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Artificial intelligence tools for optimising recruitment and retention in clinical trials: a scoping review protocol

Por: Lu · X. · Chen · M. · Lu · Z. · Shi · X. · Liang · L.
Introduction

In recent years, the influence of artificial intelligence technology on clinical trials has been steadily increasing. It has brought about significant improvements in the efficiency and cost reduction of clinical trials. The objective of this scoping review is to systematically map, describe and summarise the current utilisation of artificial intelligence in recruitment and retention process of clinical trials that has been reported in research. Additionally, the review aims to identify benefits and drawbacks, as well as barriers and facilitators associated with the application of artificial intelligence in optimising recruitment and retention in clinical trials. The findings of this review will provide insights and recommendations for future development of artificial intelligence in the context of clinical trials.

Methods and analysis

The review of relevant literature will follow the methodological framework for scoping studies provided by the Joanna Briggs Institute. A comprehensive electronic search will be conducted using the search strategy developed by the authors. Leading medical and computer science databases such as PubMed, Embase, Scopus, IEEE Xplore and Web of Science Core Collection will be searched. The search will encompass analytical observational studies, descriptive observational studies, experimental and quasi-experimental studies published in all languages, without any time limitations, which use artificial intelligence tools in the recruitment and retention process of clinical trials. The review team will screen the identified studies and import them into a dedicated electronic library specifically created for this review. Data extraction will be performed using a data charting table.

Ethics and dissemination

Secondary data will be attained in this scoping review; therefore, no ethical approval is required. The results of the final review will be published in a peer-reviewed journal. It is expected that results will inform future artificial intelligence and clinical trials research.

Voluntariness of consent in paediatric HIV clinical trials: a mixed-methods, cross-sectional study of participants in the CHAPAS-4 and ODYSSEY trials in Uganda

Por: Makumbi · S. · Bajunirwe · F. · Ford · D. · Turkova · A. · South · A. · Lugemwa · A. · Musiime · V. · Gibb · D. · Tamwesigire · I. K.
Objectives

To examine the voluntariness of consent in paediatric HIV clinical trials and the associated factors.

Design

Mixed-methods, cross-sectional study combining a quantitative survey conducted concurrently with indepth interviews.

Setting and participants

From January 2021 to April 2021, we interviewed parents of children on first-line or second-line Anti-retroviral therapy (ART) in two ongoing paediatric HIV clinical trials [CHAPAS-4 (ISRCTN22964075) and ODYSSEY (ISRCTN91737921)] at the Joint Clinical Research Centre Mbarara, Uganda.

Outcome measures

The outcome measures were the proportion of parents with voluntary consent, factors affecting voluntariness and the sources of external influence. Parents rated the voluntariness of their consent on a voluntariness ladder. Indepth interviews described participants’ lived experiences and were aimed at adding context.

Results

All 151 parents randomly sampled for the survey participated (84% female, median age 40 years). Most (67%) gave a fully voluntary decision, with a score of 10 on the voluntariness ladder, whereas 8% scored 9, 9% scored 8, 6% scored 7, 8% scored 6 and 2.7% scored 4. Trust in medical researchers (adjusted OR 9.90, 95% CI 1.01 to 97.20, p=0.049) and male sex of the parent (adjusted OR 3.66, 95% CI 1.00 to 13.38, p=0.05) were positively associated with voluntariness of consent. Prior research experience (adjusted OR 0.31, 95% CI 0.12 to 0.78, p=0.014) and consulting (adjusted OR 0.25. 95% CI 0.10 to 0.60, p=0.002) were negatively associated with voluntariness. Consultation and advice came from referring health workers (36%), spouses (29%), other family members (27%), friends (15%) and researchers (7%). The indepth interviews (n=14) identified the health condition of the child, advice from referring health workers and the opportunity to access better care as factors affecting the voluntariness of consent.

Conclusions

This study demonstrated a high voluntariness of consent, which was enhanced among male parents and by parents’ trust in medical researchers. Prior research experience of the child and advice from health workers and spouses were negatively associated with the voluntariness of parents’ consent. Female parents and parents of children with prior research experience may benefit from additional interventions to support voluntary participation.

Comparative survey among paediatricians, nurses and health information technicians on ethics implementation knowledge of and attitude towards social experiments based on medical artificial intelligence at childrens hospitals in Shanghai: a cross-sectional

Por: Wang · Y. · Fu · W. · Gu · Y. · Fang · W. · Zhang · Y. · Jin · C. · Yin · J. · Wang · W. · Xu · H. · Ge · X. · Ye · C. · Tang · L. · Fang · J. · Wang · D. · Su · L. · Wang · J. · Zhang · X. · Feng · R.
Objectives

Implementing ethics is crucial to prevent harm and promote widespread benefits in social experiments based on medical artificial intelligence (MAI). However, insufficient information is available concerning this within the paediatric healthcare sector. We aimed to conduct a comparative survey among paediatricians, nurses and health information technicians regarding ethics implementation knowledge of and attitude towards MAI social experiments at children’s hospitals in Shanghai.

Design and setting

A cross-sectional electronic questionnaire was administered from 1 July 2022 to 31 July 2022, at tertiary children’s hospitals in Shanghai.

Participants

All the eligible individuals were recruited. The inclusion criteria were as follows: (1) should be a paediatrician, nurse and health information technician, (2) should have been engaged in or currently participating in social experiments based on MAI, and (3) voluntary participation in the survey.

Primary outcome

Ethics implementation knowledge of and attitude to MAI social experiments among paediatricians, nurses and health information technicians.

Results

There were 137 paediatricians, 135 nurses and 60 health information technicians who responded to the questionnaire at tertiary children’s hospitals. 2.4–9.6% of participants were familiar with ethics implementation knowledge of MAI social experiments. 31.9–86.1% of participants held an ‘agree’ ethics implementation attitude. Health information technicians accounted for the highest proportion of the participants who were familiar with the knowledge of implementing ethics, and paediatricians or nurses accounted for the highest proportion among those who held ‘agree’ attitudes.

Conclusions

There is a significant knowledge gap and variations in attitudes among paediatricians, nurses and health information technicians, which underscore the urgent need for individualised education and training programmes to enhance MAI ethics implementation in paediatric healthcare.

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