Understanding of topic
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Literature reviews are comprehensive summaries and syntheses of the previous research on a given topic. While narrative reviews are common across all academic disciplines, reviews that focus on appraising and synthesizing research evidence are increasingly important in the health and social sciences.
Most evidence synthesis methods use formal and explicit methods to identify, select and combine results from multiple studies, making evidence synthesis a form of meta-research.
The review purpose, methods used and the results produced vary among different kinds of literature reviews; some of the common types of literature review are detailed below.
Narrative (literature) review.
1. Adapted from:
Eldermire, E. (2021, November 15). A guide to evidence synthesis: Types of evidence synthesis. Cornell University LibGuides. https://guides.library.cornell.edu/evidence-synthesis/types
Nolfi, D. (2021, October 6). Integrative Review: Systematic vs. Scoping vs. Integrative. Duquesne University LibGuides. https://guides.library.duq.edu/c.php?g=1055475&p=7725920
Delaney, L. (2021, November 24). Systematic reviews: Other review types. UniSA LibGuides. https://guides.library.unisa.edu.au/SystematicReviews/OtherReviewTypes
"The integrative review method is an approach that allows for the inclusion of diverse methodologies (i.e. experimental and non-experimental research)." (Whittemore & Knafl, 2005, p. 547).
Scoping reviews are evidence syntheses that are conducted systematically, but begin with a broader scope of question than traditional systematic reviews, allowing the research to 'map' the relevant literature on a given topic.
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Rapid reviews are systematic reviews that are undertaken under a tighter timeframe than traditional systematic reviews.
A narrative or traditional literature review is a comprehensive, critical and objective analysis of the current knowledge on a topic. They are an essential part of the research process and help to establish a theoretical framework and focus or context for your research. A literature review will help you to identify patterns and trends in the literature so that you can identify gaps or inconsistencies in a body of knowledge. This should lead you to a sufficiently focused research question that justifies your research.
Onwuegbuzie and Frels (pp 24-25, 2016) define four common types of narrative reviews:
References and additional resources
Machi, Lawrence A. & Brenda T. McEvoy (2016), The Literature Review: Six steps to success . 3rd edition.; Thousand Oaks, CA: Corwin. Onwuegbuzie, A. J. & Frels, R. (2016) 7 steps to a comprehensive literature review: A multimodal & cultural approach . London: Sage Publications.
The library's collections and services are available to all ISU students, faculty, and staff and Parks Library is open to the public .
Purpose of traditional literature reviews
Literature reviews come in many shapes and sizes, and may be placed in different areas in different theses. However, for most projects, the literature review usually has one overall purpose: to provide a rationale for your research in terms of what has gone before.
The purpose of a traditional literature review is to demonstrate a gap or problem in your field that your research seeks to address. The importance of addressing the gap for your field or discipline must not be assumed but persuasively demonstrated. Indeed, explaining why there is a need for filling the gap helps you to justify your work's value, originality and significance.
To establish your credibility as a scholar, your literature review will typically need to do at least some (if not all) of the following effectively.
The literature review helps you to establish the nature of your contribution to knoweldge. The type of contribution differs from project to project. The list below gives a variety of ways in which different projects can contribute to different fields. Does your project fit into any of these categories?
Whichever type of contribution you're making, your literature review should establish the need for your contribution.
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Placement of traditional literature reviews
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Bibliometrics & citations, view options, recommendations, software process improvement in agile software development a systematic literature review.
It is recognized the relevance and importance that software process improvement (SPI) and agile development have gained in the field of software engineering. Both are approaches that increase the efficiency and effectiveness of a software development ...
Developing software in distributed development environments exhibits coordination, control and communication challenges. Agile practices, which demand frequent communication and self-organization between remote sites, are increasingly ...
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In the era of digital transformation, businesses must innovate and adapt to sustain a competitive edge. This dynamic environment compels a reevaluation of traditional management practices, highlighting the need for highly flexible systems. Flexibility, defined as the ability to adapt organizational resources, processes, and strategies in response to environmental changes such as rapid technological advancements, is crucial. Our systematic review of 47 studies investigates how digital transformation influences performance measurement systems across various industries and global contexts. We found that digital transformation fosters the dynamism and adaptability of these systems. This study integrates strategic, organizational, and information systems flexibility concepts that are essential for effective adaptation and resilience. Our findings underscore the shifts towards decision-making agility, inclusivity, and sustainability, stressing the significant role of human resources in adapting to digital imperatives. We advocate for a comprehensive approach that fosters digital literacy, upholds ethical standards, promotes continuous skill development, and enhances strategic adaptability. Practical implications suggest integrating digital technologies into performance strategies, utilizing real-time metrics for agile decision-making and emphasizing ethical and sustainable practices to improve transparency and stakeholder trust. These strategies are crucial for optimizing performance in the digital age.
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Digital transformation (DT) is rapidly reshaping industries, requiring businesses to innovate and adapt quickly to remain competitive and meet evolving stakeholder demands (Alnoor et al., 2024 ; D’Adamo et al., 2023a , 2023b ). This environment challenges traditional performance measurement systems (PMSs), which often fail to fully leverage the benefits of emerging technologies, such as artificial intelligence (AI), big data, and the Internet of Things (IoT) (Aldoseri et al., 2024 ; Sardi et al., 2023 ). In response, flexible management has become essential, enabling organizations to adapt their operational, strategic, and measurement practices in real time to foster a culture of continuous improvement (Chowdhury et al., 2024 ; Enrique et al., 2022 ; Gao & Chen, 2021 ).
Flexibility is crucial for aligning with strategic objectives, responding to changes, and enhancing sustainability. For example, supply chain and tourism companies exemplify the rapid adaptation to new business models and unforeseen challenges (Agrawal et al., 2024 ; Pandey et al., 2024 ; Singh et al., 2023 ). Indeed, the evolving role of flexibility increasingly contributes to organizational and environmental adaptability (Singh et al., 2021 ).
The DT-driven evolution of business models, methods, and customer experiences necessitates a comprehensive understanding of how these changes impact PMSs (Sakhteh et al., 2023 ). Technical, cultural, organizational, and relational shifts underscore DTs’ role in enhancing performance and creating customer value (Mergel et al., 2019 ).
However, the broader implications for organizational flexibility and strategic alignment remain underexplored (Korsen & Ingvaldsen, 2022 ), as existing systematic reviews focus narrowly on specific technological impacts without considering pervasive organizational effects. For instance, Yadav and colleagues’ study ( 2022 ) within the agricultural food supply chain highlighted the need for PMSs that incorporate sustainability, spurred by rapid digitalization. Hidalgo Martins et al. ( 2022 ) noted challenges in performance measurement for SMEs in the manufacturing industry. Additionally, Miklosik and Evans ( 2020 ) addressed the issue of information overload in marketing organizations, a complication arising from disorganized data from digital sources. These studies detailed the technological integration within PMSs, yet seldom addressed the holistic transformation of organizational strategies.
Our study addresses this gap by examining how DT necessitates realignment within organizations, fostering a more interconnected and responsive business environment. We explore how DT enhances the flexibility and effectiveness of PMSs across diverse organizational contexts (Gong & Ribiere, 2021 ). Therefore, we propose the following research questions:
RQ1: How does DT influence PMSs in terms of organizational flexibility? This question seeks a deeper understanding of the relationship between DT and PMSs beyond technical aspects (Nadkarni & Prügl, 2021 ).
RQ2: How do digital technologies affect decision-making within PMSs? This inquiry is critical to obtain insights into maintaining innovation and agility in a fast-paced digital economy (Kamble & Gunasekaran, 2020 ).
RQ3: How do traditional measurement methods adapt in the digital era? Exploring this topic is imperative, as the pace of digital advancements threatens the relevance of conventional PMS tools, necessitating their evolution to accurately capture firm-created value (Bansal et al., 2023 ).
We conducted the first systematic review with a thematic analysis of the role of PMSs in digitally transformed environments, integrating 47 peer-reviewed articles. This analysis reveals the fundamental functions of PMSs, such as monitoring, attention focusing, strategic decision-making, and legitimacy (Henri, 2006 ), and provides a unified view that advances the understanding of modern organizations’ responsiveness to ongoing digitalizing environments.
Following this introduction, Section “ Methodology ” details our review methodology, describing the selection criteria and analysis techniques used to comprehensively examine the literature. Section “ Results ” presents our thematic findings, and Section “ Discussion ” explores the impact of DT on flexibility in decision-making within PMSs, linking to our research questions. Section “ Contributions and Implications ” concludes the paper by providing theoretical and practical implications and outlining future research directions, emphasizing the need for PMS alignment with digital advancements to boost organizational effectiveness.
We conducted a systematic review adhering to the PRISMA guidelines of Liberati et al. ( 2009 ). This approach enhances research quality and reliability by offering a comprehensive, unbiased synthesis of both published and unpublished literature. By systematically identifying, evaluating, and integrating studies based on predefined criteria, our review ensures thorough coverage of the topic, promoting the reproducibility of findings and deepening understanding in this research area (Popay et al., 2006 ; Tranfield et al., 2003 ). Such rigour is crucial for identifying knowledge gaps and directing future research (Webster & Watson, 2002 ). It supports evidence-based practice by providing clear, synthesized outcomes that aid decision-making for practitioners and policy-makers (Schardt et al., 2007 ).
Figure 1 illustrates our adopted conceptual framework, as defined by Henri ( 2006 ), which categorizes the flexible roles and capabilities of PMSs into four types: monitoring, attention focusing, strategic decision-making, and legitimization. Each category enhances organizational agility to adapt to DT.
Source: Adapted in part from Henri ( 2006 )
Conceptual framework: Uses of PMSs.
Henri’s framework is noted for its thorough examination of performance measurement complexities and has been successfully applied in fundamental studies (DeNisi & Smith, 2014 ; Franco-Santos et al., 2012 ; Ukko et al., 2019 ). Its focus on flexibility aligns with our examination of how DT reshapes PMSs to support more adaptive and dynamic organizational environments.
By applying Henri’s structured approach, we categorize the literature into four thematic areas:
Monitoring involves setting goals and using them as flexible diagnostic tools that adjust to new data and changing conditions. It is crucial for tracking progress and ensuring that firm performance aligns with stakeholder expectations.
Attention focusing enables leaders to dynamically highlight and communicate organizational priorities and critical success factors, fostering adaptability to strategic objectives.
Strategic decision-making assists in formulating long-term, adaptive decisions by providing insights into the evolving dynamics within organizational processes and facilitating strategic planning and execution.
Legitimization ensures that PMSs rationalize past decisions under changing conditions and bolster future planning efforts. Having flexible and accountable demonstrations enhances organizational credibility and secures societal support.
Henri’s framework integrates seamlessly with our research questions, coherently presenting findings and illustrating the dynamic interplay between PMSs and DT. It effectively addresses the identified gaps in the literature by offering nuanced insights into how organizations can leverage PMSs in digitally evolving business landscapes. Thus, this study provides a new perspective on the relationship between digital technologies and performance management tools crucial for strategic decision-making in modern organizational contexts.
On August 7, 2023, we searched the Web of Science, Scopus, and ProQuest databases, focusing on DT and performance measurement. This search adhered to methodologies from previously validated systematic reviews, limiting inclusion to peer-reviewed studies published in international journals and excluding conference papers and book chapters.
For DT, we utilized search terms from recent literature (Gurzhii et al., 2022 ; Hanelt et al., 2021 ; Verhoef et al., 2021 ; Zhu et al., 2021 ): “digital transformation”, “digital strategy”, “digital disruption”, “digital business strategy”, “digitalize”, “digitize”, “IT transformation”, “IS transformation”, “business transformation”, and “emerging technologies.”
In terms of performance measurement, we derived keyword variants from earlier systematic reviews (Bititci et al., 2012 ; Franco-Santos et al., 2012 ; Rojas-Lema et al., 2021 ), including “performance measurement system*”, “performance measure*”, “management control*”, “performance measurement”, “performance management”, “performance indicators”, “strategic control”, “performance evaluation”, and “performance assessment.” To address the multidisciplinary nature of our study, we expanded our search to include terms such as “organi* performance”, “firm performance”, and “SME performance.”
We employed the wildcard “*” to capture plural forms and variants in our search terms. Table 1 outlines the search strings used for each database and the results obtained.
Our expansive keyword approach aimed to overcome the limitations of keyword-centric searches, acknowledging the lack of universally accepted definitions for DT and performance measurement (Vial, 2021 ).
We performed our searches across titles, abstracts, and keywords. The initial search yielded 3109 articles, from which we removed 930 duplicates using Zotero 6.0.27. The remaining 2179 articles were screened for eligibility and focused on adaptability, agility, and resilience, which are themes relevant to the impacts of DT on PMSs.
The next stage involved screening papers using the Population, Intervention, Comparison, Outcome, Time (PICOT) framework, as suggested by Echevarria and Walker ( 2014 ). Table 2 details the inclusion and exclusion criteria, providing clear guidelines for our systematic review process.
We adopted a focused selection strategy to ensure that our research on DT’s impact on PMSs was relevant and specific. Following Franco-Santos et al. ( 2007 ), we concentrated on studies with a precise unit of analysis, aiming for clear and in-depth research outcomes. Therefore, we included only peer-reviewed articles in English that were strictly related to PMSs rather than to performance measurement in general. This approach allowed us to delve deeply into how DT influences PMSs specifically. We also excluded studies assessing the performance and metrics for the different phases of DT, as these areas have been extensively reviewed elsewhere (Ochoa-Urrego & Peña-Reyes, 2021 ; Teichert, 2019 ).
The exclusion of studies from the public and nonprofit sectors was intentional due to their unique measurement standards and challenges. The public sector is subject to diverse, legally mandated measurement standards that vary significantly across different national contexts (Speklé & Verbeeten, 2014 ), introducing variables that could confound the analysis of DT’s impact on PMSs. Similarly, the nonprofit sector’s nascent stage in adopting PMSs (Treinta et al., 2020 ) suggests that its inclusion might not offer the mature perspective necessary for our investigation.
We set our timeframe for the included studies from January 2000 to the present, following Verhoef et al. ( 2021 ). This period is significant because the internet bubble burst when tech giants such as Google, Amazon, and eBay not only survived but also began significantly shaping our understanding of DT. We did not restrict our search to journal rankings or research fields to maintain broad coverage across disciplines.
After screening the titles and abstracts, 2,132 papers were excluded, leaving 804 for full-text review. Ultimately, 47 papers met our criteria and were included in our systematic review. Figure 2 depicts the PRISMA flowchart of our screening process.
PRISMA flowchart for screening and inclusion
Our stringent selection criteria might limit the scope of the study. However, this specificity is crucial for ensuring the integrity and applicability of our findings, particularly regarding DT’s impact on PMSs within business organizations. Our focused approach strengthens the foundation for future research and enhances the precision and relevance of our contributions to discussions on DTs and PMSs.
We extracted essential information from each paper, including title, authors, abstract, and publication year. To mitigate potential biases, we also gathered detailed data, such as country of origin, research questions, study design, sample size, demographic information, and main findings.
We employed thematic analysis to systematically categorize and interpret the data. This method is particularly effective for exploring varied research questions, from subjective experiences to objective performance assessments (Clarke & Braun, 2013 ). Analysing the data this way provided deeper insights into the underlying themes and patterns that emerged.
Our focus was on PMS roles (monitoring, attention focusing, strategic decision-making, and legitimization), guided by Henri’s ( 2006 ) conceptual framework, which links specific PMS functions to their capabilities, as observed in the literature (Pinheiro de Lima et al., 2008 ).
Adhering to the PRISMA checklist and applying stringent selection criteria ensured that our review was comprehensive and sharply focused. This meticulous approach enhances the credibility of our findings and supports their applicability across diverse contexts. Section “ Results ” will delve into how these findings illustrate PMSs’ adaptive responses to DT. We explore significant themes, such as the strategic implications of these adaptations across various industries, demonstrating the practical impact of digitalization on performance management practices.
Our final sample included 47 studies, as detailed in Table 3 . The methodologies used varied and included quantitative (26 studies), qualitative (3), mixed-method (3), conceptual (6), and case studies (9). Geographically, the studies were conducted across Europe (14), Asia (12), the Americas (4), multiple countries (4), and Africa (1). Six articles did not specify a location, and the six conceptual papers inherently lacked geographical data.
Figure 3 illustrates the temporal distribution of the studies. There has been a noticeable increase in publications, with over 85% of publications released since 2019, indicating a growing academic interest in this area.
The number of studies published per year. Notes In 2023, we found 16 studies published in Web of Science, Scopus, and ProQuest as of 07/08/2023
The majority of the articles focused on strategic decision-making. Only four studies explored attention focusing, a critical element in digitally transforming environments. Figure 4 illustrates the distribution based on Henri’s ( 2006 ) categories.
Roles of PMSs in included articles
In the following sections, we will further analyse each category to understand the impact of DT on PMSs, decision-making processes, and the adaptation of traditional tools within digital contexts.
Fifteen studies focused on observing and assessing organizational activities using PMSs. These studies emphasized the importance of tracking performance metrics to align operations with strategic objectives and promptly detect deviations, underscoring the critical role of monitoring in flexible management.
We identified five clusters within this theme:
Digital tools and techniques
Methodological approaches
Context of digitalization
Challenges and opportunities
Illustrative case studies
Four studies highlighted how innovative digital tools designed for monitoring are revolutionizing industry practices. For instance, Ahmad and Qiu ( 2009 ) utilized a comprehensive dataset covering 1500 firms from 1993 to 2005 to develop an integrated model for manufacturing SMEs. This model underscores the critical role of human resources in technology adoption, especially amid widespread talent scarcity. This insight emphasizes the necessity of human capital in maximizing the benefits of digital tools. Similarly, studies by Bonci et al. ( 2019 ), Litavniece et al. ( 2023 ), and Fischer et al. ( 2021 ) demonstrated how integrating computer algorithms with physical processes enhances efficiency and sustainability across various sectors. These studies indicate that effective use of digital tools depends on integrating skilled human resources.
Three studies explored structured methodologies for digital monitoring, offering a broader perspective on the applications of such tools. Aibinu and Papadonikolaki ( 2020 ) expanded the utility of building information modelling by introducing an “effort distribution analysis” methodology. This approach aims to enhance organizational learning and innovation, illustrating the potential of structured methods to foster significant advancements in company practices. In Hong Kong, Ng et al. ( 2017 ) highlighted how adaptable performance analysis methodologies incorporating financial and nonfinancial indicators are crucial for innovative firms. Papiorek and Hiebl ( 2023 ) further supported this view by demonstrating the importance of high-quality information for effective management control systems, requiring robust IT capabilities and external expertise. These insights underscore that flexible performance analysis requires high-quality information systems. Companies must integrate these elements skilfully to optimize results, highlighting the value of technological innovation and methodological adaptability.
This cluster examines the interface between digital transformation and performance tracking. Studies such as those by Scalco and Simske ( 2023 ) and AlMujaini et al. ( 2021 ) revealed that successful DT involves more than merely implementing new technologies. It requires a strategic alignment integrating technology with insightful human management and organizational vision. Similarly, AL-Khatib ( 2022 ) demonstrated that intellectual capital coupled with big data analytics (BDA) significantly enhances innovation performance in 333 Jordanian banks. In addition, Park et al. ( 2022 ) advocated for global collaboration to leverage disruptive technologies for improved sustainability and energy efficiency in their conceptual study on appliance and equipment systems. These findings challenge traditional views of technology adoption, advocating for a more nuanced approach that leverages human insights alongside digital advancements.
The digital era introduces challenges and opportunities for monitoring, as seen in studies by Baral et al. ( 2023 ) and Globerson ( 2024 ). Baral et al. ( 2023 ) highlighted how the COVID-19 pandemic underscored the vulnerability of global supply chains, prompting SMEs to develop resilient strategic plans. This adaptation involves not only automation but also a comprehensive rethinking of performance monitoring systems to ensure resilience and real-time adaptability (Globerson, 2024 ). These studies illustrate that the digital era reshaped performance monitoring paradigms. Digital disruptions and global uncertainties highlight the vulnerabilities of traditional PMSs. The emerging digital landscape demands not only automation but also strategic rethinking of performance monitoring, ensuring resilience and real-time flexibility.
Case studies by Chhabra et al. ( 2022 ) and Quille et al. ( 2023 ) provided practical insights into how digital tools can transform traditional monitoring practices. These studies showcased the application of the IoT, BDA, global positioning system, and robotic process automation in enhancing monitoring efficiency, sustainability, and customer satisfaction. They exemplified how leveraging cutting-edge technologies can revolutionize traditional practices, offering a blueprint for future innovations in performance monitoring. Together, these case studies underscore the evolving nature of monitoring in digitalization. By leveraging such emerging technologies, businesses can dramatically boost operational flexibility, sustainability, and customer satisfaction.
Four studies explored the mechanisms organizations and individuals use to prioritize specific areas, issues, or metrics crucial for swiftly addressing vital aspects. These studies range in scope from broad organizational strategies to targeted tactical actions. Strategic considerations set the overarching corporate direction, while tactical measures focus on immediate, actionable steps.
Therefore, we classified the articles as follows:
Digital strategy shifts
Tactical performance signals
Exploring the transition from traditional to digital marketing, Homburg and Wielgos ( 2022 ) analysed responses from 382 German-speaking senior managers and financial data from 273 global companies. Their findings emphasize the necessity of a customer-centric approach and internal processes aligned with this perspective, essential for maintaining relevance in the face of rapid technological changes. Similarly, Reinking et al. ( 2020 ) interviewed 27 managers across various industries to examine how visual performance measurement tools influence managerial focus on specific metrics. Their research introduced the concept of “strategy surrogation”, where managers may prefer simpler tactics over complex strategies to align decisions with broader goals. This approach was critical for effectively diffusing corporate strategy, with PMSs providing real-time feedback that positively influences managerial behaviour. Both studies highlight that DT requires a strategic reorientation. Organizations should enhance their PMSs to focus on key areas such as employee digital marketing skills and strategic internal knowledge dissemination.
The role of performance appraisal systems in signalling organizational priorities was the focus of a study by Curzi and colleagues ( 2019 ), which surveyed 865 employees from multinational firms in Italy. Their findings suggest that appraisals aimed at specific performance outcomes or new competencies can foster innovative work behaviour. However, they noted that overly formalized systems, such as standardized yearly evaluations, may inhibit innovation. In a related study, Čizmić and Ahmić ( 2021 ) explored the impact of robust human resource practices on organizational success by studying 97 managers in Bosnia and Herzegovina. Their research showed that talent identification and skills development are crucial for boosting profitability and sales growth, emphasizing the significance of tactical measures in steering organizational direction. These studies reveal that while balanced PMSs can drive innovation and effectively signal organizational priorities, excessive formalization in appraisal systems might stifle creativity, underscoring the need for a delicate balance between individual autonomy and strategic alignment.
Twenty-one studies investigate how PMSs and performance metrics guide strategic decisions and align with organizational directions, priorities, and visions. We categorized the papers into three distinct clusters:
DT in business strategies
Technological tools in decision-making
Strategic AI and digital shifts
Nine studies examined how DT influences strategic business decisions. The significance of digital tools and a skilled workforce was highlighted by Teng and colleagues ( 2022 ) in their study of 335 Chinese SMEs. Research on Finnish SMEs offered contradictory insights. Holopainen et al. ( 2023 ) observed that technological understanding alone does not increase PMS usage. However, Joensuu-Salo and Matalamäki ( 2023 ) found that mastery of digital technologies significantly boosts performance and growth. This dichotomy underscores the diverse effects of technology on strategy depending on contextual factors. Further supporting the critical role of technology, studies by Moumtzidis et al. ( 2022 ), Hung et al. ( 2023 ), and Opazo-Basáez et al. ( 2023 ) documented the positive impacts of BDA, IoT, and cloud platforms on strategic decision-making, enhancing production efficiency and customer satisfaction.
From an innovation perspective, Trequattrini et al. ( 2022 ) conducted a case study of Soundreef S.p.A., an Italian copyright management company, showing how technologies bolster PMS transparency and accuracy. Adding services to products (servitization) and digitalization interact to create value in 828 Spanish firms (Martín-Peña et al., 2020 ). However, despite recent advances, many executives still rely on outdated indicators (Wengler et al., 2021 ).
In sum, while digital technologies are reshaping business strategies, a dichotomy exists in the perceived utility of PMS usage. Firms must align technologies with updated and relevant performance metrics to gain a competitive advantage.
This cluster focuses on strategically integrating AI and other technological tools across various industries. From an operations management lens, Ng ( 2009 ) analysed the strategic advantage of R&D activities in 12 US technology companies, showing how investment in intangible assets boosts market value. Transitioning to optimization tools, Moretti and Re Cecconi ( 2019 ) introduced a decision support system (DSS) applied to an Italian office building to predict maintenance needs and optimize operations. Building on performance measurement frameworks, Wang and Chien ( 2016 ) employed the balanced scorecard approach in 23 Taiwanese LED companies, proposing the integration of financial and nonfinancial indicators to gain a holistic view of performance.
In supply chain management, Szymczak et al. ( 2018 ) reported the cautious adoption of new technologies such as cloud computing and data mining among 200 Polish companies, while El Kihel et al. ( 2023 ) highlighted the transformative potential of BDA and AI in Stellantis car manufacturing operations in Morocco. Nudurupati et al. ( 2021 ) noted an evolution in performance measures over 17 months, incorporating broader value-creation networks.
Finally, Bititci ( 2007 ) and Meagher ( 2002 ) proposed conceptual frameworks emphasizing the seamless integration of leadership, strategy, processes, and performance metrics for business evolution, advocating a shift to evidence-based decision-making over mere intuition.
These studies underscore that PMSs streamline resource allocation and refine decision-making across industries. Embracing a comprehensive approach can enable organizations to make more informed decisions.
Four studies specifically emphasized the transformative impact of AI on business operations. Joshi and colleagues ( 2022 ) surveyed 881 global firms and introduced the concept of the IT governance process capability. It refers to a company’s ability to choose the right tech resources, make decisions, plan, update systems, deliver services, and monitor them effectively. The authors found that such capability significantly enhances technological and financial performance. Building on this technological momentum, Olan et al. ( 2022 ) demonstrated the synergistic benefits of AI integration with knowledge-sharing tools, noting improvements in organizational efficiency.
Diving deeper into AI’s potential, Samarghandi et al. ( 2023 ) applied deep learning techniques in an Iranian audit organization to predict human actions in an accounting information system (AIS), identifying key predictors of effective AIS usage. Finally, Colombo and Beuren ( 2023 ) surveyed 298 employees in a Brazilian shared services centre and found that an innovation culture and an interactive PMS significantly boost accounting process automation.
These studies emphasise that AI, data mining, and cloud systems are transforming strategic decision-making. Effective implementation requires strong governance, expert human oversight, and a proactive approach to technological innovation.
This section reviews seven studies that analyse how organizations leverage PMSs to enhance credibility and justify decisions within societal norms and expectations. We divided these articles into two primary clusters:
Stakeholder engagement and legitimacy
Ethics and sustainability management
Two articles explored the impact of DT on organizational performance and legitimization. As part of their study on incorporating stakeholder feedback in organizational decision-making, Hristov and Appolloni ( 2022 ) conducted semistructured interviews with 183 managers, surveyed 637 stakeholders from 61 Italian organizations, and analysed internal reports. Their findings underscore the importance of incorporating stakeholders’ insights into the decision-making process, identifying four key integration dimensions: sustainable development, organizational drivers, digital transformation, and cultural context. According to Vărzaru’s ( 2022 ) study, using BDA and cloud computing significantly improves sustainability reporting across 21 European Union countries. This enhances transparency in communicating sustainable development strategies to stakeholders. These studies illustrate that strategic stakeholder engagement through advanced technologies can boost organizational legitimacy and performance.
Five studies underscored how digital capabilities influence corporate sustainability practices and performance metrics. Shin et al. ( 2023 ) demonstrated that leadership proficient in digital technologies can significantly enhance corporate performance in South Korea, with a supportive technology adoption culture and digital skills among employees amplifying this effect. In the same country, the study by Kim ( 2021 ) indicated industry-specific variations in factors driving sustainable growth among SMEs in the IT/software sectors, emphasizing the impact of business technology skills. A study of 319 Indian SMEs by Vrontis and colleagues ( 2022 ) highlighted how digital tools such as social media apps, AI, BDA, the IoT, and blockchain contribute to economic growth and societal benefits.
To further emphasize the role of technology in sustainability, Lavorato and Piedepalumbo ( 2023 ) presented a case study of an innovative Italian high-tech startup, illustrating how smart technologies such as the IoT and cloud solutions enhance sustainability measures and align with sustainable development goals. Nandi and associates ( 2023 ) proposed a CE performance measurement model that integrates digital technologies with alternative pricing valuation methods, enabling firms to effectively assess sustainability performance and CE benefits.
The reviewed studies affirm that tailored digital tools are crucial for enhancing corporate sustainability and ethical management. They drive SME growth and align business practices with broader societal values, underscoring the critical role of digital expertise in achieving sustainable development goals. The integration of digital solutions into PMSs not only boosts performance but also significantly contributes to societal progress and sustainable development.
This study explored the intricate relationship between DTs and PMSs across various industries and global regions. We aimed to address critical gaps in the literature, specifically the underexplored dynamics of how DT enhances PMS dynamism and adaptability, the influence of digital technologies on decision-making processes within these systems, and the evolution of traditional PMS tools in response to digital advancements.
In addressing the first research question, we found that DT profoundly impacts PMSs by enhancing their operational dynamics through increased adaptability, agility, and resilience. These flexible management practices, enabled by digital tools such as AI and big data, deepen the integration of technology with human resources, which is essential for effective operation. This integration entails adopting new technologies and transforming decision-making cultures within organizations to be more dynamic and responsive.
Digital technologies facilitate new operational capabilities and transform organizational decision-making cultures to be more dynamic and responsive. The necessity for skilled human intervention underscores that while technology extends capabilities, human oversight ensures strategic alignment. Methods such as building information modelling (BIM) illustrate this synergy by merging advanced tools with human expertise to boost performance (Aibinu & Papadonikolaki, 2020 ; Ng et al., 2017 ; Papiorek & Hiebl, 2023 ). Moreover, the volatile digital era demands a synthesized approach integrating technology, human factors, and organizational strategy (AL-Khatib, 2022 ; Park et al., 2022 ).
Contrasting studies have shed light on the varying impacts of DT on PMS usage. While Teng et al. ( 2022 ) and Joensuu-Salo and Matalamäki ( 2023 ) emphasized the significance of managerial digital literacy, Holopainen et al. ( 2023 ) found no direct correlation between technological awareness and PMS application, suggesting that the benefits of digital tools may not be universally perceived. This can occur in sectors characterized by low competition (Soto Setzke et al., 2023 ). This diversity of findings enriches our understanding of digital tool integration across different competitive landscapes.
Our findings confirm that digitally enabled PMSs significantly enhance institutional flexibility across various sectors. For instance, using AI and BDA in the commercial agriculture industry facilitates real-time performance adjustments, supporting decisions responsive to changing market and environmental conditions (Abeysiriwardana et al., 2022 ). This capability is equally valuable in health care and manufacturing, where real-time data support enhances patient care and optimizes operational flexibility and responsiveness (Brandín & Abrishami, 2024 ; Dogra et al., 2023 ).
As we consider the enhanced operational dynamics facilitated by DT, it is also crucial to explore how these technologies specifically augment decision-making flexibility within organizations, a point we examine in the following section.
Regarding the second research question, our investigation reveals that digital technologies fundamentally enhance the flexibility of decision-making processes within PMSs, democratizing and enriching this crucial organizational function. By implementing digital tools that enable dynamic and real-time metrics, PMSs have evolved from static, rigid systems into adaptable, responsive frameworks that facilitate participatory and inclusive decision-making processes (Lavorato & Piedepalumbo, 2023 ). This shift not only entails incorporating new tools but also transforming the decision-making culture within organizations (Shukla & Shankar, 2024 ).
Digital tools such as AI-driven analytics platforms enable systems to quickly integrate new information and adapt outputs to meet changing conditions, showcasing adaptability in sectors such as construction and manufacturing (Moretti & Re Cecconi, 2019 ; Szymczak et al., 2018 ). Furthermore, decision support systems leveraging the IoT and big data provide instant insights into operational efficiency, facilitating rapid responses to logistical or supply chain challenges (Joshi et al., 2022 ; Olan et al., 2022 ).
Resilience, another critical aspect of PMSs, involves maintaining functionality and quickly recovering from setbacks. Technologies such as cloud-based PMSs ensure data integrity and availability across multiple geographies, safeguarding against localized failures (Hung et al., 2023 ; Opazo-Basáez et al., 2023 ). This is crucial in industries such as health care, where downtime can have severe repercussions (Sharma et al., 2023 ).
Our findings align with seminal studies that underscore managerial cognition’s role in dynamically and creatively interpreting performance metrics (Ittner & Larcker, 2003 ; Malmi, 2001 ). These digital tools enable a shift towards more inclusive and innovative decision-making processes, as demonstrated by the strategic value of R&D activities guided by KPIs continually refined by AI and BDA (Moretti & Re Cecconi, 2019 ; Ng, 2009 ). Integrating these technologies enhances decision-making and underscores the importance of governance and human expertise in effectively leveraging these technologies (Chen et al., 2012 ; Kar et al., 2023 ).
After exploring how digital tools enhance both the adaptability and resilience of PMSs, we now focus on how traditional PMSs have undergone significant transformations due to digital technologies.
Responding to the third research question, we observe a significant evolution in the capabilities of traditional PMSs driven by the integration of advanced technologies such as AI, BDA, and the IoT. The shift from periodic, retrospective analysis to continuous, real-time monitoring has enhanced the accuracy of performance metrics and the speed of organizational response.
Real-time dashboards, AI-enhanced forecasting tools, and blockchain technology have each played a role in advancing PMS capabilities, aligning them more closely with modern organizational needs and stakeholder expectations (El Kihel et al., 2023 ; Fischer et al., 2021 ; Hristov & Appolloni, 2022 ; Nandi et al., 2023 ). These advancements underscore the transformative impact of DT on traditional systems, enhancing its utility and strategic value.
DT’s potential to foster sustainable communities is significant. By leveraging emerging technologies, organizations can enhance operational efficiency and effectively manage their environmental impacts (Feroz et al., 2021 ). This approach ensures compliance with environmental regulations and supports broader sustainability goals that benefit entire communities (Ciasullo et al., 2024 ). For instance, digitally enabled PMSs track resource consumption and energy efficiency, providing insights that can help reduce ecological footprints (Latifah & Soewarno, 2023 ). Integrating these systems into public sector initiatives amplifies their impact, contributing to more resilient community infrastructures (Ayoko, 2021 ).
This strategic alignment between digital advancements and community development emphasizes transforming technological capabilities into tangible societal benefits (Joy et al., 2023 ). Studies such as D’Adamo et al., ( 2023a , 2023b ) show how photovoltaic systems optimize energy consumption within community frameworks, enhancing local sustainability efforts. Additionally, higher education institutions play a crucial role in promoting sustainability through community engagement projects (Biancardi et al., 2023 ).
Henri’s ( 2006 ) framework remains relevant. However, our findings extend these principles by emphasizing the role of real-time analytics and digital tools in optimizing monitoring effectiveness. Our review also highlights the continuing relevance of human resources, particularly in SMEs where talent scarcity poses significant challenges (Ahmad & Qiu., 2009 ). The complexities introduced by digital tools necessitate an approach valorizing human capabilities. DT’s influence transcends mere tool adaptation, reshaping organizational attention management. We finally identified an evolved legitimizing role. Modern PMSs now serve as strategic assets, driving ethical sustainability (Kim, 2021 ; Shin et al., 2023 ), thus enhancing their legitimizing function in the DT context. By synthesizing these findings in alignment with our research questions, we see a clear trajectory of how digital technologies have intricately and profoundly reshaped PMSs, influencing their design, functionalities, and objectives.
Theoretical contributions.
Our study enhances the understanding of PMSs by illustrating their evolution from traditional “rationalization machines” (Henri, 2006 , p. 81) to strategic assets within organizations (Nandi et al., 2023 ; Vrontis et al., 2022 ). This transition reflects a significant shift in PMS conceptualization, aligning with the principles of flexible systems management by integrating adaptability, strategic flexibility, and resilience into their core functions (Nayal et al., 2024 ).
We identified a symbiotic interplay between DTs and PMSs. Figure 5 illustrates this dynamic enrichment process, emphasizing how DT enhances PMS comprehensiveness and dynamism. This interaction underlines the importance of flexible management in increasing organizational resilience and adaptability during digital transitions, prompting a reevaluation of the discourse on the coevolution of DT and PMSs in modern organizations.
The ‘symbiotic interplay’ between DT and PMSs
Furthermore, our research broadens the application of flexible systems management by incorporating ethical and sustainable decision-making metrics into our PMS analysis. This contributes to the ongoing discourse on performance metrics (Kim, 2021 ; Shin et al., 2023 ; Vrontis et al., 2022 ) and challenges the prevailing narratives that overly emphasize technology at the expense of human involvement.
We emphasize the importance of integrating human expertise and technology to achieve the benefits of flexible systems management, highlighting that harmonization is essential for effective management flexibility. The interplay between technological capabilities and human resources marks a crucial expansion of flexible systems management. Insights from human resource management and information systems are vital to fully leverage the potential of PMSs in the digital age, suggesting a model where technology and human resource strategies are cohesively aligned.
Our findings offer actionable insights for managers, policy-makers, and organizations navigating the digital landscape. We propose several practical recommendations based on our thematic analysis to integrate DT into PMS strategies effectively:
Integrating DT into PMS Strategies : Organizations should view digital technologies as integral rather than supplementary components of performance measurement frameworks. By embedding these technologies directly into PMS strategies, organizations can adopt a more dynamic approach to performance measurement. Continuous training initiatives ensure that personnel develop the necessary digital literacy to utilize complex performance metrics effectively, thus empowering employees to leverage digital tools (Joensuu-Salo & Matalamäki, 2023 ; Teng et al., 2022 ).
Embracing Real-Time Metrics : With the increasing importance of timely data in decision-making, organizations must transition from traditional periodic reviews to dynamic, data-driven approaches. Investing in real-time analytics technologies and cultivating a culture that values data interpretation skills are essential. This shift enhances organizational agility and responsiveness by enabling quicker reactions to market changes and internal challenges (Fischer et al., 2021 ; Szymczak et al., 2018 ).
Prioritizing Ethical and Sustainable Measures : As sustainability becomes a critical performance indicator, organizations should employ digital tools to enhance the transparency of their sustainability efforts. Such transparency aids compliance with environmental standards and bolsters stakeholder trust and organizational credibility. Digital platforms that facilitate detailed tracking and reporting of sustainability metrics enable organizations to effectively communicate their efforts and impacts (Kim, 2021 ; Vrontis et al., 2022 ).
Continuous Training and Development : Adopting new technologies necessitates an ongoing commitment to training and development. Establishing continuous learning environments ensures that organizations remain current with technological advancements and that their workforce is proficient in the latest digital tools (Aibinu & Papadonikolaki, 2020 ). This commitment is vital for maintaining effective PMSs and for enabling employees to adapt to new tools and strategies as they emerge. A holistic approach that merges DTs’ technological capabilities with human resource expertise is essential for organizations aiming to enhance their performance in today’s digital era. The strategic governance of technological changes will position organizations to make informed, proactive decisions in a turbulent marketplace rather than engage in passive compliance (Cosa et al., 2024 ).
Policy Innovations for AI-driven PMSs : Integrating AI-driven PMSs with policy innovations is crucial for maintaining high integrity and aligning with evolving regulations. Implementing these systems requires policies that support continuous adaptation and learning, facilitate the seamless integration of new technologies into existing frameworks, and encourage the development of skills necessary to manage and optimize these systems. Such policies support a sustainable transition to more intelligent and responsive organizational practices.
Our systematic review has inherent limitations. First, our focus was strictly on articles that addressed PMS as the unit of analysis, excluding studies that discussed performance measurement more broadly. This selection criterion limited our final sample to 47 papers. Although this number may appear small, this focused approach was intended to maintain sharp relevance to our research objectives. This methodological rigour allows for an in-depth exploration of PMS-specific insights, providing a targeted understanding of how DT reshapes PMSs despite potentially missing broader insights from the general performance measurement literature.
Second, the diverse nature of the articles posed classification challenges. We adhered to Henri’s ( 2006 ) framework for categorization and followed Massaro et al.’s ( 2016 ) recommendation to prioritize each paper’s most prominent research focus. This approach helped maintain clarity and coherence, even as we adopted a narrative style to highlight the complex web of research angles, enriching our discussion across multiple dimensions (Popay et al., 2006 ).
A third limitation involves our terminology. Despite subtle distinctions, we used “digital transformation” and “digital technologies” interchangeably. DT refers to integrating digital technologies across all business areas, while digital technologies are specific tools, systems, devices, and resources (Berman, 2012 ). We made this choice for coherence and clarity, yet it is important to recognize these terms’ nuances when interpreting our findings.
Additionally, we excluded studies that focused on metrics for different DT phases and did not include articles from the public or nonprofit sectors due to their unique measurement dynamics. Our temporal scope, focusing on post-2000 publications, aimed to capture insights from an era shaped by the survival of tech giants post-Internet bubble burst, possibly omitting foundational insights from earlier periods. Finally, our decision to include all studies, regardless of journal rankings or research fields, aimed to broaden the perspectives considered, counterbalancing our other exclusion criteria.
Our study highlights significant opportunities for further investigation into the evolving landscape of digitalization and PMSs. Detailed research is needed on the specific advantages, challenges, and strategies for integrating individual digital tools in various industrial contexts. Such research could explore the most effective tools in the digital era and whether organizations are adopting innovative frameworks.
The rapid evolution of DT underscores the necessity for a comprehensive research agenda focused on emerging trends in performance measurement. This agenda would pinpoint critical areas for exploration, offering practitioners insights into the field’s trajectory and helping them adapt strategically.
Surprisingly, the attention-focusing role of PMSs is underrepresented in the literature despite the growing emphasis on employee well-being (Pradhan & Hati, 2022 ; Rasool et al., 2021 ). Future studies could investigate how a well-defined PMS can guide employees on what to prioritize, thereby reducing cognitive overload, uncertainty, and stress. Exploring the interplay between corporate wellness initiatives and performance measurement could yield valuable insights for enhancing organizational health in the digital era.
Another area for future exploration is human resistance and the acceptance of digital tools. Discrepancies in findings on managers’ technological understandings and their impact on PMS usage suggest that factors such as organizational culture, existing infrastructure, or the specific design and utility of PMS tools themselves might play more significant roles than previously thought (Holopainen et al., 2023 ; Joensuu-Salo & Matalamäki, 2023 ; Teng et al., 2022 ). A more nuanced exploration, potentially integrating qualitative methodologies, is necessary to fully understand these underlying dynamics.
Finally, several studies have addressed SMEs’ unique challenges and opportunities related to DT and performance measurement (Ahmad & Qiu, 2009 ; AlMujaini et al., 2021 ; Baral et al., 2023 ; Kim, 2021 ; Vrontis et al., 2022 ). Future research could focus specifically on the types of digital tools SMEs prioritize, the challenges they encounter in integrating these tools, and how their strategies differ from or converge with those of larger organizations. Such studies could help tailor performance management strategies to the needs of SMEs, fostering more effective and sustainable practices.
In what ways can PMSs contribute to enhancing organizational resilience and sustainability in the digital age?
What role do human resources play in optimizing digital tools within PMSs to enhance organizational performance?
How can organizations balance the need for technological innovation with ethical standards and sustainability practices in their PMS frameworks?
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Cosa, M., Torelli, R. Digital Transformation and Flexible Performance Management: A Systematic Literature Review of the Evolution of Performance Measurement Systems. Glob J Flex Syst Manag (2024). https://doi.org/10.1007/s40171-024-00409-9
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Philip J Mease, Dafna D Gladman, Joseph F Merola, Peter Nash, Stacy Grieve, Victor Laliman-Khara, Damon Willems, Vanessa Taieb, Adam R Prickett, Laura C Coates, Comparative efficacy and safety of bimekizumab in psoriatic arthritis: a systematic literature review and network meta-analysis, Rheumatology , Volume 63, Issue 7, July 2024, Pages 1779–1789, https://doi.org/10.1093/rheumatology/kead705
To understand the relative efficacy and safety of bimekizumab, a selective inhibitor of IL-17F in addition to IL-17A, vs other biologic and targeted synthetic DMARDs (b/tsDMARDs) for PsA using network meta-analysis (NMA).
A systematic literature review (most recent update conducted on 1 January 2023) identified randomized controlled trials (RCTs) of b/tsDMARDs in PsA. Bayesian NMAs were conducted for efficacy outcomes at Weeks 12–24 for b/tsDMARD-naïve and TNF inhibitor (TNFi)-experienced patients. Safety at Weeks 12–24 was analysed in a mixed population. Odds ratios (ORs) and differences of mean change with the associated 95% credible interval (CrI) were calculated for the best-fitting models, and the surface under the cumulative ranking curve (SUCRA) values were calculated to determine relative rank.
The NMA included 41 RCTs for 22 b/tsDMARDs. For minimal disease activity (MDA), bimekizumab ranked 1st in b/tsDMARD-naïve patients and 2nd in TNFi-experienced patients. In b/tsDMARD-naïve patients, bimekizumab ranked 6th, 5th and 3rd for ACR response ACR20/50/70, respectively. In TNFi-experienced patients, bimekizumab ranked 1st, 2nd and 1st for ACR20/50/70, respectively. For Psoriasis Area and Severity Index 90/100, bimekizumab ranked 2nd and 1st in b/tsDMARD-naïve patients, respectively, and 1st and 2nd in TNFi-experienced patients, respectively. Bimekizumab was comparable to b/tsDMARDs for serious adverse events.
Bimekizumab ranked favourably among b/tsDMARDs for efficacy on joint, skin and MDA outcomes, and showed comparable safety, suggesting it may be a beneficial treatment option for patients with PsA.
For joint efficacy, bimekizumab ranked highly among approved biologic/targeted synthetic DMARDs (b/tsDMARDs).
Bimekizumab provides better skin efficacy (Psoriasis Area and Severity Index, PASI100 and PASI90) than many other available treatments in PsA.
For minimal disease activity, bimekizumab ranked highest of all available b/tsDMARDs in b/tsDMARD-naïve and TNF inhibitor–experienced patients.
PsA is a chronic, systemic, inflammatory disease in which patients experience a high burden of illness [ 1–3 ]. PsA has multiple articular and extra-articular disease manifestations including peripheral arthritis, axial disease, enthesitis, dactylitis, skin psoriasis (PSO) and psoriatic nail disease [ 4 , 5 ]. Patients with PsA can also suffer from related inflammatory conditions, uveitis and IBD [ 4 , 5 ]. Approximately one fifth of all PSO patients, increasing to one quarter of patients with moderate to severe PSO, will develop PsA over time [ 6 , 7 ].
The goal of treatment is to control inflammation and prevent structural damage to minimize disease burden, normalize function and social participation, and maximize the quality of life of patients [ 1 , 4 ]. As PsA is a heterogeneous disease, the choice of treatment is guided by individual patient characteristics, efficacy against the broad spectrum of skin and joint symptoms, and varying contraindications to treatments [ 1 , 4 ]. There are a number of current treatments classed as conventional DMARDs such as MTX, SSZ, LEF; biologic (b) DMARDs such as TNF inhibitors (TNFi), IL inhibitors and cytotoxic T lymphocyte antigen 4 (CTLA4)-immunoglobulin; and targeted synthetic (ts) DMARDs which include phosphodiesterase-4 (PDE4) and Janus kinase (JAK) inhibitors [ 1 , 8 ].
Despite the number of available treatment options, the majority of patients with PsA report that they do not achieve remission and additional therapeutic options are needed [ 9 , 10 ]. Thus, the treatment landscape for PsA continues to evolve and treatment decisions increase in complexity, especially as direct comparative data are limited [ 2 ].
Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A, which is approved for the treatment of adults with active PsA in Europe [ 11 , 12 ]. Both IL-17A and IL-17F are pro-inflammatory cytokines implicated in PsA [ 11 , 13 ]. IL-17F is structurally similar to IL-17A and expressed by the same immune cells; however, the mechanisms that regulate expression and kinetics differ [ 13 , 14 ]. IL-17A and IL-17F are expressed as homodimers and as IL-17A–IL-17F heterodimers that bind to and signal via the same IL-17 receptor A/C complex [ 13 , 15 ].
In vitro studies have demonstrated that the dual inhibition of both IL-17A and IL-17F with bimekizumab was more effective at suppressing PsA inflammatory genes and T cell and neutrophil migration, and periosteal new bone formation, than blocking IL-17A alone [ 11 , 14 , 16 , 17 ]. Furthermore, IL-17A and IL-17F protein levels are elevated in psoriatic lesions and the superiority of bimekizumab 320 mg every 4 weeks (Q4W) or every 8 weeks (Q8W) over the IL-17A inhibitor, secukinumab, in complete clearance of psoriatic skin was demonstrated in a head-to-head trial in PSO [ 16 , 18 ]. Collectively, this evidence suggests that neutralizing both IL-17F and IL-17A may provide more potent abrogation of IL-17-mediated inflammation than IL-17A alone.
Bimekizumab 160 mg Q4W demonstrated significant improvements in efficacy outcomes compared with placebo, and an acceptable safety profile in adults with PsA in the phase 3 RCTs BE OPTIMAL (NCT03895203) (b/tsDMARD-naïve patients) and BE COMPLETE (NCT03896581) (TNFi inadequate responders) [ 19 , 20 ].
The objective of this study was to establish the comparative efficacy and safety of bimekizumab 160 mg Q4W vs other available PsA treatments, using network meta-analysis (NMA).
A systematic literature review (SLR) was conducted according to the Preferred Reporting Items for Systematic Reviews (PRISMA) guidelines [ 21 ] and adhered to the principles outlined in the Cochrane Handbook for Systematic Reviews of Interventions, Centre for Reviews and Dissemination’s Guidance for Undertaking Reviews in Healthcare, and Methods for the Development of National Institute of Health and Care Excellence (NICE) Public Health Guidance [ 22–24 ]. The SLR of English-language publications was originally conducted on 3 December 2015, with updates on 7 January 2020, 2 May 2022 and 1 January 2023 in Medical Literature Analysis and Retrieval System Online (MEDLINE ® ), Excerpta Medica Database (Embase ® ) and the Cochrane Central Register of Controlled Trials (CENTRAL) for literature published from January 1991 onward using the Ovid platform. Additionally, bibliographies of SLRs and meta-analyses identified through database searches were reviewed to ensure any publications not identified in the initial search were included in this SLR. Key clinical conference proceedings not indexed in Ovid (from October 2019 to current) and ClinicalTrials.gov were also manually searched. The search strategy is presented in Supplementary Table S1 (available at Rheumatology online).
Identified records were screened independently and in duplicate by two reviewers and any discrepancies were reconciled via discussion or a third reviewer. The SLR inclusion criteria were defined by the Patient populations, Interventions, Comparators, Outcome measures, and Study designs (PICOS) Statement ( Supplementary Table S2 , available at Rheumatology online). The SLR included published studies assessing approved therapies for the treatment of PsA. Collected data included study and patient population characteristics, interventions, comparators, and reported clinical and patient-reported outcomes relevant to PsA. For efficacy outcomes, pre-crossover data were extracted in studies where crossover occurred. All publications included in the analysis were evaluated according to the Cochrane risk-of-bias tool for randomized trials as described in the Cochrane Handbook [ 25 ].
NMA is the quantitative assessment of relative treatment effects and associated uncertainty of two or more interventions [ 26 , 27 ]. It is used frequently in health technology assessment, guideline development and to inform treatment decision making in clinical practice [ 26 ].
Bimekizumab 160 mg Q4W was compared with current b/tsDMARDs at regulatory-approved doses ( Table 1 ) by NMA. All comparators were selected on the basis they were relevant to clinical practice, i.e. recommended by key clinical guidelines, licensed by key regulatory bodies and/or routinely used.
NMA intervention and comparators
Therapeutic class . | Drug dose and frequency of administration . |
---|---|
Intervention | |
IL-17A/17Fi | Bimekizumab 160 mg Q4W |
Comparators | |
IL-17Ai | Secukinumab 150 mg with or without loading dose Q4W or 300 mg Q4W, ixekizumab 80 mg Q4W |
IL-23i | Guselkumab 100 mg every Q4W or Q8W, risankizumab 150 mg Q4W |
IL-12/23i | Ustekinumab 45 mg or 90 mg Q12W |
TNFi | Adalimumab 40 mg Q2W, certolizumab pegol 200 mg Q2W or 400 mg Q4W pooled, etanercept 25 mg twice a week, golimumab 50 mg s.c. Q4W or 2 mg/kg i.v. Q8W, infliximab 5 mg/kg on weeks 0, 2, 6, 14, 22 |
CTLA4-Ig | Abatacept 150 mg Q1W |
JAKi | Tofacitinib 5 mg BID, upadacitinib 15 mg QD |
PDE-4i | Apremilast 30 mg BID |
Other | Placebo |
Therapeutic class . | Drug dose and frequency of administration . |
---|---|
Intervention | |
IL-17A/17Fi | Bimekizumab 160 mg Q4W |
Comparators | |
IL-17Ai | Secukinumab 150 mg with or without loading dose Q4W or 300 mg Q4W, ixekizumab 80 mg Q4W |
IL-23i | Guselkumab 100 mg every Q4W or Q8W, risankizumab 150 mg Q4W |
IL-12/23i | Ustekinumab 45 mg or 90 mg Q12W |
TNFi | Adalimumab 40 mg Q2W, certolizumab pegol 200 mg Q2W or 400 mg Q4W pooled, etanercept 25 mg twice a week, golimumab 50 mg s.c. Q4W or 2 mg/kg i.v. Q8W, infliximab 5 mg/kg on weeks 0, 2, 6, 14, 22 |
CTLA4-Ig | Abatacept 150 mg Q1W |
JAKi | Tofacitinib 5 mg BID, upadacitinib 15 mg QD |
PDE-4i | Apremilast 30 mg BID |
Other | Placebo |
See Supplementary Table S4 , available at Rheumatology online for additional dosing schedules used in included studies. BID: twice daily; CTLA4-Ig: cytotoxic T lymphocyte antigen 4-immunoglobulin; IL-17A/17Fi: IL-17A/17F inhibitor; IL-17Ai: IL-17A inhibitor; IL-12/23i: IL-12/23 inhibitor; IL-23i: IL-23 inhibitor; JAKi: Janus kinase inhibitor; NMA: network meta-analysis; PDE-4i: phosphodiesterase-4 inhibitor; Q1W: once weekly; Q2W: every 2 weeks; Q4W: every 4 weeks; Q8W: every 8 weeks; Q12W: every 12 weeks; QD: once daily; TNFi: TNF inhibitor.
Two sets of primary analyses were conducted, one for a b/tsDMARD-naïve PsA population and one for a TNFi-experienced PsA population. Prior treatment with TNFis has been shown to impact the response to subsequent bDMARD treatments [ 28 ]. In addition, most trials involving b/tsDMARDs for the treatment of PsA (including bimekizumab) report separate data on both b/tsDMARD-naïve and TNFi-experienced subgroups, making NMA in each of these patient populations feasible.
For each population the following outcomes were analysed: American College of Rheumatology response (ACR20/50/70), Psoriasis Area and Severity Index (PASI90/100), and minimal disease activity (MDA). The analysis of serious adverse events (SAE) was conducted using a mixed population (i.e. b/tsDMARD-naïve, TNFi-experienced and mixed population data all were included) as patients’ previous TNFI exposure was not anticipated to impact safety outcomes following discussions with clinicians. The NMA included studies for which data were available at week 16, if 16-week data were not available (or earlier crossover occurred), data available at weeks 12, 14 or 24 were included. Pre-crossover data were included in the analyses for efficacy outcomes to avoid intercurrent events.
Heterogeneity between studies for age, sex, ethnicity, mean time since diagnosis, concomitant MTX, NSAIDs or steroid use was assessed using Grubb’s test, also called the extreme Studentized deviate method, to identify outlier studies.
All univariate analyses involved a 10 000 run-in iteration phase and a 10 000-iteration phase for parameter estimation. All calculations were performed using the R2JAGS package to run Just Another Gibbs Sampler (JAGS) 3.2.3 and the code reported in NICE Decision Support Unit (DSU) Technical Support Document Series [ 29–33 ]. Convergence was confirmed through inspection of the ratios of Monte-Carlo error to the standard deviations of the posteriors; values >5% are strong signs of convergence issues [ 31 ]. In some cases, trials reported outcome results of zero (ACR70, PASI100, SAE) in one or more arms for which a continuity correction was applied to mitigate the issue, as without the correction most models were not convergent or provided a large posterior distribution making little clinical sense [ 31 ].
Four NMA models [fixed effects (FE) unadjusted, FE baseline risk-adjusted, random effects (RE) unadjusted and RE baseline risk-adjusted] were assessed and the best-fit models were chosen using methods described in NICE DSU Technical Support Document 2 [ 31 ]. Odds ratios (ORs) and differences of mean change (MC) with the associated 95% credible intervals (CrIs) were calculated for each treatment comparison in the evidence network for the best fitting models and presented in league tables and forest plots. In addition, the probability of bimekizumab 160 mg Q4W being better than other treatments was calculated using surface under the cumulative ranking curve (SUCRA) to determine relative rank. Conclusions (i.e. better/worse or comparable) for bimekizumab 160 mg Q4W vs comparators were based on whether the pairwise 95% CrIs of the ORs/difference of MC include 1 (dichotomous outcomes), 0 (continuous outcomes) or not. In the case where the 95% CrI included 1 or 0, then bimekizumab 160 mg Q4W and the comparator were considered comparable. If the 95% CrI did not include 1 or 0, then bimekizumab 160 mg Q4W was considered either better or worse depending on the direction of the effect.
This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.
The SLR identified 4576 records through databases and 214 records through grey literature, of which 3143 were included for abstract review. Following the exclusion of a further 1609 records, a total of 1534 records were selected for full-text review. A total of 66 primary studies from 246 records were selected for data extraction. No trial was identified as having a moderate or high risk of bias ( Supplementary Table S3 , available at Rheumatology online).
Of the 66 studies identified in the SLR, 41 studies reported outcomes at weeks 12, 16 or 24 and met the criteria for inclusion in the NMA in either a b/tsDMARD-naïve population ( n = 20), a TNFi-experienced population ( n = 5), a mixed population with subgroups ( n = 13) or a mixed PsA population without subgroups reported ( n = 3). The PRISMA diagram is presented in Fig. 1 . Included and excluded studies are presented in Supplementary Tables S4 and S5 , respectively (available at Rheumatology online).
PRISMA flow diagram. The PRISMA flow diagram for the SLR conducted to identify published studies assessing approved treatments for the treatment of PsA. cDMARD: conventional DMARD; NMA: network meta-analysis; NR: not reported; PD: pharmacodynamic; PK: pharmacokinetic; PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses; RCT: randomized controlled trial; SLR: systematic literature review
The baseline study and patient characteristics (where reported) are presented in Supplementary Table S6 (available at Rheumatology online). There were 20–483 patients included in treatment arms. The median age of patients was 48.9 years, the median percentage of males was 50.3% and a median of 92.3% of patients were Caucasian. Patients had a mean time since diagnosis of 7.6 years and a mean PASI score of 8.7. The mean (range) use of concomitant MTX, NSAIDs and steroids were 53.9% (29.1% to 84.0%), 72.4% (33.3% to 100.0%) and 16.8% (9.2% to 30.0%), respectively. Heterogeneity was generally low across studies except for the concomitant use of MTX, NSAIDs and steroids. Using an approach consistent with established NMA methods in PsA [ 34–36 ], a meta-regression model using JAGS code reported in NICE DSU Technical Support Document 3 [ 33 ] was used to account for variation in placebo responses when model-fit statistics suggested that baseline risk-adjusted models provided a better fit to the data.
The network diagrams for ACR50 in b/tsDMARD-naïve and TNFi-experienced patients are presented in Fig. 2A and B with network diagrams for other outcomes presented in Supplementary Fig. S1 (available at Rheumatology online). The networks for ACR response were larger, in terms of both number of studies and patients included, than the networks for PASI. Similarly, the networks for b/tsDMARD-naïve patients were larger than TNFi-experienced patients across all outcomes analysed. Placebo was used as a common comparator in all networks and there were a few studies that included more than two arms (OPAL-Broaden, Select-PsA-1, SPIRIT-P1 and BE OPTIMAL) that included adalimumab as the reference arm in b/tsDMARD-naïve patients. Lastly, networks included studies where the primary outcome was evaluated at time points longer than 16 weeks (e.g. EXCEED study at 52 weeks) but as per the methods, 16-week data formed the network.
Network of evidence for ACR50. ( A ) b/tsDMARD-naïve patients. ( B ) TNFi-experienced patients. The size of the circle representing each intervention is proportional to the number of patients included in the analysis. The line width is proportional to the number of studies connecting the interventions. ABA: abatacept; ADA: adalimumab; APR: apremilast; b/tsDMARD-naïve: biologic and targeted synthetic DMARD-naïve; BKZ: bimekizumab; CZP: certolizumab pegol; ETA: etanercept; GOL: golimumab; GUS: guselkumab; IFX: infliximab; IV: intravenous; IXE: ixekizumab; PBO: placebo; Q4W: every 4 weeks; Q8W: every 8 weeks; RIS: risankizumab; SEC: secukinumab; TNFi-experienced: TNF inhibitor–experienced; TOF: tofacitinib; UPA: upadacitinib; UST: ustekinumab; w/o LD: without loading dose
The best-fit model is noted for each outcome with full model fit statistics for all outcomes presented in Supplementary Table S7 (available at Rheumatology online). Forest plots for ACR50 and PASI100 are presented in Figs 3 and 4 , with forest plots for other outcomes, along with the league tables in Supplementary Fig. S2 and Table S8 , respectively (available at Rheumatology online).
ACR50. The results for the NMA on ACR50 at week 16. ( A ) b/tsDMARD-naïve patients including forest plot and SUCRA values. FE baseline–adjusted model DIC = 469.59. ( B ) TNFi-experienced patients including forest plot and SUCRA values. RE-unadjusted model DIC = 205.33. a Week 24 data were used as week 16 data was not available. * The 95% CrI does not include 1; bimekizumab 160 mg Q4W is considered either better or worse depending on the direction of the effect. ABA: abatacept; ADA: adalimumab; APR: apremilast; b/tsDMARD-naïve: biologic and targeted synthetic DMARD-naïve; BKZ: bimekizumab; CrI: credible interval; CZP: certolizumab pegol; DIC: deviance information criterion; ETA: etanercept; FE: fixed effects; GOL: golimumab; GUS: guselkumab; IFX: infliximab; IV: intravenous; IXE: ixekizumab; NMA: network meta-analysis; PBO: placebo; Q4W: every 4 weeks; Q8W: every 8 weeks; RE: random effects; RIS: risankizumab; SEC: secukinumab; SUCRA: surface under the cumulative ranking curve; TNFi-experienced: TNF inhibitor–experienced; TOF: tofacitinib; UPA: upadacitinib; UST: ustekinumab; w/o LD: without loading dose
PASI100. The results for the NMA on PASI100 at week 16: ( A ) b/tsDMARD-naïve patients including forest plot and SUCRA values. FE baseline–adjusted model DIC = 150.27. ( B ) TNFi-experienced patients including forest plot and SUCRA values. RE-unadjusted model DIC = 81.76. a Week 24 data were used as week 16 data was not available. * The 95% CrI does not include 1; bimekizumab 160 mg 4W is considered better. ADA: adalimumab; b/tsDMARD-naïve: biologic and targeted synthetic DMARD-naïve; BKZ, bimekizumab; CrI, credible interval; CZP, certolizumab pegol; DIC, deviance information criterion; FE, fixed effects; GOL, golimumab; GUS, guselkumab; IXE, ixekizumab; NMA, network meta-analysis; PASI, Psoriasis Area and Severity Index; PBO, placebo; Q4W, every 4 weeks; Q8W, every 8 weeks; RE, random effects; SEC, secukinumab; SUCRA, surface under the cumulative ranking curve; TNFi-experienced, TNF inhibitor–experienced; UPA, upadacitinib
For ACR50 outcomes, the best-fit models for b/tsDMARD-naïve and TNFi-experienced were the FE baseline–adjusted model and RE-unadjusted model, respectively.
Bimekizumab 160 mg Q4W ranked 6th for ACR20 (SUCRA = 0.75), 5th for ACR50 (SUCRA = 0.74) ( Fig. 3A ) and 3rd for ACR70 (SUCRA = 0.80) among 21 treatments. For ACR50, bimekizumab 160 mg Q4W was better than placebo, abatacept 125 mg, guselkumab 100 mg Q4W, ustekinumab 45 mg, risankizumab 150 mg, guselkumab 100 mg Q8W and ustekinumab 90 mg; worse than golimumab 2 mg i.v.; and comparable to the remaining treatments in the network ( Fig. 3A ).
Bimekizumab 160 mg Q4W ranked 1st among 16 treatments for ACR20 (SUCRA = 0.96), 2nd among 15 treatments for ACR50 (SUCRA = 0.84) ( Fig. 3B ) and 1st among 16 treatments for ACR70 (SUCRA = 0.83). Bimekizumab 160 mg Q4W was better than placebo, abatacept 125 mg, secukinumab 150 mg without loading dose, tofacitinib 5 mg and secukinumab 150 mg; and comparable to the remaining treatments in the network on ACR50 ( Fig. 3B ).
For PASI100 outcomes, the best-fit models for b/tsDMARD-naïve and TNFi-experienced were the FE baseline–adjusted model and RE-unadjusted model, respectively.
Bimekizumab 160 mg Q4W ranked 2nd among 15 treatments (SUCRA = 0.89) for PASI90 and 1st among 11 treatments (SUCRA = 0.95) for PASI100 ( Fig. 4A ). Bimekizumab 160 mg Q4W was better than placebo, certolizumab pegol pooled, golimumab 2 mg i.v., secukinumab 150 mg, adalimumab 40 mg, upadacitinib 15 mg, secukinumab 300 mg and ixekizumab 80 mg Q4W; and comparable to the remaining treatments in the network on PASI100 ( Fig. 4A ).
Bimekizumab 160 mg Q4W ranked 1st among 10 treatments (SUCRA = 0.85) for PASI90 and 2nd among 7 treatments (SUCRA = 0.79) for PASI100 ( Fig. 4B ). Bimekizumab 160 mg Q4W was better than placebo, ixekizumab 80 mg Q4W and upadacitinib 15 mg; and comparable to the remaining treatments in the network on PASI100 ( Fig. 4B ).
For MDA, the best-fit models for b/tsDMARD-naïve and TNFi-experienced were the FE baseline–adjusted model and RE-unadjusted model, respectively.
Bimekizumab 160 mg Q4W ranked 1st among 13 treatments (SUCRA = 0.91) and was better than placebo [OR (95% CrI) 6.31 (4.61–8.20)], guselkumab 100 mg Q4W [2.06 (1.29–3.10)], guselkumab 100 mg Q8W [1.76 (1.09–2.69)], risankizumab 150 mg [1.99 (1.40–2.76)] and adalimumab 40 mg [1.41 (1.01–1.93)]; and comparable to the remaining treatments in the network ( Supplementary Fig. S2G , available at Rheumatology online).
Bimekizumab 160 mg Q4W ranked 1st among 11 treatments (SUCRA = 0.83) and was better than placebo [12.10 (5.31–28.19)] and tofacitinib 5 mg [6.81 (2.14–21.35)]; and comparable to the remaining treatments in the network ( Supplementary Fig. S2H , available at Rheumatology online).
The network for SAEs for a mixed population included 23 treatments and the best-fit model was an RE-unadjusted model (due to study populations and time point reporting heterogeneity). Bimekizumab 160 mg Q4W showed comparable safety to all treatments in the network ( Supplementary Fig. S2I , available at Rheumatology online).
The treatment landscape for PsA is complex, with numerous treatment options and limited direct comparative evidence. Bimekizumab 160 mg Q4W has recently been approved for the treatment of active PsA by the European Medicines Agency and recommended by NICE in the UK, and the published phase 3 results warrant comparison with existing therapies by NMA.
This NMA included 41 studies evaluating 22 b/tsDMARDs including the novel IL-17F and IL-17A inhibitor, bimekizumab. Overall, bimekizumab 160 mg Q4W ranked favourably among b/tsDMARDS for efficacy in joint, skin and disease activity outcomes in PsA across both b/tsDMARD-naïve and TNFi-experienced populations. The safety of bimekizumab 160 mg Q4W was similar to the other b/tsDMARDs.
The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and EULAR provide evidence-based recommendations for the treatment of PsA [ 1 , 2 ]. To treat peripheral arthritis symptoms in PsA, efficacy across the classes of current b/tsDMARDs are considered similar by both GRAPPA and EULAR, in part due to a lack of data comparing licensed therapies in a head-to-head trial setting [ 1 , 2 ]. EULAR recommends the use of JAK inhibitors in the case of inadequate response, intolerance or when a bDMARD is not appropriate [ 1 ]. This recommendation was made when tofacitinib was the only available JAK inhibitor, but reflects current marketing authorizations for tofacitinib and upadacitinib which indicate use in patients with an inadequate response or prior intolerance to TNFis (USA) or bDMARDs (Europe) [ 37–40 ]. This NMA suggests that bimekizumab 160 mg Q4W may have an advantage over current treatments, including IL-23 inhibitors in b/tsDMARD naïve patients, and secukinumab 150 mg and tofacitinib in TNFi-experienced patients, as evidenced by our analysis of ACR50 for which the pairwise comparisons were significantly in favour of bimekizumab 160 mg Q4W.
For the treatment of skin symptoms in PsA, IL-23, IL-12/23 and IL-17A inhibitors are currently recommended due to their greater efficacy compared with TNFis [ 1 , 4 ]. GRAPPA also suggests considering efficacy demonstrated in direct comparative studies in PSO when selecting a treatment for PsA skin symptoms [ 2 ]. In our analysis of complete skin clearance as measured by PASI100, bimekizumab 160 mg Q4W demonstrated the likelihood of significantly greater efficacy than IL-17A, JAK inhibitors and TNFis in b/tsDMARD-naïve patients and IL-17A and JAK inhibitors in TNFi-experienced patients. Furthermore, the NMA results for skin clearance in PsA are in alignment with previous studies in PSO that demonstrated superiority of bimekizumab 320 mg Q4W or Q8W vs secukinumab, ustekinumab and adalimumab ( P < 0.001) (note that the dosing of bimekizumab in PSO differs from that in PsA) [ 12 , 18 , 41 , 42 ].
There are similarities between our results and other recently published NMAs of b/tsDMARDs in PsA, although methodological heterogeneity across all NMAs makes comparisons challenging [ 34–36 , 43–45 ]. Among recent NMAs, the largest evaluated 21 treatments [ 34 ] and only four considered subgroups of b/tsDMARD-naïve and TNFi-experienced patients or those with inadequate response [ 35 , 36 , 43 , 45 ]. Furthermore, different or pooled levels of response were evaluated for ACR and PASI outcomes.
Previous NMAs also support IL-17, IL-12/23 and IL-23 inhibitors having greater efficacy for skin symptoms than TNFis [ 35 , 36 ]. In an overall PsA population, McInnes et al. demonstrated that secukinumab 300 mg, ixekizumab 80 mg Q4W, and ustekinumab 45 mg and 90 mg were likely more efficacious than TNFis for PASI90 [ 35 ]. In another NMA by Ruyssen-Witrand et al. , results suggested that ixekizumab 80 mg Q4W had significantly greater efficacy than adalimumab, certolizumab pegol pooled, and etanercept 25 mg twice weekly/50 mg once weekly for any PASI score (50%, 75%, 90% and 100% reduction) in bDMARD-naïve patients [ 36 ].
For joint outcomes, Mease et al. compared guselkumab Q4W and Q8W with other b/tsDMARDs in a network of 21 treatments in an overall PsA population for ACR50 [ 34 ]. Both guselkumab dosing schedules were better than abatacept and apremilast, but golimumab 2 mg i.v. had a higher likelihood of ACR50 response than guselkumab Q8W [ 34 ]. Despite MDA being assessed in clinical trials for bDMARD therapies and a treatment target in PsA [ 46 ], evidence for comparative efficacy for this outcome is limited. None of the most recent NMAs before this one included an analysis of MDA [ 34–36 ]. With regard to safety outcomes, previous NMAs evaluating SAEs also resulted in either no difference between b/tsDMARDs vs placebo or other b/tsDMARDs [ 34 , 36 , 44 , 45 ].
This study has a number of strengths. To our knowledge this NMA represents the most comprehensive and in-depth comparative efficacy analysis of approved treatments in PsA to date. The evidence was derived from a recent SLR, ensuring that new RCTs and updated results from previously published RCTs were included. It is also the first NMA to include the phase 3 BE COMPLETE and BE OPTIMAL trials of bimekizumab [ 19 , 20 ]. Our NMA used robust methods and accounted for variation in placebo response through network meta-regression in accordance with NICE DSU Technical Support Documents [ 31–33 ]. As an acknowledgement of the evolution of treatment advances, separate analyses of b/tsDMARD-naïve and TNFi-experienced subgroups were conducted with the intent to assist healthcare decision-making in different clinical settings. In addition, a panel of clinical experts were consulted from project inception and are authors of this paper, ensuring inclusion of a comprehensive set of clinically meaningful outcomes, including the composite, treat-to-target outcome of MDA.
Despite the robust evidence base and methodology, this NMA has limitations. Indirect treatment comparisons such as this NMA are not a substitute for head-to-head trials. There was heterogeneity in the endpoints and reporting in the included studies. Fewer studies reporting PASI outcomes resulted in smaller networks compared with the network of studies evaluating ACR response criteria. Not all trials reported outcomes at the same timepoint, thereby reducing the comparability of trial results, which has been transparently addressed by noting where week 24 data were used vs week 12, 14 or 16 data. The analyses for the TNFi-experienced population were limited by potential heterogeneity, especially in the analyses where fewer studies were included in the networks, as this group could include patients who had an inadequate response to TNFi or discontinued TNFi treatment due to other reasons (e.g. lost access). Also, in the analyses for the TNFi-experienced population, very low patient numbers for some treatments resulted in less statistical power. Additionally, the data included in the analysis were derived exclusively from RCTs, for which the study populations may not reflect a typical patient population seen in real-world practice. For example, trial results may be different in patients with oligoarthritis who are not well-represented in clinical trials.
Over the years covering our SLR, we acknowledge that patient populations and the PsA treatment landscape have evolved. After a thorough review of baseline patient characteristics, no significant differences were observed across the studies included in the NMA. To further mitigate uncertainty, baseline regression was used to actively correct for changes in the placebo rate over time ensuring a consistent and fair comparison across all included treatments. In addition, our analyses were conducted in separate b/tsDMARD-naïve and TNFi-experienced populations that reflect the evolving PsA patient population over time. Radiographic progression was not within the purview of this NMA because the NMA focused on a shorter timeframe than the 52-week duration typically recommended by the literature for investigating radiographic progression. Furthermore, there is existing literature on this topic, as exemplified by the work of Wang et al. in 2022 [ 47 ]. Nevertheless, the comprehensive and current evidence base, examination of multiple endpoints, and consistency with previous reported NMAs lend credence to our results.
Overall, the results of this NMA demonstrated the favourable relative efficacy and safety of bimekizumab 160 mg Q4W vs all approved treatments for PsA. Bimekizumab ranked high in terms of efficacy on joint, skin and MDA outcomes in both b/tsDMARD-naïve and TNFi-experienced patient populations, and showed comparable safety to other treatments. In the evolving PsA treatment landscape, bimekizumab 160 mg Q4W is a potentially beneficial treatment option for patients with PsA.
Supplementary material is available at Rheumatology online.
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
This study was funded in full by UCB Pharma.
Disclosure statement : P.J.M.: has received research grants from AbbVie, Amgen, BMS, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sun Pharma and UCB Pharma; consultancy fees from AbbVie, Acelyrin, Aclaris, Amgen, BMS, Boehringer Ingelheim, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Moonlake Pharma, Novartis, Pfizer, Sun Pharma and UCB Pharma; and speakers’ bureau for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma. L.C.C.: received grants/research support from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB; worked as a paid consultant for AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Moonlake, Novartis, Pfizer and UCB; and has been paid as a speaker for AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, Novartis, Pfizer and UCB. D.D.G.: consultant and/or received grant support from Abbvie, Amgen, BMS, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer and UCB. J.F.M.: consultant and/or investigator for AbbVie, Amgen, Biogen, BMS, Dermavant, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma and UCB Pharma. P.N.: research grants, clinical trials and honoraria for advice and lectures on behalf of AbbVie, Boehringer Ingelheim, BMS, Eli Lilly, Galapagos/Gilead, GSK, Janssen, Novartis, Pfizer, Samsung, Sanofi and UCB Pharma. S.G. and V.L.-K.: employees of Cytel, Inc. which served as a consultant on the project. A.R.P., D.W. and V.T.: employees and stockholders of UCB Pharma.
The authors acknowledge Leah Wiltshire of Cytel for medical writing and editorial assistance based on the authors’ input and direction, Heather Edens (UCB Pharma, Smyrna, GA, USA) for publication coordination and Costello Medical for review management, which were funded by UCB Pharma. This analysis was funded by UCB Pharma in accordance with Good Publication Practice (GPP 2022) guidelines ( http://www.ismpp.org/gpp-2022 ). Data were previously presented at ISPOR-US 2023 (Boston, MA, USA, 7–10 May 2023).
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1 Department of Neurology, Sichuan Taikang Hospital, Chengdu, Sichuan, China
2 Department of Rehabilitation, Affiliated Hospital of Yunnan University, Kunming, Yunnan, China
Associated data.
No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.
Epilepsy is a common and serious chronic neurological disorder, and some patients suffer from cognitive dysfunction. We aim to assess the efficacy and safety of acupuncture combined with traditional Chinese herbal for primary epilepsy patients with cognitive impairment.
To search the randomized control trials (RCTs) published before April 20, 2023 from PubMed, Embase, Cochrane Library, Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), Web of science, and Wanfang Database. The risk of bias within each individual trial was evaluated using the Cochrane Collaboration tool. RevMan5.3 software was used for statistical analysis. The odds ratio (OR) or weighted mean difference (WMD) with a 95% confidence interval (CI) was calculated for each RCT before data pooling.
The primary outcomes involve changes in cognitive function and behavioral disturbances. The secondary outcomes focused on quality of life and adverse effects.
The results of this review are expected to provide new guidelines for the treatment of primary epilepsy patients with cognitive impairment.
This systematic review protocol was registered at the International Prospective Register of Systematic Reviews (PROSPERO) (Registration number: CRD42023415355 ).
Epilepsy is a chronic disease in which sudden abnormal discharge of brain neurons leads to transient brain dysfunction [ 1 ]. Each epileptic seizure of the patient is unpredictable, which not only seriously reduces the quality of life, but also causes different degrees of cognitive dysfunction, manifested as a functional decline in attention, memory, abstract thinking ability, reasoning ability, etc. even lost [ 2 , 3 ]. Epidemiological studies revealed that the global prevalence of epilepsy has surpassed 70 million, with approximately 700,000 new cases reported annually [ 2 ]. Numerous experimental models have demonstrated that cognitive dysfunction is a common comorbidity in epilepsy. For instance, Kumar et al. discovered that all rats with pentetrazole-induced epilepsy exhibited cognitive deficits [ 4 ]. In clinical practice, the prevalence of cognitive impairment in epilepsy patients varies from 30% to 40%, depending on the assessment method and population under evaluation [ 5 ]. Cognitive impairment significantly impacts the quality of life for individuals with epilepsy, emphasizing the significance of early prediction and intervention in managing cognitive dysfunction. With the promotion and application of the “biology-psychology-social” medical model, in the process of clinical diagnosis and treatment of epilepsy, it is necessary to pay attention not only to the control of epileptic seizures but also to the accompanying cognitive impairment of patients.
The earliest records of epilepsy in China can be traced back to 2000 years ago in the Huang Di Nai Jing of traditional Chinese medicine. Traditional Chinese medicine has a long history and rich experience in the treatment of epilepsy. It has the advantages of a stable curative effect, few side effects, and can promote the recovery of brain cell function, and is expected to be applied in antiepileptic therapy [ 6 , 7 ]. Acupuncture is another important traditional healing method, which has been used and applied for more than 2000 years in China. In recent years, acupuncture has shown positive therapeutic effects in improving overall effectiveness of epilepsy treatment, reducing the severity of epileptic seizures, and minimizing adverse reactions. Research has confirmed that electroacupuncture stimulation of “Zu-san-li” and “Shang-ju-xu” for 6 weeks significantly reduces the level of cyclooxygenase-2 (COX-2) in the hippocampus of epileptic rats, resulting in an anti-inflammatory effect [ 8 ]. Furthermore, electroacupuncture intervention has been found to upregulate the expression of Nuclear factor erythroid2-related factor 2 (Nrf-2) and its downstream antioxidant factors, activating the Nrf-2-ARE signaling pathway to protect brain tissue against oxidative stress damage [ 9 ]. In summary, acupuncture’ s mechanism in treating epilepsy encompasses various aspects of the condition’ s pathogenesis, including apoptosis inhibition, inflammatory response suppression, oxidative stress reduction, ion channel regulation, and modulation of intestinal flora. However, high-quality evidence from relevant studies is lacking. Therefore, we carried out a meta-analysis of randomized controlled trials (RCTs) to reach a solid conclusion with a larger sample size. We aimed to determine the effects of acupuncture for epilepsy patients with cognitive impairment and provide evidence-based recommendations for patients with epilepsy.
This systematic review protocol was registered at PROSPERO (Registration number: CRD42023415355). The protocol is according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement guidelines. The results of this meta-analysis will be published in a journal or conferences.
2.2.1 participants.
Patients who are clinically diagnosed with epilepsy patients with cognitive impairment according to the diagnostic criteria of the 10TH revision of the International Classification of Diseases (ICD-10) (World Health Organization, 1992) and the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (American Psychiatric Association, 1994) will be included. The onset of cognitive impairment was required to be definitely and causally linked with primary epilepsy. Additionally, patients with combined heart, lung, kidney, liver, bone marrow, blood, and other systemic diseases, combined intracranial occupying lesions, combined cerebral infarction, combined hysteria, schizophrenia, and another psychiatric history should be excluded.
For the experimental group, trials that use acupuncture therapy combined with traditional Chinese herbs will be included; and acupuncture therapy involves manual acupuncture, electroacupuncture, fire acupuncture, warm acupuncture, and scalp acupuncture. For the corresponding control group, interventions could be placebo or waiting list control, sham acupuncture, conventional treatment, or pharmacotherapy that consists of the experimental group.
The primary outcomes focused on cognitive function and behavioral disturbances, which could be measured by scales such as the EpiTrack score, the Mini-mental state examination (MMSE), the Hasegawa’s Dementia Scale (HDS), the Montreal Cognitive Assessment (MoCA) score. The secondary outcomes focused on quality of life and adverse effects which could be measured by scales such as the Quality of Life Scale for Epileptic Patients-31 (QOLIE-31), the short form 36 health survey questionnaire (SF-36), the Activities of Daily Living (ADL) Scale, and the Functional Activities Questionnaire (FAQ).
Randomized controlled trials (RCTs) related to epilepsy patients with cognitive impairment will be included without language restrictions. Non-RCTs, inappropriate intervention, uncontrolled trials, reviews, and protocols for RCTs were excluded.
All published RCTs in the following databases will be searched from their inception to April 2023: PubMed, EMBASE, Web of Science, Chinese Biomedical Literature Database, the Cochrane Central Register of Controlled Trials (CENTRAL), Wanfang database, and the China National Knowledge Infrastructure (CNKI), without language restrictions.
The search terms included “epilepsy”, “Epilepsies”, “Seizure Disorder”, “Seizure Disorders”, “Cognitive Dysfunctions”, “Cognitive Impairments”, “Cognitive Impairment”, “Cognitive Disorder”, “Cognitive Decline”, “Cognitive Declines”, “Mental Deterioration”, “Acupuncture Therapy”, “Acupuncture”, “Traditional Chinese medicine”, “Traditional Chinese herbs”. An example of the search strategy for PubMed is summarized in Table 1 .
Number | Search terms (PubMed) |
---|---|
1 | Epilepsy[Mesh] |
2 | Epilepsy[Title/Abstract] |
3 | Seizure Disorder [Title/Abstract] |
4 | Seizure Disorders [Title/Abstract] |
5 | Seizure [Title/Abstract] |
6 | 1 or 2–5 |
7 | Cognitive Dysfunctions [Mesh] |
8 | Cognitive Dysfunctions [Title/Abstract] |
9 | Cognitive Impairments [Title/Abstract] |
10 | Cognitive Impairment [Title/Abstract] |
11 | Cognitive Disorder [Title/Abstract] |
12 | Cognitive Decline [Title/Abstract] |
13 | Cognitive Declines [Title/Abstract] |
14 | Mental Deterioration [Title/Abstract] |
15 | 7 or 8–14 |
16 | Acupuncture [Mesh] |
17 | Acupuncture Therapy [Title/Abstract] |
18 | Acupuncture Treatment [Title/Abstract] |
19 | Acupuncture Therapy [Title/Abstract] |
20 | Pharmacoacupuncture Treatment [Title/Abstract] |
22 | Acupotomy [Title/Abstract] |
22 | Fire acupuncture [Title/Abstract] |
23 | Warm acupuncture [Title/Abstract] |
24 | Scalp acupuncture [Title/Abstract] |
25 | Acupuncture [Title/Abstract] |
26 | 16 or 17–25 |
27 | Traditional Chinese Medicine [Mesh] |
28 | Traditional Chinese Medicine [Title/Abstract] |
29 | Chinese Herbal Drugs [Title/Abstract] |
30 | Chinese Herbal [Title/Abstract] |
31 | 27 or 28–30 |
32 | 6 and 15 and 26 and 31 |
We will import all identified literature into EndNote X9 software to delete any duplicates. Two authors will screen the titles/abstracts of all potential studies to remove studies that are not related to the topic. Then, the full text of the remaining studies will be read carefully to further determine whether they fulfill all eligible criteria. If necessary, a third author will help to solve any divergence between the two authors. The following data were extracted from the included studies: (1) basic information of the study including the first author’s name, year of publication, sample sizes, participant’s age, and disease duration; (2) interventions details; (3) control details; (4) primary outcome indicators, secondary outcome indicators before and after the intervention; (5) adverse events. If available data could not be obtained directly from the article, the corresponding author was contacted and clarification of ambiguities and missing information was provided by phone or email. Details of the selection process will be presented in the PRISMA flow chart ( Fig 1 ).
“n” represents the number of studies.
The methodological quality of the included references was assessed using the Cochrane Collaboration’s Risk of Bias (ROB) tool by two reviewers independently. This assessment tool mainly including the generation of random sequences, allocation concealment, blinding of researchers and subjects, blinding in outcome assessment, and completeness of outcome data, selective reporting of research results and other sources of bias. Each item is judged as: “low risk”, “high risk” or “unclear”. Any discrepancies concerning the assessments were resolved through the discussion with a methodological researcher.
To conduct statistical analysis, we used Review Manager (RevMan) software version 5.3.0 (Cochrane Central Executive Team, United Kingdom) as recommended by Cochrane Collaboration. Heterogeneity was measured using both Cochran’s Q-test (P value ≤0.10 was used to define a significant degree of heterogeneity) and the I 2 statistic ( I 2 >50% showed the existence of heterogeneity). If the heterogeneity was significant (P < 0.1, I 2 > 50%), a random effect (RE) model was chosen to pool the data, and if there was acceptable heterogeneity (P ≥ 0.1, I 2 ≤ 50%), a fixed effect (FE) model was used. The mean difference (MD) or standard mean difference (SMD) was used to represent continuous data, and the Odds Ratio (OR) were used to represent dichotomous data. Results were reported with 95% confidence intervals (CI), and P < 0.05 was considered a significant statistical effect. Subgroup analyses will be performed for heterogeneity by intervention, type of control (placebo, sham acupuncture, usual care, or drug treatment), duration of treatment, point, and outcome measure. Sensitivity analyses were performed on the primary endpoint to test the homogeneity of the results. After excluding low-quality studies, we will rerun the meta-analysis and use other statistical methods.
When more than 10 studies were included, publication bias was assessed using funnel plots. We analyzed potential publication bias using Egger or Begg tests and estimated results according to the Cochrane Handbook of Systematic Reviews of Interventions.
No human or animal subjects or samples were used. Patients did not participate in the formulation of research questions, measurement of outcomes, and study design.
At present, the influencing factors of cognitive dysfunction in epilepsy patients have been basically clarified, but the pathogenesis has not yet been fully clarified. Studies have found that epilepsy-related cognitive impairment may be related to damage such as hippocampal sclerosis, abnormal transmitter transmission, inflammatory factors and oxidative stress [ 10 – 14 ]. D’Avila et al. discovered that activated microglia release various inflammatory mediators, which can lead to tissue damage and neurotoxicity through mechanisms like oxidative stress and synaptic remodeling [ 15 ]. These processes have been linked to cognitive impairment. Mishra et al. conducted a study using a mouse model of epilepsy and found that reducing lipid peroxidation levels and increasing antioxidant mechanisms resulted in shorter seizure duration and improved cognitive function [ 16 ]. The existence of cognitive impairment will bring a certain burden to the life of epilepsy patients. Therefore, it is of great significance to diagnose and treat cognitive impairment in time to reduce the burden on patients and their families.
Modern pharmacological studies have shown that some traditional Chinese medicines (such as Gastrodia elata, Polygala tenuifolia, Acorus tatarinowii, Nardostachys chinensis, Safflower, etc.) have the effects of inhibiting platelet aggregation, prolonging thrombin time, protecting neurons, nourishing blood and calming the nerves, antiepileptic, sedative, antispasmodic, and analgesic [ 17 – 20 ]. Acupuncture and moxibustion treat epilepsy mainly by disrupting brain waves, inhibiting seizures, affecting the neuroendocrine immune system, and protecting neurons, thereby reducing seizures and improving the quality of life of patients with epilepsy. Acupuncture acts on acupoints through physical stimulation, stimulates related nerve veins, affects the secretion and release of neurotransmitters in the brain, and regulates the electrical activity of brain nerve cells [ 9 , 21 ].
However, there is no studies have not been systematically organized on the efficacy of acupuncture for primary epilepsy patients with cognitive impairment. Thus, it is necessary to organize evidence that has been proven by RCTs, so that it can be used.
S1 checklist, funding statement.
The author(s) received no specific funding for this work.
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Systematic review of factors influencing students’ performance in educational buildings: focus on lca, iot, and bim.
Reference | Investigated Parameter | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
RT | LI | IAQ | T | CO | ST | S-TAP | CP | A | AV | RH | |
Brink et al. (2023) [ ] | + | + | + | − | + | + | + | + | − | − | − |
Choi et al. (2014) [ ] | − | + | + | + | − | − | + | + | − | − | − |
Brink et al. (2021) [ ] | − | + | + | + | + | + | + | + | + | − | − |
Kim et al. (2012) [ ] | − | + | + | + | − | − | − | − | + | − | − |
Xiong et al. (2018) [ ] | − | + | − | + | − | + | − | + | + | − | − |
Calderón-Garcidueñas et al. (2008) [ ] | − | − | − | − | − | − | − | + | − | − | − |
Gardin et al. (2023) [ ] | − | − | − | − | − | − | − | + | − | − | − |
Duque et al. (2022) [ ] | − | − | − | − | − | − | − | + | − | − | − |
Kabirikopaei et al. (2021) [ ] | − | − | + | + | + | − | − | + | − | + | + |
Gaihre et al. (2014) [ ] | − | − | − | + | + | − | − | + | − | − | + |
Kielb et al. (2015) [ ] | − | − | + | − | − | − | − | − | − | − | − |
Mendell et al. (2005) [ ] | − | − | + | + | + | + | − | + | − | − | + |
Shendell et al. (2004) [ ] | − | − | + | + | + | − | − | − | − | − | − |
Wargocki et al. (2017) [ ] | − | − | + | + | + | + | − | + | − | + | − |
Requia et al. (2022) [ ] | − | − | − | − | − | − | − | + | − | − | − |
Guo et al. (2010) [ ] | − | − | + | + | − | − | − | − | − | − | + |
Richmond-Bryant et al. (2009) [ ] | − | − | - | + | − | − | − | − | − | + | + |
Rivas et al. (2014) [ ] | − | − | + | − | − | − | − | − | − | − | − |
Martínez-Lazcano et al. (2013) [ ] | − | − | − | − | − | − | − | + | − | − | − |
Forns et al. (2017) [ ] | − | − | − | − | − | + | − | + | − | − | − |
Benka-Coker et al. (2021) [ ] | + | + | + | + | + | + | − | + | − | − | + |
Choi et al. (2022) [ ] | − | - | + | - | + | + | − | + | − | − | + |
Wang et al. (2020) [ ] | − | + | − | + | − | + | − | + | + | + | + |
Shan et al. (2018) [ ] | − | − | + | + | + | + | + | − | − | + | + |
Ryan et al. (2022) [ ] | − | − | − | + | − | − | − | − | − | − | + |
3.1. life cycle assessment (lca), 3.2. building information modeling (bim), 3.3. internet of things (iot), 3.4. digital twins (dts), 4. discussion, 4.1. indoor environment factors, 4.2. new-generation vs. fundamental articles, 4.3. interdisciplinary research findings, 4.4. focus on iaq and overlooked aspects, 4.5. database comparison and article selection, 5. conclusions, author contributions, data availability statement, conflicts of interest.
Click here to enlarge figure
P | Population; problem; source of information | What population? What is the database? What is the source of the information? | Population: School buildings Database: Scopus and WOS Sources: Review papers, field studies, research papers, and technical reports |
I | Intervention; factors | What interventions or factors are you interested in? | Differences between fundamental and new-generation topics in school buildings |
C | Comparison; circumstances; situation | What circumstances are you interested in? What will you compare it to? | Comparison of fundamental and new-generation topics in school buildings. |
O | Outcome; main point of interest | What do you expect to learn about? Dependent variable? Main focus? | To find out the differences and similarities between fundamental research topics and new-generation research topics. The main focus is parameters tested in schools and performance of students. |
Criterion Type | Inclusion Criteria | Exclusion Criteria |
---|---|---|
Research area | Related to the civil engineering | Not Related to the civil engineering (e.g., the arts or humanities). |
Topic | LCA, BIM, IoT, educational buildings | Not educational buildings (e.g., industrial, commercial, and residential buildings) |
Year of publication | 1800–2023 | Outside the set range |
Publication source | Peer-reviewed academic journals, technical reports | Other type of sources |
Language | English | Other languages |
Type of publication | Review papers, field studies, and research papers | Other types of publication |
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Vestfal, P.; Seduikyte, L. Systematic Review of Factors Influencing Students’ Performance in Educational Buildings: Focus on LCA, IoT, and BIM. Buildings 2024 , 14 , 2007. https://doi.org/10.3390/buildings14072007
Vestfal P, Seduikyte L. Systematic Review of Factors Influencing Students’ Performance in Educational Buildings: Focus on LCA, IoT, and BIM. Buildings . 2024; 14(7):2007. https://doi.org/10.3390/buildings14072007
Vestfal, Paulius, and Lina Seduikyte. 2024. "Systematic Review of Factors Influencing Students’ Performance in Educational Buildings: Focus on LCA, IoT, and BIM" Buildings 14, no. 7: 2007. https://doi.org/10.3390/buildings14072007
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