Shared decision making (SDM) in oncology: Developing and validating cancer patient and oncologist questionnaires for realization of SDM*

There is growing recognition that shared decision making (SDM) is important,
particularly in oncology: clinicians and patients make decisions together using
the best available evidence. It is expected to lead to better experiences of
care, less overtreatment, and better patient outcomes. However, evidence shows
that available observational instruments to assess SDM do not correlate well
with patient self-report methods, and the most used self-report measure of SDM
does not seem to capture decisional roles in a valid way. Further, many
clinicians report they routinely adhere to SDM whereas observation and patient
reports show this not to be the case. Ideas about what constitutes a SDM
process thus seem to differ significantly among patients, clinicians, and
observers, and valid self-report instruments are lacking. Further, instrument
development and validation have mostly been carried out in primary care and
instruments lack components relevant to oncology. These methodological
shortcomings need urgently to be addressed, in order to gather evidence on the
realization of SDM, on barriers and facilitators to its realization, and, in
turn, on the outcomes of SDM in oncology practice.

Aims of the study are to 1) further clarify the construct of SDM for oncology;
2) find ways to operationalize SDM-realization and formulate drafts of a
patient and oncologist version of a SDM-realization questionnaire; 3) validate
the questionnaires by testing acceptability, (test-retest) reliability,
validity and finalize the questionnaires.

An observational study in experts, 16 members of the general population, 16
disease-free patients, 5 nurse practitioners, approximately 326 patients and 64
doctors, from several (academic and peripheral) hospitals and departments, to
get a representative sample. Furthermore, experts on the project group,
international SDM experts and experts on questionnaire development, will
participate in interviews and expert meetings.

The study will consist of the following phases:

The study will consist of the following phases: 1) Three systematic literature
reviews, one or two qualitative studies (taping of consultations, interviews,
(optional) focus group meetings), focus group meetings, online consultation of
experts and an expert meeting to clarify the construct of SDM in oncology. In
this phase 32 patients and 16 doctors will participate in the taping of
consultations and interviews. Also 16 members of the general population and 16
disease *free patients will participate in interviews. In the focus group
meetings 16 patients and 12 doctors will participate. In total at least 48
patients and 28 doctors will participate in this phase.

2) Interviews to draft and pilot the questionnaires.
In the interviews about the items 16 patients and 12 doctors will participate.
In the cognitive interviews 12 patients and 6 doctors will participate. In
total 28 patients and 18 doctors will participate in this phase.

3) Administering questionnaires and an expert meeting to validate the
questionnaires.
In this phase 250 patients and 50 doctors will participate. The doctors may
have participated in earlier phases of the study. The patients will fill in the
I-SHARE questionnaire twice.

The risk of participation in this study is negligible. Patients may experience
it as a token of interest to be asked for their opinion regarding the way in
which decisions about their treatment were made and as gratifying to provide
input for scientific research relevant to other patients. The burden depends on
the part of the study in which the patient participates and every patients
participates in one part only:
* The consultation is audiotaped and the patient participates in an interview
which will last approximately 1 hour and will take place within a few days
after the consultation. The interview will take place at the patient*s home or
will be combined with an appointment at the hospital. This interview will be
audiotaped. It could be confronting for patients to hear their own consultation
and to talk about their experiences and opinions.
* The member of the general population participates in an interview in the
LUMC, which will last approximately 1 hour. This interview will be audiotaped.
* The disease-free patient participates in an interview, which will last
approximately 1 hour. This interview will be audiotaped and will take place at
the patient*s home or in the LUMC. It could be disturbing for disease-free
patients to talk about their experiences and opinions.
* The patient participates in a focus group meeting of at most 2 hours. This
focus group meeting will be audiotaped. It could be disturbing for patients to
think about their own consultation and it could be challenging to talk about
the different constructs that are of interest in this study.
* The patient is interviewed for approximately 1 hour, at the patient*s home or
combined with an appointment at the hospital. This interview will be
audiotaped. It could be disturbing for patients to think about their own
consultation and it could be challenging to reflect on the items of the
questionnaire.
* The patient completes the questionnaire draft and talks out loud while doing
so, with a research assistant present to take notes and discuss any issues
related to the questionnaire that could help to improve it. This interview will
take approximately 1 hour and will take place at the patient*s home or combined
with an appointment at the hospital. This interview will be audiotaped. It
could be disturbing for patients to think about their own consultation and it
could be taxing to talk out loud while completing the questionnaire.
* The patient fills in the questionnaire at home; this includes the
I-SHAREpatient questionnaire and questionnaires for validation (approximately
45 minutes) and fills in the I-SHAREpatient questionnaire for the second time,
one to two weeks after the first time (approximately 5 minutes).
* The patient fills in the questionnaire at home; this includes the
I-SHAREpatient questionnaire and questionnaires for validation (approximately
45 minutes).