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

Cancer Education and
Career Development Program
/>
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 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
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 (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 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.

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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
Other Types of Studies and Reports: Standards........................................................................................ p. 8
p. 6

Diagnostic accuracy
Focus group studies
Other Types of Studies and Reports: Examples......................................................................................... p. 9
p. 6
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

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Science Center at Houston.
O. Observations

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Observations and commentary on implementation and practice

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General Resources for All Types of Papers
Overall

[A]

Title

o Uniform Requirements />
Keywords

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

Methods and Results
o tables (content)

[B] NB: very general

o Uniform Requirements [B]
o American Psychological Association. Publication Manual. 6th ed.

Washington, DC: American Psychological Association; 2010. Chapter 5. [C]

o figures (content)

o Uniform Requirements />o American Psychological Association. Publication Manual. 6th ed.

[B]

Washington, DC: American Psychological Association; 2010. Chapter 5. [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.
[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:
[B]

o What to cite and what not to cite:

Citing Medicine

Uniform Requirements
[B]

/>
Cover Letter

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o Uniform Requirements />
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[A ]

p. 4


Specific Resources for

Randomized Controlled Trials (RCTs)
Overall

o CONsolidated Standards Of Reporting Trials (CONSORT)
[A]

Note: Highly detailed and helpful “explanation and elaboration” document (with
examples): [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 [C]
/>
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 [C]
o CONSORT for Herbal Medicinal Interventions
[B]
o CONSORT for Non-Pharmacological Treatment Interventions
[B]
o Note: Highly detailed and helpful “explanation and elaboration” document (with
examples): [B]

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

o harms

o CONSORT Extension for [reporting] Harms[-related issues]
/>
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 [O]

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Specific Resources for

Non-Randomized Trials
Overall

o Transparent REporting of Non-randomized Designs (TREND)

2004;94(3):361-366

Am J Public Health

or
[B]

Methods (Interventions)
o behavioral
o Davidson KW, et al. Evidence-based behavioral medicine. Ann Behav Med
interventions
2003;26(3):161-171 [C]
o herbal
o CONSORT for Herbal Medicinal Interventions
[B]
o non-pharmaceutical
o CONSORT for Non-Pharmacological Treatment Interventions
[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.
[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.
[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.

[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

[B]

TREND] [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 [O]

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Specific Resources for

Observational Studies (cohort, case-control, and cross-sectional)
Overall

o 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]
o CONSORT [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

[C];

Note: better version of the checklist (Table 1) is available through
/>
Results
o harms

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o CONSORT Extension for [reporting] Harms[-related issues]
[B]

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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
[B]
Checklist and flow diagram also at

/>
Note: Highly detailed and helpful “explanation and elaboration” publication
(with examples): [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 [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.

[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 [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
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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


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]

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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

[A]

Authorship,
acknowledgements,
sponsorship, potential
conflicts of interest
Methods and Results
o study participants’
privacy and

confidentiality
o human subjects

o Uniform Requirements [A]
o Uniform Requirements [A ]
o Uniform Requirements and
[B]

o Uniform Requirements [B ]

o Uniform Requirements />
[A ]

Other Ethical Issues
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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

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o Uniform Requirements />
[A ]

o Uniform Requirements [A ]
o Uniform Requirements [A ]
o Uniform Requirements [A ]
o Uniform Requirements />o Clinical trials must be pre-registered with the WHO dataset elements

(e.g., Uniform Requirements />Register at ;
UK guidance is available at />
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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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