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- Title
Influence of Role Expectancy on Patient-Reported Outcomes Among Patients With Migraine: A Randomized Clinical Trial.
- Authors
May, Arne; Carvalho, Gabriela F.; Schwarz, Annika; Basedau, Hauke
- Abstract
Key Points: Question: Does the assigned role an individual accepts (ie, that of a patient vs a healthy control) influence clinical patient-reported outcomes? Findings: In this randomized clinical trial of 244 individuals with migraine, those who were randomly assigned to the role as a patient presented with significantly different clinical outcomes compared with patients who were assigned the role of a healthy control. Meaning: These results suggest that clinicians may need to be vigilant regarding the effect of expectations and the role of a patient with respect to study outcomes. This randomized clinical trial investigates whether assignment to the role of a patient or a healthy control has an effect on self-reported outcomes among patients with migraine. Importance: It is usually assumed that an individual's classification as a patient or a healthy person is determined by the presence or absence of disease, but little is known about whether the mere awareness of being a patient or a healthy control can play an important role for reporting outcomes. Objective: To investigate whether assignment to the role of a patient or a healthy control has an effect on patient-reported outcomes. Design, Setting, and Participants: This single center, double-blind, 3-group randomized clinical trial included consecutive patients from a tertiary headache clinic based at a single center in Germany who were invited to participate between October 2019 and June 2023. Statistical analysis was performed from January to March 2024. Intervention: Patients with migraine were randomized into 2 groups. The first group was told that this study was centered on migraine symptoms, whereas the second group was told that healthy controls were being sought for a study about patients with vertigo. A third group of age- and sex-matched headache-free participants served as controls. All participants viewed 2 standardized roller coaster videos and provided ratings of their perceived levels of motion sickness and dizziness. Main Outcomes and Measures: The primary outcome was self-reported vestibular symptoms. Secondary outcomes included differences in motion sickness, headache burden, and migraine disability. Outcomes were assessed using standardized questionnaires. Results: The final sample included 366 participants: 122 patients with migraine assigned the role of patient (MP) (migraine as patient): mean [SD] age, 37.56 [12.93] years; 105 [86.1%] female), 122 patients with migraine assigned the role of healthy participant (MH) (migraine as healthy): mean [SD] age, 37.03 [13.10] years; 107 [87.7%] female), and 122 headache-free controls (HC): mean [SD] age, 37.55 [11.56] years; 100 [82.0%] female). The assigned role of the individuals with migraine (MP vs MH) had a significant effect on self-disclosure of (1) estimation that symptoms (dizziness) will occur under specific conditions (self-reported vestibular symptoms: 79 MP [64.8%]; 29 MH [23.8%]; 9 HC [7.4%]; P <.001), (2) the increase of such symptoms (dizziness) after viewing the roller coaster video, and (3) the reported frequency (median [IQR] self-reported monthly headache days for MP: 7 [4-15] days; for MH: 5 [2-10] days; P =.008) and severity (median [IQR] migraine disability assessment score for MP: 35 [20-64] points; for MH: 25 [11-47] points; P =.005) of migraine symptoms. Statistically significant changes were also found for self-reported headache frequency and disability caused by migraine. Conclusions and Relevance: This randomized clinical trial found an effect of expectations regarding the role of a patient with respect to clinical and study outcomes. These findings suggest that role expectations should be taken into account when, for example, invasive treatments are discussed. Trial Registration: ClinicalTrials.gov Identifier: NCT06322550
- Subjects
GERMANY; HEALTH literacy; VERTIGO; PEARSON correlation (Statistics); STATISTICAL sampling; BLIND experiment; DIZZINESS; QUESTIONNAIRES; KRUSKAL-Wallis Test; TREATMENT effectiveness; RANDOMIZED controlled trials; MOTION sickness; SEVERITY of illness index; DESCRIPTIVE statistics; MANN Whitney U Test; CHI-squared test; VESTIBULAR apparatus diseases; HEALTH outcome assessment; DATA analysis software; MIGRAINE; PATIENTS' attitudes; SELF-disclosure; VIDEO recording; EVALUATION; SYMPTOMS
- Publication
JAMA Network Open, 2024, Vol 7, Issue 1, pe243223
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.3223