Approaches and experiences implementing remote, electronic consent at the Leeds Clinical Trials Research Unit.

BACKGROUND: Use of electronic methods to support informed consent ('eConsent') is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequent experiences from a range of studies at the Leeds Clinical Trials Research Unit (CTRU), a large clinical trials unit in the UK. MAIN TEXT: We implemented a remote eConsent process using the REDCap platform. The process can be used in trials of investigational medicinal products and other intervention types or research designs. Our standard eConsent system focuses on documenting informed consent, with other aspects of consent (e.g. providing information to potential participants and a recruiter discussing the study with each potential participant) occurring outside the system, though trial teams can use electronic methods for these activities where they have ethical approval. Our overall process includes a verbal consent step prior to confidential information being entered onto REDCap and an identity verification step in line with regulator guidance. We considered the regulatory requirements around the system's generation of source documents, how to ensure data protection standards were upheld and how to monitor informed consent within the system. We present four eConsent case studies from the CTRU: two randomised clinical trials and two other health research studies. These illustrate the ways eConsent can be implemented, and lessons learned, including about differences in uptake. CONCLUSIONS: We successfully implemented a remote eConsent process at the CTRU across multiple studies. Our case studies highlight benefits of study participants being able to give consent without having to be present at the study site. This may better align with patient preferences and trial site needs and therefore improve recruitment and resilience against external shocks (such as pandemics). Variation in uptake of eConsent may be influenced more by site-level factors than patient preferences, which may not align well with the aspiration towards patient-centred research. Our current process has some limitations, including the provision of all consent-related text in more than one language, and scalability of implementing more than one consent form version at a time. We consider how enhancements in CTRU processes, or external developments, might affect our approach.

Early Childhood Oral Health Impact Scale: Psychometric Evaluation in Portuguese Preschoolers.

Objective: to contribute to the validation of the Early Childhood Oral Impact Scale (ECOHIS) by studying its psychometric properties when applied to a Portuguese preschool population. Methods: Cross-sectional study conducted with children aged between three and five-years-old. The non-probabilistic sample included two preschools in the municipality of Lisbon. Children who agreed to participate and whose guardians signed the informed consent were included. Data collection included a questionnaire, administered to the parents, and an intraoral examination of the children. The questionnaire included the Portuguese version of ECOHIS. The intraoral examination included the caries diagnosis according to the World Health Organization criteria. Discriminant validity compared the ECOHIS score between children with and without caries experience (Mann-Whitney U-test). Cohen's d was calculated to estimate the magnitude of the difference. Reliability analysis included Cronbach's α and test-retest. Construct validity was analyzed by the correlation between the ECOHIS score and dmft (Spearman's correlation). A significance level of 5% was used. Results: The sample included 104 children (mean age 4.1 years). ECOHIS values were significantly different between children with and without caries (p=0.004). The Cohen's d was 0.84. The Cronbach's was 0.78, with no significant increase in value when eliminating any of the items. The test-retest showed significant correlation (r=0.76; p=0.01). There was a significant correlation between the ECOHIS score and caries experience (r=0.28; p=0.004). Conclusion: The Portuguese version of the ECOHIS showed good psychometric properties, indicating that it is a reliable and valid tool to measure the impact of oral health in preschool children.

Evaluation of oral characteristics and oral health of individuals with fragile X syndrome and related guardians perceptions.

OBJECTIVES: To relate the oral health of individuals with fragile X syndrome (FXS) with their oral characteristics, habits, and difficulties in terms of oral hygiene and the perception of oral health of the guardians. METHODS AND RESULTS: This observational transversal study included 31 volunteers who belong to the Portuguese Fragile X Syndrome Association. A questionnaire was presented to guardians, and a head and neck and oral examination was performed to the individuals: decay, missing and filled teeth index (DMFT) = 4.65, gingival index (GI) = 1.01, and simplified oral hygiene index (OHI-S) = 2.26 and Malocclusion Class Angle II (61.3%) with dental aesthetic index 34.90. A high-arch narrow palate (71%), accentuated gagging reflex (45.2%), and bruxism (22.6%) were the most common oral characteristics. There was a negative correlation between the several behaviors, attitudes, and habits reported by the guardians and all the indexes of oral health, with significance to the DMFT (P = .032), missing teeth (P = .032), and GI (P = .04). CONCLUSION: There was a variability in oral characteristics, and these can represent a difficulty in performing oral hygiene. The collected data provide information for the health professionals and guardians to guide the monitoring of patients with FXS as well as to create strategies to improve oral hygiene.

Short-term impact of an oral health program for adults with cerebral palsy.

AIM: To evaluate the impact of an oral health program for institutionalized individuals with cerebral palsy (CP) and their caregivers, after 2 and 6 months. METHODS: Sixty-two CP individuals in four homes were selected for intervention group (n = 31) and control group (n = 31). An oral hygiene practices questionnaire was applied to all caregivers at the baseline. Both groups received awareness sessions, practical demonstration of toothbrushing and adaptive techniques with role-play. In the study group, individual oral hygiene monitoring was also performed in the first 2 months. A gingival and an oral hygiene indexes were performed at the beginning, after 2 and 6 months of intervention. RESULTS: There was a significant reduction of gingival (p < 0.001) and oral hygiene (p < 0.001) indexes at 2 and 6 months in the intervention group with the most significant reductions at 2 months. Caregivers reported opening the mouth (84.6%) and swallowing toothpaste (61.5%) as the most important difficulties in performing toothbrushing. CONCLUSION: It was found that frequent and individualized monitoring of plaque control was essential to reduce dental plaque and gingivitis levels and that awareness sessions were not enough to produce clinically significant result.

Oral Health Knowledge, Perceptions, and Habits of Adolescents from Portugal, Romania, and Sweden: A Comparative Study.

AIMS: The study aimed to assess and compare the self-reported oral health knowledge, habits, and perceptions of adolescents in Portugal, Romania, and Sweden and the factors that may affect them. MATERIALS AND METHODS: An oral health questionnaire with 25 questions was put together in English language and translated into Portuguese, Romanian, and Swedish language to investigate and compare oral health-related knowledge, habits, and perceptions of adolescents from the different countries. A voluntary sample of 879 teenagers completed it, mean aged 14.9 (±1.83) years, from Romania (n = 455), Portugal (n = 200), and Sweden (n = 224) as part of the EuHyDens project. The survey took place between November 2015 and June 2016. RESULTS: It showed some differences between the countries studied but more similarities between Portuguese and Romanian adolescents as related to perceptions of oral health and the use of oral services. Sweden and Portugal are more similar regarding oral health habits (toothbrushing and diet) as compared to Romanian adolescents. Portuguese adolescents have a higher oral health-related knowledge. CONCLUSION: Assessment of knowledge, perceptions, and habits of a population is essential for the adequate understanding of the oral health-care needs of the society. From the data collected, several differences were found. These differences can be used for tailor interventions to minimize inequalities between countries.

The Dental Hygienists in Sweden and Portugal: A Comparative Study.

AIMS AND OBJECTIVES: The aim of the present study was to identify the dental hygienists (DHs)' working areas and compare these findings between Sweden and Portugal. MATERIALS AND METHODS: A web-based questionnaire was sent by E-mail to all 2943 members of the Swedish DH Association and 381 members of the Portuguese DH Association. The questionnaire contained questions about; number of years of work, which patient groups they worked with, if they had got sufficient knowledge from the education and what different tasks they worked with. Independent sample t-test, relative risk, and logistic regression analysis were used as statistical methods. RESULTS: The response rate for Sweden was 31% (n = 923) and the corresponding figure for Portugal was 53.5% (n = 204). The most common tasks for the DHs, in both countries, were to diagnose and treat patients with periodontitis and to diagnose and perform caries prevention. In Portugal, 86.5% worked with orthodontic patients compared to 32.3% in Sweden (P = 0.001). The logistic regression analysis showed that there was a 25% (P = 0.02) higher probability that Swedish DHs took more X-rays and 38% (P = 0.042) probability that they had more communications skills compared to the Portuguese DHs. CONCLUSION: The DH profession in Sweden and Portugal was overall quite similar. Despite a few local differences, both the academic education and scope of practice corresponded well between the countries. The few discrepancies could be explained by differences in legislations in each country.

Self-reported oral health-related habits, attitudes and knowledge in adults from Portugal, Romania and Sweden-A comparative study.

OBJECTIVE: The aim of the present study was to compare the self-reported oral health knowledge, habits and attitudes of adults in Portugal, Romania and Sweden, each benefitting from a different oral health system. METHODS: A cross-sectional study was conducted on 1081 adults in the three countries, using an adapted version of the WHO oral health questionnaire. This survey took place between November 2015 and June 2016. RESULTS: The mean age of the respondents was 46.85 with 95% CI (45.84, 47.86). Over 85% of the Portuguese and the Swedish, but only 55% of the Romanians, reported having 20 or more teeth left (P < 0.001). Most Swedes visit the dental office regularly, but only 50.5% of the Portuguese and 20.6% of the Romanians do so (P < 0.001). Interdental cleaning aids and fluoridated toothpaste were used the most in Sweden and the least in Romania. Daily consumption of sweets was lowest for Portugal and highest for Romania (P < 0.001), and daily intake of fresh fruits and vegetables was lowest for Sweden (P < 0.001). CONCLUSIONS: There is a difference between the three countries regarding oral health, diet, dental attendance and oral health-related quality of life, with Romania being in most need of improvement in these areas. The differences could be explained by the distinct healthcare systems adopted by the countries.

Prevalence of malocclusion in individuals with and without intellectual disability: A comparative study.

OBJECTIVE: The aim of this study was to compare the prevalence malocclusion between individuals with intellectual disability (ID) and a control group without disability (NID). METHODS: A total of 202 individuals (123 with ID and 79 with no impairment) were included in the study. Data were collected through oral examinations using the Angle classification of malocclusion and the dental aesthetic index (DAI). RESULTS: According to Angle's classification of malocclusion, it was found that 37.6% of all participants presented malocclusion. Class II malocclusion was the most common form of malocclusion in both groups, whereas class III cases were present almost exclusively in ID group (91.7%). The mean DAI score was 30.85 (± 13.7), being higher in the ID group (32.80) than in the control group (27.81; p = 0.003). A total of 45 (22.3%) participants had DAI scores of 36 and above, which indicate a handicapping malocclusion requiring mandatory orthodontic treatment. From those needing mandatory orthodontic treatment, the majority (84.4%) belonged to ID group. Mandibular irregularity (56.4%) and incisal segment crowding (45%) were the most common features of the malocclusion. Linear regression indicates that having an intellectual disability predicts severe or very severe malocclusion. CONCLUSIONS: In this study, the prevalence of malocclusion was found to be higher and more severe in intellectual disabled participants. The dental practitioner should understand the particular relevance of this problem especially in patients with intellectual disabilities where impaired oral functions and poor appearance may further complicate oral health and increase negative social responses.