The readability of currently used surgical/procedure consent forms in the United States

doi:10.1067/msy.1998.87236

Surgery

Volume 123, Issue 5, May 1998, Pages 496-503

https://doi.org/10.1067/msy.1998.87236 Get rights and content

Abstract

Background: Informed consent forms are universally used by hospitals throughout the United States before surgery or invasive procedures. This survey was undertaken to determine the content of these forms and their ability to be understood by individuals with differing reading comprehension levels. Methods: Ten percent of all U.S. hospitals were requested to forward a copy of their current surgical/procedural informed consent form. The forms received were digitized and computer assessed for readability. In addition, each form was evaluated for a variety of items with respect to content. Results: Of the 2194 requests mailed, 681 responses were received including 616 with surgical/procedural consent forms. The mean grade level required to understand these consent forms was 12.6 (± 3.1). There was no variability in readability scores on the basis of hospital bed size. Of the 616 consent forms reviewed, 29, 146, 347, and 461 forms could be understood by individuals reading at a grade level of less than 8 and at least 8, 10, and 12 years of education, respectively. Although most required the name of the patient, physician, and procedure, the majority did not describe or provide a fill-in blank for the specific benefits, risks, and alternatives to the procedure. Conclusions: The majority of surgical/procedural informed consent forms currently used by U.S. hospitals are complex and are not easily understood by the average patient. In addition, the majority of reviewed consent forms do not list specific benefits or potential complications of the planned surgery/procedure. (Surgery 1998;123:496-503.)

Section snippets

Material and methods

Every tenth hospital contained within a recent listing of all U.S. hospitals¹ was selected for inclusion in this study, regardless of location, size (number of beds), and yearly number of admissions. This directory lists alphabetically by state all U.S. hospitals certified by the American Hospital Association. The administrator of each hospital was sent a letter explaining the nature of our study and requesting that he or she provide a copy of their current surgical/procedure consent form. Once

Results

Of the 2194 requests mailed to hospitals throughout the United States, 681 replies were received. Among these, 65 did not provide their standard surgical/procedure consent form and were excluded from further analysis. Among the remaining 616, there was a wide diversity in their readability (Table I).

. Readability results (SD)

Empty Cell	N	Mean	Range	Flesch mean*	Fog mean^†	Mean	Range	Strength index
Empty Cell	N	Grade level		Flesch mean*	Fog mean^†	No. of words		Strength index
Overall	616	12.6 (3.1)	4-30	34.2 (9.5)	20.9 (4.8)	441.2 (388.8)	58-4217	0.2 (0.2)
< 100 beds	307	12.6 (3.5)

Discussion

Three key elements are embedded in the notion of informed consent. First, the patient must understand the medical procedure or research protocol, its risks, its potential benefits, and the alternatives; second, consent must be given willingly and without duress; and third, the patient must be mentally competent to give consent. All too often, however, the informed consent form is designed “less to inform the patient than to list all possible adverse occurrences—irrespective of their

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To evaluate the readability of surgical clinical trial consent forms and compare readability across surgical specialties.
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Our findings suggest that current surgical clinical trial consent documents are too long and complex, exceeding the recommended sixth-grade reading level. Ensuring readable clinical trial consent forms is not only ethically responsible but also crucial for protecting patients' rights and well-being by facilitating informed decision-making.
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Discordance of patient and provider perceptions of the meaning of verbal estimates of perioperative risk
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Citation Excerpt :
There are also a number of patient-related issues that might hinder comprehension. Prior work by other investigators has shown that low educational level as well as minority race or ethnicity correlate with limited understanding of preoperative educational material.14–17 Other patient-related factors which might limit comprehension of preoperative educational materials include low intellectual capacity or high levels of anxiety.
To determine whether the use of semiquantitative, verbal (non-numerical) language to express levels of perioperative risk is a possible cause of poor communication between practitioners and patients.
Survey forms were distributed to patients who had just completed an outpatient preoperative clinic visit at a large academic medical center. Surveys were distributed from October 2015 through March 2016. Data collected included demographic characteristics, literacy and numeracy characteristics, patient recollection of level of risk discussion, and the effect of the discussion on patient desire to pursue surgery. Patients were asked to define, using percentages, commonly used verbal semiquantitative terms for levels of risk (low, medium/intermediate, and high).
212 patients completed surveys. Overall, 84% of patients noted that the actual level of risk was discussed in quantitative or semiquantitative terms; of these patients, 66% reported risk was described using words only. When asked to numerically define low, medium/intermediate, and high risk, patient estimates were markedly discordant, being typically higher, from the usual definitions for these terms as published in the medical literature and as used by medical practitioners. More than 55% of patients surveyed indicated that high risk would correspond to a >50% chance of adverse event, whereas clinicians generally define high risk as >5% chance of adverse event.
Semiquantitative terms used to define levels of perioperative risk may have very different meanings to patients and practitioners. To facilitate true informed consent, such terms should be avoided and more precise, numerical, quantitative estimates of risk should be used instead.
POINT: Should Informed Consent Be Required for Apnea Testing in Patients With Suspected Brain Death? No
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Health Literacy, from data to action: Translation, validation and application of the European Health Literacy Survey in Portugal
2016, Revista Portuguesa de Saude Publica
Nos últimos anos, diferentes estudos têm demonstrado que um nível inadequado de literacia em saúde pode ter implicações significativas nos resultados em saúde, na utilização dos serviços de saúde e, consequentemente, nos gastos em saúde. O conceito de literacia em saúde evoluiu de uma definição meramente cognitiva para uma definição que engloba as componentes pessoal e social do indivíduo, assumindo‐se como a capacidade de tomar decisões fundamentadas no seu dia‐a‐dia.
O presente estudo transversal analítico teve como objetivo traduzir e validar para a população portuguesa o European Health Literacy Survey (HLS‐EU).
O HLS‐EU‐PT foi aplicado em todo o território nacional, incluindo as regiões autónomas, através de investigadores de uma rede académica. A recolha de dados foi realizada por entrevista presencial. A amostra final ficou constituída por 1.004 indivíduos com idades ≥ 16 anos.
Este estudo disponibilizou o instrumento de avaliação do nível de literacia para a saúde em Portugal, tão importante na gestão da saúde.
O HLS‐EU‐PT apresenta‐se como um instrumento adequado para aferir o nível de literacia em saúde da população portuguesa e evidencia propriedades psicométricas comparáveis às versões utilizadas nos outros países.
Em Portugal, 61% da população inquirida apresenta um nível de literacia geral em saúde problemático ou inadequado, situando‐se a média dos 9 países em 49,2%.
Relativamente à dimensão cuidados de saúde, apenas 44,2% apresenta um nível suficiente ou excelente de literacia em saúde. No que respeita à prevenção da doença, cerca de 45% dos inquiridos revela ter um nível suficiente ou excelente de literacia em saúde, comparativamente com a média dos 9 países, que nesta dimensão apresenta o valor de 54,5%. Na dimensão promoção da saúde, 60,2% da população auscultada apresenta um nível de literacia em saúde problemático ou inadequado, sendo que a média se situa nos 52,1%.
Assim, considera‐se fundamental e urgente a conceção e implementação de uma estratégia nacional de literacia em saúde.
In the last few years, several studies have shown that inadequate health literacy levels can have significant implications in health outcomes, in the use of health care services and, consequently, in health costs. The concept of health literacy has changed from a purely cognitive definition to a definition that includes the personal and social components of the individual, assuming the ability to make informed decisions in their everyday life.
This analytical cross‐sectional study aimed to translate and validate the European Health Literacy Survey (HLS‐EU) to the Portuguese population.
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The HLS‐EU‐PT is an adequate instrument to measure the health literacy levels of Portuguese population and shows comparable psychometric properties to versions used in the other countries.
In Portugal, 61% of the surveyed population has general health literacy level problematic or inadequate, reaching the average of the nine countries in 49.2%.
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296 COPD patients of 68(SD = 9) years and a FEV₁%predicted of 53%(SD = 18%) were enrolled and followed-up for one year. 59% showed “inadequate” HL.
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^*: Reprint requests: Kenneth D. Hopper, MD, Department of Radiology, Penn State University, P.O. Box 850, Hershey, PA 17033.

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Original CommunicationsThe readability of currently used surgical/procedure consent forms in the United States*

Abstract

Section snippets

Material and methods

Results

Discussion

Cardiovasc Intervent Radiol

Am J Med Sci

Guide to the Health Care Field

Readability of informed consent forms for use with iodinated contrast media

Radiology

Informed consent forms for clinical and research imaging procedures: how much do patients understand?

AJR

Malpractice, outcomes, and appropriateness of care

Consent forms: how to determine and improve their readability

Oncol Nurs Forum

Informed consent and hospital consent forms: paper chasing in a video world

J Urban Law

On the readability of surgical consent forms

N Engl J Med

Readability of pediatric biomedical research informed consent forms

Pediatrics

Original Communications
The readability of currently used surgical/procedure consent forms in the United States*