AA-Reporting-Stds-and-Models-11-Mar-2011

Cancer Education and Career Development Program http://www.sph.uth.tmc.edu/ncifellowships/ Reporting Standards and Models for Writing Manuscripts Background: More resources have emerged to help students and faculty write manuscripts efficiently and well Arising out of the frustration of systematic reviewers, numerous standards are now available for reporting specific types of studies (e.g., randomized controlled trials) and specific sections of manuscripts (e.g., discussions) In our opinion, following the relevant standards not only saves time, it also improves the chances of a favorable review A standards-compliant publication also fares well in comparison to similar study reports: completeness of reporting improves its quality rating, which may determine whether it is included in a systematic review Objective: To assemble and organize these standards for easy access and describe their level of “authority” Method: Entries are organized as general (pertaining to most types of papers) and by type of study The range of authority is reflected in ratings [A-D]: “A” for well-established requirements for many biomedical journals (including AJPH), such as Uniform Requirements and CONSORT; “D” for standards suggested by unaffiliated authors in published articles For the many specialized types of manuscripts that not currently have reporting standards, we have added examples of well-written articles, labeled “E”, recommended by faculty members “O” denotes helpful observations or commentary on current practice We rated standards independently and resolved disagreements by consensus Built-in redundancy allows study specific sections (e.g randomized trials) to be read independently Results: In all, 24 reporting standards with ratings A-D are included, together with models (E’s) for types of studies The “general resources for all types of papers” covers sections of a paper, including titles, keywords, and cover letters; the “responsible publication of research” covers such ethical issues as conflicts of interest, duplicate submission, and redundant publication Five types of studies have additional specific standards: randomized trials, non-randomized trials, observational studies, systematic reviews/meta-analyses, and qualitative studies Most other types of reports, e.g., policy analyses, still need recommended models Conclusions: Reporting standards, guidelines, and model papers are available to aid authors in producing complete reports and avoiding ethical breaches To make optimum use of these resources, we suggest using the “General Resources” and the relevant study-reporting standards in tandem [349 words] Notes: 1) Start by downloading two key resources: Uniform Requirements at http://www.icmje.org/ and one of the starred “explanation and elaboration” article (with helpful examples): CONSORT (p 4), CONSORT for NonPharmacologic Interventions (p 4), STROBE (p 6), or PRISMA (p 7), depending on the type of paper you are writing 2) Also check the instructions for authors for your target journal Links to most such instructions can be found at http://mulford.meduohio.edu/instr/ 3) Additional guidelines (e.g., tumor markers [REMARK] ), can be found at the Enhancing the QUAlity of Trials and Other Research (EQUATOR) project Web site http://www.equator-network.org/ (U.K National Health Service) A useful catalog (as of Nov 2010), which may be easier to navigate than the Web site itself, is at http://www.equator-network.org/about-equator/equator-publications0/equator-network-publications2010/ 4) The CONSORT website, under Database/Evidence, provides useful bibliographies Prepared by Patricia Dolan Mullen, DrPH, Professor and Program Director, and Karyn Popham, Editor for the Program Questions and comments to Mullen, Patricia.D.Mullen@uth.tmc.edu We thank UT SPH faculty members who have contributed examples [Mullen conceived of the project and its format, rated the resources, located the “O” articles, and solicited the “E” examples; Popham contributed to the format, and located and rated all the original A-D level resources.] Please see further acknowledgements at the end of this guide Mullen/Popham 11 March 2011 p Table of Contents General resources for all types of papers Title / Keywords / Tables / Figures / Discussion / References / Cover letter p Resources for specific types of papers Randomized Controlled Trials (RCTs) p Non-Randomized Trials p Observational Studies (cohort, case control, and cross-sectional surveys) p Systematic Reviews and Meta-Analyses p Other Types of Studies and Reports: Standards p p Diagnostic accuracy Focus group studies Other Types of Studies and Reports: Examples p p Confirmatory factor analyses, invariance analyses Intervention Mapping projects Lessons learned Secondary analysis—description of a parent study Responsible publication of research p 10 Acknowledgements p 11 Explanation of Ratings A Well-established and widely required The suggested standards are specified as required in common authors’ instructions, either o explicitly, by name or reference (e.g., CONSORT), or o implicitly, by repeating the major points (e.g., Uniform Requirements for byline authorship) B Recommended The suggested standards are o frequently required by top journals (e.g., STARD, PRISMA, STROBE, TREND, MOOSE) or o official extensions of such itemized standards (e.g., CONSORT for Abstracts) C Suggested (group) The suggested standards have been endorsed or proposed o by a professional society or other relevant group (e.g., NLM), or o in an editorial of a major journal for the field D Suggested (non-group) A standard has been proposed in a peer-reviewed article but not endorsed by a relevant group E Example An article that a (named) expert has suggested as a model to follow Note: unless otherwise identified, all experts are from the University of Texas Health Mullen/Popham 11 March 2011 p Science Center at Houston O Observations Mullen/Popham Observations and commentary on implementation and practice 11 March 2011 p General Resources for All Types of Papers Overall http://www.icmje.org/ [A] Title o Uniform Requirements http://www.icmje.org/manuscript_1prepare.html Keywords o Use MeSH terms [exception: Am J Public Health]; see http://www.nlm.nih.gov/mesh/MBrowser.html o Popham LK FAQ: Choosing Keywords for Manuscripts [D] Methods and Results o tables (content) [B] NB: very general o Uniform Requirements http://www.icmje.org/manuscript_1prepare.html [B] o American Psychological Association Publication Manual 6th ed Washington, DC: American Psychological Association; 2010 Chapter [C] o figures (content) o Uniform Requirements http://www.icmje.org/manuscript_1prepare.html o American Psychological Association Publication Manual 6th ed [B] Washington, DC: American Psychological Association; 2010 Chapter [C] Discussion o research recommendations References o Docherty, Smith The case for structuring the discussion of scientific papers [editorial] BMJ 1999 May 8;318(7193):1224-1225 Note: Good general advice http://www.bmj.com/cgi/reprint/318/7193/1224 [C] o Brown et al How to formulate research recommendations BMJ 2006;333(7572): 804-806 [D] o National Library of Medicine standards for references: http://www.ncbi.nlm.nih.gov/bookshelf/br.fcgi?book=citmed [B] o What to cite and what not to cite: Citing Medicine Uniform Requirements [B] http://www.icmje.org/manuscript_1prepare.html Cover Letter Mullen/Popham o Uniform Requirements http://www.icmje.org/manuscript_2send.html 11 March 2011 [A ] p Specific Resources for Randomized Controlled Trials (RCTs) Overall o CONsolidated Standards Of Reporting Trials (CONSORT) http://www.consort-statement.org/index.aspx?o=1011 [A] Note: Highly detailed and helpful “explanation and elaboration” document (with examples): http://www.consort-statement.org/index.aspx?o=1316 [A] Abstract o CONSORT for abstracts [B ] Note availability of “explanation and elaboration” document and of before-andafter examples [B ] o JAMA instructions to authors http://jama.ama-assn.org/misc/ifora.dtl#Abstracts [C] http://www.consort-statement.org/index.aspx?o=1190 adapted from Annals of Internal Medicine 1990 July 1;113(1):69-76, for which there is very poor electronic access Methods (Interventions) o behavioral interventions o herbal o non-pharmaceutical o Davidson KW, et al Evidence-based behavioral medicine Ann Behav Med 2003;26(3):161-171 http://www.sbm.org/ebbm/articles/ABM2603pp161-171.pdf [C] o CONSORT for Herbal Medicinal Interventions http://www.consort-statement.org/index.aspx?o=1067 [B] o CONSORT for Non-Pharmacological Treatment Interventions http://www.consort-statement.org/index.aspx?o=1068 [B] o Note: Highly detailed and helpful “explanation and elaboration” document (with examples): http://www.consort-statement.org/index.aspx?o=1068 [B] Methods (Design and Analysis): Variations of RCTs o cluster-randomized o CONSORT for Clusters http://www.consort-statement.org/index.aspx?o=1047 [B] o Donner, Klar Pitfalls of and controversies in cluster randomization trials Am J Public Health 2004;94(3):416-422 http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1448267&blobtype=pdf [O] o Varnell et al Design and analysis of group-randomized trials: A review of recent practices Am J Public Health 2004;94(3):393-399 http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1448264&blobtype=pdf [O] o non-inferiority / o CONSORT for Non-inferiority and Equivalence Trials equivalence‌ http://www.consort-statement.org/index.aspx?o=1049 [B] Results o harms o CONSORT Extension for [reporting] Harms[-related issues] http://www.consort-statement.org/index.aspx?o=1189 Discussion [B] o Clarke M, Alderson P, Chalmers I Discussion sections in reports of controlled trials published in general medical journals JAMA 2002 June 5; 287(21): 2799-2801 Note: e-access by subscription only From a UTSPH computer, go to http://tinyurl.com/yolrs2 [O] Mullen/Popham 11 March 2011 p Specific Resources for Non-Randomized Trials Overall o Transparent REporting of Non-randomized Designs (TREND) 2004;94(3):361-366 Am J Public Health http://www.cdc.gov/trendstatement/ or http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1448256&blobtype=pdf [B] Methods (Interventions) o behavioral o Davidson KW, et al Evidence-based behavioral medicine Ann Behav Med interventions 2003;26(3):161-171 http://www.sbm.org/ebbm/articles/ABM2603pp161-171.pdf [C] o herbal o CONSORT for Herbal Medicinal Interventions http://www.consort-statement.org/index.aspx?o=1067 [B] o non-pharmaceutical o CONSORT for Non-Pharmacological Treatment Interventions http://www.consort-statement.org/index.aspx?o=1068 [B] Methods (Design and Analysis) Note: While these two articles address randomized trials, the issues they raise are o cluster germane to all trials with assignment to condition by group assignment o Donner, Klar Pitfalls of and controversies in cluster randomization trials Am J Public Health 2004;94(3):416-422 http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1448267&blobtype=pdf [O] o Varnell et al Design and analysis of group-randomized trials: A review of recent practices Am J Public Health 2004;94(3):393-399 http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1448264&blobtype=pdf [O] o propensity o Cuellar, McReynolds, Wasserman A cure for crime: Can mental health treatment scoring diversion reduce crime among youth? J Policy Anal Manage 2006;25(1):197-214 http://www3.interscience.wiley.com/cgi-bin/fulltext/112157410/PDFSTART [E] (Recommended by Paul R Swank, PhD) Results o harms o CONSORT extension for reporting harms-related issues Discussion o CONSORT elaboration and explanation document [for those aspects in common with http://www.consort-statement.org/index.aspx?o=1189 [B] TREND] http://www.consort-statement.org/index.aspx?o=1316 [B] o Clarke M, Alderson P, Chalmers I Discussion sections in reports of controlled trials published in general medical journals JAMA 2002 June 5; 287(21): 2799-2801 Note: e-access by subscription only From a UTSPH computer, go to http://tinyurl.com/yolrs2 [O] Mullen/Popham 11 March 2011 p Specific Resources for Observational Studies (cohort, case-control, and cross-sectional) Overall o STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) http://www.strobe-statement.org/index.php?id=strobe-publications [B] Note: Separate checklists for each study type, or one combined http://www.strobe-statement.org/index.php?id=available-checklists Note: Highly detailed and helpful “explanation and elaboration” publication (with examples): http://www.strobe-statement.org/index.php?id=strobe-publications [B] o CONSORT http://www.consort-statement.org/index.aspx?o=1011 [A] Methods o Internet surveys o Checklist for Reporting Results of Internet E-Surveys (CHERRIES) [editorial] J Med Internet Res 2004 July-Sept;6(3): e34 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1550605 [C]; Note: better version of the checklist (Table 1) is available through http://www.jmir.org/2004/3/e34/HTML Results o harms Mullen/Popham o CONSORT Extension for [reporting] Harms[-related issues] http://www.consort-statement.org/index.aspx?o=1189 [B] 11 March 2011 p Mullen/Popham 11 March 2011 p Systematic Reviews (including meta-analyses) of controlled trials o Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA, formerly QUOROM) PLoS Medicine 2009;6(6):e1000097 doi: 10.1371/journal.pmed1000097 http://www.prisma-statement.org/usage.htm [B] Checklist and flow diagram also at http://www.prisma-statment.org/statement.htm Note: Highly detailed and helpful “explanation and elaboration” publication (with examples): http://www.prisma-statement.org/usage.htm [B] o search methods o research recommendations o PRISMA [B] o Booth Brimful of STARLITE: Towards standards for reporting literature searches J Med Libr Assoc 2006;94(4):421-429 http:///www.pubmedcentral.nih.gov/picrender.fcgi?artid-1629442&blobtype=pdf [D] o Good example of a search description: Rambout et al Prophylactic vaccination against human papillomavirus infection and disease in women: a systematic review of randomized controlled trials CMAJ 2007;177(5):469-479 http://www.cmaj.ca/cgi/reprint/177/5/469 [E] (Recommended by Helena VonVille, MS, Director of UTSPH Library Services) o Brown et al How to formulate research recommendations BMJ 2006;333(7572): 804-806 [D] Systematic Reviews (including meta-analyses) of observational studies o Meta-analysis Of Observational Studies in Epidemiology (MOOSE) JAMA 2000 Apr 19;283(15):2008-2012 http://www.consort-statement.org/index.aspx?o=1347 [B] o search methods o research recommendations o PRISMA [B] o Booth Brimful of STARLITE: Towards standards for reporting literature searches J Med Libr Assoc 2006;94(4):421-429 http:///www.pubmedcentral.nih.gov/picrender.fcgi?artid-1629442&blobtype=pdf [D] o Good example of a search description Rambout et al Prophylactic vaccination against human papillomavirus infection and disease in women: a systematic review of randomized controlled trials CMAJ 2007;177(5):469-479 http://www.cmaj.ca/cgi/reprint/177/5/469 [E] (Recommended by Helena VonVille, MS, Director of UTSPH Library Services) o Brown et al How to formulate research recommendations BMJ 2006;333(7572): 804-806 [D] Specific Standards for Other Types of Studies and Reports Mullen/Popham 11 March 2011 p Diagnostic accuracy studies o STAndards for Reporting Diagnostic accuracy (STARD) [C] Note: clicking on an item in the checklist takes you to an elaboration document with examples and references http://www.stard-statement.org Focus group studies, in-depth interviews o Tong A, Sainsbury P, Craig J COnsolidated criteria for Reporting Qualitative research (COREQ): A 32-item checklist for interviews and focus groups Int J Qual Health Care 2007;19(6):349-357 [D] Mullen/Popham 11 March 2011 p 10 Examples for Other Types of Studies and Reports Confirmatory factor analyses, invariance analyses o Byrne BM, Shavelson RJ, Muthén B Testing for the equivalence of factor covariance Intervention Mapping— example of a plan o Fernandez ME, Bartholomew LK, Alterman T Lessons learned o Vernon SW, Briss PA, Tiro JA, Warnecke RB Secondary analysis— description of a parent study o McQueen A, Bastian LA, Swank PR, Vernon SW Secondary analysis— description of a publicly available dataset o McQueen A, Vernon SW, Meissner HI, Rakowski W and mean structures: the issue of partial measurement invariance Psychol Bull 1989; 105(3):456-466 [E] o Marsh HW Confirmatory factor analysis of factorial invariance: a multifaceted approach Struct Equation Model 1994; 1(1):5-34 [E] (Both recommended by Pamela Diamond, PhD) Planning a multilevel intervention to prevent hearing loss among farmworkers and managers: A systematic approach Journal of Agricultural Safety and Health 2009;15(1):49-74 [E] (Recommended by L Kay Bartholomew, EdD) Some methodologic lessons learned from cancer screening research Cancer 2004;101(5 Suppl):1131-1145 [E] (Recommended by Drs Sally Vernon and Jasmine Tiro) Predictors of perceived susceptibility of breast cancer and changes over time: A mixed modeling approach Health Psychology 2008;27(1): 68-77 [E] (Recommended by Sally W Vernon, PhD) Risk perceptions and worry about cancer: Does gender make a difference? Journal of Health Communication 2008;13(1):56-79 [E] (Recommended by Patricia Dolan Mullen, DrPH) o Soumerai S, Avorn J Principles of educational outreach (“academic detailing”) to Theoretical methods: description of those of improve clinical decision making JAMA 1990;263(4):549-556 [E] a successful (Recommended by Patricia Dolan Mullen, DrPH) intervention (published after results) Responsible Publication of Research Overall http://www.icmje.org/ [A] Authorship, acknowledgements, sponsorship, potential conflicts of interest Methods and Results o study participants’ privacy and confidentiality o human subjects o Uniform Requirements http://www.icmje.org/ethical_1author.html [A] o Uniform Requirements http://www.icmje.org/ethical_4conflicts.html [A ] o Uniform Requirements http://www.icmje.org/format.pdf and http://www.icmje.org/coi_disclosure.pdf [B] o Uniform Requirements http://www.icmje.org/ethical_5privacy.html [B ] o Uniform Requirements http://www.icmje.org/ethical_6protection.html [A ] Other Ethical Issues Mullen/Popham 11 March 2011 p 11 o potential conflicts of interest for journal editors, staff, reviewers o obligation to publish negative findings o corrections, retractions o duplicate submission, redundant publication o obligation to register clinical trials Mullen/Popham o Uniform Requirements http://www.icmje.org/ethical_4conflicts.html [A ] o Uniform Requirements http://www.icmje.org/publishing_1negative.html [A ] o Uniform Requirements http://www.icmje.org/publishing_2corrections.html [A ] o Uniform Requirements http://www.icmje.org/publishing_4overlap.html [A ] o Uniform Requirements http://www.icmje.org/publishing_10register.html o Clinical trials must be pre-registered with the WHO dataset elements (e.g., Uniform Requirements http://www.icmje.org/publishing_10register.html) Register at http://www.clinicaltrials.gov/ct/gui ; UK guidance is available at http://www.ct-toolkit.ac.uk/ 11 March 2011 p 12 Acknowledgements From the Cancer Education and Career Development Program at the School of Public Health, University of Health Science Center at Houston, and funded by the National Cancer Institute through training grant R25T 2R25CA57712 The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health We would like to thank the following people for their suggestions and assistance: L Kay Bartholomew, MPH, EdD, Associate Professor, UT School of Public Health Pamela Diamond, PhD, Associate Professor, UT School of Public Health Paul Swank, PhD, Professor, UT School of Medicine, Houston Jasmine Tiro, PhD, Assistant Professor, Southwestern Medical School (SPH ’05) Mary Tripp, PhD, Instructor, UT MD Anderson Cancer Center, Houston Sally W Vernon, PhD, Professor, UT School of Public Health Helena VonVille, MS, MPH, Director of UTSPH Library Services To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/ or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA Mullen/Popham 11 March 2011 p 13