scholarly journals Going on up to the SPIRIT in AI: will new reporting guidelines for clinical trials of AI interventions improve their rigour?

BMC Medicine ◽  
2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Paul Wicks ◽  
Xiaoxuan Liu ◽  
Alastair K. Denniston
Keyword(s):  
Clinical Trials ◽  
Reporting Guidelines

scholarly journals Compliance with clinical trial registration and reporting guidelines by Latin American and Caribbean journals

2013 ◽  
Vol 29 (6) ◽  
pp. 1095-1100 ◽  
Author(s):  
Ludovic Reveiz ◽  
Eleana Villanueva ◽  
Chimaraoke Iko ◽  
Iveta Simera
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Latin American ◽  
Randomized Clinical Trials ◽  
Reporting Guidelines ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Biomedical Journals ◽  
The Caribbean ◽  
Latin American And Caribbean

The objective of this study was to determine to what extent Latin American and Caribbean biomedical journals have endorsed and complied with clinical trial registration and reporting guidelines. A search of randomized clinical trials was carried out using the LILACS database. The randomized clinical trials identified through the search were assessed to determine whether trial registration and CONSORT guidance was mentioned. Information regarding endorsement of the ICMJE, trial registration and other reporting guidelines was extracted from the online instructions for authors of the journals included in the study. The search identified 477 references. We assessed a random sample of 240 titles of which 101 were randomized clinical trials published in 56 journals. Trial registration was reported in 19.8% of the randomized clinical trials, 6.9% were prospectively registered and 3% mentioned CONSORT. The ICMJE was mentioned by 68% of the journals and 36% of journals required trial registration. Fewer journals provided advice on reporting guidelines: CONSORT (13%), PRISMA (1.8%), STROBE (1.8%), and the EQUATOR network (3.6%). Wider endorsement of trial registration and adherence to reporting guidelines is necessary in clinical trials conducted in Latin America and the Caribbean.

Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: a systematic review

2017 ◽  
Vol 91 ◽  
pp. 111-120 ◽  
Author(s):  
Anne-France Motte ◽  
Stéphanie Diallo ◽  
Hélène van den Brink ◽  
Constance Châteauvieux ◽  
Carole Serrano ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Medical Devices ◽  
Reporting Guidelines ◽  
Implantable Medical Devices

scholarly journals S591 Adherence to the SPIRIT-AI Standardized Reporting Guidelines in Artificial Intelligence Clinical Trials in Gastroenterology

2021 ◽  
Vol 116 (1) ◽  
pp. S268-S269
Author(s):  
Erik A. Holzwanger ◽  
Mohammad Bilal ◽  
Jeremy Glissen Brown ◽  
Ishita Barua ◽  
Mandeep S. Sawhney ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Clinical Trials ◽  
Reporting Guidelines ◽  
Standardized Reporting

scholarly journals A Qualitative Review of the Psychometric Properties and Feasibility of Electronic Headache Diaries for Children and Adults: Where We Are and Where We Need to Go

2013 ◽  
Vol 18 (3) ◽  
pp. 142-152 ◽  
Author(s):  
Jennifer N Stinson ◽  
Anna Huguet ◽  
Patrick McGrath ◽  
Brittany Rosenbloom ◽  
Charlene Soobiah ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Psychometric Properties ◽  
Information And Communication Technologies ◽  
Reliability And Validity ◽  
Final Analysis ◽  
Reporting Guidelines ◽  
Self Report ◽  
Measurement Properties ◽  
Essential Components ◽  
Headache Pain

BACKGROUND: While paper headache pain diaries have been used to determine the effectiveness of headache treatments in clinical trials, recent advances in information and communication technologies have resulted in the burgeoning use of electronic diaries (e-diaries) for headache pain.OBJECTIVE: To qualitatively review headache e-diaries, assess their measurement properties, examine measurement components and compare these components with recommended reporting guidelines.METHODS: The databases Medline, the Cumulative Index to Nursing and Allied Health Literature, Embase, PsychInfo, the Education Resources Information Centre and ISI Web of Science were searched for self-report headache e-diaries for children and adults. A total of 21 publications that involved e-diaries were found; five articles reported on the development of an e-diary and 16 used an e-diary as an outcome measure in randomized controlled trials or observational studies. The diary measures’ components, features and psychometric properties, as well as the quality of evidence of their psychometric properties, were evaluated.RESULTS: Five headache e-diaries met the a priori criteria and were included in the final analysis. None of these e-diaries had well-developed evidence of reliability and validity. Three e-diaries showed evidence of feasibility. E-diaries with ad hoc measures developed by the study investigators were most common, with little to no supportive evidence of reliability and/or validity. Compliance with the reporting guidelines was variable, with only one-half of the e-diaries measuring the recommended primary outcome of headache frequency.CONCLUSIONS: Specific recommendations regarding the development (including essential components) and testing of headache e-diaries are discussed. Further research is needed to strengthen the measurement of headache pain in clinical trials using headache e-diaries.

scholarly journals Do overly complex reporting guidelines remove the focus from good clinical trials?

BMJ ◽  
2021 ◽  
pp. n1793
Author(s):  
Jeremy Howick ◽  
Rebecca Webster ◽  
J André Knottnerus ◽  
David Moher
Keyword(s):  
Clinical Trials ◽  
Reporting Guidelines
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