Evidence map›Paper›PMID 35553325›Full record

ArticleQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2022

Improving the patient-reported outcome sections of clinical trial protocols: a mixed methods evaluation of educational workshops.

Madeleine T King, Margaret-Ann Tait, Rachel Campbell, Fabiola Müller, Claudia Rutherford, Corinna Beckmore, Sophie Chima, Danette Langbecker, Joanne Shaw, Rebecca Mercieca-Bebber

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Article in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

10 authors.

Madeleine T KingSydney Quality of Life Office, School of Psychology, University of Sydney, Sydney, NSW, 2006, Australia. madeleine.king@sydney.edu.au.ORCID http://orcid.org/0000-0001-7192-2887
Margaret-Ann TaitSydney Quality of Life Office, School of Psychology, University of Sydney, Sydney, NSW, 2006, Australia.
Rachel CampbellSydney Quality of Life Office, School of Psychology, University of Sydney, Sydney, NSW, 2006, Australia.
Fabiola MüllerSydney Quality of Life Office, School of Psychology, University of Sydney, Sydney, NSW, 2006, Australia.
Claudia RutherfordSydney Quality of Life Office, School of Psychology, University of Sydney, Sydney, NSW, 2006, Australia.
Corinna BeckmoreBreast Cancer Trials, Newcastle, Australia.
Sophie ChimaDepartment of General Practice, Faculty of Medicine, Dentistry and Health Sciences, Centre for Cancer Research, University of Melbourne, Victorian Comprehensive Cancer Centre, Melbourne, VIC, Australia.
Danette LangbeckerCentre for Online Health, The University of Queensland, St Lucia, Australia.
Joanne ShawPsycho-oncology Co-operative Research Group, School of Psychology, The University of Sydney, Sydney, Australia.
Rebecca Mercieca-BebberNHMRC Clinical Trial Centre, University of Sydney, Sydney, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFailure to incorporate key patient-reported outcome (PRO) content in trial protocols affects the quality and interpretability of the collected data, contributing to research waste. Our group developed evidence-based training specifically addressing PRO components of protocols. We aimed to assess whether 2-day educational workshops improved the PRO completeness of protocols against consensus-based minimum standards provided in the SPIRIT-PRO Extension in 2018.

methodAnnual workshops were conducted 2011-2017. Participants were investigators/trialists from cancer clinical trials groups. Although developed before 2018, workshops covered 15/16 SPIRIT-PRO items. Participant feedback immediately post-workshop and, retrospectively, in November 2017 was summarised descriptively. Protocols were evaluated against SPIRIT-PRO by two independent raters for workshop protocols (developed post-workshop by participants) and control protocols (contemporaneous non-workshop protocols). SPIRIT-PRO items were assessed for completeness (0 = not addressed, 10 = fully addressed). Mann-Whitney U tests assessed whether workshop protocols scored higher than controls by item and overall.

resultsParticipants (n = 107) evaluated the workshop positively. In 2017, 16/41 survey responders (39%) reported never applying in practice; barriers included role restrictions (14/41, 34%) and lack of time (5/41, 12%). SPIRIT-PRO overall scores did not differ between workshop (n = 13, median = 3.81/10, interquartile range = 3.24) and control protocols (n = 9, 3.51/10 (2.14)), (p = 0.35). Workshop protocols scored higher than controls on two items: 'specify PRO concepts/domains' (p = 0.05); 'methods for handling missing data' (p = 0.044).

conclusionAlthough participants were highly satisfied with these workshops, the completeness of PRO protocol content generally did not improve. Additional knowledge translation efforts are needed to assist protocol writers address SPIRIT-PRO guidance and avoid research waste that may eventuate from sub-optimal PRO protocol content.

Indexed as

Patient Reported Outcome MeasuresQuality of LifeClinical Trial Protocols as TopicData CollectionHumansResearch DesignRetrospective StudiesClinical trial protocolsEducationPatient-reported outcomesResearch wasteTraining

Identifiers

PMID35553325
PMCPMC9470723

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.