dear professor loder manuscript id bmj.2017.040377 ... · dear professor loder manuscript id...

Dear Professor Loder

Manuscript ID BMJ.2017.040377 entitled "A three-talk model for shared decision making"

Thank you for the response of 18 September. Please see below our full response to editor

and reviewer comments. I have the model drawn in Google documents. Very willing to have

comments / input from a graphic designer. So far we have had no input from a designer.

Sincerely

Glyn

On Mon, Sep 18, 2017 at 9:38 PM, BMJ

<[email protected]> wrote:

18-Sep-2017

Dear Prof. Elwyn,

Manuscript ID BMJ.2017.040377 entitled "A three-talk model for shared decision making"

Thank you for sending us your paper. I am sorry you have had to wait so long for a decision -

we aim to do things faster than we managed this time and I apologise. I write, though, with

good news. We sent your paper for external peer review and discussed it at our manuscript

committee meeting. We are very interested in proceeding with it provided you are willing and

able to make revisions along the lines suggested by reviewers and editors. I will look forward

to seeing the revised paper. Thank you very much for thinking of us. We look forward to

working with you on the paper.

Very truly yours,

Elizabeth Loder

[email protected]

https://mc.manuscriptcentral.com/bmj?URL_MASK=b470d754b0304a3981cba25d21609017

Comments from Editors Meeting - E ( Wim Weber (chair); Angie Wade (statistician);

Elizabeth Loder; Jose Merino; Tiago Villanueva; Daoxin Yin).

Editor Comment 1 Many of the editors noted that this paper is not a typical research article.

One said "This is an unusual paper for us. While the paper describes the deliberative process

1

to develop a concept, the concept is not a reporting checklist and this is not an E&E paper. It

is not a description of how to do research (i.e. it is not an RMR). And it is not formally

research. I wonder if they could write a slightly more traditional research paper that presents

this model but also describes the process used to develop the modifications to the existing

model and the consensus process.

Instruction Please include a traditional methods section in which this is explained. See this

BMC paper (not from the BMJ but reporting on a somewhat similar project) for one way to

report what you did:

https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-017-0927-0

Or see this BMJ paper with a format that you might adapt:

http://www.bmj.com/content/350/bmj.h1258

Response

We added more detail to the method section of this paper, to describe each step in summary,

before providing more details. The new method section is provided here:

We used a three-step consultation process to review the model. The steps consisted of:

1) Key informant commentary on a revised model;

2) Online survey to a wider academic community to seek views on a proposed revision;

3) Review by medically qualified clinicians in six clinical specialties.

Step 1 Key informant commentary on a revised model

The goal of this step was to engage a group of SDM key informants. This group was

established by inviting contributors to the academic field, to the authors of the original

model3, and where missing, ensuring representation from a range of countries. The group

was given access to a cloud-based document in July 2016, divided into three sections:

Section 1) A copy of the original three-talk model (choice, option and decision talk).

Section 2) Revision 1 of three-talk model - see Appendix Figure A.

Section 3) A draft online survey to be administered in step 2.

Members were invited to add comments, and suggest changes to the model and/or draft

survey. Both the original model and revision 1 had descriptions of the key elements. When

no further comments were forthcoming, suggestions were summarized, and changes made

to revision 1 (GE). Revision 2 of the model was included in the proposed survey (step 2).

Contributing informants were invited to consider authorship.

Step 2 Distribution of online survey to a wider academic community

The goal of this step was to gather and react to as many views as possible from individuals,

including patients, who are members of groups likely to have an interest in SDM. Revision 2

2

of the model (see Appendix Box 1 Qualtrics Survey) was inserted into an online

questionnaire (Qualtrics), circulated in February 2017, as follows: to the Shared@ Facebook-

based closed-membership group (708 members), an SDM listserv (579 members), the

Society for Participatory Medicine (circa 400 members), an overdiagnosis google-group (295

members), the evidence-based medicine listserv (1500 members), the International Patient

Decision Aids Steering Group (112 members), the Society for Medical Decision Making’s

SDM Interest Group (92 members), and to the Society of Behavioral Medicine’s Health

Decision Making Interest Group (347 members). We were unable to determine the extent of

overlapping membership. One reminder was sent to all groups after two weeks, and the

survey closed after four weeks. The results of this step were summarized.

Step 3 Review by medically qualified clinicians in six clinical specialties

The goal of this step was to obtain the views of medically qualified clinicians who are in

active practice, unlikely to be engaged in academic discussions about SDM and most likely

to meet the model in training contexts. We recognize that other healthcare professionals

have opportunities to share decisions with patients. Limiting the sample to one profession

was due to budget constraints and because decisions about medications and clinical

procedures are most often made by those with medical qualifications. To obtain these views,

we included a revised model in a short survey administered by SERMO (a network of

600,000 registered international members in over 90 specialties). We set a limit of 300

clinician responses, equally divided between the US and the UK, and requested quotas of 50

in three surgical specialties (orthopedics, urology, and obstetrics and gynecology) and 50 in

three medical specialties (internal medicine, family medicine, pediatrics). We used the results

of step 2 to present two modified versions of the model and asked for preference, ease of

understanding, helpfulness in clinical practice, and suitability for training purposes.

Analysis Plan

Step 1 Comments were summarized according to the issues raised (GE, JS, MAD).

Revisions were made to the Qualtrics survey document before being administered.

Step 2 Quantitative analyses were conducted using Stata version 13.1 (JS). Descriptive

statistics were performed to generate a summary of positive and negative opinions on model

components. Open text comments were grouped and summarized to indicate concern

patterns. After discussions, modified versions were developed (GE, JS, MAD).

Step 3 Descriptive statistics and chi-squared tests were used to examine the relationship

between the respondents’ preferred version and other characteristics (gender, years in

practice, country, specialty).

Editor Comment 2 Another editor commented "I would be more interested in a paper

evaluating the performance of clinician training based on the three talk model on a SDM

outcome (perhaps decisional regret) (a well powered RCT?)." Perhaps in the discussion you

could comment on the extent to which such work is planned.

Response

Agree. We would also like to know whether or not this model is effective - at a number of

different levels. Does the use of the model modify clinician attitude to the idea of sharing

3

decisions? This might be one of the most recalcitrant barriers to an effective process. What

dose of training is required and do the insertion of encounter tools (brief patient decision

aids) help? A factorial trial is envisaged and we are in the throes of writing an application to

the Patient Centred Outcomes Research institute to take this forward. We modified the

discussion as follows:

Implications

The high citation count for the 2012 model has indicated substantial use of the model in

presentations, training programs and workshops using standardized patients. To evaluate

this version, we plan to assess its ability to support skill development, with and without

additional training, and with and without the use of encounter-based patient decision aids.

Research will be encouraged in different countries to know whether the model can be

translated, adapted, and used in different context and cultures.

Editor Comment 3 We note that the online survey went out to several thousand people but

you have only 153 responders. We were most concerned with step 3 and the medically

qualified physicians. You used the SERMO survey and were looking for various quotas,

which is fine, but there is no description of how you identified people. How many did you

have to ask before you got numbers you wanted and how were they selected? That affects

generalizability. Confidence intervals should be given for the numbers in Figure 2.

Response

We added more detail in the method and in the results for this step. SERMO charges a fee

for each completed response, so we asked for 300 responses, as described here:

To obtain these views, we included a revised model in a short survey administered by

SERMO (a network of 600,000 registered international members in over 90 specialties). We

set a limit of 300 clinician responses, equally divided between the US and the UK, and

requested quotas of 50 in three surgical specialties (orthopedics, urology, and obstetrics and

gynecology) and 50 in three medical specialties (internal medicine, family medicine,

pediatrics).

In results, we added the following:

A total of 1,470 invitations were sent (867 in the UK and 603 in the UK) to obtain 316 (22%)

responses: 78% were male and 48% had been in practice between 11 and 20 years (see

Appendix Table B for details).

We do not want to enter a debate re methods, but note that there is significant debate about

consensus techniques - which we think is the best category for this work. We did not choose

a nominal group or delphi panel, but elaborated on a consensus panel approach by using

survey methods. We read with interest this work about consensus methods: Waggoner J,

Carline JD, Durning SJ. Is There a Consensus on Consensus Methodology? Descriptions and

Recommendations for Future Consensus Research. Acad Med 2016;91:663–8.

doi:10.1097/ACM.0000000000001092

4

Editor Comment 4 Perhaps we missed it but there did not seem to be any discussion about

the feasibility of completing all steps of this process within the very short visits most doctors

and patients are allowed in typical health systems. It's not really possible to outline every

single possible option to a patient. How are these tradeoffs to be handled? Would it be useful

to give some examples in an appendix document?

Response

Visits of a very short duration inevitably compromise the quality of communication processes,

including any efforts to do shared decision making. It also is worth noting that shared

decision making does not advocate giving information about “every single possible option” -

that would be unrealistic. But it is possible to compare the most salient and reasonable

options. Even at a cognitive level, it is hard to compare more than three options at any one

time. However, the main comment from us is that the model, as was already mentioned in

the paper, is an idealization that is meant to give clinicians an overview of the core elements

of a shared decision making conversation, but that in practice these elements might

reasonably be addressed in different ways, e.g., distributed over time or space across

different conversations or with different people, and modified according to patients'

preferences for information and participation. It is also worth noting that we have trained

many health professionals over the past 10 years, using several versions of this model

(including the latest). Clinicians we have trained have never explicitly expressed concerns

about the feasibility of completing all steps within the time allocated for a standard clinic visit.

To address the editor’s comment, we have modified the article as follows:

We should acknowledge that while it is entirely possible to conduct all three steps in a single

encounter, there is often a need to use successive visits to allow time for reflection and

deliberation, either across time or with different professionals.

Editor Comment 5 We like the graphic that you have in the abstract. Are you completely

satisfied with it or would you like some input from our special infographics editor Will

Timmins-Stahl? If so send me an email and I'll ask him to take a look at it.

Response

Email sent to E Loder - who will consult graphic designer.

Comments from Reviewers

Reviewer 1 Comment 1 Thank you for the opportunity to review this interesting manuscript.

The authors present the results of a stakeholder-engaged process to refine a model of

shared decision making called the "three-talk model." The authors should be commended for

their efforts to seek and incorporate feedback at all stages of the process. All methods are

appropriate and the authors do a good job of communicating the key quantitative and

qualitative findings succinctly. The article is generally well written, although there are some

occasional grammatical lapses that can be easily corrected.

Response

5

We have paid more attention to the writing throughout and have undertaken a detailed proof

read.

Reviewer 1 Comment 2 One point that merits consideration relates to better description of

the survey activities. It is unclear, for example, how the surveys were distributed and whether

response rates were calculable. For example, in Step 2, the authors list the SDM

communities surveyed, but they do not report whether individuals were surveyed or whether

a non-traceable link was shared. A comment about whether response rates could be

calculated is needed in the results (and the rates should be included if possible). This same

issue applies to Step 3 wherein a survey was "administered by SERMO." More detail is

needed about the survey sampling approach (a direct email; a posted link, etc) and the exact

denominator (were all 600,000 potential respondents?).

Response

We thank the reviewer for this comment and have made the following changes to clarify the

survey dissemination process.

Step 2: We sent out a public link. Online surveys usually report completion rates. We know

that of an unknown number of possible survey views, 269 individuals clicked on the link, 171

answered question 1, and N/171 completed the survey, giving a completion rate of 89%.

We made the following change in the article:

Of 269 who opened a public link, 171 completed the first question and 153 completed every

item (89%).

The following change was also made:

Responses to questions about the helpfulness of the terms are summarized in Figure 2: 59%

were previously aware of the model and 61% found it either ‘very easy’ or ‘somewhat easy’ to

understand. A substantial majority found the revision helpful or somewhat helpful (79%, 95%

CI [79%, 85%]), for details see Appendix Table A.

Step 3: SERMO uses an algorithm to send out email invitations to fulfill the quotas. SERMO

sends out invitations to physicians who are registered to SERMO panel, based on the

specialty and country that we had specified. Respondents who receive the email invitation

can complete the survey from their computer or their mobile/tablet. We had selected 6

specialties in two countries. A total of 1,470 invitations were sent (867 in the UK and 603 in

the US).

We made the following change in the article:

A total of 1,470 invitations were sent (867 in the UK and 603 in the UK) to obtain 316 (22%)

responses: 78% of the respondents were male and 48% had been in practice between 11

and 20 years (see Appendix Table B for details).

6

This inability to report response rate is normal for surveys distributed via social media, as

noted by Whitaker et al. (The use of facebook in recruiting participants for health research

purposes. JMIR 2017 Vol 19). Because the survey in step 2 was intended to collect

responses from those with a likely interest, and step 3 to a sample of medically qualified

clinicians, selection bias doesn't function in the same way. In other words, we are seeking

the responses of motivated people, which means that if only the most motivated people

response, this isn't a problem. This is in contrast to, for example, surveying people about

their experiences (not the case here), where selection bias is a concern. When surveying

experts, representativeness is much less of a concern.

Reviewer 1 Comment 3 Otherwise, I feel the paper has few methodological weaknesses as

it relates to its objective. To that end, the editors may need to base decisions on publication

on their perceived potential of the "three talk model" to impact the training and

implementation of SDM broadly. One cannot predict that future with certainty, but it appears

the authors have succeeded in seeking and incorporating the perspectives of relevant

stakeholders.

Response

We thank the reviewer for this comment - it was our intention to have many stakeholders,

from many countries. We did include input from occupational therapy and linguistics: both

provided significant critique from the perspective of patients. We do acknowledge that we did

not reach out to patients or patient advocates - we made this clear in our limitations section

of the discussion, which now reads as follows:

Critique of method

Efforts were made to collect a range of views, using a mixture of data collection strategies.

Patients are members of many of the lists we contacted, and we are aware that some

responded: other input from patients was limited. Health professionals are the target

audience of the model but we concede the need to ensure acceptability by patients. We also

recognize the limitation of only seeking the views from medically qualified professionals, and

in only two countries. It is our goal to work with others to translate and, if necessary, adapt

the model to other settings. We did not adopt a formal consensus research method because

of the need for design decisions that cannot accommodate every viewpoint. We

acknowledge that given the potential pool of respondents, we might have expected a higher

number of response. Nevertheless, we obtained over 150 detailed comments for the second

revision, indicating wide participation in the final product development and incorporating the

perspectives of relevant stakeholders.

Reviewer 2 Comment 1 This paper presents a revised “three-talk model” that is aimed at

helping clinicians learn how to do shared decision making. The existing three-talk model,

developed by some of the authors of this paper and others, was published in JGIM in 2012,

and has been cited over 700 times. The authors went through a multi-step process of

consulting shared decision making (SDM) researchers, a survey of stakeholders, and a

survey of clinicians, which they describe in the paper. My overall impression is that the

revised model is an improvement over the existing model. I also think that the model will be

7

of general interest to clinicians, as well as other stakeholders such as patients and funders.

However, I feel somewhat conflicted about the paper because the detailed description of the

process the authors went through to come up with the revised model may be of less interest

to some. I wonder if it is possible to move some of the details, such as some of the specific

comments made on different aspects of the model, to an appendix. In general, I thought

some sections of the paper could be shortened and tightened up.

Response

We have shortened sections where we feel able to do so. Our view is that the comments and

debate about the different terms used to describe the model provide key input into the

difficulty of arriving at consensus when trying to develop a tool that is brief, elegant and

practical. We elected to use short words in the model and prioritized parsimony. Showing

that not all stakeholders agreed is meant to provide context to such decisions.

Reviewer 2 Comment 2 Abstract. The abstract does not make sufficiently clear that the

model is aimed at training clinicians. In addition, parts of it read oddly, e.g., “To consider the

need to revise an existing three-talk model, and consult, if necessary, with relevant

stakeholders to update and obtain wider stakeholder engagement.” It seems to me that the

decision had already been made that the model needed updating and that consultations with

relevant stakeholders were necessary. The paper is about the process of doing that, not

whether or not to do it.

Response

We changed the abstract as follows:

Objective To revise an existing three-talk model, and consult with relevant stakeholders to

update and obtain wider engagement.

and

Conclusions We propose a model of SDM that depicts three key conversational steps,

initiated by providing support when introducing options, followed by strategies to compare

and discuss trade offs, and ending with deliberation based on informed preferences. We

invite evaluation of the model by colleagues in other contexts and cultures.

Reviewer 2 Comment 3 Although the paper has been submitted to a general medical

journal, parts of it read like a private communication between SDM researchers. E.g.,

repeated references to “colleagues,” by which is meant other SDM researchers, I assume.

For example, in the abstract, “We invite adaptation and evaluation of the model by

colleagues in other contexts and cultures.” This made me wonder if anyone who was not a

“colleague” was welcome to submit feedback.

Response

We agree - the use of this term ‘colleague’ is unhelpful and we do wish this model to be

considered by a wide clinical audience, given that there is both interest in the topic and wide

misunderstanding. Many of the respondents were not colleagues - so it is inaccurate. We

have removed the term. It is true that in step 1 there was a definite attempt to reach out to

those who have been prominent in the shared decision making field. But step 2 was

purposefully to a much wider community and we have revised the method section

8

accordingly, to emphasize the different interest of the other constituencies - EBM,

Behavioural Medicine etc. Those contacted in Step 3 would be very unlikely to have had any

special knowledge of shared decision making.

Reviewer 2 Comment 4 Page 2, line 51. Should “Yet” be “Yes”?

Response

We agree and have made that change.

Reviewer 2 Comment 5 Page 3, first full paragraph. I think the previous model should

simply be described objectively. The use of “our” seems strange, given that the list of authors

is quite different from the authors of the 2012 paper, although there is overlap.

Response

We agree with the reviewer. ‘Our’ and indications of previous association have been

removed.

Reviewer 2 Comment 6 Page 3, second full paragraph. This paragraph is too long and is

repetitive in places (e.g., goal setting is mentioned twice). The last sentence puzzled me and

may have a word missing. The sentence states that “we questioned the need for revisions”

but doesn’t say why and this seems like a distraction. Is there a word missing before

“consultations”?

Response

Agree. We have shorted the paragraph, removed the repetition and deleted the last

sentence.

This paragraph now reads as:

Many suggested refinements to the 2012 model. The terms ‘choice talk’ and ‘option talk’

were considered too similar. Others felt it odd that there was no mention of risk

communication or goal setting in the model21,22, particularly as the idea of coproduction23

gains ground, and reported too little emphasis on exploring patient preferences and context.

These critiques also reflected developments in the SDM literature. Gulbrandsen and others

argued that illness brings a state of ‘uncertainty, vulnerability, and loss of power’. They

advocated SDM in order to enhance or restore a patient's “autonomous capacity”, to pay

more attention to the emotional and relational dimensions of care, and emphasize the need

to support the patient during a process of decision making, given that it may well be a novel

experience for most20. The 2012 model was silent on these issues.

Reviewer 2 Comment 7 I wonder if more effort could have been made to involve patients in

the process. Circulating the survey on the Society for Participatory Medicine list serv seems

insufficient. (By the way, I am a member of SPM and it currently has 421 members. I do not

think it had 700 members at the time the survey was circulated.) Perhaps a formal focus

group could have been assembled.

Response

9

We acknowledge that circulation of the survey to this Society could have been augmented

with other methods. We obtained information that the SPM has around 400 members, so we

edited that number. We detail this limitation in the discussion as follows:

Critique of method Efforts were made to collect a range of views, using a mixture of data

collection strategies but input from patients was limited. Health professionals are the target

audience of the model but we concede that we definitely need to test the acceptability of the

approach with patients. We also recognize the limitation of only seeking the views from

medically qualified professionals, and in only two countries. It is our goal to work with others

to translate and, if necessary, adapt the model to other settings. We did not adopt a formal

consensus research method because of the need for design decisions that cannot

accommodate every viewpoint. We acknowledge that given the potential pool of

respondents, we might have expected a higher number of response. Nevertheless, we

obtained over 150 detailed comments for the second revision, indicating wide participation in

the final product development.

Reviewer 3 Comment 1

This manuscript describes a revised three-talk model of shared decision making (SDM) and

the process undertaken to modify the original model (published in the Journal of General

Internal Medicine in 2012). Congratulations to the authors, particularly those who were part

of the team that developed the original model, for undertaking this process and being

receptive to criticisms of the original model. As we all know, this often does not occur and

striving to improve this model is a worthwhile undertaking. There are only a few

models/approaches for explaining the SDM process (particularly when conducting training

about SDM) and the three-talk model is a useful tool for doing this, so attempts to refine it are

welcome. Some comments about the manuscript are detailed below:

Response

Agree. There are very few tools designed for training / instruction.

Reviewer 3 Comment 2 Abstract - some more detail in the methods part would be useful

here (such numbers of participants, where/how recruited, etc). Including the figure in the

Results section of the abstract would be useful, but I am unclear if this is allowed by BMJ and

the editors will need to advise on this if the manuscript is accepted.

Response

We have modified the abstract as follows:

Importance The lack of an agreed model for learning how to achieve shared decision

making impedes adoption.

Objective To revise an existing three-talk model, and consult with relevant stakeholders to

update and obtain wider engagement.

Design A three-step consultation process involving key informants, online survey to

communities of interest, and review by medically qualified clinicians in six specialties.

Participants Key informants, academic networks, and medically qualified clinicians.

10

Results After three iterations and extended consultation with 19 key informants, 153

stakeholder responses to an online survey, and 316 responses from medically qualified

clinicians from six specialties, we propose a new three-talk model of shared decision making.

Conclusions The three-talk model of SDM depicts conversational steps, initiated by

providing support when introducing options, followed by strategies to compare and discuss

tradeoffs, before deliberation based on informed preferences. We invite evaluation of the

model by in other contexts and cultures.

Reviewer 3 Comment 3 Introduction

Pg 4, line 7 - typographical error - ‘as’ is not needed.

Response

Error corrected.


Pg 4, lines 12 and 44– I believe it’s BMJ style to avoid using the word ‘significant’ unless

referring to ‘statistical significance’.

Response

We deleted ‘significant’ and used ‘substantial’.


Pg 4, line 29 – is there a reference that can be used to support the statement that ‘SDM is

easier when options are reasonable’?

Response

Yes, there are citation for this statement - they have been added.

Pollard S, Bansback N, Bryan S. Physician attitudes toward shared decision making: A

systematic review. Patient Educ Couns [Internet]. 2015;98(9):1046–57. Available from:

http://dx.doi.org/10.1016/j.pec.2015.05.004

Entwistle VA, Cribb A, Watt IS. Shared decision-making: Enhancing the clinical relevance. J

R Soc Med [Internet]. 2012 Oct 1 [cited 2013 Jan 31];105(10):416–21. Available from:

http://www.ncbi.nlm.nih.gov/pubmed/23104944


Pg 4, line 29 – can you please clarify what’s meant by ‘scientifically plausible’ – is this

referring to evidence-based or mechanistically plausible?

Response

Agree - the phrase is not needed and has been removed.


Pg 4, line 51 – suggest that this statement (“it is true that patients feel anxious when told

about existence of alternative options”) be worded less definitively. This is not always the

situation and this statement is not supported consistently by empirical studies.

Response

11

Agree. The sentence has been modified as follows.

Yes, it is true some patients feel anxious when told about the existence of alternative options

and may worry about being abandoned to make decisions alone.14


Pg 4, line 59 – is there a reference to support the claim that ‘many clinicians seem to

misunderstand this’?

Response

Agree. It does not help to raise that tangential issue. We deleted the sentence and modified

the previous sentence:

Patients may well want to be informed about options without necessarily wanting to shoulder

the entire decisional responsibility, and shared decision making accommodates this method

of approaching decisions.17


Pg 5, line 1 – the second half of this statement (and the need to make SDM process as easy

as possible to understand) doesn’t link convincingly with the issue raised in the first half of

this sentence.

Response

Agree. These sentences have been deleted or modified.


Method

Providing the survey questions is useful. Is the intent for this to be an online supplementary

material?

Response

The survey can be provided as supplementary material. Please let us know if you wish to

have that.


Pg 5, line 49 – suggest specifying that the ‘disciplines’ that representation was sought from

were ‘medical disciplines’.

Response

Agree. Changes made.


Pg 5, Step 1 – additional information about the process that was used to move from ‘revision

1’ to ‘revision 2’ would be useful.

Response

We have added the following information about the changes. More information about the

transition between revisions is provided in the appendix.

12

Based on a summary of the above comments, revision 2 was developed where descriptions

were suggested for each type of talk (see Appendix Box 1 Qualtrics Survey), more emphasis

was placed on providing support, the term ‘communicate risk and compare alternatives’ was

used and the progress arrow to decision was removed, suggesting a less linear process.


Pp 5 and 6, step 1 – some more details would be useful here and it would help the reader to

establish how representative this group was. For example, how many participants were

invited to participate in the original group of SDM experts (in the Results section, it mentions

that 18 responded) and what criteria were used to establish this ‘steering group’ (for

example, were those who had perhaps critiqued the model invited?). Later in this step, more

details about those “who contributed” would be useful (for example, was it all who

responded? Other criteria?)

Response

On checking our notes again, we note that we invited 30 key informants and 19 responded.

The names are abbreviated and most are authors on the paper. If further details are

required, we can provide. We have modified the details as follows:

Thirty informants were invited, 11 either declined or did not respond, and 19 responded with

comments; ten had clinical qualifications (PH, PK, TvdW, PG, ZB, JA, MH, AE, LT, IS), and

nine were researchers (AS, LPP, AL, MAD, NJW, HW, PJB, DLF, DG).


Pg 6, lines 26-27 – this sentence, indicating that only health professions who have a medical

qualification typically make final decisions about treatments, reflects a very narrow view of

healthcare. It is a disservice to shared decision making, all non-medically qualified health

professionals, and patients to justify the sampling decisions of this study in this way.

Response

Agreed. We do fully recognize that decisions are not limited to medically qualified

professionals. We have modified as follows:

We recognize that other healthcare professionals have opportunities to share decisions with

patients. Limiting the sample to one profession was due to budget constraints and because

decisions about medications and clinical procedures are most often made by those with

medical qualifications.


Following the flow of participants (various groups) and processes in this study is quite difficult

as is currently presented. Suggest that the authors considering using a flow diagram (such

as used in trials or systematic reviews) to succinctly explain the different steps and at each

step, the number of participants, criteria, and main processes involved.

Response

13

We are open to this suggestion if editors agree. It was our view that the nature of each group

/ step was different, that a flow diagram would mislead. We are however open to creating a

figure.


- There does not seem to be a ‘patient involvement’ section/statement in the Methods

section which I think is now required (or explained why it wasn’t appropriate) in BMJ

Research articles. Was involvement of patients considered for this research? For research

on shared decision making, this would seem particularly appropriate!

Response

The goal of this work was to develop a model that clinicians (not patients) would find helpful,

acceptable and intuitive as a model for use in training contexts, and for that reason, we did

not seek definitive patient involvement. We did reach out to the Society Participatory

Medicine and we will check how many responses we had from their membership. We do of

course acknowledge that the model has to be one that is acceptable to patients. Given the

very strong patient advocacy among those who are motivated to implement shared decision

making, and the involvement of linguists and other non-medical professionals, we hope that

our work can be regarded patient-centered, or at least, sufficiently so. Nevertheless, we

recognise this limitation and state it clearly in the discussion.


Results

The results and feedback at each step in the process are generally well-described. It’s useful

to see the iterations of the model in each step.

Response

No response.


Discussion

Pg 9, line 11 - given the response by 54% of participants that the model requires training in

how to use it, perhaps the authors could state if they do, or do not, have plans to

provide/develop this in the future.

Response

We modified as follows:

Although our experience of using the previous model in presentations and workshops using

standardized patients has been positive, we need to evaluate its utility as a framework to

support skill development, with and without additional training.


Pg 9, line 34 - related to the above comment about training, can the authors comment on if

they think this finding (that just half of participants think that training in the model is needed)

aligns with the goal of producing a model that is “as self-explanatory as possible” and

whether they think that a more self-explanatory model is possible?

14

Response

The figure has been designed to be as self-explanatory as possible. However, we do

recognize that further work is needed to develop explanatory notes around the figure and

model. We are planning that process but we have not yet completed a proposal.Trudy van

der Weidjen notes that in the Netherlands we have just finished a Delphi on translating this

model to Entrustable Professional Activities, resulting in just over 20 specific competencies /

behavioral indicators. The results are to be submitted soon.


Limitations The authors appropriately acknowledge that one of the limitations of this project

is the restriction of the project to one profession, and two countries. I think this greatly limits

the generalisability of the results of this process to revise the model, which is unfortunate, as

SDM is needed just as much in non-medical health professions and in countries other than

the two involved in this study.

Response

We have described the limitations of the consultation process. We think our results have

been of value to other professions and other contexts. The model was designed from the

start to be generic and the fact that the 2012 model has been cited over 700 times (in

research papers about SDM and training from different countries) is an indication of the

interest level. Whilst it is true that the sample in step 3 was in two countries, the participants

in step 1 and 2 were international, as is the author group.


Likewise, I agree with the authors that it remains unknown “whether this model can be

translated, adapted and used if different context and cultures” (pg 10, lines 10-11). However,

would it have been better to incorporate these considerations into the process of revising this

model that occurred, rather than presenting a revised model and then potentially having to

revise/adapt it again so that it is more widely applicable?

Response

Please refer to the response to comment 20. It is important to note that Trudy van der

Weijden notes that in the guideline community it is totally accepted that a generic,

overarching concept or model or definition (or guideline) has to be adapted to each specific

country. They have even developed validated procedures to do so (the ADAPTE tool).


Other

Was ethical approval obtained for this study? In the files that I had access to, there weren’t

any of the usual end-of-paper statements about ethics approval, contributor roles, competing

interests, etc, so I cannot comment on these issues.

Response

All authors will complete COI declarations.

The Dartmouth College Committee for the Protection of Human Subjects approved the study

(STUDY00030085) on February 2, 2017.

15

Reviewer 4 Comments 1

Review from a patient perspective

• Is this an issue that matters to you, and/or other patients and carers?

Yes, as a patient I’ve been asked to make decisions about which drug I would like to take.

Response

Agree - shared decision making is relevant to all patients in all settings.


• Are there any areas relevant to patients and carers that are missing or should be

highlighted?

The article and the model it proposes are aimed at doctors in clinical practice.

Response

Agree - that was the aim. Relevance and appropriateness to patients could have been more

rigorously assessed. See limitations paragraph.


• If the article is a research paper looking at a new intervention or treatment, say if you think

it will really work in practice. What challenges might patients face?

In my experience, there is little time for discussion around treatment options, the model

implies there would be 3 opportunities to discuss treatment options with your doctor. In my

own experience, you get handed some leaflets at your first appointment and at your 2nd one

you get asked what you’ve decided. Generally patient information leaflets are so ambiguous,

they don’t apply to anyone and always end with “ask your doctor”. Asking your doctor tends

to end with “most patients do very well on this drug”.

Response

The model does not suggest three separate opportunities or discussions. We have modified

the article to read as follows:

We should acknowledge that while it is entirely possible to conduct all three steps in a single

encounter, there is often a need to use successive visits to allow for reflection and

deliberation, either across time or with different professionals 27 28, with or without the use of

evidence-based tools to support conversations 29.


• Are the outcomes measured and issues discussed in the article the ones that are important

to patients? Are there others that should have been considered?

More generally a graphical model for indicating risk, for use with patients would be a

welcome addition to this model (even something as simple as a graph showing frequency of

side effects 1/100 1/1000 etc.) Harms are real but need to be weighed against benefits. I

have never had a consultation where the doctor honestly outlined the percentage of people

who have benefitted from a treatment. Most start with the side effects which seems like a

good way of scaring people off. Perhaps start with a bar chart saying 60% of people were

16

helped with this treatment? The literature on improving patient information leaflets may be

helpful here.

Response

The reviewer is raising a different topic - but a very important one about how best to convey

risk probabilities. We totally agree that this is important but that it is a different area of work.

There are tools that exactly fit the need - patient decision aids - we will make sure that the

text refers to these tools. Information that adds detail about how to use this model would

contain references to patient decision aids. We have added the following sentence in

discussion and added two citations to support.

SDM is sometimes supported by the use of patient decision aids, which often include risk

communication formats. These would fit naturally in the ‘option talk’ step.


• Do you have any suggestions that might help the author(s) strengthen their paper to make

it more useful for doctors to share and discuss with patients?

This model is designed to be used with doctors not patients.

Response

Agree. See previous comments.


There are quite a few errors in punctuation throughout, and in places the manuscript is

difficult to read.

I realise that this is meant to be an educational tool/model for clinicians, but it seems like

there has been little input from consumers/families (who really are the whole point of having

shared medical decision-making) into the tool. Surely consumers should have been

considered as key stakeholders in the development and refinement of the model - how else

could you ensure that the model reflects the needs of consumers? As a consumer, all I can

see is "talking", there's no indication that anyone - clinician or consumer - is going to "listen"

to what is said. It also seems strange that the term "team talk" was retained, despite a

number of respondents saying it is "somewhat unhelpful".

Response

Thank you for alerting us to this important oversight in how we described the model. We

respond to the limited involvement of patients in other comments. We have modified the

model to ensure that the Decision talk refers to the critical need to ask for, and listen, to

patients’ views. The point of the model is to work together to arrive at good decisions - and

that cannot be done without active listening by the clinician. We have added the term ‘active

listening’ to the model - indicating that listening is a core process of shared decision making.

The revised model is shown below:

17

We also added this sentence to the discussion:

Comments received during peer review led to additional insights and we added the phrase

‘active listening’ to the model, a skill that was presumed but had not been made explicit. REF

Carl Rogers.

Deadline: Your revised manuscript should be returned within one month.

How to submit your revised article: Log into http://mc.manuscriptcentral.com/bmj and enter

your Author Center, where you will find your manuscript title listed under "Manuscripts with

Decisions." Under "Actions," click on "Create a Revision." Your manuscript number has been

appended to denote a revision.

You will be unable to make your revisions on the originally submitted version of the

manuscript. Instead, revise your manuscript using a word processing program and save it on

18

your computer. Once the revised manuscript is prepared, you can upload it and submit it

through your Author Center. When submitting your revised manuscript, you will be able to

respond to the comments made by the reviewer(s) and Committee in the space provided.

You can use this space to document any changes you make to the original manuscript and to

explain your responses. In order to expedite the processing of the revised manuscript, please

be as specific as possible in your response to the reviewer(s). As well as submitting your

revised manuscript, we also require a copy of the manuscript with changes highlighted.

Please upload this as a supplemental file with file designation ‘Revised Manuscript Marked

copy’. Your original files are available to you when you upload your revised manuscript.

Please delete any redundant files before completing the submission.

When you revise and return your manuscript, please take note of all the following points

about revising your article. Even if an item, such as a competing interests statement, was

present and correct in the original draft of your paper, please check that it has not slipped out

during revision. Please include these items in the revised manuscript to comply with BMJ

style (see: http://www.bmj.com/about-bmj/resources-authors/article-submission/article-

requirements and

http://www.bmj.com/about-bmj/resources-authors/forms-policies-and-checklists).

Items to include with your revision (see http://www.bmj.com/about-bmj/resources-

authors/article-types/research):

1. What this paper adds/what is already known box (as described at

http://resources.bmj.com/bmj/authors/types-of-article/research)

What this paper adds

What is already known on this subject

Definitions and integrated descriptions of shared decision making exist but few attempts have been made to produce a brief model that succinctly portrays the key steps of how to involve patients in health care decisions. An earlier version of a three-talk model was found to be helpful although many felt that there was room for improvement.

What this study adds

This study enabled extensive consultation about a revised model with key informants, communities of practice and a sample of medically qualified practitioners from six specialties. The revised three-talk model conveys the core principles of shared decision making by proposing easy-to-remember conversational steps, portrayed in a visual format to facilitate use in teaching contexts.

19

2. Name of the ethics committee or IRB, ID# of the approval, and a statement that

participants gave informed consent before taking part. If ethics committee approval was not

required, please state so clearly and explain the reasons why (see

http://resources.bmj.com/bmj/authors/editorial-policies/guidelines.)

Response

The Dartmouth College Committee for the Protection of Human Subjects (CPHS), study

number STUDY00030085. Study was approved on February 2, 2017. This was a minimal

risk study and the participants’ consent was not required. We provided an information sheet

instead that was embedded to the second survey and a brief description in our application

about using SERMO for step 3.

3. Patient confidentiality forms when appropriate (see

http://resources.bmj.com/bmj/authors/editorial-policies/copy_of_patient-confidentiality).

Response

Not applicable.

4. Competing interests statement (see http://resources.bmj.com/bmj/authors/editorial-

policies/competing-interests)

Robin - please contact all authors to collect competing interests forms.

5. Contributorship statement+ guarantor (see

http://resources.bmj.com/bmj/authors/article-submission/authorship-contributorship)

Response

Contributorship Statement

The following people contributed as follows: conception and design (GE, MAD); data

collection (GE,MAD, JS); data analysis and interpretation (GE, MAD, JS); drafting of the

model and article (all authors), critical revision of the model and article (all authors); final

approval of the mode and article to be published (all authors).

6. Transparency statement: (see http://www.bmj.com/about-bmj/resources-authors/forms-

policies-and-checklists/transparency-policy)

Response

I confirm that this article adheres to the BMJ’s transparency requirements.

20

7. Copyright statement/licence for publication (see http://www.bmj.com/about-

bmj/resources-authors/forms-policies-and-checklists/copyright-open-access-and-permission-

reuse)

Response

Licence

The Corresponding Author has the right to grant on behalf of all authors and does grant on

behalf of all authors, a worldwide licence to the Publishers and its licensees in perpetuity, in

all forms, formats and media (whether known now or created in the future), to i) publish,

reproduce, distribute, display and store the Contribution, ii) translate the Contribution into

other languages, create adaptations, reprints, include within collections and create

summaries, extracts and/or, abstracts of the Contribution, iii) create any other derivative

work(s) based on the Contribution, iv) to exploit all subsidiary rights in the Contribution, v) the

inclusion of electronic links from the Contribution to third party material where-ever it may be

located; and, vi) licence any third party to do any or all of the above.

8. Data sharing statement (see http://www.bmj.com/about-bmj/resources-authors/article-

types/research)

Response

Not applicable.

9. Funding statement and statement of the independence of researchers from funders

(see http://resources.bmj.com/bmj/authors/article-submission/article-requirements).

Response

No direct funding.

10. Patient involvement statement (see http://www.bmj.com/about-bmj/resources-

authors/article-types/research).

Response

In step 2 of the consultation process, we sent the survey to many organisations who are

known to have patient members - EBM, SPM, Shared decision making FB.

11. Please ensure the paper complies with The BMJ’s style, as detailed below:

a. Title: this should include the study design eg "systematic review and meta-analysis.”

b. Abstract: Please include a structured abstract with key summary statistics, as explained

below (also see http://resources.bmj.com/bmj/authors/types-of-article/research). For every

clinical trial - and for any other registered study- the last line of the abstract must list the

study registration number and the name of the register.

21

c. Introduction: This should cover no more than three paragraphs, focusing on the

research question and your reasons for asking it now.

d. Methods: For an intervention study the manuscript should include enough information

about the intervention(s) and comparator(s) (even if this was usual care) for reviewers and

readers to understand fully what happened in the study. To enable readers to replicate your

work or implement the interventions in their own practice please also provide (uploaded as

one or more supplemental files, including video and audio files where appropriate) any

relevant detailed descriptions and materials. Alternatively, please provide in the manuscript

urls to openly accessible websites where these materials can be found.

e. Results: Please report statistical aspects of the study in line with the Statistical

Analyses and Methods in the Published Literature (SAMPL) guidelines http://www.equator-

network.org/reporting-guidelines/sampl/. Please include in the results section of your

structured abstract (and, of course, in the article's results section) the following terms, as

appropriate:

i. For a clinical trial: Absolute event rates among experimental and control groups; RRR

(relative risk reduction); NNT or NNH (number needed to treat or harm) and its 95%

confidence interval (or, if the trial is of a public health intervention, number helped per 1000

or 100,000.)

ii. For a cohort study: Absolute event rates over time (eg 10 years) among exposed and

non-exposed groups; RRR (relative risk reduction.)

iii. For a case control study:OR (odds ratio) for strength of association between exposure

and outcome.

iv. For a study of a diagnostic test: Sensitivity and specificity; PPV and NPV (positive and

negative predictive values.)

v. For a systematic review and/or meta-analysis: Point estimates and confidence intervals

for the main results; one or more references for the statistical package(s) used to analyse the

data, eg RevMan for a systematic review. There is no need to provide a formal reference for

a very widely used package that will be very familiar to general readers eg STATA, but

please say in the text which version you used. For articles that include explicit statements of

the quality of evidence and strength of recommendations, we prefer reporting using the

GRADE system.

f. Discussion: To minimise the risk of careful explanation giving way to polemic, please

write the discussion section of your paper in a structured way. Please follow this structure: i)

statement of principal findings of the study; ii) strengths and weaknesses of the study; iii)

strengths and weaknesses in relation to other studies, discussing important differences in

results; iv) what your study adds (whenever possible please discuss your study in the light of

relevant systematic reviews and meta-analyses); v) meaning of the study, including possible

explanations and implications for clinicians and policymakers and other researchers; vi) how

your study could promote better decisions; vi) unanswered questions and future research

22

g. Footnotes and statements

Online and print publication: All original research in The BMJ is published with open access.

Our open access policy is detailed here: http://www.bmj.com/about-bmj/resources-

authors/forms-policies-and-checklists/copyright-open-access-and-permission-reuse. The full

text online version of your article, if accepted after revision, will be the indexed citable version

(full details are at http://resources.bmj.com/bmj/about-bmj/the-bmjs-publishing-model). The

print and iPad BMJ will carry an abridged version of your article. This abridged version of the

article is essentially an evidence abstract called BMJ pico, which we would like you to write

using the template downloadable at http://resources.bmj.com/bmj/authors/bmj-pico.

Publication of research on bmj.com is definitive and is not simply interim "epublication ahead

of print", so if you do not wish to abridge your article using BMJ pico, you will be able to opt

for online only publication. Please let us know if you would prefer this option. If your article is

accepted we will invite you to submit a video abstract, lasting no longer than 4 minutes, and

based on the information in your paper’s BMJ pico evidence abstract. The content and focus

of the video must relate directly to the study that has been accepted for publication by The

BMJ, and should not stray beyond the data.

END

dear professor loder manuscript id bmj.2017.040377 ... · dear professor loder manuscript id...

Documents