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Background: Randomised controlled trials are widely established as the best method for testing health interventions whilst minimising bias. However, recruitment and subsequent retention of children and adolescents in healthcare trials is challenging. Participant information sheets are often lengthy and difficult to read and understand. Presenting key information using multimedia may help to overcome these limitations and better support young people and their parents in deciding whether to participate in a clinical trial.Methods: The TRECA (TRials Engagement in Children and Adolescents) study has two phases. The first phase involves a qualitative study with children and adolescents and their parents to inform the development of multimedia information resources and iterative user testing to refine the resources. The second phase will embed the use of the multimedia information resources into six host trials in the United Kingdom. Patients and parents approached to participate in the host trials will be randomly allocated to either use the multimedia information resource in conjunction with standard participant information sheets, the multimedia information resource alone, or the standard participant information sheets alone. The primary outcome will be the effect of the multimedia information resources on recruitment into trials. Other outcomes measured include the effect of multimedia information resources on retention of participants into the host trials and the impact on family members' decision-making processes, when compared to standard participant information sheets alone.Discussion: This study will inform whether multimedia information resources, when developed using participatory design principles, are able to increase recruitment and retention of children and adolescents into trials. There is also the potential for patients to make better informed decisions through the use of multimedia information resources. The multimedia information resources also have the potential to assist with providing information on other healthcare decisions outside of clinical trials.Trial Registration: ISRCTN registry: ISRCTN73136092 (doi: 10.1186/ISRCTN73136092 ). Registered on 24 August 2016. [ABSTRACT FROM AUTHOR]

Background: The study evaluated European Medicines Agency (EMA) recommendations on communicating frequency information on side‐effect risk. Methods: The study used a 2 × 2 factorial trial, with random allocation of information about 10 side‐effects of paclitaxel (Taxol) expressed using one of four formats. Recruitment was via the CancerHelpUK website. Information was conveyed using numerical frequency bands (e.g. ‘may affect up to 1 in 10 people’) or combined verbal terms and numerical bands (e.g. ‘common: may affect up to 1 in 10 people’); in addition, the risk qualifier verb was manipulated, with risks expressed either as ‘will affect…’ or ‘may affect…’. Participants then made six side‐effect frequency estimates indicated their satisfaction with the information and evaluated the side‐effects: how bad; how likely; how risky to health; and their influence on taking paclitaxel. Results: The sample comprised 339 people, of whom 37.5% had cancer. The combined verbal and numerical risk expressions resulted in higher estimates of side‐effects, four of which reached statistical significance (P < 0.05), and participants also said that side‐effects would be more likely. Use of ‘may affect’ or ‘will affect’ did not result in differences in any estimates. Conclusions: This is the first evaluation of the full range of combined verbal and numerical risk expressions recommended in EMA guidance; it demonstrates that they can lead to significant risk overestimations when compared to numerical frequency bands alone. The EMA should consider revising its guidance. Government agencies and professional bodies should be cautious about recommendations for risk communication in the absence of empirical evidence. [ABSTRACT FROM AUTHOR]

The article presents the research that explores on the perspectives of African Americans and ethnic minority patients on the self-management of diabetes in Great Britain. The topics discussed include the barriers they experienced in managing their ailments and the importance of their insights in improving the healthcare services and policies.

Purpose: This study implemented performance-based usability and literature testing to determine whether people could use 2 instruction booklets for hearing aids (HAs) to carry out basic maintenance tasks and find and understand key facts. Method: Using a cross-sectional study design, researchers recruited 40 participants (25 women, 15 men, ages 46-72 years) with no experience of HAs or audiology services to test instruction booklets for a Danalogic and Unitron HA (20 participants each). Participants were asked to follow instructions provided within the booklets to complete common HA tasks (e.g., cleaning the HA and mold and changing the battery) and demonstrate understanding of information. Participants' views of the booklets were then obtained within a short individual interview. Results: Participants experienced problems in completing all tasks while following instructions provided by the Danalogic and Unitron booklets. Individual interviews highlighted further issues regarding layout, diagrams, and content, including missing information. Conclusions: Some HA instruction booklets contain information that some users may find difficult to find, understand, and follow. These limitations may negatively impact on HA satisfaction and use. It is recommended that written information for clients be evaluated prior to use. This study supports the premise that performance-based usability and literature testing are appropriate methods to use. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effectiveness of presenting medicine side effect risk information in different forms, including that proposed by UK guidelines [ Medicines and Healthcare products Regulatory Agency. Always read the leaflet—Getting the best information with every medicine. (Report of the Committee on Safety of Medicines Working Group on Patient Information). London: The Stationery Office, 2005.]. Methods: 134 Cancer Research UK (CRUK) website users were recruited via a ‘pop-up’. Using a 2×2 factorial design, participants were randomly allocated to one of four conditions and asked to: imagine they had to take tamoxifen, estimate the risks of 4 side effects, and indicate a presentation mode preference. Results: Those presented with absolute frequencies demonstrated greater accuracy in estimating 2 of 4 side effects, and of any side effect occurring, than those presented with frequency bands. Those presented with combined descriptors were more accurate at estimating the risk of pulmonary embolism than those presented with numeric descriptors only. Conclusion: Absolute frequencies outperform frequency bands when presenting side effect risk information. However, presenting such exact frequencies for every side effect may be much less digestible than all side effects listed under 5 frequency bands. Combined numerical and verbal descriptors may be better than numeric only descriptors when describing infrequent side effects. Practice implications: Information about side effects should be presented in ways that patients prefer, and which result in most accurate risk estimates. [Copyright &y& Elsevier]

Objective: To evaluate the quality of patient information leaflets provided with dispensed medications in the United States, United Kingdom, and Australia. Design: Quantitative survey by an expert panel. Setting: United States, United Kingdom, and Australia. Participants: Not applicable. Intervention: Patient information leaflets for atenolol, glyburide (glibenclamide), atorvastatin, and nitroglycerin (glyceryl trinitrate) from the United States, United Kingdom, and Australia. Main Outcome Measures: Leaflets were evaluated against U.S. consensus criteria for both clinical information and general criteria, including the design of the leaflets. Results: Leaflets from Australia received a mean overall score of 90% (range 83%-94%) adherence with criteria, those from the United Kingdom a score of 81% (range 73%-84%), and those from the United States a score of 68% (range 65%-77%). The U.S. leaflets achieved 50% or less adherence for contraindication and precaution information. Omissions included warnings about preexisting allergy and illness and information about drug interactions. The U.S. leaflets also scored poorly (60%) for legibility and comprehensibility. The lower U.K. score reflected shortcomings in information about how to use and monitor the medications (46% adherence) and on adverse drug reactions (64%), largely due to the lack of clear advice about urgency of action in relation to adverse drug reactions. Conclusion: Leaflet quality varied more among the three countries than within each country, reflecting the regulatory context. The Australian leaflets performed well across all criteria, whereas the U.S. leaflets had significant shortcomings with the omission of vital information for the safe and effective use of the medications. A repeat survey is needed to assess whether new legislation and guidance in all three countries successfully addresses the shortcomings identified. [ABSTRACT FROM AUTHOR]

Objective  To review research on the role and value of written medicines information for patients from the perspective of patients and health professionals. Context  Providing written information to patients about their medicines is acknowledged as a priority but there is poor understanding of how best to meet patients’ needs. Method  A sensitive search strategy was developed to maximize the identification of relevant studies. We used a data extraction form designed to appraise qualitative research. Findings were synthesized into a narrative account. Main results  There were three broad categories of study: those which related to policy initiatives; those where the aim was to increase compliance; and those concerned with using information to support decision-making (‘informed patient’ studies). While the policy initiative and compliance studies reported that, mostly, patients were positive about written information, the ‘informed patient’ studies showed a more complex picture. Patients valued medicines information tailored to their condition. They did not want it to be a substitute for spoken information from their doctor. Not everyone wanted written information but those who did wanted sufficient detail to meet their need. Need varied over time and between patients. The small number of studies relating to health professionals showed widespread ambivalence towards using written information. Some thought it should be brief and simple, only partially disclose side-effects and saw its main role as being to increase compliance. Conclusion  The different perspectives of patients and health professionals, and the diverse and changing information needs of patients pose a challenge to providers of written medicines information. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To compare the themes emerging from a stakeholder workshop on consumers’ medicines information with themes in relevant published reviews. Methods: A stakeholder workshop was held to permit consumer orientation of a systematic review of consumer medicines information. Analysis of the workshop outputs was compared to a content analysis of the identified published reviews. Results: The workshop generated a range of responses inductively grouped into 12 over-arching themes. No reviews tackled all of these themes, nor addressed ‘informed choice and autonomy’. More recent reviews reflected more workshop themes than older ones, suggesting a temporal trend towards a greater sensitivity to consumer issues. The most common workshop themes were covered by all reviews. Six themes in the reviews were related to traditional professional concerns including compliance, which did not arise in the workshop. Conclusion: The results highlight a mismatch between the themes in previous published reviews and the themes emerging from the workshop. The most commonly reflected themes in reviews conform to the ‘patient education’ model of discourse, while workshop themes less often echoed in reviews reflect the discourse of ‘patient empowerment’. Practice Implications: The findings suggest the importance of involving patients in the development of patient literature from the outset. [Copyright &y& Elsevier]

Patients want and need comprehensive and accurate information about their medicines so that they can participate in decisions about their healthcare. In particular, they require information about the likely risks and benefits that are associated with the different treatment options. However, to provide this information in a form that people can readily understand and use is a considerable challenge to healthcare professionals. One recent attempt to standardise the language of risk has been to produce sets of verbal descriptors that correspond to specific probability ranges, such as those outlined in the European Commission (EC) Pharmaceutical Committee guidelines in 1998 for describing the incidence of adverse effects. This paper provides an overview of a number of studies involving members of the general public, patients, and hospital doctors, that evaluated the utility of the EC guideline descriptors (very common, common, uncommon, rare, very rare). In all studies it was found that people significantly over-estimated the likelihood of adverse effects occurring, given specific verbal descriptors. This in turn resulted in significantly higher ratings of their perceived risks to health and significantly lower ratings of their likelihood of taking the medicine. Such problems of interpretation are not restricted to the EC guideline descriptors. Similar levels of misinterpretation have also been demonstrated with two other recently advocated risk scales (Calman's verbal descriptor scale and Barclay, Costigan and Davies' lottery scale). In conclusion, the challenge for risk communicators and for future research will be to produce a language of risk that is sufficiently flexible to take into account different perspectives, as well as changing circumstances and contexts of illness and its treatments. In the meantime, we urge the EC and other legislative bodies to stop recommending the use of specific verbal labels or phrases until there is a stronger evidence base to support their use. [ABSTRACT FROM AUTHOR]

People with chronic illness are being encouraged to become more involved in their care. For this, they need to be well informed about their medicines, and more written medicines information is becoming available. However, there is little data about its effectiveness and impact. This study examined the patient perspective of medicines information through focus groups of people with asthma. Most participants actively sought medicines information from a variety of professional and lay sources. There were some positive experiences but many examples of partial or total information failure. Individualised information was valued and medicine leaflets were generally seen as less helpful than face-to-face advice. Some felt strongly that patients with long experience should be involved in the development of medicine information leaflets. We conclude that medicine information leaflets do not currently meet the needs of users and that people who take medicines should be involved in their development and testing. [Copyright &y& Elsevier]

Objective: To systematically identify, synthesise and evaluate the strength of the international evidence on copy letter practice.Methods: A systematic search identified original research studies on copy letters. Searches were limited by date and language as permitted in rapid review methods guidance. Article screening, data extraction and strength of evidence assessment were completed independently by multiple authors.Results: Thirty-seven studies were included. There was a lack of information about copy letter content. Many patients report being satisfied with copy letters, understand them and find them useful. However, there is a lack of objective, high quality evidence to suggest that copy letters increased patient understanding or improved physical or psychological health outcomes. Many letters were written at a level which would make them inaccessible to patients with low health literacy. The strength of evidence was either "emerging" or "acceptable" practice for most studies (n = 30).Conclusion: There is a lack of objective, high quality evidence to demonstrate the benefits of copy letters as described in health policy.Practice Implications: Personalising letters and using lay rather than medical terms appears to be useful for improving copy letter readability. Further research is required to explore this, especially in people with low health literacy levels. [ABSTRACT FROM AUTHOR]