The Reporting on ERAS Compliance, Outcomes, and Elements Research (RECOvER) Checklist: A Joint Statement by the ERAS and ERAS USA Societies

Background Enhanced recovery after surgery (ERAS) programs are multimodal care pathways designed to minimize the physiological and psychological impact of surgery for patients. Increased compliance with ERAS guidelines is associated with improved patient outcomes across surgical types. As ERAS programs have proliferated, an unintentional effect has been significant variation in how ERAS-related studies are reported in the literature. Methods To improve the quality of ERAS reporting, ERAS O USA and the ERAS O Society launched an effort to create an instrument to assist authors in manuscript preparation. Criteria to include were selected by a combination of literature review and expert opinion. The final checklist was refined by group consensus. Results The Societies present the Reporting on ERAS Compliance, Outcomes, and Elements Research (RECOvER) Checklist. The tool contains 20 items including best practices for reporting clinical pathways, compliance auditing, and formatting guidelines. Conclusions The RECOvER Checklist is intended to provide a standardized framework for the reporting of ERASrelated studies. The checklist can also assist reviewers in evaluating the quality of ERAS-related manuscripts. Authors are encouraged to include the RECOvER Checklist when submitting ERAS-related studies to peer-reviewed journals.

# Introduction
Enhanced recovery after surgery (ERAS) programs are multimodal care pathways designed to minimize the physiological and psychological impact of surgery for patients. ERAS pathways rely on multidisciplinary teams and require coordinated interventions in all parts of perioperative care, from the initial preoperative consultation through the hospitalization and onward to the return of the patient to normal activities of daily living [bib_ref] Enhanced recovery after surgery: a review, Ljungqvist [/bib_ref]. ERAS programs reduce hospital lengths of stay and postoperative complications while decreasing the costs of care for patients and health systems [bib_ref] Enhanced recovery after surgery programs improve patient outcomes and recovery: a meta-analysis, Lau [/bib_ref] [bib_ref] Enhanced recovery after surgery for noncolorectal surgery?: A systematic review and meta-analysis..., Visioni [/bib_ref]. Most ERAS pathways are designed around approximately 25 core elements outlined by the ERAS O Society [bib_ref] Understanding enhanced recovery after surgery guidelines: an introductory approach, Elias [/bib_ref]. There are data to suggest that increased compliance with these core elements is associated with improved outcomes across surgical types [bib_ref] Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal..., Gustafsson [/bib_ref] [bib_ref] Adherence to the ERAS protocol is associated with 5-year survival after colorectal..., Gustafsson [/bib_ref] [bib_ref] The impact of enhanced recovery protocol compliance on elective colorectal cancer resection:..., Group [/bib_ref].
In recent years, research in ERAS has expanded significantly. ERAS programs have expanded beyond colorectal surgery to other surgical disciplines and have been implemented successfully in pancreatic surgery, thoracic surgery, liver resection, urologic surgery, gynecologic surgery, and emergency surgery, among others [bib_ref] Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal..., Gustafsson [/bib_ref] [bib_ref] Enhanced recovery after surgery program in patients undergoing pancreaticoduodenectomy: a PRISMA-compliant systematic..., Xiong [/bib_ref] [bib_ref] Enhanced recovery after surgery using uniportal video-assisted thoracic surgery for lung cancer:..., Huang [/bib_ref] [bib_ref] Hospital charges and length of stay following radical cystectomy in the enhanced..., Semerjian [/bib_ref] [bib_ref] Guidelines for postoperative care in gynecologic/oncology surgery: enhanced recovery after surgery (ERAS(R))..., Nelson [/bib_ref] [bib_ref] Enhanced recovery after emergency surgery: a systematic review, Paduraru [/bib_ref] ]. An unintentional effect of this rapid expansion has been significant variations in how ERAS studies are reported [bib_ref] Incomplete reporting of enhanced recovery elements and its impact on achieving quality..., Day [/bib_ref]. The COMPAC (Core Outcome Measures in Perioperative and Anaesthetic Care) group has embarked on an effort to standardize the outcomes reported in perioperative medicine https://www.niaa-hsrc.org.uk/HSRC-COMPAC. While there are some efforts to apply a similarly tiered approach to reporting ERAS outcomes, we believe that a truly comprehensive ERAS report should detail not only the outcomes, but also the process by which those outcomes were achieved [bib_ref] American Society for Enhanced Recovery (ASER) and Perioperative Quality Initiative (POQI) joint..., Moonesinghe [/bib_ref]. Like any other scientific enterprise, the methods should contain sufficient detail to enable another group to reproduce the results. Moreover, as ERAS protocols have now been in place at many sites for years, there is a need to mature ERAS studies beyond the common retrospective comparisons to pre-ERAS historic controls. These lower-quality studies tend to magnify the benefits of the intervention being studied. Indeed, properly designed prospective studies have been revealing, showing that interventions which may improve outcomes under traditional perioperative management do not necessarily confer additional benefit when both groups are on ERAS pathways [bib_ref] Intraoperative goal-directed fluid therapy in elective major abdominal surgery: a meta-analysis of..., Rollins [/bib_ref]. Hence, there is a need to formalize ERASrelated research such that meaningful results are reproducible and generalizable. We created the Reporting on ERAS Compliance, Outcomes, and Elements Research (RECOvER) Checklist to provide authors and reviewers with a set of standards for excellence in reporting ERAS-related studies. This checklist is not a guideline itself-in fact, quite the opposite. It is a tool to assist authors when reporting outcomes on guidelines already in practice and, if anything, should prompt reviewers or readers to ask why elements in a report are not described or may not be appropriate. Our goal is to encourage reproducibility in clinical studies, acknowledging the different variables which may influence ERAS outcomes and the different ways in which ERAS has been implemented in units around the world. This is not a meta-analysis; rather, we aim to improve study reporting so that future meta-analyses can be more easily performed by ensuring sufficient information on ERAS practice and description of outcomes.

## Recover development
A checklist and statement were developed by a small working group of volunteers from ERAS O USA (the American chapter of the ERAS O Society). A subcommittee (KME, KM, JIT) from the ERAS O USA Research Committee reviewed ERAS-related publications from across different medical specialties and study designs. In developing the checklist, subcommittee members were asked to review 10-15 manuscripts each from anesthesia, surgery, or general interest journals and tasked to define best practices in ERAS reporting. Questions to be addressed were:
1. How are the study groups defined? 2. How do the authors convey the implementation of ERAS principles? 3. What steps are taken to assess compliance? 4. What outcomes are measured?
This subcommittee developed an initial list of 32 items for inclusion in a checklist of best practices. After discussion with the larger committee, this number was reduced to 20 items to focus the checklist on elements related to ERAS rather than to general guidelines for best practices in research reporting. The total number of elements was reduced by removing those redundant with general reporting guidelines, for example the Enhancing QUAlity and Transparency Of health Research (EQUA-TOR) network guidelines, or by combining similar elements to make the checklist more concise [bib_ref] Guidance for developers of health research reporting guidelines, Moher [/bib_ref]. Reconciliation in the rare cases where disagreement occurred was achieved by following the majority opinion of the authors. After agreement in the Research Committee was achieved, the checklist was circulated to members of the ERAS O Society Executive Committee (MJS, WJF, ND, DNL, and OLP) for further comments. Following feedback from members of the society, the final number of 20 items

## Recover items
The complete list of checklist items is shown in [fig_ref] Table 1: RECOvER Checklist for reporting of enhanced recovery research [/fig_ref].
We recommend that authors publishing research in the field of ERAS include this checklist with their submissions and indicate the location of each item in the manuscript. This is a framework for guidance. It should facilitate publication rather than serve as a barrier. The ultimate decision to accept or reject manuscripts is with the individual journal editors; the guidance is not proscriptive. Each item in the checklist pertains to a particular point in the course of conducting an ERAS research study, from conceptualization to data analysis and the writing of the manuscript. Therefore, we recommend that the researchers consult the checklist as early as possible during the study planning process. Below we provide a detailed description of each checklist item, followed by some examples. Reporting standards begin with the title page. ERAS studies should refer to enhanced recovery within the title (item 1), which will facilitate queries for future systematic reviews. The title should also relay the study type and surgical procedure studied-for example, a retrospective cohort study of patients undergoing robotic-assisted pancreaticoduodenectomies. In the introduction, the authors should explain the specific area of clinical uncertainty being addressed within the context of ERAS (item 2)-for instance, whether high-volume or high-concentration local anesthetic provides superior local analgesia to the incision. As the ERAS O Society and other perioperative research societies have published guidelines for many procedures, existing guidelines, if applicable, should be referenced (item 3). The primary outcome for the study should be clearly stated in the introduction, as well as key secondary outcomes of interest (item 4). While many ERAS studies have focused on administrative outcomes, such as hospital length of stay, or clinical outcomes, such as wound infection or transfusion rates, there is considerable need for more ERAS studies addressing functional outcomes. The latter might include outcomes such as return to work or discharge to home rather than to a rehabilitation facility [bib_ref] Short convalescence after inguinal herniorrhaphy with standardised recommendations: duration and reasons for..., Callesen [/bib_ref] [bib_ref] Validation of days at home as an outcome measure after surgery: a..., Myles [/bib_ref] [bib_ref] Enhanced recovery: More than just reducing length of stay?, Fawcett [/bib_ref]. There is also a need for more studies examining non-surgical perioperative morbidity within the context of established ERAS programs, such as the consequences of preoperative anxiety or postoperative delirium [bib_ref] Delirium after fast-track hip and knee arthroplasty-a cohort study of 6331 elderly..., Petersen [/bib_ref] [bib_ref] Predicting delayed discharge in a multimodal enhanced recovery pathway, Keller [/bib_ref].
Within the materials and methods, all ERAS studies should describe the Institutional Review Board (IRB) or Ethics Committee review or explain the rationale for IRB/ Ethics Committee exemption (item 5). The study design, including whether this is a prospective or retrospective study, should be evident (item 6). The design description should include details on the clinical context, including the setting (item 7), timing (item 8), and selection of patients (item 9) for the study. This includes the type of hospital, period of recruitment, and inclusion and exclusion criteria for the study. The authors should place the report temporally with respect to the introduction of ERAS at the institution (item 10), including differentiating pre-ERAS from post-ERAS groups of patients. An explicit statement regarding the dates of introduction of ERAS at the institution, if possible, is preferred. Paramount to ERAS-related studies is documentation that the principles of enhanced recovery are being followed (item 11). While the literature is rife with reports of ERAS failures, a closer inspection may reveal a lack of compliance with ERAS concepts [bib_ref] Enhanced recovery program and length of stay after laparotomy on a gynecologic..., Dickson [/bib_ref] [bib_ref] A randomised controlled trial of fluid restriction compared to oesophageal Doppler-guided goal-directed..., Phan [/bib_ref]. A detailed description of the ERAS pathway should cover all phases of care (preadmission, preoperative, intraoperative, post-anesthesia care, inpatient, postdischarge, and follow-up care). The description should also include the management strategies for perioperative optimization, opioid-sparing analgesia, fluid management, avoidance of starvation, nutritional care, mobilization, and discharge. These elements must then be related to an audit system for pathway compliance (item 12), whether the ERAS O Interactive Audit System O (EIAS O ) or local databases. The report should include a list of the metrics that enter into the compliance calculation. Similarly, outcomes, both primary and secondary, should be clearly defined a priori (item 13), and whenever patient-reported outcomes (PROs) or surveys are introduced, these should use validated and referenced instruments (item [bib_ref] Incomplete reporting of enhanced recovery elements and its impact on achieving quality..., Day [/bib_ref]. Results reporting in ERAS should reflect similar transparency to the methods. The reader should be able to visualize the derivation and composition of the study population (item 15). A description of the population should identify what proportion of all patients undergoing the procedure of interest is being reported and the reasons for exclusion from the study. The outcomes results should be displayed in the context of the actual compliance with the ERAS elements (item 16). Again, this requires an auditing system in place so that percentage compliance with the protocol can be plotted against the outcomes of interest. Whenever possible, regression analysis techniques should be used to test for independent associations between the primary outcome and the intervention under study (item 17). For example, in a study of ambulation from the postoperative recovery unit compared to ambulation on reaching the inpatient ward, where the primary outcome is actually the 6-minute walk test result at 2 weeks after surgery, a regression analysis should include confounders for early ambulation such as time of day, neuraxial analgesia, or receipt of opioids.
The discussion of ERAS studies should place the work within the larger context of ERAS-related care (item 18). Authors should strive to link the findings with tangible opportunities to improve clinical practice. A study that shows a decrease in visual analog scale (VAS) pain scores from 5 to 4 is of much less impact on the field than a similar study that examines the proportion of patients discharged to home rather than to a rehabilitation facility. Authors sometimes consciously or subconsciously overinterpret the results of their study, that is, they add ''spin'' to the conclusions of a scientific report. Spin is defined as a non-neutral way of reporting that distorts the interpretation of results and misleads readers [bib_ref] Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for..., Boutron [/bib_ref]. An appraisal of the study limitations should be candid (item [bib_ref] Validation of days at home as an outcome measure after surgery: a..., Myles [/bib_ref] , including critiques of the ERAS protocol itself, if indicated. Finally, authors must be open regarding funding support and possible conflicts of interest (item 20).

## Recover scope
An example of the RECOvER Checklist appears in [fig_ref] Table 2: Example of a RECOvER Checklist [/fig_ref]. The primary aim of the RECOvER Checklist is to ensure an ERAS-specific addendum accompanies ERASrelated studies so that the reader can assess the ERASspecific elements. The checklist is not mandatory; rather, it serves as a framework to make it easier to compare ERAS studies and assemble future systematic reviews and metaanalyses.

## Recover checklist availability
The RECOvER Checklist will be made available on the ERAS O USA as well as the ERAS O Society websites. It is free and available as an open access document to support higher-quality and more consistent reporting of ERAS research.
[fig] a: Preadmission patient education regarding the protocol (b) Preadmission screening and optimization as indicated for nutritional deficiency, frailty, anemia, HbA1c, tobacco cessation, and ethanol use (c) Fasting and carbohydrate loading guidelines (d) Preemptive analgesia (dose, route, timing) (e) Anti-emetic prophylaxis (dose, route, timing) the audit system for compliance with the enhanced recovery protocol and how compliance data are measured Outcomes 13 (a) Explain the criteria for assessing primary and secondary outcomes (b) Distinguish among clinical, functional, administrative, and quality of life outcome measures PROs 14If patient questionnaires are used, provide references to validation of these study instrumentsResultsPatient population 15Use a flow diagram to explain the derivation of the study population (a) Provide a [/fig]