There has been a rising interest in wearable and implantable biomedical sensors over the last decade. However, many technologies have not been integrated into clinical care, due to a limited understanding of user-centered design issues. Little information is available about these issues and there is a need to adopt more rigorous evidence standards for design features to allow important medical sensors to progress quicker into clinical care. Current trends in patient preferences need to be incorporated at an early stage into the design process of prospective clinical sensors. The first comprehensive patient data set, discussing mobile biomedical sensor technology, is presented in this paper. The study population mainly consisted of individuals suffering from arthritis. It was found that sensor systems needed to be small, discreet, unobtrusive and preferably incorporated into everyday objects. The upper extremity was seen as the favored position on the body for placement, while invasive placement yielded high levels of acceptance. Under these conditions most users were willing to wear the body-worn sensor for more than 20 h a day. This study is a first step to generate research based user-orientated design criteria's for biomedical sensors.

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Wearable and implantable sensors: the patient's perspective.

The participant information sheet (PIS) provided to potential trial participants is a critical part of the process of valid consent. However, there is long-standing concern that these lengthy and complex documents are not fit-for-purpose. This has been supported recently through the application of a performance-based approach to testing and improving readability called user testing. This method is now widely used to improve patient medicine leaflets - determining whether people can find and understand key facts. This study applied for the first time a controlled design to determine whether a PIS developed through user testing had improved readability over the original, using a sheet from a UK trial in acute myeloid leukemia (AML16). In the first phase the performance of the original PIS was tested on people in the target group for the trial. There were three rounds of testing including 50 people in total - with the information revised according to its performance after each of the first 2 rounds. In the second phase, the revised PIS was compared with the original in a parallel groups randomised controlled trial (RCT) A total of 123 participants were recruited and randomly allocated to read one version of the PIS to find and show understanding of 21 key facts. The first, developmental phase produced a revised PIS significantly altered in its wording and layout. In the second, trial phase 66% of participants who read the revised PIS were able to show understanding of all aspects of the trial, compared with 15% of those reading the original version (Odds Ratio 11.2; Chi-square = 31.5 p < .001). When asked to state a preference, 87.1% participants chose the revised PIS (Sign test p < .001). The original PIS for the AML16 trial may not have enabled valid consent. Combining performance-based user testing with expertise in writing for patients and information design led to a significantly improved and preferred information sheet. User testing is an efficient method for indicating strengths and weaknesses in trial information, and Research Ethics Committees and Institutional Review Boards should consider requesting such testing, to ensure that PIS are fit-for-purpose.

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Can user testing of a clinical trial patient information sheet make it fit-for-purpose?--a randomized controlled trial.

Health literacy is associated with a person's capacity to find, access, contextualize, and understand information needed for health care-related decisions. The level of health literacy thus has an influence on an individual's health status. It can be argued that low health literacy is associated with poor health status. Health care literature (eg, pamphlets, brochures, postcards, posters, forms) are published by public and private organizations worldwide to provide information to the general public. The ability to read, use, and understand is critical to the successful application of knowledge disseminated by this literature. This study assessed the readability, suitability, and usability of health care literature associated with concussion and traumatic brain injury published by the United States Centers for Disease Control and Prevention. The Flesch-Kincaid Grade Level, Flesch Reading Ease, Gunning Fog, Simple Measure of Gobbledygook, and Suitability Assessment of Materials indices were used to assess 40 documents obtained from the Centers for Disease Control and Prevention website. The documents analyzed were targeted towards the general public. It was found that in order to be read properly, on average, these documents needed more than an eleventh grade/high school level education. This was consistent with the findings of other similar studies. However, the qualitative Suitability Assessment of Materials index showed that, on average, usability and suitability of these documents was superior. Hence, it was concluded that formatting, illustrations, layout, and graphics play a pivotal role in improving health care-related literature and, in turn, promoting health literacy. Based on the comprehensive literature review and assessment of the 40 documents associated with concussion and traumatic brain injury, recommendations have been made for improving the readability, suitability, and usability of health care-related documents. The recommendations are presented in the form of an incremental improvement process cycle and a list of dos and don'ts.

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Readability assessment of concussion and traumatic brain injury publications by Centers for Disease Control and Prevention

Background: Mental disorders such as depression, bipolar disorder, and schizophrenia are common, incapacitating, and have the potential to be fatal. Despite the prevalence and gravity of mental disorders, our knowledge concerning everyday challenges associated with them is relatively limited. One of the most studied deficits related to everyday challenges is language impairment, yet we do not know how mental disorders can impact common forms of written communication, for example, social media. Objective: The aims of this study were to investigate written communication challenges manifest in online mental health communities focusing on depression, bipolar disorder, and schizophrenia, as well as the impact of participating in these online mental health communities on written communication. As the control, we selected three online health communities focusing on positive emotion, exercising, and weight management. Methods: We examined lexical diversity and readability, both important features for measuring the quality of writing. We used four well-established readability metrics that consider word frequencies and syntactic complexity to measure writers’ written communication ability. We then measured the lexical diversity by calculating the percentage of unique words in posts. To compare lexical diversity and readability among communities, we first applied pairwise independent sample t tests, followed by P value adjustments using the prespecified Hommel procedure to adjust for multiple comparison. To measure the changes, we applied linear least squares regression to the readability and lexical diversity scores against the interaction sequence for each member, followed by pairwise independent sample t tests and P value adjustments. Given the large sample of members, we also report effect sizes and 95% CIs for the pairwise comparisons. Results: On average, members of depression, bipolar disorder, and schizophrenia communities showed indications of difficulty expressing their ideas compared with three other online health communities. Our results also suggest that participating in these platforms has the potential to improve members’ written communication. For example, members of all three mental health communities showed statistically significant improvement in both lexical diversity and readability compared with members of the OHC focusing on positive emotion. Conclusions: We provide new insights into the written communication challenges faced by individuals suffering from depression, bipolar disorder, and schizophrenia. A comparison with three other online health communities suggests that written communication in mental health communities is significantly more difficult to read, while also consisting of a significantly less diverse lexicon. We contribute practical suggestions for utilizing our findings in Web-based communication settings to enhance members’ communicative experience. We consider these findings to be an important step toward understanding and addressing everyday written communication challenges among individuals suffering from mental disorders.

Harnessing Reddit to Understand the Written-Communication Challenges Experienced by Individuals With Mental Health Disorders: Analysis of Texts From Mental Health Communities

Background The recent withdrawal of cerivastatin by the manufacturer has led to an interest in hydroxymethylglutaryl-coenzyme A (HMG-CoA) inhibitors and the incidence of myopathy. We review the epidemiology, pharmacology, and presumed mechanisms of statin-induced myopathy, with a particular focus on cerivastatin. Methods A MEDLINE search of English-language articles published between 1985 and 2003 was performed. Key words included HMG-CoA inhibitors, statins, myopathy, myotoxicity, rhabdomyolysis, adverse events, drug interactions, and cerivastatin. Results The initial trials, which assessed the efficacy of first-generation HMG-CoA inhibitors, did not show a clinically significant increase in the incidence of myopathy. However, on the basis of Food and Drug Administration post-marketing surveys, the rate of cerivastatin-induced rhabdomyolysis appeared to be 10-fold greater than that of the other statins, despite safe pre-clinical profiles. However, no clinical trials have been performed directly comparing the rates of myotoxicity of all commercially available statins. The mechanism of statin-induced myopathy remains unclear. The prevailing theory is that lipophilic statins lead to depletion of intermediates normally formed after cholesterol synthesis within myocytes. Risk factors for the development of myopathy include drug interactions (especially with fibrates) and the coexistence of conditions known to predispose patients to rhabdomyolysis. Conclusion The cerivastatin experience emphasizes the need for large safety trials before drug approval and for vigilant post-marketing surveillance. Further research and sound clinical judgment may lead to the identification of high-risk individuals in whom statins should be avoided.

Rhabdomyolysis associated with hydroxymethylglutaryl-coenzyme-a reductase inhibitors☆

Correspondence: Marli Terblanche Room 41, Department of Cardiology, 8th Floor, Tygerberg Hospital, Parow 7500, South Africa Tel +27 21 931 7825 Fax + 27 21 933 3597 Email marli@treadresearch.com Primary objective: To investigate the readability of informed consent forms (ICF) used at TREAD Research, a private clinical trial research unit located in Tygerberg Hospital. Secondary objective: To assess if there is a difference in readability between therapeutic areas, as well as a difference in readability over two time periods. Methods: The readability of 84 ICFs given to patients at TREAD Research between the years 2000 and 2009 was quantitatively assessed by means of the Flesch–Kincaid Reading Ease, Flesch–Kincaid Grade Level, and Gunning-Fog index. Results: The mean ± standard deviation (SD) Flesch–Kincaid Reading Ease score for the 84 ICFs was 46.60 ± 5.62 (range 33.2–65.6). The mean ± SD grade level was 12.13 ± 1.8 (range 8.3–14.9) using the Flesch–Kincaid formula and 13.96 ± 1.22 (range 10.3–16.6) using the Gunning-Fog index. Readability at grade level 8 was only found in 1.2% of all the ICFs assessed. No differences were found in readability between therapeutic areas or over the two time periods. Conclusions: The main finding is that these forms are too complex to be understood by average study participants and their families.

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Examining the readability of patient-informed consent forms

Lesley Jean Burgess Berna Gerber Kathleen Coetzee Marli Terblanche Gareth Agar Theunis JvW Kotze 1TREAD Research CC, Cardiology Unit, Department of Medicine, Stellenbosch University and Tygerberg Hospital, Parow, South Africa; 2University of Liverpool/Laureate Online Education, Liverpool, UK; 3Division of SpeechLanguage and Hearing Therapy, Faculty of Medicine and Health Sciences, Stellenbosch University Stellenbosch, South Africa Introduction: The informed consent process is a fundamental part of clinical trials and is driven by both a legal and ethical agenda. The process may be seriously compromised if trial participants sign the informed consent document without fully understanding its contents. In developing countries such as South Africa, this concern is important due to the potential vulnerability of these patients and their risk for research exploitation. Aim: To evaluate the understanding of 11 important components and concepts related to clinical research by adult trial participants in a developing country at the time of providing consent for trial participation. Methods: 46 consecutive adult patients who qualified and consented to being enrolled in ongoing cardiovascular risk clinical trials at TREAD Research in the Western Cape, South Africa, were included in this study. After giving informed consent, participants were subjected to both a close-ended (self-report) and an open-ended method (descriptive narrative) to assess their understanding of various components and concepts related to clinical research pertaining to the initial informed consent document. The descriptive narrative was recorded and then later transcribed and assessed by two independent assessors. Results: There was a marked difference between the two methodologies used to assess patient comprehension of the various components. With the exception of concepts voluntariness and right to withdraw, trial participants’ understanding of the informed consent document was poor – especially with regard to the following concepts: randomization, risks, placebo and blinding. Higher levels of comprehension were obtained for the participant selfreports and lower levels for the narrative descriptions. Conclusion: The participant comprehension at this site was poor, and the process for taking informed consent subsequently needs to be modified so as to improve informed consent comprehension.

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An evaluation of informed consent comprehension by adult trial participants in South Africa at the time of providing consent for clinical trial participation and a review of the literature

Correspondence: Marli Terblanche TReAD Research/Cardiology Unit, Department of internal Medicine, Tygerberg Hospital and Stellenbosch University, Parow, South Africa Tel +27 21 931 7825 Fax +27 21 933 3597 email marli@treadresearch.com Abstract: Numerous factors contribute to the declining pharmaceutical industry on the one hand and the rapidly growing generic industry together with the growing importance of medical devices and biologicals on the other. It is clear that the pharmaceutical industry is going to undergo a change in the next decade in order to meet the current challenges facing it and ultimately sustain its profitability and growth. This paper aims to identify a number of fairly obvious trends that are likely to have a significant impact on the product development pipeline in the next decade. It is more than clear that the current production pipeline for pharmaceutical, biotechnology and medical device industries is no longer sustainable and that urgent interventions are required in order to maintain its current level of profitability.

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The future of the pharmaceutical, biological and medical device industry

Africa is a continent of great diversity and consists of extremely poor and remote rural regions characterised by traditional existences, as well as highly industrialised cities populated with people following an urban westernised lifestyle. This has resulted in an interesting presentation of diseases involving the cardiovascular system. On the one hand, rheumatic heart disease, cardiomyopathy and tuberculous pericarditis remain prevalent and under-researched among the black African population, while on the other hand, cardiovascular disease and its associated risk factors are starting to emerge and currently account for 10% of all deaths. Clinical trials play a crucial role in raising public awareness and promoting good policy-making; however, the continent's research output is still small. Opportunities and challenges facing African researchers need to be identified in order to develop a strategic plan for the way forward.

Cardiovascular clinical trials in Africa : opportunities and challenges : cardiovascular clinical trials in Africa

https://www.journals.ac.za/index.php/SAHJ/article/download/1906/999

Marli Terblanche

Papers

Examining the readability of patient-informed consent forms

An evaluation of informed consent comprehension by adult trial participants in South Africa at the time of providing consent for clinical trial participation and a review of the literature

The future of the pharmaceutical, biological and medical device industry

Cardiovascular clinical trials in Africa : opportunities and challenges : cardiovascular clinical trials in Africa

Cardiovascular clinical trials in Africa: opportunities and challenges