Mobile phone-based interventions for improving contraception use.

BACKGROUND: Contraception provides significant benefits for women's and children's health, yet many women have an unmet need for contraception. Rapid expansion in the use of mobile phones in recent years has had a dramatic impact on interpersonal communication. Within the health domain text messages and smartphone applications offer means of communication between clients and healthcare providers. This review focuses on interventions delivered by mobile phone and their effect on use of contraception. OBJECTIVES: To evaluate the benefits and harms of mobile phone-based interventions for improving contraception use. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was August 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of mobile phone-based interventions to improve forms of contraception use amongst users or potential users of contraception. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were 1. uptake of contraception, 2. uptake of a specific method of contraception, 3. adherence to contraception method, 4. safe method switching, 5. discontinuation of contraception and 6. pregnancy or abortion. Our secondary outcomes were 7. road traffic accidents, 8. any physical or psychological effect reported and 9. violence or domestic abuse. MAIN RESULTS: Twenty-three RCTs (12,793 participants) from 11 countries met our inclusion criteria. Eleven studies were conducted in high-income resource settings and 12 were in low-income settings. Thirteen studies used unidirectional text messaging-based interventions, six studies used interactive text messaging, four used voice message-based interventions and two used mobile-phone apps to improve contraception use. All studies received funding from non-commercial bodies. Mobile phone-based interventions probably increase contraception use compared to the control (odds ratio (OR) 1.30, 95% confidence interval (CI) 1.06 to 1.60; 16 studies, 8972 participants; moderate-certainty evidence). There may be little or no difference in rates of unintended pregnancy with the use of mobile phone-based interventions compared to control (OR 0.82, 95% CI 0.48 to 1.38; 8 trials, 2947 participants; moderate-certainty evidence). Subgroup analysis assessing unidirectional mobile phone interventions versus interactive mobile phone interventions found evidence of a difference between the subgroups favouring interactive interventions (P = 0.003, I2 = 88.5%). Interactive interventions had an OR of 1.71 (95% CI 1.28 to 2.29; P = 0.0003, I2 = 63%; 8 trials, 3089 participants) whilst unidirectional interventions had an OR of 1.03 (95% CI 0.87 to 1.22; P = 0.72, I2 = 17%; 9 trials, 5883 participants). Subgroup analysis assessing high-income versus low-income trial settings found no difference between groups (subgroup difference test: P = 0.70, I2 = 0%). Only six trials reported on safety and unintended outcomes; one trial reported increased partner violence whilst another four trials reported no difference in physical violence rates between control and intervention groups. One trial reported no road traffic accidents with mobile phone intervention use. AUTHORS' CONCLUSIONS: This review demonstrates there is evidence to support the use of mobile phone-based interventions in improving the use of contraception, with moderate-certainty evidence. Interactive mobile phone interventions appear more effective than unidirectional methods. The cost-effectiveness, cost benefits, safety and long-term effects of these interventions remain unknown, as does the evidence of this approach to support contraception use among specific populations. Future research should investigate the effectiveness and safety of mobile phone-based interventions with better quality trials to help establish the effects of interventions delivered by mobile phone on contraception use. This review is limited by the quality of the studies due to flaws in methodology, bias or imprecision of results.

The effectiveness of a WeChat-based self-assessment with a tailored feedback report on improving complementary feeding and movement behaviour of children aged 6-20 months in rural China: a cluster randomized controlled trial.

Background: Appropriate infant feeding and movement behaviour (i.e. physical activity, sedentary behaviour, sleep) play an important role in children's healthy development during the first two years of life. The popular Chinese social media app 'WeChat' has become a potential data collection and health promotion tool. We aimed to evaluate the effectiveness of a WeChat-based self-assessment with a tailored feedback report on improving complementary feeding practices and movement behaviour of children aged 6-20 months in rural China. Methods: We conducted a two-armed cluster randomized control trial in Datong County, Qinghai Province, China. There were 106 clusters from 257 villages allocated (1:1) to two groups: the feeding group, which received a complementary feeding recommendations feedback report; the movement behaviour group, which received movement behaviour recommendations feedback report. The feeding group acted as a control for the movement behaviour group and vice versa. Children aged 6-20 months and their primary caregivers were invited to be participants. WeChat was used to collect the data on outcomes and to deliver the interventions. Participants received the interventions by filling out the WeChat self-assessment questionnaire and reading tailored feedback reports at baseline, at the first 1-month follow-up and at the second 2-month follow-up. Outcome measures included changes in the prevalence of minimum dietary diversity (MDD), minimum meal frequency (MMF), minimum acceptable diet (MAD); and the proportion of children who met physical activity time (PAT), outdoor time (OT) and screen time (ST) recommendation between the two groups at the two follow-ups. This study is registered at Chinese Clinical Trial Registry-ChiCTR2200062529. Findings: Between September 28th and October 12th 2022, we recruited 1610 children in 106 clusters, of which 53 clusters (800 children) were randomized to the feeding group and 53 clusters (810 children) to the movement behaviour group. All caregivers of children completed questionnaires at three time points without loss to follow-up. From baseline to the second follow-up, the prevalence of MDD (OR: 1.62 [95% CI, 1.16-2.28; p = 0.0058]), MMF (OR: 1.45 [95% CI, 1.03-2.04; p = 0.032]) and MAD (OR: 1.51 [95% CI, 1.12-2.05; p = 0.0081]) in the feeding group were significantly higher than that in the movement behaviour group. The proportion of children who met PAT during the last 24 h at the second follow-up (OR: 2.22 [95% CI, 1.26-2.17; p < 0.0001]) and OT at the second follow-up (OR: 1.94 [95% CI, 1.49-2.54; p < 0.0001]) significantly improved in the movement behaviour group compared to the feeding group. Furthermore, ST in the movement behaviour group showed a significant increase only at the first follow-up (OR: 1.36 [95% CI, 1.02-1.82; p = 0.036]). Interpretation: WeChat-based self-assessment with tailored feedback was an effective channel to deliver feeding and movement behaviour recommendations in rural China in our study. This approach can be applied to change feeding practices of caregivers of young children alongside routine child health care in rural China. Funding: Capital Institute of Pediatrics.

ChroniSense National Early Warning Score Study: Comparison Study of a Wearable Wrist Device to Measure Vital Signs in Patients Who Are Hospitalized.

BACKGROUND: Wearable devices could be used to continuously monitor vital signs in patients who are hospitalized, but they require validation. OBJECTIVE: This study aimed to evaluate the clinical validity of the prototype of a semiautomated wearable wrist device (ChroniSense Polso) to measure vital signs and provide National Early Warning Scores (NEWSs). METHODS: Vital signs and NEWSs measured using the wearable device were compared with standard, nurse-lead manual measurements. We enrolled adult patients (aged ≥18 years) who required vital sign measurements at least every 6 hours in a UK teaching district general hospital. Wearable device measurements were not used for clinical decision-making. The primary outcome was the agreement on the individual National Early Warning parameter scores and vital sign measurements: respiratory rate, oxygen saturation, body temperature, systolic blood pressure, and heart rate. Secondary outcomes were the agreement on the total NEWS, incidence of adverse events, and user acceptance. To compare the wearable device measurements with the standard measurements, we analyzed vital sign measurements by limits of agreement (Bland-Altman analysis) and conducted κ agreement analyses for NEWSs. A user experience survey was conducted with questions about comfort of the wrist device, safety, preference, and use. RESULTS: We included 132 participants in the study, with a mean age of 62 (SD 15.81) years; most of them were men (102/132, 77.3%). The highest weighted κ values were found for heart rate (0.69, 95% CI 0.57-0.81 for all 385 measurements) and systolic blood pressure (0.39, 95% CI 0.30-0.47 for all 339 measurements). Weighted κ values were low for respiration rate (0.03, 95% CI -0.001 to 0.05 for all 445 measurements), temperature (0, 95% CI 0-0 for all 231 measurements), and oxygen saturation (-0.11, 95% CI -0.20 to -0.02 for all 187 measurements). Weighted κ using Cicchetti-Allison weights showed κ of 0.20 (95% CI 0.03-0.38) when using all 56 total NEWSs. The user acceptance survey found that approximately half (45/91, 49%) of the participants found it comfortable to wear the device and liked its appearance. Most (85/92, 92%) of them said that they would wear the device during their next hospital visit, and many (74/92, 80%) said that they would recommend it to others. CONCLUSIONS: This study shows the promising use of a prototype wearable device to measure vital signs in a hospital setting. Agreement between the standard measurements and wearable device measurements was acceptable for systolic blood pressure and heart rate, but needed to be improved for respiration rate, temperature, and oxygen saturation. Future studies need to improve the clinical validity of this wearable device. Large studies are required to assess clinical outcomes and cost-effectiveness of wearable devices for vital sign measurement. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2018-028219.

Life Course Digital Twins-Intelligent Monitoring for Early and Continuous Intervention and Prevention (LifeTIME): Proposal for a Retrospective Cohort Study.

BACKGROUND: Multimorbidity, which is associated with significant negative outcomes for individuals and health care systems, is increasing in the United Kingdom. However, there is a lack of knowledge about the risk factors (including health, behavior, and environment) for multimorbidity over time. An interdisciplinary approach is essential, as data science, artificial intelligence, and engineering concepts (digital twins) can identify key risk factors throughout the life course, potentially enabling personalized simulation of life-course risk for the development of multimorbidity. Predicting the risk of developing clusters of health conditions before they occur would add clinical value by enabling targeted early preventive interventions, advancing personalized care to improve outcomes, and reducing the burden on health care systems. OBJECTIVE: This study aims to identify key risk factors that predict multimorbidity throughout the life course by developing an intelligent agent using digital twins so that early interventions can be delivered to improve health outcomes. The objectives of this study are to identify key predictors of lifetime risk of multimorbidity, create a series of simulated computational digital twins that predict risk levels for specific clusters of factors, and test the feasibility of the system. METHODS: This study will use machine learning to develop digital twins by identifying key risk factors throughout the life course that predict the risk of later multimorbidity. The first stage of the development will be the training of a base predictive model. Data from the National Child Development Study, the North West London Integrated Care Record, the Clinical Practice Research Datalink, and Cerner's Real World Data will be split into subsets for training and validation, which will be done following the k-fold cross-validation procedure and assessed with the Prediction Model Risk of Bias Assessment Tool (PROBAST). In addition, 2 data sets-the Early-Life Data Cross-linkage in Research study and the Children and Young People's Health Partnership randomized controlled trial-will be used to develop a series of digital twin personas that simulate clusters of factors to predict different risk levels of developing multimorbidity. RESULTS: The expected results are a validated model, a series of digital twin personas, and a proof-of-concept assessment. CONCLUSIONS: Digital twins could provide an individualized early warning system that predicts the risk of future health conditions and recommends the most effective intervention to minimize that risk. These insights could significantly improve an individual's quality of life and healthy life expectancy and reduce population-level health burdens. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/35738.

Qualitative study on perceptions of use of Fractional Exhaled Nitric Oxide (FeNO) in asthma reviews.

Current methods to assess asthma and guide inhaled corticosteroid (ICS) dose titration mainly centre on patient-reported symptoms and lung function assessments. However, these methods correlate only weakly with airway inflammation making them unreliable predictors of future exacerbations and ICS requirement. Fractional Exhaled Nitric Oxide (FeNO) is a simple non-invasive objective measure of airways inflammation used predominantly in specialist clinics. Previous qualitative studies have mainly focused on the acceptability of FeNO in secondary care and there is limited insight to support clinicians and patients using FeNO in primary care asthma reviews. This study aimed to explore adult patient with asthma and primary care health care professional (HCP) views on introducing FeNO as part of routine asthma reviews. Twenty-three health care professionals and 22 patients were interviewed over the phone or online. Both groups reported that current asthma reviews are often seen as tick-box exercises and that introducing the FeNO test would make reviews more tailored to the individual patient, rather than relying on subjective patient reports of asthma control. Adults with asthma also highlighted support more open communication and their understanding of asthma, as they desired to feel more engaged in decisions and conversations about their asthma. HCPs reported valuing patient education and empowerment over a paternalistic approach, when time and resources allow. They also recognised FeNO to provide an objective measure of inflammation that could support them in the education and empowerment of patients. FeNO was seen by both groups as a potentially valuable addition to current asthma reviews mainly led by nurses, both for increasing their understanding of current risk of exacerbation and also to provide more tailored and personalised asthma management to patients. Our findings highlighted the need for open and clear communication about how to interpret FeNO results.

Trends in complementary feeding practices and caregivers' feeding knowledge among children aged 6-23 months: Repeated cross-sectional surveys in rural Qinghai China 2012-18.

BACKGROUND: Appropriate infant and young child feeding is the basis for child survival, growth and development. The aim of this study was to investigate trends in complementary feeding practices and caregivers' feeding knowledge among children from 2012 to 2018 in Huzhu County, Qinghai Province, China. METHODS: This study took place during and after a controlled interventional evaluation trial in Qinghai Province, China, which aimed to evaluate the effectiveness of community-based nutrient-dense complementary food supplements (YingYangBao) combined with dietary counseling on improving 6-23 month-old children's health status. We conducted four representative cross-sectional surveys on caregivers of children aged 6-23 months in Huzhu County, Qinghai Province, China (baseline survey for the trial (N = 1804) in August 2012, end-line survey for the trial (N = 2186) in August 2014, follow-up survey 1 (N = 496) in January 2016, and follow-up survey 2 (N = 754) in July 2018). In all surveys we used the same questionnaire to collect household information, infant feeding practices and caregivers' feeding knowledge. RESULTS: During the trial period (2012-2014), the proportion of children aged 6-8 months that introduced (semi-) solid food increased from 86.1% to 96.3% (P < 0.0001), however, there was a downward trend from 2014 to 2018 (P = 0.0014 for trend). The prevalence of minimum dietary diversity also increased from 51.4% at 2012 baseline survey to 57.5% at 2014 endline survey (P = 0.0004), but the upward trend did not maintain from 2014 to 2018 (P = 0.7863 for trend). The minimum dietary frequency, the minimum acceptable diet, and continued breastfeeding at one year were nearly unchanged from 2012 to 2018 (P = 0.9529, P = 0.7602 and P = 0.6013 for trend, respectively), remaining around 30%, 10% and 20% respectively in the four surveys. Caregivers' feeding knowledge on the duration of exclusive breastfeeding and introduction of semi or solid foods at 6-8 months increased from 2012 to 2018 (18.6% to 39.5%, 43.2% to 64.3%, respectively). CONCLUSION: This study showed that the sustainability of community-based YYB and dietary counseling program was suboptimal. We suggest that multiple information delivery channels such as smartphones and the Internet should be explored as a supplement to existing channels for delivering counseling information. TRIAL REGISTRATION: ChiCTRPRC12002444.

Developing a Blockchain-Based Supply Chain System for Advanced Therapies: Protocol for a Feasibility Study.

BACKGROUND: Advanced therapies, including cell and gene therapies, have shown therapeutic promise in curing life-threatening diseases, such as leukemia and lymphoma. However, these therapies can be complicated and expensive to deliver due to their sensitivity to environment; troublesome tissue, cell, or genetic material sourcing; and complicated regulatory requirements. OBJECTIVE: This study aims to create a novel connected supply chain logistics and manufacturing management platform based on blockchain, with cell and gene therapy as a use case. Objectives are to define the requirements and perform feasibility evaluations on the use of blockchain for standardized manufacturing and establishment of a chain of custody for the needle-to-needle delivery of autologous cell and gene therapies. A way of lowering overall regulatory compliance costs for running a network of facilities operating similar or parallel processes will be evaluated by lowering the monitoring costs through publishing zero-knowledge proofs and product release by exception. METHODS: The study will use blockchain technologies to digitally connect and integrate supply chain with manufacturing to address the security, scheduling, and communication issues between advanced therapy treatment centers and manufacturing facilities in order to realize a transparent, secure, automated, and cost-effective solution to the delivery of these life-saving therapies. An agile software development methodology will be used to develop, implement, and evaluate the system. The system will adhere to the EU and US good manufacturing practices and regulatory requirements. RESULTS: This is a proposed study protocol, and upon acceptance, grant funding will be pursued for its execution in 2021. CONCLUSIONS: The successful implementation of the integrated blockchain solution to supply chain and manufacturing of advanced therapies can push the industry standards toward a safer and more secure therapy delivery process. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/17005.

Effectiveness of WeChat for Improving Exclusive Breastfeeding in Huzhu County China: Randomized Controlled Trial.

BACKGROUND: The benefits of breastfeeding for both infants and mothers have been well recognized. However, the exclusive breastfeeding rate in China is low and decreasing. Mobile technologies have rapidly developed; communication apps such as WeChat (one of the largest social networking platforms in China) are widely used and have the potential to conveniently improve health behaviors. OBJECTIVE: This study aimed to assess the effectiveness of using WeChat to improve breastfeeding practices. METHODS: This 2-arm randomized controlled trial was conducted among pregnant women from May 2019 to April 2020 in Huzhu County, Qinghai Province, China. Pregnant women were eligible to participate if they were aged 18 years or older, were 11 to 37 weeks pregnant with a singleton fetus, had no known illness that could limit breastfeeding after childbirth, used WeChat through their smartphone, and had access to the internet. A total of 344 pregnant women were recruited at baseline, with 170 in the intervention group and 174 in the control group. Women in the intervention group received breastfeeding knowledge and promotion information weekly through a WeChat official account from their third month of pregnancy to 6 months postpartum. The primary outcome of exclusive and predominant breastfeeding rate was measured 0-1 month, 2-3 months, and 4-5 months postpartum. RESULTS: At 0-1 month postpartum, the exclusive breastfeeding rate was significantly higher in the intervention group than that in the control group (81.1% vs 63.3%; odds ratio [OR] 2.75, 95% CI 1.58-4.78; P<.001). Similarly, mothers in the intervention group were more likely to provide predominantly breast milk (OR 2.77, 95% CI 1.55-4.96; P<.001) and less likely to give dairy products to their children (OR 0.40, 95% CI 0.21-0.75; P=.005). There was no statistically significant difference for exclusive breastfeeding rate 2-3 months (P=.09) and 4-5 months postpartum (P=.27), though more children in the intervention group were exclusively breastfed than those in the control group 2-3 months postpartum (intervention: 111/152, 73.0%; control: 96/152, 63.2%) and 4-5 months postpartum(intervention: 50/108, 46.3%; control: 46/109, 42.2%). CONCLUSIONS: This study is the first effort to promote exclusive breastfeeding through WeChat in China, which proved to be an effective method of promoting exclusive breastfeeding in early life. WeChat health education can be used in addition to local breastfeeding promotion programs. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1800017364; http://www.chictr.org.cn/showproj.aspx?proj=29325. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-019-7676-2.

Family planning practices of women working in the Cambodian garment industry: a qualitative study.

BACKGROUND: Women working in Cambodian garment factories have unmet needs for family planning (contraception and safe abortion) services, because of their background and living conditions. This study describes their experiences regarding abortion and contraception as part of a larger project to develop an intervention to support comprehensive post-abortion care. METHODS: We conducted semi-structured interviews with women seeking abortion services at private health facilities. In addition, we interviewed the private providers of abortion and contraception services surrounding garment factories. Interviews lasted up to 60 min and were conducted in Khmer and later translated into English. A thematic analysis was undertaken, with medical abortion experiences coded according to the Cambodia comprehensive abortion care protocol. RESULTS: We interviewed 16 women and 13 providers between August and November 2018. Most women reported being married and had at least one child. Among factory workers the major reported reasons for abortion were birth spacing and financial constraints. Family, friends, or co-workers were the major information resources regarding abortion and contraception, and their positive or negative experiences strongly influenced women's attitude towards both. Medical abortion pills were not always provided with adequate instructions. Half of the participants had a manual vacuum aspiration procedure performed after medical abortion. While women knew the side effects of medical abortion, many did not know the adverse warning signs and the signs of abortion completion. Only three women started post abortion family planning, as most of the women expressed fear and hesitation due to concerns about side effects of modern contraception. Fear of infertility was particularly reported among young women without children. CONCLUSION: This research shows that in this setting not all women are receiving comprehensive abortion care and contraceptive counselling. Provision of accurate and adequate information about abortion methods and modern contraception was the dominant shortfall in abortion care. Future work to address this gap could involve the development of appropriate interventions and informative tools for women in the Cambodian garment industry such as through existing client contact-centres or social media, including creation of videos or posts on topics that come from clients questions.

Mobile apps for real-world evidence in health care.

The use of real-world evidence for health care research and evaluation is growing. Mobile health apps have often-overlooked potential to contribute valuable real-world data that are not captured by other sources and could provide data that are more cost-effective and generalizable than can randomized controlled trials. However, there are several challenges that must be overcome to realize the potential value of patient-used mobile health app real-world data, including data quality, motivation for long-term use, privacy and security, methods of analysis, and standardization and integration. Addressing these challenges will increase the value of data from mobile health apps to inform real-world evidence and improve patient empowerment, clinical management, disease research, and treatment development.

How primary healthcare workers obtain information during consultations to aid safe prescribing in low-income and lower middle-income countries: a systematic review.

Background: We systematically reviewed the evidence on how primary healthcare workers obtain information during consultations to support decision-making for prescribing in low and lower middle-income countries. Methods: We searched electronic databases, consulted the Healthcare Information For All network, hand searched reference lists, ran citation searches of included studies and emailed authors of identified papers. Two reviewers extracted data and appraised quality with relevant tools. Results: Of 60 497 records found, 23 studies met our inclusion criteria. Fourteen studies were observational and nine were interventional. Frequently mentioned sources of information were books, leaflets, guidelines, aids and the internet. These sources were sometimes out of date and health workers reported being confused which to use. Internet access varied and even when it was available, use was limited by technical issues. Of the five electronic tools that were assessed, four had positive outcomes. Tools assisted prescribers with medicine selection and dosage calculations, which increased prescribing accuracy. The quality of reporting varied but was overall low. Discussion: Studies indicated a lack of up-to-date and relevant medicine information in low and lower middle-income settings. Internet-based sources appeared to be useful when it is possible to download content for offline use and to update when there is internet access. Electronic tools showed promise, but their accuracy needs to be validated and they should focus on giving actionable advice to guide prescribers. PROSPERO registration number: CRD42018091088.

Massive Open Online Course Evaluation Methods: Systematic Review.

BACKGROUND: Massive open online courses (MOOCs) have the potential to make a broader educational impact because many learners undertake these courses. Despite their reach, there is a lack of knowledge about which methods are used for evaluating these courses. OBJECTIVE: The aim of this review was to identify current MOOC evaluation methods to inform future study designs. METHODS: We systematically searched the following databases for studies published from January 2008 to October 2018: (1) Scopus, (2) Education Resources Information Center, (3) IEEE (Institute of Electrical and Electronic Engineers) Xplore, (4) PubMed, (5) Web of Science, (6) British Education Index, and (7) Google Scholar search engine. Two reviewers independently screened the abstracts and titles of the studies. Published studies in the English language that evaluated MOOCs were included. The study design of the evaluations, the underlying motivation for the evaluation studies, data collection, and data analysis methods were quantitatively and qualitatively analyzed. The quality of the included studies was appraised using the Cochrane Collaboration Risk of Bias Tool for randomized controlled trials (RCTs) and the National Institutes of Health-National Heart, Lung, and Blood Institute quality assessment tool for cohort observational studies and for before-after (pre-post) studies with no control group. RESULTS: The initial search resulted in 3275 studies, and 33 eligible studies were included in this review. In total, 16 studies used a quantitative study design, 11 used a qualitative design, and 6 used a mixed methods study design. In all, 16 studies evaluated learner characteristics and behavior, and 20 studies evaluated learning outcomes and experiences. A total of 12 studies used 1 data source, 11 used 2 data sources, 7 used 3 data sources, 4 used 2 data sources, and 1 used 5 data sources. Overall, 3 studies used more than 3 data sources in their evaluation. In terms of the data analysis methods, quantitative methods were most prominent with descriptive and inferential statistics, which were the top 2 preferred methods. In all, 26 studies with a cross-sectional design had a low-quality assessment, whereas RCTs and quasi-experimental studies received a high-quality assessment. CONCLUSIONS: The MOOC evaluation data collection and data analysis methods should be determined carefully on the basis of the aim of the evaluation. The MOOC evaluations are subject to bias, which could be reduced using pre-MOOC measures for comparison or by controlling for confounding variables. Future MOOC evaluations should consider using more diverse data sources and data analysis methods. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/12087.

Application of Internet of Things in Cell-Based Therapy Delivery: Protocol for a Systematic Review.

BACKGROUND: Internet of Things (IoT), or Industry 4.0, represents a smart shift to more interconnected manufacturing processes where individual entities within the supply chain communicate with each other to achieve greater flexibility and responsiveness in general manufacturing and leaner manufacturing to reduce the cost of production. IoT has become instrumental in driving leaner manufacturing and more efficient systems in other industries such as transportation and logistics. Cell-based therapeutic products could potentially transform various diseases; however, the delivery of these products is complex and challenging. OBJECTIVE: This study aims to understand the applicability of IoT in cell-based product supply chains and delivery. METHODS: We will search Medline, EMBASE (OvidSP), Web of Science, Cochrane Library & HEED, Scopus, ACM digital library, INSPEC, ScienceDirect, and the IEEE Xplore Digital Library for studies published after 2008 using a combination of keywords and subject headings related to IoT used in cell therapies. Additionally, a Google search to identify gray literature will be conducted. Two authors will independently screen the titles and abstracts identified from the search and accept or reject the studies according to the study inclusion criteria. Any discrepancies will then be discussed and resolved. The quality of the selected literature will be assessed using the Critical Appraisal Skills Programme systematic review checklist. RESULTS: Data from eligible publications will be abstracted into a predesigned form to map the current and future directions of the technologies, applications, benefits, and challenges in the implementation of IoT in regenerative medicine. This study will be published in a peer-reviewed journal in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. This systematic review will be executed by June 2020, and the completed review will be published in a peer-reviewed journal to inform future developments in IoT application for the delivery of cell-based therapies. CONCLUSIONS: This review paper will provide an overview of all technologies available in the area and inspect the current IoT applications in cell-based therapies to identify the benefits, challenges, and future directions of using IoT to allow safe and cost-effective delivery of cell-based therapies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/16935.

Internet of Things-Enabled Technologies for Weight Management in Children and Adolescents: Protocol for a Systematic Review.

BACKGROUND: Childhood obesity is a serious global issue, leading to increased medical spending on obesity-related diseases such as cardiovascular diseases and diabetes. There is a need for health care services that link health behavior to risk factors, such as diet and physical activity, and that provide better advice and feedback to users, which Internet of Things-enabled technologies could facilitate. OBJECTIVE: The objective of the systematic review will be to identify available Internet of Things-enabled technologies for weight management of children and adolescents (users younger than 18 years). It will also aim to understand the use, effectiveness, and feasibility of these technologies. METHODS: We will search the Medline, PubMed, Web of Science, Scopus, ProQuest Central, and IEEE Xplore Digital Library databases for studies published after 2010, using a combination of keywords and subject headings related to health activity tracking, youth, and Internet of Things. In addition, a Google search to identify grey literature will be conducted. Two authors will independently screen the titles and abstracts identified from the search and accept or reject the studies according to the study inclusion criteria. Any discrepancies will then be discussed and resolved. The quality of the included studies will be assessed using the Critical Appraisal Skills Programme (CASP) checklists. Data from included studies will be extracted into a predesigned form to identify the types of devices or apps, Internet of Things applications, and health outcomes related to weight management. RESULTS: A preliminary search on Medline returned 484 results. The publication of the final systematic review is expected in mid-2020. CONCLUSIONS: The effectiveness and feasibility of physical activity trackers and consumer wearables for different patient groups have been well reviewed, but there are currently no published reviews that look into these technologies in the wider Internet of Things context. This review aims to address this gap by examining Internet of Things-enabled technologies that are designed for youth weight management and thus inform further research and clinical studies to reduce childhood obesity. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/16930.

Online patient feedback as a measure of quality in primary care: a multimethod study using correlation and qualitative analysis.

OBJECTIVES: To ascertain the relationship between online patient feedback and the General Practice Patient Survey (GPPS) and the Friends and Family Test (FFT). To consider the potential benefit it may add by describing the content of public reviews found on NHS Choices for all general practices in one Clinical Commissioning Group in England. DESIGN: Multimethod study using correlation and thematic analysis. SETTING: 1396 public online reviews and ratings on NHS Choices for all General Practices (n=70) in Oxfordshire Clinical Commissioning Group in England. RESULTS: Significant moderate correlations were found between the online patient feedback and the GPPS and the FFT. Three themes were developed through the qualitative analysis: (1) online feedback largely provides positive reinforcement for practice staff; (2) online feedback is used as a platform for suggesting service organisation and delivery improvements; (3) online feedback can be a source of insight into patients' expectations of care. These themes illustrate the wide range of topics commented on by patients, including their medical care, relationships with various members of staff, practice facilities, amenities and services in primary care settings. CONCLUSIONS: This multimethod study demonstrates that online feedback found on NHS Choices is significantly correlated with established measures of quality in primary care. This suggests it has a potential use in understanding patient experience and satisfaction, and a potential use in quality improvement and patient safety. The qualitative analysis shows that this form of feedback contains helpful information about patients' experiences of general practice that provide insight into issues of quality and patient safety relevant to primary care. Health providers should offer patients multiple ways of offering feedback, including online, and should have systems in place to respond to and act on this feedback.

Long-Term Weight Management Using Wearable Technology in Overweight and Obese Adults: Systematic Review.

BACKGROUND: Although there are many wearable devices available to help people lose weight and decrease the rising prevalence of obesity, the effectiveness of these devices in long-term weight management has not been established. OBJECTIVE: This study aimed to systematically review the literature on using wearable technology for long-term weight loss in overweight and obese adults. METHODS: We searched the following databases: Medical Literature Analysis and Retrieval System Online, EMBASE, Compendex, ScienceDirect, Cochrane Central, and Scopus. The inclusion criteria were studies that took measurements for a period of ≥1 year (long-term) and had adult participants with a BMI >24. A total of 2 reviewers screened titles and abstracts and assessed the selected full-text papers for eligibility. The risk of bias assessment was performed using the following tools appropriate for different study types: the Cochrane risk of bias tool, Risk Of Bias In Nonrandomized Studies-of Interventions, A MeaSurement Tool to Assess systematic Reviews, and 6 questions to trigger critical thinking. The results of the studies have been provided in a narrative summary. RESULTS: We included five intervention studies: four randomized controlled trials and one nonrandomized study. In addition, we used insights from six systematic reviews, four commentary papers, and a dissertation. The interventions delivered by wearable devices did not show a benefit over comparator interventions, but overweight and obese participants still lost weight over time. The included intervention studies were likely to suffer from bias. Significant variances in objectives, methods, and results of included studies prevented meta-analysis. CONCLUSIONS: This review showed some evidence that wearable devices can improve long-term physical activity and weight loss outcomes, but there was not enough evidence to show a benefit over the comparator methods. A major issue is the challenge of separating the effect of decreasing use of wearable devices over time from the effect of the wearable devices on the outcomes. Consistency in study methods is needed in future long-term studies on the use of wearable devices for weight loss. TRIAL REGISTRATION: PROSPERO CRD42018096932; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=96932.

Effectiveness of Conversational Agents (Virtual Assistants) in Health Care: Protocol for a Systematic Review.

BACKGROUND: Conversational agents (also known as chatbots) have evolved in recent decades to become multimodal, multifunctional platforms with potential to automate a diverse range of health-related activities supporting the general public, patients, and physicians. Multiple studies have reported the development of these agents, and recent systematic reviews have described the scope of use of conversational agents in health care. However, there is scarce research on the effectiveness of these systems; thus, their viability and applicability are unclear. OBJECTIVE: The objective of this systematic review is to assess the effectiveness of conversational agents in health care and to identify limitations, adverse events, and areas for future investigation of these agents. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols will be used to structure this protocol. The focus of the systematic review is guided by a population, intervention, comparator, and outcome framework. A systematic search of the PubMed (Medline), EMBASE, CINAHL, and Web of Science databases will be conducted. Two authors will independently screen the titles and abstracts of the identified references and select studies according to the eligibility criteria. Any discrepancies will then be discussed and resolved. Two reviewers will independently extract and validate data from the included studies into a standardized form and conduct quality appraisal. RESULTS: As of January 2020, we have begun a preliminary literature search and piloting of the study selection process. CONCLUSIONS: This systematic review aims to clarify the effectiveness, limitations, and future applications of conversational agents in health care. Our findings may be useful to inform the future development of conversational agents and promote the personalization of patient care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/16934.

Mobile Apps for Health Behavior Change in Physical Activity, Diet, Drug and Alcohol Use, and Mental Health: Systematic Review.

BACKGROUND: With a growing focus on patient interaction with health management, mobile apps are increasingly used to deliver behavioral health interventions. The large variation in these mobile health apps-their target patient group, health behavior, and behavioral change strategies-has resulted in a large but incohesive body of literature. OBJECTIVE: This systematic review aimed to assess the effectiveness of mobile apps in improving health behaviors and outcomes and to examine the inclusion and effectiveness of behavior change techniques (BCTs) in mobile health apps. METHODS: PubMed, EMBASE, CINAHL, and Web of Science were systematically searched for articles published between 2014 and 2019 that evaluated mobile apps for health behavior change. Two authors independently screened and selected studies according to the eligibility criteria. Data were extracted and the risk of bias was assessed by one reviewer and validated by a second reviewer. RESULTS: A total of 52 randomized controlled trials met the inclusion criteria and were included in the analysis-37 studies focused on physical activity, diet, or a combination of both, 11 on drug and alcohol use, and 4 on mental health. Participant perceptions were generally positive-only one app was rated as less helpful and satisfactory than the control-and the studies that measured engagement and usability found relatively high study completion rates (mean 83%; n=18, N=39) and ease-of-use ratings (3 significantly better than control, 9/15 rated >70%). However, there was little evidence of changed behavior or health outcomes. CONCLUSIONS: There was no strong evidence in support of the effectiveness of mobile apps in improving health behaviors or outcomes because few studies found significant differences between the app and control groups. Further research is needed to identify the BCTs that are most effective at promoting behavior change. Improved reporting is necessary to accurately evaluate the mobile health app effectiveness and risk of bias.

Mobile Apps for Health Behavior Change: Protocol for a Systematic Review.

BACKGROUND: The popularity and ubiquity of mobile apps have rapidly expanded in the past decade. With a growing focus on patient interaction with health management, mobile apps are increasingly used to monitor health and deliver behavioral interventions. The considerable variation in these mobile health apps, from their target patient group to their health behavior, and their behavioral change strategy, has resulted in a large but incohesive body of literature. OBJECTIVE: The purpose of this protocol is to provide an overview of the current landscape, theories behind, and effectiveness of mobile apps for health behavior change. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols will be used to structure this protocol. The focus of the systematic review is guided by a population, intervention, comparator, and outcome framework. A systematic search of Medline, EMBASE, CINAHL, and Web of Science will be conducted. Two authors will independently screen the titles and abstracts of identified references and select studies according to the eligibility criteria. Any discrepancies will then be discussed and resolved. One reviewer will extract data into a standardized form, which will be validated by a second reviewer. Risk of bias was assessed using the Cochrane Collaboration Risk of Bias tool, and a descriptive analysis will summarize the effectiveness of all the apps. RESULTS: As of November 2019, the systematic review has been completed and is in peer review for publication. CONCLUSIONS: This systematic review will summarize the current mobile app technologies and their effectiveness, usability, and coherence with behavior change theory. It will identify areas of improvement (where there is no evidence of efficacy) and help inform the development of more useful and engaging mobile health apps. TRIAL REGISTRATION: PROSPERO CRD42019155604; https://tinyurl.com/sno4lcu. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/16931.