Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Oct;31(10):2901-2916.
doi: 10.1007/s11136-022-03127-w. Epub 2022 May 12.

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

Madeleine T King  1 , Margaret-Ann Tait  2 , Rachel Campbell  2 , Fabiola Müller  2   3 , Claudia Rutherford  2   4 , Corinna Beckmore  5 , Sophie Chima  6 , Danette Langbecker  7 , Joanne Shaw  8 , Rebecca Mercieca-Bebber  9
Affiliations

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

Madeleine T King et al. Qual Life Res. 2022 Oct.

Abstract

Introduction: Failure 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.

Method: Annual 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.

Results: Participants (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).

Conclusion: Although 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.

Keywords: Clinical trial protocols; Education; Patient-reported outcomes; Research waste; Training.

PubMed Disclaimer

Conflict of interest statement

Authors MK, MT, RC, FM, CR, and RMB received partial funding towards salaries from the Australian Government through Cancer Australia while providing the Quality of Life Technical Service to the Multi-site Collaborative Cancer Clinical Trials Groups. In their roles within the Multi-site Collaborative Cancer Clinical Trials Groups, authors CB, SC, DL, and JS received partial funding towards salaries from the Australian Government through Cancer Australia. Authors MK and RMB were members of the executive group that led the development of the SPIRIT-PRO guidance.

Figures

Fig. 1
Fig. 1
SPIRIT-PRO items addressed in protocols developed by workshop participants (n = 13)
See this image and copyright information in PMC

References

    1. Macleod MR, Michie S, Roberts I, Dirnagl U, Chalmers I, Ioannidis JP, et al. Biomedical research: Increasing value, reducing waste. The Lancet. 2014;1(9912):101–104. doi: 10.1016/S0140-6736(13)62329-6. - DOI - PubMed
    1. Ioannidis JP, Greenland S, Hlatky MA, Khoury MJ, Macleod MR, Moher D, et al. Increasing value and reducing waste in research design, conduct, and analysis. The Lancet. 2014;383(9912):166–175. doi: 10.1016/s0140-6736(13)62227-8. - DOI - PMC - PubMed
    1. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: Defining standard protocol items for clinical trials. Annals of Internal Medicine. 2013;158(3):200–207. doi: 10.7326/0003-4819-158-3-201302050-00583. - DOI - PMC - PubMed
    1. Chan AW, Song F, Vickers A, Jefferson T, Dickersin K, Gøtzsche PC, et al. Increasing value and reducing waste: Addressing inaccessible research. The Lancet. 2014;383(9913):257–266. doi: 10.1016/s0140-6736(13)62296-5. - DOI - PMC - PubMed
    1. Vodicka E, Kim K, Devine EB, Gnanasakthy A, Scoggins JF, Patrick DL. Inclusion of patient-reported outcome measures in registered clinical trials: Evidence from ClinicalTrials.gov (2007–2013) Contemporary Clinical Trials. 2015;43:1–9. doi: 10.1016/j.cct.2015.04.004. - DOI - PubMed

LinkOut - more resources