Use of the patient-centered outcome Days Alive and Out of Hospital in clinical studies on perioperative care: a scoping review protocol

Nicolas Meza; Javier Bracchiglione; Eva Madrid; Camila Micaela Escobar Liquitay; Ekaterine Popova; Rolando Salazar; Gerard Urrútia

doi:10.12688/f1000research.155916.1

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Study Protocol

Use of the patient-centered outcome Days Alive and Out of Hospital in clinical studies on perioperative care: a scoping review protocol

[version 1; peer review: 1 approved with reservations]

Nicolas Meza ^1-3, Javier Bracchiglione^1,3-5, Eva Madrid^3,5, [...] Camila Micaela Escobar Liquitay⁶, Ekaterine Popova^2,5, Rolando Salazar^1,7,8, Gerard Urrútia^2-5

Nicolas Meza ^1-3, Javier Bracchiglione^1,3-5, [...] Eva Madrid^3,5, Camila Micaela Escobar Liquitay⁶, Ekaterine Popova^2,5, Rolando Salazar^1,7,8, Gerard Urrútia^2-5

PUBLISHED 10 Oct 2024

Author details Author details

¹ Departament of Pediatrics, Obstetrics and Gynecology, Preventive Medicine and Public Health, Universitat Autònoma de Barcelona, Barcelona, Spain
² Iberoamerican Cochrane Centre, Barcelona, Spain
³ Interdisciplinary Centre for Health Studies (CIESAL), Universidad de Valparaíso, Viña del Mar, Valparaiso, Chile
⁴ Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública, Madrid, Spain
⁵ Institut de Recerca Sant Pau (IR Sant Pau), Barcelona, Spain
⁶ Associate Cochrane Centre, Instituto Universitario del Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
⁷ Hospital General de Granollers, Barcelona, Spain
⁸ Hospital Universitario Bellvitge, Barcelona, Spain

Nicolas Meza
Roles: Conceptualization, Investigation, Methodology, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing

Javier Bracchiglione
Roles: Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing

Eva Madrid
Roles: Methodology, Writing – Original Draft Preparation, Writing – Review & Editing

Camila Micaela Escobar Liquitay
Roles: Methodology, Resources, Writing – Original Draft Preparation, Writing – Review & Editing

Ekaterine Popova
Roles: Conceptualization, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing

Rolando Salazar
Roles: Data Curation, Writing – Review & Editing

Gerard Urrútia
Roles: Conceptualization, Investigation, Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Background

Various studies across different settings have validated Days Alive and Out of Hospital (DAOH) as a valuable outcome for clinical research in surgery and other fields. However, there is no clear consensus on the definitions and methods used to handle and report DAOH in perioperative care studies.

Objective

We aim to identify, describe, and summarize the available research on DAOH to understand how it is being conceptualized and utilized in clinical studies on perioperative care.

Methods

We will conduct a scoping review to analyze and synthesize the existing studies using DAOH to measure clinical results on perioperative care. We will search MEDLINE, Embase, Web of Science, ClinicalTrials.gov and CENTRAL. Screening, eligibility, inclusion and data extraction processes will be performed by two reviewers, with a third reviewer solving disagreements. We will present our results descriptively.

Conclusions

We expect to provide a comprehensive overview of how DAOH is conceptualized and utilized in clinical studies on perioperative care, with particular attention to methodological approaches and the role of electronic health-care records (EHRs) among the different regions.

Keywords

Surgery, perioperative care, postoperative complications, days alive and out of hospital, patient-centered outcomes

Corresponding author: Nicolas Meza

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2024 Meza N et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Meza N, Bracchiglione J, Madrid E et al. Use of the patient-centered outcome Days Alive and Out of Hospital in clinical studies on perioperative care: a scoping review protocol [version 1; peer review: 1 approved with reservations]. F1000Research 2024, 13:1194 (https://doi.org/10.12688/f1000research.155916.1) First published: 10 Oct 2024, 13:1194 (https://doi.org/10.12688/f1000research.155916.1) Latest published: 10 Oct 2024, 13:1194 (https://doi.org/10.12688/f1000research.155916.1)

Background

Globally, over 310 million people undergo surgical procedures each year,¹ of which almost three-quarters are performed in the richest countries with a healthcare expenditure above US $400 per capita.² According to the World Bank and the World Health Organization, surgical care is a pivotal health technology for global development, improving population health and quality of life.³ Nevertheless, despite advances in anesthetic and surgical techniques, at least 4.2 million people worldwide die within 30 days after surgery annually.⁴ Moreover, approximately one-third of the patients who undergo surgery experience postoperative complications,^5,6 which increases length of stay, readmissions, mortality and the need for additional procedures.⁷ In 2008, the WHO highlighted complications of surgical procedures as a major public health concern.⁸ Thus, perioperative mortality accounts for almost 8% of global deaths, making it the third leading cause of death worldwide, after ischemic heart disease and stroke.⁴

Over 320 million surgeries were needed to address the estimated global burden of disease 2010, for a total of 6.9 billion people worldwide.⁹ As the volume of surgical procedures is growing over time,¹ it is expected that the subsequent high rates of postoperative complications may lead to further resource constraints and costs for healthcare systems.^10,11 It has been estimated that the mean cost of a one-day hospital length stay related to surgery reaches US$1200.¹² On the other hand, each year, there are around 4.8 billion people without access to surgical care worldwide, and this lack of coverage is inequitably distributed among different regions.¹³ In Latin America and the Caribbean (LAC), about 28% of the population cannot access surgical care.¹³ It is estimated that the LAC region will need above 20,000 procedures per 100,000 annually to cope with the burden of disease (for a regional population of over 590 million inhabitants in 2010).⁹

As in other low- and middle-income countries, resource-constrained LAC health systems must address the double burden of surgical diseases and postoperative complications⁸ with a cautious allocation of public health resources and policymaking. This is in a scenario where some of these countries have expanded their economies and healthcare investments, yet with an unclear impact on their surgical outcomes.^4,14

Considering that nearly half of postoperative complications are preventable, enhancing the quality of perioperative care constitutes an opportunity to reduce the risks associated with surgery.¹⁵ For instance, strategies to identify patients at risk of poor post-surgery outcomes or to improve early detection of postoperative complications may prevent both harm and additional costs.^15–18

Healthcare systems should establish registries and medical records to facilitate audits and research, and thereby promoting quality assurance of perioperative care and supporting evidence-based decision-making.³ However, the lack of adequate data collection on perioperative processes and the underreporting of complications associated with surgical procedures pose important barriers, even in high-income countries.¹⁹

Several indicators have been proposed for global surveillance of surgical and anesthesia care to accelerate the development of comprehensive and useful registries, however, a lack of consensus persists.^20,21 In parallel, initiatives such as Core Outcome Measures in Effectiveness Trials (COMET) have been promoting the use of measurements involving patients’ perspectives.²² Patient-centered outcomes provide a broad perspective of the impact of both clinical interventions and public health strategies by focusing on measures as satisfaction, quality of life, functional status, and overall life-impact.²³ These outcomes not only encompass but also surpass the information provided by traditional metrics such as short-term mortality, length of hospital stay, reoperation rates, blood loss, etc.²⁴ Furthermore, the standardization of core outcome sets enables the comparison or aggregation of relevant data from different sources, reducing low-value care and facilitating more informed decision-making.²⁵

In a joint collaboration with COMET, the Standardized Endpoints in Perioperative Medicine (StEP) initiative proposed Days Alive and Out of Hospital (DAOH) as the preferred life-impact outcome for surgical and anesthesia clinical studies.²⁴ DAOH congregates survival after discharge (with no occurrence of readmissions into any health facility) and time spent at home into a unique value.²⁶ Its patient-centered nature emphasizes the personal well-being and quality of life associated with being at home for hospitalized patients.²⁷ DAOH (also called “days at home” or “time spent at home”, among others) is often reported as a continuous variable that counts the days a patient survives at home after hospitalization, which may be assessed at different time points (e.g., 30 or 90 days).²⁸ Hence, DAOH also accounts for hospital readmissions and stays at other health facilities (such as rehabilitation units or chronic nursing institutions) while capturing the length of hospital stay and mortality. Additionally, this outcome measure assigns a DAOH value of zero if death occurs during the follow-up period, regardless of time spent at home.

Various studies across different settings have validated DAOH as a valuable outcome for clinical research in surgery and other fields.^26,29–32 DAOH has shown associations with preoperative risk factors and postoperative complications,^29,33 whereas some findings have suggested an association of DAOH with socioeconomic status³⁴ and healthcare costs.^28,35 Furthermore, DAOH can be efficiently retrieved from large administrative health registries and clinical records,^36,37 without the need for adjudication,³⁸ making it a compelling and statistically robust measure. However, there is no clear consensus on the definitions and methods used to handle and report DAOH in perioperative care studies.

Our aim is to identify, describe, and summarize the available research on DAOH to understand how it is being conceptualized and utilized in clinical studies on perioperative care.

Methods

We present a protocol of a scoping review, which adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P)³⁹ and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR)⁴⁰ statements. The protocol is also available in the Open Science Framework platform (https://osf.io/fys9u/).

Eligibility criteria

Population

We will search and retrieve studies analyzing adult patients (≥18 years) who have undergone surgical treatment or have received perioperative care.

Concept

We will include studies analyzing DAOH, defined as a composite outcome that measures the time a patient spends at home or engaged in daily activities outside of any inpatient care or healthcare institution (such as hospitals, long-term care facilities, emergency departments, home hospitalizations, and rehabilitation centers) after surgery. Additionally, we will also consider any alternative measures (such as, additive inverses or multiplicative inverses, percentages or proportions) that can be directly converted into DAOH.

Context

We will not impose restrictions related to cultural/subcultural factors, language, geographic location, racial or gender-based interests, or settings.

Types of sources

Our scoping review will consider both observational studies (cross-sectional studies, case-control studies, retrospective or prospective cohort studies), quasi-experimental designs (interrupted-time series, before-after studies, etc), and experimental studies (controlled clinical trials, either randomized or nonrandomized) exploring any clinical question on perioperative care, regardless of the date of publication or publication status. Additionally, registered protocols with results will be considered for inclusion.

We will exclude systematic reviews (and other evidence synthesis designs), narrative reviews, case reports, case series, editorials, opinion and debate articles, correspondences, conference proceedings, and qualitative studies.

Search strategy

We will search electronic databases from its inception. Restrictions on language, date, or publication status will not be considered. The databases utilized will be:

• Ovid MEDLINE(R) ALL/PubMed(R)
• Embase
• Web of Science (WoS; Clarivate)
• ClinicalTrials.gov
• Cochrane Central Register of Controlled Trials (CENTRAL)

The details of the search strategy for MEDLINE, Embase and WoS are available in Table 1. These search strategies will be adapted to the syntax of ClinicalTrials.gov and CENTRAL.

Table 1. Search strategies in MEDLINE, Embase, and Web of Science databases.

Line	Databases
Line	MEDLINE^¥	Embase^†	Web of Science^‡
1	exp Surgical Procedures, Operative/	exp surgery/	surgery (Topic)
2	(surger* or surgi* or operati* or operated or (per?operat* or peri?operat* or ((per or peri) adj (operatory or operative))) or (preoperat* or pre?operat* or pre operat) or (intraoperat or intra?operat* or intra operat) or (pos?operat or post?operat* or ((pos or post) adj (operatory or operative)))).tw.	(surger* or surgi* or operati* or operated or (per?operat* or peri?operat* or ((per or peri) adj (operatory or operative))) or (preoperat* or pre?operat* or pre operat) or (intraoperat or intra?operat* or intra operat) or (pos?operat or post?operat* or ((pos or post) adj (operatory or operative)))).tw.	WC=(Surgery)
3	(“Days at home” or “Time at home” or “Institution days” or “Time in institution” or “Home time” or “Institution time” or “Days out of Institution” or “Days alive and out of the hospital” or “Days alive spent living at home” or “Days alive and out of hospital” or “Days alive out of the hospital” or “Days alive and at home” or “Days alive out of hospital” or “Days alive at home” or “Days alive outside hospital” or “Days at home alive“ or ”Institution-free days” or “Days alive and outside of hospital” or “Time spent alive and out of the hospital” or “Time spent alive and out of hospital” or “Time spent alive and at home” or “Time spent away from the home” or “Time spent away from home” or “Days Spent at Home” or “Days spent in hospital” or “Time spent at home” or “Time spent in hospital“ or ”Hospital-Free Days” or “DAH” or “DAOH”).tw.	(“Days at home” or “Time at home” or “Institution days” or “Time in institution” or “Home time” or “Institution time” or “Days out of Institution” or “Days alive and out of the hospital” or “Days alive spent living at home” or “Days alive and out of hospital” or “Days alive out of the hospital” or “Days alive and at home” or “Days alive out of hospital” or “Days alive at home” or “Days alive outside hospital” or “Days at home alive“ or ”Institution-free days” or “Days alive and outside of hospital” or “Time spent alive and out of the hospital” or “Time spent alive and out of hospital” or “Time spent alive and at home” or “Time spent away from the home” or “Time spent away from home” or “Days Spent at Home” or “Days spent in hospital” or “Time spent at home” or “Time spent in hospital“ or ”Hospital-Free Days” or “DAH” or “DAOH”).tw.	#2 OR #1
4	1 or 2	1 or 2	ALL=((surger* or surgi* or operati* or operated or (per?operat* or peri?operat* or ((per or peri) adj (operatory or operative))) or (preoperat* or pre?operat* or pre operat) or (intraoperat or intra?operat* or intra operat) or (pos?operat or post?operat* or ((pos or post) adj (operatory or operative)))))
5	3 and 4	3 and 4	ALL=((“Days at home” or “Time at home” or “Institution days” or “Time in institution” or “Home time” or “Institution time” or “Days out of Institution” or “Days alive and out of the hospital” or “Days alive spent living at home” or “Days alive and out of hospital” or “Days alive out of the hospital” or “Days alive and at home” or “Days alive out of hospital” or “Days alive at home” or “Days alive outside hospital” or “Days at home alive“ or ”Institution-free days” or “Days alive and outside of hospital” or “Time spent alive and out of the hospital” or “Time spent alive and out of hospital” or “Time spent alive and at home” or “Time spent away from the home” or “Time spent away from home” or “Days Spent at Home” or “Days spent in hospital” or “Time spent at home” or “Time spent in hospital“ or ”Hospital-Free Days” or “DAH” or “DAOH”))
6	-	5 not medline.cr.	#3 OR #4
7	-	-	5 AND #6

¥ Ovid MEDLINE(R) ALL/PubMed(R) <1946 to Present>.

† Embase <1974 to Present>.

‡ ISI Web Of Science (Clarivate).

Study selection

Two independent authors will screen the studies based on titles and abstract, with a third author solving discrepancies. We will obtain the full text of each potentially eligible study. Following this, two reviewers will independently assess the full-text articles, with a third reviewer addressing any disagreements to determine the final inclusion. The selection process will be managed using Covidence and summarized using a PRISMA 2020 flow diagram.

Whenever a study has two or more references with the same results, we will studify them, so our unit of analysis will be the studies and not publications.

Data extraction and synthesis

Data extraction will be performed by two independent authors, and a third reviewer will solve discrepancies. We will collect:

• First author
• Year of publication
• Identifier (such as DOI or PMID)
• Location of the study

Study design

• Protocol registration number
• Data source (clinical records, prospectively collected clinical data, or administrative electronic health-care records (EHRs))
• Population characteristics (including primary diagnoses or conditions, age, and gender)
• Intervention/exposure characteristics (including type of surgery or procedure, duration, and concomitant surgery or procedure).
• Data on DAOH:
- ○ Outcome denomination (e.g. DAOH, days at home, etc).
- ○ Outcome definition
- ○ Outcome prioritization (i.e. primary or secondary outcome)
- ○ Unit of measurement and descriptive statistics used
- ○ Statistical considerations (type of variable, type of distribution, inferential statistical analyses used, adjustments performed, etc)
- ○ Follow-up period (and whether censoring or truncation were applied)
- ○ Handling of missing data

We will enter the retrieved information into a data extraction form (based on Covidence), after a pilot test is conducted (on five randomly sampled studies) by two authors, with a third reviewer solving discrepancies.

Data analysis and presentation

We will present the results descriptively. We expect to synthesize our findings narratively, accompanied with figures and tables (with descriptive statistics).

Conclusions

We expect to provide a comprehensive overview of how DAOH is conceptualized and utilized in clinical studies on perioperative care, with particular attention to geographical variation and the role of electronic health-care records among the different regions, emphasizing findings from Latin America. Additionally, we will explore how DAOH is being integrated into studies using EHRs, given their increasing role in efficiently capturing clinical outcomes. These insights will contribute to a better understanding of the relevance of DAOH, reveal gaps and inconsistencies in its definitions, methodologies, and applications; and guide future research towards standardizing its use in clinical studies, enhancing perioperative care worldwide.

Ethics and dissemination

No ethical approval and written consent were required; this study will not involve human participants. We expect to submit a manuscript in a peer-reviewed journal.

Data availability

Extended data

OSF: Use of Days Alive and Out of Hospital (DAOH) in clinical studies on perioperative care. https://doi.org/10.17605/OSF.IO/FYS9U.⁴¹

This project contains the following underlying data:

• PRISMA-P checklist

Reporting guidelines

OSF: PRISMA-P Use of the patient-centred outcome days alive and out of hospital in clinical studies on perioperative care: a scoping review protocol. https://doi.org/10.17605/OSF.IO/FYS9U.⁴¹

Data are available under the terms of the Creative Commons Zero “No rights reserved” data waiver (CC0 1.0 Public domain dedication).

Acknowledgements

Nicolás Meza is a PhD candidate at the Doctorate Program on Biomedical Research and Public Health, Universitat Autònoma de Barcelona, Barcelona, Spain.

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