Assessing the readability statistics of national consent forms in the UK

When obtaining consent for an invasive procedure, the patient needs to understand what is happening to them in broad terms. Best medical practice advocates that written consent is given to acknowledge patient agreement. Across the UK, the Department of Health has provided standard consent forms for obtaining consent in all situations. Potentially these written sources of information may not be comprehended by patients and thus invalidate consent.

Consent forms were assessed by the Flesch readability and Flesch-Kincaid grade formulae and compared with the national reading age, the recommended level for patient medical information, three newspaper articles and a journal article.

The consent forms have acceptable statistics [average Flesch readability 61.1 (range 57.2-66.1) and Flesch-Kincaid grade 7 (range 6.3-8)]. This grade, however, is above the recommended level of patient health information (Flesch-Kincaid grade 6). When the patient statements are isolated the reading statistics worsen [average Flesch readability 52.6 (range 41-62.6) and Flesch-Kincaid grade 9.6 (range 7.9-11.1)].

Consent forms should be used as adjuncts to detailed conversations, describing what a procedure involves to ensure that a patient understands, in broad terms, what is happening to them. The patient's statement section of the form may be being written at a level above patient comprehension currently and thus could invalidate any consent given. We would advocate a documented conversation with patients to ensure they have a broad understanding of the procedure and using the consent form as an adjunct to this discussion. The patient's statement section should be re-written to avoid invalidating consent.