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      Integration of an electronic Drug Burden Index risk assessment tool into Home Medicines Reviews: deprescribing anticholinergic and sedative medications

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          Abstract

          Background:

          Our aim in this research was to establish whether integrating an electronically generated calculation and report on the Drug Burden Index (DBI) in the Home Medicines Review (HMR) setting is an accurate, feasible and useful risk assessment tool to assess risk of anticholinergic and sedative medications; and to establish whether the intervention of DBI together with HMR is associated with a reduced use of anticholinergic and sedative medications in older community-dwelling adults in Australia.

          Methods:

          An interventional feasibility study was conducted. Accredited clinical pharmacists (APs) were recruited to participate. Each AP was educated on implementation of the DBI into HMR practice and given access to the DBI Calculator© web-based software to generate the DBI report for inclusion in HMR reports for general practitioners (GPs). APs recruited patients (⩾65 years) who were referred to them for HMRs. Patients were sent a letter about their DBI exposure, and a prompt to visit their GP to discuss their medication management options. GPs, APs and patients were asked to evaluate the feasibility and utility of the DBI report. A medication inventory was collected from patients at the time of the HMR and at 3 months to determine whether the intervention affected deprescribing of medications with anticholinergic and sedative effects.

          Results:

          Regarding the feasibility of the DBI report as a risk assessment tool within HMR, 89% of APs and 67% of GPs agreed that it would be feasible. The DBI Calculator© was potentially inaccurate, as 26% of DBI scores were underestimated and 7% were overestimated (at baseline). At 3 months, the median (interquartile range) DBI for patients ( n = 100) significantly decreased from 0.82 (0–1.33) to 0.67 (0–1.29) ( p = 0.014). Additionally, of patients with a DBI > 0 ( n = 66), 36.4% had their DBI score decrease, and 6.1% had a score increase.

          Conclusion:

          This study demonstrated that integration of the DBI Calculator© into HMR is a feasible and useful method to prompt deprescribing of anticholinergic and sedative medications in older adults. There is potential for the accuracy of the web-based platform to be improved.

          Registration of trial:

          Name: Feasibility study of the Drug Burden Index with Home Medicines Review.

          Website: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368523

          Trial ID: ACTRN 12615000539538.

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          Most cited references30

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          An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database

          Background There is little published guidance as to the sample size required for a pilot or feasibility trial despite the fact that a sample size justification is a key element in the design of a trial. A sample size justification should give the minimum number of participants needed in order to meet the objectives of the trial. This paper seeks to describe the target sample sizes set for pilot and feasibility randomised controlled trials, currently running within the United Kingdom. Methods Data were gathered from the United Kingdom Clinical Research Network (UKCRN) database using the search terms ‘pilot’ and ‘feasibility’. From this search 513 studies were assessed for eligibility of which 79 met the inclusion criteria. Where the data summary on the UKCRN Database was incomplete, data were also gathered from: the International Standardised Randomised Controlled Trial Number (ISRCTN) register; the clinicaltrials.gov website and the website of the funders. For 62 of the trials, it was necessary to contact members of the research team by email to ensure completeness. Results Of the 79 trials analysed, 50 (63.3%) were labelled as pilot trials, 25 (31.6%) feasibility and 14 were described as both pilot and feasibility trials. The majority had two arms (n = 68, 86.1%) and the two most common endpoints were continuous (n = 45, 57.0%) and dichotomous (n = 31, 39.2%). Pilot trials were found to have a smaller sample size per arm (median = 30, range = 8 to 114 participants) than feasibility trials (median = 36, range = 10 to 300 participants). By type of endpoint, across feasibility and pilot trials, the median sample size per arm was 36 (range = 10 to 300 participants) for trials with a dichotomous endpoint and 30 (range = 8 to 114 participants) for trials with a continuous endpoint. Publicly funded pilot trials appear to be larger than industry funded pilot trials: median sample sizes of 33 (range = 15 to 114 participants) and 25 (range = 8 to 100 participants) respectively. Conclusion All studies should have a sample size justification. Not all studies however need to have a sample size calculation. For pilot and feasibility trials, while a sample size justification is important, a formal sample size calculation may not be appropriate. The results in this paper describe the observed sample sizes in feasibility and pilot randomised controlled trials on the UKCRN Database.
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            A drug burden index to define the functional burden of medications in older people.

            Older people carry a high burden of illness for which medications are indicated, along with increased risk of adverse drug reactions. We developed an index to determine drug burden based on pharmacologic principles. We evaluated the relationship of this index to physical and cognitive performance apart from disease indication. Data from the Health, Aging, and Body Composition Study on 3075 well-functioning community-dwelling persons aged 70 to 79 years were analyzed by multiple linear regression to assess the cross-sectional association of drug burden index with a validated composite continuous measure for physical function, and with the Digit Symbol Substitution Test for cognitive performance. Use of anticholinergic and sedative medications was associated with poorer physical performance score (anticholinergic exposure, 2.08 vs 2.21, P<.001; sedative exposure, 2.09 vs 2.19, P<.001) and cognitive performance on the Digit Symbol Substitution Test (anticholinergic exposure, 34.5 vs 35.5, P = .045; sedative exposure, 34.0 vs 35.5, P = .01). Associations were strengthened when exposure was calculated by principles of dose response. An increase of 1 U in drug burden index was associated with a deficit of 0.15 point (P<.001) on the physical function scale and 1.5 points (P = .01) on the Digit Symbol Substitution Test. These values were more than 3 times those associated with a single comorbid illness. The drug burden index demonstrates that anticholinergic and sedative drug exposure is associated with poorer function in community-dwelling older people. This pharmacologic approach provides a useful evidence-based tool for assessing the functional effect of exposure to medications in this population.
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              Interventions to improve the appropriate use of polypharmacy for older people.

              Inappropriate polypharmacy is a particular concern in older people and is associated with negative health outcomes. Choosing the best interventions to improve appropriate polypharmacy is a priority, hence interest in appropriate polypharmacy, where many medicines may be used to achieve better clinical outcomes for patients, is growing. This review sought to determine which interventions, alone or in combination, are effective in improving the appropriate use of polypharmacy and reducing medication-related problems in older people. In November 2013, for this first update, a range of literature databases including MEDLINE and EMBASE were searched, and handsearching of reference lists was performed. Search terms included 'polypharmacy', 'medication appropriateness' and 'inappropriate prescribing'. A range of study designs were eligible. Eligible studies described interventions affecting prescribing aimed at improving appropriate polypharmacy in people 65 years of age and older in which a validated measure of appropriateness was used (e.g. Beers criteria, Medication Appropriateness Index (MAI)). Two review authors independently reviewed abstracts of eligible studies, extracted data and assessed risk of bias of included studies. Study-specific estimates were pooled, and a random-effects model was used to yield summary estimates of effect and 95% confidence intervals (CIs). The GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach was used to assess the overall quality of evidence for each pooled outcome. Two studies were added to this review to bring the total number of included studies to 12. One intervention consisted of computerised decision support; 11 complex, multi-faceted pharmaceutical approaches to interventions were provided in a variety of settings. Interventions were delivered by healthcare professionals, such as prescribers and pharmacists. Appropriateness of prescribing was measured using validated tools, including the MAI score post intervention (eight studies), Beers criteria (four studies), STOPP criteria (two studies) and START criteria (one study). Interventions included in this review resulted in a reduction in inappropriate medication usage. Based on the GRADE approach, the overall quality of evidence for all pooled outcomes ranged from very low to low. A greater reduction in MAI scores between baseline and follow-up was seen in the intervention group when compared with the control group (four studies; mean difference -6.78, 95% CI -12.34 to -1.22). Postintervention pooled data showed a lower summated MAI score (five studies; mean difference -3.88, 95% CI -5.40 to -2.35) and fewer Beers drugs per participant (two studies; mean difference -0.1, 95% CI -0.28 to 0.09) in the intervention group compared with the control group. Evidence of the effects of interventions on hospital admissions (five studies) and of medication-related problems (six studies) was conflicting. It is unclear whether interventions to improve appropriate polypharmacy, such as pharmaceutical care, resulted in clinically significant improvement; however, they appear beneficial in terms of reducing inappropriate prescribing.
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                Author and article information

                Contributors
                Journal
                Ther Adv Drug Saf
                Ther Adv Drug Saf
                TAW
                sptaw
                Therapeutic Advances in Drug Safety
                SAGE Publications (Sage UK: London, England )
                2042-0986
                2042-0994
                05 March 2019
                2019
                : 10
                : 2042098619832471
                Affiliations
                [1-2042098619832471]Departments of Clinical Pharmacology and Aged Care, Level 13 Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065, Australia
                [2-2042098619832471]School of Pharmacy, Faculty of Medicine and Health and Charles Perkins Centre, The University of Sydney, Sydney, NSW, Australia
                [3-2042098619832471]School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia
                [4-2042098619832471]Departments of Clinical Pharmacology and Aged Care, Royal North Shore Hospital, Sydney, NSW, Australia NHMRC Cognitive Decline Partnership Centre, Kolling Institute of Medical Research, Sydney Medical School University of Sydney, NSW, Australia
                Author notes
                Author information
                https://orcid.org/0000-0003-0927-7295
                https://orcid.org/0000-0002-9404-3401
                Article
                10.1177_2042098619832471
                10.1177/2042098619832471
                6402056
                30858967
                c4e15213-a6fd-4558-b5a1-2ed826ca8a30
                © The Author(s), 2019

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 9 June 2018
                : 30 January 2019
                Categories
                Original Research
                Custom metadata
                January-December 2019

                deprescribing,drug burden index,intervention,older adults,polypharmacy

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