Cognitive Bias and Heuristics in Patients With Knee Osteoarthritis
Conditions: Knee Osteoarthritis
Sponsor: Frederiksberg University Hospital

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Cognitive Bias and Heuristics in Patients with Knee Osteoarthritis Being Treated with Open Label 
Placebo. Protocol For an Explorative Study Using Questionnaire and Group Concept Mapping 
Designs in Participants from a Randomised Clinical Trial Evaluating Two Different Conversations 
Designed to Reinforce Open Label Placebo Response in Knee Osteoarthritis. 
 
INVESTIGATORS 
Tommy K Annfeldt (Project manager) 
 
Elisabeth Ginnerup-Nielsen 
Lene Vase 
Eva E Wæhrens (Questionnaire expert) 
Lars E Kristensen 
Tanja S Jørgensen (Concept mapping expert) 
 
Date: Thursday, 4th May 2023 
Version: 1,0 
 

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Contents 
FULL TITLE .......................................................................................................................................................... 3 
SHORT TITLE....................................................................................................................................................... 3 
INTERNAL PROTOCOL ID .................................................................................................................................... 3 
DATA APPROVAL NUMBER ................................................................................................................................ 3 
PATIENT RESEARCH PARTNERS ......................................................................................................................... 3 
BACKGROUND ................................................................................................................................................... 4 
Problem statement: ....................................................................................................................................... 5 
STUDY AIM ......................................................................................................................................................... 5 
STUDY PURPOSE ................................................................................................................................................ 5 
METHOD ............................................................................................................................................................ 6 
STUDY DESIGN ............................................................................................................................................... 6 
QUESTIONNAIRE ............................................................................................................................................ 6 
Section 1: are there an affective tag associated with OLP and the conversation? ................................... 6 
Section 2: impact of the affect heuristic. .................................................................................................. 7 
Questionnaire Data Collection .................................................................................................................. 8 
GROUP CONCEPT MAPPING (GCM) ............................................................................................................... 9 
Group Content Mapping Data Generation ................................................................................................ 9 
Group Concept Mapping Participants ...................................................................................................... 12 
Concept mapping personnel ................................................................................................................... 13 
DURATION OF THE STUDY ............................................................................................................................... 13 
RESEARCH ETHICS ............................................................................................................................................ 14 
Questionnaire .............................................................................................................................................. 14 
Group Content Mapping .............................................................................................................................. 14 
SOURCE DOCUMENTS ..................................................................................................................................... 15 
REGULATORY STANDARDS .............................................................................................................................. 15 
PARTICIPANT CONFIDENTIALITY .................................................................................................................. 15 
DATA PROTECTION ACT AND GENERAL DATA PROTECTION REGULATION ................................................ 15 
FINANCING INFORMATION.......................................................................................................................... 16 
PUBLICATION ................................................................................................................................................... 16 
REFERENCE LIST ............................................................................................................................................... 17 
 
 
 

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FULL TITLE 
Cognitive Bias and Heuristics in Patients with Knee Osteoarthritis Being Treated with Open Label 
Placebo. Protocol For an Explorative Study Using Questionnaire and Group Concept Mapping 
Designs in Participants from a Randomised Clinical Trial Evaluating Two Different Conversations 
Designed to Reinforce Open Label Placebo Response in Knee Osteoarthritis. 
SHORT TITLE 
Cognitive biases and Heuristics In patients with knee osteoarthritiS (CHIPS). 
 
INTERNAL PROTOCOL ID 
P:\BFH\PARKER\APPI2\MSK\Placebo and Context\Tommy Annfeldt (PhD)\CHIPS_Cognitive bias 
and Heuristics In Patients with osteoarthritiS 
DATA APPROVAL NUMBER 
P-2021-451  
 
PATIENT RESEARCH PARTNERS 
This protocol has been reviewed by two patient research partners with knee osteoarthritis (male 
and female, neither of which who participated in the parent RCT study). 
 

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BACKGROUND 
Placebo has previously been suggested to have clinical effect on patient-related subjective 
outcomes such as pain, stiffness, and self-reported function, in patients with knee osteoarthritis 
(OA) (1). It has also been suggested that open label placebo result in a higher effect than blinded 
placebo (1). And while the clinical use of placebo is still under debate and ethical examination, a 
recent review suggested that 63%-77% of surveyed physicians use placebo weekly, and it is 
estimated that 40% of all prescriptions functions as placebo (2). Thus, the use of placebo in a real-
world clinic setting is widespread and, it is increasingly recognised that placebo should be 
considered either as a treatment option or as an add on to the treatment (2).  
Placebos, although pharmacologic inert substances, triggers an effect and a subsequent response 
through a complex series of neurochemical, -hormonal, and -biological mechanisms that are still 
not fully understood (2). Although the exact interplay between contextual factors and the brain 
has not yet been fully alluded to in connection to the placebo response, it is recognised as a mind-
body phenomenon and thus a result of the psychosocial context around the patient and the 
therapy including the patient’s own characteristics (3).  
Other contextual factors that can influence the placebo effect include the placebo itself, where 
taste(4) colour, and route of administration (1) have all shown to influence the outcome, but also 
personality (5) and the healthcare provider and patient relationship (2). 
Behavioural Economics 
Behavioural economics (BE) study the effects of psychological, cognitive, emotional, cultural, and 
social factors on the decisions of individuals. Conventional economics (CE) assumes that all people 
are both rational and selfish however, in practice this is often not the case, which leads to the 
failure of traditional models. Central to BE are cognitive biases (CB), and heuristics (H) which are 
used to explain the decisions and choices that people make. Cognitive biases are systematic 
patterns of deviation from norm or rationality in judgment, while heuristics are tactics, or mental 
shortcuts to aid in the decision-making process. Cognitive biases and heuristics are often used to 
explain certain patterns of seemingly irrational behaviour and decisions.  

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Although originated in economics academia, theories such as CB/H developed in BE are 
increasingly being used in healthcare to facilitate good health decisions, improved care, and in 
designing new interventions (6). 
Cognitive biases have also been shown to influence how patients and non-patients rate their own 
health or that of others (7). Most studies are concerned with how CB/H influence physician´s and 
nurse´s decisions however, a more advanced understanding of what influences patients’ decisions 
could open the door for specialised design of treatment contexts, and ad-on programs to 
treatments. This could increase the adherence to treatment regimens as well as the overall 
efficacy experienced by the patient leading to better outcomes as well as a better usage of 
healthcare resources.   
 
Problem statement: 
Cognitive bias and heuristics have shown to influence how we make decisions about health and 
medicine, and they have also been shown to influence how we rate our own health. Less is known 
about which specific cognitive biases and/or heuristics that are in play when patients form their 
treatment expectations and evaluate their health following an intervention. 
 
STUDY AIM 
This study aims to understand if certain cognitive biases and heuristics are present in patients with 
knee (OA) being treated with open label placebo. 
 
STUDY PURPOSE 
Understanding which cognitive biases and/or heuristics that are in play when patients evaluate 
their health following open label placebo, allows future treatment context to be designed in a way 
that actively utilises these to obtain a greater magnitude of response.  
 

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METHOD 
STUDY DESIGN 
This study combines a global questionnaire sent to all participants from the study “Reinforcement 
of Treatment Response in Knee Osteoarthritis: A Randomised Trial” (Clinical trial.gov registration: 
NCT05225480) with structured conceptualization based on group interviews with responders and 
non-responders respectively from the same study; the group content mapping (GCM) method. 
This design will allow us to get in-depth knowledge on one particular heuristic based on the 
questionnaire, while the GCM methods will provide a broader view of other potential concepts 
and CB/H that might be present in this patient group.  
 
QUESTIONNAIRE 
A review (8) examining the most studied CB/H in medical decision making for both healthcare 
personnel and patients, was used to short list 5 CB/H (table 1). The reason for shortlisting them 
can be found in table 1. After having reviewed the references from the review (8) connected with 
the 5 selected CB/H, we chose to investigate the effect of the affect heuristic (AH) using the 
questionnaire developed by (Skagerlund K. et al., 2020) (11) to quantify the presence and impact 
of the AH on all participants. Reasons for choosing to investigate the AH and excluding the other 4 
CB/H can be found in table 1.   
The questionnaire will have two sections and will be used to determine if, and to what degree, 
participants are influenced by the AH. Later the strength of the AH will be correlated to the change 
in the individual’s ∆VAS pain score (baseline VAS – follow up VAS) via regression. 
Section 1: are there an affective tag associated with OLP and the conversation? 
This section is intended to investigate whether participants have attached a positive or negative affect tag 
to OLP and/or the conversation. 
- 
Question #1 asks the participant to rate their experience of the OLP procedure on a 7-point Likert 
scale 
- 
Question #2 asks the participant to rate their experience of the conversation on a 7-point Likert 
scale 

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Section 2: impact of the affect heuristic. 
Based on the correlation between perceived risk and benefit, it can be determined how strong the AH is 
influencing the individual participant (11). If participants are strictly rational and not susceptible to the AH 
there would be no correlation. If they are influenced by the AH, we would see a positive correlation 
between benefit and risk i.e., the more perceived benefit the less risky the activity would seem. Questions 
will be translated from Swedish to Danish by two investigators (EEW, TKA) and compared for consistency. 
Disagreements will be solved by consensus by the two investigators. 
- 
Question 3 – 67: questions related to the “perceived benefit” of a range of activities translated 
from (11) 
- 
Questions 68 – 113: questions related to the “perceived risk” of the same range of activities 
translated from (11). 
 
COGNITIVE 
BIAS OR 
HEURISTIC 
DESCRIPTION (8) 
REASON FOR 
SHORTLISTING 
REFS FROM 
(8) THAT 
ASSESSED 
THE CB/H 
REASONS FOR INCLUDING 
OR EXCLUDING FROM THE 
QUESTIONNAIRE 
AFFECT 
HEURISTIC 
Representations of objects 
and events in people’s 
minds are tagged to 
varying degrees with 
affect. People consult or 
refer to an ‘affective pool’ 
(containing all the positive 
and negative tags 
associated with the 
representations 
consciously or 
unconsciously) in the 
process of making 
judgments. 
If participants 
experienced the 
conversations as 
pleasant, they are 
likely to “tag” the 
treatment with a 
positive tag. Thus, 
when asked about 
their knee OA 
symptoms they recall 
the positive-, or 
negative tag  
(25) (26a) 
(27) (28) (29) 
Include. AH can impact 
how the participant judges 
the effect of the 
intervention based on a 
positive or negative tag. 
AVAILABILITY 
BIAS 
People assess the 
probability of an event by 
the ease with which the 
instance or occurrences 
can be recalled. 
They only remember 
the most recent 
feelings and not the 
entire duration since 
last visit. Or, if either 
being in pain or free 
of pain is more 
memorable to them, 
then this is more 
likely to stick out.  
(46a) (47a) 
(48) (49a) 
(50a) (51) 
(52) (53a) 
(54) (55a) 
(56) (57a) 
(58) (59a) 
(60) (61a) 
(62) (63a) 
Exclude. This CB is more 
relevant in the moment of 
deciding to participate or 
not. Or when judging a 
situation involving others. 
E.g., when someone makes 
a decision based on 
anecdotal evidence.  

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(64a) (65) 
(66) (67) 
DEFAULT BIAS 
Individuals have a strong 
tendency to remain at 
status quo, because the 
disadvantage of leaving it 
seems larger than the 
advantages. 
Having knee pain due 
to OA might have 
been their “default” 
state for many years, 
and leaving that state 
introduces 
uncertainty. 
(90) (91) (92) 
(93) 
Exclude. More likely to 
influence the decision to do 
something else than what 
they usually do. And thus 
not likey  
IMPACT BIAS 
People tend to 
overestimate the long-
term impact of positive 
and negative events. 
If they had a good 
experience in the 
conversation this bias 
could lead to an 
improved response 
(97) (98) (99) 
(100) (101) 
(102a) (103) 
(104) (105) 
(106) 
Excluded. The impact bias 
has more to do with how 
we might assess what 
might happen in the future, 
or what the effect on 
others might be. E.g., we 
are more likely the 
negative effect a disease 
has on others quality of 
life. Or to overestimate the 
positive effect an action 
will have in the future.  
OUTCOME 
BIAS 
Allowing a prior event or 
decision outcome to 
influence subsequent 
independent decisions. 
The participants have 
made an explicit 
decision to 
participate in the 
study, and thus 
unconsciously are 
more prone to 
wanting a good 
effect.  
(210) (211) 
(212a) 
Excluded. Outcome bias 
would be relevant if we 
asked participants if 
participating would be a 
good decision. In that case, 
the outcome bias would 
dictate, that those with a 
positive outcome would 
view the decision to decide 
as a good decision.  
Table 1: CB and HE shortlisted and the reasons for including/ excluding in the questionnaire (8). 
 
Questionnaire Data Collection 
All participants from the study “Reinforcement of Treatment Response in Knee Osteoarthritis: A 
Randomised Trial” will receive an invitation to populate the questionnaire in their electronic 
mailbox (Mit.dk) via the software Research Electronic Data Capture (REDCap) with an introduction 
and explanation on the objective of the questionnaire.  
For each populated questionnaire 10 DKK will be donated to the Parker Institute´s patient 
organisation. Each week following the first email, the survey will be resent to those who did not 

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respond to the first survey round, until the survey has been sent a total of three times (or 100% 
response rate has been achieved whichever comes first).  
Data will be collected and managed using REDCap electronic data capture tools hosted at The 
Parker Institute, Frederiksberg and Bispebjerg Hospital, Denmark. REDCap is a secure, web-based 
software platform supporting data capture for research studies, providing validated data capture, 
audit trails for tracking data manipulation automated export functions to statistical programs 
(9,10). 
GROUP CONCEPT MAPPING (GCM) 
Using the group concept mapping data, we will explore what concepts and CB/H that are present 
in the responders- and non-responders respectively and compare the similarities and differences 
between the two groups. 
GCM is a formal group process using a structured approach to identify ideas on a topic of interest 
and organize them into domains based on a mixed-method participatory design that incorporates 
group processes and multivariate statistical analyses (multidimensional scaling and hierarchical 
cluster analysis) (12,13). 
The structured conceptualization will be captured, and conceptualised using the software Concept 
System GroupWisdom software, (14) which supports the steps in the GCM process. 
Group Content Mapping Data Generation 
The concept mapping method used in this study is based on William Trochim’s framework for 
concept mapping that follows six predefined steps to yield the conceptual presentation. 
(15,16,17,18). All GCM sessions will be carried out via in-person attendance of all group members 
in the respective groups. 
 
Step 1. Preparation 
This step contains two aspects, selecting participants and developing the focus. Selecting 
participants should aim at using a broad heterogeneous group to ensure a wide variety of 
viewpoints. Responders and non-responders respectively (as defined below), from the RCT study 

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“Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial", will be invited 
to take part in the concept mapping session in random order until the desired number of groups 
have been reached. 
When developing the focus, a seeding question based on the aim of this study will be asked to the 
participants.  
Seeding question: Tænk så bredt som muligt - hvad var din begrundelse for at sige ja til en 
saltvandsindsprøjtning, og hvilke forventninger havde du (både til indsprøjtningen og samtalen)? 
Thinking as broad as you can – what was your reason for accepting a saline injection, and what 
expectations did you have (both for the injection as well as the conversation)? 
The seeding question will be tested with the patient research partners beforehand, to make sure it 
resonates with patients, and invites participants to share emotions and statements. The concept 
mapping software will be used to sort the statements into meaningful categories/themes and 
guide the brainstorming in the desired direction. In addition, a rating focus will be used to identify 
which statements are of most importance. 
 
Step 2. Generation of Statements 
During this step the statements will be generated using the brainstorming format; that is, people 
are encouraged to generate a lot of statements without criticism or discussion regarding 
legitimacy. As the statements are generated, they will be entered into the software, with the 
screen projected so that all participants can see the statements. After the generation of 
statements, these will be read and re-written, if necessary, by the participants to ensure clarity 
and avoid duplicates. If over 100 statements are generated, participant will be asked to examine of 
there are redundancies or if one statement can represent a subset of others. 
 
Step 3. Structuring of Statements 
The final statements are sorted into meaningful piles by each participant. When each participant 
has finished sorting the statements, they will be put into a matrix allowing for quantification of 

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how the individual participant conceptualize the statements and which statements are 
conceptually agreeable between participants.  
 
Step 4. Representation of Statements 
The representation of statements is presented using multidimensional scaling analysis on a map 
with statements that have been sorted frequently together placed close to each other. The results 
will be represented in a two-dimensional graph (19). 
Secondly a hierarchical cluster analysis (20,21) is performed to identify which statements 
presumably represent the same concepts. The number of clusters needed, for the best 
representation of the sorted statements, is decided by looking at different cluster map 
representation of the data. The decision of number of clusters needed rely on the number of 
concepts developed by the participants (e.g., the highest number one participant use, is the 
maximum number of clusters and the lowest number of clusters one participant use will be the 
lower limit of clusters looked at). The typical solution will be a cluster map between 3 to 12 
clusters. A cluster map has a good representation of the results when statements in the different 
clusters make sense as concepts. 
Finally, a point map and a cluster map are generated. These maps are based on the average rating 
across participants for each statement and each cluster. All participants will be asked to rate the 
relevance of each statement and each cluster on a five-point scale; 1: ‘Not relevant for people in 
my situation’, 2: ‘Rarely relevant for people in my situation, 3: ‘Sometimes relevant for people in 
my situation, 4: ‘Very relevant for people in my situation, and 5: ‘Of essential relevance for people 
in my situation. 
 
Step 5. Interpretation of Maps 
The participants will be asked to interpret the results that have emerged in the different maps, 
there should be 6 maps available: 
1. 
The statement list. 

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2. 
The cluster list. 
3. 
The point map. 
4. 
The cluster map. 
5. 
The point rating map. 
6. 
The cluster rating map. 
 
Each of these maps/list represents the results from the different steps in the concept mapping 
session. The participants will be asked to look at the statements in the different clusters, on the 
cluster map, and decide whether statements are presented in the right group or needs to be 
removed and name each cluster. Agreement is reached by discussion. 
Secondly the point rating map and cluster rating map is presented to the participants, and they are 
asked to examine if the rating of the statements makes sense. Secondly, they are sked to assess if 
the names given based on the cluster map, still fits when looking at the cluster rating map. Lastly, 
it is checked whether the concept (name of the cluster) is closely related to the highest rated 
statement within that cluster. 
 
Step 6. Utilization of Maps 
Using the concept maps and statements, we will assess if they belong to specific CB/H or, if they fit 
into one of the proposed taxonomies of CB/H. This can be used to design contextual factors to 
target these specific cognitive biases and heuristics to further improve the response to open label 
placebo.  
Group Concept Mapping Participants 
A list of randomly selected responders, and non-responders respectively from the study 
“Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial”, will be 
generated and participants will be contacted by TSJ or TKA and asked if they wish to participate in 
a group concept mapping interview. 
 

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Definition of responders and non-responders  
Participants from the trial “Reinforcement of Treatment Response in Knee Osteoarthritis: A 
Randomised Trial” will be defined as responders if they belong to the upper quartile of the ΔVAS 
(those who had the greatest positive changes) and non-responders will be defined as those 
belonging to the lower quartile of the delta VAS (those who had the smallest change).   
 
Number of participants 
Usually, it takes two to three concept mapping sessions with groups of 4-6 persons to reach 
saturation of the concepts/statements given by the participants. Therefore, a total of 18 
participants will be sought recruited from each group (responder/non-responder) to participate in 
the GCM sessions after which the concept mapping expert (TSJ) will assess if saturation has been 
reached, if not, additional sessions will be held. 
 
Concept mapping personnel 
The sessions will be led by TSJ, who is an expert in concept mapping, and EG-N. The project 
manager TKA will be present during the sessions to observe. 
 
DURATION OF THE STUDY 
Two to three concept mapping sessions will be performed during May depending on number of 
sessions needed to reach saturation in the statement. 
The Questionnaire will also be sent out during May. 
Data will be analysed after summer after which a manuscript will be prepared and sent to selected 
publishers ultimo 2023. 
 

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RESEARCH ETHICS 
According to the Danish regulations, questionnaires and interviews does not require submission 
to, or approval from, the Health Research Ethics Committee. 
Questionnaire 
Participants will be invited via an introductory email with information regarding the project in an easy-to-
understand plain Danish. Herein they will be informed that participation is completely voluntarily, and that 
they can choose to opt-out at any time without having to explain why. 
An informed consent form (ICF) will be prepared and included in the introductory email. When a participant 
chooses to answer the questionnaire, they will check a box stating that they acknowledge that they have 
read and understood the ICF. This will be captured along with the responses to the questionnaire. 
Group Content Mapping 
When a potential participant is contacted via phone regarding the GCM sessions, they will receive 
oral information regarding the project. The information will be given in easy-to-understand plain 
Danish. If a participant wishes to participate, they will receive a written description of the project 
and the role of the participant. If a participant still wishes to participate, they will be invited to a 
concept mapping session. 
All participants will be informed, that participation in the GCM sessions is completely voluntarily, 
and that they can choose to opt-out at any time without having to explain why. 
An informed consent form (ICF) will be prepared and must be signed and dated by the participants 
prior to participation in the GCM sessions. A copy of the from is provided to the participants. Prior 
to consent, it must be ensured that a potential participant has been given enough time to consider 
his or her participation. The signed ICF must remain in each participant’s study file and must be 
available for verification by inspection at any time. 
After a participant has signed the ICF, the following information will be collected from the 
participant’s medical records: 
- 
Contact information 
- 
Response status on all endpoints from the study “Reinforcement of Treatment Response in 
Knee Osteoarthritis: A Randomised Trial”. 

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SOURCE DOCUMENTS 
Source documents are defined as populated questionnaires, data from the concept mapping 
sessions and the participants medical records. 
 
REGULATORY STANDARDS 
Information on this study will be published on the ClinicalTrials.gov website prior to data collection.  
 
PARTICIPANT CONFIDENTIALITY  
When data from this study is published, the presentation format will not include names, 
recognisable photos, personal information, or other data which compromises the anonymity of 
participating participants. If statements from the concept mapping sessions are used to emphasize 
the findings, no personal information will be present in the statement. 
 
DATA PROTECTION ACT AND GENERAL DATA PROTECTION REGULATION 
The study will be conducted in accordance with the Data Protection Act and follow the General 
Data Protection Regulation. The study´s data management and data security procedures are 
approved by the Regional Knowledge Centre on Data Protection Compliance (videnscenter for 
dataanmeldelser i Region Hovedstaden) on behalf of the Danish Data Protection agency as a sub 
study under the study “Reinforcement of Treatment Response in Knee Osteoarthritis: A 
Randomised Trial” (P-2021-451). 
All demographic and personal identifier data will be stored electronically for analysis and 
reporting. Upon completion of data entry, the information will be checked to ensure acceptable 
accuracy and completeness. All data will be anonymized when the study has been completed. 
 

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FINANCING INFORMATION 
This study is initiated by PhD student Tommy K Annfeldt. No specific funding has been received, 
however salary of TSJ, EGN, EEW, and LEK is covered by the Parker Institute. TKA is employed by 
Biogen International GmbH and the Parker Institute however, his salary is paid solely by Biogen 
International GmbH. LV is employed by the University of Aarhus.  If future financial support is 
obtained, it will be disclosed to the participants and reported in the final article.  
 
PUBLICATION 
The development of the research article will be coordinated by Tommy K Annfeldt, and all 
individuals who have provided significant input to study design, implementation, conduct and 
interpretation, and fulfil the requirements for authorship as recommended by the international 
committee of medical journal editors (ICMJE) will be eligible to be mentioned as authors.   
In accordance with the principles of the Helsinki declaration, all results of the study, positive as 
well as negative and inconclusive will be published. 
 
 
 
 
 

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