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Guidelines for reporting observational studies:
the newly published STROBE statement

Carmine Zoccali
OO.RR and CNR Istituto di Biomedicina Reggio Calabria, Italy
MAY 12th  COMPACT PRIMERS  2 -  HALL K1/K2 8.00-9.30

Observational studies constitute a category of studies that are being performed for various purposes in medical research. For example, to explore cause-effect associations or to identify prognostic factors or to verify the magnitude of previously reported associations. Importantly, observational Studies are the most frequent study type in Nephrology Journal (>80%). The clinical trial is the unbeatable standard for assessing the value of treatment but some epidemiologists argue that well conceived observational studies can be useful to measure the effect of interventions (Benson K NEJM 2000).
There is a background complaint that notwithstanding the advancements of modern sciences, the quality of medical research, clinical research in particular, is poor. A medical biostatistics and methodology guru, Douglas Altman, went into saying that poor medical research is a scandal (BMJ 308:283, 1994). In 2004 S.Pockock, again in the BMJ (329:883; 2004) exposed the problem of poor reporting in epidemiological studies. His wording “….This survey raises concerns regarding inadequacies in the analysis and reporting of epidemiological publications in mainstream journals….”. This problem was well known to nephrologists because two appraisals   published in AJKD one in 1996 on the fallacies in the use of Cox regression analysis and another (published in 2002) on problems related with prognostic studies showed that the quality of these studies in nephrology journal was suboptimal.
In the last two years a group of distinguished epidemiologists and methodologists convened several times to produce guidance aimed at improving reporting of epidemiological studies and the result of this effort is STROBE, i.e. strengthening reporting of observational studies in epidemiology. The manuscript was disseminated in a long and in a short format on several major journals (PlOSs Annals of Internal Medicine, Lancet and other epidemiology journals) and was accompanied by a checklist of 22 recommendations. A nephrology journal (Am J Kidney Disease) has already adopted STROBE and it is hoped that also other major nephrology journal adopts it very soon. Rigorous reporting rules   and the diffusion of indispensable methodology for producing valuable studies is the best defence against bad clinical science. STROBE is undoubtedly a relevant step forward in that direction because it sets a well conceived set of recommendations related with the most frequent study design in nephrology, i.e. observational studies...