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临床试验/NCT06443073
NCT06443073招募中不适用

The Mere-measurement Effect in Patient-reported Outcomes: A Randomized Control Trial With Speech Pathology Patients

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
170
试验地点
2
主要终点
audio recording of a standardized text

研究概览

简要总结

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?

详细描述

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 (1,2). 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 (3) Research supports the claim that asking certain questions can influence behaviours on the same topic (4,5). 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 (6). 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 (7). 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 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 (8,9,10). 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Under the age of 18

结局指标

主要结局

audio recording of a standardized text

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

• 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.

次要结局

  • Disease Impact(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)
  • Self-Esteem Stability Scale (SESS)(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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Preston Long

Principal Investigator

Medical University of Vienna

研究点 (2)

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