The benefits of providing benefit information in a patient information leaflet

Objective: To examine the effects of providing two different types of written information about medicine benefits in a patient information leaflet (PIL). Setting: Participants were 358 adult volunteers from the general population recruited from a London railway station and central Reading. Method: The study used a controlled empirical methodology in which people were given a hypothetical, but realistic, scenario about visiting their doctor and being prescribed medication. They then read an information leaflet about the medicine that contained neither, one, or both benefit statements, and finally completed a number of Likert rating scales. Outcome measures included perceived satisfaction and helpfulness of the information, effectiveness and appropriateness of the medicine, benefit and risk to health, and intention to comply. Key findings: Both types of benefit information led to significantly higher ratings on all of the measures taken. Conclusions: Provision of a relatively short ‘benefit’ statement can significantly improve people’s judgements and intention to take a medicine. The findings are important and timely as the European Union is currently considering reviewing their regulations to allow for the inclusion of limited non-promotional benefit information in PILs.

Health-related quality of life in Huntington’s Disease patients: a comparison of proxy assessment and patient self-rating using the disease-specific Huntington’s Disease health-related quality of life questionnaire (HDQoL)

Huntington’s disease (HD) is a fatal, neurodegenerative disease for which there is no known cure. Proxy evaluation is relevant for HD as its manifestation might limit the ability of persons to report their health-related quality of life (HrQoL). This study explored patient–proxy ratings of HrQoL of persons at different stages of HD, and examined factors that may affect proxy ratings. A total of 105 patient–proxy pairs completed the Huntington’s disease health-related quality of life questionnaire (HDQoL) and other established HrQoL measures (EQ-5D and SF-12v2). Proxy–patient agreement was assessed in terms of absolute level (mean ratings) and intraclass correlation. Proxies’ ratings were at a similar level to patients’ self-ratings on an overall Summary Score and on most of the six Specific Scales of the HDQoL. On the Specific Hopes and Worries Scale, proxies on average rated HrQoL as better than patients’ self-ratings, while on both the Specific Cognitive Scale and Specific Physical and Functional Scale proxies tended to rate HrQoL more poorly than patients themselves. The patient’s disease stage and mental wellbeing (SF-12 Mental Component scale) were the two factors that primarily affected proxy assessment. Proxy scores were strongly correlated with patients’ self-ratings of HrQoL, on the Summary Scale and all Specific Scales. The patient–proxy correlation was lower for patients at moderate stages of HD compared to patients at early and advanced stages. The proxy report version of the HDQoL is a useful complementary tool to self-assessment, and a promising alternative when individual patients with advanced HD are unable to self-report.

Cognitive behaviour therapy (CBT) for depression by computer vs. therapist: patient experiences and therapeutic processes

This case series compares patient experiences and therapeutic processes between two modalities of cognitive behaviour therapy (CBT) for depression: computerized CBT (cCBT) and therapist-delivered CBT (tCBT). In a mixed-methods repeated-measures case series, six participants were offered cCBT and tCBT in sequence, with the order of delivery randomized across participants. Questionnaires about patient experiences were administered after each session and a semi-structured interview was completed with each participant at the end of each therapy modality. Therapy expectations, patient experiences and session impact ratings in this study generally favoured tCBT. Participants typically experienced cCBT sessions as less meaningful, less positive and less helpful compared to tCBT sessions in terms of developing understanding, facilitating problem-solving and building a therapeutic relationship.

Evaluating explanations about drug prescriptions: effects of varying the nature of information about side effects and its relative position in explanations

This study evaluates computer-generated written explanations about drug prescriptions that are based on an analysis of both patient and doctor informational needs. Three experiments examine the effects of varying the type of information given about the possible side effects of the medication, and the order of information within the explanation. Experiment 1 investigated the effects of these two factors on people's ratings of how good they consider the explanations to be and of their perceived likelihood of taking the medication, as well as on their memory for the information in the explanation. Experiment 2 further examined the effects of varying information about side effects by separating out the contribution of number and severity of side effects. It was found that participants in this study did not “like” explanations that described severe side effects, and also judged that they would be less likely to take the medication if given such explanations. Experiment 3 therefore investigated whether information about severe side effects could be presented in such a way as to increase judgements of how good explanations are thought to be, as well as the perceived likelihood of adherence. The results showed some benefits of providing additional explanatory information.

What do patients want to know about their medicines, and what do doctors want to tell them?: a comparative study

A two phase study is reported. In the first phase, we asked a number of doctors to rate a list of information categories (identified by Berry, Gillie and Banbury 1995) in terms of how important they felt it was for the items to be included in an explanation to a patient about a drug prescription. In the second phase, we presented a large sample of people with a scenario about visiting their doctor and being prescribed medication, together with an explanation about the prescription which was said to be provided by the doctor. Four different explanations were compared, which were either based on what people in our earlier study wanted to know about drug prescriptions or on what the doctors thought it was important lo tell them. We also manipulated whether or not the explanations conveyed negative information (e.g. about the possible side effects of the medication). The results showed that people 'preferred' the explanations based on what the participants in the earlier study wanted to know about their medicines, rather than those based on what the doctors thought they should be told. They also 'preferred' the explanations that did not convey negative information, rather than those that did convey some negative information. In addition, the inclusion of negative information affected ratings of likely compliance with the prescribed medication.

How was patient empowerment portrayed in information leaflets describing the community pharmacy Medicines Use Review service in the UK?

Objective The Medicines Use Review (MUR) community pharmacy service was introduced in 2005 to enhance patient empowerment but the service has not been taken up as widely as expected. We investigated the depiction of the patient–pharmacist power relationship within MUR patient information leaflets. Methods We identified 11 MUR leaflets including the official Department of Health MUR booklet and through discourse analysis examined the way language and imagery had been used to symbolise and give meaning to the MUR service, especially the portrayal of the patient–pharmacist interactions and the implied power relations. Results A variety of terminology was used to describe the MUR, a service that aimed ultimately to produce more informed patients through the information imparted by knowledgeable, skilled pharmacists. Conclusion The educational role of the MUR overshadowed the intended patient empowerment that would take place with a true concordance-centred approach. Although patient empowerment was implied, this was within the boundaries of the biomedical model with the pharmacist as the expert provider of medicines information. Practice implications If patient empowerment is to be conveyed this needs to be communicated to patients through consistent use of language and imagery that portrays the inclusivity intended.

What is the new medicines use review ‘patient survey’ attempting to capture in the context of existing patient satisfaction with pharmacy questionnaires and a new conceptual framework?

The community pharmacy service medicines use review (MUR) was introduced in 2005 ‘to improve patient knowledge, concordance and use of medicines’ through a private patient–pharmacist consultation. The MUR presents a fundamental change in community pharmacy service provision. While traditionally pharmacists are dispensers of medicines and providers of medicines advice, and patients as recipients, the MUR considers pharmacists providing consultation-type activities and patients as active participants. The MUR facilitates a two-way discussion about medicines use. Traditional patient–pharmacist behaviours transform into a new set of behaviours involving the booking of appointments, consultation processes and form completion, and the physical environment of the patient–pharmacist interaction moves from the traditional setting of the dispensary and medicines counter to a private consultation room. Thus, the new service challenges traditional identities and behaviours of the patient and the pharmacist as well as the environment in which the interaction takes place. In 2008, the UK government concluded there is at present too much emphasis on the quantity of MURs rather than on their quality.[1] A number of plans to remedy the perceived imbalance included a suggestion to reward ‘health outcomes’ achieved, with calls for a more focussed and scientific approach to the evaluation of pharmacy services using outcomes research. Specifically, the UK government set out the main principal research areas for the evaluation of pharmacy services to include ‘patient and public perceptions and satisfaction’as well as ‘impact on care and outcomes’. A limited number of ‘patient satisfaction with pharmacy services’ type questionnaires are available, of varying quality, measuring dimensions relating to pharmacists’ technical competence, behavioural impressions and general satisfaction. For example, an often cited paper by Larson[2] uses two factors to measure satisfaction, namely ‘friendly explanation’ and ‘managing therapy’; the factors are highly interrelated and the questions somewhat awkwardly phrased, but more importantly, we believe the questionnaire excludes some specific domains unique to the MUR. By conducting patient interviews with recent MUR recipients, we have been working to identify relevant concepts and develop a conceptual framework to inform item development for a Patient Reported Outcome Measure questionnaire bespoke to the MUR. We note with interest the recent launch of a multidisciplinary audit template by the Royal Pharmaceutical Society of Great Britain (RPSGB) in an attempt to review the effectiveness of MURs and improve their quality.[3] This template includes an MUR ‘patient survey’. We will discuss this ‘patient survey’ in light of our work and existing patient satisfaction with pharmacy questionnaires, outlining a new conceptual framework as a basis for measuring patient satisfaction with the MUR. Ethical approval for the study was obtained from the NHS Surrey Research Ethics Committee on 2 June 2008. References 1. Department of Health (2008). Pharmacy in England: Building on Strengths – Delivering the Future. London: HMSO. www. official-documents.gov.uk/document/cm73/7341/7341.pdf (accessed 29 September 2009). 2. Larson LN et al. Patient satisfaction with pharmaceutical care: update of a validated instrument. JAmPharmAssoc 2002; 42: 44–50. 3. Royal Pharmaceutical Society of Great Britain (2009). Pharmacy Medicines Use Review – Patient Audit. London: RPSGB. http:// qi4pd.org.uk/index.php/Medicines-Use-Review-Patient-Audit. html (accessed 29 September 2009).

Donepezil for the symptomatic treatment of patients with mild to moderate Alzheimer's disease: a meta-analysis of individual patient data from randomised controlled trials

Background: The objective was to evaluate the efficacy and tolerability of donepezil (5 and 10 mg/day) compared with placebo in alleviating manifestations of mild to moderate Alzheimer's disease (AD). Method: A systematic review of individual patient data from Phase II and III double-blind, randomised, placebo-controlled studies of up to 24 weeks and completed by 20 December 1999. The main outcome measures were the ADAS-cog, the CIBIC-plus, and reports of adverse events. Results: A total of 2376 patients from ten trials were randomised to either donepezil 5 mg/day (n = 821), 10 mg/day (n = 662) or placebo (n = 893). Cognitive performance was better in patients receiving donepezil than in patients receiving placebo. At 12 weeks the differences in ADAS-cog scores were 5 mg/day-placebo: - 2.1 [95% confidence interval (CI), - 2.6 to - 1.6; p < 0.001], 10 mg/day-placebo: - 2.5 ( - 3.1 to - 2.0; p < 0.001). The corresponding results at 24 weeks were - 2.0 ( - 2.7 to - 1.3; p < 0.001) and - 3.1 ( - 3.9 to - 2.4; p < 0.001). The difference between the 5 and 10 mg/day doses was significant at 24 weeks (p = 0.005). The odds ratios (OR) of improvement on the CIBIC-plus at 12 weeks were: 5 mg/day-placebo 1.8 (1.5 to 2.1; p < 0.001), 10 mg/day-placebo 1.9 (1.5 to 2.4; p < 0.001). The corresponding values at 24 weeks were 1.9 (1.5 to 2.4; p = 0.001) and 2.1 (1.6 to 2.8; p < 0.001). Donepezil was well tolerated; adverse events were cholinergic in nature and generally of mild severity and brief in duration. Conclusion: Donepezil (5 and 10 mg/day) provides meaningful benefits in alleviating deficits in cognitive and clinician-rated global function in AD patients relative to placebo. Increased improvements in cognition were indicated for the higher dose. Copyright © 2004 John Wiley & Sons, Ltd.

Meta-analysis of individual patient data from randomised trials: a review of methods used in practice

Background: Meta-analyses based on individual patient data (IPD) are regarded as the gold standard for systematic reviews. However, the methods used for analysing and presenting results from IPD meta-analyses have received little discussion. Methods We review 44 IPD meta-analyses published during the years 1999–2001. We summarize whether they obtained all the data they sought, what types of approaches were used in the analysis, including assumptions of common or random effects, and how they examined the effects of covariates. Results: Twenty-four out of 44 analyses focused on time-to-event outcomes, and most analyses (28) estimated treatment effects within each trial and then combined the results assuming a common treatment effect across trials. Three analyses failed to stratify by trial, analysing the data is if they came from a single mega-trial. Only nine analyses used random effects methods. Covariate-treatment interactions were generally investigated by subgrouping patients. Seven of the meta-analyses included data from less than 80% of the randomized patients sought, but did not address the resulting potential biases. Conclusions: Although IPD meta-analyses have many advantages in assessing the effects of health care, there are several aspects that could be further developed to make fuller use of the potential of these time-consuming projects. In particular, IPD could be used to more fully investigate the influence of covariates on heterogeneity of treatment effects, both within and between trials. The impact of heterogeneity, or use of random effects, are seldom discussed. There is thus considerable scope for enhancing the methods of analysis and presentation of IPD meta-analysis.

A score test for binary data with patient non-compliance

A score test is developed for binary clinical trial data, which incorporates patient non-compliance while respecting randomization. It is assumed in this paper that compliance is all-or-nothing, in the sense that a patient either accepts all of the treatment assigned as specified in the protocol, or none of it. Direct analytic comparisons of the adjusted test statistic for both the score test and the likelihood ratio test are made with the corresponding test statistics that adhere to the intention-to-treat principle. It is shown that no gain in power is possible over the intention-to-treat analysis, by adjusting for patient non-compliance. Sample size formulae are derived and simulation studies are used to demonstrate that the sample size approximation holds. Copyright © 2003 John Wiley & Sons, Ltd.

Drivers' ratings of different components of their own driving skill: a greater illusion of superiority for skills that relate to accident involvement

Different components of driving skill relate to accident involvement in different ways. For instance, while hazard-perception skill has been found to predict accident involvement, vehicle-control skill has not. We found that drivers rated themselves superior to both their peers and the average driver on 18 components of driving skill (N = 181 respondents). These biases were greater for hazard-perception skills than for either vehicle-control skills or driving skill in general. Also, ratings of hazard-perception skill related to self-perceived safety after overall skill was controlled for. We suggest that although drivers appear to appreciate the role of hazard perception in safe driving, any safety benefit to be derived from this appreciation may be undermined by drivers' inflated opinions of their own hazard-perception skill. We also tested the relationship between illusory beliefs about driving skill and risk taking and looked at ways of manipulating drivers' illusory beliefs.

Health informatics: improving patient-centred healthcare pathway

Nowadays the use of information and communication technology is becoming prevalent in many aspects of healthcare services from patient registration, to consultation, treatment and pathology tests request. Manual interface techniques have dominated data-capture activities in primary care and secondary care settings for decades. Despites the improvements made in IT, usability issues still remain over the use of I/O devices like the computer keyboard, touch-sensitive screens, light pen and barcodes. Furthermore, clinicians have to use several computer applications when providing healthcare services to patients. One of the problems faced by medical professionals is the lack of data integrity between the different software applications which in turn can hinder the provision of healthcare services tailored to the needs of the patients. The use of digital pen and paper technology integrated with legacy medical systems hold the promise of improving healthcare quality. This paper discusses the issue of data integrity in e-health systems and proposes the modelling of "Smart Forms" via semiotics to potentially improve integrity between legacy systems, making the work of medical professionals easier and improve the quality of care in primary care practices and hospitals.