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

doi:10.1007/s11136-022-03127-w

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

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

1 Citation (Scopus)

44 Downloads (Pure)

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.

Original language	English
Pages (from-to)	2901–2916
Number of pages	16
Journal	Quality of Life Research
Volume	31
Early online date	12-May-2022
DOIs	https://doi.org/10.1007/s11136-022-03127-w
Publication status	Published - Oct-2022
Externally published	Yes

Access to Document

10.1007/s11136-022-03127-wLicence: CC BY

Improving the patient-reported outcome sections of clinical trial protocolsFinal publisher's version, 619 KBLicence: CC BY

Handle.net

Persistent link

Cite this

@article{65dc5241132b47c38bac48e049bbfd32,

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

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.",

author = "King, {Madeleine T} and Margaret-Ann Tait and Rachel Campbell and Fabiola M{\"u}ller and Claudia Rutherford and Corinna Beckmore and Sophie Chima and Danette Langbecker and Joanne Shaw and Rebecca Mercieca-Bebber",

note = "{\textcopyright} 2022. The Author(s).",

year = "2022",

month = oct,

doi = "10.1007/s11136-022-03127-w",

language = "English",

volume = "31",

pages = "2901–2916",

journal = "Quality of Life Research",

issn = "1573-2649",

publisher = "Springer",

}

TY - JOUR

T1 - Improving the patient-reported outcome sections of clinical trial protocols

T2 - a mixed methods evaluation of educational workshops

AU - King, Madeleine T

AU - Tait, Margaret-Ann

AU - Campbell, Rachel

AU - Müller, Fabiola

AU - Rutherford, Claudia

AU - Beckmore, Corinna

AU - Chima, Sophie

AU - Langbecker, Danette

AU - Shaw, Joanne

AU - Mercieca-Bebber, Rebecca

PY - 2022/10

Y1 - 2022/10

N2 - 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.

AB - 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.

U2 - 10.1007/s11136-022-03127-w

DO - 10.1007/s11136-022-03127-w

M3 - Article

C2 - 35553325

SN - 1573-2649

VL - 31

SP - 2901

EP - 2916

JO - Quality of Life Research

JF - Quality of Life Research

ER -

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

Abstract

Access to Document

Handle.net

Fingerprint

Cite this