Conclusions
Better information recall, a trusting relationship with healthcare
professionals, and a time out period for the consideration of treatment
options are important determinants that influence patients in their
treatment decisions and their preferred participation role during shared
decision-making.
Keywords : Shared decision-making, determinants, option talk,
decision talk, pancreatic neoplasm
Introduction
Patients with pancreatic cancer need to make difficult decisions about
intensive medical treatment weighed against their quality of life in a
short period of time. Pancreatic cancer carries a poor prognosis with an
overall survival rate of 2–7% and has a great impact on a patient’s
life.1,2 Over the period 1990-2017, the incidence of
patients with pancreatic cancer in the Netherlands increased by 2-3
times due to aging, overweight and diabetes.1 The only
curative option is resection of (a part of) the pancreas, often combined
with (neo)adjuvant chemotherapy. Resection of (a part of) the pancreas
is a major operation with the risk of severe complications, such as
sepsis, bleeding or wound infection.3 Long-term
consequences such as diabetes and digestive problems can also
occur.4 In addition, in almost 50% of patients the
tumour relapses within 2 years after surgery.3 This
information, together with the up-to-date short-term outcome results of
these operations, should be shared with patients and considered in light
of patients’ expectations regarding quality of life.
Shared decision-making (SDM) is an approach whereby clinicians and
patients make decisions together using the best available evidence.
Patients are encouraged to think about the available treatment options
and the likely benefits and harms of each, so that they can communicate
their preferences and help select the best treatment for
them.5
While the most common cancers studied in relation to SDM are breast and
prostate, little is known about SDM in patients with pancreatic
cancer.6 Since 2017, healthcare professionals working
in an University Medical Center for pancreatic cancer in the Netherlands
have used SDM according to the revised three-talk model of Elwyn et
al..7 This SDM model is characterised by an option
talk, a time out period, and a decision talk. In the option talk, the
surgeon and case manager discuss the treatment options in terms of the
potential harms and benefits of each treatment. After this, the patient
is given a time out period of four days (reflection period). During the
time out, the patient considers the treatment options together with
their general practitioner (GP) or social network. In the decision talk,
the surgeon and case manager guide the patient to make a
preference-based treatment decision.
In the period of 2017–18, in the run up for the present study, a cohort
of 30 patients, characterised by (borderline) resectable pancreatic
cancer, an older age (over 75 years) and multiple comorbidities, was
followed at the outpatient clinic at the Radboud University Medical
Center. After starting with SDM as a communication model, almost 30% of
these patients did not opt for surgery in their decision talks. Before
2017, treatment options and best supportive care were not discussed
according to the SDM model.5
The observation that 30% of these patients did not opt for surgery
after the implementation of the SDM model was the reason for initiating
the present study. We aimed to identify the determinants that influence
the treatment decisions of patients with pancreatic cancer during SDM.
Methods
Study design and setting
We performed a qualitative study consisting of a literature review on
SDM determinants, followed by interviews and observations to
substantiate the findings of the
review with practical experiences. The study was carried out at the
outpatient clinic of the pancreas center in the Department of Surgery at
the Radboud University Medical Center in the Netherlands. Approximately
350 patients are discussed annually by the pancreatic tumour board (a
multidisciplinary team of clinicians) at this institution. Of these
patients, approximately 200 have their option and decision talks at the
outpatient clinic.
The study was approved by the local medical ethical committee
(registration number: 2021/7316). There was no pre-existing relationship
between the researcher (LD) and the participants in the observations and
interviews. LD is an experienced nurse and trained in conducting
observations and interviews.
Literature review
We reviewed the literature on the determinants that influence patients
with pancreatic cancer during SDM. Search terms were developed to
capture three concepts: pancreatic neoplasms, patient participation and
patient decision-making. Appendix 1 provides a detailed list of the
search strings. Full-text studies published between 2000 and 2019 on
PubMed (including MEDLINE), CINAHL and PsycINFO were included. The
references of the included studies were manually checked, and the
authors’ personal files and the bibliographies of previously published
related reviews were searched to identify additional relevant studies
(snowballing). Only English-language studies were considered for this
review. The inclusion criteria for the studies were 1) the determinants
affecting SDM were described, 2) the population consisted of patients
with pancreatic cancer, and 3) the studied patients were over 18 years
old. Studies were excluded if only medical treatments were reported. The
titles and abstracts of the included studies were initially screened by
one researcher (LD). Subsequently, the full text of the selected studies
was screened by LD in consultation with a second researcher (MH-S).
Quality assessment of the selected literature
The methodological quality of the selected studies was assessed by LD in
consultation with a second researcher (MH-S). For the selected
qualitative studies, the Criteria for Reporting Qualitative Research
guidelines (COREQ)8 were used for evaluation. For
observational (cohort) studies, the Strengthening the Reporting of
Observational Studies in Epidemiology (STROBE)8 was
used. For systematic reviews, the Preferred Reporting Items for
Systematic Reviews and Meta-Analyses (PRISMA) were
used.8 For rating and standardising the methodological
assessments of the studies, we developed a four-point scoring form, with
studies rated from ‘Very good (++): Fully met the standards of
COREQ, STROBE, PRISMA’ to ‘Poor (- -): Assessment was not
possible, exclusion of the study ’ (e.g., the study design does not
match with the research data analysis).
Observations of patients
Patients who were referred for surgery at the outpatient clinic of the
Radboud University Medical Center were purposive sampled to represent
the patient population of this outpatient clinic in terms of the (no)
present of comorbidities and chemotherapy treatments. The included
patients had an option or decision talk.
Patients gave verbal informed consent to the researcher (LD) before
their option or decision talk. They gave permission for the observations
to be written up and published (including quotes). The researcher (LD)
observed the conversation and used a standardised observation list based
on the determinants found in the literature review (Appendix 2). LD made
field notes about the patients’ context (e.g., social support, disease
stage) during the observations for correct interpretation of the data.
The observations took place in a regular consultation room in the period
September–December 2019.
Interviews with professionals and patients
A purposive sampling strategy was used to ensure a representative sample
of healthcare professionals in terms of positions (clinician, case
manager and physician assistant) and characteristics, such as their role
within SDM. LD approached patients with pancreatic cancer for an
interview after their option talk at the pancreatic outpatient clinic.
Patients were recruited based on their age (< 65 and ≥ 65
years old) and gender. The
patients were informed about the study by e-mail and provided verbal
informed consent at the beginning of the interview. Their verbal
informed consent was audio recorded. The interviews with the healthcare
professionals took place at the hospital. Patients were interviewed at
their homes or at a hospital location with sufficient privacy, depending
on their preference. LD conducted the semi-structured face-to-face
interviews (45 min each) from September 2019 to January 2020. The
interviews were guided by an interview topic guide (see Appendix 3),
audio recorded and then transcribed ad verbatim by LD. The transcripts
were returned to the interviewees for comment and correction.
Data analysis
The study characteristics and outcomes, such as study design, sample,
population and methodology, were tabulated (see the data extraction form
in Appendix 4). The data from the literature review, observations and
interviews were analysed manually. We used Bandura’s Social Cognitive
theory (SCT) to identify the determinants of SDM, since this theory has
shown to be helpful in explaining behaviour in relation to health
outcomes.9 Bandura emphasised that behaviour is the
result of continuous interactions between aspects of the social
environment, the person, and the person’s behaviour.9
The determinants of SDM in the included studies were identified and
analysed by LD in consultation with two researchers (MH-S and AJ). The
identified determinants of SDM were divided into the three categories
related to behaviour, the physical and socio-cultural environment and
the person9, and further classified into
subcategories.
The interview transcripts and observation lists were systematically
analysed according to directed content analysis.10Relevant data were identified and structured by initial codes based on
Bandura’s SCT9, and open coding to create new codes
(see Appendix 5). The coding took place under the supervision of MH-S
and AJ. Issues that occurred during the analysis were resolved by
consensus meetings.
The categories, subcategories and determinants from the literature
review, interviews and observations were merged, restructured and
tabulated. The determinants were substantiated with illustrative quotes.
We used the COREQ guideline to report the qualitative
data8 (see Appendix 6 for the completed checklist for
this study).
Results
Literature search
Our initial search for studies on the determinants influencing SDM
resulted in 141 studies (Figure 1). Additionally, 22 studies were
identified manually (snowballing). After scanning the titles, abstracts
and full texts, the methodologies were assessed. The final set consisted
of 13 studies: 6 qualitative studies, 4 quantitative studies and 3
systematic reviews (Appendix 7).