Abstract
BackgroundMultimorbidity and polypharmacy are common in older people. Assessment tools or lists of criteria aimed at supporting prescription decisions for older people exist, but have often been based on expert opinion with insufficient consideration of the evidence available. The present paper describes the methods we are using to systematically review the existing evidence on the efficacy and safety of the most commonly prescribed drugs for older people in the management of their chronic medical conditions and to develop recommendations to reduce inappropriate prescriptions for incorporation into the Comprehensive Medication Review (CMR) tool developed by the PRIMA-eDS European project.MethodsWe selected the 20 most relevant drugs/drug classes in terms of prescription volumes and risk of hospitalisation for older people and the most relevant indications for the most common chronic conditions among older people and a total of 35 distinct drug-indication pairs were chosen. Based on clinical considerations we collapsed some indications together, reducing the 35 pairs to a final total of 22 separate systematic reviews (SR). A common methodology will be used for each individual SR, based on the methodological manuals of the Cochrane collaboration and the PRISMA statement for reporting systematic reviews. Our search strategy will have a staged approach where we initially search for systematic reviews and meta-analyses, but if relevant reviews are not found, then search for individual studies (controlled intervention and observational studies). Our pilot work and initial scoping of the literature suggested that very few, relevant individual trials or existing systematic reviews have researched or reported exclusively on older people. Therefore, sufficient data might not be available to perform meta-analysis but we will provide a narrative synthesis describing characteristics and findings of included studies. The collected evidence will be used to construct recommendations on when not to use or to discontinue a drug, or when to reduce its dose. Recommendations will be developed in team meetings using the GRADE methodology to reflect the strength of the recommendation and the quality of the evidence. Recommendations will be built into the CMR tool.DiscussionThis protocol has been prepared for a series of systematic reviews which will provide research-based evidence to develop recommendations to reduce inappropriate polypharmacy in older people as part of the CMR tool of the PRIMA-eDS project.
Highlights
Multimorbidity and polypharmacy are common in older people
Participating countries (Social Insurance Institute of Finland/Statistical Database Kelasto in Finland (Jaana Harsia-Alatalo, People aged over 75 using prescription drugs, Social Insurance Institute of Finland, personal communication, 2012); Medicines Utilisation Monitoring Centre (OsMed) in Italy [16], research network of the Italian General Practice (Giuliano Piccoliori, The most common drugs in people over 74, personal communication, 2012); and AOK North Rhine-Westphalia in Germany (AOK Northwest Department of Pharmacology, List of most commonly prescribed drugs in people >65 years of age, Dortmund, 2012, unpublished data)), and from a pilot study carried out in Austria [17], we identified seventy five drugs or drug classes as the most commonly prescribed to people aged 65 years and older
Preparatory phase We developed a Protocol Template (PT) and a Standard Operating Procedures (SOP) document specifying the methodology for the systematic reviews (SR) in detail, for reviewers to follow and to achieve uniformity of approach
Summary
This document will include: a) relevant information from all selected studies such as study design, target population and sample size, intervention and comparison groups, outcomes, main results, subgroup analysis if applicable; b) results of the quality appraisal of the studies; and c) proposed recommendations to discuss. The evidence is insufficient on both risks and benefits; in this case we will take into consideration the evidence on general population and clinical guidelines as identified from the additional references of interest and discuss, for each individual case, whether a recommendation on the potential discontinuation of the drug could be developed where clinicians are drawn attention about the lack of evidence on its use for this age group. General practitioners using the CMR tool will be informed and trained that the recommendations made by the tool do not substitute for careful individual clinical considerations or clinical guidelines, but are only intended to support the clinical decision making process
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