Dear Dr. Aris Papageorghiou,
Upon perusing the recently published article by Elisa Piovano et al. in your esteemed journal, which details a stepped-wedge cluster randomized trial (SW-CRT) of the Enhanced Recovery After Surgery (ERAS) protocol within a hospital network, I was intrigued by the findings.1 The study’s innovative approach to surgical care quality enhancement through audit and feedback mechanisms has indeed charted a novel trajectory for clinical improvement. However, despite the authors’ acknowledgment of certain limitations, there are additional aspects that could potentially enrich the study’s scope.
A notable aspect of the study is the utilization of the SW-CRT design. However, in the setting of the model, as a stratification criterion for the randomized grouping of hospitals in different columns, we believe that the mere consideration of surgical volume may not suffice to ensure homogeneity across groups.The geographical distribution of gynecological units, alongside the varying medical resources, baseline health status of the patient populations, and the socio-economic milieu, could significantly influence patient adherence to treatment protocols and subsequent postoperative outcomes.2 It is our view that a more nuanced stratification strategy, which accounts for these potential confounding variables, could bolster the study’s internal validity.
Furthermore, the study’s focus on short-term postoperative outcomes does not provide conclusive evidence regarding the impact on length of stay (LOS) and complication rates. We propose that the authors consider extending the duration of follow-up and incorporating a multidimensional assessment of Patient-Reported Outcomes (PROs).3 This could encompass parameters such as physical recovery timeframe, psychological stress variations, social function recovery, and the psychosocial implications of total hysterectomy on self-identity. Standardizing these follow-up indicators and evaluations could render the study’s findings more holistic and robust.
In terms of clinical translation, an analysis of the cost-effectiveness of implementing the ERAS protocol during the SW-CRT could offer valuable data to health policy makers.4 Such an analysis could facilitate more informed decisions regarding the clinical application of ERAS protocols and encourage hospitals to adopt these practices beyond the purview of external audit and feedback mechanisms.
The seminal study conducted by Piovano et al. adeptly underscores the pivotal role of ERAS protocol implementation in gynecological surgery, coupled with the efficacy of audit and feedback mechanisms in augmenting the quality of patient care. As clinicians, we have benefited greatly from this study. We look forward to Piovano et al. delving deeper and refining this investigative study to benefit more gynecologic oncology patients in the future.
1. Piovano E, Puppo A, Camanni M, et al. Implementing Enhanced Recovery After Surgery for hysterectomy in a hospital network with audit and feedback: A stepped‐wedge cluster randomised trial. BJOG Int J Obstet Gynaecol . 2024;131(9):1207-1217. doi:10.1111/1471-0528.177972. Guyatt GH, Oxman AD, Kunz R, et al. Incorporating considerations of resources use into grading recommendations. BMJ . 2008;336(7654):1170-1173. doi:10.1136/bmj.39504.506319.803. Mehran R, Baber U, Dangas G. Guidelines for Patient-Reported Outcomes in Clinical Trial Protocols. JAMA . 2018;319(5):450-451. doi:10.1001/jama.2017.215414. de Groot JJ, Maessen JM, Slangen BF, Winkens B, Dirksen CD, van der Weijden T. A stepped strategy that aims at the nationwide implementation of the Enhanced Recovery After Surgery programme in major gynaecological surgery: study protocol of a cluster randomised controlled trial. Implement Sci IS . 2015;10:106. doi:10.1186/s13012-015-0298-x