Reviewer: Dr. Arwen H Pieterse
Thank you very much for your comments. Our responses are below.
1. They conclude that the decision aid “improves the decision making process
[…] in cognitively impaired older patients”. This conclusion is not warranted
based on the sample used in the study. Please correct in the title, the Abstract
and the Discussion section.
→ We have revised the title, Abstract (lines 16-18) and Discussion (lines
367-368) to reflect the fact that the decision aid targets substitute decision
makers, not cognitively impaired older patients.
2. The small scale of the study should be reflected in the title of the manuscript
as well as in the Discussion section. In particular, the authors should avoid
over-reaching with their conclusions. Please make changes.
→ We have revised title and Discussion section (lines 349-351) to reflect the
small scale of the study.
A related point concerns the statistical analyses that were used. Wouldn’t
non-parametric tests be more appropriate? Please comment.
→ We checked whether the Decisional Conflict Scale and the mean
percentage of knowledge had a normal distribution. If the Decisional
Conflict Scale and the mean percentage of knowledge did not have a
normal distribution, we would have used non-parametric tests. However,
since the Decisional Conflict Scale and the mean percentage of knowledge
had a normal distribution, we used paired t-tests for statistical analysis.
As a precaution, we also checked p-values using Wilcoxon’s signed-rank
test. The mean score for the Decisional Conflict Scale decreased
significantly after exposure to the tube feeding decision aid compared with
before (2.561.16(SD) vs. 3.241.37(SD), P<.001). The mean percentage
of knowledge questions answered correctly by subjects was significantly
greater after using the
38.1%13.5%(SD), P<.01).
decision
aid
(64.6%25.9%(SD)
vs.
3. From the Introduction section it is unclear to what extent patients and their
families usually are involved in decision making regarding tube feeding in
Japan,what difficulties patients and substitute decision makers encounter and
why a patient decision aid would seem a helpful intervention. Please clarify.
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→ We have revised the text to include this information (lines 85-94).
4. It is unclear at what stage in the decision process the first assessment took
place – was it before the participants received information about tube
feeding? And if so, how much information did they receive about it?
→ We have revised the text (lines 179-181) to clarify this. To measure the
effect of the intervention, we did not give the participants information about
PEG before they responded to the pre-questionnaire.
5. the authors do not describe what the decision aid contained or looked like nor
what changes were made compared to the original aid – for example, how did
the physicians’ involvement affect the design of the aid? Please provide
details.
→ We have revised the text to include this information (lines 147-155).
The authors do not explain why though having tried to improve the readability
of the booklet – they did not offer the aid in the original format. Clearly, an
audio booklet seems easier to implement and use on a larger scale as it is less
costly (in terms of effort from providers or others and time). Please explain.
→ We have revised the text to clarify this point (lines 185-188). We thought a
paper booklet would be better than a self-paced audio booklet because, in
Japan, healthcare providers often provide information to patients and
families orally and respond to their questions at that time. However, an
audio booklet may be easier to implement and use on a larger scale, as it is
less costly. We are planning to conduct another study using an audio
booklet.
6. The authors do not give any details as to how often it was a researcher and
how often it was a physician who worked through the decision aid with the
substitute decision maker, whether it made a difference in acceptability, and if
so, what difference.
→ We have revised the text to include this information (lines 225-231
Also, they do not report as to whether the substitute decision makers
asked questions while working through the aid about the aid and/or its content
and if so, what kind of questions. Please clarify.
→ We have included this information in the revised manuscript (lines 254-263
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7. The authors seem to equate communication about tube feeding and shared
decision making, though even if physicians would communicate about that
option, this would not necessarily imply that patients and substitute decision
makers would become involved in the decision.
→ We have clarified this point (lines 318-323
The more so that it is still unclear how physicians evaluate the decision
aid and how willing they are to use it in clinical practice. Please discuss.
→ We have added these points (lines 323-327
Minor Essential Revisions
1.Please add background information to the Abstract．
→ Background information has been added to the Abstract (lines 16-19).
2.
Why would it not be necessary to include information on levels of evidence in the
decision aid (see p. 12, lines 227-228)? Should the strength of the evidence not
be shared with users of the aid? Please clarify.
→ We have revised the text (lines 286-290hink that the strength of evidence is
important information for substitute decision makers. However, the literacy of
substitute decision makers may vary, and some substitute decision makers
may have difficulty understanding the concept of strength of evidence. Thus,
we are currently considering ways to improve substitute decision makers’
understanding, such as adding an appendix to the end of the booklet and
simplifying the language used in the booklet.
3.
The authors conclude that given that the decisional conflict scores were still high
in some of the participants after using the decision aid, substitute decision
makers need a decision aid for this decision. Do the authors mean that the
decision aid should be adapted (further)? Please explain.
→ We mean that this decision involves high levels of conflict by nature, and that
we need to consider the causes of this conflict and formulate approaches to
further reduce the conflict in the future. We have clarified this point (lines
297-300)
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4.
In the Conclusion section the authors state that a randomized controlled trial
design is needed to “examine decision making further” and that “continuing
research dealing with substitute decision makers who make decision about
feeding is an area for future research”. Please provide aims for such studies
and the reasons why they are needed.
→ We have included this information (lines 371-375
5.From my understanding, the Figures do not show mean scores. Please adapt
The legends accordingly.
→ We have added mean scores to the figure legends.
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Reviewer: Dr. Laura C Hanson
Thank you very much for your comments. Our responses are below.
1. Introduction (line 45) – The authors need to do a better review of the evidence
base for tube feeding outcomes and provide clarity here.
→ We have fleshed out this part of the Introduction (lines 45-58)
2. Methods (line 109) – Authors state that survival probabilities were changed “to
be appropriate for Japanese people.” This section needs to be more
transparent to the reader.
→We explained this on lines 137-146. The study on survival of geriatric
patients after PEG in Japan was published in 2010.
3. Methods (line 119) – Cognitive impairment is stated as an inclusion criterion;
however, it is unclear whether this impairment was moderate or severe,
reversible or irreversible, and cause is not provided.
→ We have qualified cognitive impairment as “severe” (line 168). We obtained
only information about diagnostic indications for PEG placement. We did not
obtain information about the causes of cognitive impairment.
The English language decision aid on which this study depends, is specific to
advanced dementia.
→ The target for the English-language decision aid is the substitute decision
maker for an older person who is currently unable to make his/her own
health care decisions. The English-language decision aid is not limited to
substitute decision makers for dementia patients. The English-language
decision aid explains the common causes of eating and swallowing
problems in older persons with cognitive impairment, such as damage to
the muscles and nerves needed for proper swallowing (e.g., stroke),
inability to eat independently (e.g., Alzheimer’s disease), blockage of the
esophagus (e.g., esophageal cancer), or severe loss of appetite or interest
in eating (e.g., major depression). We have clarified this in the revised
manuscript (lines 124-128).
In addition, the English-language decision aid explains that “stroke
patients who have swallowing problems may recover better if the feeding
tube is placed earlier on in their illness, rather than waiting a few weeks”
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and “patients who have been totally unaware of their surroundings and
dependent on others to look after their basic needs for several months are
less likely to improve, whether they have a feeding tube or not”. We
considered this to be correct based on current evidence, so we used the
same explanations in the Japanese version.
In the previous study (Mitchell, 2001), the diagnostic indications for PEG
placement were acute cerebrovascular accident (n=11), dementia (n=2),
postoperative complications with delirium (n=1), and Huntington’s disease
(n=1). The authors did not limit the study to substitute decision makers for
dementia patients.
4. Methods (line 127) – The technique for measuring tube feeding preference is
not clearly described.
→ We have clarified this (lines 203-204).
5. Results and Discussion (line 176-189, again at 220, 234) – Authors expand on
Individual decision-maker results, which is methodologically insignificant and
distracts from actual research findings. Recommend deletion of these
sections.
→ We have deleted the indicated text (lines 176-189, 220, 234).
6. Results – (line 196-201) It would be helpful to state the percent that prefer
tube feeding before and after the decision aid.
→ We have revised the text (lines 242-248).
7. Discussion (line 227-228) – Authors dismiss the concept of providing
evidence to families facing this difficult decision. Informed decision-making
means that families facing this difficult choice must have valid information in
order to exercise preferences in a meaningful manner.
→ We do believe that valid information is important for families facing this
difficult decision. However, because the literacy of substitute decision
makers is likely to vary, some substitute decision makers may have
difficulty understanding written protocols for randomized controlled trials.
Thus, we are currently considering ways to improve substitute decision
makers’ understanding, such as adding an appendix to the end of the
booklet and simplifying the language used in the booklet.
6
We have included this information in the revised manuscript (lines
286-290).
8. Discussion (beginning line 264) –Authors discuss WHO guidelines for shared
decision-making; however, this is not placed in context for Japan. Medical
ethics guidance for shared decisions varies culturally, and this paragraph
could more expressly address Japanese medical ethics as this is the setting
for the current sample.
→ We have added information on the cultural background of Japan with
regard to talking about death and end-of-life care (lines 331-335).
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Reviewer: Dr. Thomas Finucane
Thank you very much for your comments. Our responses are below.
1.
First is the sentence that "For patients with swallowing difficulty, artificial 45
nutrition by tube feeding has a life-prolonging effect."This is simply not
based on evidence. The overwhelming sum of the data is that tube
feeding does not prolong life in elderly patients. The strongest data
concerns dementia patients. If the authors have data for a survival
advantage, it is extremely important and should be referenced.
→ Thank you for this important comment. We have revised the Background
section to include this information (lines 45-58).
2.
If the authors presented the choice as either tube feeding or death related to
under nutrition, I believe they have fatally misrepresented what is being
offered. This is absolutely critical.
→ When we supported decision making, we explained that 50% of 931
geriatric patients who underwent PEG survived more than 753 days.
3.
Second, I would very much like to see what choices were actually made
after the intervention.
→We did not obtain this information because it was not the focus of our
study. We obtained only information on the predisposition of decision
makers toward options after the intervention.
4.
A more minor point is this phrase: "Since elderly patients often cannot make
choices for themselves due to advanced age or dementia"
Do the authors believe that advanced age by itself is enough to render a
person unable to make choices?
→ We do not believe that advanced age by itself is enough to render a
person unable to make choices. However, elderly patients who have
cognitive impairment are often unable to make choices. Thus, we have
deleted “elderly patients often cannot make choices for themselves due to
advanced age” and we have revised the text (lines 63-64).
5.
I think we need finer detail about who was chosen to make the decision.
→ The relationships of the substitute decision makers to the patients are
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described in the manuscript (lines 222-224). This is the only information
we collected about the relationship between substitute decision makers
and patients.
6. Whether the paper should be accepted depends largely on whether the data
in the decision aid was accurate and on clarification of the decisional
process.
→ We have added an explanation of the data collection in the text (lines
175-185,192-193). Af ter obtaining informed consent, we administered the
pre-questionnaire to substitute decision makers. At this time the substitute
decision maker did not receive information about PEG from the
researcher/research assistant or physician. Then, the physician gave the
substitute decision maker information about the patient’s condition and the
reasons for considering tube feeding. The researcher or physician then
gave the substitute decision maker information about tube feeding using
the decision aid booklet. After working through the decision aid, the
substitute decision maker decided whether to perform PEG and completed
a post-questionnaire.
We have revised the description of the decisional process in the
manuscript (lines 188-192).
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