Analysis of patient information leaflets provided by a district general hospital by the Flesch and Flesch-Kincaid method

Introduction: Patient information leaflets (PILs) remain the most frequently used sources of medical information. There is a concern that the reading age of these leaflets may exceed patient comprehension, thus negating their beneficial effect. The ‘Flesch Reading Ease’ and the ‘Flesch–Kincaid grade level’ are established methods for providing reliable and reproducible scores of readability. Method: All available hospital PILs (171) were assessed and divided into 21 departments. Microsoft Word was used to provide Flesch and Flesch–Kincaid readability statistics and compared against the national reading age and the recommended level for provision of medical information. Results: The average Flesch readability of all of the hospital’s PILs is 60, with a Flesch–Kincaid grade of 7.8 (12–13 years old). There is considerable variation in the average readability between departments (Flesch readability 43.8–76.9, Flesch–Kincaid 5.4–10.2). The average scores of two departments have PILs scores suitable for patient information. Conclusion: Although our PILs were well laid out and easy to read, the majority would have exceeded patient comprehension. The current advice for provision of NHS information does not highlight the importance of a recommended reading level when designing a PIL. Potentially a wide group of patients are being excluded from the benefits of a PIL.     

Readability of Invasive Procedure Consent Forms

Background

Informed consent is a pillar of ethical medicine which requires patients to fully comprehend relevant issues including the risks, benefits, and alternatives of an intervention. Given the average reading skill of US adults is at the 8th grade level, the American Medical Association (AMA) and the National Institutes of Health (NIH) recommend patient information materials should not exceed a 6th grade reading level. We hypothesized that text provided in invasive procedure consent forms would exceed recommended readability guidelines for medical information.

Materials and methods

To test this hypothesis, we gathered procedure consent forms from all surgical inpatient hospitals in the state of Rhode Island. For each consent form, readability analysis was measured with the following measures: Flesch Reading Ease Formula, Flesch–Kincaid Grade Level, Fog Scale, SMOG Index, Coleman–Liau Index, Automated Readability Index, and Linsear Write Formula. These readability scores were used to calculate a composite Text Readability Consensus Grade Level.

Results

Invasive procedure consent forms were found to be written at an average of 15th grade level (i.e., third year of college), which is significantly higher than the average US adult reading level of 8th grade (p < 0.0001) and the AMA/NIH recommended readability guidelines for patient materials of 6th grade (p < 0.0001).

Conclusion

Invasive procedure consent forms have readability levels which makes comprehension difficult or impossible for many patients. Efforts to improve the readability of procedural consent forms should improve patient understanding regarding their healthcare decisions.     

Readability of Participant Informed Consent Forms and Informational Documents: From Phase 3 COVID-19 Vaccine Clinical Trials in the United States

ObjectiveTo assess the readability of the informed consent forms from the phase 3 COVID-19 vaccine trials conducted in the United States.Patients and MethodsEnglish consent forms were used for patients in phase 3 COVID-19 vaccine clinical trials. Consent forms were obtained in October 2020. Using Microsoft Word tools, we analyzed the readability (ie, the ease of reading) of written consent forms and informational documents from phase 3 COVID-19 vaccine clinical trials in the United States from the following manufacturers: AstraZeneca, Moderna, Pfizer, Johnson & Johnson, and Novavax.ResultsOwing to low readability and several format factors, this study determined that none of the consent forms or informational documents from the recent phase 3 COVID-19 vaccine clinical trials conducted in the United States met readability standards at the recommended 7th grade readability level for the average vaccine research volunteer in any readability category. The average English-speaking vaccine trial volunteer would have great difficulty comprehending the information provided in the consent forms and informational documents. To ensure that study subjects receive and fully comprehend information regarding a clinical study and can provide reliable consent, greater attention should be given to the development and use of simplified consent forms, multimedia formatting, personal discussion, and comprehension assessments.     

Assessing readability and comprehension of informed consent materials for medical device research: A survey of informed consents from FDA's Center for Devices and Radiological Health

Legally effective informed consent has been a long-standing requirement for FDA-regulated clinical studies. However, informed consent forms (ICFs) are often thought to be too long, too complex, and too difficult for participants to understand. In this article, investigators from the FDAs Center for Devices and Radiological Health (CDRH) surveyed 399 ICFs from approved investigational device exemption (IDE) applications for fiscal years 2015 and 2016 to evaluate the readability of ICFs.The investigators collected data from the ICFs, using variables related to structure, readability, and comprehension.The investigators found that the mean grade-reading levels of the ICFs ranged from 10th grade to college level (Table 2), higher than the recommended 6th to 8th grade level, when measured by major readability evaluation tools (the SMOG readability grade level formula, the Flesch-Kincaid Index Grade Level Readability Formula, the Flesch Reading Ease test, and the Dale-Chall readability formula).Overall, the ICFs and informed consent (IC) processes, as described in the IDE application, lacked components that enhanced participants' comprehension, such as short sentences (e.g., no more than 8 to 10 to words) and the use of pictures, tables, and diagrams.CDRH investigators believe that information about ICFs' readability, comprehension, and structure will help support current and future efforts to improve the IC process. The intent of the article is to demonstrate that improvements are needed in the IC process and to encourage clinical trial stakeholders to consider implementing those approaches that optimize patient comprehension in the development of their IC processes.     

Obtaining consent: the use of a consent form

A consent form provides clear, unambiguous proof that a patient consented to treatment. Consent forms do not reveal the content of discussions with a patient. Staff awareness needs to be raised of the importance of providing information, obtaining consent and demonstrating that this has occurred.     

Improved readability and functions needed for mHealth apps targeting patients with heart failure: An app store review

To maintain their quality of life and avoid hospitalization and early mortality, patients with heart failure must recognize and respond to symptoms of exacerbation. A promising method for engaging patients in their self‐care is through mobile health applications (mHealth apps). However, for mHealth to have its greatest chance for improving patient outcomes, the app content must be readable, provide useful functions and be based in evidence. The study aimed to determine: (1) readability, (2) types of functions, and (3) linkage to authoritative sources of evidence for self‐care focused mHealth apps targeting heart failure patients that are available in the Apple and Google Play Stores. We systematically searched for mHealth apps targeting patients with heart failure in the Apple and Google Play Stores and applied selection criteria. Readability of randomly selected informational paragraphs were determined using Flesch–Kincaid grade level test tool in Microsoft Word. Ten mHealth apps met our criteria. Only one had a reading grade level at or below the recommended 6th grade reading level (average 9.35). The most common functions were tracking, clinical data feedback, and non‐data‐based reminders and alerts. Only three had statements that clearly linked the mHealth app content to trustworthy, evidence‐based sources. Only two had interoperability with the electronic health record and only one had a communication feature with clinicians. Future mHealth designs that are tailored to patients’ literacy level and have advanced functions may hold greater potential for improving patient outcomes.     

The effects of local review on informed consent documents from a multicenter clinical trials consortium

There is increasing controversy about the appropriate role of the local institutional review board in the review of multicenter clinical studies. We evaluated the effects of the local review process at 25 study sites on the consent forms from two studies of the Tuberculosis Trials Consortium, a multicenter trials group. Two independent reviewers classified all changes made in the centrally approved consent forms; a third reviewer evaluated those changes if the two initial reviewers disagreed. The median time to initial local approval was 104.5 days (range 31-346). There were no changes in the study protocols as a result of local review. Consent forms became longer and less readable after local review, with a mean increase in grade level of 0.9 (+/-0.9) reading grade levels (p<0.001). A median of 46.5 changes (range 3-160) were made in the centrally approved forms. Most changes (85.2%) involved altering wording without affecting meaning. Errors were commonly introduced (11.2% of changes), and 33 of 50 (66%) locally approved consent forms contained at least one error in protocol presentation or a required consent form element. Local approval of two multicenter clinical trials was time-consuming and resulted in many changes in centrally approved consent forms. These changes frequently decreased readability and introduced errors.     

Patient reading ability: an overlooked problem in health care

Health care workers often assume that patients who have completed a certain grade in school can read at that level. This study examines the relationships between patient reading ability, the last grade completed, and the reading ability necessary to comprehend commonly used written materials. We tested 528 patients during regular visits to seven outpatient clinics serving a predominantly indigent population. In addition, we analyzed the readability of 280 brochures and consent forms used in these clinics. Most patients had reading abilities on a level far below their last grade completed, while almost all materials tested were written on a level far above average patient reading ability. We conclude that patient reading ability should be routinely tested and that written materials should be developed on a level commensurate with patient reading ability.     

Understanding informed consent

The failure of a physician to disclose all of the risks associated with an operative procedure is considered a breach of professional duty and, therefore, a negligent act. Consent for a procedure does not necessarily have to be written; however, signed forms provide written evidence of the patient's agreement. Documentation is essential, especially in cases where the consent form is incomplete or incorrectly filled out. Any concerns about a patient's consent or lack of consent should be discussed with the surgeon.     

Effectiveness of a writing improvement intervention program on the readability of the research informed consent document.

BACKGROUND: Problems with the comprehensibility of human research informed consent have been documented since the 1970s, and efforts aimed at rewriting consents have not been successful in consistently producing more readable consents. This study employed researched principles of reading comprehension research to create writing intervention program designed to help the research writer produce more comprehensible informed consent documents. The purpose of this study was to determine if this intervention program was effective. METHOD: The key component of the writing improvement intervention packet was a newly formatted consent form that contained annotated instructions for researchers on how to write each section for optimum comprehension. The resulting consent forms were evaluated using a Readability and Processability Form (RPF). The RPF is based on reading research and includes the Fry Scale, which yields an approximate grade reading level. The RPF assigned points to each of the 20 areas of comprehension analysis according to strict scoring criteria, and target scores were established by the authors in consultation with the hospital institutional review board. RESULTS: We evaluated 66 post-intervention informed consents. The mean readability and processability score was 62, resulting in the RPF classification of "good." The established readability and processability target range was good to excellent or 61-100 points; 66% of the forms scored in this range. In our 1995 pre-intervention study, the corresponding score was 12%. The target range for grade reading level was 8th grade: 53% scored in that range as compared with 4% in 1995. A question-by-question analysis of each of the 20 checklist items on the RPF identified important aspects of the consent writing that improved and others that were still weak and needed improvement. CONCLUSIONS: The Hartford Hospital writing improvement intervention program was associated with the production of more comprehensible informed consent documents. Using the intervention materials, investigators from a variety of departments could function independently to produce readable consent forms. This program may help others who wish to assist their research departments in creating consents that are written for optimal reading comprehension.     

The readability of online Canadian radiotherapy patient educational materials

Introduction/backgroundIt is not clear if online radiotherapy patient educational materials that are published by the Canadian Cancer Society (CCS) and the various provincial health authorities meet the appropriate readability levels. The aim of this study is to determine the readability of online Canadian radiotherapy patient educational materials.MethodsThe publicly available educational materials were acquired from the provincial health authorities' and the CCS's websites. Only English language materials were included. Documents which mainly contained instructions or were part of interactive modules were excluded. The materials were transferred to Microsoft Word documents and labelled by source and category. Editing was then performed and the readability scores were acquired for each document.ResultsA total of 67 documents were included and 4 were excluded. The overall mean Flesch-Kincaid Grade Level from all sources was 7.5 (range, 3.6–13.2; 95% confidence interval [CI] 7.1–7.9), while the overall mean Flesch Reading Ease from all sources was 64.0 (range, 44.2–78.1; 95% confidence interval [CI] 62.0–66.1). The mean Flesch-Kincaid Grade Level scores from all sources were higher than the grade 6 recommended reading level for patient educational materials. This difference was found to be statistically significant (p ≤ 0.05) for Alberta, New Brunswick, Quebec, and Nova Scotia.Discussion/conclusionsOverall, the readability levels of online Canadian radiotherapy patient educational materials exceed the recommended grade 6 readability for patient educational resources. It is hoped that the findings of this study would inform and guide the future development and distribution of materials that meet the appropriate readability standards.     

Informed Consent for Medical Research: Common Discrepancies and Readability

Objective: To identify common discrepancies and average reading grade levels for informed consent forms (ICFs) us submitted to institutional review boards (IRBs) by medical researchers.
Methods: A retrospective evaluation of ICFs as submitted to IRBs of 3 university-affiliated hospitals during a I-year period. ICF content was evaluated using a checklist of 23 requirements specified in the federal regulations governing human research. Documents then were computer-analyzed to determine the readability scores using 2 common indexes of comprehension. A discrepancy was defined as any instance in which an ICF did not address an applicable requirement in the Code of Federal Regulations.
Results: Eighty-two ICFs representing 16 medical specialties were evaluated; 8 (10%) were from emergency medicine. Eighteen ICFs (22%) were conspicuously incomplete, lacking 29 federal requirements. The mean number of discrepancies was 4.7 (95% CI, 3.9–5.5) Common omissions included: a statement about who is doing the research, number of subjects in the study, circumstances when a subject's participation may be terminated, disclosure of alternative procedures, and notice to subjects regarding new findings. The mean Flesch grade level required to read all ICFs was 13.8 (95% CI, 13.5–14.2), implying that the majority of the U.S. adult population would be unable to comprehend these forms.
Conclusion: Designing a consent form to meet all of the federal requirements while maintaining a level of reading comprehension suitable for the general population is a difficult task for investigators.     

Informed consent for blood transfusion: a regional hospital survey

Ninety-two hospitals in a three-state mid-Atlantic region were surveyed to determine their policy toward obtaining written informed consent for transfusion and to examine the content of written consent documents and the process by which consent is obtained. Of 81 hospitals responding, 50 (62%) required written informed consent. Hospitals with fewer than 200 beds were more likely to require written informed consent. The attending physicians had responsibility for obtaining consent in 28 (57%) of 49 institutions, most often on the day or evening before surgery. Twenty-seven of 48 forms mentioned complications: hepatitis in 80 percent, human immunodeficiency virus infection in 46 percent, nonhemolytic reactions in 32 percent, and hemolysis in 25 percent. Alternatives to allogeneic transfusion were mentioned infrequently; eight hospital forms listed autologous transfusion options and only two mentioned designated donation. The reading level required to comprehend 34 consent forms submitted was grade 14.6, which has been attained by only 23 percent of the adult United States population. Although the majority of respondent institutions require written informed consent, those forms, per se, do not document that the fundamental tenets of informed choice have been applied to the decision to transfuse blood.     

A systematic evaluation of advance care planning patient educational resources

Background

Advance care planning (ACP) conversations help individuals exercise autonomy and make informed decisions about their care. There are many ACP resources available to support the process of advance care planning, yet available resources not universally accepted and under-utilized in clinical practice.

The legal framework for informed consent.

Touching a patient without consent can leave the nurse open to action for battery. Consent must be informed and not given under duress. Consent can be written, verbal or implied. Patients should be advised if the risk of complications is other than minimal.     

Direct‐to‐consumer advertising for bleeding disorders: a content analysis and expert evaluation of advertising claims

Summary. Objective: In the United States, the Food and Drug Administration (FDA) requires that all direct‐to‐consumer advertising (DTCA) contain both an accurate statement of a medication’s effects (‘truth’) and an even‐handed discussion of its benefits and risks/adverse effects (‘fair balance’). DTCA for medications to treat rare diseases such as bleeding disorders is unlikely to be given high priority for FDA review. Methods: We reviewed all DTCA for bleeding disorder products appearing in the patient‐directed magazine HemeAware from January 2004 to June 2006. We categorized the information presented in each advertisement as benefit, risk/adverse effect, or neither, and assessed the amount of text and type size devoted to each. We also assessed the readability of each type of text using the Flesch Reading Ease Score (FRES, where a score of ≥65 is considered of average readability), and assessed the accuracy of the advertising claims utilizing a panel of five bleeding disorder experts. Results: A total of 39 unique advertisements for 12 products were found. On average, approximately twice the amount of text was devoted to benefits as compared with risks/adverse effects, and the latter was more difficult to read [FRES of 32.0 for benefits vs. 20.5 for risks/adverse effects, a difference of 11.5 (95% CI: 4.5–18.5)]. Only about two‐thirds of the advertising claims were considered by a majority of the experts to be based on at least low‐quality evidence. Conclusion: As measured by our methods, print DTCA for bleeding disorders may not reach the FDA’s standards of truth and fair balance.     

Physician-Investigator Phone Elicitation of Consent in the Field: A Novel Method To Obtain Explicit Informed Consent For Prehospital Clinical Research

Objective. To describe andreport the feasibility of a novel field telephonic strategy to elicit explicit informed consent in prehospital trials for conditions in which patients retain decision-making capacity. Methods. In a pilot prehospital neuroprotective stroke therapy trial, ambulances carried written informed consent forms anddedicated trial cellular phones permitting rapid connection to on call physician-investigators. The physician-investigator discussed the trial with the consent provider [patient if competent, on scene legally authorized representative (LAR) if patient not competent] by phone, while paramedics carried out prehospital care duties unimpeded. Results. 32 patients met consent elicitation criteria. 20 (63%) were enrolled. The most frequent reasons for non-enrollment were: patient not competent andno available on-scene LAR–5; patient/LAR declined participation–4. Among enrollees, 15 (75%) were competent andself-enrolled; 5 (25%) were not competent andwere enrolled by LAR family members. Site of consent initiation was: patient home–15 (74 = 5%), work–2(10)%, other–3(15)%. Consent was elicited via cell phone in 11 (55%) andsite landline in 9 (45%). Compared with patients enrolled in prior studies employing standard in-hospital consent, prehospital consent procedures reduced time from paramedic arrival on–scene to start of study agent (26 vs 139 mins, p < 0.0001), anddid not prolong the on-scene to ED arrival time (37 vs 34 min, p = 0.50). No patient/family withdrew consent during the 3-month follow-up period. Conclusion. Physician phone elicitation of prehospital research consent from individuals with retained competency or on-scene legally authorized representatives is feasible, permits rapid patient study entry, anddoes not delay field transport times.