Ethics of Treatment Decisions for Extremely Premature Newborns with Poor Prognoses: Comparison of Shared Decision Making in Norway and Japan

Round 1

Reviewer 1 Report

This is a 'communication', an opinion piece, and therefore is intended to be a contribution to the debates about the ethics of decision about the treatment in neonatal critical care. It does not involve or rest on original research. Had it done so, I would have suggested that some points should be supported by further research evidence. However, even as an opinion piece, some points are expressed somewhat too categorically, too strongly; as suggested below, points might be expressed more tentatively, allowing for consideration of other evidence/opinion. Nonetheless, this provides a nuanced view of the ethical issues involved in these decisions, especially as regards the significance of economic, cultural and religious factors that may obtain in different countries. It is therefore a useful contribution to the debates, highlighting a 'one size fits all' approach may not be appropriate. Some of my detailed suggestions concern style (e.g. reducing number of words), others concern the 'strength' with which the authors' opinions are asserted.

line 32 "Syltern et al. in Norway has recently published an article to propose" should be revised (e.g. should have been 'have' not 'has' - plural) and shortened to "On the basis of the Norwegian system, Syltern et a. propose a new approach . . ."

line 36 omit both "very' ('very suprrised' and 'very problematic'). Unnecessary, and impossible to guage.

line 45 Omit first sentence, beginning "We would like". Unnecessary - begin with "Shared decision-making refers to . . ."

line 46 "cooperate" should be replaced by 'collaborate'

line 47 "The people" should be replaced by 'Those'.

line 50 "various opinions" should be expanded to be 'various and discrepant opinions'.

line 53 I wonder whether the caveat "in societies that emphasize individual self-determination" is rather too simplistic or too limiting. The UK is such a society, and yet whilst making an important and perhaps 'equal' contribution to decisions, parents' decisions are not "prevalent", if by that the authors mean 'prevail' 'Prevalent' does not mean 'prevail'; instead it means something like widespread. This caveat should be considered more carefully.

lines 63/64 should be revised to ". . . shared decision-making, as indicated by Nishida [3]:"

line 96 delete "article" at the end of the line: "The authors' is sufficient.

Table 2 and beyond I'm curious that 'baby's best interests' in not mentioned in this table, under either approach. In the UK, at least, there is explicitly a proviso for 'baby's best interests' to be taken into account in treatment decisions, and to be employed by doctors as grounds for recommending certain options to parents. In some respects one might regard 'baby's best interests' as prevailing (insofar as doctors appeal to 'baby's best interests). Is this not a factor in Norwegian or Japanese practice (though I notice brief mention is made later, and alluded to in references to babies' suffering etc.)?

line 122 'diverse views' and 'conflicts arising between them' are unclear. 'Conflicts arising between them' might seem to refer to conflict between parents, and this might be what is intended. But as fas as I'm aware there are more likely to be conflicts - well, differences - between parents and doctors as regards the desirability of parental involvement in sharing decision-making with doctors. This should be clarified and again considered more carefully.

line 131 "nothing but a nudge intervention" is too strong, too disparaging, indeed almost offensive. It might be reasonable to say that selecting (not the purpose of - delte that) PPWH "might be regarded as a nudge intervention".

line 137 delete "highly"

line 141 "weak" is wrong or at best misleading. You probably mean 'vulnerable'

lines 142/43 should be reduced to "PPWH may not fully respect . . ." The reference to being idealistic and wishful (predictions) is gratuitously evaluative.

line 148 delete "clealry . . . because it is a nudge", to read "might be understood as a nudge in the direction of stopping treatment as soon as . . . "

Paragraph from lines 155 to 162 is rather speculative insofar as it relies on questions and suppositions about practice in Norway (practice regarding emotional and spiritual support). And why is Japan only 'supposed to be' a developed country? The authors may not be aware of the pragmatic force of 'supposed to be' = scepticism, may not really be. But some attempt should be made to find out about Norwegian practice; rather than pose questions about these matters, these arguments would be more cogent if they were based on evidence, on what is known to be the case. The authors should take the trouble to find out.

line 173 "intravenous" in a different size and font

lines 177/78 "the trial of life support as a noin-decision" is unclear.

lines 182/83 "In Jaopan, traditionally, we assume that" - but is this in fact the case that families do this?

lines 193-195 This argument should be phrased more carefully. The authors mean to point out, reasonably, that what is affordable in terms of healthcare in Norway, which is comparative rich, may not be affordable in other countries/economies. This is a real issue in even (comparatively) wealthy countries like the UK, where the costs of neonatal care and treatment have become so high that some might argue funding is being diverted from other areas of healthcare. This is of course a matter of debate about allforms of healthcare, in most societies. This is an important point, but should be approached and expressed more carefully.

line 226 "is of course" should be revised as 'may be'

line 233 there's a glitch towards the end of the lune, after '[7]'

lines 241/42 line wraps over too soon

line 244 "psychological burden, namely psychological costs, will peak" is at best unclear, unspecific, imprecise. This should be expressed with greater care.

line 260 Delete NEW - that is, not only should it not be in CAPs, but 'new' is not apposite here.

line 108 Evaluations and Syltern mispelled.

Author Response

Reply to Rev.1  Open Review

 (x) Moderate English changes required
Comments and Suggestions for Authors

This is a 'communication', an opinion piece, and therefore is intended to be a contribution to the debates about the ethics of decision about the treatment in neonatal critical care. It does not involve or rest on original research. Had it done so, I would have suggested that some points should be supported by further research evidence. However, even as an opinion piece, some points are expressed somewhat too categorically, too strongly; as suggested below, points might be expressed more tentatively, allowing for consideration of other evidence/opinion. Nonetheless, this provides a nuanced view of the ethical issues involved in these decisions, especially as regards the significance of economic, cultural and religious factors that may obtain in different countries. It is therefore a useful contribution to the debates, highlighting a 'one size fits all' approach may not be appropriate. Some of my detailed suggestions concern style (e.g. reducing number of words), others concern the 'strength' with which the authors' opinions are asserted.

# Thank you very much for the suggestion. We totally agree and have revised the manuscript according to your suggestion.

line 32 "Syltern et al. in Norway has recently published an article to propose" should be revised (e.g. should have been 'have' not 'has' - plural) and shortened to "On the basis of the Norwegian system, Syltern et a. propose a new approach . . .

# Changed

line 36 omit both "very' ('very suprrised' and 'very problematic'). Unnecessary, and impossible to guage.

# Deleted

line 45 Omit first sentence, beginning "We would like". Unnecessary - begin with "Shared decision-making refers to . . ."]

# Deleted

line 46 "cooperate" should be replaced by 'collaborate'

# Replaced

line 47 "The people" should be replaced by 'Those'.

# Replaced

line 50 "various opinions" should be expanded to be 'various and discrepant opinions'.

# Changed

line 53 I wonder whether the caveat "in societies that emphasize individual self-determination" is rather too simplistic or too limiting. The UK is such a society, and yet whilst making an important and perhaps 'equal' contribution to decisions, parents' decisions are not "prevalent", if by that the authors mean 'prevail' 'Prevalent' does not mean 'prevail'; instead it means something like widespread. This caveat should be considered more carefully.

# Thank you for your comment. We totally agree that "in societies that emphasize individual self-determination" is rather too simplistic or too limiting. We have deleted the sentences.

lines 63/64 should be revised to ". . . shared decision-making, as indicated by Nishida [3]:"

#Revised

line 96 delete "article" at the end of the line: "The authors' is sufficient.

# Deleted

Table 2 and beyond I'm curious that 'baby's best interests' in not mentioned in this table, under either approach. In the UK, at least, there is explicitly a proviso for 'baby's best interests' to be taken into account in treatment decisions, and to be employed by doctors as grounds for recommending certain options to parents. In some respects one might regard 'baby's best interests' as prevailing (insofar as doctors appeal to 'baby's best interests). Is this not a factor in Norwegian or Japanese practice (though I notice brief mention is made later, and alluded to in references to babies' suffering etc.)?

# Thank you for pointing out. In the case of Japan, 'baby's best interest’ is of course one of important factors. We have made it clear by adding the below phrase.

The attending physician and the NICU supervisor lead a discussion among those involved in the medical and nursing care of the patient based on medical and family information, and taking into account baby’s best interests. 

Table 2 is Norwegian approach. We have no evidences to answer your question, but it is Table for ‘shared decision making’ 'baby's best interest’ may be considered in Norway, too.

line 122 'diverse views' and 'conflicts arising between them' are unclear. 'Conflicts arising between them' might seem to refer to conflict between parents, and this might be what is intended. But as fas as I'm aware there are more likely to be conflicts - well, differences - between parents and doctors as regards the desirability of parental involvement in sharing decision-making with doctors. This should be clarified and again considered more carefully.

#Thank you for pointing out. You are right, and the sentences were deleted

line 131 "nothing but a nudge intervention" is too strong, too disparaging, indeed almost offensive. It might be reasonable to say that selecting (not the purpose of - delte that) PPWH "might be regarded as a nudge intervention".

#Thank you. We have changed to ‘"might be regarded as a nudge intervention".

line 137 delete "highly"

#Deleted

line 141 "weak" is wrong or at best misleading. You probably mean 'vulnerable'

#Changed

lines 142/43 should be reduced to "PPWH may not fully respect . . ." The reference to being idealistic and wishful (predictions) is gratuitously evaluative.

# Thank you. We have reduced the sentence.

line 148 delete "clealry . . . because it is a nudge", to read "might be understood as a nudge in the direction of stopping treatment as soon as . . . "

#Deleted, and replaced.

Paragraph from lines 155 to 162 is rather speculative insofar as it relies on questions and suppositions about practice in Norway (practice regarding emotional and spiritual support). And why is Japan only 'supposed to be' a developed country? The authors may not be aware of the pragmatic force of 'supposed to be' = scepticism, may not really be. But some attempt should be made to find out about Norwegian practice; rather than pose questions about these matters, these arguments would be more cogent if they were based on evidence, on what is known to be the case. The authors should take the trouble to find out.

# Thank you. We just want to say Japanese healthcare system is NOT enough and with fragile financial condition. So, we revised. “Japan is said to have a relatively good healthcare system but with fragile financial condition.”

In Norway,I have checked all the references of Syltern et al.’s paper but could not find appropriate evidence. I also searched by Pubmed and found one good review.

Health Syst Transit. 2020 Jan;22(1):1-163.

Norway: Health System Review

Ingrid Sperre Saunes ¹, Marina Karanikolos ², Anna Sagan ²

Abstract

This analysis of the Norwegian health system reviews recent developments in organization and governance, health financing, health care provision, health reforms and health system performance. Norway is among the wealthiest nations in the world, with low levels of income inequality. Norwegians enjoy long and healthy lives, with substantial improvement made due to effective and high-quality medical care and the impact of broader public health policies. However, this comes at a high cost, as the Norwegian health system is among the most expensive in Europe, with most financing coming from public funds. Yet there are several areas requiring substantial co-payments, such as adult dental care, outpatient pharmaceuticals, and institutional care for older or disabled people. Recent and ongoing reforms have focused on aligning provision of care to changing population health needs, including adapting medical education, strengthening primary care and improving coordination between primary and specialist care sectors. There has been an increasing use of e-health solutions, and information and communication technologies. Improvements in measuring performance and a more effective use of indicators is expected to play a larger role in informing policy and planning of health services.

As far as I read this review article, Norway’s health care system spent a large amount of money, and I speculate that’s why Norway can afford counselling at NICU. Japan is not rich at all. Moreover, Japanese has to pay 30% of the medical cost even Japan has a national insurance system.

Did I answer your question?

line 173 "intravenous" in a different size and font

#Changed

lines 177/78 "the trial of life support as a noin-decision" is unclear.

#Changed. "the trial of life support as a non-decision

lines 182/83 "In Jaopan, traditionally, we assume that" - but is this in fact the case that families do this?

# We do not have academic evidences, though, this is a common practice in Japan.

lines 193-195 This argument should be phrased more carefully. The authors mean to point out, reasonably, that what is affordable in terms of healthcare in Norway, which is comparative rich, may not be affordable in other countries/economies. This is a real issue in even (comparatively) wealthy countries like the UK, where the costs of neonatal care and treatment have become so high that some might argue funding is being diverted from other areas of healthcare. This is of course a matter of debate about allforms of healthcare, in most societies. This is an important point, but should be approached and expressed more carefully.

# Thank you. You are noting following expression, right? “How many countries in the world, where medical resources are scarce and medical personnel are extremely busy, provide this kind of care in NICUs?”

According to your suggestion, we have revised as follows:

“How to allocate limited healthcare resource is a matter of debate about all forms of healthcare, in most societies worldwide.”

Is this OK? We are ready to rephrase further as you desire.

line 226 "is of course" should be revised as 'may be'

# Revised.

line 233 there's a glitch towards the end of the lune, after '[7]'

# Corrected.

lines 241/42 line wraps over too soon

# Revised.

line 244 "psychological burden, namely psychological costs, will peak" is at best unclear, unspecific, imprecise. This should be expressed with greater care.

# Thank you. Revised as follows.

In this case, we speculate the physician’s psychological burden will peak. If treatment to Baby K is stopped, infant suffering may be reduced, and the infant will benefit. Also, medical economic costs may be reduced, It is also worthwhile to note that in economically poor regions, mercy killing of newborns is/was implicitly permitted as a survival strategy.

line 260 Delete NEW - that is, not only should it not be in CAPs, but 'new' is not apposite here.

#Deleted

line 108 Evaluations and Syltern mispelled.

#Corrected

Once again, thank you for reading our manuscript in detail. Native English proof reading is also done. We are ready to revise further if you fell you need. We hope this is now acceptable for publication.

Author Response File: Author Response.pdf

Reviewer 2 Report

The Authors discuss the issue of ethical decision-making for extremely preterm infants with poor prognosisi, at the light of the "Postponed withholding" approach (PPWH) described by Syltern et al, and of the Japanese model.

Main concerns:

1. the  “verbatim” quotation (page 3) of  the definition of postponed withholding (PPWH) according to Syltern et al (NOT Shelter et al, as incorrectly written) is incompletely reported, and therefore totally incomprehensible.

I had to retrieve the original Syltern’s paper to find the correct definition:

“  The basic idea of this approach is, firstly, to regard the provision of life support at birth as a non-decision. Secondly, after a thorough counseling process within a shared decision-making model, further provision of life support should depend on active parental request for continuation. We believe that this change in the NICU choice architecture will contribute to empowering parents and enable them to act based on their situation and values.”

I have highlighted in bold the parts omitted in the Authors’ transcription are highlighted in bold.

Authors also reproduce, in Table 2, the Syltern’s Table 1 contrasting the traditional European approach with the proposed PPWH.

However, a definition and a table are not sufficient to present a novel approach to shared decision-making in the complex situations of end-of-life for infants born at the margins of viability.  If Authors really wish to discuss/criticize PPWH as presented by Syltern et al, they should summarize such approach more clearly and in detail, identifying its elements and describing its aims. The critic should then refer specifically to these points. Ideally, a reader should not need to retrieve the original Syltern’s paper to follow the Authors’ reasoning.

Otherwise, I suggest that the Authors just focus on presenting and discussing the Japanese approach, without the need to identify a single paper to discuss and criticize. The shared decision-making model is generally widely accepted in Europe and North America, so the Authors do not need to refer to a specific paper to contrast it with the Japanese model.  Also, I would avoid comparisons with the Dutch example, as the Netherlands represents a very special case where active euthanasia is, under certain conditions, legal.

2. The Authors present the Japanese paternalistic approach where end-of-life decisions are made by the NICU director after a discussion within the medical team. Ethical decisions are very much culture-based, and I understand that this approach may be acceptable within the Japanese culture. Thus, I do not intend to challenge or criticize it.

However, I have one main comment and a few questions.

2.1 Comment. I agree that the medical staff have the knowledge to best appreciate the severity of the diagnosis and the implications in terms of patient needs, suffering, short and long-term consequences. However, I question the Authors’ proposition that ethical decisions are medical decisions. They are not, as they are often necessary when medical uncertainty about prognosis and best therapeutic options are high. If prognosis is good, physicians have the duty to prescribe treatment and protect their patients from treatment deprivation. Similarly, if the prognosis is extremely bad in terms of survival, they have to protect their patients from useless and possibly painful treatments that might be asked for by desperate parents. It is when diagnosis is severe but prognosis is not so certain, particularly in terms of long-term outcome, that the most difficult decisions have to be made. These are value-based decisions that include assessment of the best interest of the patient, of the burden to benefits balance of treatment, and depend on values attributed to life, life with disability, willingness to accept and take care of a disabled child. Are we sure that medical values, and not parental values, should guide decision-making? Or rather the higher is medical uncertainly the larger should be the role for parents in decision-making?

In this paper, the Authors discuss economic issues but, unless I have overseen it, the principles of patient best interest and treatment burden to benefits  balance are not discussed, possibly implying that their determination is left to physicians only.

2.2 Questions. I can agree with the Authors that a decision made by the NICU director can spare the parents, and also the staff, from the pain and conflict  involved in end-of-life decisions.  However in these cases, under the Japanese approach, what are the parents told? Are they explicitely told that the director has decided that treatment has to be withheld or withdrawn? Or is such proposal made to them, with request for consent? The Authors write that when “families have clear opinions, that opinion takes precedence.” So:

- Which information is given to parents? How and by whom?

- If the decision to withhold/withdraw treatment is made, can parents stay with the infant when, say, mechanical ventilation is withdrawn?

3. I think that it would be interesting to have a more detailed description of the process applied in Japanese NICUs when a decision to withhold/withdraw treatment is made in the NICU, possibly accompanied by description of cases. Also, it would be interesting to know more about the relevant Japanese legislation.

Author Response

Reply to Rev. 2  Open Review

 (x) Moderate English changes required

Comments and Suggestions for Authors

The Authors discuss the issue of ethical decision-making for extremely preterm infants with poor prognosisi, at the light of the "Postponed withholding" approach (PPWH) described by Syltern et al, and of the Japanese model.

Main concerns:

1. the  “verbatim” quotation (page 3) of  the definition of postponed withholding (PPWH) according to Syltern et al (NOT Shelter et al, as incorrectly written) is incompletely reported, and therefore totally incomprehensible.

I had to retrieve the original Syltern’s paper to find the correct definition:

“  The basic idea of this approach is, firstly, to regard the provision of life support at birth as a non-decision. Secondly, after a thorough counseling process within a shared decision-making model, further provision of life support should depend on active parental request for continuation. We believe that this change in the NICU choice architecture will contribute to empowering parents and enable them to act based on their situation and values.”

I have highlighted in bold the parts omitted in the Authors’ transcription are highlighted in bold.

Authors also reproduce, in Table 2, the Syltern’s Table 1 contrasting the traditional European approach with the proposed PPWH.

However, a definition and a table are not sufficient to present a novel approach to shared decision-making in the complex situations of end-of-life for infants born at the margins of viability.  If Authors really wish to discuss/criticize PPWH as presented by Syltern et al, they should summarize such approach more clearly and in detail, identifying its elements and describing its aims. The critic should then refer specifically to these points. Ideally, a reader should not need to retrieve the original Syltern’s paper to follow the Authors’ reasoning.

Otherwise, I suggest that the Authors just focus on presenting and discussing the Japanese approach, without the need to identify a single paper to discuss and criticize. The shared decision-making model is generally widely accepted in Europe and North America, so the Authors do not need to refer to a specific paper to contrast it with the Japanese model.  Also, I would avoid comparisons with the Dutch example, as the Netherlands represents a very special case where active euthanasia is, under certain conditions, legal.

# Thank you for your comment. First, our paper is focusing on WHO decide finally at the NICU. As we will state below, Norway and Japan are both performing so-called ‘shared decision making’ process. However, there seems to exist some differences. Second, we are not aiming a new approach. Third, we took Norway and Japan as an example for the sake of comparison. To this end, further description of Syltern’s approach would not be needed. Just information for ‘non-decision,’ ‘active counseling,’ ‘empowerment,’ and ‘final decision-maker is parent’ are enough.

To reply your concern, we have

• Cited full definition of PPWH as it appeared in the original paper.
• We have deleted the Netherland example.
• The original Figure is as follows. We have not reproduced the Figure, at all. We did not change any words. Do you still feel we should replace it? If you feel so, I will ask technical staff of the publisher.

2. The Authors present the Japanese paternalistic approach where end-of-life decisions are made by the NICU director after a discussion within the medical team. Ethical decisions are very much culture-based, and I understand that this approach may be acceptable within the Japanese culture. Thus, I do not intend to challenge or criticize it.

However, I have one main comment and a few questions.

2.1 Comment. I agree that the medical staff have the knowledge to best appreciate the severity of the diagnosis and the implications in terms of patient needs, suffering, short and long-term consequences. However, I question the Authors’ proposition that ethical decisions are medical decisions. They are not, as they are often necessary when medical uncertainty about prognosis and best therapeutic options are high. If prognosis is good, physicians have the duty to prescribe treatment and protect their patients from treatment deprivation. Similarly, if the prognosis is extremely bad in terms of survival, they have to protect their patients from useless and possibly painful treatments that might be asked for by desperate parents. It is when diagnosis is severe but prognosis is not so certain, particularly in terms of long-term outcome, that the most difficult decisions have to be made. These are value-based decisions that include assessment of the best interest of the patient, of the burden to benefits balance of treatment, and depend on values attributed to life, life with disability, willingness to accept and take care of a disabled child. Are we sure that medical values, and not parental values, should guide decision-making? Or rather the higher is medical uncertainly the larger should be the role for parents in decision-making?

In this paper, the Authors discuss economic issues but, unless I have overseen it, the principles of patient best interest and treatment burden to benefits  balance are not discussed, possibly implying that their determination is left to physicians only.

# Thank you very much for your comment. We totally understand what you say. However, we are focusing on the discussion regarding WHO decide finally. As we wrote in the manuscript, parents and family are fully informed and their opinion (including entrusting the physicians’ judgement) is all took into consideration at the final decision-making meeting by NICU team. So, we believe that ‘shared decision making’ is performed in the Japanese settings, too. Please do not misunderstand that Japanese physicians are just paternalistic. It is a simplistic understanding. In Norway, if parents finally decide to withdraw the ventilator, it is a ‘shared decision making’ and the main difference is WHO decide finally.

2.2 Questions. I can agree with the Authors that a decision made by the NICU director can spare the parents, and also the staff, from the pain and conflict  involved in end-of-life decisions.  However in these cases, under the Japanese approach, what are the parents told? Are they explicitely told that the director has decided that treatment has to be withheld or withdrawn? Or is such proposal made to them, with request for consent? The Authors write that when “families have clear opinions, that opinion takes precedence.” So:

- Which information is given to parents? How and by whom?

# There is no academic reference to cite the concrete words physicians tell the parents, but as far as we understand, and from personal communication with neonatal physicians, it is often used “There is no medical indication to continue the treatment.” By whom: By the director or attending physician, usually in a quiet meeting room.

To answer your question directly, “such proposals made to them, with request for consent.”

- If the decision to withhold/withdraw treatment is made, can parents stay with the infant when, say, mechanical ventilation is withdrawn?

# Again, there is no academic reference to cite, but from our ethics consultation case experience, parents can stay with the infant when mechanical ventilation is withdrawn, and physician or nurse hand the baby without any machine or tube to parents. Parents have enough time to hugging the baby until heart really stop beating, and her/his body become cold.

3. I think that it would be interesting to have a more detailed description of the process applied in Japanese NICUs when a decision to withhold/withdraw treatment is made in the NICU, possibly accompanied by description of cases. Also, it would be interesting to know more about the relevant Japanese legislation.

# Thank you. We think introducing detailed Japanese description is out of scope of this paper. Also, there is no specific legislation on this matter in Japan. However, ventilator withdrawal is a topic of discussion for a long time, but has not decided yet (reference below).

Nakazawa E, Yamamoto K, Ozeki-Hayashi R, Akabayashi A. Why Can’t Japanese People Decide?—Withdrawal of Ventilatory Support in End-of-Life Scenarios and Their Indecisiveness  Asian Bioethics Review 11: 343-347, 2019. https://doi.org/10.1007/s41649-019-00107-0

Once again, thank you for reading our manuscript in detail. Native English proof reading is also done. We are ready to revise further if you fell you need. We hope this is now acceptable for publication.

Author Response File: Author Response.pdf

Round 2

Reviewer 2 Report

The Authors have answered some of my queries, and have mentioned the patient's best interest which is a crucial element in ethical decision.making. The description of the Japanese approach is very interesting.

However, I still feel that the main aim of the paper remains ambiguous, between:-

a) critique of the newly proposed  PPWH approach (stated aim);

b) a comparison between the Japanese and the Norway traditional approach (carried out).

I do not see in this manuscript a real ethical critique of the PPWH approach, identifying strenghts and weaknesses. I can see a comparison between the Japanese and the traditional Norway approach (which is common to many European countries), and which can be of interest to readers.

I therefore still believe that a better alignment between the stated aim and the manuscript contents would benefit this paper.

Author Response

Reply to Rev 2.   Comments and Suggestions for Authors

The Authors have answered some of my queries, and have mentioned the patient's best interest which is a crucial element in ethical decision.making. The description of the Japanese approach is very interesting.

However, I still feel that the main aim of the paper remains ambiguous, between:-

1. a) critique of the newly proposed  PPWH approach (stated aim);
2. b) a comparison between the Japanese and the Norway traditional approach (carried out).

I do not see in this manuscript a real ethical critique of the PPWH approach, identifying strenghts and weaknesses. I can see a comparison between the Japanese and the traditional Norway approach (which is common to many European countries), and which can be of interest to readers.

I therefore still believe that a better alignment between the stated aim and the manuscript contents would benefit this paper.

#Thank you very much for your comment. I believe b) is of interest to readers since the final decision maker is different between Japan and Norway (and many European countries). PPWH is just taken as an example. Also, in this current health economic disparity, the meaning of shared decision making should be re-examined. So, I revised the whole text to make these point clear. I believe you will be satisfied with this revision. I am happy to revise further. I hope this version is now acceptable to you.

Once again, thank you for reading our manuscript in detail.