Methods and timing in the assessment of postoperative recovery: a scoping review.

BACKGROUND: There is no consensus about the type of instrument with which to assess postoperative recovery or the time points when assessments are most appropriate. It is also unclear whether instruments measure the four dimensions of postoperative recovery, that is physical, psychological, social, and habitual recovery. This scoping review had three objectives: (1) to identify and describe instruments used in clinical trials to assess postoperative recovery; (2) to determine how, when, and the number of times postoperative recovery was measured; and (3) to explore whether the four dimensions of postoperative recovery are represented in the identified instruments. METHODS: A literature search was conducted in CINAHL, MEDLINE, and Web of Science. The search terms were related to three search strands: postoperative recovery, instrument, and clinical trials. The limits were English language and publication January 2010 to November 2021. In total, 5015 studies were identified. RESULTS: A total of 198 studies were included in the results. We identified 20 instruments measuring postoperative recovery. Different versions of Quality of Recovery represented 81.8% of the included instruments. Postoperative recovery was often assessed at one time point (47.2%) and most often on postoperative day 1 (81.5%). Thirteen instruments had items covering all four dimensions of postoperative recovery. CONCLUSIONS: Assessing recovery is important to evaluate and improve perioperative care. We emphasise the importance of choosing the right instrument for the concept studied and, if postoperative recovery is of interest, of assessing more than once. Ideally, instruments should include all four dimensions to cover the whole recovery process.

Validation of the days alive and out of hospital outcome measure after emergency laparotomy: a retrospective cohort study.

BACKGROUND: Days alive and out of hospital (DAOH) is a composite, patient-centred outcome measure describing a patient's postoperative recovery, encompassing hospitalisation and mortality. DAOH is the number of days not in hospital over a defined postoperative period; patients who die have DAOH of zero. The Standardising Endpoints in Perioperative Medicine (StEP) group recommended DAOH as a perioperative outcome. However, DAOH has never been validated in patients undergoing emergency laparotomy. Here, we validate DAOH after emergency laparotomy and establish the optimal duration of observation. METHODS: Prospectively collected data of patients having emergency laparotomy in England (December 1, 2013-November 30, 2017) were linked to national hospital admission and mortality records for the year after surgery. We evaluated construct validity by assessing DAOH variation with known perioperative risk factors and predictive validity for 1 yr mortality using a multivariate Bayesian mixed-effects logistic regression. The optimal postoperative DAOH period (30 or 90 days) was judged on distributional and pragmatic properties. RESULTS: We analysed 78 921 records. The median 30-day DAOH (DAOH30) was 16 (inter-quartile range [IQR], 0-22) days and the median DAOH90 was 75 (46-82) days. DAOH was shorter in the presence of known perioperative risk factors. For patients surviving the first 30 postoperative days, shorter DAOH30 was associated with higher 1-yr mortality (odds ratio=0.94; 95% credible interval, 0.94-0.94). CONCLUSION: DAOH is a valid, patient-centred outcome after emergency laparotomy. We recommend its use in clinical trials, quality assurance, and quality improvement, measured at 30 days as mortality heavily skews DAOH measured at 90 days and beyond.

Systematic review and consensus definitions for the Standardized Endpoints in Perioperative Medicine (StEP) initiative: cardiovascular outcomes.

BACKGROUND: Adverse cardiovascular events are a leading cause of perioperative morbidity and mortality. The definitions of perioperative cardiovascular adverse events are heterogeneous. As part of the international Standardized Endpoints in Perioperative Medicine initiative, this study aimed to find consensus amongst clinical trialists on a set of standardised and valid cardiovascular outcomes for use in future perioperative clinical trials. METHODS: We identified currently used perioperative cardiovascular outcomes by a systematic review of the anaesthesia and perioperative medicine literature (PubMed/Ovid, Embase, and Cochrane Library). We performed a three-stage Delphi consensus-gaining process that involved 55 clinician researchers worldwide. Cardiovascular outcomes were first shortlisted and the most suitable definitions determined. These cardiovascular outcomes were then assessed for validity, reliability, feasibility, and clarity. RESULTS: We identified 18 cardiovascular outcomes. Participation in the three Delphi rounds was 100% (n=19), 71% (n=55), and 89% (n=17), respectively. A final list of nine cardiovascular outcomes was elicited from the consensus: myocardial infarction, myocardial injury, cardiovascular death, non-fatal cardiac arrest, coronary revascularisation, major adverse cardiac events, pulmonary embolism, deep vein thrombosis, and atrial fibrillation. These nine cardiovascular outcomes were rated by the majority of experts as valid, reliable, feasible, and clearly defined. CONCLUSIONS: These nine consensus cardiovascular outcomes can be confidently used as endpoints in clinical trials designed to evaluate perioperative interventions with the goal of improving perioperative outcomes.

Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: clinical indicators.

BACKGROUND: Clinical indicators are powerful tools to quantify the safety and quality of patient care. Their validity is often unclear and definitions extremely heterogeneous. As part of the International Standardised Endpoints in Perioperative Medicine (StEP) initiative, this study aimed to derive a set of standardised and valid clinical outcome indicators for use in perioperative clinical trials. METHODS: We identified clinical indicators via a systematic review of the anaesthesia and perioperative medicine literature (PubMed/OVID, EMBASE, and Cochrane Library). We performed a three-stage Delphi consensus-gaining process that involved 54 clinician-researchers worldwide. Indicators were first shortlisted and the most suitable definitions for evaluation of quality and safety interventions determined. Indicators were then assessed for validity, reliability, feasibility, and clarity. RESULTS: We identified 167 clinical outcome indicators. Participation in the three Delphi rounds was 100% (n=13), 68% (n=54), and 85% (n= 6), respectively. A final list of eight outcome indicators was generated: surgical site infection at 30 days, stroke within 30 days of surgery, death within 30 days of coronary artery bypass grafting, death within 30 days of surgery, admission to the intensive care unit within 14 days of surgery, readmission to hospital within 30 days of surgery, and length of hospital stay (with or without in-hospital mortality). They were rated by the majority of experts as valid, reliable, easy to use, and clearly defined. CONCLUSIONS: These clinical indicators can be confidently used as endpoints in clinical trials measuring quality, safety, and improvement in perioperative care. REGISTRATION: PROSPERO 2016 CRD42016042102 (http://www.crd.york.ac.uk/PROSPERO/display_record.php? ID=CRD42016042102).

Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: patient-centred outcomes.

BACKGROUND: Patient-centred outcomes are increasingly used in perioperative clinical trials. The Standardised Endpoints in Perioperative Medicine (StEP) initiative aims to define which measures should be used in future research to facilitate comparison between studies and to enable robust evidence synthesis. METHODS: A systematic review was conducted to create a longlist of patient satisfaction, health-related quality of life, functional status, patient well-being, and life-impact measures for consideration. A three-stage Delphi consensus process involving 89 international experts was then conducted in order to refine this list into a set of recommendations. RESULTS: The literature review yielded six patient-satisfaction measures, seven generic health-related quality-of-life measures, eight patient well-being measures, five functional-status measures, and five life-impact measures for consideration. The Delphi response rates were 92%, 87%, and 100% for Rounds 1, 2, and 3, respectively. Three additional measures were added during the Delphi process as a result of contributions from the StEP group members. Firm recommendations have been made about one health-related quality-of-life measure (EuroQol 5 Dimension, five-level version with visual analogue scale), one functional-status measure (WHO Disability Assessment Schedule version 2.0, 12-question version), and one life-impact measure (days alive and out of hospital at 30 days after surgery). Recommendations with caveats have been made about the Bauer patient-satisfaction measure and two life-impact measures (days alive and out of hospital at 1 yr after surgery, and discharge destination). CONCLUSIONS: Several patient-centred outcome measures have been recommended for use in future perioperative studies. We suggest that every clinical study should consider using at least one patient-centred outcome within a suite of endpoints.