Considering sex/gender in interventions to promote children’s and adolescents’ leisure-time physical activity: a systematic review and meta-analysis

Aim The main objectives of this systematic review were to evaluate the effects of interventions on leisure-time PA of boys and girls and to appraise the extent to which studies have taken sex/gender into account. Subject and methods PRISMA guidelines were followed. Two researchers independently screened studies for eligibility and assessed the risk of bias. Descriptive analyses were conducted to evaluate intervention effects in relation to the consideration of sex/gender in the studies based on a newly developed checklist. Additionally, meta-analyses were performed to determine the effect of interventions on girls’ and boys’ leisure-time PA. Results Overall 31 unique studies reported 44 outcomes on leisure-time PA and 20,088 participants were included in the current study. Consideration of sex/gender aspects in studies is low. PA outcomes with statistically significant same/similar effects in boys and girls showed higher quality of reporting sex/gender aspects of theoretical and/or conceptual linkages with sex/gender, measurement instruments, intervention delivery, location and interventionists and participant flow than PA outcomes without significant effects in both boys and girls or effects only in boys or girls. Interventions had a small but significant effect on girls (number of included studies (k) = 9, g = 0.220, p = .003) and boys (k = 7, g = 0.193, p = .020) leisure-time PA. Conclusion Higher reporting of sex/gender aspects may improve leisure-time PA of boys and girls. Nevertheless, there remains a need to address sufficient consideration of sex/gender aspects in interventions in the context of PA.

Adherence to participant flow diagrams in trials on postoperative pain management after total hip and knee arthroplasty: a methodological review

Background The Consolidated Standards of Reporting Trials (CONSORT) statement aims to improve transparent reporting of randomised clinical trials. It comprises a participant flow diagram with the reporting of essential numbers for enrolment, allocation and analyses. We aimed to quantify the use of participant flow diagrams in randomised clinical trials on postoperative pain management after total hip and knee arthroplasty. Methods We searched PubMed, Embase and CENTRAL up till January 2020. The primary outcome was the proportion of trials with adequate reporting of participant flow diagrams, defined as reporting of number of participants screened for eligibility, randomised and included in the primary analysis. Secondary outcomes were recruitment (randomised:screened) and retention (analysed:randomised) rates, reporting of a statistical strategy, reasons for exclusion from the primary analysis and handling of missing outcome data. Trends over time were assessed with statistical process control. Results Of the 570 included trials, we found adequate reporting in 240 (42%). Reporting with participant flow diagram increased significantly over time. Median recruitment was 73% (IQR 44–91%), and retention was 97% (IQR 93–100%). These rates did not change over time. Trials with adequate reporting of participant flow were more likely to report a statistical strategy (41% vs 8%), reasons for post-randomisation exclusions (100% vs 55%) and handling of missing outcome data (14% vs 6%). Conclusions Adherence to participant flow diagrams for RCTs has increased significantly over time. Still, there is room for improvement of adequate reporting of flow diagrams, to increase transparency of trials details.

Artificial Intelligence Chatbot for Depression: Descriptive Study of Usage

Background Chatbots could be a scalable solution that provides an interactive means of engaging users in behavioral health interventions driven by artificial intelligence. Although some chatbots have shown promising early efficacy results, there is limited information about how people use these chatbots. Understanding the usage patterns of chatbots for depression represents a crucial step toward improving chatbot design and providing information about the strengths and limitations of the chatbots. Objective This study aims to understand how users engage and are redirected through a chatbot for depression (Tess) to provide design recommendations. Methods Interactions of 354 users with the Tess depression modules were analyzed to understand chatbot usage across and within modules. Descriptive statistics were used to analyze participant flow through each depression module, including characters per message, completion rate, and time spent per module. Slide plots were also used to analyze the flow across and within modules. Results Users sent a total of 6220 messages, with a total of 86,298 characters, and, on average, they engaged with Tess depression modules for 46 days. There was large heterogeneity in user engagement across different modules, which appeared to be affected by the length, complexity, content, and style of questions within the modules and the routing between modules. Conclusions Overall, participants engaged with Tess; however, there was a heterogeneous usage pattern because of varying module designs. Major implications for future chatbot design and evaluation are discussed in the paper.

Vitamin D and Calcium Milk Fortification in Pregnant Women with Periodontitis: A Feasibility Trial

This study aims to assess the acceptability, adherence, and retention of a feasibility trial on milk fortification with calcium and vitamin D (Ca + VitD) and periodontal therapy (PT) among low income Brazilian pregnant women with periodontitis (IMPROVE trial). This 2 × 2 factorial feasibility trial used a mixed-methods evaluation. In total, 69 pregnant women were randomly allocated to four groups: 1. fortified sachet with Ca+VitD and milk plus early PT (throughout gestation); 2. placebo and milk plus early PT; 3. fortified sachet with Ca+VitD and milk plus late PT after childbirth; 4. placebo and milk plus late PT. Data were collected via questionnaires, field notes, participant flow logs, treatment diary, and focal group discussions. Quantitative and qualitative data were analysed using appropriate descriptive statistics and content analysis, respectively. Eligibility rate (12%) was below the target of 15%, but participation (76.1%) and recruitment rate (2 women/week) exceeded the targets. Retention rate (78.6%) was slightly below the target (80%). Adherence to the PT was significantly higher in the early treatment groups (98.8%) compared to the late treatment groups (29%). All women accepted the random allocation, and baseline groups were balanced. There was no report of adverse events. This multi-component intervention is acceptable, well-tolerated, and feasible among low-risk pregnant women in Brazil.

A sex/gender perspective on interventions to promote children’s and adolescents’ overall physical activity: Results from genEffects systematic review

Background To evaluate the effects of interventions on children’s and adolescents’ overall physical activity (PA) for boys and girls separately and to appraise the extent to which the studies haven taken sex/gender into account. Methods Systematic review and semi-quantitative analysis. Eleven electronic databases were searched to identify all relevant randomized and non-randomized controlled trials. Studies had to report overall PA as the main outcome to be eligible for inclusion in the review. The main outcomes of the studies is a quantified measure of overall PA. Additionally, all studies had to report sex/gender disaggregated overall PA at baseline and/or follow up and/or explain how they dealt with sex/gender during outcome analysis (i.e., sex/gender adjusted analyses) and/or report that there were no differences in the outcome when looking at sex/gender. PRISMA guidelines were followed. Two authors independently screened studies for eligibility and assessed the risk of bias. Semi-quantitative analyses were conducted to evaluate intervention effects, taking into account the extent to which studies have considered sex/gender aspects. To evaluate sex/gender considerations in primary studies, a newly developed sex/gender checklist was used. The study was registered previously (registration number CRD42018109528). Results In total, 97 articles reporting 94 unique studies with 164 outcomes for overall PA were included in the present review. Average sample size was 829 participants, ranging from five to 9,839. Participants’ ages ranged from three to 19 years. Our review shows that overall 35% of PA outcomes had significant effects in increasing overall PA of children and adolescents. Not including single sex/gender studies, 105 out of 120 PA outcomes resulted in same intervention effects for boys and girls. The interventions reported to have similar effects on PA outcomes for boys and girls showed higher quality of reporting sex/gender aspects of measurement instruments, participant flow and intervention content and materials than PA outcomes with effects only in boys or only in girls. Overall, consideration of sex/gender aspects in intervention studies is low. Conclusions There is still a need to address sufficient consideration of sex/gender aspects in developing and implementing interventions in the context of PA.

A sex/gender perspective on interventions to promote children’s and adolescents’ overall physical activity: results from genEffects systematic review

Background To evaluate the effects of interventions on children’s and adolescents’ overall physical activity (PA) for boys and girls separately and to appraise the extent to which the studies haven taken sex/gender into account. Methods Systematic review and semi-quantitative analysis. Eleven electronic databases were searched to identify all relevant randomized and non-randomized controlled trials. Studies had to report overall PA as the main outcome to be eligible for inclusion in the review. The main outcomes of the studies is a quantified measure of overall PA. Additionally, all studies had to report sex/gender disaggregated overall PA at baseline and/or follow up and/or explain how they dealt with sex/gender during outcome analysis (i.e., sex/gender adjusted analyses) and/or report that there were no differences in the outcome when looking at sex/gender. PRISMA guidelines were followed. Two authors independently screened studies for eligibility and assessed the risk of bias. Semi-quantitative analyses were conducted to evaluate intervention effects, taking into account the extent to which studies have considered sex/gender aspects. To evaluate sex/gender considerations in primary studies, a newly developed sex/gender checklist was used. The study was registered previously (registration number CRD42018109528). Results In total, 97 articles reporting 94 unique studies with 164 outcomes for overall PA were included in the present review. Average sample size was 829 participants, ranging from five to 9839. Participants’ ages ranged from three to 19 years. Our review shows that overall 35% of PA outcomes had significant effects in increasing overall PA of children and adolescents. Not including single sex/gender studies, 105 out of 120 PA outcomes resulted in same intervention effects for boys and girls. The interventions reported to have similar effects on PA outcomes for boys and girls showed higher quality of reporting sex/gender aspects of measurement instruments, participant flow and intervention content and materials than PA outcomes with effects only in boys or only in girls. Overall, consideration of sex/gender aspects in intervention studies is low. Conclusions There is still a need to address sufficient consideration of sex/gender aspects in developing and implementing interventions in the context of PA.

A sex/gender perspective on interventions to promote children’s and adolescents’ overall physical activity: Results from genEffects systematic review

Background To evaluate the effects of interventions on children’s and adolescents’ overall physical activity (PA) for boys and girls separately and to appraise the extent to which the studies haven taken sex/gender into account.Methods Systematic review and semi-quantitative analysis. Eleven electronic databases were searched to identify all relevant randomized and non-randomized controlled trials. Studies had to report overall PA as the main outcome to be eligible for inclusion in the review. The main outcomes of the studies is a quantified measure of overall PA. Additionally, all studies had to report sex/gender disaggregated overall PA at baseline and/or follow up and/or explain how they dealt with sex/gender during outcome analysis (i.e., sex/gender adjusted analyses) and/or report that there were no differences in the outcome when looking at sex/gender. PRISMA guidelines were followed. Two authors independently screened studies for eligibility and assessed the risk of bias. Semi-quantitative analyses were conducted to evaluate intervention effects, taking into account the extent to which studies have considered sex/gender aspects. To evaluate sex/gender considerations in primary studies, a newly developed sex/gender checklist was used. The study was registered previously (registration number CRD42018109528).Results In total, 97 articles reporting 94 unique studies with 164 outcomes for overall PA were included in the present review. Average sample size was 829 participants, ranging from five to 9,839. Participants’ ages ranged from three to 19 years. Our review shows that overall 35% of PA outcomes had significant effects in increasing overall PA of children and adolescents. Not including single sex/gender studies, 105 out of 120 PA outcomes resulted in same intervention effects for boys and girls. The interventions reported to have similar effects on PA outcomes for boys and girls showed higher quality of reporting sex/gender aspects of measurement instruments, participant flow and intervention content and materials than PA outcomes with effects only in boys or only in girls. Overall, consideration of sex/gender aspects in intervention studies is low.Conclusions There is still a need to address sufficient consideration of sex/gender aspects in developing and implementing interventions in the context of PA.

A sex/gender perspective on interventions to promote children’s and adolescents’ overall physical activity: Results from genEffects systematic review

Background To evaluate the effects of interventions on children’s and adolescents’ overall physical activity (PA) for boys and girls separately and to appraise the extent to which the studies haven taken sex/gender into account.Methods Systematic review and semi-quantitative analysis. Eleven electronic databases were searched to identify all relevant randomized and non-randomized controlled trials. The main outcomes of the studies is a quantified measure of overall PA. Additionally, all studies had to report sex/gender disaggregated overall PA at baseline and/or follow up and/or explain how they dealt with sex/gender during outcome analysis (i.e., sex/gender adjusted analyses) and/or report that there were no differences in the outcome when looking at sex/gender. PRISMA guidelines were followed. Two authors independently screened studies for eligibility and assessed the risk of bias. Semi-quantitative analyses were conducted to evaluate intervention effects, taking into account the extent to which studies have considered sex/gender aspects. To evaluate sex/gender considerations in primary studies, a newly developed sex/gender checklist was used. The study was registered previously (registration number CRD42018109528)Results Our review shows that overall 35% of PA outcomes had significant effects in increasing overall PA of children and adolescents. Not including single sex/gender studies, 105 out of 120 PA outcomes resulted in same intervention effects for boys and girls. These PA outcomes showed higher quality of reporting sex/gender aspects of measurement instruments, participant flow and intervention content and materials than PA outcomes with effects only in boys or only in girls. Overall, consideration of sex/gender aspects in intervention studies is low.Conclusions There is still a need to address sufficient consideration of sex/gender aspects in developing and implementing interventions in the context of PA.

Artificial Intelligence Chatbot for Depression: Descriptive Study of Usage (Preprint)

BACKGROUND Chatbots could be a scalable solution that provides an interactive means of engaging users in behavioral health interventions driven by artificial intelligence. Although some chatbots have shown promising early efficacy results, there is limited information about how people use these chatbots. Understanding the usage patterns of chatbots for depression represents a crucial step toward improving chatbot design and providing information about the strengths and limitations of the chatbots. OBJECTIVE This study aims to understand how users engage and are redirected through a chatbot for depression (Tess) to provide design recommendations. METHODS Interactions of 354 users with the Tess depression modules were analyzed to understand chatbot usage across and within modules. Descriptive statistics were used to analyze participant flow through each depression module, including characters per message, completion rate, and time spent per module. Slide plots were also used to analyze the flow across and within modules. RESULTS Users sent a total of 6220 messages, with a total of 86,298 characters, and, on average, they engaged with Tess depression modules for 46 days. There was large heterogeneity in user engagement across different modules, which appeared to be affected by the length, complexity, content, and style of questions within the modules and the routing between modules. CONCLUSIONS Overall, participants engaged with Tess; however, there was a heterogeneous usage pattern because of varying module designs. Major implications for future chatbot design and evaluation are discussed in the paper.

A Practical Do-It-Yourself Recruitment Framework for Concurrent eHealth Clinical Trials: Simple Architecture (Part 1) (Preprint)

BACKGROUND The ability to identify, screen, and enroll potential research participants in an efficient and timely manner is crucial to the success of clinical trials. In the age of the internet, researchers can be confronted with large numbers of people contacting the program, overwhelming study staff and frustrating potential participants. OBJECTIVE This paper describes a “do-it-yourself” recruitment support framework (DIY-RSF) that uses tools readily available in many academic research settings to support remote participant recruitment, prescreening, enrollment, and management across multiple concurrent eHealth clinical trials. METHODS This work was conducted in an academic research center focused on developing and evaluating behavioral intervention technologies. A needs assessment consisting of unstructured individual and group interviews was conducted to identify barriers to recruitment and important features for the new system. RESULTS We describe a practical and adaptable recruitment management architecture that used readily available software, such as REDCap (Research Electronic Data Capture) and standard statistical software (eg, SAS, R), to create an automated recruitment framework that supported prescreening potential participants, consent to join a research registry, triaging for management of multiple trials, capture of eligibility information for each phase of a recruitment pipeline, and staff management tools including monitoring of participant flow and task assignment/reassignment features. The DIY-RSF was launched in July 2015. As of July 2017, the DIY-RSF has supported the successful recruitment efforts for eight trials, producing 14,557 participant records in the referral tracking database and 5337 participants in the center research registry. The DIY-RSF has allowed for more efficient use of staff time and more rapid processing of potential applicants. CONCLUSIONS Using tools already supported at many academic institutions, we describe the architecture and utilization of an adaptable referral management framework to support recruitment for multiple concurrent clinical trials. The DIY-RSF can serve as a guide for leveraging common technologies to improve clinical trial recruitment procedures.