Table 1.
Item | Recommendation | Page | |
---|---|---|---|
Title | |||
Title | 1 | Indicate that this is an enhanced recovery study in the title | |
Introduction | |||
Background | 2 | Explain the area of uncertainty that the study seeks to address | |
Guidelines | 3 | If a published set of enhanced recovery guidelines exists for this procedure, include a reference to the guidelines | |
Outcomes | 4 | Define the primary outcome and any key prespecified secondary outcomes for the study | |
Methods | |||
IRB approval | 5 | Give the Institutional Review Board/Ethics Committee name and approval number. If permission was not required, reasons should be stated | |
Study design | 6 | Indicate what type of study is presented (randomized controlled trial, cohort, cross-sectional, etc.) The individual guidelines for the type of study should be followed (e.g., CONSORT for randomized controlled trial, STROBE for cohort studies, etc.) | |
Setting | 7 | Describe whether this is a single or multicenter study, the type of practice (academic vs. community, tertiary vs. primary), and the providers (limited group or all providers on a service) | |
Timing | 8 | Describe periods of recruitment, time points at which outcomes assessed, and follow-up | |
Participants | 9 | Define study inclusion and exclusion criteria | |
Enhanced recovery protocol | 10 | Describe when the enhanced recovery protocol was implemented relative to the study period | |
11 | Provide a flow diagram or table through the continuum of care detailing the enhanced recovery protocol including the following elements: | ||
(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) | |||
(f) Intraoperative fluid management strategy | |||
(g) Types, doses, and routes of anesthetics administered | |||
(h) Patient warming strategy | |||
(i) Management of postoperative fluids | |||
(j) Postoperative analgesia and anti-emetic plans | |||
(k) Plan for opioid minimization | |||
(l) Drain and line management | |||
(m) Early mobilization strategy | |||
(n) Postoperative diet and bowel regimen management | |||
(o) Criteria for discharge | |||
(p) Tracking of post-discharge outcomes | |||
Enhanced recovery auditing | 12 | Describe 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 | 14 | If patient questionnaires are used, provide references to validation of these study instruments | |
Results | |||
Patient population | 15 | Use a flow diagram to explain the derivation of the study population | |
(a) Provide a Table I with the key demographic and clinical features of the study population | |||
(b) Indicate number of participants with missing data for each variable of interest | |||
Enhanced recovery compliance | 16 | Provide a Table II with average compliance for each enhanced recovery protocol element and present a comparison of the variation in enhanced recovery compliance among the study groups | |
Correlations | 17 | Perform logistic regression to correlate the change in primary outcome with the study intervention | |
Discussion | |||
Context | 18 | Explain what the study adds to the body of knowledge regarding the study intervention within the context of enhanced recovery after surgery care | |
Limitations | 19 | Discuss the limitations of the study and how these might temper the findings | |
Other information | |||
Funding | 20 | Document all sources of funding and potential conflicts of interest for the study authors |
RECOvER Reporting on ERAS Compliance, Outcomes, and Elements Research, CONSORT Consolidated Standards Of Reporting Trials, STROBE STrengthening the Reporting of OBservational studies in Epidemiology, PROs patient-reported outcomes