Development of a Core Outcome Measurement Set for studies of community pharmacist-led medication reviews in older patients with multimorbidity and polypharmacy
11 affiliations
- 1Heidelberg University, Medical Faculty Heidelberg / Heidelberg University Hospital, Internal Medicine IX – Department of Clinical Pharmacology and Pharmacoepidemiology, Cooperation Unit Clinical Pharmacy, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany
- 2Department of Medicine, ABDA-Federal Union of German Associations of Pharmacists, Berlin, Germany
- 3Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Louvain, Belgium
- 4School of Pharmacy, Queen’s University Belfast, Belfast, Northern Ireland
- 5Medical Faculty Heidelberg, Department of Anesthesiology, Pain Medicine Section, Heidelberg University, Heidelberg, Germany
- 6Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg, Heidelberg, Germany
- 7Institute for General Practice and Interprofessional Care, Tübingen University Hospital, Tübingen, Germany
- 8School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin, Republic of Ireland
- 9Institute of Pharmacy, Freie Universität Berlin, Berlin, Germany
- 10Primary Health Care, Leiden University Medical Center, Leiden, The Netherlands
- 11Department of Clinical Pharmacy, Institute of Pharmacy, University of Bonn, Bonn, Germany
Abstract
Introduction: A Core Outcome Set (COS) can harmonize outcome reporting. For medication review (MR) studies targeting older, multi-morbid patients with polypharmacy, a COS with seven outcomes is available: Health-related Quality of Life (HRQoL), pain relief, overuse, underuse, potentially inappropriate medications (PIMs), clinically significant drug-drug-interactions (DDIs), drug-related hospitalization. However, the lack of standardized outcome measurement is a barrier to its application. Thus, the next step is to operationalize each outcome by standardizing their measurement, resulting in a Core Outcome Measurement Set (COMS). As operationalization is setting-specific, a COMS was developed for MR studies in community pharmacies. Depending on the outcome type, the aims were to (1) identify outcome measurement instruments (OMIs), (2) define quality criteria for OMI selection, (3) refine outcome definitions, and/or (4) seek agreement on the appropriate measurement methods.
Method: Literature searches were conducted to identify OMIs. A group of 10 experts was assembled, with at least one expert contributing to each outcome. Throughout the study, they completed two online surveys and took part in two online workshops. Based on the type of outcome, different approaches were undertaken: (1) The experts selected the most appropriate OMIs for HRQoL and pain relief. (2) Recognizing national differences in OMIs for overuse, underuse and PIMs, experts established universal quality criteria for OMIs’ selection to be applied for studies. (3) To operationalize DDIs and drug-related hospitalization, experts refined the definitions of what to measure. (4) For drug-related hospitalization experts sought to identify the best measurement method.
Results: (1) The experts selected the EQ-5D-5L as most appropriate OMI for HRQoL and upon numerical and visual analogue scales for pain relief. (2) Seven quality criteria were defined for the content of OMIs on overuse, underuse, and PIMs. No thresholds were established for validity and feasibility criteria. (3) DDIs to be measured were refined as those with a 'major' severity rating. Drug-related hospitalization was refined as unplanned overnight stays; (4) measured by patients’ reporting.
Conclusion: By translating the existing COS into a practical measurement framework, this COMS supports more standardized and comparable MR research.
Trial registration: Registered on 16 August 2023 at Open Science Framework (https://osf.io/57jfc).
Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s11096-026-02223-y.
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BibTeX
@article{vogt2026development,
title = {{Development of a Core Outcome Measurement Set for studies of community pharmacist-led medication reviews in older patients with multimorbidity and polypharmacy}},
author = {Cathrin J. Vogt and Christiane Eickhoff and Veerle Foulon and Carmel Hughes and Jens Kessler and Cinara Paul and Cristín Ryan and Martin Schulz and Martina Teichert and Ronja Woltersdorf and Viktoria S. Wurmbach and Hanna M. Seidling},
journal = {International Journal of Clinical Pharmacy},
year = {2026},
month = sep,
doi = {10.1007/s11096-026-02223-y},
url = {https://doi.org/10.1007/s11096-026-02223-y},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Development of a Core Outcome Measurement Set for studies of community pharmacist-led medication reviews in older patients with multimorbidity and polypharmacy
AU - Cathrin J. Vogt
AU - Christiane Eickhoff
AU - Veerle Foulon
AU - Carmel Hughes
AU - Jens Kessler
AU - Cinara Paul
AU - Cristín Ryan
AU - Martin Schulz
AU - Martina Teichert
AU - Ronja Woltersdorf
AU - Viktoria S. Wurmbach
AU - Hanna M. Seidling
PY - 2026
DA - 2026/09/16
JO - International Journal of Clinical Pharmacy
DO - 10.1007/s11096-026-02223-y
UR - https://doi.org/10.1007/s11096-026-02223-y
AB - Introduction: A Core Outcome Set (COS) can harmonize outcome reporting. For medication review (MR) studies targeting older, multi-morbid patients with polypharmacy, a COS with seven outcomes is available: Health-related Quality of Life (HRQoL), pain relief, overuse, underuse, potentially inappropriate medications (PIMs), clinically significant drug-drug-interactions (DDIs), drug-related hospitalization. However, the lack of standardized outcome measurement is a barrier to its application. Thus, the next step is to operationalize each outcome by standardizing their measurement, resulting in a Core Outcome Measurement Set (COMS). As operationalization is setting-specific, a COMS was developed for MR studies in community pharmacies. Depending on the outcome type, the aims were to (1) identify outcome measurement instruments (OMIs), (2) define quality criteria for OMI selection, (3) refine outcome definitions, and/or (4) seek agreement on the appropriate measurement methods. Method: Literature searches were conducted to identify OMIs. A group of 10 experts was assembled, with at least one expert contributing to each outcome. Throughout the study, they completed two online surveys and took part in two online workshops. Based on the type of outcome, different approaches were undertaken: (1) The experts selected the most appropriate OMIs for HRQoL and pain relief. (2) Recognizing national differences in OMIs for overuse, underuse and PIMs, experts established universal quality criteria for OMIs’ selection to be applied for studies. (3) To operationalize DDIs and drug-related hospitalization, experts refined the definitions of what to measure. (4) For drug-related hospitalization experts sought to identify the best measurement method. Results: (1) The experts selected the EQ-5D-5L as most appropriate OMI for HRQoL and upon numerical and visual analogue scales for pain relief. (2) Seven quality criteria were defined for the content of OMIs on overuse, underuse, and PIMs. No thresholds were established for validity and feasibility criteria. (3) DDIs to be measured were refined as those with a 'major' severity rating. Drug-related hospitalization was refined as unplanned overnight stays; (4) measured by patients’ reporting. Conclusion: By translating the existing COS into a practical measurement framework, this COMS supports more standardized and comparable MR research. Trial registration: Registered on 16 August 2023 at Open Science Framework (https://osf.io/57jfc). Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s11096-026-02223-y.
SN - 2210-7703
SN - 2210-7711
ER -