/ Cancer Education and
Career Development Program

Reporting Standards and Modelsfor Writing Manuscripts

Background: Moreresources have emerged to help students and faculty write manuscripts efficiently and well. Arising out of the frustration of systematic reviewers, numerous standardsare 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 improvesthe chances of a favorable review. Astandards-compliant publicationalso 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 assembleand organize these standards for easy access anddescribe 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 asUniform Requirements and CONSORT;“D” forstandards 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 standardsindependently 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. Mostother 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. [349words]

Notes: 1)Start by downloading two key resources: Uniform Requirements at 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 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 National Health Service). A useful catalog (as of 1 Nov 2010), which may be easier to navigate than the Web site itself, is at 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, . 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/Popham11 March 2011p. 1

Table 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
OtherTypes 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
  • explicitly, by name or reference (e.g., CONSORT), or
  • implicitly, by repeating the major points (e.g., Uniform Requirements for byline
    authorship)

B. Recommended / The suggested standards are
  • frequently required by top journals (e.g., STARD, PRISMA, STROBE, TREND, MOOSE) or
  • official extensions of such itemized standards (e.g., CONSORT for Abstracts)

C. Suggested (group) / The suggested standards have been endorsed or proposed
  • by a professional society or other relevant group (e.g., NLM), or
  • 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 Science Center at Houston.
O. Observations / Observations and commentary on implementation and practice

Mullen/Popham11 March 2011p. 1

General Resources for All Types of Papers
Overall /
A]
Title /
  • Uniform RequirementsB]NB: very general

Keywords /
  • Use MeSH terms [exception: Am J Public Health]; see
  • Popham LK. FAQ: Choosing Keywords for Manuscripts [D]

Methods and Results
  • tables(content)
/
  • Uniform Requirements B]
  • American Psychological Association. Publication Manual. 6th ed.
    Washington, DC: American Psychological Association; 2010. Chapter 5. [C]

  • figures(content)
/
  • Uniform Requirements [B]
  • American Psychological Association. Publication Manual.6th ed.
    Washington, DC: American Psychological Association; 2010. Chapter 5.[C]

Discussion /
  • Docherty, Smith. The case for structuring the discussion of scientific papers [editorial]. BMJ 1999 May 8;318(7193):1224-1225. Note: Good general advice. [C]

  • research
    recommendations
/
  • Brown et al. How to formulate research recommendations. BMJ 2006;333(7572): 804-806. [D]

References /
  • National Library of Medicine standards for references: Citing MedicineB]
  • What to cite and what not to cite: Uniform Requirements [B]

Cover Letter /
  • Uniform Requirements [A ]

Mullen/Popham11 March 2011p. 1

Specific Resources for
Randomized Controlled Trials (RCTs)
Overall /
  • CONsolidated Standards Of Reporting Trials (CONSORT)
    A]
Note: Highly detailed and helpful “explanation and elaboration” document(with examples): A]
Abstract /
  • CONSORT for abstracts
    [B ]
    Noteavailability of “explanation and elaboration” document and of before-and-after examples [B ]
  • JAMA instructions to authors C]
    adapted from Annals of Internal Medicine 1990 July 1;113(1):69-76, for which there is very poor electronic access

Methods (Interventions)
  • behavioral
    interventions
/
  • Davidson KW, et al. Evidence-based behavioral medicine. Ann Behav Med2003;26(3):161-171 C]

  • herbal
/
  • CONSORT for Herbal Medicinal Interventions
    [B]

  • non-pharmaceutical
/
  • CONSORT for Non-Pharmacological Treatment Interventions
    B]
  • Note: Highly detailed and helpful “explanation and elaboration” document(with examples): B]

Methods (Design and Analysis): Variations of RCTs
  • cluster-randomized
/
  • CONSORT for Clusters B]
  • Donner, Klar. Pitfalls of and controversies in cluster randomization trials. Am J Public Health 2004;94(3):416-422.
    [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. [O]

  • non-inferiority /
    equivalence‌
/
  • CONSORT for Non-inferiority and Equivalence Trials
    B]

Results
  • harms
/
  • CONSORT Extension for [reporting] Harms[-related issues]
    B]

Discussion /
  • 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 [O]

Mullen/Popham11 March 2011p. 1

Specific Resources for
Non-Randomized Trials
Overall /
  • Transparent REporting of Non-randomized Designs (TREND) Am J Public Health 2004;94(3):361-366
    or
    B]

Methods (Interventions)
  • behavioral
    interventions
/
  • Davidson KW, et al. Evidence-based behavioral medicine. Ann Behav Med 2003;26(3):161-171 [C]

  • herbal
/
  • CONSORT for Herbal Medicinal Interventions
    B]

  • non-pharmaceutical
/
  • CONSORT for Non-Pharmacological Treatment Interventions
    B]

Methods (Design and Analysis)
  • cluster
    assignment
/ Note: While these two articles address randomized trials, the issues they raise are germane to all trials with assignment to condition by group.
  • Donner, Klar. Pitfalls of and controversies in cluster randomization trials. Am J Public Health 2004;94(3):416-422.
    [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. [O]

  • propensity
    scoring
/
  • Cuellar, McReynolds, Wasserman. A cure for crime: Can mental health treatment diversion reduce crime among youth? J Policy Anal Manage 2006;25(1):197-214.
    [E]
    (Recommended by Paul R. Swank, PhD)

Results
  • harms
/
  • CONSORT extension for reporting harms-related issues
    B]

Discussion /
  • CONSORTelaboration and explanation document [for those aspects in common with TREND] B]
  • 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 [O]

Mullen/Popham11 March 2011p. 1

Specific Resources for
Observational Studies (cohort, case-control, and cross-sectional)
Overall /
  • STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) B]
Note: Separate checklists for each study type, or one combined

Note: Highly detailed and helpful “explanation and elaboration” publication(with examples): B]
  • CONSORT A]

Methods
  • Internet surveys
/
  • Checklist for Reporting Results of Internet E-Surveys (CHERRIES) [editorial]. J Med Internet Res 2004 July-Sept;6(3): e34
    C];
Note: better version of the checklist (Table 1) is available through
Results
  • harms
/
  • CONSORT Extension for [reporting]Harms[-related issues]
    B]

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Specific Resources for
Systematic Reviews and Meta-Analyses
Systematic Reviews
(including meta-analyses) of controlled trials /
  • Preferred Reporting Items for Systematic reviews and Meta-Analyses
    (PRISMA, formerly QUOROM)
    PLoS Medicine 2009;6(6):e1000097. doi: 10.1371/journal.pmed1000097
    [B]
Checklist and flow diagram also at

Note: Highly detailed and helpful “explanation and elaboration” publication(with examples): B]
  • search methods
/
  • PRISMA [B]
  • Booth. Brimful of STARLITE: Towards standards for reporting literature searches. J Med Libr Assoc 2006;94(4):421-429.
    D]
  • 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 [E]
    (Recommended by Helena VonVille, MS, Director of UTSPH Library Services)

  • research
    recommendations
/
  • Brown et al. How to formulate research recommendations. BMJ 2006;333(7572): 804-806. [D]

Systematic Reviews
(including meta-analyses) of observational studies /
  • Meta-analysis Of Observational Studies in Epidemiology (MOOSE)
    JAMA 2000 Apr 19;283(15):2008-2012.
    B]

  • search methods
/
  • PRISMA [B]
  • Booth. Brimful of STARLITE: Towards standards for reporting literature searches. J Med Libr Assoc 2006;94(4):421-429.
    D]
  • 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 [E]
    (Recommended by Helena VonVille, MS, Director of UTSPH Library Services)

  • research
    recommendations
/
  • Brown et al. How to formulate research recommendations. BMJ 2006;333(7572): 804-806 [D]

Specific Standards for
Other Types of Studies and Reports
Diagnostic accuracy
studies /
  • 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

Focus group studies,
in-depth interviews /
  • 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]

Examples for
Other Types of Studies and Reports
Confirmatory factor
analyses,
invariance analyses /
  • Byrne 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]
  • 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)
Intervention Mapping—example of a plan /
  • Fernandez 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 /
  • Vernon 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 /
  • McQueen 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
/
  • McQueen 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) /
  • Soumerai 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 /
A]
Authorship,
acknowledgements, sponsorship, potential conflicts of interest /
  • Uniform Requirements [A]
  • Uniform Requirements [A ]
  • Uniform Requirements andB]

Methods and Results
  • study participants’ privacy and confidentiality
/
  • Uniform RequirementsB ]

  • human subjects
/
  • Uniform Requirements [A ]

Other Ethical Issues
  • potential conflicts of interest for journal editors, staff, reviewers
/
  • Uniform Requirements [A ]

  • obligation to publish negative findings
/
  • Uniform Requirements [A ]

  • corrections, retractions
/
  • Uniform Requirements [A ]

  • duplicate submission, redundant publication
/
  • Uniform Requirements [A ]

  • obligation to register clinical trials
/
  • Uniform Requirements
  • Clinical trials must be pre-registered with the WHO dataset elements
    (e.g., Uniform Requirements
Register at ;
UK guidance is available at

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 or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.

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