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 secti
Trang 1Cancer 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 do 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 7 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
Non-Pharmacologic 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 1 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-publications-2010/ 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
Trang 2Table of Contents General resources for all types of papers
Title / Keywords / Tables / Figures / Discussion / References / Cover letter
p 3
Resources for specific types of papers
Randomized Controlled Trials (RCTs) p 4 Non-Randomized Trials p 5 Observational Studies (cohort, case control, and cross-sectional surveys) p 6 Systematic Reviews and Meta-Analyses p 7 Other Types of Studies and Reports: Standards
p 6
Diagnostic accuracy
Focus group studies
p 8
Other Types of Studies and Reports: Examples
p 6
Confirmatory factor analyses, invariance analyses
Intervention Mapping projects
Lessons learned
Secondary analysis—description of a parent study
p 9
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
oexplicitly, by name or reference (e.g., CONSORT), or
oimplicitly, by repeating the major points (e.g., Uniform Requirements for byline authorship)
ofrequently required by top journals (e.g., STARD, PRISMA, STROBE, TREND, MOOSE) or
Trang 3Science Center at Houston.
O Observations Observations and commentary on implementation and practice
Trang 4General Resources for All Types of Papers
Overall
http://www.icmje.org/ [A] Title oUniform Requirementshttp://www.icmje.org/manuscript_1prepare.html[B] NB: very general
http://www.nlm.nih.gov/mesh/MBrowser.html
oPopham LK FAQ: Choosing Keywords for Manuscripts [D]
Methods and Results
otables (content) oUniform Requirements http://www.icmje.org/manuscript_1prepare.html[B]
oAmerican Psychological Association Publication Manual 6th ed
Washington, DC: American Psychological Association; 2010 Chapter 5 [C]
ofigures (content) oUniform Requirements http://www.icmje.org/manuscript_1prepare.html [B]
oAmerican Psychological Association Publication Manual 6th ed
Washington, DC: American Psychological Association; 2010 Chapter 5 [C]
Discussion oDocherty, 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]
oresearch
recommendations
oBrown et al How to formulate research recommendations BMJ 2006;333(7572):
804-806 [D]
References oNational Library of Medicine standards for references: Citing Medicine
http://www.ncbi.nlm.nih.gov/bookshelf/br.fcgi?book=citmed[B]
oWhat to cite and what not to cite: Uniform Requirements
http://www.icmje.org/manuscript_1prepare.html [B]
Cover Letter oUniform Requirements http://www.icmje.org/manuscript_2send.html [A ]
Trang 5Specific Resources for
Randomized Controlled Trials (RCTs)
Overall
oCONsolidated 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]
http://www.consort-statement.org/index.aspx?o=1190 [B ]
Note availability of “explanation and elaboration” document and of
before-and-after examples [B ]
oJAMA instructions to authors http://jama.ama-assn.org/misc/ifora.dtl#Abstracts [C]
adapted from Annals of Internal Medicine 1990 July 1;113(1):69-76, for which there is very poor electronic access
Methods (Interventions)
obehavioral
interventions
oDavidson 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]
http://www.consort-statement.org/index.aspx?o=1067 [B]
onon-pharmaceutical oCONSORT for Non-Pharmacological Treatment Interventions
http://www.consort-statement.org/index.aspx?o=1068 [B]
oNote: 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
ocluster-randomized oCONSORT for Clusters http://www.consort-statement.org/index.aspx?o=1047 [B]
oDonner, 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]
oVarnell 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]
onon-inferiority /
equivalence
oCONSORT for Non-inferiority and Equivalence Trials
http://www.consort-statement.org/index.aspx?o=1049 [B]
Results
http://www.consort-statement.org/index.aspx?o=1189 [B]
Discussion oClarke 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
Trang 6Specific Resources for
Non-Randomized Trials
Overall
oTransparent REporting of Non-randomized Designs (TREND) Am J Public Health
2004;94(3):361-366
http://www.cdc.gov/trendstatement/ or
http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1448256&blobtype=pdf[B]
Methods (Interventions)
obehavioral
interventions
oDavidson 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]
http://www.consort-statement.org/index.aspx?o=1067[B]
onon-pharmaceutical oCONSORT for Non-Pharmacological Treatment Interventions
http://www.consort-statement.org/index.aspx?o=1068 [B]
Methods (Design and Analysis)
ocluster
assignment
Note: While these two articles address randomized trials, the issues they raise are
germane to all trials with assignment to condition by group
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]
opropensity
scoring
oCuellar, McReynolds, Wasserman A cure for crime: Can mental health treatment
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
http://www.consort-statement.org/index.aspx?o=1189 [B]
Discussion oCONSORT elaboration and explanation document [for those aspects in common with
TREND] http://www.consort-statement.org/index.aspx?o=1316 [B]
oClarke 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]
Trang 7Specific Resources for
Observational Studies (cohort, case-control, and cross-sectional)
Overall
oSTrengthening 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]
oCONSORT http://www.consort-statement.org/index.aspx?o=1011[A]
Methods
oInternet surveys
oChecklist 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
http://www.consort-statement.org/index.aspx?o=1189 [B]
Trang 9Systematic Reviews
(including meta-analyses) of
controlled trials
oPreferred 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]
oBooth 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]
oGood 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)
oresearch
recommendations
oBrown et al How to formulate research recommendations BMJ
2006;333(7572): 804-806 [D]
Systematic Reviews
(including meta-analyses) of
observational studies
oMeta-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]
oBooth 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]
oGood 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)
Trang 10Diagnostic accuracy
studies
oSTAndards for Reporting Diagnostic accuracy (STARD)
http://www.stard-statement.org[C]
Note: clicking on an item in the checklist takes you to an elaboration document
with examples and references Focus group studies,
in-depth interviews
oTong 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]
Trang 11Examples for
Other Types of Studies and Reports
Confirmatory factor
analyses,
invariance analyses
oByrne BM, Shavelson RJ, Muthén B Testing for the equivalence of factor covariance
and mean structures: the issue of partial measurement invariance Psychol Bull
1989; 105(3):456-466 [E]
oMarsh 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) Intervention Mapping—
example of a plan
oFernandez ME, Bartholomew LK, Alterman T 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) Lessons learned oVernon SW, Briss PA, Tiro JA, Warnecke RB Some methodologic lessons learned
from cancer screening research Cancer 2004;101(5 Suppl):1131-1145 [E]
(Recommended by Drs Sally Vernon and Jasmine Tiro) Secondary analysis—
description of a
parent study
oMcQueen A, Bastian LA, Swank PR, Vernon SW 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) Secondary analysis—
description of a
publicly available
dataset
oMcQueen A, Vernon SW, Meissner HI, Rakowski W 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)
Theoretical methods:
description of those of
a successful
intervention
(published after
results)
oSoumerai S, Avorn J Principles of educational outreach (“academic detailing”) to
improve clinical decision making JAMA 1990;263(4):549-556 [E]
(Recommended by Patricia Dolan Mullen, DrPH)
Responsible Publication of Research
Overall
http://www.icmje.org/ [A]
Authorship,
acknowledgements,
sponsorship, potential
conflicts of interest
oUniform Requirements http://www.icmje.org/ethical_1author.html [A]
oUniform Requirements http://www.icmje.org/ethical_4conflicts.html [A ]
oUniform Requirements http://www.icmje.org/format.pdf and
http://www.icmje.org/coi_disclosure.pdf[B]