Holst Christine, Woloshin Steven, Oxman Andrew D, Rose Christopher, Rosenbaum Sarah, Munthe-Kaas Heather Menzies
Centre for Epidemic Interventions Research, Norwegian Institute of Public Health, Oslo, Norway.
Lisa Schwartz Foundation for Truth in Medicine, Norwich, VT, United States.
JMIR Public Health Surveill. 2025 Mar 18;11:e62828. doi: 10.2196/62828.
Well-designed public health messages can help people make informed choices, while poorly designed messages or persuasive messages can confuse, lead to poorly informed decisions, and diminish trust in health authorities and research. Communicating uncertainties to the public about the results of health research is challenging, necessitating research on effective ways to disseminate this important aspect of randomized trials.
This study aimed to evaluate people's understanding of overall and statistical uncertainty when presented with alternative ways of expressing randomized trial results.
Two parallel, web-based, individually randomized trials (3×2 factorial designs) were conducted in the United States and Norway. Participants were randomized to 1 of 6 versions of a text (summary) communicating results from a study examining the effects of wearing glasses to prevent COVID-19 infection. The summaries varied in how overall uncertainty ("Grading of Recommendations Assessment, Development and Evaluation [GRADE] language," "plain language," or "no explicit language") and statistical uncertainty (whether a margin of error was shown or not) were presented. Participants completed a web-based questionnaire exploring 4 coprimary outcomes: 3 to measure understanding of overall uncertainty (benefits, harms, and sufficiency of evidence), and one to measure statistical uncertainty. Participants were adults who do not wear glasses recruited from web-based research panels in the United States and Norway. Results of the trials were analyzed separately and combined in a meta-analysis.
In the US and Norwegian trials, 730 and 497 individuals were randomized, respectively; data for 543 (74.4%) and 452 (90.9%) were analyzed. More participants had a correct understanding of uncertainty when presented with plain language (United States: 37/99, 37% and Norway: 40/76, 53%) than no explicit language (United States: 18/86, 21% and Norway: 34/80, 42%). Similar positive effect was seen for the GRADE language in the United States (26/79, 33%) but not in Norway (30/71, 42%). There were only small differences between groups for understanding the uncertainty of harms. Plain language improved correct understanding of evidence sufficiency (odds ratio 2.05, 95% CI 1.17-3.57), compared to no explicit language. The effect of GRADE language was inconclusive (odds ratio 1.34, 95% CI 0.79-2.28). The understanding of statistical uncertainty was improved when the participants were shown the margin of error compared to not being shown: Norway: 16/75, 21% to 24/71, 34% vs 1/71, 1% to 2/76, 3% and the United States: 21/101, 21% to 32/90, 36% vs 0/86, 0% to 3/79, 4%).
Plain language, but not GRADE language, was better than no explicit language in helping people understand overall uncertainty of benefits and harms. Reporting margin of error improved understanding of statistical uncertainty around the effect of wearing glasses, but only for a minority of participants.
ClinicalTrials.gov NCT05642754; https://tinyurl.com/4mhjsm7s.
精心设计的公共卫生信息有助于人们做出明智的选择，而设计不佳的信息或具有说服力的信息可能会造成混淆，导致决策缺乏充分信息，并削弱对卫生当局和研究的信任。向公众传达健康研究结果的不确定性具有挑战性，因此需要研究传播随机试验这一重要方面的有效方法。
本研究旨在评估当以不同方式呈现随机试验结果时，人们对总体不确定性和统计不确定性的理解。
在美国和挪威进行了两项平行的基于网络的个体随机试验（3×2析因设计）。参与者被随机分配到6个版本文本（摘要）中的1个，该文本传达了一项关于戴眼镜预防新冠病毒感染效果研究的结果。这些摘要在呈现总体不确定性（“推荐分级评估、制定和评价[GRADE]语言”、“通俗易懂的语言”或“无明确语言”）和统计不确定性（是否显示误差幅度）的方式上有所不同。参与者完成了一份基于网络的问卷，该问卷探索了4个共同主要结局：3个用于衡量对总体不确定性的理解（益处、危害和证据充分性），1个用于衡量统计不确定性。参与者是从美国和挪威基于网络的研究小组招募的不戴眼镜的成年人。试验结果分别进行分析，并合并进行荟萃分析。
在美国和挪威的试验中，分别有730人和497人被随机分配；分析了543人（74.4%）和452人（90.9%）的数据。与无明确语言相比，当以通俗易懂的语言呈现时，更多参与者对不确定性有正确理解（美国：37/99，37%；挪威：40/76，53%），而无明确语言组（美国：18/86，21%；挪威：34/80，42%）。在美国，GRADE语言也有类似的积极效果（26/79，33%），但在挪威没有（30/71，42%）。在理解危害的不确定性方面，各组之间只有微小差异。与无明确语言相比，通俗易懂的语言提高了对证据充分性的正确理解（优势比2.05，95%置信区间1.17 - 3.57）。GRADE语言的效果尚无定论（优势比1.34，95%置信区间0.79 - 2.28）。与未显示误差幅度相比，当向参与者显示误差幅度时，对统计不确定性的理解得到改善：挪威：16/75，21%至24/71，34% 对比 1/71，1%至2/76，3%；美国：21/101，21%至32/90，36% 对比 0/86，0%至3/79，4%）。
在帮助人们理解益处和危害的总体不确定性方面，通俗易懂的语言比GRADE语言更好，优于无明确语言。报告误差幅度提高了对戴眼镜效果统计不确定性的理解，但仅对少数参与者有效。
ClinicalTrials.gov NCT05642754；https://tinyurl.com/4mhjsm7s。
