A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines.

OBJECTIVES: To establish the role and value of written information available to patients about individual medicines from the perspective of patients, carers and professionals. To determine how effective this information is in improving patients' knowledge and understanding of treatment and health outcomes. DATA SOURCES: Electronic databases searched to late 2004, experts in information design, and stakeholder workshops (including patients and patient organisations). REVIEW METHODS: Data from selected studies were tabulated and the results were qualitatively synthesised along with findings from the information design and stakeholder workshop strands. RESULTS: Most people do not value the written information they receive. They had concerns about the use of complex language and poor visual presentation and in most cases the research showed that the information did not increase knowledge. The research showed that patients valued written information that was tailored to their individual circumstances and illness, and that contained a balance of harm and benefit information. Most patients wanted to know about any adverse effects that could arise. Patients require information to help decision-making about whether to take a medicine or not and (once taking a medicine) with ongoing decisions about the management of the medicine and interpreting symptoms. Patients did not want written information to be a substitute for spoken information from their prescriber. While not everyone wanted written information, those who did wanted sufficient detail to meet their need. Some health professionals thought that written information for patients should be brief and simple, with concerns about providing side-effect information. They saw increasing compliance as a prime function, in contrast to patients who saw an informed decision not to take a medicine as an acceptable outcome. CONCLUSIONS: The combination of a quantitative and qualitative review, an exploration of best practice in information design, plus the input of patients at stakeholder workshops, allowed this review to look at all perspectives. There is a gap between currently provided leaflets and information which patients would value and find more useful. The challenge is to develop methods of provision flexible enough to allow uptake of varying amounts and types of information, depending on needs at different times in an illness. This review has identified a number of areas where future research could be improved in terms of the robustness of its design and conduct, and the use of patient-focused outcomes. The scope for this research includes determining the content, delivery and layout of statutory leaflets that best meet patients' needs, and providing individualised information, which includes both benefit and harm information. In particular, studies of the effectiveness and role and value of Internet-based medicines information are needed.

Hypoglycaemia induced by exogenous insulin--'human' and animal insulin compared.

AIMS: A systematic review of the literature was carried out to examine whether published evidence suggests a difference in the frequency and awareness of hypoglycaemia induced by 'human' and animal insulin. METHODS: The review identified randomized controlled trials and studies of other designs including observational comparisons, case series and case reports in which the use of 'human' insulin was compared to animal insulin in people with diabetes. These were identified from bibliographic databases and hand-searches of key journals. The main outcome measures were frequency, severity, awareness and symptoms of insulin induced hypoglycaemia. RESULTS: Fifty-two randomized controlled trials, 37 of double-blind design, were identified which included one or more of the relevant outcome measures. Of these, 21 specifically investigated hypoglycaemic frequency and awareness as primary outcomes (six in people with previously reported reduced hypoglycaemic awareness). The remainder of the identified trials reported hypoglycaemic outcomes as a secondary or incidental outcome during comparative investigations of efficacy or immunogenicity. Seven of the double-blind studies reported differences in frequency of hypoglycaemia or awareness of symptoms, although none of the studies which selected subjects on the basis of previously reported impaired awareness demonstrated significant differences between insulin species. Four of the unblinded trials reported differences in hypoglycaemia. This reached statistical significance in two of the studies. A further 56 studies of other designs and case reports were considered. In addition to the 10 case reports describing individuals with impaired hypoglycaemic awareness, nine studies reported differences in the incidence and manifestation of hypoglycaemia during 'human' insulin treatment. Notably, none of the four population time trend studies found any relationship between the increasing use of 'human' insulin and hospital admission for hypoglycaemia or unexplained death among those with diabetes. The largest case series could find no support for the hypothesis that an influence of treatment with 'human' insulin on hypoglycaemia had contributed to any of the 50 deaths investigated. When all types of studies considered are ranked in order of rigour (according to the accepted 'hierarchy of evidence'), it is the least rigorous which lend most support to the notion that treatment with 'human' insulin has an effect on the frequency, severity or symptoms of hypoglycaemia. CONCLUSIONS: Evidence does not support the contention that treatment with 'human' insulin per se affects the frequency, severity or symptoms of hypoglycaemia. However, a number of studies, mainly those of less rigorous design, describe an effect when people are transferred from animal insulin to 'human' insulin. It is not possible to state how common this is or whether the phenomenon is specific to 'human' insulin or an effect resulting from stricter glycaemic control (perhaps compounded, in some cases, by neurological complications in long-standing diabetes). This remaining uncertainty makes it essential that insulin from animal sources continues to be available so that clinicians and patients may retain this choice of treatment.