Grossman S A, Piantadosi S, Covahey C
Johns Hopkins Oncology Center, Baltimore, MD 21287.
J Clin Oncol. 1994 Oct;12(10):2211-5. doi: 10.1200/JCO.1994.12.10.2211.
This study was conducted to assess the readability of informed consent forms that describe clinical oncology protocols.
One hundred thirty-seven consent forms from 88 protocols that accrued patients at The Johns Hopkins Oncology Center were quantitatively analyzed. These included 58 of 99 (59%) institutional protocols approved by The Johns Hopkins Oncology Center's Clinical Research Committee and the Institutional Review Board (IRB) over a 2-year period, and 30 active Eastern Cooperative Oncology Group (ECOG), Radiation Therapy Oncology Group (RTOG), and Pediatric Oncology Group (POG) trials. The consent forms described phase I (17%), phase I/II (36%), phase III (29%), and nontherapeutic (18%) studies. Each was optically scanned, checked for accuracy, and analyzed using readability software. The following three readability indices were obtained for each consent form: the Flesch Reading Ease Score, and grade level readability as determined by the Flesch-Kincaid Formula and the Gunning Fog Index.
The mean +/- SD Flesch Reading Ease Score for the consent forms was 52.6 +/- 8.7 (range, 33 to 78). The mean grade level was 11.1 +/- 1.67 (range, 6 to 14) using the Flesch-Kincaid Formula and 14.1 +/- 1.8 (range, 8 to 17) using the Gunning Fog Index. Readability at or below an eighth-grade level was found in 6% of the consent forms using the Flesch-Kincaid Formula and in 1% using the Gunning Fog Index. Readability was similar for consent forms that described institutional, cooperative group, and phase I, II, and III protocols.
Consent forms from clinical oncology protocols are written at a level that is difficult for most patients to read, despite national, cooperative group, institutional, and departmental review. The consent process, which is crucial to clinical research, should be strengthened by improving the readability of the consent forms.
本研究旨在评估描述临床肿瘤学方案的知情同意书的可读性。
对约翰霍普金斯肿瘤中心88项招募患者的方案中的137份同意书进行了定量分析。其中包括约翰霍普金斯肿瘤中心临床研究委员会和机构审查委员会（IRB）在两年内批准的99项机构方案中的58项（59%），以及30项正在进行的东部肿瘤协作组（ECOG）、放射治疗肿瘤学组（RTOG）和儿科肿瘤学组（POG）试验。同意书描述了I期（17%）、I/II期（36%）、III期（29%）和非治疗性（18%）研究。每份同意书都进行了光学扫描、准确性检查，并使用可读性软件进行分析。为每份同意书获得了以下三个可读性指标：弗莱什易读性得分，以及由弗莱什-金凯德公式和冈宁雾度指数确定的年级水平可读性。
同意书的平均±标准差弗莱什易读性得分为52.6±8.7（范围为33至78）。使用弗莱什-金凯德公式的平均年级水平为11.1±1.67（范围为6至14），使用冈宁雾度指数的平均年级水平为14.1±1.8（范围为8至17）。使用弗莱什-金凯德公式，6%的同意书可读性处于或低于八年级水平；使用冈宁雾度指数，这一比例为1%。描述机构、协作组以及I期、II期和III期方案的同意书可读性相似。
尽管经过了国家、协作组、机构和部门审查，但临床肿瘤学方案的同意书的撰写水平对于大多数患者来说难以阅读。对临床研究至关重要的同意过程应通过提高同意书的可读性来加强。
