340 research outputs found

    Impact of written drug information in patient package inserts: Acceptance and impact on benefit/risk perception

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    This thesis discusses the patient package insert (PPI), a folded sheet of paper in the drug package with a text which is supposed to be comprehensible for the general public. The PPI contains information on how the drug must be taken, on the risks of taking the drug, and a limited amount of information on whatthe drug is for. Belgium was the first country in Europe, together with Switzerland, to introduce PPIs. PPIs were first introduced in 1988 and the process was completed in 1992. In Europe, health authorities decided in 1992 that all medicinal product packages should contain a comprehensible insert. This decision is slowly but surely being implemented in all European countries. Similar developments did not take place in the US and other parts of the world, where medicines are distributed in bulk and dispensed without much information, even when dealing with powerful prescription drugs. During the introduction of PPIs in Belgium, a research programme wasconducted to evaluate this change in the way drug information was provided in the drug distribution system. This thesis provides an overview of the studiescarried out during that period. In addition, a number of other descriptive studies of the flow of drug information in specific patients groups is provided. Finally, a number of experimental studies is presented, which evaluate the impact of written drug information on patients? benefit/risk perception. The acceptance of a drug distribution system with mandatory PPIs in all drug packages will be evaluated on the basis of Belgium?s relatively long and welldocumented experience with PPIs. We address the following questions: what is the percentage of patients who read, accept and appreciate PPIs; what happens when a country changes from technical inserts with difficult jargon to comprehensible PPIs; what do we know about the impact of PPIs on patients knowledge and feelings about their drugs? In this thesis, an attempt is made to understand the mental processing of drug information which precedes patients' decisions and coping strategies, necessary for successful drug treatment. The question here is whether the PPI is capable of influencing the benefit/risk perception of patients. A further step is to study the impact of the PPI on behaviour. Here, other questions are at stake. Does the PPI have an impact on patients' reporting of health problems and side-effects, on their ability to carry out a treatment correctly and safely, on their adherence to therapy at the beginning of treatment, and on their motivation to continue crucial therapy? These questions are addressed only to a limited extent in this work, as we have focused on the preceding cognitive process of benefit/risk perception

    Development of a complex intervention to support the initiation of advance care planning by general practitioners in patients at risk of deteriorating or dying: a phase 0-1 study

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    Background: Most patients with life-limiting illnesses are treated and cared for over a long period of time in primary care and guidelines suggest that ACP discussions should be initiated in primary care. However, a practical model to implement ACP in general practice is lacking. Therefore, the objective of this study is to develop an intervention to support the initiation of ACP in general practice. Methods: We conducted a Phase 0-I study according to the Medical Research Council (MRC) Framework. Phase 0 consisted of a systematic literature review about the barriers and facilitators for GPs to engage in ACP, focus groups with GPs were held about their experiences, attitudes and concerns regarding initiating ACP in general practice and a review of ACP interventions to identify potential components for the development of our intervention. In Phase 1, we developed a complex intervention to support the initiation of ACP in general practice in patients at risk of deteriorating or dying, based on the results of Phase 0. The complex intervention and its components were reviewed and refined by two expert panels. Results: Phase 0 resulted in the identification of the factors inhibiting or enabling GPs' initiation of ACP and important components underpinning existing ACP interventions. Based on these findings, an intervention was developed in Phase 1 consisting of: (1) a training for GPs in initiating and conducting ACP discussions, (2) a register of patients eligible for ACP discussions, (3) an educational booklet on ACP for patients to prepare the ACP discussions that includes general information on ACP, a section on the role of GPs in the process of ACP and a prompt list, (4) a conversation guide to support GPs in the ACP discussions and (5) a structured documentation template to record the outcomes of discussions. Conclusion: Taking into account the barriers and facilitators for GPs to initiate ACP as well as the key factors underpinning successful ACP intervention in other health care settings, a complex intervention for general practice was developed, after gaining feedback from two expert panels. The feasibility and acceptability of the intervention will subsequently be tested in a Phase II study

    Silence of the limbs: pharmacological symptomatic treatment of intermittent claudication

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    Several oral "vasoactive" drugs claim to increase walking capacity in patients with intermittent claudication (IC). Naftidrofuryl, cilostazol, buflomedil, and pentoxifylline are the most studied molecules. Although spanning several decades, several studies underlying these claims were not properly designed, underpowered or showed clinically doubtful outcomes. The evidence for these "vasoactive" drugs has always been received with scepticism, creating the need for systematic reviews and meta-analyses. This brief review discusses the benefit-risk assessment of vasoactive drugs, by applying a systematic review to evaluate randomized, placebo-controlled trials. Oral naftidrofuryl and cilostazol have an acceptable safety profile as well as sustained evidence (documented by Cochrane analyses) of increased walking capacity. Subsequently, these drugs entered recommendations for peripheral arterial disease (PAD). In contrast, buflomedil and pentoxifylline have limited and/or doubtful evidence to increase walking capacity. Moreover, there were safety concerns about the narrow therapeutic range of buflomedil. Most other "vasoactive" drugs were either inappropriately or insufficiently tested or showed no significant if not negative effects on IC. "Vasoactive" drugs are no substitutes for lifestyle or exercise therapy but are adjuvant treatment to the well-appreciated triad of cardiovascular prevention (antiplatelet agents, statins and ACE-inhibitors), of which statins in their own right have documented claims to significantly increase walking capacity. "Vasoactive" drugs may have a place in the pharmacological management of symptomatic PAD in addition to the basic cardiovascular pharmacotherapy, when revascularization is not indicated, when exercise therapy is not feasible or when there is still insufficient benefit

    The use of antidepressants in Belgian nursing homes : focus on indications and dosages in the PHEBE study

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    Background : Since antidepressants are prescribed for multiple indications, the use of an antidepressant cannot be equated with a diagnosis of depression. Objective : The objective of this study was to examine the quality of antidepressant prescribing in Belgian nursing homes, with a critical evaluation of indications and dosages, to see whether depression was appropriately treated in terms of drug choice, the indications for which antidepressants were being prescribed and whether there was underdosing. Methods : This analysis was based on data obtained in the Prescribing in Homes for the Elderly in Belgium (PHEBE) study, a cross-sectional, descriptive study of a representative, stratified, random sample of 1,730 residents from 76 Belgian nursing homes. The PHEBE study investigated overall drug utilization in Belgian nursing homes in 2006. Clinical and medication data for the present study were obtained from this study. A 28-item checklist of clinical conditions was designed ad hoc for the PHEBE study and sent to the residents' general practitioners (GPs) to collect clinical information. We copied the residents' medication charts, classified the drugs using the Anatomical Therapeutic Chemical (ATC) classification system codes and transferred the drug names and dosages into a database. Information on indications was retrospectively obtained from the GPs, so that we could link the indication to each medication. Minimum effective doses (MEDs) of antidepressants to treat major depression were obtained from the literature to assess underdosing. Results : The overall use of antidepressants in nursing homes was 39.5 % (95 % CI 37.2, 41.8). The physicians classified 34.2 % (95 % CI 32.0, 36.4) of the residents as having depression, and 80.9 To of these patients were treated with an antidepressant. Indications among the single antidepressant users (n = 551) were depression (66.2 %), insomnia (13.4 %), anxiety (6.2 %) and neuropathic pain (1.6 %). In the indication of depression, 74.8 % used a selective serotonin reuptake inhibitor (SSRI), predominantly citalopram, sertraline and escitalopram. Venlafaxine was used by 10.7 % of the residents. Dosages for these antidepressants were equal to or higher than the MED. But when trazodone, amitriptyline or mirtazapine were used to treat depression, respectively, 92.3, 55.5 and 44.5 % of prescribed dosages were below the MED. In the indication of insomnia, most of the time, trazodone (90.5 %) or mirtazapine (5.4 %) were used, and in lower dosages than those required for depression treatment (<MED). Tricyclic antidepressants were predominantly used for the treatment of neuropathic pain and were also used at lower dosages. Of all the residents receiving a medication for anxiety, only 13.9 % received an antidepressant (mostly an SSRI), and the remaining received a benzodiazepine. Conclusions : The number one indication for the use of an antidepressant was depression. Within this indication, mostly the recommended SSRIs were used, in dosages equal to or higher than the MED. Furthermore, we noticed that there was substantial use of sedative antidepressants for insomnia and that the physicians preferred to prescribe benzodiazepines over the recommended SSRIs to treat anxiety chronically

    Feasibility and impact of an evidence-based electronic decision support system for diabetes care in family medicine: protocol for a cluster randomized controlled trial

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    Background: In Belgium, the construction of the national electronic point-of-care information service, EBMPracticeNet, was initiated in 2011 to optimize quality of care by promoting evidence-based decision-making. The collaboration of the government, healthcare providers, Evidence-Based Medicine (EBM) partners, and vendors of Electronic Health Records (EHR) is unique to this project. All Belgian healthcare professionals get free access to an up-to-date database of validated Belgian and nearly 1,000 international guidelines, incorporated in a portal that also provides EBM information from sources other than guidelines, including computerized clinical decision support that is integrated in the EHRs. The EBMeDS system is the electronic evidence-based decision support system of EBMPracticeNet. The EBMeDS system covers all clinical areas of diseases and could play a crucial role in response to the emerging challenge posed by chronic conditions. Diabetes was chosen as the analysis topic of interest. The objective of this study is to assess the effectiveness of EBMeDS use in improving diabetes care. This objective will be enhanced by a formal process evaluation to provide crucial information on the feasibility of using the system in daily Belgian family medicine. Methods: The study is a cluster-randomized trial with before/after measurements conducted in Belgian family medicine. Physicians' practices will be randomly assigned to the intervention or control group in a 1: 1 ratio, to receive either the EBMeDS reminders or to follow the usual care process. Randomization will be performed by a statistical consultant with an electronic random list generator, anonymously for the researchers. The follow-up period of the study will be 12 months with interim analysis points at 3, 6 and 9 months. Primary outcome is the one-year pre- to post-implementation change in HbA1c. Patients will not be informed about the intervention. Data analysts will be kept blinded to the allocation. Discussion: The knowledge obtained in this study will be useful for further integration in other Belgian software packages. Users' perceptions and process evaluation will provide information for improving the feasibility of the system

    Evaluation of medication adherence methods in the treatment of malaria in Rwandan infants

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    Objectives: To compare three methods for evaluating treatment adherence in a 7-day controlled treatment period for malaria in children in Rwanda. Methods: Fifty-six children (< 5 years) with malaria were recruited at the University Hospital of Butare, Rwanda. Patients were treated with quinine sulfate, taste-masked, pellets during seven days: three days in hospital (in-patient) followed by a four-day out-patient period. Three methods to evaluate medication adherence among patients were compared: manual pill count of returned tablets, patient self-report and electronic pill-box monitoring. These pill-boxes were equipped with a microchip registering date and time of every opening. Medication adherence was defined as the proportion of prescribed doses taken. The inter-dose intervals were analysed as well. Results: Medication adherence data were available for 54 of the 56 patients. Manual pill count and patient self-report yielded a medication adherence of 100% for the in-and out-patient treatment periods. Based on electronic pill-box monitoring, medication adherence during the seven-day treatment period was 90.5 +/- 8.3%. Based on electronic pillbox monitoring inpatient medication adherence (99.3 +/- 2.7%) was markedly higher (p < 0.03) than out-patient adherence (82.7 +/- 14.7%), showing a clear difference between health workers' and consumers' medication adherence. Conclusion: Health workers' medication adherence was good. However, a significant lower medication adherence was observed for consumers' adherence in the outpatient setting. This was only detected by electronic pill-box monitoring. Therefore, this latter method is more accurate than the two other methods used in this study
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