The Mere-measurement Effect in Patient-reported Outcomes: A Randomized Control Trial With Speech Pathology Patients
Phase: NA
Conditions: Measurement, Psychological Stress, Speech Disorders, Assessment, Self
Sponsor: Medical University of Vienna

Study protocol 
 
 
 
 
 
 
 
 
 
 
 
 
04.08.2024 
 
1 
PROTOCOL 
TITLE: 
The Mere-measurement effect in patient-reported 
outcomes: A randomized control trial with speech 
pathology patients 
STUDY INITIATOR:  
Institute for Outcomes Research, MUW 
MAIN AUTHOR: 
Preston Long1*, Valentin Ritschl1,2*, Melanie Ferk-
Dornstauder1, Tanja Stamm1,2*, Philipp Aichinger3* 
 
1 Medical University of Vienna, Centre for Medical Data 
Science, Institute of Outcomes Research, Vienna, Austria  
2 Ludwig Boltzmann Institute for Arthritis and 
Rehabilitation, Vienna, Austria 
3 Medical University of Vienna, Department of 
Otorhinolaryngology, Division of Phoniatrics-Logopedics, 
Speech and Hearing Science Lab, Vienna, Austria 
 
*Contributed equally 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study protocol 
 
 
 
 
 
 
 
 
 
 
 
 
04.08.2024 
 
2 
Preface 
 
The use of patient-reported outcome (PROs) have become increasingly 
commonplace across many healthcare settings over the past two decades. The value of 
PROs is now acknowledged by healthcare providers and patients alike. However, to date, 
little is known about the best practices for formulating PRO measures (PROMS), but 
even more specifically, the effect had on the responding patients as a result of item word 
choice, emotional valence, or frequency of use. That is, 1) does the positive or negative 
wording of items affect the patient’s perspective on the latent variable, 2) is there a 
degree of subliminal influence or measurement effects on their behaviour resulting from 
exposure to PROs, and finally, 3) is such an effect amplified with repeated exposure? 
 
 

 
 
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1. 
FEASIBILITY STUDY PROTOCOL 
1.1 
BACKGROUND 
There is currently sufficient evidence to suggest that attributes such as the wording of 
questions, their presentation order, the context where they are asked, and the item’s social 
sensitivity (e.g. I do not abuse my prescriptions), have an effect on participant responses 
(Schwarz, 1999; Näher & Krumpal, 2012). This family of variables are most oft referred 
to as method effects. Method effects largely regard the phenomenon in which the 
presentation of an item affects the participant’s response independent of the content in 
question. The end goal within this area of study is to correct for any response bias resulting 
from the items used. This research primarily concerns psychometrics. It is important to 
note that while method effects relate to the research questions proposed, it is not the key 
feature of interest. The ensuing inquiry will not simply focus directly on changes to item 
responses, but instead, on changes to patient perceptions and behaviours as a result of their 
exposure to the measures themselves. This has been coined the mere-measurement effect 
(Morwitz, Johnson, & Schmittlein, 1993).    
Research supports the claim that asking certain questions can influence behaviours on the 
same topic (Sandberg & Conner, 2009; Godin et al., 2010). For example, a randomized-
control trial was conducted to assess the impact of asking questions pertaining to blood 
donation habits of the participants. The researchers found that the subjects whom were 
asked about their habits were significantly more likely to donate blood than their control 
counter parts at the following blood-drive (Godin, Sheeran, Conner, & Germain, 2008). 
Other researchers found that when clinicians did not ask patients with Attention Deficit 
Hyperactivity Disorder (ADHD) to report whether they were currently medicated on a 
disease-related severity questionnaire, patients were more likely to report un-medicated 
symptomologies (Lineweaver et al., 2021). In other words, patients on ADHD medications 
responded more symptomatically similar to their un-medicated selves when their 
medication status was not included on the questionnaire. This suggests that the medication 
status item itself, may have mitigated ADHD symptoms by bringing the patient’s treatment 
into a higher state of awareness/directing attention.  
Thus, it may be that asking patients about their intent to have an operation increases the 
likelihood of them opting for it, or, that asking them about their exercise increases their 
physical activity level. If so, this may have significant implications for the effect of 
routinely collecting patient-reported outcomes (PROs), as well as for utilizing 
measurements as interventions. However, before value can be attached to such an effect, 
first the presence and strength must be evaluated in the patient-specific context.   
To date, no mere-measurement effect factors have been investigated in the context of 
patient-reported outcomes measures (PROMs) and particularly not in regard to how they 
may influence patient perceptions and behaviours. Therefore, exploration of this family of 

 
 
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effects must be reduced to a few key anticipated features, namely, emotional valence 
(positive/negative) and frequency. For instance, would wording a cleft-lip question 
negatively, such as “I do not like my face”, actually decrease the patient’s preference for 
their own face, and, does repeated exposure to this question increase the magnitude of the 
effect.  
This randomized controlled trial (RCT) review will be the first to the authors’ knowledge 
to examine if measuring patient- reported outcomes directly effects their corresponding 
behaviour, and if this effect can be attributed in part to item wording and/or frequency of 
exposure. 
PROMs & Speech Disorders 
Three recent reviews regarding patient-reported outcomes in speech pathologies were 
identified (Cohen & Hula, 2020; Francis et al., 2017; Slavych, Zraick & Ruleman, 2021). 
Francis et al. list a number of PRO measures that were designed for administration with 
subjects with any kind of voice disorders. The Evaluating Voice Disability-Quality of Life 
Questionaire (EVD-QOL) aims at assessing the general range of functional problems in 
voice disorders. The 30-items Voice Handicap Index (VHI) and its 10-items short version 
VHI-10 aim at providing a psychometrically robust voice diasability/handicap inventory. 
The Voice-Related Quality of Life (V-RQOL) aims at measuring the impact of voice 
problems on the quality of life. The Voice Activity and Participation Profile (VAPP) aims 
at identifying voice activity limitation and participation restriction separately. The Voice 
Symptom Scale (VoiSS) is an inventory of voice symptoms for assessing baseline 
pathology and response to change. The Communicative Participation Item Bank (CPIB) 
aims at assessing communication participation in all kinds of communication disorders. 
The Voice Self-Efficacy Questionnaire (VSEQ) monitors self-efficacy in individuals with 
self-declared voice problems before and after interventions. The Vocal Fatigue Handicap 
Questionnaire (VFHQ) and the Vocal Fatigue Index (VFI) aim at reflecting vocal fatigue.  
Additional PROs include the Aging Voice Index, the Evaluation of the Ability to Sing 
Easily, the Glottal Function Index, the Linear Analog Scale of Assessment of Voice Quality, 
the Speech Disability Questionnaire, the Trans Woman Voice Questionnaire, the Vocal 
Cord Dysfunction Questionnaire, and the Vocal Tract Discomfort Scale Slavych, Zraick & 
Ruleman, 2021. 
We have opted to use the CPIB and the VHI because these are well established and the 
former covers all kinds of communication disorders, while the VHI is using particularly 
negative wording in its original form. 

 
 
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1.2 
STUDY RATIONALE 
The purpose of the mere-measurement study is to identify the most advantageous way 
to measure outcomes for patients. This will be accomplished by collecting measures on the 
same topic at different time intervals and with different wording of questions. The findings 
of this study should help researchers and clinicians collect measurements from patients in 
the least burdensome and most beneficial manner possible.  
The primary objective of the mere-measurement study is to assess the effects of different 
collection methods on the responders wellbeing. 
The secondary objectives of this study are to: 
• 
What frequency of collection is best for patients? 
• 
What style of question wording is best for patients? 
 
1.3 
BENEFIT/RISK ASSESSMENT  
No additional risks are anticipated through participation in the study than those that would 
be expected from daily life. The negative questionnaire group will receive an un-adapted, 
standardly collected questionnaire for speech pathologies, as such, we have not identified 
any potential risks associated with the participation in this study. Upon completion of your 
participation participants will receive a 50€ payment. In addition, participation in this study 
will provide insights to the scientific and medical community which in turn will help ensure 
we measure pathologies in the most beneficial manner possible. Potential benefits include 
societal contribution to healthcare and science, personal enrichment of the participants’ 
treatment assessment and understanding of their wellbeing. 
 
1.4 
STUDY OBJECTIVES 
The aim of this RCT is to identify and report the impact of collecting the PROMs 
controlling for topic content, and simply adjusting the frequency of collection and the 
emotional framing of the items. Thus, the researchers hope to shed light on the effects of 
measuring patient reported outcomes, as it relates to patient perceptions and behaviours 
on the item topics of inquiry.  
 
Research Questions: 
 Does the assigned positivity or negativity of an item effect patient perception or 
behaviour on the topic inquired?    
 
 Does frequency of exposure to an item have an effect on patient perception or 
behaviour of the topic inquired?  
 

 
 
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Hypotheses: 
 
H1 = The more a patient reads and responds to questions about their speech condition 
the more their speech condition will be affected. 
 
H2 = The directionality of impact on a speech condition will be congruent with the 
emotional valence of the items used. 
 
 
1.5 
STUDY DESIGN 
Once a subject has agreed to participate in this study, they will be asked to complete 
online questionnaires as well as record their voice reading a collection of random words 
2-4 times.  
 
This study follows a 2x2 design. Participants will be randomly assigned to one of four 
groups. Randomization will be accomplished by using the MUW randomizer. 
Participants will be stratified by education and speech disorder type. The healthy case 
control group will undergo case matching to ensure comparability across groups. Each 
group will receive two brief speech pathology severity questionnaires but at different 
frequencies, and with slight adjustments to the wording. Depending on your group, a 
subject will complete the questionnaires either two or four times, separated each time by 
one week. The questionnaires, in all groups, will take approximately 15 minutes to 
complete. Lastly, at the very start and once at the very end of the study, every participant 
will also be asked to record a brief 45 second audio file in the online survey as well as 
complete two additional psychological questionnaires.  
 
The measures in this study cover the following tools (complete measures are uploaded in 
the ECS):  
• 
A patient-reported outcome on voice health - Voice Handicap Index (VHI) or Voice 
Handicap Index Positively adapted (VHI-PA) 
• 
A patient-reported outcome on speech health - Communicative Participation Item 
Bank (CPIB) or Communicative Participation Item Bank Positively adapted (CPIB-
PA) 
• 
A self-esteem stability scale - Self-Esteem Stability Scale (SESS) 
• 
A self-esteem scale - Rosenberg Self-Esteem Scale (RSS) 
• 
Two question measure of disease impact (2DB) 
• 
A single-question measure of disease activity (1DS) 
• 
Audio recording of text read aloud (ARec) 

 
 
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Start of study 
The study start date will be the date of the first patient consenting to participate. The 
planned start date is February 2024 
 
End of study 
The end of the study will be the date from which the analysis has been completed on all 
data. The planned end of study date is April 2025 
Length of study  
This study will last 15 months, including a recruitment period of 2 months. Data of each 
participant will be collected over a period of 12 months. 
The experimental/data collection portion of the study duration is only five weeks. The 
majority of the timeframe will be spent in recruitment, analysis and interpretation of the 
results.  
Study population  
All patients with Muscle tension dysphonia, Inducible laryngeal obstruction, Amyotrophic 
lateral sclerosis (ALS), suffering from a stroke or other brain injury/damage/trauma, 
(aphasia, dysarthria), and Parkinson's disease will be targeted for recruitment. There are no 
geographic location requirements.  The participation schedule can be found below. Patients 
will be informed of the schedule in advance. A subject must complete any respective 
sampling epoch within 48 hours of the prescribed date in order to qualify as completed. 
Subjects must also have strong English skills and be technologically savvy to participate. 
Only adults will be included in the study.  
Study Design Flow 
Group 1: High frequency-negative: 1 week between each collection 
1: Demographics, VHI, CPIB, SESS, RSS, 1DS, 1DB, ARec* 
2: VHI, CPIB, SE, SSE, 1DS, 2DB, ARec 
3: VHI, CPIB, SE, SSE, 1DS, 2DB, ARec 
4: VHI, CPIB, SE, SSE, 1DS, 2DB, ARec 
Group 2: High frequency-positive: 1 week between each collection 
1: Demographics, VHI-PA, CPIB-PA, SESS, RSS, 1DS, 2DB, ARec* 

 
 
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2: VHI-PA, CPIB-PA, SE, SSE, 1DS, 2DB, ARec 
3: VHI-PA, CPIB-PA, SE, SSE, 1DS, 2DB, ARec 
4: VHI-PA, CPIB-PA, SE, SSE, 1DS, 2DB, ARec 
Group 3: Low frequency-negative: 2 weeks between each collection 
1: Demographics, VHI, CPIB, SESS, RSS, 1DS, 2DB, ARec* 
2: VHI, CPIB, SE, SSE, 1DS, 2DB, ARec 
Group 4: Low frequency-positive: 2 weeks between each collection 
1: Demographics, VHI-PA, CPIB-PA, SESS, RSS, 1DS, 2DB, 1ARec* 
2: VHI-PA, CPIB-PA, SE, SSE, 1DS, 2DB, 1ARec 
Control: (once at start, once at low frequency completion/final outcome collection, once 
at high frequency completion) 
 
1: Demographics, ARec x 3  
 
Healthy Control: (once at start, once at low frequency completion/ final outcome 
collection, once at high frequency completion) 
 
1: Demographics, ARec x 3 
 
*completed prior to assessments  
 
Procedural step by step:  
1. Probando advertises across their social media channels and website 
2. Potential subjects log-in to Probando or create an account 
3. Potential subjects are screened for inclusion and exclusion criteria in their profile 
4. If they meet the criteria, and state permission to contact, their contact information 
will be passed on to the study investigators 
5. The study investigators collect the informed consent via the online survey tool, 
following the patients review and signature 

 
 
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6. Each experimental subject will be randomly assigned into one of the four 
intervention groups; random assignment will not be used for the control or healthy group. 
The study investigators will handle all survey disbursement and participant 
communication over email or telephone. 
7. As soon as the random assignment is complete, each subject will begin their 
respective trial spanning either two or four weeks. The study length is standardized and 
newly recruited participants will always start on the closest Wednesday to their entry, i.e. 
entered on a standard rolling basis. If subject’s withdrawal from the study, their data will 
only be used up until the time point of their last complete submission but not in a full 
group analysis.  
8. Payments will be made to participants once the last questionnaire has completed the 
trial. 
1.6 
PATIENT TARGET POPULATION 
All patients will be required to have a qualifying disorder known to effect speech as 
identified below. Patients who meet the eligibility criteria will be invited to participate in 
the study by the researchers. Eligibility will be assessed prior to enrolment recruitment 
screening. AKH patients are not targeted for this study. All patients, regardless of 
geographic location around the world, can be recruited. The study is entirely online. 
 
Subjects must meet the following inclusion criteria for study entry: 
 Strong English skills* 
 Technology savvy – able to complete online questionnaire 
 Suffering from one of the following: 
-Muscle tension dysphonia 
-Inducible laryngeal obstruction 
-Amyotrophic lateral sclerosis (ALS) 
-Patients after a stroke or other brain injury/damage/trauma, (aphasia, dysarthria) 
-Parkinson's disease 
 
*English was chosen as the study language as a wider range of validated assessments 
exist in this language. The AI used for speech analysis is also best suited for and trained 
(66%) on English. Lastly, English is the most prolific language (native + secondary 
speakers) in the world which will facilitate the speed of recruitment. 
 
Subjects who meet any of the following criteria will be excluded from study entry: 

 
 
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 Under the age of 18 
 
3.6.1 RATIONALE FOR SUBJECT POPULATION 
The initial disease and/or problem areas, aforementioned, were chosen due to their known 
connection with speech disorders (Slavych, Zraick, & Ruleman, 2021). Speech disorders 
may be more susceptible to the mere-measurement effect as they are more closely 
influenced by an individual’s psyche or mood state than many other conditions.  
 
1.7 
NUMBER OF SUBJECTS PARTICIPATING IN THE STUDY 
We intend to include a total of 200 patients from across the acceptable condition types.  
They will be randomly separated into six groups including control and healthy control, 
with approximately 33 subjects per group. A formal power analysis was performed using 
G*power with parameters sourced from relevant seminal research (Conner et al., 2011; 
Godin et al., 2011). The following parameters were used for the sample size analysis: two-
tailed directionality; effect size of 0.30; a priori computation, anticipate power of 0.95, 
and an error rate of 0.0023. Means difference tests between independent groups within the 
t-test family were utilized. 
 
1.8 
PARTICIPATING SITES 
No additional sites will participate in this study.  
1.9 
RECRUITMENT PROCEDURE 
Recruitment into the mere-measurement study will be performed supported by Probando. 
Probando is a previously approved patient recruitment services which specializes in online 
advertising.  All recruitment materials are uploaded in the ECS. A description of the 
Probando recruitment service and procedures can be found as an attachment, as well as the 
recruitment materials for all subjects including healthy controls and a screenshot of the 
currently inactive landing page. As a part of their service, Probando uses the study 
inclusion and exclusion criteria to screen potential interested subjects. If they qualify and 
permit contact, their contact information will be provided to the MUW researchers for 
direct outreach. Therefore, all study timings, measures, and data will be distributed and 
collected only by the study researchers. Patients will be able to withdraw from the study at 
any time without providing a reason. To limit potential bias, an initial self-report of an 
official diagnosis is required to participate. Additionally, the patients will also confirm their 
diagnosis with a checkbox, for the purpose of minimizing the risk of malingering patients. 
If an individual is highly motivated to participate and does not suffer from a qualifying 
speech disorder they can still apply to participate as a healthy control. Furthermore, this 
sample would be more representative of a telemedicine community. 

 
 
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1.10 
VARIABLES 
Variables will consist of disease-specific PROMs, generic PROMs, audio recording of 
speech, and demographic variables. In order to minimize the non-interventional mere-
measurement effect, the outcome measures were chosen as they are counter balanced 
between positive and negatively worded items.  
Primary outcome variable  
The primary outcome variable of this study is as follows: 
 An audio recording of a standardized text, with the order of the paragraphs 
randomized in between every exposure. This text was adapted from the standard 
“Rainbow Passage” read aloud assessment with the field of speech pathologies 
(Dietsch et al., 2023). Artificial intelligence - ChatGPT - was used to recreate novel 
text of the same length and difficulty as the “Rainbow Passage” which is called “In 
the heart of a lush valley” (the text is uploaded in the ECS). An adapted version was 
opted for to eliminate the possibility of previous exposure.  
 
Secondary variables 
Secondary variables collected from patients include: 
A patient-reported outcome on speech health - Communicative Participation Item 
Bank (CPIB) 
• 
A self-esteem stability scale - Self-Esteem Stability Scale (SESS) 
• 
A self-esteem scale - Rosenberg Self-Esteem Scale (RSS) 
• 
Two question measure of disease impact (2DB) 
• 
A single-question measure of disease activity (1DS) 
 
Other variables of interest are: 
 Demographics 
 Qualifying disease or condition type 
 
1.11 
 DATA SOURCES 
Participants’ and study data will be recorded in the study database. Study data will be 
collected at defined time points (see Section 1.5) using a single online format: 
 SoSci survey (www.soscisurvey.de) is a routinely used, safe, online questionnaire 
distribution and data retrieval platform. Within this platform, five links will be 
created, one for each group. These will connect subjects to the questionnaires and 
to the instructions for and capturing of the audio file. 

 
 
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An email address for every participant will be required for communication and 
dissemination of participation credits. All individuals with access to participant personal 
information are obligated to respect their privacy and only use and disclose their 
information as described in the informed consent document.  
Demographic information and mere-measurement study results are secured against 
unauthorized access. Security measures reduce the risk of unauthorized individuals 
accessing your personal information, but such risks cannot be entirely eliminated. All audio 
recordings will be stored only for the duration of the study. Upon closure, they will be 
deleted.  
The information that we collect from the mere-measurement study will be kept confidential. 
Your personal information will be stored safely at MUW and pseudonymized as discussed 
in the previous section. 
1.12 
DATA COLLECTION 
Online, subjects will complete a battery of questionnaires totalling approximately 15-20 
minutes of time following the informed consent. Informed consent will be collected online 
via the SoSci survey tool. The following parameters will be applied to the virtual informed 
consent: 
 The patient information including the data protection section is displayed above the 
checkbox. The patients are informed about what happens to their data, their benefits, 
and risks in sufficient detail but simple detail in this section. 
 The checkbox says that patients have read and understood the text and that they 
agree. 
 The patients will confirm their diagnosis with a checkbox, for the purpose of 
minimizing the risk of malingering patients  
Depending on the group assigned, a participant will have to complete this battery either 2 
or 4 times. The control and healthy group will complete only demographics questions and 
the audio recordings, no PROMs will be collected. The four intervention groups will be 
randomized 
using 
a 
digital 
randomization 
tool 
provided 
by 
the 
MUW 
(https://www.meduniwien.ac.at/randomizer/ ). 
All patients, across all intervention groups, will complete the read-aloud activity prior to 
the first collection of PROMs. This will serve as the baseline for later comparison. 
Following the first recording, all subsequent recordings will be completed after completing 
the PROMs. An electronic bank transfer form (MUW standard bank form) will be emailed 

 
 
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to participants at the end of the study to complete the 50€ transfer. These electronic records 
will be immediately destroyed upon successful completion. 
1.13 
SUBJECT, STUDY, AND SITE DISCONTINUATION 
3.13.1 SUBJECT WITHDRAWAL 
Subjects have the right to withdraw their consent to data storage and collection at any time 
and without providing a reason. Expected reasons for withdrawal from the study may 
include, but are not limited to: 
 
Consent withdrawal  
 
Loss to follow-up 
 
Death 
Where possible, the primary reason for withdrawal from the study should be documented. 
Subjects will not be followed up for any reason after consent has been withdrawn. Subjects 
who withdraw from the study will not be replaced. Partially completed data may be still 
included in the analysis if appropriate. Only participants who complete the study will 
receive payment. This will aid in subject motivation. There will also be additional bank 
transfer costs (16€ up to 37.40€) for individuals from countries outside the EU, thus, it is 
poor use of resources to make smaller payments 
 
1.14 
DATA MANAGEMENT 
Patient-reported data will be captured using SoSci survey with an account owned by the 
Center for Outcomes research. These data will not be transferred outside of the MUW. 
Data transfers between the investigators of this study will be managed using procedures 
described in a jointly developed Data Transfer Plan. All data transferred between the two 
MUW centres, speech pathology and outcome research, will be identified only by a subject 
ID code, unless otherwise consented by patients and agreed upon in the Data Transfer Plan.  
3.14.1 DATA QUALITY ASSURANCE 
Patients will consent that pseudonymised patient data will be hosted and analysed at the 
MUW. MUW will not share the data with any third parties or collaborators. MUW 
regularly processes medical data and is subject to the GDPR requirements. MUW is 
responsible for data quality and will perform oversight of the data management of this 
study. Investigators and study coordinators will receive an initial training session on the 
protocol, study flow, study database, the survey tool, documentation, and expectations, and 
any applicable study processes. Access to data for secondary use cases will not be enabled. 

 
 
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3.14.2 SOURCE DATA DOCUMENTATION  
Source documents (electronic) are those in which participant data are recorded and 
documented for the first time. The source documentation for this study will be:  
 Participant demographic information and eligibility assessment  
 Completed Informed Consent Forms 
 Audio recordings 
 Completed PROMs 
 
1.15 
STATISTICAL ANALYSES 
Descriptive statistics and respective tables will be produced for every group which will 
include means, mediums, standard deviations, and size.  
 
Primary outcome variable  
The primary outcome variable of this study is as follows: 
An audio recording of a standardized text, with the order of the paragraphs randomized 
in between every exposure. This text was adapted from the standard “Rainbow 
Passage” read aloud assessment with the field of speech pathologies (Dietsch et al., 
2023). Artificial intelligence - ChatGPT - was used to recreate novel text of the 
same length and difficulty as the “Rainbow Passage” which is called “In the heart of 
a lush valley” (the text is uploaded in the ECS). An adapted version was opted for to 
eliminate the possibility of previous exposure.  
The primary assessment parameter for the audio recordings is the number of words 
misspoken, as seen in the transcription. This parameter will undergo a secondary human 
assessment to ensure that the error was caused by the subject and not the AI. The length 
of the recordings will be used as a secondary factor. For the statistical analysis, we will 
prioritize accuracy over speed and perform a hierarchical hypothesis testing. The data and 
its residuals from the ANCOVA will be explored for normal distribution. If the data or 
residuals are non-normally distributed, we will use a nonparametric test or a longitudinal 
linear mixed model taking into account variance resulting from change over time. 
Secondary variables 
Secondary variables collected from patients include: 

 
 
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A patient-reported outcome on speech health - Communicative Participation Item 
Bank (CPIB) 
• 
A self-esteem stability scale - Self-Esteem Stability Scale (SESS) 
• 
A self-esteem scale - Rosenberg Self-Esteem Scale (RSS) 
• 
A single-question measure of disease impact 
• 
A single-question measure of disease activity 
 
Other variables of interest are: 
-Demographics 
-Qualifying disease or condition type 
 
Planned Analyses 
 
Between Subjects Analysis: 
 
All experimental groups in the 2x2 design will have their outcomes assessed in 
comparison to the control group as well as the healthy group at each collection point. 
This totals 24 tests which will require a family-wise error adjustment using the 
Bonferroni technique. The mean differences will be compared between each group 
respectively using an analysis of covariance (ANCOVA). 
 
Within-Subjects Analysis: 
 
All participants in every group will be compared to themselves over time. Each collection 
point, ranging from 2-4 depending on the group, will serve as an epoch. This can be 
completed through a single analysis using a repeated-measures analysis of covariance 
(RM-ANCOVA). 
 
The following variables will be used as statistical controls in the analysis to ensure that 
any significant effect is appropriately assigned to the mere-measurement effect: gender, 
age, response location, educational achievement, native language, and speech pathology 
disorder type.  
 
Post Hoc Analysis: 
 
An exploratory post hoc analysis will be conducted comparing the scores of the 
interventions measures between positive and negative groups. This will provide insight 
on possible method effects resulting from the adaptation of the questionnaires. The mean 

 
 
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differences will be compared between both groups using an analysis of variance 
(ANOVA). 
 
The primary outcome will be assessed using Automatic Speech Recognition (ASR) 
artificial intelligence software called Whisper (Radford et al., 2023). All analyses will be 
conducted on MUW computers and through MUW servers. No upload is necessary and 
the analyse will be ran in campus. All secondary outcomes measures will be scored and 
reported following their published procedures. 
 
3.15.1 INTERIM AND FINAL ANALYSES AND TIMING OF ANALYSES  
The following analyses for the study are planned: 
 Assessment of the baseline audio recordings – week 1 
 Analysis of low frequency completion – week 2  
 Analysis of low frequency compared to control – week 3 
 Analysis of high frequency completion – week 4 
 Analysis of high frequency compared to control – week 5 
 Analysis of high frequency compared to low – week 6 
 Analysis of positive compared to negative items – month 2-5 
 Analysis of positive compared and negative items compared to control -  month 5-
7 
 Final analysis including all conditions and levels controlling for demographics – 
month 7-15 
No mid-study decisions will be made based on the interim assessments. All comparisons 
will occur following final closure of the study data collection, i.e. following the last 
groups completion. 
1.16 
STUDY DOCUMENTATION AND MONITORING 
The researchers will maintain adequate and accurate records to enable the conduct of the 
study to be fully documented, including but not limited to the protocol, protocol 
amendments, Informed Consent Forms, and documentation of IRB/EC. The study initiator 
shall ensure that the dataset and statistical programs used for generating the data included 
in the final study report are kept in electronic format and are available for auditing and 
inspection. 
3.16.1 RETENTION OF RECORDS 
Archiving at the study site will last for a minimum of five years after final study report or 
first publication of study results, whichever comes later; or according to local regulation. 
Records and documents pertaining to the conduct of this study must be retained by the 

 
 
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study initiator for at least 25 years after completion of the study, or for the length of time 
required by relevant national or local health authorities, whichever is longer. After that 
period of time, the documents may be destroyed, subject to local regulations. Bank details 
for participant pay will be deleted immediately following confirmation of payment receipt. 
No records may be disposed of without the written approval of the study initiator. Written 
notification should be provided to the study initiator prior to transferring any records to 
another party or moving them to another location. All supporting functional parties will 
comply with the study initiator procedures regarding archiving and record management. 
1.17 
STUDY LIMITATIONS 
The patient selection and the diagnostic or monitoring procedures are those applied per the 
usual treatment paradigm of the treating physician and not dictated by the protocol. As with 
all studies that require patients to self-report outcomes and behaviour, completeness and 
accuracy of reporting can be a concern. The data collection methods have been designed 
to be appropriate and accessible to the study population. Nevertheless, some errors in 
recording information and some missing information can be anticipated, particularly given 
the frequency of questionnaires required for data collection. As this study will collect PRO 
data through the use of devices, ability to use these devices is required and this may limit 
representativeness of the study sample. In summary, the design of this protocol presents 
inherent limitations that cannot be prevented and that are typical of non-interventional real-
world studies. These studies have the potential for missing, inaccurate, or incomplete data. 
These limitations can result in methodological challenges in attributing causality to 
outcomes.  
1.18 
PROTECTION OF HUMAN SUBJECTS 
3.18.1 COMPLIANCE WITH LAWS AND REGULATIONS 
This study will be conducted in full conformance with the Declaration of Helsinki and the 
laws and regulations of the country in which the research is conducted. Data will be stored 
and handled according to the General Data Protection Regulation (GDPR). Patients will be 
made aware of their rights to consult or change their own data and of their possibilities to 
report any faults to the corresponding authorities. 
3.18.2 INFORMED CONSENT  
The Informed Consent Form will be provided via the online survey tool. The Consent 
Forms must be read, reviewed, and indicated online before start of documentation entering 
any data in the study database. By checking the consent form box, subjects confirm that 
they have been informed about the study procedures and agree to data collection. A digital 
copy of the Consent Form will be provided to the subject via a pop-up window with a 
download feature. The document titled ‘Information_questionnaire_first_page’ will be the 

 
 
Study Protocol 
 
 
18 
text located above the check-box informed consent; this is the first page the participants 
will see. 
1.19 
INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE 
The mere-measurement study protocol, the Informed Consent Forms, and any study-related 
material will be submitted to the IRB/EC by the study initiators listed in this protocol and 
reviewed and approved by the IRB/EC before the study is initiated. In addition, any patient 
recruitment materials will be approved by the IRB/EC. 
1.20 
CONFIDENTIALITY 
The study initiator maintains confidentiality standards by coding each subject enrolled in 
the study through assignment of a unique subject identification number. This means that 
identifiable data are not included in datasets that are transmitted to any study initiator’s 
location. Subject medical information obtained by this study is confidential and will not be 
disclosed to third parties. The study initiator, including all listed investigators may use 
study data labelled with the patient ID numbers.   

 
 
References
 
 
19 
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