Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Research

Development of a core outcome set for effectiveness trials aimed at optimising prescribing in older adults in care homes

Authors: Anna N. Millar, Amrit Daffu-O’Reilly, Carmel M. Hughes, David P. Alldred, Garry Barton, Christine M. Bond, James A. Desborough, Phyo K. Myint, Richard Holland, Fiona M. Poland, David Wright, On behalf of the CHIPPS Team, University of East Anglia

Published in: Trials | Issue 1/2017

Login to get access

Abstract

Background

Prescribing medicines for older adults in care homes is known to be sub-optimal. Whilst trials testing interventions to optimise prescribing in this setting have been published, heterogeneity in outcome reporting has hindered comparison of interventions, thus limiting evidence synthesis. The aim of this study was to develop a core outcome set (COS), a list of outcomes which should be measured and reported, as a minimum, for all effectiveness trials involving optimising prescribing in care homes. The COS was developed as part of the Care Homes Independent Pharmacist Prescribing Study (CHIPPS).

Methods

A long-list of outcomes was identified through a review of published literature and stakeholder input. Outcomes were reviewed and refined prior to entering a two-round online Delphi exercise and then distributed via a web link to the CHIPPS Management Team, a multidisciplinary team including pharmacists, doctors and Patient Public Involvement representatives (amongst others), who comprised the Delphi panel. The Delphi panellists (n = 19) rated the importance of outcomes on a 9-point Likert scale from 1 (not important) to 9 (critically important). Consensus for an outcome being included in the COS was defined as ≥70% participants scoring 7–9 and <15% scoring 1–3. Exclusion was defined as ≥70% scoring 1–3 and <15% 7–9. Individual and group scores were fed back to participants alongside the second questionnaire round, which included outcomes for which no consensus had been achieved.

Results

A long-list of 63 potential outcomes was identified. Refinement of this long-list of outcomes resulted in 29 outcomes, which were included in the Delphi questionnaire (round 1). Following both rounds of the Delphi exercise, 13 outcomes (organised into seven overarching domains: medication appropriateness, adverse drug events, prescribing errors, falls, quality of life, all-cause mortality and admissions to hospital (and associated costs)) met the criteria for inclusion in the final COS.

Conclusions

We have developed a COS for effectiveness trials aimed at optimising prescribing in older adults in care homes using robust methodology. Widespread adoption of this COS will facilitate evidence synthesis between trials. Future work should focus on evaluating appropriate tools for these key outcomes to further reduce heterogeneity in outcome measurement in this context.
Literature
1.
Williamson PR, Altman D, Blazeby J, Clarke M, Gargon E. Driving up the quality and relevance of research through the use of agreed core outcomes. J Health Serv Res Policy. 2012;17:1–2.CrossRefPubMed
2.
Gargon E, Gurung B, Medley N, Altman DG, Blazeby JN, Clarke M, et al. Choosing important health outcomes for comparative effectiveness research: a systematic review. PLoS One. 2014;9:1–11.CrossRef
3.
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 Group. Trials. 2013;14:21–5.CrossRefPubMedPubMedCentral
4.
5.
Hirsch BR, Califf RM, Cheng SK, Tasneem A, Horton J, Chiswell K, et al. Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov. JAMA Intern Med. 2013;173:972–9.CrossRefPubMed
6.
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. Br Med J. 2010. doi:10.​1136/​bmj.​c365.
7.
8.
MacLennan S, Bekema HJ, Williamson PR, Campbell MK, Stewart F, MacLennan SJ, et al. A core outcome set for localised prostate cancer effectiveness trials: protocol for a systematic review of the literature and stakeholder involvement through interviews and a Delphi survey. Trials. 2015;16:76–86.CrossRefPubMedPubMedCentral
9.
Catumbela E, Certal V, Freitas A, Costa C, Sarmento A, de Costa Pereira A. Definition of a core set of quality indicators for the assessment of IV/AIDS clinical care: a systematic review. BMC Health Serv Res. 2013;13:236–47.CrossRefPubMedPubMedCentral
10.
Chiarotto A, Terwee CB, Deyo RA, Boers M, Lin CW, Buchbinder R, et al. A core outcome set for clinical trials on non-specific low back pain: study protocol for the development of a core domain set. Trials. 2014;15:511–20.CrossRefPubMedPubMedCentral
11.
Keeley T, Khan H, Pinfold V, Williamson P, Mathers J, Davies L, et al. Core outcome sets for use in effectiveness trials involving people with bipolar and schizophrenia in a community-based setting (PARTNERS2): study protocol for the development of two core outcome sets. Trials. 2015;16:47–56.CrossRefPubMedPubMedCentral
12.
Benstöm C, Moza A, Autschbach R, Stoppe C, Goetzenich A. A minimum core outcome set for clinical trials on non-minimal-invasive off- or on-pump cardiothoracic surgery. Trials. 2015;16 Suppl 3:O1.CrossRefPubMedCentral
13.
Sinha IP, Gallagher RL, Williamson PR, Smyth RL. Development of a core outcome set for clinical trials in childhood asthma: a survey of clinicians, parents, and young people. Trials. 2012;13:103.CrossRefPubMedPubMedCentral
14.
Kopkow C, Deckert S, Schmitt J, Sabatowski R, Kaiser U. Core outcome set to assess effectiveness in multimodal pain therapy — preliminary results of an interdisciplinary online survey. Trials. 2016;16 Suppl 1:P1.
15.
Copsey B, Hopewell S, Becker C, Cameron ID, Lamb SE. Appraising the uptake and use of recommendations for a common outcome data set for clinical trials: a case study in fall injury prevention. Trials. 2016;17:131–42.CrossRefPubMedPubMedCentral
16.
Spinewine A, Schmader KE, Barber N, Hughes C, Lapane KL, Swine C, et al. Appropriate prescribing in elderly people: how well can it be measured and optimised? Lancet. 2007;370:173–84.CrossRefPubMed
17.
18.
19.
20.
Loganathan M, Singh S, Franklin BD, Bottle A, Majeed A. Interventions to optimise prescribing in care homes: a systematic review. Age Ageing. 2011;40:150–62.CrossRefPubMed
21.
22.
23.
24.
Parsons C, Lapane K, Kerse N, Hughes C. Prescribing for older people in nursing homes: a review of the key issues. Int J Older People Nurs. 2011;6:45–54.CrossRefPubMed
25.
Guyatt GH, Oxman AD, Kunz R, Atkins D, Brozek J, Vist G, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol. 2011;64:395–400.CrossRefPubMed
26.
27.
28.
29.
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. Br Med J. 2004;329:15.CrossRef
30.
Ellett LM, Pratt NL, Ramsay EN, Barratt JD, Roughead EE. Multiple anticholinergic medication use and risk of hospital admission for confusion or dementia. J Am Geriatr Soc. 2014;62:1916–22.CrossRef
31.
32.
Shippee TP, Henning-Smith C, Kane RL, Lewis T. Resident- and facility-level predictors of quality of life in long-term care. Gerontologist. 2013;55:643–55.CrossRefPubMedPubMedCentral
33.
34.
Mease PJ, Arnold LM, Crofford LJ, Williams DA, Russell IJ, Humphrey L, Abetz L, Martin SA. Identifying the clinical domains of fibromyalgia: contributions from clinician and patient Delphi exercises. Arthritis Rheum. 2008;15(59):952–60.CrossRef
35.
Avery K, Chalmers K, Whale K, Blencowe N, Macefield R, Brookes S, et al. The importance of stakeholder selection in core outcome set development: how surveying different health professionals may influence outcome selection. Trials. 2015;16 Suppl 2:47.CrossRef
36.
37.
Potter S, Holcombe C, Ward JA, Blazeby JM, on behalf of the BRAVO Steering Group. Development of a core outcome set for research and audit studies in reconstructive breast surgery. Brit J Surg. 2015;102:1360–71.CrossRefPubMedPubMedCentral
38.
Gerritsen A, Jacobs M, Henselmans I, van Hattum J, Efficace F, Creemers GJ, et al. Developing a core set of patient-reported outcomes in pancreatic cancer: a Delphi survey. Eur J Cancer. 2016;57:68–77.CrossRefPubMed
39.
van’t Hooft J, Duffy JM, Daly M, Williamson PR, Meher S, Thom E, et al. A core outcome set for evaluation of interventions to prevent preterm birth. Obstet Gynecol. 2016;127:49–58.CrossRef
40.
Donohoe H, Stellefson M, Tennant B. Advantages and limitations of the e-Delphi technique: implications for health education researchers. Am J Health Educ. 2012;43:38–46.CrossRef
41.
Wylde V, MacKichan F, Bruce J, Gooberman-Hill R. Assessment of chronic post-surgical pain after knee replacement: development of a core outcome set. Eur J Pain. 2015;19:611–20.CrossRefPubMed
42.
Gallagher P, Ryan C, Byrne S, Kennedy J, O’Mahony D. STOPP (Screening Tool of Older Person’s Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment). Consensus validation. Int J Clin Pharmacol Ther. 2008;46:72–83.CrossRefPubMed
43.
Hanlon JT, Schmader KE, Samsa GP, Weinberger M, Uttech KM, Lewis IK, et al. A method for assessing drug therapy appropriateness. J Clin Epidemiol. 1992;45:1045–51.CrossRefPubMed
44.
Fick DM, Cooper JW, Wade WE, Waller JL, Maclean JR, Beers MH. Updating the Beers criteria for potentially inappropriate medication use in older adults: results of a US consensus panel of experts. Arch Intern Med. 2003;163:2716–24.CrossRefPubMed
45.
Sintonen H. The 15D instrument of health-related quality of life: properties and applications. Ann Med. 2001;33:328–36.CrossRefPubMed
46.
Ware J, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220–33.CrossRefPubMed
47.
Hilmer SN, Mager DE, Simonsick EM, Cao Y, Ling SM, Windham BG, et al. A drug burden index to define the functional burden of medications in older people. Arch Intern Med. 2007;167:781–7.CrossRefPubMed
48.
Boustani M, Campbell N, Munger S, Maidment I, Fox C. Impact of anticholinergics on the aging brain: a review and practical application. Aging Health. 2008;4:311–20.CrossRef
49.
Prinsen C, Vohra S, Rose MR, King-Jones S, Ishaque S, Bhaloo Z, et al. Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’. Trials. 2014;15:247.CrossRefPubMedPubMedCentral
50.
Lidwine B, Mokkink CB, Terwee DL, Alonso PJ, Stratford PW, Knol DL, et al. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010;19:539–49.CrossRef
51.
Higginson IJ, Carr AJ. Using quality of life measures in the clinical setting. Br Med J. 2001;26(322):1297–300.CrossRef
52.
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
53.
Gallagher P, Barry P, O’Mahony D. Inappropriate prescribing in the elderly. J Clin Pharm Ther. 2007;32:113–21.CrossRefPubMed
54.
O’Mahony D, O’Sullivan D, Byrne S, O’Connor MN, Ryan C, Gallagher P. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing. 2014;0:1–6. doi:10.​1093/​ageing/​afu145.
55.
Joint Formulary Committee. British National Formulary. 70th ed. London: BMJ Group and Pharmaceutical Press; 2016.
56.
Mallet M, Spinewine A, Huang A. The challenge of managing drug interactions in elderly people. Lancet. 2007;370:185–91.CrossRefPubMed
57.
58.
Bates DW, Cullen DJ, Laird N, Petersen MD, Small SD, Servi D, et al. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. J Am Med Assoc. 1995;274:29–34.CrossRef
59.
60.
61.
Fallowfield L. The quality of life: the missing measurement in health care. London: Souvenir; 1990.
Metadata
Title
Development of a core outcome set for effectiveness trials aimed at optimising prescribing in older adults in care homes
Authors
Anna N. Millar
Amrit Daffu-O’Reilly
Carmel M. Hughes
David P. Alldred
Garry Barton
Christine M. Bond
James A. Desborough
Phyo K. Myint
Richard Holland
Fiona M. Poland
David Wright
On behalf of the CHIPPS Team, University of East Anglia
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1915-6

Other articles of this Issue 1/2017

Trials 1/2017 Go to the issue

Study protocol

Low-volume versus high-volume initiated trans-anal irrigation therapy in adults with chronic constipation: study protocol for a randomised controlled trial

Study protocol

Radiation-induced toxicity after image-guided and intensity-modulated radiotherapy versus external beam radiotherapy for patients with spinal bone metastases (IRON-1): a study protocol for a randomized controlled pilot trial

Study protocol

Does intensive management improve remission rates in patients with intermediate rheumatoid arthritis? (the TITRATE trial): study protocol for a randomised controlled trial

Study protocol

COllaborative Shared care to IMprove Psychosis Outcome (COSIMPO): study protocol for a randomized controlled trial

Study protocol

Cardioprotective effect of Platycodon grandiflorum in patients with early breast cancer receiving anthracycline-based chemotherapy: study protocol for a randomized controlled trial

Commentary

Assessing loss to follow-up in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial