Effective Use of Reporting Guidelines to Improve the Quality of Surgical Research
Historically, the surgical literature was defined based on a predominance of case series, case reports, and anecdotal experiences of surgical investigators. But over the past several decades, the methodologic quality of surgical research has significantly improved, concurrent with increasing use of more robust study designs. Contemporary evidence published to support the use of surgical interventions now routinely comes from randomized clinical trials, meta-analyses, qualitative studies, cost-effectiveness analyses, and comparative effectiveness research studies, to name a few. Many of these study designs and advanced methodologies were highlighted in the most recent Guide to Statistics and Methods series published in JAMA Surgery this past year.
But learning how to apply complex or unfamiliar study designs to surgical research can be challenging. There are common pitfalls associated with every type of clinical research study that investigators may experience. This includes failing to define inclusion and exclusion criteria for the study population, overlooking errors in outcome measurement, failing to specify statistical assumptions in the analysis, and neglecting to identify or include measures to control for bias.3 Furthermore, investigators may fail to accurately report these limitations or account for other essential components of the study’s background, methods, or results in an article. These types of mistakes in either the analysis or reporting of outcomes can significantly alter the takeaway message for the reader and the ability for reviewers to critically assess the quality of the study.
Consistent with the prior Guide to Statistics and Methods series on surgical data sets and the methodology toolbox, this overview of reporting guidelines was undertaken in partnership with the Surgical Outcomes Club (http://www.surgicaloutcomesclub.com). This collaboration was designed to ensure that each article is relevant to the needs of surgical clinical investigators. A 3-person authorship team was assembled for each article, which included (1) a surgeon-investigator member of the Surgical Outcomes Club with practical experience using the study design and associated reporting guideline, (2) a member of the JAMA Surgery editorial board who commonly reviews and publishes manuscripts using the study design and reporting guideline, and (3) a JAMA Surgery biostatistician who is routinely consulted to critically evaluate manuscripts that use the specific study design.
We hope that these articles will increase the awareness and effective use of reporting guidelines throughout the surgical literature. Surgical investigators must continue to raise the bar for research across all specialties and aim for the highest standards by which evidence for surgical interventions is evaluated and disseminated. The routine use of reporting standards represents another incremental step toward meeting these goals.
