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1.
BMC Med Inform Decis Mak ; 22(1): 131, 2022 05 13.
Article in English | MEDLINE | ID: covidwho-1846832

ABSTRACT

BACKGROUND: The COVID-19 pandemic has caused significant morbidity and mortality. To mitigate its spread, members in the general population were prompted to apply significant behavioral changes. This required an effective dissemination of understandable information accessible for people with a wide range of literacy backgrounds. The aim of this study was to investigate the readability, understandability and language accessibility of Swedish consumer-oriented websites containing information about COVID-19. METHODS: Websites were identified through systematic searches in Google.se (n = 76), and were collected in May 2020 when the pandemic spread started in Sweden. Readability and understandability were assessed with the Readability Index, the Ensuring Quality Information for Patients (EQIP) tool, and the Patient Education Materials Assessment Tool Understandability subscale (PEMAT-PU). RESULTS: The median total sample score for Readability Index was 42.0, with the majority of scores being classified as moderate (n = 30, 39%) or difficult (n = 43, 57%). Median total sample scores were for EQIP 54.0% (IQR = 17.0, Range = 8-75) and for PEMAT-PU 60.0% (IQR = 14.75, Range = 12-87). The majority of the websites did not have any texts or links containing information in an alternative language (n = 58, 76%). CONCLUSIONS: Swedish websites contained information of difficult readability and understandability at the beginning of the coronavirus disease 2019 pandemic, with few providing information available in alternative languages. It is possible that these deficits contributed to the spread and impact of the virus. There is a need for studies investigating methods aiming to enhance the readability, understandability and language accessibility of web-based information at the beginning of an epidemic or pandemic.


Subject(s)
COVID-19 , Health Literacy , Comprehension , Cross-Sectional Studies , Humans , Internet , Language , Pandemics , Sweden
2.
Aesthetic Plast Surg ; 46(2): 712-718, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1844355

ABSTRACT

BACKGROUND: Patients often utilize the Internet to seek information related to their care. This study assesses the readability of online patient educational materials for submental fat reduction. METHODS: Patient educational materials from the 12 most popular websites related to submental fat reduction were downloaded and assessed for readability grade level using 10 unique scales. RESULTS: Analysis of the 12 most popular websites (and corresponding 47 articles) revealed that patient educational materials were written, on average, at an 11th grade reading level. The Flesch Reading Ease score was 48.9 (range 39.8-59.2), representing a "difficult" level of reading. Mean readability grade levels (range 9-13th grade for individual websites) were as follows: Coleman-Liau, 11.1; Flesch-Kincaid, 10.8; FORCAST, 10.8; Fry Graph, 10.1; Gunning Fog, 12.7; New Dale-Chall, 10.1; New Fog Count, 11.8; Simple Measure of Gobbledygook, 11.7; Raygor, 6.7. No website was at the 6th grade reading level for patient educational materials recommended by the American Medical Association and National Institutes of Health. CONCLUSIONS: Online patient educational materials for submental fat reduction are written well above the recommended reading level. Recognition of disparities in health literacy is necessary to enable patients to make informed decisions and become active participants in their own care. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors   www.springer.com/00266.


Subject(s)
Health Literacy , Reconstructive Surgical Procedures , Comprehension , Humans , Internet , United States
3.
Vaccine ; 40(25): 3466-3469, 2022 May 31.
Article in English | MEDLINE | ID: covidwho-1819623

ABSTRACT

BACKGROUND: More than 130 million individuals in the United States have now received at least one dose of a COVID-19 vaccine. Currently, all adults in the Unites States now have access to one of three COVID-19 vaccines. As part of the vaccination procedure, Emergency Use Authorization (EUA) fact sheets, which contain information regarding the vaccine, are provided. The purpose of this study was to analyze the ease of reading (i.e., readability) of the EUA-approved fact sheets for the vaccines currently available in the United States, the V-Safe adverse event survey script, and the Centers for Disease Control and Prevention (CDC) website information on COVID-19 vaccines designed for the general public in the United States. METHODS: We acquired the Pfizer, Moderna, and Janssen EUA fact sheets, as well as the V-Safe survey script and the CDC website information regarding COVID-19 vaccines. These documents were analyzed for their complexity regarding the following readability factors: average length of paragraphs, sentences, and words; font size and style; use of passive voice; the Gunning-Fog index; the Flesch Reading Ease index; and the Flesch-Kincaid Grade Level index. RESULTS: Only the V-Safe adverse-event survey script met readability standards for adequate comprehension. The mean readability scores of the EUA fact sheets and the CDC website were as follows: Flesch Reading Ease score (44.35 avg); Flesch-Kincaid Grade Level (10.48 avg); and Gunning-Fog index (11.8 avg).These scores indicate that at least a 10th-grade level education would be required to understand these reading materials. CONCLUSION: The average person in the United States would have difficulty understanding the information provided in the EUA fact sheets and CDC COVID-19 vaccine website documents; however, the V-Safe survey was written at an adequate reading level. To ensure that the general public fully understands information regarding COVID-19 vaccines, greater care and effort should be given to the development of simplified information material.


Subject(s)
COVID-19 Vaccines , COVID-19 , Comprehension , Consumer Health Information , COVID-19/prevention & control , Humans , Internet , Language , Surveys and Questionnaires , United States
4.
Front Public Health ; 9: 725840, 2021.
Article in English | MEDLINE | ID: covidwho-1775845

ABSTRACT

Background: Health literacy, a recently determined construct plays an important role in how individuals are able to manage their health. A useful approach for the assessment of health literacy is to measure the comprehension of available patient education materials (PEMs). Objective: We aimed at assessing the usefulness of PEMS available in Hungarian by testing comprehension of selected PEMs in different groups of users. Methods: Comprehension of patient education materials in the domain of healthcare was tested by selecting PEMs and creating questions based on their text in 3 dimensions of health literacy: understand, process/appraise, apply/use. Twenty questions were created that could be answered without pre-existing knowledge by reading the appropriate text taken from PEMs. Comprehension was examined in four groups: laypersons, non-professional healthcare workers, 1st year healthcare students, and 5th year medical students. Readability indices were calculated for the same texts to which questions were created. Results: Laypersons answered <50% of the PEMs-based questions correctly. Non-professional healthcare workers performed better with 57% of right answers but significantly worse than healthcare students or medical students. Those with at least high school qualification (maturity exam) showed significantly higher comprehension compared to those with lower educational attainment. Persons in good or very good health also had significantly better comprehension than those in less favorable health. All readability indices showed that comprehension of the tested PEMs required at least 10 years of schooling or more. Therefore, these PEMS are difficult to understand for persons with less than high school level of education. Conclusion: Rephrasing of the investigated patient educational materials would be recommended so that they better fit the educational attainment of the Hungarian population. Evaluation of the readability and comprehensibility of other PEMs also seems warranted.


Subject(s)
Health Literacy , Comprehension , Educational Status , Humans , Patient Education as Topic
5.
JMIR Public Health Surveill ; 8(3): e34003, 2022 Mar 15.
Article in English | MEDLINE | ID: covidwho-1742128

ABSTRACT

BACKGROUND: Online information on COVID-19 vaccination may influence people's perception and willingness to be vaccinated. Official websites of vaccination programs have not been systematically assessed before. OBJECTIVE: This study aims to assess and compare the readability and content quality of web-based information on COVID-19 vaccination posted on official/governmental websites. Furthermore, the relationship between evaluated website parameters and country vaccination rates were calculated. METHODS: By referring to an open data set hosted at Our World in Data, the 58 countries/regions with the highest total vaccination count as of July 8, 2021, were identified. Together with the websites from the World Health Organization and European Union, a total of 60 vaccination campaign websites were targeted. The "frequently asked questions" or "questions and answers" section of the websites were evaluated in terms of readability (Flesch Reading Ease score and Flesch-Kincaid Grade Level), quality (Health On the Net Foundation code [HONcode] certification and Quality Evaluation Scoring Tool), and content stating vaccination duration of protection and potential side effects. RESULTS: In terms of readability, the Flesch Reading Ease score of the vaccination frequently asked questions websites ranged between 11.2 and 69.5, with a mean of 40.9 (SD 13.2). Meanwhile, the Flesch-Kincaid Grade Level ranged between 6.5 and 17.6, with a mean of 12.1 (SD 2.8). In terms of quality, only 2 websites were HONcode certified, and the Quality Evaluation Scoring Tool score of the websites ranged between 7 and 20, with a mean of 15.3 (SD 3.1). Half of the websites (25/50) did not present a publication date or date of the last update. Regarding the duration of protection offered by the vaccines, 46% (23/50) of the websites stated that they do not know, and another 40% (20/50) did not address it. Five side effects of the vaccinations were most frequently mentioned, namely, fever/chill (41/50, 82%), various injection site discomfort events (eg, swelling, redness, or pain; 39/50, 78%), headache (36/50, 72%), fatigue (33/50, 66%), and muscle/joint pain (31/50, 62%). CONCLUSIONS: In general, the content quality of most of the evaluated websites was good, but HONcode certification should be considered, content should be written in a more readable manner, and a publication date or date of the last update should be presented.


Subject(s)
COVID-19 Vaccines , COVID-19 , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Comprehension , Humans , Reading , Vaccination
6.
JAMA Intern Med ; 182(3): 332-341, 2022 Mar 01.
Article in English | MEDLINE | ID: covidwho-1661563

ABSTRACT

IMPORTANCE: The US Food and Drug Administration (FDA) authorized SARS-CoV-2 rapid at-home self-test kits for individuals with and without symptoms. How appropriately users interpret and act on the results of at-home COVID-19 self-tests is unknown. OBJECTIVE: To assess how users of at-home COVID-19 self-test kits interpret and act on results when given instructions authorized by the FDA, instructions based on decision science principles, or no instructions. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial was conducted of 360 adults in the US who were recruited in April 2021 to complete an online survey on their interpretation of at-home COVID-19 self-test results. Participants were given 1 of 3 instruction types and were presented with 1 of 4 risk scenarios. Participants were paid $5 and had a median survey completion time of 8.7 minutes. Data analyses were performed from June to July 2021. INTERVENTION: Participants were randomized to receiving either the FDA-authorized instructions (authorized), the intervention instructions (intervention), or no instructions (control), and to 1 of 4 scenarios: 3 with a high pretest probability of infection (COVID-19 symptoms and/or a close contact with COVID-19) and 1 with low pretest probability (no symptoms and no contact). The intervention instructions were designed using decision science principles. MAIN OUTCOMES AND MEASURES: Proportion of participants in the high pretest probability scenarios choosing to quarantine per federal recommendations and perceived probabilities of infection given a negative or positive COVID-19 test result. A Bonferroni correction accounted for multiple comparisons (3 instruction types × 4 scenarios; α = 0.004). RESULTS: After excluding 22 individuals who completed the survey too quickly, the responses of 338 participants (median [IQR] age, 38 [31 to 48] years; 154 (46%) women; 215 (64%) with a college degree or higher) were included in the study analysis. Given a positive test result, 95% (322 of 338; 95% CI, 0.92 to 0.97) of the total participants appropriately chose to quarantine regardless of which instructions they had received. Given a negative test result, participants in the high pretest probability scenarios were more likely to fail to quarantine appropriately with the authorized instructions (33%) than with the intervention (14%; 95% CI for the 19% difference, 6% to 31%; P = .004) or control (24%; 95% CI for the 9% difference, -4% to 23%; P = .02). In the low pretest probability scenario, the proportion choosing unnecessary quarantine was higher with the authorized instructions (31%) than with the intervention (22%; 95% CI for the 9% difference, -14% to 31%) or control (10%; 95% CI for the 21% difference, 0.5% to 41%)-neither comparison was statistically significant (P = .05 and P = .20 respectively). CONCLUSIONS AND RELEVANCE: The findings of this randomized clinical trial indicate that at-home COVID-19 self-test kit users relying on the authorized instructions may not follow the Centers for Disease Control and Prevention's quarantine recommendations, producing unintended risks and unnecessary disruptions. Redesigned instructions that follow decision science principles may improve compliance. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04758299.


Subject(s)
COVID-19 Testing/methods , COVID-19/diagnosis , Comprehension , Self-Testing , Adult , Female , Humans , Male , Middle Aged , Quarantine , United States , United States Food and Drug Administration
7.
Pediatr Rheumatol Online J ; 19(1): 158, 2021 Nov 08.
Article in English | MEDLINE | ID: covidwho-1506686

ABSTRACT

INTRODUCTION: Juvenile idiopathic arthritis (JIA) is the leading chronic rheumatic disease in childhood. To achieve adherence to therapy, in-depth understanding of disease and treatment options are important. OBJECTIVE: Development of specifically designed illustrations and standardised, easy-to-read texts for children and adolescents with JIA. Education materials were tested for comprehensibility and content validity. We hypothesised that children would be able to increase their knowledge about JIA after presentation of materials. METHODS: The illustrations were designed by a graphic artist and the informative texts consecutively transformed to easy-to-read language. The materials appear as a modular system to allow individualized information for each patient. The illustrations and texts were tested for knowledge gain and improvement of self-efficacy in children affected by JIA/ rheumatic diseases and controls. Health-related quality of life (HRQoL) was tested as an overall assessment of patients' well-being. RESULTS: 46 controls (71% female) and 38 patients (48% female) with a median age of 11 years were tested in a standardised setting. In both groups knowledge gain was significant (controls: t (44) = 11.08, p < 0.001, d = 1.65; patients: t (37) = 7.48, p < 0.001, d = 1.21). The control group had a significantly higher enhancement of disease knowledge compared to patients' group (p = .046) The follow-up testing was only performed in one school class (20 controls) due to Covid-19 pandemic with significant improvement compared to the pre-test results (p = .002). The enhancement of self-efficacy through the teaching session was significantly higher in the patients' group. No impairment of HRQoL was seen. CONCLUSION: Explaining juvenile rheumatic diseases and therapeutic strategies is an important task in paediatric rheumatology. To avoid incomprehensible explanations in medical jargon, illustrations and easy-to-read texts were developed. Standardised presentation of the newly created materials resulted in a significant improvement of disease knowledge in patients and controls in addition to an enhancement of self-efficacy in patients.


Subject(s)
Arthritis, Juvenile/therapy , Health Knowledge, Attitudes, Practice , Patient Compliance , Patient Education as Topic/methods , Adolescent , Art , Child , Comprehension , Female , Humans , Male
8.
J Speech Lang Hear Res ; 64(3): 1008-1022, 2021 03 17.
Article in English | MEDLINE | ID: covidwho-1454832

ABSTRACT

Aim The aim of this scoping review is to identify the eye tracking paradigms and eye movement measures used to investigate auditory and reading comprehension deficits in persons with aphasia (PWA). Method MEDLINE via PubMed, Cochrane, CINAHL, Embase, PsycINFO, OTseeker, Scopus, Google Scholar, Grey Literature Database, and ProQuest Search (Dissertations & Theses) were searched for relevant studies. The Covidence software was used to manage the initial and full-text screening process for the search. Results and Discussion From a total of 1,803 studies, 68 studies were included for full-text screening. In addition, 418 records from gray literature were also screened. After full-text screening, 16 studies were included for this review-12 studies for auditory comprehension in PWA and four studies for reading comprehension in PWA. The review highlights the use of common eye tracking paradigms used to study language comprehension in PWA. We also discusse eye movement measures and how they help in assessing auditory and reading comprehension. Methodological challenges of using eye tracking are discussed. Conclusion The studies summarized in this scoping review provide evidence that the eye tracking methods are beneficial for studying auditory and reading comprehension in PWA.


Subject(s)
Aphasia , Comprehension , Eye Movements , Eye-Tracking Technology , Humans
10.
Hist Philos Life Sci ; 43(4): 107, 2021 Sep 21.
Article in English | MEDLINE | ID: covidwho-1427456

ABSTRACT

COVID-19 has substantially affected our lives during 2020. Since its beginning, several epidemiological models have been developed to investigate the specific dynamics of the disease. Early COVID-19 epidemiological models were purely statistical, based on a curve-fitting approach, and did not include causal knowledge about the disease. Yet, these models had predictive capacity; thus they were used to ground important political decisions, in virtue of the understanding of the dynamics of the pandemic that they offered. This raises a philosophical question about how purely statistical models can yield understanding, and if so, what the relationship between prediction and understanding in these models is. Drawing on the model that was developed by the Institute of Health Metrics and Evaluation, we argue that early epidemiological models yielded a modality of understanding that we call descriptive understanding, which contrasts with the so-called explanatory understanding which is assumed to be the main form of scientific understanding. We spell out the exact details of how descriptive understanding works, and efficiently yields understanding of the phenomena. Finally, we vindicate the necessity of studying other modalities of understanding that go beyond the conventionally assumed explanatory understanding.


Subject(s)
COVID-19/epidemiology , Comprehension , Models, Statistical , Humans , SARS-CoV-2
13.
Br J Educ Psychol ; 92(1): 258-279, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1324979

ABSTRACT

BACKGROUND: Online multiple-text comprehension is a key skill of the 21st Century, yet the study of its relations with boredom in young students has been disregarded. Boredom is an achievement emotion expected to be predicted negatively by antecedents like control and value appraisals and to be associated to a negative performance. Notwithstanding its documented domain-specificity, scarce attention has been paid to investigating these relations with primary-school students in the reading domain, and specifically for online multiple-text comprehension, and to how such relations are moderated by basic cognitive abilities. AIMS: Considering separately two settings (homework, test), we studied the mediation of boredom in the relation between control-value appraisals and online multiple-text comprehension in primary-school students, focusing on the moderating role of word-reading fluency. SAMPLE: Participants were 334 fourth and fifth graders. METHODS: We evaluated students' reading-related self-efficacy and task-value, reading-related boredom for homework and tests, word-reading fluency, and online multiple-text comprehension. RESULTS: Path analyses revealed negative relations between control-value appraisals and boredom for homework and tests, and between boredom and online multiple-text comprehension for tests only. For the latter, word-reading fluency moderated the relation between appraisals, boredom, and comprehension: Boredom negatively related to comprehension only for students with high word-reading fluency. CONCLUSIONS: Findings are discussed focusing on antecedents of online multiple-text comprehension as a literacy skill critical in the 21st Century. We underlined their implications for learning in general and specifically for the current educational changes due to the COVID-19 pandemic.


Subject(s)
COVID-19 , Reading , Boredom , Comprehension , Humans , Pandemics , SARS-CoV-2 , Schools
14.
Patient Educ Couns ; 105(2): 331-338, 2022 02.
Article in English | MEDLINE | ID: covidwho-1251451

ABSTRACT

OBJECTIVE: Vaccine hesitancy is a problem attracting growing attention and concern. Communication can be an effective tool to counteract vaccine hesitancy and promote optimal vaccine uptake. Readability has been recognized as one of the more important aspects of health communication for achieving good health literacy. We reviewed studies of readability assessment in the area of vaccine communication. METHODS: We conducted a systematic literature search in September 2020, using four online databases (Medline, CINAHL, PsycArticles, and PsycINFO). We included studies that assessed the readability level of online and offline vaccine information materials. RESULTS: We found 12 articles that were appropriate for inclusion. Ten of the studies were published after 2016. The readability levels of the majority of the materials assessed were found to be difficult and higher than 8th-grade level. CONCLUSION: Readability assessments of vaccine information are scarce. The limited evidence shows that the readability level of vaccine information supplied by health care providers is more difficult to read than recommended. More studies on the readability of vaccine information are recommended. PRACTICE IMPLICATIONS: Difficulty reading vaccine information may influence attitudes toward acceptance of or hesitancy to take vaccines. It is recommended that health care professionals use guidelines and tools to create easy-to-read vaccine information.


Subject(s)
Health Communication , Health Literacy , Vaccines , Comprehension , Humans , Internet
15.
J Biomed Inform ; 120: 103861, 2021 08.
Article in English | MEDLINE | ID: covidwho-1293913

ABSTRACT

The current intensive research on potential remedies and vaccinations for COVID-19 would greatly benefit from an ontology of standardized COVID terms. The Coronavirus Infectious Disease Ontology (CIDO) is the largest among several COVID ontologies, and it keeps growing, but it is still a medium sized ontology. Sophisticated CIDO users, who need more than searching for a specific concept, require orientation and comprehension of CIDO. In previous research, we designed a summarization network called "partial-area taxonomy" to support comprehension of ontologies. The partial-area taxonomy for CIDO is of smaller magnitude than CIDO, but is still too large for comprehension. We present here the "weighted aggregate taxonomy" of CIDO, designed to provide compact views at various granularities of our partial-area taxonomy (and the CIDO ontology). Such a compact view provides a "big picture" of the content of an ontology. In previous work, in the visualization patterns used for partial-area taxonomies, the nodes were arranged in levels according to the numbers of relationships of their concepts. Applying this visualization pattern to CIDO's weighted aggregate taxonomy resulted in an overly long and narrow layout that does not support orientation and comprehension since the names of nodes are barely readable. Thus, we introduce in this paper an innovative visualization of the weighted aggregate taxonomy for better orientation and comprehension of CIDO (and other ontologies). A measure for the efficiency of a layout is introduced and is used to demonstrate the advantage of the new layout over the previous one. With this new visualization, the user can "see the forest for the trees" of the ontology. Benefits of this visualization in highlighting insights into CIDO's content are provided. Generality of the new layout is demonstrated.


Subject(s)
Biological Ontologies , COVID-19 , Communicable Diseases , Comprehension , Humans , SARS-CoV-2
16.
Br J Gen Pract ; 71(707): 254, 2021 06.
Article in English | MEDLINE | ID: covidwho-1278523
17.
Mayo Clin Proc ; 96(8): 2095-2101, 2021 08.
Article in English | MEDLINE | ID: covidwho-1253365

ABSTRACT

OBJECTIVE: To assess the readability of the informed consent forms from the phase 3 COVID-19 vaccine trials conducted in the United States. PATIENTS AND METHODS: English 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. RESULTS: Owing 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.


Subject(s)
COVID-19 Vaccines , Comprehension , Consumer Health Information , Health Literacy , Informed Consent , Clinical Trials, Phase III as Topic , Humans , United States
18.
J Clin Pharm Ther ; 46(6): 1498-1500, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1247224

ABSTRACT

WHAT IS KNOWN AND OBJECTIVE: Preparation of patient-facing materials of a complex topic, such as describing new vaccines for COVID-19, is difficult to accomplish. This study examined the readability of patient information leaflets accompanying approved COVID-19 vaccines. COMMENT: Readability of patient-facing literature by the medicines regulator in the United States and the United Kingdom describing the recently US (FDA) and UK (MHRA) COVID-19 approved vaccines (Pfizer/BioNTech, AstraZeneca, Moderna) was assessed employing 10 metrics. Analyses showed that showed that this material had a Flesch Ease of Reading score of 53.5 and 54, respectively and a Flesch-Kincaid reading age of between 7th and 8th Grade (12-13 year olds) and between 8th and 9th Grade (13-14 year olds), respectively. When compared to a recent study on COVID-19 information on healthcare websites, the vaccine literature readability was favourable. WHAT IS NEW & CONCLUSION: Adoption of readability calculators and scrutiny of materials of their readability will help authors develop materials with improved understanding for COVID-19 vaccine recipients, carers and family, potentially leading to improved health literacy and vaccine uptake.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Health Literacy/methods , Health Literacy/statistics & numerical data , Pamphlets , Patient Acceptance of Health Care/statistics & numerical data , Comprehension , Humans , SARS-CoV-2
19.
BMC Public Health ; 21(1): 892, 2021 05 10.
Article in English | MEDLINE | ID: covidwho-1223768

ABSTRACT

BACKGROUND: In the COVID-19 pandemic, it is imperative that people understand and comply with self-isolation guidelines. We tested whether a simplified version of the guidelines and a simplified version with visual aids would affect comprehension and intention to self-isolate during the containment phase of the pandemic in the UK, in March 2020, compared to the standard guidelines. METHODS: We conducted an online, three-armed parallel randomized controlled trial. Participants were English and over 18. The survey software randomized them into conditions; they were blind to condition. The control group read the 7-page standard guidelines (the current version at the time of the trial). The intervention groups were given either a 3-page simplified version, with a summary box on the front page and numbered bullet points, or the same simplified version with pictograms illustrating the points in the box. Primary outcomes were comprehension of the guidelines, as measured by the number of correct answers given to six questions about the content, and the proportion who answered that they would 'definitely' stay at home for 7 days if symptomatic. FINDINGS: Recruitment was from 13 to 16 March 2020, with 1845 participants randomised and all data analysed. The Control group averaged 4.27 correct answers, the Simplified 4.20, and the Simplified + visual aids 4.13, out of a possible total of 6 correct answers. There were no differences in comprehension in the unadjusted models; however, when the model was adjusted for demographic variables, there was lower comprehension in the simplified + visual aids condition than in the control, (ß = - 0.16, p = 0.04998). There were no statistically significant differences in intention to stay home: Control was 85%, Simplified 83%, and Simplified + visual aids condition 84%. CONCLUSION: Simplified guidance did not improve comprehension compared to the standard guidance issued in the containment phase of the COVID-19 pandemic in March 2020, and simplified guidance with visual aids may even have worsened comprehension. Simplified guidance had no effect on intention to stay home if symptomatic. This trial informed COVID-19 policy and provides insights relevant to guidance production in the acute phase of a major public health emergency.


Subject(s)
COVID-19 , Pandemics , Comprehension , Humans , Intention , SARS-CoV-2 , Treatment Outcome
20.
JAMA Netw Open ; 4(4): e2110843, 2021 04 01.
Article in English | MEDLINE | ID: covidwho-1204592

ABSTRACT

Importance: Informed consent is a fundamental element of research ethics. The COVID-19 vaccine trials are high profile trials that have enrolled more than 100 000 participants. Consent documents must be succinct and understandable to ensure informed voluntary participation. Objective: To assess how well informed consent documents of the COVID-19 vaccine trials achieve the ideal of being succinct and understandable, and to create a shorter, more readable document. Design, Setting, and Participants: This quality improvement study collected and analyzed the informed consent documents used in 4 COVID-19 vaccine phase III randomized clinical trials to quantitatively assess readability and length and, based on this analysis, created a measurably more accessible informed consent document. Analysis was conducted from October 2020 to January 2021. Main Outcomes and Measures: The main outcomes were number of words (measured as word count), time-to-read (measured at reading speeds of 175-300 words per minute), language complexity (measured using Flesch-Kincaid Grade Level assessment), and readability (measured using Flesch Reading Ease Score). Secondary outcomes included clarity of how the placebo group could access the vaccine if it is proven safe and effective. The study also examined the length and readability of an improved consent document. Results: The 4 informed consent documents were a mean (range) of 8333 (7821 to 9340) words long, with a mean (range) 35 (32.6 to 38.9) minutes to read at 240 words per minute. All documents exceeded grade 9 language complexity and scored lower than 60 in the formal reading ease metric, which constitutes difficult. Only 1 document specified that participants in the placebo group might receive vaccine. It was possible to write a document in fewer than 3000 words with a grade 7 to 8 reading level and a formal readability score that was not difficult. Conclusions and Relevance: These findings suggest that existing COVID-19 vaccine informed consent documents were too long, difficult to read, and exceeded grade 9 in language complexity. It was possible to create a shorter, more readable informed consent document for these trials.


Subject(s)
COVID-19 Vaccines , COVID-19/prevention & control , Clinical Trials as Topic/methods , Comprehension , Consent Forms/standards , Informed Consent , Language , Clinical Trials, Phase III as Topic , Humans , Randomized Controlled Trials as Topic , Reading , SARS-CoV-2
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