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Procedural fairness for radiotherapy priority setting in a low resource context

Abstract Radiotherapy is an essential component of cancer treatment, yet many countries do not have adequate capacity to serve their populations. This mismatch between demand and supply creates the need for priority setting. There is no widely accepted system to guide patient prioritization for radiotherapy in a low resource context. In the absence of consensus on allocation principles, fair procedures for priority setting should be established. Research is needed to understand what elements of procedural fairness are important to decision makers in diverse settings, assess the feasibility of implementing fair procedures for priority setting in low resource contexts, and improve these processes. This study presents the views of decision makers engaged in everyday radiotherapy priority setting at a cancer center in Rwanda. Semi‐structured interviews with 22 oncology physicians, nurses, program leaders, and advisors were conducted. Participants evaluated actual radiotherapy priority setting procedures at the program (meso) and patient (micro) levels, reporting facilitators, barriers, and recommendations. We discuss our findings in relation to the leading Accountability for Reasonableness (AFR) framework. Participants emphasized procedural elements that facilitate adherence to normative principles, such as objective criteria that maximize lives saved. They ascribed fairness to AFR's substantive requirement of relevance more than transparency, appeals, and enforcement. They identified several challenges unresolved by AFR, such as conflicting relevant rationales and unintended consequences of publicity and appeals. Implementing fair procedure itself is resource intensive, a paradox that calls for innovative, context‐appropriate solutions. Finally, socioeconomic and structural barriers to care that undermine procedural fairness must be addressed.

Radiotherapy is an essential component of effective cancer treatment. An estimated half of all cancer patients would benefit from radiotherapy for curative treatment, local disease control, or palliation. 1 However, there is a severe worldwide shortage of radiotherapy resources, and many African countries do not have adequate capacity to serve their populations. 2 This mismatch between demand and supply creates the need for priority setting. At the macro level of governments and the meso level of institutions or insurance plans, radiotherapy priority setting takes the form of budget resource allocation. At the micro level of patient care, radiotherapy resources must be rationed in settings of absolute scarcity. When explicit priority setting systems are not in place, resources tend to be distributed implicitly based on morally arbitrary factors such as ability to pay, social privilege, or a first-come, first-served basis. 3 Generations of ethicists, economists, and policymakers have articulated principles to guide healthcare resource allocation and rationing. Major categories of distributive principles include maximizing total benefits (e.g., utilitarianism), favoring the worst off (e.g., prioritarianism), treating people equally, and promoting social usefulness. 4 However, principles often prove too general or unclear in practice, and stakeholders may reasonably disagree over which principle should take precedence when in conflict. In the absence of consensus on normative principles for priority setting, an influential response has been to focus instead on developing fair processes for decision making. 5 Proponents of this approach hold that fair deliberative procedure establishes the moral legitimacy and fairness of decisions.
Despite the number of overburdened radiotherapy machines globally, there is no widely accepted system to guide radiotherapy priority setting across heterogeneous clinical indications at meso and micro levels. Frameworks have been proposed to guide macro level radiotherapy resource allocation in low and middle income countries (LMICs), 6 and a handful of patient prioritization systems have been reported from high income countries (HICs) with universal coverage systems and long waiting lines. 7 These predominantly utilitarian prioritization systems use varying approaches to benefit maximization and incorporate other distributive principles to different degrees, based oncology specialists over weekly teleconferences and frequent emails. 12 Until 2019, there was no radiotherapy facility in Rwanda, and PIH/IMB was able to support a finite number of patients per month to receive radiotherapy in neighboring countries. Initially, budgeted funds were adequate to send most patients who were potentially curable with (and only with) radiotherapy. As patient volumes grew and the need for radiotherapy began to outstrip supply, patients were added to a waiting list, creating the obligation to prioritize. Individual physicians selected patients from the list based on a combination of perceived curability and a firstcome, first-served basis. Assessment of curability across diseases became increasingly complex, and in 2016 the team developed Clinical Radiotherapy Prioritization Guidelines ("Guidelines").
Drafted during a 2-hr deliberation among advisors, program leaders, and oncology clinicians, the Guidelines ranked categories of cancer type and stage by an estimation of the incremental chance of cure, or absolute survival benefit, conferred by radiotherapy.
For instance, early stage cervical cancer was ranked first because the difference between the chance of cure with radiotherapy versus without was considered highest, followed by several categories of head and neck cancer. By contrast, lymph nodepositive breast cancer was ranked much lower because radiotherapy adds modest survival benefit to other available treatment modalities (e.g., mastectomy and chemotherapy). With the implementation of these Guidelines, the team instituted regular meetings during which a group of physicians selects patients from the waiting list.

| Study design and participant recruitment
This paper reports on a subset of themes from a qualitative study aimed at understanding the experience and views of oncology clinicians, advisors, and program leaders engaged in clinical priority setting at BCCOE. Here, we focus on participants' evaluation of actual radiotherapy priority setting procedures at the meso and micro levels, including barriers, facilitators, and recommendations for improvement. Separate analyses of the normative principles and values considered in radiotherapy priority setting at BCCOE and the moral distress of clinicians who make priority setting decisions are reported elsewhere. 13 Purposive sampling was used to recruit oncology physicians and nurses (collectively "clinicians"), past and present program leaders, and US-based oncology specialists who serve as clinical advisors.
Participants were recruited onsite at BCCOE through verbal invitation or offsite by email. The study was led by a former oncology physician now clinical advisor and researcher at BCCOE (R.J.D.) and the BCCOE Director of Oncology (C.S.). Recruitment and interviews were conducted by R.J.D.
This study was approved by the Rwanda National Ethics Committee, the IMB Research Committee, and the Institutional Review Board of the University of California, San Francisco.

| Data collection
Semi-structured interviews were conducted between October 2018 and February 2019. The interview guide was developed by a multidisciplinary team of study investigators based on their knowledge of priority setting at BCCOE, patient care experience, and a review of relevant literature.
After the first two interviews, the guide was revised to enhance clarity and flow. Participants provided written informed consent. Interviews were conducted in English, audio-recorded, and transcribed verbatim.
Transcripts were de-identified to protect confidentiality.

| Data analysis
Textual data were analyzed using the framework approach, a method developed for applied qualitative research in which objectives are set in advance and data collection is structured. 14 We chose this approach because we sought to apply our qualitative data directly to revision of the Guidelines and improvement of patient selection procedures at BCCOE. A multidisciplinary team of study investigators performed the analysis, contributing expertise in bioethics, oncology, and qualitative research. A working analytical framework was developed through a combination of a priori concepts used in the interview guide and themes that emerged inductively during an initial open coding process. All transcripts were independently coded by R.J.D. and one of two co-investigators (E.M. or C.N.). Intercoder agreement was assessed for each transcript, and discrepancies were reviewed by both coders and adjudicated through discussion. The framework was continually refined throughout the coding process.
Matrices for each conceptual category in the framework were cre-

| RESULTS
Participant and interview characteristics are presented in Table 1. In this section, we report participants' evaluation of radiotherapy priority setting procedures at BCCOE at the program (meso) and patient (micro) levels, including perceived facilitators, barriers, and suggestions for improvement. We then present participants' views about which stakeholders should be involved and the appropriateness of transparency in this context.
3.1 | Procedure for program level radiotherapy priority setting: Guidelines

| Facilitators
At the program level, radiotherapy priority setting at BCCOE has taken the form of Guidelines, which serve the critical function of translating the principle of curability into practical, evidence-based clinical criteria. Specifically, the Guidelines rank categories of cancer type and stage by the incremental overall survival benefit conferred by radiotherapy for each category, based on available data in the oncology literature. Participants emphasized the importance of objectivity in decision making, which is facilitated by the Guidelines: We have to be guided by literature and data. Our criteria have been designed with consultation of experts in many oncology areas… they are most objective. (P06) The more you can define the criteria, the easier it makes the decision because you have objective criteria and then you look at the objective data for each patient, and it sort of falls out naturally, as opposed to somebody being on the spot, deciding if patient A or patient B is going to go, not based on anything. The crisper the criteria can be, with country/cultural context built into the criteria, the easier it will be. (P14) The Guidelines reflected program level priority setting by a large team that included oncology specialists, transferring some of the burden of prioritization decisions from patient (micro) to program (meso) level.

| Suggestions
Overcoming socioeconomic and structural barriers to care is a core mission of PIH/IMB, and participants advocated for ongoing efforts to provide social support to mitigate these barriers for radiotherapy candidates, for example: We should have someone at our meeting, a nurse or somebody who knows all the radiation patients and is like, actually, it's better for this person to go at this time, or their family member is sick and they can't go, maybe they could go the next cycle, or we need to help set up [childcare] for 6 weeks so they can go. (P20) Clinicians offered several suggestions for improving the structure of the selection meetings: adhering to a more regular schedule "so that we don't escape a month" (P02); circulating case summaries in advance "so at the meeting, I will have some information and questions for each patient so the discussion will be easy" (P04); and having complete information available.

| Requirements of procedural fairness
Relevance, the substantive condition of AFR, requires that rationales for priority setting decisions are relevant to stakeholders. In our study, participants placed supreme importance on the requirement that radiotherapy priority setting decisions adhere to morally relevant principles. The overarching principle for radiotherapy prioritization at BCCOE is maximizing lives saved, operationalized by the Guidelines.
In keeping with the mission of PIH/IMB, participants widely affirmed that poverty should not be a barrier to radiotherapy access. They also asserted that priority setting decisions should not be unduly influenced by personal relationships or biases.
However, our study illustrates two key shortcomings of the relevance condition in real world priority setting. First, several principles other than curability were considered relevant: maximizing lifeyears through considering age in addition to curability, prioritarian obligations to treat the youngest first or sickest first, and a deontological duty to alleviate suffering with palliative radiotherapy. 22 These principles frequently conflict with curability or lead to divergent decision outcomes among patients with similar chances of cure, generating reasonable disagreement between decision makers. AFR does not provide procedural guidance for resolving conflict between relevant rationales, nor does it define what constitutes a fair outcome of priority setting processes. 23 Thus, decision makers are still left with the difficult procedural task of resolving reasonable disagreement.
Second, determination of which rationales are relevant in a given context is itself a complex, resource-intensive process. Several participants called for incorporating local cultural values into the radiotherapy prioritization system, acknowledging that "local cultural values" are not monolithic and opinions will differ across stakeholders. Ideally, rationales would be systematically vetted through research or stakeholder deliberations, potentially including the broader community. However, such efforts require time, funding, skilled leadership, and so forth, and numerous competing demands on these resources exist.
Transparency is the hallmark of fair process in AFR. The requirement that people should be made aware of the grounds for decisions that affect their well-being is taken for granted in Western democracies. Our participants supported transparency of the general principles guiding radiotherapy priority setting, but had mixed views about how proactively specific decisions (e.g., the Guidelines) should be publicized and were wary of causing more harm than good. Some scholars have argued that nonpublic priority setting methods in the hands of experts are sometimes morally superior to public ones, weighing all costs, including social conflict and practical burdens, against the benefits. 24 Daniels counters that "the public" is too suspicious of decision-making bodies to accept implicit priority setting on the basis of authority. 25 However, this assertion is contextual and may not apply in societies with a high level of trust and acceptance of decision-making authorities, or situations where scarce resources are funded by philanthropy.
The appeals condition of AFR requires opportunities to challenge and revise decisions. Participants believed the Guidelines should be revisited and revised on an ongoing basis and described a mechanism in place for clinicians to advocate for patients who would require an exception. Challenges from patients, however, were avoided. Here it is important to distinguish between macro or meso level priority setting, which are generally the purview of AFR, and micro level priority setting. Inviting patients or advocates to vet and appeal the Guidelines was more palatable than accepting appeals to time-sensitive individual patient prioritization decisions. In addition to being extraordinarily complicated logistically, appeals to patient prioritization could exacerbate the moral distress experienced by clinicians, which was a major concern. 13 Finally, the enforcement condition requires regulation of the priority setting process to ensure all other AFR conditions are met. In our study, adherence to relevant rationales was reinforced through group selection meetings, though participants also advocated for data collection to track priority setting decisions.
Empiric evidence characterizing the patients selected for radiotherapy and their outcomes was seen as a critical feedback loop to inform iterative revision of the priority setting process. Notably, these data only provide evidence of procedural fairness insofar as the morally relevant principles for priority setting are agreed upon, again underscoring the importance of substantive principles and values in our study.

| Implementation of procedural fairness
In addition to raising questions about context-appropriate requirements for procedural fairness, our study highlights two key challenges in its real world implementation. First, the elements of procedural fairness require dedicated resources, from vetting locally relevant rationales to publicizing these rationales effectively to  The second critical challenge to implementation of procedural fairness in our study was the reality of practical barriers that undermine fair, legitimate priority setting decisions. System-level barriers such as delays in obtaining staging evaluations or patientlevel barriers such as difficulty with travel arrangements or unreliable access to a telephone may have more bearing on whether a patient receives life-saving radiotherapy than prioritization decisions. Participants in our study strongly emphasized this point, recognizing that social determinants of health and weaknesses in healthcare systems are often at the root of these barriers. A primary task of procedural justice, then, is removing these barriers. In line with the core mission of PIH/IMB, they called for enhanced social support and healthcare system strengthening, which may do as much if not more to lend legitimacy and fairness to priority setting than the conditions of AFR.

| Limitations
This study should be interpreted in light of its limitations. As a qua-

| CONCLUSION
The perspectives of decision makers engaged in everyday priority setting in LMICs are underrepresented in the literature, yet contribute valuable insights into procedural fairness from real world experience. Faced with a routine need to prioritize patients for scarce radiotherapy resources, our participants placed supreme importance on adherence to explicit criteria that are based on morally relevant principles. They identified several challenges that are inadequately addressed by the AFR framework, such as conflicting relevant rationales and unintended consequences of publicizing priority setting decisions. They also proposed many solutions, underscoring that the implementation of fair procedure itself requires resources, a paradox that calls for innovative and context-appropriate strategies. More work is needed to refine theory and practice of procedural fairness in diverse low resource settings, where it is arguably needed most.

ACKNOWLEDGMENTS
We would like to acknowledge Drs Lawrence N. Shulman, Leslie