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Don C. Des Jarlais, PhD, Cynthia Lyles, PhD, Nicole Crepaz, PhD and the TREND Group

Don C. Des Jarlais is with the Baron Edmond de Rothschild Chemical Dependency Institute, Beth Israel Medical Center, New York City. Cynthia Lyles and Nicole Crepaz are with the Centers for Disease Control and Prevention, Atlanta, Ga. TREND Group members are listed below in the Acknowledgments.

Correspondence: Requests for reprints should be sent to Don C. Des Jarlais, PhD, Beth Israel Medical Center, Chemical Dependency Institute, First Ave at 16 St, New York, NY 10003 (e-mail: dcdesjarla{at}aol.com).

	ABSTRACT

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Developing an evidence base for making public health decisions will require using data from evaluation studies with randomized and nonrandomized designs. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study, with sufficient detail and clarity to readily see differences and similarities among studies in the same area. The Consolidated Standards of Reporting Trials (CONSORT) statement provides guidelines for transparent reporting of randomized clinical trials.

We present the initial version of the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statement. These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions, research design, and methods of adjusting for possible biases in evaluation studies that use nonrandomized designs.

OVER THE PAST SEVERAL decades, a strong movement toward evidence-based medicine has emerged.^1–3 In the context of evidence-based medicine, clinical decisions are based on the best available scientific data rather than on customary practices or the personal beliefs of the health care provider. There is now a parallel movement toward evidence-based public health practices.^4,5 The movement is intended to utilize the best available scientific knowledge as the foundation for public health–related decisionmaking.

In the context of evidence-based medicine, the randomized controlled trial (RCT) is usually considered of greatest evidentiary value for assessing the efficacy of interventions. Indeed, the preference for this design is sufficiently strong that when empirical evidence from RCTs is available, "weaker" designs are often considered to be of little or no evidentiary value. In this issue, Victora et al.⁶ make a strong argument that evidence-based public health will necessarily involve the use of research designs other than RCTs. Most important, they argue that RCTs are often not practical or not ethical for evaluating many public health interventions and discuss methods for drawing causal inferences from nonrandomized evaluation designs ("plausibility" and "adequacy" designs in their terminology).

Also in this issue, Donner and Klar,⁷ Murray et al.,⁸ and Varnell et al.⁹ provide overviews of the benefits and pitfalls of the group-randomized trial, which, in some situations, may be a reasonable alternative to the RCT. There are also a wide variety of nonrandomized evaluation designs that can contribute important data on the efficacy or effectiveness of interventions, such as quasi-experimental designs,¹⁰ nonrandomized trials, and natural experiments. Including these types of designs in developing evidence-based recommendations can provide a more integrated picture of the existing evidence and could help to strengthen public health practice. Excluding data collected under such designs would undoubtedly bias the evidence base toward interventions that are "easier" to evaluate but not necessarily more effective or cost-effective.

If nonrandomized designs are to be systematically used in building evidence-based public health practices, it will be necessary to improve the reporting quality of these types of studies. The transparency, or clarity, in the reporting of individual studies is key. Sufficient detail and clarity in the report allow readers to understand the conduct and findings of the intervention study and how the study was different from or similar to other studies in the field.

Furthermore, evidence-based practice may often rely on meta-analyses of large numbers of studies, some of which may report negative results. Metaanalysis requires full reporting of methods and outcomes to enable assessment of comparability of different studies. Inadequate, or nontransparent, reporting may make it difficult to understand the variables that affect intervention outcomes and the central elements in intervention success or failure over multiple studies.

In recent years, efforts have been made to improve the quality of reporting of RCTs. The Consolidated Standards of Reporting Trials (CONSORT) statement¹¹ provides a 22-item checklist and subject flow chart for the transparent reporting of RCTs. This statement has been adopted as a framework for the reporting of RCTs by a large number of medical, clinical, and psychological journals (153, according to http://www.consort-statement.org, as of September 16, 2003). Use of the CONSORT statement has improved the quality of RCT reports over the past several years.¹² There is yet, however, no agreed-upon framework for the transparent reporting of nonrandomized research evaluations.

The HIV/AIDS Prevention Research Synthesis (PRS) team of the Centers for Disease Control and Prevention (CDC) has been synthesizing evidence from HIV behavioral intervention studies involving RCT and nonrandomized designs. The PRS team found that many study reports failed to include critical information (e.g., intervention timing and dosage, effect size data) necessary for research syntheses.^13–17 To improve their ability to synthesize HIV behavioral prevention research, the PRS team convened the CDC’s Journal Editors Meeting in Atlanta, Ga, on July 24–25, 2003; this meeting was attended by editors and representatives of 18 journals that publish HIV behavioral intervention studies (a complete list of the journals is available from the authors and at http://www.TREND-statement.org). The main goals of the meeting were to (1) communicate the usefulness and importance of adequate reporting standards, (2) reach consensus on reporting standards for behavioral interventions, (3) develop a checklist of reporting standards to guide authors and journal reviewers, and (4) develop strategies to disseminate the resulting reporting standards.

The discussions at the meeting broadened to include standardized reporting of behavioral and public health interventions in general, rather than focusing only on HIV behavioral interventions. There was strong consensus at the meeting in regard to more standardized and transparent reporting of research evaluations using other than randomized designs, particularly those with some form of comparison group. This agreement was reached with the realization that additional input would be needed from a wide variety of researchers, other journal editors, and practitioners in the public health field before the adoption of a final set of reporting standards.

Table 1 presents a proposed checklist—the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) checklist—for reporting standards of behavioral and public health intervention evaluations involving nonrandomized designs. The TREND checklist is meant to be consistent with the CONSORT checklist for the reporting of RCTs. Items presented in boldface type in the table are particularly relevant to behavioral and public health intervention studies, whether or not randomized designs are used. Thus, we would suggest that they be used to expand the information requested by CONSORT for RCTs of behavioral and public health interventions. Some of the items (8, 10, and 15) presented in the proposed TREND checklist are not relevant to RCTs and, thus, not included in the CONSORT checklist, but they are extremely relevant to nonrandomized designs. We also refer readers to CONSORT elaboration reports^11,18 that provide rationales and examples for items in Table 1 that are shared with the CONSORT checklist.

• Use of theory (item 2). Behavioral and social science theories provide a framework for generating cumulative knowledge. Thus, it would be very helpful to include references to the theoretical bases of the intervention being evaluated. This would permit identification of theories that are useful in developing interventions in different fields. Some interventions, however, are based on atheoretical needs assessments or simply the experience of the individuals who designed the intervention. In these situations, a post hoc application of a theory is not likely to be helpful.
  
• Description of the intervention condition and the services provided in a comparison condition (item 4). Although space is limited in many journals, it is still critical to provide sufficient detail so that a reader has an understanding of the content and delivery of both the experimental intervention and the services in the comparison condition. For example, "usual care" is not a helpful description of a comparison condition.
  
• Description of the research design (item 8). We recognize that there can be meaningful disagreement about what research design was actually used in an intervention study, including whether an RCT design was used. To minimize confusion, it would be helpful for authors to specify the design they intended to use, particularly the method of assignment, and any variations or deviations from the design.
  

It is important to note that the TREND checklist is not intended to serve as a criterion for evaluating papers for publication. Rather, it is intended to improve the quality of data reporting in peer-reviewed publications so that the conduct and the findings of research are transparent. As the volume of public health literature is consistently expanding, research synthesis becomes an important tool for creating a cumulative body of knowledge and making evidence-based recommendations of effective interventions. Reporting standards will help ensure that fewer intervention trials with nonrandomized designs are missing information critical for research synthesis and that comparable information across studies can be more easily consolidated and translated into generalizable knowledge and practice.

We recognize several challenges in promoting and disseminating reporting standards for nonrandomized intervention evaluations. Most important, the TREND checklist is only a suggested set of guidelines and should be considered a work in progress. It is highly likely that improvements will be necessary; moreover, adaptations may be needed to refine the standards for specific fields of intervention research, and additional specifications for specific types of nonrandomized evaluation designs are likely to be needed. Furthermore, page limitations in many journals create strong pressure toward shorter rather than longer articles. Some alternatives were recommended in the CDC’s Journal Editors Meeting to resolve the space issue, such as having additional information from a published study provided on a journal’s Web site or on an author’s Web site or having authors send additional information to relevant research synthesis groups or a central repository.

Finally, the process has so far involved only CDC scientists and journal editors in a single meeting along with the preparation of this commentary. Although many of the journal editors included are notable researchers in the fields of HIV, public health, and drug abuse prevention, we realize that successful promotion and dissemination of these guidelines must involve an ongoing dialogue and must be extended to a large number of other researchers, methodologists, and statisticians across various healthrelated research fields.

In an effort to initiate this dialogue, we invite all editors, reviewers, authors, and readers to provide comments and feedback to help us revise the standards. Comments can be sent to TREND{at}cdc.gov, and the TREND group will periodically revise the guidelines accordingly. Also, journals are encouraged to endorse this effort by publishing editorials or commentaries on the TREND statement or by referencing it in their publication guidelines for authors and reviewers. To increase accessibility and ease of use, the revised versions of the TREND statement will be posted on an open access Web site (http://www.TREND-statement.org).

If the movement toward evidence-based public health is to succeed, it will be necessary to improve our ability to synthesize research on public health interventions. As Victora and colleagues note, this will include using data from intervention evaluations that do not involve randomized designs. The TREND statement presented here is proposed as a first step toward developing standardized and transparent reporting for nonrandomized intervention research evaluations in public health–related fields.

	Acknowledgments

 
Members of the TREND Group are as follows: Kamran Abbasi, MBChB, MRCP (BMJ), William Blattner, MD (University of Maryland, Baltimore; Journal of Acquired Immune Deficiency Syndromes), Jay Bernhardt, PhD, MPH (Emory University; Health Education Research), Bruce Bullington, PhD (Florida State University; Journal of Drug Issues), Raul Caetano, MD, PhD, MPH (University of Texas; Addiction), Terry Chambers, BA (Journal of Psychoactive Drugs), Harris Cooper, PhD (Duke University; Psychological Bulletin), Roel A. Coutinho, MD, PhD (University of Amsterdam; AIDS), Nicole Crepaz, PhD (Centers for Disease Control and Prevention), John D. DeLamater, PhD (University of Wisconsin, Madison; Journal of Sex Research), Don C. Des Jarlais, PhD (Beth Israel Medical Center; American Journal of Public Health), Jeffrey H. Herbst, PhD (Centers for Disease Control and Prevention), David Holtgrave, PhD (Emory University), Barry Hong, PhD (Washington University at St. Louis; Journal of Consulting and Clinical Psychology), Angela B. Hutchinson, PhD (Centers for Disease Control and Prevention), Seth Kalichman, PhD (University of Connecticut; Health Psychology), Linda Kay, MPH (Centers for Disease Control and Prevention), Cynthia Lyles, PhD (Centers for Disease Control and Prevention), Robert McNutt, MD (Rush St. Luke’s Medical Center at Chicago; Journal of the American Medical Association), Thomas L. Patterson, PhD (University of California, San Diego; AIDS and Behavior), Michael Ross, PhD, MPH, MA, MHPEd (University of Texas, Houston; AIDS Care), Theo Sandfort, PhD (Columbia University; Archives of Sexual Behavior), Ron Stall, PhD, MPH (Centers for Disease Control and Prevention), Francisco S. Sy, MD, DrPH (Centers for Disease Control and Prevention; AIDS Education and Prevention), Cesar G. Victora, MD, PhD (Universidade Federal de Pelotas), and David Vlahov, PhD (New York Academy of Medicine; American Journal of Epidemiology, Journal of Urban Health).

We also thank the following Prevention Research Synthesis team members for their assistance in the meeting preparation and contribution to the data reporting presentation: Julia Britton, Tanesha Griffin, Angela Kim, Mary Mullins, Paola Marrero-Gonzalez, Sima Rama, R. Thomas Sherba, and Sekhar Thadiparthi.

	Footnotes

 
Contributors
Don Des Jarlais, Cynthia Lyles, and Nicole Crepaz developed the initial draft of the article and made the successive revisions. All members of the TREND group contributed to the ideas in the article and reviewed the initial draft and revisions.

Peer Reviewed

Accepted for publication October 26, 2003.

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3. Evidence-Based Medicine Resource Center, New York Academy of Medicine. Home page. Available at: http://www.ebmny.org/thecentr2.html. Accessed January 5, 2004.

4. Agency for Healthcare Research and Quality. AHRQ’s evidence-based practice centers. Available at: http://www.ahrq.gov/clinic/epc. Accessed January 5, 2004.

5. Centers for Disease Control and Prevention. Guide to community preventive services. Available at: http://www.thecommunityguide.org. Accessed January 5, 2004.

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