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Abstract
Introduction Research indicates that older hospitalised individuals are more susceptible to hospital adverse events (AEs). Frailty is a syndrome marked by increased vulnerability, sudden and severe health changes and the risk of adverse outcomes. The majority of the available research puts a limited emphasis on those who live with frailty and examines the relationship between age alone and the occurrence of AEs. This review investigates the association between frailty and the likelihood of hospital AE occurrences in hospitalised older patients.
Methods and analysis The proposed systematic review will search Ovid MEDLINE, CINAHL, Scopus and Web of Science databases. Studies that published original data in English using any methodology will be included. A manual search of the final included studies reference list will be made to identify studies that meet the inclusion criteria. If feasible, a meta-analysis will be conducted using the R statistical programme, and results will be visually presented using a forest plot. If there is high heterogeneity and a meta-analysis is not feasible, a narrative synthesis and analysis guided by Cochrane criteria will be conducted, and results will be presented in appropriate tables and figures.
Ethics and dissemination No ethical approval will be obtained for this review since it will use secondary published data. The systematic review’s results will be published in a peer-reviewed frailty and geriatrics care-related journal and disseminated in conferences, congresses and scientific meetings.
- Frailty
- Frail Elderly
- Adverse events
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STRENGTHS AND LIMITATIONS OF THIS STUDY
This protocol well-defined the inclusion and exclusion criteria to improve the transparency and reproducibility of the review.
Multiple reviewers will independently screen and extract data to reduce bias and errors.
Variations in how frailty and adverse events are defined and measured may limit the potential of meta-analysis and comparability.
Introduction
There is an increasing number of older people in the world. The United Nations (UN) reported 703 million people aged 65 years or older in 2019 and projected that this number could increase to 1 billion by 2050.1 Increasing numbers of older persons living in the community will increase healthcare demands. The National Audit Office in the United Kingdom (UK) reported that in 2014/2015, patients aged 65 years or older occupied 62% of all hospital beds.2 As people age, the prevalence of age-related syndromes continues to increase, with frailty being one of the most significant. Approximately 1 in 10 individuals aged 65 years and older live with frailty, with a higher proportion of women affected compared with men.3
Frailty is an age-related syndrome that results in the loss of ability in different body systems to maintain homeostatic function and lowered resilience when exposed to stressors, leaving older people living with frailty more vulnerable to further deficits and death.4 Frailty is associated with increased mortality, poor outcomes, physical disability and increased use of hospital.5
Adverse events (AEs) are any injury, or a negative consequence caused by medical care and not related to the underlying patient disease, condition or medical history that resulted in harm to the patient.6 7 AEs might be preventable, caused by commission (by mistake or an error) or omission (failing to do the correct thing), or they might not be avoidable due to the complexity of healthcare.8 9 Harm is a temporary or permanent impairment that could affect the patient’s physical, emotional, psychological or financial status.10–13 Harm could be an impairment of the body function, causing disability, or it could be lethal, causing death.14 The WHO, in its report Patient Safety, listed the most frequent AEs, including medication errors and adverse reactions, healthcare-associated infections, patient falls and pressure ulcers.15
While most of the published studies focus on the association between age and AEs, there remains a notable gap in the literature regarding the relationship between frailty and the incidence of AEs in hospitalised older adults. Identifying frailty in older hospitalised patients is particularly valuable because it often indicates reduced physiological reserves and resilience. Frailty is strongly associated with a heightened risk of AEs during hospital admissions such as falls, delirium, pressure ulcers, infections and unfavourable recovery trajectories primarily due to a diminished capacity to cope with stressors (eg, surgery and acute illness).16 17 This study protocol aims to systematically collect evidence from the published literature on the association between frailty and in-hospital AEs, thereby helping clinicians to optimise treatments and interventions, refine risk stratification, adopt preventive measures and strengthen communication and shared decision-making.
Review objective
To assess if older people living with frailty are at different risk of in-hospital AEs compared with non-frail hospitalised older people.
Methods and analysis
This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) 2015 statement.18 The review protocol is registered with the International Prospective Register of Ongoing Systematic Reviews (PROSPERO: CRD42024560071).19 A comprehensive database search was completed in February 2024, and the final review and data analysis are expected to conclude by February 2025.
Research question development
The Population, Intervention, Comparison and Outcome (PICO) model, outlined in table 1, helped develop a valid research question to achieve the systematic review’s objective. We determined the population of the systematic review to be older patients aged 65 years and older. The intervention involved hospitalisation. Older people living with frailty were compared with non-frail older people. The outcome was hospital-related AEs. In this systematic review, we will try to answer the following question: Are hospitalised older people living with frailty at a higher risk of hospital-related AEs compared with non-frail older people?
PICO component and information
Information sources
Two independent reviewers will conduct an online data search using keywords and alternatives derived from the PICO components through four databases: MEDLINE, Scopus, CINAHL and Web of Science.
Search strategy
The keywords target the concepts of frailty, hospitalisation and AEs; exact search terms and limits are outlined in online supplemental table 1. Researchers will extract the articles from the four databases into Rayyan AI (an artificially intelligent website and mobile application for systematic reviews).20 Rayyan AI will be used to detect duplicates and to facilitate article screening for inclusion and exclusion decision by tagging articles. First, two independent reviewers will screen the titles and abstracts to make inclusion or exclusion decisions. If a conflict arises, the reviewers will try to resolve it through discussion, or they will invite a third reviewer to make the final decision. After that, the two independent reviewers will conduct a full-text screening of the remaining articles to determine the final set for inclusion in the systematic review. Finally, researchers will perform a hand search of the reference lists from the included papers to identify additional relevant articles. They will report the identified articles according to PRISMA guidelines and the flow chart.
Supplemental material
Study selection
Inclusion criteria
When identifying studies for inclusion in this systematic review, we will consider any study design (eg, observational, experimental, cross-sectional, cohort and case–control) that explicitly examines hospital-related AEs among patients aged 65 years and older. To qualify, studies must use at least one validated frailty assessment tool. This inclusive approach ensures that we capture a broad spectrum of evidence regarding how frailty influences the risk of hospital-caused AEs in older adults. Additionally, only studies that present original data and are published in English will be considered.
Exclusion criteria
In this systematic review, we will exclude articles that report on older patients without using at least one frailty score. We will also exclude studies that focus on postdischarge events or in-home incidents rather than hospital-caused AEs. Additionally, reviews, abstracts, editorials, protocols, letters to editors and correspondences will not be included.
Data extraction
Risk of bias
Two independent reviewers will conduct the critical appraisal to assess the quality of each included study using a modified version of the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Analytical Cross-Sectional Studies to assess the risk of bias of all the included studies in the review.21
Data extraction
Two independent reviewers will extract and present the data using an MS Excel sheet. The extracted data will include the following: title, publication date, author, study location, study type, study aim, population, sample size, age (mean or median), gender, frailty assessment tool, frailty definition, types of AEs, AE measurement, incidence of AEs (n, %), association between frailty and AEs, effect measures, effect estimates, statistical significance (p value or other indicators), preventability of AEs (if reported) and the authors’ conclusions.
Data synthesis and analysis
We will examine the assumptions of fixed and random effects models. We will use risk or ORs with associated 95% CIs to compute effect sizes. Forest plots will be created using R statistical programming to visually investigate effect sizes and related uncertainties across the studies. If a significant level of heterogeneity is observed among the included studies in the systematic review and meta-analysis, we will present the results narratively, providing possible explanations through tables and figures following Cochrane guidelines.22
Assessing certainty of evidence
The included studies will be subjected to certainty of evidence assessment using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). Two independent reviewers will assess all the included studies using GRADE. If any disagreement arises, they will resolve it by discussion or inviting a third reviewer.
Amendments
We will record any modifications made to this systematic review protocol and document the following processes for any changes: saved database searches, study selection, the PRISMA flowchart, data extraction and critical appraisal, all of which will be recorded in EndNote, MS Excel spreadsheets and bibliographic databases (such as Ovid).
Patient and public involvement
None.
Ethics and dissemination
No ethical approval will be obtained for this review since it will use secondary published data. The systematic review’s results will be published in a peer-reviewed frailty and geriatrics care-related journal and disseminated at conferences, congresses and scientific meetings.
Discussion
This systematic review will explore the literature on the relationship between living with frailty and its association with hospital AEs in older patients. Frailty is a dynamic syndrome that could change from one state to another.23 Even though it has proven its ability to predict adverse outcomes,24 frailty has no ‘gold standard’ measuring tool in the literature. However, studies used various tools and concepts to identify and measure patients’ frailty.25 Understanding the relationship between frailty and in-hospital AE will help policymakers, caregivers, clinicians, researchers, patients and their families in the daily care and treatment of frail patients since it will inform how frailty is associated with the occurrence of AEs during the patient’s stay in the hospital. Moreover, it supports deciding whether to change the care plan, risk assess any healthcare intervention for frail persons or discuss options with the patient and their family to prevent further harm caused by healthcare.
To our knowledge, this review protocol is the first to address the relationship between living with frailty and in-hospital AE for older hospitalised patients. It has defined the research question based on PICO components (identifying the population of interest, intervention, comparison and outcome), outlined the inclusion/exclusion criteria, data source and search strategy, risk of bias assessment, data extraction and synthesis approach.26 By making this protocol public, the systematic review approach will be more transparent, there will be less waste in research, the risk of bias will be lower and the risk of reporting selected outcomes will be reduced.22 Possible limitations of this review are the heterogeneity in the included studies, including different frailty measuring tools used between studies, diverse definitions and types of AEs, and many factors and comorbidities that might contribute to the incidence of AE which make it hard to pole, analyse, and compare the data across the included studies.
Ethics statements
Patient consent for publication
References
Footnotes
X @ABE-1833-2021, @POBanerjee
Contributors FA is the guarantor. FA drafted, reviewed and edited the manuscript. AA, JB and BM were significantly involved in this manuscript. They contributed to developing the design and revising this study protocol. All authors read and approved the final manuscript.
Funding This systematic review protocol is part of Mr Faris Alotaibi’s PhD, which Imam Abdulrahman bin Faisal University funds through the Saudi Arabian Cultural Bureau in London
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.