Navigating High Risk Surgery: Empowering Older Adults to Ask Questions That Inform Decisions About Surgical Treatment
Phase: NA
Conditions: Communication
Sponsor: University of Wisconsin, Madison



 
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Contents 
Introduction ................................................................................................................................. 3 
Background and rationale ....................................................................................................... 3 
Specific aims ........................................................................................................................ 4 
Study design ......................................................................................................................... 5 
Blinding ............................................................................................................................... 6 
Data and Safety Monitoring Plan ............................................................................................. 7 
Data coding .......................................................................................................................... 7 
Per-Protocol Analysis of Primary Outcomes ................................................................................10 
General Analysis Plan ...........................................................................................................10 
Aim-1 primary outcomes [Question Counting, PEPPI-5] ...........................................................10 
Aim-2 primary outcomes [Regret, MYCaW] ...........................................................................11 
Further analysis of primary endpoints generated prior to un-blinding ..............................................11 
Updated analysis plan and modified power analysis ..................................................................11 
Additional considerations: Aim-1 question asking ....................................................................13 
Additional considerations: Aim-2 regret ..................................................................................13 
Stratified Analysis: Aim-2 MYCaW .......................................................................................14 
Secondary outcomes: Aim-1: patient engagement [PEPPI-5, OPTION5, HCCQ] .........................14 
Secondary outcomes: Aim-2: treatment received, well-being [PROMIS] .....................................14 
Additional important outcomes ..............................................................................................15 
Exploratory analyses ................................................................................................................16 
Aim-3 .................................................................................................................................16 
References ..............................................................................................................................18 
Appendix ................................................................................................................................21 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Introduction  
Background and rationale  
 
Each year, many of the 500,000 older Americans having high risk surgery1,2 will do so without fully 
understanding how it will affect them. Given trends in the number of patients 65 and older undergoing 
high risk surgery,3,4 this number is expected to grow as the U.S. population ages. High risk surgery can 
prolong older patients’ lives and/or improve their symptoms. Yet it can also result in unwanted outcomes, 
including serious postoperative complications, lower quality of life,5 more hospitalizations,6,7 and 
potential suffering at the end of life.8,9 For example, of older patients who undergo coronary artery bypass 
grafting, nearly one in 20 will die within 30 days of surgery; those who survive are three times more 
likely to suffer a stroke or renal failure and nearly twice as likely to require prolonged mechanical 
ventilation than younger patients.10 This profile is typical of other high risk operations, including major 
cancer operations, vascular procedures and neurosurgeries.2,11 Fifty percent of older patients also have one 
or more chronic condition,12 putting them at even greater risk for postoperative complications and 
death.13,14  
 
Because older patients are more likely to require intensive care or lengthy hospitalizations 
postoperatively,15,16 a decision to proceed with surgery can start a patient along a care trajectory that is 
ultimately inconsistent with his or her personal preferences and goals; for example, confinement in a 
nursing home or prolonged life support in intensive care. For these reasons, the decision-making process 
for older patients considering high risk surgery is complicated. Because the consequences of these 
decisions affect not only patients, but also their family members, the stakes are high. 
 
Poor preoperative communication can lead to unwanted treatment, unanticipated postoperative challenges 
and conflict between surgeons and patients. Surgeons currently rely on best-practices—including 
informed consent—to help patients make decisions about surgery. This process is deficient because it 
does not provide an accessible explanation about how a patient might experience complications, or even 
expected downstream outcomes, such as the need for additional invasive treatments or predictable 
changes in functional status.17,18 Given the trade-offs between the possible benefits of surgery and the real 
potential for an unwanted outcome, there is no “right” treatment for each patient’s surgical problem. 
Patients and families need to know what the outcomes of surgery mean for them and how surgical 
treatment can be understood in the context of their overall prognosis, particularly for patients with other 
chronic illnesses.19,20 Even an “uncomplicated” recovery from a major vascular or cancer operation can 
impact patients’ and their family members’ wellbeing. Patients whose expectations for surgery are not 
met suffer as they try to make sense of their situation, feel a loss of control and assume self-blame.21 
Items in the lay press tell stories of difficult surgical decisions,22 struggles to understand the likely 
outcomes of surgery,23 and challenging negotiations with surgeons about preferences for limiting 
aggressive postoperative treatments.24,25 
 
These decision-making conversations can have serious implications for a modest subgroup of patients 
who experience life-threatening complications.  From the surgeon’s perspective, the patient has agreed to 

 
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the operative procedure as well as all postoperative care anticipated by the surgeon. We call this 
implicitly understood contract “surgical buy-in.”26,27 Although surgeons perceive a mutual commitment to 
postoperative life-supporting treatments if necessary, this is not recognized by patients, who may desire 
treatment limitations and value some outcomes but not others.28 This disconnect can lead to postoperative 
conflict between surgeons and patients, and between surgeons and other providers,29,30 when patients 
and/or their families want to withhold or withdraw treatments that the surgeon believes the patient agreed 
to. 
 
We need to bridge the gap between what surgeons know and what patients understand. The structure of 
preoperative decision-making conversations is inadequate to assist patients in their deliberation about 
high risk surgery; falls short in establishing expectations for known and unexpected outcomes; and fails to 
accommodate patients’ preferences as they shift in the context of a specific illness or burdensome 
treatments. While current practices satisfy the legal requirements for informed consent, they lack essential 
elements for preference-sensitive decision making. Patients need surgeons to help them compare 
treatment options and evaluate their effectiveness by providing information about what surgery means for 
them. Given the gravity of these decisions—specifically, the potential for life-changing benefits and 
harms—simple risk disclosure and surgeon-directed deliberation is not enough. We need evidence about 
alternative strategies to improve these high-stakes conversations, support value-directed deliberation, set 
realistic postoperative expectations and avoid conflict between patients and surgeons in the setting of an 
unwanted outcome. 
 
Question prompt lists have proven efficacy for improving patient-doctor communication. Question 
prompt list (QPL) interventions can effectively change how patients and family members communicate 
with physicians, improve patients’ and family members’ psychological outcomes, and better meet 
patients’ informational needs.31-33 Effective QPL interventions require physicians to endorse and support 
the patient’s use of the question list, but do not require patient navigators or patient coaching.34 For 
patients considering surgery35 and patients with life-limiting illness36 QPLs effectively increase the 
number of questions about prognosis and about “what to expect in the future.” QPL interventions effect 
behavior change in physicians (including surgeons)35 so that patients receive “more evidence related to 
options” and more “consideration of patient of preferences.”37  
 
To address the communication problems in preoperative decision making, we worked with stakeholders 
to design a QPL specifically targeting the needs of patients considering high risk surgery. We developed a 
QPL for use in the surgical clinic by patients considering major vascular (cardiac, peripheral, neuro) and 
oncologic operations. It encourages patients and families to ask questions that allow them to compare 
treatment options and get information about what surgery means for them.  More information on the 
rationale and development of our QPL is available in our manuscript documenting this process.38  
Specific aims 
To answer our research question, “Could a patient-driven approach that improves decision making and 
informs postoperative expectations have more effectiveness than the current surgeon-directed 
preoperative conversation?” we will conduct a multi-site randomized controlled trial of the question 
prompt list intervention for high risk surgery that will: 

 
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1) Compare the effectiveness of the intervention relative to usual care on the extent of patient 
engagement in decision making for high risk surgery.  
2) Compare the effectiveness of the intervention relative to usual care on treatment choice and on 
psychological well-being and post-treatment regret for patients and family members. 
3) Compare the effectiveness of the intervention relative to usual care on interpersonal and intrapersonal 
conflict relating to treatment decisions and subsequent treatments received. 
Our overall goals are to help patients and families 1) make treatment decisions in line with their values 
and goals; 2) anticipate and make sense of postoperative outcomes; and 3) experience less postoperative 
conflict about treatment of serious complications.  
Study design  
We will perform a multi-site cluster randomized trial that uses a stepped-wedged design to compare the 
effectiveness of our Question Prompt List (QPL) intervention to usual care for patients considering high 
risk vascular (peripheral, cardiac, neuro) and oncologic operations. The intervention we are testing in this 
study is the QPL plus a letter from the patient’s surgeon endorsing its use. Effective QPL interventions 
require physicians to endorse and support the patient’s use of the question list, but do not require patient 
navigators or patient coaching.34 Therefore, this study involves no training or coaching. 
 
This 24-month study will use a time-dependent cluster randomization plan within each of our five study 
sites. We will enroll surgeons at 5 sites whose practice is largely comprised of older adults considering 
high risk procedures. Then we will randomly assign time points for the surgeons to cross over from usual 
care to the QPL intervention. Surgeons who have crossed over to the intervention group will be notified 
when the QPL intervention has been implemented in their clinic and will be encouraged with bi-weekly 
email or text reminders to support patient use of the question list during the clinical encounters with new 
patients. We will enroll up to 3 patients per surgeon in each wave.  To maintain enrollment we will move 
through each wave every 4 months or, if enrollment goals have not been met by 4 months, when sites 
have meet 70% of their enrollment goal for each wave.  Wave changes will not be made with any 
consideration of treatment group.   
 
We will audiotape one preoperative clinic visit; administer questionnaires to patients and family members 
at three time points after that visit; and record surgical decisions, treatments received and associated 
outcomes via chart review. The first questionnaires will be administered by phone and the latter two may 
be completed by phone, mail or online survey, based on participant preference. The questionnaires 
include questions on concerns, self-efficacy, well-being and post-treatment regret, as shown in Table 1.  
 
For aim 3, we will use stratified purposeful sampling to identify a subset of patients (and their family 
members, if applicable) in each study arm who have experienced serious complications for open-ended 
interviews. Open-ended interviews will occur up to 3 months after completion of the third survey.  
More information on the study design is available in our published protocol.39 
 
 

 
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Table 1: Primary and Secondary Outcomes Measures for Aims 1 and 2. 
Construct 
Specific Measure  
Type; range 
Source 
Timing 
Aim 1: patient engagement 
Engagement in 
decision making 
Number and type of questions posed by patient and 
family members during T0 consultation using a pre-
defined coding scheme (Table 2) 
OPTION 5 (physician engagement with patient) 
count; 0-25 
 
 
continuous 
Audio 
recording 
 
T0 
Self-efficacy in 
patient physician 
interactions 
PEPPI-5-5 (perceived efficacy) 
HCCQ (autonomy support) 
continuous 
continuous 
Patient and 
family member  
T1 
Aim 2: psychological wellbeing and treatment received 
Concerns and 
wellbeing 
MYCaW (self-identified concerns and wellbeing) 
continuous 
Patient and 
family member 
T1-T2 
T1-T3 
Post-treatment 
regret 
“Looking back, is there anything about your 
treatment that you would do differently?” 
Binary 
Patient and 
family member 
T3 
Patient – 
psychological 
wellbeing, PROMIS 
Psychosocial Illness Impact-Neg 4a 
Psychosocial Illness Impact-Pos 4a 
Anxiety 4a* 
continuous 
continuous 
continuous 
Patient 
T2 
T3 
Family – 
psychological 
wellbeing, PROMIS 
PROMIS SF Global Health 
Anxiety 4a 
continuous 
continuous 
Family 
member 
T2 
T3 
Treatment received 
Total number of operations scheduled after visit with 
surgeon 
Total number of operations scheduled and performed 
count; 0-3 
count; 0-3 
Chart review 
T0 
T3 
* Items in bold are primary outcomes. 
T0: Audio recorded clinic visit between patient, family member and surgeon 
T1: Phone questionnaire with patient and family member 24-48 hours after visit with surgeon 
T2: Questionnaire 1-2 weeks post-surgery or, for patients who do not have surgery, 6-8 weeks post initial visit  
T3: Questionnaire and chart review 6-8 weeks post-surgery or, for patients who do not have surgery, 12-14 weeks post 
initial visit   
 
Blinding 
Although we cannot blind surgeons to intervention group, based on the need for them to endorse use of 
the QPL during clinic visits, they will not be informed of the outcomes measured in this study. Patient 
and family member participants will be told that the study goal is to evaluate surgeon-patient 
communication and will be blinded to objectives regarding testing of the QPL intervention. We expect 
negligible contamination between patient participants in different study arms as the intervention requires 
surgeon endorsement of the QPL with a letter from the patient’s surgeon and the surgeons work in 
different clinics on different days. Although patients in the control arm may access question lists from 
outside sources, we know from previous research that surgeons do not routinely ask patients about such 
instruments.  
 
Study staff will not be blinded during data collection but will adhere to a study script and query about 
receipt of the QPL intervention as the last question in the first survey (T1) to try to keep study staff 
insulated during the assessment of primary outcomes.  Data will be labeled with a pseudo ID during 
coding to ensure that coders remain blinded to the patient’s intervention status. We will provide coders 
with an even mix of control and intervention data during the coding period, so that they cannot impute 
intervention status based on the timing of coding assignments  

 
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Data and Safety Monitoring Plan 
UW-Institute for Clinical and Translational Research (ICTR) has established a Data Monitoring 
Committee (DMC) for UW-Madison investigators conducting clinical research. This DMC provides 
investigators services to ensure appropriate measures are in place to promote subject safety, research 
integrity and compliance with federal regulations and local policies for individual clinical research 
protocols in need of DMC review. For this study, the UW ICTR DMC will be the primary data and safety 
advisory group for the PI and all study sites.  
 
In providing oversight for the conduct of this study, the ICTR DMC will meet every 6 months during the 
3-year study. Additional meetings may be scheduled as determined by the DMC. The DMC members will 
review protocol-specific reports created by statisticians that serve a non-voting member role on the DMC. 
These standard reports will include an overview of study objectives, a review of actual and projected 
accrual rates, an evaluation of patient demographics for balance of randomization, and a summary of the 
number and seriousness of adverse events. An interim analysis of study results will be performed, and 
source documents may be reviewed to allow the DMC to independently judge whether the overall 
integrity and conduct of the protocol remain acceptable based on data provided and reported by the PI. 
The DMC will make recommendations to the PI that could include actions of continuation, modification, 
suspension, or termination. 
 
Research team members may also be involved in safety monitoring throughout the study. Although not 
expected, research staff will be prepared to address any negative reactions to study procedures including 
audio recording of the conversation with the surgeon, survey questions and open-ended interviews. All 
negative reactions will be reviewed to determine whether a change in protocol is necessary. The PI 
(Schwarze) will report any policy violations to the IRB immediately. The PI will also report any adverse 
events in compliance with the IRB policy for reporting. In addition to the DMC, the PI will review the 
research study and the accrued data on a monthly basis in project meetings so as to ensure the validity and 
integrity of the data and to evaluate whether changes to the anticipated benefit-to-risk ratio of study 
participation have occurred. 
Data coding 
All coding will be completed prior to unblinding.  
 
Coding of number and types of questions will follow a pre-defined coding scheme (Table 2). We 
developed a detailed codebook based on an established coding scheme31 as noted in the PCORI proposal. 
Coders coded each question by speaker and question type/content area.  The coding schema was tested 
twice, with acceptable intraclass correlation found between coders. The first round of testing drew a 
random sample of 45 transcripts from a prior project. Intraclass correlations were acceptable for all but 
one question category. We reviewed all discrepancies for this category and revised the codebook. The 
second round of assessment was comprised of a random set of 30 transcripts from this project. Coders 
were blinded to arm status of the transcripts. This sample was generated by the independent statistician 
who maintains our blinding procedures and synthetic study ID’s. We found an acceptable ICC for all 
question categories, as shown in Table 3. 

 
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Table 2: Predefined coding scheme to characterize questions asked by patients and 
family members during surgical consultation (T0) 
Category 
Definition  
Example 
Options 
Seeks to understand different 
treatment pathways. 
 “Is there another way?”  
Expectati
ons 
Seeks to understand what life would 
look like after treatment. 
 “Like, you know, how long will be 
the recovery?”  
 
Advance 
Directives 
Asks about care and consequences if 
patient is unable to speak for 
him/herself. 
 "Then, you know, why continue?"  
 
Risks & 
Complicat
ions 
Seeks to understand what could go 
wrong, bad outcomes or hazards of 
surgery. 
 “As far as the location of the tumor 
that remains in those veins…is 
anything at risk as far as… blood 
flow function of any of those parts?”  
Logistical 
& 
Technical 
Seeks to understand the technical 
details about how surgical treatment 
is performed and how to coordinate 
personal needs associated with 
treatment. 
 “How long does the surgery take?”  
 
Other 
 Queries regarding things external to 
the diagnosis, decision-making or 
treatment. 
 “How many grandkids do you 
have?”   
 
Question categories in bold are primary outcomes.  
 
 
Table 3:  Intraclass correlation between coders for 
question category coding of patient and family members 
during T0 surgical consult 
Category 
ICC 1  
ICC 2 
Options 
 0.45 
0.76 
Expectations 
 0.95 
0.83 
 
Risks & Complications 
 0.79 
0.87 
Logistical & Technical 
0.93 
0.92 
Advance Directives 
Not analyzed 
Not analyzed 
Other 
Not analyzed 
Not analyzed 
 
Each transcript will be coded by one coder. A full codebook is provided in the Appendix. Audio 
recordings will be transcribed with all identifying information removed including names, dates and 
locations. Prior to coding, every transcript will have a thorough quality assurance check by a member of 
the study team to ensure the transcript fully captured what occurred during the T0 visit, and that all 
questions were appropriately transcribed. Prior to categorizing each question, questions asked by patients 

 
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or family members will be identified by a Microsoft Visual Basic program, which will generate a coding 
sheet containing all questions asked by patients and family members during the T0 surgeon visit.   
 
Each transcript will also be coded based on the OPTION 5 instrument, a measure of observer measured 
shared decision making40 as designed by Elwyn (see Appendix). Satisfactory acceptable intraclass 
correlation for this measurement was difficult to attain so each transcript will be OPTION 5 scored by 2 
coders and then consensus coded during group coding sessions.  
 
Each transcript will be coded for other variables, as shown in Table 4. This coding will be done by a 
single coder and then consensus coded as part of group coding sessions. 
 
Table 4:  Additional variables derived from the transcribed audio recordings 
Variable 
Coding details 
Length of audio file 
Duration of the transcribed audio recording 
Number of clinicians and family members present 
Presence of others in the room in addition to 
patient and surgeon  
Any part of the transcript in a language other 
than English 
Presence of any language other than English 
spoken by any person present during the 
audio recording  
Audio-recording and transcript captured full 
conversation  
Presence of gaps or content that appears to be 
missing from the surgeon’s visit with the 
patient, pauses, lack of greetings or goodbyes  
Discussion included any consideration of 
operative treatment/surgery and, if yes, was this 
a high-risk procedure or operation 
Presence of a discussion about any major 
operative procedure  
Mention that surgery had been discussed with 
this patient and this surgeon or another surgeon 
before 
Reference to previous discussions or 
interactions with another surgeon prior 
Type of indication 
Presence of a discussion about a vascular or 
oncologic problem 
Additional specific topics covered 
Goals of treatment as stated by surgeon, 
patient goals, advance care planning, and 
surgeon’s ambivalence about surgical 
intervention 
 
 
Data from the “Measure Yourself Concerns and Well-being” (MYCaW) instrument will be coded 
using a codebook developed by the research team. The coding scheme was developed in the following 
way: each concern is given a primary code that best captures the essence of the concern. Up to 4 
secondary codes can also be applied to each concern to capture additional themes raised. Two coders will 
independently code each concern, blinded to treatment arm status and site. Three study team members 
will meet to consensus code and resolve all discrepancies.  
 

 
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Data on regrets expressed by patients and family members during the T3 survey will be coded by 2 
coders, blinded to intervention arm, based on a previously developed coding scheme.41  Data from this 
survey item will be coded for the presence or absence of regret and, when regrets are present, will be 
coded with one or more topic areas.  
Per-Protocol Analysis of Primary Outcomes  
General Analysis Plan   
As described in our PCORI funded proposal, our primary analysis will compare the effectiveness of the 
QPL intervention relative to usual care on patient engagement for aim 1 and psychological wellbeing for 
aim 2. We will use an intention to treat (ITT) analysis using all available data from participants based on 
group assignment.  
 
The intervention effect will be tested in the framework of generalized linear mixed effects models42,43 
with a treatment dummy variable, surgeon random effect and site-by-time dummy variables to control 
site-specific secular trends.  
 
All models will be estimated and tested using SAS version 9.3 (SAS Institute, Cary, NC), specifically 
PROC MIXED and PROC NLMIX.   
 
We do not plan to impute missing data if the rate of missingness is low. Currently, our rate of missingness 
is quite low: 97% of patients and 92% of family members have completed T1. For T2, 88% of patients 
and 86% of family members have completed the survey and for T3 87% of both patients and family 
members have completed their survey. We plan to exclude variables for which there is no response (rather 
than impute these variables).  Although we have a small number of incomplete audio recordings, we will 
treat audio recordings where less than half of the encounter with the surgeon was captured (a total of 6 
recordings) as completely missing and those with more than half recorded as complete.  We will perform 
sensitivity analysis to test whether this small loss of data impacts our findings by comparing the outcomes 
with and without inclusion of audio recordings that are more than half complete. 
Aim-1 primary outcomes [Question Counting, PEPPI-5] 
Aim 1 has five primary outcomes and as such will be analyzed with a Type I error rate of α=0.01.   
 
For question counting, we consider four specific types of questions and evaluate them with ordinal 
categories: 
 
-Number of OPTIONS questions asked by patients and family members (0, 1, 2+) 
-Number of EXPECTATION questions asked by patients and family members (0, 1, 2+) 
-Number of ADVANCE DIRECTIVES questions asked by patients and family members (0, 1+) 
-Number of RISKS questions asked by patients and family members (0, 1, 2+) 
 

 
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We will denote each question type with [Q-type], where type is either Options, Expectation, Advance 
Directives, or Risks. [Q-Advance Directives] is a binary variable, the other three types are three-category 
ordinal variables. Accordingly, a logistic random effects model will be used to analyze [Q-Advance 
Directives], while ordinal logistic random effects models will be used for analyzing the other three types. 
We have not included logistic and technical concerns and “other” questions as primary outcomes because 
these are not the types of questions that indicate improvement in patient activation. Logistic and technical 
concerns are already very commonly asked by patients and rarely provide information that would assist 
patients in a decision to have surgery and “other” questions are largely irrelevant to surgery or surgical 
decision making.38,44 
 
PEPPI-5 will be analyzed as a continuous variable based on a summary score of the entire survey. We 
will use linear mixed effects models for continuous responses (PEPPI-5), and ordinal logistic random 
effect models for ordinal variables (question categories).  
Aim-2 primary outcomes [Regret, MYCaW] 
Aim 2 has two primary outcomes and as such will be analyzed with a Type I error rate of α=0.025.  
 
Regret will be coded as a binary variable (yes/no) and analyzed with a logistic random effects model. We 
will evaluate regret as a binary variable where patient-family dyads are coded as 0 if neither participant 
expressed any regrets and 1 if either expressed regret.  Responses will be coded as positive for regret if 
participant answered in the affirmative or if they responded “No” but then shared a regret. Responses that 
were characterized by dissatisfaction but not self-blame will be coded as “no regret.” Impossible, 
counterfactual responses, in which participants regretted or wished for something outside their control, 
will also be coded as “no regret.” 
 
MYCaW: The difference in the rating of the primary concern between T1 and T2, regardless of the 
categorization of this concern, as reported by the patient will be treated as a continuous outcome and 
analyzed with a linear mixed effect model. We will accommodate the longitudinal nature of the data with 
a patient level random effect.  Analyses will be based on a treatment difference relative to T1 at T2 in a 
random effects model with:  a treatment difference at T1, a time (0/1) variable indicating either T1 versus 
T2, an intervention-by-time interaction representing the treatment difference, and a random effect at the 
patient level. 
 
We will use linear mixed effects models for continuous responses (MYCaW), logistic random effects 
models for binary responses (regret). 
Further analysis of primary endpoints generated prior to un-blinding 
Updated analysis plan and modified power analysis   
Rationale: Prior to unblinding (looking at treatment group assignment) and after commencement of data 
coding in preparation for analysis, the research team became aware of 2 issues that prompted modification 

 
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of our per-protocol analysis plan.  First, reports from our DSMB demonstrate that PEPPI-5 for this cohort 
of patients and family members has remarkable ceiling effects (for 333 enrolled participants, mean score 
21.4, IQR 20-24, scale range: 0 - 25). Thus, even if we demonstrate a significant difference it would be 
clinically meaningless.  Second, the variability in self-reported concerns using the open-ended MYCaW 
instrument for patients and family members in this study is enormous.  For example, some patients note 
concerns about parking or how the surgeon communicated with them, whereas others note concerns about 
removing their cancer or how they will feel after surgery.  This makes it difficult to compare concerns 
between the entirety of the two groups and suggests a need for stratification of these outcomes in relation 
to the patient’s clinical course, specifically whether there was a decision to have surgery.  As surgical 
treatment is a post-randomization variable, such analysis is not appropriate for a primary outcome.  In 
response to these 2 concerns, we recalculated our power analysis without the PEPPI-5 endpoint in aim 1 
and without the MYCaW endpoint in aim 2 as these were no longer valid primary outcomes. 
 
Power calculations for Aims 1 and 2 were updated to harmonize with the final analysis plan and the 
realized recruitment, which had a slight reduction in patient-level sample size (from 240/240 
control/treatment to 222/221 control/treatment, given that the stepped-wedge study design wave rollover 
rules were not dependent on intervention assignment). The overall design is retained (relative to the 
submitted proposal) and the power numbers remain robust. Notably, surgeon-level sample size has not 
changed, and it is this sample size that is primarily driving the power. We have not modified the 
assumption that the between-surgeon variance accounts for 30% of the total variance. As noted 
previously, this is conservative considering preliminary data suggests this variance is as low as 5%.  
 
Under our modified plan, there are four endpoints in Aim 1, the four question types. In this case, tests will 
be conducted with nominal α=0.05/4 = 0.0125. Supported by our preliminary data, we assume a worst-
case scenario of 65% of control patients will be in the non-activation set (the zero category). We consider 
an odds-ratio of improved category (moving to a higher category of questions asked) in the treatment 
(relative to control) of 1.3. Under these settings, we have 85% power to detect a treatment difference in 
[Q-Advance Directives]. For each of the other three categories, we have over 93% power to detect a 
difference. Under our modified protocol, regret is the only endpoint in Aim 2. In this case, testing will be 
conducted with nominal α =.05. We assume the upper bound risk of regret is 0.3; we will have over 91% 
power to detect a regret risk difference of 0.23. 
 
This additional analysis of our primary endpoints is otherwise unchanged from our per-protocol plan. Our 
modified analysis will compare the effectiveness of the QPL intervention relative to usual care on patient 
engagement. We will use an intention to treat (ITT) analysis using all available data from participants 
based on group assignment. The intervention effect will be tested in the framework of generalized linear 
mixed effects models with a treatment dummy variable, surgeon random effect and site-by-time dummy 
variables to control site-specific secular trends.  Again, we will consider four specific types of questions 
and evaluate them with ordinal categories: 
 
-Number of OPTIONS questions asked by patients and family members (0, 1, 2+) 
-Number of EXPECTATION questions asked by patients and family members (0, 1, 2+) 
-Number of ADVANCE DIRECTIVES questions asked by patients and family members (0, 1+) 

 
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-Number of RISKS questions asked by patients and family members (0, 1, 2+) 
 
Denote each question type with [Q-type], where type is either Options, Expectation, Advance Directives, 
or Risks. [Q-Advance Directives] is a binary variable, the other three types are three-category ordinal 
variables. Accordingly, a logistic random effects model will be used to analyze [Q-Advance Directives], 
while ordinal logistic random effects models will be used for analyzing the other three types. 
 
For Aim 2, there is no change to the modeling approach for regret: we will use a logistic random effects 
model. We will use an intention to treat analysis using all available data from participants based on group 
assignment. We will use a logistic random effects model with a treatment dummy variable, surgeon 
random effect and site-by-time dummy variables to control site-specific secular trends. 
Additional considerations: Aim-1 question asking 
After performing the ITT analysis, we will restrict the analysis by removing the dyads (patient and family 
member) where major surgery was not discussed or the patient did not have a vascular or oncologic 
problem.  This is based on the T0 transcript of the conversation with the surgeon, which confirms whether 
the patient discussed surgery with the surgeon and had a vascular or oncologic problem. Specifically, we 
will use the subgroup analysis document, coded by the primary coder and confirmed in group consensus, 
to identify enrolled patients for whom surgical treatment was not discussed, or on evaluation after 
enrollment, the patient did not make entry criteria to be in the study, specifically, the patient did not have 
a diagnosis of cancer or vascular disease.  
 
Next, we will further restrict the analysis based on penetrance of the intervention.  We will identify 
patients in the intervention group with a clear signal that they received the QPL prior to the visit with the 
surgeon. This will be identified by one or more of the following criteria 1) clear presence or use of the 
QPL in the audio recorded conversation with the surgeon (noted in less than 20 transcripts), 2) coder 
identification of something that could be the QPL used during the conversation with the surgeon (coder 
marked this as unsure), 3) affirmative answer on the T1 survey from the patient or family member that 
they received something that might be the QPL from the surgeon prior to clinic visit (using a sensitivity 
analysis based on the certainty around receipt of the QPL within the response to this question), 4) a 
maybe answer on the T1 survey, 5) notes from the research coordinator that the patient was seen in clinic 
with a QPL.  
 
Additional analysis will adjust for age and comorbidity.  We will also evaluate a composite endpoint of 
all 4 question types where each of the 4 question types is categorized as binary and the composite score is 
ordinal (0, 1, 2, 3, 4) such that 4 signifies that a question of each type has been asked. 
Additional considerations: Aim-2 regret 
We will first consider regret as a binary outcome and then do additional analysis with regret considering 
this as a categorical variable with 0 = neither patient or family member has regret, 1 = either patient or 
family member has regret, 2 = both patient and family member have regret.  

 
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Stratified Analysis: Aim-2 MYCaW 
The goal of evaluating MYCaW is to test how much participant-reported concerns change over time for 
patients who did and did not receive the QPL. Our understanding of the MYCaW measure evolved since 
the start of the study based on the blinded coding of MYCaW data which revealed a much wider range of 
problems and concerns in response to MYCaW items than our previous and current review of the 
literature would suggest. Because not all patients in our study will plan to have surgery after meeting with 
a surgeon, there is heterogeneity in the description of concerns that is dependent on their treatment plan. 
Without changing our pre-specified analytic plan, we believe we will have findings that are extremely 
difficult to interpret. Furthermore, if an effect (positive or negative) of the intervention is identified, it 
would be challenging to assist surgeons and patients in using these results as many different types of 
concerns will be lumped together. These proposed changes are responsive to the data and the setting of 
this trial. 
 
As such, we will conduct a stratified analysis based on the post-randomization variable of a treatment 
plan to have surgical intervention as determined by the T0 conversation with the surgeon. To this end, our 
analysis will exclude patients whose treatment plan did not include surgery upon leaving the surgical 
consultation at T0, and whose treatment plan was unclear at the end of the T0 consultation (this 
corresponds to categories #2 and #3 below regarding the “treatment plan”).  
 
Within the cohort of patients whose treatment plan includes surgery, we will compare intervention to 
control patients who noted similar concerns.  We will first categorize participants (both patients and 
family members) by the primary (first) concern expressed and then compare the respondent-reported 
rating of that concern, assessing the mean score between treatment groups for each category.  We will 
next separate respondents by type: patient and family and repeat this analysis. We will also compare the 
change of the respondent’s (patient or family member in separate groups) rating of that concern between 
T1 and T2 using a respondent-level random effects model. We will similarly analyze the change between 
T1 and T3. 
Secondary outcomes: Aim-1: patient engagement [PEPPI-5, OPTION5, HCCQ] 
PEPPI-5 and HCCQ will be analyzed as continuous variables, based on the summary score of the entire 
survey (PEPPI-5 scale 0 – 25, HCCQ scale 1-7).  We will first analyze all respondents (patients and 
family members) together, and then separate respondents into patient and family outcomes.   
 
OPTION5 will be analyzed as a continuous variable with a scale that goes from 0 – 100 based on 
consensus coding of each T0 transcript. This is a surgeon/patient/family score that cannot be stratified by 
respondent. We will compare the average score between intervention and control for the entire cohort.  
Secondary outcomes: Aim-2: treatment received, well-being [PROMIS] 
Treatment received will be defined as patients who had at least one major operation during the study 
period (identified on completion of T3 chart review). 
 

 
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We will also analyze this outcome according to the following classification scheme to characterize the 
treatment plan after meeting with a surgeon:  
1. Plan for major surgery (includes plans where surgery is the treatment decision but additional 
tests are required) 
2. Plan to not have surgery (includes a decision that no surgery will be pursued or other clear 
treatment plan – e.g., chemo) 
3. Plan is unclear – returning to discuss later, needs more information 
PROMIS: These measures will be analyzed by respondent type (patient/family), and measures will be 
analyzed separately dependent on time of reporting (T2 and T3). 
 
Patient: Impact of illness – positive: continuous scale:  8-20 
 
Impact of illness – negative: continuous scale: 8-20 
 
 
Family member: SF Global Health Physical Score: continuous scale raw score: 4-20 
Family member: SF Global Health Mental Score: continuous scale raw score: 4-20 
Patient and family member: Anxiety 4a: continuous scale: 4-20 
 
We will then restrict the analysis to patients who plan to have major surgery, and family members’ 
outcomes for family members whose dyad patient has a treatment plan for surgery. We will then adjust 
the analysis for patients who had a major complication with surgical intervention.  
 
For all secondary outcomes after completing the ITT analysis, we will perform a restricted analysis as 
described in the additional considerations section above.  Specifically, we will restrict the analysis by 
removing the dyads (patient and family member) based on the T0 transcript of the conversation with the 
surgeon, which confirms whether the patient discussed surgery with the surgeon and had a vascular or 
oncologic problem. Next, we will further restrict the analysis based on penetrance of the intervention 
based on the criteria described above.   
Additional important outcomes 
Family member presence: We plan to compare the proportion of patients who are accompanied by a 
family member or “like family” friend to the visit with the surgeon between the intervention and control 
group as receipt of the QPL prior to a visit with a surgeon may prompt patients to bring a family member 
with them to the consultation visit for additional decision-making support.  This binary outcome variable 
(yes/no family member present) will be ascertained from the T0 transcript which clearly notes number of 
family members/friends.  Family members do not need to be enrolled in the study to be counted as 
present. We will use ITT analysis as well as a restricted analysis (as described above) to analyze this 
outcome. 
 
Consult duration: We will compare the median consult length at T0 between groups.  This is not an 
effectiveness outcome but rather information that clinicians and patients might want to know in 
considering use of the intervention in their clinic.  We will also compare the median consult length within 
surgeon (pre/post) to account for fairly wide variation in surgeon routine (some surgeons clearly spend 

 
Statistical Analysis Plan 
 
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45-60 minutes with patients whereas others spend 7-15 minutes with patients).  Given that surgeons will 
have been assigned randomly to intervention wave the incidence of pre/post measurements will not be 
evenly distributed and may be too variable to determine real differences.     
Exploratory analyses 
There are several factors that might impact the effect of the intervention that we have described in our 
protocol for exploratory heterogeneity of treatment effect (HTE) analysis.  These include insurance status 
(as a marker of socioeconomic status): we will use a binary variable defined by standard insurance 
(Medicare/private/supplemental) or (Medicaid, dual eligible, charity care, none).  We will also consider 
oncologic indications for surgery as distinct from vascular (as identified in the T0 transcript). We will 
also consider extent of comorbid illnesses, stratifying patients by Charlson score and categorizing high, 
medium and low comorbidity.  
 
We will perform additional analysis of OPTION 5 (shared decision making) scores, evaluating the 
variability in OPTION 5 scores before and after intervention, considering that these scores likely have 
more between surgeon variability than within surgeon variability. Specifically, we will estimate the 
correlation on the surgeon random effect pre- and post- intervention.   
 
Aim-3  
We will analyze qualitative data with directed content analysis45 using a deductive theory-driven analytic 
framework to evaluate interpersonal and intrapersonal conflict and to compare the similarities and 
differences between both arms of the study. To enrich the coding process and attend to professional 
biases, we will include investigators with diverse clinical backgrounds (nursing, palliative care, surgery 
and patient advocacy). To gain understanding of the trajectory of the patient’s story we will triangulate 
data sources by linking the audio tape of the initial surgeon-patient conversation and the patient’s clinical 
history from chart review, with the follow-up interview. We have previously shown that surgeons see 
preoperative conversations as a significant event, a time when a two-way agreement is made whereby the 
surgeon commits to operating and the patient commits to endure potentially burdensome postoperative 
care.27 We will use this understanding of surgical buy-in to code and analyze preoperative visit and 
postoperative interview transcripts with the goal of understanding how the contractual relationship that 
surgeons perceive is experienced by patients. We will explore how postoperative complications were 
discussed during the initial patient-surgeon interaction with and without the QPL and whether this 
interaction has impact on subsequent treatment decisions, interpersonal and intrapersonal conflict. 
 
Investigators will independently review the transcript of each interview linked with each initial patient-
surgeon conversation, generating codes to describe and classify events, processes, and concepts in the 
text. A team of at least three investigators will come together to jointly review each transcript in order to 
generate consensus and examine discord about all codes as part of the process of higher level analysis. 
The coding taxonomy will be revised in an iterative fashion throughout the analytic process. We will use 
context charts46 to evaluate differences and similarities between control and intervention groups. We will 

 
Statistical Analysis Plan 
 
Protocol Number: NCT02623335 
SAP Version Number: 1.0 
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use qualitative research software, NVivo 10 (QSR International), to organize and store codes, facilitate 
comparison of cases, and access data to support themes and patterns. Using data linkage with our 
quantitative outcomes, specifically patient engagement and psychological wellbeing, we will mix these 
methods to identify trends that inform our understanding of the interaction between conflict, engagement, 
wellbeing and regret.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Statistical Analysis Plan 
 
Protocol Number: NCT02623335 
SAP Version Number: 1.0 
Page 18 
SAP Version Date: 11/1/18 
 
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Statistical Analysis Plan 
 
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SAP Version Number: 1.0 
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22. 
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Schwarze ML, Bradley CT, Brasel KJ. Surgical "buy-in": the contractual relationship between 
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Nabozny MJ, Kruser JM, Pecanac KE, et al. Do Patients Buy-In to the Use of Postoperative Life 
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Smets EM, van Heijl M, van Wijngaarden AK, Henselmans I, van Berge Henegouwen MI. 
Addressing patients' information needs: a first evaluation of a question prompt sheet in the 
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Clayton JM, Butow PN, Tattersall MH, et al. Randomized controlled trial of a prompt list to help 
advanced cancer patients and their caregivers to ask questions about prognosis and end-of-life 
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37. 
Shepherd HL, Barratt A, Trevena LJ, et al. Three questions that patients can ask to improve the 
quality of information physicians give about treatment options: a cross-over trial. Patient Educ 
Couns. 2011;84(3):379-385. 
38. 
Steffens NM, Tucholka JL, Nabozny MJ, Schmick AE, Brasel KJ, Schwarze ML. Engaging 
Patients, Health Care Professionals, and Community Members to Improve Preoperative Decision 
Making for Older Adults Facing High-Risk Surgery. JAMA Surg. 2016; [Epub ahead of print]. 
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Taylor LJ, Rathouz PJ, Berlin A, et al. Navigating high-risk surgery: protocol for a multisite, 
stepped wedge, cluster-randomised trial of a question prompt list intervention to empower older 
adults to ask questions that inform treatment decisions. BMJ Open. 2017;7(5):e014002. 

 
Statistical Analysis Plan 
 
Protocol Number: NCT02623335 
SAP Version Number: 1.0 
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40. 
Elwyn G, Tsulukidze M, Edwards A, Legare F, Newcombe R. Using a 'talk' model of shared 
decision making to propose an observation-based measure: Observer OPTION 5 Item. Patient 
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44. 
Pecanac KE, Kehler JM, Brasel KJ, et al. It's big surgery: preoperative expressions of risk, 
responsibility, and commitment to treatment after high-risk operations. Ann Surg. 
2014;259(3):458-463. 
45. 
Hsieh H-F, Shannon SE. Three Approaches to Qualitative Content Analysis. Qual Health Res. 
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1994. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Statistical Analysis Plan 
 
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SAP Version Number: 1.0 
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Appendix  
 
Pre-defined coding scheme for number and type of questions 
OPTION 5 scoring sheet 
QPL development paper 
Published study protocol  
 
 

Version 6/5/18  
 
1 
 
PCORI Navigating Surgery Question Coding Manual 
 
 
General Guidance ......................................................................................................................................... 2 
Step 1: Figure out what to code as a question ............................................................................................ 2 
What DOES count as a question that should be coded for this study? ..................................................... 2 
What DOES NOT count as a question for this study? ............................................................................... 2 
What about multi-part questions where there are 2 or more questions included in the same section of 
text? How many questions does this count as? ........................................................................................ 3 
What if the speaker is interrupted while asking a question? .................................................................... 3 
What do I put in the “Wording of Question” field? ................................................................................... 3 
A note on interpretation, transcription and translation and what counts as a question ......................... 3 
Step 2: Who said it? Determine the speaker ............................................................................................... 5 
Step 3: Code the topic area .......................................................................................................................... 5 
OPTIONS ................................................................................................................................................... 6 
LOGISTICS AND TECHNICAL CONCERNS ................................................................................................... 8 
EXPECTATIONS .......................................................................................................................................... 9 
RISKS/COMPLICATIONS .......................................................................................................................... 10 
ADVANCE DIRECTIVES ............................................................................................................................ 10 
OTHER ..................................................................................................................................................... 11 
Step 4: Final check for questions ............................................................................................................... 11 
 
 
 
 

Version 6/5/18  
 
2 
 
General Guidance 
x 
Do not code more than 2-3 transcripts in a single sitting  
x 
Coding each transcript should take about 15-30 minutes 
x 
After you’ve finished coding a transcript, do a final check by using the find function in Word 
(Ctrl-F) to locate question marks (clicking through to view all instances), ensure that you’ve 
identified all questions, and labeled speakers correctly    
 
Step 1: Figure out what to code as a question  
 
What DOES count as a question that should be coded for this study? 
x 
We are only coding questions asked by patients or family members while surgeon is in the room  
o Typically, the transcripts end when the surgeon leaves the room but you may come 
across a transcript in which a surgeon temporarily leaves a room- this will be noted 
clearly in the transcript. In this case, do not code questions asked during the surgeon’s 
absence 
x 
It does not matter who the question is directed at, even if it is obvious the question is not 
directed at the surgeon 
x 
Questions must have a question mark at the end  
o Prior to categorizing each question, questions asked by patients or family members will 
be identified by a Microsoft Visual Basic program, which will generate a coding sheet 
containing all questions asked by patients and family members during the T0 surgeon 
visit.   
o After you have coded the entire transcript, use “Ctrl-F” to skip from question mark to 
question mark to double check that you haven’t missed any questions and have labeled 
speakers correctly  
x 
If a question is within quotation marks (for example, if a patient is quoting someone else’s 
question), that counts as a question and should be coded for topic area just like any other 
question 
o Example: “And then others go, ‘what are you crazy, you're going to get it fixed?... Why 
would you even think about getting it fixed?’”  
 
This counts as two questions 
x 
 1) “’What are you crazy, you’re going to get it fixed?”’  
x 
2) “’…Why would you even think about getting it fixed?’” 
 
What DOES NOT count as a question for this study? 
x 
Do not code questions asked by the surgeon or another member of the clinical care team 
x 
Do not code questions asked by patients or family members when the surgeon is not in the 
room 
x 
Do not code anything that appears question-like but lacks a question mark at the end. These 
utterances do not count. The following are NOT questions as they lack question marks: 
o  “Is there a possibility of me getting a recording from this, because...”  
o “So in my case, you have to remove it.”   
o “I don’t know what the plasma is.”   
x 
Question marks that appear inside square brackets [?] refer to transcriptionist questions (usually 
about content that is inaudible or medical jargon) and do not count.  
o For example, the following do not count as questions:  
 
[inaudible?]  

Version 6/5/18  
 
3 
 
 
[Lovastatin?]  
 
“He’s teaching me [lots? 2:49]”  
o However, question marks that appear outside a square bracket do count as questions. 
Example: “Do I have to go back to [REHAB NAME]?”  
 
What about multi-part questions where there are 2 or more questions included in the same 
section of text? How many questions does this count as?   
x 
The number of questions is based solely on the number of question marks 
o For example, this is 5 questions, each entered as its own row in the coding sheet: “But, I 
mean, does he make an appointment for this surgery in October?  I mean, how far out 
are you looking?  Is it really full?  I mean, do you ask for that now, the appointment?  Do 
you . . . cancel?”  
x 
Words like "So?" or “Right?” at the end of another question count as unique questions  
o This is two questions: “So the chances of it opening up again are low? Right?” 
o See Step 3 on how to code the topic area for tag-on words like this 
 
What if the speaker is interrupted while asking a question? 
x 
Again, refer to the question marks for guidance. If they’re briefly interrupted (a few words at 
most) before finishing the question you may need to combine the two question segments 
together as shown below:  
FAMILY:  “It's not laparoscopic . . .”  
DOCTOR:  “So . . .”  
FAMILY: “. . . option?”  
This would be coded as one question, which you would enter in your coding sheet as “It’s not 
laparoscopic…option?”  
x 
On the coding sheet enter all questions from the beginning of the question to the question 
mark, regardless of interruptions  
 
What do I put in the “Wording of Question” field? 
x 
Paste the entire question into this field. If there is a 1-2 word question after a more substantive 
statement, include the whole thing.  
o Example: “Oh, you mentioned that he may have some pain in the L2, L3 area. Both?” 
You would paste all of this, not just the “Both?” into the “wording of question” field 
x 
If more than one question is asked in a row, paste each unique question in its own field.  
o Example: “So the chances of it opening up again are low? Right? 
You would paste “So the chances of it opening up again are low?” in one row, and “Right?” 
in a second, separate row; they are two separate entries.  
 
A note on interpretation, transcription and translation and what counts as a question  
x 
In this manual, we distinguish between interpretation and translation  
o Interpretation is the real-time conversion between spoken Spanish and English. This may 
be provided by a professional interpreter who is present in the consultation room or via 
a telephone interpreter service. Family members may also provide interpretation  
o Translation is the delayed conversion between Spanish and English provided by a 
transcriptionist listening to the audio file of the consult  

Version 6/5/18  
 
4 
 
x 
In a subset of transcripts for this study, a professional interpreter or family member provides 
interpretation between the patient/family and surgeon 
x 
When coding this content, first consider the directionality of the question 
o DO NOT code/count any questions that are asked by the surgeon and then interpreted 
by an interpreter or the family back to the patient/family 
 
We are only interested in questions posed by patients or family members 
(either questions they ask the surgeon or ask each other) 
o DO NOT code/count any questions that are posed to the surgeon by an interpreter that 
were not originally asked by a patient or family member  
x 
For questions asked by patients/family members in Spanish, keep the following in mind:  
o Transcripts are fully translated at time of transcription so you may see content that 
presents as: 
1. Patient: Asks question in Spanish, shown as Spanish in transcript 
2. English translation of what patient just said, translated by transcriptionist  
3. Family member or interpreter: Interprets Spanish question  to English for 
surgeon 
4. Surgeon: Answers question in English or asks a question to patient in English  
5. Family member or interpreter: Interprets English surgeon answer or question to 
Spanish for patient  
o The only part of the above exchange that should be coded/counted as a question to be 
coded is #2. Copy the transcriptionist-provided English version of this question or 
questions into your codebook  
x 
It is important not to double-count these questions if the same question appears in both English 
and Spanish in the transcript 
o Do not code/count questions that appear in Spanish in the transcript. Do not count #1 
and #3 above as questions for this reason 
x 
It is possible that the interpreter or family member providing interpretation could misinterpret 
the patient/family question (for instance, condensing multiple questions into a shorter, simpler 
question). Since we are interested in patient/family member activation and want to count all 
questions they intended to ask we do not want to code the interpretation of their questions, 
only what they actually said, as translated by a bilingual transcriptionist. Transcriptionist-
provided translation will appear in brackets or bolded text after the original text, as shown 
below: 
o Patient: Cuánto dura la operación? Estaré en el hospital por mucho tiempo? [How long 
is the operation? Will I be in the hospital long?] 
o Interpreter: How long will I be in the hospital? 
In the example above, this would count as 2 patient questions because the patient asked 2 
questions, as translated by the transcriptionist. It is not counted as just one question 
because we are reliant upon the transcriptionist’s translation, not the interpreter’s. The 
same would be true if a family member had been present and translating during the consult 
and condensed this into one question 

Version 6/5/18  
 
5 
 
x 
If a professional interpreter is present do not code/count their questions   
x 
If a family member is providing interpretation 
o If the family member is literally relaying a surgeon’s questions to a patient, or even 
relaying but also adding their own content beyond what the surgeon asked, do not 
count this as a question 
o If the family member is relaying a patient or another family member’s question to the 
surgeon, do count this as question, as the question will separately be coded/counted as 
shown in #2 above 
o If a family member acting as an interpreter asks their own question to the surgeon, this 
is coded/counted as any other family member question would be  
Step 2: Who said it? Determine the speaker 
x 
Code all questions asked by patients or family members/loved ones while surgeon is in the room 
x 
Do not distinguish between family members – these are all coded as “family member”  
o In some cases, a support person such as a friend may be present. Code their questions 
as “family member” as well  
x 
If question speaker is unknown, count these as patient questions UNLESS transcriptionist makes 
a note it’s a medical provider (though they are unsure of which provider) AND the content of the 
question indicates that a clinician asked it 
x 
Do not code questions asked by the surgeon, resident(s), or other clinical staff 
x 
Exclude questions asked while the surgeon is not present  
 
Step 3: Code the topic area 
Look for content before and after the question to determine its topic area/context.  However, do not 
exclusively base your topic coding on how the surgeon answers the question – it is possible the surgeon 
may have misinterpreted the question or even ignored it. However, if the conversation seems to be 
consistently in one line of thought, the surgeon’s response may help clue you into what the topic area 
should be coded as. What the patient says immediately before/after the question may also be helpful if 
you are struggling to identify the topic area.  You may only code each question as having one topic area 
so carefully review the topic area codes to determine which best fits the question.  
 
There are 6 topic area codes: OPTIONS, EXPECTATIONS, LOGISTICS AND TECHNICAL CONCERNS, 
RISKS/COMPLICATIONS, ADVANCE DIRECTIVES, OTHER. These are each described in more detail below. 
But first, here is some guidance on how to handle very short questions. 
 
How should I code the topic area for very short questions? 
x 
Short questions that stand all alone without any text surrounding them on that line of the 
transcript are always coded as “OTHER” and count as a single question. Examples: 
o “Is that right?”   
o “Really?” 
o “Huh?”   
o “Oh did he?”   
o “You know what I’m saying?”  
o “Oh, yeah?”  
 

Version 6/5/18  
 
6 
 
x 
Similarly, short questions that are a reiteration of what was previously said or are purely 
rhetorical are coded as one question with “OTHER” as the topic area. Examples:  
o “Oh really, two thirds?”  
o “It does, doesn’t it?” 
o “Now what was I going to say?” 
o Surgeon: “I’ve trained since 1984, so. So if you, we all do about 200 to 250 operations, 
200 to 250 operations a year.” 
Patient: “Wow. Since ’84?”  
x 
If a patient or family member asks the same question twice or more with the exact same 
wording, code the first instance of the question based on its content and code the second/any 
later instances as “OTHER”. Example:  
o Patient: Rehab for 6 weeks? [this would be coded as “EXPECTATIONS”]  
o Surgeon: Yeah. 
o Family member: Rehab for 6 weeks? [this would be coded as “OTHER”] 
The question must be exactly the same for this rule to apply. If there are minor wording 
changes, code each question as you would normally. Example:  
o Patient: Rehab for 6 weeks? [this would be coded as “EXPECTATIONS”]  
o Surgeon: Yeah. 
o Family member:  ‘He’d be in rehab for 6 weeks?” [this would be coded as 
“EXPECTATIONS”] 
 
x 
Short questions that are attached or directly next to a statement (in the same line of text) that is 
substantive (not simply re-stating what has already been said) are coded based upon the topic 
of the statement that precedes the short question. The short question is considered attached to 
the longer statement to be coded as ONE question. When filling out the coding sheet, include 
both the statement and the short question. This applies to short questions that are next to a 
statement and separated either by a comma OR a period  
o “But it’s inside the aorta, right?” 
 
This question should be coded as “LOGISTICS AND TECHNICAL CONCERNS” 
o  “But it’s in the aorta. No?” 
 
This question should be coded as “LOGISTICS AND TECHNCAL CONCERNS” 
o “There’s no nano-technology on it yet. Right?” 
 
This question should be coded as “LOGISTICS AND TECHNICAL CONCERNS” 
o “So this seems like my only option, right?”  
 
This question should be coded as “OPTIONS” 
 
x 
Short questions that are attached or directly next to a substantive question count as two 
questions ALTHOUGH the topic code for each question may be different. Usually, the short 
question is coded as “OTHER” while the longer question is coded according to the topic 
o “So the chances of it opening up again are low? Right?”  
 
This is two questions; the first coded as “RISKS/COMPLICATIONS”, the second 
coded as “OTHER”  
 
OPTIONS 
“What can I do for this problem?” or “Are there other treatments apart from surgery?” are the main 
sentiments behind this topic area. This code should be used for questions that seek to understand what 

Version 6/5/18  
 
7 
 
the different treatment paths or choices are or to compare treatments. Look for words like: options, 
choices, alternatives 
 
x 
Use this code for any questions that reference seeking additional information on possible 
treatment options including 
o Surgery Choice #1 vs Surgery Choice #2 
o Observation vs Surgery  (Observation includes non-surgical alternatives like symptom 
management/medical treatment) 
o Different approaches to surgery:– open, laparoscopic, endoscopic (e.g. with catheters) 
(see Appendix A for examples of approaches) 
o Radiation vs chemotherapy  
x 
Use this code for questions that are asking for recommendations: What do you think? What 
would you recommend?  
o Some requests for recommendations may be subtle and may sound like the 
patient/family member is asking for reassurance regarding a particular treatment choice 
o For example: “So there’s really no point in putting it off, right?” or “So I’m not a 
gambling man, but that sounds like a reasonable investment, right?” 
x 
This includes questions about having more options if the patient does something (gains weight, 
stops smoking, tumor shrinks with chemo) or something happens to allow another option to be 
available: “If I ____, is this treatment possible?” 
x 
Do not code questions as being “OPTIONS” if they’re about options for other things within the 
major treatment (such as whether to get a blood transfusion during surgery, what type of 
equipment the surgeon will use, or where an incision is made). These would instead be coded 
under "Logistics and Technical Concerns" 
x 
“OPTIONS” VS “LOGISTICS” – is it about an option or a technique within an option?  
o What vs. how is a good way to distinguish between these two topic areas. Questions 
asking what are the options are coded as “OPTIONS” whereas questions on how to do it 
are coded as “LOGISTICS” 
o If the question is about a treatment approach code it as “OPTIONS”. Words that indicate 
a treatment approach is being discussed include:  open, minimally invasive, 
laparoscopic, endoscopic, robotic, endovascular or catheter based approach (includes 
TAVR/TAVI, EVAR or TEVAR), single incision/single port, or any option that involves 
interventional radiology instead of surgery  
o However, if a question is about a technique within an option, code it as “LOGISTICS”. 
Techniques include: staples versus stitches/hand sewn, type of stent or catheter, type of 
graft, and reference to specific equipment/techniques – e.g. lasers, ablation, 
coagulation devices, ultrasound, ligasure, staplers, fluoro, dilators, scopes, cameras, 
specific needles or types of sutures  
x 
 “OPTIONS” VS. “EXPECTATIONS” OR “RISKS” 
o If a question is comparing outcomes/risks/expectations between two or more 
treatment options, code it as “OPTIONS”. Look for words that indicate the speaker is 
thinking about the relative value of things (better/worse than)  
 
Example: “It’ll give it a better chance?” 
o However, if the question is asking about risks of a procedure, what life will be like within 
a given treatment, or after a treatment decision has been made, code this as “RISKS” or 
“EXPECTATIONS”.  A question is NOT coded as “OPTIONS” unless it seeks to compare 
two or more options. 

Version 6/5/18  
 
8 
 
o Example: “So I would end up with paralysis if I didn't have the surgery?” [This is coded as 
OPTIONS because it’s focused on comparing outcomes between surgery and no surgery] 
Example: “How likely is it that I will be paralyzed after surgery? [This is coded as “RISKS” 
because it is focused on the risks of surgery only] 
x 
“OPTIONS” examples: 
o  "What is the difference between the aftereffects of radiation versus chemo as far 
as…the feeling?” 
o  “Is there another way?” 
 
o “So what alternative do you think would be good?” 
o “If I was your dad, what would your advice be?” 
o “So if I, if I put weight on, and I gain some more weight, that would make a difference?” 
[asking if they could get a specific surgery if they put weight on] 
o “So this seems like my only option, right?” 
 
 
LOGISTICS AND TECHNICAL CONCERNS 
Questions about how things will work up to and through surgery. Once they hit the post-operative stage, 
those questions go under “EXPECTATIONS”. Use the time period in the question as your guide on when to 
use this code.  
 
This code includes a broad range of questions about technical or logistical aspects of surgery/treatment 
but also the health condition itself: Why do I have this? What’s going on here? 
 
x 
Includes any questions that reference surgical instruments, length of surgery, medications, 
surgeon expertise, surgeon practice patterns, surgical technique or procedure (see Appendix A 
for examples of techniques) surgery names and technique names, locations on surgery day, pre-
op instructions, timing issues 
x 
Includes specific questions about anatomy and physiology*, surgery, medications, blood 
products, surgeon expertise, institutional quality/expertise** practice patterns (who actually 
does the surgery, how many times per year this surgeon does it, etc.)  
o * These changes may include things such as cell or organ level functions/changes.  
Questions about physiological or anatomical changes up to and during the treatment 
are coded as logistics. Questions about these changes occurring following treatment are 
coded as expectations.  
o **Sometimes people ask about other institutions (like Mayo Clinic) but their question is 
not really about going there or the logistics of having treatment at another institution. 
What they’re really asking about it is whether the procedure they do there could be 
done here. In this case, the question should be coded as “OPTIONS”.  Read questions 
asking about other institutions carefully as they could fall under logistics or options. 
x 
Includes questions on location of providers and services only if they relate to the health 
condition and treatment being discussed  
o Example: “Is it here in this building?” would be coded as “LOGISTICS” if it’s a question of 
where the patient’s loved ones would wait for them during surgery.  
o If it was a question about where another doctor practices who is not involved in their 
care for the health condition being discussed with the surgeon, this would be coded as 
“OTHER”.  

Version 6/5/18  
 
9 
 
 
For example, if a patient and surgeon are discussing the town the patient lives in 
and the patient says, “Oh do you know, Dr. X? He’s my neighbor! Do you know 
where he works?” without any reference to Dr. X being involved in their care, 
this would be coded as “OTHER”. 
x 
Includes questions about other doctors or medical personnel but only when they are related to 
the health condition prompting the surgical consult (questions such as “Should I let my PCP 
know I’m scheduled for surgery?” should be coded as “LOGISTICS” but questions about other 
doctors unrelated to the condition being discussed are coded as “OTHER”- an example of this 
would be “Do you know Dr. X?” where there is no connection between Dr. X and their condition 
described)  
 
x 
 “LOGISTICS AND TECHNICAL CONCERNS” examples: 
o “How long does the surgery take?” or “Any idea of timing?” [When will surgery be?] 
o “How will blood drain from…after you take the vein out?”  
o “Is this something like, this is not uncommon for you people?”  
o “So how many bypasses are there?” 
o “Yeah, how long do you think this has…?” [referring to discussion of blockages building 
up] 
o “Do you work with him a lot?” [Though note that this is coded as “LOGISTICS” only if it’s 
asking about a doctor involved in the treatment of their condition being discussed with 
the surgeon. If this was about a doctor unrelated to the health condition being 
discussed, this would be coded as “OTHER”] 
o “But that other way is easier to get to? [This is coded as “LOGISTICS” as opposed to is 
there another option]”  
o “Which valve?”  
o “What does TAVI stand for?”  
 
EXPECTATIONS 
Questions about what will happen AFTER surgery, including in the immediate, post-operative period right 
after surgery. Use the time period in the question as your guide on when to use this code- it must relate 
to something after surgery. “If we do this, what’s gonna happen after surgery?” is the main point of this 
topic area.  
 
This topic area includes questions that seek to understand how the patient’s life will change or remain 
the same following a specific treatment option, particularly in terms of quality of life and patient 
reported outcomes. Look for words like: feeling, after-effect.  
 
x 
Includes patient reported outcomes such as quality of life, recurrence, changes in energy levels, 
mobility, continence, scarring, wound-care, bags/drains/tubes after surgery, rehab details, 
recovery time, limitations in function or other capacity, durability of procedure (for example 
how long will my new heart valve last?), length of hospital stay after surgery,  
x 
Note: questions about the length of the surgery or procedure are coded under logistic/technical 
concerns, NOT expectations because this question relates to the procedure itself, not what 
happens after 
x 
Note: questions about physiological or anatomical changes following a treatment are coded 
under EXPECTATIONS. These changes may include things such as cell or organ level 
functions/changes 

Version 6/5/18  
 
10 
 
 
x 
“EXPECTATIONS” examples: 
o “Like, you know, how long will be the recovery?” 
o “Like my nose going to be running all the time or?” 
o “Right, but would there be any additional pain?” 
o “It like, I mean, do you have a timeline historically when it would start to . . . regenerate 
again or grow again?”  
o “These are maybe questions for later, but since they're on my mind now, when can he 
take aspirin again?” 
o “After the two weeks [post-op] or even during those two weeks, can he go visit him or 
not?” 
o “So how long would he need somebody with him kind of 24 hours after he gets home?” 
 
 
RISKS/COMPLICATIONS 
This topic area includes questions that seek to understand what could go wrong during or following the 
treatments options that are being discussed (operating, not operating, chemo, radiation, etc.) 
Technical discussion of near-term, surgeon-defined complications (e.g. 30 days). Look for words like: 
risks, complications, chances, odds. Note that this includes the risks of not operating as well as risks 
associated with surgery or other treatment options.  
 
x 
Include any questions that reference short-term, surgeon defined effects from treatment 
including extended hospital stay, extended recovery time, blood clotting, bleeding, etc.  
x 
“RISKS” VS “EXPECTATIONS” code: Code any questions that reference long-term 
effects/outcomes including recurrence, durability of procedure as “EXPECTATIONS”, not “RISKS” 
o Be careful about the context:  is the patient specifically asking about how it's going to 
get done or about bad outcomes? (How it's going to get done would go under 
"LOGISTICS AND TECHNICAL CONCERNS"—even if it's serious or dangerous. Whereas 
questions on bad outcomes are coded as “RISKS”) 
o If the question is comparing risks of two or more treatment options, code this as 
“OPTIONS” 
 
x 
“RISKS/COMPLICATIONS” examples:  
o “How many people have to be on a ventilator after?”  
o “As far as the location of the tumor that remains in those veins and stuff, is everything, 
is anything at risk as far as, I don't know, blood flow function of any of those parts?” 
 
ADVANCE DIRECTIVES 
This topic area includes questions that seek information on options or preparation in the case that the 
patient cannot speak for him/herself.  It also includes any questions that are part of a discussion of 
advanced care planning. This includes questions that express a preference about kinds of health states 
you might talk about in an advance directive: life sustaining medical treatment, feeding tubes, serious 
stroke, lack of independence. Look for words like: DNR, Power of Attorney (POA), living will, advance 
directives. 
 

Version 6/5/18  
 
11 
 
x 
If they are expressing preferences about what should be done if a bad outcome occurs, code this 
as “ADVANCE DIRECTIVES”. If they are merely discussing the risk/complications related to a 
surgery (likelihood of them happening), code it as “RISKS/COMPLICATIONS”.  
 
x 
“ADVANCE DIRECTIVES” examples:  
o Doctor: “Yeah. Well if something goes terribly wrong, you’re, and you’re not able to 
even communicate with us, I’m assuming your wife would answer for you, and not, not, 
she would express to us what your wishes would be. I mean, normally I wouldn’t keep 
people going, sort of, inappropriately on life support. I think that’s a cruel thing to do.” 
Family Member: “Then, you know, why continue?” 
o “What if I can’t talk after surgery, how can I make sure someone knows what I want to 
be done?” 
o “How do I set it up so my wife can make decisions for me if something goes wrong?”  
 
 
OTHER  
This topic area includes the following types of content:  
x 
Sometimes very short questions like “Right?” are coded as “OTHER”. See guidance at the 
beginning of this section on how to code the topic area for very short questions  
x 
Questions that refer to something about the patient’s health that do not fit in any of the other 
categories (e.g. Genetic testing, complications of past procedures, family history and health of 
others) 
x 
Includes questions about other doctors or medical personnel unrelated to the treatment of the 
health condition prompting the surgical consult  
x 
Includes questions on location of providers and services if they are NOT related to the health 
condition and treatment being discussed  
x 
Non-health questions:  
o “Do you mind if I write too?”   
o “How many grandkids do you have?”   
o “Are you writing with a fountain pen?”  
o “Wow, you typed all of these files?”  
o “Are you in favor of this being recorded?”  
o “You need some water?”  
 
Use caution in applying this code – do not use it as a catchall when you’re unsure of the topic area code.   
 
Step 4: Final check for questions 
Once you have read through the transcript and coded each question, go through and review to ensure 
that you didn’t miss any questions. This is a critical step as it is all too easy to miss a question.  
Starting from the beginning, hit “Ctrl+F” to find all of the “?” marks in the transcript. Compare the 
questions highlighted in the transcript to the questions you have indicated on your coding sheet. Make 
sure you only included questions from the patient and/or family member(s), and that you have labeled 
the speakers correctly. 
 
 
 
 

Version 6/5/18  
 
12 
 
Appendix A: Approaches vs. techniques 
 
Use the following list of approaches vs. techniques to distinguish between OPTIONS and LOGISTICS AND 
TECHNICAL CONCERNS 
 
Approaches: (Typically coded as OPTIONS) 
x 
Open 
x 
Minimally invasive 
x 
Laparoscopic  
x 
Endoscopic 
x 
Robotic 
x 
Endovascular or catheter based approach (includes TAVR/TAVI, EVAR or TEVAR) 
x 
Single incision/single port 
x 
Any option that involves interventional radiology instead of surgery  
Techniques within a given approach: (Typically coded as LOGISTICS AND TECHNICAL CONCERNS) 
x 
Staples versus stitches/hand sewn 
x 
Type of stent or catheter 
x 
Type of graft 
x 
Reference to specific equipment/techniques – e.g. lasers, ablation, coagulation devices, 
ultrasound, ligasure, staplers, fluoro, dilators, scopes, cameras, specific needles or types of 
sutures  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Version 6/5/18  
 
13 
 
Appendix B: Code comparisons (taken from main text of coding manual) 
 
 
“OPTIONS” vs. “LOGISTICS AND TECHNICAL CONCERNS” 
x 
OPTIONS includes approaches to surgery (“what”) 
o Look for things like: open, minimally invasive, laparoscopic, endoscopic, robotic, 
endovascular or catheter based approach (includes TAVR/TAVI, EVAR or TEVAR), single 
incision/single port, any option that involves interventional radiology instead of surgery  
x 
LOGISTICS AND TECHNICAL CONCERNS includes techniques within an approach (“how”) 
o Look for things like: staples versus stitches/hand sewn, type of stent or catheter, type of 
graft, reference to specific equipment/techniques – e.g. lasers, ablation, coagulation 
devices, ultrasound, ligasure, staplers, fluoro, dilators, scopes, cameras, specific needles 
or types of sutures  
“OPTIONS” vs. “RISKS/COMPLICATIONS” or “EXPECTATIONS” 
x 
OPTIONS includes comparison of outcomes/expectations/risks 
o Look for words like better/worse than 
o Examples   
 
“It’ll give a better chance?”  
 
“So I would end up with paralysis if I didn’t have the surgery?” 
x 
RISKS or EXPECTATIONS include questions about the risks of an option or what life will look like 
with a certain option, without comparison to the alternative 
o Example 
 
“How likely is it that I will be paralyzed after surgery?” 
“LOGISTICS AND TECHNICAL CONCERNS” vs. “EXPECTATIONS” 
x 
LOGISTICS AND TECHNICAL CONCERNS includes questions about how things will work up to and 
through surgery 
x 
EXPECTATIONS includes questions about the immediate post-operative stage onward 
“RISKS/COMPLICATIONS” vs. “EXPECTATIONS” 
x 
RISKS/COMPLICATIONS includes short-term, surgeon-defined effects from treatment 
x 
EXPECTATIONS includes any questions that reference long-term effects/outcomes including 
recurrence and durability of procedure 
“RISKS/COMPLICATIONS” vs. “LOGISTICS AND TECHNICAL CONCERNS” 
x 
RISKS/COMPLICATIONS includes questions on bad outcomes 
x 
LOGISTICS AND TECHNICAL CONCERNS includes how it’s going to get done – even if it’s serious 
or dangerous 
 
 

PCORI – OPTION 5 Scoring Sheet 
 
 
TRANSCRIPT ID    
RATER  
  
 
 
If a resident or another clinician is present while the enrolled study surgeon is in the room, incorporate the other clinicians’ 
comments into your scoring. The goal is to code a conversation about a decision and this conversation includes many things.  
 
 
 
 
Item 1. For the health issue being discussed, the clinician (1) draws attention to or re-affirms that alternate treatment or management 
options exist or that the (2) need for a decision exists. If the patient rather than the clinicians draws attention to the availability of 
options, the clinician responds by agreeing that the options need deliberation. 
Score 
Description 
Notes 
0 
No alternatives mentioned, no mention of need for 
decision at all OR doesn’t respond to patient question 
about alternatives (If they do any of the 3 things they get 
higher than 0 score) (MD states need to deliberate about 
alts. mentioned by patient to get higher than 0 score)  
  
 
1 
Get credit for doing minimal effort of any: call attention to 
a decision, presents alternatives or responds to patient’s 
question about alts. 
 
2 
Must both say there is a decision AND there are options 
(more than one treatment is mentioned (can include 
palliative care or “do nothing”) 
 
3 
MD says we need to make a decision AND alternatives 
have been described as valid/not ridiculous (do nothing, or 
you die), does not make the point that this is preference 
sensitive 
 
4 
MD says we need to make a decision AND that it’s 
preference sensitive, AND alternatives have been well 
described as valid/not ridiculous (do nothing, or you die) 
 
 
 
Item 1 Score =  
Item 2. The clinician reassures the patient, or re-affirms, that the clinician will support the patient to become informed and to 
deliberate about the options. If the patient states that they have sought or obtained information prior to the encounter, the clinician 
supports such a deliberation process. 
Score 
Description 
Notes 
0 
No mention of patient partnership, helping match 
preferences with treatment options 
 
1 
MD conveys empathy or any acknowledgement of 
patient/family emotions/fears but does not make a point of 
how MD will provide support. Examples: “I know this is a 
difficult decision.” “Many families of patients in the ICU tell 
me this can be an overwhelming experience.” 
 
2 
ANY: Mentions partnership, working together, matching 
surgeon expertise with patient values/goals 
 
3 
MD provides clear indication of support, but not specific to 
decision-making. Example: “Our team cares about you and 
will do whatever we can to help you get through this.”  
 
4 
MD 
provides 
explicit 
support 
of 
patient/family 
in 
deliberation. Examples: “My role is to provide you with 
information and to guide you” “the decision that you and I 
make together” 
 
 
 
Item 2 Score =  

PCORI – OPTION 5 Scoring Sheet 
 
 
TREATMENT OPTIONS 
PROS 
CONS 
Option 1 
 
  
Option 2 
 
 
Option 3 
 
 
***Add all treatment options discussed in table (including name of surgery) – even if the pros and cons are not discussed*** 
 
 
Treatment plan 
at end of consult: 
  
 
 
 
 
Item 3. The clinician gives information, or checks understanding, about the pros and cons of the options that are considered 
reasonable (including taking ‘no action’), to support the patient in comparing the alternatives. If the patient requests clarification, 
explores options, or compares options, the clinician supports the process. (we are not going to worry about check for understanding 
here) 
Score 
Description 
Notes 
0 
No pros and cons of any treatment described 
 
1 
Pros OR cons of one option (no second option) 
 
2 
Pros AND cons of one option (no second option) OR says two 
options but only gives the pros OR cons of one of the options 
 
3 
Pros OR cons of both (all) options 
 
4 
Pros AND cons of both (all) options. Must state ALL to get a 4. 
 
 
 
Item 3 Score =  

PCORI – OPTION 5 Scoring Sheet 
 
 
 
 
 
 
 
 
 
 
 
 
Item 4. The clinician makes an effort to elicit the patient's preferences in response to the options that have been described. If the 
patient declares their preference(s), the clinician is receptive / supportive. 
Score 
Description 
Notes 
0 
No phrases for deliberation, doesn’t ask if patient has 
questions 
 
1 
Asks if patient has “any questions” (cursory effort) 
 
2 
Asks a more sophisticated question about whether the 
patient has questions/input “does this make sense to you?” 
 
3 
Non-specific question for deliberation in unclear context  
 
4 
Uses a clear question for deliberation – (how are you thinking 
about this, what is important to you now, how does this 
outcome seem to you?)  
 
 
 
Item 4 Score =  
Item 5. The clinician makes an effort to integrate the patient’s preferences as decisions are made. If the patient indicates how best to 
integrate their preferences as decisions are made, the clinician is supportive. (this is about the recommendation/need to make a 
recommendation at some point, i.e. come back and reconsider,  – do they make one and is it related to the patient’s preferences, 
“this is what we are going to do AND this is why”) 
Score 
Description 
Notes 
0 
Makes a decision without patient input OR doesn’t make a 
decision AND doesn’t note that the decision will be deferred 
 
1 
“It’s up to you, you decide” OR gets deferred based on 
another test (clinical momentum) 
 
2 
Decision gets deferred but recognition of patient preferences 
incorporated somehow 
 
3 
Surgeon makes a plan, some suggestion that this would be 
aligned with pts values 
 
 
4 
Surgeon makes a recommendation and says that it is 
concordant with what is important/valuable to the patient 
(uses what the patient has said to promote this as the right 
decision; says that this is the right decision based on a specific 
value the patient has) 
 
 
 
Item 5 Score =  
TOTAL OPTION SCORE 
Item 
1 
2 
3 
4 
5 
Total 
Score 
 
 
 
 
 
 

Copyright 2016 American Medical Association. All rights reserved.
Engaging Patients, Health Care Professionals,
and Community Members to Improve Preoperative
Decision Making for Older Adults Facing High-Risk Surgery
Nicole M. Steffens, MPH; Jennifer L. Tucholka, BS; Michael J. Nabozny, MD; Andrea E. Schmick, BA;
Karen J. Brasel, MD, MPH; Margaret L. Schwarze, MD, MPP
IMPORTANCE Older patients are at greater risk for postoperative complications, yet they are
less likely than younger patients to ask questions about surgery.
OBJECTIVE To design an intervention to improve preoperative decision making and manage
postoperative expectations.
DESIGN, SETTING, AND PARTICIPANTS A Patient and Family Advisory Council (PFAC) was
created to help identify preoperative decisional needs. The PFAC included 4 men and women
who had previous experience with high-risk surgery as older patients or their family
members; the PFAC met monthly at a local library from May 2014 to April 2015 to examine
findings from a prior qualitative study and to integrate themes with PFAC members’
experiences. Patient observations included 91 recorded conversations between patients and
surgeons and 61 patient interviews before and after surgery. The PFAC members and other
stakeholders evaluated 118 publicly available questions and selected 12 corresponding to
identified needs to generate a question prompt list (QPL). Three focus groups, including 31
community members from diverse backgrounds, were conducted at community centers in
Madison and Milwaukee, Wisconsin, to refine the QPL. A clinical pilot with 42 patients
considering surgery was conducted in one outpatient surgical clinic in Madison.
MAIN OUTCOMES AND MEASURES Generation of a QPL to address patients’ preoperative
informational and decisional needs.
RESULTS Through exploration of qualitative data, the PFAC noted 3 critical problems. Patients
and family members believed surgery had to be done, were surprised that postoperative
recovery was difficult, and lacked knowledge about the perioperative use of advance
directives. The PFAC identified a need for more information and decisional support during
preoperative conversations that included clarification of treatment options, setting
postoperative expectations, and advance care planning. The following 3 question prompt
categories arose: “Should I have surgery?” “What should I expect if everything goes well?” and
“What happens if things go wrong?” The final list included 11 questions within these domains,
was understandable in English and Spanish, and was acceptable to patients in the clinic.
CONCLUSIONS AND RELEVANCE Through direct engagement of stakeholders, a QPL was
created to address core decisional and informational needs of surgical patients. Future testing
will evaluate whether this list can be used to improve patient engagement and reduce
postoperative regret and conflict about postoperative treatments.
JAMA Surg. 2016;151(10):938-945. doi:10.1001/jamasurg.2016.1308
Published online June 29, 2016.
Invited Commentary
page 945
Author Affiliations: Department of
Surgery, University of Wisconsin,
Madison (Steffens, Tucholka,
Nabozny, Schwarze); Denver Public
Health, Denver Health and Hospital
Authority, Denver, Colorado
(Steffens); Department of Family
Medicine and Community Health,
University of Wisconsin, Madison
(Schmick); Department of Pediatrics,
University of Wisconsin, Madison
(Schmick); Department of Surgery,
Oregon Health and Science
University, Portland (Brasel);
Department of Medical History and
Bioethics, University of Wisconsin,
Madison (Schwarze).
Corresponding Author: Margaret L.
Schwarze, MD, MPP, Department of
Surgery, University of Wisconsin,
600 Highland Ave, G5/315 CSC,
Madison, WI 53792
(schwarze@surgery.wisc.edu).
Research
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E
ach year, approximately 500 000 Americans 65 years
or older will have a high-risk operation, such as heart
bypass or major cancer surgery.1-3 Although many pa-
tients benefit from high-risk surgery, it carries a real potential
for mortality and serious complications, particularly for older
patients with multiple comorbidities. High-risk surgery can
have other unintended consequences, including postopera-
tive suffering, conflict about additional aggressive treat-
ments, and receipt of unwanted interventions.4,5 Thus, much
is at stake for patients in the decision to proceed.
Surgeons play an important role helping patients make
preference-sensitive decisions. However, surgeons often miss
opportunitiesforthesediscussions.6-11Patientsreportthat“ex-
planations are rushed, issues are not explained, [and] choices
are not understood.”12(p6-6) Although patients generally pre-
fer involvement in the decision-making process, they fre-
quently do not know how to engage.13,14 Patients who are ac-
tivated receive more patient-focused care and are more likely
to take part in collaborative decision making.15,16 This activa-
tion is especially critical for older patients, who are less likely
to ask questions and less effective in ensuring that physicians
attend to their concerns than younger patients.17
In other settings, question prompt lists (QPLs) can effec-
tively improve patient engagement.18-22 Standardized lists of
questions to ask the physician are available, but patients who
have experience with surgery rarely participate in their devel-
opment. To improve patient engagement in surgical decision
making, we need to bridge the gap between patients’ need to
make the consequences of surgery relevant to their lives and
the surgeon’s goal of setting realistic expectations. Our objec-
tive was to design an intervention to improve preoperative de-
cision making. By formalizing a partnership among patients,
family members, and researchers, our Patient and Family Ad-
visoryCouncil(PFAC)developedaQPLtohelpolderadultswith
high-stakes surgical decisions.
Methods
Development of a PFAC
Our PFAC served as consultants to provide feedback and re-
flection on our research, specifically to clarify concepts from
previously generated qualitative data and to integrate the
PFAC’s life experiences with identified priorities. We enlisted
PFAC members through clinic nurses, surgeons, and hospital
patient relations departments. We invited patients and fam-
ily members of older patients who had experience with high-
risk surgery and purposely selected a small group with strong
literacyskillswhocouldcriticallyinterpretabstracteddata.Two
members previously had major surgery (cardiac and neuro-
logic) and 2 members were primary caregivers for patients who
had surgery (vascular and oncologic). This group of 2 men and
2 women met monthly at a public library and received $1000
for attendance at twelve 90-minute meetings (May 2014 to
April 2015), independent review of materials, and travel.
Collection of qualitative data was approved by the insti-
tutional review boards of the University of Wisconsin and Part-
ners Health Care System and the research ethics board of the
UniversityofToronto.TheinstitutionalreviewboardoftheUni-
versity of Wisconsin exempted the QPL clinical pilot from re-
view. We did not pursue the boards’ approval for the work de-
scribed by the PFAC or community groups because they did
not have access to protected health information and are con-
sidered research advisors. All PFAC members were apprised
of the extent of this project in advance and their compensa-
tion and participated voluntarily.
Origins of Qualitative Data
Before conception of our PFAC, we conducted an observa-
tional qualitative study during a 3-year period that included
91 audio-recorded preoperative conversations between pa-
tients and 11 surgeons described in-depth elsewhere.10,11,23 We
also interviewed patients before (n = 34) and after (n = 27) sur-
gery. We used an inductive coding strategy and deliberative
adjudication process among researchers to support higher-
level analysis whereby codes were expanded and refined to
capture phenomena present in the data.
PFAC Process
Meeting agendas included an opening question, a statement
of the meeting objectives, and a wrap-up forecasting the next
steps (Table 1). Our first meetings established project goals, a
timeline, and expectations. Members also shared their expe-
riencewithsurgery.Next,wepresentedthemesfromourquali-
tative analysis and linked each theme with a deidentified pa-
tient story. Members discussed their reactions and connected
study data with their personal experience with high-risk sur-
gery. This member-checking process24 enriched data integra-
tion with the lived experience of members of our PFAC
(Figure 1).
QPL Development
Discussions from the first 3 PFAC meetings generated key in-
formational and decisional deficits to guide development of
theQPL.Wethencollected271questions“toaskadoctor”from
publicly available websites25-28 and published literature.21,29-31
We excluded duplicate questions and concerns irrelevant to
our targets (eg, “Is there anything specific I need to bring to
the hospital?”). We asked PFAC members, 2 surgeons who rou-
tinely perform high-risk operations on older patients, a pa-
Key Points
Question Can researchers engage with surgical patients and
family members to develop an intervention to address
preoperative decisional and informational needs?
Findings The experiences of patients and family members were
integrated through observational study and direct engagement to
create a question prompt list for older adults considering high-risk
surgery. Three decision-making needs were addressed, including
clarification of treatment options, setting postoperative
expectations, and advance care planning.
Meaning This intervention was designed to overcome gaps in
current practice by activating patients to promote deliberation and
to prepare them for expected and unexpected outcomes.
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tient advocate, and a hospital administrator to score the re-
maining 118 questions on a 5-point Likert scale.
We brought the 20 highest-rated questions to the PFAC.
Members deliberated about the meaning of each question,
whether they could ask each question, and whether the sur-
geon’s answer would be valuable. Using these criteria, they
generated a 12-question prototype QPL.
Community Focus Groups
We presented the prototype QPL to focus groups and itera-
tively revised it in response to feedback. We engaged a well-
established panel of 6 participants specifically trained to pro-
vide feedback to researchers and hailing from difficult-to-
reachpopulationsrecruitedfromserviceprogramssuchasfood
pantries and parenting groups.32 A facilitator presented each
question and asked:
• “Does this question make sense?”
• “Would you feel comfortable asking this question?” and
• “If you ask this question, what information are you hoping
to get?”
We brought the revised prototype to a second group of 6 par-
ticipants and a Spanish version to 19 Spanish-speaking older
adults who reflected on the appearance and comprehensibil-
ity of the QPL and whether they could ask a surgeon the ques-
tions. Because QPLs are effective only when physicians en-
dorse their use,20 we used this same iterative process with our
stakeholders—thePFAC,2surgeons,andcommunitygroups—to
generate a letter from the surgeon to accompany the QPL.
QPL Pilot
ToevaluatetheacceptabilityofourQPL,wetestedprevisitmail
delivery of the QPL and surgeon letter at a local vascular sur-
gery clinic. We then informally interviewed patients who had
received the QPL about its use and ascertained their level of
comfort asking the questions. We also solicited feedback from
surgeons.
Results
Members of the PFAC identified informational and decision
support failures in the qualitative data, including misunder-
standings about treatment options and postoperative expec-
tations. They then integrated this information with their lived
experience to generate a QPL to address these deficiencies. Af-
terexaminingthequalitativedata,PFACmembersbelievedthat
patients and family members were unprepared for surgery.
They were concerned that patients believed surgery had to be
done, were surprised that postoperative recovery was diffi-
cult, and lacked knowledge about the use of advance direc-
tives (Table 2).
Choices
The PFAC members examined qualitative data that exposed a
lack of choice about whether to have surgery. Patients in the
qualitative study reported their surgeon had not presented al-
ternatives or that the alternatives presented were unaccept-
Figure 1. Process and Activities for Engaging Patients, Family Members, and Community Members
in Creating a Question Prompt List (QPL)
Assembled PFAC
Integrated preliminary
qualitative data to
identify needs of 
older patients
Evaluation 
of questions 
from publicly 
available lists
QPL prototype
Focus groups
with community
members
Clinical pilot
May to 
July 2014
August to 
October 2014
November to 
December 2014
December 
2014
January to 
February 2015
March to
April 2015
PFAC indicates Patient and Family
Advisory Council.
Table 1. PFAC Meeting Timeline, Objectives, Activities, and Outcomes
Time, mo
Meeting
Objectives
Activities
Outcomes
1-2
Establish expectations
and group harmony
• Introduce members
• Establish standards for engagement
• State project goals, timeline, and expectations
• Share personal experiences with surgery
• Clear understanding of group conduct, PFAC expectations,
and researcher roles
• Recognition that PFAC members’ experience can contribute
to the research project
3-5
Integrate preliminary
qualitative study results
with PFAC experience
with high-risk surgery
• Learn about qualitative research methods
• Reflect on study patients’ stories and integrate
with personal experience
• Identify personally important themes extant in
qualitative data
• Identification of core decisional and informational needs
• Identification of targets for intervention: choices,
expectations, and complications
6-8
Create QPL
• Brainstorm questions to ask a surgeon
• Discuss top 20 questions from 118 that PFAC and
other stakeholders ranked in premeeting online survey
• Explore question applicability to preoperative
decisional needs
• Provide feedback on 12-question prototype of QPL
• Prototype QPL
8-12
Gain input on design for
future comparative
effectiveness study
• Assess measures and outcomes that are valuable
and meaningful to patients and family members
• Provide feedback on grant application
• Provide feedback on study recruitment materials
• Research protocol that is acceptable and relevant to
stakeholders
Abbreviations: PFAC, Patient and Family Advisory Council; QPL, question prompt list.
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able. This notion was linked to the patients’ belief that the sur-
geon felt strongly that surgery should be done or a personal
understanding that their illness required surgery. These data
showed patients and families had developed an understand-
ing that the disease itself compelled the need for surgery,
thereby determining the absence of alternatives.
Furthermore, in the setting of an unwanted outcome, this
inextricable link between surgery and disease provided reas-
surance about the choice to proceed with surgery. For ex-
ample, the wife of a patient whose cognitive impairment pro-
gressed markedly with surgery sought comfort with their
decision:
…because we asked the doctor…because he said about the
confusion [dementia], it could have been worse with the
surgery. I said, well, what’s my option? Does he really need the
surgery…and he goes, no, he did need it.
Another patient who spent months in the hospital after resec-
tionofabenignpancreaticmassreported,“Iwouldn’thavehad
surgery if I didn’t have to have the tumor removed.” Belief that
there was no choice or surgery had to be done appeared com-
forting to patients with serious illness and generated concern
from the research team that this conviction should not be dis-
rupted by efforts to improve decision making.
The PFAC members were distressed that our qualitative
study patients appeared uninformed about alternatives. Si-
multaneously they empathized with the notion that surgery
had to be done. One member told us: “[patients] already have
one foot into the surgery room” before meeting a surgeon be-
cause the referral process promotes a message that surgery is
essential. Still, they were clear that informed decision mak-
ing was crucial for all patients, even if they ultimately con-
cludedsurgeryhadtobedone.Theystressedthatpatientsneed
to be “told all the ramifications and possibilities of both hav-
ing [surgery] and not having it,” which requires a clear expla-
nation about what could be gained and what would happen
without surgery.
These discussions generated the first decision support tar-
get for our QPL: “Should I have surgery?” Our PFAC wanted
patients to deliberate about having surgery and receive ex-
plicit information about how surgery might improve symp-
toms or longevity. To address this need, our stakeholders
selected the question prompts:
• “What are my options?”
• “What is likely to happen if I do have surgery? If I don’t have
surgery?”
• “Will surgery make me feel better?” and
• “Will surgery help me live longer? If so, how much longer?”
Expectations
The PFAC explored qualitative data suggesting patients were
unprepared for what occurred postoperatively. For example,
1 patient noted she had been apprised of specific risks, but did
not recognize this information could be used to prepare for
complications or prolonged recuperation. She described how
frightened she was by her slow recovery and postoperative
weakness:
No, no I wasn’t expecting anything. They didn’t tell me there
could be [complications]. They did say you could develop A-fib
and they did say that after the operation you could have a stroke
or heart attack.…So I didn’t really, I did ask questions, but I
guess I didn’t ask if it would be a long recovery or what could
happen…Imeanyou’renotexpecting,andIdon’tthinkyouknow
all the questions you should ask.
Table 2. Informational and Decision Support Failures Identified in Qualitative Data by the PFAC
Perception
Qualitative Studya
PFAC Discussion
Preoperative Interview
Postoperative Interview
Surgery must be
performed
“I didn’t really decide I wanted to have it…after all
those tests…sent me to the heart surgeon…he
said, well it should be done.”
“…there wasn’t really any other options,
and then so, you know, there wasn’t uh,
nothing to think about really.”
• Patients need more information about
alternatives.
• Patients “already have one foot into
the surgery room” because the surgical
referral process implies that surgery is
the only option.
• Patients may still conclude surgery
has to be done but need to have more
information about what would happen
if they did not have surgery.
“I don't know. Just get it done and go on with
your life, I guess.”
“But, you know, what, what’s the option?
Um, do you not have the surgery and
wait for a heart attack and then your
recovery is going to be a whole lot
more complicated and probably
protracted.…So, to me it was like a no
brainer, you know.”
Surprise that
recovery is arduous
“Just to fix the problem which I am having….That
is my expectation.”
“Hey if I’m gonna feel like I got hit by a
truck, tell me before. So it was more, it
was more intensive…than I realized it
would be.”
• Patients are not fully prepared for the
intensity of surgery and the recovery
process.
• Patients should know what to expect
postoperatively.
• Patients who are surprised
postoperatively may be upset with the
surgeon.
“[Surgery is] going to be the easiest, best
opportunity for me to live a couple more
years….It’s just a little treatment here and there
afterward.”
“I thought it was going to be an
in-and-out thing.”
Unclear advance
directive
“They just know what they got to do. I don’t want
to be laying around being a vegetable.”
“Should I let him go ahead and do the
CPR? …I didn't want to put him through
that….It’s the hardest decision I’ve ever
made.”
• Patients do not have the opportunity
to clearly express their preferences for
postoperative life-supporting
treatments.
• PFAC member: “There is a disconnect
between what the patients want and
who is the right person to tell these
wishes.”
“Yeah I think [the surgeon] knows [what to do in
an event of a complication]…Whatever he thinks
is best.”
“…if you were going to get good results,
it’s one thing, but if you’re going to come
home and do nothing…stick your finger
in a light socket.”
Abbreviations: CPR, cardiopulmonary resuscitation; PFAC, Patient and Family Advisory Council.
a Quotations are from interviews with 34 patients before and 27 patients after surgery as part of the observational qualitative study.
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Although surgeons named risks and described operations un-
der consideration as big surgery, patients struggled to trans-
late this information. Patients assumed they would return to
normal postoperatively: “If I can’t come back normal, I don’t
want to come back.”
The PFAC expressed concern that patients underestimated
the impact of surgery and had a naive outlook about the seri-
ousness of surgery, leading to surprise or distress when recov-
erywasarduous.ThisnotionwasfamiliartoPFACmemberswho
reportedfeeling“blindsided”postoperatively.Theyworriedthat
what was normal after surgery for the surgeon was not normal
forthepatientandthismightcausedistresswhenthesurgeon’s
expected outcome was unexpected by the patient.
This discussion generated the target: “What should I ex-
pect if everything goes well?” The PFAC chose question
prompts to prepare for recovery and long-term physical
changes, including:
• “How do you think my daily life will look after surgery? Right
after surgery, 3 months later, 1 year later?”
• “Will I have any tubes or drains put in during or after sur-
gery? Will I need them at home?”
• “How will this surgery affect my other health problems?” and
• “After I leave the hospital, what type of care do you think I
will need?”
Complications
The PFAC reviewed qualitative data that exposed a wide varia-
tion in treatment preferences for serious postoperative com-
plications.Patientsbelievedthesurgeonknewtheirwishesde-
spitethelackofexplicitdiscussion.Forexample,1studypatient
stated, “The only thing I don’t want, if I do die, I don’t want to
be revived.” This type of information was not discussed with
surgeons. A few patients mentioned their advance directive,
but the surgeon did not explore their preferences further. Thus
how to proceed in the event of a postoperative complication
wasunclear.Somebelievedfamilymemberswerefamiliarwith
their preferences and could make decisions if needed.
The PFAC members were concerned that patients needed
more advance care planning. They expressed dismay that pa-
tients’ treatment preferences were not communicated: “There
is a disconnect between what the patients want and who is the
rightpersontotellthesewishes.”ThePFACstruggledtounder-
stand how specific directives might need to be tailored to the
surgical setting and were shocked by the lack of standard pro-
cedures for notifying all health care professionals about exist-
ing directives. They identified a critical need for patients to
clarify their preferences with the surgeon and to discuss how
directivesmightbeinterpretedduringtheperioperativeperiod.
ThePFACsoughtquestionstopromoteconversationabout
“What happens if things go wrong?” They chose the follow-
ing question prompts to encourage this type of discussion:
• “Can you describe serious complications and explain what
those might mean for me?”
• “If I’m too sick to speak for myself, how can I make sure you
know my wishes?” and
• “If I decide to appoint someone to make medical decisions
for me, what do I need to do to make those arrangements
official?”
Acceptability of the QPL
English- and Spanish-speaking community members en-
dorsed the questions on the QPL and believed that they could
ask all the questions on the list. Surgeon stakeholders agreed
they could answer the questions.
Weiterativelyrevisedwordsthatcommunitymembersbe-
lieved were difficult to understand or to use in conversation.
Community members worried that “Will surgery help me live
longer?” was difficult to answer because it suggested sur-
geons can guarantee specific outcomes. They did not want pa-
tients to “hold doctor[s] accountable” for unreasonable infor-
mation and suggested we add in your opinion to 3 questions.
Community members praised the brochure’s clarity and un-
derstood they did not need to ask every question. They were
not frightened by questions about advance care planning. Our
finalQPLinterventionisabrochurewith11questions(Figure2)
and a letter from the surgeon endorsing its use.
Pilot Testing
In the clinic, patients used the QPL to assist communication
and felt confident that they were well informed. They noted
“it puts questions in your mind,” including “questions you
neverwouldhavethoughttoask.”Theybelievedtheywereable
to explore how surgery might affect their quality of life and to
secure formal designation of a health care proxy “just in case.”
One patient reported nervousness on receiving the QPL be-
cause he did not know “surgery was on the table” and had in-
ferred his problem was serious. Still, this patient understood
surgical consultation was an opportunity to get his questions
answered. During consultations surgeons noted that patients
would pull the list out to ensure their questions were
answered.
Discussion
Through engagement of patients, family members, and other
stakeholders, we created a QPL to address core decisional and
informational needs of patients considering high-risk sur-
gery.Theintervention,whichincludesthelistofquestionsand
a supportive letter from the surgeon (https://www.hipxchange
.org/SurgicalQPL), targets elements of primary importance for
informed decision making, including discussion of treatment
options,clarificationofgoals,andpreparationforexpectedand
unexpected outcomes. Although these elements seem to be
covered during traditional informed consent, this intervention
is designed to rectify gaps in communication identified by
patients and family members that current practices fail to
address. These results have important implications for
surgeons, patients, and their family members.
Forsurgeons,thisinterventionwillrequiretranslatingpro-
fessionally defined notions of risk and benefit into patient-
centered outcomes, specifically goals and expectations. Pe-
canac et al23 have previously documented that surgeons
skillfully describe the gravity of high-risk surgery and rou-
tinely disclose risk, yet we find it remarkable that this process
inadequately supports patients as they decide whether to have
surgery or prepare for expected outcomes. Although sur-
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geons work hard to provide critical information, the meaning
of big surgery and risk of heart attack is unfamiliar to patients
and families who struggle to imagine how such events may be
experienced. Rather than more information, they need more
interpretationoftheinformationsurgeonscurrentlyprovide.33
The QPL questions are framed to help patients access
surgeons’ knowledge in a way that patients can understand.
For patients, the QPL aims to promote informed decision
making by supporting inquiry with questions they would not
have thought to ask. Traditional models of clinical decision
making theorize that patient preferences for decisional con-
trol are unique and decision dependent; some prefer com-
pletephysiciancontrolwhereasotherswantequallysharedde-
cisions or complete control.34,35 Newer theoretical models
propose that most patients want to be involved but simply do
notknowhow.14Thisproblemcanbemediatedbyprevisitedu-
cation or coaching with interventions such as the QPL. Be-
cause the patient experience is transactional (ie, determined
by the actions of surgeons and patients),36 patients who are
motivated to be involved are more likely to participate in
collaborative decision making.
Although many versions of questions to ask physicians
exist, they contain questions that patients ask spontane-
ously. In our observation, surgeons regularly inquire
whether patients have questions and patients respond with
logistic or technical concerns, such as “Can my wife sleep in
my room?” and “Will you use stiches or staples?”23 Although
these concerns are important to patients, they do little to
engage patients in a discussion about trade-offs or to set
realistic expectations for what life might be like after sur-
gery. The QPL addresses specific needs that are not routinely
queried by patients and families.
Figure 2. Patient and Family Advisory Council Question Prompt List Brochure
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For family members, the QPL provides an opportunity to
discuss unwanted outcomes at a time when the patient, sur-
geon, and family are together and able to communicate to-
gether. Postoperative conflict about life-supporting treat-
mentisdistressing37becausepatientsarenotalwaysclearabout
their preferences preoperatively,11 and surgeons are sur-
prised when patients have not bought in to the use of pro-
longed life support.8 Although some patients may be too anx-
ioustohavesuchconversationsbeforemajorsurgery,wefound
many patients who desired this type of discussion.11 Further-
more, respondents in our focus groups and patients in the
pilot understood they did not need to ask every question.
Our study has strengths and limitations. Our qualitative
datawascollectedinmultiplesitestocapturegeographicvaria-
tion and demonstrated robust patterns of preoperative
conversation.10 However, regional differences in how surgery
is presented and understood by patients may not be captured
by our sample. Although we have piloted the QPL and other
investigators have demonstrated the efficacy of such
interventions,18-22theeffectivenessofthisQPLisunknown.We
need evidence about how the QPL might improve these high-
stakes conversations, support value-directed deliberation, set
realistic postoperative expectations, and avoid conflict in the
setting of an unwanted outcome. We have recently received
funding from the Patient-Centered Outcomes Research Insti-
tute to test these effects in a randomized clinical trial.
Conclusions
We integrated the experiences of patients and family mem-
bers through observational study and direct stakeholder en-
gagement to create a QPL for older adults considering high-
risksurgery.Thisinterventionaimstoovercomegapsincurrent
practice by activating patients and family members before sur-
gical consultation to promote deliberation about treatment
choices and prepare patients for expected and unexpected
outcomes.
ARTICLE INFORMATION
Accepted for Publication: March 25, 2016.
Published Online: June 29, 2016.
doi:10.1001/jamasurg.2016.1308.
Author Contributions: Dr Schwarze had full access
to all the data in the study and takes responsibility
for the integrity of the data and the accuracy of the
data analysis.
Study concept and design: Steffens, Nabozny,
Schmick, Schwarze.
Acquisition, analysis, or interpretation of data: All
authors.
Drafting of the manuscript: Steffens, Tucholka,
Schwarze.
Critical revision of the manuscript for important
intellectual content: Steffens, Nabozny, Schmick,
Brasel, Schwarze.
Statistical analysis: Schwarze.
Obtained funding: Steffens, Schmick, Schwarze.
Administrative, technical, or material support:
Steffens, Tucholka, Nabozny, Schmick.
Study supervision: Steffens, Schwarze.
Conflict of Interest Disclosures: None reported.
Funding/Support: This study was supported by
training award KL2TR000428 of the Clinical and
Translational Science Award program (Dr Schwarze)
as part of grant UL1TR000427 to the Institute for
Clinical and Translational Research (ICTR),
University of Wisconsin, from the National
Institutes of Health, National Center for Advancing
Translational Sciences; by grant 3086 from the
ICTR, through the University of Wisconsin School of
Medicine and Public Health’s Wisconsin Partnership
Program (Dr Schwarze); by the Greenwall
Foundation Kornfeld grant; by grant
5P60MD003428 from the National Institute for
Minority Health and Health Disparities Center of
Excellence program through the University of
Wisconsin Collaborative Center for Health Equity;
and by award CDR-1502-27462 from the Patient-
Centered Outcomes Research Institute (PCORI).
Role of the Funder/Sponsor: The funding sources
had no role in the design and conduct of the study;
collection, management, analysis, and
interpretation of the data; preparation, review, or
approval of the manuscript; and decision to submit
the manuscript for publication.
Disclaimer: The statements in this article are solely
the responsibility of the authors and do not
necessarily represent the views of the PCORI, its
board of governors, or its methodology committee.
Additional Contributions: Betty Kaiser, PhD, RN,
and Gay Thomas, MA, Wisconsin Network for
Research Support, provided guidance in creating
the Patient and Family Advisory Council, planning
the meetings, and evaluation. Nora Jacobson, PhD,
and the Qualitative Research Group supported by
the ICTR at the University of Wisconsin assisted
with the study research design and analysis. None
of these contributors received direct
compensation.
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Research Original Investigation
Preoperative Decision Making for Older Adults Facing High-Risk Surgery
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October 2016
Volume 151, Number 10
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16. Hibbard JH, Stockard J, Mahoney ER, Tusler M.
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18. Walczak A, Butow PN, Clayton JM, et al.
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patients and caregivers. BMJ Open. 2014;4(6):
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22. Clayton JM, Butow PN, Tattersall MH, et al.
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24. Patton MQ. Qualitative Evaluation and
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25. Agency for Healthcare Research and Quality.
Questions to ask your doctor. http://www.ahrq.gov
/patients-consumers/patient-involvement/ask
-your-doctor/index.html. Updated September
2012. Accessed November 26, 2014.
26. American Association of Retired Persons.
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Accessed November 26, 2014.
27. Agency for Healthcare Research and Quality.
Having surgery? what you need to know: questions
to ask your doctor and your surgeon. http:
//archive.ahrq.gov/patients-consumers/diagnosis
-treatment/surgery/questions/index.html. Updated
October 2005. Accessed November 26, 2014.
28. Doctella. https://www.doctella.com/. Accessed
November 26, 2014.
29. Clayton J, Butow P, Tattersall M, et al. Asking
questions can help: development and preliminary
evaluation of a question prompt list for palliative
care patients. Br J Cancer. 2003;89(11):2069-2077.
30. Brandes K, Butow PN, Tattersall MH, et al.
Advanced cancer patients’ and caregivers’ use of a
Question Prompt List. Patient Educ Couns. 2014;97
(1):30-37.
31. Johns Hopkins Medicine. Questions to ask
before surgery. http://www.hopkinsmedicine.org
/healthlibrary/conditions/surgical_care/questions
_to_ask_before_surgery_85,P01409/. Accessed
November 26, 2014.
32. Wisconsin Network for Research Support.
Community advisors on research design and
strategies. http://winrs.son.wisc.edu/index.php
/services/cards/. Accessed February 16, 2015.
33. Russ AJ, Kaufman SR. Family perceptions of
prognosis, silence, and the “suddenness” of death.
Cult Med Psychiatry. 2005;29(1):103-123.
34. Singh JA, Sloan JA, Atherton PJ, et al. Preferred
roles in treatment decision making among patients
with cancer: a pooled analysis of studies using the
Control Preferences Scale. Am J Manag Care. 2010;
16(9):688-696.
35. Degner LF, Sloan JA, Venkatesh P. The Control
Preferences Scale. Can J Nurs Res. 1997;29(3):21-43.
36. Greene J, Hibbard JH, Sacks R, Overton V.
When seeing the same physician, highly activated
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Invited Commentary
Patient-Centered Outcomes Research—Opportunities
for Novel, Innovative, and Transformative Partnerships
With Patients and Their Families
Rebecca A. Aslakson, MD, PhD; Matthew Weiss, MD
The US Patient Protection and Affordable Care Act of 2010
established the Patient-Centered Outcomes Research Insti-
tute (PCORI), a national nonprofit to fund patient-centered
comparative effectiveness
researchandextend“thecon-
cept of patient-centeredness
from health care delivery to
health care research.”1(p1513) As defined by PCORI, patient-
centered outcomes research (PCOR) is “the evaluation of ques-
tions and outcomes meaningful and important to patients and
caregivers.”1(p1513)Sincelate2012,PCORIhasdirectedmorethan
$1 billion into nearly 700 projects in 45 states, Puerto Rico, and
the District of Columbia.2 At least 10 surgical projects are cur-
rentlyfundedandrangefrompatient-reportedoutcomesacross
different types of bariatric surgery3 to advance care planning
before major cancer surgery,4 with some groups already
publishing results.5
In this issue of JAMA Surgery, Steffens et al6 report
PCORI-funded work to improve preoperative decision mak-
ing and postoperative expectations among patients and
their family members. The team developed a Patient and
Family Advisory Council (PFAC), which consisted of 2
patients and 2 family members. A question prompt list
(QPL) was generated by collecting questions from websites
and published literature, which the PFAC members and 2
surgeons scored based on a 5-point Likert scale. The PFAC
reviewed the top-scoring 20 questions and ultimately
developed a 12-question prototype QPL after further evalua-
tion by an English- and a Spanish-speaking community
focus group. This prototype was piloted in a vascular sur-
gery clinic. The final QPL includes 11 questions divided
among the following 3 categories: “Should I have surgery?”
“What should I expect if everything goes well?” and “What
happens if things go wrong after surgery?”
Related article page 938
Preoperative Decision Making for Older Adults Facing High-Risk Surgery
Original Investigation Research
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October 2016
Volume 151, Number 10
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Taylor LJ, et al. BMJ Open 2017;7:e014002. doi:10.1136/bmjopen-2016-014002
Open Access 
Navigating high-risk surgery: protocol 
for a multisite, stepped wedge, cluster-
randomised trial of a question prompt 
list intervention to empower older 
adults to ask questions that inform 
treatment decisions
Lauren J Taylor,1 Paul J Rathouz,2 Ana Berlin,3 Karen J Brasel,4 Anne C Mosenthal,3 
Emily Finlayson,5 Zara Cooper,6 Nicole M Steffens,7 Nora Jacobson,8 
Anne Buffington,1 Jennifer L Tucholka,1 Qianqian Zhao,2 Margaret L Schwarze9,10 
To cite: Taylor LJ, Rathouz PJ, 
Berlin A, et al. Navigating 
high-risk surgery: protocol for 
a multisite, stepped wedge, 
cluster-randomised trial of a 
question prompt list intervention 
to empower older adults to 
ask questions that inform 
treatment decisions. BMJ Open 
2017;7:e014002. doi:10.1136/
bmjopen-2016-014002
Received 23 August 2016
Revised 10 January 2017
Accepted 31 March 2017
For numbered affiliations see 
end of article.
Correspondence to
Dr Margaret L Schwarze;  
 schwarze@ surgery. wisc. edu
Protocol
ABSTRACT
Introduction Older patients frequently undergo operations 
that carry high risk for postoperative complications 
and death. Poor preoperative communication between 
patients and surgeons can lead to uninformed decisions 
and result in unexpected outcomes, conflict between 
surgeons and patients, and treatment inconsistent with 
patient preferences. This article describes the protocol for 
a multisite, cluster-randomised trial that uses a stepped 
wedge design to test a patient-driven question prompt list 
(QPL) intervention aimed to improve preoperative decision 
making and inform postoperative expectations.
Methods and analysis This Patient-Centered Outcomes 
Research Institute-funded trial will be conducted at five 
academic medical centres in the USA. Study participants 
include surgeons who routinely perform vascular or 
oncological surgery, their patients and families. We aim 
to enrol 40 surgeons and 480 patients over 24 months. 
Patients age 65 or older who see a study-enrolled surgeon 
to discuss a vascular or oncological problem that could 
be treated with high-risk surgery will be enrolled at their 
clinic visit. Together with stakeholders, we developed a 
QPL intervention addressing preoperative communication 
needs of patients considering major surgery. Guided by 
the theories of self-determination and relational autonomy, 
this intervention is designed to increase patient activation. 
Patients will receive the QPL brochure and a letter from 
their surgeon encouraging its use. Using audio recordings 
of the outpatient surgical consultation, patient and family 
member questionnaires administered at three time 
points and retrospective chart review, we will compare 
the effectiveness of the QPL intervention to usual care 
with respect to the following primary outcomes: patient 
engagement in decision making, psychological well-
being and post-treatment regret for patients and families, 
and interpersonal and intrapersonal conflict relating to 
treatment decisions and treatments received.
Ethics and dissemination Approvals have been granted 
by the Institutional Review Board at the University of 
Wisconsin and at each participating site, and a Certificate 
of Confidentiality has been obtained. Results will be 
reported in peer-reviewed publications and presented at 
national meetings.
Trial registration number NCT02623335.
INTRODUCTION
Each year, many of the 500 000 older Amer-
icans having high-risk surgery1 2 will do so 
without fully understanding how it will 
impact them. Given operative trends for 
patients age 65 and older,3 4 this number 
is expected to grow as the US population 
ages. Although major surgery has poten-
tial to prolong life and improve symptoms, 
it can have unwanted outcomes for older 
adults, including reduced quality of life,5 
more 
hospitalisations6 
7 
and 
potential 
suffering at the end of life.8 9 Furthermore, 
50% of patients 65 and older have one or 
more chronic conditions,10 putting them 
at greater risk than younger patients for 
death and postoperative complications11 12 
that necessitate intensive care or lengthy 
hospitalisations.13 14 Therefore, a decision 
to proceed with surgery can initiate a care 
trajectory that is ultimately inconsistent 
with personal preferences and goals, for 
example confinement in a nursing home 
or prolonged life support in an intensive 
care unit. Patients whose postoperative 
expectations are not met may suffer as they 
try to make sense of their situation, feel a 
loss of control and assume self-blame.15 
For these reasons, the decision-making 
process for older patients considering high-
risk surgery is complicated, and because 
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the consequences of these decisions also affect family 
members, the stakes are high.
Current communication practices inadequately support 
preoperative decision making about major surgery. 
According to the Institute of Medicine,16 most patients 
prefer to share in decision making; however, ‘they are 
often not afforded the chance to participate’ (ch3, p38),16 
and studies suggest that surgeons rarely employ a coop-
erative decision-making process.17–19 Instead, surgeons 
rely on best practices, specifically informed consent, to 
disclose procedural risks and help patients make choices. 
However, existing decision-making standards do not 
adequately engage patients in deliberation, and the 
process of informed consent fails to explain how a patient 
might actually experience complications, or even expected 
downstream outcomes, such as the need for additional 
invasive treatments or predictable changes in functional 
status.20 21 To make value-laden decisions, patients and 
families need to know what the outcomes of surgery mean 
for them and how surgical treatment can be understood 
in the context of their overall prognosis, particularly for 
patients with other chronic illnesses.22 23 To be successful, 
this process requires partnership; surgeons need patients 
to share what matters to them, and patients need surgeons 
to help them compare treatment options and evaluate 
their effectiveness based on patients’ values and goals.
We designed a multisite, cluster-randomised trial of an 
intervention to improve preoperative communication 
between surgeons and older adults considering major 
vascular or oncological operations. Our study evaluates 
a question prompt list (QPL) intervention for use in the 
surgical clinic that our research group developed with 
input from patients, families and surgeons who have 
experience with high-risk surgery. The intervention aims 
to encourage patients and families to ask questions that 
allow them to compare treatment options and get infor-
mation about how surgery might impact their lives. First, 
we discuss the rationale and theoretical foundations of 
the surgical QPL intervention. We then describe the 
research protocol together with details of study design, 
data collection, outcomes and analysis plan.
Current gaps in communication about high-risk surgery
To gain a better understanding of usual practice, our 
research group analysed over 90 preoperative conversa-
tions between surgeons and patients considering high-risk 
cardiovascular, oncological and neurosurgical proce-
dures as part of a multi-institutional study.18 21 24 Analysis 
of these conversations revealed three primary barriers to 
decision making. One, surgeons employ a ‘fix-it’ model25 
by describing the patient’s disease as an isolated abnor-
mality linked directly with a surgical solution. This model 
supports an implicit message about the ‘benefits’ of 
surgery: the reason to operate is to fix what has been iden-
tified as broken, and the language implies the patient 
will return to ‘normal’ after the problem has been fixed. 
However, this ‘fix-it’ model lacks an explicit descrip-
tion about what surgery might mean more broadly, for 
example how surgery will impact the patient’s functional 
independence or other health problems. Lack of context 
regarding their overall health state makes it challenging 
for patients to understand the need to deliberate about 
the value of surgery given their chronic health conditions 
and quality-of-life preferences.18 Two, surgeons present 
their own evaluation of the trade-offs associated with 
the proposed intervention. Surgeons struggle to elicit 
patient preferences, and efforts to encourage questions 
are often ineffective as patients regularly respond with 
logistical or technical concerns, for example what time 
surgery will take place or whether stitches or staples will 
be used. The result is surgeon-generated assumptions 
about the value of specific outcomes and acceptability of 
trade-offs.18 Three, informed consent requires surgeons 
to convey risks that are typically described as objective 
estimates of isolated physiological harms, for example 
a 45% chance of renal failure. However, this approach 
does not describe outcomes in a way that allows patients 
and families to understand what life might be like after 
surgery.21 These three barriers highlight the need to 
bridge the gap between what surgeons know and what 
patients understand about treatment outcomes. These 
findings complement work by Blazeby and colleagues 
who have observed that surgeons emphasise in-hospital 
Figure 1 Patient and family stakeholder-proposed question prompt list targets and resulting goals.
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risks and technical aspects of the procedure rather than 
long-term functional outcomes.26 27
We also drew from our previous work using physician 
surveys28–31 and qualitative interviews with surgeons32 
to identify a fourth problem with preoperative commu-
nication. Our research group has previously described 
‘surgical buy-in’, whereby surgeons operate under an 
assumption that the patient has agreed to both the surgical 
procedure as well as all postoperative care anticipated by 
the surgeon, including life-supporting treatments.28 32 
While this implicit contract is understood by surgeons, it 
is not recognised by patients who may desire treatment 
limitations based on their evaluation of certain health 
outcomes.24 This disconnect can result in postoperative 
conflict between surgeons, patients and families33 34 when 
patients or surrogates on behalf of patients request to 
forgo aggressive treatments which the surgeon believes 
the patient agreed to preoperatively.
Development of an intervention to improve preoperative 
communication
QPLs have proven efficacy for improving patient–doctor 
communication. QPL interventions can effectively 
change how patients and families communicate with 
physicians, improve patients’ and family members’ 
psychological outcomes, and better meet patients’ infor-
mational needs.35–37 Effective QPL interventions require 
physicians to endorse and support the patient’s use of 
the question list, but do not require resource-intensive 
adjuncts like patient navigators or patient coaching.38 For 
patients considering surgery39 and those with life-limiting 
illness,40 QPLs effectively increase the number of ques-
tions about prognosis and facilitate better alignment 
between treatment expectations and likely outcomes. 
These interventions also produce behaviour change in 
physicians, including surgeons,39 so that patients receive 
more information about treatment alternatives and atten-
tion to personal preferences.41
We met regularly for 10 months with a dedicated 
group of patients and family members to design a QPL 
specifically targeting the preoperative decisional needs 
of patients considering high-risk surgery.42 Our research 
group gathered over 300 questions from publicly avail-
able ‘questions to ask your surgeon’ and focused on three 
patient-mediated targets identified by our patient and 
family advisors: ‘Should I have surgery?’, ‘What should 
I expect if everything goes well?’, and ‘What happens 
if things go wrong?’ (figure 1). We discarded questions 
that were either redundant or irrelevant to these targets 
and used feedback from our patient, family, surgeon and 
hospital stakeholders to refine the list to create a surgical 
QPL brochure containing 11 questions. Details of the 
QPL development have been previously published.42
Theoretical framework underlying the QPL intervention
Based on the theories of self-determination43 and rela-
tional autonomy44 45 described by Elwyn et al,46 QPLs aim 
to overcome structural and interactional barriers and 
promote patient activation, thereby increasing patient 
engagement in decision making. Given the transactional 
nature of the patient experience,47 activated patients will 
receive more patient-centred care and take part in more 
collaborative decision making, even within the same 
provider. By supporting patients’ need for autonomy and 
relatedness, interventions — such as a QPL — to help 
patients gain knowledge about treatment options offer 
a strategy to promote patients’ self-perceived capacity to 
engage in treatment decisions.48
Randomised comparative effectiveness study
Our intervention consists of the surgical QPL and a 
brief letter from the surgeon endorsing its use, mailed 
to the patient in advance of the clinic appointment. The 
intervention targets patients and family members in the 
preoperative period and seeks to impact (1) patient 
engagement in decision making for high-risk surgery, 
Figure 2 Theoretical framework behind the QPL intervention and the study design. MD, medical doctor; QPL, question prompt 
list.
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(2) psychological well-being and post-treatment regret 
for patients and family members and (3) interpersonal 
and intrapersonal conflict relating to treatment decisions 
and received treatments (figure 2). We hypothesise that 
through patient activation the intervention will:
 
Ź improve patient self-efficacy in communication so 
patients can engage with surgeons in deliberation 
over treatment options
 
Ź enable patients to share in decision making so 
that treatment decisions are aligned with their 
preferences
 
Ź promote accurate patient expectations for both 
known and unanticipated outcomes
 
Ź reduce post-treatment regret for patients and 
family members through increased participation in 
decision making
 
Ź increase patient’s and family member’s psychological 
well-being
 
Ź reduce postoperative conflict between surgeons, 
patients and families for patients who have an 
unwanted outcome.
METHODS AND ANALYSIS
Setting and design
This study is a multisite, prospective, cluster-randomised 
trial using a stepped wedge design49 to compare the 
effectiveness of the surgical QPL intervention with usual 
care for older patients considering high-risk vascular and 
oncological procedures. We are conducting the study 
in the outpatient surgical clinics at five high-volume 
academic medical centres across the USA: University of 
Wisconsin Hospital and Clinics (Madison, Wisconsin), 
University of California San Francisco (San Francisco, 
California), Brigham and Women’s Hospital (Boston, 
Massachusetts), Rutgers New Jersey Medical School/The 
University Hospital (Newark, New Jersey) and Oregon 
Health Sciences University Hospital and Clinics (Port-
land, Oregon). We selected these five sites to represent 
distinct geographical regions and demographic groups in 
order to capture diverse experiences with surgical deci-
sion making.
Participating surgeons from these five centres routinely 
perform high-risk oncological or vascular surgery. 
Patients and family members are invited to participate 
as dyads. However, patients may participate alone while 
family members can only enrol with a corresponding 
patient. We will enrol patients in each surgeon’s clinic 
according to a stepped wedge design implemented in six 
4-month waves over a 24-month period (table 1). In wave 
0, all patients will receive usual care. With each subse-
quent wave, 8 of the 40 enrolled surgeons will cross over 
into the intervention group. Once a surgeon has entered 
the intervention arm, all patients scheduled to see that 
surgeon in clinic to discuss a new surgical problem will 
receive the QPL intervention. We will audio-record the 
surgeon–patient conversation in clinic, and patients and 
family members will complete questionnaires at three 
subsequent predefined time points. In addition, we will 
perform qualitative interviews with a subset of participants 
who experienced serious postoperative complications.
Participants
Attending surgeons at participating sites who routinely 
perform high-risk vascular (peripheral, neurological 
or cardiovascular) or oncological operations on older 
patients will be invited to participate. Eligible patients are 
age 65 years and older with one or more chronic health 
conditions who have an outpatient consultation with a 
study-enrolled surgeon to discuss a new surgical problem. 
The surgical problem must be vascular or oncological in 
nature and could be treated with one of the 227 ICD-9-
coded procedures our research group previously defined 
as high risk.50 For each enrolled patient, we will approach 
one family member to participate who is present during 
the conversation with the surgeon in clinic. Eligible partic-
ipants must be English-speaking or Spanish-speaking and 
able to converse with the surgeon without an interpreter 
(aside from Spanish-speaking participants who may use 
an interpreter), have self-reported visual acuity and 
literacy skills sufficient to read a newspaper, and be able 
to provide written informed consent. Patients who do 
not have a problem that can be potentially treated with 
Table 1 Stepped wedge study design: 40 surgeons at five sites
Number of surgeons in the intervention group at each site (number of surgeons added per wave)
Wave
Portland
Newark
Boston
San Francisco
Madison
Total
0
0
0
0
0
0
0
1
2 (2)
1 (1)
2 (2)
1 (1)
2 (2)
8
2
3 (1)
3 (2)
3 (1)
3 (2)
4 (2)
16
3
4 (1)
4 (1)
5 (2)
5 (2)
6 (2)
24
4
5 (1)
6 (2)
6 (1)
7 (2)
8 (2)
32
5
6 (1)
7 (1)
8 (2)
9 (2)
10 (2)
40
Total number of 
patients per site*
72
84
96
108
120
480
*Half of all patients will have received the question prompt list intervention by the end of wave 5, for a final sample size of 240 patients in each 
study arm.
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surgery, for example an aneurysm that does not meet size 
guidelines for operative repair, will be excluded based on 
chart review or previsit determination by the surgeon.
Recruitment
At each study site, all eligible surgeons will receive an invi-
tation via e-mail by the site principal investigator. Surgeons 
who do not opt out will be chosen first based on surgical 
subspecialty to capture variability in high-risk procedures 
and second by random selection of surgeons within a 
given subspecialty. Surgeons will not receive incentives 
for participation. We aim to enrol 40 surgeons in total, 
with the number of surgeons selected to be approxi-
mately proportional to the surgical volume at each site.
Study staff will review the clinic schedule of each 
enrolled surgeon and identify eligible patients based on 
chart review and clinic intake forms. On the day of clinic, 
study staff will meet with interested patients and family 
members to explain the study and obtain informed consent 
prior to the conversation with the surgeon. Patients and 
family members will receive financial incentives valued at 
$55 for participation. To avoid over-representation of any 
one surgeon, after each surgeon has two patients enrolled 
within the 4-month wave, recruitment will cease for that 
surgeon’s patients until the next wave begins. We aim to 
enrol a total of 480 patients across all five sites, with 12 
patients per surgeon.
We will use stratified purposeful sampling to iden-
tify a subset of enrolled patients (and family members, 
if applicable) who underwent surgery and experienced 
a serious postoperative complication, as determined by 
chart review. Serious complications include prolonged 
hospitalisation (more than 8 days postoperatively), 
prolonged length of stay in intensive care (greater than 
3 days), prolonged mechanical ventilation, myocardial 
Figure 3 Screening, recruitment, enrolment and data collection points for patients in the control and intervention arms at each 
site. 
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infarction, major cerebral vascular accident, new-onset 
dialysis or death.12 38 We will invite these patients and 
family members to participate in a face-to-face qualitative 
interview within 30 days after surgery. We will continue to 
interview patients until we reach saturation, meaning that 
data from subsequent transcripts become redundant with 
developed concepts. We anticipate this will occur with a 
sample of approximately 20 patients per study arm based 
on previous studies.18 21
Randomisation and blinding
Surgeons will be stratified by study site and randomly 
assigned within each site to cross over from usual care to 
the QPL intervention in different study waves. On study 
commencement, a master’s level statistician established 
a step-wise randomisation using a computer-generated 
randomisation schedule for the list of enrolled surgeons 
by site. The schedule determined the crossover wave for 
each surgeon and was designed to balance transitions to 
the intervention arm across sites in each wave according 
to the design in table 1. Surgeon crossover will occur 
in one direction only, and each within-site change will 
happen once every 4 months during the 24-month dura-
tion of the study. A 2-week hiatus in data collection at the 
start of the crossover will be instituted in transitioning 
clinics to ensure patients in the intervention group have 
had the opportunity to receive the QPL and endorsement 
letter from the surgeon. Study staff will notify enrolled 
surgeons prior to the upcoming crossover as the interven-
tion is dependent on surgeon endorsement. We expect 
negligible contamination between study arms as the 
intervention requires surgeon endorsement of the QPL. 
Only patients whose surgeons have crossed over into 
the intervention arm will receive the QPL and surgeon 
endorsement letter in the mail prior to consultation. 
Although patients in the control arm may access question 
lists from outside sources, our prior observational studies 
confirm surgeons do not routinely endorse the use of 
question prompts.
Whereas surgeons are not blinded to the intervention, 
every effort will be made to maintain blinding for patients 
and family members. Participants will be told the goal of 
the study is to evaluate communication between surgeons 
and patients, but they will not be informed about the 
distribution of the QPL. Transcriptionists and qualitative 
interviewers will be blinded to the intervention status of 
each encounter. Study staff are tasked with assuring the 
QPL has been sent and providing regular reminders to 
the surgeon to endorse the QPL with all new patients. 
Study staff will not know if the patient has received the 
QPL at the time of enrolment but will not be blinded 
during data collection. In an attempt to insulate study staff 
from group assignment during data collection, they will 
strictly adhere to a script and enquire about receipt of the 
QPL (with all patients regardless of group assignment) 1 
Table 2 Primary and secondary outcome measures (items in bold are primary outcomes)
Construct
Specific measure
Source
Timing
Aim 1: Patient engagement
Engagement in decision 
making
 
Ź Number and type of questions using a 
predefined coding scheme
 
Ź OPTION
Audio recording
Clinic visit
Self-efficacy in patient–
physician interactions
 
Ź PEPPI-5 (perceived efficacy)
 
Ź HCCQ (autonomy support)
Patient and family 
member
First questionnaire
Aim 2: Psychological well-being and treatment received
Concerns and well-being
 
Ź MyCaW (self-identified concerns and 
well-being)
Patient and family 
member
First to second
First to third questionnaires
Post-treatment regret
 
Ź ‘Looking back, is there anything about your 
treatment that you would do differently?’
Patient and family 
member
Third questionnaire
Psychological well-being 
(patient)
 
Ź PROMISPsychosocial Illness 
Impact-Neg 4a
 
Ź Psychosocial Illness Impact-
Pos 4a
 
Ź Anxiety 4a
Patient
Second and third 
questionnaires
Psychological well-being 
(family)
 
Ź PROMISSF Global Health
 
Ź Anxiety 4a
Family member
Second and 
third questionnaires
Treatment received
 
Ź Total number of operations 
scheduled after visit with surgeon
 
Ź Total number of operations 
scheduled and performed
Chart review
Clinic visit
Third questionnaire
HCCQ, Health Care Climate Questionnaire; MyCAW, Measure Yourself Concerns and Wellbeing; OPTION, Observing Patient Involvement 
score; PEPPI-5, Perceived Efficacy in Patient–Physician Interactions; PROMIS, Patient-Reported Outcomes Measurement Information 
System; SF, short form.
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day after enrolment following administration of the first 
questionnaire. Furthermore, data collected from chart 
abstraction will be reviewed by a blinded clinician for 
10% of the sample to ensure accuracy of data entry.
Intervention
Our intervention consists of the QPL brochure and a 
letter from the patient’s surgeon encouraging its use. The 
surgical QPL contains 11 questions to help patients and 
families (1) make treatment decisions in line with their 
values and goals, (2) anticipate and make sense of post-
operative outcomes and (3) experience less postoperative 
conflict about treatment of serious complications. Once 
a surgeon has crossed over into the intervention arm, all 
of his or her patients with a new vascular or oncological 
problem will receive the QPL intervention via US mail 
prior to the scheduled clinic appointment. To ensure that 
there is sufficient time for patients to receive the QPL 
intervention, we will only recruit patients who have been 
identified as eligible at least 5 days in advance of their 
appointment. This timeframe will remain consistent for 
both control and intervention patients as those who are 
scheduled more urgently may be systemically different.
Data collection
Audio recording
We plan to audio-record and transcribe verbatim one 
conversation between the attending surgeon, patient and 
accompanying family member(s). In order to capture the 
primary decision-making conversation, this may occur 
during either the first or second clinic visit depending on 
the usual practice pattern of each surgeon. Prior to study 
commencement, each surgeon will select their usual 
approach: either (1) treatment decisions are typically 
made during the first clinical encounter, or (2) treatment 
decisions are typically made during the second clinic visit.
Patient and family member questionnaires
After the primary decision-making conversation with 
the surgeon, patients and family members will receive 
three questionnaires. Study staff will conduct follow-up 
phone interviews to administer the first questionnaire 
Table 3 Mediating variables and covariates
Construct
Specific measure
Source
Timing
Variables mediating patient engagement
Family member present
Observation: Was a family member 
present during clinic visit?
Audio recording
Clinic visit
MD endorsement of QPL
Observation: no endorsement, any 
endorsement, extensive endorsement
Audio recording
Clinic visit
QPL intervention penetrance
To patient: ‘Did you receive information 
in the mail to prepare you for your 
appointment with the surgeon?’ (yes/no/
uncertain)
Patient
First questionnaire
Variables mediating psychological well-being
Surgical complications
National Surgical Quality Improvement 
Project definition (yes/no)
Chart review
Third questionnaire
Advance directive
New advance directive completed or 
prior advance directive documented in 
patient chart (yes/no)
Chart review
Third questionnaire
DNR
New DNR order placed or existing DNR 
order documented in patient chart (yes/
no)
Chart review
Third questionnaire
Covariates
Comorbid illness
Charlson comorbidity score
Chart review
Clinic visit
Indication for surgery
Patient’s presenting problem
Chart review
Clinic visit
MD subspecialty
Oncology or vascular subspecialty
Surgeon
Clinic visit
MD practice intensity
Average number of operations surgeon 
performs monthly
Operative log
3-month lead-in
Patient insurance status
Medicare, Medicare + Supplemental, 
Medicare+Medicaid, other
Chart review
Clinic visit
Patient demographics
Age, gender, race/ethnicity, educational 
attainment, health literacy
Patient
First questionnaire
MD demographics
Languages spoken, age, gender, race/
ethnicity
Surgeon
Clinic visit
DNR, do not resuscitate; MD, medical doctor; QPL, question prompt list.
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within 24–48 hours of the patient’s clinic visit. Patients 
and family members will complete these questionnaires 
independently. Administration of two subsequent ques-
tionnaires will be linked to the treatment plan and 
administered via phone or e-mail based on patient pref-
erence. For patients who receive surgery, questionnaires 
will be administered at 1–2 weeks and 6–8 weeks postop-
eratively. For those who undergo medical management 
or observation, questionnaires will be given at 6–8 weeks 
and 12–14 weeks following the clinic visit. We deliberately 
chose this timing to create similar administration sched-
ules regardless of whether the patient pursues surgery 
(figure 3). We allow for up to six contact attempts at each 
time point.
Chart review
Study staff will use chart review to record clinical data, 
treatments received and outcomes of treatment. Data 
collected will be limited to clinical information pertaining 
to surgical care from the initial visit through to administra-
tion of the final survey. Data collected from chart review 
and questionnaires will be stored using the REDCap 
(Research Electronic Data Capture) software hosted at 
the University of Wisconsin.51
Qualitative interviews
For patients who suffer serious postoperative complica-
tions, a trained interviewer from each centre will perform 
a face-to-face interview with the patient, if able, and/or 
the family member. Interviews will be audio-recorded and 
transcribed verbatim.
Outcomes
Aim 1: patient engagement
To assess patient engagement in decision making, we 
will use direct observation and patient report measured 
using a coding scheme established by Walczak and 
colleagues35 and the Perceived Efficacy in Patient–Physi-
cian Interactions (PEPPI-5) scale as our primary outcome 
measures. From transcriptions of the clinic conversa-
tions, two blinded and trained coders will independently 
count all questions, cues and concerns mentioned by the 
patient and all family members, friends or other care-
givers present during the conversation. Our secondary 
outcomes for patient engagement include the Observing 
Patient Involvement score52 53 used for the recorded 
conversation, and the Health Care Climate Questionnaire 
(HCCQ)54 administered to patients and family members 
at the time of the first questionnaire 24–48 hours after the 
visit with the surgeon. We adapted both the PEPPI-5 and 
the HCCQ for use by family members (table 2).
Aim 2: psychological well-being
We selected psychological well-being as an important 
outcome based on feedback from our patient and family 
stakeholders who reported significant emotional harm; 
specifically they felt ‘blindsided’ when surgical results 
did not match their expectations. The primary outcome 
measures to assess psychological well-being are the 
Measure Yourself Concerns and Wellbeing (MYCaW) 
and patient-reported post-treatment regret. MYCaW is a 
patient-reported outcome measure originally designed 
for patients with cancer and their family members, which 
we have adopted for use with patients who have vascular 
disease. MYCaW allows patients and family members to 
identify their own most pressing health concerns and 
rate their well-being. We will administer the MYCaW at 
the three time points. Patients and family members will 
report their initial responses to the MYCaW at the time 
of the first questionnaire, 24–48 hours after the clinic 
visit. Participants will independently rescore their initial 
concerns and well-being at the two subsequent time 
points corresponding to the second and third question-
naires; the difference in scores describes improvement or 
deterioration in their well-being. To assess treatment-asso-
ciated regret, we will ask patients and family members at 
the time of the third and final questionnaire — ‘Looking 
back, is there anything about your treatment/your family 
member’s treatment that you would do differently?’ 
— and transform responses into a dichotomous variable 
(regret, no regret) for analysis.55 We will also analyse these 
responses qualitatively.
Secondary 
outcome 
measures 
include 
validated 
measures 
from 
the 
Patient-Reported 
Outcomes 
Measurement Information System (PROMIS) to assess 
the psychological impact of illness from the patient’s 
perspective.56 Patients will receive the Psychosocial Illness 
Impact-Neg 4a, Psychosocial Illness Impact-Pos 4a and 
Anxiety 4a; family members will be asked to complete 
Anxiety 4a and PROMIS short form (SF) Global Health. 
Because studies of other interventions that support shared 
decision making show that in some situations informed 
patients elect more conservative treatment,57 we will 
compare the total number of operations scheduled and 
performed on enrolled patients by their study surgeon 
between the control and intervention groups. We will also 
collect information about potential mediating variables 
and covariates described in table 3.
Aim 3: postoperative conflict
In qualitative interviews with a subset of participants who 
suffered a serious postoperative complication, we will 
use questions designed to explore the content of patient 
and family experience with perioperative conflict. The 
interview guide is structured around open-ended ques-
tions about perioperative events, including ‘Tell me the 
story of your experience with surgery’.58 The interviewer 
will follow up the respondents’ narrative description 
with probing on the following domains: patient and 
family values and goals, decision making, interpersonal 
relationships (between surgeons and patients/family 
members, between treating physicians and between 
family members) and intrapersonal conflict (relating to 
post-treatment regret and self-blame). We will use feed-
back during concurrent coding and analysis to prompt 
additional questioning on emerging themes and trends.
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Planned analyses
Quantitative analyses
Our primary analysis will compare the effectiveness of 
the QPL intervention relative to usual care in regard to 
patient engagement and patient psychological well-being. 
We will use an intention-to-treat analysis with all avail-
able data from participants based on group assignment. 
The intervention effect will be tested in the framework 
of generalised linear mixed-effects models59 60 with a 
treatment dummy variable, surgeon random effect and 
site-by-time dummy variables to control for site-specific 
secular trends. We will use linear mixed-effect models 
for continuous responses such as self-efficacy (PEPPI-5) 
and well-being (MYCaW), logistic random-effects models 
for binary responses such as post-treatment regret, and 
log-linear random-effect models for count-dependent 
variables such as the number and type of questions asked 
during the preoperative visit. For linear models, we will 
adjust for prespecified covariates to increase the statistical 
precision of our treatment effect estimation.
Our secondary analyses will examine other patient 
endpoints such as psychological well-being (PROMIS 
measures) and nature of treatment received. These anal-
yses will also test for intervention effects in family member 
outcomes such as PEPPI-5, HCCQ, MYCaW, post-treat-
ment regret and psychological well-being. We will use 
the generalised linear mixed modelling framework used 
in primary analyses for these outcomes. All models will 
be estimated and tested using PROC MIXED or PROC 
NLMIX in SAS V.9.3.
We will perform additional analyses to test and quan-
tify whether and to what extent the effect of the QPL 
intervention on patient engagement outcome measures 
is mediated by the presence of a family member during 
the visit with the surgeon. Exploratory analysis of fami-
ly-reported outcomes will occur independently of 
patient-reported outcomes. To accomplish this, we will 
compare the indirect effect with the total effect in joint 
linear structural equation models for the endpoint and 
the mediator, including correlated random surgeon 
effects for each of the mediator and endpoint parts of 
the models. In addition, we anticipate treatment effect 
could vary across subpopulations defined by the following 
covariates: indication for surgery, patient comorbid illness 
and insurance status. Therefore, we will test the effect of 
treatment separately in subpopulations defined by these 
variables.
To decrease missing data, we limited the number of 
questions in the follow-up questionnaires and will provide 
a bonus incentive for participants who complete all three 
questionnaires. At the time of analysis, we will develop a 
comprehensive description of the missingness patterns 
and develop a plan for imputation that leverages the 
available data and concentrates on the data most heavily 
subject to missingness. If data are missing on predictor 
variables of interest, values will be imputed using multiple 
imputation techniques (ie, chained equations impu-
tations).61 62 If dropout is substantial, we will again use 
multiple imputation, including exploiting responses 
from the first two time points (day of clinic visit and 
24–48 hours postvisit), to impute responses from the final 
two questionnaires, to maximise statistical efficiency and 
to minimise bias.
Sample size and power calculation
Each arm will contain 240 patients, for a total of 480 
patient participants. Based on our prior work, we expect 
about 70%–80% of patients will have a family member 
present who will participate. Therefore, we estimate 384 
family members from all sites will partake, although we 
will enrol up to 480 family members if all patients have 
a family member interested in participating. Assuming 
all enrolled patients enrol with a family member, the 
maximum number of all possible participants (surgeons, 
patients and family members) is 1000.
For each quantitative aim, we desire a family-wise 
two-sided type I error rate of α=0.05; under a Bonfer-
roni correction, tests will be conducted with nominal 
α=0.05/2=0.025 because there are two primary endpoints 
for aim 1 and aim 2 (table 2). Using patient satisfaction 
data at one site, we found that between-surgeon vari-
ance accounts for only 5% of the total variance. Because 
power in the stepped wedge design is slightly degraded 
with greater variance between (vs within) surgeons, we 
assumed a worst-case scenario between-surgeon variance 
of 30%. We interpreted this as the interclass correlation 
between multiple patients of the same surgeon at a given 
site and included a surgeon-level random effect in our 
calculation, anticipating between 5% and 30% of the 
total variance to be accounted for by surgeon effects (ie, 
interclass correlation (ICC) =0.05–0.30). Extending the 
information-based method of computing power for a 
basic stepped wedge design49 to the case of our multisite 
stepped wedge design, we custom-programmed power 
calculations using R V.3.2.1 (R Foundation for Statistical 
Computing).
With this method, we computed power of 82% to detect 
small-to-medium and 93% to detect medium effect sizes of 
Cohen’s d63=0.425 and d=0.5, respectively. Assuming the 
SD for PEPPI-5 within each treatment arm is 4.3,64 we will 
have 93% power to detect effects as small as 2.15 points. 
For the number of patient questions, we assumed a mean 
difference of 1.4 questions between arms.40 Assuming 
overdispersion of two relative to Poisson data, within 
arm SD=2.7, yielding d=1.4/2.7=0.52, which we are 
well powered to detect. For the MYCaW well-being scale, 
Jolliffe et al65 found SD=1.26 at 6 weeks, and a 6-week 
versus baseline mean difference of 0.59. We will also have 
93% power to detect an MYCaW difference as small as 
0.5×1.26=0.63, comparable with the difference over time 
in Jolliffe et al.65 For regret, we assume the upper bound 
risk of the presence of regret is 0.3,55 yielding SD=0.46; 
we will have over 90% power to detect a regret risk differ-
ence of 0.23. Nearly identical power results were obtained 
via a continuous latent liability model for a binary event 
(regret).66 To account for clustering within sites, this 
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calculation includes fixed effects terms for site, time 
(wave) and site-by-time, reflecting our a priori analysis 
plan.
Qualitative analysis
We will use directed content analysis67 to compare inter-
personal and intrapersonal conflict between study arms 
as it relates to the phenomenon of surgical buy-in.28 32 68 
To gain understanding of the trajectory of each patient’s 
story, we will triangulate data sources by linking the 
audio tape of the surgeon–patient decision-making 
conversation and the patient’s clinical history from chart 
review with the follow-up interview. We have previously 
shown that surgeons see preoperative conversations as 
a significant event, a time when a two-way agreement is 
made whereby the surgeon commits to operating and 
the patient commits to endure potentially burdensome 
postoperative care.28 We will use this understanding of 
surgical buy-in to code and analyse preoperative clinic 
visits and postoperative interview transcripts with the 
goal of understanding how the contractual relationship 
that surgeons perceive is experienced by patients. We will 
explore how postoperative complications were discussed 
during the initial patient–surgeon interaction with and 
without the QPL and whether this interaction has impact 
on subsequent treatment decisions, interpersonal and 
intrapersonal conflict.
ETHICS AND DISSEMINATION
Ethical review
All participants will provide written informed consent 
and may withdraw from the study at any time without 
affecting the medical care they receive from the clinical 
team. For surgeons, study participation will not affect 
their professional standing. Institutional review board 
approval has been granted at each of the five sites, and 
a Certificate of Confidentiality has been granted in 
order to offer enrolled surgeons protection from legal 
demands, such as subpoenas and court orders for study 
data. Identifying information on recorded transcripts will 
be redacted prior to analysis, and all audio recordings 
and hard copies of data will be destroyed after analysis 
is complete and manuscripts are submitted. The aims of 
the study meet the criteria for minimal risk. We will follow 
accepted adverse event monitoring procedures including 
regular review by the Data Monitoring Committee.
Relevance and dissemination
The design of the QPL intervention addresses important 
gaps in preoperative communication between surgeons 
and older adults facing a decision about high-risk surgery. 
The results of this study will inform our understanding 
of how interventions to confront interactional barriers 
between doctors and patients affect patients’ capacity to 
participate and share in decision making. The engage-
ment of a variety of stakeholders and incorporation of 
deeply held concerns of patients and families into the 
development of the QPL are strengths that create potential 
for significant impact. Furthermore, should we find the 
intervention superior to usual care, it is inexpensive and 
easily scalable to facilitate widespread dissemination in all 
outpatient clinics where high-risk surgery is considered. 
We anticipate these results will be generalisable to other 
surgical settings as well as encounters for patients who 
have been referred specifically for discussion of other 
types of treatment, for example in medical or radiation 
oncology clinics.
Efficacy, however, is contingent upon a letter of 
endorsement from the surgeon that accompanies 
the QPL brochure. Furthermore, durable changes in 
surgeon behaviour as a result of questions and attitudes 
the QPL engenders in their patients may contribute to 
the effectiveness of the intervention over time. As such, 
our dissemination strategies will be targeted primarily at 
surgeons. We have support of leadership at the American 
College of Surgeons (ACS) and anticipate dissemination 
through various ACS portals, including the National 
Surgical Quality Improvement Program and the Coalition 
for Quality in Geriatric Surgery, as well as distribution of 
the intervention and description of the implementa-
tion processes on the ACS website. In addition, based 
on feedback from our patient and family advisors who 
felt dissemination of results to patients and families is 
critically important, we will provide study updates and 
distribute study results via a study website. We plan to 
present study results at the annual ACS Clinical Congress 
and local chapter meetings. We plan to publish the main 
trial outcomes in a peer-reviewed journal. We will follow 
the CONSORT reporting standards for pragmatic69 and 
cluster-randomised70 trials. Study results will be released 
to participating surgeons, patients, families and the 
general medical community.
Author affiliations
1Department of Surgery, University of Wisconsin, Madison, Wisconsin, USA
2Department of Biostatistics and Medical Informatics, University of Wisconsin, 
Madison, Wisconsin, USA
3Department of Surgery, Rutgers New Jersey Medical School, Newark, New Jersey, 
USA
4Department of Surgery, Oregon Health and Science University, Portland, Oregon, 
USA
5Department of Surgery, University of California, San Francisco, California, USA
6Department of Surgery, Brigham and Women’s Hospital, Boston, Massachusetts, 
USA
7Denver Public Health, Denver Health and Hospital Authority, Denver, Colorado, USA
8University of Wisconsin Institute for Clinical and Translational Research, Madison, 
Wisconsin, USA
9Department of Surgery, University of Wisconsin, Madison, Wisconsin, USA
10Department of Medical History and Bioethics, University of Wisconsin, Madison, 
Wisconsin, USA
Acknowledgements The authors would like to thank Betty Kaiser, PhD, RN, and 
Gay Thomas, MA, of the Wisconsin Network for Research Support for guidance in 
creating and planning the Patient and Family Advisory Council. They would also 
like to acknowledge the patients and family stakeholders who provided invaluable 
feedback throughout the development of the QPL intervention and development of 
study materials.
Contributors MLS is the principal investigator for this study. She developed the 
original study design and protocol together with PJR, who provided study design 
and biostatistical support, and the site principal investigators ZC, AnaB, ACM, 
EF and KJB. NJ provided guidance in study design specific to the qualitative 
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components. QZ provided biostatistics support. AnneB is the study coordinator and 
has the primary responsibility of coordinating development of all study materials. 
LJT drafted this manuscript and along with JLT helped with development of study 
materials. JLT and NMS synthesised input from patient and family stakeholders 
and contributed to study design. All authors reviewed and approved this 
manuscript.
Funding Research reported in this work was funded through a Patient-Centered 
Outcomes Research Institute (PCORI) Award (CDR-1502-27462). MLS was also 
supported by (1) Training Award KL2TR000428 from the Clinical and Translational 
Science Award program, in part by Grant UL1TR000427 to UW ICTR from NIH/
NCATS; (2) through the University of Wisconsin-Madison School of Medicine and 
Public Health’s Wisconsin Partnership Program, WPP-ICTR Grant #3086; and (3) 
the Greenwall Foundation Kornfeld grant. LJT is supported by a Training Award 
T32CA090217 from the NIH. AnaB is supported by the New Jersey Medical School 
Hispanic Center of Excellence, Health Resources and Services Administration 
through Grant D34HP26020. This content is solely the responsibility of the authors 
and does not necessarily represent the official views of the NIH or the views of the 
Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or 
Methodology Committee.
Competing interests None declared.
Ethics approval The trial protocol and all study forms and material have been 
approved by the University of Wisconsin Institutional Review Board, as well as the 
institutional review boards at each participating site.
Provenance and peer review Not commissioned; externally peer reviewed.
Open Access This is an Open Access article distributed in accordance with the 
Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which 
permits others to distribute, remix, adapt, build upon this work non-commercially, 
and license their derivative works on different terms, provided the original work is 
properly cited and the use is non-commercial. See: http:// creativecommons. org/ 
licenses/ by- nc/ 4.0/
© Article author(s) (or their employer(s) unless otherwise stated in the text of the 
article) 2017. All rights reserved. No commercial use is permitted unless otherwise 
expressly granted.
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