Journal of affective disorders · 2026
Assessing the presence of biasing and non-biasing unblinding in a randomized controlled trial of a home-use tDCS device: An exploratory analysis.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Hieronymus Fredrik, Huneke Nathan T M, Månsson Daniel, Rehn Erik M, Hagsäter Melker, Woodham Rachel D, Soares Jair C, Young Allan H, Machado-Vieira Rodrigo, Selvaraj Sudhakar, Fu Cynthia
Аннотация
BACKGROUND: Better-than-chance guessing of treatment assignment raises concerns about unblinding as this opens efficacy estimates up to being influenced by factors other than the true efficacy of the intervention. However, such accuracy does not necessarily indicate that efficacy estimates are biased.
OBJECTIVE: To assess whether unblinding was biasing (impacting on efficacy estimates) or non-biasing (not impacting on efficacy estimates) in a sham-controlled trial of a home-use transcranial direct-current stimulation (tDCS) device, in which treatment allocation guesses at endpoint were unbalanced.
METHODS: Interrelations between i) treatment allocation, ii) treatment allocation guesses, iii) adverse event reports, and iv) depressive symptom severity, as measured by Hamilton Depression Rating Scale, after ten weeks of treatment were examined using linear regression (n = 149).
RESULTS: Receiving tDCS was positively associated with a) guessing that one had received tDCS (p = .01704), b) number of adverse events (beta: 0.69, p = .0046), and c) improvement after ten weeks (beta: -2.39, p = .0049). Guessing that one had received tDCS was positively associated with greater improvement (beta: -3.16, p = .0005), whereas the number of reported adverse events correlated negatively with improvement (beta: 0.68, p = .0186). Moreover, among participants who received tDCS, those who reported any of nine examined adverse events consistently showed numerically worse outcomes than those who did not report the same adverse events.
CONCLUSIONS: In this exploratory analysis, adverse events correlated negatively with HDRS-rated improvement. This is not consistent with a pathway where adverse events lead to unblinding and, subsequently, to improvement via expectancy effects and/or biased ratings.
OBJECTIVE: To assess whether unblinding was biasing (impacting on efficacy estimates) or non-biasing (not impacting on efficacy estimates) in a sham-controlled trial of a home-use transcranial direct-current stimulation (tDCS) device, in which treatment allocation guesses at endpoint were unbalanced.
METHODS: Interrelations between i) treatment allocation, ii) treatment allocation guesses, iii) adverse event reports, and iv) depressive symptom severity, as measured by Hamilton Depression Rating Scale, after ten weeks of treatment were examined using linear regression (n = 149).
RESULTS: Receiving tDCS was positively associated with a) guessing that one had received tDCS (p = .01704), b) number of adverse events (beta: 0.69, p = .0046), and c) improvement after ten weeks (beta: -2.39, p = .0049). Guessing that one had received tDCS was positively associated with greater improvement (beta: -3.16, p = .0005), whereas the number of reported adverse events correlated negatively with improvement (beta: 0.68, p = .0186). Moreover, among participants who received tDCS, those who reported any of nine examined adverse events consistently showed numerically worse outcomes than those who did not report the same adverse events.
CONCLUSIONS: In this exploratory analysis, adverse events correlated negatively with HDRS-rated improvement. This is not consistent with a pathway where adverse events lead to unblinding and, subsequently, to improvement via expectancy effects and/or biased ratings.