Article Text

Paper
Settling for second best: when should doctors agree to parental demands for suboptimal medical treatment?
1. Tara Nair1,2,
2. Julian Savulescu2,
3. Jim Everett2,3,
4. Ryan Tonkens4,
5. Dominic Wilkinson2,5
1. 1 Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia
2. 2 Oxford Uehiro Centre for Practical Ethics, Faculty of Philosophy, University of Oxford, Oxford, UK
3. 3 Department of Experimental Psychology, University of Oxford, Oxford, UK
4. 4 Centre for Human Bioethics, Monash University, Melbourne, Victoria, Australia
5. 5 Department of Paediatrics, John Radcliffe Hospital, Oxford, UK
1. Correspondence to Tara Nair, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia; trnai1{at}student.monash.edu

## Abstract

Background Doctors sometimes encounter parents who object to prescribed treatment for their children, and request suboptimal substitutes be administered instead (suboptimal being defined as less effective and/or more expensive). Previous studies have focused on parental refusal of treatment and when this should be permitted, but the ethics of requests for suboptimal treatment has not been explored.

Methods The paper consists of two parts: an empirical analysis and an ethical analysis. We performed an online survey with a sample of the general public to assess respondents’ thresholds for acceptable harm and expense resulting from parental choice, and the role that religion played in their judgement. We also identified and applied existing ethical frameworks to the case described in the survey to compare theoretical and empirical results.

Results Two hundred and forty-two Mechanical Turk workers took our survey and there were 178 valid responses (73.6%). Respondents’ agreement to provide treatment decreased as the risk or cost of the requested substitute increased (p<0.001). More than 50% of participants were prepared to provide treatment that would involve a small absolute increased risk of death for the child (<5%) and a cost increase of US$<500, respectively. Religiously motivated requests were significantly more likely to be allowed (p<0.001). Existing ethical frameworks largely yielded ambiguous results for the case. There were clear inconsistencies between the theoretical and empirical results. Conclusion Drawing on both survey results and ethical analysis, we propose a potential model and thresholds for deciding about the permissibility of suboptimal treatment requests. • newborns and minors • paediatrics • decision-making • demographic surveys/attitudes • right to refuse treatment This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/ ## Statistics from Altmetric.com ## Request Permissions If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways. ## Introduction Patients’ opinions, beliefs and values hold an important place in clinical decision making in modern medicine.1 A competent patient may refuse treatment for themselves on religious or non-religious grounds and a doctor must respect this decision, even if they consider it to be irrational.2 However, this is more complicated when the individual is making decisions on behalf of another (eg, a parent making treatment decisions for their child). Parents’ right to make medical treatment decisions on behalf of their child is not unlimited.3 There has been research into the ethics of parental refusal of treatment, for example, Jehovah’s Witness parents who refuse a blood transfusion for their children. In cases where the life of the child is at risk, it is widely accepted that doctors should over-ride parents’ wishes.3 But the question of what doctors should do when parents are not refusing treatment, rather requesting a substitute ‘second best’ treatment, has attracted less attention. Box 1 describes a paradigm example of such a case. Box 1 ### An example request for substitute suboptimal treatment. (A substitute treatment is defined as suboptimal if it is less effective and/or more costly than the standard treatment) A very premature baby has just been born. The neonate is seriously ill and in intensive care with respiratory distress syndrome (RDS), a common complication of prematurity40 ,41 caused by a deficiency of surfactant. Surfactant replacement therapy (SRT) is a highly effective treatment for RDS, which reduces the risk of air leak, pneumothorax, pulmonary interstitial emphysema, bronchopulmonary dysplasia and neonatal mortality.13 However, the parents of this child have an objection to the prescribed medication because they are Muslim and the medication contains pork-derived ingredients which they consider haram (forbidden by Allah).42 (This medication may also receive objections from Jewish parents,43 as well as parents who are vegetarian, vegan or have an interest in animal rights.44) The parents have requested a substitute preparation of surfactant. There is a bovine-derived surfactant preparation which is both less effective39 45 and more expensive,38 and a synthetic preparation which may potentially be equally effective46 47 but is significantly more expensive than both the porcine and bovine-derived preparations.48 Previous empirical research indicates that professionals are unsure how to respond to parental choice around treatments in cases like the one described in box 1. Two surveys of UK and US doctors indicated that professionals did not usually discuss the constituents of surfactant replacement with parents of premature newborns.4 5 However, in another survey, when asked from the perspective of a parent, a majority of medical and non-medical staff (74%) wanted the different types of surfactant replacement to be discussed before administration and 79% said that the hospital should stock at least one substitute preparation.6 Numerous pressing ethical questions emerge from cases like this. First, is it permissible for parents to choose substitute medical treatments that are less effective than those recommended by doctors? If so, how much less effective? Second, is it permissible in a public healthcare system for parents to choose more expensive medical treatments than those recommended by doctors? If so, what additional cost is acceptable? And third, does the reason behind the parents’ choice make a difference? Normative models have been developed that can be used to assess whether or not it is justified for a physician to over-ride parents’ medical decision making for their child.7–9 However, these models have not been specifically applied to requests for suboptimal treatment. The aim of this study was to explore the boundaries of parental choice and identify thresholds of acceptable levels of harm and cost using both empirical and theoretical methods. In the first part of the paper we perform an empirical test of the general public’s intuitions about permissible levels of harm and expense caused by parental choice. In the second part of the paper we discuss existing ethical frameworks and compare and contrast the data gathered from our survey with the suggestions offered by ethical theory to aim at reflective equilibrium. ## Part 1: Empirical analysis ### Methods #### Participants and procedure American participants (n=242) were recruited online through Amazon Mechanical Turk (MTurk) and paid$1 for their time. MTurk is a website that facilitates payment for completing Human Intelligence Tasks (HITs) posted by researchers, and is widely used in social science research because it provides participants who vary in age, socioeconomic status and ethnic background10 and are broadly representative of the US population. A power analysis revealed that a minimum of 128 participants was required to detect a moderate effect size (d=0.5) at the 5% level with 80% chance. Participants were excluded from data analysis if they failed to complete the survey (n=33) or failed a simple attention check11 (n=31). Thus, our final sample used in analysis consisted of 178 participants.

Participants completed the study through the online survey tool Qualtrics. The survey was piloted for face validity with a cohort of students and colleagues, and the order of the questions within all sections was randomised to reduce order effect.12 Ethics approval for this study was provided by the Social Sciences and Humanities Inter-Divisional Research Ethics Committee of the University of Oxford.

#### Design

We hypothesised that when faced with a request for a substitute medical treatment, members of the public would be increasingly inclined to refuse parents’ requests as the comparative efficacy decreases, and as the expense increases. We predicted that survey respondents would be more likely to allow requests based on religious rather than non-religious reasons.

#### Sections 1 and 2

The first two sections of the study had a mixed-subjects design: a between-subjects factor of whether the reasons for requesting the substitute treatment were ‘religious’ or ‘ethical’; and a within-subjects factor of whether this treatment was less efficacious or more expensive (figure 1).

Figure 1

Flow chart of survey structure (see full survey; Appendix A). SRT, surfactant replacement therapy.

### Supplementary file

Respondents were asked to imagine themselves as health professionals facing a request for substitute treatment (using the example of surfactant replacement). Participants were informed that without treatment the infant was stated to have a 30% absolute risk of mortality, and with the standard form of treatment this risk was reduced to 15% (these figures were based on data13 on the effectiveness of surfactant replacement therapy, but slightly exaggerated and simplified for the sake of clarity). Respondents were randomised to receive one of two versions of these sections of the survey; 50% were told the parents’ reason for objecting was ‘religious’ and the other 50% were told the parents’ reason for objecting was ‘ethical.’

To look at the influence of efficacy and expense on support for substitute treatments, we asked participants to respond to a series of variations of the case example. First, participants were told that the hypothetical parents had either refused treatment or had requested treatments with varying degrees of reduced efficacy. The substitute treatments had a higher risk of pneumothorax needing drainage (higher risk of a painful procedure), intraventricular haemorrhage (higher risk of disability) or of death (4%, 9% or 14% absolute increase in risk: see figure 2A). Next, participants were told that the substitute treatments requested were equally effective, but associated with varying degrees of additional cost (see figure 2B). To provide context for the cost of treatment, indicative examples were provided of other medical treatments with similar expense.14 Respondents were asked to indicate their level of agreement with allowing these parental requests on a 7-point Likert scale (1=strongly disagree, 7=strongly agree).

Figure 2

(A) Sample question from the survey, investigating willingness to provide less effective treatment. (B) Sample question from the survey, investigating willingness to provide more expensive treatment.

#### Section 3

This part of the study assessed all participants’ agreement to different reasons behind parental requests. There were five versions in a within-subjects design presented to all participants: three religious reasons for objection (Muslim, Christian and Jewish parents) and two non-religious reasons (vegan parents and parents with an irrational fear their child will develop an allergy to the medication). For each, respondents were asked whether they would agree to provide either a less effective substitute (with a higher, but unspecified chance of death) or a more expensive substitute (double the cost of the standard treatment).

#### Section 4

In order to allow comparison between requests for suboptimal treatment and other examples of parental discretion around treatment, the fourth part of the survey assessed respondents’ willingness to accede to two other widely discussed controversial parental requests. They were asked if they would agree to prolong treatment deemed futile by medical professionals, or allow parents to decline a blood transfusion in a severely anaemic child. For each case, the respondents were provided with two versions, one where the parents’ request was based on a religious reason and the other on a non-religious reason.

#### Section 5

Finally, to look at how beliefs about the acceptability of suboptimal treatments might differ across different groups, we collected basic demographic information. Given that some of the reasons the hypothetical parents gave for refusing treatment were religious ones, we measured how religious participants considered themselves using the Central Religiosity Scale (CRS).15 The CRS (α=0.93) consists of five items tapping different dimensions of religious belief (eg, private practice, public practice and religious experience). Similarly, because some of the reasons the hypothetical parents gave were based on ethical views relating to the use of animals, we measured participants’ concern with animal welfare using an 8-itemed Speciesism Scalei (α=0.87).

Statistical analysis was conducted using SPSS Statistics V.22 for Windows (IBM). Paired samples t-tests were used to compare the participants’ responses between questions. Independent samples t-tests were used to investigate the differences between the participants given religious-based requests and those given non-religious versions. A p value of <0.05 was considered significant.

## Results

### Participants

The majority of the respondents were between 25 and 34 years old, and there were more female participants (Appendix B). Forty-one per cent had a tertiary education and three quarters of respondents were employed. All resided in the USA, but nearly 40% originated elsewhere. Just over half of the cohort had a religious affiliation (the most common religion was Christianity), while over a third considered themselves atheists. The CRS showed approximately half of the cohort to be ‘Religious’ or ‘Highly Religious’ (Appendix C). Eighty per cent had no dietary preference.

### Sections 1 and 2

When given scenarios of parents requesting less effective treatment, the majority of respondents agreed to provide substitute treatment with a small increased mortality risk (19% absolute mortality risk). Participants were less inclined to provide treatment that would increase a child’s risk of disability (mean agreement score (M)=3.66, SD=1.95) compared with a treatment that would increase the risk of pain (M=4.12, SD=1.91) (t(177)=4.78, p<0.001), indicating that participants were more concerned about whether the treatment would cause disability than whether it would cause pain (figure 3). Participants were significantly less likely to provide treatment as the increased absolute risk of death from the substitute treatment went from small (+4%) to medium (+9%) to large (+14%) (F(2,354)=37.94, p<0.001).

Figure 3

Level of agreement to provide no treatment or substitute treatments of reduced efficacy.

Twenty-eight per cent of respondents strongly agreed or agreed to allow parental refusal of treatment (30% absolute mortality, M=3.8, SD=2.04). Of note, this was higher than the level of agreement to provide a substitute treatment associated with a large increased risk of death (lower risk than that of no treatment; 29% absolute mortality risk; 26% agreed or strongly agreed, M=3.51, SD=2.08, t(177)=2.52, p<0.05).

## Conclusions

This study has explored the boundaries of parental choice in medical decision making for children. Expanding medical possibilities, expanding access to information and increasing diversity of values in society are likely to lead to more situations where parents request treatment that differs from those recommended by health professionals. It will be important to determine when such requests should be accepted, and when they should not.

Our study brings together empirical research and ethical analysis. As noted above, the empirical findings may not be generalisable to other populations, and a repeat survey in a group with different values or norms might yield significantly different thresholds. Endorsement of a particular view by the general public does not necessarily mean this is the ethically correct approach. Where a process of wide reflective equilibrium identifies a conflict between ethical theory and the intuitions of the general public, it may be appropriate either to reconsider or modify the theory, or to reject the intuitions. However, it is not always clear which course to take.

Our survey sample appeared to have intuitions which were most consistent with the Harm Model or Zone of Parental Discretion. They were inconsistent with the Best Interests Standard which officially governs medical ethics and practice.

We have outlined one potential model for arbitrating decisions about suboptimal treatment, and drawn on our empirical work to suggest some potential harm and cost thresholds as a starting point for debate. An expected harm approach which considers both magnitude and probability of harm is a promising approach which appears consistent with public intuition. Further empirical study, including qualitative research, is necessary to help test our proposed model against other medical decisions, and assess the views of stakeholders, including medical professionals, about it. Further ethical research will also be crucial, in particular to address the difficult question of the acceptability of different reasons underlying parental choice.

## Footnotes

• i Caviola, L., Everett, J. A. C., Mannino, A., & Faber, N. S. (2016), manuscript in preparation.

• ii The middle category,‘Religious' (N=62), was not included in this analysis.

• iii This is not to say that current clinical practice is necessarily correct, however it is important to compare suggestions offered by theoretical frameworks to existing guidelines and practice.

• iv The model is derived from analysis of the ethical considerations at stake in decisions about substitute treatment, as well as review of theoretical models previously published. This generated a set of normative conclusions that form the foundation of the model: Parents’ requests for suboptimal treatments should be rejected if the parents are not competent to decide, or the reasons appear trivial or irrational; requests for suboptimal treatment may be permissible if the additional cost to the public health system is not excessive, and if the harm caused to the child is not excessive.

• Contributors TN, JS, DW and RT contributed to study design, drafting and editing of the original manuscript, and revising the manuscript. JE contributed to study design, statistical analysis and interpretation, editing of manuscript and revising the manuscript.

• Funding This work was supported by the Wellcome Trust [WT104848/Z/14/Z; WT106587/Z/14/Z].

• Competing interests None declared.

• Ethics approval Social Sciences and Humanities Inter-Divisional Research Ethics Committee, University of Oxford.

• Provenance and peer review Not commissioned; externally peer reviewed.

• Correction notice This article has been corrected since it was published Online First. Funding information has been added.