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Accountability and Social Accounting for Social and Non-Profit Organizations

ISBN : 978-1-78441-005-6 , eISBN : 978-1-78441-004-9

Publication date: 27 November 2014

This article focuses on the lesser-used notion of stewardship and stewardship-ism. Stewardship is a concept that has inspired the activities of several organizations whose mission is to preserve, protect and maintain natural, social and economic assets for the benefit of stakeholders and communities. As observed by Contrafatto and Bebbington (2013), stewardship has some resonance with current policy agendas that attend to the issues related to sustainable development, corporate social responsibility and accountability. Most of the existing works on stewardship provide several perspectives with the focus being either on normative foundations of stewardship or on its organizational and managerial implications. In particular, the stewardship-related literature offers a range of conceptions and approaches ranking from a relatively narrow view of the resources, sources and time frame of stewardship to very broad specification. In this article, the management, organization and accounting literature is analysed to propose a map of current theorizing on stewardship. In particular, drawing on the methodological approach adopted by Lowndes (1996), four theoretical vignettes have been proposed to illustrate different variants and approaches in stewardship framework. Each vignette provides a set of conceptual constructs, ideas and views to understand stewardship and stewardship-inspired behaviour. The variety of approaches/perspectives on stewardship, as illustrated from the analysis undertaken in this article, provides an opportunity for deeper theory-based understanding of social and organizational dynamics. In particular, it is argued that the richness of perspectives, focus and levels of analysis could offer insights to conceptualize, see and make sense of some of the challenges that are posed by a desire for promoting transition towards more sustainable ways of organizing our society.

• Stewardship and stewardship-ism
• Stewardship theory
• Stewardship and sustainable development

Acknowledgements

I would like to thank John Ferguson, Sara Moggi, the two anonymous reviewers and especially the guest editors, Ericka Costa, Lee D. Parker and Michele Andreaus, for their advice and helpful comments on earlier drafts of this article.

Contrafatto, M. (2014), "Stewardship Theory: Approaches and Perspectives", Accountability and Social Accounting for Social and Non-Profit Organizations ( Advances in Public Interest Accounting, Vol. 17 ), Emerald Group Publishing Limited, Leeds, pp. 177-196. https://doi.org/10.1108/S1041-706020140000017007

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• DOI: 10.1177/0974686218776026
• Corpus ID: 169485113

Stewardship Theory of Corporate Governance and Value System: The Case of a Family-owned Business Group in India

• S. Subramanian
• Published in Indian Journal of Corporate… 1 June 2018

31 Citations

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Introduction The view of organizations as “purely rational and calculated systems” (Frost et al. 2006, 843) has a long history, underpinned by a ‘model of man’ that depicts actors as inherently self-interested, aiming to maximize their economic gain (Donaldson and Davis 1991). Many theories of organizations irrespective of their origin have built upon this simplied view of human action, seeing it as “the pursuit of self-interest by rational, more or less atomized individuals” (Granovetter 1985, 482). As Ghoshal argued, the view of business studies as science has resulted in the “the denial of any moral or ethical considerations in our theories,” which in turn has negatively informed management practice (2005, 77). However, there is a recent contra-trend acknowledging the plurality of human behavior and motivation going beyond self-serving behavior. For instance, the rich literature on corporate social responsibility (CSR) has tried to capture and explain responsibility in the context of corporate environments. The concept is thus dierentiated from “business fulllment of core prot-making responsibility and from the social responsibilities of government” (Matten and Moon 2008, 405). Also the growing body of research on social entrepreneurship captures business activity which is not primarily directed towards nancial outcomes, but to “pursue opportunities to catalyze social change and address social needs” (Mair and Martí 2006, 37).

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Governance Practices in Poverty Alleviation Projects: Case Study from Stewardship-Driven Perspective and Sustainability Context

• First Online: 06 December 2021

Cite this chapter

• Abdul Muhaimin Abdul Latiff 8 ,
• Che Maznah Mat Isa 8 &
• Aini Jaapar 8  

562 Accesses

The successful planning and implementation of poverty alleviation projects are crucial for establishing optimum benefits to its intended target groups in line with the Sustainable Development Goals charted by the United Nations. This chapter focuses on exploring the project governance practices in poverty alleviation projects from public officials’ perspective through the lens of stewardship theory. Project governance is a framework and functions to guide project management activities to meet organisational strategic and operational goals, leading to project success. By investigating three (3) public poverty alleviation projects in Malaysia, it is discovered that project governance is practised and positively interplayed with several project governance elements throughout the project planning and implementation. Several insights and rationales of the decision-making process from the sustainability contexts are also explored where the target groups should be allowed to participate in decision making in the front-end of the project, while lessons learnt from previous projects are invaluable input that should be compiled and documented for future references. Although the fragmented nature of public projects is considered a point of weakness, project delivery success could be achieved by utilising project governance practices applicable in public poverty alleviation projects.

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Acknowledgements

The researcher acknowledges the Ministry of Rural Development Malaysia and Ministry of Housing and Local Government Malaysia for their permission to conduct this study.

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Latiff, A.M.A., Isa, C.M.M., Jaapar, A. (2022). Governance Practices in Poverty Alleviation Projects: Case Study from Stewardship-Driven Perspective and Sustainability Context. In: Hassan, R., et al. Green Infrastructure. Springer, Singapore. https://doi.org/10.1007/978-981-16-6383-3_14

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The growing role and impact of stewardship: case studies.

Purposeful stewardship comes down to achieving a tangible and lasting commitment to sustainability.

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Approaching the Presidency: Roosevelt & Taft

Some presidents view their responsibilities in strictly legal terms, others according to duty. Roosevelt and Taft took two extreme approaches.

Theodore Roosevelt, President of the United States from 1901-1909, embodied what many scholars typically refer to as the ‘stewardship presidency.’ In the words of Roosevelt, it is the president’s “duty to do anything that the needs of the nation demanded unless such action was forbidden by the Constitution or by the laws.” Under Roosevelt’s expansionist view, anything the president does is considered acceptable unless it is expressly forbidden by the Constitution or laws passed by Congress. Roosevelt believed he served the people, not just the government. He took many actions as president that stretched the limits of the executive branch, including the creation of national parks without regard for states’ jurisdiction and fostering revolt in Colombia to establish the Panama Canal.

On the other hand, William Howard Taft, President of the United States from 1909-1913, embodied what many scholars refer to as a ‘strict constructionist’ model of the presidency. Under this approach, unless the Constitution or Congress explicitly grants a certain power, the president does not have the right to act. In Taft’s words, “the President can exercise no power which cannot be fairly and reasonably traced to some specific grant of power or justly implied and included within such express grant as proper and necessary to its exercise.”

While Roosevelt expanded federal power in many areas, Taft felt many of these actions were legal overreaches. For example, as a “trust-buster” Roosevelt differentiated between ‘good’ trusts and ‘bad’ trusts, using his expanded powers as president to make this distinction unilaterally. He made a ‘gentlemen’s agreement’ with U.S. Steel and told them that the American government would not attack their corporation as a monopoly since he believed the company was working in the interests of the American people. Roosevelt did not, however, pass any legislation or make any binding orders to this effect. Taft took a more legalistic view and later, as president, directed his attorney general to file an anti-trust lawsuit against U.S. Steel. Roosevelt took Taft’s actions as a personal attack upon Roosevelt’s presidency and positions.

Although Taft continued many of Roosevelt’s policies, he was inclined to look at the facts of the situation and make a choice based on evidence. Roosevelt, on the other hand, was more inclined to do what he felt was “right.” Their disagreements, which hinged on the grey areas of the legal and the ethical, ultimately propelled the break within the Republican Party during the 1912 elections.

Discussion Questions

1. What differences do you see between Roosevelt’s and Taft’s views of their ethical responsibilities as president?

2. How did Roosevelt and Taft each negotiate the line between law and ethics?

3. Between Roosevelt and Taft, do you think one demonstrated overconfidence bias more than the other? Explain.

4. In the case of U.S. Steel, whose actions caused more harm: Roosevelt by making an informal agreement, or Taft by violating that agreement? Explain.

5. Whose approach to the U.S. presidency, Taft’s or Roosevelt’s, do you think is preferable in light of both legal and ethical considerations? Why?

6. Can you think of an example of another president or world leader whose approach to leadership is similar to either Roosevelt or Taft? How does this leader’s approach affect his/her political actions?

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The overconfidence bias is our tendency to be more confident in our ability to act ethically than is objectively justified by our abilities and moral character.

Bibliography

The Constitutional Presidency http://www.worldcat.org/title/constitutional-presidency/oclc/263497942  

The Evolving Presidency: Landmark Documents, 1787-2010 http://www.worldcat.org/title/evolving-presidency-landmark-documents-1787-2015/oclc/911004600

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Stewardship as process: A paradox perspective

Miguel pina e cunha.

a Nova School of Business & Economics, Universidade Nova de lisboa, Lisbon, Portugal

Arménio Rego

b Católica Porto Business School and BRU, ISCTE-IUL, Porto, Portugal

Stewart Clegg

c University of Technology Sydney, Sydney, Australia

Walter P. Jarvis

Long-term stewardship is usually represented as a stable structural condition and portrayed as a source of competitive advantage to firms (including family businesses) that use it as a mode of governance. Less is known about how organizations engage with stewardship as a process . We embrace a process approach to report a case study about the unfolding of stewardship in a multi-business family group. We conclude that stewardship is a process marked by critical tensions and paradoxes; by exploring the nature of these we uncover further dimensions and responses to the paradoxes of stewardship.

1. Introduction

Stewardship may be defined “as the extent to which an individual willingly subjugates his or her personal interests to act in protection of others’ long-term welfare” ( Hernandez, 2012 , p. 174). As such, stewardship is seen as a way not only to influence an organization positively but also to have an impact on the “welfare of society”. Such societal impact is particularly worth studying in family owned businesses (FOB) for two interrelated reasons. First, family firms employ about 60% of the global workforce ( Neckebrouck, Schulze, & Zellweger, 2018 ). Second, in the context of the FOB literature, there is an implicit dualism pitting stewardship against managerial agency in which stewardship is postulated as an institutional source of competitive advantage over managerial agency ( James, Jennings, & Devereaux-Jennings, 2017 ; Neubaum, Thomas, Dibrell, & Craig, 2017 ).

From this perspective, FOBs, “the most prevalent form of organization in the world” ( Campbell, Hoffman, Campbell, & Marchisio, 2011 , p. 277; see also; Chen, Liu, Yang, & Chen, 2016 ), will “be exempt from problems of agency … by virtue of their intra-familial altruistic element” ( Chrisman, Chua, & Litz, 2004 , p. 337) and thus are seen as potentially superior to other organizational forms because their familial managers have a natural predisposition to act as stewards of the business ( Keyt, 2015 ; Neubaum et al., 2017 ). The a priori assumption is that family managers tend to think and act as stewards serving a common family good. The assumption may be erroneous. Families may often be idealized by politicians, clergy, and advertising agencies but that is no reason why management scholars should follow suit. The daily pages of the financial press are replete with stories of family business foundering on the reef of politics, not surprisingly, if only because the institutions of family and business do not coincide in their logics. Families lack the formal constraints and boundaries defining normal workplaces. Professional norms may govern family relations in the firm; nonetheless, relatives will still often fight and argue, emotionally, with passions fuelled by memories of prior struggles, as they would at home. In such circumstances, decision-making can become either an agonizing process, especially if roles and responsibilities are poorly defined, or something settled by autocratic, usually patriarchal, fiat. Sibling rivalries, dynastic struggles and antagonistic divorces are routinely exposed in the business press reporting family businesses (see Hill, 2019 , on the Redstone family and their stewardship of CBS and Viacom, for a recent example). The case of Familia (a pseudonym for the Southern European family multi-business group studied inductively in this paper) might, in many respects, be regarded as an ideal mediation of family inclusion and formal organization and governance; however, even in a context of clear rules, the emotional struggles of family are not contained and bounded, as we shall see.

The assumptions relating family firms and good stewardship have been, at least partially, challenged by researchers. Neckebrouck et al. (2018 , p. 571) found, in a sample of almost 15,000 private Belgian firms over a 19-year period, that although family firms are good financial stewards, they are “surprisingly poor organizational stewards”. Empirical evidence such as this does not reduce the importance of stewardship for FOB, on the contrary, it suggests that it is necessary to get a more nuanced perspective of how stewardship really works at FOBs. By attending to the stewardship process in FOBs, i.e. by approaching stewardship not as a thing made but as a thing in the making ( Langley & Tsoukas, 2010 ), this paper contributes to a better understanding of stewardship in FOBs, not as a structural condition but as a process emerging, developing, growing and terminating over time. Drawing on a case study and conceptually adopting a process perspective ( Langley, Smallman, Tsoukas, & Van de Ven, 2013 ), we consider that changes in family dynamics have consequences for the business, as different family branches (and non-family members, over time) and different generations nurture divergent interests.

As we engaged with Familia, we realized that there were tensions around the idea of stewardship. We therefore decided to study stewardship as a process rich in tension and ambivalence. Sustaining stewardship can be challenging as familial generations and branches jostle and replace each other and the representation of the business evolves and diversifies, raising our research question: how does stewardship in an FOB involve the ongoing navigation of paradoxes at the boundary of the family and the firm? Overall, we approach our theme with the lens of a process view (rather than from a stable entity perspective): stewardship as an ongoing fragile and political construction, a construction that can be represented as paradoxical and therefore unstable, one whose tensions are dealt with dialogically, over time, between generations. The exploration of tension and paradox is still limited in the family business literature ( Ingram, Lewis, Barton, & Gartner, 2016 ). We use paradox as a meta-theory to illuminate stewardship as a process rich in tension. We thus depart from a more structural-stable understanding for a processual view, according to which the condition of stewardship is in fact an ongoing construction. The fact that this ongoing dynamic construction challenges existing equilibria, creates conditions for tensions and paradoxes to emerge around disputes over the role of the firm.

We begin by initially locating a duality between structure and process approaches to stewardship, opting for the latter. We present an overview of stewardship to situate the contradictions, paradoxes, and tensions confronting family and family business. Second, we explain methodological options, from which we choose an interpretive logic of multiple data collection techniques. Third, as three main paradoxes are brought into consideration, the main findings are presented, leading to conclusions and implications.

The outcomes of our research have significant bearings on how stewardship might be further developed, especially through informal learning suited to unstable and dynamic situations ( Beckett & Hager, 2002 ; Hager & Beckett, 2019 ). As process-inclined scholars we contribute to the literature by exploring the role of contradiction in the nurturing of stewardship. We do not advocate the superiority of stewardship over agency but explore how conceptions of strategy by the leaders of Familia change over time in the face of dynamic conflicts and contradictory challenges launched by different branches of the family.

1.1. Family business stewardship: condition or process?

We depart from the representation of stewardship as a structural (stable) condition , seeing it instead as a process , as something potentially unstable, dynamic, paradoxical and reversible ( Gersick, Davis, Hampton, & Lansberg, 1997 ; Langley et al., 2013 ; Miller & Le Breton-Miller, 2005 ) around which many contradictions and tensions may revolve. We do not oppose structural condition and process as a dualism; instead, we stress the concept of duality in theoretical opposition to dualism (see Knights & Willmott, 1983 for an early statement of this distinction). In a duality the self is engaged in processes of multiple role enactments through which the solidity of the stewardship role (a) is understood and engaged as a variable process and (b), is thus involved in paradoxical oppositions, which are experienced as tensions. As a concept, duality is attracting increased attention from organizational scholars ( Farjoun, 2010 ; Sonenshein, 2016 ) but in the FOB domain its presence is still limited, posing a need for additional research ( Chen et al., 2016 ; Chirico, Melin, Salvato, & Seidl, 2015 ; Neubaum et al., 2017 ) that strives to explain contradiction, paradox and tension as phenomena at the heart of the family organization, as we find in this case. In such a perspective, stewardship is no structural fait accompli but a process of entangled and emergent power relations producing a situation of constant negotiation between competing interests and representations of the organization and its governance.

Chrisman, Chua, Kellermanns, and Chang (2007 , p. 1030) summarize a positive perspective on the structure of FOBs in the following way:

“[S]tewardship theorists suggest that family managers, regardless of ownership, will generally behave in the organization’s best interest ( Davis, Schoorman, & Donaldson, 1997 ). Family managers are presumed to behave this way because they subordinate personal goals to family goals, pursue non-financial goals, and abide by relational contracts that govern family firm behaviour (…)”.

In a similar vein, Neubaum et al. (2017) argued that because FOBs have a stronger stewardship climate, they have a competitive advantage. That stewardship can be described as a structural condition, given by family ownership, is a somewhat limited view that tends to idealize family life in the aspic of normative stasis. Perhaps more likely, it will be riven by conflicts, deceits and inter-generational tensions than occur in other forms of formal organization. Rather than focus just on the structural properties of the firm, stewardship should be seen as a complex process, not as a condition. By process we refer to “how and why things emerge, develop, grow, or terminate over time, as distinct from variance questions dealing with co-variation among dependent and independent variables” ( Langley et al., 2013 , p. 1). Typically, processes are analytically characterized by the three intertwined phenomena of contradictions, paradoxes and tensions ( Langley et al., 2013 ). We define these terms next.

Contradictions are “bipolar opposites that are mutually exclusive and interdependent such that the opposites define and potentially negate each other” ( Putnam, Fairhurst & Banghat, 2016 , p. 70). Paradoxes are “contradictory yet interrelated elements that exist simultaneously and persist over time” ( Smith & Lewis, 2011 , p. 386). Paradoxes have been seen as pervasive phenomena in organizational settings ( Gaim, 2018 ; Schnellbächer, Heidenreich, & Wald, 2019 ) that may create tensions , experienced as “stress, anxiety, discomfort, or tightness in making choices and moving forward in organizational situations” ( Putnam, Fairhurst, & Banghart, 2016 , p. 69). Tensions may occur as a result of facing paradoxical contradictions.

Literature on paradoxes has developed significantly in recent years, although family business is scarcely represented within the field. For example, among the twenty-eight chapters of The Oxford Handbook of Organizational Paradox ( Smith, Lewis, Jarzabkowski & Langley, 2017 ) none focus on family business, such a context being almost absent across the entire handbook (by the way, nor is there any mention of stewardship, either). Family businesses’ social and organizational relations may be anticipated to be intertwined and entangled, deep and inescapable, covering multiple life domains that are liable to “strong conflicts of interest” ( Meier & Schier, 2016 , p. 256). The present paper contributes to literature that explores stewardship paradoxes that emerge from different family nuclei developing diverse forms of connection and commitment towards the family and the firm. These features make FOBs especially interesting for the study of paradoxes and tensions.

Families face a number of paradoxes involving difficult stewarding choices because FOBs are characterized by deep and inescapable relationships covering distinct life domains in which multiple relationships may develop over time. Within these familial dynamics, relationships develop processually between family and non-family members. Sustaining stewardship can become a challenging endeavor as these relations change both structurally and contingently as a result of unfolding processes. Stewardship is not a simple top-down process in which the steward leader/owner/founder elicits stewardship behaviors from others within (employees and other leaders) and outside the firm (e.g., family members who are not organizational members). Intergenerational dialogues have a propensity to exacerbate conflict ( Chen et al., 2016 ; Davis & Harveston, 1999 ). As the family divides into different branches, factionalism can replace cohesion and personal interests collide with collective gain ( Miller & Le Breton-Miller, 2005 ).

Despite the dominant, positive view of stewardship in the family business literature, previous research indicates that family executives may act as agents rather than as principals embracing stewardship ( Chrisman et al., 2007 ), which means that the assumptions of stewardship theory need to be questioned and explored rather than simply claimed ( Chrisman, 2019 ). Such an agency orientation becomes more likely over time as different family branches (and non-family members) come to constitute the company’s arena. We consider that stewardship deserves to be studied from the angle of paradox theory, as this meta -theorical approach ( Lewis & Smith, 2014 ) may help to illuminate dimensions of stewardship that have not hitherto been explored, given organization studies’ propensity to develop theories based on consistency, not contradiction ( Poole & Van de Ven, 1989 ). In short, FOBs are not necessarily governed by positive stewardship assumptions ( Madison, Holt, Kellermanns, & Ranft, 2016 ; Neckebrouck et al., 2018 ). Moreover, as we shall see, where family members espouse different assumptions and adopt different (instrumental versus social-emotional, or normative) behaviors tensions, rather than mutual commitment, may pervade the firm and the family. While erosion of stewardship has been considered as a possibility in the literature (e.g., Miller & Le Breton-Miller, 2005 ), the process has been insufficiently explored.

A substantial literature on stewardship (e.g., Block, 1993 ; Davis et al., 1997 ; Hernandez, 2012 ; Miller & Le Breton-Miller, 2005 ) considers multiple stakeholders as de facto relevant to an organization. As stated by Caldwell, Hoffman, Campbell, and Marchisio, (2008, p. 154), in this perspective, “managers are stewards whose motives are aligned with the objectives of several parties.” The assumption of multiple alignment poses a number of important challenges because the interests of different parties necessarily present potential for divergence and thus for conflict (e.g., March & Simon, 1958 ; Puranam, Alexy, & Reitzing, 2014 ), especially over time, as a paradox lens can illuminate.

In the case of Familia, even though the company chairperson emphasized a stewardship approach, the stewardship “philosophy” proved not to be consistent across different family members and branches, or between family and non-family members. Those who were stewardship-oriented experienced tensions emerging from contradictory challenges launched by different branches of the family. In such a context, acting as a steward was perceived as a paradoxical challenge, an exercise in the articulation of opposites, rather than the systematic application of a governance policy. Indeed, it was this initial apparent tension that stimulated our curiosity, as we discuss next.

The study considers the case of Familia, a diversified family business group in a southern country of the European Union (a summary of the characteristics of Familia can be found in Table 1 ; some details, which do not affect the analysis, have been changed to ensure the business group’s anonymity). Familia is a diversified corporation, competing in services and manufacturing. Its consolidated operating income is about two billion Euros, with about a quarter of that earned through exports. Familia has an international presence in several continents, including the US. Each family branch ( n  = 12) is represented by the siblings ( n  = 12 children of the founder). Family’s ownership is organized through a holding company (equal distribution between the branches) that has a controlling stake in each of the different businesses. Governance includes two main bodies (the Owners’ Council, with performs a strategic role, is composed by four senior family members) and a Family Council (one member per each of the 12 branches). Access to jobs in Familia is regulated by a family protocol. This protocol (a) establishes that Family and Group are separate entities, and the interests of the latter prevail upon the family members’ individual needs, (b) upholds that the Family Council acts as the conflict management entity for Family and Family/Group matters and (c), rules that the management of the Group is 100% professional (although not precluding family members from being part of the management team). The management is professional with the majority of the executives not being family members.

Table 1

Characteristics of familia (circa 2016).

One of the authors has collaborated, intermittently, with Familia, participating as a guest speaker in management meetings and in family gatherings, maintaining regular contact with a group of managers and non-executive members of Familia, teaching younger members of the family, eventually being invited to study the leadership development of younger family members. Such on/off involvement allowed for a mix of personal distance and proximity in the interactions of organization, culture and ethics involved in the socialization and reproduction of the business ( Anteby, 2013 ). The other authors did not have direct access to the site, which allowed them to play critical roles, including the role of devil’s advocates ( Dittrich & Seidl, 2018 ; Nemeth, Brown, & Rogers, 2001 ). Using multiple authorship reduces, if not eliminates, risks flowing from a relationship with informants ( Anteby, 2013 ), meaning that we were able to use this plurality to enrich the discussion without incurring the costs of being an insider, bound by rule, obligation or tradition.

The main source of structured and formal data collection was a family gathering that occurred in the first quarter of 2014. Data sources included meetings with the CEO and members of the executive and non-executive boards, as well as semi-structured formal interviews with 16 members of the owning family. While the management limited the number of informants we felt no need to ask for an increase in the sample size because similar themes repeatedly emerged as we approached the upper limit, an indication of conceptual saturation ( Francis et al., 2010 ). The interviews (interviewing process and protocol are shown in the Appendix) typically lasted around 1 h and were conducted in the company’s headquarters. The profiles of our interviewees (27–58 years old) ranged from the CEO to younger members with no direct involvement in the daily management of the operations. The data collected from the interviews was preceded by a document analysis that covered several types of archival materials, including annual reports, written sources produced by the founders of Familia, as well as books published about the company. These formal interactions were complemented by informal interactions. Table 2 summarizes the types of data we considered and their relevance for our study.

Table 2

Data sources for the study.

The various data sources were used to identify and refine emerging patterns in the spirit of grounded theory ( Glaser & Strauss, 1967 ; Walsh et al., 2015 ). We were not seeking to test hypotheses but to make sense of the challenges confronting managers who sought to cultivate and embed the values of stewardship in the younger members of their enterprising family. We were more interested in gaining richly nuanced knowledge ( Bettis, Gambardella, Helfat, & Mitchell, 2015 ) about the dynamics of stewardship than in challenging some specific aspect of stewardship theory. The findings motivated us to explore the process of stewardship as phenomenologically experienced, departing from the mainstream literature in which stewardship is often viewed on the basis of positive assumptions. For this reason, we composed our study on the basis of an in-depth inductive perspective.

Methodologically, the interview data yielded major emergent conceptual themes and categories ( Feldman, 1995 ; Gioia, Corley, & Hamilton, 2012 ) that focused the challenges involved in the cultivation of stewardship. First, the data was organized around central categories based on the coding of the interviews. Initial coding produced 12 first order in-vivo categories ( Table 3 ), based on the informants’ own terms. Through constant comparison, these initial categories were consolidated into 6 s order themes of intermediate abstraction via axial coding ( Strauss & Corbin, 1998 ). Data were finally reduced to three major aggregate theoretical dimensions that captured the informants’ deep views related to the self-indexing of the paradoxical conceptual domains of identity, inclusion and purpose . These final overarching dimensions defined the ultimate concepts related to the paradoxes of stewardship, as our informants framed them. The other sources (documents, participation in meetings, and informal interactions; Table 2 ) helped to make sense of the categories, themes and dimensions emerging from interviews with their respective implications for the stewardship process in a FOB.

Table 3

Representative 1st order data/categories as reflecting 2nd order themes.

3. Findings

Table 4 presents the data structure (organized around the three aggregate conceptual dimensions conceived as paradoxes of identity, inclusion, and purpose) derived from the analytic process. The final three dimensions emerging from the analysis are situated on the right side; in addition, we display the second (indirect) themes and the first order (direct) categories underlay theoretical constitution. In identifying all the identified tensions an element of paradox is pervasive because they all involve contradictory choices that persist ( Putnam et al., 2016 ), i.e., conflicts where it is not adequate to exclude any of the terms. We explore the three dimensions/paradoxes in what follows.

Table 4

Data structure.

3.1. Paradoxes of identity

A fundamental dimension of stewardship development refers to the collective negotiation of identity at the boundary of the family and the firm. This dimension triggers interrelated persistent oppositions between the family and economic dimensions of the firm and between present and future generations, the temporal horizon. Overall, this dimension refers to the question “who are we?” as family and its implications for the identity of the business. Two second-order themes were rendered salient: (1) the construction of the organizational ethos (supported by the first order categories of the group as family institution and the group as economic institution) as well as (2), the choice of a temporal frame articulating the past, present and future organizational identity (focus on long or short run).

Organizational ethos. Many family members at Familia represented their firm as an extension and embodiment of the family, articulating past, present and future. For them, the organization should be assumed to be a family institution, emphasizing the values carried from family to business, which emphatically associated the business with the family itself. The perspective is evident in comments such as the following:

“I want to believe that we are all acting as stewards of the same interest: giving continuity to Familia, taking care of the business. Preserving the values of my family inculcated throughout the generations: the importance of family, the importance of mutual help, having one’s feet on the ground, putting the interests of the companies of Familia above our individual interest”.

For other family members, however, Familia is first and foremost an economic institution. It competes in markets with other market-oriented firms and in this sense the business of (the family) business is business, not family. In this case, the personal relationship with the firm is marked less by a sense of long-term emotional attachment and more by regard for instrumentally economic transactions. An informant described it in the following terms:

“Some family members may be detached, putting share price above the role of the business. Those people do not accompany the activities of the business, they can be less ethical, only want their Euros, no matter how.”

These two poles constitute a paradoxical logic of stewardship in Familia: on the one hand, a sense of family and historical tradition, which takes precedence as the objective of the family business; on the other hand, this is opposed by a sense of the family as an object subordinated to the business. These two orders seem to coexist in a state of dynamic tension.

Time reckoning strategies . From a process view, time is a core dimension of organizing ( Hernes, 2014 ), with Familia’s temporal orientation referring to the time reckoning strategies favored by the family members. We witnessed the tension between the long run and the short run as constitutive of both the organization and individual family members’ identity. Some members saw Familia as a continuation of a project transcending individuals, an orientation to the long term being at the core of the organization’s identity. One informant stated: “A good owner must consider the long term”. Another assumed that “The difference between a family firm and a public firm is in the long-term vision”. Other members were more sensitive to immediate pressures, favoring pragmatic consideration of current issues, including their own gains: one family member mentioned the “long time before gains happen”. Others complained about being the immediate losers from such a short-term attitude: “It is not enough to say, ‘We are doing this because one day you’ll inherit it all.’ Those on the other side [third generation] think ‘ah! But it will take a long time before that happens.”

3.2. Paradoxes of inclusion

We identified two main intermediate second-level themes that define inclusion: participation intensity (supported by first order categories of engagement and disengagement) and representation of voice (opposing the right to voice with the feeling of powerlessness). These themes express a persistent tension between inclusion and exclusion. One implication is that the same mechanisms that were seen by some as facilitators of participation and inclusion were represented by others as leading to exclusion. Feelings of inclusion and exclusion were thus closely linked as two sides of the same coin.

Participation intensity. The levels of proactive participatory intensity of family members in the activities of Familia varied significantly. Some members adhered to initiatives with enthusiasm and expressed their genuine interest for them, whereas others disengaged from those activities. As a senior manager critically noted “A bad owner thinks ‘What I want is money, I want to sell, I want to go surfing’“. A young family member corroborated the provenance of this point of view amongst some family members by noting that “Some cousins just don’t seem to care.” Low participation can be a matter of choice, as these quotations indicate; indeed, the intensity of participation in the activities of Familia was highly diverse. The data suggest that those family members that were most likely to develop as stewards were those more engaged, whereas the disengaged seemed less likely to embrace a stewardship philosophy, creating tensions around issues of inclusion and participation. The dynamic process is epitomized in the following comment by a family member:

“What my uncles are doing is a very good starting point for the next generation to contribute positively for Familia, as stewards. Informing the people, giving them the bases for understanding the business. Then my generation will split up in two or three groups. There is this group that wants and is prepared to take an active part in the business; there is a second group that does not (…)”.

Voice. Voice expresses a right to be heard and to speak up ( Hirschman, 1970 ; Morrison, 2014 ). This theme differs from the previous one in the sense that it is possible to favor low intensity engagement whilst preserving the right to speak up. Young family members at Familia represented voice in diverse ways. Some next generation family members conveyed the idea that, although young, they should have a voice and expressed the view that they had the right to be considered, whereas some others felt marginalized or marginalized themselves through their lack of involvement in the firm: “At this moment Familia is a reality of mine, but a distant reality”, as one of them acknowledged. Another participant stated that “it is very important to engage in dialogue (…) the openness to put the cards over the table.”

Discord arose from existing formal rules being defined by a family protocol that, according to some next generation family members, limited voice. One member identified a group of individuals that “cannot take an active part in the business, given the protocol”. Another member stated that some next generation family members “are not much interested because they feel they are too remote”. Divergence was evident at the family gathering, an occasion to make sense of the governance as a dynamic process. A young woman assertively argued that family members in her cohort should be more involved, in what can be taken as a proxy of a pro-stewardship attitude. Another participant explained “To me the [development] program has contributed a more uniform knowledge of Familia. But it should be deeper.” Other family members, on the contrary, saw themselves as too distant to be heard. Some young family members expressed the view that their voice’s volume was too low: “We can’t work at Familia but they involve us in those things [the development program]. But we are not really involved.” In short, some people felt committed and included, whereas others expressed the sentiment of being excluded developing a sense of powerlessness, a perception that was created over time and that was verbalized in the gathering.

3.3. Paradoxes of purpose

Our informants expressed two sorts of tensions regarding Familia’s purpose, a purpose that we define as a desired result, in relation to familial relations and the protocol governing these. First, while some informants defended the view that the group should emphasize merit, others appreciated the importance of care. Second, two initial categories emerged as opposed: protocol as an organizational constitution, a “sacred” text, versus the interpretation of protocol as open and revisable. Merit and care thus existed in a state of tension and created ongoing paradoxical tensions between the governing logic of the company and its ultimate purpose. While there may be merit in both perspectives their articulation is difficult.

Emphasis: Merit vs. care. Some family members expressed sympathy for a duty of familial care, thus expressing a preference for nepotism against meritocracy. One member pronounced in favor of the company providing jobs to family members, complaining that “the fact that the protocol establishes that we have to work outside an X number of years (…) can be a limitation.” Differently, other family members, including the executive team, vigorously defend meritocracy, reinforcing a culture of merit and the countering of nepotism. While some arguments have been made for the positive aspects of nepotism inside Familia, it was mostly seen as negative and debilitating. One member stated: “I also agree with the anti-inbreeding policies (…) They counter any kind of nepotism, be it real or perceived.” In our interviews, informants explicitly invoked prominent and “bad” local cases to justify the soundness of the Familia’s choices. To counter nepotism, Familia created a formal set of access rules that are strict and demanding. Given the policy, it is very difficult for a family member to gain access to managerial positions in Familia, something viewed as positive because hiring family members can lead to nepotism. The policy creates tension because some members perceive the rules as rigid, demanding, even dysfunctional:

“[T]he protocol establishes a given number years of experience [to be considered to a job in Familia], ideally international experience. Then what? Do I join the business as a director? This is why I am against it.”

Preferences/outcomes. Some family members saw the family protocol as a de facto organizational constitution and defended action guided by the spirit and the rule of the protocol. Confronted with regular claims by younger members or their parents about the limited opportunities for participation inside the organization, the CEO defended the status quo in the family gathering. “These are our rules. Once we [the older generation] retire, you change the rules if you want.“ 1 It is a statement reflecting the potential instability of stewardship and the importance of top executives for its enactment over time. Rules premised on patrimonial rather than legal-rational bureaucracy ( Weber, 1978 ) were critical to sustaining the ethos of Familia.

Some family members enunciated a less positive reading of the protocol, seeing it as a source of rigidity and psychological distance, leading to decisions that countered a genuine logic of care and limiting the sense of ownership ( Bernhard & O’Driscoll, 2011 ; Pittino, Martínez, Chirico, & Galván, 2018 ). In some cases, the family protocol was described as a neutralizer of a major advantage of FOBs, that is having had contact and familiarization with the business since an early age. The protocol, in fact, limits access to those people that express a vocation to work for the family business. The tension is experienced as real: rules can be beneficial and damaging. During the interviews, some family members expressed their desire that the protocol be amended.

Summary . In summary our findings evidence that there seemed to exist opposing stances between members in how they navigate/construct contradictions or paradoxes over time. Some members seem to engage an either/or approach to managing oppositions, rather than a both/and approach. There was some equilibrium obtained via the formal governance mechanisms and the formal gatherings that provided numerous opportunities for informal conversations. The family governance structure played a key role in the maintenance of the balance but the interference of factors such as environmental shocks introduces the potential for unbalance.

4. Discussion

We have identified three paradoxes of stewardship. First, we observed that the firm is represented by some as a family mission, a collective endeavor that emerged from the family, transcending any specific generation, articulating the past, present, and future around a common sense of trans-generational continuity. The firm is an extension of the family, a vehicle for its values and its name. Other members, however, represented the firm as an economic institution that should be regulated by the logic and rules of the market. There is an element of paradox here: the two views make sense when considered in and of themselves but taken together they trigger mutually defining persistent contradictions, indicating that the interpretation of the meaning socioemotional wealth can also be studied processually, in articulation with stewardship. Leading the business as a competitive economic entity is not quite the same as managing it as a trans-generational family accomplishment: these are critical but oftentimes colliding logics. A prevalent focus on the family entity may endanger the business entity and vice-versa. However, from a paradoxical perspective, focusing on both entities and managing the tension between them may be the best way to respect both forces generatively. In short: (a) the emphasis on “business” over family may jeopardize family and, as a consequence, the business; (b) the emphasis on “family” over business may jeopardize the business and, as a consequence, the family.

To put it another way: emphasizing the family is necessary to preserve the business and preserving the business entails emphasizing the family. Rather than stewardship being viewed as a condition that family ownership ensures, it should be represented as an ongoing construction resulting from the articulation of the two elements (family institution and economic entity), a process occurring at the interface of issues of identity ( Phillips & Lawrence, 2012 ) and temporality ( Kaplan & Orlikowski, 2013 ). Although that stewardship involves the obligation to pursue and protect the interests of the organization ( Neubaum et al., 2017 ), managing the business-family tension is a core role of steward leadership.

A second paradox emerges around participation. Levels of participation were variable, with some family members intensely engaged, whereas others did not participate at all. In isolation, these differential levels of involvement are natural and even predictable but from a stewardship perspective, they constitute a formidable challenge in terms of leading and managing a family business. Tensions are constantly evident around related themes; these include how fault lines of variable participation influence stewardship; how family members who participate intensely affect and are affected by those who do not; how do different participants represent each other as members of the same family; how do the two groups define organizational fairness? These tensions may be hard to manage and to sustain in a generative fashion but managing them is inextricably associated with stewardship.

A third paradox is present in the establishment of preferences about the ultimate goal of Familia. The firm can be represented as a meritocratic project, whose sustainability in the long run depends on the quality of its governance and administration. In this sense, the best way to protect the family’s ownership lies in avoiding family interference in the running of the business; an approach that raises the contradiction that the family must avoid being protective in order to protect its position in the face of competition. Paradoxical demands are not easy to balance, as some family members consider that the ultimate mission of the business is to protect the family. Most family businesses are launched with that purpose in mind ( Kets de Vries, Carlock, & Florent-Treacy, 2007 ). The avoidance of protection in the name of protection may be framed as a deviation from the original raison d’être of the firm: how might one claim to protect the family by defining rules that limit protection?

The framing of the issues involved in the three paradoxes is formidably complex. Such complexity commends seeing stewardship not as a structural condition but as an ongoing, dynamic and unstable process. As we discuss next, stewardship is simultaneously an ongoing fragile and political construction; an exercise in paradox, an endeavor whose tensions render the process unstable, a process in which tensions are related dialogically.

4.1. Stewardship as an ongoing fragile and political construction

The way different parties represent their issues over time and attract allies to their cause or fail to convince them ( Ashford & Detert, 2015 ) will establish receptivity towards stewardship and the trade-offs it entails. The political dimension of stewardship seeks to manage a delicate balance between perspectives about the business that are fundamentally antithetical, existing in tension and thus being potentially unstable ( Sundaramurthy & Lewis, 2003 ). Given the centrality of the economic component of the contemporary organization ( Donaldson & Walsh, 2015 ), stewardship should be regarded as a fragile construction, a process bounded by constitutive tensions embedded in social and familial relations, therefore requiring sophisticated competencies of paradoxical leadership ( Smith, Lewis, & Tushman, 2016 ). Our findings thus suggest the need to conceptualize stewardship as a fragile and politically negotiated order, a result of a power balance that needs to be regularly validated and that is permanently open to revision, meaning that its paradoxical core cannot be “tamed” ( Cunha & Putnam, 2019 ). Such revision is especially likely when the power circuitry ( Clegg, 1989 ) that sustains stewardship is challenged, for example following a change of CEO or as a result of an environmental jolt ( Meyer, 1982 ), such as the Eurozone crisis. In this light, stewardship is best viewed as an ongoing political and social construction, a paradoxical condition rather than as an organizational governance , a stable structure.

4.2. Stewardship as an exercise in paradox

There is more nuance in stewardship than merely pure altruism (Eddleston & Kellermanns, 2007), long-term orientation ( Chrisman, Steier, & Chua, 2006 ) and intense family commitment ( Zahra, Heyton, Neubam, Dibrell, & Craig, 2008 ). We challenge Eddleston and Kellermanns’ (2007, p. 549) claim that “altruistic family members can be seen as stewards of the firm … characterized as possessing collectivistic orientations that encourage family members to exercise self-restraint and to consider the effect of their actions on the firm”, despite it being an accepted view of stewardship as stable. As a paradox, stewardship incorporates synergy and trade-off ( Li, 2016 ), a combination that renders it hard to manage.

Fig. 1 depicts stewardship as paradox, a process that can create synergy or trade-off depending on how the family articulates the three paradoxes of identity, inclusion and purpose; hence the presence of the yin-yang as background. When the forces in opposition are fruitfully equilibrated, stewardship can be a source of synergy and virtuous circles; when some poles start to predominate, the system unbalances. Stewardship is a paradoxical endeavor in which tensions between poles, expressed as mixes of synergy and trade-off, can be more or less dynamically equilibrated. In this light, stewardship involves friction, opposition and tension: putting “family” into “business” is no panacea producing harmony. From a paradoxical perspective, these symptoms are inherent and not necessarily dysfunctional. Their existence per se is not problematic but how they are managed can turn them to problems.

Stewardship in FOBs: A paradoxical balancing act.

4.3. Tensions rendering the process unstable

Stewardship as a process is shaped by accounts that are rational when isolated but that, conjunctively, can be difficult to articulate and to transcend ( Clegg, Cunha, & Cunha, 2002 ; Putnam et al., 2016 ). These tensions render the stewardship process unstable, with the possibility of it becoming virtuous or vicious ( Ropo & Hunt, 1995 ) through repetition and feedback ( Tsoukas, 2017 ), depending on how the poles in tension are enacted and articulated. Following our interpretive model, it is the constant attempt to make the latent explicit and subsequently workable via paradoxical thinking that makes paradox generative (see Table 5 ). Latent tensions that are not approached in their paradoxical duality will potentially emerge as conflicts that divide rather than unite.

Table 5

Implications for a paradoxical study of family businesses.

Where merit and vocation are highly prized characterization of family businesses as managed for the long run, the family’s dominant coalition represents itself as responsible for guarding values and a legacy that transcends any individual or any specific generation. Against this ethos are arraigned family members whose accounts represent the business from a market perspective, invoking a self-centered and rent-seeking dynamic rather than an altruistic, long term family-based orientation. In such cases, family involvement can be less intense and less emotional, the business being framed as a source of economic resources. Such a dynamic results not from intrinsic individual flaws but from the fact that people can be conceptualized as being both self-interested and altruistic ( Jensen & Meckling, 1994 ; see Wade-Benzoni & Tost, 2009 , for the interplay between egoism and altruism of intergenerational behavior). Moreover, as the family divides, younger family generations will be exposed to diverse and potentially diverging sets of values and attitudes, some of them less favorable to an ever more distant family legacy. Scholars explained how important families are in inculcating the right values and attitudes; however, what is right for one part of the family may be less so for another, an effect that different generations amplify ( Gersick et al., 1997 ). At some point, tensions can surface and become explicit. Paradoxes can be contained but it is difficult to keep them in a latent state. As generations pass, the value of the socio-emotional component becomes less explicit in terms of justifying accounts and the relevance of economic rents becomes more explicit ( Gomez-Mejia, Cruz, Berrone, & Castro, 2011 ). As such, the equilibrium that supports stewardship may be challenged in favor of rent-seeking behaviors, which may unbalance the paradoxical equilibrium.

4.4. Relating tensions dialogically

When parties engage in relating tensions dialogically, they can be positive and constructive ( Tsoukas, 2009 ). Finding some workable balance between modes of thinking, those inclined to economic interpretations may introduce market realism, whereas the stewards may impede short-termism, creating a dynamic understanding of the logic of stewardship not as a stable condition but as ongoing processual construction. Based on the findings, the foundations for such a paradoxical view of stewardship are presented in Table 5 . The table suggests that the two modes can be articulated and that such articulation can contribute to a duality-informed approach to family business governance ( Chen et al., 2016 ). The mishandling of this tension, however, can lead to dysfunctional conflict, trapping the firm in a conflict, in which some members defend the traditional view of the family project and fight their opponents as coldly utilitarian, whereas the less stewardship inclined criticize the romantic view of the former. Instead of articulating their points of view, proponents of one account may ignore the other and deny its relative merits, which, in turn, will decrease trust and potentially entrap the organization in a cycle in which every attempt to solve the problem will render the parties increasingly more distant ( Masuch, 1985 ).

Stewardship is best protected by creating spaces for the ventilation of opposition and dialogue between the proponents of different positions, rather than by representing it as an inherently good, morally superior philosophy for governing the family business. On the contrary, the interaction between the proponents of different positions may be more and more polarized, making it more and more difficult to “manage” contradictions and tensions. According to paradox theory, denying one pole of a tension is possible but unfruitful in the long run ( Smith & Lewis, 2011 ). While claims of superiority may justify the negation of the other pole a dynamic equilibrium view would recommend the articulation of opposition via some identity-related overarching goal ( Ashforth & Reingen, 2014 ). The prospect of ongoing irresolution will trouble both FOB parties. Are there any practical options beyond merely accepting paradox as irresolvable? What might we learn from other workplace situations characterized by the politics of contrasting logics? To canvass these questions, we will clarify some of the implications of our findings.

5. Implications

Previous work studied the situational mechanisms of stewardship in the family firm, showing that this is dynamic rather than fixed ( Davis, Allen, & Hayes, 2010 ). We extend this work, elaborating the paradoxical contradictions and tensions raised by the logic of stewardship. Conceptual awareness allows for reciprocal interaction ( Pitts, Fowler, Kaplan, Nussbaum, & Becker, 2009 ; Tsoukas, 2017 ), while the search for solutions via synthetic learning ( Miller, 1996 ) permits nuanced stewardship accounts to coexist paradoxically and to reinforce one another. Paradoxes differ from dilemmas (which are approached from an either/or perspective) inasmuch as they demand integrative approaches of “both/and”. When paradoxes are approached by managers as dilemmas to be resolved, the tensions between the two sides of paradox that mutually constitute each other potentially create dysfunctions. Therefore, one important contribution of our study belongs to rendering explicit that paradoxes of mutually constituting and persistent tensions should not be approached simply as dilemmas.

In terms of family business management ( Madison et al., 2016 ), a paradox perspective that encompasses engagement between dynamic forces triggered by the adoption of stewardship logic better attends to process than one that sees the oppositional poles as incommensurable. Creating openness to integrate the arguments of the opposing party without dissolving the tension, using contradictions as a generative source of change and renewal ( Tse, 2013 ), while it can be difficult to achieve and sustain, can be a creative form incorporating and respecting different family accounts and to facilitate constrictive dialogue over time. From a paradox perspective, stewards may be given the right to run the business and to sustain their presumably superior model, yet they need to validate this superiority in a way that convinces those less inclined to stewardship. Family members motivated by stewardship as a long-term paradigm must consider and embrace the interests and motivations of the more economically inclined and the reverse is also the case. Paradoxically, the economically inclined actors may benefit from the FOB being managed according to stewardship principles – i.e., stewards are, by definition, focused on the economic survival and development of the FOB, using the poles in tension to affirm the overall vitality of the system. Stewardship-motivated family members may even foster the stewardship behaviors of the more instrumentally motivated through implementing procedures such as executive compensation schemes that stress pay for performance: paradoxically, such agentic motivational incentives may encourage stewardship behaviors ( Chen et al., 2016 ; Chng, Rodgers, Shih, & Song, 2012 ). Managing the tension between differing stewardship orientations may be the necessary, albeit difficult, means to assure firm survival and development.

The pursuit of a stewardship approach to managing FOB requires a paradox mindset ( Ingram et al., 2016 ; Miron-Spektor, Ingram, Keller, Smith, & Lewis, 2018 ). In fact, stewardship implies ongoing negotiation of contested outlooks and priorities. Negotiation concerning stewardship issues calls for patience and mutual respect, underlining pivotal relational issues in social theory ( Donati & Archer, 2015 ). Negotiation is also central to a conception of processes of paradox, vital in multi-party articulation between different interests. Negotiating the politics of competing stewardship vistas as logics of duality involves ambiguity and uncertainty about contingencies related to authority, power and performance. Other conflicts concern the requisite knowledge for each party’s agenda, with the least stewardship inclined promoting managerially explicit data while those with a stewardship perspective are more likely to embrace a tacit dimension. One implication is that, in a succession process aimed at preserving a stewardship approach to managing FOB, espousing a stewardship approach is not enough; having a paradox mindset (i.e., valuing, accepting, and feeling comfortable with tensions; Miron-Spektor et al., 2019) is also a critical individual characteristic to seek in the successor. As Ingram et al. (2016 , p. 162) noted, “Instead of seeking a clear, ‘either/or’ decision using formal logic to weigh the pros and cons of each side [e.g., the stewardship orientation versus the economic one, as pursued by different family members, we argue], paradoxical tensions demand paradoxical thinking, a more fluid and holistic mindset that leverages the distinctions and synergies between elements in search of both/and solutions”.

6. Limitations and future research

Data were collected during the serious economic crisis of the Eurozone that occurred after the Global Financial Crisis of 2008. Our interviewees’ accounts may have been exacerbated by this critical contingency (and we could speculate that such an exacerbation might be reinforced during the Covid-19 crisis). In more munificent times, the relevance of the family business as a source of jobs for the younger members may be less pronounced. The role of contextual contingencies on the balance of power between accounts favoring the logics of stewardship and agency in family businesses is a topic that requires further consideration. The sectors within which Familia operates may affect the interplay between stewardship and non-stewardship approaches and firms operating in other sectors, facing different challenges, may behave differently.

In spite of these limitations, the paper prepares a number of avenues for further research on the process and dynamics of stewardship and the paradoxes of FOB (see Table 5 for a summary of the paradox perspective as well as possible avenues). Extant stewardship research has evolved from separation to dualism. Stewardship evolved in opposition to theories of managerial agency, sometimes with a romanticized view of stewards as individuals who put aside particularistic interests in order to sustain a patrimonial legacy. This study suggests that the forces of stewardship and non-stewardship coexist in duality in their interpenetration ( Chen et al., 2016 ; Farjoun, 2010 ; Madison et al., 2016 ). Researchers may consider exploration of duality’s possibilities, such as the extent to which stewardship takes place not because the forces of the short-run were contained or neutralized but because paradox-savvy leaders discovered how to articulate them productively, as a pair of interdependent opposites ( Waldman & Bowen, 2016 ). They may do so, for example, via co-leadership or rotating leadership involving stewards and agents ( Ashforth & Reingen, 2014 ) or through articulating a “superior family interest” ( Meier & Schier, 2016 , p. 272) that accommodates both short-term and long-term business goals. Organizational tools of engagement, such as a substantive mission ( Miller & Le Breton-Miller, 2007 ), functioning as an overarching goal that articulates opposing sub-goals, may compose the common ground for competing parties to find shared social understandings in the midst of disagreements.

Exploring the tensions between high and low stewardship orientations may offer open avenues to explore paradoxical processes and to test the assumptions of stewardship theory in action ( Chrisman, 2019 ). Instead of seeing different logics as exclusive or synergistic, they can better be viewed as involving synergy and trade-off ( Li, 2016 ). Instead of “solving” the tension, the stewards of FOB can use tension to facilitate renewal and to counter familial conservatism. The paradox perspective has the advantage of representing the need to view opposing logics (economic and social, long term and short term, etc.) as healthy signs of vitality that should not be suppressed. We unearthed some possible expressions of dualism in the enterprising family and stressed the relevance of handling them as paradoxes. Longitudinal designs can help to overcome some of the limitations of this in-depth study.

7. Conclusion

Meier and Schier (2016) suggested that there was considerable future potential in research approaches to stewardship that focused on possible resolution of conflicts of interest between family members and between the family and the firm: this is what the paper provides. The family business literature tends to divide family companies into those run according to the principles of stewardship and those that are potentially vulnerable to short-termism ( Miller, Le Breton-Miller, & Scholnick, 2008 ). We found that such dualism can be textured with duality-influenced, paradoxical theorizing: in the same organization, opposing agents and accounts coexist, interact, negotiate and hybridize, rendering stewardship an evolving complex process, rich in paradoxical nuance.

The analysis of interactive dynamics generates insights richer than those dependent on the assumptions of dualism prevalent in the literature. A paradoxical articulation of opposites around identity, inclusion, and purpose, rather than stressing the prevalence of one of the poles, aids understanding of stewardship as a duality rather than a dualism ( Smith, Erez, Jarvenpaa, Lewis, & Tracey, 2017 ). Sundaramurthy and Lewis (2003 , pp. 411–412) point out that “governing a modern corporation is an intricate challenge driven by competing needs and perspectives. Theory and practice that embrace such complexity are increasingly imperative”. FOBs contain layers of complexity that facile structural analysis occludes: their processes are more complex and more challenging than structural arguments suggest. FOBs constitute a fertile ground for the exploration of paradox ( Hargrave & Van de Ven, 2017 ) at the boundary of family and organization, a boundary in constant process, subject to conflict, contest and capitulation, as the life course frames its contours.

Acknowledgement

This work was funded by Fundação para a Ciência e a Tecnologia (UID/ECO/00124/2013, UID/ECO/00124/2019 and Social Sciences DataLab, LISBOA-01-0145-FEDER-022209), POR Lisboa (LISBOA-01-0145-FEDER-007722, LISBOA-01-0145-FEDER-022209) and POR Norte (LISBOA-01-0145-FEDER-022209).

1 Quote based on the notes taken after the meeting.

Appendix. Interviewing process and protocol

The protocol for interviewing family members was organized according to four steps.

the interviewer explained the purpose of the conversation, the reason why Familia accepted the study and issues related to confidentiality.

Interviews were conducted according to a semi-structured format based on the stewardship literature, especially that pertaining to the domain of the family-owned firm. Questions derived from these literatures were adapted to interviewee characteristics (e.g., executive or non-executive; younger or senior). Sample questions include the following:

• (1) How do you see the role of family members in the governance of Familia?
• (2) Considering your personal perspective how do you define a good family contributor? And a not-so-good one?
• (3) In your view, what purpose should Familia fulfil with regards to the family?
• (4) How do younger generation members respond to learning processes about the business?
• (5) Can you identify important challenges at the boundary between family and firm?

Interviews were recorded and fully transcribed verbatim.

An overview of the interviews, in the form of the main themes uncovered, was devolved to the interviewees and other family members in the context of a family gathering, to check for accuracy and feedback. Notes were taken within 24 h for further incorporation in the analysis.

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Role of policy-supported hog insurance in promoting green total factor productivity: the case of china during 2005–2021.

1. Introduction

2. literature review, 2.1. research on agricultural insurance, 2.2. research on gtfp, 2.3. research on the impact of agricultural insurance on gtfp, 3. policy background and theoretical analysis, 3.1. policy background on china’s policy-supported hog insurance, 3.2. theoretical analyses and research hypotheses, 3.2.1. impact analysis of hog insurance on gtfp in farming, 3.2.2. mechanism analysis of hog insurance for gtfp in farming, 4. materials and methods, 4.1. model settings, 4.1.1. sbm-ddf model with undesirable outputs, 4.1.2. multiple-time-point difference-in-differences model, 4.2. data, variables, and descriptive statistics, 5.1. parallel trend test, 5.2. baseline regression: impact of hog insurance policy on gtfp, 5.3. robustness checks, 5.3.1. placebo test, 5.3.2. preceding and lagging policy by three years, 5.3.3. lagging of control variables by one period, 6. mechanism analysis, 6.1. scale effects test, 6.2. structural effects test, 6.3. technological effects test, 7. heterogeneity analysis, 7.1. economic heterogeneity, 7.2. scale heterogeneity, 8. discussion, 9. concluding remarks and policy implications, author contributions, data availability statement, acknowledgments, conflicts of interest.

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Wu, D.; He, S.; Qin, L.; Feng, J.; Gao, Y. Role of Policy-Supported Hog Insurance in Promoting Green Total Factor Productivity: The Case of China during 2005–2021. Agriculture 2024 , 14 , 1051. https://doi.org/10.3390/agriculture14071051

Wu D, He S, Qin L, Feng J, Gao Y. Role of Policy-Supported Hog Insurance in Promoting Green Total Factor Productivity: The Case of China during 2005–2021. Agriculture . 2024; 14(7):1051. https://doi.org/10.3390/agriculture14071051

Wu, Dongli, Shan He, Lingui Qin, Jingyue Feng, and Yu Gao. 2024. "Role of Policy-Supported Hog Insurance in Promoting Green Total Factor Productivity: The Case of China during 2005–2021" Agriculture 14, no. 7: 1051. https://doi.org/10.3390/agriculture14071051

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• Study protocol
• Open access
• Published: 28 June 2024

Biomarker Driven Antifungal Stewardship (BioDriveAFS) in acute leukaemia—a multi-centre randomised controlled trial to assess clinical and cost effectiveness: a study protocol for a randomised controlled trial

• Lydia Flett   ORCID: orcid.org/0000-0002-8280-826X 1 ,
• Radwa Abdelatif 1 ,
• Sarah Akhtar Baz 1 ,
• Samantha Brady 1 ,
• Belén Corbacho 1 ,
• Kate Common 2 ,
• Abbie Cowling 1 ,
• Caroline Fairhurst 1 ,
• Ellie Fitzmaurice 1 ,
• Shreyans Gandhi 3 ,
• Andrea Hilton 4 ,
• William Hope 5 ,
• Alex Howard 6 ,
• Joanne Laycock 1 ,
• Patrick Lillie 7 ,
• Gemma Mitchell 8 ,
• Adwoa Parker 1 ,
• Mary Peel 2 ,
• Laura Sheard 1 ,
• Jacqueline Sneddon 9 ,
• Thomas Taynton 7 ,
• Puvan Tharmanathan 1 ,
• David Torgerson 1 ,
• Han-I Wang 1 ,
• David Allsup 10   na1 &
• Gavin Barlow 11   na1  

Trials volume  25 , Article number:  427 ( 2024 ) Cite this article

31 Accesses

Metrics details

Acute leukaemias (AL) are life-threatening blood cancers that can be potentially cured with treatment involving myelosuppressive, multiagent, intensive chemotherapy (IC). However, such treatment is associated with a risk of serious infection, in particular invasive fungal infection (IFI) associated with prolonged neutropenia. Current practice guidelines recommend primary antifungal (AF) prophylaxis to be administered to high-risk patients to reduce IFI incidence. AFs are also used empirically to manage prolonged neutropenic fever. Current strategies lead to substantial overuse of AFs. Galactomannan (GM) and β-D-glucan (BG) biomarkers are also used to diagnose IFI. Combining both biomarkers may enhance the predictability of IFI compared to administering each test alone. Currently, no large-scale randomised controlled trial (RCT) has directly compared a biomarker-based diagnostic screening strategy without AF prophylaxis to AF prophylaxis (without systematic biomarker testing).

BioDriveAFS is a multicentre, parallel, two-arm RCT of 404 participants from UK NHS Haematology departments. Participants will be allocated on a 1:1 basis to receive either a biomarker-based antifungal stewardship (AFS) strategy, or a prophylactic AF strategy, which includes existing standard of care (SoC).

The co-primary outcomes will be AF exposure in the 12-month post randomisation and the patient-reported EQ-5D-5L measured at 12-month post randomisation. Secondary outcomes will include total AF exposure, probable/proven IFI, survival (all-cause mortality and IFI mortality), IFI treatment outcome, AF-associated adverse effects/events/complications, resource use, episodes of neutropenic fever requiring hospital admission or outpatient management, AF resistance in fungi (non-invasive and invasive) and a Desirability of Outcome Ranking.

The trial will have an internal pilot phase during the first 9 months. A mixed methods process evaluation will be integrated in parallel to the internal pilot phase and full trial, aiming to robustly assess how the intervention is delivered. Cost-effectiveness analysis will also be performed.

The BioDriveAFS trial aims to further the knowledge of strategies that will safely optimise AF use through comparison of the clinical and cost-effectiveness of a biomarker-led diagnostic strategy versus prophylactic AF to prevent and manage IFI within acute leukaemia. The evidence generated from the study will help inform global clinical practice and approaches within antifungal stewardship.

Trial registration

ISRCTN11633399. Registered 24/06/2022.

Peer Review reports

Introduction

Background and rationale {6a}.

Acute leukaemias (AL) are life-threatening blood cancers which include the conditions acute myeloid leukaemia (AML) and acute lymphoblastic leukaemia (ALL). AL is potentially curable but treatment involves the use of myelosuppressive, multiagent, intensive chemotherapy (IC). Related conditions such as high-risk myelodysplastic syndromes (HRMDS) and transformed myeloproliferative neoplasms (tMPN) are also sometimes treated with IC with the same approach as AL. Such therapy is associated with significant toxicities which include the risk of serious infection. Of particular concern is invasive fungal infection (IFI) associated with prolonged neutropenia. The IFI invasive aspergillosis (IA) has an incidence of approximately 4–11% in the AL population with an associated case fatality rate of up to 30% [ 1 ]. Practice guidelines recommend the use of primary antifungal (AF) prophylaxis in high-risk patients to reduce the incidence of IFI [ 2 , 3 , 4 ]; however, other strategies have been proposed to try and limit exposure to AF medication [ 5 ].

Mould-active triazoles are commonly prescribed for AF prophylaxis but echinocandins or amphotericin-based agents are also used dependent upon the type of AL, the chemotherapy regimen deployed, and the perceived risk of IFI [ 4 ]. Antifungal medications have significant toxicities, drug-drug interactions and are associated with a subsequent increase in antifungal resistance [ 6 ].

Current management strategies for prolonged neutropenic fever include the empiric use of an AF when patients have been febrile after 72–96 h of broad-spectrum antibacterial treatment [ 7 ]. This approach is based upon the supposition that antibiotic-resistant pyrexia, or other signs of infection, may be due to undiagnosed fungal infection. However, such an empiric strategy leads to substantial overuse of AFs, with one United Kingdom (UK)-based study finding that less than 20% of patients empirically treated with AFs have IFI [ 8 ].

Fungal infection biomarkers such as galactomannan (GM) and (1,3)-β-D-glucan (BG) are used in the diagnosis of IFI, and combined use may be more predictive of IFI than the use of either test in isolation [ 9 ]. GM and BG become positive several days before clinical symptoms or signs of infection (GM 4–9 days, BG 5–11 days) [ 10 ]. In the UK, GM and BG are the most commonly used IFI biomarkers with the majority of testing performed at reference laboratories rather than locally. A consequence of such biomarker analysis at remote sites is that any gains in early detection may be offset by test turn-around-times (TAT). TAT has been improving and the UK national fungal reference laboratory now has a median internal TAT of less than 24 h [ 11 ]. Emerging technologies, including point of care tests, may reduce TAT in the future.

A large-scale randomised controlled trial (RCT) to directly compare a biomarker-based diagnostic screening strategy without AF prophylaxis to AF prophylaxis (without systematic biomarker testing) has not been conducted. However, a study for the European Organization for the Research and Treatment of Cancer and the Mycoses Study Group (EORTC/MSG) compared a GM-based screening approach to an empirical treatment strategy; in both arms patients only received fluconazole prophylaxis, which is a non-mould acting AF that does not prevent IA. The GM-based approach reduced AF usage by more than half without any difference in fungal-free survival [ 12 ].

BioDriveAFS is a multi-centre RCT that aims to compare twice-weekly combined GM and BG biomarker screening without antifungal prophylaxis, to mould-active AF prophylaxis without biomarker screening, in patients with AL, HRMDS and tMPN treated with IC. The co-primary outcomes are the proportion of patients with 3 or more days of systemic antifungal exposure and health-related quality of life (HRQoL) at 12 months.

Objectives {7}

Primary objective.

To conduct a multi-centre RCT to investigate whether a biomarker-based antifungal stewardship (AFS) strategy is superior to a prophylactic mould-acting AF strategy in reducing AF therapy use in patients with AL (AML/ALL), HRMDS and tMPN treated with IC, without adverse impact on HRQoL in the 12 months from trial enrolment.

Secondary objectives

To conduct a 9-month internal pilot to assess trial feasibility and to optimise processes for trial continuation.

To conduct a mixed methods process evaluation alongside the RCT, focusing on assessment of fidelity and implementation via qualitative methods and clinical data collection. Findings will inform ongoing feedback to local research teams and potential amendments to trial processes and training as appropriate; and will subsequently inform dissemination and implementation plans within the UK National Health Service (NHS) as appropriate.

To investigate the cost-effectiveness of a biomarker driven AFS strategy compared to prophylactic mould-acting AF within the existing local standard of care (SoC).

To develop and strengthen a sustainable training, engagement and Patient and Public Involvement (PPI) legacy along with a network of engaged stakeholders.

Trial design {8}

BioDriveAFS is a prospective, multi-centre, two-arm, parallel group RCT to assess the clinical and cost-effectiveness of a biomarker-based AFS strategy versus a prophylactic mould-acting AF strategy, including existing SoC, in reducing AF therapy use in adult patients (≥16 years) with AL, HRMDS and tMPN treated with IC.

A mixed methods process evaluation will be performed in parallel, which will focus on fidelity to the clinical pathway and barriers and facilitators to site trial participation and intervention implementation.

An internal pilot phase will run during the first 9 months from the start of recruitment. This period will be used to assess recruitment and retention rates, and intervention fidelity, and provide guidance on optimising the trial processes.

Methods: participants, interventions and outcomes

Study setting {9}.

NHS haematology departments in tertiary and secondary care hospitals in the UK responsible for the delivery of IC to AL, HRMDS and tMPN patients in line with national guidance. Sites must also be able to currently have or ascertain access to GM and BG testing either internally or externally.

Eligibility criteria {10}

Inclusion criteria.

To be eligible for the trial, patients must meet all of the following criteria:

Aged ≥16 years

Diagnosis of new, or relapsed, AL or haematological disorder judged to need IC by the patient’s clinical care team. Eligible conditions include AML, ALL, HRMDS or tMPN

The patient is expected to have prolonged neutropenia related to IC which would mandate either using mould-acting AF prophylaxis and/or systematic IFI biomarker monitoring (at least weekly)

Patient is willing and able to give informed consent for participation in the study

Exclusion criteria

Patients will be excluded from study entry if any of the following apply:

Previous proven or probable IFI (according to the EORTC/MSG criteria [ 13 ])

Contraindication to all potential prophylactic AF agents (i.e. cannot be prescribed any recognised anti-aspergillus agent as prophylaxis)

Planned chemotherapy using any regimen that mandates the use of systemic AF medication (i.e. venetoclax-based regimens)

Received >72 h of systemic mould-acting AF prophylaxis or therapy, or biomarker monitoring for IFI, prior to trial enrolment

Commenced the first cycle of chemotherapy >72 h prior to trial enrolment

Current diagnosis of prolonged (>72 h) of neutropenic fever

Informed consent {26a}

Once eligibility has been confirmed, written informed consent will be obtained from the patient by a suitably qualified and experienced local research nurse or clinician who has been authorised to do so by the Chief Investigator or recruiting site Principal Investigator, as detailed on the study Delegation of Authority and Signature Log for the study site.

Consent will be recorded via paper consent forms, which will be uploaded onto the secure web-based data collection interface Research Electronic Data Capture ‘REDCap’ once complete, or via participant electronic informed consent (e-consent) directly within the REDCap system.

Additional consent provisions for collection and use of participant data and biological specimens {26b}

Alongside the main BioDriveAFS trial, there will be optional parallel studies available to trial participants at sites who are able and willing to be involved in these, and who have been invited to take part with the available local funding and approvals to do so. Participation in parallel studies will involve collecting a small number of additional samples (blood samples and/or skin/oral swabs, and breath samples) from participants who agree to this (both control and intervention arms). Further information on these studies, including objectives, is given in Additional File 1.

Patients will be able to participate in the main BioDriveAFS trial without consenting to the parallel studies, with no impact on their involvement in the main trial or on the quality of their routine clinical care. If the patient chooses to withdraw from the parallel studies, they can request that any stored samples be destroyed. Where sites are invited and agree to be involved in the parallel studies, a specific, tailored patient information leaflet (PIL) will be provided to patients who are approached about BioDriveAFS at that site, which will include details of the relevant additional optional studies. A specific, tailored consent form will be used at sites who are taking part in any of the parallel studies, which will include all main study consent statements, with statements for the additional parallel studies. This will allow consent for the main study and parallel studies to be taken at the same time to minimise any additional burden on patients and sites. The collection of samples will be aligned with routine blood tests/clinic visits wherever possible.

Interventions

Explanation for the choice of comparators {6b}, control arm: prophylactic antifungals and standard of care approach.

Patients will receive a prophylactic mould-acting AF in keeping with guidelines [ 14 , 15 ]. As a minimum, prophylaxis should be given for the duration of chemotherapy-related neutropenia, at least until neutrophil recovery (>0.5 × 10 9 /L). Prophylaxis can be given either with each cycle of chemotherapy, or throughout and between subsequent cycles of IC, as per the usual SoC at the local study site. Some sites stop AF prophylaxis at neutrophil recovery between cycles of chemotherapy in routine care—this is acceptable if it is the usual practice at the study site. Monitoring (regular testing) with GM or BG while the patient is stable (i.e. does not have neutropenic fever (NF) or illness) will not be used in this arm. Patients with persistent NF lasting more than 96 h or with other symptoms suggestive of IFI will be investigated and managed according to existing local SoC (non-culture-based biomarker tests are allowed when used in a ‘reactive’ manner). Participants in this arm must receive prophylactic AF therapy with a recognised anti-aspergillus agent (posaconazole [used by 66% in the survey performed during trial design with key stakeholders and service providers], itraconazole [only when one of the other azoles cannot be used], isavuconazole, voriconazole, liposomal amphotericin B, or [when azoles cannot be used] anidulafungin, caspofungin or micafungin). Fluconazole cannot be used as the sole prophylactic agent.

Intervention description {11a}

Intervention arm: biomarker-driven approach.

Patients will have twice weekly blood tests for GM and BG from the start of IC until at least 7 days after neutrophil recovery with each cycle of IC as per usual local cut-off for neutropenia and clinical practice. Patients may spend a high proportion of their time as inpatients during this period, but during periods of lower risk (as deemed by the clinical care team), when the patient is being seen via outpatient clinics, testing can be reduced to once weekly or as often as the patient is attending (but no more than twice weekly) [i.e. patients do not require additional outpatient clinic appointments above what is the normal SoC to participate in this trial].

A clinical pathway approach (see intervention flow chart, Fig.  1 ), with integration of existing guidelines and definitions will guide the prevention, investigation and therapy of IFI [ 3 , 13 , 16 , 17 ]. Whether symptoms are present or not, patients with two positive tests (either GM and BG both positive or GM or BG positive on consecutive occasions) will be recommended for an urgent high-resolution CT (HRCT) scan of the lungs (≤24 h or as soon as possible thereafter) and, if indicated, of other body sites. A bronchoscopy and AF therapy will be recommended if there are radiological features of IFI in line with guidance and, for centres with access to it, GM testing of bronchoalveolar lavage (BAL) fluid is recommended (though this is not mandated as part of the trial) [ 3 , 16 , 17 ]. If the patient meets the criteria, based on testing, for proven/probable IFI then targeted AF therapy according to site or national/international guidelines, at the discretion of the patient’s clinical team, will be recommended.

BioDriveAFS intervention arm flowchart

HRCT (± BAL), or other directed tests in line with guidance [ 3 , 16 ], will also be recommended for patients with NF ≥ 96 h or other symptoms suggestive of IFI, but AF therapy will be discouraged if GM and BG remain negative in the absence of other evidence of IFI (proven/probable) [ 13 ]. In the survey performed during trial design with key stakeholders and service providers, the most used test for the investigation of IFI in an AML patient with prolonged NF was HRCT (75%) followed by GM (69%), BG (61%), BAL (58%) and then BAL GM (44%); these have all been incorporated into the trial care pathway.

In the event that a performed biomarker test fails due to technical or other reasons, the site team will repeat the test as soon as practically possible.

The clinical team will always retain the right to deviate from the pathway. When this occurs, it will need to be documented within the case report form (CRF) by site research teams. Additional biomarkers (e.g. Candida or Aspergillus PCR) cannot be used as regular IFI surveillance tools (as GM or BG are being used) but can be used ‘reactively’ at the clinical care team’s discretion during episodes of prolonged NF or when the patient exhibits other symptoms/signs of IFI (as is the case in the control/SoC arm).

Criteria for discontinuing or modifying allocated interventions {11b}

BioDriveAFS is a pragmatic trial. Any modifications or changes to allocated interventions deemed clinically appropriate by a patient’s clinical care team will be recorded and reported in the trial CRFs. Participants can choose to withdraw from receiving the trial intervention in favour of SoC at any time.

Strategies to improve adherence to interventions {11c}

The central trial team will be in regular contact with participating sites throughout the trial. Any potential issues raised by sites, including those that may impact adherence to the intervention (e.g. biomarker turnaround times) will be addressed appropriately. CRF return will be monitored on an ongoing basis, which will include auditing data on AFs and biomarkers.

Relevant concomitant care permitted or prohibited during the trial {11d}

Additional clinical review and any further treatments will be determined by clinical need as per usual SoC.

Provisions for post-trial care {30}

Following completion of their follow-up, participants will remain in the care of the treating clinicians as per usual clinical practice.

Outcomes {12}

Co-primary outcome measures.

AF exposure in the 12 months post-randomisation, defined as receipt of more than 72 h of therapeutic systemic AF.

Patient-reported EQ-5D-5L index utility value at 12 months post-randomisation. The EQ-5D-5L measures HRQoL in five dimensions: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, and anxiety and depression. EQ-5D-5L data will be collected via patient questionnaires by site research staff at baseline and then at 3, 6 and 12 months post-randomisation.

Secondary outcome measures, measured over 12 months

Total AF exposure: total defined daily doses (DDD) and whole days of prophylactic and therapeutic AF use.

Assessment of probable/proven IFI, which will be as per the consensus definitions of the Infectious Diseases Group of the EORTC/MSG [ 13 ]. The same definitions will be used for both arms of the trial (full definition provided below).

Survival: all-cause mortality and IFI mortality.

IFI treatment outcome, collected during the last follow-up assessment and categorised as treatment given and completed with no relapse; treatment given and completed, but with relapse; ongoing treatment; and IFI-related mortality.

AF-associated adverse effects/events/complications using the adverse event (AE) reporting procedure and/or from relevant follow-up CRFs as appropriate.

Resource use, collected to inform the economic evaluation. This will include hospital care health service use (e.g. length of hospital inpatient stay, readmissions and outpatient visits) and product costs. These data will be collected from hospital records and through patient questionnaires at baseline, and at 3, 6 and 12 months.

Episodes of NF requiring hospital admission or outpatient management will be assessed using the standard European Society of Medical Oncology Clinical Practice Guidelines (ESMO CPG) definition [ 18 ].

AF resistance in fungi (non-invasive and invasive) isolated from clinical specimens will be taken as part of routine care (i.e. additional samples will not be taken unless the patient has consented and the site is participating in additional sampling for storage/research).

Desirability of Outcome Ranking (DOOR) [ 19 ], which is defined as hierarchical levels to be developed and confirmed following discussion with stakeholders, using Delphi methodology [ 20 ], and the trial Patient Advisory Group.

Definition of invasive fungal infection (IFI) in the BioDriveAFS trial

For a patient within the trial to be defined as having probable IFI they must have at least one clinical feature plus mycological evidence as detailed in Table 1 (all patients, by definition due to their diagnosis, will have at least one host factor), based on the definitions from the EORTC/MSG [ 13 ]. For the purposes of the proposed care pathway in the intervention (biomarker) arm, the cut-offs to trigger further investigation for IFI when the patient does not have NF are any value above the upper limit of the normal range for the test (GM or BG) being used, as defined by local definitions. For the purposes of diagnosis for the endpoints of the trial and where it states ‘probable/proven IFI’ in the proposed care pathway, the cut-offs in Table 1 will be used. The definitions for diagnosis of IFI will be the same for both arms of this trial. Patients who do not fit the EORTC/MSG definition of possible infection but who have persistently unexplained positive biomarkers (both GM or BG, or the same single biomarker consecutively), and are remaining to be or are progressively unwell, should be managed as a possible IFI in terms of considering therapeutic antifungals.

Participant timeline {13}

Participant timeline is shown in Fig.  2 .

BioDriveAFS participant timeline

Sample size {14}

This trial has two co-primary endpoints (AF exposure over 12 months and EQ-5D-5L at 12 months) and is powered such that success must be shown for both outcomes for the intervention to be deemed beneficial (see Table 2 ); therefore, no adjustment for multiple comparisons is required. The comparison of AF use between the two groups is based on showing superiority, while the comparison of EQ-5D-5L index values is based on non-inferiority. The sample size is calculated at 404 patients, as follows.

Sample size for antifungal therapy use

Based on published AF use, an estimated 30% of acute leukaemia patients will receive ≥3 days of therapeutic systemic AF during IC with AF prophylaxis/SoC [ 21 ]. Studies of biomarker-led approaches have shown reductions in AF use of >50% [ 22 , 23 ]. To identify a reduction in this binary outcome from 30 to 15% of patients, with 90% power and two-sided statistical significance of 5%, and allowing for 20% attrition, requires 404 patients.

Sample size for health-related quality of life (EQ-5D-5L)

Pickard et al. estimated the minimal clinically important difference for the EQ-5D-3L UK-utility scores in cancer patients (all cancers) to be between 0.09 and 0.12 [ 24 ]. McClure and colleagues found a difference of 0.063 for the EQ-5D-5L using simulated data for a general population [ 25 ]. Accounting for 15% attrition (participants known to be alive but lost to follow-up; participants who die can be given a score of 0 for any assessment time point following their date of death), a sample size of 404 will be sufficient to assess the hypothesis that the intervention is non-inferior to control, based on a non-inferiority margin of 0.07, SD 0.20 [ 26 ], 90% power and a 95% two-sided confidence interval.

Sample size for proven/probable fungal infection (key secondary clinical outcome)

This sample size will also provide adequate power for the key secondary outcome of proven/probable IFI, to show that the intervention does not increase this outcome by more than 5% provided the proportion in the control group is no more than 2% [ 21 ], allowing for 20% attrition.

Recruitment {15}

Patients will be provided with a paper or electronic PIL. For those unable to speak English, either a translator or language line will be used depending on local availability. Patients will have the opportunity to ask questions of the recruiting research team (i.e. research clinician or nurse) and given as much time as they need to decide if they would like to take part before completing consent processes, within the time constraints of clinical decisions associated with commencing their treatment.

To ensure diversity of participation, data will be collected at screening/randomisation about patient characteristics that could potentially impact trial endpoints such as age, postcode (to estimate index of multiple deprivation score (IMD), with only the first half of the postcode collected from non-randomised patients), ethnicity and sex, which will be monitored by the Trial Management Group (TMG) and the independent Trial Steering Committee (TSC).

The central study team will work closely with the treating clinicians and local research teams at each participating site via engagement, training and networking to optimise the local screening and recruitment processes, initially at the point of site set-up and initiation. Thereafter, there will be various opportunities to adapt and optimise this further; including at planned site training events, through real-time site networking, based on advice from patient/public involvement meetings and learnings from the pilot phase process evaluation work.

The PIL will be developed in close collaboration with the Patient Advisory Group (PAG) to ensure that this is accessible to this patient group and presents all relevant information appropriately. All information required by the UK Health Research Authority (HRA) will be included. Throughout the whole study, screening logs will be kept at each site to determine the number of patients assessed for eligibility and reasons for any exclusion, including any given for patients declining involvement, to help to inform where action may be necessary to maximise recruitment.

Assignment of interventions: allocation

Sequence generation {16a}, concealment mechanism {16b} and implementation {16c}.

The allocation sequence will be generated in Stata v17, by a statistician at York Trials Unit (YTU) not involved in the recruitment of participants using block randomisation stratified by site, with randomly permuted block sizes.

Once eligibility has been confirmed, consent has been obtained, and baseline data collected, participants will be randomised 1:1 (Intervention : Control) by local site staff using REDCap.

Assignment of interventions: blinding

Who will be blinded {17a}.

Due to the nature of the intervention, this is an unblinded trial, and treating clinicians will be informed of the allocation via the online secure REDCap system and will then tell the patient. Therefore, an unblinding procedure is not required for this study.

Procedure for unblinding if needed {17b}

Not applicable as no blinding will be used in this trial.

Data collection and management

Plans for assessment and collection of outcomes {18a}.

Data will be collected using bespoke CRFs completed electronically via REDCap, or collected on paper CRFs returned via post to YTU with data then manually entered into REDCap. An overview of the data collection assessment schedule is given in Fig.  3 .

BioDriveAFS data collection assessment schedule

Investigator-completed hospital CRFs will only be completed by personnel authorised to do so by the Principal Investigator, as recorded on the trial-specific delegation log for each hospital site. Investigators will be trained in data completion by the central study team prior to commencing work on the trial and data entry and refresher training will be made available whenever required. A trial manual detailing all trial processes will be provided to participating sites. Investigator-completed data can be submitted at any stage during the participant’s follow-up and reminders will be sent to research staff at sites to do this.

Plans to promote participant retention and complete follow-up {18b}

To minimise attrition, several methods will be used to keep in contact with participants. Multiple options are available for questionnaire completion depending on participant preference and to allow alternative options where there is no response initially: online via a REDCap link to their email where an email address is provided, a REDCap link sent via SMS (using the secure UK-based text message gateway software ‘IntelliSMS’— https://www.intellisoftware.co.uk ) if the patient provides a mobile phone number, postal completion, or completion over the phone with the study team at YTU. The participant follow-up questionnaires at 3, 6 and 12 months are short, only containing the primary outcome (EQ-5D-5L).

Pre-notification emails will be sent to participants (where an email address has been provided) 1 week before the follow-up questionnaires are due, to help prime them to complete this when the email is sent containing the REDCap link [ 27 ]. Automated reminder emails are also sent 1 and 2 weeks after the due date. Where no response is received to email questionnaires, participants will be given the option to complete over the phone or via post if preferred.

Participants will be given an unconditional £10 voucher with each follow-up questionnaire (at 3, 6 and 12 months). Due to the nature of their illness, patients may be very unwell at certain time points. Research teams at hospital sites will be contacted by the trial team to ensure this is taken into account for questionnaire completion, for example when completing these over the phone with patients, to ensure they are contacted at appropriate times.

Newsletters will also be sent to participants throughout the trial to keep them informed and engaged with the study [ 28 ]. Patient/public contributors will be heavily involved throughout the trial design, recruitment and follow-up periods to ensure methods used are the most appropriate for this patient group.

Patients are free to withdraw from data collection at any point without any compromise or change in their clinical care. It will be possible for them to withdraw only from one aspect of data collection if needed. For example, they could continue with participant questionnaire completion only, or continue with only data collection from their hospital records with no participant-completed data. This should minimise the need for patients to fully withdraw and enable maximum data to be collected.

Data management {19}

Data entry and storage.

The data collected by sites will be entered onto the secure web-based REDCap interface. Data will be held securely on a cloud-hosted REDCap server. Access to the study interface will be restricted to named authorised individuals granted user rights by a REDCap administrator at YTU.

Data protection

Data will be processed in accordance with the General Data Protection Regulations (GDPR) and the Data Protection Act 2018.

Management of qualitative data

This relates to qualitative data collected as part of the Process Evaluation (see ‘ Mixed methods process evaluation ’ section). All qualitative data will be analysed and stored at the University of York (UoY), UK. Audio data will be removed from recording devices as soon as is practicable and will be transferred, stored on and accessed via secure, password-protected servers at UoY. Audio files will be transcribed in house by a trained typist (an administrator at UoY). A confidentiality and data security agreement is in place and only research team members can access data. Separate verbal consent audio recordings will be stored for 5 years, and then deleted. Interview audio recordings will be deleted as soon as possible following transcription. Interview transcripts and any paper data will be stored for a period of 10 years, when paper data, confidential waste and electronic data no longer required for analysis will be disposed of/deleted.

Confidentiality {27}

To maintain anonymity and confidentiality, patients will be assigned a Unique Trial Number which will be used to identify participant data. All study data used for analysis will be pseudonymised using only the Trial Number to identify the patient, and patients will not be identifiable in any reports or publications. All data will be processed and stored in accordance with the GDPR and the Data Protection Act 2018. All records will be stored in secure locked locations, with consent forms stored securely on password-protected servers and/or in secure locked cabinets with authorised access only. Only the study team, the Sponsor, the NHS Trust or regulatory authorities will review clinical information where it is relevant to the patient taking part in the research, agreed by the patient at the time of consent.

Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}

Clinical samples, for example the serum biomarker tests as part of the intervention arm, will be collected, handled and analysed according to routine NHS procedures. Optional parallel studies will take place at some sites involving collection and analysis of additional biological samples, which are described in further detail in Additional File 1.

Statistical methods

Statistical methods for primary and secondary outcomes {20a}.

Full analyses will be detailed in a Statistical Analysis Plan (SAP), which will be finalised prior to the end of data collection, and reviewed and approved by the TMG and independent oversight committees (Data Monitoring and Ethics Committee (DMEC) and TSC). Analyses will be carried out using two-sided statistical tests at the 5% significance level under the principles of intention-to-treat. The trial will be reported according to the CONSORT guidelines for clinical trials and participant flow will be presented in a CONSORT diagram [ 29 ].

Main trial analysis

Baseline data will be summarised descriptively by trial arm, both as randomised and as included in the primary analyses. No formal statistical testing will be conducted on baseline data.

For intervention participants, the following will be summarised: the number and frequency of their blood tests for GM/BG from the start of IC until neutrophil recovery after the final IC; the number who undergo a HRCT scan following one or two positive tests but without symptoms; the number who undergo a bronchoscopy and GM BAL; and those prescribed systemic AF therapy among those with/without features of proven/probable IFI. For patients with NF ≥96 h or other symptoms suggestive of IFI, the number who undergo a HRCT (± GM BAL) or other directed tests and/or are prescribed systemic AF therapy will be summarised, stratified by whether or not their GM/BG remain negative. The same measures will be assessed in the comparator group to assess for contamination. It would be expected that the use of GM/BG during periods of clinical stability (i.e. no neutropenia and/or fever and/or IFI symptoms) will to be zero or very low in the control group. The use, defined daily doses, and full days of therapy of prophylactic and therapeutic systemic AF for all participants over the course of the trial will be summarised.

The co-primary outcome of AF use, as a binary outcome, will be analysed via a mixed-effects logistic regression model, adjusting for pertinent participant-level covariates as fixed effects and site as a random effect. EQ-5D-5L index values will be compared between the two groups using a covariance pattern linear mixed model incorporating all post-randomisation assessment points adjusting for baseline value, other pertinent baseline covariates, time and an interaction between treatment group and time as fixed effects. Participant and site will be specified as random effects. The adjusted mean difference in EQ-5D-5L score over the whole 12 months and at each time point will be calculated with its 95% confidence interval; the treatment effect at 12 months will be the primary endpoint, while the other differences will serve as secondary investigations.

Secondary outcomes will be analysed using appropriate regression techniques; for example, logistic regression for probable/proven IFI, and the presence of AF associated adverse events; Cox Proportional Hazards regression for survival outcomes (time to all cause and IFI mortality); a proportional odds logistic model for the DOOR outcome; and Poisson regression for count data of number of episodes of NF requiring hospital admission or outpatient management.

Interim analyses {21b}

No formal interim analyses will be performed.

Relevant data from the internal pilot trial (first 9 months of recruitment) will be assessed against predefined progression criteria (Table 3 ) by the TSC, DMEC, PAG and the NIHR prior to progression to the main trial to help determine whether continuation is warranted. The NIHR will make the final decision as to whether the trial continues or is terminated.

Methods for additional analyses (e.g. subgroup analyses) {20b}

Any additional analyses to those detailed in this protocol will be detailed in the SAP, which will be finalised prior to the end of data collection, and reviewed and approved by the TMG, DMEC and TSC.

Health economic evaluation analyses

The objective of the economic evaluation analysis is to assess the cost-effectiveness of the biomarker-led diagnostic strategy in preventing and managing IFI in patient with AML/ALL/HRMDS/tMPN, as compared to prophylactic AF/SoC. The evaluation, conducted from the perspective of the NHS and personal social service (PSS), aims to analyse the health benefits and associated costs of both interventions.

Cost calculation will employ a bottom-up methodology encompassing resources necessary for intervention delivery and individual health and social service utilisation over the study period. Data on resource use will be collected from participating sites though tailored CRFs completed by health care staff (i.e. costs associated with prophylaxis/empiric AF, AF related AEs, biomarker implementation and testing, length of stay, readmissions and follow-up visits related to infections). Collected resource use information will be multiplied by unit costs obtained from authoritative sources including the National Cost Collection by NHS England [ 30 ] the Unit of pf Health and Social Care report by Personal Social Services Research Unit (PSSRU) [ 31 ] and other appropriate national sources.

Health outcomes will be expressed in terms of the quality-adjusted life year (QALY), utilising the EQ-5D-5L instrument to measure the impact on both quantity and quality of life. Individual-level responses to EQ-5D-5L will be used to calculate utility scores based on UK population value set, and an area under the curve approach will be used to calculated QALYs [ 32 ]. To handle the missingness, multiple imputation with chained equations will be employed to address anticipated missing data for resource use and utility measures, imputing costs and utility measures based on patient characteristics and baseline costs and QALYs [ 33 , 34 ].

The primary economic analysis will be a within-trial cost-utility analysis conducted at the end of trial (12-month follow-up) to evaluate the short-term cost-effectiveness. Mean total costs and QALYs will be compared between two interventions using regression models, controlling for baseline characteristics, such as baseline utility [ 35 ]. These models will not only consider the distribution of the cost and QALY estimates but also the correlation between them [ 36 ]. To handle the uncertainty, a non-parametric bootstrap will be used to produce confidence intervals around the incremental cost, incremental QALY and incremental cost-effectiveness ratio (ICER), as the regression residuals are likely to be skewed [ 37 ]. Bootstrapped results will be graphically presented in the conventional form of a cost-effectiveness plane (CE-plane) and cost-effectiveness acceptability curve (CEAC), with the calculated ICER assessed against the NICE willingness-to-pay (WTP) threshold of £20,000 to £30,000 per QALY gained to determine the short-term cost-effectiveness of the biomarker-led diagnostic.

For long-term effects, a decision-analytic model may be developed to project costs and QALYs over the patient’s lifetime. The model structure will be informed by existing literature and expert consultations, while parameters will be sourced from previous modelling studies and the best available evidence from the literature. A 3.5% annual discount rate will be applied to both costs and QALY predictions. Same to the short-term within-trial analysis, the projected results will be plotted, and the ICER will be calculated against the WTP threshold to assess the long-term cost-effectiveness of biomarker-led diagnostic strategy.

This study will follow the National Institute for Health and Care Excellence (NICE) Guide to the Methods of Technology Appraisal [ 38 ], and a detailed health economics analysis plan (HEAP) will be drawn up in advance of the analysis and approved by the trial DMEC and TSC.

A within trial analysis with total costs and QALYs will be presented for both trial groups. This analysis will be conducted using regression methods and will assess the short-term effect on patients’ health and costs to the NHS of the interventions in the trial.

However, it is unlikely to provide all the evidence relevant to the decision on whether a biomarker-led strategy represents a cost-effective option for the NHS. Hence, a decision-analytic model will be developed to extrapolate the effect on lifetime costs and QALYs combining the best available evidence. A state-transition model will be used in this analysis. State-transition models use a series of health states which demark important changes to prognosis, costs or quality of life. Parameter estimates, including HRQoL associated with long-term consequences of infections, will be sourced from primary data sources, previous modelling studies and the best available evidence from the literature. Systematic searches will be conducted to update the most comprehensive evidence in this area. A 3.5% annual discount rate will be applied for costs and outcomes.

Mixed methods process evaluation

The overall aim of the process evaluation is to robustly evaluate how the intervention is delivered during the internal pilot and main trial via the collection of both qualitative and quantitative data. The specific aims of the process evaluation are to:

Understand the contexts/settings in which the intervention works better, and why (qualitative);

Explore implementation barriers/facilitators to inform post-trial implementation (qualitative);

Assess fidelity to the clinical pathway (quantitative and qualitative).

Quantitative data collection—assessment of fidelity to the clinical pathway

Quantitative measurement will focus on the core principles of adherence, defined as:

Content: did the clinical team deliver the intervention as designed by the research team?

Frequency and duration: did the clinical team deliver the intervention as often and as long as planned, based on pre-specified targets?

Coverage: was the intervention delivered to all eligible participants?

The assessment criteria will include exploring:

Whether participants undergo GM/BG testing as per the care pathway and if not, why not? (information collected will include frequency of testing and duration).

Modifications/adaptations to the care pathway and the reasons behind this.

Whether patients received AF therapy diverging from the care pathway.

Data will be collected for every intervention patient enrolled in both the pilot and main trial (about 200 patients), across all sites.

Figure 4 shows quantitative fidelity assessment procedure.

Quantitative fidelity assessment procedure

Fidelity scoring:

An intervention fidelity scoring matrix will be developed [ 39 ]. Towards the end of the study an aggregate score will be produced from the three fidelity domains (content, frequency and duration, coverage). Adherence will be categorised on a scale of 0–3 (0 being no adherence, and 3 for full adherence) for each site with interviews conducted with the lead clinician at 10 sites to understand site level fidelity.

Qualitative data collection—understanding context and exploring implementation

There are five components to the qualitative work with a primary goal to understand ‘what works, for whom, when and why?’ It will capture contextual site factors that may shape intervention implementation and delivery, alongside levers behind accepting or declining to take part in the trial.

Patient interviews:

Phone or video interviews lasting approximately 40 to 60 min will be conducted with a purposive sample of 40 unique intervention arm participants overall (20 patients at two different timepoints) after hospital discharge. Participants will be sampled on age, gender, ethnicity and length of hospital stay.

The aim of the patient interviews is to understand patients’ perceptions of the intervention by exploring their experience of hospital treatment and knowledge of the intervention. The topic guide will be developed with PPI input and will have questions on areas such as inpatient experience and how the intervention was delivered.

In collaboration with the process evaluation researcher, Research Nurses (RNs) will identify participants who might be interested in taking part. Permission will be sought to forward their contact details to a researcher at the UoY. Either an information sheet and consent form will be given to patients for consideration while in hospital by RNs (where they feel it is appropriate) or the researcher will provide these documents (post or email) after first contacting the patient via phone to gauge their interest in taking part. Once they agree to participate and an interview is set up, verbal consent will be obtained during the interview via audio recording. They will be reassured that involvement is entirely voluntary, the interview can be stopped at any time and they have a right to withdraw without any effect on their medical care.

Healthcare staff interviews:

A mixture of face-to-face, phone and video interviews lasting around 30 min will be conducted with approximately five healthcare professionals per site who are key implementers of the intervention and those who provide clinical care for patients (e.g. haematologists, infection doctors, pharmacists, nurses, allied health professionals and lead RNs who recruit patients to the trial). In total, staff from eight sites will be interviewed, with a total of 40 participants interviewed during the pilot phase and 40 participants interviewed towards the end of the trial. There will be a mixture of individual or focus group interviews, depending on preferences.

Healthcare professionals will be asked to talk in a non-identifying manner about an intervention and a control arm patient, to ground focus. The topic guide will be based on core constructs of Normalisation Process Theory [ 40 ] and will focus on areas such as practicalities of the intervention, problems and successes, systems/relationships/site set-up and any changes in practice occurring with control group patients.

A researcher from YTU will invite staff to take part in an interview/focus group. The initial approach will be via email or a short verbal description of what is involved. RNs will likely identify healthcare staff for interviews. If there is interest in being involved, an information sheet will be provided with opportunities to ask questions. Those who subsequently agree to participate will be emailed a consent form. Audio recorded verbal consent will be taken.

Lead clinician interviews:

Brief structured one-off telephone interviews will be conducted with lead clinicians from the five least and five highest adherent sites. The approach and consent process will be the same as for healthcare staff.

Questions will be based on the moderating factors developed via staff and patient interviews. Lead clinician’s thoughts as to why the intervention may have succeeded well or less well at their site will be encouraged. Lead clinicians will also be asked why their site agreed to participate in the trial.

Declining site interviews:

Brief semi-structured one-off telephone interviews will be conducted with clinicians at 8–10 sites that have declined to take part in the BioDriveAFS trial. It is anticipated these interviews will last approximately 20 min. The approach and consent process will be the same as described above.

These interviews will explore and provide more nuanced understandings of why sites decline.

Site initiation ‘visit’ (SIV) video analysis:

As part of the pilot phase, YTU staff will conduct SIVs when a site indicates it is ready to go ahead with the trial. This will also include a preliminary meeting between YTU and site teams (pre-SIV) to discuss clinical aspects of the trial. These video calls will be recorded as standard practice and analysed as part of the process evaluation. This will help provide an understanding of the levers of accepting and declining trial participation as well as the context of practices within sites where the trial would be situated.

Each clinical team member appearing in the recording will be emailed asking for their consent to include their contribution and conversation in the analysis (with an explanation of the approach and a ‘further information’ sheet). If an individual declines, their contribution will not be included in the analysis. If no email response is received, two further emails will be sent with an option to opt out. If there is still no response, the YTU research team will proceed to include their contribution (they will be clearly made aware of this in emails). There will be no reference to individual patients or individual care provision in recordings.

A summary of other data collection methods, samples and timepoints for the process evaluation can be found in Additional File 2.

Process evaluation analysis plan

Analysis of quantitative data will include basic descriptive statistical analysis. After the pilot stage of the trial, analysis will pay attention to interim levels of adherence and differences between sites. Towards the end of the trial, analysis of fidelity data from the main trial will be undertaken. A fidelity scoring matrix will also be used.

Analysis of qualitative data will include a rapid descriptive thematic analysis to generate headline themes emerging during the trial. Towards the end of the recruitment period, there will be a mixture of deductive analysis and inductive descriptive analysis to explore intervention implementation and fidelity. Towards the end of the trial, deductive analysis will be undertaken to analyse fidelity as well as framework analysis of responses.

Finally, after the pilot stage, there will be a mixed methods integration of qualitative and quantitative data to refine the treatment pathway/clinician training to improve adherence moving forward into the main trial.

Additional File 2 shows further in-depth details regarding analysis methods, frameworks and outcomes.

Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}

Complier Average Causal Effect sensitivity analyses for the primary outcomes will be conducted to account for non-compliance with the intervention and contamination, which will consider the number and frequency of GM/BG tests undertaken for participants over the relevant follow-up period.

Plans to give access to the full protocol, participant-level data and statistical code {31c}

The full protocol is available via the Funder website: https://www.fundingawards.nihr.ac.uk/award/NIHR132674

In principle, once analysis and all intended outputs are complete, anonymised data will be made available for meta-analysis and where requested by other authorised researchers and journals for publication purposes. Requests for access to data or documentation will be reviewed by the Chief Investigators and study Sponsor.

Oversight and monitoring

Composition of the coordinating centre and trial steering committee {5d}.

YTU will lead on overall trial management and governance in close collaboration with the Co-Chief investigators and co-applicants. YTU has an established track record of running large clinical trials and will be responsible for delivering the trial with quality assured trial processes. YTU will communicate regularly with trial sites and monitor trial activities to ensure compliance with Good Clinical Practice (GCP). Key members from YTU will be part of the TMG, including the trial statisticians, trial manager, trial coordinators, health economist and qualitative researcher.

The TMG will meet approximately bimonthly via videoconference/teleconference or in person.

The TSC is independent and established to provide overall independent oversight for BioDriveAFS on behalf of the Sponsor and Project Funder and to ensure that the project is conducted to the rigorous standards set out in the Department of Health’s Research Governance Framework for Health and Social Care and the Guidelines for GCP. The committee comprises an independent academic haematologist, a pharmacist specialising in antimicrobial stewardship, an infectious diseases physician, a biostatistician, a health economist, an academic researcher with expertise in process evaluation work and a patient/public contributor. The TSC will meet routinely during the trial to monitor the progress of the trial and provide independent advice. A Sponsor representative will also be invited to attend TSC meetings.

Composition of the data monitoring committee, its role and reporting structure {21a}

The BioDriveAFS DMEC is independent of the study sponsor and comprises independent clinicians, a statistician and a pharmacist. All DMEC members have signed a DMEC charter and confirmed they have no competing interests. This is stored in the trial master file at YTU.

The DMEC will meet annually (or more frequently if the committee requests) to provide project oversight to the trial. This will include monitoring safety and efficacy data, and quality and compliance data, while ensuring the protocol is accurately followed, and the study is GCP compliant. The committee will recommend whether there are any ethical or safety reasons why the trial should not continue, and report these in writing to the TSC. Independent members of the DMEC committee will be allowed to see unblinded data on request.

Patient and public involvement (PPI)

The BioDriveAFS Trial protocol was developed with input from the Patient Advisory Group (PAG), including primary and secondary outcomes (informing the choice of the EQ-5D-5L quality of life assessment as a co-primary outcome), study assessment schedule, inclusion and exclusion criteria, outcome assessment tools and ways to support diversity and inclusivity in the trial.

The PAG will meet regularly throughout the study and will continue to work with the study team to optimise recruitment, retention and dissemination of findings through activities such as the co-development of study documents and communication tools. Their contributions will help to ensure that documentation and dissemination is engaging and accessible for patients, their carers and the public.

PPI contributors will be part of the relevant trial committees, with two PPI members on the TMG, and one member on the TSC.

Adverse event reporting and harms {22}

The BioDriveAFS trial will comprise adult patients with acute leukaemias undergoing IC. Prolonged hospital inpatient admission and complex clinical events, common in this patient group, will be captured within trial CRFs and will not necessarily require AE reporting. For the purposes of the BioDriveAFS trial, AEs are defined as any untoward medical occurrence (i.e. any unfavourable and unintended sign, symptom or disease) in a trial participant that logically could or is likely to have a causal relationship with the intervention (i.e. intervention pathway biomarker/diagnostic tests and associated treatments thereof). This could include AEs as a result of, for example, interventions (tests or treatments) that occur because of a false positive biomarker result or AEs due to a lack of an intervention because of a false negative biomarker result.

The following events will not need to be reported routinely as an AE for this trial unless the criteria above or serious adverse event (SAE) criteria are fulfilled:

Respiratory infection or failure, including mechanical ventilation and acute lung injury

Hepatic infection or failure

Renal infection or failure, including the need for renal replacement therapy

Haematological/coagulation failure, including anaemia, leucopenia, thrombocytopaenia or pancytopaenia

Neurological infection or failure

Unscheduled care escalation

Infection relapse/recurrence requiring further antimicrobials

Super- or secondary infection defined as a new infection at a different body site

Suspected antimicrobial adverse reactions/events

Progression of the underlying haematological disease or non-response to systemic antineoplastic chemotherapy

AEs related to the antineoplastic chemotherapy

Although the above will not require expedited reporting as an AE on the study, key complications will be captured in other routine follow-up CRFs. For example, details of fungal infections, and key bacterial and viral infections (including NF) will be captured on a monthly basis. Attendance at and admission to hospital for reasons relating to the management of a participant’s leukaemia will be captured.

For the BioDriveAFS trial, SAEs are defined as events resulting in (i) persistent or significant disability or incapacity or (ii) a congenital anomaly or birth defect.

All SAEs should be reported to YTU within 24 h of the investigator becoming aware of the event. Once received, causality and expectedness will be confirmed by one of the Co-Chief Investigators or a medical co-applicant or TSC member not acting as a site Principal Investigator (PI). Any change of condition or other follow-up information should be sent as soon as it is available or at least within 24 h of the information becoming available. Events will be followed up until the event has resolved or a final outcome has been reached.

AEs that are deemed to be unexpected and related to the trial will be notified to the REC and sponsor within 15 days. All such events will be reported to the TSC and DMEC at their next meetings.

Frequency and plans for auditing trial conduct {23}

The study will be conducted in accordance with the current approved protocol, ICH GCP, relevant regulations, standard operating and trial-specific procedures.

Regular central monitoring will be performed according to ICH GCP and the BioDriveAFS monitoring plan. The BioDriveAFS monitoring plan which will be agreed by the Sponsor, TMG, TSC and Co-Chief Investigators. Data will be evaluated for compliance with the protocol and GCP and the applicable regulatory requirements.

Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}

Substantial protocol changes will firstly be agreed with the Funding Body, Sponsor, TSC, DMEC and TMG. Agreement for minor protocol changes will be sought from the TMG and Sponsor. Amendments will then be made to the required documentation, and the HRA amendment tool completed to confirm the category of the amendment. Once Sponsor authorisation has been confirmed, YTU will submit via IRAS and, where necessary, obtain approval from the Research Ethics Committee (REC), HRA and host institution(s) for approval of all substantial amendments to the original approved documents. Once approvals are received, the new documents/versions will be shared with sites and the study version control log will be updated for sites to check they are using only the most recent versions of trial documents.

For any amendments to trial eligibility criteria, the ISRCTN registry will also be updated. Trial participants will be written to, if necessary, to explain any changes.

Dissemination plans {31a}

Through the planned methods and outputs, the study is expected to play a key role in enhancing the evidence base on the effectiveness of a biomarker-based antifungal stewardship strategy vs a prophylactic AF strategy in reducing AF therapy use in patients with AL undergoing IC. The economic analyses will help identify the most efficient and responsible (in terms of AFS) provision of future care and thus savings and benefits to the NHS and society.

Results from this study will be written up and submitted to peer-reviewed journals. Several dissemination channels will be used to ensure patients and the public are also informed of the study results. Engagement will continue to take place throughout the trial and beyond with key stakeholders, partners and collaborators as part of the dissemination strategy. These include relevant charities and patient organisations, relevant NIHR Applied Research Collaboratives, key opinion leaders (e.g. in AFS, infection and haematology) and other relevant stakeholder organisations such as laboratories performing IFI-related tests, Royal Colleges and specialist societies such as the British Infection Association, the British Society for Haematology, the British Society for Medical Mycology and the Royal Pharmaceutical Society.

Other core outputs from the trial will be:

Quantitative and qualitative process evaluation data to inform the pathway to adoption and dissemination/implementation, and other AFS interventions and the wider AFS agenda

A training, engagement and PPI legacy built around the development of a network of stakeholders interested in this aspect of AFS and the wider AFS agenda

The results of this trial are likely to be practice changing/informing and are therefore highly likely to be incorporated into national and international guidelines

Publications in high-impact open-access journals relating to the work packages as outlined

Conference presentations at high-impact, relevant national and international conferences relating to the key components of the work packages: trial design, main trial, process evaluation and cost-effectiveness

Cost-effectiveness data to inform the NHS about the value for money of the intervention

A potential research resource for the global research community to perform further research relating to the stored blood samples with linked clinical data, as outlined above

Development and use of a DOOR endpoint as an exploratory outcome to assess relevance within the context of this trial and AFS

A partnership has been agreed with the British Society for Antimicrobial Chemotherapy (BSAC) to help deliver key engagement and post-trial adoption, training, and implementation for example through the following:

A BSAC hosted, bespoke networking/project website (E-forum) to facilitate and enhance sharing and communication of research outputs. Resources from webinars and training events will be housed on this site, providing key output legacy and reusable and updateable materials that are available beyond the projects timeframe

Hosting of a national trial-related event and series of up to four separate webinars to promote dissemination of research outputs, stakeholder involvement and networking. Recordings of events will be hosted on the BSAC e-learning hub ( https://www.infectionlearninghub.co.uk/ )

Development of an accredited e-learning course relating to project outputs. The course will be hosted on the FutureLearn Platform https://www.futurelearn.com/ and developed as a SCORM (Sharable Content Object Reference Model) compliant course to enable NHS trusts to download and deploy on local intranets

Outputs of webinars and other meetings as potential leading articles in BSAC journals

Appropriate use of social media to engage with the public, professionals and stakeholders

The use of empirical or preemptive systemic AFs in patients with AL and related conditions undergoing intensive chemotherapy is a controversial area of clinical practice with a sub-optimal high-quality evidence base to inform how we currently prescribe and order tests. In the UK NHS, heterogeneity in clinical practice in this area appears to be considerable with some centres performing systematic IFI biomarker monitoring while prescribing mould-acting antifungal prophylaxis while others do much less. This is unacceptable in the context of emerging antimicrobial resistance in fungi, as well as the associated fiscal costs, medication burden for patients, drug-drug interactions and adverse effects of AF agents. This trial aims to further the knowledge of strategies to safely optimise AF use and will generate the next step on the evidence ladder following the recent trial of Maertens et al. [ 12 ]; i.e. can antifungal prophylaxis be safely omitted by using a biomarker-based diagnostics approach in the prevention and treatment of IFI in a high-risk patient group.

The clinical and cost-effectiveness of two strategies will be compared: a biomarker-based AFS strategy, vs a prophylactic strategy (the current most commonly used SoC for these patients in the UK’s NHS). The trial has an inbuilt 9-month pilot phase and mixed methods process evaluation to assess the fidelity and feasibility of the trial and the intervention, and to inform post-trial implementation. The results will be disseminated through various relevant outputs in collaboration with stakeholders, including peer-reviewed publications and a legacy engagement website. Patient and public involvement was important in informing the design of the trial, including the choice of primary outcome.

The generated evidence will inform global clinical practice and approaches within the emerging discipline of antifungal stewardship, as well as improving knowledge about how to prescribe antifungals for optimal patient safety while minimising costs and emerging antifungal resistance.

Trial status

The BioDriveAFS trial is working to protocol version 2.4 (12/02/2024). Recruitment began in September 2022 and is due to be complete by 30th August 2024.

Availability of data and materials {29}

The patient consent form will be inclusive of a statement of permission to access source data by staff working on the study, and for regulatory and audit purposes. This will be explicitly explained as part of the consent process and within the Participant Information Sheet.

Upon completion of analysis and all intended outputs by YTU, anonymised data will be made available for meta-analysis, and for other authorised researchers and journals who request this data for publication purposes. The Chief Investigator and study sponsor will review all requests for access to data.

Abbreviations

Adverse events

Antifungal Stewardship

Acute graft-versus-host disease

• Acute leukaemia

Acute lymphoblastic leukaemia

Acute myeloid leukaemia

Broncho-alveolar lavage

Beta-D-glucan (biomarker)

British Society for Antimicrobial Chemotherapy

Case Report Form

Consolidated Framework for Implementation Research

Central nervous system

Clinical Practice Guidelines

Case report form

Cerebrospinal fluid

Defined daily dose

Deoxyribonucleic acid

Data Monitoring and Ethics Committee

Desirability of Outcome Ranking

Electronic informed consent

European Organization for Research and Treatment of Cancer and the Mycoses Study Group

European Society of Medical Oncology

EuroQol Quality of Life Measure

General Data Protection Regulations

Galactomannan (biomarker)

Good Clinical Practice

High-resolution CT

High-risk myelodysplastic syndromes

Health-related quality of life

Human immunodeficiency virus

Health Research Authority

Invasive aspergillosis

Intensive chemotherapy

Incremental cost-effectiveness ratios

• Invasive fungal infection

Index of multiple deprivation score

Magnetic resonance imaging

National Health Service

Patient Advisory Group

Patient Information Leaflet

Principal Investigator

Polymerase chain reaction

Pneumocystis pneumonia

Quality-adjusted life year

Randomised control trial

Research Ethics Committee

Research nurse

Serious adverse events

Statistical Analysis Plan

Sharable Content Object Reference Model

Site Initiation Visit

Standard of Care

Turnaround time

Trial Management System

University of York

York Trials Unit

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Acknowledgements

The BioDriveAFS trial is sponsored by Hull University Teaching Hospitals NHS Trust. The authors extend their thanks to all members of the Patent Advisory Group for their input and advice throughout the whole of the trial and its development. Their comments and contributions have been extremely insightful. Thanks also to the Trial Steering Committee and Data and Ethics Monitoring Committee for their continued support and guidance.

A further thank you to the British Society for Antimicrobial Chemotherapy (BSAC) for their partnership in delivering key engagement, training and post-trial adoption and implementation activities. Authors would finally like to thank all the individuals who have consented to participate in this trial, alongside all the teams working on the trial at each of the participating sites, who have enabled this research to take place.

This project is funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme (NIHR132674).

The views and opinions expressed are those of the authors and do not necessarily reflect those of the Health Technology Assessment programme, NIHR, NHS or the Department of Health.

The funders have had no direct role in study design nor in the collection, management, analysis or interpretation of data. They will have no role in the writing of associated publications and the decision to submit papers for publication.

The financial arrangements for the study will be as contractually agreed between the funder, the University of York and the Sponsor (Hull University Teaching Hospitals NHS Trust).

Author information

David Allsup and Gavin Barlow co-chief investigators—joint senior authorship.

Authors and Affiliations

Department of Health Sciences, University of York, York, UK

Lydia Flett, Radwa Abdelatif, Sarah Akhtar Baz, Samantha Brady, Belén Corbacho, Abbie Cowling, Caroline Fairhurst, Ellie Fitzmaurice, Joanne Laycock, Adwoa Parker, Laura Sheard, Puvan Tharmanathan, David Torgerson & Han-I Wang

Patient and Public Involvement, University of York, York, UK

Kate Common & Mary Peel

King’s College Hospital NHS Foundation Trust, London, UK

Shreyans Gandhi

Faculty of Health Sciences, University of Hull, Hull, UK

Andrea Hilton

Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK

William Hope

Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK

Alex Howard

Hull University Teaching Hospitals NHS Trust, Hull, UK

Patrick Lillie & Thomas Taynton

Institute for Social Marketing and Health, University of Stirling, Stirling, UK

Gemma Mitchell

British Society for Antimicrobial Chemotherapy, Birmingham, UK

Jacqueline Sneddon

Biomedical Institute for Multimorbidity, Hull York Medical School, University of Hull, Hull, UK

David Allsup

Department of Experimental Medicine & Biomedicine, Hull York Medical School, University of York, York, UK

Gavin Barlow

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Contributions

DA and GB are Co-Chief Investigators (Co-CIs). AHi, AP, BC, CF, DT, GM, JL, JS, LF, LS, PL, PT, SG, TT, WH and PAG members contributed to the study design and protocol development alongside the Co-CIs. LF, SBr, JL, RA, EF, SBa, LS, PT, TT, CF, AC, HW, DA and GB drafted the manuscript which has been reviewed and approved by all authors.

Corresponding author

Correspondence to Lydia Flett .

Ethics declarations

Ethics approval and consent to participate {24}.

Ethical approval for this study was sought and received from South West Frenchay Research Ethics Committee on the (REC Ref: 22/SW/0053).

Written informed consent will be obtained from all participants in the trial.

Consent for publication {32}

Not applicable. No identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the authors on request.

Competing interests {28}

The authors declare that they have no competing interests.

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Supplementary Information

13063_2024_8272_moesm1_esm.pdf.

Additional file 1. BioDriveAFS Parallel Studies: Description of the planned additional research running in parallel to the main BioDriveAFS trial, with consenting main trial participants and certain participating sites. Consent to these are optional and will not impact on patients’ involvement in the main trial, or impact on their standard of care. 

13063_2024_8272_MOESM2_ESM.pdf

Additional file 2. BioDriveAFS Mixed Methods Process Evaluation: A summary of further in-depth details regarding data collection, analysis methods, frameworks and outcomes. 

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Flett, L., Abdelatif, R., Baz, S.A. et al. Biomarker Driven Antifungal Stewardship (BioDriveAFS) in acute leukaemia—a multi-centre randomised controlled trial to assess clinical and cost effectiveness: a study protocol for a randomised controlled trial. Trials 25 , 427 (2024). https://doi.org/10.1186/s13063-024-08272-w

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Received : 11 March 2024

Accepted : 19 June 2024

Published : 28 June 2024

DOI : https://doi.org/10.1186/s13063-024-08272-w

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ISSN: 1745-6215

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