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BMC Medicine
Published in: BMC Medicine 1/2018

Open Access 01-12-2018 | Research article

International core outcome set for clinical trials of medication review in multi-morbid older patients with polypharmacy

Authors: Jean-Baptiste Beuscart, Wilma Knol, Shane Cullinan, Claudio Schneider, Olivia Dalleur, Benoit Boland, Stefanie Thevelin, Paul A. F. Jansen, Denis O’Mahony, Nicolas Rodondi, Anne Spinewine

Published in: BMC Medicine | Issue 1/2018

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Abstract

Background

Comparisons of clinical trial findings in systematic reviews can be hindered by the heterogeneity of the outcomes reported. Moreover, the outcomes that matter most to patients might be underreported. A core outcome set can address these issues, as it defines a minimum set of outcomes that should be reported in all clinical trials in a particular area of research. The objective in this study was to develop a core outcome set for clinical trials of medication review in multi-morbid older patients with polypharmacy.

Methods

Firstly, eligible outcomes were identified through a systematic review of trials of medication review in older patients (≥65 years) and interviews with 15 older patients. Secondly, an international three-round Delphi survey in four countries involving patients, healthcare professionals, and experts was conducted to validate outcomes to be included in the core outcome set. Consensus meetings were conducted to validate the results.

Results

Of the 164 participants invited to take part in the Delphi survey, 150 completed Round 1, including 55 patients or family caregivers, 55 healthcare professionals, and 40 experts. A total of 129 participants completed all three rounds. Sixty-four eligible outcomes were extracted from 47 articles, 32 clinical trial protocols, and patient interviews. Thirty outcomes were removed and one added after Round 1, 18 outcomes were removed after Round 2, and seven after Round 3. Results were discussed during consensus meetings. Consensus was reached on seven outcomes, which constitute the core outcome set: drug-related hospital admissions; drug overuse; drug underuse; potentially inappropriate medications; clinically significant drug-drug interactions; health-related quality of life; pain relief.

Conclusions

We developed a core outcome set of seven outcomes which should be used in future trials of medication review in multi-morbid older patients with polypharmacy.
Appendix
Available only for authorised users
Footnotes
1
In this online test version, the user chooses the language, participant category, and age group before accessing the questionnaire. During the Delphi survey, these questions were pre-filled and hidden. The participants had direct access to the questionnaire in the right form and the appropriate language.
 
Literature
1.
Payne RA, Avery AJ, Duerden M, Saunders CL, Simpson CR, Abel GA. Prevalence of polypharmacy in a Scottish primary care population. Eur J Clin Pharmacol. 2014;70:575–81.CrossRefPubMed
2.
Hovstadius B, Hovstadius K, Astrand B, Petersson G. Increasing polypharmacy — an individual-based study of the Swedish population 2005–2008. BMC Clin Pharmacol. 2010;10:16.CrossRefPubMedPubMedCentral
3.
Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004;329:15–9.CrossRefPubMedPubMedCentral
4.
Ma J, Wang Y, Gao M, Meng Q, Liu J. Adverse drug reactions as the cause of emergency department admission of patients aged 80 years and older. Eur J Intern Med. 2012;23:e162–3.CrossRefPubMed
5.
Conforti A, Costantini D, Zanetti F, Moretti U, Grezzana M, Leone R. Adverse drug reactions in older patients: an Italian observational prospective hospital study. Drug Health Patient Safe. 2012;4:75–80.CrossRef
6.
Kongkaew C, Noyce PR, Ashcroft DM. Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies. Ann Pharmacother. 2008;42:1017–25.CrossRefPubMed
7.
8.
Meid AD, Lampert A, Burnett A, Seidling HM, Haefeli WE. The impact of pharmaceutical care interventions for medication underuse in older people: a systematic review and meta-analysis. Br J Clin Pharmacol. 2015;80:768–76.CrossRefPubMedPubMedCentral
9.
Lehnbom EC, Stewart MJ, Manias E, Westbrook JI. Impact of medication reconciliation and review on clinical outcomes. Ann Pharmacother. 2014;48:1298–312.CrossRefPubMed
10.
Hatah E, Braund R, Tordoff J, Duffull SB. A systematic review and meta-analysis of pharmacist-led fee-for-services medication review. Br J Clin Pharmacol. 2014;77:102–15.CrossRefPubMed
11.
Christensen M, Lundh A. Medication review in hospitalised patients to reduce morbidity and mortality. Cochrane Database Syst Rev. 2016;2, CD008986.PubMed
12.
Graabæk T, Kjeldsen LJ. Medication reviews by clinical pharmacists at hospitals lead to improved patient outcomes: a systematic review. Basic Clin Pharmacol Toxicol. 2013;112:359–73.CrossRefPubMed
13.
Forsetlund L, Eike MC, Gjerberg E, Vist GE. Effect of interventions to reduce potentially inappropriate use of drugs in nursing homes: a systematic review of randomised controlled trials. BMC Geriatr. 2011;11:16.CrossRefPubMedPubMedCentral
14.
Wallerstedt SM, Kindblom JM, Nylén K, Samuelsson O, Strandell A. Medication reviews for nursing home residents to reduce mortality and hospitalization: systematic review and meta-analysis. Br J Clin Pharmacol. 2014;78:488–97.CrossRefPubMedPubMedCentral
15.
Thomas R, Huntley AL, Mann M, Huws D, Elwyn G, Paranjothy S, et al. Pharmacist-led interventions to reduce unplanned admissions for older people: a systematic review and meta-analysis of randomised controlled trials. Age Ageing. 2014;43:174–87.CrossRefPubMed
16.
Holland R, Desborough J, Goodyer L, Hall S, Wright D, Loke YK. Does pharmacist-led medication review help to reduce hospital admissions and deaths in older people? A systematic review and meta-analysis. Br J Clin Pharmacol. 2008;65:303–16.CrossRefPubMed
17.
18.
Geurts MME, Talsma J, Brouwers JRBJ, de Gier JJ. Medication review and reconciliation with cooperation between pharmacist and general practitioner and the benefit for the patient: a systematic review. Br J Clin Pharmacol. 2012;74:16–33.CrossRefPubMedPubMedCentral
19.
Viswanathan M, Kahwati LC, Golin CE, Blalock SJ, Coker-Schwimmer E, Posey R, et al. Medication therapy management interventions in outpatient settings: a systematic review and meta-analysis. JAMA Intern Med. 2015;175:76–87.CrossRefPubMed
20.
Hohl CM, Wickham ME, Sobolev B, Perry JJ, Sivilotti MLA, Garrison S, et al. The effect of early in-hospital medication review on health outcomes: a systematic review. Br J Clin Pharmacol. 2015;80:51–61.CrossRefPubMedPubMedCentral
21.
Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13:132.CrossRefPubMedPubMedCentral
22.
Idzerda L, Rader T, Tugwell P, Boers M. Can we decide which outcomes should be measured in every clinical trial? A scoping review of the existing conceptual frameworks and processes to develop core outcome sets. J Rheumatol. 2014;41:986–93.CrossRefPubMed
23.
Kirkham JJ, Gargon E, Clarke M, Williamson PR. Can a core outcome set improve the quality of systematic reviews?—a survey of the Co-ordinating Editors of Cochrane Review Groups. Trials. 2013;14:21.CrossRefPubMedPubMedCentral
24.
Kirkham JJ, Dwan KM, Altman DG, Gamble C, Dodd S, Smyth R, et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ. 2010;340:c365.CrossRefPubMed
25.
Hart B, Lundh A, Bero L. Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses. BMJ. 2012;344:d7202.CrossRefPubMed
26.
Page MJ, McKenzie JE, Kirkham J, Dwan K, Kramer S, Green S, et al. Bias due to selective inclusion and reporting of outcomes and analyses in systematic reviews of randomised trials of healthcare interventions. Cochrane Database Syst Rev. 2014;10, MR000035.
27.
Zulman DM, Sussman JB, Chen X, Cigolle CT, Blaum CS, Hayward RA. Examining the evidence: a systematic review of the inclusion and analysis of older adults in randomized controlled trials. J Gen Intern Med. 2011;26:783–90.CrossRefPubMedPubMedCentral
28.
Cherubini A, Del Signore S, Ouslander J, Semla T, Michel J-P. Fighting against age discrimination in clinical trials. J Am Geriatr Soc. 2010;58:1791–6.CrossRefPubMed
29.
Boers M, Kirwan JR, Wells G, Beaton D, Gossec L, d’Agostino M-A, et al. Developing core outcome measurement sets for clinical trials: OMERACT Filter 2.0. J Clin Epidemiol. 2014;67:745–53.CrossRefPubMed
30.
Kirkham JJ, Gorst S, Altman DG, Blazeby JM, Clarke M, Devane D, et al. Core Outcome Set–STAndards for Reporting: the COS-STAR Statement. PLoS Med. 2016;13, e1002148.CrossRefPubMedPubMedCentral
31.
Beuscart J-B, Dalleur O, Boland B, Thevelin S, Knol W, Cullinan S, et al. Development of a core outcome set for medication review in older patients with multimorbidity and polypharmacy: a study protocol. Clin Interventions Aging. 2017;12:1379–89.CrossRef
32.
Beuscart J-B, Pont LG, Thevelin S, Boland B, Dalleur O, Rutjes A, et al. A systematic review of the outcomes reported in trials of medication review in older patients: the need for a core outcome set. Br J Clin Pharmacol. 2017;83:942–52.CrossRefPubMed
33.
von der Gracht HA. Consensus measurement in Delphi studies: Review and implications for future quality assurance. Technol Forecast Soc Change. 2012;79:1525–36.CrossRef
34.
Matanović SM, Vlahovic-Palcevski V. Potentially inappropriate medications in the elderly: a comprehensive protocol. Eur J Clin Pharmacol. 2012;68:1123–38.CrossRef
35.
Wong C-M, Ko Y, Chan A. Clinically significant drug–drug interactions between oral anticancer agents and nonanticancer agents: profiling and comparison of two drug compendia. Ann Pharmacother. 2008;42:1737–48.CrossRefPubMed
36.
Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. Adverse drug events occurring following hospital discharge. J Gen Intern Med. 2005;20:317–23.CrossRefPubMedPubMedCentral
37.
Schmader KE, Hanlon JT, Pieper CF, Sloane R, Ruby CM, Twersky J, et al. Effects of geriatric evaluation and management on adverse drug reactions and suboptimal prescribing in the frail elderly. Am J Med. 2004;116:394–401.CrossRefPubMed
38.
Dragioti E, Larsson B, Bernfort L, Levin LÅ, Gerdle B. Prevalence of different pain categories based on pain spreading on the bodies of older adults in Sweden: a descriptive-level and multilevel association with demographics, comorbidities, medications, and certain lifestyle factors (PainS65+). J Pain Res. 2016;9:1131–41.CrossRefPubMedPubMedCentral
39.
Patel KV, Phelan EA, Leveille SG, Lamb SE, Missikpode C, Wallace RB, et al. High prevalence of falls, fear of falling, and impaired balance in older adults with pain in the United States: findings from the 2011 National Health and Aging Trends Study. J Am Geriatr Soc. 2014;62:1844–52.CrossRefPubMedPubMedCentral
40.
Patel KV, Guralnik JM, Dansie EJ, Turk DC. Prevalence and impact of pain among older adults in the United States: findings from the 2011 National Health and Aging Trends Study. Pain. 2013;154:2649–57.CrossRefPubMed
41.
Richards T, Montori VM, Godlee F, Lapsley P, Paul D. Let the patient revolution begin. BMJ. 2013;346:f2614.CrossRefPubMed
Metadata
Title
International core outcome set for clinical trials of medication review in multi-morbid older patients with polypharmacy
Authors
Jean-Baptiste Beuscart
Wilma Knol
Shane Cullinan
Claudio Schneider
Olivia Dalleur
Benoit Boland
Stefanie Thevelin
Paul A. F. Jansen
Denis O’Mahony
Nicolas Rodondi
Anne Spinewine
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Medicine / Issue 1/2018
Electronic ISSN: 1741-7015
DOI
https://doi.org/10.1186/s12916-018-1007-9

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