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Abstract
Background Patients and their caregivers incur significant financial burden from health care costs, but the financial burden often does not consider additional impacts from non-monetary burdens.
Objectives Examine the extent to which non-monetary burdens have been investigated and identify the methods and instruments used to collect non-monetary burdens through a systematic scoping review.
Methods Scoping review guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis and Joanna Briggs Institute guidance for scoping reviews.
Data sources PubMed, CINAHL, EconLit and Web of Science were searched from 1 January 2013 to 7 November 2023. The search identified 950 articles.
Data extraction and synthesis A dual independent review of titles, abstracts and full texts was conducted for inclusion, and data were extracted using DistillerSR software; 166 articles met the inclusion criteria.
Results The included studies suggest three overarching categories of non-monetary burdens: material, psychological or psychosocial and coping behaviour. Within each of these categories, the literature has identified subcategories of burdens that vary in the extent to which they have been studied. This review also identifies 29 instruments used to collect non-monetary burdens from patients and caregivers across the included studies, of which 19 were validated. Many of these instruments were used in a single study.
Conclusions The findings help illustrate the gaps in the literature on non-monetary burdens for patients and caregivers and provide a starting point for further investigation of this topic as well as implications for policy. Future research may reference the instruments highlighted in this study to help develop new instruments for capturing non-monetary burdens to better reflect the patient and caregiver experiences with financial toxicity due to medical expenses. Collecting more comprehensive data will provide a better understanding of the range and the extent of the non-monetary burdens faced by patients and caregivers. It will also increase the evidence to support new or existing targeted programmes and policies to help patients and caregivers better cope with these non-monetary burdens.
- Caregivers
- Patients
- Health Care Costs
Data availability statement
Data sharing not applicable as no datasets generated and/or analysed for this study.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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STRENGTHS AND LIMITATIONS OF THIS STUDY
Broad search strategy not limited to a specific medical condition that differentiates between patient and caregiver studies.
Wide inclusion criteria to capture the maximal number of relevant studies.
Studies were not indexed in a consistent way; thus, this review may have missed some relevant studies.
Did not include a formal assessment of quality for the studies identified in the review.
Introduction
Many patients and their caregivers in the USA incur significant financial burden from healthcare costs, with the national total out-of-pocket spending reaching US$471.4 billion in 2022.1 Furthermore, many patients and caregivers who pay these costs experience additional impacts, aside from the direct financial burden, that are not captured within this dollar amount. The full spectrum of clinical and patient-centred outcomes, including both the potential burdens and economic impacts of the utilisation of medical treatments, items and services, is defined as patient-centred burdens and economic outcomes (PCBEOs).2
Defining PCBEOs
To our knowledge, the PCBEO framework developed by the Patient-Centered Outcomes Research Institute (PCORI) is the first framework that includes direct, indirect and intangible burdens (online supplemental figure 1) that can be assessed with monetary and non-monetary measurements.2 Direct costs are easily monetised and are further classified as direct medical or direct non-medical, which is determined by whether or not the PCBEO is a component of healthcare delivery. Direct medical PCBEOs are actual expenses, such as copayment for an appointment, incurred by patients for medical care or treatment. Direct non-medical PCBEOs are actual expenses incurred by patients that are related to a health condition or medical care but are not directly part of that medical care, such as a fee to park at the clinician’s office during the appointment.
Supplemental material
Supplemental material
Indirect PCBEOs are monetary or non-monetary burdens incurred by patients due to a medical condition or need. For example, paying for childcare during a medical appointment is an indirect PCBEO that can be easily monetised. Some indirect PCBEOs can be converted to monetary terms, such as valuing the time off from work to receive medical care in terms of lost earnings. Other indirect PCBEOs are non-monetary with respect to measurement and analysis, such as lost time with family due to a long medical treatment schedule.
Finally, intangible PCBEOs are non-monetary burdens of pain, suffering and anxiety experienced by patients due to a medical condition, such as the anxiety over the ability to afford the monetary costs of medical care.
Intangible and indirect burdens
Researchers have previously characterised intangible and indirect (monetary and non-monetary) burdens for people with cancer specifically caused by medical financial hardship across three domains: material burdens, psychological burdens and coping behaviours.3 4 Material burdens include changes in material conditions owing to healthcare costs such as medical debt or income loss resulting from healthcare costs and changes in ability to work.5 Psychological burdens include negative impacts on mental and emotional well-being, caused by burdens such as anxiety around finances.6 Coping behaviours describe changes in behaviour due to healthcare costs, such as delaying treatment or taking less medication to cut costs.7 8
Researchers have noted inconsistencies in documenting and addressing intangible and indirect (monetary and non-monetary) burdens from medical financial hardship in the literature that may be due to loosely defined terms.9–12 For example, some studies use a broader definition of medical financial hardship where the material burdens domain includes out-of-pocket costs, which are quantified with a dollar amount.13–16 Other studies have narrower definitions of financial hardship that only include subjective or psychological responses to costs related to healthcare.17–19
Although these three domains (material burdens, psychological burdens and coping behaviours) originally described hardships for people with cancer, other patients and caregivers interacting with the US healthcare system experience these burdens. For example, a 2019 study of medical financial hardship in the USA found that 56% of US adults experienced material, psychological and behavioural hardships from healthcare costs.20 The intangible and indirect burdens attributable to healthcare costs contribute to additional hardships beyond the anxiety or pain caused by illness and treatment side effects. Understanding the complex burdens of rising healthcare costs in the USA is imperative for health policy makers and for healthcare providers and systems to better support the well-being of patients and their support systems.
Study purpose
In alignment with the definition of PCORI PCBEOs, this study defines non-monetary burdens as the non-monetary indirect and intangible burdens and economic outcomes for patients and caregivers due to costs related to healthcare and health conditions that cannot be monetised or are difficult to monetise. In our definition, we include experiences such as medical debt and bankruptcy, and we exclude costs that are only reported as a monetary value. We choose to examine this broader concept of non-monetary burdens within the framework of PCBEOs because of inconsistencies in terminology around intangible and indirect (monetary and non-monetary) burdens in the literature. Furthermore, limited differentiation between patient and caregiver non-monetary burdens in the literature points to the need for comprehensive definitions of non-monetary burdens as a result of financial costs of healthcare, as defined by patients and their caregivers across the USA, for all medical conditions.
This scoping review seeks to answer two research questions (RQs):
To what extent have non-monetary burdens been empirically investigated?
What methods and instruments have been used to collect non-monetary burdens?
Methods
The protocol for this scoping review was registered at AsPredicted on 21 December 2023. Rigorous and systematic methods were used in this review, as published in previous reports.21 22
Search and data sources
We searched PubMed, CINAHL, EconLit and Web of Science for original peer-reviewed research in the USA that was published in English from 1 January 2013 to 7 November 2023. Search terms related to financial toxicity, healthcare, patients, caregivers and the outcomes of interest (eg, non-monetary indirect and intangible burdens such as distress, mental health, coping and quality of life). The detailed search strategy is presented in online supplemental appendix A. Where relevant, the team searched reference lists of systematic and narrative reviews.
Supplemental material
Study selection
We used DistillerSR software to conduct the various stages of the review. Our screening and abstraction processes were guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) and Joanna Briggs Institute guidance for scoping reviews.23 24 For the title/abstract and full-text review stages, a dual independent review of each article was conducted. A third reviewer was consulted to resolve disagreements at each stage. Online supplemental appendix B details the study selection criteria.
Supplemental material
In brief, for all RQs, the population included patients and/or families and caregivers of patients in the USA. We focused on literature from the USA to increase the applicability of findings because the US healthcare system is unique in its payment structure, which likely influences the non-monetary burdens of out-of-pocket costs incurred by patients and caregivers for their medical care. Therefore, the non-monetary burdens experienced are unique within the USA. The intervention was a medical condition causing financial hardship. Non-medical conditions causing financial hardship (eg, COVID-19 pandemic, environmental disaster or job loss not due to a medical condition) were excluded. Eligible outcomes included non-monetary burdens that stemmed from healthcare costs. For example, anxiety, stress, depression, medical debt or inability to pay for leisure activities due to financial situations from having to pay healthcare costs were included. Direct costs for and monetary indirect burdens as a result of healthcare treatment were excluded. Because of inconsistencies in the definition of intangible burdens from medical financial hardship in the literature, we did not have a predefined list of non-monetary burdens but instead captured and categorised all non-monetary burdens that met our definition outlined in the Introduction, which we identified in the literature.
Data abstraction and synthesis
For each article included, one reviewer abstracted relevant study characteristics and outcomes, and a second reviewer checked the abstraction for completeness and accuracy. After abstraction, findings were synthesised by summarising the characteristics of the included studies in both narrative and tabular formats. An inductive thematic analysis was then conducted by RQ. Because this was designed as a scoping review, risk of bias assessments were not conducted on included studies, findings were not quantitatively synthesised and strength of evidence assessments were not conducted.22
Patient and public involvement
Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.
Results
Overview of results
The search resulted in 950 titles and abstracts and 317 full-text articles; after they were screened, a total of 166 studies were included (figure 1).
Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) diagram. Note: PRISMA flow diagram for the selection of studies from the database and hand searches.
Of the 166 total studies, non-monetary burdens were the primary focus of 144 studies and the secondary focus of 22 studies. Most of the studies were quantitative only (n=142) and focused on patients (n=139), not caregivers. The most common condition covered by studies was cancer (n=121). Other medical conditions, such as diabetes (n=3), inflammatory or irritable bowel disease (n=3) and multiple sclerosis (n=2), were covered much less frequently in the literature. Approximately 40% of the studies used a national sample (n=67), 40% focused on a single institute, city or state (n=66) and 20% (n=33) examined populations in multiple cities and/or states. We examine how the term ‘financial burden/toxicity’ was defined and then discuss results by RQs. Detailed information on each included study is in online supplemental appendix C.
Supplemental material
How ‘financial burden/toxicity’ was defined across included studies
We tracked the terms used to describe intangible and indirect (monetary and non-monetary) burdens in the 166 included studies (table 1). Studies used ‘financial toxicity’ the most (n=77), followed by ‘financial burden’ (n=68), ‘financial hardship’ (n=41) and ‘financial distress’ (n=39). While the definitions of each term varied across studies, trends emerged for the most common definitions of the term and the domain or domains of intangible and indirect burdens that the term most often described (figure 2). For example, studies using financial toxicity often defined it as consisting of material burdens (eg, out-of-pocket costs and medical debt) and psychological burdens (eg, stress and anxiety around finances) and, in some cases, behavioural changes (eg, forgoing healthcare due to cost). In addition, definitions of financial toxicity frequently included costs specifically associated with cancer care.
Financial burden/toxicity terms used in the included studies
Common definitions of intangible and indirect burden terms. Note: not defined with any categories: financial strain, financial problem. Behavioural changes are not included as they are not as commonly a part of the definitions of these terms.
Studies using financial burden often defined it as material burdens without including subjective costs. Similarly, many studies used financial hardship to describe material financial hardship. However, other studies defined financial hardship as consisting of material, psychological and behavioural financial hardship, which aligns with the common definition of financial toxicity.
Unlike financial burden and financial hardship, studies typically used financial distress to describe psychological or subjective difficulties related to healthcare costs. Many studies also used two or more terms to describe intangible and indirect burdens. In some cases, the terms were used interchangeably to describe the same group of costs, whereas other studies used different terms to differentiate between distinct types of costs such as material versus psychological.
The terminology changed over the 2013–2023 study period. Although financial toxicity was used most frequently, it started becoming the most common term in 2021. Prior to the increase in use, studies most often used financial burden, which remained the second most frequently used term from 2021 to 2023. Additionally, the use of financial hardship fluctuated over time; it was first used in 2015 in five studies and was the most used intangible and indirect burden term in 2019.
Studies dating back to 2013 used financial distress, with its use increasing from 2018 to 2021. In 2023, financial distress surpassed financial hardship as the third most used term after financial toxicity and financial burden. The changing popularity of terms and the range of definitions employed for each term represent a lack of uniform language to describe a range of under-identifiable problems that are included under intangible and indirect burdens. As the terms used and the definitions of the terms changed across studies and over time, it is difficult to tell how different components of intangible and indirect burdens are described with the different language. Because our first RQ is to examine the extent to which non-monetary burdens have been empirically investigated, we chose to use the broader definition of non-monetary burdens which allows us to be comprehensive in the inclusion of studies that use many of these terms and definitions described above so that no potentially useful data would be missed.
To what extent have non-monetary burdens been empirically investigated?
Overview of the categories of results
Table 2 presents categories of non-monetary burdens stratified by a study’s population: (1) patient; (2) caregiver; or (3) patient/caregiver combination. The review categorised non-monetary burdens as material burdens, defined as material conditions resulting from increased out-of-pocket healthcare expenses and lower income; psychological or psychosocial burdens, defined as cognitive responses to financial toxicity caused by a medical condition; or coping behaviour burdens, defined as actions taken by a patient or caregiver to alleviate the financial burden caused by a medical condition. Studies often examined more than one type of burden. Across all reviewed studies, the most frequent measurement of non-monetary burdens was psychological burdens, which were included in nearly 75% of studies (n=124). The next most common measures were material burdens (n=122, 73%), coping measures implemented in response to financial burdens of medical treatment (n=116, 70%) and composite or summary measures (n=66, 40%). Composite or summary measures used one or more questions to provide an overall summary of non-monetary burdens.
Categories of non-monetary burdens
Among studies that examined financial toxicity for patients, the distribution of studies across nonmonetary burden categories was fairly even: 115 studies (76%) assessed psychological costs, followed by material costs (n=111, 74%) and coping measures (n=109, 72%).
Among studies that examined financial toxicity experienced by caregivers, the most common type of non-monetary burdens measured were material burdens (n=20, 74%) followed by psychological burdens (n=18, 67%) and coping measures (n=13, 48%). The least common type of non-monetary burdens indicated for caregiver studies was composite or summary measures of financial toxicity (n=8, 30%). 14 studies used metrics that looked specifically at financial toxicity among caregivers of patients. These measures included qualitative interviews during which caregivers were prompted to describe their experiences with financial toxicity,25 26 as well as specific metrics of financial toxicity for caregivers including medical debt or worry about bills.27
Material non-monetary burdens
Material non-monetary burdens are material conditions resulting from increased out-of-pocket healthcare expenses and lower income.20 We identified 122 articles that described 10 subcategories of material non-monetary burdens (table 3). Note that studies may address more than one type of material non-monetary burden. Changes in employment status (n=62), depletion of assets (n=51) and medical debt (n=49) were the most frequent material nonmonetary burdens among the identified articles.
Material non-monetary burdens
Psychological or psychosocial nonmonetary burdens
Psychological or psychosocial non-monetary burdens are cognitive responses to financial toxicity caused by a medical condition.20 We identified 125 articles that described six subcategories of psychological or psychosocial non-monetary burdens (table 4). Studies may address more than one type of psychological or psychosocial non-monetary burden. Anxiety, stress or depression related to the financial burden/toxicity caused by a medical condition (n=96) was the most frequent psychological or psychosocial nonmonetary burden among the articles we identified. Quality of life, excluding quality-adjusted life years or disability-adjusted life years (n=41), and productivity loss related to fear and distress (n=38) were also commonly described categories of psychological or psychosocial nonmonetary burdens.
Psychological and psychosocial non-monetary burdens
To capture how financial toxicity creates multiple stressors for patients and caregivers, we separated the intangible burdens of anxiety, stress or depression related to finances and the intangible burdens of concerns or anxiety about ability to pay for future medical treatment or medications. The first category describes the psychological effects of a difficult financial situation caused by a medical condition. The second category highlights the psychological effects of uncertainty surrounding whether a patient or caregiver can afford treatment or medications in the future.
Coping behaviour non-monetary burdens
Coping behaviours are actions taken by a patient or caregiver to alleviate the financial burden caused by a medical condition.20 We identified 116 articles that described six categories of coping behaviours (table 5). Studies may address more than one type of coping behaviour for non-monetary burdens. Changing or delaying treatment or not receiving treatment due to medical expenses (n=65) was the most frequent coping behaviour. Borrowing money (n=58), low medication adherence (excluding pill splitting) (n=56) and reduced spending on basic goods, groceries or leisure activities (n=55) were also commonly described coping behaviours. Note that pill splitting was excluded from the low medication adherence subcategory because it is a relatively tangible and quantifiable coping behaviour compared with taking less medication due to fear surrounding the cost of medication, which is intangible. However, we acknowledge that pill splitting is a form of low medication adherence.
Coping behaviour non-monetary burdens
What methods and instruments are used to collect nonmonetary burdens?
Table 6 describes the type of data collected (qualitative, quantitative) on financial toxicity across patients and caregivers. Most studies (n=142, 85%) used quantitative measures to assess financial toxicity. Fewer studies (n=13, 8%) used qualitative instruments, and 11 studies (7%) used both qualitative and quantitative measures. Mixed method studies were more common among studies with patient and caregiver populations than were studies that assessed only caregiver or patient financial toxicity.
Qualitative and quantitative instruments used for collecting data on patients and caregivers
29 instruments were used to collect data on financial distress/financial toxicity across the 166 included studies (online supplemental appendix D). The Comprehensive Score for Financial Toxicity (COST) tool was the most widely implemented instrument to measure financial toxicity and was used in 53 studies. Following the COST tool, the second most frequently used tool was researcher designed (ie, self-designed) questionnaires (n=46, 28%). Other commonly used measurement tools included qualitative interviews (n=17, 10%), the Medical Expenditures Panel Survey (MEPS) instrument (n=8, 5%), the Financial Burden Composite Score (n=5, 3%) and the Dichotomized Worry Score (n=5, 3%). Of the 29 instruments, 18 instruments were used by only one study. Two-thirds of the instruments (n=19, 66%) were validated; 10 were unvalidated.
Supplemental material
Furthermore, six datasets were used by researchers to examine measures of financial toxicity (online supplemental appendix E). The most used datasets were the National Health Interview Survey (n=21, 13%) and MEPS (n=12, 7%). These two surveys are implemented by US government agencies and collect data on a broad range of health topics, including financial toxicity related to healthcare costs. Another dataset, the SAMFund grant, was used by two separate studies to measure patient experiences with financial toxicity. The Livestrong survey used the same questions used by the 2011 MEPS Experiences with Cancer Supplement.
Supplemental material
Discussion
This scoping review sought to examine the extent to which non-monetary burdens have been empirically investigated with patients and caregivers as well as to document the instruments and methods used to study these burdens. Using rigorous scoping review methods, we identified 166 articles that met the inclusion criteria and captured studies that used a variety of designs (quantitative, qualitative and mixed methods) to capture non-monetary burdens for patients and caregivers experiencing various medical conditions. The results of the scoping review suggest three overarching categories of non-monetary burdens: material, psychological or psychosocial and coping behaviour. Because the literature may focus on some non-monetary burdens and their subcategories of costs more than on others, information may be more available on some subcategories. This review also identifies the methods and instruments used to collect non-monetary burdens. The included studies used a variety of instruments (validated and unvalidated) to collect information on non-monetary burdens from patients and caregivers; however, many of these instruments were used only in a single study.
From the existing literature, we identified four overarching gaps in the categories of non-monetary burdens and instruments used to collect the data in these studies. The first gap is that the terms used to describe financial toxicity and definitions of these terms varied across studies and have changed over time. For example, financial toxicity only became the most frequently used term beginning in 2021. In addition, some studies used different terms interchangeably. This lack of consistency makes comparisons among studies challenging.
A second gap is the lack of studies on and instruments available to collect caregiver non-monetary burdens. Of the 166 studies, only 27 examined non-monetary burdens experienced by caregivers. Most patients have a caregiver in some capacity, but much of the current literature lacks information on caregivers’ non-monetary burdens. Furthermore, the use of caregiver-specific validated instruments to measure burdens among caregivers is minimal. Of the included studies that examined non-monetary burdens among caregivers, two-fifths used self-designed questionnaires or qualitative interviews. Even among studies that used validated instruments, some of these instruments are not specific to caregivers while others are not focused on financial toxicity.
A third gap is that most studies (n=121, 73%) focused on non-monetary burdens related to cancer diagnoses. While new cancer cases will affect an estimated 2 million individuals each year,28 the literature lacks a substantial body of evidence on non-monetary burdens associated with other potentially costly and prevalent medical conditions, such as cardiovascular disease, stroke, diabetes and Alzheimer’s disease and other dementias, which impact millions of Americans. COST, which is validated and was used in nearly one-third of the included studies, is focused on the burdens experienced by people with cancer. The instrument has been validated for pregnancy and diabetes, but validating COST for more medical conditions or developing a new instrument would likely increase assessment of the different categories of intangible burdens.
A fourth gap is the lack of qualitative studies in the literature. Qualitative research tends to ask open-ended questions that are not easily captured in quantitative data and are difficult to quantify. Qualitative data examine experiences, attitudes and behaviours that are important to study in the context of non-monetary burdens because every patient’s treatment experiences are unique.
Strengths and limitations
The current scoping review has several strengths. While most reviews of non-monetary burdens focus on a specific medical condition, this review is not limited to a specific medical condition, noting the preponderance of research around cancer. In addition, this review differentiates between patient and caregiver studies, observing the lack of research including caregivers. This study also identifies the various instruments available to collect measures of non-monetary burdens and can be a resource to researchers collecting these burdens in future studies. Furthermore, this review identifies gaps in the categories of non-monetary burdens reported in the literature and the instruments available to collect these measures. Identification of these gaps provides researchers with areas for future research.
The current scoping review has some limitations. The search found that studies were not indexed in a consistent way; thus, this review may have missed some relevant studies. However, an extensive hand-search process attempted to mitigate this possibility, as described in the methods section. In addition, the concept of intangible and indirect burdens is somewhat subjective; therefore, our study may not have included a category that others may consider a non-monetary burden (eg, pill splitting as a coping behaviour). To increase the applicability of findings, the review was limited to studies published in English from the USA. This study did not include a formal assessment of quality for the studies identified in the review. Thus, this study cannot draw conclusions about the strength of the body of evidence. However, future systematic reviews and meta-analyses on a more focused topic, such as a specific category or subcategory of non-monetary burdens, may answer questions about consistency of findings and strength of evidence.
Conclusions and future directions
The current study examines the extent to which non-monetary burdens have been investigated and identifies the methods and instruments used to collect non-monetary burdens. The findings help illustrate gaps in the literature and provide a starting point for further investigation and implications for policy. Overarching gaps include inconsistent use of terminology around financial toxicity, limited research on non-monetary burdens experienced by caregivers, limited research on non-monetary burdens from medical conditions other than cancer, the need for a comprehensive measure to study the non-monetary burdens from medical conditions experienced by patients more generally and validated measures to assess non-monetary burdens experienced by caregivers.
Future research may reference the highlighted methods and instruments to help develop new instruments or further adapt existing instruments for capturing non-monetary burdens. These new or updated instruments could better reflect the patient and caregiver experiences with financial toxicity due to medical expenses across medical conditions. Collecting more comprehensive data will provide a better understanding of the range and the extent of the non-monetary burdens faced by patients and caregivers. It will also increase the evidence to support new or existing targeted programmes and policies to help patients and caregivers better cope with these non-monetary burdens. For example, more research could be used to develop medical condition-specific resources or support groups that could be incorporated into the standard of care.
The varied literature demonstrates the importance of research around financial toxicity: patients and their caregivers may incur significant financial burden from healthcare costs, yet current studies may not include the additional non-monetary burdens. This scoping review identified a sizeable body of empirical evidence and suggests areas of research that warrant further exploration. Continued assessments of non-monetary burdens faced by patients with varying medical conditions and their caregivers are critical to improving outcomes and experiences. Finally, validated measures for this field of research must be further developed and tested.
Data availability statement
Data sharing not applicable as no datasets generated and/or analysed for this study.
Ethics statements
Patient consent for publication
Ethics approval
Not applicable.
Acknowledgments
Editorial support for this manuscript was supported by Marceline Murawski and Michelle Bogus from RTI International and was funded by the PCORI contract.
References
Footnotes
Contributors KCG was responsible for study conception and design. KCG, SD, SK and ES were responsible for the stages of review and drafting the manuscript. KCG is the guarantor.
Funding All statements, findings, and conclusions in this publication are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI). This publication was developed through a contract to support PCORI’s work (PCORI Contract No. IDIQ-TO#05-RTI-ENG-AOSEPP-09-20-2021). Questions or comments may be sent to PCORI at info@pcori.org.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, conduct, 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.