Identifying the participant characteristics that predict recruitment and retention of participants to RCTs involving children : a systematic review

Background: Randomised controlled trials (RCTs) are recommended as the gold standard in evaluating healthcare interventions. The conduct of RCTs is often impacted by difficulties surrounding recruitment and retention of participants in both adult and child populations. Factors influencing recruitment and retention of children to RCTs can be more complex than in adults. There is little synthesised evidence of what influences participation in research involving parents and children. Aim: To identify predictors of recruitment and retention in RCTs involving children. Methods/ Design: A systematic review of RCTs was conducted to synthesise the available evidence. An electronic search strategy was applied to four databases and restricted to English language publications. Quantitative studies reporting participant predictors of recruitment and retention in RCTs involving children aged 0-12 were identified. Data was extracted and synthesised narratively. Quality assessment of articles was conducted using a structured tool developed from two existing quality evaluation checklists. Results: 28 studies were included in the review. Of the 154 participant factors reported, 66 were found to be significant predictors of recruitment and retention in at least one study. These were classified as parent, child, family and neighbourhood characteristics. Parent characteristics (e.g. ethnicity, age, education, socio economic status) were the most commonly reported predictors of participation for both recruitment and retention. Being young, less educated, of an ethnic minority and low socio economic status (SES) appear to be barriers to participation in RCTs although there was little agreement between studies. When analysed according to setting and severity of the child’s illness there appeared to be little variation between groups. The quality of the studies varied. Articles adhered well to reporting guidelines around provision of a scientific rationale for the study and background information as well as displaying good internal consistency of results. However, few studies discussed the external validity of the results or provided recommendations for future research. Conclusion: Parent characteristics may predict participation of children and their families to RCTs, however, there was a lack of consensus. Whilst socio-demographics variables may be useful in identifying which groups are least likely to participate they do not provide insight into the processes and barriers to participation for children and families. Further studies that explore variables that can be influenced are warranted. Reporting of studies in this field need greater clarity as well as agreed definitions of what is meant by retention

Pathology Data Prioritisation: A Study of Using Multi-variate Time Series

In any hospital, pathology results play an important role for decision making. However, it is not unusual for clinicians to have hundreds of pathology results to review on a single shift; this “information overload” presents a particular challenge. Some form of pathology result prioritisation is therefore a necessity. One idea to deal with this problem is to adopt the tools and techniques of machine learning to identify prioritisation patterns within pathology results and use these patterns to label new pathology data according to a prioritisation classification protocol. However, in most clinical situations there is an absence of any pathology prioritisation ground truth. The usage of supervised learning therefore becomes a challenge. Unsupervised learning methods are available, but are not considered to be as effective as supervised learning methods. This paper considers two mechanisms for pathology data prioritisation in the absence of a ground truth: (i) Proxy Ground Truth Pathology Data Prioritisation (PGR-PDP), and (ii) Future Result Forecast Pathology Data Prioritisation (FRF-PDP). The first uses the outcome event, what happened to a patient, as a proxy for a ground truth, and the second forecasted future pathology results compared with the known normal clinical reference range. Two variation of each are considered: kNN-based and LSTM-based PGR-PDP, and LSTM-based and Facebook Profit-based FRF-PDP. The reported evaluation indicated that the PGR-PDP mechanism produced the best results with little distinction between the two variations

Assessing the association between oral hygiene and preterm birth by quantitative light-induced fluorescence

The aim of this study was to investigate the purported link between oral hygiene and preterm birth by using image analysis tools to quantify dental plaque biofilm. Volunteers (η = 91) attending an antenatal clinic were identified as those considered to be “at high risk” of preterm delivery (i.e., a previous history of idiopathic preterm delivery, case group) or those who were not considered to be at risk (control group). The women had images of their anterior teeth captured using quantitative light-induced fluorescence (QLF). These images were analysed to calculate the amount of red fluorescent plaque (ΔR%) and percentage of plaque coverage. QLF showed little difference in ΔR% between the two groups, 65.00% case versus 68.70% control, whereas there was 19.29% difference with regard to the mean plaque coverage, 25.50% case versus 20.58% control. A logistic regression model showed a significant association between plaque coverage and case/control status (Ρ = 0.031), controlling for other potential predictor variables, namely, smoking status, maternal age, and body mass index (BMI)

Managing clustering effects and learning effects in the design and analysis of multicentre randomised trials: a survey to establish current practice.

BACKGROUND:Patient outcomes can depend on the treating centre, or health professional, delivering the intervention. A health professional's skill in delivery improves with experience, meaning that outcomes may be associated with learning. Considering differences in intervention delivery at trial design will ensure that any appropriate adjustments can be made during analysis. This work aimed to establish practice for the allowance of clustering and learning effects in the design and analysis of randomised multicentre trials. METHODS:A survey that drew upon quotes from existing guidelines, references to relevant publications and example trial scenarios was delivered. Registered UK Clinical Research Collaboration Registered Clinical Trials Units were invited to participate. RESULTS:Forty-four Units participated (N = 50). Clustering was managed through design by stratification, more commonly by centre than by treatment provider. Managing learning by design through defining a minimum expertise level for treatment provider was common (89%). One-third reported experience in expertise-based designs. The majority of Units had adjusted for clustering during analysis, although approaches varied. Analysis of learning was rarely performed for the main analysis (n = 1), although it was explored by other means. The insight behind the approaches used within and reasons for, or against, alternative approaches were provided. CONCLUSIONS:Widespread awareness of challenges in designing and analysing multicentre trials is identified. Approaches used, and opinions on these, vary both across and within Units, indicating that approaches are dependent on the type of trial. Agreeing principles to guide trial design and analysis across a range of realistic clinical scenarios should be considered

Development of a patient reported outcome measures for measuring the impact of visual impairment following stroke

Background Among the available patient-reported outcome measures (PROMs) there is an absence of a PROM with a specific focus on the impact of the wide variety of visual impairments following stroke. Our aim was to develop a patient reported quality of life outcome measure for stroke survivors with visual impairment. Methods Potential items were sourced from a combination of existing PROMs from a systematic review and qualitative in-depth interviews, duplicates were removed and items shortlisted. The initial pilot instrument was created following a ranking exercise of these potential items and consultation with stroke survivors. Version 1 was piloted with 37 stroke survivors at acute and chronic stages. Version 2 was piloted with 243 stroke survivors with visual impairment at acute and chronic stages. This data was analysed using the Rasch measurement model. Simultaneously, items from Version 2 underwent a Delphi process with stroke survivors and stroke clinicians, to assess the importance of each item. Final consensus decisions on item removal were made using the combined analysis from the Rasch measurement model and Delphi process in a nominal group meeting. Results Due to the wide range of rank given to the majority of categories/items, only two items were discarded. Version 1 comprised of 102 items with 5 response categories relating to amount of difficulty. The pilot of Version 1 allowed item reduction based on analysis of floor/ceiling effects and not applicable responses. Version 2 comprised of 62 items. Within the nominal group meeting, the expert panel created a set of rules which aided them with decision making in addition to the Rasch and Delphi analysis data. This resulted in the removal of 43 items and the combination of seven items to create three new items. The expert panel also recommended the rewording of three items. Conclusion The Brain Injury associated Visual Impairment Impact Questionnaire (BIVI-IQ-15), a 15-item instrument with 4 response categories has been developed for capturing vision-related quality of life of stroke survivors with any of the predominant types of visual impairment, in the presence of other impairments and for both inpatients and outpatients