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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
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 
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
7.  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
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.  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
10.  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
11.  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
12.  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
13.  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
14.  The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration 
PLoS Medicine  2009;6(7):e1000100.
Alessandro Liberati and colleagues present an Explanation and Elaboration of the PRISMA Statement, updated guidelines for the reporting of systematic reviews and meta-analyses.
Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safety of health care interventions accurately and reliably. The clarity and transparency of these reports, however, is not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users.
Since the development of the QUOROM (QUality Of Reporting Of Meta-analysis) Statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realizing these issues, an international group that included experienced authors and methodologists developed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions.
The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this Explanation and Elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA Statement, this document, and the associated Web site (http://www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses.
doi:10.1371/journal.pmed.1000100
PMCID: PMC2707010  PMID: 19621070
15.  The SQUIRE (Standards for QUality Improvement Reporting Excellence) guidelines for quality improvement reporting: explanation and elaboration 
Quality & Safety in Health Care  2008;17(Suppl_1):i13-i32.
As the science of quality improvement in health care advances, the importance of sharing its accomplishments through the published literature increases. Current reporting of improvement work in health care varies widely in both content and quality. It is against this backdrop that a group of stakeholders from a variety of disciplines has created the Standards for QUality Improvement Reporting Excellence, which we refer to as the SQUIRE publication guidelines or SQUIRE statement. The SQUIRE statement consists of a checklist of 19 items that authors need to consider when writing articles that describe formal studies of quality improvement. Most of the items in the checklist are common to all scientific reporting, but virtually all of them have been modified to reflect the unique nature of medical improvement work.
This “Explanation and Elaboration” document (E & E) is a companion to the SQUIRE statement. For each item in the SQUIRE guidelines the E & E document provides one or two examples from the published improvement literature, followed by an analysis of the ways in which the example expresses the intent of the guideline item. As with the E & E documents created to accompany other biomedical publication guidelines, the purpose of the SQUIRE E & E document is to assist authors along the path from completion of a quality improvement project to its publication. The SQUIRE statement itself, this E & E document, and additional information about reporting improvement work can be found at http://www.squire-statement.org.
doi:10.1136/qshc.2008.029058
PMCID: PMC2602740  PMID: 18836062
16.  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
17.  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
18.  Clinical practice guideline development manual: A quality-driven approach for translating evidence into action 
Background
Guidelines translate best evidence into best practice. A well-crafted guideline promotes quality by reducing healthcare variations, improving diagnostic accuracy, promoting effective therapy, and discouraging ineffective – or potentially harmful – interventions. Despite a plethora of published guidelines, methodology is often poorly defined and varies greatly within and among organizations.
Purpose
This manual describes the principles and practices used successfully by the American Academy of Otolaryngology – Head and Neck Surgery to produce quality-driven, evidence-based guidelines using efficient and transparent methodology for action-ready recommendations with multi-disciplinary applicability. The development process, which allows moving from conception to completion in twelve months, emphasizes a logical sequence of key action statements supported by amplifying text, evidence profiles, and recommendation grades that link action to evidence.
Conclusions
As clinical practice guidelines become more prominent as a key metric of quality healthcare, organizations must develop efficient production strategies that balance rigor and pragmatism. Equally important, clinicians must become savvy in understanding what guidelines are – and are not – and how they are best utilized to improve care. The information in this manual should help clinicians and organizations achieve these goals.
doi:10.1016/j.otohns.2009.04.015
PMCID: PMC2851142  PMID: 19464525
19.  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
20.  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
21.  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
22.  Does journal endorsement of reporting guidelines influence the completeness of reporting of health research? A systematic review protocol 
Systematic Reviews  2012;1:24.
Background
Reporting of health research is often inadequate and incomplete. Complete and transparent reporting is imperative to enable readers to assess the validity of research findings for use in healthcare and policy decision-making. To this end, many guidelines, aimed at improving the quality of health research reports, have been developed for reporting a variety of research types. Despite efforts, many reporting guidelines are underused. In order to increase their uptake, evidence of their effectiveness is important and will provide authors, peer reviewers and editors with an important resource for use and implementation of pertinent guidance. The objective of this study was to assess whether endorsement of reporting guidelines by journals influences the completeness of reporting of health studies.
Methods
Guidelines providing a minimum set of items to guide authors in reporting a specific type of research, developed with explicit methodology, and using a consensus process will be identified from an earlier systematic review and from the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network’s reporting guidelines library. MEDLINE, EMBASE, the Cochrane Methodology Register and Scopus will be searched for evaluations of those reporting guidelines; relevant evaluations from the recently conducted CONSORT systematic review will also be included. Single data extraction with 10% verification of study characteristics, 20% of outcomes and complete verification of aspects of study validity will be carried out. We will include evaluations of reporting guidelines that assess the completeness of reporting: (1) before and after journal endorsement, and/or (2) between endorsing and non-endorsing journals. For a given guideline, analyses will be conducted for individual and the total sum of items. When possible, standard, pooled effects with 99% confidence intervals using random effects models will be calculated.
Discussion
Evidence on which guidelines have been evaluated and which are associated with improved completeness of reporting is important for various stakeholders, including editors who consider which guidelines to endorse in their journal editorial policies.
doi:10.1186/2046-4053-1-24
PMCID: PMC3482392  PMID: 22626029
Reporting guidelines; Evaluation; Systematic review; Completeness of reporting
23.  Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement 
Acupuncture in Medicine  2010;28(2):83-93.
The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision.
To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination.
The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word ‘controlled’ in STRICTA is replaced by ‘clinical’, to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture.
doi:10.1136/aim.2009.001370
PMCID: PMC3002761  PMID: 20615861
24.  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
25.  Reporting Guidelines: Optimal Use in Preventive Medicine and Public Health 
Numerous reporting guidelines are available to help authors write higher quality manuscripts more efficiently. Almost 200 are listed on the EQUATOR (Enhancing the Quality and Transparency of Health Research) Network’s website and they vary in authority, usability, and breadth, making it difficult to decide which one(s) to use. This paper provides consistent information about guidelines for preventive medicine and public health and a framework and sequential approach for selecting them.
EQUATOR guidelines were reviewed for relevance to target audiences; selected guidelines were classified as “core” (frequently recommended) or specialized, and the latter were grouped by their focus. Core and specialized guidelines were coded for indicators of authority (simultaneous publication in multiple journals, rationale, scientific background supporting each element, expertise of designers, permanent website/named group), usability (presence of checklists and examples of good reporting), and breadth (manuscript sections covered). Discrepancies were resolved by consensus. Selected guidelines are presented in four tables arranged to facilitate selection: core guidelines, all of which pertain to major research designs; guidelines for additional study designs, topical guidelines, and guidelines for particular manuscript sections. A flow diagram provides an overview. The framework and sequential approach will enable authors as well as editors, peer reviewers, researchers, and systematic reviewers to make optimal use of available guidelines to improve the transparency, clarity, and rigor of manuscripts and research protocols and the efficiency of conducing systematic reviews and meta-analyses.
doi:10.1016/j.amepre.2012.06.031
PMCID: PMC3475417  PMID: 22992369

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