We read with great interest the randomized trial by Ngo-Huang et al1 on the effects of preoperative home-based exercise programs in patients with pancreatic cancer published in the July 2023 issue of Annals of Surgery. We commend the authors for their rigorous and insightful randomized study, and the editors for their commitment to publishing null trials.
In a constructive spirit, we would like to raise a concern regarding the wording and structure of the paper’s abstract and discussion. Generally, we notice poor compliance with the recommendations from the CONSORT Statement,2 as exemplified by the failure to state a specific hypothesis or the methods of allocation.
Of greater concern is the failure to clearly report the missing difference between the randomized arms concerning the primary outcome. Instead, the authors focus on the “significant” improvements in walking distance over time within each cohort. Such findings must be interpreted, in practice, as the result of 2 parallel cohort studies and are susceptible to the same biases (ie, Hawthorne effect, reporting bias, and post hoc analysis) that randomized studies are designed to mitigate. Presenting them as the main results of a randomized study can be misleading for the inexperienced reader. Similarly, the assertion in the conclusion section of the abstract, according to which the study results highlight the importance of physical activity before surgery, does not appear to be supported by either primary or secondary outcomes at the level of evidence expected from a randomized trial.
Given that usage of medical literature is often limited to the reading of abstracts,3 we stress the importance of clearly reporting therein on the predetermined main outcomes of a study—in this case the absence of evidence suggesting superiority of a structured training program over enhanced usual care.
Footnotes
Disclosure: The authors declare that they have nothing to disclose.
References
- 1.Ngo-Huang AT, Parker NH, Xiao L, et al. Effects of a pragmatic home-based exercise program concurrent with Neoadjuvant therapy on physical function of patients with pancreatic cancer: the PancFit randomized clinical trial. Ann Surg. 2023;278:22–30. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Boutron I, Altman DG, Moher D, et al. ; CONSORT NPT Group. CONSORT statement for randomized trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann Intern Med. 2017;167:40–47. [DOI] [PubMed] [Google Scholar]
- 3.Saint S, Christakis DA, Saha S, et al. Journal reading habits of internists. J Gen Intern Med. 2000;15:881–884. [DOI] [PMC free article] [PubMed] [Google Scholar]