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PubMed2003

Training, quality assurance, and assessment of medical record abstraction in a multisite study.

Clinical studies using medical record review should include careful training and quality assurance methods to enhance the reliability and validity of data obtained from the records. Because of time and budget constraints, comprehensive assessments of data quality and reliability, including masking of medical record abstractors, are not always possible. This paper describes the abstractor training and quality control methods and results of a masked medical record review study. The medical record review study was carried out within a larger multisite study of the effectiveness of screening mammography in preventing breast cancer mortality with an observation period within 1983 and 1993, with mortality follow-up through 1998. An eight-step program was developed to train medical record abstractors and monitor the quality of their work. A key follow-up component to the training protocol was a 5% reabstraction of medical records (n = 160), masked and reviewed by a second abstractor. High agreement was found between initial (unmasked) abstractors and masked abstractors for all key exposure variables (kappa ranged from 0.76 to 0.91), with no evidence of biased directionality by unmasked reviewers. Rigorous ongoing training programs for medical record abstractors provide assurance of good quality control in large multisite studies. Additionally, a masking study with a subsample of subjects may be a feasible and cost-effective alternative to the time- and cost-intensive methodological approach of masking all medical records.

Adult↗

PubMed2006

Association of educational level with inflammatory markers in the Framingham Offspring Study.

Socioeconomic position consistently predicts coronary heart disease; however, the biologic mechanisms that may mediate this association are not well understood. The objective of this study was to determine whether socioeconomic position (measured as educational level) is associated with inflammatory risk factors for coronary heart disease, including C-reactive protein, interleukin-6, soluble intercellular adhesion molecule-1, monocyte chemoattractant protein-1, and P-selectin. The study sample included 2,729 participants (53.4% women; mean age, 62 +/- 10 years) from the US Framingham Offspring Study cohort who attended examination cycles 3 (1984-1987) and 7 (1998-2001) and provided educational attainment data. Inflammatory markers were measured in fasting serum samples. Multivariable linear regression analyses were performed, adjusting for potential confounders including age, sex, and clinical risk factors. In age- and sex-adjusted analyses, educational attainment was significantly inversely associated with C-reactive protein (p < 0.0001), interleukin-6 (p < 0.0001), soluble intercellular adhesion molecule-1 (p < 0.0001), and monocyte chemoattractant protein-1 (p = 0.0004). After further adjustment for clinical risk factors, educational level remained significantly associated with C-reactive protein (p = 0.0002), soluble intercellular adhesion molecule-1 (p = 0.01), and monocyte chemoattractant protein-1 (p = 0.01). In conclusion, educational attainment is associated with inflammatory risk factors for coronary heart disease. The association provides evidence suggestive of a biologic pathway by which socioeconomic position may predispose to coronary heart disease.

Biomarkers↗

PubMed2006

Community influenza activity and risk of acute influenza-like illness episodes among healthy unvaccinated pregnant and postpartum women.

This study investigated the relation between weekly levels of influenza activity and the risk of acute influenza-like illness episodes among 8,323 healthy pregnant and postpartum women enrolled in a Puget Sound region, Washington, health maintenance organization, Group Health Cooperative, between June 1991 and December 1997. The authors classified weeks between October and May for isolate activity level based on surveillance data for influenza, respiratory syncytial virus, parainfluenza, and adenovirus infection. Influenza-like illness episodes were identified from medical encounters assigned a diagnostic code consistent with a symptomatic influenza infection. The authors compared the occurrence of influenza-like illness episodes within each pregnancy stage for periods with varying levels of influenza isolate detection in the community. Repeated-measures logistic regression methods accounted for time-dependent factors. The adjusted strength of association between influenza exposure and influenza-like illness episodes increased as the pregnancy stage progressed (first trimester odds ratio = 1.12, 95% confidence interval: 0.79, 1.59; second trimester odds ratio = 1.30, 95% confidence interval: 0.97, 1.73; third trimester odds ratio = 1.84, 95% confidence interval: 1.31, 2.59; postpartum period odds ratio = 2.28, 95% confidence interval: 1.42, 3.68). Pregnancy stage modified the association between influenza activity and influenza-like illness episodes. Findings estimate that 20-43 pregnant/postpartum women would need to be vaccinated with an 80% effective vaccine to prevent one influenza-like illness episode.

Acute Disease↗

PubMed2003

Recruitment of the proneural gene scute to the Drosophila sex-determination pathway.

In flies, scute (sc) works with its paralogs in the achaete-scute-complex (ASC) to direct neuronal development. However, in the family Drosophilidae, sc also acquired a role in the primary event of sex determination, X chromosome counting, by becoming an X chromosome signal element (XSE)-an evolutionary step shown here to have occurred after sc diverged from its closest paralog, achaete (ac). Two temperature-sensitive alleles, sc(sisB2) and sc(sisB3), which disrupt only sex determination, were recovered in a powerful F1 genetic selection and used to investigate how sc was recruited to the sex-determination pathway. sc(sisB2) revealed 3' nontranscribed regulatory sequences likely to be involved. The sc(sisB2) lesion abolished XSE activity when combined with mutations engineered in a sequence upstream of all XSEs. In contrast, changes in Sc protein sequence seem not to have been important for recruitment. The observation that the other new allele, sc(sisB3), eliminates the C-terminal half of Sc without affecting neurogenesis and that sc(sisB1), the most XSE-specific allele previously available, is a nonsense mutant, would seem to suggest the opposite, but we show that housefly Sc can substitute for fruit fly Sc in sex determination, despite lacking Drosophilidae-specific conserved residues in its C-terminal half. Lack of synergistic lethality among mutations in sc, twist, and dorsal argue against a proposed role for sc in mesoderm formation that had seemed potentially relevant to sex-pathway recruitment. The screen that yielded new sc alleles also generated autosomal duplications that argue against the textbook view that fruit fly sex signal evolution recruited a set of autosomal signal elements comparable to the XSEs.

Amino Acid Sequence↗

PubMed2003

Robustness into advanced age of atopy-specific mechanisms in atopy-prone families.

We evaluated atopy-associated parameters in 1,099 people (aged 6-84 years) from families with history for atopy. All were tested for serum total immunoglobulin E (IgE) and allergen sensitivity by skin prick test. Specific IgE tests were done in randomly selected families. There was a decline with age in serum total IgE values, and relative atopy "incidence rates" were slightly lower among those older than 60 years. However, there was no change with age in sensitivity or severity of atopy. Among those sensitized to ragweed (Ambrosia artemisilfolia), there was no age-associated change in IgE levels specific to Amb a 1, a major allergen extracted from ragweed, and no change in the binding affinity of IgE for the Amb a 1 allergen. Among families with atopic histories, the underlying atopic mechanisms are particularly robust, and the atopic propensity remains into advanced age. In addition, established atopic responses may be focused in an immune system compartment either independent of or minimally influenced by T-cell activity.

Adolescent↗

PubMed2003

Development of a comparative genomic hybridization microarray and demonstration of its utility with 25 well-characterized 1p36 deletions.

Chromosomal abnormalities, such as deletions and duplications, are characterized by specific and often complex phenotypes resulting from an imbalance in normal gene dosage. However, routine chromosome banding is not sensitive enough to detect subtle chromosome aberrations (<5-10 Mb). Array-based comparative genomic hybridization (array CGH) is a powerful new technology capable of identifying chromosomal imbalance at a high resolution by co-hybridizing differentially labeled test and control DNAs to a microarray of genomic clones. We used a previously assembled contig of large-insert clones that span 10.5 Mb of the most distal region of 1p36 to design a microarray. The array includes 97 clones from 1p36, 41 clones from the subtelomeric regions of all human chromosomes, and three clones from each of the X and Y chromosomes. We used this microarray to study 25 subjects with well-characterized deletions of 1p36. All array CGH results agree with the deletion sizes and locations of the breakpoints in these subjects as determined previously by FISH and microsatellite analyses. Terminal deletions, interstitial deletions, derivative chromosomes and complex rearrangements were also identified. We anticipate that array CGH will change the diagnostic approach to many congenital and acquired genetic diseases such as mental retardation, birth defects and cancer.

Chromosome Aberrations↗

PubMed2005

A mutation in NFkB interacting protein 1 results in cardiomyopathy and abnormal skin development in wa3 mice.

We have identified waved 3 (wa3), a novel recessive mutation that causes abnormalities of the heart and skin. The cardiac defect results in a severe and rapidly progressive dilated cardiomyopathy. We identified the gene mutated in these mice, which we call NFkB interacting protein1 (Nkip1), using positional cloning. Nkip1 is expressed in skin, heart and vascular endothelium and shares homology with a small family of proteins that play a role in the regulation of transcription factors. A C-terminal fragment of this protein was previously identified as the RelA associated inhibitor (RAI). We show that the full-length protein is larger than previously described, and we confirm that it interacts with NFkB in vivo. Expression analysis of genes known to be regulated by NFkB revealed that Intercellular adhesion molecule 1 (Icam1) expression is consistently elevated in mutant mice. This result suggests that wa3 mutant mice represent a potentially important model for the analysis of the role of inflammatory processes in heart disease.

Animals↗

PubMed2005

Efficacy of breast cancer screening in the community according to risk level.

BACKGROUND: The efficacy of breast cancer screening in the community may differ from that suggested by the results of randomized trials, and no data have been available on efficacy among women who have different levels of breast cancer risk. METHODS: We conducted a matched case-control study among women enrolled in six health plans in Washington, Oregon, California, Massachusetts, and Minnesota. We examined the efficacy of screening by mammography and/or clinical breast examination among women in two age cohorts (40-49 years and 50-65 years) and in two breast cancer risk levels (average and increased risk). Women who died from breast cancer from January 1, 1983, through December 31, 1998, (N = 1351; case subjects) were matched to control subjects (N = 2501) on age and risk level. Increased risk was defined as a family history of breast cancer or a breast biopsy noted in the medical records before the index date (defined as date of first suspicion of breast abnormalities in case subjects, with the same date used for matched control subjects). Data on screening, risk status, and other variables were abstracted from medical records. Conditional logistic regression was used to examine the association between breast cancer mortality and receipt of screening. All statistical tests were two-sided. RESULTS: There were small, non-statistically significant associations between breast cancer mortality and receipt of screening during the 3 years prior to the index date for both the younger women [odds ratio (OR) = 0.92; 95% confidence interval (CI) = 0.76 to 1.13] and the older women (OR = 0.87; 95% CI = 0.68 to 1.12). The association among women at increased risk (OR = 0.74; 95% CI = 0.50 to 1.03) was stronger than that among women at average risk (OR = 0.96; 95% CI = 0.80 to 1.14), but the difference was not statistically significant (P = .17). CONCLUSIONS: In this community-based study, screening history was not associated with breast cancer mortality. However, potential limitations of this study argue for a cautious interpretation of these findings.

Adult↗

PubMed2005

Screening clinical breast examination: how often does it miss lethal breast cancer?

BACKGROUND: Although most American women regularly receive screening clinical breast examination (CBE), little is known about CBE accuracy in community practice. We sought to estimate the rate of cancer detection (sensitivity) of screening CBE performed by community-based clinicians on women who ultimately died of breast cancer, as well as to identify factors associated with accurate detection. SUBJECTS AND METHODS: We evaluated CBE accuracy among asymptomatic female health plan enrollees in five states (WA, OR, CA, MA, and MN) who received a CBE within 1 year of breast cancer diagnosis and who died of breast cancer within 15 years of diagnosis (N = 485). Sensitivity was estimated as the proportion whose exam was abnormal. Bivariate and logistic regression analyses identified patient characteristics associated with cancer detection. RESULTS: An abnormality was noted on screening CBE in one of five women who ultimately succumbed to breast cancer (sensitivity = 21.6%; 95% confidence interval [CI] = 18.1% to 25.6%). The odds of a true-positive screening CBE (sensitivity) were decreased among women using estrogen (odds ratio [OR] = 0.23; 95% CI = 0.07 to 0.80), receiving a Pap smear during the same visit as CBE (OR = 0.45; 95% CI = 0.27 to 0.72), and with increasing chronic disease comorbidity (P(trend) = .08). CONCLUSION: Screening CBE as performed in the community may be insufficiently sensitive to detect most lethal breast cancers. Low sensitivity of screening CBE in community practice may be partly attributable to its performance alongside time-consuming clinical tasks such as Pap smear screening or chronic illness care.

Adult↗

PubMed2004

The Schizophrenia Patient Outcomes Research Team (PORT): updated treatment recommendations 2003.

Since publication of the original Schizophrenia Patient Outcomes Research Team (PORT) treatment recommendations in 1998, considerable scientific advances have occurred in our knowledge about how to help persons with schizophrenia. Today an even stronger body of research supports the scientific basis of treatment. This evidence, taken in its entirety, points to the value of treatment approaches combining medications with psychosocial treatments, including psychological interventions, family interventions, supported employment, assertive community treatment, and skills training. The most significant advances lie in the increased options for pharmacotherapy, with the introduction of second generation antipsychotic medications, and greater confidence and specificity in the application of psychosocial interventions. Currently available treatment technologies, when appropriately applied and accessible, should provide most patients with significant relief from psychotic symptoms and improved opportunities to lead more fulfilling lives in the community. Nonetheless, major challenges remain, including the need for (1) better knowledge about the underlying etiologies of the neurocognitive impairments and deficit symptoms that account for much of the disability still associated with schizophrenia; (2) treatments that more directly address functional impairments and that promote recovery; and (3) approaches that facilitate access to scientifically based treatments for patients, the vast majority of whom currently do not have such access.

Antipsychotic Agents↗

PubMed2002

Proinflammatory and Th1 cytokine alterations following ultraviolet radiation enhancement of disease due to influenza infection in mice.

Exposure of rodents to immunosuppressive agents such as ozone, dioxin, or ultraviolet radiation (UVR) leads to increased morbidity and mortality following influenza virus infection. However, these adverse effects are not related to the suppression of virus-specific immune responses. Our laboratory showed that UVR increased the morbidity, mortality, and pathogenesis of influenza virus without affecting protective immunity to the virus, as measured by resistance to reinfection, suggesting that UVR and other immunosuppressive pollutants such as dioxin and ozone may exacerbate early responses that contribute to the pathogenesis of a primary viral infection. In the present study, we examined the mechanism of UVR-enhanced mortality in the absence of effects on virus-specific immunity and tested the hypothesis that modulation of cytokine levels was associated with increased deaths and body weight loss. BALB/c mice were exposed to 8.2 kJ/m(2) UVR and were infected 3 days later with a sublethal influenza virus infection (LD(40) of mouse-adapted Hong Kong influenza A/68, H(3)N(2)). Influx of inflammatory cells, proinflammatory cytokines, and cytokines produced by T-helper lymphocytes (Th1 and Th2) were measured in lung homogenates (LH) as well as in bronchoalveolar lavage fluid (BAL). UVR preexposure decreased the influenza-induced lymphocytic influx 5 days after infection, but did not alter macrophage and neutrophil influx into the lung, or increase virus titers significantly. Although interferon (IFN)-gamma, total interleukin (IL)-12, IL-6, and TNF-alpha were altered in mice that received UVR exposure prior to infection, no clear association was made that correlated with the UVR-induced increase in body weight loss and mortality due to influenza infection.

Animals↗

PubMed2004

Use of standardized patients to enhance a psychiatry clerkship.

Changes in psychiatric health care delivery driven by such major shifts as deinstitutionalization, community-based care, and managed care have greatly altered the educational milieu for third-year psychiatry clerkships. Students may be assigned exclusively to alcohol and substance abuse treatment units, consultation-liaison services, or outpatient clinics, and may not have as broad an exposure as is desirable to patients with a variety of psychiatric illnesses. The authors describe a pilot course they developed in 2001, Clinical Psychiatric Assessment and Diagnosis, for third-year medical students at the Uniformed Services University of the Health Sciences medical school. The course uses standardized patients (SPs) to help students gain broader clinical experience. In psychiatry, a growing body of literature supports the acceptability, reliability, and validity of objective structured clinical examination assessment using SPs for medical students. Only a few articles report the use of SPs to primarily teach psychiatry instead of evaluating student proficiency in clinical psychiatry. Since this course was developed, the National Board of Medical Examiners announced that all medical students will be required to pass a clinical skills test in order to practice medicine, beginning with the class of 2005. The examination will use SPs modeling different clinical scenarios. In light of this change, many medical schools may have to reevaluate and possibly revamp their curriculums to insure sufficient acquisition of clinical skills in different specialties. The use of SPs in psychiatry could provide an effective, primary clinical teaching experience to address this new requirement as well.

Clinical Clerkship↗

PubMedDate not supplied

The changing face of critical care medicine: nurse practitioners in the pediatric intensive care unit.

Over the last 50 years, healthcare has undergone countless changes. Some of the important changes in recent years have been budget cuts, decreased resident work hours, and increased patient acuity. The need for additional clinical expertise at the bedside has resulted in nurse practitioners becoming an integral part of the healthcare delivery team. To date, little has been published regarding the role of the nurse practitioners in intensive care units. This article outlines how one pediatric hospital has successfully utilized nurse practitioners in the intensive care unit.

Certification↗

PubMed2002

The PACE Clinic: identification and management of young people at "ultra" high risk of psychosis.

Over the past decade, both clinical and research interest in the early stages of psychotic disorders has grown. This has been associated with research suggesting that early intervention in these disorders may limit their impact on the life of the affected individual and his or her family. It has also been recognized that the biological and psychological changes underpinning the development of psychotic disorders may already be active in the prepsychotic or prodromal phase. It has been suggested that efforts to prevent psychotic disorders should be focused on this phase of emerging illness. In this article, the authors review work conducted at the PACE Clinic in Melbourne, Australia since 1994. This clinical research program was established to develop strategies for identifying young people at high risk for developing a psychotic disorder within a short period. The program has also investigated biological and psychological processes thought to underlie the development of psychosis and evaluated potential preventive interventions.

Journal Article↗

PubMed2006

Comparing a supine radiologic versus standing clinical measurement of kyphosis in older women: the Fracture Intervention Trial.

STUDY DESIGN: A study of agreement between different measures of kyphosis, a clinical standing measure (Debrunner kyphometer; Protek AG, Bern, Switzerland) versus a supine radiologic measure (Cobb angle). OBJECTIVES: To determine whether a supine radiologic measure of kyphosis in older women is a reasonable estimate of clinical kyphosis determined in the standing position, and to investigate a computerized assessment of the Cobb angle. SUMMARY OF BACKGROUND DATA: Few studies have investigated kyphosis measurement agreement involving older adults. METHODS: Using data from the Fracture Intervention Trial, we randomly selected 120 women, aged 55-80 years, who had a Debrunner kyphometer measure of kyphosis and supine lateral spine radiographs from which we measured the Cobb angle (either manually or by digitization). We calculated the intraclass correlation coefficient (ICC) from repeated measures analysis of variance to assess the agreement among the: (1) manual Cobb angle and Debrunner kyphometer, (2) digitized Cobb angle and Debrunner kyphometer, and (3) manual and digitized Cobb angle. RESULTS: The mean of both the manual and digitized Cobb angle was 45 degrees (range 18 degrees-83 degrees), and the mean Debrunner kyphometer reading was 48 degrees (range 17 degrees-83 degrees). The ICC between either of the 2 measures of the Cobb angle and Debrunner measurement was 0.68, indicating reasonable agreement. The ICC between the manual and digitized Cobb angle was 0.99, indicating excellent agreement. CONCLUSIONS: There is reasonable agreement between a supine radiologic and standing clinical measurement of kyphosis in older women.

Aged↗

PubMedDate not supplied

Mutations in genes required for T-cell development: IL7R, CD45, IL2RG, JAK3, RAG1, RAG2, ARTEMIS, and ADA and severe combined immunodeficiency: HuGE review.

Severe combined immunodeficiency (SCID) is an inherited immune disorder characterized by T-cell lymphopenia (TCLP), a profound lack of cellular (T-cell) and humoral (B-cell) immunity and, in some cases, decreased NK-cell number and function. Affected children develop severe bacterial and viral infections within the first 6 months of life and die before 1 year of age without treatment. Mutations in any of eight known genes: IL2RG, ARTEMIS, RAG1, RAG2, ADA, CD45, JAK3, and IL7R cause SCID. Mutations in unidentified genes may also cause SCID. Population-based genotype and allelic frequencies of these gene defects have not been measured. Some minimal estimates of SCID prevalence are presented. Currently, hematopoietic stem cell transplants are the standard treatment. In clinical trials, gene therapy has been used to reconstitute immune function in patients with IL2RG and ADA defects. The availability of effective therapies, plus the short asymptomatic period after birth, (when stem-cell transplantation is most effective), make SCID a potentially good candidate for newborn screening. Dried blood spots are currently collected from all infants at birth for newborn metabolic screening. Tests for TCLP on dried blood spots could be developed as a screen for SCID. Because SCID may be unrecognized, with infant deaths from infection attributed to other causes, newborn screening is the only way to ascertain true birth prevalence. Validated tests and pilot population studies are necessary to determine newborn screening's potential for identifying infants with SCID.

Genetic Variation↗

PubMed2004

Stakeholder perspectives on radiation protection.

Standards for permissible exposure to radiation and the way they are established must incorporate a set of principles that uphold both health and democracy. When the science is uncertain, the burden of proof that risk is not being imposed should be on the source of the risk, not on the possibly affected public or workforce. Scientific processes must be transparent to the public, must address all relevant risk issues and endpoints (and not only cancer), and must be inclusive of the actual experience and opinion of the people who are exposed to radiation risks. Scientists are too often dismissive of public experience and interests, as for instance with worker illnesses or fallout, even though input from the public and workers has frequently proven to be valuable in the development of radiation protection principles. Incorporating the concerns, views, and experiences of workers and the public in a respectful way while maintaining a high standard of scientific work must be an essential part of the standard-setting process. Further, the clearly enunciated International Commission on Radiological Protection principle that the imposition of risk must be accompanied by a clear benefit needs to be a far more explicit part of standard-setting processes, which must also ensure that all known risks are disclosed and that suspected risks, such as possible synergisms between some radionuclides and hormone-disrupting chemicals, are carefully considered. Finally, given the long-lived nature of risks from many radionuclides and the large uncertainties about future physical, social, economic, and other conditions, the issue of how the interests of future generations can be included in standard setting is a difficult but vital matter.

Community Participation↗

PubMed2005

Comparison of corneal surface effects of gatifloxacin and moxifloxacin using intensive and prolonged dosing protocols.

PURPOSE: To compare the effects of the commercial formulations of moxifloxacin and gatifloxacin on rabbit corneal epithelium using two dosing protocols: high-frequency dosing for bacterial keratitis and cataract surgery prophylaxis. METHODS: Forty eyes of 20 New Zealand white rabbits were randomized to receive topical gatifloxacin, topical moxifloxacin, or no drops as controls. Eighteen eyes received 1 drop of antibiotic every 5 minutes for 15 minutes followed by 1 drop every 15 minutes for 4 hours. Twelve eyes received topical gatifloxacin or topical moxifloxacin 4 times a day for 10 days. Rabbits were euthanized, eyes enucleated, and the corneas separated, washed, and fixed; scanning electron microscopy was performed. Photomicrographs of three separate areas from the corneal apex were taken at x1200 and x3000 for each cornea. Two masked, experienced examiners then graded the corneal epithelial damage. RESULTS: In the high-frequency dosing group, mean corneal damage score for eyes treated with gatifloxacin was 1.593, that for moxifloxacin was 1.407, and control was 1.000. No statistically significant difference was found between gatifloxacin and moxifloxacin (P = 0.41), gatifloxacin and control (P = 0.14), or moxifloxacin and control (P = 0.23). In the cataract surgery prophylaxis group, mean corneal damage scores for eyes treated with gatifloxacin was 1.167, that for moxifloxacin was 1.368, and control was 1.000. No statistically significant difference was found between gatifloxacin and moxifloxacin (P = 0.23), gatifloxacin and control (P = 0.08), or moxifloxacin and control (P = 0.23). CONCLUSION: Despite differences in formulations, with short-term dosing neither gatifloxacin nor moxifloxacin appears to be toxic to the corneal epithelium in this rabbit model.

Animals↗