Current medicolegal and confidentiality issues in large, multicenter research programs.

The convenience of fast computers and the Internet have encouraged large collaborative research efforts by allowing transfers of data from multiple sites to a single data repository; however, standards for managing data security are needed to protect the confidentiality of participants. Through Dartmouth Medical School, in 1996-1998, the authors conducted a medicolegal analysis of federal laws, state statutes, and institutional policies in eight states and three different types of health care settings, which are part of a breast cancer surveillance consortium contributing data electronically to a centralized data repository. They learned that a variety of state and federal laws are available to protect confidentiality of professional and lay research participants. The strongest protection available is the Federal Certificate of Confidentiality, which supersedes state statutory protection, has been tested in court, and extends protection from forced disclosure (in litigation) to health care providers as well as patients. This paper describes the careful planning necessary to ensure adequate legal protection and data security, which must include a comprehensive understanding of state and federal protections applicable to medical research. Researchers must also develop rules or guidelines to ensure appropriate collection, use, and sharing of data. Finally, systems for the storage of both paper and electronic records must be as secure as possible.

Epidemiology and clinical outcomes of neurotrauma in New South Wales.

This study of 1161 neurotrauma patients in New South Wales hospitals was designed to examine the role of preventable causes of death and disability in cases of spinal injury, extradural, subdural and multiple intracranial haematomas in order to make recommendations for improvements in accident, emergency, ambulance and hospital services. Methods have been developed for standardizing diagnosis in different classes of hospital for the assessment of severity in terms of the patient's age, sex, physical signs, head and spine injuries and other injuries. Estimates have been made of the number of preventable deaths by a case control study of each category of neurotrauma under study.

Logistics of early management of head and spinal injuries.

The logistics of early management have been studied in a series of 1161 patients with head and/or spinal injuries, who were admitted to hospital in NSW in 1977-78. Special attention has been given to three subgroups: 336 head injuries with records of impaired consciousness before first hospital admission, 355 head injuries later transferred because of deterioration, and 202 serious spinal injuries. It was found that in at least 18% of unconscious head injuries, and a similar percentage of spinal injuries, first aid and transport to hospital were provided by ambulances recorded to have only one trained staff member. In country areas, 41% of unconscious head injuries reached hospital after periods of time exceeding 1 h. For administrative as well as geographic reasons, more than 80% of initially unconscious head injuries and spinal injuries were first admitted to hospitals without neurosurgical and/or spinal services; the majority of cases in both groups, therefore, had to be transferred to other hospitals, often within 6 h of first admission. In the subgroup of cases transferred because of deterioration, mortality increased with distance from a neurosurgical unit. These findings are related to the concept of an integrated regional trauma service.

Trauma to the central and peripheral nervous systems: Part I: an overview of mortality, morbidity and costs; N.S.W. 1977.

An epidemiological study of neurotrauma in New South Wales, South Australia and the Australian Capital Territory, 1977, was initiated and sponsored by the Neurosurgical Society of Australasia, conducted by its Trauma Subcommittee in collaboration with the Division of Health Services Research, Health Commission of New South Wales, funded by the Australian Brain Foundation and the Commonwealth Department of Health and supported by the Health Commissions of New South Wales and South Australia. The following communication is structured so as to present the essential findings on mortality, morbidity and costs in New South Wales in 1977 in the first part and the more specific statistical profile of surgical treatment in New South Wales, 1977, in a separate, second part. The most revealing data found by this research is that cranio-cerebral and spinal injury was the leading cause of death up to the age of 44 in New South Wales (and South Australia) and up to the age of 49 in the male population and in the country regions. It accounted for 45% of all deaths to those aged 15 to 24. Cranio-cerebral and spinal injury caused 71% of all deaths on the roads. Sixty-four per cent of those dying in road accidents never reached hospital. The figures for mortality and morbidity in the country regions were significantly worse than those in the metropolitan regions. The most important causes were identified and recommendations aimed at reducing this record were formulated.