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Everybody's talkin' ‘bout a new way of reportin’ observational studies

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Preventive Medicine 45 (2007) 245 – 246

This Month in Preventive Medicine

Everybody's talkin' ‘bout a new way of reportin’
observational studies
In this issue of Preventive Medicine, we publish the guidelines of a new research
initiative aimed at “Strengthening the Reporting of Observational Studies in Epidemiology” and abbreviated STROBE (von Elm et al., 2007). In contrast to what its acronym may
suggest, STROBE is meant to shed perpetual light, not just flashes, on the nature and
content of observational research.
Like its predecessors the Consolidated Standards of Reporting Trials (CONSORT, and the STAndards for the Reporting of Diagnostic Accuracy
studies (STARD,, STROBE is the third chapter in the
continuing saga that originated from the frustrations of meta-analysts with the
heterogeneity and incompleteness of study reports for, respectively, randomized clinical
trials (RCTs), evaluation of diagnostic tests, and observational studies. Meta-analyses and
systematic reviews have become an essential mode of compiling epidemiological and,
more generally, medical knowledge. Because new health-related knowledge never stems
from a single study, it is the researcher's responsibility to provide the information
necessary so that their individual study results can be integrated into future meta-analyses
or systematic reviews.
Our experience with CONSORT has been positive. It serves as a well-thought-out
checklist for both contributors and reviewers, without imposing unwarranted constraints.
We have not had the opportunity so far to experiment with STARD. Editorial convenience
is one reason why we welcome STROBE and will propose to our Editorial Board that it
should become part of PM's guidelines as a systematic requirement for our contributors. At
the very least, we see it as a very useful tool. For example, our readers would be amazed to
learn how often we have to remind authors to simply mention where and when their study
was co; nducted.
There is also a deeper reason that gives STROBE its historical significance. We view it as
one more important step in the convergence of epidemiology and medicine that has been
occurring since the 1960s. Clinical decision analysis (CDA) has contributed to familiarizing
a generation of mostly young physicians with difficult concepts such as sensitivity,
specificity, and predictive values. “Evidence-Based-Medicine” (EBM) has further
stimulated the curiosity of clinicians for study designs, measures of effect, and assessment
of interaction. However, epidemiology still has many features that have not been fully
integrated into clinical research, in particular those related to observational studies. Cohort
and case-control studies with their related biases and management of confounding represent
the greatest theoretical and technical wealth of epidemiology. The current hierarchy of
evidence for treatment efficacy, which values the results of RCTs ahead of those of both
cohort and case-control studies, the lowest level being the clinician’s opinion (www.cebm.
net/index.aspx?o=1025), has been widely misinterpreted as a hierarchy of design validity,
which sets a questionable boundary between good and bad science, with experiments on one
side and observational studies on the other. We think it harms a good idea like EBM to
reduce it to such superficial application.
In focusing on the thorough reporting of observational studies, STROBE should
provide clinical research with a new impetus toward valuing them. A few years from now,
0091-7435/$ - see front matter © 2007 Published by Elsevier Inc.


This Month in Preventive Medicine

many of the current controversies regarding observational vs. experimental studies will
become outdated (Concato et al., 2000; Pocock and Elbourne, 2000; Benson and Hartz,
2000) and will be considered as neo-classical examples of past intellectual rigidity. The
complexity of the phenomena that medical and health clinicians are dealing with is so great
that it would be naïve to posit that one type of evidence is superior for all of them. As stated
by Susser, 30 years ago, “Differences in strength of inference from experimental and
observational studies are relative, not absolute, as anyone who has conducted large
experimental trials will know, and to test their validity requires that we bring to bear all
possible criteria of judgment to all the data” (Susser, 1977, p. 12).
It is crucial for clinicians to develop their ability to integrate evidence from difference
sources, valuing each source for its specific strengths and weaknesses. Because the
progressive convergence of epidemiology and medicine has been paved with acronyms
(CDA, EBM, CONSORT, STARD, STROBE), we propose to add “AMBER” (for
“Appropriate Methods-Based Evaluation and Research”). AMBER posits that the relevant
epistemological demarcation is between science and techniques. Research techniques
serve scientific thinking and not vice versa. A given technique can be totally valid in one
context and inappropriate in another. For example, a randomized clinical trial can be the
optimal experimental design for testing the efficacy of a drug, but completely inadequate
when specific populations cannot be marshalled into the constraints of an RCT or
unacceptable for determining harm from exposure or treatment. Indeed, for seeking new
information on the adverse effects of treatment, observational studies are the best if not the
only source of evidence.
We expect the new way of reportin’ observational studies that everybody's talkin' 'bout
to be more than just a set of walk right in, sit right down instructions. STROBE should
contribute to a fuller convergence of epidemiology and medicine.
Benson, K., Hartz, A.J., 2000. A comparison of observational studies and randomized, controlled trials. N. Engl.
J. Med. 342, 1878–1886.
Concato, J., Shah, N., Horwitz, R.I., 2000. Randomized, controlled trials, observational studies, and the hierarchy
of research designs. N. Engl. J. Med. 342, 1887–1892.
Pocock, S.J., Elbourne, D.R., 2000. Randomized trials or observational tribulations? N. Engl. J. Med. 342,
Susser, M., 1977. Judgement and causal inference: criteria in epidemiologic studies. Am. J. Epidemiol. 105, 1–15.
von Elm, E., Altman, D.G., Egger, M., Pocock, S.J., Gøtzsche, P.C., Vandenbroucke, J.P., for the STROBE
Initiative, 2007. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)
Statement: guidelines for reporting observational studies. Prev. Med. 45, 247–251.

Alfredo Morabia, M.D., Ph.D.
Center for the Biology of Natural Systems,
Queens College–CUNY,
163-03 Horace Harding Expressway,
Flushing, NY 11365, USA

Michael C. Costanza, Ph.D.
Geneva University Hospitals,
Division of Clinical Epidemiology,
25, Rue Micheli-du-Crest,
CH-1211 Geneva 14, Switzerland
E-mail address: