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1.  Strengthening the reporting of genetic risk prediction studies (GRIPS): explanation and elaboration 
European Journal of Epidemiology  2011;26(4):313-337.
The rapid and continuing progress in gene discovery for complex diseases is fuelling interest in the potential application of genetic risk models for clinical and public health practice. The number of studies assessing the predictive ability is steadily increasing, but they vary widely in completeness of reporting and apparent quality. Transparent reporting of the strengths and weaknesses of these studies is important to facilitate the accumulation of evidence on genetic risk prediction. A multidisciplinary workshop sponsored by the Human Genome Epidemiology Network developed a checklist of 25 items recommended for strengthening the reporting of Genetic RIsk Prediction Studies (GRIPS), building on the principles established by prior reporting guidelines. These recommendations aim to enhance the transparency, quality and completeness of study reporting, and thereby to improve the synthesis and application of information from multiple studies that might differ in design, conduct or analysis.
doi:10.1007/s10654-011-9551-z
PMCID: PMC3088812  PMID: 21424820
Genetic; Risk prediction; Methodology; Guidelines; Reporting
2.  Strengthening the reporting of genetic risk prediction studies: the GRIPS statement 
Genome Medicine  2011;3(3):16.
The rapid and continuing progress in gene discovery for complex diseases is fueling interest in the potential application of genetic risk models for clinical and public health practice. The number of studies assessing the predictive ability is steadily increasing, but the quality and completeness of reporting varies. A multidisciplinary workshop sponsored by the Human Genome Epidemiology Network developed a checklist of 25 items recommended for strengthening the reporting of genetic risk prediction studies (the GRIPS statement), building on the principles established by prior reporting guidelines. These recommendations aim to enhance the transparency of study reporting, and thereby to improve the synthesis and application of information from multiple studies that might differ in design, conduct, or analysis. A detailed Explanation and Elaboration document is published at http://www.plosmedicine.org.
doi:10.1186/gm230
PMCID: PMC3092101  PMID: 21410995
3.  Strengthening the reporting of genetic risk prediction studies: the GRIPS statement 
European Journal of Epidemiology  2011;26(4):255-259.
The rapid and continuing progress in gene discovery for complex diseases is fueling interest in the potential application of genetic risk models for clinical and public health practice. The number of studies assessing the predictive ability is steadily increasing, but the quality and completeness of reporting varies. A multidisciplinary workshop sponsored by the Human Genome Epidemiology Network developed a checklist of 25 items recommended for strengthening the reporting of Genetic RIsk Prediction Studies (GRIPS), building on the principles established by prior reporting guidelines. These recommendations aim to enhance the transparency of study reporting, and thereby to improve the synthesis and application of information from multiple studies that might differ in design, conduct, or analysis. A detailed Explanation and Elaboration document is published.
doi:10.1007/s10654-011-9552-y
PMCID: PMC3088799  PMID: 21431409
Genetic; Risk prediction; Methodology; Guidelines; Reporting
4.  Strengthening the reporting of genetic risk prediction studies (GRIPS): explanation and elaboration 
The rapid and continuing progress in gene discovery for complex diseases is fueling interest in the potential application of genetic risk models for clinical and public health practice. The number of studies assessing the predictive ability is steadily increasing, but they vary widely in completeness of reporting and apparent quality. Transparent reporting of the strengths and weaknesses of these studies is important to facilitate the accumulation of evidence on genetic risk prediction. A multidisciplinary workshop sponsored by the Human Genome Epidemiology Network developed a checklist of 25 items recommended for strengthening the reporting of Genetic RIsk Prediction Studies (GRIPS), building on the principles established by previous reporting guidelines. These recommendations aim to enhance the transparency, quality and completeness of study reporting, and thereby to improve the synthesis and application of information from multiple studies that might differ in design, conduct or analysis.
doi:10.1038/ejhg.2011.27
PMCID: PMC3083630  PMID: 21407270
5.  Strengthening the reporting of genetic risk prediction studies: the GRIPS statement 
The rapid and continuing progress in gene discovery for complex diseases is fueling interest in the potential application of genetic risk models for clinical and public health practice. The number of studies assessing the predictive ability is steadily increasing, but the quality and completeness of reporting varies. A multidisciplinary workshop sponsored by the Human Genome Epidemiology Network developed a checklist of 25 items recommended for strengthening the reporting of Genetic RIsk Prediction Studies, building on the principles established by previous reporting guidelines. These recommendations aim to enhance the transparency of study reporting, and thereby to improve the synthesis and application of information from multiple studies that might differ in design, conduct, or analysis. A detailed Explanation and Elaboration document is published on the EJHG website.
doi:10.1038/ejhg.2011.25
PMCID: PMC3172920  PMID: 21407265
6.  Strengthening the Reporting of Genetic Risk Prediction Studies: The GRIPS Statement 
PLoS Medicine  2011;8(3):e1000420.
Cecile Janssens and colleagues present the GRIPS Statement, a checklist to help strengthen the reporting of genetic risk prediction studies.
doi:10.1371/journal.pmed.1000420
PMCID: PMC3058100  PMID: 21423587
7.  Strengthening the reporting of genetic risk prediction studies: the GRIPS statement 
The number of known genetic markers of risk is increasing but the interpretation of their clinical effect is hampered by poor reporting of prediction studies. These guidelines from the GRIPS group aim to ensure transparent reporting of prediction studies
doi:10.1136/bmj.d631
PMCID: PMC3175742  PMID: 21411493
8.  The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies 
PLoS Medicine  2007;4(10):e296.
Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the Web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.
This paper describes the recommendations of The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative on what should be included in an accurate and complete report of an observational study.
doi:10.1371/journal.pmed.0040296
PMCID: PMC2020495  PMID: 17941714
9.  Health Impact Assessment of Free Immunization Program in Jinju City, Korea 
Objectives
This study was conducted to assess the potential health impacts and improve the quality of the free immunization program in Jinju City by maximizing the predicted positive health gains and minimizing the negative health risks.
Methods
A steering committee was established in September 2010 to carry out the health impact assessment (HIA) and began the screening and scoping stages. In the appraisal stage, analysis of secondary data, a literature review, case studies, geographic information systems analysis, a questionnaire, and expert consultations were used. The results of the data collection and analyses were discussed during a workshop, after which recommendations were finalized in a written report.
Results
Increased access to immunization, comprehensive services provided by physicians, the strengthened role of the public health center in increasing immunization rates and services, and the ripple effect to other neighboring communities were identified as potential positive impacts. On the other hand, the program might be inaccessible to rural regions with no private clinics where there are more at-risk children, vaccine management and quality control at the clinics may be poor, and vaccines may be misused. Recommendations to maximize health gains and minimize risks were separately developed for the public health center and private clinics.
Conclusions
The HIA provided an opportunity for stakeholders to comprehensively overview the potential positive and negative impacts of the program before it was implemented. An HIA is a powerful tool that should be used when developing and implementing diverse health-related policies and programs in the community.
doi:10.3961/jpmph.2012.45.4.267
PMCID: PMC3412990  PMID: 22880159
Immunization programs; Health impact assessment; Health policy
10.  Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration 
PLoS Medicine  2007;4(10):e297.
Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalisability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies. The STROBE Statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to cohort studies, case-control studies and cross-sectional studies and four are specific to each of the three study designs. The STROBE Statement provides guidance to authors about how to improve the reporting of observational studies and facilitates critical appraisal and interpretation of studies by reviewers, journal editors and readers. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the STROBE Statement. The meaning and rationale for each checklist item are presented. For each item, one or several published examples and, where possible, references to relevant empirical studies and methodological literature are provided. Examples of useful flow diagrams are also included. The STROBE Statement, this document, and the associated Web site (http://www.strobe-statement.org/) should be helpful resources to improve reporting of observational research.
In this explanatory and elaboration document Mattias Egger and colleagues provide the meaning and rationale of each checklist item on the STROBE Statement.
doi:10.1371/journal.pmed.0040297
PMCID: PMC2020496  PMID: 17941715
11.  PredictABEL: an R package for the assessment of risk prediction models 
European Journal of Epidemiology  2011;26(4):261-264.
The rapid identification of genetic markers for multifactorial diseases from genome-wide association studies is fuelling interest in investigating the predictive ability and health care utility of genetic risk models. Various measures are available for the assessment of risk prediction models, each addressing a different aspect of performance and utility. We developed PredictABEL, a package in R that covers descriptive tables, measures and figures that are used in the analysis of risk prediction studies such as measures of model fit, predictive ability and clinical utility, and risk distributions, calibration plot and the receiver operating characteristic plot. Tables and figures are saved as separate files in a user-specified format, which include publication-quality EPS and TIFF formats. All figures are available in a ready-made layout, but they can be customized to the preferences of the user. The package has been developed for the analysis of genetic risk prediction studies, but can also be used for studies that only include non-genetic risk factors. PredictABEL is freely available at the websites of GenABEL (http://www.genabel.org) and CRAN (http://cran.r-project.org/).
doi:10.1007/s10654-011-9567-4
PMCID: PMC3088798  PMID: 21431839
Risk prediction; Genetic; Assessment; Measures; Software
12.  Reporting recommendations for tumor marker prognostic studies (REMARK): explanation and elaboration 
BMC Medicine  2012;10:51.
Background
The Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK) checklist consists of 20 items to report for published tumor marker prognostic studies. It was developed to address widespread deficiencies in the reporting of such studies. In this paper we expand on the REMARK checklist to enhance its use and effectiveness through better understanding of the intent of each item and why the information is important to report.
Methods
REMARK recommends including a transparent and full description of research goals and hypotheses, subject selection, specimen and assay considerations, marker measurement methods, statistical design and analysis, and study results. Each checklist item is explained and accompanied by published examples of good reporting, and relevant empirical evidence of the quality of reporting. We give prominence to discussion of the 'REMARK profile', a suggested tabular format for summarizing key study details.
Summary
The paper provides a comprehensive overview to educate on good reporting and provide a valuable reference for the many issues to consider when designing, conducting, and analyzing tumor marker studies and prognostic studies in medicine in general.
To encourage dissemination of the Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK): Explanation and Elaboration, this article has also been published in PLoS Medicine.
doi:10.1186/1741-7015-10-51
PMCID: PMC3362748  PMID: 22642691
13.  STrengthening the REporting of Genetic Association studies (STREGA) – an extension of the STROBE statement 
Making sense of rapidly evolving evidence on genetic associations is crucial to making genuine advances in human genomics and the eventual integration of this information in the practice of medicine and public health. Assessment of the strengths and weaknesses of this evidence, and hence the ability to synthesize it, has been limited by inadequate reporting of results. The STrengthening the REporting of Genetic Association studies (STREGA) initiative builds on the STrengthening the Reporting of OBservational Studies in Epidemiology (STROBE) Statement and provides additions to 12 of the 22 items on the STROBE checklist. The additions concern population stratification, genotyping errors, modelling haplotype variation, Hardy–Weinberg equilibrium, replication, selection of participants, rationale for choice of genes and variants, treatment effects in studying quantitative traits, statistical methods, relatedness, reporting of descriptive and outcome data and the volume of data issues that are important to consider in genetic association studies. The STREGA recommendations do not prescribe or dictate how a genetic association study should be designed, but seek to enhance the transparency of its reporting, regardless of choices made during design, conduct or analysis.
doi:10.1111/j.1365-2362.2009.02125.x
PMCID: PMC2730482  PMID: 19297801
Epidemiology; gene-disease associations; gene-environment interaction; genetics; genome-wide association; meta-analysis; reporting recommendations; systematic review
14.  Strengthening the reporting of genetic association studies (STREGA): an extension of the STROBE statement 
Making sense of rapidly evolving evidence on genetic associations is crucial to making genuine advances in human genomics and the eventual integration of this information in the practice of medicine and public health. Assessment of the strengths and weaknesses of this evidence, and hence the ability to synthesize it, has been limited by inadequate reporting of results. The STrengthening the REporting of Genetic Association studies (STREGA) initiative builds on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement and provides additions to 12 of the 22 items on the STROBE checklist. The additions concern population stratification, genotyping errors, modeling haplotype variation, Hardy–Weinberg equilibrium, replication, selection of participants, rationale for choice of genes and variants, treatment effects in studying quantitative traits, statistical methods, relatedness, reporting of descriptive and outcome data, and the volume of data issues that are important to consider in genetic association studies. The STREGA recommendations do not prescribe or dictate how a genetic association study should be designed but seek to enhance the transparency of its reporting, regardless of choices made during design, conduct, or analysis.
doi:10.1007/s10654-008-9302-y
PMCID: PMC2764094  PMID: 19189221
Gene–disease associations; Genetics; Gene–environment interaction; Systematic review; Meta analysis; Reporting recommendations; Epidemiology; Genome-wide association
15.  Incorporating genomics into breast and prostate cancer screening: assessing the implications 
Genetics in Medicine  2013;15(6):423-432.
Individual risk prediction and stratification based on polygenic profiling may be useful in disease prevention. Risk-stratified population screening based on multiple factors including a polygenic risk profile has the potential to be more efficient than age-stratified screening. In this article, we summarize the implications of personalized screening for breast and prostate cancers. We report the opinions of multidisciplinary international experts who have explored the scientific, ethical, and logistical aspects of stratified screening. We have identified (i) the need to recognize the benefits and harms of personalized screening as compared with existing screening methods, (ii) that the use of genetic data highlights complex ethical issues including discrimination against high-risk individuals by insurers and employers and patient autonomy in relation to genetic testing of minors, (iii) the need for transparency and clear communication about risk scores, about harms and benefits, and about reasons for inclusion and exclusion from the risk-based screening process, and (iv) the need to develop new professional competences and to assess cost-effectiveness and acceptability of stratified screening programs before implementation. We conclude that health professionals and stakeholders need to consider the implications of incorporating genetic information in intervention strategies for health-care planning in the future.
Genet Med 2013:15(6):423–432
doi:10.1038/gim.2012.167
PMCID: PMC3941015  PMID: 23412607
cancer; COGS; genetic information; implications; personalized; prevention; public health; risk; screening; stratification
16.  Uses and misuses of the STROBE statement: bibliographic study 
BMJ Open  2011;1(1):e000048.
Objectives
Appropriate reporting is central to the application of findings from research to clinical practice. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations consist of a checklist of 22 items that provide guidance on the reporting of cohort, case–control and cross-sectional studies, in order to facilitate critical appraisal and interpretation of results. STROBE was published in October 2007 in several journals including The Lancet, BMJ, Annals of Internal Medicine and PLoS Medicine. Within the framework of the revision of the STROBE recommendations, the authors examined the context and circumstances in which the STROBE statement was used in the past.
Design
The authors searched the Web of Science database in August 2010 for articles which cited STROBE and examined a random sample of 100 articles using a standardised, piloted data extraction form. The use of STROBE in observational studies and systematic reviews (including meta-analyses) was classified as appropriate or inappropriate. The use of STROBE to guide the reporting of observational studies was considered appropriate. Inappropriate uses included the use of STROBE as a tool to assess the methodological quality of studies or as a guideline on how to design and conduct studies.
Results
The authors identified 640 articles that cited STROBE. In the random sample of 100 articles, about half were observational studies (32%) or systematic reviews (19%). Comments, editorials and letters accounted for 15%, methodological articles for 8%, and recommendations and narrative reviews for 26% of articles. Of the 32 observational studies, 26 (81%) made appropriate use of STROBE, and three uses (10%) were considered inappropriate. Among 19 systematic reviews, 10 (53%) used STROBE inappropriately as a tool to assess study quality.
Conclusions
The STROBE reporting recommendations are frequently used inappropriately in systematic reviews and meta-analyses as an instrument to assess the methodological quality of observational studies.
Article summary
Article focus
Appropriate reporting is central for the proper application of findings from clinical research into clinical practice.
The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations aim to provide guidance to authors on how to improve the reporting of observational studies to facilitate critical appraisal and interpretation of results.
We examined the reasons for citing STROBE and found that most observational studies used STROBE as a reporting guideline, while about half of systematic reviews used STROBE as a tool to assess the methodological quality of the studies.
Key messages
Our study provides further evidence that authors of systematic reviews inappropriately use reporting guidelines to assess methodological study quality. Given the identified common misuse of STROBE, we discuss possible reasons and potential pitfalls of such misuse.
Strengths and limitations of this study
We conducted a systematic review of the literature to address a relevant and insufficiently discussed issue concerning misuses of reporting guidelines. One of the main concerns of such misuse is the potential introduction of bias into systematic reviews and meta-analysis.
A limitation of our findings is the fact that we included only articles which cited STROBE. This may have resulted in a selection bias, since some researchers may use STROBE in their study and mention it in their manuscript but do not formally cite it.
doi:10.1136/bmjopen-2010-000048
PMCID: PMC3191404  PMID: 22021739
Rheumatology; public health; rehabilitation medicine; epidemiology; systematic reviews; prognostic studies; statistics; research designs in field of test evaluations; heterogeneity; bias; diagnostic accuracy; HIV/AIDS; metaanalysis; social medicine; reporting guideline; methodological study; STROBE; methodological quality; quality assessment
17.  The need for translational research on antidotes for pesticide poisoning 
Summary
Pesticide poisoning kills hundreds of thousands of people in the Asia Pacific region each year. The majority are from deliberate self-poisoning with organophosphorus pesticides (OP), aluminium phosphide and paraquat. The current response from a public health, medical and research perspective is inadequate.There are few proven or effective treatments; in addition, very little clinical research has been done to transfer antidotes shown to work in animal studies into clinical practice.The human toxicity of pesticides is poorly studied and better information might inform a more sustained and appropriate regulatory response. Further understanding may also lead to improvement in diagnosis and treatment.The few effective treatments are not being recommended or delivered in an optimal and timely fashion to poisoned patients. A regional approach to facilitate appropriate pricing, packaging and delivery of antidotes is required.
doi:10.1111/j.1440-1681.2005.04298.x
PMCID: PMC1475780  PMID: 16405459
Keywords: Pesticide; poisoning; antidotes; paraquat; organophosphorus.
18.  Abbreviated report of the NIH/NINDS workshop on sudden unexpected death in epilepsy 
Neurology  2011;76(22):1932-1938.
Sudden unexpected death in epilepsy (SUDEP) is a devastating complication of epilepsy and is not rare. The NIH and National Institute of Neurological Disorders and Stroke sponsored a 3-day multidisciplinary workshop to advance research into SUDEP and its prevention. Parallel sessions were held: one with a focus on the science of SUDEP, and the other with a focus on issues related to the education of health care practitioners and people with epilepsy. This report summarizes the discussions and recommendations of the workshop, including lessons learned from investigations of sudden infant death syndrome (SIDS), sudden cardiac death, autonomic and respiratory physiology, medical devices, genetics, and animal models. Recommendations include educating all people with epilepsy about SUDEP as part of their general education on the potential harm of seizures, except in extenuating circumstances. Increasing awareness of SUDEP may facilitate improved seizure control, possibly decreasing SUDEP incidence. There have been significant advances in our understanding of the clinical and physiologic features of SIDS, sudden cardiac death, and SUDEP in both people and animals. Research should continue to focus on the cardiac, autonomic, respiratory, and genetic factors that likely contribute to the risk of SUDEP. Multicenter collaborative research should be encouraged, especially investigations with direct implications for the prevention of SUDEP. An ongoing SUDEP Coalition has been established to facilitate this effort. With the expansion of clinical, genetic, and basic science research, there is reasonable hope of advancing our understanding of SUDEP and ultimately our ability to prevent it. Neurology® 2011;76:1932–1938
doi:10.1212/WNL.0b013e31821de7de
PMCID: PMC3115809  PMID: 21543734
19.  Next Generation Analytic Tools for Large Scale Genetic Epidemiology Studies of Complex Diseases 
Genetic epidemiology  2011;36(1):22-35.
Over the past several years, genome-wide association studies (GWAS) have succeeded in identifying hundreds of genetic markers associated with common diseases. However, most of these markers confer relatively small increments of risk and explain only a small proportion of familial clustering. To identify obstacles to future progress in genetic epidemiology research and provide recommendations to NIH for overcoming these barriers, the National Cancer Institute sponsored a workshop entitled “Next Generation Analytic Tools for Large-Scale Genetic Epidemiology Studies of Complex Diseases” on September 15–16, 2010. The goal of the workshop was to facilitate discussions on (1) statistical strategies and methods to efficiently identify genetic and environmental factors contributing to the risk of complex disease; and (2) how to develop, apply, and evaluate these strategies for the design, analysis, and interpretation of large-scale complex disease association studies in order to guide NIH in setting the future agenda in this area of research. The workshop was organized as a series of short presentations covering scientific (gene-gene and gene-environment interaction, complex phenotypes, and rare variants and next generation sequencing) and methodological (simulation modeling and computational resources and data management) topic areas. Specific needs to advance the field were identified during each session and are summarized.
doi:10.1002/gepi.20652
PMCID: PMC3368075  PMID: 22147673
gene-gene interactions; gene-environment interactions; rare variants; next generation sequencing; complex phenotypes; simulations; computational resources
20.  SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials 
High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol.
This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org).
The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
doi:10.1136/bmj.e7586
PMCID: PMC3541470  PMID: 23303884
21.  Diagnosis and treatment of dementia: 1. Risk assessment and primary prevention of Alzheimer disease 
Background
In addition to nonmodifiable genetic risk factors, potentially modifiable factors such as hypertension, hyperlipidemia and environmental exposures have been identified as risk factors for Alzheimer disease. In this article, we provide physicians with practical guidance on risk assessment and primary prevention of Alzheimer disease based on recommendations from the Third Canadian Consensus Conference on the Diagnosis and Treatment of Dementia, held in March 2006.
Methods
We developed evidence-based guidelines using systematic literature searches, with specific criteria for study selection and quality assessment, and a clear and transparent decision-making process. We selected studies published from January 1996 to December 2005 that met the following criteria: dementia (all-cause, Alzheimer disease or vascular dementia) as the outcome; longitudinal cohort study; study population broadly reflective of Canadian demographics; and genetic risk factors and general risk factors (e.g., hypertension, education, occupation and chemical exposure) identified. We graded the strength of evidence using the criteria of the Canadian Task Force on Preventive Health Care.
Results
Of 3424 articles on potentially modifiable risk factors for dementia, 1719 met our inclusion criteria; 60 were deemed to be of good or fair quality. Of 1721 articles on genetic risk factors, 62 that met our inclusion criteria were deemed to be of good or fair quality. On the basis of evidence from these articles, we made recommendations for the risk assessment and primary prevention of Alzheimer disease. For the primary prevention of Alzheimer's disease, there is good evidence for controlling vascular risk factors, especially hypertension (grade A), and weak or insufficient evidence for manipulation of lifestyle factors and prescribing of medications (grade C). There is good evidence to avoid estrogens and high-dose (> 400 IU/d) of vitamin E for this purpose (grade E). Genetic counselling and testing may be offered to at-risk individuals with an apparent autosomal dominant inheritance (grade B). Screening for the apolipoprotein E genotype in asymptomatic individuals in the general population is not recommended (grade E).
Interpretation
Despite the personal and societal burden of dementia, our understanding of genetic predisposition to dementias and the contribution of other risk factors remains limited. More importantly, there are few data to explain the overall risks and benefits of prevention strategies or their impact of risk modification.
Articles to date in this seriesChertkow H. Diagnosis and treatment of dementia: Introduction. Introducing a series based on the Third Canadian Consensus Conference on the Diagnosis and Treatment of Dementia. CMAJ 2008;178:316-21.
doi:10.1503/cmaj.070796
PMCID: PMC2244657  PMID: 18299540
22.  Disease modeling in zebrafish: cancer and immune responses 
Zebrafish  2009;6(4):445-451.
The highly successful zebrafish workshop on infectious disease and cancer in zebrafish in Leiden (Netherlands) in 20071 strongly motivated the authors of this report to organize a follow-up meeting.Prompted by the prediction that similarities between defense mechanisms against microbes and cancer cells can reveal new insights into specific determinants of innate immune responses, this workshop focused on cancer models and infection studies. Due to the amenability of zebrafish to large scale forward and reverse genetic screens this model organism is ideal for discovery of novel gene functions in disease processes at a throughput level that can not be matched by rodent models. Furthermore, owing to its small size and optical transparency, disease manifestations and resulting immune responses can be studied at the whole organism level. Particularly advantageous in this context are fluorescence multicolor labeling techniques that allow tagging of the players in disease processes (e.g. cancer cells, immune cells, and microbes) for easy detection in vivo. In the following report the oral presentations at the meeting are summarized chronologically.
doi:10.1089/zeb.2009.0638
PMCID: PMC2846593  PMID: 20047471
23.  Reporting quality of randomized trials in the diet and exercise literature for weight loss 
Background
To adequately assess individual studies and synthesize quantitative research on weight loss studies, transparent reporting of data is required. The authors examined the reporting quality of randomized trials in the weight loss literature, focusing exclusively on subject characteristics as they relate to enrollment, allocation, and follow-up.
Methods
An extensive literature review, which included a computerized search of the MEDLINE database, manual searches of bibliographic references, and cross-referencing of 92 review articles was conducted. A checklist, based on CONSORT recommendations, was used to collect information on whether or not authors reported age, gender, co-morbid disease, medication use, race/ethnicity, and postmenopausal status. Also tracked was whether or not initial and final sample size was reported and stratified by gender.
Results
Of 604 possible articles, 231 articles met eligibility criteria. Important subject characteristics were not reported as the following breakdown indicates: age (11%), gender (4%), race/ethnicity (86%), co-morbid disease states (34%), and medication use (92%). Additionally, 21% of articles failed to report initial sample size by gender while 69% neglected to report final sample size by gender.
Conclusion
Inadequate reporting can create difficulties with interpretation and can lead to biased results receiving false credibility. The quality of reporting for weight loss studies needs considerable improvement.
doi:10.1186/1471-2288-5-9
PMCID: PMC554784  PMID: 15727681
24.  The “Child Health Evidence Week” and GRADE grid may aid transparency in the deliberative process of guideline development 
Journal of Clinical Epidemiology  2012;65(9-10):962-969.
Objective
To explore the evidence translation process during a 1-week national guideline development workshop (“Child Health Evidence Week”) in Kenya.
Study Design and Setting
Nonparticipant observational study of the discussions of a multidisciplinary guideline development panel in Kenya. Discussions were aided by GRADE (Grading of Recommendations Assessment, Development, and Evaluation) grid.
Results
Three key thematic categories emerged: 1) “referral to other evidence to support or refute the proposed recommendations;” 2) “assessment of the presented research evidence;” and 3) “assessment of the local applicability of evidence.” The types of evidence cited included research evidence and anecdotal evidence based on clinician experiences. Assessment of the research evidence revealed important challenges in the translation of evidence into recommendations, including absence of evidence, low quality or inconclusive evidence, inadequate reporting of key features of the management under consideration, and differences in panelists’ interpretation of the research literature. A broad range of factors with potential to affect local applicability of evidence were discussed.
Conclusion
The process of the “Child Health Evidence Week” combined with the GRADE grid may aid transparency in the deliberative process of guideline development, and provide a mechanism for comprehensive assessment, documentation, and reporting of multiple factors that influence the quality and applicability of guideline recommendations.
doi:10.1016/j.jclinepi.2012.03.004
PMCID: PMC3413881  PMID: 22742914
Clinical practice guidelines; Evidence; Knowledge translation; Transparency; GRADE; Pediatrics
25.  Workshop on The Epidemiology of the ATM Gene: Impact on Breast Cancer Risk and Treatment, Present Status and Future Focus, Lillehammer, Norway, 29 June 2002 
Breast Cancer Research  2002;4(6):249-252.
The role of ataxia-telangiectasia mutated (ATM) heterozygosity in cancer is uncertain. In vitro studies of cells from ATM heterozygotes provide strong evidence of radiation sensitivity. Some, but not all, clinical studies suggest an increased risk of breast cancer among ATM gene carriers, and this risk may be greater among those exposed to radiation. This possible excess risk of breast cancer associated with ATM heterozygosity constitutes the basis for several genetic epidemiological studies designed to clarify the role that the ATM gene plays in the etiology of breast and other cancers. The primary focus of this international, multidisciplinary, National Cancer Institute-sponsored workshop was to discuss ongoing and planned epidemiologic studies aimed at understanding the complexities of the ATM gene and its role in carcinogenesis. The invited participants were from diverse disciplines including molecular and clinical genetics, radiation biology and physics, epidemiology, biostatistics, pathology, and medicine. In the present meeting report, the aims of each project are described.
PMCID: PMC137944  PMID: 12473172
ATM gene; breast cancer risk; heterozygote; radiation

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