Feasibility of a hybrid clinical trial for respiratory virus detection in toddlers during the influenza season

Background Traditional clinical trials are conducted at investigator sites. Participants must visit healthcare facilities several times for the trial procedures. Decentralized clinical trials offer an interesting alternative. They use telemedicine and other technological solutions (apps, monitoring devices or web platforms) to decrease the number of visits to study sites, minimise the impact on daily routine, and decrease geographical barriers for participants. Not much information is available on the use of decentralization in randomized clinical trials with vaccines. Methods A hybrid clinical trial may be assisted by parental recording of symptoms using electronic log diaries in combination with home collected nasal swabs. During two influenza seasons, children aged 12 to 35 months with a history of recurrent acute respiratory infections were recruited in 12 primary health centers of the Valencia Region in Spain. Parents completed a symptom diary through an ad hoc mobile app that subsequently assessed whether it was an acute respiratory infection and requested collection of a nasal swab. Feasibility was measured using the percentage of returned electronic diaries and the validity of nasal swabs collected during the influenza season. Respiratory viruses were detected by real-time PCR. Results Ninety-nine toddlers were enrolled. Parents completed 10,476 electronic diaries out of the 10,804 requested (97%). The mobile app detected 188 potential acute respiratory infections (ARIs) and requested a nasal swab. In 173 (92%) ARI episodes a swab was taken. 165 (95.4%) of these swabs were collected at home and 144 (87.3%) of them were considered valid for laboratory testing. Overall, 152 (81%) of the ARIs detected in the study had its corresponding valid sample collected. Conclusions Hybrid procedures used in this clinical trial with the influenza vaccine in toddlers were considered adequate, as we diagnosed most of the ARI cases on time, and had a valid swab in 81% of the cases. Hybrid clinical trials improve participant adherence to the study procedures and could improve recruitment and quality of life of the participants and the research team by decreasing the number of visits to the investigator site. This report emphasises that the conduct of hybrid CTs is a valid alternative to traditional CTs with vaccines. This hybrid CT achieved high adherence of participant to the study procedures. Trial registration 2019–001186-33 (EudraCT).

Factors That Influence the Use of Electronic Diaries in Health Care: Scoping Review

Background A large number of people suffer from psychosocial or physical problems. Adequate strategies to alleviate needs are scarce or lacking. Symptom variation can offer insights into personal profiles of coping and resilience (detailed functional analyses). Hence, diaries are used to report mood and behavior occurring in daily life. To reduce inaccuracies, biases, and noncompliance with paper diaries, a shift to electronic diaries has occurred. Although these diaries are increasingly used in health care, information is lacking about what determines their use. Objective The aim of this study was to map the existing empirical knowledge and gaps concerning factors that influence the use of electronic diaries, defined as repeated recording of psychosocial or physical data lasting at least one week using a smartphone or a computer, in health care. Methods A scoping review of the literature published between January 2000 and December 2018 was conducted using queries in PubMed and PsycInfo databases. English or Dutch publications based on empirical data about factors that influence the use of electronic diaries for psychosocial or physical purposes in health care were included. Both databases were screened, and findings were summarized using a directed content analysis organized by the Consolidated Framework for Implementation Research (CFIR). Results Out of 3170 articles, 22 studies were selected for qualitative synthesis. Eleven themes were determined in the CFIR categories of intervention, user characteristics, and process. No information was found for the CFIR categories inner (eg, organizational resources, innovation climate) and outer (eg, external policies and incentives, pressure from competitors) settings. Reminders, attractive designs, tailored and clear data visualizations (intervention), smartphone experience, and intrinsic motivation to change behavior (user characteristics) could influence the use of electronic diaries. During the implementation process, attention should be paid to both theoretical and practical training. Conclusions Design aspects, user characteristics, and training and instructions determine the use of electronic diaries in health care. It is remarkable that there were no empirical data about factors related to embedding electronic diaries in daily clinical practice. More research is needed to better understand influencing factors for optimal electronic diary use.

Factors That Influence the Use of Electronic Diaries in Health Care: Scoping Review (Preprint)

BACKGROUND A large number of people suffer from psychosocial or physical problems. Adequate strategies to alleviate needs are scarce or lacking. Symptom variation can offer insights into personal profiles of coping and resilience (detailed functional analyses). Hence, diaries are used to report mood and behavior occurring in daily life. To reduce inaccuracies, biases, and noncompliance with paper diaries, a shift to electronic diaries has occurred. Although these diaries are increasingly used in health care, information is lacking about what determines their use. OBJECTIVE The aim of this study was to map the existing empirical knowledge and gaps concerning factors that influence the use of electronic diaries, defined as repeated recording of psychosocial or physical data lasting at least one week using a smartphone or a computer, in health care. METHODS A scoping review of the literature published between January 2000 and December 2018 was conducted using queries in PubMed and PsycInfo databases. English or Dutch publications based on empirical data about factors that influence the use of electronic diaries for psychosocial or physical purposes in health care were included. Both databases were screened, and findings were summarized using a directed content analysis organized by the Consolidated Framework for Implementation Research (CFIR). RESULTS Out of 3170 articles, 22 studies were selected for qualitative synthesis. Eleven themes were determined in the CFIR categories of intervention, user characteristics, and process. No information was found for the CFIR categories inner (eg, organizational resources, innovation climate) and outer (eg, external policies and incentives, pressure from competitors) settings. Reminders, attractive designs, tailored and clear data visualizations (intervention), smartphone experience, and intrinsic motivation to change behavior (user characteristics) could influence the use of electronic diaries. During the implementation process, attention should be paid to both theoretical and practical training. CONCLUSIONS Design aspects, user characteristics, and training and instructions determine the use of electronic diaries in health care. It is remarkable that there were no empirical data about factors related to embedding electronic diaries in daily clinical practice. More research is needed to better understand influencing factors for optimal electronic diary use.

The Feasibility of Measuring Sleep and Circadian Characteristics in Adults with Inflammatory Bowel Disease

Interest in sleep and circadian research in inflammatory bowel disease (IBD) (Crohn’s disease and ulcerative colitis) is growing; however, few studies have objectively measured sleep or circadian rhythms in people with these conditions. The purpose was to determine the feasibility of the use of wrist actigraphy, electronic sleep/activity diaries, and participant-collected saliva among adults with both active and inactive IBD. We conducted a 10-day feasibility study of adults aged 18 years to 60 years with IBD. We measured sleep and rest-activity rhythms with wrist actigraphy, self-reported sleep/activity using electronic diaries, and participant-collected saliva to compute salivary dim light melatonin onset. All 37 (100%) participants wore the wrist actigraphs, 91.8% (N = 34) participants completed at least 15 of the 18 electronic diaries, and 34 (91.9%) completed the saliva collection. It is feasible to use wrist actigraphy and electronic sleep/activity diaries in adult participants with inflammatory bowel disease.