Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews

Objectives(a) To adapt the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-patient-reported outcome (PRO) Extension guidance to a user-friendly format for patient partners and (b) to codesign a web-based tool to support the dissemination and uptake of the SPIRIT-PRO Extension by patient partners.DesignA 1-day patient and public involvement session.ParticipantsSeven patient partners.MethodsA patient partner produced an initial lay summary of the SPIRIT-PRO guideline and a glossary. We held a 1-day PPI session in November 2019 at the University of Birmingham. Five patient partners discussed the draft lay summary, agreed on the final wording, codesigned and agreed the final content for both tools. Two additional patient partners were involved in writing the manuscript. The study compiled with INVOLVE guidelines and was reported according to the Guidance for Reporting Involvement of Patients and the Public 2 checklist.ResultsTwo user-friendly tools were developed to help patients and members of the public be involved in the codesign of clinical trials collecting PROs. The first tool presents a lay version of the SPIRIT-PRO Extension guidance. The second depicts the most relevant points, identified by the patient partners, of the guidance through an interactive flow diagram.ConclusionsThese tools have the potential to support the involvement of patient partners in making informed contributions to the development of PRO aspects of clinical trial protocols, in accordance with the SPIRIT-PRO Extension guidelines. The involvement of patient partners ensured the tools focused on issues most relevant to them.

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Longitudinal assessment of Integra in primary burn management: A randomized pediatric clinical trial*

Critical Care Medicine ◽

10.1097/01.ccm.0000285991.36698.e2 ◽

2007 ◽

Vol 35 (11) ◽

pp. 2615-2623 ◽

Cited By ~ 114

Author(s):

Ludwik K. Branski ◽

David N. Herndon ◽

Clifford Pereira ◽

Ronald P. Mlcak ◽

Mario M. Celis ◽

...

Keyword(s):

Clinical Trial ◽

Longitudinal Assessment ◽

Pediatric Clinical Trial

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The impact of clinical trial protocols on patient care in a community hospital

Cancer ◽

10.1002/1097-0142(19931101)72:9+<2828::aid-cncr2820721511>3.0.co;2-b ◽

1993 ◽

Vol 72 (S9) ◽

pp. 2828-2833 ◽

Cited By ~ 1

Author(s):

Robert J. Mckenna

Keyword(s):

Clinical Trial ◽

Patient Care ◽

Community Hospital ◽

Trial Protocols ◽

The Impact

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Adaptive Semantic Tag Mining from Heterogeneous Clinical Research Texts

Methods of Information in Medicine ◽

10.3414/me13-01-0130 ◽

2015 ◽

Vol 54 (02) ◽

pp. 164-170 ◽

Cited By ~ 5

Author(s):

T. Hao ◽

C. Weng

Keyword(s):

Clinical Trial ◽

Clinical Research ◽

Architectural Design ◽

Semantic Equivalence ◽

Clinical Text ◽

Mining Algorithm ◽

Prevalence Trends ◽

Trial Protocols ◽

Mining Methods ◽

Frequency Threshold

SummaryObjectives: To develop an adaptive approach to mine frequent semantic tags (FSTs) from heterogeneous clinical research texts.Methods: We develop a “plug-n-play” framework that integrates replaceable un-supervised kernel algorithms with formatting, functional, and utility wrappers for FST mining. Temporal information identification and semantic equivalence detection were two example functional wrappers. We first compared this approach’s recall and efficiency for mining FSTs from ClinicalTrials.gov to that of a recently published tag-mining algorithm. Then we assessed this approach’s adaptability to two other types of clinical research texts: clinical data requests and clinical trial protocols, by comparing the prevalence trends of FSTs across three texts.Results: Our approach increased the average recall and speed by 12.8% and 47.02% respectively upon the baseline when mining FSTs from ClinicalTrials.gov, and maintained an overlap in relevant FSTs with the baseline ranging between 76.9% and 100% for varying FST frequency thresholds. The FSTs saturated when the data size reached 200 documents. Consistent trends in the prevalence of FST were observed across the three texts as the data size or frequency threshold changed.Conclusions: This paper contributes an adaptive tag-mining framework that is scalable and adaptable without sacrificing its recall. This component-based architectural design can be potentially generalizable to improve the adaptability of other clinical text mining methods.

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