The Mere-measurement Effect of Patient-reported Outcomes

NCT06443073 | Recruiting

• 1 other identifier: ECS 2153/2023
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Measurement, Psychological Stress; Speech Disorders; Assessment, Self

Outcome Measures

Primary Outcomes (1)

• audio recording of a standardized text

  • 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.

  Baseline and at each experimental instance occuring once a week for up to four weeks

Secondary Outcomes (4)

• Self-Esteem Stability Scale (SESS)

  Baseline and at each experimental instance occuring once a week for up to four weeks

• Disease activity (1DS)

  Baseline and at each experimental instance occuring once a week for up to four weeks

• A self-esteem scale - Rosenberg Self-Esteem Scale (RSS)

  Baseline and at each experimental instance occuring once a week for up to four weeks

• Disease Impact

  Baseline and at each experimental instance occuring once a week for up to four weeks

Study Arms (3)

Control: unhealthy

NO INTERVENTION

Participants with a speech disorder who do not receive the intervention and only complete the outcomes.

Control: healthy

NO INTERVENTION

Participants without a speech disorder who do not receive the intervention and only complete the outcomes.

Experimental groups

EXPERIMENTAL

Four groups receiving different rates of questionnaire exposure and wording at either two or four week intervals.

Other: Patient-reported outcomes for speech disorders: positive

Interventions

Patient-reported outcomes for speech disorders: positive OTHER

The Communicative Participation Item Bank (CPIB) aims to assess 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. Both have been adapted to reflect purely positive wording.

Also known as: Patient-reported outcomes for speech disorders: negative

Experimental groups

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• Under the age of 18

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Preston Long

Vienna, 1020, Austria

RECRUITING

Related Publications (10)

• Schwarz, N. (1999). Self-reports: How the questions shape the answers. American Psychologist, 54(2), 93-105. https://doi.org/10.1037/0003-066X.54.2.93

  BACKGROUND

• Näher, A.-F., & Krumpal, I. (2012). Asking sensitive questions: The impact of forgiving wording and question context on social desirability bias. Quality & Quantity: International Journal of Methodology, 46(5), 1601-1616. https://doi.org/10.1007/s11135-011-9469-2

  BACKGROUND

• Morwitz, V. G., Johnson, E., & Schmittlein, D. (1993). Does measuring intent change behavior?. Journal of consumer research, 20(1), 46-61.

  BACKGROUND

• Sandberg T, Conner M. A mere measurement effect for anticipated regret: impacts on cervical screening attendance. Br J Soc Psychol. 2009 Jun;48(Pt 2):221-36. doi: 10.1348/014466608X347001. Epub 2008 Sep 12.

  PMID: 18793492 BACKGROUND

• Godin G, Sheeran P, Conner M, Delage G, Germain M, Belanger-Gravel A, Naccache H. Which survey questions change behavior? Randomized controlled trial of mere measurement interventions. Health Psychol. 2010 Nov;29(6):636-44. doi: 10.1037/a0021131.

  PMID: 20939639 BACKGROUND

• Godin G, Sheeran P, Conner M, Germain M. Asking questions changes behavior: mere measurement effects on frequency of blood donation. Health Psychol. 2008 Mar;27(2):179-84. doi: 10.1037/0278-6133.27.2.179.

  PMID: 18377136 BACKGROUND

• Lineweaver TT, Kercood S, Gabor AJ, Cervantes J, Laine A, Baker E. The effect of medication and question wording on self-reported symptoms and their accuracy in young adults with attention-deficit/hyperactivity disorder. Br J Clin Psychol. 2021 Jun;60(2):252-269. doi: 10.1111/bjc.12276. Epub 2021 Jan 4.

  PMID: 33393098 BACKGROUND

• Cohen ML, Hula WD. Patient-Reported Outcomes and Evidence-Based Practice in Speech-Language Pathology. Am J Speech Lang Pathol. 2020 Feb 7;29(1):357-370. doi: 10.1044/2019_AJSLP-19-00076. Epub 2020 Feb 3.

  PMID: 32011905 BACKGROUND

• Francis DO, Daniero JJ, Hovis KL, Sathe N, Jacobson B, Penson DF, Feurer ID, McPheeters ML. Voice-Related Patient-Reported Outcome Measures: A Systematic Review of Instrument Development and Validation. J Speech Lang Hear Res. 2017 Jan 1;60(1):62-88. doi: 10.1044/2016_JSLHR-S-16-0022.

  PMID: 28030869 BACKGROUND

• Slavych BK, Zraick RI, Ruleman A. A Systematic Review of Voice-Related Patient-Reported Outcome Measures for Use with Adults. J Voice. 2024 Mar;38(2):544.e1-544.e14. doi: 10.1016/j.jvoice.2021.09.032. Epub 2021 Nov 12.

  PMID: 34782227 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological; Speech Disorders

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Central Study Contacts

Preston Long, PhD

CONTACT

+43 (0)1 40400-66100; preston.long@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: June 5, 2024
• Study Start: May 1, 2024
• Primary Completion: September 22, 2025
• Study Completion: December 22, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

AU (1)