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PERSPECTIVES

Taking into Account Patient Preferences:

A Consensus Study on the Assessment of
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Psychological Dimensions Within Patient

Preference Studies

Selena Russo 1,2, * Abstract: Patient preferences are gaining recognition among key stakeholders involved in
Dario Monzani 3,4, * benefit-risk decision-making along the medical product lifecycle. However, one of the main
For personal use only.

Cathy Anne Pinto 5 challenges of integrating patient preferences in benefit-risk decision-making is understand­
Laura Vergani 3,4 ing differences in patient preference, which may be attributable to clinical characteristics
(eg age, medical history) or psychosocial factors. Measuring the latter may provide
Giulia Marton 3,4
valuable information to decision-makers but there is limited guidance regarding which
Marie Falahee 6
psychological dimensions may influence patient preferences and which psychological
Gwenda Simons 6
instruments should be considered for inclusion in patient preference studies. This paper
Chiara Whichello 7 aims to provide such guidance by advancing evidence and consensus-based recommenda­
Ulrik Kihlbom 8, * tions and considerations. Findings of a recent systematic review on psychological con­
3,4,
Gabriella Pravettoni * structs having an impact on patients’ preferences and health-related decisions were
1
Department of Medicine and Surgery, expanded with input from an expert group (n = 11). These data were then used as the
University of Milano-Bicocca, Milan, Italy; basis for final recommendations developed through two rounds of formal evaluation via an
2
Discipline of Paediatrics, School of
Women’s and Children’s Health, The online Delphi consensus process involving international experts in the field of psychology,
University of New South Wales, medical decision-making, and risk communication (n = 27). Three classes of recommenda­
Kensington, NSW, Australia; 3Applied tions emerged. Eleven psychological constructs reached consensus to be recommended for
Research Division for Cognitive and
Psychological Science, IEO, European inclusion with the strongest consensus existing for health literacy, numeracy, illness
Institute of Oncology IRCCS, Milan, Italy; perception and treatment-related beliefs. We also proposed a set of descriptive and check­
4
Department of Oncology and Hemato-
list criteria to appraise available psychological measures to assist researchers and other
oncology, University of Milan, Milan, Italy;
5
Department of Pharmacoepidemiology, stakeholders in including psychological assessment when planning patient preference
Merck & Co., Inc., Kenilworth, NJ, USA; studies. These recommendations can guide researchers and other stakeholders when design­
6
Rheumatology Research Group, Institute
of Inflammation and Ageing (IIA), University
ing and interpreting patient preference studies with a potential high impact in clinical
of Birmingham, Birmingham, UK; 7Erasmus practice and medical product benefit-risk decision-making processes.
School of Health Policy & Management Keywords: patient preferences, patients reported outcomes, psychological assessment,
(ESHPM) and Erasmus Choice Modelling
Centre (ECMC), Erasmus University decision-making
Rotterdam, Rotterdam, The Netherlands;
8
Centre for Research Ethics and Bioethics,
Uppsala University, Uppsala, Sweden

*These authors contributed equally to this Key Points

work ● In the medical products benefit-risk decision-making process and in the
research field of preference studies, patient preferences are gaining recognition
Correspondence: Selena Russo
Department of Medicine and Surgery, among key stakeholders. There is a strong need for evidence-based guidance
University of Milano, Bicocca, via Cadore on what psychological dimensions may influence patient preferences and
48, Monza (MB), 20052, Italy
Email [email protected] which should be considered for inclusion in patient preferences studies.

Patient Preference and Adherence 2021:15 1331–1345 1331

Received: 7 May 2020 © 2021 Russo et al. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.
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● This study fills an important gap in patient preference Benefit-Risk Assessments during the Drug Life Cycle
methodology. It helps stakeholders selecting psycho­ (PREFER) project, a European undertaking supported by
logical constructs and measurements to use for eval­ the Innovative Medicines Initiative (IMI). The main objec­
uating how patients form, maintain, change and tive of PREFER is to strengthen patient-centric decision-
negotiate preferences in medical and healthcare con­ making throughout the medical product life-cycle by
text. In addition, psychological assessments can developing evidence-based recommendations to guide
assist in explaining preference heterogeneity in industry, regulatory authorities, health technology assess­
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cases where research participants’ preferences ment (HTA)/payer bodies, reimbursement agencies, acade­
diverge. mia, and health care professionals on how and when
● Evidence- and consensus-based considerations on patient-preference studies should be performed and the
what psychological constructs to include in patient results used to support and inform decision-making
preference studies are advanced. A criteria checklist throughout the medical products lifecycle and enable the
to select appropriate psychological measurements to implementation of personalised medicine.8 However, as
include in patient preference studies are also reported by a recent systematic review by Huls and
advanced. Recommendations and criteria proposed colleagues,9 one of the main challenges of integrating PP
will inform stakeholders involved in the medical in benefit-risk decision-making is taking into account
products benefit-risk decision-making of the patient’s patient preference heterogeneity and formation. PP hetero­
formative abilities and describe preference geneity can be defined as “differences in preferences
For personal use only.

heterogeneity. among a sample”10 with the existence of subgroups of

patients with relevant differences in preferences. Within
Introduction this framework, the measurement of psychological con­
Patient preferences are gaining recognition among key structs might be relevant to obtain a psychological profile
stakeholders involved in benefit-risk decision-making of subpopulations of patients with relevant differences in
along the medical product lifecycle.1,2 A patient prefer­ preferences. The identification of subgroups of patients
ence (PP) may be defined as with heterogeneous preferences could

A statement of the relative desirability or acceptability to Be particularly valuable when there is a suggestion that
patients of specified alternatives or choices among out­ these differences are important enough to alter the deci­
comes or other attributes that differ among alternative sion whether to approve a product for at least one sub­
health interventions.1 group of patients.10

PPs are specific type of patient perspective. Patient per­ The need to better understand sources of PP heterogeneity
spective can be defined as any information related to is also stressed by a qualitative study carried out within the
patients’ experiences with a medical condition and its PREFER project investigating stakeholders’ attitudes,
management. Overall, this information allows a better expectations and concerns towards measuring and includ­
comprehension of the disease and its impact, the effective ing PP in decision-making along the medical product life­
identification of outcomes that are more relevant for cycle. Its results highlighted that stakeholders were often
patients, and a more fine-grained understanding of the concerned about whether and how psychological and emo­
benefit-risk trade-off for treatment.3 PPs are especially tional factors may influence PP. Stakeholders reasoned that
relevant for the evaluation of the benefit-risk profile of these factors and their impact on preferences are often
medical products in case of preference-sensitive decisions, unknown for researchers and, hence, difficult to control
namely situations where medical equipoise among alter­ for in PP studies.11,12
native treatments exists.4 In the clinical setting, the atten­ All this empirical evidence and the practical demands
tion given to PP is relevant in different theoretical and called for a need of identifying, describing and assess the
practical approaches, such as the shared decision-making feasibility of using different ways to profile psychological
model that underlies the relevance of recognising PP to variables that, alongside demographic (eg, age, gender,
empower patients and personalise treatment and care.5–7 culture) and clinical (eg, disease stage, comorbidity) char­
The present paper is a direct result of the tasks carried out acteristics of patients, can affect the construction, elicita­
within the framework of The Patient Preferences in tion, and interpretation of PP. With this purpose,

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 Dovepress Russo et al

a systematic review was carried out within the PREFER were asked to supplement the list with: Psychological
project to explore the existing instruments which are cur­ dimensions that can empirically or theoretically have
rently used in PP studies or health-related decision studies a bearing on patients’ preferences formation and/or
to measure the psychological variables that can affect the explain PP heterogeneity. Three authors (SR, DM, GP)
formation of PP, its elicitation and its heterogeneity.13 This independently analysed the experts’ contributions to eval­
initial step provided an overview of the literature on the uate whether the suggested constructs met the aforemen­
psychological constructs measured in PP or health-related tioned inclusion criteria. Disagreements in
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decisions studies and the instruments used to measure construct selection were resolved through discussion
these constructs. This review resulted in the identification between the researchers until consensus was reached.
of 18 constructs and 33 psychological instruments indicat­ The panel of experts indicated 13 constructs which sup­
ing that health literacy, numeracy, and locus of control plemented the 18 constructs identified in the systematic
have an impact on health-related preferences and decisions review leading to the identification of a total of 31 psy­
The present work builds upon these results and aims at chological constructs which could be relevant for future
providing researchers and stakeholders with useful criteria PP studies (Table 1).
and tools to select psychological constructs to include in We grouped the psychological constructs considering
PP studies to take into account patient heterogeneity and the available scientific evidence supporting the relevance
preferences formation. Specifically, three main tasks were of the psychological constructs for PP studies. Four
undertaken to achieve this goal: (i) identifying a list of researchers (UK, DM, CAP, SR) organised the constructs
For personal use only.

candidate psychological constructs by supplementing the in three classes basing their grouping on the quality and
results of the PREFER systematic review13 with input soundness of the available evidence of the association
from experts in the field of PP studies, health psychology, between psychological constructs and PP within the con­
and psychological assessments; (ii) proposing recommen­ text of decision-making processes. In particular, to classify
dations on which psychosocial constructs to include in PP these psychological constructs the researchers considered:
studies reached through a consensus-based process, that is (i) the number of studies assessing the association between
a two-round Delphi method; (iii) advancing a set of cri­ each psychological construct and PP; (ii) the quality of
teria and a check list that can assist in describing and these studies; (iii) the overall agreement and consistency
selecting psychological instruments to be included in PP of their finding. For each identified construct emerging
studies. from the systematic review an overall rating of the quality
of the empirical evidence was considered. In Russo et al13
each study received a score based on its quality ranging
Psychological Constructs Linked to from 1 to 3 (1=weak; 2=moderate; 3=strong), then
Patient Preferences summed to the score of the other studies investigating
To provide researchers and other stakeholders with prac­ the same construct and the mathematical average of the
tical advice on psychological constructs that can influence resulting value was categorised as follow: from 1 to 1.4
PP formation and its heterogeneity, we propose a list of weak; from 1.41 to 1.8 weak to moderate; from 1.81 to 2.2
psychological constructs empirically and theoretically moderate; from 2.21 to 2.6 moderate to strong; from 2.61
linked to PP. Specifically, a pool of 19 international to 3 strong. The constructs suggested by the experts were
experts in the fields of PP studies, health psychology, included in the Group C as no empirical data are yet
and psychological assessment were invited to review an available on the association between these constructs and
existing list of psychological constructs identified during PP (see Table 2). Disagreements in grouping between
an earlier systematic review conducted within the researchers were resolved through discussion until consen­
PREFER project.13 Reviewers were internationally recog­ sus was reached.
nised experts both within and external to the PREFER
project who were not involved in the original systematic ● Group A: psychological constructs for which there
review. The reviewers were invited to contribute via are strong and consistent results regarding their role
e-mail. Out of 19 experts contacted, 11 provided their in influencing patients’ preferences and decisions.
feedback. Participants were provided with the list of psy­ ● Group B: psychological constructs that could be the­
chological constructs from the systematic review, and they oretically promising in the field of PP studies, but the

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number of available studies with consistent results is Participants were asked to provide demographic and
not yet satisfactory. professional information and rate their level of agreement
● Group C: psychological constructs for which data are on considering and measuring each of the 31 constructs
not available, or there are inconclusive or inconsis­ in PP studies (Table 1) on a 5-point Likert scale
tent results on their role in influencing PPs and (“strongly disagree” to “strongly agree”) and also pro­
decisions. vided open text space for participants to give reasons for
their evaluations. For each psychological construct out­
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lined, the proportion of panel members that either agreed

or disagreed with the inclusion/usefulness of each corre­
Development of Recommendations:
sponding construct in PP studies was calculated. Criteria
A Delphi Consensus Process for the level of consensus were defined a priori based on
To further assist researchers and stakeholders with the
agreement responses on the Likert scale [“agree” or
selection of psychological constructs for preference stu­
“strongly agree”], and included the following categories
dies, we developed recommendations based on the empiri­ of consensus: “unanimity” of inclusion, “consensus”,
cal evidence and experts’ contributions previously “majority” and “discrepancy” when 100%, 80%, ≥70%,
gathered using a consensus-based process. Formal expert and <70% of participants agreed with inclusion. Two
review via an online two-round Delphi panel was used to drag-and-drop items asked participants to indicate
reach consensus.50 which of the outlined psychological constructs could
For personal use only.

account for preference heterogeneity and misunderstand­

Materials and Procedures ing differences in PP, respectively. “Preference heteroge­
Although there is no standardized sample size for the neity” was defined as differences in preferences across
Delphi approach, 8 to 15 panel members may be ade­ sub-populations or classes of people, while “misunder­
quate for a focused Delphi study51 such as the one standing differences” were defined as differences in
reported here. Kezar and Maxey52 suggest that patient preferences due to patients not understanding or
a smaller expert panel is appropriate when the panel is not interpreting the patient preference study questions
heterogeneous and up to 30 or more panel members may and information as meant by the researcher. After pre­
be required with a homogenous panel of experts. senting the two operational definitions, participants were
Accordingly, a minimum sample of 15 experts was tar­ also asked to select one of five figures visually presenting
the possible relations between the two concepts (see
geted for the panel. Researchers and professionals with
Figure 1).
a diverse range of expertise were invited via email to
Participants who completed the questionnaire in round
participate in the online Delphi consensus process. Fields
one of the Delphi survey were invited via email to com­
of expertise included health preference research, clinical
plete round two of the survey. For each construct, partici­
and health psychology, health economics, public health,
pants were presented with the rating they provided during
risk communication, and decision-making. Panel mem­
round one and the overall mean and standard deviation
bers were recruited through searching relevant literature
from the panel and were asked to rate again their level of
and recommendations from the project team.
agreement for inclusion of each construct in PP studies
Additionally, five international organisations (European
using the same 5-point Likert scale (“strongly disagree” to
Health Psychology Society, Society for Health
“strongly agree”).
Psychology, European Association for Communication
in Healthcare, Society for Medical Decision Making,
and International Society for Pharmacoeconomics and Results
Outcomes Research) were contacted and asked to for­ Delphi Panel Demographic and
ward the Delphi survey invitation to their associates. No Professional Features
remuneration was offered to participants. Participants Twenty-seven out of the 34 experts who participated in
were sent a web link to the consent form and once round one participated in round two of the Delphi survey.
informed consent was provided, participants were pre­ As reported in Table 3, panel members had a mean age of
sented with the study survey. 41.19 years (SD= 9.77) and 59.3% were female. They

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Table 1 List and Definition of Psychological Constructs Identified by the Systematic Literature Review from Russo et al13 and the
Panel of Experts. They are Reported in Alphabetic Order
Construct Description of Construct

Anxiety A distinction between state and trait anxiety has become commonplace.14,15 State anxiety is defined as an
unpleasant emotional arousal in face of threatening demands or dangers. A cognitive appraisal of threat is
a prerequisite for the experience of this emotion.16 Trait anxiety, on the other hand, reflects the existence of
stable individual differences in the tendency to respond with state anxiety in the anticipation of threatening
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situations.

Assertiveness Assertiveness is a proactive response in difficult situations to contrast with passive or aggressive reactions.17

Autonomy preference Autonomy is self-governance over decisions; a decision or choice of action is considered autonomous if it
comes from within and is free from external control or influence.18,19 Thus, autonomy preference reflects
patient’s preference for self-governance in medical care.

Behavioural inhibition and Behavioural inhibition system and the behavioural approach system are two general motivational systems that
activation underlie behaviour. The behavioural approach system is believed to regulate appetitive motives, in which the
goal is to move toward objectives and something desired. A behavioural avoidance (or inhibition) system is
said to regulate aversive motives, in which the goal is to move away from something unpleasant.20

Conservatism Conservatism is defined as the disposition to preserve tradition and established institutions and resist and
oppose to change.21
For personal use only.

Control preference Control preference reflects patient’s preferred level of their own versus their physician’s control or
a collaborative role over a treatment decision.22

Coping style Coping style is defined as the habitual pattern of individuals when reacting to stress either across different
situations or over time.23

Decision-making styles Decision-making style is the habitual pattern individuals use in decision-making, or characteristic mode of
perceiving and responding to decision-making tasks.24,25

Depression Depression is a state of low mood and aversion to activity that can affect a person’s thoughts, behaviour,
feelings, and sense of well-being.26

Dispositional optimism Dispositional optimism is defined as generalized expectancy for positive future events.27

Health anxiety Health anxiety is defined as a worry about physical health and can range from mild concern to severe or
persistent anxiety such as that found in hypochondriasis.26

Health literacy Health literacy is the patient’s ability to read, understand and use healthcare information appropriately.28

Health locus of control Health locus of control is defined as a generalized expectation about whether one’s health is controlled by
one’s own behaviour or forces external to oneself.29 An individual with an internal locus of control believes
that outcomes are a direct result of his or her own behaviour. An individual with an external locus of control
believes that outcomes are a result of either chance or powerful other people, such as physicians.

Health numeracy Health numeracy refers to the patient’s ability to apply and manipulate numerical concepts in the healthcare
context.30,31

Health orientation Health orientation is an individual-differences concept defined as an individual’s motivation to engage in
healthy attitudes, beliefs, and behaviours.32

Illness perception Illness perception is defined as patients’ own implicit and common-sense beliefs about their illness.33

Mastery Mastery motivation has been defined as a psychological force that stimulates an individual to attempt
independently, in a focused and persistent manner, to solve a problem or master a skill or task which is at least
moderately challenging for him or her.34

Mood states In contrast to emotion mood is defined as a transient, low-intensity, nonspecific, and subtle affective state that
often has no definite cause.35

(Continued)

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Table 1 (Continued).

Construct Description of Construct

Need for closure The need for cognitive closure is conceptualized as a cognitive-motivational factor that underlies how
laypersons approach and form their knowledge about the social world.36 Need for closure varies along
a continuum with one end representing a need to attain cognitive closure and the other end representing
a need to avoid cognitive closure. People with high need for closure can be described as having a preference
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for quick decision-making, predictability, structure, and low tolerance for ambiguity. Individuals with a low
need for closure prefer variety, flexibility, uncertainty, and slow decision-making.

Need for cognition Need for cognition refers to peoples “tendency to engage in and enjoy effortful cognitive endeavors.”37
Individuals with a high need for cognition enjoy the thinking process, are motivated to apply their thinking
skills and are more likely to be able to process and systematize information.38

Patient Activation Patient activation refers to the degree to which an individual has knowledge, motivation, skills, and confidence
to make effective health-related decisions.39

Personality Personality is the dynamic organisation within the individual of those psychophysical systems that determine
his characteristic behaviour and thought.40

Psychological well-being Psychological well-being is defined as a combination of several aspects of positive psychological functioning,
which includes self-acceptance, positive relations with others, autonomy, environmental mastery, purpose in
For personal use only.

life, and personal growth.41

Rational and experiential Rational and experiential thinking styles are habitual pattern of information processing.42 While the rational
thinking styles style emphasizes a conscious and analytical approach, the experiential style emphasizes a pre-conscious and
a more affective approach.

Resilience Resilience is defined as the process of adapting well in facing traumas, adversities, threats, tragedies, and
sources of stress.43

Risk propensity Risk propensity is described as a function of the person’s perception of risk and the person’s willingness to
take on this risk.44

Self-efficacy Self-efficacy is an individual’s belief in his or her capacity to master the cognitive, motivational, and behavioural
resources required to perform a specific action in a given situation.45

Sensation Seeking Sensation seeking is defined as the seeking of various, novel, complex, and intense sensations and experiences,
and the willingness to take physical, social, legal, and financial risks for the sake of such experience.46

Sense of coherence The sense of coherence is a construct that refers to the extent to which one sees one’s world as
comprehensible, manageable, and meaningful.47

Social support Social support is defined as a “social network’s provision of psychological and material resources intended to
benefit an individual’s ability to cope with stress”.48

Treatment-related beliefs Treatment-related beliefs are defined as the specific patient’s perception of the need to take medication and
concerns about it as well as the general beliefs about pharmacotherapy.49
Note: Psychological constructs proposed by experts which supplement the list of the systematic review from Russo et al13 are indicated in bold.

mainly worked in the European Union (41%), followed by allowed to provide more than one area of expertise if applic­
North America (33%), the United Kingdom (15%), with the able: 41% of panel members declared to work in the health
remainder split among Asia, Australia, and Switzerland. The psychology, 15% in clinical psychology, 22% in risk com­
panel was heterogeneous in terms of both work sector and munication, 30% in medical decision-making, 30% in other
field of expertise. Most panel members (74%) worked in the types of decision-making, 26% in public health, and 22% in
academic sector, followed by industry, government agencies, other fields (ie, health preference research, medical educa­
and other sectors (ie, consulting services and hospitals). tion, and sociology). The average years of experience in
When considering field of expertise, participants were their field of expertise was 13.48 (SD= 8.40).

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Table 2 List of Identified Psychological Constructs Organised by misunderstanding differences refer to the same concept
Strength of Available Empirical Evidence (Alphabetically Ordered (Figure 1C), and % reported that PP heterogeneity is
Within Each Class)
a specific subtype of misunderstanding differences
Constructs (Figure 1A).
Group A Health literacy
Health locus of control
Health numeracy
Delphi Consensus
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Based on the results of round two of the Delphi survey,

Group B Assertiveness
three classes of consensus-based recommendation on
Autonomy preference
inclusion of the listed psychological constructs in PP
Conservatism
Control preference were created (Table 4):
Coping style
Decision-making style ● Class I: psychological constructs for which there is
Dispositional optimism unanimity or consensus regarding their inclusion in
Health orientation
PP studies. The evaluation of these constructs is
Patient activation
Resilience
recommended for inclusion in PP studies when
Risk propensity deemed relevant to address the research question
Self-efficacy and describing preference heterogeneity.
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Treatment-related beliefs ● Class II: psychological constructs for which the

Group C Anxiety majority of experts agreed for their inclusion in PP

Behavioural inhibition and activation studies. The evaluation of these constructs could be
Depression recommended to understand PP in a healthcare set­
Health anxiety ting. The decision about including or not including
Illness perception
a psychological construct should be made by consid­
Mastery
ering: its theoretical link with PP, the previous
Mood states
Need for closure empirical evidence about its role in influencing PP,
Need for cognition the possible cognitive load for patients in including
Personality a further instrument to complete and other feasibility
Psychological well-being criteria (eg timelines, costs).
Rational and experiential thinking styles ● Class III: psychological constructs for which there is
Sensation seeking
discrepancy among experts regarding their inclusion
Sense of coherence
Social-support in PP studies. Therefore, their evaluation could not
be recommended based on current expert evaluation
to understand PP in a healthcare setting.

Preference Heterogeneity and As reported in Table 4, the percentages of agreement at

Misunderstanding Differences the second round of the Delphi ranged between 11% and
In round one of the Delphi survey, experts were asked to 96%, with the lowest percentage for the inclusion of mood
report their opinion regarding the relationship between PP states and sense of coherence, and the highest percentages
heterogeneity and misunderstanding differences in PPs by for the inclusion of health literacy. Specifically, consensus
choosing one among five figures graphically representing was reached for the inclusion of eight psychological con­
different relationship between them (Figure 1). Most structs, namely health literacy, health numeracy, illness
experts (44%) reported that PP heterogeneity and misun­ perception, treatment-related beliefs, risk propensity,
derstanding differences in PPs are different but overlap­ health locus of control, control preference, and patient
ping aspects (Figure 1E); 26% that they are different and activation (Class I). Three constructs, namely autonomy
not overlapping phenomena (Figure 1D); 18% that mis­ preference, decision-making style, and health orientation,
understanding differences is a specific subtype of PP het­ reached the majority consensus (Class II). Twenty out of
erogeneity (Figure 1B); 7% that PP heterogeneity and the 31 psychological constructs considered by the Delphi

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Figure 1 Item asking participants’ understanding of the relations between heterogeneity differences and misunderstanding differences in patient preference studies.
Note: (A) Hetereogeneity differences as subset of misunderstanding differences; (B) misunderstanding differences as subset of heterogeneity differences; (C) misunder­
stading and heterogeneity differences completley overlap; (D) misunderstanding and heterogeneity differences are completely distinct; (E) misunderstading and hetero­
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geneity differences partially overlap.

panel did not reach consensus about their inclusion or Supplementary Material B) to assist researchers and other
exclusion when considering PP studies falling into the stakeholders respectively in i) assessing the overall quality
Class III of recommendation. and usability of each tool, comparing different instruments
As reported in Table 5 amongst the 11 constructs when more than one instrument is available for the same
included in Class I and II, health literacy and health numer­ construct, and selecting the best measure and ii) evaluating
acy were mainly conceptualized as psychological constructs the feasibility of measuring candidate psychological dif­
that can account for understanding differences in patient ferences in the context of a specific PP study. In detail, two
preferences due to patients not understanding or not inter­ researchers (SR, DM) developed a set of descriptive cri­
preting the patient preference study questions and informa­ teria and a checklist to evaluate psychological instruments
tion as meant by the researcher (ie, misunderstanding and to guide researchers to decide which tool best fit the
differences in PPs). On the contrary, the remaining nine research needs of a specific PP study. The initial lists of
constructs were mainly considered as relevant psychologi­ descriptive criteria and the initial draft of the checklist
cal characteristics that could account for PP heterogeneity. were extended and revised based on conversations and
feedback from the authors and other members of
PREFER consortium with expertise and experience in the
Descriptive Criteria and Checklist fields of PP studies, health psychology, and psychological
for Selecting Measurement assessment.
Instruments Starting from the final list of descriptive criteria (see
After deciding which construct(s) to measure depending Supplementary Material A), here we are proposing
on evidence- and consensus-based considerations, stake­ a briefer set of questions addressing the main features
holders and researchers should appraise available instru­ of psychological instruments that could support stake­
ments in terms of quality, usability, restrictions, and holders and researchers in evaluating and selecting
shortcomings and select the best tool to evaluate these available measures. This checklist – reported in Table
candidate psychological differences. This step is especially 6 - may be especially helpful when more than one
relevant when more than one instrument is available for instrument is available for the same construct. By
the same construct. given answers to each question, stakeholders are
We therefore propose a set of descriptive criteria (see assisted in assessing the overall quality and usability
Supplementary Material A) and a criteria checklist (see of each tool.

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Table 3 Delphi Panel Sociodemographic and Professional psychological measures. Stakeholders are recommended to
Characteristics use only those psychological tools with consistently proven
Characteristics n= 27 reliability and validity in the specific population under
Gender, n (%) female 16 (59.3%)
investigation in the PP study. Second, psychological instru­
ments are generally developed, constructed, and validated
Age years, mean (SD) 41.19 (±9.77)
for a specific language and culture. They can be adapted for
Field of expertise, n (%)a use in a new country, culture, and/or language through
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Health psychology 11 (40.7%) “cross-cultural adaptation”, namely a unique and complex

Clinical psychology 4 (14.8%)
method to reach equivalence between the original and the
Risk communication 6 (22.2%)
Medical decision-making 8 (29.6%) translated versions of the instrument.55 Caution should be
Decision-making (non-medical) 8 (29.6%) taken when using in a PP study a translated version of an
Public health 7 (25.9%) instrument that has not been properly adapted to the new
Other fields 6 (22.2%) language and culture. Thus, stakeholders are always recom­
Work sector, n (%) mended to choose only those psychological instruments
Academic sector 20 (74.1%) specifically developed or properly adapted to the language
Government 1 (3.7%) and culture of the target population of their PP study. Third,
Industry 4 (14.8%)
since psychological instruments are often constructed and
Other 2 (7.4%)
validated for a specific population of patients, caution
For personal use only.

Years of expertise, mean (SD) 13.48 (±9.77) should be taken when using the tool to a different popula­
Expertise level in patient preference study 3.04 (±1.43) tion without previous empirical evidence regarding its
(from 1 “not at all expert” to 5 “to a large extent validity and reliability in the new population. Thus, stake­
expert”) holders are recommended to prefer those psychological
Country of work, n (%) instruments that have been developed specifically for the
European Union 11 (40.8%) population being targeted by the PP study over other avail­
North America 9 (33.3%) able tools. Fourth, while some psychological instruments
United Kingdom 4 (14.8%)
return only raw scores that may be difficult to interpret
Asia 1 (3.70%)
Australia 1 (3.70%) without knowledge of how one raw score compares to
Switzerland 1 (3.70%) a norm group, other psychological tools adopt a reference
a
Note: Percentages sum up to more than 100, as more than one option could be group and can provide standardized scores. The latter might
selected. help stakeholders to get a clearer picture of the position of
each patient in a predefined population for the psychologi­
Strong knowledge and skills concerning psychometrics, cal differences being measured. Thus, if relevant, psycho­
psychological assessment and testing are essential to prop­ logical measures with standardized and norm-referenced
erly evaluate available psychological measures and select scores should be preferred over instruments with only raw
the best measurement tool based on its features and psycho­ scores. Fifth, some psychological tools can also provide
metric characteristics. Specifically, the first criterion meaningful cut-off scores to classify patients into groups
advanced deals with two essential features of any psycho­ based on their scores. These cut-off scores are generally
logical tool: validity and reliability. They refer respectively used with screening purposes to differentiate clinical popu­
to the extent to which any tool actually measures what it is lations from non-clinical ones or differentiate among people
intended to measure53 and the precision of psychological with adequate or inadequate abilities. If relevant, stake­
measures in terms of internal consistency or the consistency holders are recommended to prefer psychological measures
of observed scores over different administration of the same providing cut-off scores over tools providing only raw or
instrument.54 Since validity and reliability of an instrument standardized scores. Sixth, while the noncommercial use of
should be investigated and demonstrated in a specific con­ psychological instruments is often allowed without requir­
text of use, empirical evidence coming from previous vali­ ing written permission, a license or a fee, sometimes devel­
dation studies in similar contexts of the PP study should be opers require explicit approval to use their instrument.56
considered to assess the appropriateness of candidate Other authors use the copyright status and put limits on

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Table 4 Consensus-Based Recommendations at the Two Rounds of the Delphi Method

Psychological 1st Round (% Agree and 2nd Round (% Agree and Group of the Empirical Class of
Construct Agree Strongly) Agree Strongly) Evidence Available Recommendation

Anxiety 44.4% 37.0% C III

Assertiveness 33.3% 22.2% B III

Autonomy preference 59.3% 74.1%a B II

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Behavioural inhibition and 25.9% 18.5% C III

activation

Conservatism 33.3% 14.8% B III

a b
Control preference 70.4% 85.2% B I

Coping style 48.1% 48.1% B III

a
Decision-making style 59.3% 70.4% B II

Depression 44.4% 51.9% C III

Dispositional optimism 40.7% 33.3% B III

Health anxiety 55.6% 59.3% C III

For personal use only.

b b
Health literacy 85.2% 96.3% A I

Health locus of control 70.4%a 85.2%b A I

Health numeracy 81.5%b 92.6%b A I

Health orientation 70.4% 74.1%a B II

Illness perception 70.4%b 92.6%b C I

Mastery 33.3% 25.9% C III

Mood states 22.2% 11.1% C III

Need for closure 37.0% 25.9% C III

Need for cognition 37.0% 33.3% C III

a b
Patient activation 70.4% 85.2% B I

Personality 37.0% 29.6% C III

Psychological well-being 59.3% 55.6% C III

Rational and experiential 48.1% 33.3% C III

thinking styles

Resilience 44.4% 33.3% B III

Risk propensity 77.8%b 88.9%b B I

Self-efficacy 55.9% 63.0% B III

Sensation seeking 25.9% 14.8% C III

Sense of coherence 29.6% 11.1% C III

Social support 59.3% 55.6% C III

a b
Treatment-related beliefs 74.1% 92.6% B I
a b
Notes: Highlighted majority; highlighted consensus.

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Table 5 Percentages of Selection of the Class I and Class II Psychological Constructs as Relevant Information to Account for PP
Heterogeneity or Misunderstanding Differences in PPs
Constructs Account for PP Heterogeneity (%) Account for Misunderstanding Differences
in PPs (%)

Autonomy preference 59.3% 14.8%

Control preference 51.9% 22.2%

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Decision-making style 37.0% 29.6%

Health literacy 44.4% 85.2%

Health locus of control 59.3% 25.9%

Health numeracy 37.0% 81.5%

Health orientation 33.3% 11.1%

Illness perception 55.6% 29.6%

Patient activation 29.2% 22.2%

Risk propensity 51.9%% 14.8%

For personal use only.

Treatment-related beliefs 55.6% 37.0%

Table 6 Brief Checklist for the Evaluation and Selection of Available Measures to Assess Psychological Constructs
Criteria Recommendations

1. Is the instrument valid and reliable? It could be recommended to use in a PP study only psychological measures with
consistently proven reliability and validity in the specific population under
investigation.

2. Is the instrument available in the language the patient The use of psychological instruments specifically developed or properly adapted to
preference study will be conducted? the language and culture of the target population for the PP study is recommended.

3. Is this instrument designed for a particular population of Psychological instruments developed specifically for the population being targeted
patients or a specific disease? by the PP study should be preferred to other tools.

4. What is the outcome measure of the instrument? Psychological measures with standardized and norm-referenced scores should be
preferred over instruments with only raw scores.

5. Does the instrument provide cut-offs classifying patients? If relevant, psychological measures providing cut-off scores are preferred over
instruments with only raw or standardized scores.

6. Is the instrument protected by copyright/license? When budget constraints do not allow the use of psychological instruments with
fees, researchers might consider alternative measures with equivalent
characteristics but not requiring payment.

7. What is the average cognitive burden and time commit­ Required time for completion and associated patient-reported respondent burden
ment for respondents completing the instrument? should be investigated through pretesting and piloting studies. When available
psychological instruments are deemed to be equivalent in their informative values,
the less cognitively burdensome and time-consuming tool should be preferred over
more cognitively and time-demanding ones.

use, adaptations, and translations. Finally, other instrument of psychological instruments with fees, stakeholders might
developers can charge fees to use their tools, namely licen­ consider alternative measures with equivalent characteris­
sing fee, administration fee or fee for obtaining scoring tics but not requiring payment. Finally, the protection of
instructions. When budget constraints do not allow the use people participating in research demands investigators and

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regulatory bodies to minimize the respondent burden.57 propensity, and treatment-related beliefs have been recognised
Respondent burden is a multifaceted phenomenon encom­ as those with a theoretical basis for forming preferences and
passing mainly cognitive burden and time commitment to predicting preference heterogeneity. These constructs should
take part in a study,58 as well as participants’ perceived be a basic consideration for inclusion in preference studies
psychological, physical, and economic discomfort caused conducted for medical product decision-making. Constructs
by the participation in research.59 Psychological instruments in Class II (autonomy preference, decision-making style, and
can vary in both their completion time and required cogni­ health orientation, reached the majority consensus) have been
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tive effort for completion. Thus, stakeholders should bal­ considered as promising constructs to better understand PPs. In
ance the benefits of including psychological profiling within Class III are listed psychological constructs for which there
PP studies with the possible additional respondent burden. was not consensus among experts regarding their inclusion in
Moreover, when two psychological instruments are deemed PP studies. Our expert panel did not recognise the potential
to be equivalent in their informative values, the less cogni­ contribution of these psychological constructs in shedding
tively burdensome and time-consuming tool should be pre­ light on PP formation or heterogeneity. Because of lack of
ferred over the more cognitively and time demanding. consensus, their evaluation could not be recommended.
We would like to stress that the criteria and checklist Nevertheless it has to be noted that expert consensus on inclu­
advanced here is not intended to be rigidly applied to PP sion might fail to be reached due to lack of scientific evidence
studies but rather to function as an initial guide to support on the relationship between PP and the psychological dimen­
PP researchers and other relevant stakeholders in selecting sions considered. Out of the 11 psychological dimensions
For personal use only.

psychological instruments to be included in PP studies. reaching expert agreement for inclusion, 10 belong to Group
A or B showing association between expert-consensus and the
Discussion and Limitations empirical data. Psychological constructs that have an important
The present paper provides scholars and other stakeholders role in PPs may not yet have been studied systematically.
involved in the field of PP studies with consensus-based Moreover, it should be underlined that available empirical
recommendations for the inclusion of psychological dimen­ evidence concerning the impact of psychological constructs
sions in PP studies and a checklist for the appraisal and selec­ on PP is still limited to specific contexts, patient populations, or
tion of psychological instruments to assess the candidate diseases. Thus, the generalizability of these results to other
psychological constructs. Building upon literature on the rela­ medical conditions might not be guaranteed. More investiga­
tionship between psychological dimensions and PP and on tions are needed on the link between PP and psychological
contributions from experts, we identified a list of 31 psycho­ dimensions. It is particularly relevant to explore how particular
logical constructs which could be relevant when planning PP psychological dimensions connect to PP heterogeneity. As the
studies. A panel of experts in PP studies and related disciplines Medical Device Innovation Consortium highlighted10 differ­
enlarged a list of psychological constructs that emerged from ences in PP amongst subgroups of patients may be highly
a systematic literature on psychological dimensions known to relevant to guide decision in medical products and devices
have an impact on patients’ preferences and health-related approval process. From this perspective, detecting patient pre­
decisions. To provide the reader with a snapshot of the current ference heterogeneity can be considered as a complement of
scientific data on the relationship of each construct with PP, the understanding heterogeneity of treatment effects based on
authors grouped the final list of psychological constructs in other observable characteristics because it might assure that
three clusters according to the strength and soundness of the sponsors and regulators have appropriately identified the spe­
existing empirical evidence. cific population for which the medical product should be
Furthermore, the psychological dimensions underwent indicated. Understanding patient preference heterogeneity
a consensus-based process to identify those psychological might be especially relevant if the benefits of a medical product
constructs to be recommended for inclusion in PP studies. outweigh its risks only for a subgroup of patients but not for
Consensus for inclusion was reached for 11 psychological others. In this case, it would be meaningful to infer the size of
constructs. A consensus-based classification of the psycholo­ the overall patient population presumably outweighing bene­
gical constructs also emerged. Three classes of recommenda­ fits over risks and identify specific patients’ characteristics that
tion have been detected. Class I-constructs, namely control are associated with the likelihood of being in this group.10 The
preference, health literacy, health locus of control, health identification of heterogeneity in patient preferences might
numeracy, illness perception, patient activation, risk inform patient subgroup considerations as part of the benefit-

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risk assessments.1 Specifically, it is relevant to identify any instruments to be include in PP studies. It should be stressed
potential population-, condition-, and treatment-variability in that the applicability and usefulness of the checklist and
patient preferences to obtain a clear picture of preferences of descriptive criteria advanced here are not confined to the
patients from the full spectrum of disease for which the medical assessment of PP. Our checklist and criteria are all grounded
product is intended to be used. Working in this direction our in the common need for good study design principles and are
study explored how our expert panel members understand the intended to support researchers to select or develop an optimal
role that psychological constructs can play in explaining differ­ instrument to address specific research questions. Overall, the
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ences in PP. In particular, in the context of PP studies, we asked decisions concerning the inclusion of psychological constructs
them which psychological constructs could explain both pre­ and related psychological tools for their measurement should
ference heterogeneity and possible differences springing from be made by a multidisciplinary team with clinical and psycho­
misunderstanding between experimental requests and patients’ logical expertise, and study management experience.
understanding of those. Specifically, psychological knowledge is needed to identify
Amongst the 11 constructs that reached agreement on relevant psychological differences that can be related to the
inclusion, health literacy and health numeracy were the ones formation and heterogeneity of patient preferences. Moreover,
considered the more informative when it comes to differences strong knowledge and skills concerning psychological assess­
due to misunderstanding. For example, in a PP study aimed to ment and measurement are essential to properly evaluate avail­
determine maximal acceptable risk levels for a certain treat­ able psychological measures and select the best measurement
ment in elderly people with a chronic disease, the assessment tool based on its psychometric characteristics, such as overall
For personal use only.

of health literacy and numeracy may be especially relevant to validity, reliability, and measurement properties.
identify patients that may not able to properly understand
complex numerical and/or medical information or the scenario
Conclusions
proposed by the researcher.
The list of psychological constructs identified in this study,
We furthermore investigated what relationship our
along with the classes of recommendations, the checklist and
experts assumed exist between heterogeneity in PP defined
descriptive criteria to evaluate psychological measures are
as “differences in preferences across sub-populations or
valuable tools to assist researchers and stakeholders when
classes of people” and differences in misunderstanding
designing PP studies in order to obtain results that can inform
differences defined as “differences in patient preferences
decision-making along the medical product lifecycle and
due to patients not understanding or not interpreting the
enable the implementation of personalised medicine and
patient preference study questions and information as
patient-centred care. The classification and criteria advanced
meant by the researcher.” The majority of the expert
here are meant to assist and to be considered in light of existing
panel members reported that the two phenomena are simi­
guidelines on qualities and characteristics of PP information
lar, sometimes overlapping, but distinct.
from relevant agencies and authorities such as the FDA’s
Further research is necessary to expand the recommen­
Center for Devices and Radiological Health guidance on
dations advanced here and base them on scientific data to
Patient Preference Information.60 The present study serves as
further them towards more comprehensive and evidence-
a common framework to stimulate further research, and foster
based guidance. Specifically, the classes of recommenda­
reflection and discussion on the formalisation of guidelines to
tion identified here are a first attempt to develop a common
assist stakeholders in whether and how to include psychologi­
framework to further facilitate sharing of information and
cal dimensions and measurements when designing PP studies.
the accumulation of evidence to demonstrate how
a specific psychological construct relates to PPs and
which measures should be considered within a given con­ Acknowledgments
text. It is particularly relevant to explore how a particular We would like to thank the PREFER members of the work
psychological dimension connects to PP heterogeneity. package 2.5 who contributed providing their precious
Once the psychological dimensions to be investigated and insight and expertise: Jorien Veldwijk, Rosanne Janssens,
included in a PP study have been identified, researchers need to Chiara Jongerius, Isabelle Huys, Richard Hermann, Flavia
select appropriate measurement instruments. We have sug­ Faccio, Silvia Pizzoli. We furthermore are deeply grateful
gested a checklist and set of descriptive criteria to assist and to the experts who contributed to the study as either
guide scholars in the selection of relevant psychological advisory experts or Delphi panel members.

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Funding 10. (MDIC) MDIC. Patient centered risk-benefit project report. Available
from: https://mdic-spi.org/tag/project-report/.
This research was supported by The Patient Preferences in 11. Whichello C, Van Overbeeke E, Janssens R, et al. Factors and
Benefit-Risk Assessments during the Drug Life Cycle situations affecting the value of patient preference studies:
semi-structured interviews in Europe and the US. Front Pharmacol.
(PREFER) project. PREFER has received funding from the
2019;10:1009. doi:10.3389/fphar.2019.01009
Innovative Medicines Initiative 2 Joint Undertaking under 12. Janssens R, Russo S, van Overbeeke E, et al. Patient preferences in
grant agreement No 115966. This Joint Undertaking receives the medical product life cycle: what do stakeholders think?
Semi-structured qualitative interviews in Europe and the USA.
support from the European Union’s Horizon 2020 research and
Patient Preference and Adherence downloaded from https://www.dovepress.com/ by 213.184.92.187 on 18-Jun-2021

Patient. 2019;12(1):1–14. doi:10.1007/s40271-018-0324-6

innovation programme and EFPIA. This text and its contents 13. Russo S, Jongerius C, Faccio F, et al. Understanding patients’ pre­
reflects the author’s and PREFER project’s view and not the ferences: a systematic review of psychological instruments used in
patients’ preference and decision studies. Value Health. 2019;22
view of IMI, the European Union or EFPIA. (4):491–501. doi:10.1016/j.jval.2018.12.007
14. Lazarus RS. Progress on a cognitive-motivational-relational theory of
emotion. Am Psychol. 1991;46(8):819. doi:10.1037/0003-066X.46.8.819
Disclosure 15. Spielberger CD, Gorsuch RL, Lushene RE. Manual for the state-trait
The authors report no conflicts of interest in this work. anxiety inventory 1970; 2018. Available from: https://ubir.buffalo.
edu/xmlui/handle/10477/2895. Accessed September 8, 2018.
16. Lazarus RS. Emotion and Adaptation. Oxford University Press on
Demand; 1991.
References 17. Rakos RF. Assertive Behavior: Theory, Research, and Training.
Taylor & Frances/Routledge; 1991.
1. FDA. Patient preference information – voluntary submission, review in
18. Deci EL, Ryan RM. The support of autonomy and the control of behavior.
premarket approval applications, humanitarian device exemption applica­
J Pers Soc Psychol. 1987;53(6):1024. doi:10.1037/0022-3514.53.6.1024
For personal use only.

tions, and de novo requests, and inclusion in decision summaries and device
19. Kasser VG, Ryan RM. The relation of psychological needs for
labeling: guidance for industry, food and drug administration staff, and other
autonomy and relatedness to vitality, well-being, and mortality in
stakeholders. U.S. Department of Health and Human Services Food and
a nursing home 1. J Appl Soc Psychol. 1999;29(5):935–954.
Drug Administration, Center for Devices and Radiological Health and
doi:10.1111/j.1559-1816.1999.tb00133.x
Center for Biologics Evaluation and Research, ed. Available from: http://
20. Gray J, McNaughton N. The Neuropsychology of Anxiety. Oxford
www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/
University Press; 1982.
guidancedocuments/ucm446680.pdf2016. Accessed May 25, 2021.
21. Suziedelis A, Lorr M. Conservative attitudes and authoritarian values.
2. EMA. The Patient’s Voice in the Evaluation of Medicines. European
J Psychol. 1973;83(2):287–294. doi:10.1080/00223980.1973.9915616
Medicines Agency, Stakeholders and Communication Division; 2013.
22. Degner LF, Sloan JA, Venkatesh P. The control preferences scale.
Available from: https://www.ema.europa.eu/en/documents/report/
Can J Nurs Res. 1997;29(3).
report-workshop-patients-voice-evaluation-medicines_en.pdf.
23. Compas BE. Coping with stress during childhood and adolescence.
Accessed April 14, 2021
Psychol Bull. 1987;101(3):393. doi:10.1037/0033-2909.101.3.393
3. US Department of Health and Human Services Food and Drug
24. Driver MJ. Individual decision making and creativity. Organ Behav.
Administration, Center for Devices and Radiological Health and Center
1979;59–91.
for Biologics Evaluation and Research. Patient preference information—
25. Harren VA. A model of career decision making for college students.
voluntary submission, review in premarket approval applications, humani­
J Vocat Behav. 1979;14(2):119–133. doi:10.1016/0001-8791(79)90065-4
tarian device exemption applications, and de novo requests, and inclusion in
26. American Psychiatric Association. Diagnostic and Statistical Manual
decision summaries and device labeling: guidance for industry, food and
of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric
drug administration staff, and other stakeholders. Available from: https://
Publishing; 2013.
www.fda.gov/media/92593/download. Accessed May 25, 2021.
27. Scheier MF, Carver CS. Optimism, coping, and health: assessment
4. Elwyn G, Frosch D, Rollnick S. Dual equipoise shared decision making:
and implications of generalized outcome expectancies. Health
definitions for decision and behaviour support interventions. Implement Sci.
2009;4(1):1–8. doi:10.1186/1748-5908-4-75 Psychol. 1985;4(3):219. doi:10.1037/0278-6133.4.3.219
5. Cutica I, Mc Vie G, Pravettoni G. Personalised medicine: the cognitive 28. Baker DW, Williams MV, Parker RM, Gazmararian JA, Nurss J.
side of patients. Eur J Intern Med. 2014;25(8):685–688. doi:10.1016/j. Development of a brief test to measure functional health literacy. Patient
ejim.2014.07.002 Educ Couns. 1999;38(1):33–42. doi:10.1016/S0738-3991(98)00116-5
6. Kondylakis H, Kazantzaki E, Koumakis L, et al. Development of interactive 29. Wallston KA, Strudler wallston B, DeVellis R. Development of the multi­
empowerment services in support of personalised medicine. dimensional health locus of control (MHLC) scales. Health Educ Monogr.
Ecancermedicalscience. 2014;8:8. doi:10.3332/ecancer.2014.400 1978;6(1):160–170. doi:10.1177/109019817800600107
7. Renzi C, Riva S, Masiero M, Pravettoni G. The choice dilemma in 30. Reyna VF, Nelson WL, Han PK, Dieckmann NF. How numeracy
chronic hematological conditions: why choosing is not only a medical influences risk comprehension and medical decision making. Psychol
issue? A psycho-cognitive perspective. Crit Rev Oncol Hematol. Bull. 2009;135(6):943. doi:10.1037/a0017327
2016;99:134–140. doi:10.1016/j.critrevonc.2015.12.010 31. Zikmund-Fisher BJ, Smith DM, Ubel PA, Fagerlin A. Validation of
8. de Bekker-grob EW, Berlin C, Levitan B, et al. Giving Patients’ the subjective numeracy scale: effects of low numeracy on compre­
Preferences a Voice in Medical Treatment Life Cycle: The PREFER hension of risk communications and utility elicitations. Med Decis
Public–Private Project. Springer; 2017. Mak. 2007;27(5):663–671. doi:10.1177/0272989X07303824
9. Huls SP, Whichello CL, van Exel J, Uyl-de Groot CA, de Bekker-grob 32. Dutta M, Bodie G, Basu A. Health disparity and the racial divide
EW. What is next for patient preferences in health technology assess­ among the nation’s youth: internet as a site for change? In: John D,
ment? A systematic review of the challenges. Value Health. 2019;22 Catherine T, editors. MacArthur Foundation Series on Digital Media
(11):1318–1328. doi:10.1016/j.jval.2019.04.1930 and Learning. Cambridge, MA: The MIT Pr; 2008:175–198.

1344 https://doi.org/10.2147/PPA.S261615 Patient Preference and Adherence 2021:15

DovePress

Powered by TCPDF (www.tcpdf.org)

 Dovepress Russo et al

33. Baker K, Jaksic S, Rowley D. The self-regulation model of illness 47. Antonovsky A, Sourani T. Family sense of coherence and family
representation applied to stuttering. J Psychosom Res. adaptation. J Marriage Fam. 1988;50(1):79–92. doi:10.2307/352429
1995;60:631–637. 48. Cohen S. Social relationships and health. Am Psychol. 2004;59
34. Morgan GA, Harmon RJ, Maslin-Cole CA. Mastery motivation: (8):676. doi:10.1037/0003-066X.59.8.676
definition and measurement. Early Educ Dev. 1990;1(5):318–339. 49. Horne R, Weinman J. Patients’ beliefs about prescribed medicines and
doi:10.1207/s15566935eed0105_1 their role in adherence to treatment in chronic physical illness.
35. Kleinstäuber M. Mood. In: Encyclopedia of Behavioral Medicine. J Psychosom Res. 1999;47(6):555–567. doi:10.1016/S0022-3999(99)
New York: Springer; 2013:1259–1261. 00057-4
36. Kruglanski AW, Webster DM. Motivated closing of the mind: ‘seiz­ 50. Keeney S, McKenna H, Hasson F. The Delphi Technique in Nursing
Patient Preference and Adherence downloaded from https://www.dovepress.com/ by 213.184.92.187 on 18-Jun-2021

ing’ and ‘freezing’. Psychol Rev. 1996;103(2):263–283. doi:10.1037/ and Health Research. John Wiley & Sons; 2011.
0033-295X.103.2.263 51. Vernon W. The delphi technique: a review. Int J Ther Rehabil.
37. Cacioppo JT, Petty RE, Feinstein JA, Jarvis WBG. Dispositional 2009;16(2):69–76. doi:10.12968/ijtr.2009.16.2.38892
differences in cognitive motivation: the life and times of individuals 52. Kezar A, Maxey D. The delphi technique: an untapped approach of
varying in need for cognition. Psychol Bull. 1996;119(2):197. participatory research. Int J Soc Res Methodol. 2016;19(2):143–160.
doi:10.1037/0033-2909.119.2.197 53. Carmines EG, Woods J. Validity. In: Lewis-Beck M, Liao TF, editors.
38. Cacioppo JT, Petty RE, Feng Kao C. The efficient assessment of need The Sage Encyclopedia of Social Science Research Methods. 2003.
for cognition. J Pers Assess. 1984;48(3):306–307. doi:10.1207/ 54. Gushta MM, Rupp AA. Reliability. In: Salkind NJ, editor.
s15327752jpa4803_13 Encyclopedia of Research Design. 2010.
39. Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing 55. Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the
of a short form of the patient activation measure. Health Serv Res. 2005;40 process of cross-cultural adaptation of self-report measures. Spine.
(6p1):1918–1930. doi:10.1111/j.1475-6773.2005.00438.x 2000;25(24):3186–3191. doi:10.1097/00007632-200012150-00014
40. Allport GW. Pattern and Growth in Personality. New York: Holt, 56. Hays RD, Weech-Maldonado R, Teresi JA, Wallace SP, Stewart AL.
Rinehart & Winston; 1961. Commentary: copyright restrictions versus open access to survey
41. Ryff CD, Singer BH. Best news yet on the six-factor model of instruments. Med Care. 2018;56(2):107–110. doi:10.1097/
well-being. Soc Sci Res. 2006;35(4):1103–1119. doi:10.1016/j. MLR.0000000000000857
For personal use only.

ssresearch.2006.01.002 57. Lingler JH, Schmidt K, Gentry A, Hu L, Terhorst L. Perceived

42. Pacini R, Epstein S. The relation of rational and experiential informa­ Research Burden Assessment (PeRBA): instrument development
tion processing styles to personality, basic beliefs, and the ratio-bias and psychometric evaluation. J Empir Res Hum Res Ethics. 2014;9
phenomenon. J Pers Soc Psychol. 1999;76(6):972. doi:10.1037/0022- (4):46. doi:10.1177/1556264614545037
3514.76.6.972 58. Sharp LM, Frankel J. Respondent burden: a test of some common
43. American Psychological Association. The road to resilience 2014; assumptions. Public Opin Q. 1983;47(1):36–53. doi:10.1086/268765
2017. Available from: http://www.apa.org/helpcenter/road-resilience. 59. Ulrich CM, Wallen GR, Feister A, Grady C. Respondent burden in
aspx. Accessed May 25, 2021. clinical research: when are we asking too much of subjects? Ethics
44. Mellers BA, Cooke AD. The role of task and context in preference Hum Res. 2005;27(4):17–20. doi:10.2307/3563957
measurement. Psychol Sci. 1996;7(2):76–82. doi:10.1111/j.1467- 60. CDRH F. Patient Preference information–voluntary submission,
9280.1996.tb00333.x review in premarket approval applications, humanitarian device
45. Bandura A. Self-efficacy. In: Ramachandran VS, editor. Encyclopedia of exemption applications, and de novo requests, and inclusion in deci­
Human Behavior. Vol. 4. San Diego: Academic Press; 1994:71–81. sion summaries and device labeling. Food and Drug Administration
46. Zuckerman M. Behavioral Expressions and Biosocial Bases of Staff, and Other Stakeholders. 2016.
Sensation Seeking. Cambridge university press; 1994.

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