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