An Analysis of the Readability of Patient Information and Consent forms used in Research Studies in Anaesthesia in Australia and New Zealand

Taylor, H.; Bramley, David E.

doi:10.1177/0310057x1204000610

Cited by 29 publications

(33 citation statements)

References 15 publications

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“…This text was then pasted in its entirety into the automated readability tool. The online utility tool [30] used for English text analysis was extensively used to measure English readability in several Anglophone countries [21,31-33] and provided scores for each of the following reliable and validated readability formulae: the Fog Index, the Simplified Measure of Gobbledygook (SMOG), and the Flesch Kincaid Grade level [34-36]. These formulae calculate the grade level necessary to understand content based on the characteristics of text such as number of syllables per word and number of words per sentence; higher scores reflect lower readability.…”

Section: Methodsmentioning

confidence: 99%

Online Health Information Regarding Male Infertility: An Evaluation of Readability, Suitability, and Quality

Robins¹,

Barr²,

Idelson³

et al. 2016

Interact J Med Res

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BackgroundMany men lack knowledge about male infertility, and this may have consequences for their reproductive and general health. Men may prefer to seek health information online, but these sources of information vary in quality.ObjectiveThe objective of this study is to determine if online sources of information regarding male infertility are readable, suitable, and of appropriate quality for Internet users in the general population.MethodsThis study used a cross-sectional design to evaluate online sources resulting from search engine queries. The following categories of websites were considered: (1) Canadian fertility clinics, (2) North American organizations related to fertility, and (3) the first 20 results of Google searches using the terms “male infertility” and “male fertility preservation” set to the search locations worldwide, English Canada, and French Canada. Websites that met inclusion criteria (N=85) were assessed using readability indices, the Suitability Assessment of Materials (SAM), and the DISCERN tool. The associations between website affiliation (government, university/medical, non-profit organization, commercial/corporate, private practice) and Google placement to readability, suitability, and quality were also examined.ResultsNone of the sampled websites met recommended levels of readability. Across all websites, the mean SAM score for suitability was 45.37% (SD 11.21), or “adequate”, while the DISCERN mean score for quality was 43.19 (SD 10.46) or “fair”. Websites that placed higher in Google obtained a higher overall score for quality with an r (58) value of -.328 and a P value of .012, but this position was not related to readability or suitability. In addition, 20% of fertility clinic websites did not include fertility information for men.ConclusionsThere is a lack of high quality online sources of information on male fertility. Many websites target their information to women, or fail to meet established readability criteria for the general population. Since men may prefer to seek health information online, it is important that health care professionals develop high quality sources of information on male fertility for the general population.

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Section: Methodsmentioning

confidence: 99%

Online Health Information Regarding Male Infertility: An Evaluation of Readability, Suitability, and Quality

Robins¹,

Barr²,

Idelson³

et al. 2016

Interact J Med Res

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“…Frequently, both the informed consent document (ICD) and the patient information sheet are excessively long documents that are difficult to read and understand. 50 , 51 Because of this, ~30% of participants are unaware of basic aspects of the research, such as the existence of random assignment, the possibility that they will be assigned to placebo, the fact that adverse effects could occur during the study, and even the availability of an insurance policy. 52 , 53 …”

Section: Adequate Information About the Studymentioning

confidence: 99%

Patient involvement in clinical research: why, when, and how

Sacristán¹,

Aguarón²,

Avendaño-Solá³

et al. 2016

PPA

290

252

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The development of a patient-centered approach to medicine is gradually allowing more patients to be involved in their own medical decisions. However, this change is not happening at the same rate in clinical research, where research generally continues to be carried out on patients, but not with patients. This work describes the why, when, and how of more active patient participation in the research process. Specific measures are proposed to improve patient involvement in 1) setting priorities, 2) study leadership and design, 3) improved access to clinical trials, 4) preparation and oversight of the information provided to participants, 5) post-study evaluation of the patient experience, and 6) the dissemination and application of results. In order to achieve these aims, the relative emphases on the ethical principles underlying research need to be changed. The current model based on the principle of beneficence must be left behind, and one that upholds the ethical principles of autonomy and non maleficence should be embraced. There is a need to improve the level of information that patients and society as a whole have on research objectives and processes; the goal is to promote the gradual emergence of the expert patient.

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“…Today, three forms of research in informed consent are moving forward to improve informed consent communications. First, readability studies of informed consent forms in both clinical care (Terranova et al 2012) and research on humans (Taylor and Bramley 2012) have resurged to improve communication through printed forms. Second, interactive web-based programs that include home-based learning, audiovisual options, and interactive quizzes to improve patient and participant understanding are being studied in clinical care (Gautschi et al 2010) and research on humans (Leclercq et al 2013;Rowbotham et al 2013).…”

Section: Court-based Standards Of Consent and Informed Consentmentioning

confidence: 99%

Informed Consent in the Twenty‐First Century: What It Is, What It Isn't, and Future Challenges in Informed Consent and Shared Decision Making

Mazur

2013

Sociology Compass

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Consent evolved from judge-made law in Great Britain in 1767. The term informed consent entered the judicial lexicon in 1957. The first court case to articulate a reasonable person standard adopted by the high courts in Canada and Australia was heard in the U.S. in 1972. Today, informed consent continues to develop in four areas: (i) the court-based doctrines of consent and informed consent in clinical care in judge-made law; (ii) federal regulations related to research on human study participants; (iii) shared decision making adopted by care organizations and medical societies in the US, Canada, and Europe; and (iv) areas including decision analysis, discourse analysis, ethics, linguistic analysis, patient-physician communication, risk and evidence communication, and social theory.In this paper, we will focus on consent and informed consent in the first part of the twenty-first century. We will examine a range of information and decision making frameworks from the oldest court-established frameworks of consent and informed consent to recent conceptions of information and decision making in evidence-based decision making and shared decision making in the patient-physician relationship. This paper is divided into three parts: I. What informed consent is, II. What informed consent isn't, and III. Future challenges in informed consent and shared decision making.

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An Analysis of the Readability of Patient Information and Consent forms used in Research Studies in Anaesthesia in Australia and New Zealand

Cited by 29 publications

References 15 publications

Online Health Information Regarding Male Infertility: An Evaluation of Readability, Suitability, and Quality

Online Health Information Regarding Male Infertility: An Evaluation of Readability, Suitability, and Quality

Patient involvement in clinical research: why, when, and how

Informed Consent in the Twenty‐First Century: What It Is, What It Isn't, and Future Challenges in Informed Consent and Shared Decision Making

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