While it is difficult to critique the RE-AIM framework specifically, the concept of non-randomized, non-experimental study designs has come under significant scrutiny. Not only are the conclusions from such studies difficult to interpret, but their ability to consistently detect significant changes in behavior can be limited. With these caveats in mind, many health promotion interventions are evaluated with such study designs due to lack of finances or logistical issues inherent in randomized designs.
In order to maximize the ability of the health behavior community to understand and critically assess the quality of nonrandomized and observational study designs, the TREND and STROBE Statements were developed.
TREND Statement (Transparent Reporting of Evaluations with Nonrandomized Designs) guides researchers through accurate and thorough reporting of their non-experimental designs.
The STROBE Statement (Strengthening the Reporting of Observational Studies in Epidemiology) was developed for reporting of cohort, case-control and cross-sectional studies which may be a part of an evaluation plan.
Reporting Evaluations - TREND Statement
The Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) Statement was designed for the reporting of nonrandomized evaluations of public health programs. The TREND Statement is based on the CONSORT Statement for reporting of randomized trials. The CONSORT (Consolidated Standards of Reporting Trials) Statement, is an evidence-based, minimum set of recommendations for reporting randomized clinical trials. It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, and aiding their critical appraisal and interpretation.
TREND provides specific information about the basis for the intervention and rationale for specific evaluation methodology used in the study. Specifically, the Statement includes mention of the theoretical basis of the program, methods used to select participants and controls (if applicable), and descriptive data on the demographic and other relevant characteristics of both participants and controls.
The following journals have printed publications on TREND or provide support by recommending the Statement to authors:
- AIDS and Behavior
- AIDS Care
- AIDS Education and Prevention
- American Journal of Preventive Medicine
- American Journal of Public Health
- Annals of Behavioral Medicine
- Archives of Sexual Behavior
- British Medical Journal
- Health Promotion Journal of Australia
- Journal of Alcohol and Drug Education
- Journal of Consulting & Clinical Psychology
- Journal of Psychoactive Drugs
- Journal of Urban Health
The following is an abbreviated, paraphrased list of the aspects of the TREND Statement that are not found in CONSORT. Readers are encouraged to consult with the published articles on the Statement including:
Des Jarlais, DC, Lyles, C et al. (2004). Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND Statement. American Journal of Public Health, 94:361-366.
Title and Abstract:
Describe target population or sample.
Describe theories used in designing intervention.
Provide information on sampling methodology, recruitment setting(s) and inclusion/exclusion criteria.
Present data on differences between participants and controls at baseline and follow-up(s).
Present results of mediation/moderation analyses that depict theorized pathways through which intervention was designed to operate.
Present information on the policy implications of the study.
Reporting Evaluations - STROBE Statement
The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement provides guidance for researchers reporting the results of observational studies (e.g. case-control, cohort & cross-sectional studies). The Statement includes numerous research design considerations, methods and results that should be included in published reports. It is broken down into the typical sections of a published journal article (title/abstract, introduction, methods, results, discussion) but is not a prescriptive formula for writing. Instead, it offers advice about the types of research decision-related information to include in the publication.
The following journals have printed publications on STROBE or provide support by recommending the Statement to authors:
- Acta Gastroenterologica Latinoamericana
- American Journal of Kidney Diseases
- Annals of Internal Medicine
- Bulletin of the WHO
- Down Syndrome Research and Practice
- Drug and Alcohol Dependence
- East African Journal of Public Health
- European Respiratory Journal
- Indian Journal of Ophthalmology
- Int'l Journal of Clinical Practice
- Int'l Journal of Nursing Studies
- Journal of Bone and Joint Surgery
- Journal of Investigational Allergology & Clinical Immunology
- Journal of Orthopaedic & Sports Physical Therapy
- The Lancet
The following is a paraphrased, abbreviated list of the aspects of the STROBE Statement. Readers are encouraged to consult with the two main published articles on the Statement:
Von Elm, E, Altman, DG et al. (2007). The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. Preventive Medicine, 45: 247-251.
Vandenbroucje, JP von Elm, E et al. (2007). Strengthening the reporting of observational studies in epidemiology (STROBE): explanation and elaboration. Epidemiology, 18(6): 805-835
Title and Abstract:
Include the study's design using common language in the title and/or abstract.
Include the background and rationale for the study with specific study objectives and a priori hypotheses.
Describe setting including recruitment periods, locations and dates.
Explain and define predictor and outcome variables including diagnostic criteria (e.g. reliability and validity) if available.
Provide both unadjusted and adjusted estimates of the main results.
Include discussion of the limitations of the study including potential sources of bias and/or confounding.
Provide information about the funding source for the research.
For more information:
Consolidated Standards of Reporting Trials (CONSORT) Statement
Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) Statement
Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement