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

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 Poland; David  Wright; CHIPPS Team Trials

doi:10.1186/s13063-017-1915-6

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

Anna N. Millar (Corresponding Author), Amrit Daffu-O'Reilly, Carmel M Hughes, David P Alldred, Garry Barton, Christine M Bond, James A Desborough, Phyo K Myint, Richard Holland, Fiona Poland, David Wright, CHIPPS Team Trials

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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.

Original language	English
Article number	175
Journal	Trials
Volume	18
DOIs	https://doi.org/10.1186/s13063-017-1915-6
Publication status	Published - 12 Apr 2017

Bibliographical note

Acknowledgements
We wish to thank all the participants in this study. On behalf of the CHIPPS Team, we would also like to acknowledge the South Norfolk Clinical Commissioning Group as the study sponsor. We thank also the following members of the CHIPPS Team for their contribution towards the preparation of this manuscript: Annie Blyth, University of East Anglia; Kate Massey, Norfolk & Suffolk Primary and Community Care Research Office; Vivienne Maskrey, University of East Anglia; Clare Symms, Norfolk & Suffolk Primary and Community Care Research Office; Arnold Zermansky, University of Leeds.

Funding
This is a summary of independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Grant Reference Number RP-PG-0613-20007). The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR or the Department of Health.

Keywords

Core outcome set
COS
Optimising prescribing
Medicines Optimisation
Older adults
Care homes
Delphi technique
Consensus
CHIPPS

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Development of a core outcome set for effectiveness trials aimed at optimising prescribing in older adults in care homes
© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated
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Cite this

Millar, A. N., Daffu-O'Reilly, A., Hughes, C. M., Alldred, D. P., Barton, G., Bond, C. M., Desborough, J. A., Myint, P. K., Holland, R., Poland, F., Wright, D., & CHIPPS Team Trials (2017). Development of a core outcome set for effectiveness trials aimed at optimising prescribing in older adults in care homes. Trials, 18, Article 175. https://doi.org/10.1186/s13063-017-1915-6

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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.",

keywords = "Core outcome set, COS, Optimising prescribing, Medicines Optimisation, Older adults, Care homes, Delphi technique, Consensus, CHIPPS",

author = "Millar, {Anna N.} and Amrit Daffu-O'Reilly and Hughes, {Carmel M} and Alldred, {David P} and Garry Barton and Bond, {Christine M} and Desborough, {James A} and Myint, {Phyo K} and Richard Holland and Fiona Poland and David Wright and {CHIPPS Team Trials}",

note = "Acknowledgements We wish to thank all the participants in this study. On behalf of the CHIPPS Team, we would also like to acknowledge the South Norfolk Clinical Commissioning Group as the study sponsor. We thank also the following members of the CHIPPS Team for their contribution towards the preparation of this manuscript: Annie Blyth, University of East Anglia; Kate Massey, Norfolk & Suffolk Primary and Community Care Research Office; Vivienne Maskrey, University of East Anglia; Clare Symms, Norfolk & Suffolk Primary and Community Care Research Office; Arnold Zermansky, University of Leeds. Funding This is a summary of independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Grant Reference Number RP-PG-0613-20007). The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR or the Department of Health.",

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day = "12",

doi = "10.1186/s13063-017-1915-6",

language = "English",

volume = "18",

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TY - JOUR

T1 - Development of a core outcome set for effectiveness trials aimed at optimising prescribing in older adults in care homes

AU - Millar, Anna N.

AU - Daffu-O'Reilly, Amrit

AU - Hughes, Carmel M

AU - Alldred, David P

AU - Barton, Garry

AU - Bond, Christine M

AU - Desborough, James A

AU - Myint, Phyo K

AU - Holland, Richard

AU - Poland, Fiona

AU - Wright, David

AU - CHIPPS Team Trials

N1 - Acknowledgements We wish to thank all the participants in this study. On behalf of the CHIPPS Team, we would also like to acknowledge the South Norfolk Clinical Commissioning Group as the study sponsor. We thank also the following members of the CHIPPS Team for their contribution towards the preparation of this manuscript: Annie Blyth, University of East Anglia; Kate Massey, Norfolk & Suffolk Primary and Community Care Research Office; Vivienne Maskrey, University of East Anglia; Clare Symms, Norfolk & Suffolk Primary and Community Care Research Office; Arnold Zermansky, University of Leeds. Funding This is a summary of independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Grant Reference Number RP-PG-0613-20007). The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR or the Department of Health.

PY - 2017/4/12

Y1 - 2017/4/12

N2 - 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.

AB - 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.

KW - Core outcome set

KW - COS

KW - Optimising prescribing

KW - Medicines Optimisation

KW - Older adults

KW - Care homes

KW - Delphi technique

KW - Consensus

KW - CHIPPS

U2 - 10.1186/s13063-017-1915-6

DO - 10.1186/s13063-017-1915-6

M3 - Article

SN - 1745-6215

VL - 18

JO - Trials

JF - Trials

M1 - 175

ER -

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

Abstract

Bibliographical note

Keywords

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