Developing a core outcome measurement set for clinical trials in acute diarrhoea

ObjectiveCore outcome sets are the baseline for what should be measured in clinical research and, thus, should serve as a guide for what should be collected and reported. The Consensus Group on Outcome Measures Made in Pediatric Enteral Nutrition Clinical Trials, established in 2012, agreed that consensus on a core set of outcomes with agreed-upon definitions that should be measured and reported in clinical trials was needed. To achieve this goal, six working groups (WGs) were setup, including WG on acute diarrhoea, whose main goal was to develop a core outcome set for trials in acute diarrhoea.MethodsThe first step identified how published outcomes related to acute diarrhoea were reported. The second focused on the methodology for determining which outcomes to measure in clinical trials. The third employed a two-phase questionnaire study using the Delphi technique to define clinically important outcomes to clinicians and parents.ResultsFor therapeutic studies, the five most important outcome measures were diarrhoea duration, degree of dehydration, need for hospitalisation (or duration of hospitalisation for inpatients), the proportion of patients recovered by 48 h and adverse effects. The prophylactic core outcome set included prevention of diarrhoea, prevention of dehydration, prevention of hospitalisation and adverse effects.ConclusionsThe outcome sets for therapy and prevention can be recommended for use in future trials of patients with gastroenteritis. Their envisioned goal is to decrease study heterogeneity and to ease the comparability of studies. WG's next step is to determine how to measure the outcomes included in the core set.

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Core outcome measurement instruments for clinical trials in nonspecific low back pain

Pain ◽

10.1097/j.pain.0000000000001117 ◽

2018 ◽

Vol 159 (3) ◽

pp. 481-495 ◽

Cited By ~ 80

Author(s):

Alessandro Chiarotto ◽

Maarten Boers ◽

Richard A. Deyo ◽

Rachelle Buchbinder ◽

Terry P. Corbin ◽

...

Keyword(s):

Clinical Trials ◽

Low Back Pain ◽

Back Pain ◽

Outcome Measurement ◽

Core Outcome ◽

Low Back ◽

Measurement Instruments

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Development of a core outcome set for clinical trials aimed at improving antimicrobial stewardship in care homes

Antimicrobial Resistance and Infection Control ◽

10.1186/s13756-021-00925-8 ◽

2021 ◽

Vol 10 (1) ◽

Author(s):

Hoa Q. Nguyen ◽

Declan T. Bradley ◽

Michael M. Tunney ◽

Carmel M. Hughes

Keyword(s):

Clinical Trials ◽

Antimicrobial Stewardship ◽

Outcome Measurement ◽

Evidence Synthesis ◽

Core Outcome Set ◽

Delphi Survey ◽

Care Homes ◽

Core Outcome ◽

Outcome Set ◽

Days Of Therapy

Abstract Background Diverse outcomes reported in clinical trials of antimicrobial stewardship (AMS) interventions in care homes have hindered evidence synthesis. Our main objective was to develop a core outcome set (COS) for use in trials aimed at improving AMS in care homes. Methods A refined inventory of outcomes for AMS interventions in care homes, compiled from a previous study, was rated in a three-round international Delphi survey with 82 participants, using a nine-point Likert scale (from 1, unimportant, to 9, critical). This was followed by an online consensus exercise with 12 participants from Northern Ireland to finalise the COS content. Subsequently, a suitable outcome measurement instrument (OMI) was selected for each outcome in the COS by: identifying existing OMIs through a literature search and experts’ suggestions, assessing the quality of OMIs, and selecting one OMI for each core outcome via a two-round international Delphi survey with 59 participants. Results Of 14 outcomes initially presented, consensus was reached for inclusion of five outcomes in the COS after the three-round Delphi survey and the online consensus exercise, comprising the total number of antimicrobial courses prescribed, appropriateness of antimicrobial prescribing, days of therapy per 1000 resident-days, rate of antimicrobial resistance, and mortality related to infection. Of 17 potential OMIs identified, three were selected for the two-round Delphi exercise after the quality assessment. Consensus was reached for selection of two OMIs for the COS. Conclusion This COS is recommended to be used in clinical trials aimed at improving AMS in care homes.

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Developing Core Outcome Measurement Sets for Clinical Trials: OMERACT Filter 2.0

Journal of Clinical Epidemiology ◽

10.1016/j.jclinepi.2013.11.013 ◽

2014 ◽

Vol 67 (7) ◽

pp. 745-753 ◽

Cited By ~ 433

Author(s):

Maarten Boers ◽

John R. Kirwan ◽

George Wells ◽

Dorcas Beaton ◽

Laure Gossec ◽

...

Keyword(s):

Clinical Trials ◽

Outcome Measurement ◽

Core Outcome

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Defining Outcome Measures for Psoriatic Arthritis: A Report from the GRAPPA-OMERACT Working Group

The Journal of Rheumatology ◽

10.3899/jrheum.170150 ◽

2017 ◽

Vol 44 (5) ◽

pp. 697-700 ◽

Cited By ~ 18

Author(s):

Alexis Ogdie ◽

Maarten de Wit ◽

Kristina Callis Duffin ◽

Willemina Campbell ◽

Jeffrey Chau ◽

...

Keyword(s):

Clinical Trials ◽

Psoriatic Arthritis ◽

Outcome Measures ◽

Working Group ◽

Development Process ◽

Outcome Measurement ◽

Core Outcome ◽

Core Domain ◽

Core Set ◽

Core Domain Set

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Core Set working group recently published the updated 2016 psoriatic arthritis (PsA) core domain set, a set of disease features that should be measured in all clinical trials. At the GRAPPA annual meeting in July 2016, the PsA working group presented the updated PsA core domain set endorsed by 90% of participants at OMERACT in May 2016 and drafted a roadmap for the development of the PsA core outcome measurement set. In this manuscript, we review the development process of the PsA core domain set and the ongoing and proposed work streams for development of a PsA core measurement set.

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