ORIGINAL RESEARCH ARTICLE

Novel Statistical Approach to Determine Inflammatory BowelDisease: Patients’ Perspectives on Shared Decision Making

Corey A. Siegel1 • Jennifer H. Lofland2 • Ahmad Naim3• Jan Gollins4 •

Danielle M. Walls5 • Laura E. Rudder6 • Chuck Reynolds6

� Springer International Publishing Switzerland 2015

Abstract

Background Limited information is available on patients’

perspectives of shared decision-making practices used in

inflammatory bowel disease (IBD).

Objective The aim of this study was to examine patient

insights regarding shared decision making among patients

with IBD using novel statistical technology to analyze

qualitative data.

Methods Two 10-patient focus groups (10 ulcerative

colitis patients and 10 Crohn’s disease patients) were

conducted in Chicago in January 2012 to explore patients’

experiences, concerns, and preferences related to shared

decision making. Key audio excerpts of focus group in-

sights were embedded within a 25-min online patient sur-

vey and used for moment-to-moment affect trace analysis.

Results A total of 355 IBD patients completed the survey

(ulcerative colitis 51 %; Crohn’s disease 49 %; female

54 %; 18–50 years of age 50 %). The majority of patients

(66 %) reported increased satisfaction when they par-

ticipated in shared decision making. Three unique patient

clusters were identified based on their involvement in

shared decision making: satisfied, content, and dissatisfied.

Satisfied patients (18 %) had a positive physician rela-

tionship and a high level of trust with their physician.

Content patients (48 %) had a moderate level of trust with

their physician. Dissatisfied patients (34 %) had a life

greatly affected by IBD, a low level of trust of their

physician, a negative relationship with their physician,

were skeptical of decisions, and did not rely on their

physician for assistance.

Conclusion This study provides valuable insights re-

garding patients’ perceptions of the shared decision-mak-

ing process in IBD treatment using a novel moment-to-

moment hybrid technology approach. Patient perspectives

in this study indicate an increased desire for shared deci-

sion making in determining an optimal IBD treatment plan.

This work has been presented in part at the American College of

Gastroenterology Annual Meeting, Las Vegas, NV, USA, on 22

October 2012.

Electronic supplementary material The online version of thisarticle (doi:10.1007/s40271-015-0126-z) contains supplementarymaterial, which is available to authorized users.

& Jennifer H. Lofland

jlofland@its.jnj.com

1 Inflammatory Bowel Disease Center, Dartmouth–Hitchcock

Medical Center, Lebanon, NH, USA

2 Health Economics and Outcomes Research, Janssen

Scientific Affairs, LLC, 850 Ridgeview Drive, Horsham, PA

19044, USA

3 Incyte Corporation, Wilmington, DE, USA

4 Delta Modelling, Mt Prospect, IL, USA

5 BDJ Solutions, Melrose, MA, USA

6 The Benfield Group, St Louis, MO, USA

Patient

DOI 10.1007/s40271-015-0126-z

Key Points for Decision Makers

This study provides valuable patient insights

regarding the shared decision-making process in IBD

treatment using a novel moment-to-moment hybrid

research approach, which quantifies information

from focus groups using a large sample of cohorts.

Cluster analyses applied to the moment-to-moment

variables identified three unique patient clusters of

satisfaction with their role in decision making:

satisfied, content, and dissatisfied.

The majority of IBD patients want to be actively

involved in treatment decision making, want to be

well informed, and report increased satisfaction

when they participate in shared decision making.

However, a notable proportion of patients report

dissatisfaction with their role in shared decision

making, often resulting in a search for a new

physician.

Further research into the three distinct IBD patient

types, particularly the ‘Dissatisfied’ cluster of

patients who experience less shared decision making,

is warranted.

1 Introduction

Shared decision making is a collaborative engagement

process between patient and clinician through which de-

cisions are shared based on evidence-based medicine and

the values and needs of the patient [1]. Shared decision-

making tools, such as decision aids, are often used to

prepare patients for making a decision about a treatment

choice. Decision aids used in the decision-making process

have been shown to increase patient participation in deci-

sion making, reduce decisional conflict, and increase pa-

tient satisfaction [2–4]. Emerging evidence suggests that

other benefits of shared decision making and decision aids

include better self-management of disease, reduced medi-

cal costs, and physician satisfaction [5–7]. Shared decision

making is a model of healthcare that can promote quality

care and benefit multiple stakeholders throughout the

healthcare supply chain. Although existing data support the

benefits of implementing the shared decision-making

model, the model has not been widely adopted by health-

care practitioners [8]. The actual implementation of a

structured shared decision-making model will require a

paradigm shift among many stakeholders, and will need to

address the barriers that healthcare professionals have

identified in implementing a shared decision-making model

in clinical practice [8].

Inflammatory bowel disease (IBD) is comprised mainly

of two major chronic inflammatory disorders of the gas-

trointestinal tract—Crohn’s disease and ulcerative colitis.

IBD is a complex disease whose heterogeneous disease

process offers a clinical scenario that is unique for each

patient and requires long-term management. With the ad-

vent of biologic therapies (e.g. anti-tumor necrosis factor

[TNF] agents), which are currently considered standard

treatment for IBD, treatment options have greatly im-

proved. Furthermore, as a result of cumulative research that

has shown improved efficacy with early combined anti-

TNF and immunomodulator (thiopurine) therapy, a ‘top-

down’ versus ‘step-up’ approach to the use of anti-TNF

agents has become more accepted [9]. Based on the mul-

tiple medication options and different proposed treatment

algorithms, patients have a myriad of treatment choices

with varying risk–benefit profiles to consider, often leading

to patient psychosocial distress in the decision-making

process [10].

Because of the increasing complexity of IBD treatment

choices, it is critically important that patients with IBD

understand the potential benefits and risks of therapeutic

options prior to choosing an appropriate treatment. Shared

decision making is a collaborative way for IBD patients to

participate in choosing a treatment that best suits their

values and preferences. Unfortunately, prior research sug-

gests that individuals with IBD have brief, limited dis-

cussions with their gastroenterologists regarding treatment

options [11].

Siegel et al. have recently developed a shared decision-

making tool for patients with Crohn’s disease who are

contemplating a decision to use immunomodulators, anti-

TNF agents, or combination therapy [12, 13]. The decision

aid, using both pictorial and verbal explanations, offers

information regarding long-term treatment options, in-

cluding benefits and side effects. To date, limited infor-

mation is available on patients’ perspectives of shared

decision making or shared decision-making tools (i.e. de-

cision aids) used in IBD. In a survey conducted in over

1000 IBD patients, 81 % of respondents reported that it

was very important to be actively involved in the decision-

making process regarding treatment options [14]. There-

fore, additional research from the patient’s perspective is

needed to examine the barriers and motivations for im-

plementing shared decision making in the physician–pa-

tient conversation regarding IBD therapeutic intervention.

The objectives of the current study were to examine

patient insights about shared decision making among pa-

tients with IBD using novel statistical technology to ana-

lyze qualitative data. These patient-oriented data in the

C. A. Siegel et al.

current study are part of a three-phase, multi-stakeholder

research project that also includes physician research and

an expert consensus panel. It is hoped that the combined

data from these three research phases will offer key

learnings regarding stakeholders’ motivations and barriers,

and will generate recommendations for the effective and

efficient implementation of shared decision making.

2 Materials and Methods

2.1 Study Design

This was a mixed-methods research study consisting of

qualitative and quantitative components. This hybrid ap-

proach consisted of the following: (1) a qualitative com-

ponent—two focus groups; and (2) a quantitative

component—an online patient survey using key focus

group insights with moment-by-moment rated discussion.

2.2 Participants and Recruitment

Qualitative After approval from the Dartmouth College

Committee for the Protection of Human Subjects, two fo-

cus groups (one group of 10 ulcerative colitis patients and

one group of 10 Crohn’s disease patients) were conducted

in January 2012. Focus group patients were recruited

through Schlessinger Associates, a professional research

panel (Iselin, NJ, USA). Qualified focus group participants

were 18 years of age or older and resided in the US. Par-

ticipants had been diagnosed with Crohn’s disease and/or

ulcerative colitis by a gastroenterologist for 2 or more

years, had tried three or more different treatments since

IBD diagnosis, and had participated in an IBD focus group

no more than six times. Participants could also not be a

medical or market research professional. Potential par-

ticipants answered a brief screener survey to identify if

they qualified and were interested in participating in the

focus group.

Quantitative Survey participants were recruited in April

2012 through Research Now (Plano, TX, USA), a profes-

sional research panel. Qualified focus group participants

were 18 years of age or older and lived in the US. Par-

ticipants had been diagnosed with Crohn’s disease and/or

ulcerative colitis. If the participant had been diagnosed

with ulcerative colitis, the patient could not have had a

colectomy. Neither the participant nor a member of their

household could have been a medical professional.

2.3 Data Collection

Qualitative The purpose of the recorded focus group dis-

cussion was to explore patients’ experiences, concerns, and

preferences related to shared decision making in order to

identify how shared decision making tools can be more

commonly used and effectively and efficiently imple-

mented. Participants were asked about perception of their

disease, its management, and decision-making practices (if

any), relationship with their physician, knowledge of

shared decision making, and their insights towards imple-

mentation of shared decision making in their treatment

decision planning. The guiding principle in the focus

groups was to elicit both similar and contrasting opinions.

The focus group discussion followed the following format

(see online supplementary appendix for focus group mod-

erator guide): (1) began broadly by asking patients what

they considered to be a successful outcome of their

treatments; (2) explored patients’ knowledge level of IBD

and what actions they take to understand their disease and

its treatments; (3) moderated an in-depth discussion about

patients’ experiences with decision making; (4) discussed

patients’ assumptions about providers to understand per-

ceptions and attitudes that may impact the decision-mak-

ing process (from the patient perspective); (5) explored

patient ideas and recommendations regarding the approach

and processes that physicians and clinical staff should

have in place to promote patient engagement in decision

making; (6) focused on how treatment benefits and risks

should be addressed during the decision-making process;

and (7) included rating and prioritization of specific

treatment risks and benefits. The focus group discussion

lasted 2 h.

Quantitative The 25-min online patient survey consisted

of two audio clips featuring key excerpts taken from de-

identified focus group recordings, as well as 40 demo-

graphic and quantitative questions. Key audio excerpts (see

online supplementary appendix for survey details and au-

dio transcripts) were identified based on comments relative

to objectives of the research, comments about experiences

that might be relevant to large numbers of IBD patients,

and different opinions about common IBD-related issues.

Survey participants answered demographic and back-

ground health questions before they watched a 1-min video

tutorial that explained the use of a media rating tool and

allowed participants to practice using the tool (see online

supplementary appendix for audio training video script). A

total of 355 IBD patient participants were then asked to

‘listen and rate’ the key audio excerpts from the two focus

groups. The excerpts were approximately 8 and 4 min,

respectively. The content of the focus group excerpts re-

flected a range of patients’ perspectives on shared decision

making and experiences with IBD as described above in

the objectives of focus groups discussions.

The purpose of the media rating tool was to capture

participants’ ongoing reactions to what they were hearing

in a media stimuli. For this research application, a 0–10

Patients’ Perspectives on Shared Decision Making

Likert agreement scale was used, with ‘0’ representing

strongly disagree, ‘5’ representing neutral, and ‘10’ rep-

resenting strongly agree. Participants moved their pointing

device (mouse or touchpad) up and down to register their

agreement or disagreement while listening to the audio.

The rating tool was located directly under the media and

participants had easy visual clues, including a position

marker on the large scale and a number representing their

current rating position. Participants were instructed to re-

turn their mouse to a neutral position (5 on the 1–10 scale)

when the moderator was speaking, otherwise participants

could rate their level of agreement at any time during the

audio. Participant media rating position was recorded every

second, and up to 240 distinct data points were possible for

a 4-min media clip. The range of possible values was 0 and

10 with precision of 2 decimal points.

Following the rating of the audio, participants were asked

a set of discrete follow-up questions related to the focus

group discussion topics (see survey in the online supple-

mentary appendix for further details). No formal pilot study

was conducted; however, after 50 survey completions by

IBD patients, researchers reviewed the responses to assess

the quality of the data. Finding no discrepancies in patient

responses, no modifications to the survey were made and the

survey was continued to the conclusion of the study.

2.4 Data Analyses

Survey and media rating data were analyzed using a variety of

techniques, including descriptive statistics, crosstabs, sig-

nificance testing including Chi-square test for independence,

cluster analysis, and multiple discriminant analysis. The Chi-

square test for independence helped identify significant rela-

tionships between variables, while cluster analysis and mul-

tiple discriminant analysis were used exclusively for

analyzing media rating data. Simple descriptive statistics were

used to summarize demographics and discreet choice re-

sponses. An average of all participants’ second-by-second

ratings/traces were presented as a single ‘all-trace’ line. Ad-

ditional moment-to-moment trace lines using demographic

and other discrete variables were created to examine subseg-

ments of the sample such as gender, income, and age.

Cluster analysis was employed in order to detect distinct

patterns in media rating data that could not otherwise be

uncovered by looking at demographic or other quantitative

segments. The specific method of clustering used was

K-means, a non-hierarchical mutually exclusive clustering

method which allows cases to be reassigned until an opti-

mal cluster solution is reached. The clusters were not re-

quired to be of equal sizes. There was one outlier whose

data were not used or analyzed.

For each cluster, average moment-to-moment traces

were created and the patterns of response for each

individual cluster were examined on a second-by-second

basis over the audio portion of the survey. The mutually

exclusive cluster groups contain respondents who have a

similar response pattern. Specifically, patient response

patterns within a cluster group are more similar to each

other than the patterns identified in the other clusters. The

consistent pattern of the moment-to-moment traces is an

overall reflection of the group’s attitudinal and cognitive

response and reaction to the issues put forth in the focus

group audio excerpts. The different response patterns of

each cluster are remarkably different from the ‘all’ trace or

any other trace pattern generated by standard demographics

or a priori participant segments. Examining the trace pat-

terns of all the clusters over the course of an entire audio

discussion visually illustrates where clusters converge on a

common point of view (i.e. agree) and where their views

dramatically differ (i.e. disagree).

Clusters were named based on their respective cognitive

responses and attitudes inherent in moment-to-moment

trace patterns. Each cluster name was based upon the

unique response pattern and reaction (i.e. positive/nega-

tive) related to the content discussed throughout the

discussion.

Cross-tabs were used to identify significant relationships

between clusters in terms of demographics, attitudinal,

behavioral, and other relevant participant data to profile the

distinguishing characteristics of each cluster segment. The

frequency distribution (percentage of population) was re-

ported for categorical variables and descriptive statistics

(mean, standard deviation) were reported for continuous

variables. The Chi-square test for independence was used

to determine if there was a statistically significant rela-

tionship between the cluster group and other categorical

variables.

Multiple discriminant analysis was used to determine

divergent points of discussion between the three clusters.

The potency index was calculated based upon the structure

matrix and eigenvalues to determine the overall impact of

each second of the discussion group. Statistically sig-

nificant subsegments (blocks of time in seconds) within the

discussion were identified as the most divisive and dis-

criminating opinions among the clusters.

3 Results

Of the 355 IBD patients who completed the survey, mean

age was 49 years (range 18–50; 54 % female), 51 % had

ulcerative colitis, 49 % had Crohn’s disease, 21.4 % were

diagnosed less than 2 years ago, 39.4 % were diagnosed

between 2 and 10 years ago, and 39.2 % were diagnosed

10 or more years ago. Respondents represented different

levels of severity, as measured by abbreviated Mayo Clinic

C. A. Siegel et al.

and Crohn’s Disease Activity Index (CDAI) scores. The

majority of patients were well-educated (57 %) with a

bachelor’s or post-graduate degree. Almost half (47 %) of

IBD patients received insurance coverage through an em-

ployer. The majority of patients (55 %) had never used a

biologic medication. One-third of patients had used or were

using a biologic medication to treat their IBD, and 12 %

responded ‘don’t know’.

3.1 Quantitative Survey Results

3.1.1 Patient Knowledge of Inflammatory Bowel Disease

Almost all patients responded that they had some knowl-

edge of their IBD. The majority of patients said they were

knowledgeable to very knowledgeable about their disease

(66 %). Over three-quarters of patients had some knowl-

edge of the IBD treatment available to them; however, less

than half (41 %) said they were knowledgeable to very

knowledgeable about their treatment options.

3.1.2 Sources of Shared Decision-Making Information

The vast majority of patients receive information about

IBD from their physicians (88 %), and half of the patients

used health information websites to learn about IBD

(Fig. 1). Physicians are patients’ most trusted source of

shared decision-making information (high trust 49 %).

Almost three-quarters of patients would prefer to receive

information about how shared decision making can help

them make decisions about IBD treatment from a face-to-

face conversation with physicians or their staff (74 %).

However, a large percentage are also comfortable learning

more about shared decision making and IBD from the In-

ternet (63 %).

3.1.3 Patient Satisfaction with Shared Decision Making

The majority of patients (66 %) reported increased satis-

faction with their care when they participated in shared

decision making. Many patients believe that they are al-

ready experiencing a form of shared decision making, with

72 % of patients indicating that their physician practices

shared decision making regularly or even more frequently.

The majority of patients believe that their physicians treat

them with respect and listen to what they have to say

(Fig. 2).

Patients were largely satisfied with their role in decision

making and said that they have satisfactorily experienced

or understood components of the decision-making process.

However, approximately one-third of patients did not un-

derstand the benefits, risks, and side effects of each treat-

ment option, and 19 % were not satisfied with how much

they were participating in making decisions about their

IBD treatment. Approximately one-third of patients (32 %)

switched physicians because of the way the physicians

made IBD decisions. Patients who did not experience

shared decision making were interested in making shared

decisions more frequently (extremely interested 42 %).

When answering the question ‘‘What would you change

Fig. 1 Sources of IBD

information. IBD inflammatory

bowel disease

Patients’ Perspectives on Shared Decision Making

between you and your physician to make shared decision

making a positive experience for you?’’, patients had bal-

anced and pragmatic expectations of decision-making roles

and responsibilities (Fig. 3).

3.1.4 Patient Clusters

Cluster analyses applied to the moment-to-moment vari-

ables identified three unique patient clusters of satisfaction

with their role in decision making: satisfied (17.5 %),

content (47.7 %), and dissatisfied (34.7 %) (Fig. 4;

Table 1). Clusters were named based on their respective

cognitive responses and attitudes inherent in moment-to-

moment trace patterns. Each cluster name was based upon

the unique response pattern and reaction (i.e. positive/

negative) related to the content presented throughout the

discussion.

Satisfied patients (18 %) were characterized as having a

positive physician relationship and a high level of trust

with their physician. Ninety-seven percent of satisfied pa-

tients indicated high trust in their physician as an infor-

mation source compared with 81 % of content and 66 % of

dissatisfied patients (p\ 0.001). Satisfied patients

(n = 62) were more likely to agree with a set of statements

in the survey that generally indicated more confidence in

their decision making about their IBD and more

23%

19%

18%

14%

26%

27%

25%

25%

27%

30%

38%

45%

0% 20% 40% 60% 80% 100%

Agree Strongly Agree Completely Agree

My doctor treats me with respect

My doctor listens to what I have to say

in making decisions about my IBD treatment

Overall, I am confident in my IBD treatment decisions

84%

80%

76%

76%

Fig. 2 Decision-making

process between physician and

patient. IBD inflammatory

bowel disease

Fig. 3 Moment-to-moment of patient ideal scenario of shared decision making. SDM shared decision making

C. A. Siegel et al.

understanding of the risks and benefits. A higher percent-

age of satisfied patients (66 %) indicated that their physi-

cian practices shared decision making compared with

content (53 %) and dissatisfied (33 %) patients

(p\ 0.001).

Satisfied patients were more likely to be male (60 %;

p\ 0.001), older (52 % over 60 years of age), insured

through Medicare (42 %; p\ 0.001), and be diagnosed 10

or more years ago (52 %; p = 0.006). Disease severity was

generally mild to moderate, with the majority of satisfied

patients reporting a normal number of daily stools (ul-

cerative colitis, n = 180, 56 %; p\ 0.001). A majority of

satisfied Crohn’s disease patients (47 %; p = 0.019) indi-

cated that their overall well-being was ‘well’. Ap-

proximately three-quarters of satisfied patients indicated

that IBD had little effect on their work (77 %; p\ 0.001).

IBD had the least effect on satisfied patients, 74 % of

whom indicated that IBD had little effect on daily life

(p\ 0.001) compared with 64 % of content and 29 % of

dissatisfied patients.

Figure 5 features a cluster trace for a key section of

audio related to physician–patient relationship. Table 2

contains the quotes associated with the Fig. 5 rated audio

clip. This audio clip demonstrates how the clusters’ cog-

nitive responses and inherent attitudes differed from each

other. When responding to audio about physician–patient

relationships, the satisfied cluster showed a significantly

more positive relationship with their physician and the

dissatisfied cluster had less trust and a weaker relationship

overall with their physician. For example, the satisfied

Fig. 4 Patient moment-to-moment responses based on cluster analysis-audio segment: perspectives on treatment decisions with physicians

Table 1 Cluster profiles

Cluster description

Satisfied cluster

(17.5 %)

More positive relationship with physician

Higher level of trust with their physician

Older and more likely to have been diagnosed

10 or more years ago

Less severe and better managed IBD

Content cluster

(47.7 %)

More or less content

Moderate level of trust in their physician

Dissatisfied cluster

(34.7 %)

Dissatisfied and negative relationship with

physician

Life and work more affected by IBD

Lower level of trust in their physician

More skeptical about decisions made by

physician

More interested in getting information about

IBD from sources other than their physician

IBD inflammatory bowel disease

Patients’ Perspectives on Shared Decision Making

cluster agreed very strongly with the sentiment ‘‘I had a

wonderful doctor who was all about health…I trust his

opinion and his treatment choices…’’, moving from an

average rating near 2 to an average rating near 9. The

content cluster also agreed with this statement, shifting

from an average rating of approximately 5 to almost 7.

Meanwhile, the dissatisfied cluster was the only cluster

where the average rating decreased (from approximately 8

to 7).

Content patients had less severe or more controlled

cases of IBD. Furthermore, the effect of IBD on the life of

content patients was generally moderate or minimal. Fifty-

eight percent (58 %) of content ulcerative colitis patients

indicated a normal number of stools. This percentage is

similar to the 56 % of satisfied patients but quite different

from the 23 % of dissatisfied patients (p\ 0.001). Almost

two-thirds (64 %) of content patients indicated that IBD

had little effect on work compared with 77 % of satisfied

patients and 39 % of dissatisfied patients (p\ 0.001). Over

one-third of content patients (36 %) indicated that IBD had

some effect on their daily life compared with 26 % of

satisfied patients and 71 % of dissatisfied patients

Fig. 5 Audio snapshot of moment-to-moment response regarding the doctor–patient relationship

Table 2 Cluster trace quotes for Fig. 5

Marker Quote

G I don’t trust them. I want to know what they’re up to and what they’re thinking and I want to talk to another doctor if I don’t think I’m

getting enough information from them

H I’ve seen a few doctors that I feel like are a bit arrogant and they talk to you like you’re an idiot, and at times I won’t listen to advice

that I’ve been given

I I had a wonderful doctor who was all about health, restoration, and prosperity. Because of that, I trust his opinion and his treatment

choices, and if it’s not broke, don’t fix it

J I think maybe if I had more trust in my doctor then I wouldn’t be so skeptical of his suggestions

K I try to take as little prescription drugs as possible. I’d rather have a doctor that’s going to help me treat myself

L I am not saying I don’t believe in doing all I can to help control my disease, but at the end of the day, I trust my doctor to prescribe

medications that will help me get better

M Sometimes when I ask for the options, he might tell me, with this percentage of your colon being inflamed, this is the only option you

have, he’ll explain it to me. But, I have to push for that, for him to say, these are all the options that are available to you and this is the

percentage of good they would be by treating it or not

C. A. Siegel et al.

(p\ 0.001). Content patients (48 %) were characterized as

having a moderate level of trust with their physician.

Eighty-one percent (81 %) of content patients indicated a

high level of trust in their doctor compared with 97 % of

satisfied patients and 66 % of dissatisfied patients

(p\ 0.001). Gender distribution was skewed slightly to-

wards males in content patients (56 %; p\ 0.001).

Dissatisfied patients were characterized by the follow-

ing: (1) being dissatisfied; (2) having a life that is greatly

affected by IBD; (3) having a low level of trust of their

physician; (4) having a negative relationship with their

physician; (5) being skeptical of decisions made by their

physician; and (6) not relying on their physician for as-

sistance. Dissatisfied patients were more likely to be female

(76 %; p\ 0.001), younger (over 60 years of age, 12 %;

35 years of age or younger, 32 %; p\ 0.001), and not as

likely to be diagnosed 10 or more years ago (27 %;

p = 0.006) compared with satisfied patients.

Only one-third (33 %; p\ 0.001) of dissatisfied patients

indicated that their physician almost always practices

shared decision making with them. Dissatisfied patients

(59 %; p = 0.022) were also more likely than the other

clusters to get information about their IBD from health

information websites. Approximately 95 % of patients in

the satisfied and content patient clusters thought that the

physician was the most useful information source com-

pared with 85 % of dissatisfied patients (p = 0.004). In

general, dissatisfied patients reported higher severity of

disease compared with satisfied patients. Unlike satisfied

patients, fewer dissatisfied patients had normal stools (ul-

cerative colitis, 23 %; p = 0.001). Similarly, only 16 %

(p = 0.019) of dissatisfied Crohn’s disease patients indi-

cated that their overall well-being was ‘well’. Ap-

proximately one-third of dissatisfied patients indicated that

IBD had little effect on their work (39 %; p\ 0.001) and

daily life (29 %; p\ 0.001). Thirty-nine percent (39 %) of

dissatisfied patients indicated that IBD had a moderate

effect on daily life compared with less than 15 % for sat-

isfied and content patients.

4 Discussion

The results of this study offer unique insights into IBD

patients’ perspectives on shared decision making as it re-

lates to treatment of their disease. Although IBD patients

are knowledgeable about their disease, they fall short of

understanding the risks and benefits of IBD treatment op-

tions. IBD patients value their physicians’ support and

expertise as a trusted source of information and prefer face-

to-face conversations. The majority of patients use Internet

resources to gather shared decision making and IBD in-

formation. These IBD patients want to be actively involved

in treatment decision making, want to be well informed,

and report increased satisfaction when they participate in

shared decision making. However, the data show that a

notable proportion of patients report dissatisfaction with

their role in shared decision making, often resulting in a

search for a new physician.

The three distinct clusters of patients identified were

those who were satisfied, content, or dissatisfied with the

shared decision-making process with regard to the deter-

mination of an optimal IBD treatment strategy. The dif-

ference in demographics and disease characteristics

between satisfied and dissatisfied patients are notable yet

inconclusive. The dissatisfied cluster of IBD patients de-

scribes a population of patients who tend to be younger,

female, have greater disease severity, and report less shared

decision making. The reasons for these patients’ dissatis-

faction are unknown. However, contributing factors may

include, but are not limited to, patients not participating in

shared decision making with their physicians, or severity of

disease (i.e. patients’ disease process was less treatable).

Regardless of the reason for the dissatisfaction in the shared

decision-making process, these patients are clearly suffer-

ing to a greater degree than other patients and deserve closer

examination. More research is needed to learn more about

this dissatisfied cluster of patients, their current experi-

ences, and how systematic shared decision making may

improve their future experiences. Similarly, further research

on the satisfied and content clusters of patients may enhance

understanding around the favorable aspects of the shared

decision-making process from the patient’s perspective.

The management of a chronic condition such as IBD,

with cycles of severe symptoms and remission, is par-

ticularly challenging to treat and manage long term. This

makes IBD well-suited to a comprehensive shared deci-

sion-making approach to treatment. A fundamental re-

quirement of effective shared decision-making practice is a

strong doctor–patient relationship. The cluster analysis has

enabled us to identify and begin to describe the relationship

between shared decision making, patient–physician inter-

actions, and disease severity. Although this relationship

seems intuitive, the research confirms that shared decision

making for a chronic condition such as IBD is likely easier

and more effective among patients who have a strong

positive relationship with their physician [15, 16]. The

satisfied cluster of patients in this study illustrates one end

of a spectrum featuring a patient group with a high level of

trust in their physician and less severe or better-managed

IBD. In contrast, the dissatisfied cluster is on the other end

of the spectrum and is characterized by a poor relationship

and less trust in their doctor, more severe IBD, more

skepticism of the information provided by their physician,

and a greater desire to get information from alternative

sources.

Patients’ Perspectives on Shared Decision Making

Shared decision-making tools, such as treatment deci-

sion aids, can increase patient involvement and satisfaction

in the shared decision-making process [3, 4]. However,

understanding patients’ perspectives on shared decision

making is the essential first step for implementing the ap-

propriate shared decision-making tools and decision aids in

patients with IBD. Patients with IBD have been shown to

misperceive the benefits and risks of IBD treatment options

and demand a high remission rate before they are willing to

accept treatment-related risks [11]. Although there is a

paucity of data on the subject of shared decision making in

IBD patients, the conclusions of the few existing reports

support those of the current study in that patients are often

confused about the benefit–risk profiles of IBD treatments,

and they feel it is important to be actively involved in

making decisions regarding treatment of IBD [14].

Focus groups are a widely used research method to gain

various patient insights and provide qualitative in-depth

learning of behaviors, attitudes, and perceptions. However,

due to the small number of participants (usually 10–12) in a

focus group, qualitative information derived from these

groups lacks the empirical robustness of traditional quan-

titative approaches. Furthermore, researchers struggle to

quantify, analyze, and interpret focus group research re-

sults in order to generalize qualitative opinions to larger

populations. Therefore, the objective of the online-rated

focus group discussion was to understand why IBD patients

think and feel the way they do about shared decision

making and IBD and to quantify those emotions.

The online-rated focus group discussion is a research

method that generates a moment-to-moment tracking pro-

cess similar to the research method currently used to track

the level of positive or negative affect that a consumer

experiences and displays while watching a television ad-

vertisement. This technology has also been used to visu-

alize feedback to candidates’ comments from opposing

party focus groups during a political debate. Prior research

using moment-to-moment evaluations of television adver-

tisements has typically used this methodology to link key

aspects of the affect trace to retrospective evaluations of

the advertisement [17]. Similarly, this approach in the

current study assumes that participants listening and rating

an IBD patient focus group discussion are integrating both

positive and negative emotional content in forming their

overall evaluation of the focus group discussion. The novel

hybrid research methodology used in this study, which

integrates traditional qualitative and quantitative research

in a single process, has identified varying patient shared

decision-making needs based on patient characteristics,

perceptions, and beliefs of different IBD populations.

Media rating technology has been employed most ex-

tensively in the testing of commercials by major advertisers

and for political research [17, 18]. The use of the media

rating technology specifically for longer form audio such as

focus groups is, to our knowledge, not common. The value

of applying this methodology to patient research is poten-

tially enormous and still not fully realized. Better under-

standing of patient experience is critical to better disease

management and patient outcomes. Standard qualitative

research, including interviews and focus groups, is effec-

tive at getting in-depth patient perspectives. However, this

kind of research is difficult to generalize and to know how

representative these perspectives are to the patient

population as a whole. Quantitative research, including

surveys, can provide a summary overview of a wide range

of topics but provides shallow understanding. The media

rating technology seeks to bridge this gap by quantifying

qualitative data. A more nuanced and complex under-

standing of patients’ feelings about their disease, their re-

lationship with their doctor, and the overall treatment

process can be achieved through examination of overall

average, segment, and cluster media rating data.

Interpretations of the results of this study may be limited

by the following factors. First, this moment-to-moment

hybrid approach is a novel statistical method, particularly

in the field of shared decision making, and few published

data are available by which to compare the results of the

current study. To our knowledge, there is no published

literature where moment-to-moment trace methodology is

used to measure cognitive responses in either focus group

or in-depth interview research. Second, the views repre-

sented by the few patients in this study may not be repre-

sentative of the entire population of patients with IBD.

Third, only patients who had a computer and Internet ac-

cess were eligible to participate. Finally, some participants

may not have completely understood the moment-to-mo-

ment technology required for appropriate response and

participation.

5 Conclusions

This study provides valuable patient insights regarding the

shared decision-making process in IBD treatment using a

novel moment-to-moment hybrid technology approach.

Patient perspectives in this study indicate an increased

desire for shared decision making in determining an opti-

mal IBD treatment plan. Further research into the three

distinct IBD patient types, particularly the ‘Dissatisfied’

cluster of patients who experience less shared decision

making, is warranted. Finally, results from the online-rated

focus group discussions support the shared decision-mak-

ing model approach to IBD treatment.

Acknowledgments The authors wish to acknowledge the following

individuals for their contributions and critical review during the

C. A. Siegel et al.

development of this manuscript on behalf of Janssen Scientific Af-

fairs, LLC: Kim Poinsett-Holmes, PharmD, Poinsett Publications,

Inc., for medical writing and editorial assistance. This study was

sponsored by Janssen Scientific Affairs, LLC (Horsham, PA, USA).

Corey Siegel contributed to the study concept and design. Jennifer

Lofland and Ahmad Naim contributed to the study concept, design,

methods, and analyses. Jan Collins and Danielle Walls contributed to

the study design, methods, data collection, and analyses. Laura

Rudder and Chuck Reynolds contributed to the study design, meth-

ods, and data collection. All authors discussed the results and im-

plications, and commented on the manuscript at all stages. All authors

reviewed the final manuscript. Jennifer Lofland is the guarantor for

the study.

Conflict of interest Corey Siegel has received consulting fees from

Abbvie, BiolineRX, Given Imaging, Lilly, Janssen, Salix, Millenium,

Pfizer, Prometheus, Takeda, and UCB, as well as grants from the

Crohn’s and Colitis Foundation of American (CCFA), the Agency for

Healthcare Research and Quality (AHRQ) [1R01HS021747-01],

Abbvie, Janssen, Salix, Warner-Chilcott, and UCB.

Jennifer Lofland is an employee of Janssen Scientific Affairs, LLC.

At the time of the study, Ahmad Naim was an employee of Janssen

Scientific Affairs, LLC. Danielle Walls, Jan Collins, Laura Rudder,

and Chuck Reynolds were employed as subcontractors by Janssen

Scientific Affairs, LLC.

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Patients’ Perspectives on Shared Decision Making