: Inspired by reliable protein structure and genomics data formats, we present HXMS, a unified, lightweight, scalable, and human-readable file format for HX-MS data. The HXMS format preserves the isotopic mass envelopes for all peptides, captures the full experimental time-course including fully deuterated control samples, and contains all other key information. It supports multimodal distributions, post-translational modifications (PTMs), and experimental replicates. To promote compatibility with existing HX-MS workflows, we also developed PFLink, a Python package that converts exported data files from commonly used HX-MS software to the HXMS format. PFLink and the HXMS format will enable quantitative, higher-resolution data processing, improved data sharing and storage among HX-MS practitioners, future machine learning applications, and further developments in HX-MS analysis. AVAILABILITY AND IMPLEMENTATION: PFLink is publicly available to install locally on HuggingFace, alongside documentation, or use online at HuggingFace (https://huggingface.co/spaces/glasgow-lab/PFlink). The supplementary information includes sample input files, sample HXMS files, and a generic unfilled PFlink custom CSV file that users may populate with key experimental conditions and results, which can then be read and converted into the HXMS format.

Software↗

Circular genome visualization and exploration using CGView.

UNLABELLED: CGView (Circular Genome Viewer) is a Java application and library for generating high-quality, zoomable maps of circular genomes. It converts XML or tab-delimited input into a graphical map (PNG, JPG or Scalable Vector Graphics format), complete with sequence features, labels, legends and footnotes. In addition to the default full view map, the program can generate a series of hyperlinked maps showing expanded views. The linked maps can be explored using any Web browser, allowing rapid genome browsing and facilitating data sharing. AVAILABILITY: CGView (the standalone application, library or applet), sample input, sample maps and documentation can be obtained from http://wishart.biology.ualberta.ca/cgview/ CONTACT: david.wishart@ualberta.ca.

Chromosome Mapping↗

The infusion center: a model for outpatient parenteral antibiotic therapy.

Outpatient parenteral treatment of infectious diseases has developed from primitive beginnings to its present state as the standard of care in many areas. The large infusion center described here is headed by physicians who specialize in infectious diseases and occupies a free-standing building where the pharmacy, laboratory, physicians' offices, examination rooms, and finance departments are centralized for efficiency, flexibility, and convenience. Each patient is seen by a physician, pharmacist, and nurse; these health care professionals share data about the patient and offer 24-hour coverage of questions and emergencies. Treating a wide variety of diseases, physicians utilize their experience and the center's intercommunication system to choose drugs most suitable for outpatient use and to carry on research. Costs in the center run between 50% and 60% lower than those in the hospital. Reimbursement, although difficult in the past, has improved considerably, but some third-party payers, including Medicare, have not reimbursed for outpatient intravenous antibiotic therapy.

Ambulatory Care↗

The Behavior Change Consortium: setting the stage for a new century of health behavior-change research.

The Behavior Change Consortium (BCC), a collective of 15 National Institutes of Health-funded behavior-change projects, was conceived with the goal of evaluating the efficacy and effectiveness of novel ways of intervening in diverse populations to reduce tobacco dependence, and improve physical activity, nutrition and other health behaviors. The purpose of this article is to provide a general introduction and context to this theme issue by: (1) reviewing the promises and challenges of past efforts related to promoting change for three key health behaviors; (2) reviewing successful intervention strategies and principles of health behavior change; (3) discussing major theoretical approaches for obtaining successful behavior change; (4) setting BCC activities within the context of recent recommendations for the behavioral and social sciences; and (5) providing an organizational framework for describing each of the projects within this consortium. In addition to the rich database on behavioral outcomes for tobacco dependence, physical activity and diet, the BCC represents a unique opportunity to share data and address cross-cutting intervention research issues critical for strengthening the field of behavior change research.

Health Behavior↗

A DNA sequence analysis program for the Apple Macintosh.

This paper describes a new set of programs for analyzing DNA sequences using the Apple Macintosh computer, a computer ideally suited for this kind of analysis. Because of the Macintosh interface and the availability of high quality software-only speech synthesis, these programs are truly easy to use. Instead of typing in commands, the user directs the program by making selections with the mouse, thereby eliminating most typographical and syntax errors. Output options are selected by "pressing buttons" and then clicking "OK" with the mouse. DNA sequences are confirmed by having the program speak them. The high resolution graphics on the Macintosh not only allow for explanatory diagrams to be used to aid in deciding on input parameters, but can be used to produce slides for presentations and figures for papers. Because of the clipboard and the ability of the Macintosh to readily share data among different applications, data can be saved for use directly in word processing documents (e.g. manuscripts).

Animals↗

The Stanford Microarray Database: implementation of new analysis tools and open source release of software.

The Stanford Microarray Database (SMD; http://smd.stanford.edu/) is a research tool and archive that allows hundreds of researchers worldwide to store, annotate, analyze and share data generated by microarray technology. SMD supports most major microarray platforms, and is MIAME-supportive and can export or import MAGE-ML. The primary mission of SMD is to be a research tool that supports researchers from the point of data generation to data publication and dissemination, but it also provides unrestricted access to analysis tools and public data from 300 publications. In addition to supporting ongoing research, SMD makes its source code fully and freely available to others under an Open Source license, enabling other groups to create a local installation of SMD. In this article, we describe several data analysis tools implemented in SMD and we discuss features of our software release.

Animals↗

Occupational epidemiology.

The epidemiological literature for assessing risk in many, if not most, modern occupations has now become sufficiently obsolete that it can no longer be depended upon to guide either prevention or adjudication of compensation. This obsolescence must be dealt with by developing new sources of information pertinent to occupational hazards and the risks associated with most occupations. Ideally, a comprehensive surveillance mechanism that would be automatically updated for the changing risk in a changing economy would be ideal and may be attainable with further developments in health information technology. The characteristics of such a system are described. However, there are many obstacles to such a system which appear insurmountable in the short term. A more eclectic plan for cooperation and data-sharing would help in the short term and would establish a pattern of collaboration that could both place adjudication on a more solid foundation and avoid allegations of collusion in business. The general outline for a practical programme of collaboration along these lines is presented.

Epidemiology↗

Research on first-episode psychosis: report on a National Institute of Mental Health Workshop.

The need to focus increased research on patients experiencing their first episode of psychosis was emphasized in A National Plan for Schizophrenia Research. To develop strategies for enhancing research in this area, a National Institute of Mental Health Workshop on First-Episode Psychosis was held in 1991. The topics discussed at that workshop are summarized, with key issues including the following: (1) the need for better operational definitions of onset, end of an episode, and relapse of psychosis; (2) careful consideration of inclusion and exclusion criteria related to age, gender, prior treatment, comorbid substance abuse, and similar issues; (3) the challenge of finding patients never exposed to neuroleptics and the value of entering first-episode patients into standardized treatment protocols; (4) the design of followup studies; (5) strategies to increase the pool of applicants; and (6) approaches for increasing power through data sharing and collaboration between groups.

Age Factors↗

Schizophrenia Spectrum Biomarkers Consortium: Establishment of a Biorepository for the Discovery of Quantitative Fluid Biomarkers.

BACKGROUND AND HYPOTHESIS: Schizophrenia spectrum disorders (SSDs) produce severe symptoms, disability, and premature mortality, but only partially effective symptomatic treatments exist. Treatment development is impeded by lack of insight into disease mechanisms or objective biomarkers for clinical trials. Advances in genetics and neurobiology have converged on strong pathogenic hypotheses for SSDs centered on synapse dysfunction and excessive pruning, pathogenic processes that may produce measurable proteomic evidence in cerebrospinal fluid (CSF). Leveraging design precedents from successful fluid biomarkers discovery for Alzheimer's disease, we undertook a pilot study to test the feasibility of repeated CSF and blood samples collection from individuals with SSDs. Here we report on successful implementation of longitudinal bio-behavioral phenotyping in SSDs and establishment of a repository to permit broad sample and data sharing. STUDY DESIGN: The Schizophrenia Spectrum Biomarkers Consortium (SSBC) study principles included longitudinal study design, paired CSF and plasma collection associated with robust phenotypic characterization, at 3 academic sites and the establishment of a biorepository. Participants underwent clinical and cognitive assessments, neuroimaging, blood draws, and CSF collection via lumbar puncture (LP) every 6 months. STUDY RESULTS: SSBC successfully enrolled 48 SSD and 41 Healthy Controls with a 73% longitudinal retention. Clinical, cognitive, and neuroimaging results were consistent across sites and with existing studies. Study procedures were well tolerated, and almost all LPs (99%) resulted in either no or minor headache/backache that resolved without medical interventions. CONCLUSIONS: The pilot SSBC study demonstrates that a multi-site, longitudinal study with repeat CSF collection is feasible, with excellent participant acceptability and retention.

Humans↗

Networking: an overview for leaders of academic medical centers.

Organizations face a unique challenge over the next decade. When technology was expensive, it was arguably necessary to use an undifferentiated, or monolithic, model for computer-based solutions to problems. This has fundamentally changed. Technology is now so inexpensive that solutions are not limited by costs, but rather by how well the implementors understand the many different problem domains. Thus, academic medical centers are faced with successive waves in information technology use. First, there will be a wave of innovation, driven by the need for specialization in problem solving. This will be followed by consolidation of the best of the approaches into the core systems of the institution. The average level of heterogeneity (cost) will be higher, but the overall quality of the solutions (benefit) will also be higher. If one can develop a strategy for managing and creatively limiting the heterogeneity, the cost-benefit ratio will be much more favorable. While there may be other strategies that will do this, we support the use of a strategy centered on enterprise networking. This strategy emphasizes not simply technology but also the cultural and organizational changes that empower innovation--within a framework that makes it possible to simply implement interoperability and data sharing within nearly all solutions. The organizations that survive the coming period of change and external pressure will be those that do the best job of managing their resources. Information will continue to be one of the most important resources.(ABSTRACT TRUNCATED AT 250 WORDS)

Academic Medical Centers↗

Syringe HIV seroprevalence and behavioural and demographic characteristics of intravenous drug users in Sydney, Australia, 1987.

The contents of needles and syringes returned by intravenous drug users to two Sydney needle and syringe exchange centres were analysed for HIV antibodies by the enzyme-linked immunosorbent assay (ELISA). Reactive and borderline samples were further tested by the Western blot method. Basic demographic and needle sharing data were also collected from the clients of the exchanges. Of a sample of 1544 returned syringes, 48 (3%) were confirmed as containing HIV-infected blood. The proportion of infected syringes at exchange 2 was 6% (33 out of 545), which was significantly greater (P less than 0.05) than the proportion of exchange 1 at 1.5% (15 out of 999). The difference in seroprevalence between the two centres may be related to the behavioural characteristics of the client populations that attended each of the exchanges. The maintenance of a low syringe HIV seroprevalence (1-1.5%) over a 7-month period at one exchange may indicate that the availability of sterile needles and syringes prevented transmission of HIV among the clients of that exchange. HIV antibody testing of the contents of used syringes is a potentially valuable method of monitoring HIV infection among intravenous drug users. In this study, syringe exchange schemes have proved to be suitable venues for investigating the demographic characteristics and risk-taking behaviours of this population.

Adult↗

Antilymphocyte induction therapy in cadaver renal transplantation: a retrospective, multicenter United Network for Organ Sharing Study.

Antilymphocyte induction therapy in cadaver renal transplantation is controversial. The effectiveness of antilymphocyte therapy in the current era of cyclosporine and tacrolimus use has been questioned. The United Network for Organ Sharing data set for the Center-Specific Outcomes Analysis, which has been verified by the transplant centers, was used for this study. At the time information in the database was confirmed, all transplant centers were queried on their use of an antilymphocyte preparation at the time of transplantation, and whether it was used within 24 hr of transplant surgery, the duration of the specific reagent. This allowed us to analyze 24,191 cadaver transplant procedures performed between the October 1, 1987, and the January 31, 1991. Using Cox regression analysis, as well as semiparametric logistic regression models, we demonstrated improved allograft outcomes in patients who received either Minnesota antilymphocyte globulin for 5 days or more or OKT3 for 7 days or more. The relative risk was 0.82 for Minnesota antilymphocyte globulin and 0.86 for OKT3 (for both, P<0.001). Semiparametric models were then used to compare the effectiveness of the antilymphocyte preparation in both a patient with at least a three-antigen mismatch and patients who had a zero-antigen mismatch. The improvement in graft survival was seen in both match grades. These data demonstrate the improved outcomes with the use of antilymphocyte preparations during the early posttransplant period in the modern cyclosporine era.

Antibodies, Monoclonal↗

National impact of pulsatile perfusion on cadaveric kidney transplantation.

BACKGROUND: The simplicity and success of cold storage of cadaveric kidneys have led to the infrequent use of pulsatile perfusion. However, there may be advantages to pulsatile perfusion for less optimal donors. METHODS: United Network for Organ Sharing data were analyzed retrospectively to determine the impact of pulsatile perfusion on initial function and 1-year graft survival. The analysis included 60,827 cadaveric kidney transplants performed between 1988 and 1995. Multivariate logistic regression analyses were used to determine the effect of preservation method on both early kidney function (need for first-week dialysis after transplant) and 1-year graft survival, after adjusting for other known risk factors. RESULTS: The preservation method exhibited a highly significant impact on the need for first-week dialysis. Ice-preserved kidneys were associated with a 2.13-fold increase in the odds of requiring dialysis compared with perfused kidneys. If the donor age was > or =55 years, the odds were 2.33-fold higher for ice-preserved as compared with perfused. If cold ischemic time was > or =24 hr, there was a 2.19-fold increase in the odds of dialysis for ice-preserved kidneys. African-American recipients of cold-stored kidneys had a 2.29-fold greater odds of first-week dialysis. CONCLUSIONS: Based on these findings, it was estimated that the increased cost of perfusing kidneys from all donors > or =55 years of age would be balanced by the decreased need for posttransplant dialysis if the cost related to dialysis were $14,700 or greater per patient. These facts, coupled with the ability to assess an older donor kidney before transplant, could make pulsatile perfusion for the expanded donor financially as well as medically desirable.

Adult↗

Risk factors for renal allograft survival from older cadaver donors.

BACKGROUND: The shortage of cadaver donors for kidney transplantation has prompted many centers to use kidneys from older donors. The use of older donor kidneys has been associated with lower graft survival. METHODS: United Network for Organ Sharing data of all adult cadaveric renal transplant recipients receiving kidneys from adult donors between 1988 and 1994 (transplants, n=35,621) were analyzed to further study this issue. All patients were followed for a minimum of 1 year after transplantation. The recipients were classified according to donor age: group 1, 19-50 years; group 2, 51-60 years; and group 3, >60 years. RESULTS: The actuarial kidney survival estimates for group 1: (n=27,999) at 1, 3, and 5 years were 82.7%, 72.2%, and 61.4%. The corresponding values for group 2 (n=5,367) and group 3 (n=2,255) were 77.3%, 63.3%, and 51.3%; and 71.7%, 55.3%, and 42.7%, respectively (P<0.0001). Logistic regression analysis for 1-year graft survival was performed, and odds ratios (ORs) were computed for various risk factors. Increased odds of graft failure were seen with increasing donor age, previous transplantation, and elevated panel-reactive antibody. In the older donor group, lower ORs were observed if the recipients were Hispanic or Asian. In addition, kidneys from African-American or Asian donors had a poorer graft outcome. A similar analysis for 3-year graft survival for those grafts functioning at 1 year revealed poorer survival with older African-American donors (OR=1.78, P<0.02), whereas improved survival rates were seen when older kidneys were used for older (OR=0.635, P<0.01) and female (OR=0.733, P < 0.01) recipients. Statistically significant factors such as HLA mismatch, cold ischemia time, and African-American or diabetic recipients differ in their impact on graft survival across the donor age groups. CONCLUSION: In conclusion, kidneys from older donors are associated with poorer graft survival rates with African-American and Asian donors and African-American recipients, and no detrimental effects when used for older, Hispanic, Asian, or female recipients.

Adult↗

Cardiac transplantation in survivors of lymphoma: a multi-institutional survey.

BACKGROUND: Cardiac transplantation has been successfully performed in patients with a history of presumably cured Hodgkin's disease (HD) and non-Hodgkin's lymphoma (NHL). Though the risk of recurrence is a major concern, the long-term influence of prior cancer and cancer therapy on posttransplant outcome has not been previously investigated. METHODS: Questionnaires were sent to 130 cardiac transplant centers in the United States registered with the United Network for Organ Sharing. Data collected included patient demographics; type, stage, and timing of HD/NHL; treatment for HD/NHL; posttransplant immunosuppressive regimen, rejection history, and outcomes; and Epstein-Barr virus status. RESULTS: Thirty-four cardiac transplant recipients with a previous history of HD (n=16) or NHL (n=18) were identified. HD patients averaged 41+/-15 years of age, with a mean disease-free interval of 15+/-9 years at the time of transplantation. NHL patients averaged 42+/-17 years of age with a mean disease-free interval of 10+/-9 years at the time of transplantation. The mean follow-up for the entire group was 50 months (range, 2 days to 136 months), and mean follow-up for the survivors was 67 months (range, 23-136 months). The 1-, 3-, 5-, 7-, and 10-year actuarial survival estimates for the entire group are 77%, 64%, 64%, 64%, and 50%, respectively. Actuarial survival was lower in HD patients (P=0.04) and in patients who had previously undergone splenectomy (P=0.008). Cox regression analysis identified only prior splenectomy (P=0.02) as an independent risk factor for mortality after cardiac transplantation with an adjusted relative risk of 6.2 (1.7-21.9, 95% confidence intervals). CONCLUSIONS: Although the numbers are small, these data strongly suggest that there is an increased mortality risk for cardiac transplant recipients with prior HD who have undergone splenectomy.

Actuarial Analysis↗

Cornerstone: Illinois' approach to service integration.

Cornerstone is a management information system developed and implemented by the Illinois Department of Public Health as a mechanism to facilitate maternal and child health service integration. Its design features combined program registration, standardized risk assessment, automated care plan development, and consolidated referral and scheduling. Cornerstone is a flexible, PC- and local area network-based system, allowing portability across program applications and geographic areas. A wide-area network enables local agencies to share data about clients. Development of Cornerstone was a collaborative effort by potential Cornerstone users and statewide administrative staff. The standard for equipment is set at a one-to-one ratio of workstations to case managers.

Computer Systems↗