Co-designing an intervention to improve the process of deprescribing for older people living with frailty in the United Kingdom.

BACKGROUND: In older people living with frailty, polypharmacy can lead to preventable harm like adverse drug reactions and hospitalization. Deprescribing is a strategy to reduce problematic polypharmacy. All stakeholders should be actively involved in developing a person-centred deprescribing process that involves shared decision-making. OBJECTIVE: To co-design an intervention, supported by a logic model, to increase the engagement of older people living with frailty in the process of deprescribing. DESIGN: Experience-based co-design is an approach to service improvement, which uses service users and providers to identify problems and design solutions. This was used to create a person-centred intervention with the potential to improve the quality and outcomes of the deprescribing process. A 'trigger film' showing older people talking about their healthcare experiences was created and facilitated discussions about current problems in the deprescribing process. Problems were then prioritized and appropriate solutions were developed. The review located the solutions in the context of current processes and procedures. An ideal care pathway and a complex intervention to deliver better care were developed. SETTING AND PARTICIPANTS: Older people living with frailty, their informal carers and professionals living and/or working in West Yorkshire, England, UK. Deprescribing was considered in the context of primary care. RESULTS: The current deprescribing process differed from an ideal pathway. A complex intervention containing seven elements was required to move towards the ideal pathway. Three of these elements were prototyped and four still need development. The complex intervention responded to priorities about (a) clarity for older people about what was happening at all stages in the deprescribing process and (b) the quality of one-to-one consultations. CONCLUSIONS: Priorities for improving the current deprescribing process were successfully identified. Solutions were developed and structured as a complex intervention. Further work is underway to (a) complete the prototyping of the intervention and (b) conduct feasibility testing. PATIENT OR PUBLIC CONTRIBUTION: Older people living with frailty (and their informal carers) have made a central contribution, as collaborators, to ensure that a complex intervention has the greatest possible potential to enhance the experience of deprescribing medicines.

Developing and user testing new pharmacy label formats-A study to inform labelling standards.

BACKGROUND: Dispensed prescription medicine labels (prescription labels) are important information sources supporting safe and appropriate medicines use. OBJECTIVE: To develop and user test patient-centred prescription label formats. METHODS: Five stages: developing 12 labels for four fictitious medicines of varying dosage forms; diagnostic user testing of labels (Round 1) with 40 consumers (each testing three labels); iterative label revision, and development of Round 2 labels (n = 7); user testing of labels (Round 2) with 20 consumers (each testing four labels); labelling recommendations. Evaluated labels stated the active ingredient and brand name, using various design features (eg upper case and bold). Dosing was expressed differently across labels: frequency of doses/day, approximate times of day (eg morning), explicit times (eg 7 to 9 AM), and/or explicit dosing interval. Participants' ability to find and understand medicines information and plan a dosing schedule were assessed. RESULTS: Participants demonstrated satisfactory ability to find and understand the dosage for all label formats. Excluding active ingredient and dosing schedule, 14/19 labels (8/12 in Round 1; 6/7 in Round 2) met industry standard on performance. Participants' ability to correctly identify the active ingredient varied, with clear medicine name sign-posting enabling all participants evaluating these labels to find and understand the active ingredient. When planning a dosing schedule, doses were correctly spaced if the label stated a dosing interval, or frequency of doses/day. Two-thirds planned appropriate dosing schedules using a dosing table. CONCLUSIONS: Effective prescription label formatting and sign-posting of active ingredient improved communication of information on labels, potentially supporting safe medicines use. PATIENT AND PUBLIC INVOLVEMENT: Consumers actively contributed to the development of dispensed prescription medicine labels. Feedback from consumers following the first round was incorporated in revisions of the labels for the next round. Patient and public involvement in this study was critical to the development of readable and understandable dispensed prescription medicine labels.

Experience-based co-design-Adapting the method for a researcher-initiated study in a multi-site setting.

BACKGROUND: Experience-based co-design (EBCD) brings patients and staff together to co-design services. It is normally conducted in one organization which initiates and implements the process. We used the traditional EBCD method with a number of adaptations as part of a larger research study in the British National Health Service. METHODS: The primary aim was to assess the feasibility and acceptability of conducting research-initiated EBCD, to enhance intervention development prior to testing. As well as embedding the method in a research study, there were 3 further key adaptations: (a) working across primary and secondary care sectors, (b) working on multiple sites and (c) incorporating theory-informed analysis. RESULTS: We recruited four sites (covering both primary and secondary care) and, on each site, conducted the initial traditional EBCD meetings, with separate staff and patient groups-followed by a single joint patient-staff event, where four priority areas for co-design were agreed. This event was driven by theory-informed analysis, as well as the traditional trigger film of patient experiences. Each site worked on one priority area, and the four co-design groups met over 2-3 months to design prototype tools. A second joint event was held (not usually undertaken in single-site EBCD) where they shared and compared outputs. The research team combined elements of these outputs to create an intervention, now being tested in a cluster randomized controlled trial. CONCLUSIONS: EBCD can be successfully adapted for use across an entire patient pathway with multiple organizations and as part of a research process to identify an intervention for subsequent testing in a randomized trial. Our pragmatic approach used the patient experience to identify areas for improvement and co-designed an intervention which directly reflected patient priorities.

Exploring consumer opinions on the presentation of side-effects information in Australian Consumer Medicine Information leaflets.

BACKGROUND: Consumer Medicine Information (CMI) is a brand-specific and standardized source of written medicine information available in Australia for all prescription medicines. Side-effect information is poorly presented in CMI and may not adequately address consumer information needs. OBJECTIVE: To explore consumer opinions on (i) the presentation of side-effect information in existing Australian CMI leaflets and alternative study-designed CMIs and (ii) side-effect risk information and its impact on treatment decision making. DESIGN: Fuzzy trace, affect heuristic, frequency hypothesis and cognitive-experiential theories were applied when revising existing CMI side-effects sections. Together with good information design, functional linguistics and medicine information expertise, alternative ramipril and clopidogrel CMI versions were proposed. Focus groups were then conducted to address the study objectives. PARTICIPANTS AND SETTING: Three focus groups (n = 18) were conducted in Sydney, Australia. Mean consumer age was 58 years (range 50-65 years), with equal number of males and females. RESULTS: All consumers preferred the alternative CMIs developed as part of the study, with unequivocal preference for the side-effects presented in a simple tabular format, as it allowed quick and easy access to information. Consumer misunderstandings reflected literacy and numeracy issues inherent in consumer risk appraisal. Many preferred no numerical information and a large proportion preferred natural frequencies. CONCLUSIONS: One single method of risk presentation in CMI is unable to cater for all consumers. Consumer misunderstandings are indicative of possible health literacy and numeracy factors that influence consumer risk appraisal, which should be explored further.

'It's all there in black and white' - or is it? Consumer perspectives on the proposed Australian Medicine Information Box over-the-counter label format.

BACKGROUND: Over-the-counter (OTC) labels help support safe medication use by consumers. In 2012, the Australian Therapeutic Goods Administration (TGA) released a consultation paper proposing OTC label standardization to improve label quality via implementation of the Medicine Information Box (MIB) label. However, consumer opinions of the MIB and standardization of OTC labelling remain unexplored. OBJECTIVE: To explore consumer perspectives of OTC label standardization and the proposed MIB. DESIGN: Mock MIB labels were developed by the research team, guided by the TGA consultation paper, and used as interview stimulus material. PARTICIPANTS AND SETTING: Semi-structured interviews were conducted with 38 Australian and 39 UK adult participants. Participant perspectives on OTC label standardization, opinions on the MIB and perceived improvements were explored. All interviews were audio-recorded with permission, transcribed verbatim, and the content thematically analysed. RESULTS: Participants expressed a range of opinions towards OTC label standardization, from welcoming standardization to concern that important details may be overlooked. The MIB was generally positively received due to its perceived good information design and ease of navigation. Participants requested reordering of information-specifically, for the active ingredient to be moved to a less prominent position. Suggested improvements centred on content and design changes, for example colour, pictograms, bolding. CONCLUSIONS: Participants felt positively towards OTC label standardization and saw the MIB as a feasible standardized format to implement for OTC labels. Although they appreciated its good information design, they felt further improvements to its content and design are required to enhance its quality and usability.

Beyond needs and expectations: identifying the barriers and facilitators to written medicine information provision and use in Australia.

PURPOSE: This study aimed to explore peoples' needs and expectations of written medicines information (WMI), and to determine the barriers and facilitators experienced or perceived in the context of WMI provision and use. METHODS: We conducted eight focus groups with 62 participants over 6 weeks in late 2008 in New South Wales, Australia. Using a semi-structured topic schedule and examples of WMI from Australia and other English-speaking countries as a guide, we explored themes relevant to WMI, including participant experiences, attitudes, beliefs and expectations. FINDINGS: Our findings suggest less than half had previously received WMI, with many unaware of its availability. Many, but not all, wanted WMI to supplement the spoken information they received but not to replace it, and it was predominantly used to facilitate informed choice, ascertain medicine suitability and review instructions. The current leaflets were considered technical and long, and a summary leaflet in addition to comprehensive information was favoured. Accurate side-effect information was the most important element that participants desired. The most common barriers to effective WMI use were time constraints and patient confidence, with participants citing empowerment, time and health-care professional (HCP)-patient relationships as important facilitators. CONCLUSION: The findings provide insight and understanding of peoples needs and expectations, and clarify issues associated with use and non-use of WMI. Challenges include addressing the barriers, especially of time and HCP attitudes to drive changes to workplace practices, and learning from the facilitating factors to encourage awareness and accessibility to WMI as a tool to empower patients.

Enhancing provision of written medicine information in Australia: pharmacist, general practitioner and consumer perceptions of the barriers and facilitators.

BACKGROUND: Written medicine information can play an important role in educating consumers about their medicines. In Australia, standardised, comprehensive written information known as Consumer Medicine Information (CMI) is available for all prescription medicines. CMI is reportedly under-utilised by general practitioners (GPs) and community pharmacists in consultations, despite consumer desire for medicine information. This study aimed to determine consumers', GPs' and community pharmacists' preferences for CMI provision and identify barriers and facilitators to its use. METHOD: Structured questionnaires were developed and administered to a national sample of Australian consumers (phone survey), community pharmacists and GPs (postal surveys) surrounding utilisation of CMI. Descriptive and comparative analyses were conducted. RESULTS: Half of consumers surveyed wanted to receive CMI for their prescription medicine, with spoken information preferable to written medicine information for many consumers and healthcare professionals. GPs and pharmacists remained a preferred source of medicine information for consumers, although package inserts were appealing to many among all three cohorts. Overall pharmacists were the preferred provider of CMI primarily due to their medicine expertise, accessibility and perceived availability. GPs preferred CMI dissemination through both the GP and pharmacist. Some consumers preferred GPs as the provider of medicines information because of their knowledge of the patients' medicines and/or medical history, regularity of seeing the patient and good relationship with the patient. Common barriers to CMI provision cited included: time constraints, CMI length and perceptions that patients are not interested in receiving CMI. Facilitators to enhance provision included: strategies to increase consumer awareness, longer consultation times and counseling appointments, and improvements to pharmacy software technology and workflow. CONCLUSION: Medicine information is important to consumers, whether as spoken, written or a combination of both. A tailored approach is needed to ascertain individual patient preference for delivery and scope of medicine information desired so that appropriate information is provided. The barriers of time and perceived attitudes of healthcare practitioners present challenges which may be overcome through changes to workplace practices, adoption of identified facilitators, and education about the positive benefits of CMI as a tool to engage and empower patients.

Interventions to optimise prescribing for older people in care homes.

BACKGROUND: There is a substantial body of evidence that prescribing for care home residents is suboptimal and requires improvement. Consequently, there is a need to identify effective interventions to optimise prescribing and resident outcomes in this context. OBJECTIVES: The objective of the review was to determine the effect of interventions to optimise prescribing for older people living in care homes. SEARCH METHODS: We searched the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register; Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library (Issue 11, 2012); Cochrane Database of Systematic Reviews, The Cochrane Library (Issue 11, 2012); MEDLINE OvidSP (1980 on); EMBASE, OvidSP (1980 on); Ageline, EBSCO (1966 on); CINAHL, EBSCO (1980 on); International Pharmaceutical Abstracts, OvidSP (1980 on); PsycINFO, OvidSP (1980 on); conference proceedings in Web of Science, Conference Proceedings Citation Index - SSH & Science, ISI Web of Knowledge (1990 on); grey literature sources and trial registries; and contacted authors of relevant studies. We also reviewed the references lists of included studies and related reviews (search period November 2012). SELECTION CRITERIA: We included randomised controlled trials evaluating interventions aimed at optimising prescribing for older people (aged 65 years or older) living in institutionalised care facilities. Studies were included if they measured one or more of the following primary outcomes, adverse drug events; hospital admissions;mortality; or secondary outcomes, quality of life (using validated instrument); medication-related problems; medication appropriateness (using validated instrument); medicine costs. DATA COLLECTION AND ANALYSIS: Two authors independently screened titles and abstracts, assessed studies for eligibility, assessed risk of bias and extracted data. A narrative summary of results was presented. MAIN RESULTS: The eight included studies involved 7653 residents in 262 (range 1 to 85) care homes in six countries. Six studies were cluster-randomised controlled trials and two studies were patient-randomised controlled trials. The interventions evaluated were diverse and often multifaceted. Medication review was a component of seven studies, three studies involved multidisciplinary case-conferencing, two studies involved an educational element for care home staff and one study evaluated the use of clinical decision support technology. Due to heterogeneity, results were not combined in a meta-analysis. There was no evidence of an effect of the interventions on any of the primary outcomes of the review (adverse drug events, hospital admissions and mortality). No studies measured quality of life. There was evidence that the interventions led to the identification and resolution of medication-related problems. There was evidence from two studies that medication appropriateness was improved. The evidence for an effect on medicine costs was equivocal. AUTHORS' CONCLUSIONS: Robust conclusions could not be drawn from the evidence due to variability in design, interventions, outcomes and results. The interventions implemented in the studies in this review led to the identification and resolution of medication-related problems, however evidence of an effect on resident-related outcomes was not found. There is a need for high-quality cluster-randomised controlled trials testing clinical decision support systems and multidisciplinary interventions that measure well-defined, important resident-related outcomes.

Balance appointment information leaflets: employing performance-based user-testing to improve understanding.

OBJECTIVE: To use performance-based user-testing to evaluate the effectiveness of balance appointment patient information leaflets (PILs) in conveying important information. DESIGN: The study used a sequential groups design. Twenty participants were asked to find and demonstrate understanding of 11 key points of information contained within two NHS leaflets, A and B (10 participants each), through individual structured-interviews. Participants' views of the leaflets were explored through a short semi-structured interview. Following analysis, a revised leaflet was developed and tested on a further 20 participants. STUDY SAMPLE: 40 participants (25F/15M, aged 46-72) with no experience of balance problems or balance assessment appointments. RESULTS: Participants exhibited difficulties with finding and/or understanding 5/11 and 6/11 points of information within leaflets A and B, respectively. Five out of eleven points of the revised leaflet also posed problems. Ten out of eleven points were understood by > 90% of participants testing the revised leaflet compared with 6/11 points for leaflets A and B. CONCLUSIONS: Some balance appointment PILs contain information which is difficult to find and/or understand for some readers. PILs should be evaluated prior to use using performance-based methods, since poor information provision may lead to increased patient anxiety and appointment non-attendance, cancellation, or postponement.

Person-centred deprescribing for patients living with frailty: a qualitative interview study and proposal of a collaborative model.

OBJECTIVES: (1) Present deprescribing experiences of patients living with frailty, their informal carers and healthcare professionals; (2) interpret whether their experiences are reflective of person-centred/collaborative care; (3) complement our findings with existing evidence to present a model for person-centred deprescribing for patients living with frailty, based on a previous collaborative care model. METHODS: Qualitative design in English primary care (general practice). Semi-structured interviews were undertaken immediately post-deprescribing and 5/6 weeks later with nine patients aged 65+ living with frailty and three informal carers of patients living with frailty. Fourteen primary care professionals with experience in deprescribing were also interviewed. In total, 38 interviews were conducted. A two-staged approach to data analysis was undertaken. KEY FINDINGS: Three themes were developed: attitudes, beliefs and understanding of medicines management and responsibility; attributes of a collaborative, person-centred deprescribing consultation; organisational factors to support person-centred deprescribing. Based on these findings and complementary to existing evidence, we offer a model for person-centred deprescribing for patients living with frailty. CONCLUSIONS: Previous models of deprescribing for patients living with frailty while, of value, do not consider the contextual factors that govern the implementation and success of models in practice. In this paper, we propose a novel person-centred model for deprescribing for people living with frailty, based on our own empirical findings, and the wider evidence base.

Prescribing and partnership with patients.

There have been widespread changes in society and the roles of professionals. This change is also reflected in health care, where there is now acceptance of the need to involve patients in decision making. In prescribing specifically, the concordance agenda was developed alongside these initiatives to encourage improved medication taking and reduce wastage. However the extent to which these partnerships are delivered in practice remains unclear. This paper explores some of the issues to be considered when preparing patients and professionals for partnership and summarizes the limited evidence of barriers to, and benefits of, this approach. Firstly patients must be given the confidence, skills and knowledge to be partners. They need information about medicines, provided in ways known to be acceptable to them. Likewise professionals may need new skills to be partners. They need to understand the patient agenda and may need training and support to change the ways in which they consult with patients. There are also practical issues such as the perceived increase in time taken when consulting in partnership mode, room layout, computer interfaces and record keeping. Health care professionals other than doctors are also expected to behave in partnership mode, whether this is as prescribers in their own right or in supporting the prescribing of others. Whilst much has been claimed for the benefit of partnership approaches, hard evidence is limited. However whilst there is still much more to understand there will be no going back to the paternalistic model of the mid 20th century.

Medication reviews.

Recent years have seen a formalization of medication review by pharmacists in all settings of care. This article describes the different types of medication review provided in primary care in the UK National Health Service (NHS), summarizes the evidence of effectiveness and considers how such reviews might develop in the future. Medication review is, at heart, a diagnostic intervention which aims to identify problems for action by the prescriber, the clinician conducting the review, the patient or all three but can also be regarded as an educational intervention to support patient knowledge and adherence. There is good evidence that medication review improves process outcomes of prescribing including reduced polypharmacy, use of more appropriate medicines formulation and more appropriate choice of medicine. When 'harder' outcome measures have been included, such as hospitalizations or mortality in elderly patients, available evidence indicates that whilst interventions could improve knowledge and adherence they did not reduce mortality or hospital admissions with one study showing an increase in hospital admissions. Robust health economic studies of medication reviews remain rare. However a review of cost-effectiveness analyses of medication reviews found no studies in which the cost of the intervention was greater than the benefit. The value of medication reviews is now generally accepted despite lack of robust research evidence consistently demonstrating cost or clinical effectiveness compared with traditional care. Medication reviews can be more effectively deployed in the future by targeting, multi-professional involvement and paying greater attention to medicines which could be safely stopped.

Barriers and facilitators of successful deprescribing as described by older patients living with frailty, their informal carers and clinicians: a qualitative interview study.

OBJECTIVE: To explore the barriers/facilitators to deprescribing in primary care in England from the perspectives of clinicians, patients living with frailty who reside at home, and their informal carers, drawing on the Theoretical Domains Framework to identify behavioural components associated with barriers/facilitators of the process. DESIGN: Exploratory qualitative study. SETTING: General practice (primary care) in England. PARTICIPANTS: 9 patients aged 65+ living with frailty who attended a consultation to reduce or stop a medicine/s. 3 informal carers of patients living with frailty. 14 primary care clinicians including general practitioners, practice pharmacists and advanced nurse practitioners. METHODS: Qualitative semistructured interviews took place with patients living with frailty, their informal carers and clinicians. Patients (n=9) and informal carers (n=3) were interviewed two times: immediately after deprescribing and 5/6 weeks later. Clinicians (n=14) were interviewed once. In total, 38 interviews were undertaken. Framework analysis was applied to manage and analyse the data. RESULTS: 6 themes associated with facilitators and barriers to deprescribing were generated, respectively, with each supported by between two and three subthemes. Identified facilitators of deprescribing with patients living with frailty included shared decision-making, gradual introduction of the topic, clear communication of the topic to the patient and multidisciplinary working. Identified barriers of deprescribing included consultation constraints, patients' fear of negative consequences and inaccessible terminology and information. CONCLUSIONS: This paper offers timely insight into the barriers and facilitators to deprescribing for patients living with frailty within the context of primary care in England. As deprescribing continues to grow in national and international significance, it is important that future deprescribing interventions acknowledge the current barriers and facilitators and their associated behavioural components experienced by clinicians, patients living with frailty and their informal carers to improve the safety and effectiveness of the process.

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

BACKGROUND: 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). METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Buyer beware? Does the information provided with herbal products available over the counter enable safe use?

BACKGROUND: Herbal products obtained over the counter are commonly used in Europe, North America and Australia. Although there is concern about a lack of information provided to consumers to allow the safe use of these products, there has been no published research to confirm these fears. In this study, we evaluated written information provided with commonly used herbal products in the UK in advance of a European Union Directive issued in April 2011 that tightened regulations for some herbal products, including requirements to provide safety information. METHODS: Five commonly used herbal products were purchased from pharmacies, health food shops and supermarkets: St John's wort, Asian ginseng, echinacea, garlic and ginkgo. Written information provided with the products (on the package or on a leaflet contained in the package) was evaluated for inclusion of each of the key safety messages included in the monographs of the US National Center for Complementary and Alternative Medicine. Specifically, we looked for information on precautions (such as Asian ginseng not being suitable for people with diabetes), interactions with conventional medicines (such as St John's wort with the contraceptive pill and warfarin) and side effects (such as ginkgo and allergic reactions). RESULTS: Our analysis showed that, overall, 51 (75%) of 68 products contained none of the key safety messages. This included 4 of 12 St John's wort products, 12 of 12 ginkgo products, 6 of 7 Asian ginseng products, 20 of 21 garlic products and 9 of 13 echinacea products. The two products purchased that are registered under the new European Union regulations (for St John's wort) contained at least 85% of the safety messages. CONCLUSIONS: Most of the herbal medicine products studied did not provide key safety information which consumers need for their safe use. The new European Union legislation should ensure that St John's wort and echinacea products will include the previously missing information in due course. The legislation does not apply to existing stock. Depending on therapeutic claims made by manufacturers, garlic, ginkgo and Asian ginseng products may not be covered by the legislation and can continue to be bought without the safety information. Also, consumers will still be able to buy products over the internet from locations outside European Union jurisdiction. Potential purchasers need to know, in both the short term and the long term, how to purchase herbal products which provide the information they need for the safe use of these products.

Using experience-based co-design with patients, carers and healthcare professionals to develop theory-based interventions for safer medicines use.

BACKGROUND: Experience-Based Co-Design (EBCD) is a participatory design method which was originally developed and is still primarily used as a healthcare quality improvement tool. Traditionally, EBCD has been sited within single services or settings and has yielded improvements grounded in the experiences of those delivering and receiving care. METHOD: In this article we present how EBCD can be adapted to develop complex interventions, underpinned by theory, to be tested more widely within the healthcare system as part of a multi-phase, multi-site research study. We begin with an outline of co-design and the stages of EBCD. We then provide an overview of how EBCD can be assimilated into an intervention development and evaluation study, giving examples of the adaptations and research tools and methods that can be deployed. We also suggest how to appraise the resulting intervention so it is realistic and tractable in multiple sites. We describe how EBCD can be combined with different behaviour change theories and methods for intervention development and finally, we make suggestions about the skills needed for successful intervention development using EBCD. CONCLUSION: EBCD has been recognised as being a collaborative approach to improving healthcare services that puts patients and healthcare staff at the heart of initiatives and potential changes. We have demonstrated how EBCD can be integrated into a research project and how existing research approaches can be assimilated into EBCD stages. We have also suggested where behaviour change theories can be used to better understand intervention change mechanisms.

Written medicine information from English-speaking countries--how does it compare?

BACKGROUND: There has been an increasing drive from consumers for more information to be available about their medicines. However, the layout and presentation of such written information is variable, and the poor format and design discourages people from reading the documents. OBJECTIVE: To identify, collate, and evaluate different formats of written medicine information (WMI). METHODS: Three researchers evaluated 157 samples of WMI for 10 prescription and 3 over-the-counter medicines from 6 English-speaking countries compared with the United States Keystone Consensus Criterion 8 (USKCC8) and the Ten Key Principles (TKP) of Consumer Medicine Information. Readability was measured using Flesch-Kincaid Grade Level (FKGL) and Fog tests. Compliance (%) with the criteria was computed and examined using the median test. RESULTS: Overall median compliance with USKCC8 was 70%, and 74% to TKP. New Zealand leaflets achieved the highest compliance with USKCC8 (83%, Interquartile range (IQR) 70-89%), with US leaflets the lowest (55%, IQR 45-70%). Australian and New Zealand leaflets showed the highest compliance with TKP (90%, IQR 80-100% and 87-97%, respectively), while UK leaflets demonstrated the lowest (60%, IQR 52-71%). Overall median reading grades for the leaflets were 10 (Flesch-Kincaid Grade Level) and 11 (Fog). CONCLUSIONS: Compliance with USKCC8 and TKP varied greatly between countries, with readability grades exceeding the recommended range. International examples of WMI show wide variation in compliance with guidelines on recommended format and presentation. These examples of WMI require high literacy to read. Future WMI development should use more recommended formats and increase comprehensibility.

Optimised patient information materials and recruitment to a study of behavioural activation in older adults: an embedded study within a trial.

Background: Printed participant information about randomised controlled trials is often long, technical and difficult to navigate. Improving information materials is possible through optimisation and user-testing, and may impact on participant understanding and rates of recruitment. Methods: A study within a trial (SWAT) was undertaken within the CASPER trial. Potential CASPER participants were randomised to receive either the standard trial information or revised information that had been optimised through information design and user testing. Results: A total of 11,531 patients were randomised in the SWAT. Rates of recruitment to the CASPER trial were 2.0% in the optimised information group and 1.9% in the standard information group (odds ratio 1.027; 95% CI 0.79 to 1.33; p=0.202). Conclusions: Participant information that had been optimised through information design and user testing did not result in any change to rate of recruitment to the host trial. Registration: ISRCTN ID ISRCTN02202951; registered on 3 June 2009.

Key principles to guide development of consumer medicine information--content analysis of information design texts.

BACKGROUND: Effective written consumer medicines information is essential to support safe and effective medicine taking, but the wording and layout of currently provided materials do not meet patients' needs. OBJECTIVE: To identify principles from the wider discipline of information design for use by health professionals when developing or assessing written drug information for patients. METHODS: Six experts in information design nominated texts on best practice in information design applicable to consumer medicines information. A content analysis identified key principles that were tabulated to bring out key themes. RESULTS: Six texts that met the inclusion criteria, were identified, and content analysis indentified 4 themes: words, type, lines, and layout. Within these main themes, there were 24 subthemes. Selected principles relating to these subthemes were: use short familiar words, short sentences, and short headings that stand out from the text; use a conversational tone of voice, addressing the reader as "you"; use a large type size while retaining sufficient white space; use bullet points to organize lists; use unjustified text (ragged right) and bold, lower-case text for emphasis. Pictures or graphics do not necessarily improve a document. CONCLUSIONS: Applying the good information design principles identified to written consumer medicines information could support health professionals when developing and assessing drug information for patients.

A questionnaire to measure health practitioners' attitudes to partnership in medicine taking: LATCon II.

OBJECTIVES: To revise and improve an existing scale to measure health practitioners' attitudes to partnership in medicine taking and to ascertain the views of medical students, nursing students and pre-registration pharmacists on concordance. BACKGROUND: The traditional model of the practitioner-patient interaction incorporates a practitioner-centred approach, focusing on the disease rather than the patient. The philosophy of 'concordance' (or 'partnership in medicine-taking') puts the patient at the centre of the interaction, with the patient interacting reciprocally with the practitioner. The Leeds Attitude to Concordance (LATCon) scale was developed in 2001 to assess practitioners' and patients' attitudes to concordance. However, thinking on concordance has developed since then and the present study aimed to revise the scale to ensure that it reflected current thinking and also to increase its reliability and validity. DESIGN: A pool of potential items was developed and sent to three subject experts for opinion. An attitudinal Likert scale of 31 items was developed. Its completion was followed by statistical item reduction to 20 items. The shorter scale was completed by the same participants 4-6 weeks later. SETTING AND PARTICIPANTS: The study was set in a university in the UK. Participants were 183 medical students, nursing students, and pre-registration pharmacists. RESULTS AND DISCUSSION: The study derived a 20 item scale, including five negatively-worded items, with good levels of internal and test-retest reliability. Factor analysis suggested five main factors. A statistically significant difference in attitudes was found between student nurses and medical students, and student nurses and pre-registration pharmacists, with student nurses being more in agreement with the concordant approach. Overall, participants were in agreement with the concordant approach to medicine taking. The UK National Health Service advocates partnership in medical care and is encouraging both practitioners and patients to work to introduce this. There is increased awareness of the patients' perspective by practitioners, but its impact on their practice remains unclear. Education and skills teaching must continue for the benefits of a concordant approach to be seen. The LATCon scale could play a useful role in education and training, and in research assessing the movement towards the new approach.