Therapeutic advances in psychopharmacology · 2026
Readability of informed consent forms from ClinicalTrials.gov in ketamine clinical trials for mental health conditions: a cross-sectional analysis.
СтатьяНазвание 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.
Swieczkowski Damian, Kwaśny Aleksander, Cubała Wiesław Jerzy
Аннотация
BACKGROUND: Ensuring participants understand informed consent forms (ICFs) is a core ethical requirement of clinical research, particularly in psychiatry, where cognitive and affective symptoms can compromise decisional capacity. As ketamine-based interventions are increasingly studied for mental health conditions, the readability of consent materials in these trials warrants systematic evaluation.
OBJECTIVES: To assess the readability and linguistic complexity of ICFs from ClinicalTrials.gov used in ketamine clinical trials for mental health conditions.
DESIGN: Cross-sectional analysis.
METHODS: We conducted a cross-sectional analysis of English-language ICFs posted on ClinicalTrials.gov for interventional ketamine clinical trials involving mental health conditions. All documents were converted to plain text and standardised for text-based analysis. Readability and linguistic complexity were assessed using established indices, including the Flesch-Kincaid Grade Level, Gunning Fog Index, Flesch Reading Ease Score, and Fry Readability Graph. Document length and estimated silent reading time were also calculated. Descriptive statistics summarised the findings.
RESULTS: Fourteen ketamine clinical trials met the inclusion criteria. ICFs ranged from 1681 to 8637 words (mean: 5031; median: 4622), with sentence counts from 129 to 503. Estimated silent reading times ranged from 7.0 to 36.0 min (mean: 21.4; median: 19.5). Flesch-Kincaid Grade Level scores ranged from 5.7 to 11.5 (mean: 9.8), with 13 of 14 documents above grade 8. Gunning Fog Index values ranged from 7.7 to 13.8 (mean: 11.7). Flesch Reading Ease Scores ranged from 41.3 to 73.9 (mean: 52.8). Fry Readability scores ranged from grade 6 to grade 13.
CONCLUSION: Thirteen of fourteen ketamine mental health trial consent forms on ClinicalTrials.gov exceeded recommended readability thresholds. Sponsors and ethics committees should require consent materials to meet an eighth-grade reading level, verified by a documented readability assessment before approval, to support informed participation in psychiatric research.
OBJECTIVES: To assess the readability and linguistic complexity of ICFs from ClinicalTrials.gov used in ketamine clinical trials for mental health conditions.
DESIGN: Cross-sectional analysis.
METHODS: We conducted a cross-sectional analysis of English-language ICFs posted on ClinicalTrials.gov for interventional ketamine clinical trials involving mental health conditions. All documents were converted to plain text and standardised for text-based analysis. Readability and linguistic complexity were assessed using established indices, including the Flesch-Kincaid Grade Level, Gunning Fog Index, Flesch Reading Ease Score, and Fry Readability Graph. Document length and estimated silent reading time were also calculated. Descriptive statistics summarised the findings.
RESULTS: Fourteen ketamine clinical trials met the inclusion criteria. ICFs ranged from 1681 to 8637 words (mean: 5031; median: 4622), with sentence counts from 129 to 503. Estimated silent reading times ranged from 7.0 to 36.0 min (mean: 21.4; median: 19.5). Flesch-Kincaid Grade Level scores ranged from 5.7 to 11.5 (mean: 9.8), with 13 of 14 documents above grade 8. Gunning Fog Index values ranged from 7.7 to 13.8 (mean: 11.7). Flesch Reading Ease Scores ranged from 41.3 to 73.9 (mean: 52.8). Fry Readability scores ranged from grade 6 to grade 13.
CONCLUSION: Thirteen of fourteen ketamine mental health trial consent forms on ClinicalTrials.gov exceeded recommended readability thresholds. Sponsors and ethics committees should require consent materials to meet an eighth-grade reading level, verified by a documented readability assessment before approval, to support informed participation in psychiatric research.