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Coordination and management of a large multicenter screening trial: the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.

The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial is a large and complex multi-institutional, multifaceted organization with a 20-year horizon. The implementation of the trial began with the creation of an organizational structure that supports strong leadership, cooperation, and effective communication among the trial collaborators including an operational framework for the development, review, and pretest of instruments, data collection, and management procedures; the setting of high-quality standards for training of trial staff; and the development of a comprehensive assessment plan for evaluation of all trial activities. This paper describes the process and methods used in the coordination and management of the PLCO trial. These include the role of the steering committee and its subcommittees and working groups, the establishment of regular and ad hoc communications among collaborators, the training of screening center coordinators and examiners, the PLCO manual of operations and procedures, and the development and implementation of a comprehensive quality assurance plan.

Colorectal Neoplasms↗

Coronary angiography observations: evidence-based or ritualistic practice?

OBJECTIVE: The purposes of this study were to describe the incidence and occurrence of femoral artery bleeding during the first 6 hours after coronary angiography and to determine whether there is a relationship between current postangiogram observation protocols and the detection of complications. DESIGN: This was a prospective descriptive study. SETTING: The study was conducted in 3 university hospitals in Melbourne, Australia. PATIENTS: Subjects included 55 patients representing the complication rate of 1075 patients, mean age 61 years (SD, 12), 69% male. RESULTS: About 5.1% of patients had 1 or more incidents of bleeding requiring manual compression. In 4.2% of patients, bleeding occurred within 6 hours of angiography. Bleeding occurred a median of 2.02 hours (Q1 = 45 minutes, Q3 = 4.31 hours) after angiography. Patients without pressure bandaging bled a median of 1.32 hours (Q1 = 36.50 minutes, Q3 = 2.59 hours) after angiography. Patients with pressure bandaging bled a median of 4.75 hours (Q1 = 2.25 hours, Q3 = 7.28 hours) after angiography. In 40.6% of cases, bleeding was detected through the patient's call for assistance, and in 59.4% of cases nurses noted bleeding while checking the puncture site. Postcatheter observations were recorded 23.70 (SD, 14.60) minutes before the bleeding incident. There were no significant changes in vital signs, systolic blood pressure (P >.05), diastolic blood pressure (P >.05), or pulse (P >.05) before or during a bleeding episode. All were within normal parameters. No neurovascular assessment anomalies were detected. CONCLUSION: The use of pressure bandaging has a significant effect on the incidence and pattern of bleeding. Routine vital sign measurement has no relevance in detecting local complications after angiography. The most significant complication is bleeding that requires manual compression. Detection is through frequent puncture site observation and patient recognition and communication.

Aged↗

Apolipoprotein E genotype and mortality: findings from the Cache County Study.

OBJECTIVES: To evaluate the association between apolipoprotein E (apo E) epsilon4 and mortality, the population attributable risk for mortality with epsilon4, and relative contributions of cardiovascular disease (CVD) and Alzheimer's disease (AD). DESIGN: Population-based cohort study. SETTING: Community-based. PARTICIPANTS: Permanent residents of Cache County, Utah, aged 65 and older as of January 1, 1995. MEASUREMENTS: Participants were genotyped at the apo E locus using buccal-swab deoxyribonucleic acid. Cardiovascular health was ascertained using self- or proxy-report interviews at participants' residences. AD was diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, Third Edition, Revised, and National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders criteria. Utah Department of Vital Statistics quarterly reports were reviewed to identify participants who died. RESULTS: Crude evaluations showed nonsignificantly greater risk of death for epsilon2/2 (hazard ratio (HR)=1.66, 95% confidence interval (CI)=0.92-2.76) and epsilon3/4 (HR=1.11, 95% CI=0.97-1.26) genotypes and significantly greater risk for epsilon4/4 (HR=1.48, 95% CI=1.09-1.96). After adjustment for age, age(2), sex, and education, risks increased to 1.98 (95% CI=1.08-3.35), 1.28 (95% CI=1.12-1.46), and 2.02 (95% CI=1.47-2.71), respectively, compared with epsilon3/3 genotypes. Adjustment for presence of any CVD did not change the risk of death for epsilon3/4 and epsilon4/4. Adjustment for AD reduced the risk of death for epsilon3/4 (HR=1.13, 95% CI=0.99-1.30) and epsilon4/4 (HR=1.59, 95% CI=1.15-2.14). The population attributable risk of death for epsilon3/4 and epsilon4/4 genotypes combined is estimated at 9.6%. CONCLUSION: These findings suggested that the epsilon2/2, epsilon3/4, and epsilon4/4 genotypes have greater early mortality risks. Further analyses showed that AD partially mediates the association between epsilon3/4, epsilon4/4, and death.

Age Distribution↗

Age-specific incidence rates of Alzheimer's disease: the Baltimore Longitudinal Study of Aging.

OBJECTIVE: To estimate age-specific incidence rates of AD in the Baltimore Longitudinal Study of Aging (BLSA). BACKGROUND: The BLSA is a volunteer cohort of normal subjects followed longitudinally with biennial evaluations at the Gerontology Research Center of the National Institute on Aging. METHODS: Subjects are 1236 participants (802 men, 434 women) in the BLSA with longitudinal follow-up between January 1985 and May 1998. The average length of follow-up was 7.5 years, with participants evaluated every 2 years by physical, neurologic, and neuropsychological examinations. Using Diagnostic and Statistical Manual of Mental Disorders, 3rd ed., revised and National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria, the authors diagnosed dementia and AD. RESULTS: The authors diagnosed 155 cases of dementia, of which 114 (74%) were AD. Incidence rates of AD increased with age from an estimated 0.08% per year (95% CI 0.00 to 0.43) in the 60 to 65 age group to an estimated 6.48% per year (95% CI 5.01 to 8.38) in the 85+ age group for men and women combined. The doubling time of incidence rates was estimated to be approximately 4.4 years and the median time of conversion from mild cognitive impairment to diagnosis of AD was estimated to be 4.4 years. There was a trend for women to have higher incidence rates than men and for fewer years of education to be associated with higher incidence rates; however, these effects were not significant. CONCLUSION: Incidence rates for AD in the BLSA are consistent with published rates in other studies. The longitudinally followed subjects of the BLSA offer a unique opportunity to prospectively investigate the antecedents of AD.

Age Factors↗

Incidence of Alzheimer's disease in a rural community in India: the Indo-US study.

OBJECTIVE: To determine overall and age-specific incidence rates of AD in a rural, population-based cohort in Ballabgarh, India, and to compare them with those of a reference US population in the Monongahela Valley of Pennsylvania. METHODS: A 2-year, prospective, epidemiologic study of subjects aged > or =55 years utilizing repeated cognitive and functional ability screening, followed by standardized clinical evaluation using the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, and the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria for the diagnosis, and the Clinical Dementia Rating scale for the staging, of dementia and AD. RESULTS: Incidence rates per 1000 person-years for AD with CDR > or =0.5 were 3.24 (95% CI: 1.48-6.14) for those aged > or =65 years and 1.74 (95% CI: 0.84-3.20) for those aged > or =55 years. Standardized against the age distribution of the 1990 US Census, the overall incidence rate in those aged > or =65 years was 4.7 per 1000 person-years, substantially lower than the corresponding rate of 17.5 per 1000 person-years in the Monongahela Valley. CONCLUSION: These are the first AD incidence rates to be reported from the Indian subcontinent, and they appear to be among the lowest ever reported. However, the relatively short duration of follow-up, cultural factors, and other potential confounders suggest caution in interpreting this finding.

Age Factors↗

Implementation of the Integrated Library System: University of Maryland Health Sciences Library.

The Health Sciences Library, University of Maryland, has implemented the Integrated Library System (ILS), a minicomputer-based library automation system developed by the Lister Hill National Center for Biomedical Communications, National Library of Medicine. The process of moving a library from a manual to a computerized system required comprehensive planning and strong commitment by the staff. Implementation activities included hardware and software modification, conversion of manual files, staff training, and system publicity. ILS implementation resulted in major changes in procedures in the circulation, reference, and cataloging departments.

Computers↗

Determinants of parental satisfaction with disclosure of disability.

Parental satisfaction with the process of disclosure of disability was investigated in interviews with 103 parents of children with severe physical disability. Only 37 per cent of parents were satisfied with disclosure. Parents were more likely to be satisfied if they felt that the professional carrying out the disclosure had a sympathetic, understanding and approachable manner, and was direct and communicated well; if they had been given sufficient information and opportunities to ask questions; and if they were from a manual social-class background. Factors in the procedure of the disclosure, such as the timing, were not significantly related to satisfaction. These results demonstrate the importance of the parent-professional interaction and point towards an increased emphasis on communication skills in medical training.

Adolescent↗

Computerized system analyzes epidemiological data.

The computer is a valuable tool in helping to analyze epidemiological data that are collected through the infection surveillance system. The computerized system described has many significant advantages over the manual system of infection surveillance: quick assimilation, computation, and dissemination of the nosocomial infection summary report (within seven working days of the month's end); identification of infection problems and problem areas; and ability to retrieve data necessary for a complete establishment of a hypothesis regarding cause and effect implicated by an epidemiological investigation. Above all, timely and accurate infection data must be obtained in order for the reports to be beneficial in the decision-making process used by the infection control committee. Manual systems of month-to-month correlation of infection data are difficult and extremely time consuming for the surveillance person. Often the infection control committee cannot act intelligently and quickly because it is not knowledgeable of current trends occurring within the hospital. The computer has a number of limitations, and any computerized surveillance system should be approached with caution, especially during the developmental stages. The computer uses input data, follows instructions, and thus formulates output. If the computer is given either inadequate input data or inaccurately programmed instructions, the output will be erroneous. Therefore, a close working relationship should be established between the epidemiologist and the hospital's data processing department. The goals of the system must be clearly defined and understood by both areas. Once the system is established, the output is only as good as the data supplied by the epidemiologist. If this system is properly utilized, valuable information can be obtained that would have been difficult to obtain using a manual surveillance method.

Communicable Disease Control↗

Standardizing medical device communications: the Medical Information Bus.

Data collection from different types of medical devices is currently a time-consuming process that is done manually. The Medical Information Bus (MIB) defines standardized methods for interfacing medical devices and computer systems. The potential impact on current electromedical products and future product developments is huge. This article describes MIB and identifies some of the issues that must be resolved for its successful implementation.

Data Collection↗

A systematic approach to finding answers over the Internet.

New users often are surprised at how chaotic the Internet appears. They have heard so much about it and then find that it is a jumble of menus and resources. Even so, it is possible to find answers to reference questions on the Internet. This paper outlines a method for doing so. The method involves five steps: gather information and tools, learn the terminology, assemble a manual, write a strategy, and make bookmarks. The paper offers medical reference scenarios that illustrate how to search a database, find a program, find a document, and telnet to another site on the Internet.

Computer Communication Networks↗

Non-speech communication symbols and systems: where have we been and where are we going?

During the past quarter century, and especially during the past decade, we have seen the emergence of various non-speech communication symbols and systems as viable means of communication by and with severely handicapped individuals. A brief overview of the full range of both aided (static or graphic) and unaided (dynamic or manual) non-speech symbols and systems is presented. A hierarchy of difficulty, cognitive requisites, approximation to English (or other natural languages), abstraction, acceptance, etc. is considered. Advantages of non-speech communication are related to general input simplification, response production, receptive language/auditory processing, stimulus processing/stimulus association, and symbolic representation. The advantages of vocabulary limits and attentional facilitation for intervention with severely handicapped individuals are discussed. Major research issues are also explored.

Attention↗

Teaching nonvocal communication skills to multihandicapped retarded adults.

A training program for teaching communication skills to nonvocal retarded adults was evaluated in three experiments. The four subjects were severely disabled physically and had never demonstrated functional speech. Each person was taught to use either a prosthetic head pointer or to point with a hand in using a communication board for expressive language. Following baseline in Experiment I, coordination training was implemented, consisting of instructions, manual guidance, praise, feedback, and practice. Each person demonstrated a higher frequency of accurate pointing to designated areas on the board during coordination training than during baseline. In Experiment II, identification training, consisting of instructions, praise, feedback, and practice was introduced after baseline. Subjects pointed more frequently to specific word-photograph combinations to correspond to descriptive verbal labels after introduction of identification training. Social validation measures in Experiment III indicated that the communication board skills were functional in providing a method of expressing a choice of a leisure activity to people who previously could not understand the subjects' communication attempts. The acquired skills maintained throughout a seven-week followup period.

Adult↗

A method for communication analysis in prosthodontics.

Particularly in prosthodontics, in which the issues of esthetic preferences and possibilities are abundant, improved knowledge about dentist patient communication during clinical encounters is important. Because previous studies on communication used different methods and patient materials, the results are difficult to evaluate. There is, therefore, a need for methodologic development. One method that makes it possible to quantitatively describe different interaction behaviors during clinical encounters is the Roter Method of Interaction Process Analysis (RIAS). Since the method was developed in the USA for use in the medical context, a translation of the method into Swedish and a modification of the categories for use in prosthodontics were necessary. The revised manual was used to code 10 audio recordings of dentist patient encounters at a specialist clinic for prosthodontics. No major alterations of the RIAS manual were made during the translation and modification. The study shows that it is possible to distinguish patterns of communication in audio-recorded dentist patient encounters. The method also made the identification of different interaction profiles possible. These profiles distinguished well among the audio-recorded encounters. The coding procedures were tested for intra-rater reliability and found to be 97% for utterance classification and lambda = 0.76 for categorization definition. It was concluded that the revised RIAS method is applicable in communication studies in prosthodontics.

Communication↗

Apolipoprotein E in cerebrospinal fluid in 85-year-old subjects. Relation to dementia, apolipoprotein E polymorphism, cerebral atrophy, and white matter lesions.

OBJECTIVE: To further elucidate the pathogenetic role of apolipoprotein E (Apo E) in degenerative brain disorders, we analyzed cerebrospinal fluid (CSF) levels of Apo E in 85-year-old subjects with dementia disorders. DESIGN: Survey. SETTING: Community. PARTICIPANTS: Population-based sample of 27 demented (12 with Alzheimer disease [AD]; 13, vascular dementia [VAD]; and 2, other types of dementia) and 35 nondemented individuals. MAIN OUTCOME MEASURES: Cerebrospinal fluid levels of Apo E, Apo E polymorphism, and brain atrophy and white matter lesions (WMLs) measured by computed tomography (CT) of the brain. Dementia was defined according to Diagnostic and Statistical Manual of Mental Disorders, Third Edition, Revised criteria; AD, National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association criteria; and VAD, National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Enseignement en Neuroscience criteria. RESULTS: The mean (+/- SD) CSF levels of Apo E were lower in the AD (2.6 +/- 1.5 mg/L; P < .02) and VAD groups (2.5 +/- 0.9 mg/L; P < .002) than in the nondemented group (3.8 +/- 1.7 mg/L). Cerebrospinal fluid levels of Apo E decreased with increasing severity of dementia and with increasing temporal cortical and central frontal atrophy. In nondemented individuals, CSF levels of Apo E decreased with increasing degree of WMLs. Cerebrospinal fluid levels of Apo E were not influenced by the Apo E4 isoform. CONCLUSIONS: Whether our finding of an association between low CSF levels of Apo E and dementia disorders (both degenerative, such as AD, and vascular, such as VAD) is related to the pathogenesis of these disorders or is a secondary consequence of the disease process remains to be established. Although statistical correlations do not give direct evidence of causal relations, the correlations between CSF level of Apo E and severity of dementia and cortical atrophy suggest that CSF level of Apo E follows the disease process.

Aged↗

Mild cognitive impairment: clinical characterization and outcome.

BACKGROUND: Subjects with a mild cognitive impairment (MCI) have a memory impairment beyond that expected for age and education yet are not demented. These subjects are becoming the focus of many prediction studies and early intervention trials. OBJECTIVE: To characterize clinically subjects with MCI cross-sectionally and longitudinally. DESIGN: A prospective, longitudinal inception cohort. SETTING: General community clinic. PARTICIPANTS: A sample of 76 consecutively evaluated subjects with MCI were compared with 234 healthy control subjects and 106 patients with mild Alzheimer disease (AD), all from a community setting as part of the Mayo Clinic Alzheimer's Disease Center/Alzheimer's Disease Patient Registry, Rochester, Minn. MAIN OUTCOME MEASURES: The 3 groups of individuals were compared on demographic factors and measures of cognitive function including the Mini-Mental State Examination, Wechsler Adult Intelligence Scale-Revised, Wechsler Memory Scale-Revised, Dementia Rating Scale, Free and Cued Selective Reminding Test, and Auditory Verbal Learning Test. Clinical classifications of dementia and AD were determined according to the Diagnostic and Statistical Manual of Mental Disorders, Revised Third Edition and the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria, respectively. RESULTS: The primary distinction between control subjects and subjects with MCI was in the area of memory, while other cognitive functions were comparable. However, when the subjects with MCI were compared with the patients with very mild AD, memory performance was similar, but patients with AD were more impaired in other cognitive domains as well. Longitudinal performance demonstrated that the subjects with MCI declined at a rate greater than that of the controls but less rapidly than the patients with mild AD. CONCLUSIONS: Patients who meet the criteria for MCI can be differentiated from healthy control subjects and those with very mild AD. They appear to constitute a clinical entity that can be characterized for treatment interventions.

Aged↗

Progress in clinical neurosciences: cognitive markers of progression in Alzheimer's disease.

The objective of this review is to summarize the literature on Alzheimer's disease progression utilizing cognitive batteries to track change over time. Studies published in English and obtained through PubMed searches (1983-2004) were included (i) if they had a longitudinal design and followed probable Alzheimer's patients diagnosed by National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association or Diagnostic and Statistical Manual III/IV criteria, and (ii) if the techniques used for serial assessment were well-established in terms of validity and reliability. Longitudinal studies examining Alzheimer's disease progression report highly variable annual rates of change in decline rate. It remains unclear if this reflects disease subgroups or stage-related rate of decline. In conclusion a combination of stage-appropriate cognitive tests such as the Mattis Dementia Rating Scale and the Severe Impairment Battery, along with appropriate statistical methods to account for individual variability in decline rates, can capture the progression of Alzheimer disease and may be useful in further investigation.

Alzheimer Disease↗

Severity of hyperactivity and the comorbidity of hyperactivity with clumsiness in three sample sources: school, support group and hospital.

The aim of this study was to examine whether or not there were any differences in the severity of hyperactivity and the comorbidity of hyperactivity with clumsiness due to the sampling sources of hyperactive children. It was hypothesized that hyperactivity would be more severe and the comorbidity higher in the hospital sample than in the community support group and the school sample. A total of 47 hyperactive children were assessed with the German version of the Conners Teacher Rating Scale (CTRS) and the Movement Assessment Battery for Children (Movement ABC). The hypotheses were not supported by the results. Although the school sample demonstrated the least prevalence rate of comorbid clumsiness, their conduct problems were rated higher than were the hospital and the support group samples. The possible difference in teachers' perception was discussed in terms of their understanding and communication with parents and professionals. The need to determine the effect of inattention on manual performance is addressed with a research strategy.

Attention Deficit Disorder with Hyperactivity↗