Health Equity in Clinical Research Informatics

Summary

Objectives: Through a scoping review, we examine in this survey what ways health equity has been promoted in clinical research informatics with patient implications and especially published in the year of 2021 (and some in 2022).

Method: A scoping review was conducted guided by using methods described in the Joanna Briggs Institute Manual. The review process consisted of five stages: 1) development of aim and research question, 2) literature search, 3) literature screening and selection, 4) data extraction, and 5) accumulate and report results.

Results: From the 478 identified papers in 2021 on the topic of clinical research informatics with focus on health equity as a patient implication, 8 papers met our inclusion criteria. All included papers focused on artificial intelligence (AI) technology. The papers addressed health equity in clinical research informatics either through the exposure of inequity in AI-based solutions or using AI as a tool for promoting health equity in the delivery of healthcare services. While algorithmic bias poses a risk to health equity within AI-based solutions, AI has also uncovered inequity in traditional treatment and demonstrated effective complements and alternatives that promotes health equity.

Conclusions: Clinical research informatics with implications for patients still face challenges of ethical nature and clinical value. However, used prudently—for the right purpose in the right context—clinical research informatics could bring powerful tools in advancing health equity in patient care.

Keywords

International Medical Informatics Association Yearbook - clinical research informatics - health equity - structural bias - discrimination - artificial intelligence - prediction models - algorithmic bias

1 Introduction

Clinical research informatics (CRI) is a sub-discipline within biomedical and health informatics that focuses on the analysis, interpretation, and presentation of clinical knowledge generated through informatics [[1]]. This definition by Embi and Payne [[1]], dates back over a decade ago and has previously been mentioned in this journal by Solomonides [[2]]. Acknowledging and including topics that have flourished since Embi and Payne’s definition [[2]], the most notable addition is Artificial Intelligence (AI), referring in a broad sense to the ability of technology to resemble functions and processes of human beings. Machine Learning (ML) [[3]], and Natural Language Processing (NLP) [[4], [5]], are notable subgroups of AI technologies using relevant clinical data sets to advance the representation and understanding of a problem. Increased availability of clinical data in digital form and expanding computational capacity enable more complex and sophisticated processing of clinical data in CRI [[6]]. This appears as prevalent use of AI techniques in CRI, seeking to advance clinical practice through decision-support and prediction capabilities to support health practitioners in different specialties [[7] [8] [9] [10] [11] [12] [13] [14]]. However, extensive use of AI algorithms has also revealed potential risks with implications for patients and their prospects of best possible treatment [[15]]. An example is the “black box” challenge, which delineates the necessity of making complex AI operations transparent and comprehensible to end-users [[16]]. Vast databases are being queried by algorithms, as researchers and clinicians are seeking patterns that can guide decisions in clinical care and result in opaque explanations for how the algorithms reach their guidance [[17]]. The challenge here may not be a result of secrecy or inadequate knowledge, but rather ML outputs without regard for human comprehension and careful consideration of clinical relevance [[18]]. In other words, “black box” approaches to decision-making in patient care may incur significant risk, as neither practitioner nor patient can fully comprehend the steps leading to recommendations [[3], [19]]. In addition to well-known problems being addressed in the development of AI services in health [[20]], issues like access to and ownership of clinical data, and possible exacerbation of health inequity [[21], [22]] are important ethical issues of concern. The focus on these topics seems further accelerated by the unprecedented deployment of digital solutions within healthcare during the COVID-19 pandemic. Consequently, several issues were illuminated, including dependence on digital health, how to enable digital solutions to provide better healthcare, as well as existing inequalities and structural discrimination [[23]].

Health is associated with a non-medical social gradient, where those on the lower socioeconomic end often have the least chance for good health. The circumstances in which an individual is born, ages, lives, and works, usually referred to as “social determinants of health” (SDoH), can be exacerbated by discrimination, prejudice, and stereotyping [[24]]. Health equity, as defined by the World Health Organization, is ‘the absence of unfair, avoidable and remediable differences in health status among groups of people’, and requires actions that even out differences in health outcomes between populations with different socioeconomic foundations [[24]]. While holding great promise for the use of AI in health care, CRI can pose risk of reflecting and reproducing analytical and algorithmic biases that potentially increase health inequities that come with SDoH [[21], [25]]. Algorithmic bias that discriminates based on characteristics integral to the person, such as race and ethnicity, has received particular attention in this context [[26] [27] [28] [29] [30]]. Considering ‘race’ and ‘ethnicity’, ‘ethnicity’ comes with similar interpretation in the literature, but it is necessary to address the conflicting use of the term ‘race’ in European and American contexts. The US Census Bureau and the Office of Management and Budget (OMB) refer to race as a socially constructed way of separating humans into different sociocultural and ancestral groups [[31]], while in Europe, the term ‘race’ is avoided due to its association with the wrong notion of biological different races among human beings, preceding the linked historical and ideological associations. Racism is, on the other hand, an acknowledged term in Europe, referring to discrimination based on the notion of biological differences [[32]]. Recognizing this distinction, this article uses the term ‘race’ when referring to the cited sources that apply this in line with the definition of the US Census Bureau and OMB.

A key concern in Real World Data (RWD) based studies is representativeness. Using such data sets for training algorithms poses a risk for algorithmic biases in AI [[33]], originating from, e.g., lack of inclusion of underrepresented population groups in samples [[34], [35]], and subjective assessments [[36], [37]] within the data material. An example of this problem is the socially inconsistent and intermixing use of the terms ‘ethnicity’ and ‘race’, possibly affecting the creation and collection of data [[30]]. Another key concern is to delineate which circumstances one is to discern between different populations as it may be of relevance to some conditions and completely irrelevant to others [[38]].

CRI hold much promise for improving clinical practice [[1]], but needs to incorporate assessment of its impact on health equity to provide healthcare to all patients, regardless of SDoH [[16], [21], [39]]. Illustrating this concern is the establishment of the High-Level Expert Group on Artificial Intelligence (AI HLEG) by the European Commission [[15]], to accommodate for the implementation of the Commission’s vision for ethical AI [[40]]. As an output, seven requirements for Trustworthy AI have been published from this group: 1) Human agency and oversight, 2) Technical robustness and safety, 3) Privacy and data governance, 4) Transparency, 5) Diversity, non-discrimination and fairness, 6) Societal and environmental wellbeing, and 7) Accountability [[15]]. Taking this into account, CRI should go beyond monitoring, controlling, and guarding against unintentional outcomes that may exacerbate structural health inequality, to actively address and hence, improve health equity [[21], [35], [41]]. Experience gained during the COVID-19 pandemic has highlighted the need for a more systematic approach to ensure that digital health and CRI promotes health equity and the goal towards universal health coverage [[23]]. With this aspiration and inspired by the topic of the 2022 IMIA Yearbook: “Inclusive Digital Health: Addressing Equity, Literacy, and Bias for Resilient Health Systems” [[42]], the aim of this scoping review was to examine in what ways research in CRI, published in the year of 2021, has included health equity to promote patient health and care.

2 Method

This scoping review applied methods as outlined in the Joanna Briggs Institute (JBI) Manual [[43]]. The process of the review proceeded as follows: 1) identify research question, search terms and keywords, 2) search for literature, 3) screening and selecting relevant literature, 4) extract data from selected literature and, 5) summarize and present the results. A protocol defining the research question, aim, screening process, search terms and criteria for inclusion and exclusion was developed in advance of the literature search. The approach is illustrated in a PRISMA flow diagram (see [Figure 1]) [[44]].

Fig. 1 PRISMA Flow Diagram

2.1 Search Strategy

A medical librarian guided our search in September 2022, using the following databases: Medline, Embase, ACM library and Epistemonikos. In line with the JBI Manual [[43]], a PCC framework was applied for the literature search:

• Population –Clinical Research Informatics

• Concept – Health Equity

• Context – Patient Implications

The documentation of the search and the overview of identified literature in the databases are available upon request.

2.2 Screening and Selection of Literature

Ahead of the screening process, we screened the titles and abstracts of 25 randomly selected sources from the search results to reach a general agreement on Inclusion and Exclusion criteria before the selection of sources (see [Table 1]). All sources were then screened by the first and second author using the predetermined criteria for inclusion and exclusion. The sources were screened in two subsequent rounds supported by Covidence, a web-based collaboration software platform used for screening and data extraction in literature reviews [[45]]. The first round of screening extracted literature based on titles and abstract, while the second round of screening extracted literature through full-text reading. The first round of screening resulted in conflicts on 86 sources (18 % of the total sources screened), all of which were resolved through a plenary review. The second screening round resulted in one conflict among the 58 sources that underwent full-text review. The conflict was resolved through a plenary review of the source. Specific quality assessment of the literature was not carried out as this is generally not a priority in scoping reviews [[43]].

Table 1 Inclusion and exclusion criteria for the screening of literature.

2.3 Data Extraction

A spreadsheet with the data material was created to extract information on the study reference, population characteristics and key findings that relate to the aim of the scoping review. The first and second authors read the full text sources with the purpose to identify and extract aspects of clinical research informatics, aspects of health equity, and aspects of patient implications.

3 Results

Of the 58 sources that underwent full-text review, eight studies were included in this study. The reasons for exclusion are listed in [Figure 1]. Although five sources focused on health equity in CRI, they did not focus on what ways CRI can drive health equity and was therefore excluded under the reason “General data suitability and ethical considerations for AI research”. Among the eight included studies, three were reviews and therefore controlled for duplicates. Patra et al. [[46]] and Pham et al. [[47]] are both citing Hazlehurst et al. [[48]]. Patra et al. [[46]] also share an article with Craig et al. [[49]], both citing Navathe et al. [[50]]. However, as the included sources have different focus and have contributed different findings, we did not consider the reviews as overlapping. No overlapping articles were identified between Pham et al. [[47]] and Craig et al. [[49]]. With the exception of one Canadian study [[47]], all studies were conducted in the United States. The focus on CRI in these papers was consistently on AI technology with two themes identified on how CRI with patient implications can drive health equity:

• 1) Exposing health inequity in CRI and addressing the need for adequate measures;

• 2) Promoting health equity through CRI.

The included publications are presented in [Table 2] with descriptions of how health equity in CRI with patient implications is addressed in each paper.

Table 2 Included sources for study. The articles are listed in alphabetical order of the first author’s surname.

4 Discussion

Health equity, CRI and AI are topics in a global setting. It is therefore interesting that all the included papers in this review are of North American origin. Except for one Canadian study, all included studies are conducted in the US It may be that this simply reflects a greater focus on health equity in CRI and AI in the US compared to other countries, responding to a policy that focuses on promoting equity and justice for all [[57], [58]]. Furthermore, low- and middle income countries still appear to face challenges considering the implementation of AI in health [[59]]. The US, compared to other high-income countries, are ranking well below in health care system performance. Among the domains that pull the performance down are less access and equity, despite the significant amount of the US gross domestic product that are spent on health care [[60]].

Although it appears the COVID-19 pandemic has highlighted established disparities in health and digital health [[23]], interestingly only one study identified in the survey as published in 2021 acknowledged the COVID-19 pandemic as a catalyst [[53]]. However, the recognition of social inequities and its influence on health or digital health in all included publications may rather reflect the COVID-19 pandemic’s role as a catalyst in illuminating and driving the focus on health equity [[23]].

4.1 Exposing Health Inequity in CRI

In line with concerns articulated in previously cited literature [[21], [25] [26] [27] [28] [29] [30]], three of the included sources discussed risk for health inequity in AI-based health technology [[47], [51], [55]]. Coley et al. [[51]] assessed differences in the performance of two prediction models. They found that these addressed subpopulations of ethnic or racial minorities in an inadequate manner, identifying a smaller proportion of anticipated suicides in patients who report race/ethnicity to be Black and Alaskan Native/American Indian, and in patients who do not report race/ethnicity. The secondary analysis conducted by Pham et al. [[47]] of 141 articles from a literature review, looked into ethnoracial considerations in AI diabetes tools, to propose a strategy for equity for such technology. As the creators of an NLP opioid misuse classifier, Thompson et al. [[55]] evaluated the impact of bias against historically and structurally disadvantaged groups. All three CRI studies acknowledged the challenges for health equity within AI, mainly expressed through algorithmic bias [[47], [51], [55]]. This is echoing the fact that RWD used to train algorithms risk reproducing bias in technological solutions [[33]], possibly through lower accuracy for underrepresented samples of underserved groups [[34], [35]], or through subjective assessments [[36]], reinforcing possible judgemental biases from healthcare providers [[37]]. Thompson et al. [[55]] acknowledge their previous lack of consideration for disadvantaged populations in the creation of their instrument, and thus mirror the concern of Coley et al. [[51]] for insufficient attention to the clinical usefulness or utility of AI technology to disadvantaged subpopulations. Besides, Pham et al. [[47]] identified only 10 out of 141 papers on AI diabetes tools that inconsistently addressed race or ethnicity, or both (race/ethnicity), pointing to a lack of reliable data and a lack of focus for ensuring adequate training algorithms for ethnic or racial minority populations. Even if assessed for algorithmic bias, the “black box” nature of AI will still challenge transparency, potentially including unintended bias, or withhold information underlying the performance of a model [[17], [18], [55]]. This is crucially important [[21], [22]], as it emphasizes the responsibility of CRI to acknowledge and act upon this in digital health technology [[46], [55]], and incorporate principles for ethical AI, as outlined by the AI HLEG [[15]].

4.2 Promoting Health Equity in CRI

The remaining five papers examined ways in which CRI may enable and promote health equity. Craig et al. [[49]] and Patra et al. [[46]] did so in an indirect manner, through literature reviews examining and promoting the utility of AI to actively include and use SDoH data from electronic records. However, it appears to be beyond the scope of both reviews [[46], [49]], to discuss value in subjective data, as well as potential bias introduced by the source of data. As clinical text include subjective data in EHR [[36]], this illustrates the issue of possibly overlooked subjective bias in algorithmic performance [[30], [36], [37]]. Indeed, algorithmic bias appears in general as a difficult barrier for health equity to overcome [[26] [27] [28] [29] [30], [33] [34] [35] [36] [37], [51], [55]]. The current conditions where CRI demonstrates promotion of health equity appears admittedly to be those where CRI is used specifically to address inequity in health; not only in the evaluation of AI-based healthcare instruments ability to promote health equity [[51], [55]], but through AI-based methods demonstrating and addressing disparities in the delivery of healthcare services [[52] [53] [54]].

Building from observations that underserved populations experience a greater amount of pain in osteoarthritis, Pierson et al. [[54]] used a deep learning approach on radiographs to predict the pain level of the individual patient, finding that the approach significantly reduced unexplained racial pain disparities compared to traditional methods. Through a ML-based method, Hammarlund [[52]] demonstrated disparities between black and white patients in acute myocardial infarction treatment, beyond that explained by health risk differences. As a response to how language discordances limited the contact tracing of a non-English speaking population in California, already disproportionately affected by COVID-19, Lu et al. [[53]] used an ML-based approach to predict the language of an incoming patient and match this to the language of the contact tracer. In contrast to the other included sources in this scoping review, these sources address health equity by directly responding to existing health inequities. Pierson et al. [[54]] and Hammarlund [[52]] both have in common the use of AI in exposing health inequity in clinical practices and providing alternative solutions, while Lu et al. [[53]] uses AI to promote health equity in a setting known to be characterized by disparities in health and access to health. All the included sources of this scoping review address health equity in CRI with patient implications, either by exposing health inequality in AI-based solutions or by examining possibilities for AI to extract data of importance to address health equity [[46], [47], [49], [51], [55]]. However, Pierson et al. [[53]], Lu et al. [[53]], and Hammarlund [[52]] all stand out in their application of AI to drive health equity. The accomplishments of these three studies appear to stem from how they approach the issue of health equity. Instead of illuminating health inequity present in CRI-driven solutions, such as algorithmic bias within AI-based prediction models [[51], [55]], they use AI to promote and improve health equity in the deliverance of existing treatments and health care services [[52] [53] [54]].

4.3 The Way Forward

To further assess the result of our findings, we performed a similar search for the year of 2022 to discern if more recent literature would add to the significance for this study. We identified at least 21 papers [[61] [62] [63] [64] [65] [66] [67] [68] [69] [70] [71] [72] [73] [74] [75] [76] [77] [78] [79] [80] [81]] that met our inclusion criteria, including results from the 2022 IMIA Yearbook [[64], [68], [78]]. Reading through these articles, we did not identify additional thematic areas than those we have included for the year of 2021. However, it appears to be a change in terms of attention to the topic. The focus on health equity in CRI seems to increase considering the 21 studies we found published in 2022 compared to the 8 from 2021. Following this again, three studies were also identified, just for the first month of 2023 [[82] [83] [84]]. The interest for the topic are expanding from North America based study reports to other parts of the world, including Europe [[63], [65], [67], [77]] and Asia [[84]]. The scope of health equity in CRI also appears to have expanded and evolved. Primarily centred on challenges considering race and/or ethnicity in 2021 [[47], [51] [52] [53] [54] [55]], health equity in CRI has extended to diagnosis bias in rural populations [[75]], age [[64]], and gender or sex-specific bias [[63], [64], [67], [70], [73], [77]].

5 Conclusion

Several of the studies on Clinical Research Informatics presented here highlight algorithmic bias as a factor in the promotion of health equity in digital solutions [[47], [51], [55]]. It appears to be a considerable challenge for CRI to provide AI-based solutions without algorithmic bias that prove counterproductive to the intention and goal of the solutions. Carefully selecting and appropriately balancing different characteristics may reduce algorithmic bias and adjust outcomes in some cases, but bias can also remain hidden which make correction nearly impossible [[38]]. Based on the findings in this scoping review, our impression is that the field of CRI, here exemplified by AI as the focus of the recent publications found, is more aware of the challenges at hand, which is an important starting point to find solutions that remedy this challenge. This way CRI will increase capability to promote and improve health equity. This review illustrates that when the right form of digital technology is correctly adapted to the population in question at the right time, AI-based CRI-solutions hold a promise to drive equity in health. Recent publications, in 2022 and beyond, illustrate advancements and endeavour to improve AI algorithms that leverage and combine efforts to reduce and eliminate algorithmic bias. Further progress and full incorporation into CRI require thorough assessment and improvement for equitable and ethical distribution of health care services that respect patient autonomy and dignity.

Going forward, CRI holds opportunities for novel patient- focused digital tools that stimulate engagement and promote health equity. This requires tools that do not exacerbate structural inequalities, incorporate ethical consideration to avoid harm, and mitigate risks related to sub-populations already exposed to disparities in society and health.

Die Autoren geben an, dass kein Interessenkonflikt besteht.

Acknowledgement

We would like to thank Toril M. Hestnes, Senior Librarian, University of Oslo, Library of Medicine and Science, for her contribution to the literature search. The work is partly funded by University of Oslo (AM), Gravitate-Health, EU H2020 agreement 945334 (SM), and CORAL, the Research Council of Norway project 301517 (SHH).

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Artikel online veröffentlicht:
06. Juli 2023