1514 articles - 10.09.10
1: J Clin Epidemiol. 2010 Aug 27; [Epub ahead of print]
Parekh-Bhurke S, Kwok CS, Pang C, Hooper L, Loke YK, Ryder JJ, Sutton AJ, Hing CB, Harvey I, Song F.
Faculty of Health, School of Medicine, Health Policy and Practice, University of East Anglia, Norwich, United Kingdom; Faculty of Health, School of Allied Health Professions, University of East Anglia, Norwich, United Kingdom.
OBJECTIVE: To evaluate the measures taken to deal with publication bias across different categories of systematic reviews published in 2006 and to compare these with reviews published in 1996. STUDY DESIGN AND SETTING: PubMed was searched for systematic reviews published in 2006; 100 treatment effect, 50 diagnostic accuracy, 100 risk factor, and 50 gene-disease association reviews were randomly selected. RESULTS: The use of MEDLINE increased from 74% to 95%; checking references increased from 42% to 73%; use of Cochrane Library increased from 5% to 58%; and use of CINAHL increased from 8% in 1996 to 24% in treatment reviews, 20% in diagnostic reviews, 18% in risk factor reviews, and 0% in genetic reviews published in 2006. A 20% increase was observed for explicit searching of non-English-language studies in all reviews published in 2006. Efforts to search for unpublished studies increased to 61% from 35% in treatment reviews published in 1996. Twenty-six percent of the reviews used funnel plots or related methods to test for publication bias compared with less than 6% in earlier reviews. CONCLUSION: Recent reviews show a significant improvement in the measures taken to prevent publication bias. However, few methods exist to deal with publication bias in the nonquantitative findings of systematic reviews. Copyright (c) 2010 Elsevier Inc. All rights reserved.
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PMID: 20800992 [PubMed - as supplied by publisher]2: J Clin Epidemiol. 2010 Aug 26; [Epub ahead of print]
Aaron SD, Ramsay T, Vandemheen K, Whitmore GA.
Ottawa Health Research Institute, Ottawa, Ontario, Canada K1H 8L6.
OBJECTIVE: Respiratory exacerbations are a major source of morbidity in patients with chronic obstructive pulmonary disease (COPD). In this article, we model COPD health status as a formal stochastic process. A successful model will provide a suitable statistical structure for analysis of the effects of medical interventions on a patient's health status, and, possibly, offer new insights into the underlying disease process. STUDY DESIGN AND SETTING: Our approach uses a regression methodology for time-to-event data called threshold regression (TR). We test the methodology on COPD data from a randomized clinical trial. Two TR models are studied: one based on a Poisson process and the other, a Wiener diffusion process. RESULTS: Both models provide reasonably accurate fits to the clinical trial data. The insights offered by the fitted models are interpreted. Analysis of the clinical trial data set using these TR models revealed that patients who experienced multiple exacerbations showed a progressive acceleration in rate of exacerbations, and successive shortening of stable intervals between exacerbations. CONCLUSION: TR techniques allow for realistic modeling of the COPD health state. A hybrid Poisson/Wiener diffusion TR model that incorporates the causal determinants of disease operating in each patient may be preferable. Copyright (c) 2010 Elsevier Inc. All rights reserved.
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PMID: 20800447 [PubMed - as supplied by publisher]3: J Clin Epidemiol. 2010 Aug 26; [Epub ahead of print]
Pibouleau L, Chevret S.
INSERM, UMR-S717, Paris, F-75000, France; Departement de Biostatistique et Informatique Medicale, Hopital Saint Louis, Assistance Publique-Hopitaux de Paris, Paris F-75000, France; Universite Paris 7, UMR-S717, Paris, F-75000, France.
OBJECTIVE: We sought to review the use of Bayesian methods in the evaluation of the effectiveness of implantable medical devices (IMDs) to identify which areas of research need to be further investigated to improve IMD assessment. STUDY DESIGN AND SETTING: Relevant studies were identified by searching PubMed and the Food and Drug Administration Web site. Data were extracted independently by the two authors. The quality of Bayesian analysis reporting was summarized using the ROBUST (Reporting Of Bayes Used in clinical STudies) checklist. RESULTS: Seventeen studies met the inclusion criteria; five published meta-analyses and 12 clinical studies were reported as FDA summaries of safety and effectiveness. Reporting of data was of high quality in meta-analyses, whereas it was of poor quality in clinical studies. Bayesian methods were used in meta-analyses to model study heterogeneity. In clinical studies, the objectives of the Bayesian analyses were mostly to address the question of equivalence and to use surrogate outcome predictors. Prior information, when reported, was less informative. Clinical data external to the trial itself and expert opinions were never used to elicit prior information. CONCLUSION: Our review highlighted the underuse of Bayesian methods in IMD assessment. The major challenge is to provide to clinical researchers a framework that helps them use external evidence to elicit prior distributions. Copyright (c) 2010 Elsevier Inc. All rights reserved.
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PMID: 20800443 [PubMed - as supplied by publisher]4: J Clin Epidemiol. 2010 Aug 26; [Epub ahead of print]
Norris SL, McNally TK, Zhang X, Burda B, Chan B, Chowdhury FM, Zhang P, Patrick D.
Department of Medical Informatics and Clinical Epidemiology, Oregon Health and Science University, Portland, OR, USA.
OBJECTIVE: To assess health-related quality of life (HRQL) among adults with type 2 diabetes using the Short Form (SF)-36 and to obtain pooled estimates of HRQL for subpopulations defined by demographic characteristics, diabetes-related complications, and comorbidities. STUDY DESIGN AND METHODS: We conducted computerized searches of multiple electronic bibliographic databases, and studies in any language were selected in which HRQL was reported among adults with type 2 diabetes using the SF-36. Estimates were combined using a random-effects model. RESULTS: One hundred eighteen studies fulfilled the inclusion criteria. HRQL was lower in persons with type 2 diabetes, as measured by all the eight component scores of the SF-36 when compared with the existing U.S. population norms and with previously published type 2 diabetes norms. SF-36 component and summary scores were extremely heterogeneous, and subpopulation data were sparse; this precluded obtaining meaningful pooled scores for most populations of interest and made comparisons among subpopulations difficult. CONCLUSION: Our data suggest that previously published norms may underestimate the effect of diabetes on HRQL, and diabetes populations are extremely heterogeneous, making broad population "norms" for HRQL in type 2 diabetes of limited use. Additional research with important subpopulations and individual-level data are needed to further explore the effect of diabetes on HRQL. Published by Elsevier Inc.
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PMID: 20800442 [PubMed - as supplied by publisher]5: J Clin Epidemiol. 2010 Oct;63(10):1061-70.
Shamliyan T, Kane RL, Dickinson S.
Minnesota Evidence-based Practice Center, University of Minnesota School of Public Health, Minneapolis, MN 55455, USA. shaml005@umn.edu
OBJECTIVE: To create a comprehensive evaluation of checklists and scales used to evaluate observational studies that examine incidence or prevalence and risk factors for diseases. STUDY DESIGN: We did a literature search of several databases to abstract format, content, development, and validation of the tools. RESULTS: We identified 46 scales and 51 checklists. Forty-seven of these tools were created for therapeutic studies, 48 for risk factors, and 5 for incidence studies. Forty-seven percent were modifications of previously published peer-reviewed appraisals, 18% were developed based on methodological standards, and 35% did not report development. Twenty-two percent reported reliability and 10% the validation procedure. Tools did not discriminate poor reporting vs. methodological quality of studies or external vs. internal validity; 35% categorize quality by the presence of predefined major flaws in design or by total score from the scale. Level of evidence was proposed in 22% of the tools by criteria of causality or internal validity of the studies. Evaluation required different degrees of subjectivity. CONCLUSIONS: Format, length, and content varied substantially across available checklists and scales. Development, validation, and reliability were not consistently reported. Transparent objective quality assessments should be developed in the future. Copyright (c) 2010 Elsevier Inc. All rights reserved.
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PMID: 20728045 [PubMed - in process]6: Am J Public Health. 2010 Aug 19; [Epub ahead of print]
Mayer KH, Venkatesh KK.
Brown Univ/Miriam Hospital/Fenway Community Health.
As antiretroviral treatment of HIV infection has become increasingly accessible,attention has focused on whether these drugs can used for prevention because of increased tolerability of newer medications, decreased cost, and the limitations of other approaches. We review the status of antiretroviral HIV prevention, including chemoprophylaxis, as well as the effects of treatment of infected individuals on prevention. It is possible that the life-saving agents that have transformed the natural history of AIDS can be a critical component of HIV prevention efforts, but their ultimate role in affecting HIV transmission dynamics remains to be defined. (Am J Public Health. Published online ahead of print August 19, 2010: e1-e10. doi:10.2105/AJPH.2009.184796).
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PMID: 20724682 [PubMed - as supplied by publisher]7: Am J Public Health. 2010 Aug 19; [Epub ahead of print]
Lifson AR, Neuhaus J, Arribas JR, van den Berg-Wolf M, Labriola AM, Read TR.
University of Minnesota, Minneapolis, MN.
Objectives. We sought to determine smoking-related hazard ratios (HRs) and population-attributable risk percentage (PAR%) for serious clinical events and death among HIV-positive persons, whose smoking prevalence is higher than in the general population. Methods. For 5472 HIV-infected persons enrolled from 33 countries in the Strategies for Management of Antiretroviral Therapy clinical trial, we evaluated the relationship between baseline smoking status and development of AIDS related or serious non-AIDS events and overall mortality. Results. Among all participants, 40.5% were current smokers and 24.8% were former smokers. Adjusted HRs were higher for current than for never smokers for overall mortality (2.4; P<.001), major cardiovascular disease (2.0; P=.002), non-AIDS cancer (1.8; P=.008), and bacterial pneumonia (2.3; P<.001). Adjusted HRs also were significantly higher for these outcomes among current than among former smokers. The PAR% for current versus former and never smokers combined was 24.3% for overall mortality, 25.3% for major cardiovascular disease, 30.6% for non-AIDS cancer, and 25.4% for bacterial pneumonia. Conclusions. Smoking contributes to substantial morbidity and mortality in this HIV-infected population. Providers should routinely integrate smoking cessation programs into HIV health care. (Am J Public Health. Published online ahead of print August 19, 2010: e1-e8. doi:10.2105/AJPH.2009.188664).
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PMID: 20724677 [PubMed - as supplied by publisher]8: J Clin Epidemiol. 2010 Aug 11; [Epub ahead of print]
Rahn DD, Abed H, Sung VW, Matteson KA, Rogers RG, Morrill MY, Barber MD, Schaffer JI, Wheeler TL 2nd, Balk EM, Uhlig K; for the Society of Gynecologic Surgeons-Systematic Review Group.
University of Texas Southwestern Medical Center, Dallas, TX, USA.
OBJECTIVES: (1) To systematically collect and organize into clinical categories all outcomes reported in trials for abnormal uterine bleeding (AUB); (2) to rank the importance of outcomes for patient decision making; and (3) to improve future comparisons of effects in trials of AUB interventions. STUDY DESIGN AND SETTING: Systematic review of English-language randomized controlled trials of AUB treatments in MEDLINE from 1950 to June 2008. All outcomes and definitions were extracted and organized into major outcome categories by an expert group. Each outcome was ranked "critically important," "important," or "not important" for informing patients' choices. RESULTS: One hundred thirteen articles from 79 trials met the criteria. One hundred fourteen different outcomes were identified, only 15 (13%) of which were ranked as critically important and 29 (25%) as important. Outcomes were grouped into eight categories: (1) bleeding; (2) quality of life; (3) pain; (4) sexual health; (5) patient satisfaction; (6) bulk-related complaints; (7) need for subsequent surgical treatment; and (8) adverse events. CONCLUSION: To improve the quality, consistency, and utility of future AUB trials, we recommend assessing a limited number of clinical outcomes for bleeding, disease-specific quality of life, pain, sexual health, and bulk-related symptoms both before and after treatment and reporting satisfaction and adverse events. Further development of validated patient-based outcome measures and the standardization of outcome reporting are needed. Copyright (c) 2010 Elsevier Inc. All rights reserved.
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PMID: 20705427 [PubMed - as supplied by publisher]9: Am J Epidemiol. 2010 Sep 1;172(5):517-24. Epub 2010 Aug 5.
Khoury MJ, Gwinn M, Ioannidis JP.
Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA. muk1@cdc.gov
Recent emphasis on translational research (TR) is highlighting the role of epidemiology in translating scientific discoveries into population health impact. The authors present applications of epidemiology in TR through 4 phases designated T1-T4, illustrated by examples from human genomics. In T1, epidemiology explores the role of a basic scientific discovery (e.g., a disease risk factor or biomarker) in developing a "candidate application" for use in practice (e.g., a test used to guide interventions). In T2, epidemiology can help to evaluate the efficacy of a candidate application by using observational studies and randomized controlled trials. In T3, epidemiology can help to assess facilitators and barriers for uptake and implementation of candidate applications in practice. In T4, epidemiology can help to assess the impact of using candidate applications on population health outcomes. Epidemiology also has a leading role in knowledge synthesis, especially using quantitative methods (e.g., meta-analysis). To explore the emergence of TR in epidemiology, the authors compared articles published in selected issues of the Journal in 1999 and 2009. The proportion of articles identified as translational doubled from 16% (11/69) in 1999 to 33% (22/66) in 2009 (P = 0.02). Epidemiology is increasingly recognized as an important component of TR. By quantifying and integrating knowledge across disciplines, epidemiology provides crucial methods and tools for TR.
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PMID: 20688899 [PubMed - in process]10: J Clin Epidemiol. 2010 Aug 3; [Epub ahead of print]
Salanti G, Ades AE, Ioannidis JP.
Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece.
OBJECTIVE: To present some simple graphical and quantitative ways to assist interpretation and improve presentation of results from multiple-treatment meta-analysis (MTM). STUDY DESIGN AND SETTING: We reanalyze a published network of trials comparing various antiplatelet interventions regarding the incidence of serious vascular events using Bayesian approaches for random effects MTM, and we explore the advantages and drawbacks of various traditional and new forms of quantitative displays and graphical presentations of results. RESULTS: We present the results under various forms, conventionally based on the mean of the distribution of the effect sizes; based on predictions; based on ranking probabilities; and finally, based on probabilities to be within an acceptable range from a reference. We show how to obtain and present results on ranking of all treatments and how to appraise the overall ranks. CONCLUSIONS: Bayesian methodology offers a multitude of ways to present results from MTM models, as it enables a natural and easy estimation of all measures based on probabilities, ranks, or predictions. Copyright (c) 2010 Elsevier Inc. All rights reserved.
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PMID: 20688472 [PubMed - as supplied by publisher]11: Am J Epidemiol. 2010 Aug 2; [Epub ahead of print]
Bao W, Song F, Li X, Rong S, Yang W, Wang D, Xu J, Fu J, Zhao Y, Liu L.
Several studies have recently focused on the association between heme oxygenase-1 (HMOX1) gene promoter polymorphisms and susceptibility to type 2 diabetes mellitus; however, results have been conflicting. This systematic Human Genome Epidemiology review and meta-analysis was undertaken to integrate previous findings and summarize the effect size of the association of HMOX1 gene promoter polymorphisms with susceptibility to type 2 diabetes. The authors retrieved all studies matched to search terms from the PubMed/MEDLINE, EMBASE, and ISI Web of Science databases that had been published through December 31, 2009. The articles were then checked independently by 2 investigators according to the eligibility and exclusion criteria. For all alleles and genotypes, odds ratios were pooled using either fixed-effects or random-effects models. An increased odds ratio for type 2 diabetes was observed in persons with the (GT)(n) L (long) allele as compared with those with the (GT)(n) S (short) allele (odds ratio = 1.12, 95% confidence interval: 1.02, 1.24; P = 0.02). Furthermore, the diabetes odds ratio for persons with the LL genotype, versus those with the SS genotype, was significantly increased (odds ratio = 1.25, 95% confidence interval: 1.04, 1.50; P = 0.02). Persons carrying longer (GT)(n) repeats in the HMOX1 gene promoter may have a higher risk of type 2 diabetes.
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20682519&dopt=ExternalLink
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PMID: 20682519 [PubMed - as supplied by publisher]12: Am J Epidemiol. 2010 Sep 1;172(5):591-9. Epub 2010 Aug 1.
Kabat GC, Kim M, Kakani C, Tindle H, Wactawski-Wende J, Ockene JK, Luo J, Wassertheil-Smoller S, Rohan TE.
Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Yeshiva University, Bronx, New York 10461, USA. geoffrey.kabat@einstein.yu.edu
In numerous studies, investigators have examined the association of active smoking with risk of invasive breast cancer, but to the authors' knowledge, no cohort study has assessed smoking in relation to the risk of in situ breast cancer, the postulated penultimate stage preceding invasive breast cancer. The authors examined the latter association using data collected at baseline from 63,393 women in the Women's Health Initiative Clinical Trial. A total of 486 cases of ductal carcinoma in situ (DCIS) of the breast were identified during 8 years of follow-up between 1993 and 2005. Cox proportional hazards models were used to estimate hazard ratios and 95% confidence intervals. For the primary analysis, invasive breast cancer was treated as a competing risk. After adjustment for covariates, associations with smoking status, smoking intensity, duration, pack-years, and age at quitting were all close to the null value and showed few meaningful trends. Sensitivity analyses performed to address different possibilities with respect to the natural history of breast cancer also did not provide consistent evidence of an association of smoking with DCIS. The results of this large cohort study provide little support for an association of cigarette smoking with risk of DCIS in postmenopausal women.
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PMID: 20679068 [PubMed - in process]13: Am J Epidemiol. 2010 Sep 1;172(5):501-16. Epub 2010 Jul 28.
Pennant M, Davenport C, Bayliss S, Greenheld W, Marshall T, Hyde C.
Unit of Public Health, Epidemiology and Biostatistics, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom. m.pennant@bham.ac.uk
In this systematic review, the authors aimed to assess the effectiveness of community programs for prevention of cardiovascular disease (CVD). They searched numerous electronic databases (CDSR, DARE, HTA, EED, and CENTRAL via the Cochrane Library, MEDLINE, MEDLINE In Process, EMBASE, CINAHL, PsycINFO, HMIC, and ASSIA) and relevant Web sites from January 1970 to mid-July 2008. Controlled studies of community programs for the primary prevention of CVD were included. Net changes in CVD risk factors were used to generate an overall index for net change in 10-year CVD risk. The authors identified 36 relevant community programs that took place between 1970 and 2008. These programs were multifaceted interventions employing combinations of media, screening, and counseling activities and environmental changes and were primarily evaluated using controlled before-after studies. In 7 studies, investigators reported changes in CVD/total mortality rates, and in 5 they reported net changes. In all cases, these net changes were positive but were largely nonsignificant. In 22 studies, investigators reported changes in physiologic CVD risk factors, and there was a positive trend in the calculated CVD risk score. The average net reduction in 10-year CVD risk was 0.65%. Community programs for CVD prevention appear to have generally achieved favorable changes in overall CVD risk and, with adaptation to current circumstances, deserve continued consideration as possible approaches to preventing CVD.
Publication Types: Research Support, Non-U.S. Gov't
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PMID: 20667932 [PubMed - in process]14: J Clin Epidemiol. 2010 Jul 17; [Epub ahead of print]
Swaen GM, Carmichael N, Doe J.
Epidemiology, Health Services, The Dow Chemical Company, P.O. Box 444, 4530 AK Terneuzen, The Netherlands.
OBJECTIVE: To evaluate the need for the creation of a system in which observational epidemiology studies are registered; an Observational Studies Register (OSR). STUDY DESIGN AND SETTING: The current scientific process for observational epidemiology studies is described. Next, a parallel is made with the clinical trials area, where the creation of clinical trial registers has greatly restored and improved their credibility and reliability. Next, the advantages and disadvantages of an OSR are compared. RESULTS: The advantages of an OSR outweigh its disadvantages. CONCLUSION: The creation of an OSR, similar to the existing Clinical Trials Registers, will improve the assessment of publication bias and will provide an opportunity to compare the original study protocol with the results reported in the publication. Reliability, credibility, and transparency of observational epidemiology studies are strengthened by the creation of an OSR. We propose a structured, collaborative, and coordinated approach for observational epidemiology studies that can provide solutions for existing weaknesses and will strengthen credibility and reliability, similar to the approach currently used in clinical trials, where Clinical Trials Registers have played a key role in strengthening their scientific value. Copyright (c) 2010 Elsevier Inc. All rights reserved.
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PMID: 20643528 [PubMed - as supplied by publisher]15: J Clin Epidemiol. 2010 Jul 16; [Epub ahead of print]
Jordan JE, Osborne RH, Buchbinder R.
Department of Medicine, Centre for Rheumatic Diseases, The Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia.
OBJECTIVE: Health literacy refers to an individual's ability to seek, understand, and use health information. A range of indices exist that purport to measure health literacy across individuals and populations. This study aimed to review the development and content of existing indices and to critically appraise their properties. STUDY DESIGN AND SETTING: Using standardized search terms, published generic health literacy indices (1990-2008) were identified. Using a methodological framework, each was evaluated for purpose, validity (face, content, construct), reliability, responsiveness, feasibility, and generalizability. RESULTS: Nineteen instruments were evaluated. Three measurement approaches were identified: direct testing of individual abilities, self-report of abilities, and population-based proxy measures. Composition of underlying constructs and content varied widely across instruments, and none appeared to fully measure a person's ability to seek, understand, and use health information. The content was focused primarily on reading comprehension and numeracy; scoring categories were poorly defined and may not be mutually exclusive, and few indices had been assessed for reliability. CONCLUSION: Health literacy is not consistently measured, making it difficult to interpret and compare health literacy at individual and population levels. Empirical evidence demonstrating validity and reliability of existing indices is required, and more comprehensive health literacy instruments need to be developed. Copyright (c) 2010 Elsevier Inc. All rights reserved.
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PMID: 20638235 [PubMed - as supplied by publisher]16: Am J Public Health. 2010 Sep;100(9):1641-7. Epub 2010 Jul 15.
Guilamo-Ramos V, Jaccard J, Dittus P, Gonzalez B, Bouris A, Banspach S.
Columbia University School of Social Work, 1255 Amsterdam Ave, New York, NY 10027, USA. rg650@columbia.edu
OBJECTIVES: We evaluated the effectiveness of a parent-based add-on component to a school-based intervention to prevent cigarette smoking among African American and Latino middle school youths. METHODS: Mother-adolescent dyads (n=1386) were randomly assigned to 2 groups: (1) a school-based smoking-prevention intervention or (2) the same intervention with a parent-based add-on component called Raising Smoke-Free Kids. Mothers in the experimental condition received the parent add-on component. Mothers in the control condition received information on selecting a high school. All adolescents received a version of Project Towards No Tobacco Use (TNT). The primary outcome was a reduction in adolescent cigarette smoking. Follow-up data were obtained from 1096 mother-adolescent dyads at 15 months postintervention. RESULTS: At follow-up, the odds of smoking cigarettes were reduced by 42% for adolescents in the parent add-on condition versus the TNT-only condition. Mothers in the parent add-on condition were more likely than were mothers in the TNT-only condition to set rules about risk-sensitive social activities and to be perceived as trustworthy by their child. Group differences also were found in the frequency and quality of mother-adolescent communication. CONCLUSIONS: Including parent add-on components in school-based smoking prevention programs can reduce smoking behavior on the part of inner-city middle school youths.
Publication Types: Research Support, U.S. Gov't, P.H.S.
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PMID: 20634469 [PubMed - in process]17: J Clin Epidemiol. 2010 Aug;63(8):841-53.
Cataldo JK, Bero LA, Malone RE.
Department of Physiological Nursing-Gerontology, University of California San Francisco, CA 94143-0610, USA.
BACKGROUND: The Framingham Heart Study (henceforth Framingham) is among the gold standards for epidemiological research. Being a prospective cohort study of 5,000+ men and women, it provided early findings about the causes of coronary heart disease (CHD), following a cohort over the course of 24 years. After US government funding ended, the tobacco industry funded Council for Tobacco Research (CTR) provided continued funding for analyses related to smoking. OBJECTIVE: This study sought to understand the tobacco industry's motivation and activities in funding Framingham. STUDY DESIGN AND SETTING: We analyzed previously undisclosed tobacco industry documents, conducting iterative searches of the Legacy Tobacco Documents Library (http://legacy.library.ucsf.edu/), and assembled a historical case study. RESULTS: CTR funded Framingham to obtain full access to Framingham data. CTR planned for long-time industry consultant Carl Seltzer to reanalyze them to suggest that tobacco-related morbidity and mortality primarily resulted from "constitutional" factors, such as age or ethnicity. Once data were obtained, CTR terminated funding for the Framingham principal investigator, who disagreed with Seltzer. Seltzer's critical analyses of subsequently published work by the Framingham team created confusion about the association between CHD and cigarette smoking. CONCLUSION: Researchers accepting tobacco industry funding risk losing control of data, analysis, and publication. Copyright (c) 2010 Elsevier Inc. All rights reserved.Publication Types: Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't">Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20630333&dopt=ExternalLink
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PMID: 20630333 [PubMed - in process]18: J Clin Epidemiol. 2010 Jul 5; [Epub ahead of print]
Herbison P, Hay-Smith J, Gillespie WJ.
Department of Preventive and Social Medicine, University of Otago, P.O. Box 913, Dunedin 9054, New Zealand.
OBJECTIVE: Many systematic reviews include only a few studies. It is unclear whether recommendations based on these will be correct in the longer term; hence, this article explores whether meta-analyses give reliable results after only a few studies. STUDY DESIGN AND SETTING: Cumulative meta-analysis of data from 65 meta-analyses from 18 Cochrane systematic reviews was carried out. Various measures of closeness to the pooled estimate from all trials after three and five trials were included. Changes during the accumulation of evidence were noted. RESULTS: The 95% confidence interval included the final estimate in 72% of meta-analyses after three studies and in 83% after five studies. It took a median of four (interquartile range: 1.25-6) studies to get within 10% of the final point estimate. Agreement between the results at three and five studies and the final estimate was not predicted by the number of participants, the number of events, tau(2), or I(2). Estimates could still change substantially after many trials were included. CONCLUSION: Many of the conclusions drawn from systematic reviews with small numbers of included studies will be correct in the long run, but it is not possible to predict which ones. Copyright (c) 2010 Elsevier Inc. All rights reserved.
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PMID: 20609563 [PubMed - as supplied by publisher]19: J Clin Epidemiol. 2010 Sep;63(9):950-9. Epub 2010 Jun 25.
Kim K, Zakharkin SO, Allison DB.
Division of Biostatistics, Department of Public Health Sciences, University of California, Davis, CA 95616, USA. kmkim@ucdavis.edu
OBJECTIVE: To provide a critical overview of gene expression profiling methodology and discuss areas of future development. RESULTS: Gene expression profiling has been used extensively in biological research and has resulted in significant advances in the understanding of the molecular mechanisms of complex disorders, including cancer, heart disease, and metabolic disorders. However, translating this technology into genomic medicine for use in diagnosis and prognosis faces many challenges. In addition, gene expression profile analysis is frequently controversial, because its conclusions often lack reproducibility and claims of effective dissemination into translational medicine have, in some cases, been remarkably unjustified. In the last decade, a large number of methodological and technical solutions have been offered to overcome the challenges. STUDY DESIGN AND SETTING: We consider the strengths, limitations, and appropriate applications of gene expression profiling techniques, with particular reference to the clinical relevance. CONCLUSION: Some studies have demonstrated the ability and clinical utility of gene expression profiling for use as diagnostic, prognostic, and predictive molecular markers. The challenges of gene expression profiling lie with the standardization of analytic approaches and the evaluation of the clinical merit in broader heterogeneous populations by prospective clinical trials.
Publication Types: Research Support, N.I.H., Extramural
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20579843&dopt=ExternalLink
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PMID: 20579843 [PubMed - in process]20: J Clin Epidemiol. 2010 Sep;63(9):992-7. Epub 2010 Jun 22.
Borm GF, Bloem BR, Munneke M, Teerenstra S.
Department of Epidemiology, Biostatistics and HTA, Radboud University Nijmegen Medical Centre, Geert Grooteplein 21, Nijmegen, The Netherlands. g.borm@ebh.umcn.nl
OBJECTIVE: When an investigator wants to base the power of a planned clinical trial on the outcome of another trial, the latter study may not have been reported in sufficient detail to allow this. For example, when the outcome is a change from baseline, the power calculation requires the standard deviation of the difference, and it frequently happens that only the standard deviations of the baseline and the follow-up measurements are reported. Also when a complex analysis or an analysis with covariates is planned, the power calculation may be difficult or impossible. The objective was to develop a method to determine the power of a trial, based on minimal information from a previous (reference) trial. STUDY DESIGN AND SETTING: We investigated the power calculation for a range of statistical methods, including the t-test, analysis of covariance, analysis of variance, linear regression, logistic regression, Poisson regression, the Wilcoxon test, and the logrank test. RESULTS: A method to calculate the power of a trial solely based on the P-value or the confidence interval of the outcome of the reference study. CONCLUSION: A power calculation based on an earlier similar trial only requires its P-value.
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20573484&dopt=ExternalLink
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PMID: 20573484 [PubMed - in process]